Prosthetic valve assembly with a radially biased anchoring frame

Abstract

An implant assembly includes a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame. The valve frame comprises an inflow end and an outflow end. The leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end. The implant assembly further includes an anchoring frame disposed radially outwardly from the valve frame and a connecting structure connecting the valve frame to the anchoring frame. The anchoring frame has an inflow end portion and an outflow end portion. The connecting structure is configured to apply a biasing force to the inflow end portion and the outflow end portion of the anchoring frame to radially expand the anchoring frame and restrict axial movement of the anchoring frame relative to the valve frame.

Description

PROSTHETIC VALVE ASSEMBLY WITH A RADIALLY BIASED ANCHORING FRAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 551,652, filed February 9, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure generally concerns implantable prosthetic devices and more particularly devices and related methods for securing prosthetic devices relative to native tissue within a patient’s vasculature.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally - invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0005] Once expanded, the prosthetic heart valve contacts the surrounding native heart valve tissue to secure the prosthetic heart valve in place. For example, when replacing a stenosed (calcified) native aortic valve, the prosthetic valve can be expanded against the native aortic annulus and sufficiently anchored in place via the outward radial force of the prosthetic valve against the surrounding annulus. Replacing a non-stenosed native aortic valve or a nativetricuspid valve with a transcatheter heart valve has proven more difficult than replacing a stenosed native aortic valve due to the lack of calcification. For example, tricuspid regurgitation (TR) can result from annular dilation, which can be associated with pulmonary hypertension and / or right ventricular dysfunction. One challenge associated with treatment of TR relates to the variable nature of the annulus, which can be subject to significant size changes over a short period of time, for example, as a function of a patient’s hydration status and fluid volume. Another challenge associated with treatment of TR involves the risks associated with increased post-procedural pressure gradient due to a sudden significant decrease in flow from the right atrium to the right ventricle due to the implantation of a prosthetic valve or other flow-restricting device. As such, there is continuing need for prosthetic heart valves that are suitable for various implantation locations, especially for replacing an insufficient native tricuspid or mitral valve.SUMMARY

[0006] Described herein are prosthetic heart valves and other prosthesis that can be implanted in patients and / or living animals.

[0007] In some examples, representative prosthetic valve assemblies are disclosed. The disclosed prosthetic valve assemblies have anchoring frames configured for securing the prosthetic valves to the native tissue.

[0008] In some examples, the anchoring frames can comprise tissue-engaging elements configured to increase friction between the prosthetic valve assembly and the native tissue. As such, the prosthetic valve assemblies disclosed herein can resist migration relative to the native tissue. The disclosed assemblies can be used, for example, at implantation locations that would not provide sufficient structure for a typical prosthetic valve to be secured therein. For example, these assemblies can be implanted at a native heart valve, including an aortic valve, a mitral valve, a tricuspid valve, and / or a pulmonary valve). In particular, the disclosed prosthetic valve assemblies can be implanted in non-stenotic and / or non-calcified native valves. Additionally, or alternatively, the prosthetic valve assemblies disclosed herein can be implanted at other locations within a patient’s vasculature, such as a blood vessel (e.g., a vena cava).

[0009] In some examples, the prosthetic valve assemblies can include connecting structures connecting the prosthetic valves to the anchoring frames. In some examples, the connecting structure can apply a biasing force to radially expand the anchoring frame.

[0010] In some examples, a tissue ingrowth material can be disposed within an annular space between the prosthetic valve and the anchoring frame. The tissue ingrowth material can promote tissue ingrowth within the annular space, thereby gradually sealing the annular space to reduce or prevent the flow of blood through the annular space over a period of time.

[0011] In one representative example, an implant assembly includes a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, an anchoring frame disposed radially outwardly from the valve frame, and a connecting structure connecting the valve frame to the anchoring frame. The valve frame includes an inflow end and an outflow end. The leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end. The anchoring frame includes an inflow end portion and an outflow end portion. The connecting structure can be configured to apply a biasing force to the inflow end portion and the outflow end portion of the anchoring frame to radially expand the anchoring frame and restrict axial movement of the anchoring frame relative to the valve frame.

[0012] In another representative example, an implant assembly includes a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, an anchoring frame disposed radially outwardly from the valve frame; and a connecting structure connecting the valve frame to the anchoring frame. The valve frame includes an inflow end and an outflow end. The leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end. The connecting structure can be connected to the valve frame at a plurality of first locations on the valve frame and at a plurality of second locations on the valve frame. The first locations are axially spaced apart from the second locations.

[0013] In another representative example, an implant assembly includes a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, an anchoring frame disposed radially outwardly from the valve frame, a connecting structure connecting the valve frame to the anchoring frame; and a tissue ingrowth material disposed within an annular space defined between the valve frame and the anchoring frame. The valve frame comprises an inflow end and an outflow end. The leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end. The tissue ingrowth material can be configured to transform the annular space from a leaking state in which blood is allowed to flow through the annularspace when the implant assembly is initially implanted at an implantation location to a sealed state after a period of time has elapsed following the implantation.

[0014] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 depicts a perspective view of an exemplary implant assembly including a valve frame and an anchoring frame.

[0016] FIG. 2 depicts a perspective view of the valve frame of FIG. 1.

[0017] FIG. 3 depicts a perspective view of the anchoring frame of FIG. 1.

[0018] FIG. 4 depicts a schematic cross-sectional view of another example of an implant assembly, as well as native tissue surrounding the implant assembly.

[0019] FIG. 5 schematically depicts the implant assembly of FIG. 4, including a connecting structure bridging the valve frame and the anchoring frame, when viewed from an outflow end of the valve frame.

[0020] FIG. 6 schematically depicts a perspective view of the connecting structure of FIG. 5.

[0021] FIG. 7A schematically depicts a cross-section of a portion of another implant assembly (taken along a longitudinal axis) having filaments extending from a fabric skirt disposed on an outer surface of a valve frame of the implant assembly (a connecting structure of the implant assembly is omitted for purposes of illustration), according to one example.

[0022] FIG. 7B schematically depicts a cross-section of a portion of another implant assembly (taken along a longitudinal axis) having filaments extending from a fabric skirt disposed on an inner surface of an anchoring frame of the implant assembly (a connecting structure of the implant assembly is omitted for purposes of illustration), according to one example.

[0023] FIG. 7C schematically depicts a cross-section of a portion of another implant assembly (taken along a longitudinal axis) having filaments extending between a valve frameand an anchoring frame of the implant assembly and additional filament extending outside the anchoring frame (a connecting structure of the implant assembly is omitted for purposes of illustration), according to one example.

[0024] FIG. 7D schematically depicts a cross-section of a portion of another implant assembly (taken along a longitudinal axis) having filaments extending from strut segments of a connecting structure, according to one example.

[0025] FIG. 8 schematically depicts a cross-section of a portion of another implant assembly (taken along a longitudinal axis) having a valve frame, an anchoring frame, and a connecting structure connecting between the valve frame and the anchoring frame, according to another example.

[0026] FIG. 9 depicts an exemplary implant assembly implanted in a native mitral valve of a heart, which is shown in partial cross-section.DETAILED DESCRIPTIONGeneral Considerations

[0027] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0028] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations thatcorrespond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0029] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0030] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0031] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Introduction to the Disclosed Technology

[0032] The native valves of the heart can suffer from various problems that cause the native valve to improperly function. For example, aortic insufficiency (“Al”) or aortic regurgitation (“AR”) is characterized by diastolic reflux of blood through the native aortic valve back into the left ventricle (“LV”). Chronic Al can result in LV volume increase and / or pressure overload due to the heart’s attempt to overcome the reduced cardiac output.

[0033] These conditions can, in some instances, be treated by implanting a prosthetic heart valve to replace the functionality of the malfunctioning native valve. Some prosthetic heart valves can be implanted in a minimally-invasive manner. These valves are typically referred to as “transcatheter heart valves” (“THVs”). THVs have many advantages, including requiring less recovery time and / or being suitable for a wider range of patients. Despite these advantages, many known THVs are designed to be deployed in a native heart valve annulus (e.g., a native aortic valve annulus) in cases of native stenosis or calcification of the native leaflets. In the absence of stenosis or calcification, many typical THVs lack sufficientanchoring mechanisms to secure the THV relative to the native anatomy. This can, in some instances, cause the THV to migrate and / or slip out of position under physiological pressures at the implantation site. Further, a significant challenge in treating valvular regurgitation is managing the dynamic nature of the annulus, which can undergo substantial size fluctuations in a short span of time, potentially as a result of changes in a patient’ s hydration status and fluid volume.

[0034] Thus, it is desirable to provide a prosthetic heart valve that can be securely anchored against the native anatomy, even in the absence of local stenosis and / or calcified anatomy. This is particularly important given the variable size of the annulus, which can change significantly in a short period of time. Additionally, it is desirable that the proposed solution can be used with existing prosthetic heart valves, thereby eliminating the need for a complex and time-intensive redesign.

[0035] In some circumstances, implantation of a prosthetic heart valve can lead to a sudden decrease in blood flow across the newly implanted prosthetic valve, which can cause the patient to have an acute physiological response that may be undesirable. This issue arises because the patient’s physiology may have become accustomed to an increased, unrestricted flow through the previously dilated native valve. When the native valve is replaced and the flow is suddenly reduced, it can trigger an acute response. This could potentially lead to complications such as low blood pressure, inadequate blood flow to the body’s tissues (ischemia), or other cardiovascular issues.

[0036] Thus, it is desirable to provide a prosthetic heart valve that allows short-term regurgitation to limit the acute post-implantation response and gradually seals itself to prevent further regurgitation, thus potentially reducing post-operative complications.

[0037] Described herein are implant assemblies with improved anchoring mechanisms. In some examples, the disclosed implant assemblies include prosthetic heart valves with valve frames and anchoring frames configured for securing the prosthetic heart valves to surrounding native tissue. The anchoring frames can, in some instances, comprise tissueengaging elements configured to increase friction between the implant assembly and the native tissue. The disclosed implant assemblies also include connecting structures which connect the valve frames to the anchoring frames. In some examples, the connecting structures can apply a biasing force to radially expand the anchoring frames so that the anchoring frames can adapt to annuluses of varying sizes. As such, the implant assembliesdisclosed herein can resist migration relative to the native tissue. The disclosed assemblies can be used, for example, in patients with relatively non-stenotic anatomy, with an annulus experiencing dynamic size variation, and / or at implantation locations that do not provide sufficient structure for a typical prosthetic heart valve (e.g., at a native mitral valve, a native tricuspid valve, etc.). Additionally, the anchoring frames disclosed herein can, for example, be attached (e.g., retrofitted) to a commercially available prosthetic heart valve. Therefore, the disclosed devices improve stability and reduce migration of prosthetic heart valves, while also being relatively simple and cost-effective to implement.

[0038] In some examples, the disclosed implant assemblies include a tissue ingrowth material disposed between a valve frame and an anchoring frame. The tissue ingrowth material can be filaments and / or sutures configured to allow blood to flow through an annular space between the valve frame and the anchoring frame upon initial implantation and promote tissue ingrowth between the valve frame and the anchoring frame, thereby gradually sealing the annular space between the valve frame and the anchoring frame to reduce or prevent the flow of blood through the annular space over a period of time. As a result, the patient’ s body can gradually adapt to the reduced blood flow, mitigating the risk of an acute physiological response and potential complications. This gradual transition allows the patient’s physiology to adjust to the new flow conditions in a more controlled manner, potentially improving patient outcomes and reducing the risk of complications associated with sudden changes in blood flow.

[0039] In lieu of or in addition to the various native valves of a heart, the implant assemblies disclosed herein can be configured to be implanted at other locations within a patient’s vasculature, such as a blood vessel (e.g., a vena cava).

[0040] The disclosed implant assemblies can also be used for various other types of devices and / or frames (i.e., besides prosthetic heart valves / frames). These devices / frames can be coupled to or integrally formed with valve docking devices, grafts, stents, and / or other devices that are implanted within and engage a patient’s vasculature (e.g., heart valve tissue, blood vessels, etc.).

[0041] Described below are some particular examples of the disclosed technology.Examples of the Disclosed Technology

[0042] FIGS. 1-3 depict an exemplary implant assembly 100a and its components.

[0043] Referring to FIG. 1, the implant assembly 100a comprises a prosthetic heart valve 102 and an anchoring frame 104 disposed outside the prosthetic heart valve 102. In the depicted example, the anchoring frame 104 is directly coupled to the prosthetic heart valve 102. In other examples, a connecting structure (e.g., the connecting structure 150 described below) can be used to connect the anchoring frame 104 to the prosthetic heart valve. The implant assembly 100a can be radially compressed (which can also be referred to as “crimped”) to a delivery configuration and advanced through a patient’s vasculature to an implantation location. The implant assembly 100a can be radially expanded from the delivery configuration to a functional or deployed configuration and positioned in a native heart valve annulus. As an example, FIG. 9 depicts an implant assembly 100 implanted in a native mitral valve 105 of a heart. In other examples, the implant assembly 100 can be implanted at or within other locations (e.g., a tricuspid valve, a pulmonary valve, an aortic valve). The implant assembly 100 can be any of the implant assemblies described herein, such as 100a, 100b, 100c, etc.Exemplary Prosthetic Heart Valve

[0044] The prosthetic heart valve 102 is configured for regulating the flow of blood in one direction through the prosthetic heart valve 102. For example, the prosthetic heart valve 102 comprises a valve frame 106, a valvular structure 108, and optionally one or more sealing members 110 (which can also be referred to as “a sealing skirt” or “a PVL skirt”). The valve frame 106 is configured for supporting the valvular structure 108 and / or to help secure the prosthetic heart valve 102 to native heart valve tissue (e.g., a native heart valve annulus and / or native leaflets). The valvular structure 108 is configured to open to allow blood flow through the prosthetic heart valve 102 from an inflow end 112 to an outflow end 114 of the valve frame 106. The valvular structure 108 is also configured to close to prevent or restrict blood flow through the prosthetic heart valve 102 from the outflow end 114 to the inflow end 112. The sealing member 110 is configured for reducing or eliminating blood flow around the valvular structure 108 and / or native tissue (which can also be referred to as “paravalvular leakage,” “perivalvular leakage”, or “PVL”).

[0045] FIG. 2 depicts the valve frame 106 of the prosthetic heart valve 102 with the other components removed. The valve frame 106 comprises a plurality of interconnected struts. In some examples, the struts form a plurality of cells. For example, the struts of the valve frame 106 form a plurality of rows of cells, including a first row of cells I, a second row of cells II, a third row of cells III, and a fourth row of cells IV. In the illustrated example, the cells ofrow I are larger than the cells of rows II and III but are smaller than the cells of row IV. The cells of row II are the same size or at least substantially the same size as the cells of row III. In the depicted example, the cells in rows I and IV are generally hexagonal shaped and the cells in rows II and III are generally diamond shaped. In other examples, a valve frame can comprise various other numbers of rows of cells, the cells can comprise different sizes, and / or the cells can comprise different shapes.

[0046] The valve frame 106 also comprises a plurality of commissure windows 116 (e.g., three in the illustrated example). The commissure windows 116 are configured for coupling the valvular structure 108 to the valve frame 106.

[0047] The valve frame 106 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) and / or self-expanding materials (e.g., Nitinol). When the valve frame 106 comprises plastically-expandable material, the valve frame 106 (and thus the prosthetic heart valve 102) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism of a delivery apparatus. When the valve frame 106 comprises self-expandable material, the valve frame 106 (and thus the prosthetic heart valve 102) can be crimped to a radially compressed state and restrained in the compressed state by a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the prosthetic heart valve 102 can be advanced from the delivery sheath, which allows the prosthetic heart valve 102 to selfexpand to its functional size.

[0048] Suitable plastically-expandable materials that can be used to form the valve frame 106 include stainless steel, nickel-based alloys (e.g., cobalt-chromium alloy or nickel-cobalt- chromium alloy), polymers, and / or combinations thereof. In particular examples, the valve frame 106 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of STS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0049] Additional details about valve frames can be found in U.S. Patent No. 9,393,110 and U.S. Publication No. 2018 / 0028310, both of which are incorporated by reference herein.

[0050] The valvular structure 108 comprises a plurality of leaflets 118 (e.g., three leaflets in the illustrated example), which collectively form a leaflet structure. The lower edge of the leaflet structure can have an undulating, curved scalloped shape. A suture line 120 generallytracks the scalloped shape of the leaflet structure. The upper edge of each leaflet 118 comprises tabs 122 at opposing sides of the leaflet. Pairs of adjacent tabs 122 of adjacent pairs of leaflets can be joined together to form commissures. The pairs of tabs 122 can be inserted through the respective commissure windows 116 of the valve frame 106 and secured to the valve frame 106.

[0051] Additional details about valve structure and the manner in which a valvular structure can be secured to a valve frame can be found in U.S. Patent No. 9,393,110 and U.S.Publication No. 2018 / 0028310.

[0052] The leaflets 118 can be formed of pericardial tissue (e.g., bovine, porcine, and / or equine pericardial tissue), biocompatible synthetic materials, and / or various other suitable natural or synthetic materials as described in U.S. Patent No. 6,730,1 18, which is incorporated by reference herein.

[0053] The sealing member 110 can assist in securing the valvular structure 108 to the valve frame 106 and in forming a good seal between the prosthetic heart valve 102 and the native annulus by blocking the flow of blood through the open cells of the valve frame 106 below the lower edge of the leaflets 118. In the illustrated example, the sealing member 110 is disposed on the inside of valve frame 106. In other examples, the sealing member can extend from the inside of the valve frame to the outside of the valve frame. Additionally, or alternatively, the prosthetic heart valve 102 can comprise a plurality of sealing members, including a first sealing member (i.e., an inner skirt) disposed on the inside of the valve frame and a second sealing member (i.e., an outer skirt) disposed on the outside of the valve frame.

[0054] The sealing member 110 can be formed of various materials such as a fabric or cloth. In some instances, the sealing member can be formed from polyethylene terephthalate (“PET”) and / or ultra-high molecular weight polyethylene (“UHMWPE”) fabric. In other examples, various other synthetic or natural materials can be used.

[0055] The valvular structure 108 can be attached to the sealing member 110 in various ways, including sutures, fasteners, etc. Additional details about sealing members can be found in U.S. Patent No. 9,393,110 and U.S. Publication No. 2018 / 0028310.Exemplary Anchoring Frame

[0056] As shown in FIG. 3, the anchoring frame 104 comprises a plurality of struts configured in an annular shape. The anchoring frame 104 is disposed radially outwardly from the valve frame 106. Due to their relative locations, the anchoring frame 104 can alsobe referred to as “the outer frame,” and the valve frame 106 can also be referred to as “the inner frame.”

[0057] The anchoring frame 104 comprises a plurality of tissue-engagement elements configured to help secure the prosthetic heart valve 102 to native heart valve tissue and / or to help promote tissue ingrowth between the native tissue and the implant assembly 100a. The tissue-engaging elements can include projections 124 (which can also be referred to as “anchors”) extending from the struts of the anchoring frame 104. The projections 124 can be configured to engage (and in some instances penetrate) the native heart valve tissue. In this manner, the projections 124 can increase the frictional engagement between the implant assembly 100a and surrounding native tissue, thus helping to reduce migration of the implant assembly 100a relative to the surrounding native tissue after it is released from the delivery apparatus. The projections 124 can also help to improve tissue ingrowth and / or reduce PVL.

[0058] The projections 124 can extend in various directions from the struts of the anchoring frame 104. For example, some of the projections 124 can extend from the struts at an angle relative to a central longitudinal axis extending from the inflow end 112 to the outflow end 114. In some instances, the projections 124 can be perpendicular or at least substantially perpendicular (e.g., forming an angle of 80-100 degrees) to the struts from which they extend. In other examples, the projections 124 can extend from their respective struts at various other angles (e.g., between 1-79 degrees). For example, in some instances, the projections 124 can extend from their respective struts at an angle of about 45 degrees such that the projections 124 are parallel or at least substantially parallel to a central longitudinal axis extending from the inflow end 112 to the outflow end 114.

[0059] The projections 124 can comprise various shapes and lengths such that the projections 124 provide sufficient retention force for the implant assembly 100a, while reducing potential harm to the surrounding native tissue. For instance, in the illustrated example, the projections 124 comprise tines or spikes. In other examples, the projections 124 can comprise ball- shaped bulges and / or a rectangular shape. Additionally, or alternatively, one or more of the projections 124 can comprise a curved shape, a hook shape, a cross shape, a T-shape, and / or a barbed shape. Various combinations of shapes and / or sizes of projections can be used.

[0060] In some examples, the anchoring frame 104 can include other types of tissue engaging elements in lieu of or in addition to the projections 124, such as one or more clippingmembers configured to extend behind native leaflets so as to capture the native leaflets between the clipping members and the anchoring frame 104.

[0061] In some examples, the anchoring frame 104 can be removably coupled to the prosthetic heart valve 102. As used herein, “removably coupled” means coupled in such a way that two components are coupled together and can be separated without plastically deforming either of the components. In other examples, the anchoring frame 104 can be permanently coupled to the prosthetic heart valve 102. As used herein, “permanently coupled” means coupled in such a way that the two components cannot be separated without plastically deforming at least one of the components.

[0062] The anchoring frame 104 optionally can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) and / or self-expanding materials (e.g., Nitinol). When the anchoring frame 104 comprises a plastically-expandable material, the anchoring frame 104 (and thus implant assembly 100a) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism of a delivery apparatus. When the anchoring frame 104 comprises a self-expandable material, the anchoring frame 104 (and thus the implant assembly 100a) can be crimped to a radially compressed state and restrained in the compressed state by a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the implant assembly 100a can be advanced from the deliver}' sheath, which allows the implant assembly 100a (including the anchoring frame 104) to expand to its functional size.

[0063] Suitable plastically-expandable materials that can be used to form the anchoring frame 104 include stainless steel, nickel based alloys (e.g., cobalt-chromium alloy or nickel- cobalt-chromium alloy), polymers, and / or combinations thereof. In particular examples, the anchoring frame 104 can be made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0064] The anchoring frame 104 can be relatively thinner than the valve frame 106 because the anchoring frame 104 does not substantially support loads applied to the valve frame by the valvular structure 108 (at least not substantially). In some examples, the thickness of the valve frame 106 can be within a range of 0.3 - 0.9 mm and the thickness of the anchoringframe 104 can be within a range of 0.01 - 0.1 mm. In some examples, a ratio of the thickness of the anchoring frame 104 to the thickness of the valve frame 106 can be within a range of 0.3 - 0.9.

[0065] Since the anchoring frame 104 is relatively thin and flexible, it does not significantly increase the radial profile of the prosthetic heart valve 102 in the radially compressed configuration. This can, for example, allow the implant assembly 100a to be implanted in the same manner as a prosthetic heart valve 102 that does not include the anchoring frame 104. It can also allow the same delivery apparatus to be used for delivering the prosthetic heart valve 102 either with or without the anchoring frame 104 coupled thereto.

[0066] FIG. 3 depicts the anchoring frame 104 of the implant assembly 100a detached from the prosthetic heart valve 102. In some examples, the struts of the anchoring frame 104 can form a plurality of cells. As shown in FIG. 3, the struts of anchoring frame 104 form a plurality of rows of cells, including a first row of cells I, a second row of cells II, and a third row of cells III. In the illustrated example, the cells of the first row I are larger than the cells of rows II and III. The cells of the second row II are the same size or at least substantially the same size as the cells of the third row III. The cells in row III are generally hexagonal shaped and the cells in rows I and II are generally diamond shaped. In other examples, an anchoring frame can comprise various other numbers of rows of cells (e.g., 1, 2, 4, etc.), the cells can comprise different sizes, and / or the cells can comprise different shapes.

[0067] In the example depicted in FIG. 1, the anchoring frame 104 can be configured such that the struts of the anchoring frame 104 align with respective struts of the valve frame 106. In other examples, the struts of the anchoring frame can be configured to do not align with the struts of the valve frame 106.

[0068] It should be noted that the anchoring frame 104 depicted in FIGS. 1 and 3 is just one specific example. The anchoring frame can be configured to have different geometric shapes, sizes, and / or with different types of tissue-engagement elements. Additional examples of the anchoring frame are described in International Application No. PCT / US2021 / 034399, which is incorporated by reference herein.Exemplary Connecting Structure

[0069] FIGS. 4-5 show an implant assembly 100b, according to another example. The implant assembly 100b includes the prosthetic heart valve 102, the anchoring frame 104, and a connecting structure 150 coupling or bridging the prosthetic heart valve 102 and theanchoring frame 104. In some examples, the connecting structure 150 can extend around a circumference of the valve frame 106. FIG. 4 also schematically depicts the implant assembly 100b being implanted in a native tricuspid valve with native leaflets 126 (e.g., for treating an insufficient native tricuspid valve).

[0070] In some examples, the connecting structure 150 is self-expandable. For example, the connecting structure 150 can comprise a shape memory material, such as Nitinol.

[0071] In some examples, the connecting structure 150 is configured to apply or exert a biasing force to move the anchoring frame 104 from a radially compressed state to a radially expanded state. For example, when the implant assembly 100b is crimped into its delivery configuration, the connecting structure 150 can be radially compressed into a biased configuration. When the implant assembly 100b is radially expanded to its deployed configuration, the connecting structure 150 can self-expand, driven by its biasing force, into an unbiased configuration. The transition of the connecting structure 150 from the biased to the unbiased configuration facilitates and / or aids the movement of the anchoring frame 104 from the radially compressed state to the radially expanded state. In some examples, the connecting structure 150, the anchoring frame 104, and the valve frame 106 are selfexpandable and are made of a shape-memory material, such as Nitinol.

[0072] In some examples, the connecting structure 150 can be configured to be stiffer than the anchoring frame 104, that is, the anchoring frame 104 has a higher degree of flexibility or pliability compared to the connecting structure 150. This difference in material properties allows the anchoring frame 104 to adapt and conform to the expansion of the connecting structure 150. For example, when the connecting structure 150 expands, its inherent stiffness can drive the expansion process and the more flexible anchoring frame 104 can yield to this force and expands correspondingly. In some examples, the anchoring frame 104, when expanded, can conform to the shape of the native annulus in which the anchoring frame is implanted.

[0073] Thus, when deploying the implant assembly 100b, it is not necessary to expand the prosthetic heart valve 102 to the size of the native annulus, which is often dilated. Instead, the prosthetic heart valve 102 can be expand to a diameter representative of a non-diseased native annulus (for example, 30-40 mm for a tricuspid valve). The connecting structure 150 can bias the anchoring frame 104 radially outward, up to full contact with the native annulus (for example, to a diameter of about 50-60 mm for implantation in a native tricuspid valve).

[0074] Advantageously, the biasing connecting structure 150 allows the anchoring frame 104 to maintain contact with the surrounding native tissue, even if the diameter of native annulus changes after implantation, or is different at the time of implantation — relative to the diameter assessed at the time of imaging (before implantation), for example. This ensures that the anchoring frame 104 can conform to the shape of the native annulus in which it is implanted, regardless of changes in the annular diameter. Thus, the implant assembly 100b provides a flexible and adaptable solution for treating conditions such as an insufficient native tricuspid valve.

[0075] In some examples, in lieu of or in addition to the anchoring frame 104, the connecting structure 150 itself can have tissue-engaging elements (e.g., projections 124) and have a radially strong frame to provide a proper anchoring force for securing the prosthetic heart valve 102 to the native annulus.

[0076] In some examples, the connecting structure 150 is configured to apply the biasing force to both an inflow end portion 104a and an outflow end portion 104b of the anchoring frame 104. The inflow end portion 104a is closer to the inflow end 112 than the outflow end portion 104b, and the outflow end portion 104b is closer to the outflow end 114 than the inflow end portion 104a. The connecting structure 150 can also be configured to restrict axial movement of the anchoring frame 104 relative to the valve frame 106.

[0077] For example, the connecting structure 150 can comprise a plurality of interconnected strut segments 152 bridging the valve frame 106 and the anchoring frame 104. In some examples, as shown in FIGS. 4-6, the connecting structure 150 can include a first row 154 and a second row 156 of interconnected strut segments 152, each of which forms an annular ring having a zigzag pattern.

[0078] The strut segments 152 of the first row 154 and second row 156 can form a lattice structure. For example, adjacent struts of the first row 154 and second row 156 can overlap with each other and optionally can be connected to each other. In some examples, the first row 154 can form an outer ring and the second row 156 can form an inner ring, or vice versa. In some examples, the inner and outer rings are separately formed and optionally can be connected to each other, such as with sutures, pins, an adhesive, welding, fasteners, etc. In some examples, the first row 154 can interlace with the second row 156. In some examples, the connecting structure comprises a unitary structure made by forming (e.g., laser cutting) the strut segments 152 of the first row 154 and second row 156 from a single piece ofmaterial (e.g., a tube). The lattice form of the connecting structure 150 allows the anchoring frame 104 to move radially relative to the valve frame 106, but restricts axial movement between the anchoring frame 104 and the valve frame 106.

[0079] The first row 154 of interconnected strut segments 152 can define one or more outflow apices 158 and inflow apices 160. The outflow apices 158 can be fixedly attached to the outflow end portion 104b of the anchoring frame 104 (e.g., via sutures, fasteners, etc.) and the inflow apices 160 can be fixedly attached to an inflow end portion 106a of the valve frame 106 (e.g., via sutures, fasteners, etc.). The second row 156 of interconnected strut segments 152 can also define one or more outflow apices 162 and inflow apices 164. The outflow apices 162 can be fixedly attached to an outflow end portion 106b of the valve frame 106 (e.g., via sutures, fasteners, etc.) and the inflow apices 164 can be fixedly attached to the inflow end portion 104a of the anchoring frame 104 (e.g., via sutures, fasteners, etc.). Thus, via connections to the anchoring frame 104 at outflow apices 158 of the first row 154 and inflow apices 164 of the second row 156, the connecting structure 150 can apply the biasing force to both the inflow end portion 104a and outflow end portion 104b of the anchoring frame 104. Also, the connecting structure 150 is connected to the valve frame 106 at outflow apices 162 of the second row 156 and inflow apices 160 of the first row 154, which are axially spaced apart from one another. In this manner, the connecting structure 150 can apply a radial outwardly directed biasing force that is substantially consistent along the length of the anchoring frame 104, thereby ensuring that the anchoring frame is evenly expanded along its entire length.

[0080] Although two rows of interconnected strut segments 152 are shown in the examples depicted in FIGS. 1 and 4-6, in other examples, the connecting structure can have only one row or more than two rows of interconnected strut segments bridging the valve frame 106 and the anchoring frame 104.

[0081] In lieu of or in addition to the interconnected strut segments 152, the connecting structure can take other forms. For example, FIG. 8 schematically depicts a cross-section of a portion of an implant assembly 100c, according to another example, which includes the valve frame 106, the anchoring frame 104, and a connecting structure 170 positioned between and connecting the valve frame 106 and the anchoring frame 104. In some examples, the connecting structure 170 includes one or more elastic elements 172 (e.g., coil springs, or the like). In the illustrated example, the connecting structure 170 includes a plurality of elastic elements 172 that are spaced apart from each other along the length of the implant assembly,with at least one elastic element 172 at the inflow end portion 104a of the anchoring frame 104 and at least one elastic element at the outflow end portion 104b of the anchoring frame 104.

[0082] Each elastic element 172 has a first end 174 and a second end 176. The first end 174 is attached to the valve frame 106 and the second end 176 is connected to the anchoring frame 104. The first ends 174 of different elastic elements 172 can be axially spaced apart from one another. The second ends 176 of different elastic elements 172 can also be axially spaced apart from one another. In some examples, the elastic elements 172 can be arranged in circumferentially extending rows of elastic elements 172 between the valve frame 106 and the anchoring frame 104, with the rows spaced apart from each other along the length of the implant assembly. Similar to the connecting structure 150 depicted in FIGS. 1 and 4-6, the connecting structure 170 can apply the biasing force to both the inflow end portion 104a and outflow end portion 104b of the anchoring frame 104 and restrict axial movement of the anchoring frame 104 relative to the valve frame 106.Exemplary Ingrowth Material

[0083] In any of the examples described herein, a tissue ingrowth material can be disposed within an annular space between the valve frame and the anchoring frame. Example tissue ingrowth materials include, but are not limited to, yarns or filaments of natural and / or synthetic materials (e.g., PET, UHMWPE, etc.), biocompatible sponge or foam material (e.g., polyurethane foam, etc.), and a hydrogel (e.g., which can have pre-formed apertures to allow blood to flow therethrough). The tissue ingrowth material can be configured to transform the annular space from a leaking state in which blood is allowed to flow through the annular space when the implant assembly is initially implanted at an implantation location to a sealed state after a period of time (e.g., several days, weeks, etc.) has elapsed following the implantation. This gradual sealing process allows the patient’ s body to adapt to the reduced blood flow over time, rather than experiencing a sudden change, thereby helping to minimize the risk of some adverse complications.

[0084] For example, as schematically depicted in FIG. 4, a plurality of filaments 180 or filament fringes can be disposed in an annular space 140 formed between the valve frame 106 and the anchoring frame 104. In some examples, the filaments 180 can include dissolvable or biodegradable sutures. The filaments 180 can be disposed on an outer surface of the valve frame 106, or an inner surface of the anchoring frame 104, or both.

[0085] The filaments 180 can be configured to allow blood to flow through the annular space 140 upon initial implantation and promote tissue ingrowth between the valve frame 106 and the anchoring frame 104, thereby gradually sealing the annular space 140 to reduce or prevent the flow of blood through the annular space 140 over a period of time.

[0086] In some examples, as schematically depicted in FIG. 7 A, at least some of the plurality of filaments 180 can be connected to the valve frame 106 and extend radially outward toward the anchoring frame 104. In some examples, at least some of the plurality of filaments 180 can be woven into and extend from a fabric skirt 182 disposed around an outer surface of the valve frame 106. In some examples, the skirt 182 can comprise a plush or pile fabric comprising a base layer and a pile layer of filaments 180 woven into and extending from the base layer. Additional details regarding skirts comprising a plush or pile fabric that can be used as the skirt 182 are provided in U.S. Publication No. 2019 / 0365530, U.S. Publication No. 2023 / 0255762, and WIPO Publication No. WO2023 / 244612, which are incorporated herein by reference. In lieu of or in addition to a skirt 182 having filaments 180, respective end portions of the filaments 180 can be connected to struts of the valve frame 106 (for example, the end portions of the filaments can be tied off to struts of the valve frame).

[0087] In some examples, as schematically depicted in FIG. 7B, at least some of the plurality of filaments 180 can be connected to the anchoring frame 104 and extend radially inward toward the valve frame 106. In some examples, at least some of the plurality of filaments 180 can be woven into and extend from a fabric skirt 184 disposed around an inner surface of the anchoring frame 104. In some examples, the skirt 184 can comprise a plush or pile fabric comprising a base layer and a pile layer of filaments 180 woven into and extending from the base layer. Additional details regarding skirts comprising a plush or pile fabric that can be used as the skirt 184 are provided in U.S. Publication No. 2019 / 0365530, U.S. Publication No. 2023 / 0255762, and WIPO Publication No. WO2023 / 244612. In lieu of or in addition to a skirt 184 having filaments 180, respective end portions of the filaments 180 can be connected to struts of the anchoring frame 104 (for example, the end portions of the filaments can be tied off to struts of the anchoring frame).

[0088] In some examples, as schematically depicted in FIG. 7C, at least some of the plurality of filaments 180 can connect the valve frame 106 to the anchoring frame 104. For example, some filaments 180 can include sutures having respective first ends 180a connected to the skirt 182 (for example, the ends 180a can be woven into the skirt 182) and respective second ends 180b connected to the skirt 184 (for example, the ends 180b can be woven into the skirt184). In lieu of or in addition to skirt(s) 182, 184, one or more of the filaments 180 can have first and second ends 180a, 180b connected directly to the valve frame 106 and the anchoring frame 104, respectively.

[0089] In some examples, in lieu or in addition to skirt(s) 182, 184, the tissue ingrowth material can comprise sutures extending radially between the anchoring frame 104 and the valve frame 106. Respective inner ends of the sutures can be secured (for example, tied off) to struts of the valve frame 106 and / or respective outer ends of the sutures can be secured (for example, tied off) to struts of the anchoring frame 104. In some examples, the sutures can be biodegradable sutures.

[0090] In some examples, as schematically depicted in FIGS. 4 and 7C, tissue ingrowth materials, e.g., filaments 180, can also be disposed over an outer surface of the anchoring frame 104 and configured to promote tissue ingrowth between the anchoring frame 104 and surrounding native tissue, thereby gradually sealing a gap between the anchoring frame 104 and the surrounding native leaflets 126. In some examples, the filaments 180 can be woven into and extend from a fabric skirt 186 disposed around the anchoring frame 104. The skirt 186 can be, for example, any of the skirts disclosed in U.S. Publication No. 2019 / 0365530, U.S. Publication No. 2023 / 0255762, and WIPO Publication No. WO2023 / 244612.

[0091] In some examples, in lieu of or in additional to filaments extending in radial directions from the valve frame 106 and / or the anchoring frame 104 (or from respective skirts), as shown in FIGS. 4, 7A, 7B, and 7D, the implant assembly can have tissue ingrowth material oriented in other directions. For example, as schematically depicted in FIG. 7D, at least some of the plurality of filaments 180 can extend sideways from stmt segments 152 (e.g., perpendicular to the longitudinal axis of each stmt segment) of the connecting structure 150 which bridges the valve frame 106 and the anchoring frame 104.Exemplary Implantation Techniques

[0092] For implanting an implant assembly including a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the implant assembly can be mounted in a radially compressed state along the distal end portion of a delivery apparatus. The implant assembly and the distal end portion of the delivery apparatus can be inserted into a femoral artery and then advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The implant assembly can be positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or moreactuators of the delivery apparatus, or deploying the implant assembly from a sheath to allow the implant assembly to self-expand). Alternatively, an implant assembly can be implanted within the native aortic valve in a transapical procedure, whereby the implant assembly (on the distal end portion of the delivery apparatus) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the implant assembly can be positioned within the native aortic valve. Alternatively, in a transaortic procedure, an implant assembly (on the distal end portion of the delivery apparatus) can be introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0093] For implanting an implant assembly including a prosthetic valve within the native mitral valve via a transseptal delivery approach, the implant assembly can be mounted in a radially compressed state along the distal end portion of a delivery apparatus. The implant assembly and the distal end portion of the delivery apparatus can be inserted into a femoral vein and then advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (for example, through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, an implant assembly can be implanted within the native mitral valve in a transapical procedure, whereby the implant assembly (on the distal end portion of the delivery apparatus) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the implant assembly can be positioned within the native mitral valve.

[0094] For implanting an implant assembly including a prosthetic valve within the native tricuspid valve, the implant assembly can be mounted in a radially compressed state along the distal end portion of a delivery apparatus. The implant assembly and the distal end portion of the delivery apparatus can be inserted into a femoral vein and then advanced into and through the inferior vena cava, and into the right atrium, and the implant assembly can be positioned within the native tricuspid valve. A similar approach can be used for implanting the implant assembly within the native pulmonary valve or the pulmonary artery, except that the implant assembly can be advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0095] Another delivery approach is a trans-atrial approach whereby an implant assembly including a prosthetic valve (on the distal end portion of the delivery apparatus) can be inserted through an incision in the chest and an incision made through an atrial wall (of theright or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a trans-ventricular approach whereby an implant assembly including a prosthetic valve (on the distal end portion of the delivery apparatus) can be inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the implant assembly within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0096] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the implant assemblies disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.Sterilization

[0097] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Additional Examples of the Disclosed Technology

[0098] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0099] Example 1. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end, wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valveframe, the anchoring frame having an inflow end portion and an outflow end portion; and a connecting structure connecting the valve frame to the anchoring frame, wherein the connecting structure is configured to apply a biasing force to the inflow end portion and the outflow end portion of the anchoring frame to radially expand the anchoring frame and restrict axial movement of the anchoring frame relative to the valve frame.

[0100] Example 2. The implant assembly of any example herein, particularly example 1, wherein the anchoring frame comprises one or more tissue-engaging elements configured for securing the implant assembly at an implantation location, wherein the one or more tissueengaging elements comprise one or more projections extending from one or more struts of the anchoring frame.

[0101] Example 3. The implant assembly of any example herein, particularly any one of examples 1-2, wherein the connecting structure comprises a shape memory material.

[0102] Example 4. The implant assembly of any example herein, particularly any one of examples 1-3, wherein the connecting structure extends around a circumference of the valve frame.

[0103] Example 5. The implant assembly of any example herein, particularly example 4, wherein the connecting structure comprises a first row of interconnected strut segments forming a zigzag pattern.

[0104] Example 6. The implant assembly of any example herein, particularly example 5, wherein the first row of interconnected strut segments defines one or more outflow apices and inflow apices, wherein the outflow apices of the first row are fixedly attached to the anchoring frame and the inflow apices of the first row are fixedly attached to the valve frame.

[0105] Example 7. The implant assembly of any example herein, particularly any one of examples 5-6, wherein the connecting structure further comprises a second row of interconnected strut segments forming a zigzag pattern.

[0106] Example 8. The implant assembly of any example herein, particularly example 7, wherein the second row of interconnected strut segments defines one or more outflow apices and inflow apices, wherein the outflow apices of the second first row are fixedly attached to the valve frame and the inflow apices of the second row are fixedly attached to the anchoring frame.

[0107] Example 9. The implant assembly of any example herein, particularly any one of examples 1-8, further comprising a plurality of filaments disposed between the valve frame and the anchoring frame, wherein the plurality of filaments is configured to allow blood to flow through an annular space between the valve frame and the anchoring frame upon initial implantation and promote tissue ingrowth between the valve frame and the anchoring frame, thereby gradually sealing the annular space between the valve frame and the anchoring frame to reduce or prevent the flow of blood through the annular space over a period of time.

[0108] Example 10. The implant assembly of any example herein, particularly example 9, wherein at least some of the plurality of filaments are connected to the valve frame and extend radially toward the anchoring frame.

[0109] Example 1 1. The implant assembly of any example herein, particularly any one of examples 9-10, wherein at least some of the plurality of filaments are connected to the anchoring frame and extend radially toward the valve frame.

[0110] Example 12. The implant assembly of any example herein, particularly any one of examples 10-11, wherein at least some of the plurality of filaments have respective first ends connected to the valve frame and respective second ends connected to the anchoring frame.

[0111] Example 13. The implant assembly of any example herein, particularly any one of examples 9-12, wherein at least some of the plurality of filaments are woven into and extend from a fabric skirt disposed around the valve frame.

[0112] Example 14. The implant assembly of any example herein, particularly any one of examples 9-13, wherein at least some of the plurality of filaments extend sideways from one or more strut segments of the connecting structure.

[0113] Example 15. The implant assembly of any example herein, particularly any one of examples 9-14, wherein the plurality of filaments comprises dissolvable or biodegradable sutures.

[0114] Example 16. The implant assembly of any example herein, particularly any one of examples 1-15, further comprising a plurality of filaments disposed over an outer surface of the anchoring frame and configured to promote tissue ingrowth between the anchoring frame and surrounding native tissue, thereby gradually sealing a gap between the anchoring frame and the surrounding native tissue.

[0115] Example 17. The implant assembly of any example herein, particularly any one of examples 1-16, wherein the implant assembly is radially compressible and expandable between a radially compressed state for delivery into a patient and a radially expanded state for deploying at an implantation location.

[0116] Example 18. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end, wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valve frame; and a connecting structure connecting the valve frame to the anchoring frame, wherein the connecting structure is connected to the valve frame at a plurality of first locations on the valve frame and at a plurality of second locations on the valve frame, wherein the first locations are axially spaced apart from the second locations.

[0117] Example 19. The implant assembly of any example herein, particularly example 18, wherein the anchoring frame is self-expandable.

[0118] Example 20. The implant assembly of any example herein, particularly any one of examples 18-19, wherein the connecting structure is configured to apply a biasing force to move the anchoring frame from a radially compressed state to a radially expanded state.

[0119] Example 21. The implant assembly of any example herein, particularly any one of examples 18-20, wherein the connecting structure comprises a plurality of interconnected strut segments bridging the valve frame and the anchoring frame.

[0120] Example 22. The implant assembly of any example herein, particularly any one of examples 18-21, wherein the connecting structure comprises one or more elastic elements, each elastic element comprising a first end and a second end, wherein the first end is attached to the valve frame and the second end is connected to the anchoring frame.

[0121] Example 23. The implant assembly of any example herein, particularly any one of examples 18-22, further comprising a plurality of filaments disposed between the valve frame and the anchoring frame, wherein the plurality of filaments is configured to allow blood to flow through an annular space between the valve frame and the anchoring frame upon initial implantation and promote tissue ingrowth between the valve frame and the anchoring frame, thereby gradually sealing the annular space between the valve frame and the anchoring frame to reduce or prevent the flow of blood through the annular space over a period of time.

[0122] Example 24. The implant assembly of any example herein, particularly any one of examples 18-23, wherein the connecting structure is connected to valve frame at the first and second locations with sutures.

[0123] Example 25. The implant assembly of any example herein, particularly any one of examples 18-24, wherein the connecting structure is connected to the anchoring frame at a plurality of third locations on the anchoring frame and a plurality of fourth locations on the anchoring frame, wherein the third locations are axially spaced apart from the fourth locations.

[0124] Example 26. The implant assembly of any example herein, particularly example 25, wherein the connecting structure is connected to the anchoring frame at the third and fourth locations with sutures.

[0125] Example 27. The implant assembly of any example herein, particularly any one of examples 18-26, wherein the anchoring frame comprises one or more tissue-engaging elements configured for securing the implant assembly at an implantation location.

[0126] Example 28. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end, wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valve frame, wherein the valve frame and the anchoring frame define an annular space therebetween; a connecting structure connecting the valve frame to the anchoring frame; and a tissue ingrowth material disposed within the annular space configured to transform the annular space from a leaking state in which blood is allowed to flow through the annular space when the implant assembly is initially implanted at an implantation location to a sealed state after a period of time has elapsed following the implantation.

[0127] Example 29. The implant assembly of any example herein, particularly example 28, wherein the tissue ingrowth material comprises one or more filaments disposed on an outer surface of the valve frame.

[0128] Example 30. The implant assembly of any example herein, particularly any one of examples 28-29, wherein the tissue ingrowth material comprises one or more filaments disposed on an inner surface of the anchoring frame.

[0129] Example 31. The implant assembly of any example herein, particularly any one of examples 28-30, wherein the tissue ingrowth material comprises one or more sutures connecting the valve frame to the anchoring frame.

[0130] Example 32. The implant assembly of any example herein, particularly any one of examples 28-31 , wherein the connecting structure is configured to apply a biasing force to move the anchoring frame from a radially compressed state to a radially expanded state.

[0131] Example 33. The implant assembly of any example herein, particularly any one of examples 28-32, wherein the connecting structure comprises one or more elastic elements, each elastic element comprising a first end and a second end, wherein the first end is attached to the valve frame and the second end is connected to the anchoring frame.

[0132] Example 34. The implant assembly of any example herein, particularly any one of examples 28-33, wherein the anchoring frame comprises one or more tissue-engaging elements configured for securing the implant assembly at an implantation location.

[0133] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one prosthetic valve assembly can be combined with any one or more features of another prosthetic valve assembly. As another example, any one or more features of one connecting structure can be combined with any one or more features of another connecting structure.

[0134] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

What is claimed is:

1. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end, wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valve frame, the anchoring frame having an inflow end portion and an outflow end portion; and a connecting structure connecting the valve frame to the anchoring frame, wherein the connecting structure is configured to apply a biasing force to the inflow end portion and the outflow end portion of the anchoring frame to radially expand the anchoring frame and restrict axial movement of the anchoring frame relative to the valve frame.

2. The implant assembly of claim 1, wherein the anchoring frame comprises one or more tissue-engaging elements configured for securing the implant assembly at an implantation location, wherein the one or more tissue-engaging elements comprise one or more projections extending from one or more struts of the anchoring frame.

3. The implant assembly of any one of claims 1-2, wherein the connecting structure comprises a shape memory material.

4. The implant assembly of any one of claims 1-3, wherein the connecting structure extends around a circumference of the valve frame.

5. The implant assembly of claim 4, wherein the connecting structure comprises a first row of interconnected strut segments forming a zigzag pattern.

6. The implant assembly of claim 5, wherein the first row of interconnected strut segments defines one or more outflow apices and inflow apices, wherein the outflow apices of the first row are fixedly attached to the anchoring frame and the inflow apices of the first row are fixedly attached to the valve frame.

7. The implant assembly of any one of claims 5-6, wherein the connecting structure further comprises a second row of interconnected strut segments forming a zigzag pattern.

8. The implant assembly of claim 7, wherein the second row of interconnected strut segments defines one or more outflow apices and inflow apices, wherein the outflow apices of the second row are fixedly attached to the valve frame and the inflow apices of the second row are fixedly attached to the anchoring frame.

9. The implant assembly of any one of claims 1-8, further comprising a plurality of filaments disposed between the valve frame and the anchoring frame, wherein the plurality of filaments is configured to allow blood to flow through an annular space between the valve frame and the anchoring frame upon initial implantation and promote tissue ingrowth between the valve frame and the anchoring frame, thereby gradually sealing the annular space between the valve frame and the anchoring frame to reduce or prevent the flow of blood through the annular space over a period of time.

10. The implant assembly of claim 9, wherein at least some of the plurality of filaments are connected to the valve frame and extend radially toward the anchoring frame.

11. The implant assembly of any one of claims 9-10, wherein at least some of the plurality of filaments are connected to the anchoring frame and extend radially toward the valve frame.

12. The implant assembly of any of claims 10-11, wherein at least some of the plurality of filaments have respective first ends connected to the valve frame and respective second ends connected to the anchoring frame.

13. The implant assembly of any one of claims 9-12, wherein at least some of the plurality of filaments are woven into and extend from a fabric skirt disposed around the valve frame.

14. The implant assembly of any one of claims 9-13, wherein at least some of the plurality of filaments extend sideways from one or more strut segments of the connecting structure.

15. The implant assembly of any one of claims 9-14, wherein the plurality of filaments comprises dissolvable or biodegradable sutures.

16. The implant assembly of any one of claims 1 -15, further comprising a plurality of filaments disposed over an outer surface of the anchoring frame and configured to promote tissue ingrowth between the anchoring frame and surrounding native tissue, thereby gradually sealing a gap between the anchoring frame and the surrounding native tissue.

17. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end, wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valve frame; and a connecting structure connecting the valve frame to the anchoring frame, wherein the connecting structure is connected to the valve frame at a plurality of first locations on the valve frame and at a plurality of second locations on the valve frame, wherein the first locations are axially spaced apart from the second locations.

18. The implant assembly of claim 17, wherein the anchoring frame is selfexpandable.

19. The implant assembly of any one of claims 17-18, wherein the connecting structure comprises one or more elastic elements, each elastic element comprising a first end and a second end, wherein the first end is attached to the valve frame and the second end is connected to the anchoring frame.

20. An implant assembly comprising: a prosthetic heart valve comprising a valve frame and a leaflet structure positioned within the valve frame, wherein the valve frame comprises an inflow end and an outflow end,wherein the leaflet structure is configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end; an anchoring frame disposed radially outwardly from the valve frame, wherein the valve frame and the anchoring frame define an annular space therebetween; a connecting structure connecting the valve frame to the anchoring frame; and a tissue ingrowth material disposed within the annular space configured to transform the annular space from a leaking state in which blood is allowed to flow through the annular space when the implant assembly is initially implanted at an implantation location to a sealed state after a period of time has elapsed following the implantation.

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