Minimal frame prosthetic heart valve delivery device, system, and method

Abstract

A device for treating a diseased native valve in a patient includes a frame structure and valve segments connected to the frame structure. The frame structure has an unexpanded configuration and an expanded configuration. The valve segments include a plurality of leaflets, a seal, and a seal support. The inflow edges of the plurality of leaflets are not supported by the frame structure. The seal is attached to the inflow edges of the plurality of leaflets and positioned radially between the frame structure and the plurality of leaflets. The seal support is attached to or within the seal and provides axial rigidity to the seal.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 039,909, filed June 16, 2020, entitled "Minimal Frame Prosthetic Cardiac Valve Delivery Devices, Systems, and Methods," the entire contents of which are incorporated herein by reference.

[0002]

[0002] This application may be related to international application PCT / US2020 / 027744, filed April 10, 2020, entitled "Minimal Frame Prosthetic Cardiac Valve Delivery Devices, Systems, and Methods," the entire contents of which are incorporated herein by reference.

[0003]

[0003] This application is further related to U.S. patent application Ser. No. 16 / 546,901, filed August 21, 2019, entitled "Prosthetic Cardiac Valve Devices, Systems, and Methods"; U.S. patent application Ser. No. 116 / 594,946, filed October 7, 2019, entitled "Prosthetic Cardiac Valve Devices, Systems, and Methods"; International patent application PCT / US2019 / 057082, filed October 18, 2019, entitled "Adjustable Medical Device"; U.S. patent application Ser. No. 16 / 723,537, filed December 20, 2019, entitled "Prosthetic Cardiac Valve Devices, Systems, and Methods"; This application may be related to International Patent Application PCT / US2020 / 023671, filed March 19, 2020, entitled "Methods for Producing and Promoting a Novel Combination of Inorganic and Non-Inorganic Compounds," which is incorporated herein by reference in its entirety. [Background technology]

[0004]

[0004] Blood flow between cardiac chambers is regulated by native valves (mitral, aortic, pulmonary, and tricuspid valves). Each of these valves is a passive, one-way valve that opens and closes in response to pressure differences. Patients with valvular disease have abnormal anatomy and / or function of at least one valve. For example, a valve can suffer from dysfunction, also known as regurgitation, when the valve does not close completely, thereby allowing blood to flow backward. Valve stenosis can cause a valve to fail to open properly. Other diseases can also cause valve dysfunction.

[0005]

[0005] The mitral valve, for example, is located between the left atrium and the left ventricle, and when functioning properly, allows blood to flow from the left atrium to the left ventricle while preventing backward flow, or regurgitation. However, the native valve leaflets of a diseased mitral valve do not fully prolapse, causing the patient to experience regurgitation.

[0006]

[0006] While medical therapy can be used to treat diseased native valves, failed valves often need to be repaired or replaced at some point in a patient's life. Existing prosthetic valves and surgical repair and / or replacement procedures carry high risks, have limited service life, and / or are highly invasive. While some less invasive transcatheter options are available, many are not ideal. A major limitation of existing transcatheter mitral valve devices is that, for example, their diameter is excessively large for transseptal delivery, thereby requiring transapical access instead. Furthermore, existing mitral valve replacement devices are not optimized for strength-to-weight ratio and often occupy excessive space within the cardiac cavity, thereby leading to occlusion of outflow from the ventricle into the aorta and / or thrombosis. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0007] Therefore, new valve devices that overcome some or all of these deficiencies are desirable. [Means for solving the problem]

[0008]

[0008] Described herein are devices for repairing and / or replacing heart valves, including mitral valves, that are deliverable via minimally invasive techniques and have minimal amounts of valve and / or stent material. Not necessarily all such aspects or advantages may be achieved by any particular embodiment. Thus, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages or groups of advantages taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0009]

[0009] The present disclosure relates generally to prosthetic heart valves for the treatment or replacement of diseased native valves in patients, and more specifically to prosthetic heart valves formed from a minimal amount of material and / or having a minimal length of high stiffness region.

[0010]

[0010] The present disclosure relates generally to treating diseased native valves in a subject, and more particularly to prosthetic heart valves.

[0011] In general, in one embodiment, a device for treating a diseased native valve in a patient includes a frame structure and a valve segment coupled to the frame structure. The frame structure has an unexpanded configuration and an expanded configuration. The valve segment includes a plurality of leaflets, a seal, and a seal support. The inflow edges of the plurality of leaflets are not supported by the frame structure (e.g., unattached and / or disconnected). The seal is attached to the inflow edges of the plurality of leaflets and is positioned radially between the frame structure and the plurality of leaflets. A seal support is attached to or within the seal and provides axial rigidity to the seal.

[0012] This and other embodiments may include one or more of the following features: The inflow edges of the leaflets may be spaced radially inward from the inflow edge of the framework when the framework is in the expanded configuration. The device may further include a lowest support skirt extending between the seal and the inflow edge of the framework. The inflow edges of the leaflets may extend axially beyond the inflow edge of the framework, such that the inflow edges of the leaflets extend further in the inflow direction compared to the inflow edge of the framework. The seal support may be laminated within the seal. The seal may include polyurethane. The seal support may extend annularly within the seal. The seal support may have a corrugated wireform. The seal support may extend near the inflow edge of the valve segment. The seal support may extend closer to the inflow edge of the seal than the outflow edge of the seal. The seal support may be configured to apply a pretensioning force to the seal. The seal support may be disconnected from the framework. The seal support may have multiple axial folds within the seal. Each axial fold may extend from the inflow edge of the seal to the outflow edge of the seal. The framework may have a longitudinal length of less than 35 mm in the expanded configuration. The framework may have an overhanging inflow section, a central annular section, and an overhanging outflow portion. The seal may be attached to the central annular portion. The overhanging inflow section and the overhanging outflow section may be configured to engage with an external anchor between the overhanging inflow section and the overhanging outflow section when the framework is in the expanded configuration. Leaflets of the plurality of leaflets may be attached to the framework only at their junctions. At least a portion of the inflow edges of the plurality of leaflets may extend axially beyond the framework structure, while the entire outflow edges of the plurality of leaflets are positioned within the framework structure.

[0013] In general, in one embodiment, a device for treating a diseased native valve in a patient includes a frame structure, a valve segment coupled to the frame structure, and a nadir support skirt. The frame structure has an unexpanded configuration and an expanded configuration. The valve segment includes a plurality of leaflets and a seal. The inflow edges of the plurality of leaflets are not supported by the frame structure (e.g., unattached and / or disconnected). The seal is attached to the inflow edges of the plurality of leaflets and is positioned radially between the frame structure and the plurality of leaflets. The nadir support skirt extends between the seal and the inflow edge of the frame structure.

[0014] This and other embodiments may have one or more of the following features. The lowest support skirt may extend from the inflow edge of the seal to the inflow edge of the framework. The inflow edge of the seal may be attached to the inflow edges of the plurality of leaflets. The inflow edges of the plurality of leaflets may be spaced radially inward from the inflow edge of the framework when the framework is in the expanded configuration. The inflow edges of the plurality of leaflets may extend axially beyond the inflow edge of the framework, such that the inflow edges of the plurality of leaflets extend further in the inflow direction compared to the inflow edge of the framework. The framework may have a longitudinal length of less than 35 mm in the expanded configuration. The framework may have a flared inflow section, a central annular section, and a flared outflow portion. The seal may be attached to the central annular portion. The flared inflow section and the flared outflow section may be configured to engage an external anchor located between the flared inflow section and the flared outflow section when the framework is in the expanded configuration. The leaflets of the plurality of leaflets may be attached to the frame structure only at their joints, and at least a portion of the inflow edges of the plurality of leaflets may extend beyond the frame structure, while the entire outflow edges of the plurality of leaflets are positioned within the frame structure. Incorporation by Reference

[0015] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0015]

[0016] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized. [Brief explanation of the drawings]

[0016] [Figure 1]

[0017] 1 is a perspective view of an implantable valve prosthesis according to an embodiment. [Figure 2]

[0018] 2 is a side view illustrating the implantable valve prosthesis of FIG. 1 in a contracted state, according to an embodiment. [Figure 3]

[0019] 2 is a side view showing the implantable valve prosthesis device of FIG. 1 connected to an anchor, according to an embodiment. [Figure 4]

[0020] 1 is a perspective view of an implantable valve prosthesis according to an embodiment. [Figure 5]

[0021] 1 is a perspective view of an implantable valve prosthesis according to an embodiment. [Figure 6]

[0022] 1 is a perspective view of an implantable valve prosthesis according to an embodiment. [Figure 7A]

[0023] FIG. 7A is a side view illustrating an implantable valve prosthesis including valve segments extending proximally of a strut frame, according to an embodiment. [Figure 7B]

[0024] FIG. 7B is a bottom view (ie, view from the outflow end) of the implantable valve prosthesis of FIG. 7A. [Figure 8A]

[0025] 1A-1C illustrate a portion of a valve prosthesis, according to an embodiment. [Figure 8B]

[0026] FIG. 8B is a bottom view of the valve prosthesis of FIG. 8A. [Figure 8C]

[0027] FIG. 8B is a detailed side view of the valve prosthesis of FIG. 8A. [Figure 9A]

[0028] 1 is a side view illustrating a valve prosthesis, according to an embodiment. [Figure 9B]

[0029] FIG. 9B is a bottom view of the valve prosthesis of FIG. 9A. [Figure 10A]

[0030] 1 is a side view illustrating an implantable prosthesis with minimal valve support, according to an embodiment. [Figure 10B]

[0031] FIG. 10B is a bottom view of the prosthesis of FIG. 10A. [Figure 11]

[0032] 1 is a perspective view of a valve prosthesis according to an embodiment. [Figure 12]

[0033] 1 is a detailed side view illustrating a valve prosthesis with a minimal valve support, according to an embodiment. [Figure 13]

[0034] 1 is a detailed side view illustrating a valve prosthesis with a minimal valve support, according to an embodiment. [Figure 14]

[0035] 1 is a detailed side view illustrating a valve prosthesis with a minimal valve support, according to an embodiment. [Figure 15A]

[0036] FIG. 15A illustrates a valve prosthesis having a seal with a seal support. [Figure 15B]

[0037] FIG. 15B shows the seal of FIG. 15A. [Figure 16A]

[0038] FIG. 16A illustrates a method for pretensioning a seal with a seal support. [Figure 16B]

[0039] FIG. 16B illustrates an exemplary effect of pretensioning the seal. [Figure 17A]

[0040] FIG. 17A illustrates a valve prosthesis with a nadir support skirt. [Figure 17B]

[0041] FIG. 17B is an enlarged view of a portion of the valvular prosthesis of FIG. 17A. [Figure 18A]

[0042] 1 is a schematic diagram showing a valve prosthesis with a seal support and a nadir support skirt when the valve is closed. [Figure 18B]

[0043] FIG. 18B is a schematic diagram showing the valve prosthesis of FIG. 18A when the valve is open. [Figure 18C]

[0044] 18B is another schematic view showing the valve prosthesis of FIG. 18A when the valve is open. [Figure 19A]

[0045] FIG. 19A shows an exemplary seal having an axial fold therein. [Figure 19B]

[0046] FIG. 19B is an enlarged view showing the axial fold of the seal of FIG. 19A. DETAILED DESCRIPTION OF THE INVENTION

[0017]

[0047] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like numerals generally identify like elements unless otherwise noted. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure as generally described and illustrated in the figures herein can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly contemplated herein.

[0018]

[0048] Although specific embodiments and examples are disclosed below, the subject matter of the present invention extends in scope beyond the specifically disclosed embodiments to other alternative embodiments and / or alternative uses, and even to modifications and equivalents thereof. Accordingly, the scope of the appended claims is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Furthermore, while various operations may be described as multiple specific operations in a manner that may be useful in understanding particular embodiments, the order of description should not be construed as implying that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components.

[0019]

[0049] Certain aspects and advantages of these embodiments are described for purposes of comparing various components. Not all of these aspects or advantages are necessarily achieved by any one particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0020]

[0050] The present disclosure will be described in the context of systems, devices, or methods for the treatment or replacement of diseased native valves of the heart, such as the mitral valve, but those skilled in the art will recognize that this is not intended to be limiting and that the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.

[0021]

[0051] FIG. 1 illustrates a valvular prosthesis 10 (e.g., an implantable valvular prosthesis). The exemplary valvular prosthesis 10 can include a framework 12 and valve segments 14 positioned on the framework. The valve segments 14 can include a plurality of valve leaflets 16. In an expanded configuration, the valve segments 14 can function as fluid valves in place of native valve tissue (e.g., a heart valve such as the mitral valve). The framework 12 can provide circumferential and / or longitudinal strength to the valvular prosthesis device 10.

[0022]

[0052] One or more portions of the valvular prosthesis 10 may be shaped and configured to assist in securing the valvular prosthesis 10 in a location (e.g., within the bore of a native heart valve). For example, various embodiments of anchors (e.g., helical anchor 15) and flaring portions (e.g., flange 159) are described herein that can assist in establishing or maintaining the valvular prosthesis 10 in a location. In some embodiments, the valvular prosthesis 10 may include one or more hook-, barb-, or scallop-shaped anchors to assist in deploying and / or positioning the valvular prosthesis 10 in a location. In some instances, one or more hook-, barb-, or scallop-shaped anchors may be coupled to a portion of the framework 12 (e.g., commissural post 117, strut 113, proximal arch 115, or distal arch 116). For example, the framework 12 may include one or more hooks or barbs (e.g., connected to struts 113) that can contact the tissue of the native heart valve or the tissue surrounding the native heart valve in order to prevent the valve prosthesis 10 from migrating or becoming dislodged from the location where the prosthetic valve 10 has been placed or deployed.

[0023]

[0053] FIG. 1 illustrates a valve prosthesis 10 in an expanded configuration. The valve prosthesis 10 can be deployed in the expanded configuration according to the methods described herein. For example, the valve prosthesis 10 can be deployed to the expanded configuration in a replacement or repair method. In the expanded configuration, the valve prosthesis 10 can be positioned and / or secured to a target area of ​​a subject (an organ or tissue of an animal, such as a dog, cat, horse, or human). For example, the valve prosthesis 10 can be positioned in the expanded configuration within the orifice of a heart valve, such as the mitral valve or tricuspid valve (e.g., to function as a temporary or permanent replacement for an existing mitral or tricuspid valve in the heart).

[0024]

[0054] 2 shows the valve prosthesis 10 in an unexpanded configuration (or a folded or crimped configuration). In some cases, the valve prosthesis 10 can be delivered to a target region (e.g., a region of the heart that includes a native valve) in the unexpanded configuration. In some cases, the valve prosthesis 10 in the unexpanded configuration can allow for delivery of the valve prosthesis 10 via minimally invasive means (e.g., via a delivery device as described herein).

[0025]

[0055] 2 , the longitudinal length 127 of the collapsed valvular prosthesis 10 may be minimized, which may be advantageous for delivering the valvular prosthesis 10. For example, minimizing the overall longitudinal length 127 of the collapsed valvular prosthesis 10 may facilitate improved maneuverability within a delivery device while maintaining the structural strength of the device. In some cases, minimizing the overall longitudinal length 127 of the collapsed valvular prosthesis 10 may facilitate inserting the valvular prosthesis 10 through access routes that are difficult for a longer device to traverse (e.g., access routes that include tortuous passageways or passageways with sharp bends). In some cases, the valve prosthesis 10 in its unexpanded configuration has an overall longitudinal length 127 of 1 mm to 50 mm, 1 mm to 45 mm, 1 mm to 40 mm, 1 mm to 35 mm, 1 mm to 30 mm, 1 mm to 25 mm, 1 mm to 20 mm, 1 mm to 10 mm, 10 mm to 45 mm, 20 mm to 45 mm, 20 mm to 30 mm, 25 mm to 35 mm, or 27.5 mm to 32.5 mm. In some cases, the prosthetic delivery device 10 in its expanded configuration can have an overall longitudinal length of 1 mm to 45 mm, 10 mm to 45 mm, 15 mm to 45 mm, 15 mm to 35 mm, 16 mm to 34 mm, 17 mm to 33 mm, 18 mm to 32 mm, 19 mm to 31 mm, 20 mm to 30 mm, 25 mm to 35 mm, or 27.5 mm to 32.5 mm. In some embodiments, the valvular prosthesis 10 can shorten as it expands, such that the length 126 in the expanded configuration is less than the length 127 in the collapsed configuration.

[0026]

[0056] Furthermore, the diameter 128 of the collapsed valve prosthesis 10 can be minimized, which may also be advantageous for delivering the valve prosthesis 10. For example, a collapsed valve prosthesis 10 having a smaller diameter 128 can fit within a delivery device having a smaller diameter, thereby allowing for less invasive delivery and improved maneuverability within a subject's body. Reducing the diameter 128 of the collapsed valve prosthesis 10 (e.g., for use in treating or replacing a mitral, tricuspid, aortic, or pulmonary valve) may further allow the valve prosthesis 10 to be more easily delivered to a target area of ​​a subject, allow a subject receiving the valve prosthesis 10 to recover more quickly, and / or improve clinical outcomes for the subject receiving the valve prosthesis 10 (e.g., increasing subject survival, improving ejection fraction, improving cardiac output, reducing valvular regurgitation, and / or reducing edema). In some cases, reducing the diameter 128 of the collapsed valve prosthesis 10 can enable transseptal access and delivery in addition to transapical access. In some cases, the diameter 128 of the collapsed valve prosthesis 10, or a portion thereof (e.g., framework 12), can be between 0.01 mm and 20 mm, 0.01 mm and 15 mm, 0.01 mm and 10 mm, 0.01 mm and 9 mm, 0.01 mm and 8 mm, 0.01 mm and 7 mm, 0.01 mm and 6 mm, 0.01 mm and 5 mm, 0.01 mm and 4 mm, 0.01 mm and 3 mm, 0.01 mm and 5 ... It may be 1 mm to 2 mm, 0.01 mm to 1 mm, 1 mm to 15 mm, 2 mm to 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 10 mm, 6 mm to 10 mm, 7 mm to 10 mm, 8 mm to 10 mm, 9 mm to 10 mm, 10 mm to 15 mm, 20 mm or less, 15 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, or 5 mm or less.

[0027]

[0057] Diameter 139 of framework 12 in the expanded configuration (see FIG. 1 ) may be larger than diameter 128 of framework 12 in the unexpanded configuration (see FIG. 2 ). In some cases, framework 12 or a portion thereof (e.g., annular central portion 158 of framework 12) can have an expanded diameter 139 of 10 mm to 50 mm, 20 mm to 40 mm, 25 mm to 35 mm, 27 mm to 33 mm, 50 mm or less, 40 mm or less, 35 mm or less, 33 mm or less, 30 mm or less, 25 mm or less, 20 mm or less, or 15 mm or less when framework 12 is in the expanded configuration.

[0028]

[0058] In some cases, diameter 128 or 139 refers to the maximum cross-sectional width of valvular prosthesis 10 or a portion thereof, e.g., as measured in a plane perpendicular to the longitudinal axis of valvular prosthesis 10 in a longitudinal location. In some situations, valvular prosthesis 10 has a polygonal cross-section. In some cases, diameter 128, 139 can refer to the maximum distance from a first side of the polygonal cross-section of valvular prosthesis 10 to a second side of the polygonal cross-section of valvular prosthesis 10.

[0029]

[0059] In some cases, the valvular prosthesis 10, or a portion thereof, may be sized or shaped to be positioned in a particular location or target area. For example, the framework 12 may be sized to be positioned within a valve, such as the mitral valve (e.g., by designing the dimensions of the framework to fit within the valve, such as the mitral valve, when in an expanded configuration).

[0030]

[0060] As shown in FIGS. 1-2 , the valvular prosthesis 10 can have a first portion 129 including only the valve segments 14 and / or minimal valve support 124, and a second portion 130 including the framework 12 and the valve segments 14. In some embodiments, the valve segments 14 can be entirely unsupported or largely unsupported in the first portion 129, while the valve segments 14 can be fully supported (e.g., by the framework 12) in the second portion 130. For example, the minimal valve support 124 can extend from the framework 12 to support the valve segments 14 within the first portion 129. The minimal valve support 124 can, for example, support only the inflow edges of the valve segments 14 within the first portion 129, leaving the remainder of the valve segments 14 unsupported within the first portion 129. The first portion 129 of the valvular prosthesis 10 can be connected to or continuous with the second portion 130. For example, the framework 12 may be connected to the minimum valve support 124 at a joint 125 (e.g., a fastener or a crimp) or may be continuous with the minimum valve support 124 (e.g., via fusion, welding, or by being formed from a continuous piece of material). Further, the valve segments 14 may be connected to the minimum valve support 124 in the first portion 129 and to the framework 12 in the section portion 130. For example, when the valvular prosthesis 10 is deployed in the orifice of the native mitral valve, the valvular prosthesis 10 may be oriented to allow the first portion 129 to be positioned closer to the atrium than the second portion 130 and the second portion 130 to be positioned closer to the ventricle than the first portion 129.

[0031]

[0061] 3 shows an exemplary example of valvular prosthesis 10 in an unexpanded configuration coupled to anchor 15. In some embodiments, anchor 15 can have a helical shape, for example, spiraling around valvular prosthesis 10 in the unexpanded and / or expanded configurations. Anchor 15 can have a free end 22. In some cases, free end 22 of anchor 15 can be useful when deploying anchor 15 into a native heart valve (e.g., by entraining chordae or other structures when prosthesis 10, anchor 15, and / or delivery device are rotated about the longitudinal axis of valvular prosthesis 10). Anchor 15 can be coupled directly to framework 12, for example, at its first end (e.g., proximal end) or at its second end (e.g., distal end). Alternatively, anchors 15 may be physically detached (i.e., uncoupled) from framework 12 while providing an anchor for frame 12 as the frame expands within the native valve orifice (thereby sandwiching tissue between frame 12 and anchors 15). In some embodiments, framework 12 may be at least partially held in place within the native valve through interaction with anchors 15. For example, the expanded diameter of framework 12 may be greater than or equal to the inner diameter of helical anchor 15, such that framework 12 expands into and engages anchor 15 (with native valve leaflets, chordae tendineae, or other tissue between framework 12 and anchor 15).

[0032]

[0062] The longitudinal axis of anchor 15 may be coaxial or concentric with the longitudinal axis of the delivery device when anchor 15 is in the deployed configuration. In some embodiments, the deployed anchor 15 may be removably coupled to the delivery device prior to deploying valvular prosthesis 10. For example, anchor 15 may be deployed from the delivery device and held by a tether (i.e., a string) until framework 12 expands within the native valve orifice and anchor 15.

[0033]

[0063] In some embodiments, the valvular prosthesis 10 described herein can have one or more flaring portions for engaging the anchors 15 and / or to help prevent the valvular prosthesis 10 from sliding through the valve orifice. For example, as shown in FIGS. 17A-17C , the framework 12 can have an atrial flaring portion 157 extending radially outward from the central annular portion 158. The atrial flaring portion 157 can extend, for example, from the central annular portion 158 into the atrium of the heart when the valvular prosthesis 10 is deployed in a native mitral valve. Alternatively or additionally, the atrial flaring portion 157 can contact tissue in the atrium of the heart, for example, the mitral valve annulus, when the valvular prosthesis 10 is deployed in a native mitral valve.

[0034]

[0064] The valvular prosthesis 10 described herein can have first and second ends opposite each other, with the first end (e.g., the proximal end) facing closest to the atrium when the valvular prosthesis 10 is deployed in the orifice of the native mitral valve, and the second end (e.g., the distal end) facing closest to the ventricle when the valvular prosthesis 10 is deployed in the orifice of the native mitral valve. Alternatively, the framework 12 can be configured to be positioned generally below the native valve when the framework 12 is secured to the native valve. In some cases, the first portion of the framework 12 can be disposed in a longitudinal location closer to the first end of the valvular prosthesis 10 than the second portion of the framework 12 (e.g., when the framework is in an unexpanded configuration). The first and / or second portions of the framework 12 can have a first longitudinal end and a second longitudinal end. In some cases, the first longitudinal end of the framework 12 can be oriented closer to the first end of the valvular prosthesis 10 than the second longitudinal end of the framework 12. In some cases, the second longitudinal end of the framework 12 is oriented closer to the second end of the valvular prosthesis 10 than the first longitudinal end of the framework.

[0035]

[0065] Any of the framework structures 12 described herein can provide structural strength to the valvular prosthesis device 10. For example, the framework structure 12 can be used to secure the valvular prosthesis 10 in place at a target location in a subject (e.g., within the ostium of a heart valve, such as the mitral or tricuspid valve).

[0036]

[0066] The valve prostheses 10 described herein can have one or more valve segments 14 arranged to replace the native valve leaflets. For example, the valve segments 14 can have multiple leaflets 16, forming, for example, a biocompatible one-way valve. Flow in one direction can cause the leaflets 16 to flex open, and flow in the opposite direction can cause the leaflets 16 to close.

[0037]

[0067] Any of the valve segments 14 described herein may be formed with multiple layers of material for preferential function. Referring to FIG. 4 , for example, valve prosthesis 10C may have a valve segment 14 with a seal 177 (also referred to as an outer leaflet, outer layer, or skirt) positioned radially between leaflets 16 (also referred to as inner leaflets 16 or inner layers) and framework 12. Seal 177 may be a single piece wrapped around leaflets 16 or may be a separate piece shaped to fit leaflets 16. In some cases, seal 177 and / or leaflets 16 may be formed from or coated with a material that provides a benefit to the valve segment 14. For example, a layer or surface of a valve segment 14 may be formed from or coated with a biocompatible material. In some cases, a layer or surface of a valve segment 14 may be formed from or coated with a thrombogenic material. In some cases, the valve segment 14 (or a portion thereof, such as the leaflet 16 of the valve segment) comprises a synthetic material. In some cases, the valve segment 14 (or a portion thereof, such as the leaflet) comprises biological tissue. In many cases, the valve segment 14 (or a portion thereof, such as the leaflet) comprises pericardial tissue. In some embodiments, the valve segment 14 (or a portion thereof, such as the leaflet 16 of the valve segment 14) comprises decellularized biological tissue. For example, the valve segment 14 (or a portion thereof, such as the leaflet 16 of the valve segment) can comprise decellularized pericardium.

[0038]

[0068] Valve segments 14 may be attached to framework 12, which may further be attached to anchors 15. Framework 12 may be connected to anchors 15 before or after framework 12 is deployed adjacent the native valve. Framework 12 may be attached to valve segments 14, for example, via attaching framework 12 to seals 177, which may further be attached to leaflets 16.

[0039]

[0069] In some embodiments, two or more portions of a valve segment 15 (e.g., two or more leaflets 16 and / or seal 177) can comprise a single piece of material (e.g., a single piece of biological or synthetic tissue formed into a functional valve shape). In some cases, two or more portions of a valve segment (e.g., two or more of the first and second leaflets 16 and / or seal 177) can be joined together. In some embodiments, two or more portions of a valve segment (e.g., two or more of the first and second leaflets 16 and / or seal 177) can be joined together by suturing the two or more portions together (e.g., at sutured connection points 166 shown in FIG. 4). In some cases, one, two, three, four, five, or six or more leaflets 16 can be coupled to a single seal 177.

[0040]

[0070] In many cases, the leaflet attachment points 166 are disposed at the inflow end of the valvular prosthesis 10 during deployment (i.e., closest to the source of flow through the device, e.g., by a contracting heart chamber). In some cases, connecting two or more portions of the valve segments 14 at the inflow end of the valvular prosthesis 10 (or a portion thereof) allows the valve segments 14 to fold or collapse (e.g., radially away from the longitudinal axis of the valvular prosthesis device 10) during contraction of the heart chamber upstream of the deployed device (i.e., during diastole). Additionally, in some cases, connecting two or more portions of the valve segments 14 at the inflow end of the valvular prosthesis 10 allows the valve segments 14 to expand (e.g., radially toward the longitudinal axis of the valvular prosthesis device 10) during refill of the heart chamber upstream of the deployed device (i.e., during systole). Such expansion of the valve segment 14 may, for example, cause the valve segment 14 to bulge or parachute (e.g., between the seal 177 and the leaflet 16), thereby blocking the flow of blood therethrough.

[0041]

[0071] As shown in FIG. 4 , the valve segments 14 may be attached to one or more struts 113 of the framework 12. In some embodiments, a portion of the valve segments 14 (e.g., leaflets 16 or seals 177) may be sewn to the central annular portion 158 of the framework 12 rather than to the inflow portion of the framework 12 or the outflow portion of the framework 12 (e.g., may not be attached to the distal arches 116 and the proximal arches 115 as shown in FIG. 4 ). In some embodiments, a portion of the valve segments 14 (e.g., leaflets 16 or seals 177) may be sewn to one or more outflow portions of the framework 12 rather than to the inflow portion of the framework 12 (e.g., may be sewn to one or more distal arches 116 but not to one or more proximal arches 115 as shown in FIG. 9A ). In some embodiments, a portion of the valve segment 14 (e.g., a leaflet 16 or a seal 177) may be sewn to one or more outflow portions of the framework 12 and to the inflow portion of the framework 12 (e.g., to one or more distal arches 116 and also to one or more proximal arches 115, as shown in valvular prosthesis 10E of FIG. 6). In some embodiments, the inflow end of the valve segment 14 may be substantially unsupported by the frame 12, while the outflow end of the valve segment 14 may be completely supported by and within the valve segment 14 (as shown in FIG. 4). The valve segment 14 (or a portion thereof, such as seal 177) may be continuously coupled to the frame 12 around the inner circumference of the frame 12 (e.g., at the distal or outflow end of the valvular prosthesis device 10).

[0042]

[0072] In some cases, the size of the attachment area of ​​the valve segments 14 (e.g., valve leaflets 16) relative to the framework 12 may be minimized, which can advantageously improve ease of delivery and shorten the required length of the frame, thereby reducing the likelihood of thrombosis and blockage of outflow from the ventricle to the aorta. Additionally, minimizing the framework 12 can improve the speed and cost of manufacturing the valvular prosthetic device 10.

[0043]

[0073] In some embodiments, the leaflets 16 attached to a first portion of the framework 12 at the distal end thereof (e.g., one or more struts 113) may not be attached to the proximal end of the framework 12 (e.g., to a strut or portion thereof at the proximal end of the framework 12). In some cases, a valvular prosthesis device 10 in which valve segments 14 are attached at the proximal end of the framework 12 but not at the proximal end of the framework 12 (and / or at the proximal ends of the valve segments 14) may require less metal and / or fewer struts than a valvular prosthesis 10 in which valve segments 14 are attached at both the proximal and distal ends of the framework 12 of the valvular prosthesis device 10. In some cases, minimizing the amount of metal used within the structure of the valvular prosthesis 10 (e.g., by reducing the number of struts and / or by shortening the length of the struts within the valvular prosthesis device 10) can reduce the risk of thrombus formation and improve the ease of deployment of the device at a target location.

[0044]

[0074] Additionally, the valve segments 14 may be configured to be substantially unsupported at their inflow edges 95. For example, as shown in FIG. 4, the entire inflow edges 95 of the valve segments may be unsupported except for a minimal valve support 124 positioned at the nadir 96 of each leaflet 16. The valve support 124 may have a pointed (i.e., protruding) proximal tip and may extend, for example, from two adjacent struts 113 of the framework 12. The minimal valve support 124 may help prevent the valve segments 14 (e.g., seals) from folding radially inward in the outflow direction (i.e., toward the ventricle) when implanted within the heart. FIG. 5 shows a valve prosthesis 10D similar to the valve prosthesis 10C of FIG. 4, except that the valve support 124 of FIG. 5 has apertures 97 for suturing the leaflets 16 to the valve support 124.

[0045]

[0075] 7A-7B show a valve prosthesis 10F in which the inflow edge 95 of the valve segment 14 is completely unsupported (ie, has no valve support therefor).

[0046]

[0076] 8A-8C illustrate another valvular prosthesis 10G in which the inflow edge 95 of the valve segment 14 is completely unsupported (i.e., has no valve support thereto). Indeed, as shown in FIGS. 8A-8C, the prosthesis 10G may have an inflow portion 167, a central annular portion 158, and an outflow portion 168. The valve segments 14 may be supported circumferentially by the framework 12 within the central annular section 158. However, the valve segments 14 may not be supported by and / or may be disconnected from the framework 12 within the inflow section 167. Furthermore, the framework 12 may flare radially outward within the inflow section 167. The flaring portion 157 of the framework 12 may have a plurality of discontinuous flanges (i.e., formed from the flaring proximal arches 115), which may function, for example, to assist in engagement with an external anchor. Additionally, overhang 157 may space valve segments 14 radially from framework 12 within inflow section 167 by distance 134 (see FIG. 8C ). In some embodiments, distance 134 may be 1-10 mm, such as 2-8 mm, 3-5 mm, etc. Finally, framework 12 may further overhang radially outward within outflow section 168. Overhang 160 of framework 12 may further function to assist in engagement with external anchor 15. For example, external anchor 15 may be located between overhang 157 and overhang 160 during implantation.

[0047]

[0077] 11 shows another valvular prosthesis 10J that is similar to valvular prosthesis 10G of FIGS. 8A-8B, except that the ratio of cell width (i.e., circumferential) to cell height may be greater for valvular prosthesis 10J than for valvular prosthesis 10G. The cell dimensions may be modified to provide desired stiffness and stability.

[0048]

[0078] 9A-9B show another valve prosthesis 10H that is similar to the valve prosthesis 10G of FIGS. 8A-8C, except that substantially the entire inflow edge 95 extends proximally beyond the proximal arch 115 of the framework 12. When the leaflets are closed (as shown in FIG. 9B), fluid pressure can act to fill the space created by the leaflets 16 and seal 177, thereby preventing the valve segments 14 from moving inward or collapsing.

[0049]

[0079] 10A-10B show a valvular prosthesis 10I that is similar to the valvular prosthesis 10H of FIGS. 9A-9B, except that the valvular prosthesis 10I includes a minimum valve support 124 at the lowest point 96 of each leaflet 16. The minimum valve support 124 is similar to the valve support 124 of FIG. 4. Additionally, the valve segments 14 of the valvular prosthesis 10I terminate short of the beginning of the outflow section 167 (i.e., terminate within the central annular section 158). Not having valve segments 14 attached to the outflow section 167 advantageously reduces tension on the framework 14 where it engages the external anchors 15 (i.e., within the outflow section 167).

[0050]

[0080] Various embodiments of the minimal valve support 124 are shown in FIGS. 12-13. For example, as shown in FIG. 12, the valve support 124 can extend from one or more longitudinal struts 113 and can be attached to the leaflet 16 at its nadir 96. As shown in FIG. 13, the minimal valve support 124 can be a ring-shaped support that extends only along the inflow edge 95, otherwise keeping the leaflet 14 unsupported within the inflow section. As shown in FIG. 14, the valve support 124 can be a wire form that extends longitudinally from one or more longitudinal struts 113. The minimal valve support 124 can advantageously help prevent partial prolapse of the leaflet 16 while keeping the majority of the leaflet 16 unsupported within the inflow section.

[0051]

[0081] In some embodiments, a minimal valve support 124 (e.g., as shown in FIGS. 12-13 ) may be positioned between the leaflets 16 and the seal 177 (e.g., as shown in FIG. 10A ). Having the minimal valve support 124 protected within the valve segment between the leaflets 16 and the seal 177 may advantageously make loading and release from the delivery system easier (e.g., by reducing friction and / or snagging). Additionally, in some embodiments, the minimal valve support 124 may be hinged at its connection to the frame 124 to aid in loading and / or release from the delivery system. In some embodiments, the minimal valve support 124 positioned between the leaflets 16 and the seal 177 may be formed with a coil to help prevent tangling.

[0052]

[0082] In some embodiments, minimal valve support 124 (e.g., as shown in FIGS. 12-13) may be at least partially laminated (i.e., overlapped) within seal 177. In some embodiments, a seal support may be laminated within seal 177 in addition to or instead of minimal valve support 124. Laminated seal 177 may include, for example, a polymeric material such as polyurethane.

[0053]

[0083] For example, FIGS. 15A-15B show a seal support 164 extending annularly within a seal 177. The seal 177 can have an inflow edge 195 with a convex profile configured to fit the inflow edges 95 of the leaflets 16 (e.g., three convex profiles to fit three leaflets 16). Additionally, the seal support 164 can have a wave- or sinusoidal-shaped element or wireform, such as, for example, a Nitinol wire, extending through the seal 177. The wave-shaped configuration can advantageously facilitate easy compression of the support 164 during delivery of the valve prosthesis. In some embodiments, the shape of the seal support 164 can vary. For example, the wave-shaped configuration can include bulbous portions at the inflow or outflow ends of the wave-shaped configuration. As another example, the seal support 164 can have discrete axially extending element locations within the seal 177.

[0054]

[0084] As shown in FIGS. 15A-15B , the seal support 164 can extend up to or near the inflow edge 195 of the seal 177. By having the seal support 164 extend close to the inflow edge 195, the seal support 164 can advantageously provide axial stiffness relative to the otherwise unsupported (or minimally supported) inflow edge 95 of the leaflet 16, thereby helping to prevent the leaflet from prolapsing during valve opening. In some examples, the seal support 164 can extend closer to the inflow edge 195 of the seal 177 than to the outflow edge 196 of the seal 177. Furthermore, the seal support 164 can be completely disconnected from the frame 12 of the valvular prosthesis in some embodiments. In other embodiments, the seal support 164 can be attached to the frame 12 (e.g., at a joint).

[0055]

[0085] 16A-16B, in some embodiments, seal support 164 can be used to pretension seal 177. That is, as shown in FIG. 16A, the wave pattern of seal support 164 can be compressed (indicated by the arrows) and laminated into seal 177. Referring to FIG. 16B, as seal support 164 expands, seal support 164 applies tension to seal 177 (as indicated by the arrows). Applying tension to seal 177 using seal support 164 can advantageously both reduce collapse of seal 177 and prevent leaflet prolapse when the valve is opened.

[0056]

[0086] 17A-17B, in some embodiments, a lowest support skirt 197 can extend between the inflow edge 195 of the seal 177 and the inflow portion 157 of the strut frame 12. That is, the skirt 177 and frame 12 can remain spaced radially inward from the inflow portion 157 at the inflow end 167 of the prosthesis, while the lowest support skirt 197 can extend across the gap between the inflow edge 195 of the seal 177 and the inflow portion 157 of the strut frame 12. Thus, the lowest support skirt 197 can act as a buffer between the leaflets 16 and the frame 12 at the inflow end 167, eliminating the need to fit or directly sew the leaflets 16 to the frame 12. The lowest support skirt 197 can advantageously help prevent the leaflets 16 from prolapsing when the valve is opened. Additionally, the lowest support skirt 197 can help prevent blood flow and / or clotting in the gap between the leaflet 16 and the frame 12 at the inflow end 167 and / or can help prevent paravalvular leakage.

[0057]

[0087] 18A-18C, in some embodiments, the valve prosthesis can have a combination of a seal support 164 and a nadir support skirt 197. During inflow (FIG. 18A), pressurization within the ventricle ensures that the leaflets 16 remain closed and that the seal 177 remains under tension. During outflow (FIG. 18B), the seal support 164 maintains the seal 177 under tension, while the nadir support skirt 197 can pull the seal 177 and leaflets 16 radially outward to prevent prolapse. As shown in FIG. 18C, in some embodiments, the inflow edge 195 of the seal 177, and thus the inflow edge 95 of the leaflets 16, can tilt radially outward as a result of blood flow distending the nadir support skirt 197 distally as the valve opens, thereby improving blood flow through the valve.

[0058]

[0088] 19A-19B, in some locations, the seal 177 can have axial folds 198 or pleats that extend from the inlet edge 195 to the outlet edge 196. The folds 198 can be secured in place using, for example, a polymer adhesive. The axial folds 198 can be positioned at various locations around the circumference of the seal 177. The axial folds 198 can function as seal supports to provide axial rigidity to the seal 177 while allowing it to be easily folded and covered for delivery.

[0059]

[0089] In some embodiments, the inflow edge 95 of the leaflet may be completely unsupported except at the juncture of the leaflet 16. In some embodiments, the inflow edge 95 of the leaflet may be unsupported except at the juncture of the leaflet 16 and the valve support 124. In some embodiments, the axial fold 198, the leaflet nadir support skirt 197, or the seal support 164 can improve the ability of the inflow edge 95 to remain unsupported by the frame 12 itself.

[0060]

[0090] 7A-7B, in some cases, the size of the valve prosthesis 10F (which may correspond to any of the valve prostheses 10 described herein), such as the size of the frame height 137 of the valve prosthesis 10F in an expanded configuration, may be measured relative to one or more structures of the valve prosthesis 10F (e.g., the valve segment height of the valve prosthesis device in an expanded configuration, the leaflet height 174 of the device when expanded, and / or the expanded frame body diameter 139) and / or relative to one or more biological structures (e.g., the average diameter of the heart valve into which the device is to be deployed).

[0061]

[0091] In some cases, the height 137 of the frame of the valve prosthesis 10F can be measured relative to the height 174 of the valve segments 14 of the valve prosthesis device 10F (e.g., the ratio of the valve segment height to the frame height, or VSTF (valve segment height-to-frame height) ratio (e.g., the ratio of the height 137 to the height 174)). In some cases, the height 174 of the valve segments 14 (or portions thereof, such as valve leaflets) of the expanded valve prosthesis 10F is greater than the height of the frame of the valve prosthesis device (e.g., a VSTF ratio greater than 1).

[0062]

[0092] Portions of the framework 12, such as the struts 113 and / or the minimum valve support 124 (e.g., annular structures), which may be used to provide compressive strength and / or resilience to the framework 12, may be made of a metal or metal alloy. Typical examples of metals and metal alloys that may be used to form all or part of a portion of the framework 12 include nickel-titanium alloy (NiTi), cobalt-chromium alloy, and stainless steel. A portion of the framework (e.g., the struts 113 or the minimum valve support 124) may be made of a material including one or more of the following metals: titanium, aluminum, cobalt, chromium, molybdenum, vanadium, zirconium, zinc, nickel, niobium, tantalum, magnesium, and iron. Specific titanium alloys that can be used include Ti-3Al-2.5V, Ti-5Al-2.5Fe, Ti-6Al-4V, Ti-6Al-4V ELI, Ti-6Al-7Nb, Ti-15Mo, Ti-13Nb-13Zr, Ti-12Mo-6Zr-2Fe, Ti-45Nb, Ti-35Nb-7Zr-5Ta, and Ti-55.8Ni. A portion of the framework 12 can include a nickel-titanium alloy having equal or nearly equal amounts of nickel and titanium. For example, the nickel-titanium alloy can be 50 mol%, 49.5 mol% to 50.5 mol%, 49 mol% to 51 mol%, 48.5 mol% to 51.5 mol%, 48 mol% to 52 mol%, 47.5 mol% to 52.5 mol%, or 47 mol% to 53 mol% nickel.

[0063]

[0093] In some cases, a portion of the valvular prosthesis 10 can include a ceramic. For example, one or more portions of the framework 12 can include one or more of alumina, zirconia, quartz, pyrolytic carbon (e.g., pyrolytic carbon coated graphite), or a calcium phosphate such as hydroxyapatite.

[0064]

[0094] A portion of the valvular prosthesis 10 can include a polymer (e.g., a sterilizable polymer and / or a biocompatible polymer). In some cases, the polymer can include one or more of polyethylene (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE)), fluoropolymer, silicone, polystyrene, nylon, polyurethane, thermoplastic polyurethane (TPU), polysiloxane, polylactide (PLA), polyglycolide (PGA), poly(lactide-co-glycolide) (PLGA), polycaprolactone (PCL), such as poly(ε-caprolactone), poly(methyl methacrylate), hyaluronan, polydioxanone, polyanhydrides, or trimethylene carbonate. In some cases, the polymer of the valvular prosthesis 10, or a portion thereof, can be a copolymer (e.g., a block copolymer). In some cases, the polymer can be crosslinked (e.g., using ultraviolet light) to improve the strength and / or elasticity of the polymer.

[0065]

[0095] The materials comprising the valvular prosthesis 10 or portions thereof (e.g., the framework 12, the woven covering 112, or the struts 113) can be formed into a solid structure or a mesh. For example, the woven covering 112 can include one or more materials (e.g., polymers such as polyester or nylon) formed into a woven fabric or mesh.

[0066]

[0096] In some cases, the valve prosthesis 10 or a portion thereof (e.g., valve leaflet 16) can include cell-based tissue. Using cell-based tissue as a material for the valve prosthesis 10 or a portion thereof can provide various advantages, such as reduced thrombogenicity, improved integration of the implanted valve prosthesis 10 with surrounding autologous tissue, improved material properties of the device or portion thereof, and, in some cases, reduced immune response. For example, a valve prosthesis 10 (or a portion thereof) including cell-based tissue can exhibit mechanical properties that approach those of a healthy valve under static and / or dynamic mechanical loading. Cell-based tissue obtained from the subject's own tissue (e.g., stem cell-derived tissue) or from an allogenic source, including all or a portion of the valve prosthesis 10, can, in some cases, reduce the likelihood of an immunogenic response after implantation. In some cases, the cell or cells of the cell-based tissue useful in the valve prosthesis 10 may be autologous, allogeneic, or xenogeneic with respect to the subject in which the prosthetic valve is to be deployed. Typical examples of sources of the cell or cells of the cell-based tissue useful in the valve prosthesis 10 are human, porcine, or bovine. One or more distal (or ventricular) surfaces of the leaflets 16 may be fabricated from, coated with, or treated with a biocompatible material.

[0067]

[0097] As will be appreciated by those skilled in the art, various embodiments of the valve segments, valve anchors, and frame anchors can provide advantages for repair or replacement of native valves.

[0068]

[0098] It should be understood that any feature described herein in connection with one embodiment may be substituted for or combined with any feature described in connection with another embodiment.

[0069]

[0099] When a feature or element is referred to herein as being "on" another feature or element, it may be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Similarly, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that it may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated in connection with one embodiment, features and elements so described or illustrated may apply to other embodiments. Additionally, those skilled in the art will recognize that a reference to a structure or feature disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0070]

[0100] The terminology used herein is merely for the purpose of describing particular embodiments and is not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. Furthermore, it will be understood that the terms "comprises" and "comprising," as used herein, specify the presence of the referenced features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The term "and / or," as used herein, includes any and all combinations of one or more of the associated listed items or items, and may also be abbreviated as " / ."

[0071]

[0101] Spatial relative terms such as "below," "lower," "lower side," "top," and "upper" may be used herein for ease of description to describe the relationship of one element or feature shown in the figures to another element or feature. It will be understood that spatial relative terms are intended to encompass various orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, an element described as being "below" or "below" another element or feature would be oriented as being "above" that other element or feature. Thus, the exemplary term "below" can encompass both an orientation of above and below. A device may be otherwise oriented (rotated 90 degrees or otherwise oriented), and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," and "horizontal" are used herein for descriptive purposes only, unless otherwise specified.

[0072]

[0102] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless otherwise specified. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element without departing from the teachings of the present invention.

[0073]

[0103] Throughout this specification and the claims that follow, unless otherwise specified, the word "comprise" and its variants, such as "comprises" or "comprising," mean that various components may be employed together in methods and matters (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" is understood to imply the inclusion of any recited elements or steps, but not the exclusion of any other elements or steps.

[0074]

[0104] All numbers used in this specification and claims, including those used in the examples, can be read as preceded by the word "about" or "approximately," unless otherwise specified, even if the word "about" or "approximately" is not explicitly stated. The phrase "about" or "approximately" can be used when describing a size and / or location to indicate that the described value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value can have a value of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Additionally, any numerical value given herein is understood to include about or approximately this value unless otherwise specified. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all subranges subsumed therein. It is also understood that when a value is disclosed as "less than or equal to" or "greater than or equal to" that value, the possible ranges between those values ​​as appropriately understood by those of ordinary skill in the art are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X (e.g., where X is a numeric value)" are also disclosed. It is also understood that data is provided throughout this specification in a number of different formats, and that this data represents endpoints and starting points, as well as ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are also considered disclosed, as well as between 10 and 15. It is also understood that each ones digit number between two specific ones digit numbers is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0075]

[0105] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Numerous modifications, changes, and substitutions will occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of these claims and their equivalents be embraced therein.

Claims

1. 1. A device for treating a diseased native valve in a patient, comprising: a frame structure having a non-expanded configuration and an expanded configuration, the frame structure having an inflow edge; a valve segment connected to the frame structure; wherein the valve segment comprises: a plurality of leaflets, wherein an inflow edge of the plurality of leaflets is not supported by the framework; a seal attached to the inflow edges of the plurality of leaflets and positioned radially between the framework and the plurality of leaflets; and a seal support attached to or within the seal and providing axial rigidity to the seal; Equipped with wherein at least a portion of the inflow edges of the plurality of leaflets extend axially beyond the inflow edge of the framework such that at least a portion of the inflow edges of the plurality of leaflets extend further in the inflow direction than the inflow edge of the framework.

2. The device of claim 1 , wherein the inflow edges of the plurality of leaflets are spaced radially inward from an inflow edge of the framework when the framework is in the expanded configuration.

3. The device of claim 1 further comprising a lowest point support skirt extending between the seal and an inlet edge of the framework.

4. 2. The device of claim 1, wherein the entire inflow edges of the plurality of leaflets extend axially beyond the inflow edge of the framework such that the entire inflow edges of the plurality of leaflets extend further in the inflow direction than the inflow edge of the framework.

5. The device of claim 1 , wherein the seal support is laminated within the seal.

6. The device of claim 1 , wherein the seal comprises polyurethane.

7. The device of claim 1 , wherein the seal support extends annularly within the seal.

8. The device of claim 1 , wherein the seal support has a corrugated wireform.

9. The device of claim 1 , wherein the seal support extends adjacent the inflow edge of the valve segment.

10. The device of claim 1 , wherein the seal support extends closer to an inflow edge of the seal than to an outflow edge of the seal.

11. The device of claim 1 , wherein the seal support is configured to apply a pretensioning force to the seal.

12. The device of claim 1 , wherein the seal support is disconnected from the framework.

13. The device of claim 1 , wherein the seal support comprises a plurality of axial folds within the seal, each axial fold extending from an inflow edge of the seal to an outflow edge of the seal.

14. The device of claim 1 , wherein the frame structure has a longitudinal length of less than 35 mm in the expanded configuration.

15. The device of claim 1 , wherein the frame structure comprises a flared inflow section, a central annular section, and a flared outflow portion.

16. The device of claim 15 , wherein the seal is attached to the central annular portion.

17. 16. The device of claim 15, wherein the flaring inflow section and the flaring outflow section are configured to engage an external anchor between the flaring inflow section and the flaring outflow section when the framework is in the expanded configuration.

18. The device of claim 1 , wherein the leaflets of the plurality of leaflets are attached to the frame structure only at the joints of the plurality of leaflets.

19. 10. The device of claim 1, wherein at least a portion of the inflow edges of the plurality of leaflets extend axially beyond the framework and the entire outflow edges of the plurality of leaflets are positioned within the framework.

20. 1. A device for treating a diseased native valve in a patient, comprising: a frame structure having a non-expanded configuration and an expanded configuration, the frame structure having an inflow edge; A valve segment coupled to the framework, comprising: a plurality of leaflets, wherein an inflow edge of the plurality of leaflets is not supported by the framework; and a seal attached to the inflow edges of the plurality of leaflets and positioned radially between the framework and the plurality of leaflets; a valve segment comprising: a lowest point support skirt extending between the seal and an inlet edge of the framework; Equipped with wherein at least a portion of the inflow edges of the plurality of leaflets extend axially beyond the inflow edge of the framework such that at least a portion of the inflow edges of the plurality of leaflets extend further in the inflow direction than the inflow edge of the framework.

21. 21. The device of claim 20, wherein the lowest support skirt extends from an inflow edge of the seal to an inflow edge of the framework.

22. 22. The device of claim 21, wherein an inflow edge of the seal is attached to the inflow edges of the plurality of leaflets.

23. 21. The device of claim 20, wherein the inflow edges of the plurality of leaflets are spaced radially inward from an inflow edge of the framework when the framework is in the expanded configuration.

24. 21. The device of claim 20, wherein the entire inflow edges of the plurality of leaflets extend axially beyond the inflow edge of the framework such that the entire inflow edges of the plurality of leaflets extend further in the inflow direction than the inflow edge of the framework.

25. 21. The device of claim 20, wherein the frame structure has a longitudinal length in the expanded configuration of less than 35 mm.

26. 21. The device of claim 20, wherein the frame structure comprises a flared inflow section, a central annular section, and a flared outflow portion.

27. 27. The device of claim 26, wherein the seal is attached to the central annular portion.

28. 27. The device of claim 26, wherein the flaring inflow section and the flaring outflow section are configured to engage an external anchor between the flaring inflow section and the flaring outflow section when the framework is in the expanded configuration.

29. 21. The device of claim 20, wherein the leaflets of the plurality of leaflets are attached to the frame structure only at the joints of the plurality of leaflets.

30. 21. The device of claim 20, wherein at least a portion of the inflow edges of the plurality of leaflets extend beyond the framework and the entire outflow edges of the plurality of leaflets are positioned within the framework.

Images