Prosthetic cardiac valve device, systems, and methods

Abstract

A device for treating a diseased native valve in a patient is provided, which can include a frame structure comprising an inflow region having an inflow end, an outflow region having an outflow end, and a central waist portion positioned between the inflow region and the outflow region, a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets, and an internal skirt coupled to an interior of the frame structure and to the valve segment and extending from the inflow region to the outflow region, wherein the internal skirt includes a plurality of leaflet tabs coupled to the plurality of leaflets, wherein an inflow edge of each of the plurality of leaflets is supported only by a corresponding leaflet tab. The device can also include an external skirt coupled to an exterior of the frame structure.

Description

PROSTHETIC CARDIAC VALVE DEVICE, SYSTEMS, AND METHODSCLAIM OF PRIORITY

[0001] This application claims priority to U.S. Provisional Application No. 63 / 515,070, titled “PROSTHETIC CARDIAC VALVE DEVICE, SYSTEMS, AND METHODS”, and filed July 21, 2023, the contents of which is incorporated herein by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0003] Blood flow between heart chambers is regulated by native valves - the mitral valve, the aortic valve, the pulmonary valve, and the tricuspid valve. Each of these valves is a passive one-way valve that opens and closes in response to differential pressures. Patients with valvular disease have abnormal anatomy and / or function of at least one valve. For example, a valve may suffer from insufficiency, also referred to as regurgitation, when the valve does not fully close, thereby allowing blood to flow retrograde. Valve stenosis can cause a valve to fail to open properly. Other diseases may also lead to dysfunction of the valves.

[0004] The mitral valve, for example, sits 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 backflow or regurgitation in the reverse direction. Native valve leaflets of a diseased mitral valve, however, do not fully prolapse, causing the patient to experience regurgitation.

[0005] While medications may be used to treat diseased native valves, the defective valve often needs to be repaired or replaced at some point during the patient’s lifetime. Existing prosthetic valves and surgical repair and / or replacement procedures may have increased risks, limited lifespans, and / or are highly invasive. Some less invasive transcatheter options are available, but most are not ideal. A major limitation of existing transcatheter mitral valve devices, for example, is that the mitral valve devices are too large in diameter to be delivered transeptally, requiring transapical access instead. Furthermore, existing mitral valve replacement devices are not optimized with respect to strength-weight ratio and often take up too much space w ithin the valve chambers, resulting in obstruction of outflow' from the ventricle into the aorta and / or thrombosis.

[0006] Thus, a new' valve device that overcomes some or all of these deficiencies is desired.SUMMARY OF THE DISCLOSURE

[0007] A device for treating a diseased native valve in a patient, the device comprising: a frame structure comprising an inflow region having an inflow end, an outflow region having an outflow end, and a central waist portion positioned between the inflow region and the outflow region; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets; and an internal skirt coupled to an interior of the frame structure and to the valve segment and extending from the inflow region to the outflow region, wherein the internal skirt includes a plurality of leaflet tabs coupled to the plurality of leaflets, wherein an inflow edge of each of the plurality of leaflets is supported only by a corresponding leaflet tab.

[0008] In some aspects, the frame structure further comprises a plurality of commissure attachment mechanisms extending radially inwards from the outflow end and attached to the valve segment.

[0009] In some aspects, the plurality of commissure attachment mechanisms are coupled to commissures of the valve segment.

[0010] In other aspects, the plurality of commissure attachment mechanisms are the only rigid attachment between the frame structure and the valve segment

[0011] In one aspect, the internal skirt further comprises a plurality of commissure tabs configured to axially align with commissures of the plurality of leaflets when the plurality of leaflet tabs are coupled to the plurality of leaflets.

[0012] In additional aspects, the commissure tabs are coupled to the frame structure.

[0013] In some aspects, the internal skirt further comprises an outflow edge pattern configured to match a cell pattern of the frame structure near the outflow end.

[0014] In other aspects, a row of cells at the outflow end of the frame structure is not covered by the internal skirt.

[0015] In one aspect, the central waist portion is configured to engage with an external anchoring device.

[0016] In some aspects, an inflow edge of the plurality of leaflets extends axially beyond the inflow region of the frame structure.

[0017] In other aspects, the plurality of leaflet tabs are not circumferentially attached to the frame around the entirety of the inflow region.

[0018] In additional aspects, the plurality of leaflets is not rigidly supported by the frame structure in the inflow region.

[0019] In some aspects, an exterior skirt is coupled to an exterior of the frame structure.

[0020] In some aspects, the exterior skirt comprises a first portion disposed along the inflow region and a second portion disposed along the outflow region.

[0021] In other aspects, the first portion comprises a first material and the second portion comprises a second material.

[0022] In some aspects, the first portion is disposed along the inflow region and at least a portion of the central waist portion.

[0023] In another aspect, the second material is less abrasive than the first material.

[0024] In one aspect, the first material comprises a polyethylene terephthalate (PET) weave material and the second material comprises a PET knit material.

[0025] A device for treating a diseased native valve in a patient is provided, the device compnsing: a frame structure comprising an inflow region, an outflow region comprising a plurality of interior commissure attachment mechanisms, and a central waist portion positioned between the inflow region and the outflow region; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets each having an inflow edge; and an internal skirt coupled an interior of the frame structure and extending from the inflow region to the outflow region, wherein the internal skirt includes a plurality of leaflet tabs coupled to the plurality of leaflets and to the inflow region to provide a non-rigid attachment between the inflow edges of the plurality of leaflets and the frame structure; wherein the plurality of leaflets are rigidly attached to the interior commissure attachment mechanisms of the frame structure.

[0026] In some aspects, the plurality of commissure attachment mechanisms extend radially inwards from the outflow portion.

[0027] In some aspects, the plurality of commissure attachment mechanisms are coupled to commissures of the valve segment.

[0028] In other aspects, the plurality of commissure attachment mechanisms are the only rigid attachment between the frame structure and the valve segment

[0029] In one aspect, the internal skirt further comprises a plurality of commissure tabs configured to axially align with commissures of the plurality' of leaflets when the plurality of leaflet tabs are coupled to the plurality of leaflets.

[0030] In additional aspects, the commissure tabs are coupled to the frame structure.

[0031] In some aspects, the internal skirt further comprises an outflow edge pattern configured to match a cell pattern of the frame structure near the outflow end.

[0032] In other aspects, a row of cells at the outflow end of the frame structure is not covered by the internal skirt.

[0033] In one aspect, the central waist portion is configured to engage with an external anchoring device.

[0034] In some aspects, an inflow edge of the plurality of leaflets extends axially beyond the inflow region of the frame structure.

[0035] In other aspects, the plurality of leaflet tabs are not circumferentially attached to the frame around the entirety of the inflow region.

[0036] In additional aspects, the plurality of leaflets is not rigidly supported by the frame structure in the inflow region.

[0037] In some aspects, an exterior skirt is coupled to an exterior of the frame structure.

[0038] In some aspects, the exterior skirt comprises a first portion disposed along the inflow region and a second portion disposed along the outflow region.

[0039] In other aspects, the first portion comprises a first material and the second portion comprises a second matenal.

[0040] In some aspects, the first portion is disposed along the inflow region and at least a portion of the central waist portion.

[0041] In another aspect, the second material is less abrasive than the first material.

[0042] In one aspect, the first material comprises a polyethylene terephthalate (PET) weave material and the second material comprises a PET knit material.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings.

[0044] FIGS. 1 A-l D show various views of a mitral valve replacement device.

[0045] FIG. 2A shows an internal skirt of a mitral valve replacement device.

[0046] FIG. 2B shows another view of a mitral valve replacement device.

[0047] FIG. 2C sho s a partially assembled mitral valve replacement device.

[0048] FIG. 2D shows another view of a mitral valve replacement device.

[0049] FIGS. 3A-3D show additional views of the internal and external skirts of a valve replacement device.DETAILED DESCRIPTION

[0050] Described herein are systems, devices, and methods for treatment or replacement of a diseased native valve of the heart, such as the mitral valve. In general, described herein is areplacement prosthesis that can include a valve frame including a plurality of leaflets and a separate anchor configured to secure the valve frame within the target anatomy.

[0051] FIGS. 1 A-l B shows a valve prosthesis 100 having a valve frame 102 and configured to support a plurality of leaflets 104 therein. The valve prosthesis is configured to be implanted in a native mitral valve of a subject’s heart. Once implanted, blood flows from the left atrium, through the leaflets of the valve prosthesis, into the left ventricle. The valve frame can include a flared atrial portion 106 configured for placement on an atrial side of a native mitral valve, a ventricular portion 108 configured for placement on a ventricular side of a native mitral valve, and a central waist portion 110 disposed between the atrial portion and ventricular portion and configured to engage with a separate anchoring device 112 as shown in FIGS. 1C-1D.

[0052] In FIG. IB. the valve frame 102 can include interior commissure attachment mechanisms 114 for attachment of the leaflets to the frame structure 102. In the embodiment shown, the valve prosthesis includes three leaflets 104 and three interior commissure attachment mechanisms 114. and commissures 115 of the leaflets are attached to the interior commissure attachment mechanisms 114. In some aspects of this disclosure, the attachment of the leaflets to the frame structure via the interior commissure mechanisms 1 14 can be characterized as a ‘'rigid” attachment to the frame structure on the ventricular side or ventricular portion of the frame. In some embodiments, the frame component that attaches to the leaflets can comprise a material that has the same or substantially the same flexibility and / or rigidity as the material of the frame structure itself. For example, the frame structure may comprise a metal, alloy, or shape memory material such as nitinol, and the interior commissure mechanism can comprise the same or similar material. It can be seen in FIG. IB that the interior commissure attachment mechanisms can be extensions of the valve frame 102 on the ventricular portion that curve radially inwards (e.g., approximately 180 degrees). However, in some embodiments, the interior commissure attachment mechanisms can be separate structures from the frame but be attached to the frame (e.g., by welding, adhesive, screws, etc.). Additional details on the interior commissure attachment mechanism can be found in US Ser. No. 18 / 246,311 which is incorporated herein by reference in its entirety.

[0053] The valve frame 102 can be deployed from a collapsed (delivery) configuration to an expanded configuration during a method of replacing or repairing a native valve, such as a mitral valve. As shown in FIGS. 1 A and IB, the valve frame 102 can include a plurality of rows (e.g., 3-7 rows) of substantially diamond-shaped cells 122. The valve frame 102 can foreshorten during delivery (i.e., as the valve frame 102 transitions from the collapsed configuration to the expanded configuration) due to the cell structure. In some embodiments, the valve frame 102 can be configured to self-expand from the collapsed configuration to the expanded configuration(e.g., can be made of a shape memory material such as nitinol). The valve frame 102 can provide circumferential strength and / or longitudinal strength to valve prosthesis 100.

[0054] One or more portions of the valve frame 102 can be shaped or configured to aid in securing the valve frame 102 at a location (e.g., in the orifice of a native heart valve). For example, the valve frame 102 can include a flared atrial portion 106 and a ventricular portion 108 configured to help secure the frame in the anatomy. The atrial and ventricular portions 106, 108 can extend radially outwards from a central waist portion 1 10. The atrial portion 106 can, for example, extend into the atrium of the heart from the central waist portion 110 when the valve prosthesis is deployed in the native mitral valve. The ventricular portion 108, in turn, can extend into the ventricle of the heart from the central waist portion 110 when the valve prosthesis is deployed in the native mitral valve. The atrial and ventncular portions 106, 108 can. for example, be configured to be positioned on either side of a separate anchoring device 112 (e.g., that is wrapped around the chordae) to anchor the valve frame 102 in the anatomy. Alternatively or additionally, the atrial and ventricular portions 106. 108 can be configured to engage with tissue to prevent the valve prosthesis from slipping through the native valve orifice.

[0055] Referring to FIGS. 1A-1D, the frame structure 102 of the valve prosthesis 100 can include a partial hourglass shape such that the ventricular portion 108 initially flares radially outwards, but then curves to point substantially axially (i.e., in the ventricular direction). In some embodiments, the ventricular portion then curves to point radially inwards. This halfhourglass or cup shape of the ventricular portion 108 can assist with anchor engagement and retainment in the central waist portion of the frame structure 102.

[0056] Further, as shown in FIGS. 1A-1D, the flared atrial portion 106 can extend further radially outwards than the ventricular portion 108. In some examples, the flared atrial portion can have a diameter up to 55mm. The larger atrial flared portion can have a compliance to allow the flared atrial portion to conform to the native tissue around the annulus and help prevent para- valvular leakage (PVL). Additionally, the large flared atrial portion increases the treatable population and fits native valves having a diameter of 40-52mm. The large wide flared atrial portion is further configured to help maintain the position of the prosthesis and prevent the valve frame from slipping or passing through the native valve annulus. In some embodiments, the atrial portion 106 is the softest or least stiff portion of the valve prosthesis. This flexibility allows the atrial portion to conform to the atrium of the patient. The central waist portion and the ventricular portion can optionally be stiffer than the atrial portion. The stiffness of the central waist portion can aid in its expansion to the target diameter and allow the prosthesis to expand into the anchoring device. In some embodiments, the central waist portion is configured to expand against the counterforce of the anchor as the anchor is expanded by the valve.

[0057] The valve frames described herein can include one or more skirts or seals thereon configured to help force or move blood through the valve prosthesis. For example, referring to FIG. 1 A, the valve frame 102 can include or be attached to an internal skirt 1 16 and one or more external skirts 118. The skirts can be made, for example, of a polymer, such as polyethylene terephthalate (PET). Further, the skirts described herein can be woven and / or knitted, or both, (e.g., with a denier of 15-25, such as approximately 20). The internal skirt 116 can include tabs 120 or other features configured to attach the leaflets of the valve prosthesis to the valve frame, as will be described below. The external skirt 118 can be configured to provide fluid impermeability, promote tissue growth in selected portions, and / or prevent tissue damage or erosion. FIG. 1A shows external skirt 118 folded or wrapped over the inflow edge of the frame and secured upon itself and the valve frame via suture line 130. as will also be described in more detail below.

[0058] FIG. 2A show s an internal skirt 216 prior to being attached to a valve prosthesis, and FIG. 2B shows a fully assembled valve prosthesis 200 including a valve frame 202, leaflets 204, the internal skirt 216, and an external skirt or seal 218.

[0059] Referring to FIG. 2A, the internal skirt 216 can be designed and configured to be attached to an interior of the valve frame of the prosthesis. In the illustrated embodiment, the internal skirt extends from the flared atrial portion of the prosthesis to the ventricular portion (e.g., from the inflow end of the prosthesis to the outflow end of the prosthesis). The internal skirt 216 can include a plurality of leaflet tabs 220 configured to be attached to both the leaflets and valve frame of the prosthesis. The tabs can provide support for the nadirs of the leaflets and also fixedly attach at least a portion of the leaflets to the valve frame, such as with sutures 226 and 227. In some embodiments, there is no rigid support or direct attachment to the leaflets at the inflow (atrial) side of the prosthesis. The non-rigid support or attachment of the leaflets on the atrial side of the frame (via the internal skirt leaflet tabs 220) is contrasted with the rigid support or attachment of the leaflets to the ventricular side of the frame (as described above with respect to the interior commissure mechanisms). Instead, only the leaflet tabs of the internal skirt provide support and attachment for the leaflet nadirs on the atrial side of the frame. In the mitral valve replacement frame of the present disclosure, the only rigid attachment between the frame and the leaflets is at the interior commissure attachment mechanisms on the outflow^ end (ventricular side) of the prosthesis.

[0060] In some embodiments, the internal skirt 216 can include a number of leaflet tabs 220 corresponding to the number of leaflets in the prosthesis. In the illustrated example, the valve prosthesis includes three leaflets and three internal skirt leaflet tabs. It should be noted that leaflet tabs of the internal skirt do not provide circumferential support around the entirety of theleaflets, but instead only provide support at the leaflets. Put another way. the internal skirt on the inflow end of the valve prosthesis is attached to the frame only at selected points along the frame (e.g., at the nadirs of the leaflets and at the commissures).

[0061] Additionally, still referring to FIG. 2 A, the internal skirt 216 can include a plurality7of commissure tabs 222. When the leaflet tabs 220 are aligned or attached with the nadirs of the leaflets, as described above, then the commissure tabs 222 are brought into alignment with the commissures 215 of the leaflets. The commissure tabs 222 can be attached to the frame as show n via sutures 229 to provide additional support to the leaflets at the commissures, or more specifically, between the inflow7of the frame and the commissures but in radial alignment with the commissures, and prevent blood from passing from the inflow portion of the valve prosthesis between the valve frame and the leaflets / commissures. It should be understood that since the commissure tabs 222 are in alignment with the commissures 215 of the leaflets, then the commissure tabs 222 are attached to the valve frame 202 so as to be generally aligned with the interior commissure attachment mechanisms (not shown). It should be understood that in various embodiments, the length and / or width or shape of the commissure tabs 222 can vary. For example, the tabs shown in FIG. 2A are longer than the tabs shown in FIG. 2B.Alternatively, the width of the tabs can be adjusted depending on the cell pattern of the valve frame.

[0062] As is also shown in FIG. 2A, the outflow end of the internal skirt 216 can include a plurality of tabs 224. Collectively, the tabs 224 can include a zig zag or chevron pattern designed and configured to correspond to the cell pattern of the valve frame 202 in the ventricular portion of the prosthesis. In one embodiment, the tabs 224 are configured to be fixed or attached to the valve frame along the cell pattern of the penultimate row of cells in the ventricular portion, such that the final row of cells in the ventricular portion (at the outflow edge of the prosthesis) does not include an internal skirt.

[0063] FIG. 2C show s the leaflets 204 and internal skirt 216 attached to an interior of the valve frame 202 of the valve prosthesis 200. In the illustrated example, the nadir of each leaflet is sewn or stitched to the internal skirt. The leaflets can be sewn or stitched to the internal skirt along stitch line 226 in FIG. 2A. The stitch line 226 can track the perimeter or nadir of each leaflet to allows the leaflet tabs 220 to extend in the region of the nadir to attach to the valve frame. Also show n in FIG. 2C, the leaflet tabs 220 and commissure tabs 222 of the internal skirt can be attached to the valve frame 202 and / or the external skirt, e g., with one or more stitches. Additionally, both the leaflet tabs and commissure tabs can be sewn or attached to the external skirt, as shown in FIG. 2D. In some examples, the one or more stitches shown in FIG. 2C are temporary for placement of the internal skirt on the frame, and are removed w hen the internalskirt is sewn or atached to the external skirt as shown in FIG. 2D. FIG. 2A shows stitch line 227 for ataching the leaflet tabs 220 to the external skirt.

[0064] Referring still to FIG. 2C, it can be seen that the leaflets, including the nadirs of the leaflets, can extend above or beyond the valve frame 202 in the inflow' or atrial portion of the device. In the illustrated example, the leaflets extend beyond the atrial portion of the frame by a distance 228. Since the leaflet tabs of the internal skirt are atached to the nadirs of the leaflets, this distance 228 can create a gap betw een the internal skirt and the frame. The leaflet tabs of the internal skirt advantageously provide support to the inflow end of the leaflets and provide a buffer between the leaflets and the frame, to prevent the leaflets from directly contacting the frame. The leaflet tabs further allow for the overall height of the valve prosthesis to be reduced, since there is no need for a rigid or frame support of the leaflet nadirs on the inflow end of the device. Supporting the leaflets with the internal skirt further provides increased packing performance in crimping, easier delivery', and may allow' for reduced diameter of the device in a delivery' configuration. Furthermore, the leaflet tabs can provide for improved leaflet motion since the leaflets are not constrained by full circumferential support, but instead are only constrained along a portion of the nadir of each leaflet where the leaflet tabs extend from the leaflets and are atached to the frame.

[0065] FIG. 2C further shows the tabs 224 on the ventricular side of the device which are paterned so as to keep the last row of the valve frame open and un-obstructed by the internal skirt.

[0066] FIG. 3A shows another view of a valve prosthesis 300 having an inflow or atrial portion 306, a central w aist portion 310, and an outflow or ventricular portion 306. FIG. 3 A also shows an external skirt 318 covering all or a portion of the exterior of the valve prosthesis. In the illustrated embodiment, the external skirt 318 can comprise two portions 318a and 318b. In some embodiments, the portions 318a and 318b of the external skirt can have different fabrics, materials, or properties. In some examples, the portions 318a and 318b can be separate portions of material that are separately stitched or atached to the valve prosthesis. In other embodiments, the two portions can have a different material or material properties, but can be a uniform or integral section of skirt (e.g., the material can transition from a weave to a knit). In some embodiments, the portion 318a of the external skirt (e.g., in the atrial portion of the valve prosthesis) can comprise a polyethylene terephthalate (PET) w eave to provide fluid impermeability, but also allow for tissue ingrowth response. In some embodiments, the portion 318b of the external skirt can comprise a PET warp knit (e.g.. 15-25 denier, 30 denier, etc.). A PET warp knit is less abrasive than the PET w eave. Using such a material on external portions of the frame can help to address tissue interaction with those portions. For example, thismaterial can help prevent chordal erosion by the device. Therefore, in the illustrated embodiment, the portion 318b disposed over the central / ventricular portions of the valve prosthesis can include the PET warp knit to prevent chordal erosion. Portions of the device, such as the leaflets can comprise a coating configured to prevent tissue ingrowth (e.g., chronosil coating). Such a coating can help to prevent pannus formation on the leaflets.

[0067] FIG. 3 A also shows stitching or suturing used to attach the external skirt 318 to the valve prosthesis 300. For example, suture line 330 is shown near the inflow end of the valve frame can secure the external skirt 318 to itself and / or to the frame. As described above, the external skirt, such as portion 318a, can be w rapped or folded over the inflow edge of the valve frame and secured with suture line 330. Portion 318b of the external skirt can be placed over portion 318a and secured to the valve frame via suture lines 332a and 332b. While two suture lines are shown, it should be understood that any number of suture lines can secure portion 318b of the external skirt to the frame and / or the portion 318a. In some embodiments, portion 318a extends axially along a portion of the frame underneath portion 318b. In other embodiments, portion 318a ends where portion 318b starts. FIG. 3 A also shows suture line 327, which corresponds to sutures 227 in FIG. 2D and is used to attach tabs 220 of the internal skirt to the valve frame and / or external skirt. As is described above, these tabs provide a non-rigid attachment between the leaflets and the valve frame.

[0068] FIG. 3B is an interior view of the atrial portion 306, including the suture line 330 where the portion 318a of the external skirt is wrapped or folded over the inflow edge of the valve prosthesis and secured to the frame and to itself. FIG. 3B also shows suture line 332a securing the portion 318b to portion 318a of the external skirt.

[0069] FIGS. 3C and 3D show interior views of the ventricular or outflow portion 308 of the valve prosthesis, including attachment of the internal skirt and external skirt to valve frame. In FIG. 3C, tabs 324 of the interior skirt 316 are sutured or stitched to the valve frame with one or more suture lines 334. In the illustrated embodiment, the suture lines form a diamond or oval shaped pattern to fully secure the tabs 324 to the entirety of a diamond or oval shaped cell of the frame. However, in other embodiments, the suture lines 334 may not fully encircle or encapsulate a row of frame cells, but instead secure the interior skirt to only a portion of the frame cells (e.g., a single suture line 334 of the two suture lines shown in FIGS. 3C-3D).Leaflets 304 are also shown attached to the interior skirt. In FIG. 3D, exterior skirt 318 is folded upon itself and secured to the frame with suture line 336. In some aspects, the suture line 336 deliberately avoids struts or portions of the frame that are immediately connected to the interior commissure attachment mechanisms of the frame. While the exterior skirt 318 is folded upon itself, it is not folded over the outflow7end of the frame, but instead the entirety7of the exteriorskirt is disposed on the exterior of the valve frame. This is in contrast to the inflow edge of the frame, where the exterior skirt is folded over the frame.

[0070] The coverings / skirts described herein can be attached using sutures. In some embodiments a polymer suture, such as polyethylene can be used. In some embodiments, the suture comprises ultra-high molecular weight (UHMW) polyethylene. In some embodiments, running stiches are used. In other embodiments, whip stiches are used. In some embodiments, a combination of stitching types is used, such as whip stitching on the ventricular portion of the frame and running stiches everywhere else.

[0071] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0072] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0073] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, w hen a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be 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 shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0074] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or"comprising," when used in this specification, specify the presence of stated 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. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0075] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different 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, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0076] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0077] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0078] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0079] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about"or "approximately." even if the term does not expressly appear. The phrase "about" or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 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. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 1 . It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0080] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0081] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A device for treating a diseased native valve in a patient, the device comprising: a frame structure comprising an inflow region having an inflow end, an outflow region having an outflow end, and a central waist portion positioned between the inflow region and the outflow region; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets; and an internal skirt coupled to an interior of the frame structure and to the valve segment and extending from the inflow region to the outflow region, wherein the internal skirt includes a plurality7of leaflet tabs coupled to the plurality' of leaflets, wherein an inflow edge of each of the plurality' of leaflets is supported only by a corresponding leaflet tab.

2. The device of claim 1, wherein the frame structure further comprises a plurality of commissure attachment mechanisms extending radially inwards from the outflow end and attached to the valve segment.

3. The device of claim 2, wherein the plurality of commissure attachment mechanisms are coupled to commissures of the valve segment.

4. The device of claim 2, wherein the plurality of commissure attachment mechanisms are the only rigid attachment between the frame structure and the valve segment.

5. The device of claim 1, wherein the internal skirt further comprises a plurality7of commissure tabs configured to axially align with commissures of the plurality' of leaflets when the plurality of leaflet tabs are coupled to the plurality of leaflets.

6. The device of claim 5, wherein the commissure tabs are coupled to the frame structure.

7. The device of claim 1, wherein the internal skirt further comprises an outflow edge pattern configured to match a cell pattern of the frame structure near the outflow end.

8. The device of claim 7, wherein a row of cells at the outflow end of the frame structure is not covered by the internal skirt.

9. The device of claim 1, wherein the central waist portion is configured to engage with an external anchoring device.

10. The device of claim 1, wherein an inflow edge of the plurality of leaflets extends axially beyond the inflow region of the frame structure.

11. The device of claim 1 , wherein the plurality of leaflet tabs are not circumferentially attached to the frame around the entirety of the inflow region.

12. The device of claim 1, wherein the plurality of leaflets is not rigidly supported by the frame structure in the inflow region.

13. The device of claim 1, further comprising an exterior skirt coupled to an exterior of the frame structure.

14. The device of claim 13, wherein the exterior skirt comprises a first portion disposed along the inflow region and a second portion disposed along the outflow region.

15. The device of claim 14, wherein the first portion comprises a first material and the second portion comprises a second material.

16. The device of claim 14, wherein the first portion is disposed along the inflow region and at least a portion of the central waist portion.

17. The device of claim 15, wherein the second material is less abrasive than the first material.

18. The device of claim 15, wherein the first material comprises a polyethylene terephthalate (PET) weave material and the second material comprises a PET knit material.

19. A device for treating a diseased native valve in a patient, the device comprising:a frame structure comprising an inflow region, an outflow region comprising a plurality of interior commissure attachment mechanisms, and a central waist portion positioned between the inflow region and the outflow region; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality' of leaflets each having an inflow edge; and an internal skirt coupled an interior of the frame structure and extending from the inflow region to the outflow region, wherein the internal skirt includes a plurality of leaflet tabs coupled to the plurality of leaflets and to the inflow region to provide a non-rigid attachment between the inflow edges of the plurality of leaflets and the frame structure; wherein the plurality of leaflets are rigidly attached to the interior commissure attachment mechanisms of the frame structure.

20. The device of claim 19, wherein the plurality' of commissure attachment mechanisms extend radially inwards from the outflow region.

21. The device of claim 20, wherein the plurality' of commissure attachment mechanisms are coupled to commissures of the valve segment.

22. The device of claim 20, wherein the plurality of commissure attachment mechanisms are the only rigid attachment between the frame structure and the valve segment.

23. The device of claim 19, wherein the internal skirt further comprises a plurality of commissure tabs configured to axially align with commissures of the plurality of leaflets when the plurality of leaflet tabs are coupled to the plurality of leaflets.

24. The device of claim 23, wherein the commissure tabs are coupled to the frame structure.

25. The device of claim 19, wherein the internal skirt further comprises an outflow edge pattern configured to match a cell pattern of the frame structure near the outflow end.

26. The device of claim 25, wherein a row of cells at the outflow end of the frame structure is not covered by the internal skirt.

27. The device of claim 19, wherein the central waist portion is configured to engage with an external anchoring device.

28. The device of claim 19, wherein the inflow edges of the plurality of leaflets extends axially beyond the inflow region of the frame structure.

29. The device of claim 19, wherein the plurality of leaflet tabs are not circumferentially attached to the frame around the entirety of the inflow region.

30. The device of claim 19, wherein the plurality of leaflets is not rigidly supported by the frame structure in the inflow region.

31. The device of claim 19, further comprising an exterior skirt coupled to an exterior of the frame structure.

32. The device of claim 31, wherein the exterior skirt comprises a first portion disposed along the inflow region and a second portion disposed along the outflow region.

33. The device of claim 32, wherein the first portion comprises a first material and the second portion comprises a second material.

34. The device of claim 32, wherein the first portion is disposed along the inflow region and at least a portion of the central waist portion.

35. The device of claim 33, wherein the second material is less abrasive than the first material.

36. The device of claim 33, wherein the first material comprises a polyethylene terephthalate (PET) weave material and the second material comprises a PET knit material.

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