Nested prosthetic valve with retention element

Abstract

An implantable device is disclosed. The device includes a leaflet frame sub-component and an anchoring frame sub-component, and these frame sub-components are configured to be delivered in a series configuration and then nested or telescoped in situ.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Non - Provisional Application No. 16 / 805,181, filed Feb. 28, 2020, which claims the benefit of U.S. Provisional Application No. 62 / 812,782, filed Mar. 1, 2019, and also claims the benefit of U.S. Provisional Application No. 62 / 833,086, filed Apr. 12, 2019, the entire disclosures of all of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present disclosure generally relates to prosthetic valves, and more particularly to flexible leaflet - type prosthetic valve devices, systems, and methods. Background Art

[0004] Bioprosthetic valves have been developed that attempt to mimic the function and performance of natural valves. Bioprosthetic valves can be formed from synthetic materials, natural tissues such as biological tissue, or combinations of synthetic and natural tissues.

[0005] Although many conventional designs require delivery to a target region within a patient's anatomy via open - heart surgery techniques, alternative methods such as transcatheter techniques have many advantages. In other examples, compared to open - heart surgical procedures, transcatheter prosthetic valves delivered intravascularly via a catheter can help minimize trauma to the patient. Open - heart surgery involves significant trauma to the patient, with attendant morbidity and an extended recovery period. On the other hand, delivering a valve via a catheter to the recipient site avoids the trauma of open - heart surgery and can be performed on patients who are too ill or weak to survive open - heart surgery.

[0006] However, there are challenges in accessing the treatment area within the anatomy and properly positioning the bioprosthesis for deployment, and depending on the specific anatomy to be repaired or augmented, the presence of the bioprosthesis can cause remodeling of the surrounding anatomy. In some cases, this corresponding remodeling of the surrounding anatomy can have a negative impact on the patient's health.

[0007] Although multiple embodiments are disclosed, other embodiments of the present application will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive. Summary of the Invention

[0008] Various aspects relate to prosthetic valves that transition between a delivery configuration and a deployed nested configuration in situ.

[0009] Various aspects relate to a prosthetic valve that includes a leaflet frame sub-component that includes a one-way valve, the leaflet frame sub-component having a leaflet frame sub-component inflow end and a leaflet frame sub-component outflow end; an anchoring frame sub-component having an anchoring frame sub-component inflow end and an anchoring frame sub-component outflow end; a connecting sheath that couples the leaflet frame sub-component to the anchoring frame sub-component; and a retaining element coupled to the connecting sheath, the retaining element configured to hold the prosthetic valve in an expanded nested configuration, wherein, in a delivery configuration, the leaflet frame sub-component and the anchoring frame sub-component are longitudinally offset relative to each other, wherein the connecting sheath is deployed and not flipped, and in the nested configuration, the leaflet frame sub-component is nested with the anchoring frame sub-component, and the connecting sheath is folded and flipped such that it is located between the leaflet frame sub-component and the anchoring frame sub-component, such that the retaining element extends from the leaflet frame sub-component inflow end to the anchoring frame sub-component inflow end.

[0010] Various aspects also relate to a prosthetic valve configured to be retrieved, or a method of retrieving a prosthetic valve, wherein the anchoring frame sub-component of the prosthetic valve has a predetermined flexibility such that the anchoring frame sub-component can be flipped into the anchoring frame sub-component lumen, such that the anchoring frame sub-component is operable to peel away from the tissue annulus and be pulled out of the anchoring frame sub-component lumen, such that the prosthetic valve can be removed from the tissue annulus. In some embodiments, a portion of the anchoring frame sub-component can pivot and compress about a location adjacent to the anchoring frame sub-component inflow end (e.g., at a dilation portion), such that the anchoring frame sub-component can pivot or fold inwardly into the anchoring frame sub-component lumen and be pulled out of the flipped anchoring frame sub-component lumen.

[0011] According to one example (“Example 1”), a prosthetic valve that can transition in situ between a delivery configuration and an expanded nested configuration includes a leaflet frame sub-component, an anchoring frame sub-component, a connecting sheath that couples the leaflet frame and the anchoring frame sub-components, and a retaining element coupled to the connecting sheath, wherein, when the prosthetic valve is in the expanded nested configuration, the connecting sheath is flipped and the leaflet frame sub-component is at least partially nested within the anchoring frame sub-component lumen, the retaining element has been translated within the anchoring frame sub-component lumen toward the anchoring frame sub-component inflow end, and the retaining element is biased outwardly against the anchoring frame sub-component by an outward bias such that the retaining element extends from the leaflet frame sub-component inflow end to the anchoring frame sub-component inflow end.

[0012] Optionally, the leaflet frame sub-component defines a tubular shape and has a leaflet frame sub-component wall extending from the leaflet frame sub-component inflow end and the leaflet frame sub-component outflow end, the leaflet frame sub-component defining a leaflet frame sub-component lumen, and the leaflet frame sub-component includes a one-way valve.

[0013] Optionally, the anchoring frame sub-component defines a tubular shape and has an anchoring frame sub-component inlet end and an anchoring frame sub-component outlet end, and the anchoring frame sub-component defines an anchoring frame sub-component inner cavity.

[0014] Optionally, the connecting sheath defines a tubular shape and has a connecting sheath inlet end coupled to the anchoring frame sub-component outlet end and a connecting sheath outlet end coupled to the leaflet frame sub-component inlet end, thereby coupling the leaflet frame sub-component to the anchoring frame sub-component, and the connecting sheath has a connecting sheath inner surface that defines a connecting sheath inner cavity.

[0015] Optionally, the retaining element has a retaining element first end and a retaining element second end, and the retaining element second end is coupled to the connecting sheath outlet end.

[0016] Optionally, when the prosthetic valve is in the delivery configuration, the leaflet frame sub-component and the anchoring frame sub-component are longitudinally offset relative to each other such that the leaflet frame sub-component inlet end is distal to the anchoring frame sub-component outlet end, wherein the retaining element is within the connecting sheath inner cavity and extends away from the leaflet frame sub-component inlet end and extends adjacent to the connecting sheath and substantially parallel to the longitudinal axis of the leaflet frame sub-component.

[0017] Optionally, when the prosthetic valve is in the deployed nested configuration, the anchoring frame sub-component inlet end radially expands or tapers outwardly.

[0018] According to another example further to Example 1 (“Example 2”), the prosthetic valve is capable of transitioning between the delivery configuration and the deployed nested configuration via an expanded pre-deployed non-nested configuration.

[0019] According to another example further to Example 2 (“Example 3”), when the retaining element is translated within the anchoring frame sub-component inner cavity towards the anchoring frame sub-component inlet end, the retaining element is capable of pivoting about the retaining element second end such that the retaining element extends from the leaflet frame sub-component inlet end to the anchoring frame sub-component inlet end.

[0020] According to another example further to any one of Examples 1 to 3 (“Example 4”), the leaflet frame sub-component includes a leaflet frame that defines a leaflet frame wall, one or more leaflets, and a leaflet frame cover, and the leaflet frame is generally tubularly shaped to define a leaflet frame inlet end and a leaflet frame outlet end, and a leaflet frame inner cavity extends through the leaflet frame inlet end and the leaflet frame outlet end.

[0021] According to another example further to Example 4 (“Example 5”), at least a portion of the leaflet frame wall of the leaflet frame is covered by the leaflet frame cover that is configured to restrict fluid flow through the covered portion of the leaflet frame wall.

[0022] According to another example (“Example 6”) that is further advanced relative to Example 4 or 5, one or more leaflets can be operated to open to allow flow from the inflow end of the leaflet frame sub-component through the outflow end of the leaflet frame sub-component under antegrade flow conditions, and can be operated to close to restrict flow from the outflow end of the leaflet frame sub-component and through the inflow end of the leaflet frame sub-component under retrograde flow conditions.

[0023] According to another example (“Example 7”) that is further advanced relative to any one of Examples 4 to 6, the second end of the retaining element is not directly coupled to the leaflet frame at the inflow end of the leaflet frame sub-component, and a portion of the connecting sheath is present therebetween.

[0024] According to another example (“Example 8”) that is further advanced relative to any one of Examples 4 to 7, the leaflet comprises a composite material, the composite material comprising a porous synthetic fluoropolymer membrane that defines pores and an elastomer or elastic material that fills the pores, and optionally a TFE-PMVE copolymer, comprising from about 27 to about 32 weight percent perfluoromethyl vinyl ether and correspondingly from about 73 to about 68 weight percent tetrafluoroethylene on at least a portion of the composite material, and optionally wherein the elastomer or elastic material comprises a TFE-PMVE copolymer, and optionally wherein the porous synthetic perfluoropolymer membrane is ePTFE.

[0025] According to another example (“Example 9”) that is further advanced relative to any one of the foregoing examples, the anchoring frame sub-component comprises an anchoring frame and an anchoring frame cover, the anchoring frame defining a generally tubular shape that extends between the inflow end and the outflow end of the anchoring frame sub-component, an inner surface of the anchoring frame that defines an anchoring frame wall, and an outer surface of the anchoring frame, the anchoring frame being at least partially covered by the anchoring frame cover to restrict fluid flow through the anchoring frame wall.

[0026] According to another example (“Example 10”) that is further advanced relative to Example 9, the prosthetic valve is in a deployed nested configuration, and the anchoring frame defines a radially outwardly flared or tapered flared portion at the inflow end of the anchoring frame sub-component.

[0027] When Example 9 or 10 is further advanced relative to any one of Examples 4 to 8, according to another example (“Example 11”) that is further advanced relative to Example 9 or 10, the connecting sheath is contiguous with the anchoring frame cover and the leaflet frame cover.

[0028] When any one of Examples 9 to 11 is further advanced relative to any one of Examples 4 to 8, according to another example ("Example 12") that is further advanced relative to any one of Examples 9 to 11, the retaining element is coupled to a connection sheath that is located between the leaflet frame or the anchoring frame but is not directly coupled to the leaflet frame or the anchoring frame, such that the retaining element can be operated to maintain the nested configuration of the anchoring frame sub-component and the leaflet frame sub-component.

[0029] According to another example ("Example 13") that is further advanced relative to any one of the foregoing examples, the prosthetic valve has a smaller diameter in the delivery configuration than in the deployed nested configuration.

[0030] According to another example ("Example 14") that is further advanced relative to any one of the foregoing examples, the anchoring frame sub-component has an inner surface of the anchoring frame sub-component, wherein, in the deployed nested configuration, the diameter of the inner surface of the anchoring frame sub-component is at least slightly larger than the outer surface of the leaflet frame sub-component of the leaflet frame sub-component, and the leaflet frame sub-component is nested within the anchoring frame sub-component.

[0031] According to another example ("Example 15") that is further advanced relative to Example 2 or further advanced than any one of Examples 3 to 14 that are further advanced than Example 2, the connection sheath is a thin-walled flexible tubular member having an inner surface of the connection sheath that defines a connection sheath lumen in fluid communication with the lumen of the anchoring member frame sub-component and the lumen of the leaflet frame sub-component, and wherein the connection sheath can be operated to fold and flip when the leaflet frame sub-component advances from a pre-deployed non-nested configuration to a deployed nested configuration to be located between the leaflet frame sub-component and the anchoring frame sub-component.

[0032] According to another example ("Example 16") that is further advanced relative to any one of the foregoing examples, the connection sheath includes flow enabling features in the wall of the connection sheath that extends between the inflow end and the outflow end of the connection sheath, wherein the flow enabling features can be operated to allow antegrade fluid flow through the wall of the connection sheath and restrict retrograde flow through the wall of the connection sheath when the leaflet frame sub-component is not in the deployed nested configuration.

[0033] According to another example, further to any one of Examples 1 to 15 (“Example 17”), the connecting sheath includes an inner film layer and an outer film layer, which are joined together at least at the inflow end of the leaflet frame sub-component and the outflow end of the anchoring frame sub-component. The inner film layer defines at least one inner hole passing therethrough adjacent to the outflow end of the anchoring frame sub-component, and the outer film layer defines at least one outer hole passing therethrough adjacent to the leaflet frame sub-component. The inner film layer and the outer film layer are not joined at least between one of the inner holes and one of the outer holes, thereby defining a flow space therebetween. When the leaflet frame sub-component is not in the deployed nested configuration in the anchoring frame sub-component, the flow space is operable to allow antegrade blood flow to pass therethrough and restrict retrograde flow therethrough. And when the leaflet frame sub-component is in the deployed nested configuration within the anchoring frame sub-component, the flow frame is operable to restrict both antegrade and retrograde flow.

[0034] According to another example, further to any one of the foregoing examples (“Example 18”), the connecting sheath includes an inner film layer and an outer film layer, which are joined together at least at the outflow end of the anchoring frame sub-component. The inner film layer defines at least one inner hole passing therethrough adjacent to the outflow end of the anchoring frame sub-component. The inner film layer and the outer film layer are not joined at least downstream of the inner hole, thereby defining a flow space therebetween. When the leaflet frame sub-component is not in the deployed nested configuration in the anchoring frame sub-component, in the case where the inner film layer is separated from the outer film layer at the inner hole, the flow space is operable to allow antegrade blood flow, and in the case where the inner film layer gathers together and covers the inner hole, the flow space is operable to restrict retrograde flow therethrough. And when the leaflet frame sub-component is in the deployed nested configuration within the anchoring frame sub-component, the flow space is operable to restrict both antegrade and retrograde flow.

[0035] According to another example, further to any one of the foregoing examples (“Example 19”), when the prosthetic valve is in the deployed nested configuration, the retaining element is configured to cover the inflow annular groove formed between the anchoring frame sub-component, the flipped connecting sheath, and the leaflet frame sub-component.

[0036] According to another example, further to any one of the foregoing examples (“Example 20”), the retaining element further includes an impermeable cover. And wherein, when the prosthetic valve is in the deployed nested configuration, the inflow annular groove is defined by the anchoring frame sub-component, the connecting sheath, and the leaflet frame sub-component at the inflow end of the prosthetic valve. And wherein, the retaining element including the impermeable cover is operable to cover the inflow annular groove and restrict fluid inflow into the inflow annular groove.

[0037] According to another example (“Example 21”) that is further relative to Example 2 or further relative to any one of Examples 3 to 20 that is further relative to Example 2, the retaining element is an elongate element that, when in the pre-deployment configuration, is operable to extend generally parallel to the central longitudinal axis X of the prosthetic valve and that, when in the deployed configuration, is operable to extend at an angle to the central longitudinal axis X.

[0038] According to another example (“Example 22”) that is further relative to any one of the foregoing examples, during transition of the prosthetic valve between the delivery configuration and the deployed nested configuration, the retaining element is operable to translate through the anchoring frame sub-component and, during transition of the prosthetic valve between the delivery configuration and the deployed nested configuration, the connecting sheath is operable to fold and flip within the lumen of the anchoring frame sub-component and is located between the leaflet frame sub-component and the anchoring frame sub-component.

[0039] According to another example (“Example 23”) that is further relative to Example 23 that is further relative to Example 20, the retaining element includes a continuous serpentine element configured to have an outward spring bias toward a flat star configuration, thereby defining an elongate element that bends around vertices, the elongate element having a first elongate element end and a second elongate element end that, when in the star configuration, extend radially, wherein the first elongate element end and the corresponding vertex define an inner perimeter at the first end of the retaining element and the second elongate element end and the corresponding vertex define an outer perimeter at the second end of the retaining element, the serpentine element being operable to elastically confine to a tubular configuration, wherein the elongate element rotates about the vertex at the first elongate element end such that the respective second elongate element ends rotate toward each other to define a tubular or tapered configuration, wherein the serpentine element defines a first tubular diameter, wherein the elongate element is lateral to the central longitudinal axis X and extends laterally along the connecting sheath and between the anchoring frame sub-component and the leaflet frame sub-component.

[0040] According to another example (“Example 24”) that is further relative to Example 23 that is further relative to Example 20, the impermeable cover extends from the vertex at the first elongate element end of the elongate element to the vertex at the second elongate element end, wherein, when the prosthetic valve is in the deployed nested configuration, the impermeable cover extends from the inflow end of the leaflet frame sub-component to the inflow end of the anchoring frame sub-component, thereby covering the inflow annular groove formed between the anchoring frame sub-component, the connecting sheath, and the leaflet frame sub-component.

[0041] According to another example, further relative to Example 23 or 24 (“Example 25”), there is also a tether element coupled to the retention element, the tether element being operable to be pulled by an operator to affect the advancement of the retention element through the anchor frame sub-component, the second end of the retention element 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 can be released and thus release the second end of the elongate element of the retention element, thereby allowing expansion and deployment of the retention element.

[0042] According to another example, further relative to any of the foregoing examples (“Example 26”), the retention element is biased towards a flat position and is operable to bias the relative positions of the outwardly biased retention flap frame sub-component and the anchor frame sub-component.

[0043] According to another example, further relative to any of the foregoing examples (“Example 27”), one or more vertices at the second end of the retention element of the retention element can abut and slide along the inner surface of the connection sheath and then along the inner surface of the anchor frame sub-component while expanding under the action of the outward bias until the vertices at the second end of the retention element are fully expanded around the inflow end of the anchor frame sub-component, wherein the outward bias generates sufficient force to cause the retention element to advance towards the inflow end of the anchor frame sub-component through the inner surfaces of the connection sheath and the anchor frame sub-component while pulling the flap frame sub-component into the anchor frame sub-component.

[0044] According to another example, further relative to any of the foregoing examples (“Example 28”), the length of the anchor frame sub-component varies along its circumference, wherein the outflow end of the anchor frame sub-component has a tapered (conical) geometry that is operable such that when the prosthetic valve is placed in the mitral annulus, the outflow end of the anchor frame sub-component can extend further into the left ventricle, adjacent to the posterior side of the left ventricle and less into the LVOT on the anterior side of the left ventricle.

[0045] According to another example, further relative to any of the foregoing examples (“Example 29”), the hoop strength of the anchor frame sub-component is variable along the length and / or circumference of the anchor frame sub-component and is predetermined to have a greater stiffness at a smaller tapered portion of the front part of the anchor frame sub-component at the outflow end of the anchor frame sub-component to substantially match the stiffness of the aortic mitral junction, while the stiffness can be relatively smaller at the longer posterior part of the prosthetic valve adjacent to the posterior side of the left ventricle.

[0046] According to another example, further to any of the foregoing examples ("Example 30"), the anchoring frame sub-component has a predetermined flexibility such that the anchoring frame sub-component can be flipped into the inner cavity of the anchoring frame sub-component, such that the anchoring frame sub-component can be operated to peel off from the tissue annulus and be pulled out from the inner cavity of the anchoring frame sub-component, such that the prosthetic valve can be removed from the tissue annulus.

[0047] According to another example, further to any of the foregoing examples ("Example 31"), the anchoring frame sub-component includes one or more tissue engaging features that project away from the outer surface of the anchoring frame of the anchoring frame sub-component and can be operated to engage the tissue annulus.

[0048] According to another example, further to any of the foregoing examples ("Example 32"), the prosthetic valve further includes an outflow annular groove cover extending from the outflow end of the anchoring frame sub-component and the outflow end of the leaflet frame sub-component.

[0049] According to another example, further to Example 32 ("Example 33"), the outflow annular groove cover is configured to be blood-permeable under physiological conditions before the prosthetic valve transitions into the deployed nested configuration.

[0050] According to another example, further to Example 32 or 33 ("Example 34"), the outflow annular groove cover is configured to be less blood-permeable under physiological conditions when the prosthetic valve is in the deployed nested configuration than when the prosthetic valve is not in the deployed nested configuration.

[0051] Also disclosed herein is a method of replacing a natural valve of a patient's anatomy. According to one example ("Example 35"), the method includes providing a prosthetic valve that includes an anchoring frame sub-component; a leaflet frame sub-component that can be nested within the anchoring frame sub-component; a connecting sheath that is coupled to the leaflet frame sub-component and the anchoring frame sub-component, the anchoring frame sub-component including an inflow end of the anchoring frame sub-component and an outflow end of the anchoring frame sub-component; and a retaining element that is adjacent to the inflow end of the leaflet frame sub-component and is coupled to the connecting sheath. The prosthetic valve in the delivery configuration is advanced to a treatment site within the patient's anatomy, wherein, in the delivery configuration, the leaflet frame sub-component and the anchoring frame sub-component are longitudinally offset relative to each other such that the inflow end of the leaflet frame sub-component of the leaflet frame sub-component is distal to the inflow end of the anchoring frame sub-component. The anchoring frame sub-component is deployed within the tissue annulus. The leaflet frame sub-component is nested within the anchoring frame sub-component by changing the relative position between the leaflet frame sub-component and the anchoring frame sub-component. The retaining element is deployed to extend from the inflow end of the leaflet frame sub-component to the inflow end of the anchoring frame sub-component.

[0052] According to another example that is further relative to Example 35 (“Example 36”), the method further includes deploying a prosthetic valve at the treatment site.

[0053] According to another example that is further relative to Example 35 or 36 (“Example 37”), after deploying the prosthetic valve at the treatment site, the leaflet frame sub-component is nested within the anchor frame sub-component.

[0054] According to another example that is further relative to any one of Examples 35 to 37 (“Example 38”), the prosthetic valve is advanced to the treatment site via a catheter.

[0055] According to another example that is further relative to any one of Examples 35 to 38 (“Example 39”), nesting the leaflet frame sub-component within the anchor frame sub-component includes pulling the leaflet frame sub-component proximally relative to the anchor frame sub-component.

[0056] According to another example that is further relative to any one of Examples 35 to 39 (“Example 40”), the method further includes fixing the prosthetic valve to the valve orifice of the native valve such that the prosthetic valve is operable to transition between an open position in which fluid flow is permitted and a closed position in which fluid flow is blocked.

[0057] According to another example that is further relative to any one of Examples 35 to 40 (“Example 41”), deploying the anchor frame within the tissue annulus includes releasing a restraint element to expand the anchor frame to a larger diameter of the tissue annulus.

[0058] According to another example that is further relative to any one of Examples 35 to 39 and 41 (“Example 42”), deploying the anchor frame within the tissue annulus includes tensioning a restraint element to recompress the anchor frame to a smaller diameter to allow repositioning of the prosthetic valve.

[0059] According to another example that is further relative to any one of Examples 35 to 42 (“Example 43”), deploying the anchor frame within the tissue annulus includes tightening a restraint element to recompress the anchor frame to a smaller diameter to allow repositioning of the prosthetic valve.

[0060] Also 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 as described in any one of claims 1 to 34.

[0061] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept provided by the present disclosure in other ways. Although multiple examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary examples of the present invention. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The drawings are provided to further understand the present disclosure, and are included in this specification and form a part thereof, showing embodiments, and are used in conjunction with the description to explain the principles of the present disclosure.

[0063] Figure 1A is a side view of a prosthetic valve in a compressed pre-deployed configuration according to some embodiments;

[0064] Figure 1B1 is in an expanded pre-deployed configuration Figure 1A of a prosthetic valve;

[0065] Figure 1B2 is a side view of a prosthetic valve in an expanded pre-deployed configuration according to some embodiments;

[0066] Figure 1B3 is a side view of a prosthetic valve in an expanded pre-deployed configuration according to some embodiments;

[0067] Figure 1C1 is in an expanded pre-deployed configuration Figure 1B1 of a prosthetic valve along the cut line 1C2;

[0068] Figure 1C2 is in the deployed configuration as Figure 7C shown Figure 1B1 of a prosthetic valve along the cut line 1C2;

[0069] Figure 1D is an axial view of a prosthetic valve in a deployed configuration Figure 1A of;

[0070] Figure 1E is in a deployed configuration Figure 1A of a prosthetic valve showing a perspective view of the leaflet frame and the anchoring frame;

[0071] Figure 2A is a side view of a leaflet frame sub-component of a prosthetic valve in an expanded configuration according to some embodiments;

[0072] Figure 2B is according to some embodiments Figure 2AAxial view of the leaflet frame sub-component;

[0073] Figure 3A Is a side view of the anchoring frame sub-component of a prosthetic valve in a delivery configuration according to some embodiments;

[0074] Figure 3B Is Figure 3A Axial view of the anchoring frame sub-component;

[0075] Figure 4 Is a side view of a prosthetic valve mounted on a delivery catheter in a compressed pre-deployment configuration according to some embodiments;

[0076] Figure 5A Is a side view of a prosthetic valve having flow enabling features in an open configuration according to some embodiments;

[0077] Figure 5B Is a prosthetic valve having Figure 5A Flow enabling features in a closed configuration;

[0078] Figure 5C Is a side view of a connection sheath according to some embodiments, the connection sheath being coupled to an anchoring frame sub-component and a leaflet frame sub-component including flow enabling features;

[0079] Figure 5D Is Figure 5C Exploded view of the connection sheath;

[0080] Figure 5E Is a side view of a connection sheath according to some embodiments, the connection sheath being coupled to an anchoring frame sub-component and a leaflet frame sub-component including flow enabling features;

[0081] Figure 6A Is a cross-sectional view of a simplified representation of a prosthetic valve according to an embodiment, the prosthetic valve being constrained to a delivery catheter and placed within a tissue annulus;

[0082] Figure 6B1 Is according to Figure 6A Embodiment of a prosthetic valve partially deployed from a delivery catheter within a tissue annulus, showing antegrade flow;

[0083] Figure 6B2 Is according to Figure 6A Embodiment of a prosthetic valve partially deployed within a tissue annulus, showing retrograde flow;

[0084] Figure 6C1 Is according to Figure 6A Embodiment of a prosthetic valve deployed within a native valve orifice, showing antegrade flow;

[0085] Figure 6C2 is a cross-sectional view of a simplified representation of a prosthetic valve deployed within a natural valve orifice according to an embodiment of Figure 6A showing retrograde flow;

[0086] Figure 6D is a cross-sectional view of a simplified representation of a prosthetic valve deployed within a natural valve orifice according to an embodiment of Figure 6A ;

[0087] Figure 7A is a side view of a retention element in a partially compressed configuration according to some embodiments;

[0088] Figure 7B is a top perspective view of a prosthetic valve according to an embodiment of Figure 1B1 showing the Figure 7A retention element in an expanded configuration according to some embodiments;

[0089] Figure 7C is a Figure 7B side perspective view of a prosthetic valve showing the Figure 7A retention element in an expanded configuration;

[0090] Figure 7D1 is a side cross-sectional view of, by way of example, a Figure 7C prosthetic valve in a deployed configuration such as that shown in Figure 7D3 along cut line 7D2;

[0091] Figure 7D2 is a side cross-sectional view of a Figure 7D3 prosthetic valve in an expanded pre-deployed configuration along cut line 7D2;

[0092] Figure 7D3 is a side view of an embodiment of a prosthetic valve in an expanded pre-deployed configuration;

[0093] Figure 8A is a partial cross-sectional view of a prosthetic valve deployed in an anatomy having a relatively large aortic-mitral angle, wherein the anchoring frame has a constant length along its periphery;

[0094] Figure 8B is a partial cross-sectional view of a prosthetic valve deployed in an anatomy having a relatively small aortic-mitral angle, wherein the anchoring frame has a constant length along its periphery;

[0095] Figure 8C is a partial cross-sectional view of a prosthetic valve deployed in an anatomy having a relatively small aortic-mitral angle, wherein the anchoring frame has a variable length along its periphery;

[0096] Figure 9A is a highly simplified partial side view cross-section of a prosthetic valve in an expanded configuration with a retrieval device, according to some embodiments, showing an exemplary prosthetic valve retrieval procedure;

[0097] Figure 9B is of a prosthetic valve in a partially compressed configuration with a retrieval device, according to some embodiments Figure 9A and is a highly simplified partial side view cross-section showing an exemplary prosthetic valve retrieval procedure;

[0098] Figure 9C1 is a highly simplified partial side view cross-section of a prosthetic valve in a partially compressed and partially deconstructed configuration, according to some embodiments, where the anchoring frame is flipped onto itself, showing an exemplary prosthetic valve retrieval procedure;

[0099] Figure 9C2 is of a prosthetic valve in a partially compressed and partially deconstructed configuration, according to some embodiments Figure 9A and is a highly simplified partial side view cross-section, where the anchoring frame is pivoted and compressed into a flipped configuration, showing an exemplary prosthetic valve retrieval procedure; and

[0100] Figure 9D is of a prosthetic valve in a compressed and deconstructed configuration within a retrieval sheath, according to some embodiments Figure 9A and is a highly simplified partial side view cross-section showing an exemplary prosthetic valve retrieval procedure;

[0101] Figure 10A is a cross-section of a heart showing an exemplary medical device delivery procedure, according to some embodiments;

[0102] Figure 10B is a partial cross-section showing a prosthetic valve positioned within a mitral tissue annulus, according to some embodiments, showing an exemplary delivery procedure;

[0103] Figure 10C is a partial cross-section showing a prosthetic valve partially deployed into a mitral tissue annulus, according to some embodiments, showing an exemplary delivery procedure;

[0104] Figure 10D is a partial cross-section showing a prosthetic valve partially deployed into a mitral tissue annulus, according to some embodiments, showing an exemplary delivery procedure;

[0105] Figure 10E is a partial cross-section showing a prosthetic valve partially deployed into a mitral tissue annulus, according to some embodiments, showing an exemplary delivery procedure;

[0106] Figure 10FA partial cross-sectional view of a prosthetic valve portion, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0107] Figure 10G A partial cross-sectional view of a prosthetic valve portion, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0108] Figure 10H A partial cross-sectional view of a prosthetic valve portion, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0109] Figure 10I A partial cross-sectional view of a prosthetic valve portion, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0110] Figure 10J A partial cross-sectional view of a prosthetic valve portion, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0111] Figure 10K A partial cross-sectional view of a prosthetic valve, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments;

[0112] Figure 10L A partial cross-sectional view of a prosthetic valve, showing an exemplary delivery procedure, deployed into a mitral tissue annulus, according to some embodiments; and

[0113] Figure 10M A partial cross-sectional view of a prosthetic valve that has been deployed into a mitral tissue annulus, showing an exemplary delivery procedure, according to some embodiments. DETAILED DESCRIPTION

[0114] DEFINITIONS AND TERMS

[0115] This disclosure is not intended to be read in a limiting sense. For example, terms used in this application should be read broadly in the context of the meanings that would be attributed to such terms by one of ordinary skill in the art.

[0116] Those skilled in the art will readily understand that aspects of this disclosure may be implemented by any number of methods and devices configured to perform the desired functions. In other words, other methods and devices may be included herein to perform the desired functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale and may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0117] Certain relative terms are used to denote the relative positions of components and features. For example, terms such as "top", "bottom", "upper", "lower", "left", "right", "horizontal", "vertical", "upward", and "downward" are used in a relative sense (e.g., how components or features are positioned relative to each other), rather than in an absolute sense, unless the context otherwise dictates. Similarly, throughout the disclosure, if a process or method is shown or described, the method can be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain actions being performed first.

[0118] Regarding imprecise terms, in some cases, the terms "about" and "approximately" may be used to refer to a measurement value that includes the stated measurement value and also any measurement value that is reasonably (substantially) close to the stated measurement value. As understood and readily determinable by one of ordinary skill in the relevant art, a measurement value that is reasonably close to the stated measurement value deviates from the stated measurement value by a relatively small amount. Such deviations can be attributed to, for example, measurement errors, differences in measurement values and / or calibration of manufacturing equipment, human error in reading and / or setting measurement values, fine-tuning for optimizing performance and / or structural parameters in view of differences in measurement values related to other components, specific implementation scenarios, imprecise adjustment and / or manipulation of an object by a person or a machine, and / or the like.

[0119] As used herein, "coupled" means to directly or indirectly and permanently or temporarily link, connect, attach, adhere, affix, or bond (combine).

[0120] As used herein, the term "diaphragm" refers to a sheet of material that includes a single composition, such as but not limited to an expandable fluoropolymer.

[0121] As used herein, the term "composite material" refers to a material that includes two or more material components, which have one or more material properties that are different from the others. In some examples, the composite material includes at least a first material component in the form of a diaphragm and a second material component in the form of a polymer that is combined with the diaphragm (e.g., by a coating and / or absorption process).

[0122] As used herein, the term "laminate" refers to a multi-layer diaphragm, composite material, or other material, such as but not limited to a polymer, such as but not limited to an elastomer, an elastic or inelastic material, and combinations thereof.

[0123] 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 rapidly retract to its approximately original length upon release.

[0124] As used herein, the term "elastomeric material" refers to a polymer or a mixture of polymers that exhibits tensile and recovery characteristics similar to those of an elastomer, although not necessarily to the same degree of tensile and / or recovery.

[0125] The term "non-elastomeric material" refers to a polymer or a mixture of polymers that exhibits tensile and recovery characteristics not similar to those of an elastomer or an elastomeric material, i.e., it is not considered to be a generally known elastomer or elastomeric material.

[0126] As used herein, the term "membrane" generally refers to one or more of a septum, a composite material, or a laminate.

[0127] As used herein, the term "biocompatible material" generally refers to any material having biocompatible characteristics, including synthetic materials such as, but not limited to, biocompatible polymers, or biomaterials such as, but not limited to, bovine pericardium. Biocompatible materials may include the first membrane and the second membrane of various embodiments described herein.

[0128] As used herein, the terms "native valve orifice" and "tissue orifice" refer to the anatomical structures into which a prosthetic valve can be placed. Such anatomical structures include, but are not limited to, locations where a heart valve may or may not have been surgically removed. It should be understood that other anatomical structures that can receive a prosthetic valve include, but are not limited to, veins, arteries, conduits, shunts. It should also be understood that the valve tissue orifice or the implantation site may also refer to a location in a synthetic or biological conduit where a valve can be received.

[0129] As used herein, the term "frame" generally refers to any structure or support for directly or indirectly supporting the leaflets of a prosthetic valve. It will be understood that, where appropriate, the term frame may be used interchangeably with a support structure. According to some embodiments, the leaflets may be supported by the wall of a solid-wall conduit, which is understood to be a frame or a support structure.

[0130] Description of various embodiments

[0131] As will be further described below, in various examples, the prosthetic valve provides a leaflet frame sub-component that is not directly coupled to the tissue annulus and is substantially suspended within an anchoring frame sub-component that is coupled to the leaflet frame sub-component by a connection sheath and supported by a retention element. In various examples, the leaflet frame sub-component, the anchoring frame sub-component, and the connection sheath are all tubular members, although non-tubular configurations for one or more of the foregoing components are contemplated. It should be understood that "tubular" as used herein includes tubes having a constant diameter along the length of the tube, as well as tubes having a variable diameter along the length of the tube, such as but not limited to tapered and irregular perimeters. For example, in at least one configuration of the tubular member, the tubular member may have a variable diameter along its length. For example, the tubular member may have a generally constant diameter in the delivery configuration and a variable diameter in the deployed or pre-deployed configuration. The anchoring frame sub-component may conform to the shape of the tissue annulus, while the leaflet frame sub-component does not necessarily conform to the shape of the tissue annulus. The leaflet frame sub-component may be maintained as a circular hollow cylinder or in a preferred geometric configuration to provide a geometrically stable platform for the leaflets, ensuring proper leaflet function, including opening and closing dynamics and coaptation in the case of flexible leaflets.

[0132] In various embodiments, the retention element is operable to maintain the relative positioning of the leaflet frame sub-component within the anchoring frame sub-component. The retention element is operable to translate within the lumen of the anchoring frame sub-component adjacent to the inflow end of the anchoring frame sub-component. The retention element hinges about a second end of the retention element 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 sub-component, wherein a first end of the retention element is adjacent to the inflow end of the anchoring frame sub-component and a second end of the retention element is adjacent to the inflow end of the leaflet frame sub-component.

[0133] In different embodiments, the retention element further includes an impermeable cover that is operable to cover an inflow annular groove defined by the anchoring frame sub-component and the connection sheath at the inflow end of the prosthetic valve. In the deployed configuration of the retention element, the retention member extends between the inflow end of the leaflet frame sub-component and the inflow end of the anchoring frame sub-component, wherein the retention element includes a cover that is operable to cover and restrict fluid flow into the inflow annular groove.

[0134] In various embodiments, the anchoring frame sub-component has a variable length about its perimeter such that the outflow end of the anchoring frame sub-component defines a tapered profile. The tapered profile is configured such that the outflow end of the anchoring frame sub-component minimizes obstruction to the left ventricular outflow tract (LVOT). For example, in the case where the prosthetic valve is used to replace the mitral valve, the shorter portion of the anchoring frame sub-component may be oriented facing the interventricular septum (the anterior portion of the tissue annulus), while the longer portion of the anchoring frame sub-component may be adjacent to the posterior wall of the left ventricle.

[0135] In various embodiments, the anchoring frame sub-component is provided with an outwardly flared inflow end that is conformal with the inflow end of the tissue annulus, such as the inflow end of the mitral valve tissue annulus at the left atrium. When the leaflets are open, the outwardly flared inflow end of the anchoring frame sub-component and / or its combination with the retention element mainly helps to resist the axial force from the atrial pressure to fix the prosthetic valve.

[0136] In various embodiments, the prosthetic valve can be retrieved after deployment within the tissue annulus. The leaflet frame sub-component is provided with a retrieval tether coupled to the inflow end of the leaflet frame sub-component, which is operable to compress the leaflet frame sub-component to a smaller diameter and pull the leaflet frame sub-component into a retrieval sheath. The anchoring frame sub-component is operable to flip under the force of pulling the retrieval tether of the leaflet frame sub-component, thereby compressing and pulling the anchoring frame sub-component into the leaflet frame sub-component and then into the retrieval sheath. The anchoring frame sub-component can provide tissue anchoring elements that are configured to allow repositioning and removal of the anchoring frame from the tissue annulus with minimal trauma, which will be discussed in more detail herein.

[0137] Although it should be understood that examples of prosthetic valves may be suitable for surgical or transcatheter applications, the examples provided herein are presented for transcatheter applications to avoid repetition while also providing surgical examples. Thus, the inventive concept can be applied to both surgical and transcatheter applications and is not limited to transcatheter applications.

[0138] The various embodiments shown and described herein relate to a prosthetic valve 1000. The prosthetic valve 1000 can transition between a delivery, compressed, un-nested configuration and a deployed, expanded, nested configuration. Figure 1A is a side view of the prosthetic valve 1000 in a pre-deployed, un-nested configuration, showing the leaflet frame sub-component 1200, the anchoring frame sub-component 1100, and a connection sheath 1300 between the leaflet frame sub-component and the anchoring frame sub-component, which is coaxially and serially aligned with the leaflet frame sub-component 1200 and connects the leaflet frame sub-component 1200 to the anchoring frame sub-component 1100. The prosthetic valve further includes a retention element 1400 coupled to the connection sheath 1300 near the leaflet frame sub-component 1200. Figure 1B1 is a side view of the prosthetic valve 1000 in an expanded, pre-deployed configuration, showing the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 relative to Figure 1A The pre-expanded configuration has expanded to a larger diameter.

[0139] Figure 1B1 The view of Figure 1AThe prosthetic valve 1000 shown is released from a constrained pre-nested configuration, such as when the prosthetic valve is placed on the delivery catheter 1504 before being constrained to the delivery catheter by a receiving element 1716 as shown in Figure 4 . The connection sheath 1300 defines a tapered configuration extending from the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100. The retaining element 1400 can be constrained by a limiting element as described below, or be allowed to assume the shape of the tapered configuration of the connection sheath 1300. The leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 are configured to be nestable. Figure 1C1 is a simplified side cross-sectional view of the Figure 1B1 prosthetic valve 1000 in an expanded pre-deployed configuration along the cut line 1C2. Figure 1C2 is a simplified side cross-sectional view of the Figure 7C prosthetic valve 1000 in the deployed configuration as shown in Figure 1B1 along the cut line 1C2, showing the leaflet frame sub-component 1200 translated into the anchoring frame sub-component 1100 in a nested alignment, where the connection sheath 1300 has been flipped and positioned between them. The retaining element 1400 has been translated through the anchoring frame sub-component 1100 and deployed to extend from the leaflet frame sub-component 1200 to the anchoring frame sub-component 1100. The leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 can be nested in situ, as will be described below.

[0140] The leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 are generally tubular and operable to have a smaller delivery configuration diameter and a larger deployed configuration diameter, which is facilitated by a balloon-expandable and / or self-expandable deployment device. The connection sheath 1300 is a flexible tubular diaphragm that is coupled to the leaflet frame sub-component 1200 at the inflow end 1202 of the leaflet frame sub-component around its periphery and to the anchoring frame sub-component 1100 at the outflow end 1104 of the anchoring frame sub-component, and is operable to couple the leaflet frame sub-component 1200 to the anchoring frame sub-component 1100. The connection sheath 1300 is thin and flexible and is operable to fold or elastically contract to a smaller diameter in the delivery configuration. The retaining element 1400 is coupled to the connection sheath 1300 adjacent to the inflow end 1202 of the leaflet frame sub-component. The retaining element 1400 is a flexible spring-like element that is operable to retract to a low radial profile in the delivery configuration and is operable to extend away from the inflow end 1202 of the leaflet frame sub-component towards the inflow end 1102 of the anchoring frame sub-component under the action of spring bias when in the deployed position. The engagement of the retaining element 1400 with the inflow end 1102 of the anchoring frame sub-component helps to maintain the relative position of the leaflet frame sub-component 1200 within the lumen 1140 of the anchoring frame sub-component.

[0141] In various embodiments, the leaflet frame sub-component 1200 can be nested within the anchoring frame sub-component 1100. Specifically, as shown, the dimensions and shapes of the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are designed such that the leaflet frame sub-component 1200 can be coaxially disposed or can be at least partially received within the anchoring frame sub-component 1100. Thus, in various examples, the anchoring frame sub-component 1100 is configured such that a part (or alternatively all) of the leaflet frame sub-component 1200 can be received within the space defined by the anchoring frame sub-component 1100 or otherwise positioned therein. In some examples, the leaflet frame sub-component 1200 is sized such that the diameter of the outer surface of the leaflet frame sub-component 1200 is less than the diameter of the inner surface of the anchoring frame sub-component 1100. In some examples, the diameter of the outer surface of the leaflet frame sub-component 1200 is in the range between seventy-five percent (75%) and ninety percent (90%) of the diameter of the inner surface of the anchoring frame sub-component 1100. In some examples, the diameter of the outer surface of the leaflet frame sub-component 1200 is seventy-five percent (75%) or less of the diameter of the inner surface of the anchoring frame sub-component 1100. In various examples, such a configuration also provides that the leaflet frame sub-component 1200 can be received within the anchoring frame sub-component 1100. In various examples, such a configuration provides that the anchoring frame sub-component 1100 can be deformed, such as but not limited to being non-circular or generally oval-shaped, to conform to or otherwise match the natural valve orifice without causing deformation of the leaflet frame sub-component 1200. The prosthetic valve 1000 provides a leaflet frame sub-component 1200 that is substantially suspended within the anchoring frame sub-component 1100 and is not directly coupled to the natural valve orifice. The anchoring frame sub-component 1100 can conform to the shape of the natural valve orifice, while the leaflet frame sub-component 1200 does not conform to the shape of the natural valve orifice. The leaflet frame sub-component 1200 remains a circular hollow cylinder or in a preferred geometric shape configuration, thereby providing a geometrically stable platform for the leaflets 1230, ensuring proper leaflet function, including opening and closing dynamics and coaptation in the case of flexible leaflets. It should be understood that these benefits associated with the leaflet frame sub-component 1200 that do not need to conform (adapt to, conform to) the natural valve orifice can be achieved during the transcatheter or surgical placement of the prosthetic valve 1000.

[0142] In various embodiments, as discussed in more detail below, the prosthetic valve 1000 is configured such that the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are capable of nesting in situ after the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are deployed to a treatment site in a patient's anatomy. That is, in various embodiments, the prosthetic valve 1000 can be delivered to a treatment region within a patient's anatomy where the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are longitudinally offset relative to each other and then nested with each other at the treatment site. In various embodiments, the prosthetic valve 1000 is loaded onto a delivery catheter where the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are longitudinally offset relative to each other, which results in a smaller profile or diameter compared to loading the prosthetic valve 1000 onto the delivery catheter in a nested configuration. The smaller delivery profile of a transcatheter delivered prosthetic valve has recognized advantages, including easier advancement through blood vessels.

[0143] It should be understood that these benefits associated with the leaflet frame sub-component 1200 not nesting into the anchoring frame sub-component 1100 during implantation can also be achieved in the surgical placement of the prosthetic valve 1000. By way of example, but not limited to, the anchoring frame sub-component 1100 can be more easily sutured into a native valve orifice without having to place the leaflet frame sub-component 1200 within the anchoring frame sub-component 1100 and in close proximity to the suturing procedure, thereby reducing the likelihood of the needle damaging the leaflets.

[0144] Leaflet frame sub-component

[0145] Figure 1D is an axial view of the prosthetic valve 1000 in an expanded configuration as viewed from the inflow end, showing the leaflet frame sub-component 1200, the anchoring frame sub-component 1100, and the connecting sheath 1300 therebetween (in accordance with an embodiment, the element 1400 is shown without a covering for clarity in viewing other components). Figure 1E is a perspective view of the leaflet frame 1220 and the anchoring frame 1120 in an expanded configuration, without other components for clarity. The leaflet frame sub-component 1200 provides the functionality of the one-way valve 1030 for the prosthetic valve 1000. It should be understood and appreciated that one-way valves 1030 are well known in the art and can be used herein. It should be understood that mechanical valves, bioprosthetic valves, and biologic and synthetic leaflet valves can be used as the one-way valve 1030 of the leaflet frame sub-component 1200. It should also be understood that for transcatheter applications, the leaflet frame sub-component 1200 needs to have a compressed configuration with a smaller diameter and an expanded configuration with a larger diameter, and the one-way valve component must be able to accommodate this functionality.

[0146] Referring to Figure 1A - 1E, according to an embodiment, the leaflet frame sub-component 1200 includes a leaflet frame 1220, one or more leaflets 1230, and a leaflet frame covering 1232. The leaflet frame sub-component 1200 is generally tubular in shape, thereby defining a leaflet frame sub-component inflow end 1202 and a leaflet frame sub-component outflow end 1204, through which a leaflet frame sub-component lumen 1240 passes.

[0147] The leaflet frame 1220 provides structural support for the leaflets 1230. The leaflet frame sub-component 1220 is operable to have a smaller delivery configuration diameter and a larger deployed configuration diameter, which is facilitated by balloon dilation and / or self-expanding deployment devices. As is known in the art, for example, structures defining orifices, such as but not limited to wire or perforated wall tubes that allow the leaflet frame to have various diameters, such as stents, are suitable for specific purposes.

[0148] The leaflet frame sub-component 1200 is configured to be received within at least a portion of the anchoring frame sub-component 1100, as shown in FIG. 1C and as will be described in more detail below. It will be understood that, depending on the patient's anatomy, non-limiting examples of the leaflet frame sub-component 1200 can be provided with a diameter in the range between twenty (20) millimeters and thirty (30) millimeters (e.g., the diameter of the inner or outer surface of the leaflet frame sub-component 1200).

[0149] Figure 2A is a side view of the leaflet frame 1220, with the leaflets 1230 and the leaflet frame covering 1232 not shown for clarity. Figure 2B is an axial view of the leaflet frame 1220, showing a plurality of leaflets 1230 therein. The leaflet frame wall 1205 of the leaflet frame 1220 can be at least partially covered with a leaflet frame covering 1232 suitable for a specific purpose, such as restricting fluid passage through the leaflet frame wall 1205 of the leaflet frame 1220, such as an impermeable film or fabric. For illustrative purposes, the following examples are particularly applicable to transcatheter applications, but are also applicable to surgical applications.

[0150] Referring to Figure 2A , the leaflet frame 1220 is a generally tubular member having a leaflet frame inflow end 1222 corresponding to the leaflet frame sub-component inflow end 1202, a leaflet frame outflow end 1224 corresponding to the leaflet frame sub-component outflow end 1204, a leaflet frame outer surface 1208 defining the leaflet frame wall 1205, and a leaflet frame inner surface 1206, wherein the leaflet frame inner surface 1206 defines a leaflet frame sub-component lumen 1210 passing therethrough. The leaflet frame sub-component lumen 1210 is a generally cylindrical void defined between the leaflet frame inflow end 1222 and the leaflet frame outflow end 1224 and the leaflet frame inner surface 1206.

[0151] The leaflet frame 1220 defines a tubular framework that defines an aperture or void 1216. For example, as shown, the leaflet frame 1220 includes a plurality of frame members 1212 that are interconnected and arranged in one or more patterns. In various examples, the frame members 1112 are connected to each other at various joints 1214. In some examples, these joints 1214 operate as flexure points to provide preferred flexure locations for the leaflet frame sub-component 1200, such as when compressed to a smaller delivery diameter required for transcatheter delivery. In some examples, the flexure points or joints 1214 include portions on the leaflet frame 1220 that are highly bent. In some examples, the flexure points or joints 1214 may include geometric, structural, or material variations, etc., that primarily bias the leaflet frame 1220 to bend at the joints 1214 when compressed or expanded between a larger diameter and a smaller diameter.

[0152] In some examples, one or more enclosed unit apertures or voids 1216 are defined between the joints 1214 and the frame members 1212 that are interconnected to the leaflet frame sub-component 1200. In some examples, these apertures or voids 1216 extend from the outer leaflet frame surface 1208 of the leaflet frame wall 1205 of the leaflet frame 1220 to the inner leaflet frame surface 1206. As Figure 2A shown in the embodiment of, when the leaflet frame sub-component 1200 is in the deployed configuration, one or more apertures or voids 1216 define a rhombus shape. When compressed to a smaller diameter (e.g., the delivery diameter), one or more joints 1214 and frame members 1212 deform such that the apertures or voids 1216 generally define an elongated rhombus shape (e.g., as generally shown in Figure 1A ). During deployment at the treatment site, after expanding the leaflet frame sub-component 1200 to a larger diameter, the apertures or voids 1216 expand to define a generally wider rhombus shape.

[0153] It should be understood that although the frame members 1212 shown and described herein are interconnected and define an aperture or void 1216 having a generally rhomboid shape, the interconnected frame members 1212 can be arranged in many alternative configurations without departing from the spirit or scope of the invention. That is, many alternative configurations are envisioned, in which the arrangement of the frame members 1212 is configured to provide a leaflet frame sub-component 1200 that is capable of being compressed to a smaller diameter for transcatheter delivery and then expanding (or being allowed to expand) to a larger diameter at the treatment site during deployment of the prosthetic valve 1000. Accordingly, the present disclosure should not be limited to the arrangement of the frame members 1212 that define the rhomboid aperture or void 1216. For example, the framework of the leaflet frame 1220 can define any number of features, such as geometric shapes and / or linear or tortuous (meandering) series of sine curves, that are repeatable or otherwise. The geometric shape can include any shape that contributes to circumferential compressibility and expandability.

[0154] In various embodiments, the leaflet frame 1220 can include a cut tube or any other element suitable for the specific purpose of the leaflet frame 1220 as described herein, or otherwise be formed from a cut tube or the other elements described above. In some examples, the leaflet frame 1220 can be etched, cut, laser cut, or stamped from a material tube, or from a sheet of material that is then formed into a tubular structure. Alternatively, a wire, a bendable strip, or a series of wires or bendable strips can be bent or woven and formed into a substantially tubular structure, wherein the wall of the tube includes an open framework that can be compressed to a smaller diameter and expanded to a larger diameter as shown and described herein.

[0155] According to an embodiment, the leaflet frame 1220 can include, but is not limited to, any elastically deformable metallic material or biocompatible polymeric material. The leaflet frame 1220 can include a shape memory material, such as nitinol, nickel-titanium alloy. Other materials suitable for the leaflet frame 1220 include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloys, polypropylene, acetyl homopolymer, acetyl copolymer, other alloys or polymers, or any other biocompatible material having sufficient physical and mechanical properties to be used as the leaflet frame sub-component 1200 described herein.

[0156] In various examples, as will be understood by those skilled in the art, since the leaflet frame 1220 is elastically deformable, it self-expands under spring loading. In some examples, as will be understood by those skilled in the art, the leaflet frame 1220 is plastically deformable, such that it can be mechanically expanded, for example, using a balloon. In still other examples, the leaflet frame 1220 is both plastically and elastically deformable. That is, in some examples, the leaflet frame 1220 includes one or more elastically deformable components or features and one or more plastically deformable components or features. Accordingly, it should be understood that the examples of the leaflet frame 1220 presented herein are not limited to a particular design or mode of expansion.

[0157] According to some embodiments, the leaflet frame 1220 includes a shape memory material that is operable to flex under a load and retain its original shape when the load is removed, thereby allowing the leaflet frame sub-component 1200 to self-expand from a compressed shape to a predetermined shape. The leaflet frame sub-component 1200 and the anchor frame sub-component 1100 may include the same or different materials. According to one embodiment, the leaflet frame 1220 is plastically deformable to be expanded by a balloon. In another embodiment, the leaflet frame 1220 is elastically deformable and thus self-expanding.

[0158] In various embodiments, the leaflet frame sub-component 1200 supports or otherwise includes a one-way valve 1030. In some examples, the one-way valve 1030 includes one or more leaflets 1230, as Figure 1D and 2B shown. A variety of mechanical valves, biological leaflets, and synthetic leaflet designs are known in the medical art, and any of these can be incorporated into the leaflet frame sub-component 1200 of the present disclosure. Examples of suitable leaflet configurations and methods of attaching to the leaflet frame sub-component are shown and described in U.S. Patent Applications Nos. 13 / 833,650, 14 / 973,589, and 14 / 622,599, the contents of each of which are incorporated herein by reference. Additional examples of suitable leaflet materials are given below.

[0159] In Figure 1D and 2B embodiments, the leaflet frame sub-component 1200 further includes one or more flexible leaflets 1230 coupled to the leaflet frame 1220, as shown in FIGS. 1B - 1C, which are operable to open to allow flow from the inflow end 1202 of the leaflet frame sub-component and allow flow through the outflow end 1204 of the leaflet frame sub-component, which is also referred to as the "forward flow direction"; and the flexible leaflets are operable to close to restrict flow from the outflow end 1204 of the leaflet frame sub-component through the inflow end 1202 of the leaflet frame sub-component, which is also referred to as the "retrograde flow direction".

[0160] In some examples, the one-way valve 1030 or the leaflet 1230 is coupled to the inner surface 1206 of the leaflet frame 1220 of the leaflet frame. In other examples, a membrane including the leaflet material is coupled to the outer surface 1208 of the leaflet frame and extends through a leaflet window defined by the leaflet frame 1220. This configuration minimizes the likelihood of the leaflet 1230 peeling or delaminating compared to a configuration where the leaflet 1230 is coupled to the inner surface 1220 of the leaflet frame 1220. In some examples, one or more portions of the leaflet 1230 are wrapped around one or more portions of the leaflet frame sub-component 1200.

[0161] The leaflet frame sub-component 1200 further includes a leaflet frame cover 1232 that is operable to prevent fluid from flowing through the walls of the leaflet frame 1220 such that fluid can only flow through the lumen defined by the open leaflet 1230. FIG. 1B provides an example where the void 1216 of the leaflet frame 1220 is covered by the leaflet frame cover 1232 to block the portion of the flow through the leaflet frame 1220 upstream of the attachment of the leaflet 1230 to the leaflet frame 1220. According to one example, the leaflet frame cover 1232 can be an impermeable membrane, sheet, or septum material that wraps around and is coupled to the outer surface 1208 of the leaflet frame. The leaflet frame cover 1232 can include any suitable material known in the art. By way of example, the leaflet frame cover 1232 can primarily be a membrane, fabric.

[0162] The leaflet frame cover 1232 can be biocompatible and configured as a sheet material that is coupled to the leaflet frame 1220. In various examples, the biocompatible material is a membrane that is not of biological origin and is sufficiently flexible and strong for a particular purpose, such as a biocompatible polymer. In one embodiment, the membrane includes a biocompatible polymer (e.g., ePTFE). In some examples, the membrane is a composite of two or more materials. The membrane can include one or more of a septum, a composite of two or more components, or a laminate of more than one layer of material. In various examples, the construction used in the membrane and the materials used are such that the leaflet frame cover 1232 is impermeable to fluid flow.

[0163] Anchoring frame sub-component

[0164] According to one embodiment, the anchoring frame sub-component 1100 includes an anchoring frame 1120 and an anchoring frame cover 1132, as shown in FIG. 1B. Figure 3A Is a side view of the anchoring frame 1120. Figure 3Bis an axial view of the anchoring frame 1120. The anchoring frame wall 1105 of the anchoring frame 1120 may be at least partially covered with, for example, a film or fabric, which is not shown for clarity, and which is adapted for a particular purpose, such as to restrict fluid passage through the anchoring frame wall 1105 of the anchoring frame 1120 or to promote tissue ingrowth into the anchoring frame sub-component 1100 at the implantation site. The anchoring frame cover 1132 may be coupled to the inner surface, outer surface, or both the inner and outer surfaces of the anchoring frame 1120. For illustrative purposes, the following examples are particularly applicable to transcatheter applications, but are also applicable to surgical applications.

[0165] Figure 3A and 3B are a side view and an axial view, respectively, of the anchoring frame 1120 according to one embodiment, without the anchoring frame cover 1132 for clarity. The anchoring frame 1120 is a generally tubular member having an anchoring frame inlet end 1122 corresponding to the anchoring frame sub-component inlet end 1102, an anchoring frame outlet end 1124 corresponding to the anchoring frame sub-component outlet end 1104, an anchoring frame outer surface 1108 defining the anchoring frame wall 1105, and an anchoring frame inner surface 1106, wherein the anchoring frame inner surface 1106 defines an anchoring frame sub-component lumen 1110 therethrough. The anchoring frame sub-component lumen 1110 is a generally cylindrical void defined between the anchoring frame sub-component inlet end 1102 and the anchoring frame sub-component outlet end 1104 and the anchoring frame inner surface 1106 of the anchoring frame sub-component 1100. However, the anchoring frame sub-component lumen 1110 may assume an irregular cross-section in situ, depending on the geometry of the tissue orifice into which it is placed and the conformability of the anchoring frame sub-component 1100 to the tissue annulus at the implantation site.

[0166] In various examples, the anchoring frame 1120 is configured to couple to a native valve orifice. Thus, in various examples, the diameter of the anchoring frame 1120 (e.g., the diameter of the anchoring frame outer surface 1108 and substantially Figure 1D the diameter of the anchoring frame sub-component outer surface 1109 of the anchoring frame sub-component 1100 as shown therein) is sized according to the patient's anatomy. It will be understood that non-limiting examples of the anchoring frame sub-component 1100 can be provided with a diameter in the range between twenty-five (25) millimeters and fifty (50) millimeters (e.g., the diameter of the outer surface of the anchoring frame sub-component 1100) according to the patient's anatomy. However, anchoring frame members 1120 having a diameter (e.g., the diameter of the anchoring frame outer surface 1106 of the anchoring frame 1120) in excess of fifty (50) millimeters are also contemplated and fall within the scope of the present disclosure. Note that as Figure 1DAs shown, the diameter of the inner surface 1107 of the anchoring frame sub-component 1100 of the anchoring frame sub-component is at least slightly larger than the outer surface 1208 of the leaflet frame sub-component 1200, such that the leaflet frame sub-component 1200 can be nested within the anchoring frame sub-component 1100 in a nested manner.

[0167] In another embodiment, the anchoring frame 1120 is elastically deformable and thus self-expanding. According to some embodiments, the anchoring frame 1120 includes a shape memory material that is operable to flex under the action of a load and retain its original shape when the load is removed, thereby allowing the anchoring frame sub-component 1100 to self-expand from a compressed shape to a predetermined larger shape. The anchoring frame 1120 may include the same or different material as the leaflet frame 1220. According to one embodiment, the anchoring frame 1120 is plastically deformable such that it can be mechanically expanded, such as by a balloon.

[0168] In some embodiments, as Figure 3A shown, the anchoring frame 1120 defines a tubular network having a framework that defines apertures or voids 1116. For example, as shown, the anchoring frame 1120 includes a plurality of frame members 1112 that are interconnected and arranged in one or more patterns. In certain examples, these patterns are repeated one or more times. In some such examples, the frame members 1112 are arranged and interconnected such that the anchoring frame 1120 includes a plurality of patterned rows. In various examples, the frame members 1112 are connected to each other at various joints 1114. In some examples, these joints 1114 operate as flexure points, thereby providing preferred flexure locations for the anchoring frame 1120. During normal operation after the delivery and deployment of the prosthetic valve 1000, when compressed to a smaller delivery diameter and when forces from the surrounding anatomy act to compress the anchoring frame 1120, the anchoring frame sub-component 1100 flexes. In some examples, the flexure points or joints 1114 include sites on the anchoring frame 1120 that are highly bent. In some examples, the joints 1114 may include geometric, structural, or material variations, etc., that bias the anchoring frame 1120 to bend at the flexure points or joints 1114 when compressed.

[0169] In some embodiments, one or more closed unit apertures or voids 1116 are defined between the joints 1114 and the interconnected frame members 1112 of the anchoring frame 1120. In some examples, these apertures or voids 1116 extend from the outer surface 1108 of the anchoring frame of the anchoring frame 1120 to the inner surface 1107 of the anchoring frame sub-component. As Figure 3A and 3BAs shown in the embodiments, when the anchoring frame 1120 is in the deployed configuration, one or more apertures or voids 1116 define a rhomboid shape. When compressed to a smaller diameter (e.g., the delivery diameter), one or more joints 1114 and frame members 1112 deform such that the apertures or voids 1116 generally define an elongated rhomboid shape (e.g., as generally shown in Figure 1A ). During deployment at the treatment site, when the anchoring frame 1120 is expanded to a larger diameter, the apertures or voids 1116 re-expand to define a generally wider rhomboid shape.

[0170] It should be understood that although the frame members 1112 shown and described herein are interconnected and define apertures or voids 1116 having a generally rhomboid shape, the interconnected frame members 1112 can be arranged in many alternative configurations. For example, the framework of the anchoring frame 1120 can define any number of features that are repeatable or have other aspects, such as geometric shapes and / or linear or meandering (winding) series of sine curves. The geometric shape can include any shape that contributes to the circumferential compressibility and expandability of the anchoring frame 1120. That is, many alternative configurations are contemplated in which the arrangement of the frame members 1112 is configured to provide an anchoring frame 1120 that can be compressed to a smaller diameter for transcatheter delivery and then expanded (or allowed to expand) to a larger diameter at the treatment site during deployment of the prosthetic valve 1000. Accordingly, the present disclosure should not be construed as limited to the arrangement of the frame members 1112 that define the rhomboid apertures or voids 1116.

[0171] In various embodiments, the anchoring frame 1120 can include a cut tube or any other element suitable for the specific purpose of the anchoring frame 1120 as described herein, or otherwise be formed from a cut tube or the aforementioned other elements. In some examples, the anchoring frame 1120 can be etched, cut, laser cut, or stamped from a material tube, or formed from a sheet of material that is then formed into a tubular structure. Alternatively, an elongated material such as wire, a bendable strip, or a series thereof can be bent or woven and formed into a tubular structure, where the wall of the tube includes an open framework that can be compressed to a smaller diameter in a generally uniform and circumferential manner as shown and described herein, and expanded to a larger diameter.

[0172] The anchoring frame 1120 can include any biocompatible material of metal or polymer. For example, the anchoring frame 1120 can include materials 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 sufficient physical and mechanical properties to function as described herein.

[0173] In various examples, as will be understood by those skilled in the art, the anchoring frame 1120 is elastically deformable and thus self-expands under the action of a spring load. In some examples, as will be understood by those skilled in the art, the anchoring frame 1120 is plastically deformable and thus mechanically expanded, for example, using a balloon. In still other examples, the anchoring frame 1120 is plastically deformable and elastically deformable. That is, in some examples, the anchoring frame 1120 includes one or more elastically deformable components or features and one or more plastically deformable components or features. Therefore, it should be understood that the examples of the anchoring frame 1120 presented herein are not limited to a particular design or expansion mode.

[0174] In various embodiments, the anchoring frame sub-component 1100 is configured to provide a positive engagement (shape fit) with the implantation site to firmly anchor the prosthetic valve 1000 to the site. This positive engagement (shape fit) with the implantation site may be facilitated by one or more of the following, but is not limited to: the spring bias of the expansion of the anchoring frame 1120; the hoop strength of the expanded anchoring frame 1120, the tissue engagement features, and the geometry, profile, and / or texture of the outer surface 1109 of the anchoring frame sub-component.

[0175] For example, in various examples, the anchoring frame sub-component 1100 includes one or more tissue engagement features 1118 that are configured to engage one or more regions of tissue at the tissue orifice surrounding the prosthetic valve 1000. In various examples, the tissue engagement features 1118 include one or more barbs or tissue anchors. The tissue engagement features 1118 will be discussed in more detail later.

[0176] In some embodiments, the anchoring frame 1120 defines a flange or flared portion 1130 at the inflow end 1102 of the anchoring frame sub-component, which radially expands or tapers outwardly when in the deployed configuration. For example, as shown in at least Figure 1B1 、 1B2 、1B3, 2A, 5A - 5C, 5E, and 10B - 10M, when in the deployed configuration, the inflow end 1102 of the anchoring frame sub-component expands or otherwise radially tapers outwardly. That is, as shown in the figures, the inflow end 1102 of the anchoring frame sub-component has a larger deployed diameter than the outflow end 1104 of the anchoring frame sub-component. In various examples, as discussed in more detail below, this configuration is used to minimize the risk of migration and to facilitate the adjacency of the anchoring frame sub-component 1100 to the native tissue annulus at the implantation site.

[0177] In some embodiments, the anchoring frame sub-component 1100 further includes a flange element 1150 that is separate from, adjacent to, and coaxial with the inflow end 1122 of the anchoring frame 1120. Figure 1B2is a side view of the prosthetic valve 1000 in an expanded pre-deployment configuration, showing that the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 have been expanded to a larger diameter so as to be compared with Figure 1B1 the overall flange or flare portion 1130 of the anchoring frame inflow end 1122 of the anchoring frame 1120 of the embodiment of

[0178] to show details of the flange element 1150. The flange element 1150 defines the flange or flare portion 1130 of the anchoring frame sub-component 1100, which also defines the anchoring frame sub-component inflow end 1102 that radially expands outwardly or tapers when in the deployed configuration. The flange element 1150 is a generally tubular member having substantially the same configuration as the anchoring frame 1120. The flange element 1150 has a flange element inflow end 1152, a flange element outflow end 1154, a flange element outer surface 1158 that defines a flange element wall 1155, and a flange element inner surface 1156, and the flange element wall defines a flange void 1157. The flange element inner surface 1156 defines a portion of the anchoring frame sub-component lumen 1110 therethrough. The flange element 1150 can adopt an irregular cross-section in situ, depending on the geometry of the tissue orifice into which it is placed and the conformability of the flange element 1150 with the tissue annulus at the implantation site.

[0179] Figure 1B2 The flange element 1150 is shown flaring outwardly in a trumpet shape and having a concave curvature to the flange element outer surface 1158. Figure 1B3 Another embodiment of the flange element 1150 is shown, where the flange element outer surface 1158 defines a convex curvature. The shape of the anatomical structure into which the anchoring frame sub-component 1100 is placed will determine Figure 1B2 - 1B3 the flange element 1150 of Figure 1B1 or the optimal shape selection of the flare portion 1130 of the anchoring frame sub-component 1100 of Figure 1B1 The flare portion 1130 of the anchoring frame sub-component 1100 of Figure 1B3 the embodiment of

[0180] The anchoring frame sub-component 1100 further includes an anchoring frame cover 1132 that is operable to prevent fluid flow through the anchoring frame wall 1105 of the anchoring frame 1120. The anchoring frame cover 1132 is also operable to provide a favorable surface for tissue adjacency at the tissue annulus and is further operable to facilitate tissue ingrowth, which can be beneficial for fixing the prosthetic valve 1000 to the tissue annulus, promoting a favorable biological response of the blood (e.g., to prevent thrombus formation reactions), and / or promoting sealing of the prosthetic valve 1000 to the tissue orifice to minimize paravalvular leakage. FIG. 1B provides an example in which all of the voids 1116 of the anchoring frame 1120 are covered by the anchoring frame cover 1132 to block flow through the anchoring frame wall 1105. According to one example, the anchoring frame cover 1132 can be an impermeable film, sheet, or septum material that wraps around and is joined to the outer surface 1108 of the anchoring frame. The anchoring frame cover 1132 can include any suitable material known in the art. By way of example, the anchoring frame cover 1132 can primarily be a film, fabric, etc.

[0181] The anchoring frame cover 1132 can be a biocompatible sheet material configured to be joined to the anchoring frame 1120. In various examples, the biocompatible material is a film that is not of biological origin and is flexible and strong enough for a particular purpose, such as a biocompatible polymer. In one embodiment, the film includes a biocompatible polymer (e.g., ePTFE). In some examples, the film is a composite of two or more materials. The film can include one or more of a septum, composite material, or laminate. In various examples, the construction of the film and the materials used are such that the anchoring frame cover 1132 is impermeable to fluid flow. In various examples, the construction of the film and the materials used are such that the anchoring frame cover 1132 promotes cell ingrowth, adhesion, and / or attachment. That is, in various examples, the anchoring frame cover 1132 is constructed in a manner that promotes ingrowth of tissue into one or more portions of the anchoring frame cover 1132. It will be understood that cell ingrowth can also increase the seal of the prosthetic valve to the tissue orifice and help minimize paravalvular leakage, i.e., leakage between the prosthetic valve and the tissue to which it is joined.

[0182] Connection sheath

[0183] According to an embodiment of the prosthetic valve 1000, the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are joined together by a connection sheath 1300. Referring to Figure 1A-1C, the connecting sheath 1300 is coupled to the outflow end 1104 of the anchoring frame sub-component 1100 at the inflow end 1322 of the connecting sheath, and is coupled to the inflow end 1202 of the leaflet frame sub-component at the outflow end 1324 of the connecting sheath. The connecting sheath 1300 is a thin-walled flexible tubular member that defines a connecting sheath lumen 1340 which, when in the pre-deployed configuration, is in fluid communication with the anchoring frame sub-component lumen 1140 and the leaflet frame sub-component lumen 1240. When the leaflet frame sub-component 1200 is nested within the anchoring frame sub-component 1100, the connecting sheath 1300 is operable to fold and flip to be positioned between the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100. The connecting sheath 1300 can include any suitable material known in the art. For example, the connecting sheath 1300 can primarily be a film, fabric, diaphragm, etc., which is flexible and impermeable to fluid flow.

[0184] The reference shows a side view of the prosthetic valve 100 in the pre-deployed configuration on the delivery catheter 1504 of the delivery device 1500 Figure 4, in some examples, the connection sheath 1300 is disposed within and / or around the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200. In some examples, the connection sheath 1300 is an abutting film that extends at least between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 and operatively couples the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 to each other. In some examples, the connection sheath 1300 extends not only between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 but also over or within one or both of them. In some examples, the connection sheath 1300 is a film that abuts the film of the anchoring frame cover 1132 and / or the leaflet frame cover 1232, which extends at least between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 and is operative to couple the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 to each other. In some examples, the connection sheath 1300 is formed of a generally tubular material and at least partially covers one or more of the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200. In some examples, the connection sheath 1300 is formed by wrapping a film on and around a cylindrical mandrel that defines a variable diameter to match the respective inner diameters of each of the leaflet frame 1220 and the anchoring frame 1120, with a tapered portion between the leaflet frame and the anchoring frame to transition from the smaller diameter of the leaflet frame 1220 to the larger diameter of the anchoring frame 1120. One or both of the anchoring frame 1120 and the leaflet frame 1220 slide on the film and bond to the film to the inner surfaces of the respective frames. In some examples, the connection sheath 1300 is formed by wrapping a film on and around one or both of the anchoring frame 1120 and the leaflet frame 1220 and bonding it to the outer surfaces of the respective frames.

[0185] The connection sheath 1300 is generally any sheet material that is biocompatible and configured to couple to the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200. In various examples, the biocompatible material is a film that is not bio-derived and is flexible and strong enough for a particular purpose, such as a biocompatible polymer. In one embodiment, the film includes a biocompatible polymer (e.g., ePTFE). In some examples, the film is a composite of two or more materials. The film may include one or more of a diaphragm, a composite material, or a laminate. In various examples, the construction used in the film and the materials used are such that the connection sheath 1300 is impermeable to fluid flow.

[0186] In various examples, the connection sheath 1300 is a tubular member having a connection sheath wall 1305 that is impermeable to fluid flow and specifically controls fluid flow only through the connection sheath lumen 1340 during deployment of the prosthetic valve 1000 into a tissue orifice as shown in FIG. 1B, and acts as an impermeable seal between the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 when in the deployed nested configuration as Figure 1D shown. As will be discussed further below, during deployment of the prosthetic valve 1000, with the anchoring frame sub-component 1100 deployed within the tissue annulus and the leaflet frame sub-component 1200 still mounted on the delivery catheter 1504, as Figure 6B1 - 6C2 shown, blood flow may be blocked until the leaflet frame sub-component 1200 is released from the delivery catheter 1504 and / or after the leaflet frame sub-component 1200 is deployed within the anchoring frame sub-component 1100 and the delivery catheter 1308 is removed from the leaflet frame sub-component 1200.

[0187] In various examples, the connection sheath 1300 is operable to permit antegrade fluid flow (i.e., blood perfusion) through the connection sheath wall 1305 during deployment of the prosthetic valve 1000 into a tissue orifice. For example, and with reference to Figure 5A - 5C FIGS. 5D and 5E, the prosthetic valve 2000 includes one or more flow enabling features 2350 formed in the connection sheath 1300, the connection sheath extending between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200. Figure 5A is a side view of the prosthetic valve 2000, where the flow enabling feature 2350 is in an open configuration that permits antegrade flow (represented by arrow "A"). Figure 5B is a side view of the prosthetic valve 2000, where the flow enabling feature 2350 is in a closed configuration that impedes retrograde flow (represented by arrow "R"). In some examples, the one or more flow enabling features 2350 include one or more perforations or orifices. The flow enabling feature 2350 is operable to permit antegrade flow and prevent retrograde flow through the flow enabling feature 2350 before the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are nested together and in a fully deployed configuration. Further, when the leaflet frame sub-component 2200 is nested into the anchoring frame sub-component 1100 and in a fully deployed configuration, the flow enabling feature 2350 is configured to be fully closed and sealed.

[0188] In some examples, one or more flow enabling features 2350 additionally or alternatively include one or more mechanisms that facilitate unidirectional flow. For example, in some examples, the flow enabling feature is configured as a one-way valve. In some examples, the one-way valve includes an orifice or perforation and a flap or element of material that covers and is larger than the orifice or perforation, such that the orifice or perforation is covered and sealed under the action of 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.

[0189] Figure 5A - 5E is a side view, as if Figure 4 the prosthetic valve 1000 shown as being released from a constrained pre-nested configuration, to more clearly show specific elements. As Figure 5A - 5B shown, one example of the flow enabling feature 2350 includes an orifice 2352 and a flap 2354 that enable antegrade flow through the prosthetic valve 2000 prior to the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 being nested together (i.e., when the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are longitudinally offset as shown and described herein). The flap 1354 is oversized relative to the orifice 2352 so as to cover the orifice 2352 under the action of retrograde flow pressure and limit or minimize retrograde flow through the orifice 2352, while during antegrade flow, the flap 1354 lifts away from the orifice 2352, thereby permitting antegrade flow through the orifice 2352. Further, when the leaflet frame sub-component 2200 is nested into the anchoring frame sub-component 1100 and in a fully deployed configuration, the flap 1354 is configured to cover and seal the orifice 2352.

[0190] In some embodiments described below, the connection sheath 1300 includes two layers of film, namely an inner film layer 1304 and an outer film layer 1306 (as Figure 5C - 5D shown), where both layers of film are coupled to the inner or outer surface of the anchoring frame 1120 and the leaflet frame 1220, or the inner film layer 1304 is bonded to the inner surface of the anchoring frame 1120 and the leaflet frame 1220, while the outer film layer 1306 is coupled to the outer surface of the anchoring frame 1120 and the leaflet frame 1220.

[0191] Figure 5C is a side view of another embodiment of the connection sheath 1300, which is shown coupled to the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100. Figure 5Dis an exploded view of the connection sheath 1300. According to this embodiment, the connection sheath 1300 is a double-layer film. The inner film layer 1304 is a conical tubular member that defines the inner layer of the connection sheath 1300, and the outer film layer 1306 is a conical tubular member slightly larger than the inner film layer 1304. When in the Figure 5C partially deployed configuration shown, it defines the outer layer of the connection sheath 1300. The inner film layer 1304 and the outer film layer 1306 are joined together at least at the inflow end 1202 of the leaflet frame sub-component 1200 of the leaflet frame sub-component and the outflow end 1104 of the anchoring frame sub-component 1100 of the anchoring frame sub-component. The inner film layer 1304 defines at least one inner film orifice 1312 passing through the inner film layer adjacent to the anchoring frame sub-component 1100, and the outer film layer 1306 defines at least one outer film orifice 1310 passing through the outer film layer adjacent to the leaflet frame sub-component 1200. The corresponding inner film orifices 1312 are radially offset from the corresponding outer film orifices 1310 to facilitate the operation as provided below. The inner film layer 1304 and the outer film layer 1306 are not joined at least between one of the inner film orifices 1312 and one of the outer film orifices 1310, thereby defining a flow space 1320 therebetween such that the outer film layer 1306 is lifted away from the inner film orifice 1312 to achieve antegrade flow through the inner film orifice 1312 and the outer film orifice 1310 before the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are nested (i.e., when the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are longitudinally offset as shown and described herein). The inner film layer 1304 and the outer film layer 1306 together enclose the flow space and cover and seal the inner film orifice 1312 and the outer film orifice 1310 under the action of retrograde flow pressure, and restrict or minimize retrograde flow through the inner film orifice 1312 and the outer film orifice 1310. Further, the inner film layer 1304 and the outer film layer 1306 are configured to cover and seal the inner film orifice 1312 and the outer film orifice 1310 when the leaflet frame sub-component 2200 is nested in the anchoring frame sub-component 1100 and in the fully deployed configuration.

[0192] In the above embodiments, the inner membrane layer 1304 and the outer membrane layer 1306 are joined together at least at the inflow end 1202 of the leaflet frame sub-component 1200 of the leaflet frame and the outflow end 1104 of the anchoring frame sub-component 1100 of the anchoring frame. It will be appreciated that, according to one embodiment, the outer membrane layer 1306 may not be joined together at or adjacent to the outflow end 1104 of the anchoring frame sub-component, but still has the function of covering the inner membrane orifice 1312 during retrograde flow conditions. As provided in the above embodiments related to the flap 2354, the outer membrane layer 1306 may function like the flap 2354; that is, it occludes the inner membrane orifice 1312 during retrograde flow conditions.

[0193] Figure 5E FIG. 4 is a side view of one embodiment of the connecting sheath 1300, as shown, which is coupled to the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100. According to this embodiment, the connecting sheath 1300 is a double-layer membrane, and the inner membrane layer 1304 is a conical tubular member that defines the inner layer of the connecting sheath 1300, and the outer membrane layer 1306 is a conical tubular member that is slightly larger but shorter than the inner membrane layer 1304, which defines the outer layer of the connecting sheath 1300 when in the Figure 5C partially deployed configuration shown. The inner membrane layer 1304 and the outer membrane layer 1306 are joined together at least at the outflow end 1104 of the anchoring frame sub-component 1100, but are not joined at the inflow end 1202 of the leaflet frame sub-component 1200 of the leaflet frame.

[0194] The inner membrane layer 1304 defines at least one inner membrane orifice 1312 passing through the inner membrane layer adjacent to the anchoring frame sub-component 1100, and the outer membrane layer 1306 is configured to cover at least one inner membrane orifice 1312. Under antegrade flow conditions, the outer membrane layer 1306 lifts away from the inner membrane layer 1304 and exposes at least one inner membrane orifice 1312, thereby defining a flow space 1320 therebetween such that the outer membrane layer 1306 lifts away from the inner membrane orifice 1312 to achieve antegrade flow through the inner membrane orifice 1312 before the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are nested (i.e., when the anchoring frame sub-component 2100 and the leaflet frame sub-component 2200 are longitudinally offset as shown and described herein). The inner membrane layer 1304 and the outer membrane layer 1306 together enclose the flow space and cover and seal the inner membrane orifice 1312 under retrograde flow pressure and restrict or minimize retrograde flow through the inner membrane orifice 1312. Further, the inner membrane layer 1304 and the outer membrane layer 1306 are configured to cover and seal the inner membrane orifice 1312 when the leaflet frame sub-component 2200 is nested into the anchoring frame sub-component 1100 and in the fully deployed configuration.

[0195] Figure 6A is a minimalist cross-sectional view illustration of a prosthetic valve 1000 according to an embodiment, the prosthetic valve being constrained to a delivery catheter 1504 and placed within a tissue annulus 1342. According to the above embodiment, as Figure 6B1 and 6B2 shown, when the anchoring frame sub-component 1100 is deployed within the tissue annulus 1342 and the leaflet frame sub-component 1200 in a pre-deployed configuration is translated and nested into the anchoring frame sub-component 1100, thereby causing the connection sheath 1300 to flip or fold / rotate, the antegrade flow pressure causes the outer membrane layer 1306 to move away from the inner membrane layer 1304, thus defining a flow space 1320 between the inner membrane layer 1304 and the outer membrane layer 1306. Specifically, when the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 still mounted on the delivery catheter block the antegrade flow and the leaflets are not yet functional, especially during the deployment of the prosthetic valve 1000, blood can flow in an antegrade direction into the inner membrane orifice 1312 and out of the outer membrane orifice 1310. In this example, blood perfusion can be maintained substantially throughout the deployment of the prosthetic valve 1000.

[0196] Under the action of retrograde flow pressure, blood is prevented from flowing in a retrograde direction through the flow enabling feature 2350. The retrograde flow pressure causes the outer membrane layer 1306 to move towards and against the inner membrane layer 1304, thereby closing the flow space 1320 between the inner membrane layer 1304 and the outer membrane layer 1306, wherein due to the radial offset of the inner membrane orifice 1312 and the outer membrane orifice 1310, the inner membrane layer 1304 covers the outer membrane orifice 1310 and / or the outer membrane layer 1306 covers the inner membrane orifice 1312. Specifically, when the deployed anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 still mounted on the delivery catheter are blocking the antegrade flow, especially during the deployment of the prosthetic valve 1000, blood is prevented from flowing in a retrograde direction into the outer membrane orifice 1310 and out of the inner membrane orifice 1312.

[0197] As Figure 6DAs shown, the leaflet frame sub-component 1200 expands into its final deployed configuration. The inner membrane layer 1304 and the outer membrane layer 1306 are brought together under antegrade and retrograde fluid pressure and / or mechanical pressure, narrowing or closing the flow space 1320, and due to the radial offset of the inner membrane orifice 1312 and the outer membrane orifice 1310, the inner membrane layer 1304 covers the outer membrane orifice 1310 and / or the outer membrane layer 1306 covers the inner membrane orifice 1312, closing the corresponding outer membrane orifice 1310 and inner membrane orifice 1312, thereby preventing flow therethrough. In this example, blood perfusion can be maintained during substantially the entire deployment process, and as the delivery catheter 1504 is removed from the prosthetic valve 1000, the leaflets 1230 become operative.

[0198] Retention element

[0199] Referring again to Figure 1A -1B, in various embodiments, the retention element 1400 is operable to position and / or hold the leaflet frame sub-component 1200 within the anchor frame sub-component. According to one embodiment, the retention element 1400 is operable to control the axial position of the leaflet frame sub-component 1200 within the anchor frame sub-component 1100. According to another embodiment, the retention element 1400 is configured to cover the inflow annular groove formed between the anchor frame sub-component 1100 and the connection sheath 1300, which has been flipped during the deployment process.

[0200] According to one embodiment, the retention element 1400 defines a retention element first end 1403 and a retention element second end 1405. The retention element second end 1405 is coupled to the sheath outflow end 1316, but is not directly coupled to the leaflet frame 1220 at the leaflet frame sub-component inflow end 1202, with a portion of the connection sheath 1300 therebetween. In the example of the retention element 1400, the retention element second end 1405 is only coupled to the connection sheath 1300 adjacent the leaflet frame sub-component inflow end 1202, thereby allowing the retention element 1400 to articulate or pivot about the retention element second end 1405. The retention element 1400 is an elongate element that, when in the pre-deployed configuration, is operable to extend generally parallel to the axis X of the prosthetic valve 1000, as shown in FIGS. 1B, 6A-6C2, 10D-10F, and 10I, and is operable to extend at an angle and, in some examples, in a generally lateral direction along the axis X when in the deployed configuration, as shown in FIGS. 1C, 1D, 6D, 7B-7C, and 10J-10K. As shown, the axis X is optionally the central longitudinal axis of the prosthetic valve 1000. As Figure 6A - 6C2As shown in FIGS. 10D - 10J, during the deployment process, the retention element 1400 is operable to translate through the anchoring frame sub - assembly 1100, while the connection sheath 1300 is operable to fold and flip within the anchoring frame sub - assembly lumen 1140 of the anchoring frame sub - assembly 1100 and be positioned between the leaflet frame sub - assembly 1200 and the anchoring frame sub - assembly 1100.

[0201] According to one embodiment, the retention element 1400 includes a continuous serpentine element 1702. As Figure 7B - 7C shown, the serpentine element 1702 is configured to have a spring bias towards a planar star configuration that defines elongate elements 1412 that bend about vertices 1414. The elongate elements 1412 have an elongate element first end 1402 and an elongate element second end 1404. In the star configuration, the elongate elements 1412 extend radially, the elongate element first end 1402 and the corresponding vertex 1414 define an inner perimeter 1422 at the retention element first end 1403, and the elongate element second end 1404 and the corresponding vertex 1414 define an outer perimeter 1424 at the retention element second end 1405. The serpentine element 1702 is operable to be elastically constrained to a tubular configuration, wherein each elongate element 1412 rotates about the vertex 1414 at the elongate element first end 1402 such that each elongate element second end 1404 rotates towards each other to define a tubular or conical configuration. In the case where the serpentine element 1702 defines a first tubular diameter, the tubular diameter can be further reduced by setting the elongate elements 1412 closer together while bending at the vertices 1414; that is, the elongate elements 1412 extend laterally to the axis X, extend along the connection sheath 1300, and extend laterally together with the anchoring frame sub - assembly 1100 and the leaflet frame sub - assembly 1200, as Figure 1A shown.

[0202] As Figure 1AAs shown, the serpentine element 1702 can be constrained to define a small tubular diameter in a constrained pre-deployment configuration, having a diameter relatively the same as and extending between the constrained leaflet frame sub-component 1200 and the constrained anchor frame sub-component 1100, with the retention element 1400 within the connection sheath lumen 1340. The connection sheath 1300 can be folded and / or wrinkled to facilitate reduction to a smaller diameter. In the deployed configuration, the first end 1403 of the retention element of the serpentine element 1702 maintains a diameter substantially the same as the expanded leaflet frame sub-component 1200, where the second end 1404 of the elongate element flares from the first end 1402 of the elongate element to substantially define the diameter of the inflow end 1102 of the anchor frame sub-component, thereby bridging the distance between the inflow end 1202 of the leaflet frame sub-component and the inflow end 1102 of the anchor frame sub-component and extending through the inflow annular recess 1704 defined by the inflow end 1102 of the anchor frame sub-component and the connection sheath 1300. The first end 1403 of the retention element is coupled to and constrained by the outflow end 1324 of the connection sheath. As shown in FIGS. 6I-6K, 7A, the second end 1405 of the retention element can be constrained by retention means 1710, such as a noose 1712, a cord, a tether element 1714, a pull cord, a removable clamp, or other constraint element, either on the prosthetic valve 1000 or on the delivery device.

[0203] Due to the spring bias of the serpentine element 1702, a resistance force relative to the retention element 1400 biased to a flat configuration, the retention element 1400 is operable to maintain the relative positions of the leaflet frame sub-component 1200 and the anchor frame sub-component 1100. The spring bias force can be predetermined such that the hydrodynamic forces on the prosthetic valve 1000 are not sufficient to overcome the spring bias force required to bend the elongate element 1412 into a tubular configuration that would cause an unacceptable distance of axial movement of the leaflet frame sub-component 1200 within the lumen 1140 of the anchor frame sub-component, and the hydrodynamic forces maintain the relative axial position (or at least minimize the relative axial movement) between the anchor frame sub-component 1100 and the leaflet frame sub-component 1200.

[0204] It will be appreciated that the retention element 1400 can be provided with a predetermined spring bias such that the retention element 1400 can operate as a shock absorber to allow a predetermined amount of movement of the leaflet frame sub-component 1200 during operation of the prosthetic valve 1000. This predetermined amount of movement can reduce stress within the various components of the prosthetic valve 1000, such as but not limited to leaflets or other valve structures.

[0205] According to an embodiment, an impermeable cover 1432 is coupled to the serpentine element 1702 such that when in the deployed configuration, fluid passage through the retention element 1400 is prevented, such as Figure 7B - 7CAs shown. The covering member 1432 extends from the apex 1414 at the first end 1402 of the elongate element 1412 of the elongate element to the apex 1414 at the second end 1404 of the elongate element. In the deployed configuration, the covering member 1432 extends from the inflow end 1202 of the leaflet frame sub-component to the inflow end 1102 of the anchoring frame sub-component, thereby effectively covering the inflow annular groove 1704 formed between the anchoring frame sub-component 1100 and the connection sheath 1300.

[0206] For various reasons, it is desirable to cover or seal the inflow annular groove 1704 from the blood flow. According to one embodiment, covering the inflow annular groove 1704 provides a smoother flow into the inflow end 1202 of the leaflet frame sub-component 1200 compared to the flow that would otherwise flow into and out of the inflow annular groove 1704 in a forward and reverse manner. Further, covering the inflow annular groove 1704 can prevent emboli that may form within the inflow annular groove 1704 from detaching and flowing through the prosthetic valve 1000.

[0207] Manual deployment

[0208] According to an embodiment, by withdrawing the delivery catheter 1504 on which the holding element 1400 is mounted, the holding element 1400 advances through the anchoring frame sub-component 1100 while in a compressed configuration constrained by the delivery catheter 1504. Subsequently, when positioned adjacent to the inflow end 1102 of the anchoring frame sub-component, the holding element 1400 is deployed. According to one example, a tether element 1714 is coupled to the holding element 1400, such as at the second end 1405 of the holding element 1400, such that the operator can pull on the tether element 1714 to affect the advancement of the holding element 1400 through the anchoring frame sub-component 1100. The second end 1405 of the holding element 1400 can be held in a compressed state by a pre-determined amount of tension on the tether element 1714. The tension on the tether element 1714 can be released, thereby releasing the second end 1404 of the elongate element of the holding element 1400, thereby allowing the expansion and deployment of the holding element 1400.

[0209] According to one example, prior to deploying the holding element 1400, the leaflet frame sub-component 1200 is nested within the anchoring frame sub-component 1100 and deployed within the anchoring frame sub-component 1100. In another example, the holding element 1400 is deployed prior to the leaflet frame sub-component 1200 being deployed within the anchoring frame sub-component 1100. According to another example, the leaflet frame sub-component 1200 and the holding element 1400 are deployed simultaneously.

[0210] Although various examples include one or more of the anchoring frame 1120, flange or flare 1130, leaflet frame 1220, and / or retaining element 1400 being discrete, independent 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 anchoring frame 1120, flange or flare 1130, leaflet frame 1220, and retaining element 1400 being formed as an integral unit (e.g., cut or formed from a single tube of material).

[0211] Passive expansion

[0212] According to other embodiments, after the anchoring frame subcomponent 1100 is deployed or expanded into the tissue annulus, the connecting sheath 1300 assumes a tapered configuration having a smaller diameter at the leaflet frame subcomponent inflow end 1202 and a larger diameter at the anchoring frame subcomponent outflow end 1104. The retaining element 1400 can be released or deployed while still within the connecting sheath 1300, wherein, as shown in FIGS. 1C and 6G , the apex 1414 at the retaining element second end 1405 of the retaining element 1400 can abut and slide along the tapered portion of the connecting sheath inner surface 1314 of the connecting sheath 1300, and subsequently abut and slide along the anchoring frame subcomponent inner surface 1107 of the anchoring frame subcomponent 1100 while expanding under the bias of the spring until the apex 1414 of the retaining element second end 1405 is fully expanded around the anchoring frame subcomponent inflow end 1102 of the anchoring frame subcomponent 1100. The spring bias may be configured to generate sufficient force to advance the retaining element 1400 through the tapered portion of the connecting sheath 1300 and the anchoring frame subcomponent inner surface 1107 of the anchoring frame subcomponent 1100 toward the anchoring frame subcomponent inflow end 1102 while pulling the leaflet frame subcomponent 1200 into the anchoring frame subcomponent 1100. Depending on the embodiment, the leaflet frame subcomponent 1200 may be retained on the delivery catheter 1504 or deployed to an expanded configuration before being pulled into the anchoring frame subcomponent 1100. In this embodiment, releasing the constrained retaining element 1400 enables a passive manner of advancing the leaflet frame subcomponent 1200 into the anchoring frame subcomponent 1100, i.e., the operator does not need to manipulate the position of the delivery catheter 1504 during deployment of the leaflet frame subcomponent 1200.

[0213] According to another embodiment, the length of the retention element 1400 is predetermined such that the vertex 1414 at the second end 1405 of the retention element of the retention element 1400 extends within the anchoring frame sub-component 1100 when in the pre-deployment configuration. When deployed, the vertex 1414 at the second end 1405 of the retention element can abut and slide along the inner surface 1107 of the anchoring frame sub-component of the anchoring frame sub-component 1100 while expanding under the action of a spring bias until the vertex 1414 at the second end 1405 of the retention element is fully expanded around the inflow end 1102 of the anchoring frame sub-component. The spring bias can be configured to generate sufficient force to cause the retention element 1400 to advance through the anchoring frame sub-component 1100 towards the inflow end 1102 of the anchoring frame sub-component while pulling the leaflet frame sub-component 1200 into and nesting within the anchoring frame sub-component 1100. According to an embodiment, the leaflet frame sub-component 1200 can be held on the delivery catheter 1504 or deployed to the expanded configuration before being pulled into and nested within the anchoring frame sub-component 1100. In this embodiment, releasing the constrained retention element 1400 provides a passive means for the leaflet frame sub-component 1200 to advance into the anchoring frame sub-component 1100, i.e., during deployment of the leaflet frame sub-component 1200, the operator does not need to manipulate the position of the delivery catheter 1504.

[0214] As will be discussed below, the delivery device can include elements to facilitate the advancement and deployment of the anchoring frame sub-component 1100, the leaflet frame sub-component 1200, and the retention element 1400. According to an embodiment, advancing the leaflet frame sub-component 1200 and the retention element 1400 into the anchoring frame sub-component 1100 is facilitated by moving the delivery catheter or by phased withdrawal of the delivery catheter. According to other embodiments, advancing the leaflet frame sub-component 1200 and the retention component 1400 into or through the anchoring frame sub-component 1100 respectively is facilitated by moving internal components of the delivery catheter 1504, such as but not limited to the leaflet frame sub-component 1200 riding on a trolley (trolley) and being advanced by pulling on a tether member 1714 or by spring biasing of the retention component 1400 or internal components of the delivery device. One embodiment of the sliding trolley can be a tubular member with a larger diameter that is operable to be slidably received onto a delivery catheter 1504 with a smaller diameter. The trolley can be constrained in its sliding on the delivery catheter 1504 by a retention device such as but not limited to a tether element 1714 or a latch.

[0215] LVOT taper

[0216] Referring again to the anchoring frame sub-component 1100, as shown in FIG. 1B, the length of the anchoring frame 1120, and thus the length of the anchoring frame sub-component 1100, is predetermined for a specific purpose. According to an embodiment, the length of the anchoring frame 1120 is primarily predetermined based on the anatomical structure of the tissue annulus of the implanted prosthetic valve 1000, including but not limited to the shape of the annulus, the amount of tissue available to support the anchoring frame sub-component 1100, the proximity to the flow path, other tissues, and nerves, and the structural characteristics of the anchoring frame sub-component (promoting engagement spring biasing or plastic deformation ring strength, retention barbs, appropriate compliance, modification / remodeling).

[0217] Figure 8A is a cross-sectional view of the heart and the prosthetic valve 1000 deployed within the tissue annulus of the mitral valve. According to an embodiment, the length of the anchoring frame sub-component 1100 is uniform along its perimeter. In other embodiments, the length of the anchoring frame sub-component 1100 varies along the perimeter. For example, when viewed laterally along axis X, the outflow end 1104 of the anchoring frame sub-component has a tapered geometry, as Figure 8C shown. By way of example, the anatomy of the mitral valve will be discussed next, with the prosthetic valve 1000 being applied to replace the mitral valve 1920 (obscured and distorted by the prosthetic valve 1000). Referring to Figure 8A , the mitral valve 1920 is a one-way valve that allows blood to flow from the left atrium 1902 to the left ventricle 1904. Blood leaves the left ventricle 1904, passes through the aortic valve 1906, and enters the aorta 1910. Just before the aortic valve 1906, the anatomy defines the left ventricular outflow tract (LVOT) 1908, which is a conduit through which blood enters the aortic valve 1906. Cardiac output is directly related to the minimum diameter of the LVOT 1908 that allows blood to flow to the aortic valve 1906. A reduced or restricted LVOT 1908, either by tissue or an implanted device, reduces cardiac output and can lead to cardiac dysfunction. Therefore, it is necessary to minimize the obstruction of the LVOT 1908 by the prosthetic valve 1000.

[0218] The mitral valve 1920 and the aortic valve 1906 are adjacent to each other and form an aortic-mitral angle 1800 with respect to their transverse axes, and this angle can vary between different patients. As can be seen from Figure 8A that in the case where the aortic-mitral angle 1800 is much greater than 90 degrees and close to 180 degrees, the degree of interference of the anchoring frame sub-component 1100 extending into the LVOT 1908 is less than the case where the aortic-mitral angle is close to 90 degrees, as Figure 8BAs shown, when the aortic mitral angle approaches 90 degrees, the amount of extension of the anterior portion 1822 of the outflow end 1104 of the anchoring frame sub-component 1100 of the anchoring frame sub-component with a given constant length into the LVOT 1908 becomes greater (longer).

[0219] According to one embodiment of the prosthetic valve 1000 for mitral valve replacement, the length of the anchoring frame sub-component 1100 is determined by considering one or more of the following parameters: the aortic mitral angle 1800, the degree of obstruction or blockage of the prosthetic valve 1000 to the LVOT 1908, the size of the tissue annulus 1930, and the amount of tissue available for engagement with the prosthetic valve 1000. According to one embodiment, in order to minimize the blockage of the LVOT with a smaller aortic mitral angle 1800, the length of the anchoring frame sub-component 1100 varies along its periphery. For example, when viewed transversely to the axis X, the outflow end 1104 of the anchoring frame sub-component has a tapered geometry. The outflow end 1104 of the anchoring frame sub-component is tapered such that the outflow end 1104 of the anchoring frame sub-component extends further into the left ventricle 1904, adjacent to the posterior side 1914 of the left ventricle 1904, and extends less into the LVOT 1908 on the anterior side 1916 of the left ventricle 1904.

[0220] As Figure 8C shown, in some embodiments, the length of the anchoring frame sub-component 1100 varies along the periphery. For example, when viewed transversely to the axis X, the outflow end 1104 of the anchoring frame sub-component has a tapered geometry. As shown, the anchoring frame sub-component 1100 can be oriented along the X axis, and the leaflet frame sub-component 1200 can be oriented along the X1 axis that deviates from the X axis. Figure 8C An embodiment is shown where "offset" can refer to an arrangement where the X1 axis can be angled with respect to the X1 axis (e.g., the X axis and the X1 axis are non-collinear or non-parallel), such that the leaflet frame sub-component 1200 is substantially tilted relative to the anchoring frame sub-component 1100. In one embodiment, the second longitudinal axis is arranged at an inclination angle A between 15° and 45° with respect to the first longitudinal axis. In another embodiment, the outflow end 1204 of the leaflet frame sub-component is substantially parallel to the outflow end 1104 of the anchoring frame sub-component, where the outflow end 1104 of the anchoring frame sub-component has a tapered portion, and the tapered portion is characterized by having a length that varies around the periphery. Along this orientation, compared with the Figure 8B coaxial anchoring frame sub-component 1100 and leaflet frame sub-component 1200 shown, the extension of the outflow end 1204 of the leaflet frame sub-component into the LVOT is reduced.

[0221] It has been found that the fixation of the anchoring frame sub-component 1100 may be greater (stronger) on the front portion 1822 of the anchoring frame sub-component adjacent to the aortic valve 1906, i.e., adjacent to the front side 1916 of the left ventricle 1904, of the prosthetic valve 1000 than on the rear portion 1932 of the anchoring frame sub-component adjacent to the rear side 1914 of the left ventricle 1904 of the prosthetic valve 1000. In such a case, the prosthetic valve 1000 may preferably pivot around the front portion 1822 of the anchoring frame sub-component. The more (longer) extensions and the tapered portions that engage with the tissue of the rear side 1914 of the left ventricle 1904 as described above will function to further resist the movement of the rear portion 1932 of the anchoring frame sub-component of the prosthetic valve 1000. The fluid pressure in the left ventricle 1904 acts on the closed leaflets of the prosthetic valve 1000, and the fluid pressure will tend to provide a cam force to further engage the rear portion 1932 of the anchoring frame sub-component with the rear side 1914 of the left atrium 1902.

[0222] Variable Stiffness of the Anchoring Frame

[0223] According to other embodiments, the hoop strength of the anchoring frame sub-component 1100 may be relatively constant along the length and periphery of the anchoring frame 1120. According to other embodiments, the hoop strength of the anchoring frame sub-component 1100 may vary along the length and / or periphery of the anchoring frame 1120. By way of example and with reference to the anatomy of the mitral valve annulus 1930, the tissue at the aortomitral junction 1940 of the valve annulus 1930 may be stiffer (more rigid) than the annulus posterior 1942 of the valve annulus 1930. The variable stiffness of the anchoring frame 1120 may be predetermined to have a greater stiffness at the smaller tapered portion of the front portion 1822 of the anchoring frame sub-component at the outflow end 1104 of the anchoring frame sub-component to match the stiffness of the aortomitral junction 1940, as Figure 8A shown, while the stiffness at the longer rear portion 1820 of the prosthetic valve adjacent to the rear side 1914 of the left ventricle 1904 may be relatively small.

[0224] Retrieval

[0225] According to another embodiment, during a transcatheter procedure, the prosthetic valve 1000 may be operable to be removable after the anchoring frame sub-component 1100 is deployed, but before the leaflet frame sub-component 1200 is deployed into the anchoring frame sub-component 1100. According to one embodiment, the anchoring frame sub-component 1100 has a predetermined flexibility such that the anchoring frame sub-component 1100 can be flipped into the lumen 1110 of the anchoring frame sub-component. In one embodiment, the bending of the anchoring frame sub-component 1100 during flipping occurs along the length of the anchoring frame 1120 such that the anchoring frame sub-component 1100 is peeled from the valve annulus 1342, as Figure 9C1As shown. According to another embodiment, a portion of the anchoring frame sub-component 1100 can pivot and compress around a position adjacent to the inflow end 1102 of the anchoring frame sub-component, such as at the expansion portion 1130, such that the anchoring frame sub-component 1100 can pivot or fold inwardly into the anchoring frame sub-component lumen 1110 and be pulled out from the inverted anchoring frame sub-component lumen 1110, as Figure 9C2 shown.

[0226] According to the method of retrieving the prosthetic valve 1000, the distal end of the retrieval sheath 1950 is positioned adjacent to the inflow end 1102 of the anchoring frame sub-component of the prosthetic valve 1000. The retrieval sheath 1950 is an elongated tubular member such as a catheter that defines a retrieval sheath lumen 1952 operable to receive at least a partially compressed prosthetic valve 1000. If the leaflet frame sub-component 1200 is fully deployed within the anchoring frame sub-component lumen 1110 by using a retraction device 1956 such as a snare, tether, etc., its diameter is reduced to be small enough to enter the diameter of the retrieval sheath lumen 1952. The retraction device 1956 extends from the retrieval sheath lumen 1952 and is operable to pull the prosthetic valve 1000 into the retrieval sheath lumen 1952.

[0227] As Figure 9A shown, the diameter of the leaflet frame sub-component 1200 is reduced and it is pulled into the retrieval sheath lumen 1952 by the retraction device 1956. As the leaflet frame sub-component 1200 and the connecting sheath 1300 are pulled into the retrieval sheath lumen 1952, the anchoring frame sub-component 1100 is pulled away from the tissue annulus 1930. In one embodiment, the bending of the anchoring frame sub-component 1100 during flipping occurs along the length of the anchoring frame 1120 such that the anchoring frame sub-component 1100 is peeled away from the tissue annulus 1342, as shown in FIG. 9B1. According to another embodiment, a portion of the anchoring frame sub-component 1100 can pivot and compress around a position adjacent to the inflow end 1102 of the anchoring frame sub-component, such as at the expansion portion 1130, such that the anchoring frame sub-component 1100 can pivot or fold inwardly into the anchoring frame sub-component lumen 1110 and be pulled out from the inverted anchoring frame sub-component lumen 1110, as shown in FIG. 9B2. As shown in FIGS. 9C - 9D, the anchoring frame sub-component 1100 is operable to be compressed to a smaller diameter to be received within the retrieval sheath lumen 1952.

[0228] It can be understood that, as shown in FIG. 1B, the anchoring frame sub-component 1100 may further include tissue engagement features 1118. Considering retrieval, the tissue engagement features 1118 are operable to minimize trauma when being pulled out from the tissue annulus 1930 during retrieval. According to one embodiment, the tissue engagement features 1118 have a predetermined angle with respect to the axis X such that when the anchoring frame sub-component 1100 flips, the tissue anchors will be withdrawn radially from the tissue annulus.

[0229] Outflow annular groove cover

[0230] Figure 7D3 is a side view of an example of a prosthetic valve 1000 in an expanded pre-deployed configuration. In various examples of the prosthetic valve 1000, when in the deployed configuration, as Figure 7D1 shown, the leaflet frame sub-component 1200 and the connecting sheath define an outflow annular groove. Figure 7D1 is, by way of example, a simplified side cross-sectional view of the Figure 7C prosthetic valve 1000 in the deployed configuration such as Figure 7D3 shown along cutting line 7D2, but also includes an outflow annular groove cover 1440. The outflow annular groove cover 1440 is an annular element that is coupled to and extends from the leaflet frame cover outflow edge 1233 of the leaflet frame sub-component outflow end 1204 to the anchor frame sub-component outflow end 1104, effectively covering the outflow annular groove 1706 formed between the connecting sheath 1300 and the leaflet frame sub-component 1200 and enclosing the volume defined by the leaflet frame cover 1232 of the leaflet frame sub-component 1200, the connecting sheath 1300, and the outflow recess cover 1432. According to another embodiment, the outflow groove cover 1432 extends between the leaflet frame sub-component outflow end 1204 and the anchor frame sub-component outflow end 1104, thereby preventing fluid from entering the outflow annular groove 1706.

[0231] For various reasons, it is desirable to cover or seal the outflow annular groove 1706 from the blood flow. According to one embodiment, covering the outflow annular groove 1706 provides a smoother flow at the leaflet frame sub-component outflow end 1204 of the leaflet frame sub-component 1200 compared to the flow that would otherwise occur into and out of the outflow annular groove 1706 in the antegrade and retrograde directions. Further, covering the outflow annular groove 1706 can prevent emboli that may form within the outflow annular groove 1706 from detaching and flowing downstream of the prosthetic valve 1000.

[0232] In various embodiments, when the prosthetic valve 1000 is fully deployed, the outflow annular groove cover 1440 can assist in maintaining the relative positioning of the leaflet frame sub-component 1200 within the anchor frame sub-component 1100. For example, the outflow annular groove cover 1440 can be elastically retractable and extensible such that the outflow annular groove cover 1440 can transition between an extended configuration and a retracted configuration.

[0233] During nesting and expansion of the leaflet frame sub-component 1200 within the anchoring frame sub-component 1100, the outflow annular groove cover 1440 can be presented from an extended configuration to a retracted configuration such that as the outflow annular groove cover 1440 contracts, the outflow annular groove cover 1440 has a relatively flat shape. For example, the outflow annular groove cover 1440 can have angled walls that are defined as the angled walls contract and angle (tilt) as the outflow annular groove cover 1440 transitions from a smaller angle (shallower angle) relative to the longitudinal axis X of the prosthetic valve 1000 to a larger angle (steeper angle) relative to the longitudinal axis X of the prosthetic valve 1000. In some examples, the outflow annular groove cover 1440 extends substantially perpendicular to the walls between the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 in the retracted configuration. In some examples, the first end 1444 of the outflow annular groove cover can be coupled to the outflow end 1104 of the anchoring frame sub-component, and the second end 1442 of the outflow annular groove cover can be coupled to the outflow end 1204 of the leaflet frame sub-component.

[0234] In the deployed or retracted configuration, the outflow annular groove cover 1440 extends between the outflow end 1204 of the leaflet frame sub-component and the outflow end 1104 of the anchoring frame sub-component, wherein the outflow annular groove cover 1440 is operable to cover and restrict fluid inflow or outflow from the outflow annular groove 1706. In various embodiments of the prosthetic valve 1000 including flow enabling features 2350 as shown in Figure 5A -E, when the prosthetic valve is in the pre-deployed configuration, it is required that the outflow annular groove cover 1440 be permeable to fluid to allow fluid to pass through the respective flow enabling features. According to one embodiment, in the retracted configuration, where the prosthetic valve 1000 is in the deployed configuration, the outflow annular groove cover 1440 has a lower permeability to blood (e.g., is impermeable to blood under physiological conditions). The outflow annular groove cover 1440 can be configured to be permeable to blood under physiological conditions when in the extended configuration, in which the prosthetic valve 1000 is in the pre-deployed configuration. For example, after activation but before completion of transitioning the prosthetic valve 1000 to the fully deployed configuration, the outflow annular groove cover 1440 is configured to be permeable to blood.

[0235] In various examples, the outflow annular groove cover 1440 is a flexible elastomeric element that is operable to elastically stow to a low radial profile in the delivery configuration and is operable to extend between the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100. The outflow annular groove cover 1440 can be implemented to inhibit blood inflow or outflow between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200.

[0236] In some examples, when in the deployed position, the effluent annular groove covers 1440 are under elastic bias such that they are held relatively tightly. According to some embodiments, the engagement of the effluent annular groove covers 1440 with the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 may assist in maintaining the relative position of the leaflet frame sub-component 1200 within the lumen 1140 of the anchoring frame sub-component.

[0237] As Figure 7D1 - 7D3 shown, the effluent annular groove covers 1440 define an effluent annular groove cover first end 1444 and an effluent annular groove cover second end 1442. The effluent annular groove cover first end 1444 is coupled to the effluent end 1104 of the anchoring frame sub-component. The effluent annular groove cover second end 1442 is coupled to the leaflet frame sub-component 1200 around the effluent edge 1233 of the leaflet frame cover 1232 adjacent to the effluent end 1204 of the leaflet frame sub-component. As Figure 7D1 - 7D3 shown, the effluent annular groove cover second end 1442 may be continuously attached to the effluent edge 1233 of the leaflet frame cover 1232. For example, the effluent annular groove covers 1440 may be coupled near and circumferentially extend from the effluent end 1104 of the anchoring frame sub-component and the effluent edge 1233 of the leaflet frame cover 1232 to prevent blood from flowing through the leaflet frame 1220 into the space or volume corresponding to the effluent annular groove 1706. In some examples, the leaflet frame cover 1232 is optionally coupled to the effluent end 1104 of the anchoring frame sub-component, and correspondingly, the effluent annular groove covers 1440 are coupled to the effluent end 1204 of the leaflet frame sub-component, where the leaflet frame cover 1232 extends to the effluent end of the leaflet frame sub-component to define a closed volume together with the connection sheath 1300 and the leaflet frame sub-component 1200. In this case, it may be desirable for the leaflet frame cover 1232 to also extend to the effluent end 1204 of the leaflet frame sub-component to prevent blood from flowing through the leaflet frame 1220 into the space corresponding to the effluent annular groove 1706.

[0238] The effluent annular groove covers 1440 are tubular elements that, when in a pre-deployed / dilated configuration (e.g., Figure 7D2 )), are operable to extend generally parallel to the longitudinal axis X of the prosthetic valve 1000 (or at a relatively small or shallow angle relative to the longitudinal axis X), and are operable to extend at an angle, and in some examples, when in a deployed / retracted configuration (e.g., Figure 7D1 ), extend in a generally lateral direction along the longitudinal axis X (or at a relatively large or steep angle relative to the longitudinal axis X). As Figure 7D1As shown, the outflow annular groove cover 1440 is operable to retract during the deployment process, while the connection sheath 1300 is operable to fold and flip within the lumen 1140 of the anchoring frame sub-component 1100 of the anchoring frame sub-component and is located between the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100, as Figure 7D1 shown.

[0239] The outflow annular groove cover 1440 can be configured to facilitate the delivery of the prosthetic valve 1000 and is operable to be elastically constrained to Figure 7D2 the extended tubular or conical configuration shown. Specifically, as Figure 4 shown, the outflow annular groove cover 1440 can also be constrained to define a small tubular diameter in the constrained pre-deployment configuration, which is relatively the same as the diameters of the constrained leaflet frame sub-component 1200 and the constrained anchoring frame sub-component 1100, where the outflow annular groove cover 1440 extends within the anchoring frame sub-component 1100. By reference, as described above, in some embodiments, the delivery device 1500 is configured to longitudinally constrain the prosthetic valve 1000 in the non-nested configuration until the time when the leaflet frame sub-component 1200 in the delivery sequence is nested into the anchoring frame sub-component 1100.

[0240] In some embodiments, the outflow annular groove cover 1440 can help maintain the relative positions of the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 by means of the elastic biasing of the outflow annular groove cover 1440. For example, the outflow annular groove cover 1440 optionally resists forces opposite to the force by which the outflow annular groove cover 1440 is biased into the retracted configuration.

[0241] If desired, the biasing can be predetermined to assist in centering or other desired positioning of the leaflet frame sub-component 1200 within the anchoring frame sub-component 1100 under physiological loading conditions. In other embodiments, the biasing can be selected to allow some elastic deflection or to adjust the position of the leaflet frame sub-component 1200 within the anchoring frame sub-component 1100 to accommodate physiological loading or perhaps even better replicate natural physiological action (e.g., closer to the movement of the natural valve during the cardiac cycle). In different terms, the biasing can be predetermined such that the hydrodynamic force on the prosthetic valve 1000 is not sufficient to overcome the elastic biasing required to stretch / dilate the outflow annular groove cover 1440, and the elastic biasing would cause unacceptable axial or radial movement of the leaflet frame sub-component 1200 within the lumen 1140 of the anchoring frame sub-component, and the hydrodynamic force maintains the relative axial and / or radial positions between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 (or at least minimizes the relative axial or radial movement).

[0242] According to one embodiment, the effluent annular groove cover 1440 includes a pleated or folded configuration having a continuous meandering configuration and / or a zigzag configuration. The pleated or folded configuration may assist in reducing the effluent annular groove cover 1440 to a smaller diameter. The pleated configuration may have an elastic bias or otherwise elastically return to a contracted or retracted configuration.

[0243] Although the various features are described above, they are provided by way of example, and additional or alternative features, related advantages, and other inventive aspects are contemplated and will be apparent from the disclosure as a whole.

[0244] Annular groove cover material

[0245] In some examples, the effluent annular groove cover 1440 is formed from a retracted microstructured membrane, such as those described in U.S. 10,166,128, issued January 1, 2019. Such retracted microstructures exhibit a high degree of recoverable elongation such that they can be extended and elastically retracted. They may be formed from a fluoropolymer membrane (e.g., a porous synthetic fluoropolymer membrane) such that they exhibit a high elongation rate while substantially maintaining the strength characteristics associated with the fluoropolymer membrane. Such retracted microstructured membranes are characterized by a microstructure having serpentine (wavy) fibrils that typically bend or turn in one direction and then typically bend or turn in another direction. It will be understood that the amplitude and / or frequency of the serpentine fibrils can be different. In some embodiments, the fluoropolymer membrane that has been retracted to provide the precursor retracted membrane is formed from an expandable fluoropolymer. Non-limiting examples of expandable fluoropolymers include, but are not limited to, expanded PTFE, expanded modified PTFE, and expanded PTFE copolymers.

[0246] High elongation is facilitated by forming relatively straight fibrils into serpentine fibrils, the wavy fibrils substantially straightening when a force is applied in a direction opposite to the compression direction. The production of serpentine fibrils can be achieved by thermally induced controlled retraction of expanded polytetrafluoroethylene (ePTFE), achieved by wetting the article with a solvent such as, but not limited to, isopropyl alcohol or (a perfluorinated solvent commercially available from 3M, Inc., St. Paul, MN), or by a combination of both techniques. Unlike what occurs during mechanical compression, the retraction of the article does not result in visible wrinkling, folding, or creasing of the ePTFE. During the retraction process, the fibrils not only become serpentine in shape but may also increase in width.

[0247] The retracted diaphragm described above can absorb an elastomeric material before, during, or after retraction to form a composite material such that at least a portion of the pores of a porous material such as ePTFE or a similar material are filled. Suitable elastomeric materials can include, but are not limited to, PMVE-TFE (perfluoromethyl vinyl ether-tetrafluoroethylene) copolymer, PAVE-TFE (perfluoro(alkyl vinyl ether)-tetrafluoroethylene) copolymer, silicone (silicone resin), polyurethane, and similar materials. It should be noted that PMVE-TFE and PAVE-TFE are fluorinated elastomers. Other fluorinated elastomers include suitable elastomeric materials determined by those skilled in the art. The resulting retracted diaphragm composite material has elastic elongation ability while substantially maintaining the strength characteristics of the fluoropolymer diaphragm. In addition, such a retracted diaphragm has the ability to have no visible (i.e., large-scale) creases, wrinkles, or folds in both the retracted configuration and the extended configuration.

[0248] As an addition to or an alternative to a diaphragm or other sheet-like component having elastic recovery work (e.g., by coating or absorbing a diaphragm with an elastomer), one or more elastomeric elements can be associated with the diaphragm or sheet-like member in other ways to provide the desired performance. For example, one or more elastic bands, members, or other features can be associated with a sheet-like member (such as a diaphragm or film) (e.g., bonded, adhered, or mechanically fastened) to provide elastic elongation ability to the (one or more) annular groove covers.

[0249] In some examples, the material flowing out of the annular groove cover 1440 includes a porous elastic film that defines pores large enough for the porous elastic film to be permeable to blood under physiological conditions when in the extended configuration, and the pores are small enough for the porous elastic film to have low permeability, such as being impermeable to blood under physiological conditions, when in the retracted configuration.

[0250] The material for the outflow annular groove cover 1440 can also be configured to promote tissue ingrowth (i.e., to assist or promote tissue ingrowth or adhesion) or to resist tissue ingrowth. In addition, one or more portions of the (one or more) covers can be configured to promote tissue ingrowth while other portions are configured to resist tissue ingrowth.

[0251] In addition to flowing into and out of the annular recess cover, a filling material may be employed. Whether injectable separately (e.g., using a syringe or other delivery mechanism) or associated with the (one or more) annular recess covers as a coating or other treatment, such filling material, if desired, can be used to help fill the inflow annular recess and inflow annular recesses 1704 and / or outflow annular recess 1706. Examples of such materials include biocompatible fillers or expanders operable to fill a volume and may include at least one of hydrogels, alginates, foams, porous expandable materials, collagen, hyaluronic acid, alginates, cellulose, chitosan, gelatin, agarose, glycosaminoglycans, polysaccharides, and combinations thereof, etc.

[0252] Tissue engagement features

[0253] In various examples, one or more tissue engagement features 1118 project radially outward from the longitudinal axis of the anchor frame sub-component 1100 and toward the tissue surrounding the prosthetic valve 1000, away from the inner surface 1106 and / or outer surface 1108 of the anchor frame of the anchor frame sub-component 1100. Generally, when the anchor frame sub-component 1100 is deployed (e.g., when the restraint member is withdrawn or otherwise removed), the tissue engagement features 1118 are operable to project away from the anchor frame sub-component 1100. In some examples, with the anchor frame sub-component 1100 in the deployed configuration, the tissue engagement features 1118 are operable to engage the tissue adjacent to the anchor frame sub-component 1100 such that the tissue engagement features 1118 fix the anchor frame sub-component 1100 to the surrounding tissue, as will be discussed in more detail below.

[0254] In some examples, in the deployed configuration, the tissue engagement features project away from the outer surface of the anchor frame sub-component at an angle within the range of thirty (30) to sixty (60) degrees. In some such examples, the tissue engagement features project away from the outer surface of the anchor frame sub-component at an angle of approximately forty-five (45) degrees, but other configurations are envisioned and fall within the scope of this application. Generally, any projection angle is suitable as long as the tissue engagement features operate for their intended purpose of engaging the tissue surrounding the anchor frame sub-component and causing the anchor frame sub-component to be fixed to the surrounding tissue. Although the tissue engagement features may include a variety of different lengths (depending on the angle at which they project from the anchor frame sub-component), it should be understood that the tissue engagement features have a length suitable for engaging the tissue and fixing the anchor frame sub-component to the surrounding tissue, but not so long as to pose a risk of causing adverse damage to the natural valve orifice. One non-limiting example configuration includes tissue engagement features projecting from the anchor frame sub-component within the range of thirty (30) to sixty (60) degrees and having a length between fifty (50) microns and two hundred (200) microns.

[0255] Typically, the tissue engaging features 1118 are positioned along the anchoring frame sub-component 1100 such that when the anchoring frame sub-component 1100 is expanded in place, these tissue engaging features are operable to engage tissue adjacent to the anchoring frame sub-component 1100. The tissue engaging features 1118 may be arranged in one or more rows along the longitudinal axis of the anchoring frame sub-component 1100. That is, in various examples, the anchoring frame sub-component 1100 may include a first set (or row) of anchors and a second set (or row) of anchors, the second set of anchors being longitudinally offset relative to the first set of anchors. In one such example, the first set of anchors is closer to the outflow end 1104 of the anchoring frame sub-component 1100 than the second set of anchors.

[0256] In various embodiments, one or more of the tissue engaging features 1118 are circumferentially arranged around the anchoring frame sub-component 1100. In some examples, one or more of the tissue engaging features 1118 are evenly dispersed around the periphery of the anchoring frame sub-component. For example, the tissue engaging features 1118 are dispersed around the frame and are offset from each other by ninety (90) degrees according to the number of anchors. Alternatively, the tissue engaging features 1118 may be dispersed around the frame and are offset from each other by sixty (60) degrees according to the number of anchors. Generally, as will be understood by those skilled in the art, the angular offset between the anchors is according to the number of anchors dispersed around the anchoring frame sub-component 1100. In some examples, the angular offset between the anchors is additionally or alternatively based on the arrangement or pattern of the frame members 1112.

[0257] In various examples, when the anchoring frame sub-component 1100 is in the deployed configuration, the tissue engaging features 1118 project away from the anchoring frame sub-component 1100, while when the anchoring frame sub-component 1100 is compressed in the delivery configuration, the tissue engaging features 1118 are retracted or otherwise do not project away from the anchoring frame sub-component 1100. Thus, in various examples, the tissue engaging features 1118 are retractable during delivery and are configured to transition to a deployed configuration in which they project away from the anchoring frame sub-component 1100. In some examples, a restraint member arranged around the anchoring frame sub-component 1100 during delivery aids in the retraction of the tissue engaging features 1118. In some examples, the tissue engaging features 1118 are retracted into the associated apertures or voids 1116 of the anchoring frame sub-component 1100.

[0258] In various embodiments, tissue engaging features 1118 are integrated into the anchoring frame sub-component 1100. For example, one or more of the tissue engaging features 1118 are combined with and formed from the same material as the frame member 1112. In other examples, one or more of the tissue engaging features 1118 are additionally or alternatively separate components that are coupled or attached to the anchoring frame sub-component 1100. For example, some non-limiting examples include crimping and / or welding one or more tissue engaging features to the anchoring frame sub-component 1100.

[0259] Leaflet material

[0260] For simplicity of discussion, when referring to the material of which the leaflets 1230 are made, it should be understood that the same material can also be used to make one or more parts or the whole of a leaflet structure composed of one or more leaflets. Thus, in such cases, the description of the leaflet material applies to options that can be used for one or more individual leaflets, one or more parts of the leaflet structure, and the whole of the leaflet structure. In the examples below, the leaflets formed of the leaflet material are flexible and composed of a flexible material.

[0261] 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, extrusion, wrapping, coating, absorption, lamination, combinations thereof, and others.

[0262] Suitable synthetic leaflet materials include polyurethanes, silicones (e.g., organopolysiloxanes), copolymers of silicone - polyurethane, styrene / isobutene copolymers, polyisobutene, polyethylene, polyethylene - co - vinyl acetate, polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, fluoroelastomers (e.g., copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymer) and (per)fluoroalkyl vinyl ether (PAVE)), and copolymers and / or mixtures of the foregoing and composite materials made therefrom. One or more suitable biocompatible polymers such as those described above may exhibit the physical properties of an elastomer, an elastic material, or a non - elastic material.

[0263] The leaflet material may include composite materials. Suitable composite leaflet materials include, but are not limited to, one or more membranes in combination with one or more polymers. According to some examples, the composite material includes membrane material (e.g., a porous synthetic polymer membrane) in the range of about 10% to about 90% by weight. For example, one or more polymers may be a coating or layer on one or more membranes and / or may be absorbed into one or more membranes (e.g., when one or more membranes include a microporous structure). The composite material may include additional or alternative components such as, but not limited to, inorganic fillers, therapeutic agents, radiopaque markers, etc. In some examples, the composite leaflet material includes at least one porous synthetic polymer membrane layer having a plurality of pores and / or spaces, and an elastomer and / or elastic material that fills the pores and / or spaces. In other examples, the composite leaflet material further includes a layer or coating of an elastomer and / or elastic material and / or non-elastic material on one or both sides of the composite leaflet material.

[0264] Membrane materials suitable for composite leaflet materials include, but are not limited to, porous synthetic polymer membranes such as microporous polyethylene and expanded fluoropolymer membranes such as expanded polytetrafluoroethylene (ePTFE). Such membranes may include PTFE homopolymers, mixtures of PTFE, expandable modified PTFE, and / or expanded copolymers of PTFE. As previously described, such membranes may have a microporous structure (such as an ePTFE membrane including a fibrillar matrix defining a plurality of spaces within a matrix).

[0265] Polymers for suitable composite leaflet materials include polymers that exhibit elastomeric, elastic, and / or inelastic material properties. Such polymers can include elastomers and elastic materials, such as fluorinated elastomers. Examples of suitable polymers include TFE-PMVE copolymers, which can exhibit elastomeric, elastic material, and / or inelastic material properties depending on the wt% or mol% of the respective polymer. As an example of a suitable elastomer, the TFE / PMVE copolymer is an elastomer when it includes substantially between 60 and 20 weight percent tetrafluoroethylene and correspondingly between 40 and 80 weight percent perfluoromethyl vinyl ether. As an example of a suitable elastic material, the TFE / PMVE copolymer is an elastic material when it includes substantially between 67 and 61 weight percent tetrafluoroethylene and correspondingly between 33 and 39 weight percent perfluoromethyl vinyl ether. As an example of a suitable inelastic material, the TFE / PMVE copolymer is an inelastic material when it includes substantially between 73 and 68 weight percent tetrafluoroethylene and correspondingly between 27 and 32 weight percent perfluoromethyl vinyl ether. In the previous examples, the TFE and PMVE components of the TFE-PMVE copolymer are expressed as weight percentages (wt%). For reference, weight percentages of 40, 33 - 39, and 27 - 32 for PMVE correspond to molar percentages (mol%) of 29, 23 - 28, and 18 - 22, respectively.

[0266] In some examples, the composite leaflet material includes an expanded polytetrafluoroethylene (ePTFE) membrane that has been absorbed with a TFE-PMVE copolymer that includes from about 60 to about 20 weight percent tetrafluoroethylene and correspondingly from about 40 to about 80 weight percent perfluoromethyl vinyl ether, and the leaflet further includes a coating of the TFE-PMVE copolymer on the blood contact surface that includes from about 73 to about 68 weight percent tetrafluoroethylene and correspondingly about 27 to about 32 weight percent perfluoromethyl vinyl ether. In other examples, the leaflet is an ePTFE membrane that has been absorbed with a TFE-PMVE copolymer that includes from about 70 to about 61 weight percent tetrafluoroethylene and correspondingly from about 33 to about 39 weight percent perfluoromethyl vinyl ether, and the leaflet further includes a coating of the TFE-PMVE copolymer on the blood contact surface that includes from about 73 to about 68 weight percent tetrafluoroethylene and correspondingly about 27 to about 32 weight percent perfluoromethyl vinyl ether.

[0267] Although some examples of suitable leaflet materials have been provided, the above examples are not intended to be understood in a limiting sense, and additional or alternative materials are envisioned.

[0268] In some examples, the leaflet frame cover 1232 and / or the anchor frame cover 1132 and / or the connection sheath 1300 and / or the outflow annular groove cover 1440 may include any of the above-described leaflet materials.

[0269] Delivery

[0270] Reference Figure 10A - 10M , an exemplary and non-limiting deployment sequence and nested configuration of the prosthetic valve 1000 during a mitral valve (“MV”) replacement surgical procedure are shown, where, for illustrative purposes, a cross-section of a portion of the heart is shown. In Figure 10A , the left atrium (“LA”) is accessed via the septum by the delivery device 1500. In various examples, the delivery device 1500 is delivered percutaneously and coupled to a control system 1600 external to the body. Access to the left atrium via the septum can be performed according to techniques known to those skilled in the art. When access to the left atrium via the septum is obtained, the delivery device 1500 is positioned for deployment of the prosthetic valve 1000. For example, as Figure 10B shown, the delivery device 1500 passes through the mitral valve and advances into the left ventricle (“LV”). In some examples, advancement of the delivery device 1500 through the mitral valve causes the anterior leaflet (“AL”) and posterior leaflet (“PL”) of the mitral valve to deflect into the left ventricle.

[0271] Figure 10A - 10M A cross-sectional view of the heart is shown, which depicts an exemplary medical device delivery procedure for implanting the prosthetic valve 1000 into the mitral valve tissue annulus 1930 using the delivery device 1500 according to some embodiments. Figure 10A The delivery device 1500 including a restraining sheath 1506 covering the prosthetic valve (1000, hidden and not visible) is shown. The restraining sheath 1506 is a tubular member that is operable to cover at least a portion of the prosthetic valve 1000 when constrained on the delivery device 1500. Covering a portion or all of the prosthetic valve 1000 with the restraining sheath 1506 primarily presents a smoother profile when traversing the anatomy of the prosthetic valve 1000 and / or for protection. In this example, the delivery device 1500 enters the left atrium (LA) during a transseptal procedure to access the mitral valve (MV). The delivery device 1500 is steerable and can flexibly traverse the anatomy. Figure 10B The distal end of the delivery device 1500 is shown positioned to pass through the mitral valve tissue annulus 1930. Figure 10C The restraining sheath 1506 is shown partially retracted to expose the leaflet frame sub-component 1200. Figure 10DThe restraining sheath 1506 is shown further retracted to fully expose the connection sheath 1300 and partially expose the anchoring frame sub-component 1100. As can now be seen, the prosthetic valve 1000 is mounted on the delivery catheter 1504 in a pre-deployed, non-nested configuration, where the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are longitudinally offset relative to each other (also referred to as "serial delivery") and connected together, with the connection sheath 1300 therebetween, which is also shown in Figure 4 The retaining element 1400 is hidden by the connection sheath 1300.

[0272] As previously described and shown in Figure 4 the inflow end 1202 of the leaflet frame sub-component of the leaflet frame sub-component 1200 is positioned distal to the outflow end 1104 of the anchoring frame sub-component of the anchoring frame sub-component 1100, and the connection sheath 1300 is coupled to and positioned therebetween to couple them together.

[0273] Figure 10E The restraining sheath 1506 is shown further retracted to fully expose the anchoring frame sub-component 1100, which allows the expansion portion 1130 to expand from the constrained configuration to the deployed configuration. In this example, the restraining sheath 1506 constrains the expansion portion 1130, and in other examples, other restraining devices may be used. As Figure 4 shown, the remaining portions of the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are still constrained on the delivery catheter 1504 by the restraining element 1716. In various examples, withdrawing the restraining sheath 1506 releases the expansion portion 1130 as shown in Figure 1B1 or the flange element 1150 as shown in Figure 1B2 - 1B3 which engages with the tissue annulus 1390, as shown in Figure 10E - 10G The other parts of the prosthetic valve 1000 are constrained on the delivery catheter 1504 by using restraining elements 1716, such as the fibrous ring shown in Figure 4 The prosthetic valve 1000 can be positioned and oriented within the tissue annulus 1390 by advancing and withdrawing and otherwise manipulating the delivery catheter 1504 or the delivery device 1500 as a whole to achieve a specific purpose, such as ensuring proper orientation and engagement with the anatomy of the tissue annulus 1390 and the surrounding tissue.

[0274] Figure 10F The expansion portion 1130 is shown advanced to the tissue annulus 1390 and placed in contact therewith. The delivery catheter 1504 or the delivery device 1500 as a whole can be manipulated such that the expansion portion 1130 and thus the anchoring frame sub-component 1100 can be positioned and repositioned to suit a specific purpose. Figure 10GThe figure shows the anchoring frame expanding to a larger diameter in the deployed configuration. Before disconnecting the restraint element 1716 that restrains the anchoring frame sub-component 1100 to the delivery catheter 1504, the position of the anchoring frame sub-component 1100 is verified. If it is incorrect, the restraint element 1716 can be used, such as by inputting tension to the restraint element 1716 via a tether, for example, to re-restrain the anchoring frame sub-component 1100 back onto the delivery catheter 1504 for repositioning or removal.

[0275] In various examples where the anchoring frame sub-component 1100 includes tissue engagement features 1118, as Figure 1B1 shown, the restraint element 1716 can restrain the deployment of the tissue engagement features 1118, thereby allowing the anchoring frame sub-component 1100 to be repositioned or withdrawn from within the tissue annulus 1390. In the case where the restraint element 1716 restrains the deployment of tissue engagement features 1118 such as tissue anchors, re-restraining and repositioning the anchoring frame sub-component 1100 can be performed without traumatizing the tissue.

[0276] In various examples, after the anchoring frame sub-component 1100 is expanded, the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are nested together. In various examples, the in-situ nesting of the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 involves advancing the leaflet frame sub-component 1200 proximally relative to the anchoring frame sub-component 1100. Figure 10H The figure shows the leaflet frame sub-component 1200 advancing proximally relative to the anchoring frame sub-component 1100 as indicated by the arrow. Figure 10H The figure shows the delivery catheter 1504 being withdrawn from the anchoring frame sub-component 1100, which pulls the connection sheath 1300 and a portion of the leaflet frame sub-component within the anchoring frame sub-component 1100 during the process of the connection sheath 1300 flipping between them.

[0277] Alternatively, or additionally, Figure 10I The figure shows the delivery catheter 1504 being further withdrawn from the anchoring frame sub-component 1100, and / or pulling a tether as discussed below, which pulls the connection sheath 1300 and a portion of the leaflet frame sub-component within the anchoring frame sub-component 1100 in the case where the connection sheath 1300 has already flipped between them. As Figure 10I shown, one or more tether elements 1714 are coupled to the retaining element 1400 as shown, and as Figure 7A alternatively shown as a noose or loop and discussed further below, which can be used to pull the retaining element 1400 through the anchoring frame sub-component 1100, and thus also pull the leaflet frame sub-component 1200 together with it into the anchoring frame sub-component 1100.

[0278] As will be discussed below, if it is necessary to remove the prosthetic valve 1000 from the heart at this moment of deployment, the leaflet frame sub-component 1200 can be recompressed by the tether element 1714, and the tether element 1714 can be used to pull the retention element 1400 and thus the leaflet frame sub-component 1200 and subsequently the anchoring frame sub-component 1100 into the restraint sheath 1506 or Figure 9A - 9D the larger retrieval sheath 1950 shown, which has advanced on the delivery device 1500. In this case, the anchoring frame sub-component 1100 is flipped starting from the outflow end 1104 of the anchoring frame sub-component so that it is withdrawn, peeled or pulled away from the tissue annulus 1930, as Figure 9A - 9D shown. Thus, the method provides a means of removing a prosthetic valve 1000 that has experienced a failed deployment without the need for invasive surgical care.

[0279] In various examples, after the leaflet frame sub-component 1200 is nested and expanded within the anchoring frame sub-component 1100, the tether element 1714 is loosened, allowing the retention element 1400 to expand and rotate downward from the leaflet frame sub-component 1200 under the action of the spring bias, as Figure 10J shown, and thus fully deployed on the inflow end 1102 of the anchoring frame sub-component, as Figure 10K shown. As Figure 10L shown, the delivery catheter 1504 can be withdrawn from the prosthetic valve 1000 to verify whether the valve 1230 is functioning properly before releasing the tether element 1714 from the retention element 1400. If the leaflets 1230 do not function properly, the delivery catheter 1504 can be advanced adjacent to or inside the leaflet frame sub-component 1200 and the prosthetic valve 1000 can be removed using the surgical procedures discussed above.

[0280] In addition, additional tethers can be coupled to the inflow end 1202 of the leaflet frame sub-component, which can be operated to restrain the leaflet frame sub-component 1200 and pull the leaflet frame sub-component 1200 out of the anchoring frame sub-component 1100, as previously referenced Figure 9A - 9D and discussed.

[0281] Figure 10L A prosthetic valve 1000 fully deployed within the tissue annulus 1390 of the mitral valve (MV) is shown. The prosthetic valve 1000 is in a fully deployed configuration where the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are nested. The prosthetic valve 1000 is fully deployed and operative when the retention element 1400 engages the inflow end 1102 of the anchoring frame sub-component, which minimizes the relative axial translation between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200.

[0282] In various examples, the longitudinal separation or offset of the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 provides a low-profile delivery configuration that can be easily tracked through a patient's vasculature. For example, by longitudinally offsetting the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200, the profile of the delivery system can be minimized because, unlike conventional designs, the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 do not overlap each other during delivery. In some examples, the maximum profile of the delivery device 1500 including the prosthetic valve 1000 can be 8 mm or less.

[0283] In addition, as Figure 4 and 10D shown, the region 1502 of the delivery device 1500 positioned between the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 and adjacent to the connection sheath 1300 and the retention element 1400 can be operable to bend such that the anchoring frame sub-component 1100 and the leaflet frame sub-component 1200 are temporarily misaligned (not aligned) with each other. In some examples, this configuration is similar to a tram traveling on a bend. This configuration is beneficial in surgical procedures in which the prosthetic valve 1000 is delivered transseptally to the treatment area, such surgical procedures may require the delivery device to bend ninety (90) degrees or more within the left atrium of the heart.

[0284] In addition, as Figure 1A shown, the tissue engagement feature 1118 of the anchoring frame sub-component 1100 extends away from the anchoring frame sub-component 1100 and engages the tissue surrounding the natural valve orifice of the prosthetic valve 1000. In some examples, the tissue engagement feature 1118 is configured to penetrate the tissue or otherwise embed within the tissue. In various examples, this interaction of the tissue engagement feature 1118 of the anchoring frame sub-component 1100 with the natural tissue surrounding the prosthetic valve 1000 is operable to fix the anchoring frame sub-component 1100 (and thus the leaflet frame sub-component 1200) to the natural tissue of the tissue annulus 1390.

[0285] Figure 10B - 10MThe inflow end 1102 of the anchoring frame sub-component 1100 shown in the figure radially expands outward and is positioned adjacent to and in contact with the annulus 1390 of the native valve tissue, as shown in the figure. In some examples, this configuration causes the inflow end 1102 of the anchoring frame sub-component 1100 to obstruct or otherwise limit the extent to which the anchoring frame sub-component 1100 can be operable to extend through the native valve. For example, in the case of mitral valve replacement, this expanded inflow end 1102 of the anchoring frame sub-component limits the extent to which the anchoring frame sub-component 1100 can advance through the native mitral orifice and into the left ventricle. In some examples, this expanded inflow end 1202 of the anchoring frame sub-component additionally operates to minimize the likelihood of distal migration of the anchoring frame sub-component 1100.

[0286] Although the embodiments and examples shown and described above relate to transseptal delivery, it should be understood that a variety of other well-known delivery procedures can be utilized without departing from the spirit or scope of the present application. Additional non-limiting delivery procedures include transapical, left atrial excision, and transaortic. Generally, regardless of the specific delivery procedure, those skilled in the art should understand that after deploying the prosthetic valve 1000, the leaflet frame sub-component 1200 and the anchoring frame sub-component 1100 are nested by advancing the leaflet frame sub-component 1200 proximally relative to the anchoring frame sub-component 1100.

[0287] Tissue ingrowth materials and modifications

[0288] In various embodiments, one or more portions of the prosthetic valve 1000, such as the leaflets 1230, are configured in a manner that promotes tissue ingrowth. In some embodiments, the leaflets 1230 and / or other portions of the valve 1000 can be configured to promote tissue ingrowth and proliferation across one or more discrete regions, portions, or segments of one or more of the materials forming the prosthetic valve 1000, or alternatively across the entirety of one or more of the materials forming the prosthetic valve 1000, such as the leaflets 1230. Tissue ingrowth and proliferation can be promoted on the outflow side or surface of such materials, and / or on the inflow side or surface of such materials, and / or within one or more of such materials.

[0289] In various embodiments, materials configured to promote tissue ingrowth include composite materials combined with a tissue ingrowth curtain, which can be incorporated into and / or coupled to the composite material.

[0290] In various embodiments, one or more portions of the leaflet frame sub-component 1230 may be covered with a material suitable for promoting ingrowth of tissue. For example, the leaflet frame sub-component 1230 may be wrapped with a material suitable for promoting ingrowth of tissue. In various examples, such tissue ingrowth promoting materials may be applied integrally to the leaflet frame sub-component 1230, or alternatively applied at least to all of the leaflet frame sub-component 1230. For example, suitable materials for promoting ingrowth of tissue may be coupled to the inner surface of the leaflet frame and the outer surface of the leaflet frame of the leaflet frame. Some non-limiting examples of materials that may be applied to the leaflet frame sub-component 1230 (or other portions of the prosthetic valve 1000) include expanded polytetrafluoroethylene (ePTFE), such as an ePTFE membrane, and fabrics, films, or coatings, and polyethylene terephthalate fabric (e.g., polyester fabric).

[0291] According to some embodiments, as will be discussed in more detail below, tissue ingrowth (or not otherwise preventing or inhibiting growth) is facilitated by coupling one or more synthetic tissue ingrowth curtains to one or more composite materials, thereby promoting tissue growth into and / or onto 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, underlying materials may be configured to inhibit or prevent tissue ingrowth.

[0292] Additionally or alternatively, in some examples, this promotion of tissue ingrowth is facilitated by selectively absorbing, for example, one or more fluorinated elastomers, one or more portions of the materials forming the leaflet 1230, and / or other portions of the prosthetic valve 1000. The reference to "selective absorption" refers to the act of absorbing a porous material with a filling material or retaining the porosity of the porous material to a lesser extent at selected portions of the porous material.

[0293] That is, in some examples, as an addition or alternative to coupling one or more synthetic tissue ingrowth curtains to one or more composite materials, the composite materials, as discussed above with respect to the leaflet materials, are configured to promote or accommodate tissue ingrowth. In some such examples, as will be discussed in more detail below, the composite materials are configured such that tissue growth (or not otherwise preventing or inhibiting growth) into and / or onto these portions is facilitated by selectively absorbing a septum associated with one or more discrete or designated sections, portions, or regions of the composite material.

[0294] In various embodiments, the tissue ingrowth curtain typically includes an expandable fluoropolymer membrane that includes a plurality of spaces within a fibrillar matrix suitable for promoting and supporting tissue ingrowth. Other non-limiting example materials include other biocompatible porous materials such as knitted PTFE. However, as noted above and discussed in more detail below, in some examples, the (one or more) tissue ingrowth curtains may be applied to the composite material in the form of one or more coatings.

[0295] In some examples, the tissue ingrowth curtain includes an expandable fluoropolymer made from a porous ePTFE membrane. However, it should be understood that the tissue ingrowth curtain can be formed from a variety of different types of membranes, including other fluoropolymer membranes and other biocompatible porous materials such as porous polyethylene membranes and knitted PTFE. For example, the expandable fluoropolymer can include PTFE homopolymer. In some examples, the tissue ingrowth curtain can be formed from a copolymer of hexafluoropropylene and tetrafluoroethylene, such as fluorinated ethylene propylene (FEP). In some examples, a mixture of PTFE, expandable modified PTFE, and / or an expandable copolymer of PTFE can be used. Thus, it will be understood that the tissue ingrowth curtain can be formed from a variety of different polymeric materials, provided they are biocompatible and have or are modified to include a suitable microstructure for promoting or supporting tissue ingrowth. In various examples, depending on the material selected, the thickness of the tissue ingrowth curtain can range from one micron to four hundred microns.

[0296] In some examples, the polymeric material can include one or more naturally occurring and / or one or more artificially created pores, recesses, channels, and / or predefined surface topologies suitable for supporting tissue ingrowth. Other biocompatible materials suitable for forming the tissue ingrowth curtain include, but are not limited to, urethanes, fluoropolymers, styrene / isobutene copolymers, polyisobutene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the foregoing.

[0297] Although the above-described tissue ingrowth curtain typically includes a diaphragm, film, knitted fabric, or other structure that is bonded, applied, or otherwise attached to the composite material as described above, in some examples, the (one or more) tissue ingrowth curtains may be applied to the composite material in the form of one or more coatings. In some such examples, a coherent, irregular network is distributed or deposited over one or more portions, regions, sections, sites, or zones of the composite material. In some examples, as will be understood by one of ordinary skill in the art, the coherent irregular network is applied to one or more portions of the composite material to create a surface texture suitable for supporting tissue ingrowth and proliferation. 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 site by masking or otherwise covering those portions of the underlying leaflets or other portions of the prosthetic valve 1000 in which tissue ingrowth is not desired, such that the covering or masking member may be removed after the coherent irregular network is applied to obtain a material having a first region including the coherent irregular network and a second region free of the coherent irregular network.

[0298] In some examples, one or more sacrificial sheets, such as one or more polyimide sheets (e.g., Kapton sheets), are disposed on the composite material and are operative to mask or otherwise prevent the coherent irregular network from being applied to the masked or covered regions. Some non-limiting examples of sacrificial sheet materials include polyester, polyetheretherketone (PEEK), PET, PTFE / Kapton mixtures such as mapton, ePTFE, PTFE, silicone, and stainless steel, or other thin metal sheets. In some examples, the one or more sacrificial sheets may be removed after the coherent irregular network is applied to expose a structure including one or more regions containing 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 a configuration that minimizes the likelihood of delamination between the bonded diaphragm layers.

[0299] As described above, in some examples, as an addition to or an alternative to applying one or more tissue ingrowth curtains to the composite material, the composite material is configured to facilitate or accommodate tissue ingrowth. For example, in some examples, the composite material is configured such that tissue growth (or not otherwise preventing or inhibiting growth) is facilitated into and / or onto one or more discrete or specified sections, portions, or regions of the composite material. For example, as described above, the composite material may include an elastomer and / or an elastic material, such as a fluorinated elastomer absorbed or otherwise incorporated into an expandable fluoropolymer membrane. In various examples, to obtain a composite material that facilitates or otherwise accommodates tissue ingrowth and proliferation, the expandable fluoropolymer membrane is selectively absorbed with one or more materials such as one or more fluorinated elastomers such that the expandable fluoropolymer membrane includes one or more discrete portions, regions, sections, zones, or sites that are not or otherwise not absorbed with an elastic filler material (or at least not filled to an extent where the elastic filler material functions to prevent tissue ingrowth). The membrane material of the composite material can be selectively absorbed according to techniques known to those skilled in the art.

[0300] While the embodiments and examples discussed above include applying a tissue ingrowth curtain to one or more portions of one or more surfaces of the composite material, or selectively absorbing one or more portions of one or more sides of the membrane of the composite material with a filler material, it will be understood that in various examples, the leaflets and / or other features of the prosthetic valve 1000 can be constructed by absorbing one or more portions of the membrane and applying a tissue ingrowth curtain to the selectively absorbed membrane.

[0301] In various examples, the septum can be impregnated with a variety of filling materials. That is, in some examples, the first part, portion, region, section, or zone of the septum of the composite material can be impregnated with a first filling material, while the second part, portion, region, section, or zone of the septum of the composite material is impregnated with a second filling material. For example, in some examples, the first part of the septum of the composite material is impregnated with a first filling material such that the first part of the septum resists or otherwise inhibits or prevents tissue ingrowth into and / or onto and / or through the first part. However, in some examples, those parts of the septum that are impregnated with the first filler may also not be suitable for accommodating the attachment or coupling of the tissue ingrowth curtain. Thus, in examples where it is desired to attach or otherwise couple the tissue ingrowth material to the second part of the septum, the second part can be impregnated with a second filling material such that the second part of the septum is adapted to have a tissue ingrowth curtain attached or otherwise coupled thereto. In some examples, the second filling material can additionally or alternatively promote tissue ingrowth. That is, in some examples, one or more parts of the septum can be impregnated with a filling material that promotes tissue ingrowth and proliferation. Alternatively, as described above, the second part can be completely free of any filling material and instead can remain unfilled.

[0302] In some examples, as an addition to or alternative to applying the adhesive to the tissue ingrowth curtain as described above, the method includes applying the adhesive to the septum. In some examples, an adhesive such as FEP is also wicked or absorbed into one or more parts of the septum, after which the tissue ingrowth curtain and the septum are pressed together and / or heat set according to known methods.

[0303] In some other examples, as an addition to or alternative to applying the adhesive separately or individually to the tissue ingrowth curtain and the septum, the tissue ingrowth curtain (e.g., having a specified pattern) and the septum are laminated with one or more adhesives or adhesive layers therebetween, after which the laminated structure is pressed and / or heat set according to known methods. The method also includes cutting the leaflets and / or other features of the prosthetic valve 1000 from the resulting structure according to known methods. In some examples, a final free edge cutting operation can be performed on the formed material according to known methods to achieve a clean free edge, as would be understood by one of ordinary skill in the art.

[0304] Bioactive agent

[0305] Any of a variety of bioactive agents can be implemented with the materials of the prosthetic valve 1000. For example, any one or more of the leaflets 1230 and / or the leaflet frame cover 1232 and / or the anchoring frame cover 1132 and / or the connecting sheath 1300 and / or the outflow annular groove cover 1440 (including portions thereof) can include a bioactive agent. The bioactive agent can be coated onto one or more of the above features to release the agent in a controlled manner after implantation of the prosthetic valve 1000. Such bioactive agents can include, but are not limited to, thrombogenic agents such as, but not limited to, heparin. The bioactive agent can also include, but is not limited to, agents such as anti-proliferative / anti-mitotic agents, including natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and desmethoxyvinblastine), paclitaxel, etoposide (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, and idarubicin), anthramycin, mitoxantrone, bleomycin, plicamycin (mithramycin), and mitomycin, enzymes (e.g., L-asparaginase, which metabolizes L-asparagine systemically, depriving cells that are unable to synthesize their own asparagine), antiplatelet drugs such as glycoprotein (GP) IIb / IIIa inhibitors and vitronectin receptor antagonists; anti-proliferative / anti-mitotic alkylating agents such as nitrogen mustards (e.g., mechlorethamine, cyclophosphamide, and analogs, melphalan, chlorambucil), ethyleneimines and methylmelamines (e.g., altretamine and thiotepa), alkyl sulfonates - busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), (trazenes) - dacarbazine (DTIC) (trazenes-dacarbazinine); anti-proliferative / anti-mitotic antimetabolites such as folic acid analogs (e.g., methotrexate), pyrimidine analogs (such as, fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thioguanine, pentostatin, and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (e.g., estrogen); anticoagulants (e.g., heparin, synthetic heparin salts, and other thrombin inhibitors); antiplatelet preparations (e.g., aspirin, clopidogrel, prasugrel, and ticagrelor); vasodilators (e.g., heparin, aspirin); fibrinolytic agents (e.g., plasminogen activators, streptokinase, and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; anti-migration agents; anti-secretory agents (e.g., breveldin); anti-inflammatory agents such as corticosteroids (e.g., corticosterone, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal drugs (e.g., salicylic acid derivatives such as aspirin);p-aminophenol derivatives (e.g., acetaminophen), indole and indene acetic acids (e.g., indomethacin, sulindac and etodalac), heteroaryl acetic acids (e.g., tolmetin, diclofenac and ketorolac), aryl propionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenylbutazone and oxyphenthatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose and sodium aurothiomalate); immunosuppressants (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine and mycophenolate mofetil); angiogenesis agents (e.g., vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; antisense oligonucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, growth factor receptor signal transduction kinase inhibitors; retinoids; cyclin / CDK inhibitors; HMG coenzyme reductase inhibitors (statins); and protease inhibitors.;

[0306] The scope of the various concepts referred to in this disclosure has been described above both generally and with specific examples. It will be apparent to those skilled in the art that various modifications and changes can be made to the examples without departing from the scope of this application. Similarly, the various components discussed in the examples herein are combinable. Accordingly, these embodiments are intended to cover modifications and variations of this scope.

Claims

1. A prosthetic valve capable of converting between a delivery configuration and a deployed nested configuration in situ, the prosthetic valve comprising: a leaflet frame sub-component that defines a tubular shape and has a leaflet frame sub-component wall extending from a leaflet frame sub-component inflow end and a leaflet frame sub-component outflow end, and the leaflet frame sub-component defines a leaflet frame sub-component lumen, and the leaflet frame sub-component includes a one-way valve; an anchoring frame sub-component that defines a tubular shape and has an anchoring frame sub-component inflow end and an anchoring frame sub-component outflow end, the anchoring frame sub-component defining an anchoring frame sub-component lumen; a connecting sheath that defines a tubular shape and has a connecting sheath inflow end coupled to the anchoring frame sub-component outflow end and a connecting sheath outflow end coupled to the leaflet frame sub-component inflow end, thereby coupling the leaflet frame sub-component to the anchoring frame sub-component, and the connecting sheath has a connecting sheath inner surface that defines a connecting sheath lumen; and a retaining element having a retaining element first end and a retaining element second end, the retaining element second end being coupled to the connecting sheath outflow end, wherein when the retaining element translates within the anchoring frame sub-component lumen toward the anchoring frame sub-component inflow end, the retaining element is capable of pivoting about the retaining element second end such that the retaining element extends from the leaflet frame sub-component inflow end to the anchoring frame sub-component inflow end; wherein, when the prosthetic valve is in the delivery configuration, the leaflet frame sub-component and the anchoring frame sub-component are longitudinally offset relative to each other such that the leaflet frame sub-component inflow end is distal to the anchoring frame sub-component outflow end, wherein the retaining element is within the connecting sheath lumen and extends away from the leaflet frame sub-component inflow end and extends parallel to the longitudinal axis of the leaflet frame sub-component and adjacent to the connecting sheath, wherein, when the prosthetic valve is in the deployed nested configuration, the anchoring frame sub-component inflow end radially expands or tapers outwardly, wherein, when the prosthetic valve is in the deployed nested configuration, the connecting sheath flips, and the leaflet frame sub-component is at least partially nested within the anchoring frame sub-component lumen, the retaining element having translated within the anchoring frame sub-component lumen toward the anchoring frame sub-component inflow end, and the retaining element being biased outwardly against the anchoring frame sub-component having an outward bias such that the retaining element extends from the leaflet frame sub-component inflow end to the anchoring frame sub-component inflow end; and wherein the prosthetic valve is capable of converting between the delivery configuration and the deployed nested configuration via an expanded pre-deployed, non-nested configuration.

2. The prosthetic valve according to claim 1, characterized in that The leaflet frame sub-component includes a leaflet frame that defines a leaflet frame wall, one or more leaflets, and a leaflet frame covering. The leaflet frame is tubularly formed, defining a leaflet frame inflow end and a leaflet frame outflow end, and a leaflet frame lumen that extends through the leaflet frame inflow end and the leaflet frame outflow end.

3. The prosthetic valve according to claim 2, wherein, at least a portion of the leaflet frame wall of the leaflet frame is covered by the leaflet frame covering, and the leaflet frame covering is configured to restrict fluid passage through the covered portion of the leaflet frame wall.

4. The prosthetic valve according to claim 2, wherein, the one or more leaflets are operable to open to permit flow from the inflow end of the leaflet frame sub-component through the outflow end of the leaflet frame sub-component under antegrade flow conditions, and are operable to close to restrict flow from the outflow end of the leaflet frame sub-component and through the inflow end of the leaflet frame sub-component under retrograde flow conditions.

5. The prosthetic valve according to claim 2, wherein, the second end of the retaining element is not directly coupled to the leaflet frame at the inflow end of the leaflet frame sub-component, and there is a portion of the connection sheath therebetween.

6. The prosthetic valve according to claim 2, wherein, the leaflet includes a composite material that includes a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores.

7. The prosthetic valve according to claim 6, wherein, the elastomer or elastic material includes a TFE-PMVE copolymer.

8. The prosthetic valve according to claim 6, wherein, the porous synthetic fluoropolymer membrane is ePTFE.

9. The prosthetic valve according to claim 2, wherein, the leaflet includes a composite material that includes a TFE-PMVE copolymer and includes, on at least a portion of the composite material, 27 to 32 weight percent perfluoromethyl vinyl ether and 73 to 68 weight percent tetrafluoroethylene, respectively.

10. The prosthetic valve according to any one of claims 1-3, wherein, the anchoring frame sub-component includes an anchoring frame and an anchoring frame covering. The anchoring frame defines a tubular shape extending between an inflow end of the anchoring frame sub-component and an outflow end of the anchoring frame sub-component, an outer surface of the anchoring frame defining an anchoring frame wall and an inner surface of the anchoring frame. The anchoring frame is at least partially covered by the anchoring frame covering to restrict fluid passage through the anchoring frame wall.

11. The prosthetic valve according to claim 10, wherein, when the prosthetic valve is in the deployed nested configuration, the anchoring frame defines a radially outwardly flared or tapered flared portion at the inflow end of the anchoring frame sub-component.

12. The prosthetic valve according to claim 10, wherein, the connection sheath is contiguous with the anchoring frame covering and the leaflet frame covering.

13. The prosthetic valve according to claim 10, wherein, The retaining element is coupled to the connection sheath, which is positioned between the leaflet frame and the anchoring frame but not directly coupled to the leaflet frame or the anchoring frame, such that the retaining element is operable to maintain a nested configuration of the anchoring frame sub-component and the leaflet frame sub-component.

14. The prosthetic valve according to any one of claims 1-3, wherein, the prosthetic valve has a smaller diameter in the delivery configuration than in the deployed nested configuration.

15. The prosthetic valve according to any one of claims 1-3, wherein, the anchoring frame sub-component has an inner surface of the anchoring frame sub-component, wherein, in the deployed nested configuration, the diameter of the inner surface of the anchoring frame sub-component is at least slightly larger than the outer surface of the leaflet frame sub-component of the leaflet frame sub-component, and the leaflet frame sub-component is nested within the anchoring frame sub-component.

16. The prosthetic valve according to claim 1, wherein, the connection sheath is a thin-walled flexible tubular member having an inner surface of the connection sheath that defines a connection sheath lumen in fluid communication with the lumen of the anchoring frame sub-component and the lumen of the leaflet frame sub-component, and wherein the connection sheath is operable to fold and flip when the leaflet frame sub-component advances from the pre-deployed, non-nested configuration to the deployed nested configuration to be positioned between the leaflet frame sub-component and the anchoring frame sub-component.

17. The prosthetic valve according to any one of claims 1-3, wherein, the connection sheath includes flow enabling features in the wall of the connection sheath that extends between an inflow end and an outflow end of the connection sheath, wherein the flow enabling features are operable to allow antegrade fluid flow through the wall of the connection sheath and restrict retrograde flow through the wall of the connection sheath when the leaflet frame sub-component is not in the deployed nested configuration.

18. The prosthetic valve according to any one of claims 1-3, wherein, the connection sheath includes an inner membrane layer and an outer membrane layer that are coupled together at least at an inflow end of the leaflet frame sub-component and an outflow end of the anchoring frame sub-component, the inner membrane layer defines at least one inner orifice adjacent to and passing through the outflow end of the anchoring frame sub-component, and the outer membrane layer defines at least one outer orifice adjacent to and passing through the leaflet frame sub-component, and the inner membrane layer and the outer membrane layer are not coupled between at least one of the inner orifices and one of the outer orifices, thereby defining a flow space therebetween that is operable to allow antegrade blood flow to pass therethrough and restrict retrograde flow therethrough when the leaflet frame sub-component is not in the deployed nested configuration within the anchoring frame sub-component, and is operable to restrict both antegrade and retrograde flow when the leaflet frame sub-component is in the deployed nested configuration within the anchoring frame sub-component.

19. The prosthetic valve according to any one of claims 1-3, It is characterized in that the connecting sheath includes an inner film layer and an outer film layer, the inner film layer and the outer film layer are joined together at least at the outflow end of the anchoring frame sub-component, the inner film layer defines at least one inner orifice adjacent to and passing through the outflow end of the anchoring frame sub-component, and the inner film layer and the outer film layer are not joined at least downstream of the inner orifice, thereby defining a flow space therebetween. When the leaflet frame sub-component is not in the deployed nested configuration in the anchoring frame sub-component, in the case where the inner film layer is separated from the outer film layer at the inner orifice, the flow space can be operated to allow antegrade blood flow, and in the case where the inner film layer gathers together and covers the inner orifice, it restricts retrograde flow therethrough, and can be operated to restrict both antegrade and retrograde flow when the leaflet frame sub-component is in the deployed nested configuration within the anchoring frame sub-component.

20. The prosthetic valve according to any one of claims 1-3, It is characterized in that when the prosthetic valve is in the deployed nested configuration, the retaining element is configured to cover the inflow annular groove formed between the anchoring frame sub-component, the flipped connecting sheath and the leaflet frame sub-component.

21. The prosthetic valve according to any one of claims 1-3, It is characterized in that the retaining element further includes an impermeable cover, and wherein, when the prosthetic valve is in the deployed nested configuration, the inflow annular groove is defined at the inflow end of the prosthetic valve by the anchoring frame sub-component, the connecting sheath and the leaflet frame sub-component, and wherein the retaining element including the impermeable cover can be operated to cover the inflow annular groove and restrict fluid flow into the inflow annular groove.

22. The prosthetic valve according to claim 1, It is characterized in that the retaining element is an elongate element, which can be operated to extend parallel to the central longitudinal axis X of the prosthetic valve when in the pre-deployed configuration, and can be operated to extend at an angle to the central longitudinal axis X when in the deployed configuration.

23. The prosthetic valve according to any one of claims 1-3, It is characterized in that during the conversion of the prosthetic valve between the delivery configuration and the deployed nested configuration, the retaining element can be operated to translate through the anchoring frame sub-component, and during the conversion of the prosthetic valve between the delivery configuration and the deployed nested configuration, the connecting sheath can be operated to fold and flip within the lumen of the anchoring frame sub-component and be located between the leaflet frame sub-component and the anchoring frame sub-component.

24. The prosthetic valve according to claim 1, It is characterized in that The retention element includes a continuous serpentine element configured to have an outward spring bias toward a flat star configuration, thereby defining an elongate element that bends about a vertex, the elongate element having a first elongate element end and a second elongate element end, the elongate element extending radially when in the star configuration, wherein the first elongate element end and the corresponding vertex define an inner periphery at the first end of the retention element, and the second elongate element end and the corresponding vertex define an outer periphery at the second end of the retention element, the serpentine element being operable to be elastically constrained in a tubular configuration, wherein the elongate element rotates about the vertex at the first elongate element end such that the second elongate element ends rotate toward each other to define a tubular or conical configuration, wherein the serpentine element defines a first tubular diameter, wherein the elongate element extends laterally to a central longitudinal axis X and along the connection sheath and laterally with respect to the anchor frame sub-component and the leaflet frame sub-component.

25. The prosthetic valve according to claim 24, wherein, the retention element further includes an impermeable cover, and wherein the impermeable cover extends from the vertex at the first elongate element end of the elongate element to the vertex at the second elongate element end of the elongate element, wherein, when the prosthetic valve is in the deployed nested configuration, the impermeable cover extends from the inflow end of the leaflet frame sub-component to the inflow end of the anchor frame sub-component, thereby covering the inflow annular groove formed between the anchor frame sub-component, the connection sheath, and the leaflet frame sub-component.

26. The prosthetic valve according to claim 24 or 25, wherein, it further includes a tether element coupled to the retention element, the tether element being operable to be pulled by an operator to effect advancement of the retention element through the anchor frame sub-component, the second end of the retention element 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 can be released and thus release the second elongate element end of the retention element, thereby allowing expansion and deployment of the retention element.

27. The prosthetic valve according to any one of claims 1-3, wherein, the retention element is biased toward a flat position and is operable to maintain the relative positions of the leaflet frame sub-component and the anchor frame sub-component by means of the outward bias.

28. The prosthetic valve according to any one of claims 1-3, wherein, One or more vertices at the second end of the retention element can abut and slide along the inner surface of the connection sheath and subsequently the inner surface of the anchoring frame sub-component while expanding under the action of the outward biasing until the vertices at the second end of the retention element are fully expanded around the inflow end of the anchoring frame sub-component, wherein the outward biasing generates sufficient force to cause the retention element to advance through the inner surfaces of the connection sheath and the anchoring frame sub-component towards the inflow end of the anchoring frame sub-component while pulling the leaflet frame sub-component into the anchoring frame sub-component.

29. The prosthetic valve according to any one of claims 1-3, wherein, the length of the anchoring frame sub-component varies along its periphery, wherein the outflow end of the anchoring frame sub-component has a tapered geometry that can be operated such that when the prosthetic valve is placed in the mitral valve annulus, the outflow end of the anchoring frame sub-component can extend further into the left ventricle adjacent to the posterior side of the left ventricle and less into the LVOT on the anterior side of the left ventricle.

30. The prosthetic valve according to any one of claims 1-3, wherein, the hoop strength of the anchoring frame sub-component can vary along the length and / or periphery of the anchoring frame sub-component and is predetermined to have a greater stiffness at a smaller tapered portion of the front part of the anchoring frame sub-component at the outflow end of the anchoring frame sub-component to match the stiffness of the aortic mitral junction, while the stiffness can be relatively smaller at the longer posterior part of the prosthetic valve adjacent to the posterior side of the left ventricle.

31. The prosthetic valve according to any one of claims 1-3, wherein, the anchoring frame sub-component has a predetermined flexibility such that the anchoring frame sub-component can flip into the lumen of the anchoring frame sub-component so that the anchoring frame sub-component can be operated to peel away from the tissue annulus and be pulled out from the lumen of the anchoring frame sub-component, such that the prosthetic valve can be removed from the tissue annulus.

32. The prosthetic valve according to any one of claims 1-3, wherein, the anchoring frame sub-component includes one or more tissue engagement features that project away from the outer surface of the anchoring frame of the anchoring frame sub-component and can be operated to engage the tissue annulus.

33. The prosthetic valve according to any one of claims 1-3, wherein, it further includes an outflow annular groove cover extending from the outflow end of the anchoring frame sub-component and the outflow end of the leaflet frame sub-component.

34. The prosthetic valve according to claim 33, wherein, the outflow annular groove cover is configured to be permeable to blood under physiological conditions before the prosthetic valve is converted into the deployed nested configuration.

35. The prosthetic valve according to claim 33, wherein, the outflow annular groove cover is configured to be less permeable to blood under physiological conditions when the prosthetic valve is in the deployed nested configuration than when the prosthetic valve is not in the deployed nested configuration.

Images