The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to assemblies and methods for facilitating change in diameter of such prosthetic 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. Surgeries are prone to an abundance of clinical complications, hence 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.
Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The actuation mechanism usually includes a plurality of actuation/locking assemblies, releasably connected to respective actuation members of the valve delivery system, controlled via the handle for actuating the assemblies to expand the valve to a desired diameter. The assemblies may optionally lock the valve's position to prevent undesired recompression thereof, and disconnection of the delivery system's actuation member from the valve actuation/locking assemblies, to enable retrieval thereof once the valve is properly positioned at the desired site of implantation.
Despite the recent advancements in prosthetic valve technology, there remains a need for improved transcatheter heart valves and delivery systems for such valves.
The present disclosure is directed toward devices and assemblies for expanding and locking prosthetic valves, as well as related methods and devices for such assemblies. In several embodiments, the disclosed assemblies are configured for delivering replacement heart valves into a heart of a patient, wherein the replacement heart valves may be expanded and locked in a desired diameter at the implantation site.
According to one aspect of the invention, there is provided a prosthetic valve comprising a frame movable between a radially compressed and a radially expanded configuration, and at least one expansion and locking mechanism. The at least one expansion and locking mechanism comprises an outer member, an inner member, and at least one plate comprising a primary aperture, disposed around the inner member. The outer member is coupled to the frame at a first location. The inner member is coupled to the frame at a second location spaced apart from the first location, the inner member extending at least partially into the outer member. The at least one plate is configured to transition between an angled locking orientation and a non-locking orientation.
The movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate. In the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume the angled locking orientation.
The at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
According to some embodiments, the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, wherein the at least one plate is disposed within the chamber.
According to some embodiments, the outer member further comprises a lateral opening exposing at least a portion of the chamber.
According to some embodiments, the at least one plate has a disc-like circular or elliptic shape.
According to some embodiments, the at least one plate has a rectangular shape.
According to some embodiments, the at least one plate comprises a rigid material.
According to some embodiments, the at least one plate comprises a plurality of plates.
According to some embodiments, the distal chamber wall comprises at least one angled portion.
According to some embodiments, the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
According to some embodiments, the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
According to some embodiments, the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
According to some embodiments, at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
According to some embodiments, the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member therein.
According to some embodiments, the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
According to some embodiments, the spring is a helical spring coiled around the inner member.
According to some embodiments, the spring is a helical spring disposed adjacent the inner member.
According to some embodiments, the spring is a leaf spring.
According to some embodiments, the plate is coupled to the proximal chamber wall via a plate hinge, and wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
According to some embodiments, the distal chamber wall comprises a proximally oriented protrusion.
According to some embodiments, the at least one expansion and locking mechanism further comprises a release member, extending at least partially into the outer member. The release member is coupled to the at least one plate, and configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled in the second direction relative to the outer member.
According to some embodiments, the outer member further comprises a release channel, configured to accommodate the release member therein.
According to some embodiments, the plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture
According to some embodiments, the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
According to some embodiments, a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
According to some embodiments, the outer member further comprises a first spring and a second spring, disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
According to some embodiments, the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
According to some embodiments, the outer member further comprises an outer member fastener extending radially outward, wherein the outer member is coupled to the frame at the first location via the outer member fastener.
According to some embodiments, the inner member further comprises an inner member fastener extending radially outward, wherein the inner member is coupled to the frame at the second location via the inner member fastener.
According to some embodiments, the frame comprises intersecting struts.
According to another aspect of the invention, there is provided a prosthetic valve comprising a frame movable between a radially compressed and a radially expanded configuration, and at least one expansion and locking mechanism. The at least one expansion and locking mechanism comprises an outer member, an inner member, at least one plate comprising a primary aperture disposed around the inner member, and at least one spring disposed between the outer member and the at least one plate. The outer member is coupled to the frame at a first location. The inner member is coupled to the frame at a second location spaced apart from the first location, the inner member extending at least partially into the outer member. The at least one plate is configured to transition between an angled locking orientation and a non-locking orientation.
The movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate. In the absence of a force applied to the plate in the first direction, the at least one spring is configured to bias the at least one plate to the angled locking orientation.
The at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
According to some embodiments, the at least one plate has a disc-like circular or elliptic shape.
According to some embodiments, the at least one plate has a rectangular shape.
According to some embodiments, the at least one plate comprises a rigid material.
According to some embodiments, the at least one plate comprises a plurality of plates.
According to some embodiments, the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
According to some embodiments, the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member therein.
According to some embodiments, the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, wherein the at least one plate and the at least one spring are disposed within the chamber.
According to some embodiments, the distal chamber wall comprises a proximally oriented protrusion.
According to some embodiments, the distal chamber wall comprises at least one angled portion.
According to some embodiments, the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
According to some embodiments, at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
According to some embodiments, the at least one spring comprises a helical spring coiled around the inner member.
According to some embodiments, the coiled spring is a compression spring disposed between the proximal chamber wall and the at least one plate.
According to some embodiments, the at least one spring comprises at least one helical spring disposed adjacent the inner member.
According to some embodiments, the at least one helical spring is a compression spring disposed between the proximal chamber wall and the at least one plate.
According to some embodiments, the at least one helical spring is an extension spring disposed between the distal chamber wall and the at least one plate.
According to some embodiments, the at least one spring is a leaf spring.
According to some embodiments, the at least one expansion and locking mechanism further comprises a release member, extending at least partially into the outer member, the release member coupled to the at least one plate, and configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled in the second direction relative to the outer member.
According to some embodiments, the outer member further comprises a release channel, configured to accommodate the release member therein.
According to some embodiments, the at least one plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture.
According to some embodiments, the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
According to some embodiments, a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
According to some embodiments, the at least one spring comprises a first spring and a second spring, both of which are disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
According to some embodiments, the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
According to yet 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 and a radially expanded configuration, and at least one expansion and locking mechanism. The at least one expansion and locking mechanism comprises an outer member, an inner member, and at least one plate comprising a primary aperture, disposed around the inner member. The outer member is coupled to the frame at a first location. The inner member is coupled to the frame at a second location spaced apart from the first location, the inner member extending at least partially into the outer member. The at least one plate is configured to transition between an angled locking orientation and a non-locking orientation.
The delivery apparatus comprises a handle, a delivery shaft extending distally from the handle, and at least one actuation assembly extending from the handle through the delivery shaft, and detachably coupled to the at least one expansion and locking assembly.
The frame is movable from the radially compressed configuration to the radially expanded configuration upon actuating the at least one expansion and locking assembly by the at least one actuation assembly. The movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate.
In the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume the angled locking orientation. The at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
According to some embodiments, the at least one actuation assembly comprises an actuation member and an actuation support sleeve disposed around the actuation member, wherein the actuation member and the actuation support sleeve are movable longitudinally relative to each other in a telescoping manner.
According to some embodiments, the at least one actuation member is chosen from: a wire, a cable, a rod, or a tube.
According to some embodiments, the actuation support sleeve is a tube or a sheath having sufficient rigidity, such that the actuation support sleeve can apply an axial force against the outer member without bending or buckling.
According to some embodiments, the at least one actuation member is threadedly engaged with the corresponding inner member.
According to some embodiments, the handle comprises a plurality of knobs.
According to some embodiments, at least one of the plurality of knobs is configured to axially move each actuation member relative to the respective actuation support sleeve.
According to some embodiments, at least one of the plurality of knobs is configured to disengage each actuation assembly from the respective expansion and locking assembly.
According to some embodiments, the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate is disposed within the chamber.
According to some embodiments, the at least one plate has a disc-like circular or elliptic shape.
According to some embodiments, the at least one plate has a rectangular shape.
According to some embodiments, the at least one plate comprises a rigid material.
According to some embodiments, the at least one plate comprises a plurality of plates.
According to some embodiments, the distal chamber wall comprises at least one angled portion.
According to some embodiments, the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
According to some embodiments, the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
According to some embodiments, the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
According to some embodiments, at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
According to some embodiments, the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member and at least a portion of the actuation member therein.
According to some embodiments, the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
According to some embodiments, the spring is a helical spring coiled around the inner member.
According to some embodiments, the spring is a helical spring disposed adjacent the inner member.
According to some embodiments, the spring is a leaf spring.
According to some embodiments, the plate is coupled to the proximal chamber wall via a plate hinge, wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
According to some embodiments, the distal chamber wall comprises a proximally oriented protrusion.
According to yet 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 and a radially expanded configuration, and at least one expansion and locking mechanism. The at least one expansion and locking mechanism comprises an outer member, an inner member, a release member, and at least one plate comprising a primary aperture, disposed around the inner member.
The outer member is coupled to the frame at a first location. The inner member is coupled to the frame at a second location spaced apart from the first location, the inner member extending at least partially into the outer member. The release member extends at least partially into the outer member, and is coupled to the at least one plate. The at least one plate is configured to transition between an angled locking orientation and a non-locking orientation.
The delivery apparatus comprises a handle, a delivery shaft extending distally from the handle, at least one actuation assembly extending from the handle through the delivery shaft, and detachably coupled to the at least one expansion and locking assembly, and at least one release assembly extending from the handle through the delivery shaft, and detachably coupled to the at least one release member.
The frame is movable from the radially compressed configuration to the radially expanded configuration upon actuating the at least one expansion and locking assembly by the at least one actuation assembly. The movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate.
In the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume the angled locking orientation. The at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
The release member is configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled by the release assembly in the first direction relative to the outer member.
According to some embodiments, the at least one actuation assembly comprises an actuation member and an actuation support sleeve disposed around the actuation member, wherein the actuation member and the support sleeve are movable longitudinally relative to each other in a telescoping manner.
According to some embodiments, the at least one actuation member is chosen from: a wire, a cable, a rod, or a tube.
According to some embodiments, the support sleeve is a tube or a sheath having sufficient rigidity, such that the support sleeve can apply an axial force against the frame without bending or buckling.
According to some embodiments, the at least one actuation member is threadedly engaged with the corresponding inner member.
According to some embodiments, the at least one release assembly comprises a release arm and a release support sleeve disposed around the release arm, and wherein the release arm and the release support sleeve are movable longitudinally relative to each other in a telescoping manner.
According to some embodiments, the at least one release arm is chosen from: a wire, a cable, a rod, or a tube.
According to some embodiments, the release support sleeve is a tube or a sheath having sufficient rigidity, such that the release support sleeve can apply an axial force against the outer member without bending or buckling.
According to some embodiments, the at least one release arm is threadedly engaged with the corresponding release member.
According to some embodiments, the handle comprises a plurality of knobs.
According to some embodiments, at least one of the plurality of knobs is configured to axially move each actuation member relative to the respective actuation support sleeve.
According to some embodiments, at least one of the plurality of knobs is configured to axially move each release arm relative to the respective release support sleeve.
According to some embodiments, at least one of the plurality of knobs is configured to disengage each actuation assembly from the respective expansion and locking assembly.
According to some embodiments, at least one of the plurality of knobs is configured to disengage each release assembly from the respective expansion and locking assembly.
According to some embodiments, the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate is disposed within the chamber.
According to some embodiments, the at least one plate has a disc-like circular or elliptic shape.
According to some embodiments, the at least one plate has a rectangular shape.
According to some embodiments, the at least one plate comprises a rigid material.
According to some embodiments, the at least one plate comprises a plurality of plates.
According to some embodiments, the distal chamber wall comprises at least one angled portion.
According to some embodiments, the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
According to some embodiments, the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
According to some embodiments, the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
According to some embodiments, at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
According to some embodiments, the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member and at least a portion of the actuation member therein.
According to some embodiments, the outer member comprises a release channel, configured to accommodate at least a portion of the release member and at least a portion of the release arm therein.
According to some embodiments, the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
According to some embodiments, the spring is a helical spring coiled around the inner member.
According to some embodiments, the spring is a helical spring disposed adjacent the inner member.
According to some embodiments, the spring is a leaf spring.
According to some embodiments, the plate is coupled to the proximal chamber wall via a plate hinge, wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
According to some embodiments, the distal chamber wall comprises a proximally oriented protrusion.
According to some embodiments, the at least one plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture.
According to some embodiments, the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
According to some embodiments, a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
According to some embodiments, the outer member comprises a first spring and a second spring, disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
According to some embodiments, the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
According to yet another aspect of the invention, there is provided a method of implanting a prosthetic valve, the method comprises positioning a prosthetic valve at a target site in a patient's body using a delivery apparatus. The method further comprises radially expanding the prosthetic valve from a radially compressed configuration to a radially expanded configuration; The method further comprises locking the expansion and locking assembly.
The prosthetic valve comprises at least one expansion and locking assembly, wherein the expansion and locking assembly comprising an outer member, an inner member partially disposed within, and movable axially relative to, the outer member, and at least one plate dispose within the outer member and around the inner member. The delivery apparatus comprises at least one actuation assembly, detachably coupled to the at least one expansion and locking assembly.
Radially expanding the prosthetic valve includes applying, via the at least one actuation assembly, a pull force on the inner member, configured to axially move the inner member in a first direction relative to the outer member.
Locking the expansion and locking assembly includes releasing the pull force exerted on the inner member by the actuation assembly, thereby allowing the at least one plate to assume an angled locking orientation.
According to some embodiments, the radially expanded configuration comprises partially expanded configurations and/or a fully expanded configuration, wherein the step of radially expanding the prosthetic valve is executed again after the locking step, so as to reorient the at least one plate from the angled locking orientation to a non-locking orientation, allowing further expansion of the prosthetic valve from a partially expanded configuration to another partially expanded configuration or to a fully expanded configuration.
According to some embodiments, the at least one actuation assembly comprises an actuation member detachably coupled to the inner member, and an actuation support sleeve disposed around the actuation member, wherein the step of radially expanding the prosthetic valve comprises exerting a pull force to move the actuation member in a first direction relative to the actuation support sleeve, while keeping the actuation support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member.
According to some embodiments, the method further comprising a step of detaching the at least one actuation member from the at least one inner member, and retrieving the delivery apparatus from the patient's body.
According to some embodiments, the at least one actuation member is threadedly engaged with the at least one inner member, wherein detaching the at least one actuation member comprises rotating the at least one actuation member around a longitudinal axis thereof.
According to yet another aspect of the invention, there is provided a method of implanting a prosthetic valve, the method comprises positioning a prosthetic valve at a target site in a patient's body using a delivery apparatus. The method further comprises radially expanding the prosthetic valve from a radially compressed configuration to a radially expanded configuration. The method further comprises locking the expansion and locking assembly. The method further comprises unlocking the expansion and locking assembly. The method further comprises re-compressing the prosthetic valve.
The prosthetic valve comprises at least one expansion and locking assembly, wherein the expansion and locking assembly comprising an outer member, an inner member partially disposed within, and movable axially relative to, the outer member, at least one plate dispose within the outer member and around the inner member, and a release member disposed within the outer member and axially movable relative thereto. The release member is coupled to the at least one plate
The delivery apparatus comprises at least one actuation assembly detachably coupled to the at least one expansion and locking assembly, and at least one release assembly detachably coupled to the release member.
Radially expanding the prosthetic valve includes applying, via the at least one actuation assembly, a pull force on the inner member, configured to axially move the inner member in a first direction relative to the outer member.
Locking the expansion and locking assembly includes releasing the pull force exerted on the inner member by the actuation assembly, thereby allowing the at least one plate to assume an angled locking orientation.
Unlocking the expansion and locking assembly includes applying, via the at least one release assembly, a pull force on the release member, configured to transition the at least one plate from the angled locking orientation to a non-locking orientation. Re-compressing the prosthetic valve is executed such that the at least one inner member is moved in a second direction relative to the at least one outer member.
According to some embodiments, any of the steps of radially expanding the prosthetic valve, locking, unlocking, and re-compressing the prosthetic valve, are repeated for any desired number of times and in any order, so as to reach a final desired expansion diameter of the prosthetic valve.
According to some embodiments, the method further comprises a step of re-positioning the prosthetic valve using the delivery apparatus, after the step of re-compressing the prosthetic valve.
According to some embodiments, the at least one actuation assembly comprises an actuation member detachably coupled to the inner member, and an actuation support sleeve disposed around the actuation member. The at least one release assembly comprises a release arm detachably coupled to the release member, and a release support sleeve disposed around the release arm.
The step of radially expanding the prosthetic valve comprises exerting a pull force to move the actuation member in a first direction relative to the actuation support sleeve, while keeping the actuation support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member
The step of unlocking the prosthetic valve comprises exerting a pull force to move the release arm in a first direction relative to the release support sleeve, while keeping the release support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member.
According to some embodiments, the method further comprises steps of detaching the at least one actuation member from the at least one inner member, detaching the at least one release arm from the release member, and retrieving the delivery apparatus from the patient's body.
According to some embodiments, the at least one actuation member is threadedly engaged with the at least one inner member, and the at least one release arm is threadedly engaged with the at least one release member. Detaching the at least one actuation member comprises rotating the at least one actuation member around a longitudinal axis thereof, and detaching the at least one release arm comprises rotating the at least one release arm around a longitudinal axis thereof.
According to another aspect of the invention, there is provided a method for assembling an expansion and locking mechanism, comprising the steps of: (i) providing an outer member comprising a chamber and a lateral opening exposing at least a portion of the chamber; (ii) inserting at least one plate, comprising a primary aperture, into the chamber through the lateral opening; (iii) orienting the at least one plate in a substantially orthogonal orientation, relative to a longitudinal axis of the outer member; and (iv) inserting the inner member into the outer member, through the primary aperture of the at least one plate.
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, configuration, and a radially expanded configuration. Thus, a prosthetic valve 100 can be crimped or retained by a delivery apparatus 12 in a compressed configuration during delivery, and then expanded to the expanded configuration once the prosthetic valve 100 reaches the implantation site. The expanded configuration may include a range of diameters to which the valve may expand, between the compressed configuration and a maximal diameter reached at a fully expanded configuration. Thus, a plurality of partially expanded configurations may relate to any expansion diameter between radially compressed or crimped configuration, and maximally expanded configuration.
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.
According to some embodiments, the prosthetic valve 100 is a mechanically expandable valve, and the delivery apparatus 12, such as the delivery apparatus 12a of a delivery assembly 10a shown in
Each actuation assembly 40 can generally include an actuation member 42 (hidden from view in
The prosthetic valve 100 can be delivered to the site of implantation via a delivery assembly 10 carrying the valve 100 in a radially compressed or crimped configuration, toward the target site, to be mounted against the native anatomy, by expanding the valve 100 via a mechanical expansion mechanism, as will be elaborated below.
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 nosecone 26 can be connected to the distal end of the nosecone shaft 24. A guidewire (not shown) can extend through a central lumen of the nosecone shaft 24 and an inner lumen of the nosecone 26, so that the delivery apparatus 12 can be advanced over the guidewire through the patient's vasculature.
A distal end portion of the outer shaft 20 can extend over the prosthetic valve 100 and contact the nosecone 26 in a delivery configuration of the delivery apparatus 12. Thus, the distal end portion of the outer shaft 20 can serve as a delivery capsule that contains, or houses, the prosthetic valve 100 in a radially compressed or crimped configuration for delivery through the patient's vasculature.
The outer shaft 20 and the delivery shaft 22 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 delivery shaft 22, or a distally oriented movement of the delivery shaft 22 relative to the outer shaft 20, can expose the prosthetic valve 100 from the outer shaft 20. In some configurations, the prosthetic valve 100 is not housed within the outer shaft 20 during delivery. Thus, according to some optional configurations, the delivery apparatus 12 does not necessarily include an outer shaft 20.
As mentioned above, the proximal ends of the nosecone shaft 24, the delivery shaft 22, components of the actuation assemblies 40, and when present—the outer shaft 20, can be coupled to the handle 30. During delivery of the prosthetic valve 100, the handle 30 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 12, such as the nosecone shaft 24, the delivery shaft 22, and/or the outer shaft 20, through the patient's vasculature, as well as to expand or contract the prosthetic valve 100, for example by maneuvering the actuation assemblies 40, and to disconnect the prosthetic valve 100 from the delivery apparatus 12, for example—by decoupling the actuation members 42 from the expansion and locking assemblies 140 of the valve 100, in order to retract it once the prosthetic valve 100 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 the delivery apparatus 12 in the proximal and distal directions, as well as to expand or contract the prosthetic valve 100 via various adjustment and activation mechanisms as will be further described below.
The handle 30 may further comprises one or more visual or auditory informative elements (not shown) configured to provide visual or auditory information and/or feedback to a user or operator of the delivery apparatus 12, such as a display, LED lights, speakers and the like.
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 longitudinal axis 6 and the outflow end 103.
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 105 and the valve longitudinal axis 6.
The valve 100 comprises a frame 106 composed of interconnected struts 110, and may be made of various suitable materials, such as stainless steel, cobalt-chrome alloy (e.g. MP35N alloy), or nickel titanium alloy such as Nitinol. According to some embodiments, the struts 110 are arranged in a lattice-type pattern. In the embodiment illustrated in
According to some embodiments, the struts 110 are pivotably coupled to each other. In the exemplary embodiment shown in
In alternative embodiments, the struts are not coupled to each other via respective hinges, but are otherwise pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.
The frame 106 further comprises a plurality of cells 108, defined between intersecting portions of struts 110. The shape of each cell 108, and the angle between intersecting portions of struts 110 defining the cell borders, vary during expansion or compression of the prosthetic valve 100. Further details regarding the construction of the frame and the prosthetic valve are described in U.S. Publication Nos. 2018/0153689; 2018/0344456; 2019/0060057, all of which are incorporated herein by reference.
A prosthetic valve 100 further comprises one or more leaflets 136, e.g., three leaflets, configured to regulate blood flow through the prosthetic valve 100 from the inflow end 105 to the outflow end 103. While three leaflets 136 arranged to collapse in a tricuspid arrangement, are shown in the exemplary embodiment illustrated in
According to some embodiments, the prosthetic valve 100 may further comprise at least one skirt or sealing member, such as the inner skirt 138 shown in the exemplary embodiment illustrated in
According to some embodiments, a prosthetic valve 100, which can be a mechanical prosthetic valve, comprises at least one expansion and locking assembly 140, and preferably a plurality of expansion and locking assemblies 140. The expansion and locking assemblies 140 are configured to facilitate expansion of the valve 100, and in some instances, to lock the valve 100 at an expanded configuration, preventing unintentional recompression thereof, as will elaborated in greater detail hereinbelow. Although
The inner member has an inner member first end, which can be an inner member proximal end portion, and an inner member second end, which can be an inner member distal end portion. The outer member has an outer member first end, which can be an outer member proximal end portion, and an outer member second end, which can be an outer member distal end portion.
It will be understood that while the inner member first end and the inner member second end are exemplified throughout the figures as the inner member proximal end portion 170 and the inner member distal end portion 172, respectively, and while the outer member first end and the outer member second end are exemplified throughout the figures as the outer member proximal end portion 146 and the outer member distal end portion 147, respectively, in alternative configurations, the inner member first end and the inner member second end may be the inner member distal end portion 172 and the inner member proximal end portion 170, respectively, and the outer member first end and the outer member second end may be the outer member distal end portion 147 and the outer member proximal end portion 146, respectively.
The outer member 142 may further comprise a chamber 152 continuous with the primary channel 144, such that one portion of the primary channel 144 extends between the outer member proximal end 146 and the chamber 152, and another portion of the primary channel 144 extends between the chamber 152 and the outer member distal end portion 147.
The chamber 152 comprises a proximal chamber wall 158 and a distal chamber wall 160, and in some implementations, may be exposed to the external environment via a lateral opening 153 formed at a sidewall of the outer member 142 at the region of the chamber 158.
According to some embodiments, the inner member proximal end portion 170 further comprises a threaded bore, configured to receive and threadedly engage with a threaded portion of a distal end portion 44 (shown for example in
The expansion and locking assembly 140 can include, in some embodiments, one or more engagement surfaces configured to prevent over-expansion of the prosthetic valve 100. For example, in the embodiment illustrated in
As shown in
Optionally, and in some embodiments preferably, the expansion and locking assembly 140 further comprises at least one plate 176 having a primary aperture 178, wherein the at least one plate 176 is disposed around the inner member 168, which extends through the primary aperture 178, and is disposed within the chamber 152 of the outer member 142.
According to some embodiments, the at least one plate 176 comprises a plurality of plates, such as plates 176aa, 176ab and 176ac shown in
The lateral opening 153 can extend through a thickness of a side wall of the outer member 142, exposing at least a portion of the chamber 152. In the illustrated embodiment, the lateral opening 153 is disposed on a side wall of the outer member 142. However, in other embodiments, the lateral opening 153 can be disposed in any other wall of the outer member 142. In some implementations, the opening 153 can have an elongated rectangular shape as shown in the illustrated embodiment. In other implementations, the lateral opening 153 can have any other shape, such as a circular, ovular, trapezoid and the like. Advantageously, the lateral opening 153 may assist in the process of assembling the expansion and locking assembly 140, by providing access for insertion of the at least one plate 176 there-through into the chamber 152.
According to some embodiments, a method of assembling an expansion and locking assembly 140 includes insertion of at least one plate 176 into the chamber 152 through the opening 153. The plate 176 may be inserted in an inclined orientation, or in a substantially parallel orientation to the longitudinal axis of the outer member 142. Once inside the chamber, the plate can be re-oriented to being substantially orthogonal to the longitudinal axis of the outer member, followed by insertion of the inner member 168 into the outer member 142, through the primary channel 144 of the outer member 142 and through the primary aperture 178 of the at least one plate 176.
The term “longitudinal axis of the outer member”, as used herein, refers to an axis which is substantially parallel to the valve longitudinal axis 6 shown in
While the outer member fastener 150 and the inner member fastener 174 are not visible in
According to some embodiments, the first location can be positioned at an outflow end portion 102, and the second location can be positioned at the inflow end portion 104. In the embodiment illustrated in
The chamber 152 may be generally divided into a first zone 154 and a second zone 156, defined as two opposite zones or volumes from both sides of the inner member 168, such that each of the first and second zones 154 and 156, respectively, is defined between the inner member 168 and an opposite inner sidewall of the chamber 152. For example, the second zone 156 may be defined as the space volume between the inner member 168 and the lateral opening 153 (if present), while the first zone 154 may be defined as the space volume between the inner member 168 and the chamber wall opposite to the lateral opening (153). In some implementations, the distal chamber wall 160 may comprise a distal wall first side 162, defined as the portion of the distal chamber wall 164 disposed within the first zone (154), and a distal wall second side 164, defined as the portion of the distal chamber wall 164 disposed within the second zone (156).
According to some embodiments, the distal chamber wall 160 comprises at least one angled portion, defined as a portion which is angled relative to a longitudinal axis of the inner member 168.
While the distal chamber wall 160a is illustrated as having a step-like configuration, wherein the distal wall first side 162a is angled and the distal wall second side 164a is substantially orthogonal relative to the longitudinal axis of the inner member 168, it will be clear that in other configurations, the distal wall second side may be continuous with the distal wall first side, such that the entire distal chamber wall may be angled relative to the longitudinal axis of the inner member 168.
The term “longitudinal axis of the inner member”, as used herein, refers to an axis which is substantially parallel to the valve longitudinal axis 6 shown in
The plate 176 may also include a plate first side 180 and an opposite plate second side 183, wherein the plate first side 180 is defined as the portion of the plate 176 residing within the first zone 154 of the chamber 152, between the primary aperture 178 and a plate first end 181, and the plate second side 182 is defined as the portion of the plate 176 residing within the second zone 156 of the chamber 152, between the primary aperture 178 and a plate second end 183.
As mentioned with respect to the configuration shown in
The actuation support sleeve 46 surrounds the actuation member 42 and may be connected to the handle 30. The actuation support sleeve 46 and the outer member 142 are sized such that the distal lip of the actuation support sleeve 46 can abut or engage the outer member proximal end 146, such that the outer member 142 is prevented from moving proximally beyond the actuation support sleeve 46.
In order to radially expand the frame 106, and therefore the valve 100, the actuation support sleeve 46 can be held firmly against the outer member 142. The actuation member 42 can then be pulled in a first direction, such as a proximally oriented direction 2, as shown in
More specifically, as shown for example in
The struts 110 to which the inner member fastener 174 is connected, are free to pivot relative to the inner member fastener 174 and to one another as the frame 106 is expanded or compressed. In this manner, the inner member fastener 174 serves as a coupling means that forms a pivotable connection between those struts 110. Similarly, struts 110 to which the outer member fastener 150 is connected, are also free to pivot relative to the outer member fastener 150 and to one another as the frame 106 is expanded or compressed. In this manner, the outer member fastener 150 also serves as a coupling means that forms a pivotable connection between those struts 110.
According to some embodiments, the diameter of the primary aperture 178 of the plate 176 is closely matched with the outer diameter of the inner member 168 extending therethrough, such that axial movement of the inner member 168 may frictionally engage with the boundaries of the primary aperture 178 and facilitate axial translation of the plate 176 there-along. In some embodiments, the diameter of the primary aperture is no more than 10 percent larger than the diameter of the inner member 168 at the portion extending therethrough. In some embodiments, the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member 168 at the portion extending therethrough.
Pulling the inner member 168 in a proximally oriented direction 2 (which may serve as the first directions, as shown in
The at least one plate 176 is configured to transition between an angled locking orientation, and a non-locking orientation. Specifically, since the distal wall first side 162 is angled, when the plate first side 180 is pressed there-against—the entire plate 176 assumes an angled locking orientation relative to the longitudinal axis of the inner member 168. Generally, in some implementation, the distal wall first side 162 includes at least one point of contact configured to contact the plate 176, which is proximal relative to any region of the distal wall second side 164 between the primary aperture 178 and the plate second end 183. In this manner, when the plate 176 is pushed in the distal direction to contact the distal chamber wall 160, it assumes an angled locking orientation such that the plate first end 181 is more proximal than the plate second end 183.
Once the plate contacts the distal chamber wall 160, it is tilted to an angled orientation over the inner member 168 until it reaches a self-friction lock angle, inhibiting further advancement of the inner member 168 in the second direction (e.g., the distal direction), which is defined as the angled locking orientation. Thus, the proposed mechanism enables a one-directional axial movement of the inner member 168 in the first direction (e.g., the proximal direction) for valve expansion, while the self-friction lock angle of the at least one plate 176 is configured to lock the valve in the expanded or partially expanded diameter, and prevent unintentional re-compression.
For the sake of simplicity, the first direction will be described in the following exemplary embodiments as the proximally oriented directions 2, and the second direction will be described as the distally oriented direction 4, though in alternative implementations, the expansion and locking assemblies may be designed to operate in reverse, such that the first direction will be the distally oriented direction 4, and the second direction will be the proximally oriented direction 2, mutatis mutandis.
As shown in
While the plate 176 is shown in
Once the desired diameter of the prosthetic valve 100 is reached, the actuation member 42 may be rotated about its axis to unscrew the actuation member 42 from the inner member 168, as shown in
The patient's native anatomy, such as the native aortic annulus in the case of transcatheter aortic valve implantation, may exert radial forces against the prosthetic valve 100 that would strive to compress it. However, the self-friction lock angle assumed by the plate 176 in the angled locking orientation, causes the inner borders of the primary aperture to press against and/or frictionally engage with the outer surface of the inner member 168, so as to prevent such forces from compressing the frame 106, thereby ensuring that the frame 106 remains locked in the desired radially expanded configuration.
Thus, the prosthetic valve 100 is radially expandable from the radially compressed configuration shown in
The terms coupled, engaged, connected and attached, as used herein, are interchangeable. Similarly, the term decoupled, disengaged, disconnected and detached, as used herein, are interchangeable.
According to some embodiments, as illustrated, the angled portion of the distal chamber wall 160, e.g. the distal wall first side 162, is oriented at an angle which is more acute, with respect to the longitudinal axis of the inner member (168), relative to the self-friction lock angle, formed between the plate 176 and the longitudinal axis of the inner member (168) at the angled locking orientation. In such embodiments, the plate first end 181 may contact the distal wall first side 162 in the angled locking orientation, while the remainder of the plate 176 may remain offset from the distal chamber wall 160. In alternative implementations, the angled portion of the distal chamber wall 160 may be angled at an angle which is substantially equal to the self-friction lock angle, such that a larger portion of the plate 176, e.g. the complete distal surface of the plate first side 180, may contact the distal wall first side 162 in the angled locking orientation.
It is to be understood that any reference to angles throughout the current disclosure, refers to angles facing the first direction, i.e., angled facing the proximal direction 2 in the illustrated embodiments.
While the inner member 168 and the outer member 142 are shown in the illustrated embodiment of
While the frame is shown in the illustrated examples to expand radially outward by axially moving the inner member 168 in a proximally oriented direction 2, relative to the outer member 142, it will be understood that similar frame expansion may be achieved by axially pushing an outer member 142 in a distally oriented direction, relative to an inner member 168. Moreover, while the illustrated embodiments in
According to some embodiments, the inner surface of the primary aperture 178 of the plate 176, and/or the outer surface of the inner member 168 extending through the primary aperture 178, further comprises a texture and/or friction-enhancement features (not shown), configured to promote or enhance frictional engagement there-between.
The outer member 142 in the illustrated embodiments is shown to have a rectangular shape in cross-section, and the inner member 168 is shown to have a circular shape in cross-section corresponding to the shape of the primary channel 144. As shown in
According to some embodiments, the handle 30 can comprise control mechanisms which may include steerable or rotatable knobs 32, levers, buttons and such, which in some implementation may be manually controllable by an operator to produce axial and/or rotatable movement of different components of the delivery apparatus 12. For example, the embodiment of handle 30a illustrated in
Knob 32aa, shown in
Knob 32ab, shown in
Knob 32ad, shown in
Knob 32ac, shown in
The handle 30 may include more or less than the four knobs 32 described herein above, configured to fulfill only some of the functionalities described for knobs 32a, 32b, 32c and 32d, and/or additional functionalities. Any of the knobs 32a, 32b, 32c and 32d may be implemented, in alternative embodiments, as other types of buttons, levers, knobs and the like, such as push/pull knobs which may be actuated by sliding or moving the knobs axially.
According to other embodiments, control mechanisms in the handle 30 and/or other components of the delivery apparatus 12 can be electrically, pneumatically and/or hydraulically controlled. According to some embodiments, the handle 30 can house one or more electric motors which can be actuated by an operator, such as by pressing a button or a switch on the handle 30, to produce movement of components of the delivery apparatus 12. For example, the handle 30 may include one or more motors operable to produce linear movement of components of the actuation assemblies 40, and/or one or more motors operable to produce rotational movement of the actuation members 42 to disconnect the threaded actuation member distal end portion 44 from the inner member proximal end portion 170. According to some embodiments, one or more manual or electric control mechanism is configured to produce simultaneous linear and/or rotational movement of all of the actuation members 42.
Optionally, but in some embodiments preferably, the expansion and locking assembly 140 further comprises at least one spring 186 disposed within the chamber 152, configured to urge the at least one plate 176 in a second direction so as to assume an angled locking orientation, for example by urging it against the distal chamber wall 160. The spring constant may be chosen to exert a force sufficient to press the at least one plate 176 against the distal chamber wall 160 in the absence of an external proximally oriented force applied to the at least one plate 176, resulting in a transition of the at least one plate 176 to the angled locking orientation, and to allow transition of the at least one plate 176 to a non-locking orientation upon application of an external proximally oriented force either directly to the plate 176, or indirectly by pulling the inner member 168 in the proximal direction, for example via the actuation assembly 40.
For sake of simplicity, the term “plate”, as used throughout the current specification, may refer to either a single plate (as shown, for example, in
The spring 186 may be disposed between the plate 176 and either one of: the proximal chamber wall 158 or the distal chamber wall 160. According to some embodiments, the spring 186 is a helical spring.
It will be clear that the embodiments illustrated in
According to some embodiments, the spring 186 is a leaf spring.
While
According to some embodiments, the plate 176 is coupled to a wall of the chamber 158 via a plate hinge 184, configured to pivot about the hinge 184 between the non-locking orientation and the angled locking orientation.
As shown in
According to some embodiments, the distal chamber wall 160 may include features other than an inclined distal wall first side 162, configured to transition the plate 176 in the angled locking position when pressed there-against, such as a proximally oriented protrusion 166 extending proximally from the distal wall second side 164.
As shown in
Pulling the inner member 168 in a proximally oriented direction 2 (as shown in
Advantageously, a plurality of plates 176, comprised within a single chamber 152, may provide several points of contact between the inner boundaries of the corresponding primary aperture 178 and the inner member 168 in the angled locking state of the plates 176, thereby providing a higher friction-force there-between to improve reliability of the locked state of the expansion and locking assemblies. While three plates 176a, 176b and 176c are shown in
Prior to implantation, the prosthetic valve 100 can be crimped onto the delivery apparatus 12. This step can include placement of the radially compressed valve 100 within the outer shaft 20. Once delivered to the site of implantation, such as a native annulus, the valve 100 can be radially expanded within the annulus, for example, by the expansion and locking assemblies 140 in the manner described herein above. However, during such implantation procedures, it may become desirable to re-compress the prosthetic valve 100 in situ in order to reposition it. Valve re-compression may be achievable only if the inner members 168 are allowed to axially translate in a distally oriented direction 4 (i.e., in the second direction), relative to the outer members 142, which in turn can occur only if the plates 176 are released from the angled locking orientations to the non-locking orientations.
According to some embodiments, the delivery assembly comprises at least one release assembly 50, and preferably a plurality release assemblies 50, detachably attached to corresponding release members 188 extending through the outer members 142 of expansion and locking assemblies 140, and configured to transition the plates 176 from an angled locking orientation to a non-locking orientation, so as to allow re-compression of the prosthetic valve 100.
As further shown in
Each release assembly 50 can generally include a release arm 52 (hidden from view in
The proximal ends of the delivery shaft 22, components of the actuation assemblies 40, components of the release assemblies 50, and when present—the outer shaft 20, can be coupled to the handle 30b. During delivery of the prosthetic valve 100, the handle 30b can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 12b, such as the delivery shaft 22 and/or the outer shaft 20, through the patient's vasculature, as well as to expand or contract the prosthetic valve 100, for example by maneuvering the actuation assemblies 40 and/or the release assemblies 50, and to disconnect the prosthetic valve 100 from the delivery apparatus 12, for example—by decoupling the actuation members 42 and the release arms 52 from the expansion and locking assemblies 140 of the valve 100, in order to retract it once the prosthetic valve 100 is mounted in the implantation site.
According to some embodiments, the delivery apparatus 12b further comprises a re-compression mechanism (not shown), configured to facilitate re-compression of the prosthetic valve 100 upon expansion thereof. Further details regarding various configurations and types of prosthetic valve re-compression mechanisms can be found, for example, in International Application Publication No. WO 2020/081893, and U.S. application No. 62/928,320, both of which are incorporated herein by reference.
According to some embodiments, the plate 176d comprises a primary aperture 178d and a release aperture 179.
According to some embodiments, the release member proximal end portion 190 further comprises a threaded bore, configured to receive and threadedly engage with a threaded portion of a distal end portion 54 (shown for example in
According to some embodiments, as shown in
In the actuation state shown in
In some implementations, the release arm 52 may be pulled in the proximal direction 2, simultaneously with the pulling of the actuation member 42, thereby pulling the release member 188 therewith in the proximal direction 2. Alternatively, the release arm 52 may remain free or even pushed in the distal direction 4, thereby either retaining the release member 188 in an axially movable free state, or pushed distally toward the distal chamber wall 160, during actuation of the actuation assembly 40, enabling bi-directional free axial movement of the inner member 168 through the primary aperture 178, without interfering with such relative movement by the release member 188.
The diameter of the release member distal end portion 192a is smaller than the diameter of the release aperture 179, allowing it to extend therethrough, while the diameter of the retention feature 194a, positioned distal to the release aperture 179, is greater than the diameter of the release aperture 179.
As shown in
While
The release support sleeve 56 surrounds the release arm 52 and may be connected to the handle 30. The release support sleeve 56 and the outer member 142d are sized such that the distal lip of the release support sleeve 56 can abut or engage the outer member proximal end 146d, such that the outer member 142d is prevented from moving proximally beyond the release support sleeve 56.
In order to re-compress the frame 106, and therefore the valve 100, the release support sleeve 56 can be held firmly against the outer member 142d, while the release arm 52 is pulled in a proximally oriented direction 2. Since the release support sleeve 56 is being held against the outer member 142d, which is connected to an outflow apex (132), the outflow end (103) of the frame (106) is prevented from moving relative to the release support sleeve 56. As such, movement of the release arm 52 in a proximally oriented direction 2 can cause movement of the release member 188a in the same direction.
As Further shown in
Once the plate 176d assumes the non-locking orientation, the inner member 168 is free to axially move through the primary aperture 178d in any direction. In some embodiments, to facilitate valve re-compression in the state shown in
In alternative embodiments, valve re-compression is not facilitated by directly applying a pushing force to the actuation members 42, but rather by utilization of a re-compression mechanism of the type disclosed, for example, in International Application Publication No. WO 2020/081893, and U.S. application No. 62/928,320, which basically includes a flexible loop circumscribing the valve 100, wherein loop contraction, for example operable tensioning the loop via handle 30, facilitates valve compression therewith, during which the inner member 168 may passively advance in the distal direction 4 as shown in
Once the valve 100 is re-compressed, the release assembly 50 can be either released by not applying any pulling forces thereto, or alternatively by pushing it in a distal direction 4, for example toward and/or into the niche 163 dimensioned to accommodate the retention feature 194a, allowing the plate 176d to re-assume the angled locking orientation as shown in
As shown in
The release member 188c can be identical to the release member 188a, comprising a release member proximal end portion (190c) and a release member distal end portion 192c, terminating at a release member distal end 193c which is attached to a retention feature 194c. The retention feature 194c, which may be identical to retention feature 194a, is shown in
According to some embodiments, the handle 30b can comprise control mechanisms which may include steerable or rotatable knobs 32b, levers, buttons and such, which in some implementation may be manually controllable by an operator to produce axial and/or rotatable movement of different components of the delivery apparatus 12b. For example, the embodiment of handle 30b illustrated in
Knob 32ba, shown in
Knob 32bb, shown in
Knob 32bd, shown in
In alternative embodiments, two or more separate knobs may be configured to facilitate expansion and compression of the valve 100. For example, one knob may control the actuation assemblies 40, while another knob may control actuation of the release assemblies 50 (embodiments not shown).
Knob 32bc, shown in
Any of the knobs 32ba, 32bb, 32bc and 32bd may be implemented, in alternative embodiments, as other types of buttons, levers, knobs and the like, such as push/pull knobs which may be actuated by sliding or moving the knobs axially.
In the actuation state shown in
In some embodiments, the release arm 52 may be pulled in the proximal direction 2, simultaneously with the pulling of the actuation member 42, thereby pulling the release member 188b therewith in the proximal direction 2. Alternatively, the release arm 52 may remain free or even pushed in the distal direction 4, thereby either retaining the release member 188b in an axially movable free state, or pushed distally toward the distal chamber wall 160e, respectively, during actuation of the actuation assembly 40, enabling free movement of the inner member 168 through the primary aperture 178e, without hindering such relative movement by the release member 188b.
In alternative embodiments, the release member distal end portion 192 is directly attached to the plate 176 in a pivotable manner, allowing the plate 176 to pivot about a release member distal hinge 196, without the use of an intermediate retention feature (194).
In order to re-compress the frame 106, and therefore the valve 100, the release support sleeve 56 can be held firmly against the outer member 142e, while the release arm 52 is pulled in a proximally oriented direction 2. Since the release support sleeve 56 is being held against the outer member 142e, which is connected to an outflow apex (132), the outflow end (103) of the frame (106) is prevented from moving relative to the release support sleeve 56. As such, movement of the release arm 52 in a proximally oriented direction 2 can cause movement of the release member 188b in the same direction.
As Further shown in
Once the plate 176e assumes the non-locking orientation, the inner member 168 is free to axially move through the primary aperture 178e in any direction. In some embodiments, to facilitate valve re-compression in the state shown in
In alternative embodiments, valve re-compression is not facilitated by directly applying a pushing force on the actuation members 42, but rather by utilization of a re-compression mechanism of the type disclosed, for example, in International Application Publication No. WO 2020/081893, and U.S. application No. 62/928,320, which basically includes a loop circumscribing the valve (100), wherein loop tensioning or contraction, for example operable via handle (30), facilitates valve contraction there-along, during which the inner member 168 may passively translate in the distal direction 4 as shown in
Once the valve 100 is re-compressed, the release assembly 50 can be either released by not applying any pulling forces thereto, or alternatively by pushing it in a distal direction 4, allowing the plate 176e to re-assume the angled locking orientation as shown in
As shown in
The release member 188d can be identical to the release member 188b, comprising a release member proximal end portion (190d) and a release member distal end portion 192d, terminating at a release member distal end 193d. The retention feature 194d, which may be identical to retention feature 194b, may be pivotably attached to the release member distal end 193d via release member distal hinge 196d, allowing the retention feature 194d to pivot about the axis defined by the hinge 196d (an axis which may be orthogonal to the cross-sectional plane shown in
The release member 188d can be releasably attached to a release assembly 50, and operable to pull the re-orient the plate 176g to the non-locking orientation, in the same manner described for release member 188b and plate 176e herein above and throughout
While a threaded engagement is described throughout the current disclosure, serving as an optional reversible-attachment mechanism between the actuation assemblies 40 and the inner members 168, or between the release assemblies 50 and the release members 188, it is to be understood that in alternative implementations, other reversible attachment mechanisms may be utilized, configured to enable the inner member 168 and/or the release members 188 (when present) to be pulled or pushed by the actuation assemblies 40 and/or the release assemblies 50, respectively, while enabling disconnection there-between in any suitable manner, potentially controllable by the handle 30, so as to allow retraction of the delivery apparatus 12 from the patient's body at the end of the implantation procedure.
The outer member 142h can be similar to any other type of outer member (142) that includes a release channel 145h for a release member 188h, except that the distal chamber wall 158h does not need to have an inclined or angled portion. As shown in the illustrated embodiment, both the distal wall first side 162h and the distal wall second side 164h may be provided as flat walls, oriented substantially perpendicularly with respect to the longitudinal axis of the inner member 168.
The plate 176h comprises a primary aperture 178h through which the inner member extends, and may further engage the release member 188h at one of its sides, such as the plate first side 180h in the illustrated example. As shown, the release member distal end portion 192e may be coupled to the plate 176h (e.g., to the plate first side 180h) via a release member distal hinge 196e, enabling the plate 176h to pivot about the hinge 196e with respect to the release member 188h. It is to be understood the other coupling means between the release member 188h and the plate 176h may be applicable, such as via retention features 194a, 194b, 194c or 194d as described hereinabove with respect to
The outer member 142h may comprise a first spring 186ha, configured to bias the plate first side 180h in a proximal direction 2, toward the proximal chamber wall 158h, and a second spring 186hb, configured to bias the plate second side 182h in a distal direction 4, toward the distal chamber wall 160h. The first spring 186ha can be a compression spring, disposed within the first zone (154) between the plate first side 180h and the distal wall first side 162h. One end of the first spring 186ha can be attached to the plate first side 180h, and the other to the distal wall first side 162h. The second spring 186hb can be an extension spring, disposed within the first zone (156) between the plate second side 182h and the distal wall second side 164h. One end of the second spring 186hb can be attached to the plate second side 182h, and the other to the distal wall second side 164h.
In some implementations, the first spring 186ha is configured to exert a proximally oriented biasing force which is greater in magnitude than the distally oriented biasing force exerted by the second spring 186hb on the plate 176h. In some implementations, the spring constant of the first spring 186ha is higher than the spring constant of the second spring 186hb.
It is to be understood that the force exerted by the first spring 186ha and the second spring 186hb on the plate 176h are configured to be high enough to bias the plate 176h to the angled locking orientation in a free state, yet allow the plate 176h to assume a non-locking orientation when the inner member 168 is pulled in the first direction (e.g., the proximal direction). For example, the spring constants and/or spring dimensions, for both first and second springs 186ha, 186hb, can be chosen to enable the inner member 168 to be pulled in a proximal direction 2, when expansion of the valve (100) is desired.
In some embodiments, to facilitate valve re-compression in the state shown in
While
While the first spring 186ha is illustrated in
mal direction 2 as shown 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:
a frame movable between a radially compressed and a radially expanded configuration;
at least one expansion and locking mechanism, comprising:
wherein movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate;
wherein in the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume the angled locking orientation; and
wherein the at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
Example 2. The prosthetic valve of any example herein, particularly example 1, wherein the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate is disposed within the chamber.
Example 3. The prosthetic valve of any example herein, particularly example 2, wherein the outer member further comprises a lateral opening exposing at least a portion of the chamber.
Example 4. The prosthetic valve of any example herein, particularly any one of examples 1 to 3, wherein the at least one plate has a disc-like circular or elliptic shape.
Example 5. The prosthetic valve of any example herein, particularly any one of examples 1 to 3, wherein the at least one plate has a rectangular shape.
Example 6. The prosthetic valve of any example herein, particularly any one of examples 1 to 5, wherein the at least one plate comprises a rigid material.
Example 7. The prosthetic valve of any example herein, particularly any one of examples 1 to 6, wherein the at least one plate comprises a plurality of plates.
Example 8. The prosthetic valve of any example herein, particularly example 2, wherein the distal chamber wall comprises at least one angled portion.
Example 9. The prosthetic valve of any example herein, particularly example 8, wherein the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
Example 10. The prosthetic valve of any example herein, particularly any one of examples 2 to 9, wherein the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
Example 11. The prosthetic valve of any example herein, particularly example 10, wherein the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
Example 12. The prosthetic valve of any example herein, particularly example 2, wherein at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
Example 13. The prosthetic valve of any example herein, particularly any one of examples 2 to 12, wherein the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member therein.
Example 14. The prosthetic valve of any example herein, particularly example 2, wherein the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
Example 15. The prosthetic valve of any example herein, particularly example 14, wherein the spring is a helical spring coiled around the inner member.
Example 16. The prosthetic valve of any example herein, particularly example 14, wherein the spring is a helical spring disposed adjacent the inner member.
Example 17. The prosthetic valve of any example herein, particularly example 14, wherein the spring is a leaf spring.
Example 18. The prosthetic valve of any example herein, particularly example 2, wherein the plate is coupled to the proximal chamber wall via a plate hinge, and wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
Example 19. The prosthetic valve of any example herein, particularly example 2, wherein the distal chamber wall comprises a proximally oriented protrusion.
Example 20. The prosthetic valve of any example herein, particularly any one of examples 2 to 13, wherein the at least one expansion and locking mechanism further comprises a release member, extending at least partially into the outer member, the release member coupled to the at least one plate, and configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled in the second direction relative to the outer member.
Example 21. The prosthetic valve of any example herein, particularly example 20, wherein the outer member further comprises a release channel, configured to accommodate the release member therein.
Example 22. The prosthetic valve of any example herein, particularly any one of examples 20 to 21, wherein the plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture.
Example 23. The prosthetic valve of any example herein, particularly example 22, wherein the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
Example 24. The prosthetic valve of any example herein, particularly any one of examples 20 to 21, wherein a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
Example 25. The prosthetic valve of any example herein, particularly any one of examples 19 to 20, wherein the outer member further comprises a first spring and a second spring, disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
Example 26. The prosthetic valve of any example herein, particularly example 25, wherein the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
Example 27. The prosthetic valve of any example herein, particularly any one of examples 1 to 26, wherein the outer member further comprises an outer member fastener extending radially outward, and wherein the outer member is coupled to the frame at the first location via the outer member fastener.
Example 28. The prosthetic valve of any example herein, particularly any one of examples 1 to 27, wherein the inner member further comprises an inner member fastener extending radially outward, and wherein the inner member is coupled to the frame at the second location via the inner member fastener.
Example 29. The prosthetic valve of any example herein, particularly any one of examples 1 to 28, wherein the frame comprises intersecting struts.
Example 30. A prosthetic valve, comprising:
a frame movable between a radially compressed and a radially expanded configuration;
at least one expansion and locking mechanism, comprising:
wherein movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate;
wherein in the absence of a force applied to the plate in the first direction, the at least one spring is configured to bias the at least one plate to the angled locking orientation; and
wherein the at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
Example 31. The prosthetic valve of any example herein, particularly example 30, wherein the at least one plate has a disc-like circular or elliptic shape.
Example 32. The prosthetic valve of any example herein, particularly any one of examples 30 to 31, wherein the at least one plate has a rectangular shape.
Example 33. The prosthetic valve of any example herein, particularly any one of examples 30 to 32, wherein the at least one plate comprises a rigid material.
Example 34. The prosthetic valve of any example herein, particularly any one of examples 30 to 33, wherein the at least one plate comprises a plurality of plates.
Example 35. The prosthetic valve of any example herein, particularly any one of examples 30 to 34, wherein the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
Example 36. The prosthetic valve of any example herein, particularly any one of examples 30 to 35, wherein the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member therein.
Example 37. The prosthetic valve of any example herein, particularly any one of examples 30 to 36, wherein the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate and the at least one spring are disposed within the chamber.
Example 38. The prosthetic valve of any example herein, particularly example 37, wherein the distal chamber wall comprises a proximally oriented protrusion.
Example 39. The prosthetic valve of any example herein, particularly example 37, wherein the distal chamber wall comprises at least one angled portion.
Example 40. The prosthetic valve of any example herein, particularly example 39, wherein the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
Example 41. The prosthetic valve of any example herein, particularly any one of examples 37 to 40, wherein at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
Example 42. The prosthetic valve of any example herein, particularly any one of examples 37 to 40, wherein the at least one spring comprises a helical spring coiled around the inner member.
Example 43. The prosthetic valve of any example herein, particularly example 42, wherein the coiled spring is a compression spring disposed between the proximal chamber wall and the at least one plate.
Example 44. The prosthetic valve of any example herein, particularly any one of examples 37 to 41, wherein the at least one spring comprises at least one helical spring disposed adjacent the inner member.
Example 45. The prosthetic valve of any example herein, particularly example 44, wherein the at least one helical spring is a compression spring disposed between the proximal chamber wall and the at least one plate.
Example 46. The prosthetic valve of any example herein, particularly example 44, wherein the at least one helical spring is an extension spring disposed between the distal chamber wall and the at least one plate.
Example 47. The prosthetic valve of any example herein, particularly any one of examples 37 to 44, wherein the at least one spring is a leaf spring.
Example 48. The prosthetic valve of any example herein, particularly any one of examples 37 to 40, wherein the at least one expansion and locking mechanism further comprises a release member, extending at least partially into the outer member, the release member coupled to the at least one plate, and configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled in the second direction relative to the outer member.
Example 49. The prosthetic valve of any example herein, particularly example 48, wherein the outer member further comprises a release channel, configured to accommodate the release member therein.
Example 50. The prosthetic valve of any example herein, particularly any one of examples 48 to 49, wherein the at least one plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture.
Example 51. The prosthetic valve of any example herein, particularly example 50, wherein the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
Example 52. The prosthetic valve of any example herein, particularly any one of examples 48 to 49, wherein a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
Example 53. The prosthetic valve of any example herein, particularly example 48, wherein the at least one spring comprises a first spring and a second spring, both of which are disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
Example 54. The prosthetic valve of any example herein, particularly example 53, wherein the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
Example 55. A delivery assembly, comprising:
a prosthetic valve comprising:
a delivery apparatus comprising:
wherein the frame is movable from the radially compressed configuration to the radially expanded configuration upon actuating the at least one expansion and locking assembly by the at least one actuation assembly;
wherein movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate;
wherein in the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume the angled locking orientation; and
wherein the at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation.
Example 56. The delivery assembly of any example herein, particularly example 55, wherein the at least one actuation assembly comprises an actuation member and an actuation support sleeve disposed around the actuation member, and wherein the actuation member and the actuation support sleeve are movable longitudinally relative to each other in a telescoping manner.
Example 57. The delivery assembly of any example herein, particularly example 56, wherein the at least one actuation member is chosen from: a wire, a cable, a rod, or a tube.
Example 58. The delivery assembly of any example herein, particularly any one of examples 56 to 57, wherein the actuation support sleeve is a tube or a sheath having sufficient rigidity, such that the actuation support sleeve can apply an axial force against the outer member without bending or buckling.
Example 59. The delivery assembly of any example herein, particularly any one of examples 56 to 58, wherein the at least one actuation member is threadedly engaged with the corresponding inner member.
Example 60. The delivery assembly of any example herein, particularly any one of examples 56 to 59, wherein the handle comprises a plurality of knobs.
Example 61. The delivery assembly of any example herein, particularly example 60, wherein at least one of the plurality of knobs is configured to axially move each actuation member relative to the respective actuation support sleeve.
Example 62. The delivery assembly of any example herein, particularly example 60, wherein at least one of the plurality of knobs is configured to disengage each actuation assembly from the respective expansion and locking assembly.
Example 63. The delivery assembly of any example herein, particularly any one of examples 55 to 62, wherein the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate is disposed within the chamber.
Example 64. The delivery assembly of any example herein, particularly any one of examples 55 to 63, wherein the at least one plate has a disc-like circular or elliptic shape.
Example 65. The delivery assembly of any example herein, particularly any one of examples 55 to 63, wherein the at least one plate has a rectangular shape.
Example 66. The delivery assembly of any example herein, particularly any one of examples 55 to 65, wherein the at least one plate comprises a rigid material.
Example 67. The delivery assembly of any example herein, particularly any one of examples 55 to 66, wherein the at least one plate comprises a plurality of plates.
Example 68. The delivery assembly of any example herein, particularly example 63, wherein the distal chamber wall comprises at least one angled portion.
Example 69. The delivery assembly of any example herein, particularly example 68, wherein the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
Example 70. The delivery assembly of any example herein, particularly any one of examples 55 to 69, wherein the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
Example 71. The delivery assembly of any example herein, particularly example 70, wherein the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
Example 72. The delivery assembly of any example herein, particularly example 63, wherein at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
Example 73. The delivery assembly of any example herein, particularly any one of examples 56 to 62, wherein the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member and at least a portion of the actuation member therein.
Example 74. The delivery assembly of any example herein, particularly example 63, wherein the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
Example 75. The delivery assembly of any example herein, particularly example 74, wherein the spring is a helical spring coiled around the inner member.
Example 76. The delivery assembly of any example herein, particularly example 74, wherein the spring is a helical spring disposed adjacent the inner member.
Example 77. The delivery assembly of any example herein, particularly example 74, wherein the spring is a leaf spring.
Example 78. The delivery assembly of any example herein, particularly example 63, wherein the plate is coupled to the proximal chamber wall via a plate hinge, and wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
Example 79. The delivery assembly of any example herein, particularly example 63, wherein the distal chamber wall comprises a proximally oriented protrusion.
Example 80. A delivery assembly, comprising:
a prosthetic valve comprising:
a delivery apparatus comprising:
wherein the frame is movable from the radially compressed configuration to the radially expanded configuration upon actuating the at least one expansion and locking assembly by the at least one actuation assembly;
wherein movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially in a non-locking orientation of the at least one plate;
wherein in the absence of a force applied to the plate in the first direction, movement of the inner member in a second direction, relative to the outer member, causes the at least one plate to assume an angled locking orientation;
wherein the at least one plate is configured to inhibit advancement of the inner member in the second direction relative to the outer member, when oriented in the angled locking orientation; and
wherein the release member is configured to transition the at least one plate to the non-locking orientation, and/or retain the at least one plate in the non-locking orientation, when the release member is pulled by the release assembly in the first direction relative to the outer member.
Example 81. The delivery assembly of any example herein, particularly example 80, wherein the at least one actuation assembly comprises an actuation member and an actuation support sleeve disposed around the actuation member, and wherein the actuation member and the support sleeve are movable longitudinally relative to each other in a telescoping manner.
Example 82. The delivery assembly of any example herein, particularly example 81, wherein the at least one actuation member is chosen from: a wire, a cable, a rod, or a tube.
Example 83. The delivery assembly of any example herein, particularly any one of examples 81 to 82, wherein the support sleeve is a tube or a sheath having sufficient rigidity, such that the support sleeve can apply an axial force against the frame without bending or buckling.
Example 84. The delivery assembly of any example herein, particularly any one of examples 81 to 83, wherein the at least one actuation member is threadedly engaged with the corresponding inner member.
Example 85. The delivery assembly of any example herein, particularly any one of examples 81 to 84, wherein the at least one release assembly comprises a release arm and a release support sleeve disposed around the release arm, and wherein the release arm and the release support sleeve are movable longitudinally relative to each other in a telescoping manner.
Example 86. The delivery assembly of any example herein, particularly example 85, wherein the at least one release arm is chosen from: a wire, a cable, a rod, or a tube.
Example 87. The delivery assembly of any example herein, particularly any one of examples 85 to 86, wherein the release support sleeve is a tube or a sheath having sufficient rigidity, such that the release support sleeve can apply an axial force against the outer member without bending or buckling.
Example 88. The delivery assembly of any example herein, particularly any one of examples 85 to 87, wherein the at least one release arm is threadedly engaged with the corresponding release member.
Example 89. The delivery assembly of any example herein, particularly any one of examples 81 to 88, wherein the handle comprises a plurality of knobs.
Example 90. The delivery assembly of any example herein, particularly example 89, wherein at least one of the plurality of knobs is configured to axially move each actuation member relative to the respective actuation support sleeve.
Example 91. The delivery assembly of any example herein, particularly example 89, wherein at least one of the plurality of knobs is configured to axially move each release arm relative to the respective release support sleeve.
Example 92. The delivery assembly of any example herein, particularly example 89, wherein at least one of the plurality of knobs is configured to disengage each actuation assembly from the respective expansion and locking assembly.
Example 93. The delivery assembly of any example herein, particularly example 89, wherein at least one of the plurality of knobs is configured to disengage each release assembly from the respective expansion and locking assembly.
Example 94. The delivery assembly of any example herein, particularly any one of examples 80 to 93, wherein the outer member further comprises a chamber comprising a proximal chamber wall and a distal chamber wall, and wherein the at least one plate is disposed within the chamber.
Example 95. The delivery assembly of any example herein, particularly any one of examples 80 to 94, wherein the at least one plate has a disc-like circular or elliptic shape.
Example 96. The delivery assembly of any example herein, particularly any one of examples 80 to 95, wherein the at least one plate has a rectangular shape.
Example 97. The delivery assembly of any example herein, particularly any one of examples 80 to 96, wherein the at least one plate comprises a rigid material.
Example 98. The delivery assembly of any example herein, particularly any one of examples 80 to 97, wherein the at least one plate comprises a plurality of plates.
Example 99. The delivery assembly of any example herein, particularly example 94, wherein the distal chamber wall comprises at least one angled portion.
Example 100. The delivery assembly of any example herein, particularly example 99, wherein the angle formed between the angled portion and the inner member is more acute than the angle formed between the plate and the inner member in the angled locking orientation.
Example 101. The delivery assembly of any example herein, particularly any one of examples 80 to 100, wherein the diameter of the primary aperture is closely matched with the outer diameter of the inner member extending therethrough, such that axial movement of the inner member frictionally engages with the primary aperture.
Example 102. The delivery assembly of any example herein, particularly example 101, wherein the diameter of the primary aperture is no more than 5 percent larger than the diameter of the inner member at the portion extending therethrough.
Example 103. The delivery assembly of any example herein, particularly example 94, wherein at least a portion of the proximal chamber wall is substantially orthogonal to a longitudinal axis of the inner member.
Example 104. The delivery assembly of any example herein, particularly any one of examples 81 to 84, wherein the outer member comprises a primary channel, configured to accommodate at least a portion of the inner member and at least a portion of the actuation member therein.
Example 105. The delivery assembly of any example herein, particularly any one of examples 85 to 88, wherein the outer member comprises a release channel, configured to accommodate at least a portion of the release member and at least a portion of the release arm therein.
Example 106. The delivery assembly of any example herein, particularly example 94, wherein the outer member further comprises a spring disposed within the chamber, configured to urge the at least one plate in the second direction.
Example 107. The delivery assembly of any example herein, particularly example 106, wherein the spring is a helical spring coiled around the inner member.
Example 108. The delivery assembly of any example herein, particularly example 106, wherein the spring is a helical spring disposed adjacent the inner member.
Example 109. The delivery assembly of any example herein, particularly example 106, wherein the spring is a leaf spring.
Example 110. The delivery assembly of any example herein, particularly example 94, wherein the plate is coupled to the proximal chamber wall via a plate hinge, and wherein the plate is configured to pivot about the plate hinge between the angled locking orientation and the non-locking orientation.
Example 111. The delivery assembly of any example herein, particularly example 94, wherein the distal chamber wall comprises a proximally oriented protrusion.
Example 112. The delivery assembly of any example herein, particularly any one of examples 80 to 111, wherein the at least one plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, and wherein a distal end of the release member comprises a retention feature distal to the release aperture.
Example 113. The delivery assembly of any example herein, particularly example 94, wherein the at least one plate further comprises a release aperture, wherein a distal end portion of the release member extends through the release aperture, wherein a distal end of the release member comprises a retention feature distal to the release aperture, and wherein the distal chamber wall comprises a niche dimensioned to accommodate the retention feature.
Example 114. The delivery assembly of any example herein, particularly any one of examples 80 to 111, wherein a distal end of the release member is pivotably coupled to the at least one plate via a release member distal hinge.
Example 115. The delivery assembly of any example herein, particularly any one of examples 80 to 105, wherein the outer member further comprises a first spring and a second spring, disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs.
Example 116. The delivery assembly of any example herein, particularly example 94, wherein the outer member further comprises a first spring and a second spring, disposed within the chamber at opposite sides of the inner member, wherein the first spring is configured to bias one side of the at least one plate in a first direction, and the second spring is configured to bias an opposite second side of the at least one plate in a second direction, thereby biasing the plate to the angled locking orientation in a free state of the first and second springs, wherein the first spring is a compression spring, disposed between the at least one plate and the distal chamber wall, and wherein the second spring is an extension spring disposed between the at least one plate and the distal chamber wall.
Example 117. A method of implanting a prosthetic valve, the method comprising:
positioning a prosthetic valve at a target site in a patient's body using a delivery apparatus, wherein the prosthetic valve comprises at least one expansion and locking assembly, the expansion and locking assembly comprising an outer member, an inner member partially disposed within, and movable axially relative to, the outer member, and at least one plate dispose within the outer member and around the inner member, and wherein the delivery apparatus comprises at least one actuation assembly, detachably coupled to the at least one expansion and locking assembly;
radially expanding the prosthetic valve from a radially compressed configuration to a radially expanded configuration, by applying, via the at least one actuation assembly, a pull force on the inner member, configured to axially move the inner member in a first direction relative to the outer member; and
locking the expansion and locking assembly by releasing the pull force exerted on the inner member by the actuation assembly, thereby allowing the at least one plate to assume an angled locking orientation.
Example 118. The method of any example herein, particularly example 117, wherein the radially expanded configuration comprises partially expanded configurations and/or a fully expanded configuration, and wherein the step of radially expanding the prosthetic valve is executed again after the locking step, so as to reorient the at least one plate from the angled locking orientation to a non-locking orientation, allowing further expansion of the prosthetic valve from a partially expanded configuration to another partially expanded configuration or to a fully expanded configuration.
Example 119. The method of any example herein, particularly any one of examples 117 to 118, wherein the at least one actuation assembly comprises an actuation member detachably coupled to the inner member, and an actuation support sleeve disposed around the actuation member, and wherein the step of radially expanding the prosthetic valve comprises exerting a pull force to move the actuation member in a first direction relative to the actuation support sleeve, while keeping the actuation support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member.
Example 120. The method of any example herein, particularly example 119, further comprising a step of detaching the at least one actuation member from the at least one inner member, and retrieving the delivery apparatus from the patient's body.
Example 121. The method of any example herein, particularly example 120, wherein the at least one actuation member is threadedly engaged with the at least one inner member, and wherein detaching the at least one actuation member comprises rotating the at least one actuation member around a longitudinal axis thereof.
Example 122. A method of implanting a prosthetic valve, the method comprising:
positioning a prosthetic valve at a target site in a patient's body using a delivery apparatus, wherein the prosthetic valve comprises at least one expansion and locking assembly, the expansion and locking assembly comprising an outer member, an inner member partially disposed within, and movable axially relative to, the outer member, at least one plate dispose within the outer member and around the inner member, and a release member disposed within the outer member and axially movable relative thereto, the release member coupled to the at least one plate, and wherein the expansion and locking assembly comprises at least one actuation assembly detachably coupled to the at least one expansion and locking assembly, and at least one release assembly detachably coupled to the release member;
radially expanding the prosthetic valve from a radially compressed configuration to a radially expanded configuration, by applying, via the at least one actuation assembly, a pull force on the inner member, configured to axially move the inner member in a first direction relative to the outer member;
locking the expansion and locking assembly by releasing the pull force exerted on the inner member by the actuation assembly, thereby allowing the at least one plate to assume an angled locking orientation;
unlocking the expansion and locking assembly by applying, via the at least one release assembly, a pull force on the release member, configured to transition the at least one plate from the angled locking orientation to a non-locking orientation; and
re-compressing the prosthetic valve such that the at least one inner member is moved in a second direction relative to the at least one outer member.
Example 123. The method of any example herein, particularly example 122, wherein any of the steps of radially expanding the prosthetic valve, locking, unlocking, and re-compressing the prosthetic valve, are repeated for any desired number of times and in any order, so as to reach a final desired expansion diameter of the prosthetic valve.
Example 124. The method of any example herein, particularly any one of examples 122 to 123, further comprising a step of re-positioning the prosthetic valve using the delivery apparatus, after the step of re-compressing the prosthetic valve.
Example 125. The method of any example herein, particularly any one of examples 122 to 124, wherein the at least one actuation assembly comprises an actuation member detachably coupled to the inner member, and an actuation support sleeve disposed around the actuation member, wherein the at least one release assembly comprises a release arm detachably coupled to the release member, and a release support sleeve disposed around the release arm, wherein the step of radially expanding the prosthetic valve comprises exerting a pull force to move the actuation member in a first direction relative to the actuation support sleeve, while keeping the actuation support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member, and wherein the step of unlocking the prosthetic valve comprises exerting a pull force to move the release arm in a first direction relative to the release support sleeve, while keeping the release support sleeve stationary or moved in an opposite second direction, so as to apply a counter force against the outer member.
Example 126. The method of any example herein, particularly example 125, further comprising steps of detaching the at least one actuation member from the at least one inner member, detaching the at least one release arm from the release member, and retrieving the delivery apparatus from the patient's body.
Example 127. The method of any example herein, particularly example 126, wherein the at least one actuation member is threadedly engaged with the at least one inner member, wherein the at least one release arm is threadedly engaged with the at least one release member, wherein detaching the at least one actuation member comprises rotating the at least one actuation member around a longitudinal axis thereof, and wherein detaching the at least one release arm comprises rotating the at least one release arm around a longitudinal axis thereof.
Example 128. A method for assembling an expansion and locking mechanism, comprising the steps of:
providing an outer member comprising a chamber and a lateral opening exposing at least a portion of the chamber;
inserting at least one plate, comprising a primary aperture, into the chamber through the lateral opening;
orienting the at least one plate in a substantially orthogonal orientation, relative to a longitudinal axis of the outer member; and
inserting the inner member into the outer member, through the primary aperture of the at least one plate.
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 sub-combination 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 a PCT Application No. PCT/US2021/041009, filed Jul. 9, 2021, which claims the benefit of U.S. Provisional Patent Application No. 63/050,292, filed Jul. 10, 2020, where each of above-referenced applications is incorporated herein by reference in its entirety.
Number | Date | Country | |
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63050292 | Jul 2020 | US |
Number | Date | Country | |
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Parent | PCT/US2021/041009 | Jul 2021 | US |
Child | 18095456 | US |