Telescoping prosthetic valve with retention element

An implantable device is disclosed. The device includes a leaflet frame subcomponent and an anchor frame subcomponent that are configured to be delivered in a series configuration and subsequently nested or telescoped in-situ.

FIELD

The present disclosure relates generally to prosthetic valves and more specifically to flexible leaflet-type prosthetic valve devices, systems and methods.

BACKGROUND

Bioprosthetic valves have been developed that attempt to mimic the function and performance of a native valve. Bioprosthetic valves may be formed from synthetic materials, natural tissue such as biological tissue, or a combination of synthetic materials and natural tissue.

Though many conventional designs require delivery to a target region within a patient's anatomy via open-heart surgical techniques, alternative approaches such as transcatheter techniques offer a number of advantages. Among other examples, a transcatheter prosthetic valve that is delivered endovascularly via a catheter can help to minimize patient trauma as compared with an open-heart, surgical procedure. Open-heart surgery involves extensive trauma to the patient, with attendant morbidity and extended recovery. On the other hand, a valve delivered to the recipient site via a catheter avoids the trauma of open-heart surgery and may be performed on patients too ill or feeble to survive the open-heart surgery.

However, challenges exist with accessing treatment regions within the anatomy, properly positioning the bioprosthesis for deployment, and depending on the particular anatomy being repaired or augmented, modifications of the surrounding anatomy may arise as a consequence of the presence of the bioprosthesis. In some instances, such consequential modifications to the surrounding anatomy may negatively impact a patient's health.

While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

SUMMARY

Various aspects relate to prosthetic valves transitional between a delivery configuration and a deployed, nested configuration in-situ.

Various aspects relate to a prosthetic valve including a leaflet frame subcomponent including a one-way valve, the leaflet frame subcomponent having a leaflet frame subcomponent inflow end and a leaflet frame subcomponent outflow end; an anchor frame subcomponent having an anchor frame subcomponent inflow end and an anchor frame subcomponent outflow end; a connecting sheath coupling the leaflet frame subcomponent to the anchor frame subcomponent; and a retention element coupled to the connecting sheath, the retention element being configured to retain the prosthetic valve in the deployed, nested configuration, wherein in the delivery configuration the leaflet frame subcomponent and the anchor frame subcomponent are longitudinally offset relative to one another with the connecting sheath being unfolded and uneverted and in the nested configuration the leaflet frame subcomponent is nested with the anchor frame subcomponent and the connecting sheath is folded and everted so as to lie between the leaflet frame subcomponent and the anchor frame subcomponent, such that the retention element extends from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end.

Various aspects also relate to a prosthetic valve configured to be retrieved, or a method of retrieving a prosthetic valve, in which an anchor frame subcomponent of the prosthetic valve has a predetermined flexibility such that the anchor frame subcomponent may be everted into an anchor frame subcomponent lumen such that the anchor frame subcomponent is operable to peel away from a tissue annulus and be drawn out of the anchor frame subcomponent lumen such that the prosthetic valve may be removed from the tissue annulus. In some implementations, a portion of the anchor frame subcomponent may pivot and compress about a location adjacent to an anchor frame subcomponent inflow end (e.g., at a flared portion), such that the anchor frame subcomponent may pivot or fold inwardly into the anchor frame subcomponent lumen and be drawn out of the anchor frame subcomponent lumen having been everted.

According to one example (“Example 1”), a prosthetic valve transitionable between a delivery configuration and a deployed, nested configuration in-situ, includes a leaflet frame subcomponent, an anchor frame subcomponent, a connecting sheath coupling the leaflet frame and anchor frame subcomponents, and a retention element coupled to the connecting sheath, wherein when the prosthetic valve is in the deployed, nested configuration, the connecting sheath is everted and the leaflet frame subcomponent is at least partially nested within an anchor frame subcomponent lumen, the retention element has translated within the anchor frame subcomponent lumen toward an anchor frame subcomponent inflow end, and the retention element is biased outwardly against the anchor frame subcomponent with an outward bias such that the retention element extends from a leaflet frame subcomponent inflow end to an anchor frame subcomponent inflow end.

Optionally, the leaflet frame subcomponent defines a tubular shape and has a leaflet frame subcomponent wall extending from the leaflet frame subcomponent inflow end and a leaflet frame subcomponent outflow end and the leaflet frame subcomponent defining a leaflet frame subcomponent lumen, the leaflet frame subcomponent including a one-way valve.

Optionally, the anchor frame subcomponent defines a tubular shape and has the anchor frame subcomponent inflow end and an anchor frame subcomponent outflow end, and the anchor frame subcomponent defines an anchor frame subcomponent lumen.

Optionally, the connecting sheath defines a tubular shape and has a connecting sheath inflow end coupled to the anchor frame subcomponent outflow end and a connecting sheath outflow end coupled to the leaflet frame subcomponent inflow end coupling the leaflet frame subcomponent to the anchor frame subcomponent, and the connecting sheath has a connecting sheath inner surface that defines a connecting sheath lumen.

Optionally, the retention element has a retention element first end and a retention element second end, the retention element second end being coupled to the connecting sheath outflow end.

Optionally, when the prosthetic valve is in the delivery configuration, the leaflet frame subcomponent and the anchor frame subcomponent are longitudinally offset from one another such that the leaflet frame subcomponent inflow end is situated distal of the anchor frame subcomponent outflow end, wherein the retention element resides within the connecting sheath lumen and extends away from the leaflet frame subcomponent inflow end and substantially parallel with a longitudinal axis of the leaflet frame subcomponent and adjacent to the connecting sheath.

Optionally, when the prosthetic valve is in the deployed, nested configuration, the anchor frame subcomponent inflow end flares or tapers radially outward.

According to another example (“Example 2”) further to Example 1, wherein the prosthetic valve is transitionable between the delivery configuration and the deployed, nested configuration via an expanded pre-deployed, un-nested configuration.

According to another example (“Example 3”) further to Example 2, the retention element is pivotable about the retention element second end upon translation of the retention element translated within the anchor frame subcomponent lumen towards the anchor frame subcomponent inflow end, such that the retention element extends from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end.

According to another example (“Example 4”) further to any one of Examples 1 to 3, the leaflet frame subcomponent includes a leaflet frame defining a leaflet frame wall, one or more leaflets, and leaflet frame cover, the leaflet frame is generally tubular shaped defining a leaflet frame inflow end and a leaflet frame outflow end with a leaflet frame lumen therethrough.

According to another example (“Example 5”) further to Example 4, the leaflet frame wall of the leaflet frame is at least partially covered with the leaflet frame cover configured to restrict fluid from passing through the covered portion of the leaflet frame wall.

According to another example (“Example 6”) further to Example 4 or 5, the one or more leaflets are operable to open to allow flow from the leaflet frame subcomponent inflow end and to pass through the leaflet frame subcomponent outflow end in antegrade flow conditions, and are operable to close to restrict flow from flowing from the leaflet frame subcomponent outflow end through the leaflet frame subcomponent inflow end in retrograde flow conditions.

According to another example (“Example 7”) further to any one of Examples 4 to 6, the retention element second end is not directly coupled to the leaflet frame at the leaflet frame subcomponent inflow end, there being a portion of the connecting sheath therebetween.

According to another example (“Example 8”) further to any one of Examples 4 to 7, the leaflets comprise a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally TFE-PMVE copolymer comprising from about 27 to about 32 weight percent perfluoromethyl vinyl ether and respectively from about 73 to about 68 weight percent tetrafluoroethylene on at least a portion of the composite material, and optionally, wherein the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally wherein the porous synthetic fluoropolymer membrane is ePTFE.

According to another example (“Example 9”) further to any one of the preceding Examples, the anchor frame subcomponent includes an anchor frame and an anchor frame cover, the anchor frame defines a generally tubular shape extending between the anchor frame subcomponent inflow end and the anchor frame subcomponent outflow end, an anchor frame inner surface and an anchor frame outer surface defining an anchor frame wall, the anchor frame is at least partially covered with the anchor frame cover to restrict fluid from passing through the anchor frame wall.

According to another example (“Example 10”) further to Example 9, the prosthetic valve is in the deployed, nested configuration, the anchor frame defines a flared portion at the anchor frame subcomponent inflow end that flares or tapers radially outward.

According to another example (“Example 11”) further to Example 9 or 10, when Example 9 or 10 is further to any one of Examples 4 to 8, the connecting sheath is contiguous with the anchor frame cover and the leaflet frame cover.

According to another example (“Example 12”) further to any one of Examples 9 to 11, when any one of Examples 9 to 11 is further to any one of Examples 4 to 8, the retention element is coupled to the connecting sheath between, but not directly coupled to, the leaflet frame or the anchor frame such that the retention element is operable to maintain the nested configuration of the anchor frame subcomponent and the leaflet frame subcomponent.

According to another example (“Example 13”) further to any preceding Example, the prosthetic valve has a smaller diameter in the delivery configuration than in the deployed, nested configuration.

According to another example (“Example 14”) further to any preceding Example, the anchor frame subcomponent has an anchor frame subcomponent inner surface, wherein, in the deployed, nested configuration, the anchor frame subcomponent inner surface has a diameter at least slightly larger than a leaflet frame subcomponent outer surface of the leaflet frame subcomponent and the leaflet frame subcomponent is nested within the anchor frame subcomponent.

According to another example (“Example 15”) further to Example 2 or further to any one of Examples 3 to 14 further to Example 2, the connecting sheath is a thin-walled flexible tubular member having a connecting sheath inner surface that defines a connecting sheath lumen in fluid communication with the anchor frame subcomponent lumen and the leaflet frame subcomponent lumen, and wherein the connecting sheath is operable to fold and evert when the leaflet frame subcomponent is advanced from the pre-deployed, un-nested configuration to the deployed, nested configuration so as to lie between the leaflet frame subcomponent and the anchor frame subcomponent.

According to another example (“Example 16”) further to any preceding Example, the connecting sheath comprises flow enabling features in a wall of the connecting sheath, the wall extending between the connecting sheath inflow end and the connecting sheath outflow end, wherein the flow enabling features are operable to allow antegrade fluid flow through the connecting sheath wall and restrict retrograde flow through the connecting sheath wall when the leaflet frame subassembly is not in the deployed, nested configuration.

According to another example (“Example 17”) further to any one of Examples 1 to 15, the connecting sheath comprises an inner film layer and an outer film layer, the inner film layer and the outer film layer being coupled together at least at the leaflet frame subcomponent inflow end and the anchor frame subcomponent outflow end, the inner film layer defining at least one inner aperture therethrough adjacent the anchor frame subcomponent outflow end and the outer film layer defines at least one outer aperture therethrough adjacent the leaflet frame subcomponent, the inner film layer and the outer film layer being not coupled at least between one of the inner apertures and one of the outer apertures so as to define a flow space therebetween operable to permit antegrade blood flow and restrict retrograde flow therethrough when the leaflet frame subcomponent is not in the deployed, nested configuration in the anchor frame subcomponent, and is operable to restrict antegrade and retrograde flow when the leaflet frame subcomponent is in the deployed, nested configuration within the anchor frame subcomponent.

According to another example (“Example 18”) further to any one of Examples 1 to 15, the connecting sheath comprises an inner film layer and an outer film layer, the inner film layer and the outer film layer being coupled together at least at the anchor frame subcomponent outflow end, the inner film layer defining at least one inner aperture therethrough adjacent the anchor frame subcomponent outflow end, the inner film layer and the outer film layer being not coupled at least downstream of the inner apertures so as to define a flow space therebetween operable to permit antegrade blood flow with the inner film layer separating from the outer film layer at the inner aperture and so as to restrict retrograde flow therethrough with the inner film layer coming together and covering the inner aperture when the leaflet frame subcomponent is not in the deployed, nested configuration in the anchor frame subcomponent, and is operable to restrict antegrade and retrograde flow when the leaflet frame subcomponent is in the deployed, nested configuration within the anchor frame subcomponent.

According to another example (“Example 19”) further to any preceding Example, when the prosthetic valve is in the deployed, nested configuration, the retention element is configured to cover an inflow annular groove formed between the anchor frame subcomponent, the everted connecting sheath, and the leaflet frame subcomponent.

According to another example (“Example 20”) further to any preceding Example, the retention element further includes a non-permeable cover and wherein, when the prosthetic valve is in the deployed, nested configuration, an inflow annular groove is defined by the anchor frame subcomponent, the connecting sheath, and the leaflet frame subcomponent at an inflow end of the prosthetic valve, and wherein the retention element, including the non-permeable cover, is operable to cover and restrict fluid flow into an inflow annular groove.

According to another example (“Example 21”) further to Example 2 or further to any one of Examples 3 to 20 further to Example 2, the retention element is an elongated element that is operable to extend generally parallel to a central, longitudinal axis X of the prosthetic valve when in the pre-deployed configuration, and operable to extend at an angle to the central, longitudinal axis X when in the deployed configuration.

According to another example (“Example 22”) further to any preceding Example, the retention element is operable to translate through the anchor frame subcomponent during transition of the prosthetic valve between the delivery configuration and the deployed, nested configuration and the connecting sheath is operable to fold and evert within the anchor frame subcomponent lumen and lie between the leaflet frame subcomponent and the anchor frame subcomponent during transition of the prosthetic valve between the delivery configuration and the deployed, nested configuration.

According to another example (“Example 23”) further to any preceding Example, the retention element comprises a continuous sinuous element configured to have an outward spring bias toward a planar star-shaped configuration defining elongated elements bending about apices, the elongated elements have an elongated element first end and an elongated element second end, when in the star-shaped configuration the elongated elements extend radially with the elongated element first ends and respective apices defining an inner circumference at a retention element first end and the elongated element second ends and respective apices defining an outer circumference at a retention element second end, the sinuous element is operable to be elastically restrained to a tubular configuration wherein the elongated elements are rotated about the apices at the elongated element first ends such that the elongated element second ends are rotated toward each other to define a tubular or conical configuration, with the sinuous element defining a first tubular diameter wherein the elongated elements extend laterally to the central, longitudinal axis X and along the connecting sheath and lateral with the anchor frame subcomponent and leaflet frame subcomponent.

According to another example (“Example 24”) further to Example 23 further to Example 20, the non-permeable cover extends from the apices at the elongated element first ends of the elongated elements to the apices at the elongated element second ends, wherein when the prosthetic valve is in the deployed, nested configuration, the non-permeable cover extends from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end covering the inflow annular groove formed between the anchor frame subcomponent, the connecting sheath and the leaflet frame subcomponent.

According to another example (“Example 25”) further to Example 23 or 24, further comprising a tether element coupled to the retention element, operable to be pulled by an operator to affect advancement of the retention element through the anchor frame subcomponent, the retention element second end of the retention element being held in a compressed state by a predetermined amount of tension on the tether element, wherein the tension of the tether element may be released and thus release the elongated element second end of the retention element so as to allow expansion and deployment of the retention element.

According to another example (“Example 26”) further to any preceding Example, the retention element is biased towards a planar position and operable to retain the relative position of the leaflet frame subcomponent and the anchor frame subcomponent by virtue of the outward bias.

According to another example (“Example 27”) further to any preceding Example, one or more apices at the retention element second end of the retention element may abut and slide along the connecting sheath inner surface and subsequently the anchor frame subcomponent inner surface while expanding under the outward bias until the apices at the retention element second end are fully expanded about the anchor frame subcomponent inflow end, wherein the outward bias produces sufficient force to advance the retention element through the connecting sheath and the anchor frame subcomponent inner surface toward the anchor frame subcomponent inflow end while pulling the leaflet frame subcomponent into the anchor frame subcomponent.

According to another example (“Example 28”) further to any preceding Example, a length of the anchor frame subcomponent varies along its circumference wherein the anchor frame subcomponent outflow end has a tapered geometry operable such that, when the prosthetic valve is placed in a mitral valve annulus, the anchor frame subcomponent outflow end may extend further into a left ventricle adjacent to a posterior side of the left ventricle and extends less into a LVOT on an anterior side of the left ventricle.

According to another example (“Example 29”) further to any preceding Example, a hoop strength of the anchor frame subcomponent is variable along a length and/or a circumference of the anchor frame subcomponent and is predetermined to have a greater stiffness at a smaller tapered portion of an anchor frame subcomponent anterior portion of the anchor frame subcomponent outflow end, to substantially match a stiffness of an aortomitral junction, whereas the stiffness may be relatively less at a longer prosthetic valve posterior portion adjacent a posterior side of the left ventricle.

According to another example (“Example 30”) further to any preceding Example, the anchor frame subcomponent has a predetermined flexibility such that the anchor frame subcomponent may be everted into the anchor frame subcomponent lumen such that the anchor frame subcomponent is operable to peel away from a tissue annulus and be drawn out of the anchor frame subcomponent lumen such that the prosthetic valve may be removed from the tissue annulus.

According to another example (“Example 31”) further to any preceding Example, the anchor frame subcomponent includes one or more tissue engagement features that project away from an anchor frame outer surface of the anchor frame subcomponent and are operable to engage a tissue annulus.

According to another example (“Example 32”) further to any preceding Example, the prosthetic valve further comprises an outflow annular groove cover extending from the anchor frame subcomponent outflow end and the leaflet frame subcomponent outflow end.

According to another example (“Example 33”) further to Example 32, the outflow annular groove cover is configured to be blood permeable under physiologic conditions prior to the prosthetic valve being transitioned to the deployed, nested configuration.

According to another example (“Example 34”) further to Examples 32 or 33, the outflow annular groove cover is configured to be less permeable to blood under physiologic conditions when the prosthetic valve is in the deployed, nested configuration than when the prosthetic valve is not in the deployed, nested configuration.

Disclosed herein are also methods of replacing a native valve of a patient's anatomy. According to one example (“Example 35”), the method includes providing a prosthetic valve including, an anchor frame subcomponent; a leaflet frame subcomponent nestable within the anchor frame subcomponent; a connecting sheath coupled to the leaflet frame subcomponent and the anchor frame subcomponent, the anchor frame subcomponent comprising an anchor frame subcomponent inflow end and anchor frame subcomponent outflow end; and a retention element coupled to the connecting sheath adjacent the leaflet frame subcomponent inflow end. The prosthetic valve is advanced in a delivery configuration to a treatment site within a patient's anatomy, wherein in the delivery configuration the leaflet frame subcomponent and the anchor frame subcomponent are longitudinally offset from one another such that a leaflet frame subcomponent inflow end of the leaflet frame subcomponent is situated distal of an anchor frame subcomponent inflow end. The anchor frame subcomponent is deployed within a tissue annulus. The leaflet frame subcomponent is nested within the anchor frame subcomponent by changing a relative position between the leaflet frame subcomponent and the anchor frame subcomponent. The retention element is deployed to extend from the leaflet frame subcomponent inflow end to the anchor frame subcomponent inflow end.

According to another example (“Example 36”) further to Example 35, the method further comprises deploying the prosthetic valve at the treatment site.

According to another example (“Example 37”) further to Examples 35 or 36, the leaflet frame subcomponent is nested within the anchor frame subcomponent after the prosthetic valve is deployed at the treatment site.

According to another example (“Example 38”) further to any one of Example 35 to 37, the prosthetic valve is advanced to the treatment site via a catheter.

According to another example (“Example 39”) further to any one of Examples 35 to 38, nesting the leaflet frame subcomponent within the anchor frame subcomponent includes drawing the leaflet frame subcomponent proximally relative to the anchor frame subcomponent.

According to another example (“Example 40”) further to any one of Examples 35 to 39, the method further comprises securing the prosthetic valve to a valve orifice of the native valve such that the prosthetic valve is operable to transition between an open position wherein fluid flow is permitted, and a closed position wherein fluid flow is obstructed.

According to another example (“Example 41”) further to any one of Examples 35 to 40, deploying the anchor frame within a tissue annulus includes releasing constraining elements to expand the anchor frame to a larger diameter of the tissue annulus.

According to another example (“Example 42”) further to any one of Examples 35 to 39 and 41, deploying the anchor frame within a tissue annulus includes tightening the constraining elements to recompress the anchor frame to a smaller diameter to allow for repositioning of the prosthetic valve.

According to another example (“Example 43”) further to any one of Examples 35 to 42, deploying the anchor frame within a tissue annulus includes tightening the constraining elements to recompress the anchor frame to a smaller diameter to allow for repositioning of the prosthetic valve.

Further disclosed herein is a method of treating a failing or dysfunctional native heart valve with a prosthetic valve. According to one example (“Example 44”), the method includes replacing the native valve with a prosthetic valve in accordance with any of claims1to34.

The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.

DETAILED DESCRIPTION

Definitions and Terminology

This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

Certain relative terminology is used to indicate the relative position of components and features. For example, words such as “top”, “bottom”, “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” are used in a relational sense (e.g., how components or features are positioned relative to one another) and not in an absolute sense unless context dictates otherwise. Similarly, throughout this disclosure, where a process or method is shown or described, the method may be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain actions being performed first.

With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, in certain instances, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, minor adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like, for example.

As used herein, “couple” means join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily.

The term “membrane” as used herein refers to a sheet of material comprising a single composition, such as, but not limited to, expanded fluoropolymer.

The term “composite material” as used herein refers to a material including two or more material components with one or more different material properties from the other. In some examples, a composite material includes at least a first material component in the form of a membrane and a second material component in the form of a polymer that is combined with the membrane (e.g., by coating and/or imbibing processes).

The term “laminate” as used herein refers to multiple layers of membrane, composite material, or other materials, such as, but not limited to a polymer, such as, but not limited to an elastomer, elastomeric or non-elastomeric material, and combinations thereof.

As used herein, the term “elastomer” refers to a polymer or a mixture of polymers that has the ability to be stretched to at least 1.3 times its original length and to retract rapidly to approximately its original length when released.

The term “elastomeric material” as used herein refers to a polymer or a mixture of polymers that displays stretch and recovery properties similar to an elastomer, although not necessarily to the same degree of stretch and/or recovery.

The term “non-elastomeric material” refers to a polymer or a mixture of polymers that displays stretch and recovery properties not similar to either an elastomer or elastomeric material, that is, considered not an elastomer or elastomeric material as is generally known.

The term “film” as used herein generically refers to one or more of the membrane, composite material, or laminate.

The term “biocompatible material” as used herein generically refers to any material with biocompatible characteristics including synthetic materials, such as, but not limited to, a biocompatible polymer, or a biological material, such as, but not limited to, bovine pericardium. Biocompatible material may comprise a first film and a second film as described herein for various embodiments.

The terms “native valve orifice” and “tissue orifice” as used herein refer to an anatomical structure into which a prosthetic valve can be placed. Such anatomical structure includes, but is not limited to, a location wherein a cardiac valve may or may not have been surgically removed. It is understood that other anatomical structures that can receive a prosthetic valve include, but are not limited to, veins, arteries, ducts and shunts. It is further understood that a valve tissue orifice or implant site may also refer to a location in a synthetic or biological conduit that may receive a valve.

The term “frame” as used herein generically refers to any structure or support used to directly or indirectly support leaflets for use in a prosthetic valve. It will be understood that, where appropriate, that the term frame may be used interchangeably with support structure. In accordance with some embodiments, the leaflets may be supported by the wall of a solid-walled conduit, the solid-walled conduit being understood to be a frame or support structure.

Description of Various Embodiments

As will be described further below, in various examples, the prosthetic valve provides a leaflet frame subcomponent that does not directly couple with a tissue annulus and essentially floats within an anchor frame subcomponent coupled together by a connecting sheath and supported by a retention element. In various examples, the leaflet frame subcomponent, anchor frame subcomponent, and the connecting sheath are all tubular members, although non-tubular configurations for one or more of the foregoing are contemplated. It is understood that “tubular” as used herein includes tubes having a constant diameter along the length of the tube, and tubes having a variable diameter along the length of the tube, such as, but not limited to, a taper and an irregular circumference. For example, a tubular member may have a variable diameter along its length in at least one configuration of the tubular member. For example, a tubular member may have a generally constant diameter in a delivery configuration, and a variable diameter in a deployed or pre-deployed configuration. The anchor frame subcomponent may conform to the shape of the tissue annulus whereas the leaflet frame subcomponent does not necessarily conform to the shape of the tissue annulus. The leaflet frame subcomponent may remain a right circular hollow cylinder or at a preferred geometrical configuration so as to present the leaflets with a geometrically stable platform ensuring proper leaflet function, including opening and closing dynamics and coaptation in the case of flexible leaflets.

In various embodiments, the retention element is operable to retain relative positioning of the leaflet frame subcomponent within the anchor frame subcomponent. The retention element is operable to translate within the lumen of the anchor frame subcomponent to adjacent the anchor frame subcomponent inflow end. The retention element hinges about the retention element second end from a compressed configuration to a deployed configuration such that the retention element is positioned substantially perpendicular to the longitudinal axis of the leaflet frame subcomponent with the retention element first end adjacent to the anchor frame subcomponent inflow end and the retention element second end adjacent to the leaflet frame subcomponent inflow end.

In various embodiments, the retention element further includes a non-permeable cover that is operable to cover an inflow annular groove defined by the anchor frame subcomponent and the connecting sheath at an inflow end of the prosthetic valve. In the retention element deployed configuration the retention element extends between the leaflet frame subcomponent inflow end and the anchor frame subcomponent inflow end with the retention element including the cover operable to cover and restrict fluid flow into the inflow annular groove.

In various embodiments, the anchor frame subcomponent has a variable length about a circumference such that the anchor frame subcomponent outflow end defines a tapered profile. The tapered profile is configured such that the outflow end of the anchor frame subcomponent minimizes obstructing the left ventricular outflow track (LVOT). For example, wherein the prosthetic valve is used to replace a mitral valve, a shorter portion of the anchor frame subcomponent may be orientated to face the interventricular septum (the anterior portion of the tissue annulus) whereas the longer portion of the anchor frame subcomponent may lay adjacent the posterior wall of the left ventricle.

In various embodiments, the anchor frame subcomponent is provided with an outwardly flared inflow end that is conformal to an inflow end of a tissue annulus, such as that of the mitral valve tissue annulus at the left atrium. The outwardly flared anchor frame subcomponent inflow end and/or in combination with the retention element, facilitates, among other things, the securing of the prosthetic valve against axial forces from atrial pressure when the leaflets are open.

In various embodiments, the prosthetic valve may be retrieved after deployment within the tissue annulus. The leaflet frame subcomponent is provided with a retrieval tether coupled to the leaflet frame subcomponent inflow end that is operable to compress the leaflet frame subcomponent to a smaller diameter and to pull the leaflet frame subcomponent into a retrieval sheath. The anchor frame subcomponent is operable to evert under the force of the retrieval tether pulling the leaflet frame subcomponent so as to compress and pull the anchor frame subcomponent into the retrieval sheath subsequent to the leaflet frame subcomponent. The anchor frame subcomponent may be provided tissue anchor elements configured to allow for repositioning and removal of the anchor frame from the tissue annulus with minimal trauma, discussed in greater detail herein.

Although it is appreciated that the examples of the prosthetic valve may be suitable for either surgical or transcatheter applications, examples provided herein are presented as for transcatheter applications to avoid the repetition if surgical examples are also presented. Therefore, the inventive concepts are applicable for both surgical and transcatheter applications and not limited to only transcatheter applications.

Various embodiments illustrated and described herein are directed to a prosthetic valve1000. The prosthetic valve1000is transitionable between a delivery, compressed, un-nested configuration and a deployed, expanded, nested configuration in-situ.FIG. 1Ais a side view of the prosthetic valve1000in the pre-deployed un-nested configuration showing a leaflet frame subcomponent1200, an anchor frame subcomponent1100, a connecting sheath1300therebetween in coaxial serial alignment with and connecting the leaflet frame subcomponent1200to the anchor frame subcomponent1100, further including a retention element1400coupled to the connecting sheath1300adjacent the leaflet frame subcomponent1200. FIG.1B1is a side view of the prosthetic valve1000in an expanded pre-deployed configuration showing the leaflet frame subcomponent1200and the anchor frame subcomponent1100having been expanded to larger diameters relative to the pre-expanded configuration ofFIG. 1A.

The view of FIG.1B1would be as if the prosthetic valve1000, as shown inFIG. 1A, was unconstrained from a constrained pre-nested configuration, such as when the prosthetic valve is placed over a delivery catheter1504prior to constraining onto the delivery catheter by a containing element1716, as shown inFIG. 4. The connecting sheath1300defines a tapered configuration extending from the leaflet frame subcomponent1200and the anchor frame subcomponent1100. The retention element1400may be either constrained by a restraining element, discussed below, or allowed to take the shape of the tapered configuration of the connecting sheath1300. The leaflet frame subcomponent1200and the anchor frame subcomponent1100are configured to be nestable. FIG.1C1a simplified side cross-sectional view along cut line1C2of the prosthetic valve1000of FIG.1B1in an expanded pre-deployed configuration. FIG.1C2is a simplified side cross-sectional view along cut line1C2of the prosthetic valve1000of FIG.1B1in a deployed configuration as shown inFIG. 7Cshowing the leaflet frame subcomponent1200translated into the anchor frame subcomponent1100in nested alignment, with the connecting sheath1300having been everted and positioned therebetween. The retention element1400having been translated through the anchor frame subcomponent1100and deployed to extend from the leaflet frame subcomponent1200to the anchor frame subcomponent1100. The leaflet frame subcomponent1200and an anchor frame subcomponent1100can be nested in-situ as will be described below.

The leaflet frame subcomponent1200and the anchor frame subcomponent1100are generally tubular shaped and operable to have a smaller delivery configuration diameter and a larger deployed configuration diameter, facilitated by balloon expansion and/or self-expansion deployment means. The connecting sheath1300is a flexible tubular membrane coupled about its circumference to the leaflet frame subcomponent1200at the leaflet frame subcomponent inflow end1202and to the anchor frame subcomponent1100at the anchor frame subcomponent outflow end1104operable to couple the leaflet frame subcomponent1200to the anchor frame subcomponent1100. The connecting sheath1300is thin and flexible, and operable to fold or elastically contract to a smaller diameter in a delivery configuration. The retention element1400is coupled to the connecting sheath1300adjacent to the leaflet frame subcomponent inflow end1202. The retention element1400is a flexible spring-like element that is operable to stow into a low radial profile in a delivery configuration and is operable to extend away from the leaflet frame subcomponent inflow end1202toward the anchor frame subcomponent inflow end1102under spring bias when in a deployed position. Engagement of the retention element1400with the anchor frame subcomponent inflow end1102assists in maintaining the relative position of the leaflet frame subcomponent1200within an anchor frame subcomponent lumen1140.

In various embodiments, the leaflet frame subcomponent1200is nestable within the anchor frame subcomponent1100. In particular, as shown, the anchor frame subcomponent1100and the leaflet frame subcomponent1200are sized and shaped in a manner that provides for the leaflet frame subcomponent1200being coaxially disposable or receivable at least partially within the anchor frame subcomponent1100. Thus, in various examples, the anchor frame subcomponent1100is configured such that a portion of (or alternatively all of) the leaflet frame subcomponent1200can be received by or otherwise positioned within a space defined by the anchor frame subcomponent1100. In some examples, the leaflet frame subcomponent1200is sized such that a diameter of the exterior surface of the leaflet frame subcomponent1200is less than a diameter of the interior surface of the anchor frame subcomponent1100. In some examples, a diameter of the exterior surface of the leaflet frame subcomponent1200is in a range of between seventy five percent (75%) and ninety percent (90%) of a diameter of the interior surface of the anchor frame subcomponent1100. In some examples, a diameter of the exterior surface of the leaflet frame subcomponent1200is seventy five percent (75%) or less than a diameter of the interior surface of the anchor frame subcomponent1100. In various examples, such configurations also provide that the leaflet frame subcomponent1200can be received within the anchor frame subcomponent1100. In various examples, such configurations provide that the anchor frame subcomponent1100can deform, such as, but not limited to being out of round or generally oval-shaped, to accommodate or otherwise conform to the native valve orifice without causing a deformation of the leaflet frame subcomponent1200. The prosthetic valve1000provides a leaflet frame subcomponent1200that essentially floats within the anchor frame subcomponent1100and does not directly couple with a native valve orifice. The anchor frame subcomponent1100may conform to the shape of the native valve orifice whereas the leaflet frame subcomponent1200does not conform to the shape of the native valve orifice. The leaflet frame subcomponent1200remains a right circular hollow cylinder or at a preferred geometrical configuration so as to present the leaflets1230with a geometrically stable platform ensuring proper leaflet function, including opening and closing dynamics and, for flexible leaflets, coaptation. It is appreciated that these benefits associated with the leaflet frame subcomponent1200not needing to conform to the native valve orifice may be realized in either transcatheter or surgical placement of the prosthetic valve1000.

In various embodiments, as discussed in greater detail below, the prosthetic valve1000is configured such that the anchor frame subcomponent1100and the leaflet frame subcomponent1200can be nested in-situ after the anchor frame subcomponent1100and the leaflet frame subcomponent1200are deployed to a treatment site in a patient's anatomy. That is, in various embodiments, the prosthetic valve1000can be delivered to a treatment region within a patient's anatomy with the anchor frame subcomponent1100and the leaflet frame subcomponent1200longitudinally offset relative to one another and subsequently nested with one another at the treatment site. In various embodiments, the prosthetic valve1000is loaded onto a delivery catheter with the anchor frame subcomponent1100and the leaflet frame subcomponent1200longitudinally offset relative to one another which presents a lower profile or diameter than if the prosthetic valve1000were to be loaded onto the delivery catheter in the nested configuration. A lower delivery profile of a transcatheter delivered prosthetic valve has well recognized advantages, including easier advancement though vessels.

It is appreciated that these benefits associated with the leaflet frame subcomponent1200not being nested into the anchor frame subcomponent1100during implantation may also be realized in surgical placement of the prosthetic valve1000. By way of example, but not limited thereto, the anchor frame subcomponent1100may be more easily sutured into the native valve orifice without the leaflet frame subcomponent1200being within the anchor frame subcomponent1100and in close proximity to the suturing procedure lessening the chance of needle damage to the leaflets.

Leaflet Frame Subcomponent

FIG. 1Dis an axial view of the prosthetic valve1000from the inflow end in the deployed configuration showing a leaflet frame subcomponent1200, an anchor frame subcomponent1100, and the connecting sheath1300therebetween (the retention element1400is shown without a cover in accordance with an embodiment and for clarity of visualizing the other components).FIG. 1Eis a perspective view of the leaflet frame1220and anchor frame1120, without other components for clarity, in the deployed configuration. The leaflet frame subcomponent1200provides the prosthetic valve1000with the functionality of a one-way valve1030. It is understood and appreciated that one-way valves1030are well known in the art and may be used herein. It is appreciated that mechanical valves, biological valves, and biological and synthetic leaflet valves may be used as the one-way valve1030of the leaflet frame subcomponent1200. It is also appreciated that, for transcatheter applications, the leaflet frame subcomponent1200is required to have a smaller-diameter compressed configuration and a larger-diameter expanded configuration, and that the one-way valve component must be able to accommodate that functionality.

Referring forFIGS. 1A-1E, in accordance with embodiments, the leaflet frame subcomponent1200includes a leaflet frame1220, one or more leaflets1230, and leaflet frame cover1232. The leaflet frame subcomponent1200is generally tubular shaped defining a leaflet frame subcomponent inflow end1202and a leaflet frame subcomponent outflow end1204with a leaflet frame subcomponent lumen1240therethrough.

The leaflet frame1220provides structural support for the leaflets1230. The leaflet frame1220is operable to have a smaller delivery configuration diameter and a larger deployed configuration diameter, facilitated by balloon expansion and/or self-expansion deployment means. As is known in the art, by way of example, a structure defining apertures, such as, but not limited to, a wire form or perforated wall tube that allows for the leaflet frame to have various diameters, such as a stent, is suitable for the particular purpose.

The leaflet frame subcomponent1200is configured to be received within at least a portion of the anchor frame subcomponent1100, as shown in FIGS.1C2,1D and10M, and as will be described in more detail below. It will be appreciated that nonlimiting examples of the leaflet frame subcomponent1200can be provided with a diameter (e.g., a diameter of an interior or exterior surface of the leaflet frame subcomponent1200) in a range of between twenty (20) millimeters and thirty (30) millimeters, depending on a patient's anatomy.

FIG. 2Ais a side view of the leaflet frame1220without leaflets1230nor leaflet frame cover1232shown for clarity.FIG. 2Bis an axial view of the leaflet frame1220showing a plurality of leaflets1230therein. The leaflet frame wall1205of the leaflet frame1220may be at least partially covered with a leaflet frame cover1232, such as an impermeable film or fabric, suitable for a particular purpose, such as to restrict fluid from passing through the leaflet frame wall1205of the leaflet frame1220. For illustrative purposes, the following examples are suitable especially for a transcatheter application, but are also suitable for a surgical application.

Referring toFIG. 2A, the leaflet frame1220is a generally tubular member having a leaflet frame inflow end1222corresponding to a leaflet frame subcomponent inflow end1202, a leaflet frame outflow end1224corresponding to a leaflet frame subcomponent outflow end1204, a leaflet frame inner surface1206and a leaflet frame outer surface1208defining a leaflet frame wall1205, wherein the leaflet frame inner surface1206defining a leaflet frame subcomponent lumen1210therethrough. The leaflet frame subcomponent lumen1210is a generally cylindrical void defined between the leaflet frame inflow end1222and the leaflet frame outflow end1224, and the leaflet frame inner surface1206.

The leaflet frame1220defines a tubular framework defining apertures or voids1216. For example, as shown, the leaflet frame1220includes a plurality of frame members1212that are interconnected and arranged in one or more patterns. In various examples, the frame members1112are connected to one another at various joints1214. In some examples, these joints1214operate as flex points so as to provide a preferential flexing location for the leaflet frame subcomponent1200, such as to flex when compressed to a smaller delivery diameter such as required for transcatheter delivery. In some examples, a flex point or joint1214comprises a site on the leaflet frame1220that undergoes a high degree of bending. In some examples, the flex points or joints1214may comprise a geometry, structural modification or material modification, among others, that biases the leaflet frame1220to bend at the joint1214when compressed or expanded between a larger diameter and a smaller diameter.

In some examples, one or more closed cell apertures or voids1216are defined between the joints1214and the interconnected frame members1212of the leaflet frame subcomponent1200. In some examples, these apertures or voids1216extend from the leaflet frame outer surface1208to the leaflet frame inner surface1206of the leaflet frame wall1205of the leaflet frame1220. As illustrated in the embodiments ofFIG. 2A, one or more of the apertures or voids1216define a diamond shape when the leaflet frame subcomponent1200is in a deployed configuration. Upon compression to a smaller diameter (e.g., a delivery diameter), one or more of the joints1214and the frame members1212deform such that the apertures or voids1216generally define an elongated diamond shape (e.g., as shown generally inFIG. 1A). Upon expanding the leaflet frame subcomponent1200to a larger diameter during deployment at a treatment site, the apertures or voids1216expand to define the generally wider diamond shape.

It should be appreciated that while the frame members1212illustrated and described herein are interconnected and define apertures or voids1216having generally a diamond shape, the interconnected frame members1212may be arranged in a number of alternative patterns without departing from the spirit or scope of the disclosure. That is, a number of alternative patterns are envisioned where the arrangement of frame members1212is configured in such a manner as to provide for a leaflet frame subcomponent1200that can be compressed to a smaller diameter for transcatheter delivery and subsequently expanded (or allowed to expand) to a larger diameter at a treatment site during deployment of the prosthetic valve1000. Accordingly, the disclosure should not be limited to arrangements of the frame members1212that define diamond-shaped apertures or voids1216. For example, a framework of the leaflet frame1220can define any number of features, repeatable or otherwise, such as geometric shapes and/or linear or meandering series of sinusoids. Geometric shapes can comprise any shape that facilitates circumferential compressibility and expandability.

In various embodiments, the leaflet frame1220may comprise or otherwise be formed from a cut tube, or any other element suitable for the particular purpose of the leaflet frame1220as described herein. In some examples, the leaflet frame1220may be etched, cut, laser cut, or stamped into a tube or a sheet of material, with the sheet then formed into a tubular structure. Alternatively, an elongated material, such as a wire, bendable strip, or a series thereof, can be bent or braided and formed into a substantially tubular structure wherein the wall of the tube comprises an open framework that is compressible to a smaller diameter and expandable to a larger diameter as illustrated and described herein.

The leaflet frame1220may comprise, such as, but not limited to, any elastically deformable metallic or polymeric biocompatible material, in accordance with embodiments. The leaflet frame1220may comprise a shape-memory material, such as nitinol, a nickel-titanium alloy. Other materials suitable for the leaflet frame1220include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer, acetyl copolymer, other alloys or polymers, or any other biocompatible material having adequate physical and mechanical properties to function as a leaflet frame subcomponent1200as described herein.

In various examples, as the leaflet frame1220is elastically deformable so as to be self-expanding under spring loads, as those of skill will appreciate. In some examples, the leaflet frame1220is plastically deformable so as to be mechanically expanded such as with a balloon, as those of skill will appreciate. In yet some other examples, the leaflet frame1220is plastically deformable as well as elastically deformable. That is, in some examples, the leaflet frame1220includes one or more elastically deformable components or features and one or more plastically deformable components or features. Thus, it should be appreciated that the examples of the leaflet frame1220presented herein are not to be limited to a specific design or mode of expansion.

In accordance with some embodiments, the leaflet frame1220comprises a shape memory material operable to flex under load and retain its original shape when the load is removed, thus allowing the leaflet frame subcomponent1200to self-expand from a compressed shape to a predetermined shape. The leaflet frame subcomponent1200and the anchor frame subcomponent1100may comprise the same or different materials. In accordance with an embodiment, the leaflet frame1220is plastically deformable to be expanded by a balloon. In another embodiment the leaflet frame1220is elastically deformable so as to be self-expanding.

In various embodiments, the leaflet frame subcomponent1200supports or otherwise includes a one-way valve1030. In some examples, the one-way valve1030includes one or more leaflets1230as shown inFIGS. 1D and 2B. A variety of mechanical valve, biological leaflet, and synthetic leaflet designs are known in the medical technology arts, any of which may be incorporated into the leaflet frame subcomponent1200of the present disclosure. Examples of suitable leaflet constructs and methods of attachment to leaflet frame subcomponents are illustrated and described in U.S. patent application Ser. Nos. 13/833,650, 14/973,589, and 14/622,599, the contents of each of which are incorporated herein by reference. Further examples of suitable leaflet material are presented below.

In the embodiments ofFIGS. 1D and 2B, the leaflet frame subcomponent1200further comprises one or more flexible leaflets1230coupled to the leaflet frame1220that are operable to open to allow flow from the leaflet frame subcomponent inflow end1202and to pass through the leaflet frame subcomponent outflow end1204, as shown in FIGS.1B1-1B3, also referred to as the forward flow direction, and are operable to close to restrict flow from flowing from the leaflet frame subcomponent outflow end1204through the leaflet frame subcomponent inflow end1202, also referred to as the retrograde flow direction.

In some examples, the one-way valve1030or leaflets1230are coupled to the leaflet frame inner surface1206of the leaflet frame1220. In other examples, a film that comprises a leaflet material is coupled to the leaflet frame outer surface1208and extends through a leaflet window defined by the leaflet frame1220. Such a configuration minimizes a potential for the leaflet1230to peel or delaminate, as compared to configurations where the leaflets1230are coupled to a leaflet frame inner surface1206of the leaflet frame1220. In some examples, one or more portions of the leaflets1230are wrapped about one or more portions of the leaflet frame subcomponent1200.

The leaflet frame subcomponent1200further comprises a leaflet frame cover1232that is operable to prevent the flow of fluid through the wall of the leaflet frame1220such that the fluid can only flow through a lumen defined by the open leaflets1230. FIGS.1B1-1B3provide embodiments wherein the voids1216of the leaflet frame1220are covered by the leaflet frame cover1232so as to block flow through the portion of the leaflet frame1220that is upstream of the attachment of leaflets1230to the leaflet frame1220. In accordance with an example, the leaflet frame cover1232may be an impermeable film, sheet or membrane material that is wrapped around and coupled to the leaflet frame outer surface1208. The leaflet frame cover1232may comprise any suitable material known in the art. By way of example, the leaflet frame cover1232may be a film, fabric, among others.

The leaflet frame cover1232may be a sheet-like material that is biologically compatible and configured to couple to the leaflet frame1220. In various examples, the biocompatible material is a film that is not of a biological source and that is sufficiently flexible and strong for the particular purpose, such as a biocompatible polymer. In an embodiment, the film comprises a biocompatible polymer (e.g., ePTFE). In some examples, the film is a composite of two or more materials. The film may comprise one or more of a membrane, composite material of two or more components, or laminate of more than one layer of material. In various examples, the construction of and materials used in the film are such that the leaflet frame cover1232is impermeable to fluid flow.

Anchor Frame Subcomponent

In accordance with an embodiment, the anchor frame subcomponent1100includes an anchor frame1120and an anchor frame cover1132as shown in FIGS.1B1-1B3.FIG. 3Ais a side view of the anchor frame1120.FIG. 3Bis an axial view of the anchor frame1120. The anchor frame wall1105of the anchor frame1120may be at least partially covered, such as with a film or fabric, not shown for clarity, suitable for a particular purpose, such as to restrict fluid from passing through the anchor frame wall1105of the anchor frame1120, or to encourage tissue ingrowth of the anchor frame subcomponent1100with the implant site. The anchor frame cover1132may be coupled to the inner surface, outer surface, or both inner surface and outer surface of the anchor frame1120. For illustrative purposes, the following examples are suitable especially for a transcatheter application, but are also suitable for a surgical application.

FIGS. 3A and 3Bare side and axial views, respectively, of the anchor frame1120without the anchor frame cover1132for clarity, in accordance with an embodiment. The anchor frame1120is a generally tubular member having an anchor frame inflow end1122corresponding to an anchor frame subcomponent inflow end1102, an anchor frame outflow end1124corresponding to an anchor frame subcomponent outflow end1104, an anchor frame inner surface1106and an anchor frame outer surface1108defining an anchor frame wall1105, wherein the anchor frame inner surface1106defining an anchor frame subcomponent lumen1110therethrough. The anchor frame subcomponent lumen1110is a generally cylindrical void defined between the anchor frame subcomponent inflow end1102and the anchor frame subcomponent outflow end1104, and the anchor frame inner surface1106of the anchor frame subcomponent1100. However, in-situ, the anchor frame subcomponent lumen1110may adopt an irregular cross section, depending on the geometry of the tissue orifice into which it is placed and the conformity of the anchor frame subcomponent1100to the tissue annulus at the implant site.

In various examples, the anchor frame1120is configured to couple to a native valve orifice. Accordingly, in various examples, a diameter of the anchor frame1120(e.g., a diameter of the anchor frame outer surface1108, and essentially the diameter of the anchor frame subcomponent outer surface1109, shown inFIG. 1D, of the anchor frame subcomponent1100) is sized in accordance with patient anatomy. It will be appreciated that nonlimiting examples of an anchor frame subcomponent1100can be provided with a diameter (e.g., a diameter of an exterior surface of the anchor frame subcomponent1100) in a range of between twenty five (25) millimeters and fifty (50) millimeters, depending on a patient's anatomy. However, anchor frames1120having diameters (e.g., a diameter of an anchor frame outer surface1106of the anchor frame1120) in excess of fifty (50) millimeters are also envisioned and fall within the scope of the present disclosure, depending on patient anatomy. Note that the anchor frame subcomponent inner surface1107, shown inFIG. 1D, of the anchor frame subcomponent1100has a diameter at least slightly larger than the leaflet frame outer surface1208of the leaflet frame subcomponent1200such that the leaflet frame subcomponent1200may telescopically nest within the anchor frame subcomponent1100.

In another embodiment the anchor frame1120is elastically deformable so as to be self-expanding. In accordance with some embodiments, the anchor frame1120comprises a shape memory material operable to flex under load and retain its original shape when the load is removed, thus allowing the anchor frame subcomponent1100to self-expand from a compressed shape to a predetermined larger shape. The anchor frame1120may comprise the same or different materials as the leaflet frame1220. In accordance with an embodiment, the anchor frame1120is plastically deformable, such that it may be mechanically expanded such as by a balloon.

In some embodiments, the anchor frame1120defines a tubular mesh having a framework defining apertures or voids1116as shown inFIG. 3A. For example, as shown, the anchor frame1120includes a plurality of frame members1112that are interconnected and arranged in one or more patterns. In some examples, these patterns repeat one or more times. In some such examples, the frame members1112are arranged and interconnected such that the anchor frame1120includes a plurality of patterned rows. In various examples, the frame members1112are connected to one another at various joints1114. In some examples, these joints1114operate as flex points so as to provide a preferential flexing location for the anchor frame1120to flex when compressed to a smaller delivery diameter and when forces from the surrounding anatomy act to compress the anchor frame1120during normal operation after delivery and deployment of the prosthetic valve1000. In some examples, a flex point or joint1114comprises a site on the anchor frame1120that undergoes a high degree of bending. In some examples, the joints1114may comprise a geometry, structural modification or material modification, among others, that biases the anchor frame1120to bend at the flex point or joint1114when compressed.

In some embodiments, one or more closed cell apertures or voids1116are defined between the joints1114and the interconnected frame members1112of the anchor frame1120. In some examples, these apertures or voids1116extend from the anchor frame outer surface1108to the anchor frame subcomponent inner surface1107of the anchor frame1120. As illustrated in the embodiments ofFIGS. 3A and 3B, one or more of the apertures or voids1116define a diamond shape when the anchor frame1120is in a deployed configuration. Upon compression to a smaller diameter (e.g., a delivery diameter), one or more of the joints1114and the frame members1112deform such that the apertures or voids1116generally define an elongated diamond shape (e.g., as shown generally inFIG. 1A). Upon expanding the anchor frame1120to a larger diameter during deployment at a treatment site, the apertures or voids1116expand to define the generally wider diamond shape.

It should be appreciated that while the frame members1112illustrated and described herein are interconnected and define apertures or voids1116having generally a diamond shape, the interconnected frame members1112may be arranged in a number of alternative patterns. For example, a framework of the anchor frame1120can define any number of features, repeatable or otherwise, such as geometric shapes and/or linear or meandering series of sinusoids. Geometric shapes can comprise any shape that facilitates circumferential compressibility and expandability of the anchor frame1120. That is, a number of alternative patterns are envisioned where the arrangement of frame members1112is configured in such a manner as to provide for an anchor frame1120that can be compressed to a smaller diameter for transcatheter delivery and subsequently expanded (or allowed to expand) to a larger diameter at a treatment site during deployment of the prosthetic valve1000. Accordingly, the disclosure should not be read as being limited to arrangements of the frame members1112that define diamond-shaped apertures or voids1116.

In various embodiments, the anchor frame1120may comprise or otherwise be formed from a cut tube, or any other element suitable for the particular purpose of the anchor frame1120as described herein. In some examples, the anchor frame1120may be etched, cut, laser cut, or stamped into a tube or a sheet of material, with the sheet then formed into a tubular structure. Alternatively, an elongated material, such as a wire, bendable strip, or a series thereof, can be bent or braided and formed into a tubular structure wherein the wall of the tube comprises an open framework that is compressible to a smaller diameter in a generally uniform and circumferential manner and expandable to a larger diameter as illustrated and described herein.

The anchor frame1120can comprise any metallic or polymeric biocompatible material. For example, the anchor frame1120can comprise a material, such as, but not limited to nitinol, cobalt-nickel alloy, stainless steel, or polypropylene, acetyl homopolymer, acetyl copolymer, ePTFE, other alloys or polymers, or any other biocompatible material having adequate physical and mechanical properties to function as described herein.

In various examples, the anchor frame1120is elastically deformable so as to be self-expanding under spring loads, as those of skill will appreciate. In some examples, the anchor frame1120is plastically deformable so as to be mechanically expanded such as with a balloon, as those of skill will appreciate. In yet some other examples, the anchor frame1120is plastically deformable as well as elastically deformable. That is, in some examples, the anchor frame1120includes one or more elastically deformable components or features and one or more plastically deformable components or features. Thus, it should be appreciated that the examples of the anchor frame1120presented herein are not to be limited to a specific design or mode of expansion.

In various embodiments, the anchor frame subcomponent1100is configured to provide positive engagement with an implant site to firmly anchor the prosthetic valve1000to the site. Such positive engagement with the implant site may be facilitated by one or more of the following, but not limited thereto: expansion spring bias of the anchor frame1120; hoop strength of the expanded anchor frame1120, tissue engagement features, and the geometric shape, contour and/or texture of the anchor frame subcomponent outer surface1109.

For instance, in various examples, the anchor frame subcomponent1100includes one or more tissue engagement features1118that are configured to engage one or more regions of tissue at the tissue orifice surrounding the prosthetic valve1000. In various examples, the tissue engagement features1118comprise one or more barbs or tissue anchors. The tissue engagement features1118will be discussed in detail later.

In some embodiments, the anchor frame1120defines a flange or a flared portion1130at the anchor frame subcomponent inflow end1102that flares or tapers radially outward when in the deployed configuration. For example, as shown in at least FIGS.1B1,1B2,1B3,2A,5A-5C,5E, and10B-10M, the anchor frame subcomponent inflow end1102is flared or otherwise tapered radially outward when in the deployed configuration. That is, as shown, the anchor frame subcomponent inflow end1102has a larger deployed diameter than does the anchor frame subcomponent outflow end1104. In various examples, as discussed in greater detail below, such a configuration operates to minimize migration risks and helps facilitate abutment of the anchor frame subcomponent1100with native tissue annulus at the implant site.

In some embodiments, the anchor frame subcomponent1100further comprises a flange element1150separate from, adjacent to, and coaxial with the anchor frame inflow end1122of the anchor frame1120. FIG.1B2is a side view of the prosthetic valve1000in an expanded pre-deployed configuration showing the leaflet frame subcomponent1200and the anchor frame subcomponent1100having been expanded to larger diameters so as to show the details of the flange element1150as compared with an integral flange or flared portion1130of the anchor frame inflow end1122of anchor frame1120of the embodiment of FIG.1B1. The flange element1150defines a flange or a flared portion1130of the anchor frame subcomponent1100that also defines the anchor frame subcomponent inflow end1102that flares or tapers radially outward when in the deployed configuration. The flange element1150is a generally tubular member of substantially the same construction as the anchor frame1120. The flange element1150has a flange element inflow end1152, a flange element outflow end1154, a flange element inner surface1156, and a flange element outer surface1158defining a flange element wall1155defining flange voids1157. The flange element inner surface1156defines a portion of the anchor frame subcomponent lumen1110therethrough. In-situ, the flange element1150may adopt an irregular cross section, depending on the geometry of the tissue orifice into which it is placed and the conformity of the flange element1150to the tissue annulus at the implant site.

The flange element1150is coupled to the anchor frame inflow end1122by the anchor frame cover1132which is described below. The flange element1150defines a flange element inflow end1152and a flange element outflow end1154. The flange element1150is located adjacent to, coaxial with, and axially spaced apart from the anchor frame1120, with the flange element outflow end1154adjacent to but separate from the anchor frame inflow end1122.

FIG.1B2shows the flange element1150flaring outward in a trumpet shape having a concave curvature to the flange element outer surface1158. FIG.1B3shows another embodiment of the flange element1150wherein the flange element outer surface1158defines a convex curvature. The shape of the anatomy into which the anchor frame subcomponent1100is placed will determine the best choice of shape for the flange element1150of FIGS.1B2-1B3or the flared portion1130of the anchor frame subcomponent1100of FIG.1B1. The flared portion1130of the anchor frame subcomponent1100of FIG.1B1may also define the convex curvature of the embodiment of FIG.1B3suitable for a particular anatomy into which is it placed.

The anchor frame subcomponent1100further comprises an anchor frame cover1132that is operable to prevent the flow of fluid through the anchor frame wall1105of the anchor frame1120. The anchor frame cover1132may also be operable to provide a favorable surface for tissue abutment at the tissue annulus, and further, may be operable to facilitate tissue ingrowth which may be advantageous for fixation of the prosthetic valve1000to the tissue annulus, facilitate a favorable biological response of the blood (e.g., to prevent a thrombotic response), and/or facilitate sealing of the prosthetic valve1000with the tissue orifice to minimize para-valvular leakage.FIG. 1Bprovides an embodiment wherein all of the voids1116of the anchor frame1120are covered by the anchor frame cover1132so as to block flow through the anchor frame wall1105. In accordance with an example, the anchor frame cover1132may be an impermeable film, sheet or membrane material that is wrapped around and coupled to the anchor frame outer surface1108. The anchor frame cover1132may comprise any suitable material known in the art. By way of example, the anchor frame cover1132may be a film, fabric, among others.

The anchor frame cover1132may be a sheet-like material that is biologically compatible and configured to couple to the anchor frame1120. In various examples, the biocompatible material is a film that is not of a biological source and that is sufficiently flexible and strong for the particular purpose, such as a biocompatible polymer. In an embodiment, the film comprises a biocompatible polymer (e.g., ePTFE). In some examples, the film is a composite of two or more materials. The film may comprise one or more of a membrane, composite material, or laminate. In various examples, the construction of and materials used in the film are such that the anchor frame cover1132is impermeable to fluid flow. In various examples, the construction of and materials used in the film are such that the anchor frame cover1132promotes cellular ingrowth, adhesion, and/or attachment. That is, in various examples, the anchor frame cover1132is constructed in a manner that promotes the ingrowth of tissue into one or more portions of the anchor frame cover1132. It will be appreciated that cellular ingrowth may further increase sealing of the prosthetic valve with the tissue orifice and helps minimize para-valvular leakage, that is, leakage between the prosthetic valve and the tissue into which it is coupled.

Connecting Sheath

In accordance with embodiments of the prosthetic valve1000, the anchor frame subcomponent1100and the leaflet frame subcomponent1200are coupled together by the connecting sheath1300. Referring toFIGS. 1A-1C2, the connecting sheath1300is coupled to the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100at a connecting sheath inflow end1322and is coupled to the leaflet frame subcomponent inflow end1202at a connecting sheath outflow end1324. The connecting sheath1300is a thin-walled flexible tubular member that defines a connecting sheath lumen1340in fluid communication with the anchor frame subcomponent lumen1140and the leaflet frame subcomponent lumen1240when in the pre-deployed configuration. When the leaflet frame subcomponent1200is nested into the anchor frame subcomponent1100the connecting sheath1300is operable to fold and evert so as to lie between the leaflet frame subcomponent1200and the anchor frame subcomponent1100. The connecting sheath1300may comprise any suitable material known in the art. By way of example, the connecting sheath1300may be a film, fabric, membrane, among others, that is flexible and impermeable to fluid flow.

Referring toFIG. 4, showing a side view of the prosthetic valve1000in a pre-deployed configuration on a delivery catheter1504of a delivery device1500, in some examples, the connecting sheath1300is disposed within and/or about the anchor frame subcomponent1100and the leaflet frame subcomponent1200. In some examples, the connecting sheath1300is a contiguous film that at least extends between and operates to couple the anchor frame subcomponent1100and the leaflet frame subcomponent1200to one another. In some examples, the connecting sheath1300extends not only between but also over or within either or both of the anchor frame subcomponent1100and the leaflet frame subcomponent1200. In some examples, the connecting sheath1300is a contiguous film with that of the anchor frame cover1132and/or the leaflet frame cover1232that at least extends between and operates to couple the anchor frame subcomponent1100and the leaflet frame subcomponent1200to one another. In some examples, the connecting sheath1300is formed from a generally tubular material and at least partially covers one or more of the anchor frame subcomponent1100and the leaflet frame subcomponent1200. In some examples, the connecting sheath1300is formed by wrapping a film over and around a cylindrical mandrel that defines a variable diameter to match the respective inner diameter of each of the leaflet frame1220and anchor frame1120with a tapered portion therebetween to transition from the smaller diameter of the leaflet frame1220to the larger diameter of the anchor frame1120. Either or both of the anchor frame1120and the leaflet frame1220are slid over the film and bonded thereto to the inner surface of the frames. In some examples, the connecting sheath1300is formed by wrapping the film over and around either or both of the anchor frame1120and the leaflet frame1220and bonded thereto to the outer surface of the frames.

The connecting sheath1300is generally any sheet-like material that is biologically compatible and configured to couple to the anchor frame subcomponent1100and the leaflet frame subcomponent1200. In various examples, the biocompatible material is a film that is not of a biological source and that is sufficiently flexible and strong for the particular purpose, such as a biocompatible polymer. In an embodiment, the film comprises a biocompatible polymer (e.g., ePTFE). In some examples, the film is a composite of two or more materials. The film may comprise one or more of a membrane, composite material, or laminate. In various examples, the construction of and materials used in the film are such that the connecting sheath1300is impermeable to fluid flow.

In various examples, the connecting sheath1300is a tubular member having a connecting sheath wall1305that is impervious to fluid flow and controls the flow of fluid only through the connecting sheath lumen1340particularly during deployment of the prosthetic valve1000into the tissue orifice, as shown in FIGS.6B1-6C2, and acts as an impermeable seal between the leaflet frame subcomponent1200and the anchor frame subcomponent1100when in the deployed nested configuration as shown inFIG. 6D. As will be discussed further below, during deployment of the prosthetic valve1000, with the anchor frame subcomponent1100deployed within the tissue annulus and the leaflet frame subcomponent1200still mounted on the delivery catheter1504, as shown in FIGS.6B1-6C2, blood flow may be occluded until which time the leaflet frame subcomponent1200is released from the delivery catheter1504and/or after the leaflet frame subcomponent1200is deployed within the anchor frame subcomponent1100and the delivery catheter1308removed from the leaflet frame subcomponent1200.

In various examples, the connecting sheath1300is operable to allow antegrade fluid flow, (i.e., blood perfusion) through the connecting sheath wall1305during deployment of the prosthetic valve1000into the tissue orifice. For example, and with reference toFIGS. 5A-5C and 5E, a prosthetic valve2000includes one or more flow enabling features2350formed in the connecting sheath1300extending between the anchor frame subcomponent1100and the leaflet frame subcomponent1200.FIG. 5Ais a side view of the prosthetic valve2000with the flow enabling features2350in an open configuration where antegrade flow (denoted by arrow “A”) is permitted.FIG. 5Bis a side view of the prosthetic valve2000with the flow enabling features2350in a closed configuration where retrograde (denoted by arrow “R”) flow is obstructed. In some examples, the one or more flow enabling feature2350include one or more perforations or apertures. The flow enabling features2350are operable to enable antegrade flow and prevent retrograde flow through the flow enabling features2350prior to the anchor frame subcomponent2100and the leaflet frame subcomponent2200being nested together and in a fully deployed configuration. Further, the flow enabling features2350are configured to be fully closed and sealed when the leaflet frame subcomponent2200is nested into the anchor frame subcomponent1100and in a fully deployed configuration.

In some examples, the one or more flow enabling features2350additionally or alternatively include one or more mechanisms that facilitate unidirectional flow. For instance, in some examples, the flow enabling features are configured as one-way valves. In some examples, one-way valves include an aperture or perforation and a flap or element of material that overlays and is larger than the aperture or perforation so as to cover and seal the aperture or perforation under retrograde flow pressure. In some examples, the one-way valve is oriented to permit antegrade flow through the prosthetic valve, while minimizing or preventing retrograde flow through the prosthetic valve.

FIGS. 5A-5Eare side views as if the prosthetic valve1000, as shown inFIG. 4, was unconstrained from a constrained pre-nested configuration in order to more clearly show the particular elements. As shown inFIGS. 5A-5B, an example of flow enabling features2350include an aperture2352and a flap2354that operate to enable antegrade flow through the prosthetic valve2000prior to the anchor frame subcomponent2100and the leaflet frame subcomponent2200being nested together (i.e., while the anchor frame subcomponent2100and the leaflet frame subcomponent2200are longitudinally offset as illustrated and described herein). The flap1354is oversized relative to the aperture2352to cover the aperture2352under retrograde flow pressure and restrict or minimize retrograde flow through the aperture2352, while during antegrade flow the flap1354lifts away from the aperture2352permitting antegrade flow through the aperture2352. Further, the flap1354is configured to cover and seal the aperture2352when the leaflet frame subcomponent2200is nested into the anchor frame subcomponent1100and in a fully deployed configuration.

In some embodiments as will be described below, the connecting sheath1300comprises two layers of film, an inner film layer1304and an outer film layer1306(as shown inFIG. 5C-5D) with both layers coupled to either the inner or outer surface of the anchor frame1120and leaflet frame1220, or the inner film layer1304bonded to the inner surfaces of the anchor frame1120and leaflet frame1220and the outer film layer1306coupled to the outer surfaces of the anchor frame1120and leaflet frame1220.

FIG. 5Cis a side view of another embodiment of the connecting sheath1300as shown coupled to the leaflet frame subcomponent1200and anchor frame subcomponent1100.FIG. 5Dis an exploded view of the connecting sheath1300. In accordance with this embodiment, the connecting sheath1300is a double layer of film, an inner film layer1304that is a conical tubular member that defines an inner layer of the connecting sheath1300and an outer film layer1306that is a conical tubular member that is slightly larger than the inner film layer1304that defines an outer layer of the connecting sheath1300when in the partially deployed configuration shown inFIG. 5C. The inner film layer1304and the outer film layer1306are coupled together at least at the leaflet frame subcomponent inflow end1202of the leaflet frame subcomponent1200and the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100. The inner film layer1304defines at least one inner film aperture1312therethrough adjacent the anchor frame subcomponent1100and the outer film layer1306defines at least one outer film aperture1310therethrough adjacent the leaflet frame subcomponent1200. A respective inner film aperture1312is offset in the radial direction from a respective outer film aperture1310to facilitate operation as provided below. The inner film layer1304and the outer film layer1306are not coupled at least between one of the inner film apertures1312and one of the outer film apertures1310so as to define a flow space1320therebetween such that the outer film layer1306lifts away from the inner film apertures1312to enable antegrade flow through the inner film apertures1312and the outer film apertures1310prior to the anchor frame subcomponent2100and the leaflet frame subcomponent2200being nested (i.e., while the anchor frame subcomponent2100and the leaflet frame subcomponent2200are longitudinally offset as illustrated and described herein). The inner film layer1304and the outer film layer1306come together to close the flow space and to cover and seal the inner film apertures1312and outer film apertures1310under retrograde flow pressure and restrict or minimize retrograde flow through the inner film apertures1312and outer film apertures1310. Further, the inner film layer1304and the outer film layer1306are configured to cover and seal the inner film apertures1312and outer film apertures1310when the leaflet frame subcomponent2200is nested into the anchor frame subcomponent1100and in a fully deployed configuration.

In the above embodiment, the inner film layer1304and the outer film layer1306are coupled together at least at the leaflet frame subcomponent inflow end1202of the leaflet frame subcomponent1200and the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100. It is appreciated that in accordance with an embodiment, the outer film layer1306may not be coupled together at or adjacent to the anchor frame subcomponent outflow end1104and still function to cover the inner film aperture1312during retrograde flow conditions. A provided in the above embodiment related to the flap2354, the outer film layer1306may function as does the flap2354; that is to occlude the inner film aperture1312during retrograde flow conditions.

FIG. 5Eis a side view of an embodiment of the connecting sheath1300as shown coupled to the leaflet frame subcomponent1200and anchor frame subcomponent1100. In accordance with this embodiment, the connecting sheath1300is a double layer of film, an inner film layer1304that is a conical tubular member that defines an inner layer of the connecting sheath1300and an outer film layer1306that is a conical tubular member that is slightly larger but shorter than the inner film layer1304that defines an outer layer of the connecting sheath1300when in the partially deployed configuration shown inFIG. 5C. The inner film layer1304and the outer film layer1306are coupled together at least at the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100but are not coupled at the leaflet frame subcomponent inflow end1202of the leaflet frame subcomponent1200.

The inner film layer1304defines at least one inner film aperture1312therethrough adjacent the anchor frame subcomponent1100and the outer film layer1306is configured to cover the at least one inner film aperture1312. Under antegrade flow conditions, the outer film layer1306lifts away from the inner film layer1304and uncovers the at least one inner film aperture1312so as to define a flow space1320therebetween such that the outer film layer1306lifts away from the inner film apertures1312to enable antegrade flow through the inner film apertures1312prior to the anchor frame subcomponent2100and the leaflet frame subcomponent2200being nested (i.e., while the anchor frame subcomponent2100and the leaflet frame subcomponent2200are longitudinally offset as illustrated and described herein). The inner film layer1304and the outer film layer1306come together to close the flow space and to cover and seal the inner film apertures1312under retrograde flow pressure and restrict or minimize retrograde flow through the inner film apertures1312. Further, the inner film layer1304and the outer film layer1306are configured to cover and seal the inner film apertures1312when the leaflet frame subcomponent2200is nested into the anchor frame subcomponent1100and in a fully deployed configuration

FIG. 6Ais a greatly simplified cross-sectional view of a representation of the prosthetic valve1000constrained onto a delivery catheter1504and placed within a tissue annulus1342, in accordance with an embodiment. In accordance with the above embodiment, as shown in FIGS.6B1and6B2, while the anchor frame subcomponent1100is being deployed within the tissue annulus1342and the leaflet frame subcomponent1200is translated and nested into the anchor frame subcomponent1100in the pre-deployed configuration, whereby everting or folding/rotating the connecting sheath1300, antegrade flow pressure causes the outer film layer1306to move away from the inner film layer1304so as to define the flow space1320between the inner film layer1304and outer film layer1306. Blood may flow in the antegrade direction into the inner film aperture1312and out of the outer film aperture1310especially during deployment of the prosthetic valve1000when the anchor frame subcomponent1100and the still mounted on the delivery catheter leaflet frame subcomponent1200are blocking antegrade flow and the leaflets1230are not yet functional. In this example, blood profusion may be maintained during substantially the entire deployment process of the prosthetic valve1000.

Under retrograde flow pressure, blood is prevented from flowing through the flow enabling features2350in a retrograde direction. Retrograde flow pressure causes the outer film layer1306to move toward and against the inner film layer1304so as to close the flow space1320between the inner film layer1304and outer film layer1306, with the inner film layer1304covering the outer film aperture1310and/or the outer film layer1306covering the inner film aperture1312due to the radial offset of the inner film aperture1312and the outer film aperture1310. Blood is prevented from flowing in the retrograde direction into the outer film aperture1310and out of the inner film aperture1312especially during deployment of the prosthetic valve1000when the deployed anchor frame subcomponent1100and the still mounted on the delivery catheter leaflet frame subcomponent1200are blocking retrograde flow.

As shown inFIG. 6Dthe leaflet frame subcomponent1200is expanded into its final deployed configuration. The inner film layer1304and the outer film layer1306are caused to come together under antegrade and retrograde fluid pressure and/or mechanical pressure narrowing or closing the flow space1320and with the inner film layer1304covering the outer film aperture1310and/or the outer film layer1306covering the inner film aperture1312closing the respective outer film aperture1310and inner film aperture1312due to the radial offset of the inner film aperture1312and the outer film aperture1310, preventing flow therethrough. In this example, blood profusion may be maintained during substantially the entire deployment process, and with the delivery catheter1504removed from the prosthetic valve1000, the leaflets1230become functional.

Retention Element

Referring again toFIGS. 1A-1B3, in various embodiments, the retention element1400is operable to position and/or retain the leaflet frame subcomponent1200within the anchor frame subcomponent. In accordance with an embodiment, the retention element1400is operable to control the axial position of the leaflet frame subcomponent1200within the anchor frame subcomponent1100. In accordance with another embodiment, the retention element1400is configured to cover an inflow annular groove formed between the anchor frame subcomponent1100and the connecting sheath1300which had been everted during the deployment process.

In accordance with an embodiment, the retention element1400defines a retention element first end1403and a retention element second end1405. The retention element second end1405is coupled to the sheath outflow end1316but is not directly coupled to the leaflet frame1220at the leaflet frame subcomponent inflow end1202, there being a portion of the connecting sheath1300therebetween. In examples of the retention element1400, the retention element second end1405is coupled only to the connecting sheath1300adjacent the leaflet frame subcomponent inflow end1202allowing the retention element1400to hinge or pivot about the retention element second end1405. The retention element1400is an elongated element that is operable to extend generally parallel to axis X of the prosthetic valve1000, as shown in FIGS.1B1-1B3,6A-6C2,10D-10F, and10I, when in the pre-deployed configuration, and operable to extend at an angle, and in some examples, in a generally lateral direction to the axis X when in the deployed configuration, as shown in FIGS.1C2,1D,6D,7B-7C, and10J-10K. As shown, the axis X is optionally a central, longitudinal axis of the prosthetic valve1000. The retention element1400is operable to translate through the anchor frame subcomponent1100during the deployment process, as shown inFIGS. 6A-6C2and10D-10J while the connecting sheath1300is operable to fold and evert within the anchor frame subcomponent lumen1140of the anchor frame subcomponent1100and lie between the leaflet frame subcomponent1200and the anchor frame subcomponent1100.

In accordance with an embodiment, the retention element1400comprises a continuous sinuous element1702. The sinuous element1702is configured to have a spring bias toward a planar star-shaped configuration defining elongated elements1412bending about apices1414, as shown inFIGS. 7B-7C. The elongated elements1412have an elongated element first end1402and an elongated element second end1404. In the star-shaped configuration, the elongated elements1412extend radially with the elongated element first ends1402and respective apices1414defining an inner circumference1422at a retention element first end1403and the elongated element second ends1404and respective apices1414defining an outer circumference1424at a retention element second end1405. The sinuous element1702is operable to be elastically restrained to a tubular configuration wherein the elongated elements1412are rotated about the apices1414at the elongated element first ends1402such that the elongated element second ends1404are rotated toward each other to define a tubular or conical configuration. With the sinuous element1702defining a first tubular diameter, the tubular diameter may be further reduced by bringing the elongated elements1412into closer arrangement while bending at the apices1414; that is, the elongated elements1412extend laterally to the axis X and along the connecting sheath1300and lateral with the anchor frame subcomponent1100and leaflet frame subcomponent1200as shown inFIG. 1A.

The sinuous element1702may be restrained to define a small tubular diameter in the constrained pre-deployment configuration at relatively the same diameter as that of the constrained leaflet frame subcomponent1200and the constrained anchor frame subcomponent1100and extending therebetween, with the retention element1400within the connecting sheath lumen1340, as shown inFIG. 1A. The connecting sheath1300may be folded and/or pleated to facilitate reduction to a smaller diameter. In the deployed configuration, the retention element first end1403of the sinuous element1702retains substantially the same diameter as the expanded leaflet frame subcomponent1200, wherein the elongated element second ends1404flare away from the elongated element first ends1402to define substantially the diameter of the anchor frame subcomponent inflow end1102, bridging the distance between the leaflet frame subcomponent inflow end1202and the anchor frame subcomponent inflow end1102and extending across an inflow annular groove1704defined by the anchor frame subcomponent inflow end1102and the connecting sheath1300. The retention element first end1403is coupled to and restrained by the connecting sheath outflow end1324. The retention element second end1405may be restrained by a retention means1710such as a lasso1712, noose, tether element1714, draw string, removable clip, or other restraining element whether on the prosthetic valve1000or on a delivery device, as shown inFIGS. 6I-6K, 7A.

The retention element1400is operable to retain the relative position of the leaflet frame subcomponent1200and the anchor frame subcomponent1100by virtue of the spring bias of the sinuous element1702resisting forces in opposition to the retention element1400being biased to a planar configuration. Spring bias forces may be predetermined such that fluid dynamic forces on the prosthetic valve1000are not sufficient to overcome the spring bias needed to bend the elongated elements1412to a tubular configuration which would lead to the leaflet frame subcomponent1200moving an unacceptable distance axially within the anchor frame subcomponent lumen1140and maintain a relative axial position (or at least minimize relative axial movement) between the anchor frame subcomponent1100and the leaflet frame subcomponent1200.

It is understood that the retention element1400may be provided with a predetermined spring bias, such that the retention element1400is operable as a shock absorber, to allow a predetermined amount of movement of the leaflet frame subcomponent1200during the operation of the prosthetic valve1000. Such predetermined amount of movement may reduce stresses within various components of the prosthetic valve1000, such as, but not limited to, the leaflets or other valve structures.

In accordance with embodiments, a non-permeable cover1432is coupled to the sinuous element1702such that fluid is prevented from passing through the retention element1400when in the deployed configuration, as shown inFIGS. 7B-7C. The cover1432extends from the apices1414at the elongated element first ends1402of the elongated elements1412to the apices1414at the elongated element second ends1404. In the deployed configuration, the cover1432extends from the leaflet frame subcomponent inflow end1202to the anchor frame subcomponent inflow end1102effectively covering the inflow annular groove1704formed between the anchor frame subcomponent1100and the connecting sheath1300.

It is desired to cover or seal off the inflow annular groove1704from blood flow for various reasons. In accordance with an embodiment, covering the inflow annular groove1704provides a smoother flow into the leaflet frame subcomponent inflow end1202of the leaflet frame subcomponent1200compared with flow that would otherwise flow antegrade into and retrograde out of the inflow annular groove1704. Further, covering the inflow annular groove1704might prevent embolus that might be formed within the inflow annular groove1704from being dislodged and flow through the prosthetic valve1000.

Manual Deployment

In accordance with embodiments, the retention element1400is advanced through the anchor frame subcomponent1100while in a compressed configuration constrained to the delivery catheter1504by withdrawing the delivery catheter1504upon which the retention element1400is mounted. The retention element1400is subsequently deployed when positioned adjacent to the anchor frame subcomponent inflow end1102. In accordance with an example, a tether element1714is coupled to the retention element1400, such as at the retention element second end1405of the retention element1400, such that an operator may pull the tether element1714to affect advancement of the retention element1400through the anchor frame subcomponent1100. The retention element second end1405of the retention element1400may be held in a compressed state by a predetermined amount of tension on the tether element1714. Tension of the tether element1714may be released and thus release the elongated element second end1404of the retention element1400so as to allow expansion and deployment of the retention element1400.

In accordance with an example, the leaflet frame subcomponent1200is nested and deployed within the anchor frame subcomponent1100prior to the deployment of the retention element1400. In another example, the retention element1400is deployed before the deployment of the leaflet frame subcomponent1200with in the anchor frame subcomponent1100. In accordance with another example, the leaflet frame subcomponent1200and the retention element1400are deployed simultaneously.

Although various examples include one or more of the anchor frame1120, flange or flared portion1130, leaflet frame1220, and/or retention element1400being discrete, separate components that are directly or indirectly coupled together, it should be understood that various examples also include one or more (e.g., all of) the anchor frame1120, flange or flared portion1130, leaflet frame1220, and retention element1400being formed as an integral unit (e.g., cut or formed from a single tube of material).

Passive Deployment

In accordance with other embodiments, after deployment or expansion of the anchor frame subcomponent1100into the tissue annulus, the connecting sheath1300presents a tapered configuration having a smaller diameter at the leaflet frame subcomponent inflow end1202to a larger diameter at the anchor frame subcomponent outflow end1104. The retention element1400may be released or deployed while still within the connecting sheath1300, wherein the apices1414at the retention element second end of the retention element1400may abut and slide along the taper of the connecting sheath inner surface1314of the connecting sheath1300, as shown in FIGS.1C1,1C2and6G, and subsequently the anchor frame subcomponent inner surface1107of the anchor frame subcomponent1100while expanding under spring bias, until the apices1414at the retention element second end are fully expanded about the anchor frame subcomponent inflow end1102of the anchor frame subcomponent1100. The spring bias may be configured such that sufficient force is produced to advance the retention element1400through the taper of the connecting sheath1300and the anchor frame subcomponent inner surface1107of the anchor frame subcomponent1100toward the anchor frame subcomponent inflow end1102while pulling the leaflet frame subcomponent1200into the anchor frame subcomponent1100. In accordance with embodiments, the leaflet frame subcomponent1200may be either retained on the delivery catheter1504or deployed to the expanded configuration prior to being pulled into the anchor frame subcomponent1100. In this embodiment, release of the constrained retention element1400allows for a passive means for advancing the leaflet frame subcomponent1200into the anchor frame subcomponent1100, that is, the operator does not need to manipulate the position of the delivery catheter1504during deployment of the leaflet frame subcomponent1200.

In accordance with another embodiment, the length of the retention element1400is predetermined such that the apices1414at the retention element second end1405of the retention element1400extend within the anchor frame subcomponent1100while in the pre-deployed configuration. When deployed, the apices1414at the retention element second end1405may abut and slide along the anchor frame subcomponent inner surface1107of the anchor frame subcomponent1100while expanding under spring bias, until the apices1414at the retention element second end1405are fully expanded about the anchor frame subcomponent inflow end1102. The spring bias may be configured such that sufficient force is produced to advance the retention element1400through the anchor frame subcomponent1100toward the anchor frame subcomponent inflow end1102while pulling the leaflet frame subcomponent1200into and nesting the anchor frame subcomponent1100. In accordance with embodiments, the leaflet frame subcomponent1200may be either retained on the delivery catheter1504or deployed to the expanded configuration prior to being pulled into and nested in the anchor frame subcomponent1100. In this embodiment, release of the constrained retention element1400allows for a passive means for advancing the leaflet frame subcomponent1200into the anchor frame subcomponent1100, that is, the operator does not need to manipulate the position of the delivery catheter1504during deployment of the leaflet frame subcomponent1200.

As will be discussed below, the delivery device may incorporate elements to facilitate the advancement and deployment of the anchor frame subcomponent1100, the leaflet frame subcomponent1200, and the retention element1400. In accordance with embodiments, the advancement of the leaflet frame subcomponent1200, and the retention element1400into the anchor frame subcomponent1100is facilitated by moving or staged withdraw of the delivery catheter. In accordance with other embodiments, the advancement of the leaflet frame subcomponent1200and the retention element1400into or through, respectively, the anchor frame subcomponent1100is facilitated by moving internal components of the delivery catheter1504, such as, but not limited to the leaflet frame subcomponent1200riding on a trolley advanced by a pulling of a tether element1714or by spring bias of the retention element1400or an internal component of the delivery device. An embodiment of a sliding trolley may be a larger diameter tubular member operable to be slidingly received onto a smaller diameter delivery catheter1504. The trolley may be constrained from sliding on the delivery catheter1504by a retention means, such as, but not limited to, a tether element1714or a latch.

Referring again to the anchor frame subcomponent1100, as shown in FIGS.1B1-1B3, the length of the anchor frame1120and thus the anchor frame subcomponent1100, is predetermined for a particular purpose. In accordance with embodiments, the length of the anchor frame1120is predetermined based on, among other things, the anatomy of the tissue annulus into which the prosthetic valve1000is implanted, including, but not limited to, the shape of the annulus, the amount of tissue available to support the anchor frame subcomponent1100, the proximity with flow paths, other tissues, and nerves, and the structural characteristics of the anchor frame subcomponent (urging engagement spring bias or plastic deformation hoop strength, fixation barbs, proper compliance, reforming/reshaping).

FIG. 8Ais a cross-sectional view of the heart and the prosthetic valve1000deployed within a tissue annulus of a mitral valve. In accordance with embodiments, the length of the anchor frame subcomponent1100is the uniform along its circumference. In other embodiments, the length of the anchor frame subcomponent1100varies along the circumference, for example, when viewed transverse to the axis X, the anchor frame subcomponent outflow end1104has a tapered geometry, as shown inFIG. 8C. By way of example, discussion of the mitral valve anatomy follows with the application of the prosthetic valve1000being used to replace a mitral valve1920(obscured and deformed by the prosthetic valve1000). Referring toFIG. 8A, the mitral valve1920is a one-way valve that allows blood flow from the left atrium1902to the left ventricle1904. Blood leaves the left ventricle1904through the aortic valve1906and into the aorta1910. Immediately before the aortic valve1906, the anatomy defines the left ventricular outflow tract (LVOT)1908, a conduit though which blood enters the aortic valve1906. Cardiac output is directly related to the smallest diameter of the LVOT1908to permit the flow of blood to the aortic valve1906. An LVOT1908that is reduced in diameter or restricted by tissue or an implanted device reduces cardiac output and can lead to debilitating cardiac function. Therefore, minimizing the blocking of the LVOT1908by the prosthetic valve1000is imperative.

The mitral valve1920and the aortic valve1906are adjacent each other and form an aortomitral angle1800relative to their transverse axes, which can vary between patients. One can see fromFIG. 8Athat where the aortomitral angle1800is much greater than 90 degrees and approaching 180 degrees, the degree of interference of the anchor frame subcomponent1100extending into the LVOT1908is less than if the aortomitral angle is closer to 90 degrees, as shown inFIG. 8B. As the aortomitral angle approaches 90 degrees, the extension of an anchor frame subcomponent anterior portion1822of the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100of a given constant length into the LVOT1908becomes greater.

In accordance with an embodiment of the prosthetic valve1000for mitral valve replacement, the length of the anchor frame subcomponent1100is determined by considering one or more of at least the following parameters: the aortomitral angle1800, and the degree of obstruction or blockage by the prosthetic valve1000of the LVOT1908, the dimensions of the tissue annulus1930and the amount of tissue available for engagement with the prosthetic valve1000. In accordance with an embodiment, to minimize blockage of the LVOT1808for smaller aortomitral angles1800, the length of the anchor frame subcomponent1100varies along its circumference, for example, when viewed transverse to the axis X, the anchor frame subcomponent outflow end1104has a tapered geometry. The anchor frame subcomponent outflow end1104is tapered such that the anchor frame subcomponent outflow end1104extends further into the left ventricle1904adjacent to a posterior side1914of the left ventricle1904and extends less into the LVOT1908on the anterior side1916of the left ventricle1904.

As shown inFIG. 8C, the length of the anchor frame subcomponent1100varies along the circumference, for example, when viewed transverse to the axis X, the anchor frame subcomponent outflow end1104has a tapered geometry, in some embodiments. As shown, the anchor frame subcomponent1100can be oriented along the X-axis and the leaflet frame subcomponent1200can be oriented along the X1-axis which is off-set to the X-axis.FIG. 8Cshows an embodiment in which “off-set” can refer to an arrangement wherein the X1-axis can be angled from the X1-axis (e.g., the X-axis and the X1-axis are non-collinear or non-parallel) such that the leaflet frame subcomponent1200is generally tilted with respect to the anchor frame subcomponent1100. In one embodiment, the second longitudinal axis is disposed at a tilt angle A between 15° and 45° relative to the first longitudinal axis. In another embodiment, the leaflet frame subcomponent outflow end1204is generally parallel with the anchor frame subcomponent outflow end1104, wherein the anchor frame subcomponent outflow end1104has a taper as characterized as having a length that varies around the circumference. In this orientation, the extension of the leaflet frame subcomponent outflow end1204into the LVOT is reduced as compared with a coaxial anchor frame subcomponent1100and leaflet frame subcomponent1200, as shown inFIG. 8B.

It has been found that fixation of the anchor frame subcomponent1100may be greater on the anchor frame subcomponent anterior portion1822of the prosthetic valve1000adjacent the aortic valve1906, that is the anterior side1916of the left ventricle1904, as compared with the anchor frame subcomponent posterior portion1932of the prosthetic valve1000adjacent the posterior side1914of the left ventricle1904. In such a case, the prosthetic valve1000may want to preferentially pivot about the anchor frame subcomponent anterior portion1822. The taper as described above having more extension and tissue engagement with the posterior side1914of the left ventricle1904, will act to further resist the movement of the anchor frame subcomponent posterior portion1932of the prosthetic valve1000. Fluid pressure in the left ventricle1904acting on the closed leaflets of the prosthetic valve1000will tend to provide a camming force to further engage the anchor frame subcomponent posterior portion1932with the posterior side1914of the left atrium1902.

Anchor Frame Variable Stiffness

In accordance with other embodiments, the hoop strength of the anchor frame subcomponent1100can be relatively invariable along the length and circumference of the anchor frame1120. In accordance with other embodiments, the hoop strength of the anchor frame subcomponent1100can be variable along the length and/or the circumference of the anchor frame1120. By way of example and in reference to the anatomy of the mitral valve tissue annulus1930, the tissue at the aortomitral junction1940side of the tissue annulus1930may be stiffer than the annulus posterior side1942of the tissue annulus1930. The variable stiffness of the anchor frame1120may be predetermined to have a greater stiffness at the smaller tapered portion of the anchor frame subcomponent anterior portion1822of the anchor frame subcomponent outflow end1104to match the stiffness of the aortomitral junction1940, as shown inFIG. 8A, whereas the stiffness may be relatively less at the longer prosthetic valve posterior portion1820adjacent the posterior side1914of the left ventricle1904.

Retrieval

In accordance with another embodiment, during a transcatheter procedure, the prosthetic valve1000is operable to be removable after deployment of the anchor frame subcomponent1100but before deployment of the leaflet frame subcomponent1200into the anchor frame subcomponent1100. In accordance with an embodiment, the anchor frame subcomponent1100has a predetermined flexibility such that the anchor frame subcomponent1100may be everted into the anchor frame subcomponent lumen1110. In an embodiment, the bending of the anchor frame subcomponent1100during eversion occurs along the length of the anchor frame1120, such that the anchor frame subcomponent1100peels away from the tissue annulus1342, as shown in FIG.9C1. In accordance with another embodiment, a portion of the anchor frame subcomponent1100may pivot and compress about a location adjacent to the anchor frame subcomponent inflow end1102, such as at the flared portion1130, such that the anchor frame subcomponent1100may pivot or fold inwardly into the anchor frame subcomponent lumen1110and be drawn out of the anchor frame subcomponent lumen1110having been everted, as shown in FIG.9C2.

In accordance with a method of retrieving the prosthetic valve1000, a distal end of a retrieval sheath1950is positioned adjacent to the anchor frame subcomponent inflow end1102of the prosthetic valve1000. The retrieval sheath1950is an elongated tubular member, such as a catheter, that defines a retrieval sheath lumen1952operable to receive the at least partially compressed prosthetic valve1000. The leaflet frame subcomponent1200is reduced in diameter if fully deployed within the anchor frame subcomponent lumen1110by use of a retraction means1956, such as a noose, tether, or the like to a diameter small enough to enter the retrieval sheath lumen1952. The retracting means1956extends from the retrieval sheath lumen1952and is operable to pull the prosthetic valve1000into the retrieval sheath lumen1952.

The leaflet frame subcomponent1200is reduced in diameter and pulled into the retrieval sheath lumen1952by the retraction means1956, as shown inFIG. 9A. As the leaflet frame subcomponent1200and the connecting sheath1300is pulled into the retrieval sheath lumen1952, the anchor frame subcomponent1100is pulled away from the tissue annulus1930. In an embodiment, the bending of the anchor frame subcomponent1100during eversion occurs along the length of the anchor frame1120, such that the anchor frame subcomponent1100peels away from the tissue annulus1342, as shown in FIG.9B1. In accordance with another embodiment, a portion of the anchor frame subcomponent1100may pivot and compress about a location adjacent to the anchor frame subcomponent inflow end1102, such as at the flared portion1130, such that the anchor frame subcomponent1100may pivot or fold inwardly into the anchor frame subcomponent lumen1110and be drawn out of the anchor frame subcomponent lumen1110having been everted, as shown in FIG.9B2. The anchor frame subcomponent1100is operable to compress to a smaller diameter to be received within the retrieval sheath lumen1952as shown inFIGS. 9A-9D.

It is appreciated that the anchor frame subcomponent1100may further comprises tissue engagement features1118, as shown in FIGS.1B1-1B3. In consideration of retrieval, the tissue engagement features1118are operable to minimize trauma as they are pulled from the tissue annulus1930during retrieval. In accordance with an embodiment, the tissue engagement features1118have a predetermined angle to the axis X such that when the anchor frame subcomponent1100is everted, the tissue anchors will radially extract from the tissue annulus.

Outflow Annular Groove Cover

FIG.7D3is a side view of an embodiment of a prosthetic valve1000in an expanded pre-deployed configuration. In various examples of the prosthetic valve1000, when in the deployed configuration, an outflow annular groove is defined by the leaflet frame subcomponent1200and the connecting sheath, as shown in FIG.7D1. FIG.7D1is a simplified side cross-sectional view along cut line7D2of the prosthetic valve1000of FIG.7D3in a deployed configuration as shown by way of example inFIG. 7C, but further comprising an outflow annular groove cover1440. The outflow annular groove cover1440is an annular element that is coupled to and extends from a leaflet frame cover outflow edge1233of the leaflet frame subcomponent outflow end1204to the anchor frame subcomponent outflow end1104effectively covering the outflow annular groove1706formed between the connecting sheath1300and the leaflet frame subcomponent1200and closing the volume defined by the leaflet frame cover1232of the leaflet frame subcomponent1200, the connecting sheath1300, and the outflow groove cover1432. In accordance with another embodiment, the outflow groove cover1432extends between the leaflet frame subcomponent outflow end1204and the anchor frame subcomponent outflow end1104such that fluid is prevented from entering into an outflow annular groove1706.

It is desired to cover or seal off the outflow annular groove1706from blood flow for various reasons. In accordance with an embodiment, covering the outflow annular groove1706provides a smoother flow at the leaflet frame subcomponent outflow end1204of the leaflet frame subcomponent1200compared with flow that would otherwise flow antegrade into and retrograde out of the outflow annular groove1706. Further, covering the outflow annular groove1706might prevent embolus that might be formed within the outflow annular groove1706from being dislodged and flow downstream of the prosthetic valve1000.

In various embodiments, the outflow annular groove cover1440may assist with maintaining the relative positioning of the leaflet frame subcomponent1200within the anchor frame subcomponent1100when the prosthetic valve1000is fully deployed. For example, the outflow annular groove cover1440may be resiliently retractable and extendible, such that the outflow annular groove cover1440is able to be transitioned between extended and retracted configurations.

The outflow annular groove cover1440can present from the extended configuration to the retracted configuration during nesting and expansion of the leaflet frame subcomponent1200within the anchor frame subcomponent1100such that the outflow annular groove cover1440takes on relatively flatter shapes as the outflow annular groove cover1440contracts. For example, the outflow annular groove cover1440may have an angular wall that is defined as the outflow annular groove cover1440contracts and angulates as it transitions from a lower angle (shallower angle) relative to a longitudinal axis X of the prosthetic valve1000to a higher angle (steeper angle) relative to the longitudinal axis X of the prosthetic valve1000. In some examples, the outflow annular groove cover1440extends approximately perpendicularly between the walls of the leaflet frame subcomponent1200and the anchor frame subcomponent1100in the retracted configuration. In some examples, the outflow annular groove cover first end1444can be coupled to the anchor frame subcomponent outflow end1104and the outflow annular groove cover second end1442can be coupled to the leaflet frame subcomponent outflow end1204.

In the deployed, or retracted configuration, the outflow annular groove cover1440extends between the leaflet frame subcomponent outflow end1204and the anchor frame subcomponent outflow end1104with the outflow annular groove cover1440operable to cover and restrict fluid flow into, or out from, the outflow annular groove1706. In various embodiments of the prosthetic valve1000that include flow enabling features2350as shown inFIGS. 5A-E, the outflow annular groove cover1440is required to be permeable to fluid when the prosthetic valve is in the pre-deployed configuration so at to allow fluid to pass through the flow enabling features. In accordance with an embodiment, the outflow annular groove cover1440is less permeable to blood (e.g., blood impermeable under physiologic conditions) when in the retracted configuration wherein the prosthetic valve1000is in the deployed configuration. The outflow annular groove cover1440may be configured to be blood permeable under physiologic conditions when in the extended configuration wherein the prosthetic valve1000is in the pre-deployed configuration. For example, after initiation, but prior to completion of transitioning the prosthetic valve1000to a fully deployed configuration the outflow annular groove cover1440is configured to be blood permeable.

In various examples, the outflow annular groove cover1440is a flexible elastic element that is operable to resiliently stow into a low radial profile in a delivery configuration and is operable to extend between the leaflet frame subcomponent1200and the anchor frame subcomponent1100. The outflow annular groove cover1440can be implemented to inhibit flood flow into or out from between the anchor frame subcomponent1100and the leaflet frame subcomponent1200.

In some examples, the outflow annular groove cover1440is under elastic bias when in a deployed position such that they are held relatively taught. Engagement of the outflow annular groove cover1440with the anchor frame subcomponent1100and the leaflet frame subcomponent1200may assist in maintaining the relative position of the leaflet frame subcomponent1200within an anchor frame subcomponent lumen1140, according to some embodiments.

As shown in FIGS.7D1-7D3, the outflow annular groove cover1440defines an outflow annular groove cover first end1444and an outflow annular groove cover second end1442. The outflow annular groove cover first end1444is coupled to the anchor frame subcomponent outflow end1104. The outflow annular groove cover second end1442is coupled to the leaflet frame subcomponent1200about the leaflet frame cover outflow edge1233of the leaflet frame cover1232adjacent to the leaflet frame subcomponent outflow end1204. As shown in FIGS.7D1-7D3, the outflow annular groove cover second end1442may be contiguously attached to the leaflet frame cover outflow edge1233of the leaflet frame cover1232. For example, the outflow annular groove cover1440may be coupled to and circumferentially extend from adjacent the anchor frame subcomponent outflow end1104and a leaflet frame cover outflow edge1233of the leaflet frame cover1232, to avoid blood flow through the leaflet frame1220into the space or volume corresponding to the outflow annular groove1706. In some examples, the leaflet frame cover1232optionally couples to the anchor frame subcomponent outflow end1104and correspondingly, the outflow annular groove cover1440is coupled to the leaflet frame subcomponent outflow end1204wherein the leaflet frame cover1232extends thereto to define a closed volume with the connecting sheath1300and the leaflet frame subcomponent1200. In such instances, it may be desirable for the leaflet frame cover1232to also extend to the leaflet frame subcomponent outflow end1204to avoid blood flow through the leaflet frame1220into the space corresponding to the outflow annular groove1706.

The outflow annular groove cover1440is a tubular element that is operable to extend generally parallel to the longitudinal axis X of the prosthetic valve1000(or at a relatively small, or shallow angle relative to the longitudinal axis X), when in the pre-deployed/expanded configuration (e.g., FIG.7D2) and operable to extend at an angle, and in some examples, in a generally lateral direction to the longitudinal axis X (or at a relatively large, or steep angle relative to the longitudinal axis X) when in the deployed/retracted configuration (e.g., FIG.7D1). The outflow annular groove cover1440is operable to retract during the deployment process, as shown in FIG.7D1while the connecting sheath1300is operable to fold and evert within the anchor frame subcomponent lumen1140of the anchor frame subcomponent1100and lie between the leaflet frame subcomponent1200and the anchor frame subcomponent1100as shown in FIG.7D1.

The outflow annular groove cover1440may be configured to facilitate delivery of the prosthetic valve1000, and is operable to be elastically restrained to an extended tubular or conical configuration as shown in FIG.7D2. In particular, the outflow annular groove cover1440may also be restrained to define a small tubular diameter in the constrained pre-deployment configuration, such as shown inFIG. 4, at relatively the same diameter as that of the constrained leaflet frame subcomponent1200and the constrained anchor frame subcomponent1100with the outflow annular groove cover1440extending within the anchor frame subcomponent1100. For reference, as indicated above, in some embodiments, the delivery device1500is configured to longitudinally restrain the prosthetic valve1000in the un-nested configuration until the time in the delivery sequence at which the leaflet frame subcomponent1200is nested into the anchor frame subcomponent1100.

In some embodiments, the outflow annular groove cover1440can help retain the relative position of the leaflet frame subcomponent1200and the anchor frame subcomponent1100by virtue of an elastic bias of the outflow annular groove cover1440. For example, the outflow annular groove cover1440optionally resists forces in opposition to the outflow annular groove cover1440being biased to the retracted configuration.

If desired, the bias may be predetermined to assist with centering or other desirable positioning of the leaflet frame subcomponent1200within the anchor frame subcomponent1100under physiologic loading conditions. In other embodiments, the bias may be selected to permit some resilient deflection, or adjustment of the position of the leaflet frame subcomponent1200within the anchor frame subcomponent1100to accommodate physiologic loading, or potentially even better replicate natural physiologic action (e.g., to more closely match movement of a natural valve during a cardiac cycle). In different terms, the bias may be predetermined the such that fluid dynamic forces on the prosthetic valve1000are not sufficient to overcome the elastic bias needed to stretch/expand the outflow annular groove cover1440which would lead to the leaflet frame subcomponent1200moving an unacceptable distance axially or radially within the anchor frame subcomponent lumen1140and maintain a relative axial and/or radial position (or at least minimize relative axial or radial movement) between the anchor frame subcomponent1100and the leaflet frame subcomponent1200.

In accordance with an embodiment, the outflow annular groove cover1440comprises a pleated, or folded configuration that has a continuous sinuous and/or zig-zag configuration. The pleated, or folded configuration may facilitate reduction of the outflow annular groove cover1440to a smaller diameter. The pleated configuration may have an elastic bias, or otherwise resiliently return to the contracted, or retracted configuration.

Although various features are described above, they are provided by way of example and additional or alternative features, associated advantages, and other inventive aspects are contemplated and will be apparent from the disclosure read as a whole.

Annular Groove Cover Materials

In some examples, the outflow annular groove cover1440is formed from a retracted microstructure membrane such as those described in U.S. Pat. No. 10,166,128, issued Jan. 1, 2019. Such retracted microstructures exhibit a high degree of recoverable elongation such that they can be extended and resilient retract. They may be formed of fluoropolymer membranes (e.g., porous synthetic fluoropolymer membranes) such that they exhibit high elongation while substantially retaining the strength properties associated with the fluoropolymer membrane. Such retracted microstructure membranes characteristically possess a microstructure of serpentine fibrils that curve or turn generally one way then generally another way. It is to be understood that the amplitude and/or frequency of the serpentine-like fibrils may vary. In some embodiments, the fluoropolymer membranes that go through a retraction process to provide a precursor retracted membrane are formed of expandable fluoropolymers. Non-limiting examples of expandable fluoropolymers include, but are not limited to, expanded PTFE, expanded modified PTFE, and expanded copolymers of PTFE.

The high elongation is facilitated by forming relatively straight fibrils into serpentine fibrils that substantially straighten upon the application of a force in a direction opposite to the compressed direction. The creation of the serpentine fibrils can be achieved through a thermally-induced controlled retraction of the expanded polytetrafluoroethylene (ePTFE), through wetting the article with a solvent, such as, but not limited to, isopropyl alcohol or Fluorinert® (a perfluorinated solvent commercially available from 3M, Inc., St. Paul, Minn.), or by a combination of these two techniques. The retraction of the article does not result in visible pleating, folding, or wrinkling of the ePTFE, unlike what occurs during mechanical compression. During the retraction process, the fibrils not only become serpentine in shape but also may also increase in width.

The retracted membranes described above can be imbibed with an elastomeric material prior, during, or subsequent to retraction to form a composite such that at least a portion of the pores of a porous material such as ePTFE or the like are filled. Suitable elastomeric materials may include, but are not limited to, PMVE-TFE (perfluoromethylvinyl ether-tetrafluoroethylene) copolymers, PAVE-TFE (perfluoro (alkyl vinyl ether)-tetrafluoroethylene) copolymers, silicones, polyurethanes, and the like. It is to be noted that PMVE-TFE and PAVE-TFE are fluoroelastomers. Other fluoroelastomers include suitable elastomeric materials as identified by those of skill in the art. The resultant retracted membrane composite possesses resilient elongation capability while substantially retaining the strength properties of the fluoropolymer membrane. Moreover, such retracted membranes have the ability to be free of creases, folds or wrinkles visible to the naked eye (i.e., on a gross scale) in both retracted and extended configurations.

In addition to or as an alternative to a membrane or other sheet-like component having elastic recovery (e.g., by coating or imbibing a membrane with elastomer), one or more elastomeric elements may otherwise be associated with a membrane or sheet-like member to provide desired properties. For example, one or more elastomeric bands, members, or other feature may be associated (e.g., bonded, adhered, or mechanically fastened) with a sheet-like member, such as a membrane or film, to provide resilient elongation capabilities to the annular groove cover(s).

In some examples, wherein the material of the outflow annular groove cover1440includes a porous elastic film that when in the extended configuration defines pores large enough to render the porous elastic film blood permeable under physiologic conditions and when in the retracted configuration the pores are small enough to render the porous elastic film low-permeability, such as blood impermeable under physiologic conditions.

The materials utilized for the outflow annular groove cover1440may also be configured for tissue ingrowth (i.e., to facilitate or promote tissue ingrowth or adhesion) or to resist tissue ingrowth. Moreover, one or more portions of the cover(s) may be configured for tissue ingrowth, whereas other portions are configured to resist tissue ingrowth.

Filler materials may also be utilized in addition to the inflow and outflow annular groove covers. Whether separately injectable (e.g., utilizing a syringe or other delivery mechanism) or associated with the annular groove cover(s) as a coating or other treatment, such filler materials may serve to help fill the inflow annular groove and inflow annular groove1704and/or the outflow annular groove1706as desired. Examples of such materials include biocompatible filler agents or bulking agents operable to fill a volume and may include at least one of hydrogel, alginate, foam, porous bulking material, collagen, hyaluronic acid, alginic salt, cellulose, chitosan, gelatin, agarose, glycosaminoglycans, polysaccharides, and combinations thereof, among others.

Tissue Engagement Features

In various examples, the one or more tissue engagement features1118project away from the anchor frame inner surface1106and/or the anchor frame outer surface1108of the anchor frame subcomponent1100, radially outward from a longitudinal axis of the anchor frame subcomponent1100, and toward the tissue surrounding the prosthetic valve1000. Generally, the tissue engagement features1118are operable to project away from the anchor frame subcomponent1100when the anchor frame subcomponent1100is deployed (e.g., when a constraining member is withdrawn or otherwise removed). In some examples, with the anchor frame subcomponent1100in the deployed configuration, the tissue engagement features1118are operable to engage the tissue proximate the anchor frame subcomponent1100such that the tissue engagement features1118secure the anchor frame subcomponent1100to the surrounding tissue, as will be discussed in greater detail below.

In some examples, in a deployed configuration, the tissue engagement features project away from an exterior surface of the anchor frame subcomponent in a range of between thirty (30) and sixty (60) degrees. In some such examples, the tissue engagement features project away from an exterior surface of the anchor frame subcomponent at an angle of approximately forty five (45) degrees, though other configurations are contemplated and fall within the scope of the present application. Generally, any angle of projection is suitable provided that the tissue engagement features operate for their intended purpose of engaging the tissue surrounding the anchor frame subcomponent and causing the anchor frame subcomponent to be secured to the surrounding tissue. Though the tissue engagement features may include a variety of different lengths (depending on the angle from which they project from the anchor frame subcomponent), it will be appreciated that the tissue engagement features are of a length suitable for engaging tissue and securing the anchor frame subcomponent to the surrounding tissue, but not so long as to risk detrimental damage to the native valve orifice. One nonlimiting example configuration includes tissue engagement features projecting from the anchor frame subcomponent in a range of between thirty (30) and sixty (60) degrees and having a length of between fifty (50) micron and two hundred (200) micron.

Generally, the tissue engagement features1118are positioned along the anchor frame subcomponent1100such that they are operable to engage tissue proximate the anchor frame subcomponent1100when the anchor frame subcomponent1100is expanded in-situ. The tissue engagement features1118may be arranged in one or more rows along a longitudinal axis of the anchor frame subcomponent1100. That is, in various examples, the anchor frame subcomponent1100may include a first set (or row) of anchors and a second set (or row) of anchors longitudinally offset relative to the first set of anchors. In one such example, the first set of anchors is more proximate the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100than is the second set of anchors.

In various embodiments, the one or more tissue engagement features1118are circumferentially arranged about the anchor frame subcomponent1100. In some examples, the one or more tissue engagement features1118are evenly dispersed about the circumference of the anchor frame subcomponent. For example, the tissue engagement features1118are dispersed about the frame and are offset from one another by ninety (90) degrees depending on the number of anchors. Alternatively, the tissue engagement features1118may be dispersed about the frame and offset from one another by sixty (60) degrees depending on the number of anchors. Generally, the angular offset between the anchors is a function of the number of anchors dispersed about the anchor frame subcomponent1100, as those of skill will appreciate. In some examples, the angular offset between the anchors is additionally or alternatively based on an arrangement or pattern of the frame members1112.

In various examples, while the tissue engagement features1118project away from the anchor frame subcomponent1100when the anchor frame subcomponent1100is in the deployed configuration, the tissue engagement features1118are stowed or do not otherwise project away from the anchor frame subcomponent1100when the anchor frame subcomponent1100is compressed in the delivery configuration. Thus, in various examples, the tissue engagement features1118are stowable during delivery and are configured to transition to a deployed configuration where they project away from the anchor frame subcomponent1100. In some examples, a constraining member disposed about the anchor frame subcomponent1100during delivery facilitates stowing of the tissue engagement features1118. In some examples, the tissue engagement features1118are stowed in associated apertures or voids1116of the anchor frame subcomponent1100.

In various embodiments, the tissue engagement features1118are integral to the anchor frame subcomponent1100. For example, one or more of the tissue engagement features1118are formed in conjunction with and from the same material as the frame members1112. In other examples, one or more of the tissue engagement features1118are separate components additionally or alternatively coupled or attached to the anchor frame subcomponent1100. For instance, some non-limiting examples include crimping and/or welding one or more tissue engagement features to the anchor frame subcomponent1100.

Leaflet Materials

For simplicity of discussion, when referring to materials from which leaflets1230are made, it is appreciated that the same material may also be used to make one or more portions or an entirety of a leaflet construct comprised of one or more leaflets. Therefore, in this context, the description of leaflet materials applies to options that may be employed for one or more individual leaflets, and also one or more portions of a leaflet construct, as well as for an entirety of the leaflet construct. In the examples that follow, the leaflets that are formed with the leaflet materials described are flexible and are comprised of flexible materials.

Suitable leaflet materials include natural materials (e.g., repurposed tissue, including bovine tissue, porcine tissue, or others), synthetic materials (e.g., biocompatible polymers), and combinations of natural and synthetic materials. Suitable leaflet forming processes include, but are not limited to, casting, molding, extruding, wrapping, coating, imbibing, laminating, combinations thereof and others.

Suitable synthetic leaflet materials include urethanes, silicones (e.g., organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, fluoroelastomers (e.g., copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE/PMVE copolymer) and (per)fluoroalkylvinylethers (PAVE)), and copolymers and/or mixtures of each of the foregoing and composite materials made therewith. Suitable biocompatible polymers, such as one or more of those described above, may exhibit the physical properties of an elastomer, elastomeric, or non-elastomeric material.

Leaflet materials may include composite materials. Suitable composite leaflet materials include, but are not limited to, one or more membranes combined with one or more polymers. In accordance with some examples, the composite material comprises a membrane material (e.g., porous synthetic polymer membrane) by weight in a range of about 10% to about 90%. The one or more polymers may be coatings or layers on the one or more membranes and/or may be imbibed into the one or more membranes (e.g., where the one or more membranes include a microporous structures), for example. Composite materials may include additional or alternative components, such as but not limited to, inorganic fillers, therapeutic agents, radiopaque markers, and others. In some examples, composite leaflet material includes at least one porous synthetic polymer membrane layer having a plurality of pores and/or spaces and a polymer that is an elastomer and/or an elastomeric material filling the pores and/or spaces. In other examples, the composite leaflet material further comprises a layer or coating of elastomer and/or elastomeric material and/or non-elastomeric material on one or both sides of the composite leaflet material.

Suitable membrane materials that is suitable for use in composite leaflet materials include, but are is not limited to, porous synthetic polymer membranes, such as microporous polyethylene and expanded fluoropolymer membranes such as expanded polytetrafluoroethylene (ePTFE). Such membranes can comprise PTFE homopolymer, blends of PTFE, expandable modified PTFE and/or expanded copolymers of PTFE. As referenced, the membranes may have a microporous structures (e.g., such as ePTFE membranes including a matrix of fibrils defining a plurality of spaces within the matrix).

Suitable polymers of composite leaflet materials include polymers that exhibit elastomer, elastomeric, and/or non-elastomeric material properties. Such polymers may include elastomers and elastomeric materials, such as fluoroelastomers. Examples of suitable polymers include TFE-PMVE copolymers, which may exhibit elastomer, elastomeric, and/or non-elastomeric material properties based on the wt % or mol % of the respective polymers. By way of example of a suitable elastomer, TFE/PMVE copolymer is an elastomer when comprising essentially of between 60 and 20 weight percent tetrafluoroethylene and respectively between 40 and 80 weight percent perfluoromethyl vinyl ether. By way of example of a suitable elastomeric material, TFE/PMVE copolymer is an elastomeric material when comprising essentially of between 67 and 61 weight percent tetrafluoroethylene and respectively between 33 and 39 weight percent perfluoromethyl vinyl ether. By way of example of a suitable non-elastomeric material, TFE/PMVE copolymer is a non-elastomeric material when comprising essentially of between 73 and 68 weight percent tetrafluoroethylene and respectively between 27 and 32 weight percent perfluoromethyl vinyl ether. In the foregoing examples, the TFE and PMVE components of the TFE-PMVE copolymer are presented in wt %. For reference, the wt % of PMVE of 40, 33-39, and 27-32 corresponds to a mol % of 29, 23-28, and 18-22, respectively.

In some examples, the composite leaflet material includes an expanded polytetrafluoroethylene (ePTFE) membrane having been imbibed with TFE-PMVE copolymer comprising from about 60 to about 20 weight percent tetrafluoroethylene and respectively from about 40 to about 80 weight percent perfluoromethyl vinyl ether, the leaflet further including a coating of TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and respectively about 27 to about 32 weight percent perfluoromethyl vinyl ether on the blood-contacting surfaces. In other examples the leaflet is an ePTFE membrane having been imbibed with TFE-PMVE copolymer comprising from about 70 to about 61 weight percent tetrafluoroethylene and respectively from about 33 to about 39 weight percent perfluoromethyl vinyl ether, the leaflet further including a coating of TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and respectively about 27 to about 32 weight percent perfluoromethyl vinyl ether on the blood-contacting surfaces.

Although some examples of suitable leaflet materials have been provided, the foregoing examples are not meant to be read in a limiting sense, and additional or alternative materials are contemplated.

In some examples, the leaflet frame cover1232and/or the anchor frame cover1132and/or connecting sheath1300and/or the outflow annular groove cover1440may comprise any of the leaflet materials as described above.

Delivery

With reference toFIGS. 10A-10Ma non-limiting exemplary deployment sequence and nesting configuration of the prosthetic valve1000in-situ during a mitral valve (“W”) replacement procedure is shown, with a cross-section of a portion of the heart for illustrative purposes. InFIG. 10A, the left atrium (“LA”) is accessed transseptally by a delivery device1500. In various examples, the delivery device1500delivered percutaneously and is coupled to a control system1600outside of the body. Accessing the left atrium transseptally can be done in accordance with techniques as known those of skilled in the art. Upon gaining access to the left atrium transseptally, the delivery device1500is positioned for deployment of the prosthetic valve1000. For example, as shown inFIG. 10B, the delivery device1500is advanced through the mitral valve and into the left ventricle (“LV”). In some examples, advancement of the delivery device1500through the mitral valve causes the anterior leaflet (“AL”) and the posterior leaflet (“PL”) of the mitral valve to deflect into the left ventricle.

FIGS. 10A-10Mshow a cross-sectional view of a heart illustrating an exemplary medical device delivery procedure using a delivery device1500to implant a prosthetic valve1000into a mitral valve tissue annulus1930, according to some embodiments.FIG. 10Ashows the delivery device1500including a constraining sheath1506covering the prosthetic valve (1000, hidden from view). The constraining sheath1506is a tubular member that is operable to cover at least a portion of the prosthetic valve1000while constrained on the delivery device1500. Covering a portion or all of the prosthetic valve1000with the constraining sheath1506presents, among other things, a smoother profile when traversing the anatomical structures and/or protection of the prosthetic valve1000. The delivery device1500is entering the left atrium (LA) in a transseptal procedure to access the mitral valve (MV), in this example. The delivery device1500is steerable and flexible to traverse the anatomy.FIG. 10Bshows the distal end of the delivery device1500being positioned through the mitral valve tissue annulus1930.FIG. 10Cshows the constraining sheath1506partially retracted to uncover the leaflet frame subcomponent1200.FIG. 10Dshows the constraining sheath1506further retracted to fully uncover the connecting sheath1300and partially uncover the anchor frame subcomponent1100. As now seen, the prosthetic valve1000is mounted on a delivery catheter1504in a pre-deployed, un-nested configuration with the anchor frame subcomponent1100and the leaflet frame subcomponent1200being longitudinally offset from one another (also referred to as being delivered in series) and coupled together with the connecting sheath1300therebetween, which is also shown inFIG. 4. The retention element1400is hidden by the connecting sheath1300.

As previously discussed and shown inFIG. 4, the leaflet frame subcomponent inflow end1202of the leaflet frame subcomponent1200is positioned distal to the anchor frame subcomponent outflow end1104of the anchor frame subcomponent1100with the connecting sheath1300coupled thereto and positioned therebetween coupling them together.

FIG. 10Eshows the constraining sheath1506further retracted to fully uncover the anchor frame subcomponent1100which allows the flared portion1130to expand to a deployed configuration from the constrained configuration. In this example, the constraining sheath1506constrained the flared portion1130, wherein in other examples other means of constraining may be used. The remaining portion of the anchor frame subcomponent1100and the leaflet frame subcomponent1200remain constrained to the delivery catheter1504by constraining elements1716as shown inFIG. 4. In various examples, withdrawal of a constraining sheath1506releases the flared portion1130as shown in FIG.1B1or flange element ofFIG. 1150as shown in FIGS.1B2-1B3which engages the tissue annulus1390, as shown inFIGS. 10E-10G. The other portions of the prosthetic valve1000are restrained to the delivery catheter1504by use of constraining elements1716such as fiber loops shown inFIG. 4. The prosthetic valve1000may be positioned and oriented within the tissue annulus1390by advancing and withdrawing and otherwise manipulating the delivery catheter1504or delivery device1500as a whole, for a particular purpose, such as to ensure correct orientation and engagement with the anatomical structure of the tissue annulus1390and surrounding tissue.

FIG. 10Fshows the flared portion1130advanced to and placed in contact with the tissue annulus1390. The delivery catheter1504or delivery device1500as a whole may be manipulated such that the flared portion1130and thus the anchor frame subcomponent1100may be positioned and repositioned suitable for a particular purpose.FIG. 10Gshows the anchor frame expanded to a larger diameter of the deployed configuration. Before disengagement of the constraining element1716that constrains the anchor frame subcomponent1100to the delivery catheter1504, the position of the anchor frame subcomponent1100is verified, and if incorrect, the constraining element1716may be used, such as by instilling tension to the constraining element1716via a tether, for example, to re-constrain the anchor frame subcomponent1100back onto the delivery catheter1504for repositioning or removal.

In various examples wherein the anchor frame subcomponent1100includes tissue engagement features1118, such as shown in FIGS.1B1, the constraining element1716may constrain the deployment of the tissue engagement features1118so as to allow for repositioning or withdrawal of the anchor frame subcomponent1100from within the tissue annulus1390. With the constraining element1716constraining the deployment of the tissue engagement features1118, such as tissue anchors, re-constraining and repositioning of the anchor frame subcomponent1100may be done without trauma to the tissue.

In various examples, after the anchor frame subcomponent1100is expanded, the anchor frame subcomponent1100and the leaflet frame subcomponent1200are nested together. In various examples, nesting of the anchor frame subcomponent1100and the leaflet frame subcomponent1200in-situ involves proximally advancing the leaflet frame subcomponent1200relative to the anchor frame subcomponent1100.FIG. 10Hillustrates the leaflet frame subcomponent1200as it is proximally advanced relative to the anchor frame subcomponent1100as indicated by the arrow.FIG. 10Hshows the delivery catheter1504being withdrawn from the anchor frame subcomponent1100which pulls the connecting sheath1300and a portion of the leaflet frame subcomponent within the anchor frame subcomponent1100with the connecting sheath1300in the process of being everted therebetween.

Alternatively, or in addition thereto,FIG. 10Ishows the delivery catheter1504being further withdrawn from the anchor frame subcomponent1100, and/or the pulling of tethers as discussed below, which pulls the connecting sheath1300and a portion of the leaflet frame subcomponent1200within the anchor frame subcomponent1100with the connecting sheath1300having been everted therebetween. As shown inFIG. 10I, one or more tether elements1714are coupled to the retention element1400as shown, and alternatively shown as a lasso or loop inFIG. 7Aand discussed further below, which may be used to pull the retention element1400through the anchor frame subcomponent1100, and therefore also pull the leaflet frame subcomponent1200therewith into the anchor frame subcomponent1100.

As will be discussed below, if it is required to remove the prosthetic valve1000from the heart at this point in the deployment, the leaflet frame subcomponent1200may be recompressed by the tether elements1714and the tether elements1714may be used to pull the retention element1400, and thus the leaflet frame subcomponent1200and subsequently the anchor frame subcomponent1100into the constraining sheath1506or a larger retrieval sheath1950, shown inFIGS. 9A-9D, that had been advanced over the delivery device1500. In this case, the anchor frame subcomponent1100is caused to evert initiating at the anchor frame subcomponent outflow end1104such that it is drawn, peeled or pulled away from the tissue annulus1930, such as illustrated inFIGS. 9A-9D. Thus, this method provides a means for removing a prosthetic valve1000that is experiencing a failed deployment without the need for invasive surgical care.

In various examples, after the leaflet frame subcomponent1200is nested and expanded within the anchor frame subcomponent1100, the tether elements1714are loosened allowing the retention element1400to expand and rotate downward from the leaflet frame subcomponent1200under spring bias as shown inFIG. 10Jso as to fully deploy over the anchor frame subcomponent inflow end1102as shown inFIG. 10K. The delivery catheter1504may be withdrawn from the prosthetic valve1000, as shown inFIG. 10L, so as to verify that the leaflets1230are properly functioning prior to releasing the tether elements1714from the retention element1400. If the leaflets1230are not functioning properly, the delivery catheter1504may be advanced adjacent to or within the leaflet frame subcomponent1200and the prosthetic valve1000removed with the procedure discussed above.

Further, additional tethers may be coupled to the leaflet frame subcomponent inflow end1202operable to constrain and pull the leaflet frame subcomponent1200out of the anchor frame subcomponent1100as discussed before in reference toFIGS. 9A-9D.

FIG. 10Lshows the prosthetic valve1000fully deployed within the tissue annulus1390of the mitral valve (MV). The prosthetic valve1000is in a fully deployed configuration wherein the anchor frame subcomponent1100and the leaflet frame subcomponent1200are nested. The prosthetic valve1000is fully deployed and operational upon the retention element1400engaging the anchor frame subcomponent inflow end1102which minimizes relative axial translation between the anchor frame subcomponent1100and the leaflet frame subcomponent1200.

In various examples, the longitudinal separation or offset of the anchor frame subcomponent1100and the leaflet frame subcomponent1200provides for a low profile delivery configuration that can be easily tracked through the vasculature of the patient. For instance, by longitudinally offsetting the anchor frame subcomponent1100and the leaflet frame subcomponent1200, a profile of the delivery system can be minimized because, unlike conventional designs, the anchor frame subcomponent1100and the leaflet frame subcomponent1200do not overlap one another during delivery. In some examples, a maximum profile of the delivery device1500including the prosthetic valve1000can be 8 mm or less.

Additionally, as shown inFIGS. 4 and 10D, a region1502of the delivery device1500positioned between the anchor frame subcomponent1100and the leaflet frame subcomponent1200and adjacent to the connecting sheath1300and retention element1400is operable to bend such that the anchor frame subcomponent1100and the leaflet frame subcomponent1200are temporarily misaligned with one another. In some examples, such a configuration is akin to rail cars navigating a curve. Such a configuration is beneficial in procedures where the prosthetic valve1000is delivered to a treatment region transseptally, which may require a delivery device to bend ninety (90) degrees or more within the left atrium of the heart.

Additionally, as shown inFIG. 1A, the tissue engagement features1118of the anchor frame subcomponent1100extend away from the anchor frame subcomponent1100and engage the tissue of the native valve orifice surrounding the prosthetic valve1000. In some examples, the tissue engagement features1118are configured to penetrate the tissue or otherwise embed within the tissue. In various examples, this interaction of the tissue engagement features1118of the anchor frame subcomponent1100with the native tissue surrounding the prosthetic valve1000operates to secure the anchor frame subcomponent1100(and thus the leaflet frame subcomponent1200) to the native tissue of the tissue annulus1390.

The anchor frame subcomponent inflow end1102of the anchor frame subcomponent1100illustrated inFIGS. 10B-10Mis flared radially outward and is situated adjacent to and in abutment with the native valve tissue annulus1390, as shown. In some examples, such a configuration provides that the anchor frame subcomponent inflow end1102of the anchor frame subcomponent1100obstructs or otherwise limits the extent to which the anchor frame subcomponent1100is operable to extend through the native valve. For instance, in the case of a mitral valve replacement, such a flared anchor frame subcomponent inflow end1102limits the extent to which the anchor frame subcomponent1100can be advanced through the natural mitral valve orifice and into the left ventricle. In some examples, such flared anchor frame subcomponent inflow end1102additionally operates to minimize the potential for the anchor frame subcomponent1100to migrate distally.

While the embodiments and examples illustrated and described above pertain to trans-septal delivery, it should be appreciated that a variety of additional well-known delivery procedures can be utilized without departing from the spirit or scope of the present application. Additional non-limiting delivery procedures include trans-apical, left atriotomy, and trans-aortic. Generally, regardless of the particular delivery procedure, those of skill should appreciate that after deploying the prosthetic valve1000, the leaflet frame subcomponent1200and the anchor frame subcomponent1100are nested by proximally advancing the leaflet frame subcomponent1200relative to the anchor frame subcomponent1100.

Tissue Ingrowth Materials and Modifications

In various embodiments, one or more portions of the prosthetic valve1000, such as the leaflets1230, are constructed in a manner that promotes tissue ingrowth. In some embodiments, the leaflets1230and/or other portions of the valve1000may be constructed to encourage tissue ingrowth and proliferation across one or more discrete regions, portions, or sections of one or more of the materials forming the prosthetic valve1000, or alternatively across an entirety of one or more of the materials forming the prosthetic valve1000, such as the leaflets1230. Tissue ingrowth and proliferation may be promoted on an outflow side or surface of such materials, and/or on an inflow side or surface of such materials, and/or within one or more such materials.

In various embodiments, materials configured to promote tissue ingrowth include a composite material combined with a tissue ingrowth curtain that may be incorporated into the composite material and/or coupled to the composite material.

In various embodiments, one or more portions of the leaflet frame subcomponent1230may be covered with material suitable for promoting tissue ingrowth. For example, the leaflet frame subcomponent1230can be wrapped with a material, suitable for promoting tissue ingrowth. In various examples, such tissue ingrowth promoting materials can be applied to the leaflet frame subcomponent1230entirely, or alternatively to less than all of the leaflet frame subcomponent1230. For example, suitable materials for promoting tissue ingrowth could be coupled to the leaflet frame inner surface and the leaflet frame outer surface of the leaflet frame. Some nonlimiting examples of materials that can be applied to the leaflet frame subcomponent1230(or other portions of the prosthetic valve1000) include expanded polytetrafluoroethylene (ePTFE), such as an ePTFE membrane, as well as fabric, film, or coating, and a polyethylene terephthalate fabric (e.g., Dacron fabric).

According to some examples, as will be discussed in greater detail below, this promotion of tissue ingrowth is facilitated by the coupling of one or more synthetic tissue ingrowth curtains to one or more composite materials such that tissue is encouraged to grow (or is not otherwise prevented or inhibited from growing) into and/or onto the one or more tissue ingrowth curtains. That is, in some examples, one or more layers configured to promote tissue ingrowth may be applied to the composite material. In some examples, as described herein, the underlying material may be configured to inhibit or prevent tissue ingrowth.

Additionally or alternatively, in some examples, this promotion of tissue ingrowth is facilitated by selectively imbibing, such as with one or more fluoroelastomers, one or more portions of the one or more materials forming the leaflet1230and/or other portions of the prosthetic valve1000. Reference to “selectively imbibing” is referring to the act of imbibing a porous material with a filling material at selected portions of the porous material or to a lesser degree leaving a degree of porosity of the porous material.

That is, in some examples, in addition to or as an alternative to coupling one or more synthetic tissue ingrowth curtains to one or more composite materials, the composite material as discussed above regarding leaflet materials is configured to promote or accommodate tissue ingrowth. In some such examples, as discussed in greater detail below, the composite material is configured such that tissue is encouraged to grow (or is not otherwise prevented or inhibited from growing) into and/or onto one or more discrete or designated sections, portions, or regions of the composite material by way of selectively imbibing the membrane associated with those portions.

In various embodiments, the tissue ingrowth curtain generally includes an expanded fluoropolymer membrane which comprises a plurality of spaces within a matrix of fibrils that is suitable for promoting and supporting the ingrowth of tissue. Other nonlimiting example materials include other biocompatible porous materials such as knit PTFE. However, as mentioned above, and as discussed in greater detail below, in some examples the tissue ingrowth curtain(s) may be applied to the composite material in the form of one or more coatings.

In some examples, the tissue ingrowth curtain includes an expanded fluoropolymer made from a porous ePTFE membrane. However, it is appreciated that the tissue ingrowth curtain may be formed from a number of different types of membranes, including other fluoropolymer membranes, and other biocompatible porous materials such as porous polyethylene membrane and knit PTFE. For instance, the expandable fluoropolymer can comprise PTFE homopolymer. In some examples, the tissue ingrowth curtain can be formed from copolymers of hexafluoropropylene and tetrafluoroethylene, such as Fluorinated Ethylene Propylene (FEP). In some examples, blends of PTFE, expandable modified PTFE and/or expanded copolymers of PTFE can be used. It will thus be appreciated that the tissue ingrowth curtain may be formed from a variety of different polymeric materials provided they are biocompatible and possess or are modified to include a suitable microstructure suitable for promoting or supporting tissue ingrowth. In various examples, the tissue ingrowth curtains may range in thickness from between one micron and four hundred microns depending on the selected material.

In some examples, the polymeric material may include one or more naturally occurring and/or one or more artificially created pores, reliefs, channels, and/or predetermined surface topology, suitable for supporting tissue ingrowth. Other biocompatible materials which can be suitable for use in forming the tissue ingrowth curtain include but are not limited to the groups of urethanes, fluoropolymers, styrene/isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing.

While the above-discussed tissue ingrowth curtains generally include membranes, films, knits, or other structures that are bonded, applied, or otherwise attached to the composite material, as mentioned above, in some examples the tissue ingrowth curtain(s) may be applied to the composite material in the form of one or more coatings. In some such example, a coherent irregular network is distributed or deposited onto one or more portions, regions, sections, areas, or zones of the composite material. In some examples, the coherent irregular network is applied to one or more portions of the composite material to create a surface texture suitable for supporting the ingrowth and proliferation of tissue, as those of skill will appreciate. For example, the coherent irregular network may be selectively applied to one or more discrete or designated sections, portions, or regions of the composite material. In some such examples, the coherent irregular network is applied to the designated areas by masking or otherwise covering those portions of the underlying leaflet, or other portion of the prosthetic valve1000, where ingrowth of tissue is undesirable such that the cover or mask can be removed subsequent to the coherent irregular network application process to achieve a material having a first region including the coherent irregular network and a second region free of a coherent irregular network.

In some examples, one or more sacrificial sheets, such as one or more polyimide sheets (e.g., Kapton sheets), are arranged on the composite material and operate to mask or otherwise prevent the coherent irregular network from being applied to the masked or covered areas. Some nonlimiting examples of sacrificial sheet materials include polyester, polyetheretherketone (PEEK), PET, ePTFE/Kapton blends such as mapton, ePTFE, PTFE, silicones, and stainless steel, or other thin metal sheeting. In some examples, the one or more sacrificial sheets can be removed after the coherent irregular network application process to reveal a structure including one or more regions including the coherent irregular network and one or more regions free of the coherent irregular network (e.g., where the underlying composite material is exposed). Such a configuration provides for a construction that minimizes a possibility for delamination between bonded membrane layers.

As mentioned above, in some examples, in addition to or as an alternative to applying one or more tissue ingrowth curtains to the composite material, the composite material is configured to promote or accommodate tissue ingrowth. For instance, in some examples, the composite material is configured such that tissue is encouraged to grow (or is not otherwise prevented or inhibited from growing) into and/or onto one or more discrete or designated sections, portions, or regions of the composite material. For instance, as mentioned above, the composite material may include an elastomer and/or an elastomeric material such as a fluoroelastomer imbibed or otherwise incorporated into the expanded fluoropolymer membrane. In various examples, to achieve a composite material that promotes or otherwise accommodates the ingrowth and proliferation of tissue the expanded fluoropolymer membrane is selectively imbibed, such as with one or more fluoroelastomers, such that the expanded fluoropolymer membrane includes one or more discrete portions, regions, sections, zones, or areas that are free of or are not otherwise imbibed with the elastomeric filler material (or at least are not filled to the extent that the elastomeric filler material operates to prevent tissue ingrowth). Selectively imbibing the membrane material of the composite material may be done in accordance with techniques as known to those of skill in the art.

While the above discussed embodiments and examples include applying a tissue ingrowth curtain to one or more portions of one or more surfaces of the composite material, or selectively imbibing one or more portions of one or more sides of a membrane of the composite material with a filler material, it will be appreciated that, in various examples, a leaflet, and/or other features of the prosthetic valve1000, may be constructed by both imbibing one or more portions of the membrane and applying a tissue ingrowth curtain to the selectively imbibed membrane.

In various examples, the membrane may be imbibed with a plurality of filler materials. That is, in some examples, a first portion, area, region, section, or zone of the membrane of composite material may be imbibed with a first filler material while a second portion, area, region, section, or zone of the membrane of the composite material is imbibed with a second filler material. For instance, in some examples, a first portion of the membrane of the composite material is imbibed with a first filler material such that the first portion of the membrane is resistant to or otherwise inhibits or prevents tissue ingrowth into and/or onto and/or across the first portion. However, in some examples, those portions of the membrane imbibed with the first filler may also be unsuitable for accommodating the bonding or coupling of a tissue ingrowth curtain. Accordingly, in examples where it is desirable bond or otherwise couple a tissue ingrowth material to a second portion of the membrane, the second portion may be imbibed with a second filler material such that the second portion of the membrane is suited to have a tissue ingrowth curtain bonded or otherwise coupled thereto. In some examples, the second filler material may additionally or alternatively encourage tissue ingrowth. That is, in some examples, one or more portions of the membrane may be imbibed with a filler material that encourages tissue ingrowth and proliferation. Alternatively, as mentioned above, the second portion may not be imbibed with any filler material at all, but may instead remain free of filler material.

In some examples, the method includes applying an adhesive to the membrane in addition to or as an alternative to applying the adhesive to the tissue ingrowth curtain, as discussed above. In some examples, an adhesive, such as FEP, is similarly wicked or imbibed into one or more portions of the membrane, after which the tissue ingrowth curtain and the membrane are pressed together and/or heat set according to known methods.

In some other examples, in addition to or as an alternative to applying adhesives to the tissue ingrowth curtain and the membrane separately or individually, the tissue ingrowth curtain (e.g., having a designated pattern) and the membrane are layered with one or more adhesives or adhesive layers therebetween, after which the layered construct is pressed and/or heat set according to known methods. The method further includes cutting the leaflet, and/or other feature of the prosthetic valve1000, from the resulting construct according to known methods. In some examples, a final free edge cutting operation may be performed on the formed material to achieve a clean free edge according to known methods, as those of skill will appreciate.

The scope of the concepts addressed in this disclosure has been described above both generically and with regard to specific examples. It will be apparent to those skilled in the art that various modifications and variations can be made in the examples without departing from the scope of the disclosure. Likewise, the various components discussed in the examples discussed herein are combinable. Thus, it is intended that the examples cover the modifications and variations of the scope.