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WO2025106770A1 - Prosthetic valve frame - Google Patents

Prosthetic valve frame
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Publication number
WO2025106770A1
WO2025106770A1PCT/US2024/056061US2024056061WWO2025106770A1WO 2025106770 A1WO2025106770 A1WO 2025106770A1US 2024056061 WUS2024056061 WUS 2024056061WWO 2025106770 A1WO2025106770 A1WO 2025106770A1
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Prior art keywords
struts
edges
examples
subset
frame
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PCT/US2024/056061
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French (fr)
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David Maimon
Michael BUKIN
Brendan Michael DALBOW
Swanand D. SARDESAI
Daniel Kim
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Edwards Lifesciences Corp
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Edwards Lifesciences Corp
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Abstract

A prosthetic valve can include a radially compressible and expandable frame comprising a longitudinal axis and a plurality of struts forming a plurality of cells. The plurality of struts can include a plurality of axially extending struts and a plurality of angled struts. The plurality of axially extending struts can include a subset of axially extending struts. Each one of the subset of axially extending struts can include a commissure window and one or more blunted edges.

Description

PROSTHETIC VALVE FRAME
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/701,979, filed on October 1, 2024, and U.S. Provisional Patent Application No. 63/599,631, filed on November 16, 2023, each of which is incorporated by reference herein in its entirety.
FIELD
[0002] The present disclosure relates to expandable prosthetic heart valves, including frames for prosthetic heart valves.
BACKGROUND
[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can selfexpand to its functional size.
SUMMARY
[0004] Frames of prosthetic heart valves are typically laser cut from tubes in a manner that forms struts having a quadrangular (for example, rectangular or trapezoidal) cross-sectional shape with relatively sharp edges. When leaflets of the prosthetic heart valve transition to an open state during working cycles (such as during systole), they hit against the frame and may degrade over time due to ongoing contact against the edges of the struts. While the frames are conventionally electro-polished after cutting to smoothen the edges, the electropolishing is very mild, such that leaflets can be still damaged when hitting against the struts in a manner that can affect their long-term durability.
[0005] Another risk associated with the leaflets relates to the risk of leaflet material being caught and pinched between adjacent vertical struts during crimping. In some cases, when a valve is crimped, relative movement between inner comers of adjacent rectangularly-shaped vertical stmts can pinch portions of the leaflets extending outwardly therebetween, which can compromise the integrity of the leaflet tissue. In some cases, when the valve is deployed using an inflatable balloon, portions of the leaflets can be pinched between the balloon and the frame.
[0006] In some examples, a frame having stmts with chamfered or rounded edges can prevent or minimize the above described risks. For example, one or more axial stmts, one or more commissure window stmts, one or more angled stmts, or any combination thereof can be chamfered or rounded. Additionally or alternatively, one or more junctions at which the stmts meet can be chamfered or rounded.
[0007] In some examples, a prosthetic valve is provided, the prosthetic valve comprising a frame having a longitudinal axis. In some examples, the frame comprises a plurality of stmts forming a plurality of cells, wherein the stmts comprise: a plurality of axially extending stmts; and a plurality of angled stmts.
[0008] In some examples, each of a first subset of the stmts has a chamfered surface at one or more edges thereof. In some examples, the first subset of the stmts comprises one or more of the axially extending stmts. In some examples, each of a second subset of the stmts does not have a chamfered surface at any edges thereof.
[0009] In some examples, for each of the first subset of stmts, the respective stmt does not have chamfered surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0010] In some examples, each of a first subset of the stmts has a rounded surface at one or more edges thereof. In some examples, the first subset of the stmts comprises one or more of the axially extending stmts. In some examples, each of a second subset of the stmts does not have a rounded surface at any edges thereof. [0011] In some examples, for each of the first subset of struts, the respective strut does not have rounded surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0012] In some examples, each of a first subset of the struts has a blunted surface at one or more edges thereof. In some examples, the first subset of the struts comprises one or more of the axially extending struts. In some examples, each of a second subset of the struts does not have a blunted surface at any edges thereof.
[0013] In some examples, for each of the first subset of struts, the respective strut does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0014] In some examples, a prosthetic valve is provided, the prosthetic valve comprising a frame having a longitudinal axis. In some examples, the frame comprises a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts, each having a trapezoid shaped cross section; and a plurality of angled struts.
[0015] In some examples, each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0016] In some examples, each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0017] In some examples, the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame
[0018] In some examples, the prosthetic valve further comprises a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0019] In some examples, a prosthetic valve is provided, the prosthetic valve comprising a frame having a longitudinal axis. In some examples, the frame comprises a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts. In some examples, the frame further comprises a plurality of inflow apices at an inflow end of the frame.
[0020] In some examples, each of the apices have a chamfered surface at a first portion thereof. In some examples, for each of the apices, the first portion faces away from the longitudinal axis of the frame.
[0021] In some examples, for each of the apices, the respective apex consists essentially of the first portion and a second portion, wherein the second portion does not have a chamfered surface.
[0022] In some examples, a prosthetic valve is provided, the prosthetic valve comprising a frame having a longitudinal axis. In some examples, the frame comprises a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts. In some examples, the frame further comprises a plurality of inflow apices at an inflow end of the frame.
[0023] In some examples, each of the apices have a rounded surface at a first portion thereof. In some examples, for each of the apices, the first portion faces away from the longitudinal axis of the frame.
[0024] In some examples, for each of the apices, the respective apex consists essentially of the first portion and a second portion, wherein the second portion does not have a rounded surface.
[0025] In some examples, a prosthetic valve is provided, the prosthetic valve comprising a frame having a longitudinal axis. In some examples, the frame comprises a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts. In some examples, the frame further comprises a plurality of inflow apices at an inflow end of the frame.
[0026] In some examples, each of the apices have a blunted surface at a first portion thereof. In some examples, for each of the apices, the first portion faces away from the longitudinal axis of the frame.
[0027] In some examples, for each of the apices, the respective apex consists essentially of the first portion and a second portion, wherein the second portion does not have a blunted surface. [0028] In some examples, a method of producing a frame of a prosthetic valve is provided, the frame having a longitudinal axis. In some examples, the method comprises forming a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0029] In some examples, the method further comprises, for each of a first subset of the struts, using a 5-axis laser to form a chamfered surface at one or more edges thereof. In some examples, each of a second subset of the struts does not have a chamfered surface at any edges thereof.
[0030] In some examples, the method further comprises electropolishing a pair of edges of each of the chamfered surfaces to be rounded.
[0031] In some examples, a method of producing a frame of a prosthetic valve is provided, the frame having a longitudinal axis. In some examples, the method comprises forming a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0032] In some examples, the method further comprises, for each of a first subset of the struts, using a 5-axis laser to form a rounded surface at one or more edges thereof. In some examples, each of a second subset of the struts does not have a rounded surface at any edges thereof.
[0033] In some examples, a method of producing a frame of a prosthetic valve is provided, the frame having a longitudinal axis. In some examples, the method comprises forming a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0034] In some examples, the method further comprises, for each of a first subset of the struts, using a 5-axis laser to form a blunted surface at one or more edges thereof. In some examples, each of a second subset of the struts does not have a blunted surface at any edges thereof.
[0035] In some examples, a method of producing a frame of a prosthetic valve is provided. In some examples, the method comprises: forming a plurality of struts, the plurality of struts forming a plurality of cells; and forming a plurality of apices at an inflow end of the frame. In some examples, the struts comprise: a plurality of axially extending struts; and a plurality of angled struts. [0036] In some examples, the method further comprises, for each of the apices, using a 5-axis laser to form a chamfered surface at a portion thereof.
[0037] In some examples, the method further comprises, for each of the apices, using a 5-axis laser to form a rounded surface at a portion thereof.
[0038] In some examples, the method further comprises, for each of the apices, using a 5-axis laser to form a blunted surface at a portion thereof.
[0039] In some examples, a method of producing a frame of a prosthetic valve is provided, the frame having a longitudinal axis. In some examples, the method comprises: using a 5-axis laser to form a plurality of struts, the plurality of struts forming a plurality of cells. In some examples, the struts comprise: a plurality of axially extending struts; and a plurality of angled struts. In some examples, each of the axially extending struts has a trapezoid shaped cross section.
[0040] In some examples, a prosthetic valve can include a radially compressible and expandable frame that includes a longitudinal axis and a plurality of struts forming a plurality of cells. In some examples, the plurality of struts can include a plurality of axially extending struts and a plurality of angled struts. In some examples, the plurality of axially extending struts can include a subset of axially extending commissure struts. In some examples, each one of the subset of axially extending commissure struts can include a commissure window and one or more blunted edges.
[0041] In some examples, each blunted edge can include a projected width in a circumferential direction of the frame.
[0042] In some examples, the projected width of the blunted edge can be less than or equal to 10% of a projected width of a corresponding one of the subset of axially extending commissure struts.
[0043] In some examples, a prosthetic valve can include a frame having a longitudinal axis. The frame can include a plurality of struts forming a plurality of cells. The struts can include a plurality of axially extending struts, each including four edges, and a plurality of angled struts. Each one of a subset of the axially extending struts can include two strut portions defining a commissure window therebetween, and one or more blunted edges on one or more of the two strut portions. [0044] In some examples, a prosthetic valve can include a frame having a longitudinal axis. In some examples, the frame can include a plurality of struts forming a plurality of cells. In some examples, the struts can include a plurality of axially extending struts and a plurality of angled struts. In some examples, the plurality of axially extending struts can include a subset of axially extending commissure struts. In some examples, each commissure strut in the subset of axially extending commissure struts can include an open commissure window and one or more radially inwards facing blunted edges. In some examples, the prosthetic valve can further include a plurality of leaflets secured to the subset of axially extending struts.
[0045] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF THE FIGURES
[0046] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.
[0047] In the Figures:
[0048] Fig. 1A shows a side view of an exemplary prosthetic valve, in accordance with some examples of the disclosure.
[0049] Fig. IB shows a side view of a frame of the prosthetic valve of Fig. 1A.
[0050] Fig. 1C shows a side view of a section of the frame of Fig. 1A. [0051] Figs. 2A - 2C show various cross-sectional shapes of struts of the frame of Fig. IB, in accordance with some examples of the disclosure.
[0052] Fig. 3 A shows a first example of a frame strut of a prosthetic valve having chamfered edges.
[0053] Fig. 3B shows an enlarged view of a portion of the strut of Fig. 3A.
[0054] Fig. 3C shows a second example of a frame strut of a prosthetic valve having chamfered edges.
[0055] Fig. 3D shows an enlarged view of a portion of the strut of Fig. 3C.
[0056] Fig. 3E shows an example of a frame strut of a prosthetic valve having rounded edges.
[0057] Fig. 3F shows an enlarged view of a portion of the strut of Fig. 3E.
[0058] Fig. 4 shows a perspective view of a frame of a prosthetic valve with a plurality of struts having chamfered edges, in accordance with some examples of the disclosure.
[0059] Fig. 5A shows a perspective view of a frame of a prosthetic valve with different shaped struts, in accordance with some examples of the disclosure.
[0060] Fig. 5B shows cross-sectional shapes of the struts of the frame of Fig. 5A.
[0061] Fig. 5C shows a perspective view of the frame of Fig. 5A, comprising struts with chamfered edges, in accordance with some examples of the disclosure.
[0062] Fig. 6A shows a cross-section view of the frame of Fig. IB within a lumen, in accordance with some examples of the disclosure.
[0063] Fig. 6B shows a block view of an example of a frame of a prosthetic valve, where apices thereof have chamfered edges, in accordance with some examples of the disclosure.
[0064] Fig. 6C shows a side view of a section of the frame of Fig. 6B, in accordance with some examples of the disclosure.
[0065] Fig. 6D shows an enlarged view of a portion of the section of the frame of Fig. 6C, in accordance with some examples of the disclosure. [0066] Fig. 6E shows a block view of an example of a frame of a prosthetic valve, where apices thereof have rounded edges, in accordance with some examples of the disclosure.
[0067] Fig. 7 shows a perspective view of an exemplary delivery apparatus carrying an exemplary prosthetic valve.
[0068] FIG. 8A shows a front view of the strut of Fig. 3E.
[0069] FIG. 8B shows a front view of a commissure strut having rounded edges, according to an example.
[0070] FIG. 8C shows a cross-sectional view of the commissure strut of FIG. 8B taken along line 8C-8C.
[0071] Figs. 9A - 9C show various cross-sectional shapes of junctions of the frame of Fig. 1C, in accordance with some examples of the disclosure.
DETAILED DESCRIPTION
[0072] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.
[0073] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
[0074] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.
[0075] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and/or" means "and" or "or", as well as "and" and "or".
[0076] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.
[0077] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.
[0078] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (for example, the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
[0079] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.
[0080] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.
[0081] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.
[0082] As used herein, terms such as "first", "second", and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and/or of forming a second component may be performed prior to a step of performing a first action and/or of forming a first component. [0083] As used herein, the term "substantially" means the listed value and/or property and any value and/or property that is at least 75% of the listed value and/or property. Equivalently, the term "substantially" means the listed value and/or property and any value and/or property that differs from the listed value and/or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.
[0084] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a", "b", "c", etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and/or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and/or characteristics as disclosed herein even when certain such components are not specifically described and/or addressed herein.
[0085] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.
[0086] FIG. 1A shows a prosthetic valve 100, such as a prosthetic heart valve. Any of the prosthetic valves disclosed herein can be adapted to be implanted in various native annuluses of the heart, including the aortic, pulmonary, mitral and tricuspid annuluses of the heart. The disclosed prosthetic valves can also be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure. [0087] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.
[0088] In some examples, the prosthetic heart valve 100 includes a frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.
[0089] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets, as shown in Fig. 1A), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 1 12 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured directly to the frame 102 (for example, by sutures). However, in alternative examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt which is then secured to the frame 102. In some examples, the leaflets 112 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.
[0090] In some examples, the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and/or individually connected to the frame 102. The outer skirt 106 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in Fig. 1A, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts, that can be used with the frame 102 can be found in PCT Publication No. WO 2023/244,6123, which is incorporated by reference herein.
[0091] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1A).
[0092] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, nickel titanium alloy (NiTi), such as nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.
[0093] Suitable plastically-expandable materials that can be used to form the frame 102 include, without limitation, stainless steel, a nickel-based alloy (for example, a cobalt-chromium or a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In particular examples, frame 102 can be made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
[0094] As shown in Fig. IB, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in Fig. IB, the frame 102 can comprise three rows of cells 118 with a first row of cells 120 disposed at the outflow end 110. This is the upper row of cells 120 in the orientation shown in Fig. IB. The first row of cells 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row of cells 120 can have a longer axial length than cells 118 in the remaining rows of cells, which can include a second row of cells 126 and a third row of cells 128, the third row of cells 128 disposed at the inflow end 108 and the second row of cells 126 disposed between the first row of cells 120 and the third row of cells 128.
[0095] In some examples, as shown in Fig. IB, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a nine-cell frame.
[0096] In alternative examples, the frame 102 can comprise more than three rows of cells (for example, four or five) and/or more or less than nine cells per row. In some examples, the cells 118 in the first row of cells 120 may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (the second row of cells 126 and the third row of cells 128).
[0097] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending, angled struts 132; a third row of circumferentially extending, angled struts 134; and a fourth row of circumferentially extending, angled struts 136 at the outflow end 110 of the frame 102. The fourth row of angled struts 136 can be connected to the third row of angled struts 134 by a plurality of axially extending struts 138 (or strut portions) and a plurality of axial (or axially extending) struts 140.
[0098] In some examples, the term "axially extending", as used herein, means extending along an axis 123 that is parallel to the central longitudinal axis 122 of the frame 102. The term "angled", as used herein, means extending in a direction, or along another axis, that is not parallel to the central longitudinal axis 122.
[0099] The axially extending struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (for example, open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114 shown in Fig. 1A). In some examples, the commissure windows 142 and/or the axially extending struts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and/or be secured to a pair of commissure tabs of a pair of adjacent leaflets.
[0100] One or more (for example, two, as shown in Fig. IB) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the struts 138. Since the frame 102 can include fewer cells per row and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and/or coronary access.
[0101] Each axial strut 140 and each strut 138 extends from a location defined by the convergence of the lower ends (for example, ends arranged inward of and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (for example, ends arranged closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 140 and each strut 138 forms an axial side of two adjacent cells of the first row of cells 120. In some examples (not shown), the upper strut junction and/or the lower strut junction can be chamfered, rounded, or otherwise blunted, as further described herein.
[0102] In some examples, as shown in Fig. 1C, each axial strut 140 can have a width 144 that is larger than a width of the angled struts 130, 132, 134, and 136. As used herein, a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). A “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial struts 140 is 50-200%, 75- 150%, or at least 100% larger than (for example, double) the width of the angled struts of the frame 102.
[0103] By providing the axial struts 140 with the width 144 that is greater than the width of other, angled struts of the frame 102, a larger contact area is provided for when the leaflets 112 contact the wider axial struts 140 during systole, thereby distributing the stress and reducing the extent to which the leaflets 112 may fold over the axial struts 140, radially outward through the cells 118. As a result, a long-term durability of the leaflets 112 can be increased.
[0104] Since the cells 118 of the frame 102 can have a relatively large width compared to alternative prosthetic valves that have more than nine cells per row (as introduced above), the wider axial struts 140 can be more easily incorporated into the frame 102, without sacrificing open space for blood flow and/or coronary access.
[0105] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114, as shown in Fig. 1 A. Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the struts 138 forming the commissure window 142. Each strut 138 can be connected at an end portion (for example, at an inflow end portion) to two corresponding angled struts 134, wherein the strut 138 and the angled struts 134 are connected at a corresponding junction 151.
[0106] The cusp edge portion (for example, scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102 (for example, angled struts 130, 132, and 134). For example, the cusp edge portions of the leaflets 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112.
[0107] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.
[0108] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication No. WO 2023/086548, and U.S. Provisional Patent Application No. 63/300,302, filed January 18, 2022, both of which are incorporated by reference herein.
[0109] As shown in Fig. IB, in some examples, one or more of or each of the axial struts 140 can comprise an inflow end portion 146 (for example, an end portion that is closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 of the axial strut 140. In some instances, the inflow end portion 146 of the axial strut 140 can comprise an aperture 147. The apertures 147 can be configured to receive fasteners (for example, sutures) for attaching soft components of the prosthetic heart valve 100 to the frame 102. For example, in some instances, the outer skirt 106 can be positioned around the outer surface of the frame 102 and an upper or outflow edge portion of the outer skirt 106 can be secured to the apertures 147 by fasteners 149 (for example, sutures), as shown in Fig. 1 A. Each axial strut 140 can be connected at its inflow end portion 146 to the corresponding end portions of two angled struts 134 at a corresponding junction 151.
[0110] The interconnected struts 116 can also comprise horizontal struts 182 that extend between adjacent cells 118 of a row of cells of the frame 102, as shown in Fig. IB. The horizontal struts 182 can extend in a circumferential direction and also be referred to as circumferentially extending struts 182. The horizontal struts 182 can connect angled struts of two adjacent rows of angled struts of the frame 102 to one another. For example, each horizontal strut 182 can connect to two angled struts of one row of struts (for example, struts 134 shown in Fig. IB) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in Fig. IB). As a result, an angled strut 184 extending between an axially extending strut 138 and the horizontal strut 182 and an angled strut 186 extending between the horizontal strut 182 and another horizontal strut 182 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 102). Thus, the horizontal struts 182 can allow the angled struts to follow a shape that more closely matches a shape of the scallop line of the leaflets when the frame 102 is in the radially expanded configuration. Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.
[0111] The frame 102 can further comprise a plurality of apex regions 152 formed at the outflow end 110 and a plurality of apex regions 153 formed at the inflow end 108, each apex region 152 and 153 extending and forming a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 and 153 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.
[0112] Each outflow apex region 152 can comprise an outflow apex 154 (the highest or most outward extending, in an axial direction, point) and two thinned strut portions 156 (as shown in Fig. 1C), one thinned strut portion 156 extending from either side of the outflow apex 154 to a corresponding angled strut 136 (at the outflow end 110). Each inflow apex region 153 can comprise an inflow apex 155 (the highest or most outward extending, in an axial direction, point) and two thinned strut portions 156 (as shown in Fig. 1C), one thinned strut portion 156 extending from either side of the inflow apex 155 to a corresponding angled strut 130 (at the inflow end 108). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding outflow apex region 152 and each of the apex regions 153 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding inflow apex region 153.
[0113] The thinned strut portions 156 of the apex regions 152 and 153 can have a width 158 that is smaller than a width 160 of the angled struts 130 or 136 (as shown in Fig. 1C). In some examples, the width 158 can be a uniform width (for example, along an entire length of the strut portion 156). In some examples, the width 158 of the thinned strut portions 156 can be from about 0.06 - 0.15 mm smaller than the width 160 of the angled struts 130 and/or 136.
[0114] The thinned strut portions 156 of the apex regions 152 and 153 can have a first length 162 (as shown in Fig. 1C). In some examples, the first length 162 is in a range of 0.8-1.4 mm, 0.9- 1.2 mm, 0.95-1.05 mm, or about 1.0 mm (for example, ±0.03 mm). In alternative examples, the first length 162 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (for example, ±0.03 mm).
[0115] Thus, each outflow apex region 152 can include two thinned strut portions 156 having the first length 162, each extending from the outflow apex 154, outward relative to a central longitudinal axis 164 of the cells 118. Thus, a total length of the outflow apex region 152 can be two times the first length 162.
[0116] Each outflow apex region 152 and two corresponding angled struts 136 at the outflow end 110 can form an outflow strut 166 and each inflow apex region 153 and two corresponding angled struts 130 at the inflow end 108 can form an inflow strut 168.
[0117] Each outflow strut 166 and inflow strut 168 can have a length that includes an apex region 152 or 153 and the two angled struts 136 or 130 (or strut portions), respectively, on either side of the apex region 152 or 153. One half the total length of each outflow strut 166 and inflow strut 168 is shown in Fig. 1C as length 170, which extends from an end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and inflow strut 168 is two times length 170. In some examples, the length 170 for half of each inflow strut 168 can be different than the length 170 for half of each outflow strut 166.
[0118] In some instances, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. Said another way, the length of each outflow apex region 152 (in other words, a total length being two times the first length 162) can be at least 25% of the total length (two times length 170) of the outflow strut 166 or inflow strut 168. In some examples, the length of each apex region 152 or 153 can be more than 25% of the total length of the corresponding outflow strut 166 or inflow strut 168, such as 25-35%.
[0119] In some examples, each apex region 152 or 153 can comprise a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner depression 174 which forms the thinned strut portions 156. For example, the curved inner depression 174 can depress toward the curved outer surface 172 from an inner surface of the angled strut portions 156, thereby forming the smaller width thinned strut portions 156. Thus, the curved inner depressions 174 can be formed on a cell side of the outflow apex region 152 of 153 (for example, as opposed to the outside of the apex region 152 or 153).
[0120] In some examples, the curved outer surface 172 of each apex region 152 or 153 can form a single, continuous curve from one angled strut portion 156 on a first side of the apex region 152 or 153 to another angled strut portion 156 on an opposite, second side of the apex region 152 or 153 (for example, the curved outer surface 172 can have a constant curvature).
[0121] Each apex region 152 or 153 can have a radius of curvature 176, along the curved outer surface 172 (for example, in some instances, along an entirety or an entire length of the curved outer surface 172) (as shown in Fig. 1C). In some instances, the radius of curvature 176 at the apex 154 or 155 and/or along the entire curved outer surface 172 of the apex region 152 or 153 can be greater than 1 mm. In some instances, the radius of curvature 176 can be in a range of 1-20 mm, 3-16 mm, or 8-14 mm. In some instances, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can be dependent on (and thus change due to changes in) the width 158 (for example, the amount of reduction in width from the angled struts 130 or 136) and the first length 162 of the thinned strut portions 156. [0122] Further, a height (an axial height) 178 of the apex regions 152 and 153, which can be defined in the axial direction from an outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 or 153 at the apex 414, can be the width 158 of the thinned strut portions 156 (as shown in Fig. 1C). In this way, the height 178 of the apex regions 152 and 153 can be relatively small and not add much to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 secured to the frame 102 (as shown in Fig. 1A) can be disposed close to the inflow end 108, thereby leaving a larger open space at the outflow end 1 10 of the frame 102 that is not blocked by the leaflets 1 12.
[0123] In some examples, each of the apex region 152 and 153 can form an angle 180 between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152 or 153 (as shown in Fig. 1C). In some instances, the angle 180 can be in a range of 120 (not inclusive) to 140 degrees (for example, such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees).
[0124] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO 2022/226147, which is incorporated by reference herein.
[0125] It is noted that the above descriptions of the frame 102 and the prosthetic valve 100 are for illustrative purposes only, and is not meant to be limiting. Other configurations of prosthetic valves and frames thereof may be used, without exceeding the scope of the disclosure.
[0126] As shown in Figs. 1A - 1C, each strut 116 has a plurality of edges 190. When leaflets 112 transition to an open state during working cycles (such as during systole), as shown in Fig. 1A, they hit against the frame 102 and may degrade over time due to ongoing contact against the edges 190 of the struts 116, and particularly the edges 190 of axial struts 140.
[0127] Although axially extending struts 138 are described herein as comprising commissure windows 142, with commissure tabs 114 extending therethrough, this is not meant to be limiting in any way. In some examples, axially extending struts 138 can comprise any appropriate means for securing the leaflets 112 thereto. In some examples, the axially extending struts 138 are in all respects similar to the axially extending struts 140, and the leaflets 112 are secured thereto by external means. [0128] Figs. 2A - 2C show various options of cross-sectional shapes of struts 116. In some examples, struts 116 can be: trapezoid shaped, with a narrow base 192 of the trapezoid facing inwards (as shown in Fig. 2A); trapezoid shaped, with a wide base 194 of the trapezoid facing outwards (as shown in Fig. 2B); or rectangular shaped (as shown in Fig. 2C). The term "inwards", as used herein, means towards central longitudinal axis 122. The term "outwards", as used herein, means away from central longitudinal axis 122.
[0129] In some examples, as shown in Fig. 2C, the edges 190 of the struts 116 can be slightly rounded due to electropolishing. The degree of curvature of the rounded edge 190 can be defined as angle a. In some examples, a projected width of the rounded portion of the edge 190 (defined as the portion of the width of length of the strut 116 that consists of the rounded surface) is denoted projected width 196.
[0130] Although Figs. 2A - 2C show examples of struts 116 being trapezoid shaped or rectangular shaped, this is not meant to be limiting in any way, and other shapes may be provided.
[0131] Fig. 3A shows a strut 200 of a frame of a prosthetic valve, the strut 200 having a plurality of edges 210 connecting a plurality of sides 220. Fig. 3B shows an enlarged view of a portion of the strut 200, at a particular cross-section thereof.
[0132] In some examples, as will be described below, strut 200 can be used in the frame 102 of the prosthetic heart valve 100 instead of one or more of the: axial struts 140; axial struts 138; and/or angled struts, such as angled struts 130, 132, 134 and 136 116. Although the strut 200 is illustrated as being similar to the axial struts 140, with the exception of the chamfered edges (as will be described below), this is not meant to be limiting in any way. Although the strut 200 is illustrated as having an aperture 147, as described above in relation to the frame 102, this is not meant to be limiting in any way, and the strut 200 can be provided without an aperture 147.
[0133] In some examples, as described above in relation to the axial struts 140, the strut 200 extends from an inflow end portion 146 to an outflow end portion 148.
[0134] In some examples, one or more of the edges 210 of the strut 200 can be chamfered, thus having a chamfered surface 230. In some examples, each chamfered surface 230 defines an angled surface between two of the sides 220. The chamfered surface 230 can have a first obtuse angle Pi with the first of the two sides 220 and a second obtuse angle 2 with the second of the two sides 220. In some examples, angles Pi and 2 are generally equal to each other. In some examples, each of the first and second obtuse angles Pi and P2 is about 30 - 60 degrees. In some examples, each of the first and second obtuse angles Pi and 2 is about 45 degrees.
[0135] In some examples, each chamfered surface 230 can have a projected width 232 (defined as the portion of the width 202 of the strut 202 that consists of the chamfered surface 230) that is at least 20% of the width 202 of the strut 200. In some examples, the projected width 232 of each chamfered surface 230 is at least 20% of the thickness 204 of the strut 200. In some examples, the thickness 204 of the strut 200 is defined as the distance, in the radial direction, between the side 220 facing inwards and the side 220 facing outwards 220, and the width 202 of the strut 200 is defined as the distance, in the circumferential direction, between the other pair of opposing sides 220. In some examples, where a pair of opposing sides 220 are not parallel, the width/thickness is defined as the longest distance between the opposing sides 220. In some examples, the projected width 232 is significantly greater than a projected width of a rounded edge formed by electropolishing, as described above in relation to projected width 196. In some examples, the chamfered surface 230 can extend to meet a corresponding chamfered surface of a corresponding angled strut 134 connected to the strut 200, thereby resulting in a continuous chamfered surface along the inside of the frame.
[0136] In some examples, as shown in Figs. 3A and 3B, not all of the edges 210 have a chamfered surface. In some examples, the inwards facing edges 210 have a chamfered surface 230 while the outwards facing edges 210 do not have a chamfered surface 230. The term "inwards facing edges", as used herein, means the edges 210 of the side 220 facing inwards. The term "outwards facing edges", as used herein, means the edges 210 of the side 220 facing outwards.
[0137] In some examples, the chamfered surface 230 is formed by cutting the strut 200 with a 5-axis laser at the respective edges 210. A 5-axis laser is a laser that can roll and pitch about respective axes, in addition to being moved along the cartesian X, Y and Z axes. Typically, frames of prosthetic valves are cut from a sheet of material using a 3-axis laser (that only allows movement along the cartesian axes). In some examples, using a 5-axis laser allows for cutting additional surfaces with various angles and/or curvatures, including small surfaces on the edges 210 of the struts 200. [0138] In some examples, the struts 200 themselves are formed by cutting material with a 5- axis laser. In some examples, the chamfered surface 230 is formed by sandblasting the respective edges 210 of the strut 200. In some examples, the sandblasting comprises utilizing an appropriately sized nozzle aimed at the respective edges 210, such as with a micro-abrasive blasting system. In some examples, the strut 200 is formed by die pressing within a die having corresponding chamfered surfaces. In some examples, the strut 200 is formed within a mold having corresponding chamfered surfaces.
[0139] Fig. 3C shows a strut 250 of a frame of a prosthetic valve. Fig. 3D shows an enlarged view of a portion of the strut 250, at a particular cross-section thereof.
[0140] In some examples, as shown in Figs. 3C and 3D, the strut 250 is in all respects similar to the strut 200 described in relation to Figs. 3 A - 3B, with the exception that the edges 234 of each chamfered surface 230 are rounded. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of each rounded edge 234 is at least 20% of the width of the chamfered surface 230.
[0141] In some examples, the degree of curvature of each of the edges 234, denoted respectively as 71 and 72, is generally equal to the degree of curvature a described above in relation to rounded edges 190 of struts 116. In some examples, the degree of curvature of each of the edges 234, denoted respectively as 71 and 72, is generally equal to the degree of curvature a described above in relation to rounded edges 190 of struts 116. In some examples, the degrees of curvature 71 and 72 are greater than the degree of curvature a described above in relation to rounded edges 190 of struts 116. In some examples, the degrees of curvature 71 and 72 are generally equal to each other.
[0142] In some examples, the edges 234 of the chamfered surfaces 230 are rounded using electropolishing. In some examples, the edges 234 of the chamfered surfaces 230 are rounded with a 5-axis laser. In some examples, the edges 234 of the chamfered surfaces 230 are rounded by sandblasting the respective edges 234. In some examples, the edges 234 of the chamfered surfaces 230 are rounded by die pressing within a die having corresponding chamfered surfaces with rounded edges. In some examples, the strut 200 is formed within a mold having corresponding chamfered surfaces with rounded edges.
[0143] Although the edges 234 of the chamfered surfaces 230 are described above as being rounded, this is not meant to be limiting in any way, and the edges 234 can have any blunt shape without exceeding the scope of the disclosure. In some examples, a "blunt shape" is defined as any shape that does not have a pointed shaped apex. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of each blunt edge 234 is at least 20% of the width of the chamfered surface 230.
[0144] In some examples, the edges 234 of the chamfered surfaces 230 are blunted using electropolishing. In some examples, the edges 234 of the chamfered surfaces 230 are blunted with a 5-axis laser. In some examples, the edges 234 of the chamfered surfaces 230 are blunted by sandblasting the respective edges 234. In some examples, the edges 234 of the chamfered surfaces 230 are blunted by die pressing within a die having corresponding chamfered surfaces with blunted edges. In some examples, the strut 200 is formed within a mold having corresponding chamfered surfaces with blunted edges.
[0145] Although the above has been described in relation to struts 200 and 250 comprising edges 210 with chamfered surfaces 230, this is not meant to be limiting in any way. Fig. 3E shows a strut 260 of a frame of a prosthetic valve. Fig. 3F shows an enlarged view of a portion of the strut 260, at a particular cross-section thereof. FIG. 8A shows a front view of the strut 260.
[0146] In some examples, as shown in Figs. 3E, 3F, and 8A, the strut 260 is in all respects similar to the strut 200 described in relation to Figs. 3A - 3B, with the exception that each chamfered surface 230 is replaced with a rounded surface 270. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of the rounded surface 270 is at least 20% of the width of the strut 260. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of the rounded surface 270 is at least 20% of the thickness of the strut 260. In some examples, the rounded surface 270 can extend to meet a corresponding rounded surface of a corresponding angled strut 134 connected to the strut 200, thereby resulting in a continuous rounded surface along the inside of the frame.
[0147] In some examples, the degree of curvature of each rounded surface 270, denoted 5, is significantly greater than the degree of curvature a described above in relation to rounded edges 190 of struts 116.
[0148] In some examples (not shown), the chamfered surfaces of struts 200 and 250 are each replaced with a rounded surface. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of each rounded surface is at least 20% of the distance between the sides 220 of either pair of opposing sides 220.
[0149] In some examples, the respective edges 210 are rounded with a 5-axis laser. In some examples, the respective edges 210 are rounded by sandblasting the respective edges 210. In some examples, the respective edges 210 are rounded by die pressing within a die having corresponding rounded edges. In some examples, the strut 200 is formed within a mold having corresponding rounded edges.
[0150] In some examples (not shown), the chamfered surfaces of struts 200 and 250 are each one non-limiting example of a blunt shaped surface. In some examples, as described above in relation to the projected width 232 of the chamfered surface 230, the projected width of each blunt shaped surface is at least 20% of the distance between the sides 220 of either pair of opposing sides 220.
[0151] In some examples, the respective edges 210 are blunted with a 5-axis laser. In some examples, the respective edges 210 are blunted by sandblasting the respective edges 210. In some examples, the respective edges 210 are blunted by die pressing within a die having corresponding blunted edges. In some examples, the strut 200 is formed within a mold having corresponding blunted edges.
[0152] Fig. 4 shows a frame 300 of a prosthetic valve. In some examples, the frame 300 is in all respects similar to the frame 102 described above, with the exception that the axial struts 140 are replaced with struts 200. Although frame 300 is shown as comprising 3 axially extending struts 200 between each pair of axially extending struts 138, this is not meant to be limiting in any way, and the frame 300 can comprise any number of axially extending struts 200, without exceeding the scope of the disclosure. Additionally, frame 300 is shown as comprising three rows of cells 118, however this is not meant to be limiting in any way, and the frame 300 can comprise any number of rows of cells 118, without exceeding the scope of the disclosure.
[0153] Thus, in some examples, a first subset of the axially extending struts (for example, struts 200) have chamfered surfaces at one or more of the edges thereof, and a second subset of the axially extending struts (for example, struts 138) do not have chamfered surfaces at one or more of the edges thereof. [0154] In some examples, the chamfered surfaces 230 of the axially extending struts 200 prevent leaflets from constantly contacting sharp edges, thereby reducing the degradation of the leaflets over time.
[0155] As described above, in some examples only the inwards facing edges 210 have chamfered surfaces. In some examples, the inwards facing edges 210 are those that are in contact with the leaflets, therefore the chamfered surfaces can be more effective on these edges, and manufacturing costs can be reduced by not having to form chamfered surfaces on all of the edges.
[0156] Although the frame 300 is shown as comprising axially extending struts 200 (having edges with chamfered surfaces) and not comprising axially extending struts 140 (having edges without chamfered surfaces), this is not meant to be limiting in any way. In some examples, some of the axially extending struts are provided with chamfered surfaces at the edges thereof (for example, struts 200) and some of the axially extending struts are provided without chamfered surfaces at the edges thereof (for example, struts 140).
[0157] In some examples, only the axially extending struts 200 are provided with edges 210 having chamfered surfaces. In some examples, similar to the example shown in FIG. 8B, alternatively or additionally, one or more axially extending struts 138 are provided with chamfered surfaces at one or more of the edges thereof, similar to the struts 200. In some examples, chamfered surfaces on the edges of axially extending struts 138 can protect commissures of the leaflets from degradation. As described above in relation to struts 200, in some examples only the inwards facing edges 210 of the axially extending struts 138 have chamfered surfaces.
[0158] In some examples, both the inwards facing edges 210 and the outwards facing edges 210 of the axially extending struts 138 have chamfered surfaces. In some examples, this can protect commissures of the leaflets that may extend around at least a majority of the thickness of the axially extending struts 138. In some examples, both the inwards facing edges 210 and the outwards facing edges 210 of the axially extending struts 138 have chamfered surfaces while only the inwards facing edges 210 of the axially extending struts 200 have chamfered surfaces.
[0159] In some examples (not shown), alternatively or additionally, one or more of the angled struts (for example, one or more of angled struts 130, 132, 134 and 136) of the frame 300 are provided with chamfered surfaces at the edges thereof, similar to the struts 200. As described above in relation to struts 200, in some examples only the inwards facing edges of the angled struts have chamfered surfaces. In some examples, angled struts 134 are provided with chamfered surfaces at one or more edges 210 thereof. Thus, in some examples, the angled struts that may come in contact with the leaflets have chamfered edges. In some examples, other angled struts (for example, angled struts 130 and/or 132) do not have chamfered surfaces at the angles thereof. In some examples, this can reduce manufacturing costs since the leaflets do not come into contact with all of the struts. In some examples, a frame of a prosthetic heart valve can include a combination of angled struts with chamfered surfaces at the edges thereof, axial struts with chamfered surfaces at the edges thereof, and commissure struts with chamfered surfaces at the edges thereof. In some of these examples, one or more junctions at which the angled struts connect to the axial struts or commissure struts can include chamfered surfaces at the edges thereof.
[0160] In some examples (not shown), one or more of the axially extending struts 200 of the frame are replaced with struts 250, such that one or more of the axially extending struts comprise edges having chamfered surfaces with rounded, or blunted, edges. As described above, in some examples only the inwards facing edges of the axially extending struts 250 have chamfered surfaces.
[0161] In some examples (not shown), alternatively or additionally, one or more axially extending struts 138 are provided with chamfered surfaces at one or more of the edges thereof, the chamfered surfaces having rounded, or blunted, edges (similar to the struts 250). As described above in relation to struts 200, in some examples only the inwards facing edges of the axially extending struts 138 have chamfered surfaces.
[0162] In some examples (not shown), alternatively or additionally, one or more of the angled struts are provided with chamfered surfaces at one or more of the edges thereof, the chamfered surfaces having rounded, or blunted, edges (similar to the struts 250). As described above in relation to struts 200, in some examples only the inwards facing edges of the angled struts have chamfered surfaces.
[0163] In some examples (not shown), one or more of the axially extending struts 200 of the frame are replaced with struts 260, such that one or more of the axially extending struts comprise edges having rounded surfaces. As described above, in some examples only the inwards facing edges of the axially extending struts 260 have rounded surfaces.
[0164] In some examples (not shown), alternatively or additionally, one or more axially extending struts 138 are provided with rounded surfaces at one or more of the edges thereof (similar to the struts 260). As described above in relation to struts 200, in some examples only the inwards facing edges of the axially extending struts 138 have rounded surfaces.
[0165] In some examples, as described above, the axially extending struts 200 have blunted edges. In some examples, as described above, only the inwards facing edges of the axially extending struts 200 have blunted edges.
[0166] In some examples, alternatively or additionally, one or more axially extending struts 138 are provided with blunted edges, similar to the struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges of the axially extending struts 138 have rounded, or blunted, edges.
[0167] In some examples, alternatively or additionally, one or more of the angled struts of the frame 300 are provided with rounded, or blunted, edges, similar to the struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges of the angled struts have rounded, or blunted, edges.
[0168] It is noted that the use of struts 200, 250 and 260 are not limited to the detailed construction of the frame 300 shown in Fig. 4, and described above in relation to Figs. 1A - 1C, and struts 200, 250 and 260 can be utilized in any suitable frame of a prosthetic valve, without exceeding the scope of the disclosure.
[0169] In some cases, when a frame (for example, 102 or 300) is in a crimped position, material of the prosthetic valve (for example, leaflets, skirt material) can get pinched between adjacent axially extending struts (for example, struts 140, 200, 250 or 260).
[0170] Fig. 5A shows a frame 400 of a prosthetic valve. In some examples, the frame 400 is in all respects similar to the frame 102 described above, with the exception that the axial struts 140 are replaced with a plurality of axially extending struts 410 and a plurality of axially extending struts 420. Fig. 5B shows cross-sectional shapes of axially extending struts 410 and 420. [0171] Although frame 400 is shown as comprising 2 axially extending struts 410 and 1 axially extending strut 420 between each pair of axially extending struts 138, this is not meant to be limiting in any way, and the frame 400 can comprise any number of axially extending struts 410 and any number of axially extending struts 420, without exceeding the scope of the disclosure. Additionally, frame 400 is shown as comprising three rows of cells 118, however this is not meant to be limiting in any way, and the frame 400 can comprise any number of rows of cells 118, without exceeding the scope of the disclosure.
[0172] In some examples, each axially extending strut 420 is positioned in between a pair of axially extending struts 410.
[0173] In some examples, each axially extending strut 410 and each axially extending strut 420 are in all respects similar to axially extending struts 140 of the frame 102, and each have a trapezoid shaped cross-section, having a narrow base 192 opposing a wide base 194, as described above in relation to Figs. 2A and 2B.
[0174] In some examples, axially extending struts 420 are in all respects similar to axially extending struts 410, with the exception that the narrow base 192 of each of the axially extending struts 410 faces inwards and the wide base 194 of each of the axially extending struts 420 face inwards. Although the frame 400 is shown in a configuration where each of the axially extending struts 420 is positioned between two of the axially extending struts 410, such that each edge of the axially extending strut 420 advances towards a respective edge of an adjacent axially extending strut 410 when in the crimped position, this is not meant to be limiting in any way. In some examples, each of the axially extending struts 410 is positioned between two of the axially extending struts 420, such that each edge of the axially extending strut 410 advances towards a respective edge of an adjacent axially extending strut 420 when in the crimped position.
[0175] In some examples, axially extending struts 410 and axially extending struts 420 are alternately arranged around a circumference of the frame 400. The term "alternately arranged around a circumference of the frame", as used herein, means that going in a clockwise, or counter-clockwise, direction, each axially extending strut 410 is succeeded by an axially extending strut 420, unless it is succeeded by an axially extending strut 138. Similarly, each axially extending strut 420 is succeeded by an axially extending strut 410, unless it is succeeded by an axially extending strut 138. [0176] In some examples, if two axially extending struts 410 and 420 are present between each pair of axially extending struts 138, one will be an axially extending strut 410 and one will be an axially extending strut 420. If two axially extending struts 410 and one axially extending strut 420 are present between a pair of axially extending struts 138 (as shown in Fig. 5A), each axially extending strut 410 will be next to a respective axially extending strut 138, and the axially extending strut 420 will be between the two axially extending struts 410. If two axially extending struts 420 and one axially extending strut 410 are present between a pair of axially extending struts 138, each axially extending strut 420 will be next to a respective axially extending strut 138, and the axially extending strut 410 will be between the two axially extending struts 420.
[0177] If two axially extending struts 410 and two axially extending struts 420 are present between a pair of axially extending struts 138, the first axially extending strut 410 will be next to the first axially extending strut 138, the first axially extending strut 420 will be next to the first axially extending strut 410, the second axially extending strut 410 will be next to the first axially extending strut 420 and the second axially extending strut 420 will be next to the second axially extending struts 138. In some examples, the same is true for any number of axially extending struts 410 and axially extending struts 138.
[0178] In some examples, when the frame 400 is in a crimped position, the opposing orientations of axially extending struts 410 and axially extending struts 420 can prevent, or reduce the likelihood of, material of the prosthetic valve (for example, leaflets, skirt material) from getting pinched between adjacent struts 410 and 420.
[0179] In some examples (not shown), each axially extending strut 138 similarly has a trapezoid shaped cross-section, and the orientations of the axially extending struts 138, 410 and 420 are alternately arranged such that the narrow base 192 of each trapezoid is between wide bases 194 of the adjacent trapezoids.
[0180] As described above, in some examples each of the axially extending struts 420 is positioned between two of the axially extending struts 410 (as shown in Fig. 4). In some examples, each of the axially extending struts 420 is thus in the center of the space between adjacent axially extending struts 138. In some cases, a mid-portion of a leaflet may move across the greatest radial distance when transitioning to the open state, in which case this portion may have the highest risk of hitting against the strut/s circumferentially aligned therewith. Thus, in some examples, having axially extending strut 420 (which has its wide base 194 facing inwards) in the center of the space between axially extending struts 138 will provide this section of the leaflet with a wider surface to come in contact therewith, which can reduce the degradation of the leaflet.
[0181] In some examples, a 5-axis laser is used to cut a sheet of material to form the frame 400 such that alternately oriented trapezoid shaped struts 410 and 420 are formed. Typically, frames with trapezoid shaped struts are cut using an off-axis laser, and trapezoid shaped struts are all oriented in the same direction. Using an off-axis laser, it can be difficult to form the alternating struts 410 and 420 within a single frame 400. In some examples, using a 5-axis laser allows for different orientations of the trapezoid shapes of the struts 410 and 420 within the frame 400.
[0182] It is noted that the use of struts 410 and 420 are not limited to the detailed construction of the frame 400 shown in Fig. 5A, and described above in relation to Figs. 1A - 1C, and struts 410 and 420 can be utilized in any suitable frame of a prosthetic valve, without exceeding the scope of the disclosure.
[0183] Fig. 5C shows a frame 500 of a prosthetic valve. In some examples, the frame 500 is in all respects similar to the frame 400 described above, with the exception that each of the axially extending struts 410 is replaced with an axially extending strut 510 and each of the axially extending struts 420 is replaced with an axially extending strut 520.
[0184] In some examples, strut 510 is in all respects similar to strut 410, with the exception that one or more edges 210 of the strut 510 have a chamfered surface 230, as described above in relation to struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges 210 of the narrow base 192 have chamfered surfaces 230.
[0185] In some examples, strut 520 is in all respects similar to strut 420, with the exception that one or more edges 210 of the strut 520 have a chamfered surface 230, as described above in relation to struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges 210 of the wide base 194 have chamfered surfaces 230.
[0186] In some examples, only the axially extending struts 510 and 520 are provided with edges 210 having chamfered surfaces. In some examples (not shown), alternatively or additionally, one or more axially extending struts 138 are provided with chamfered surfaces at one or more of the edges thereof, similar to the struts 510 and 520. As described above in relation to struts 200, in some examples only the inwards facing edges of the axially extending struts 138 have chamfered surfaces.
[0187] In some examples (not shown), alternatively or additionally, one or more angled struts of the frame 500 are provided with chamfered surfaces at one or more of the edges thereof, similar to the struts 510 and 520. As described above in relation to struts 200, in some examples only the inwards facing edges of the angled struts of the frame 500 have chamfered surfaces.
[0188] In some examples, strut 510 is in all respects similar to strut 410, with the exception that one or more edges 210 of the strut 510 have a chamfered surface 230 with rounded edges, as described above in relation to struts 250. In some examples, as described above in relation to struts 250, only the inwards facing edges 210 of the narrow base 192 have chamfered surfaces 230.
[0189] In some examples, strut 520 is in all respects similar to strut 420, with the exception that one or more edges 210 of the strut 520 have a chamfered surface 230 with chamfered edges, as described above in relation to struts 250. In some examples, as described above in relation to struts 200, only the inwards facing edges 210 of the wide base 194 have chamfered surfaces 230.
[0190] In some examples, only the axially extending struts 510 and 520 are provided with edges 210 having chamfered surfaces with rounded edges. In some examples (not shown), alternatively or additionally, one or more axially extending struts 138 are provided with chamfered surfaces at one or more of the edges thereof, the chamfered surfaces having rounded edges, similar to the struts 510 and 520. As described above in relation to struts 200, in some examples only the inwards facing edges of the axially extending struts 138 have chamfered surfaces.
[0191] In some examples (not shown), alternatively or additionally, one or more of the angled struts of the frame 500 are provided with chamfered surfaces at one or more of the edges thereof, the chamfered surfaces having rounded edges, similar to the struts 510 and 520. As described above in relation to struts 200, in some examples only the inwards facing edges of the angled struts of the frame 500 have chamfered surfaces.
[0192] In some examples, strut 510 is in all respects similar to strut 410, with the exception that one or more edges 210 of the strut 510 are rounded, or blunted, as described above in relation to struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges 210 of the narrow base 192 have are rounded, or blunted.
[0193] In some examples, strut 520 is in all respects similar to strut 420, with the exception that one or more edges 210 of the strut 520 are rounded, or blunted, as described above in relation to struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges 210 of the wide base 194 are rounded, or blunted.
[0194] In some examples (not shown), alternatively or additionally, one or more of the angled struts of the frame 500 are provided with chamfered surfaces at the edges thereof, similar to the struts 410 and 420. As described above in relation to struts 200, in some examples only the inwards facing edges of the angled struts have chamfered surfaces.
[0195] In some examples, only the axially extending struts 510 and 520 are provided with rounded, or blunted, edges 210. In some examples (not shown), alternatively or additionally, one or more axially extending struts 138 are provided with rounded, or blunted, edges, similar to the struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges of the axially extending struts 138 have rounded, or blunted, edges.
[0196] In some examples (not shown), alternatively or additionally, one or more of the angled struts of the frame 500 are provided with rounded, or blunted, edges, similar to the struts 200. In some examples, as described above in relation to struts 200, only the inwards facing edges of the angled struts have rounded, or blunted, edges.
[0197] It is noted that the use of struts 510 and 520 are not limited to the detailed construction of the frame 500 shown in Fig. 5C, and described above in relation to Figs. 1 A - 1C, and struts 510 and 520 can be utilized in any suitable frame of a prosthetic valve, without exceeding the scope of the disclosure.
[0198] Fig. 6A shows a block view of the frame 102 of Fig. IB within a lumen 600. In Fig. 6A, the frame 102 is shown in a crimped position. In some examples, the lumen 600 is a catheter of delivery shaft of a delivery system through which the frame 102 of the prosthetic valve is advanced, in its crimped configuration, during delivery towards the site of implantation. In some examples, the frame 102 is carried over a catheter 610 of the delivery system, which may also carry thereof an inflatable balloon (not shown) that is configured to expand the frame 102 from the crimped position to the open position upon deployment. [0199] As shown in Fig. 6A, frame 102 can have generally sharp edges 602 at inflow apices 155 of the inflow end 108. Arrow 604 shows the direction of advancement of the frame 102 through the lumen 600. As shown, while advancing the frame 102 through the lumen 600 the edges 602 can hit against the inner wall of the lumen 600, which can result in increased push forces required for advancement of the valve through the lumen 600, and in extreme cases, can damage or puncture the lumen 600.
[0200] Fig. 6B shows a block view of a frame 700, in a crimped position, within the lumen 600. Fig. 6C shows a side view of a section of the frame 700 and Fig. 6D shows an enlarged bottom view of a portion of the section of Fig. 6C.
[0201] In some examples, the frame 700 is in all respects similar to any of frames 102, 300, 400 or 500, with the exception that at least a portion 620 of one or more apices 622 at the inflow end 108 have a chamfered surface 630. In some examples, the portion 620 is an outward facing portion of the respective apex 622. In some examples, as shown in Fig. 6C - 6D, and as described above in relation to chamfered surface 230, a width 632 of chamfered surface 630 is at least 20% of the thickness 633 of the apex 622.
[0202] In some examples, the chamfered surface 630 is formed by cutting the apex 622 with a 5-axis laser at the respective edges 602. In some examples, the apices 622 themselves are formed by cutting material with a 5-axis laser. In some examples, the chamfered surface 630 is formed by sandblasting the respective edge 602 of the apex 622. In some examples, the apex 622 is formed by die pressing within a die having corresponding chamfered surfaces. In some examples, the apex 622 is formed within a mold having corresponding chamfered surfaces.
[0203] In some examples, the chamfered surfaces 630 reduce the friction of the outward facing portion 620 of the apex 622 with the inner wall of the lumen 600 when the frame 700 is advanced therethrough. In some examples, the chamfered surfaces 630 can be provided on an outward facing portion 620 of the apex 622 to further reduce push forces required to advance the valve through the lumen 600. In some examples, the chamfered surfaces 630 can be provided on an inward facing portion 624 of the apex 622 to mitigate the pinching of the leaflets 112 between an inflation balloon and the frame. In some examples, only the outward facing portion 620, only the inward facing portion 624, or both the outward facing portion 620 and the inward facing portion 624 can be chamfered or blunted. In some examples, one or more of the outflow apices (for example, outflow apex 152) can include a chamfered surface 630, which can be formed on the outward facing portion of the outflow apex, the inward facing portion of the outflow apex, or both the outward facing portion and the inward facing portion of the outflow apex.
[0204] It is noted that the chamfered surfaces 630 are not limited to the detailed construction of the apices 622 of frame 700 shown in Fig. 6C, and described above in relation to apices 153 of Figs. 1A - 1C, and the chamfered surfaces 630 can be provided in apices of any suitable frame of a prosthetic valve, without exceeding the scope of the disclosure.
[0205] As described above in relation to struts 260, in some examples the chamfered surfaces 630 are each replaced with a rounded surface. Fig. 6E shows a block view of a frame 710, in a crimped position, within the lumen 600. In some examples, the frame 710 is in all respects similar to frame 700, with the exception that apices 622 are provided with a rounded surface 720. In some examples, as described above in relation to width 632 of the chamfered surface 630, the width 722 of each rounded surface 720 is at least 20% of the thickness 633 of the apex 622.
[0206] In some examples, the rounded surfaces 720 are formed with a 5-axis laser. In some examples, the rounded surfaces 720 are formed by sandblasting the respective portions 620 of apices 622. In some examples, the rounded surfaces 720 are formed by die pressing within a die having corresponding rounded edges. In some examples, the apex 622 is formed within a mold having corresponding rounded edges.
[0207] It is noted that the rounded surfaces 720 are not limited to the detailed construction of the apices 622 shown in Fig. 6C, and described above in relation to apices 153 of Figs. 1A - 1C, and the chamfered surfaces 630 can be provided in apices of any suitable frame of a prosthetic valve, without exceeding the scope of the disclosure.
[0208] In some examples, as described above, the chamfered and rounded surfaces of apices 622 are each one non-limiting example of a blunt shaped surface. In some examples, as described above in relation to width 632 of the chamfered surface 630, and width 722 of the rounded surface 720, the width of each blunt shaped surface is at least 20% of the thickness of the apex 622.
[0209] In some examples, the respective apices 622 are blunted with a 5-axis laser. In some examples, the respective apices 622 are blunted by sandblasting the respective edges 602. In some examples, the respective apices 622 are blunted by die pressing within a die having corresponding blunted edges. In some examples, the apex 622 is formed within a mold having corresponding blunted edges.
[0210] FIGS. 8B and 8C show an axially extending commissure strut 938 of a frame of a prosthetic valve. FIG. 8C is cross-sectional view of the commissure strut of FIG. 8B taken along line 8C-8C, which is shown in FIG. 8B.
[0211] In some examples, the strut 938 can share certain similarities with the strut 138 described in relation to FIGS. 1A-1C, 4, 5A, and 5C. For example, the axially extending commissure strut 938 (which can also be referred to as an axial strut that includes a commissure window) can define a commissure window 942 (for example, an open window). The axially extending commissure strut 938 can be spaced apart from similar axially extending struts in a circumferential direction around the frame. The axially extending commissure strut 938 can be adapted to receive a pair of commissure tabs of a pair of adjacent leaflets (for example, the leaflets 112 shown in FIG. 1 A) arranged into a commissure (for example, the commissure 114 shown in FIG. 1A). In some examples, the commissure window 942 and/or the axially extending commissure strut 938 defining the commissure window 942 can be referred to herein as a “commissure feature’’ or a “commissure support,’’ wherein the commissure feature or support can be configured to receive and/or be secured to a pair of commissure tabs of a pair of adjacent leaflets.
[0212] Each commissure strut 938 comprises two axially extending, circumferentially spaced strut portions 940 defining the commissure window 942 therebetween. The commissure strut portion 940 can comprise a plurality of sides. For example, as shown, each strut portion 940 includes one circumferentially outwards-facing side 910 (in other words, the side facing away from the center of the commissure strut 938) and one circumferentially inwards-facing side 912 (in other words, the side partially defining the perimeter of the commissure window 942). As further shown, each strut portion 940 further includes one radially inwards-facing side 920 (in other words, the side facing the center of the prosthetic heart valve) and one radially outwards-facing side 922 facing the opposite direction as the radially inwards-facing side 920.
[0213] Each pair of adjacent sides forms a corresponding edge of the commissure strut portion 940. As shown, each commissure strut portion 940 includes an edge 970 joining the circumferentially outwards-facing side 910 and the radially outwards-facing side 922, an edge 972 joining the circumferentially inwards-facing side 912 and the radially outwards-facing side 922, an edge 974 joining the circumferentially inwards -facing side 912 and the radially inwards-facing side 920, and an edge 974 joining the circumferentially outwards -facing side 910 and the radially inwards-facing side 920. One or more of the edges 970, 972, 974, 976 can be blunted (for example, rounded or chamfered). As used herein, a “blunted” edge can be defined as any edge that does not have a pointed shaped apex in cross-section, including but not limited to a rounded edge or a chamfered edge.
[0214] Any combination of the edges 970, 972, 974, 976 of any combinations of the strut portions 940 can be blunted. For example, as shown in FIG. 8C, each one of the edges 970, 972, 974, 976 is rounded. However, in some examples, one or more of the circumferentially outwards-facing edges 970, 976 of one or more of the strut portions 940 can be blunted. In some examples, only one of the edges 970, 976 of one or more of the strut portions 940 can be blunted. In some examples, each of the edges 970, 976 of one or more of the strut portions 940 can be blunted. In some of these examples, blunting the circumferentially outwards-facing edges 970, 976 of the strut portions 940 can help mitigate any pinching of the leaflets (for example, the leaflets 112) that may occur as the frame is crimped or expanded. For example, the leaflets can sometimes protrude through cells (for example, the cells 118) that are disposed adjacent the windows 942 when the frame is in the crimped state. When the leaflets protrude through the cells, the leaflets can contact at least one of the circumferentially outwards-facing edges 970, 976 of at least one of the commissure strut portions 940. In some examples, rounding the edges 970, 976 that may come into contact with the leaflets can help further reduce leaflet degradation.
[0215] In some examples, one or more of the circumferentially inwards-facing edges 972, 974 can be blunted. For example, only one of the edges 972, 974 or both of the edges 972, 974 can be blunted. In some examples, blunting the circumferentially inwards-facing edges 972, 974 that may come into contact with the leaflets (for example, the portions of the leaflets adjacent the commissures) can help further reduce leaflet degradation.
[0216] As shown in FIG. 8B, one or more of the blunted edges (for example, edge 976) can have a projected width 932 that is projected in a circumferential direction of the frame. In some examples, the projected width 932 can be less than or equal to approximately 10% (for example, ±10%) of an overall projected width 902 of the commissure strut 938. Any combination of the blunted edges 970, 972, 974, 976 can be less than or equal to approximately 10% of the overall projected width 902.
[0217] In some examples, any of the blunted edges 970, 972, 974, 976 can share certain similarities with or can be the same as the rounded edges 210 shown in FIG. 2C and/or the edges 210 shown in FIGS. 3E-3F and 8 A. For example, any combination of the blunted edges 970, 972, 974, 976 can have the same or similar dimensions (for example, degrees of curvature and/or projected widths 932) as other rounded surfaces disclosed herein.
[0218] In some examples, the edges 970, 972, 974, 976 can be blunted (for example, rounded) using electropolishing. In some examples, the edges 970, 972, 974, 976 can be blunted with a 5-axis laser. In some examples, the edges 970, 972, 974, 976 can be blunted by sandblasting the respective edges 970, 972, 974, 976 . In some examples, the edges 970, 972, 974, 976 can be blunted by die pressing within a die having corresponding blunted surfaces. In some examples, the strut 938 can be formed within a mold having corresponding blunted surfaces.
[0219] Although the edges 970, 972, 974, 976 are illustrated in FIGS. 8B-8C as being rounded, the edges 970, 972, 974, 976 can have other shapes, including any blunt shape. In some examples, a “blunt shape” can be defined as any shape that does not have a pointed shaped apex in a cross-section taken perpendicular to the strut portion 940, including but not limited to a rounded shape or a chamfered shape. For example, any combination of the edges 970, 972, 974, 976 can be chamfered (as shown in FIGS. 3A-3B) or chamfered and rounded (as shown in FIGS. 3C-3D).
[0220] In some examples, a frame can include one or more axial struts with one or more blunted edges (for example, struts 200, 250, 260) and one or more commissure struts with one or more blunted edges (for example, commissure struts 938). In some examples, each axial strut of the frame can include at least one blunted edge and each commissure strut of the frame can include at least one blunted edge. In some of these examples, one or more (for example, each) angled strut of the frame can have one or more blunted edges. Thus, in some of these examples, each strut of the frame can include at least one blunted (for example, chamfered, rounded, or filleted) surface at an edge thereof. In some examples, one or more junctions at which an angled strut meets an axial strut or a commissure strut can include at least one blunted edge. In some examples, blunting one or more edges of a junction can further reduce leaflet pinching during crimping and/or balloon deployment. [0221] Figs. 9A - 9C show various options of cross-sectional shapes of junctions 151 at which the angled struts 134 connect to struts 138 or struts 140 (as shown in FIG. 1C). In some examples, the junctions 151 can be: trapezoid shaped, with a narrow base 192 of the trapezoid facing inwards (as shown in Fig. 9A); trapezoid shaped, with a wide base 194 of the trapezoid facing outwards (as shown in Fig. 9B); or rectangular shaped (as shown in Fig. 9C).
[0222] In some examples, as shown in Fig. 9C, the edges 190 of the junctions 151 can be slightly rounded, for example, due to electropolishing. The degree of curvature of the rounded edge 190 can be defined as angle a. In some examples, a projected width of the rounded portion of the edge 190 (defined as the portion of the width of length of the junction 151 that consists of the rounded surface) is denoted projected width 196. In some examples, blunting (for example, rounding, chamfering, or filleting) the edges 190 of the junctions 151 (for example, the radially inwards-facing edges 190) can help further minimize the pinching of the leaflets 112 between an inflatable balloon (for example, a catheter balloon) and the frame 102. In some examples, the blunted (for example, rounded, chamfered, or filleted) edge 190 of the junction 151 can extend between a blunted edge of an angled strut 134 and a corresponding blunted edge of one of a commissure strut 138 or an axial strut 140 to create a continuously blunted edge, further minimizing the occurrence of sharp edges on the inside of the frame 102.
[0223] Although Figs. 9 A - 9C show examples of junctions 151 being trapezoid shaped or rectangular shaped, this is not meant to be limiting in any way, and other shapes may be provided. In some examples, one or more of the junctions between adjacent cells (for example, junctions between adjacent cells 126 and/or the junctions between adjacent cells 128), such as the horizontal struts 182, can have blunted edges, including any of the rounded, chamfered or fillet edges disclosed herein. In some examples, the cross-sections of FIGS. 9A-9C can represent cross-sections of the horizontal struts 182.
[0224] Fig. 7 shows a perspective view of an exemplary delivery assembly 800 that includes a delivery apparatus 812 adapted to deliver a prosthetic device 830. Prosthetic valve 830 carried by delivery apparatus 812 can be exemplary valve 100 described above with respect to Figs. 1A-1C, or any other prosthetic valve. In some examples, prosthetic valve 830 can comprise any of the frames described herein, including, but not limited to, frames 102, 300, 400, 500, 700 and 710. The delivery apparatus 812 can include a handle 814 and at least one catheter extending therefrom, configured to carry a prosthetic valve 830 in a crimped state through the patient's vasculature. In some examples, delivery apparatus 812 configured to carry a balloon expandable prosthetic valve. The delivery apparatus 812 can comprise a balloon catheter 820 having an inflatable balloon 822 mounted on its distal end. A prosthetic device, such as prosthetic valve 830, can be carried in a crimped state over the balloon catheter 820.
[0225] In some examples, a delivery apparatus 812 further comprises an outer shaft 818. Optionally, an outer shaft 818 of a delivery apparatus 812 can concentrically extend over the balloon catheter 820.
[0226] The outer shaft 818 and the balloon catheter 820 can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 818 relative to the balloon catheter 820, or a distally oriented movement of the balloon catheter 820 relative to the outer shaft 818, can expose the prosthetic valve 830 from the outer shaft 818.
[0227] The delivery apparatus 812 can further include a nosecone 824 to facilitate advancement of the delivery apparatus 812 through the patient's vasculature to the site of treatment. A nosecone shaft (concealed from view in Fig. 7) can extend proximally from the nosecone 824 through a lumen of the balloon catheter 820, towards the handle 814.
[0228] In Fig. 7, a prosthetic valve 830 is mounted on the balloon 822 and is shown in a crimped state, providing prosthetic valve 830 with a reduced diameter for delivery to the heart via the patient's vasculature. While the prosthetic valve 830 is shown in Fig. 7 as being crimped or mounted on the balloon 822 for delivery to the treatment location, it should be understood that the prosthetic valve can be crimped or mounted at a location different from the location of balloon 822 (for example, proximal to the balloon 822) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve. This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 822. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient's vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.
[0229] The proximal ends of the balloon catheter 820, the outer shaft 818, and/or the nosecone shaft, can be coupled to the handle 814. During delivery, the handle 814 can be maneuvered by an operator (for example, a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 812, such as the nosecone shaft, the outer shaft 818, and/or the balloon catheter 820, through the patient's vasculature and/or along the target site of implantation, as well as to inflate the balloon 822 mounted on the balloon catheter 820, for example to expand a prosthetic valve 830 mounted on the balloon 822, and to deflate the balloon 822 and retract the delivery apparatus 812, for example once the prosthetic valve 830 is mounted in the implantation site.
[0230] The handle 814 can include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 812. In the illustrated example, the handle 814 includes an adjustment member, such as the illustrated rotatable knob 816a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle 814 through the outer shaft 818 and has a distal end portion affixed to the outer shaft 818 at or near the distal end of the outer shaft 818. Rotating the knob 816a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 812. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.
[0231] In some examples, the handle 814 can include an adjustment members such as the illustrated rotatable knob 816b, configured to adjust the axial position of the balloon catheter 820 relative to the outer shaft 818, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 812. Further details on the delivery apparatus 812 can be found in PCT Publication No. WO 2022/046585, which is incorporated by reference herein.
[0232] A prosthetic valve 830 can be carried by the delivery apparatus 812 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures). In some examples, the balloon 822 is secured to a distal end portion of the balloon catheter 820 at its proximal end, while the balloon's distal end can be coupled, directly or indirectly, to another component of the delivery apparatus 812, such as the nosecone 824 or nosecone shaft.
[0233] Balloon 822 is configured to transition between a deflated and inflated states. Upon reaching the site of implantation, the balloon 822 can be inflated to radially expand the prosthetic valve 830. Once the prosthetic valve 830 is expanded to its functional diameter within a native annulus, the balloon 822 can be deflated, and the delivery apparatus 812 can be retrieved from the patient's body.
[0234] In some examples, the delivery apparatus 812 with the prosthetic valve 830 assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve and the delivery apparatus, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.
Additional Examples of the Disclosed Technology
[0235] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.
[0236] Example 1. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein each of a first subset of the struts has a chamfered surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the struts does not have a chamfered surface at any edges thereof.
[0237] Example 2. The prosthetic valve of any example herein, particularly example 1, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0238] Example 3. The prosthetic valve of any example herein, particularly any one of examples 1 - 2, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a width of the respective strut. [0239] Example 4. The prosthetic valve of any example herein, particularly any one of examples 1 - 2, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a thickness of the respective strut.
[0240] Example 5. The prosthetic valve of any example herein, particularly any one of examples 1 - 4, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second stmts, the one or more axially extending stmts of the first subset of stmts comprising the plurality of axially extending first stmts, wherein the leaflets are secured to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second stmts.
[0241] Example 6. The prosthetic valve of any example herein, particularly any one of examples 1 - 5, wherein, for each of the first subset of stmts, the respective stmt has a chamfered surface at each of a pair of the edges thereof.
[0242] Example 7. The prosthetic valve of any example herein, particularly example 6, wherein, for each of the first subset of stmts, the pair of edges face the longitudinal axis of the frame.
[0243] Example 8. The prosthetic valve of any example herein, particularly example 7, wherein, for each of the first subset of stmts, the respective stmt does not have chamfered surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0244] Example 9. The prosthetic valve of any example herein, particularly any one of examples 1 - 8, wherein the first subset of the stmts comprises one or more of the angled stmts.
[0245] Example 10. The prosthetic valve of any example herein, particularly example 9, wherein each of the one or more angled stmts of the first subset of stmts extends from a respective one of the axially extending stmts.
[0246] Example 11. The prosthetic valve of any example herein, particularly any one of examples 2 - 8, wherein each of the first subset of stmts has a trapezoid shaped cross section.
[0247] Example 12. The prosthetic valve of any example herein, particularly example 11, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0248] Example 13. The prosthetic valve of any example herein, particularly example 12, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0249] Example 14. The prosthetic valve of any example herein, particularly any one of examples 12 - 13, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0250] Example 15. The prosthetic valve of any example herein, particularly any one of examples 12 - 14, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the chamfered surface comprise edges of the wide base of the trapezoid shape.
[0251] Example 16. The prosthetic valve of any example herein, particularly example 1, wherein each of the first subset of stmts has a trapezoid shaped cross section.
[0252] Example 17. The prosthetic valve of any example herein, particularly example 16, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0253] Example 18. The prosthetic valve of any example herein, particularly example 17, wherein each of the second subset of the trapezoid shaped stmts is positioned between a pair of the first subset of the trapezoid shaped stmts.
[0254] Example 19. The prosthetic valve of any example herein, particularly any one of examples 17 - 18, wherein the trapezoid shaped stmts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame. [0255] Example 20. The prosthetic valve of any example herein, particularly any one of examples 18 - 19, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0256] Example 21. The prosthetic valve of any example herein, particularly any one of examples 17 - 20, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the chamfered surface comprise edges of the wide base of the trapezoid shape.
[0257] Example 22. The prosthetic valve of any example herein, particularly any one of examples 1 - 21, wherein, for each of the chamfered surfaces, a pair of edges thereof are rounded.
[0258] Example 23. The prosthetic valve of any example herein, particularly example 22, wherein, for each of the pair of rounded edges of each of the chamfered surfaces, a width of each rounded edge is at least 20% of a width of the chamfered surface.
[0259] Example 24. The prosthetic valve of any example herein, particularly any one of examples 1 - 21, wherein, for each of the chamfered surfaces, a pair of edges thereof are blunted.
[0260] Example 25. The prosthetic valve of any example herein, particularly example 24, wherein, for each of the pair of blunted edges of each of the chamfered surfaces, a width of each blunted edge is at least 20% of a width of the chamfered surface.
[0261] Example 26. The prosthetic valve of any example herein, particularly any one of examples 1 - 25, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a chamfered surface at a portion thereof.
[0262] Example 27. The prosthetic valve of any example herein, particularly example 26, wherein, for each of the inflow apices, the chamfered surface faces away from the longitudinal axis of the frame. [0263] Example 28. The prosthetic valve of any example herein, particularly example 27, wherein, for each of the inflow apices, a width of the chamfered surface is at least 20% of a thickness of the inflow apex.
[0264] Example 29. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein each of a first subset of the struts has a rounded surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the struts does not have a rounded surface at any edges thereof.
[0265] Example 30. The prosthetic valve of any example herein, particularly example 29, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0266] Example 31. The prosthetic valve of any example herein, particularly any one of examples 29 - 30, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a width of the respective strut.
[0267] Example 32. The prosthetic valve of any example herein, particularly any one of examples 29 - 30, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a thickness of the respective strut.
[0268] Example 33. The prosthetic valve of any example herein, particularly any one of examples 29 - 32, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the leaflets are secured to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second struts.
[0269] Example 34. The prosthetic valve of any example herein, particularly any one of examples 29 - 33, wherein, for each of the first subset of stmts, the respective stmt has a rounded surface at each of a pair of the edges thereof. [0270] Example 35. The prosthetic valve of any example herein, particularly example 34, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0271] Example 36. The prosthetic valve of any example herein, particularly example 35, wherein, for each of the first subset of struts, the respective strut does not have rounded surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0272] Example 37. The prosthetic valve of any example herein, particularly any one of examples 29 - 36, wherein the first subset of the struts comprises one or more of the angled struts.
[0273] Example 38. The prosthetic valve of any example herein, particularly example 37, wherein each of the one or more angled struts of the first subset of struts extends from a respective one of the axially extending struts.
[0274] Example 39. The prosthetic valve of any example herein, particularly any one of examples 30 - 36, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0275] Example 40. The prosthetic valve of any example herein, particularly example 39, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0276] Example 41. The prosthetic valve of any example herein, particularly example 40, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0277] Example 42. The prosthetic valve of any example herein, particularly any one of examples 40 - 41, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0278] Example 43. The prosthetic valve of any example herein, particularly any one of examples 40 - 42, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the wide base of the trapezoid shape.
[0279] Example 44. The prosthetic valve of any example herein, particularly example 29, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0280] Example 45. The prosthetic valve of any example herein, particularly example 44, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0281] Example 46. The prosthetic valve of any example herein, particularly example 45, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0282] Example 47. The prosthetic valve of any example herein, particularly any one of examples 45 - 46, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0283] Example 48. The prosthetic valve of any example herein, particularly any one of examples 46 - 47, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0284] Example 49. The prosthetic valve of any example herein, particularly of any one of examples 45 - 48, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the wide base of the trapezoid shape.
[0285] Example 50. The prosthetic valve of any example herein, particularly any one of examples 29 - 49, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a rounded surface at a portion thereof. [0286] Example 51. The prosthetic valve of any example herein, particularly example 50, wherein, for each of the inflow apices, the rounded surface faces away from the longitudinal axis of the frame.
[0287] Example 52. The prosthetic valve of any example herein, particularly example 51, wherein, for each of the inflow apices, a width of the rounded surface is at least 20% of a thickness of the inflow apex.
[0288] Example 53. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein each of a first subset of the struts has a blunted surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the struts does not have a blunted surface at any edges thereof.
[0289] Example 54. The prosthetic valve of any example herein, particularly example 53, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0290] Example 55. The prosthetic valve of any example herein, particularly any one of examples 53 - 54, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a width of the respective strut.
[0291] Example 56. The prosthetic valve of any example herein, particularly any one of examples 53 - 54, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a thickness of the respective strut.
[0292] Example 57. The prosthetic valve of any example herein, particularly any one of examples 53 - 56, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the leaflets are secured to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second struts. [0293] Example 58. The prosthetic valve of any example herein, particularly any one of examples 53 - 57, wherein, for each of the first subset of struts, the respective strut has a blunted surface at each of a pair of the edges thereof.
[0294] Example 59. The prosthetic valve of any example herein, particularly example 58, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0295] Example 60. The prosthetic valve of any example herein, particularly example 59, wherein, for each of the first subset of struts, the respective strut does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0296] Example 61. The prosthetic valve of any example herein, particularly any one of examples 53 - 60, wherein the first subset of the struts comprises one or more of the angled struts.
[0297] Example 62. The prosthetic valve of any example herein, particularly example 61, wherein each of the one or more angled struts of the first subset of struts extends from a respective one of the axially extending struts.
[0298] Example 63. The prosthetic valve of any example herein, particularly any one of examples 54 - 60, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0299] Example 64. The prosthetic valve of any example herein, particularly example 63, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0300] Example 65. The prosthetic valve of any example herein, particularly example 64, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0301] Example 66. The prosthetic valve of any example herein, particularly any one of examples 64 - 65, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame. [0302] Example 67. The prosthetic valve of any example herein, particularly any one of examples 64 - 66, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the wide base of the trapezoid shape.
[0303] Example 68. The prosthetic valve of any example herein, particularly example 53, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0304] Example 69. The prosthetic valve of any example herein, particularly example 68, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0305] Example 70. The prosthetic valve of any example herein, particularly example 69, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0306] Example 71. The prosthetic valve of any example herein, particularly any one of examples 69 - 70, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0307] Example 72. The prosthetic valve of any example herein, particularly any one of examples 70 - 71, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0308] Example 73. The prosthetic valve of any example herein, particularly any one of examples 69 - 72, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the wide base of the trapezoid shape.
[0309] Example 74. The prosthetic valve of any example herein, particularly any one of examples 53 - 73, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a blunted chamfered surface at a portion thereof.
[0310] Example 75. The prosthetic valve of any example herein, particularly example 74, wherein, for each of the inflow apices, the blunted surface faces away from the longitudinal axis of the frame.
[0311] Example 76. The prosthetic valve of any example herein, particularly example 75, wherein, for each of the inflow apices, a width of the blunted surface is at least 20% of a thickness of the inflow apex.
[0312] Example 77. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts, each having a trapezoid shaped cross section; and a plurality of angled struts, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0313] Example 78. The prosthetic valve of any example herein, particularly example 77, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0314] Example 79. The prosthetic valve of any example herein, particularly example 78, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0315] Example 80. The prosthetic valve of any example herein, particularly any one of examples 77 - 79, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0316] Example 81. The prosthetic valve of any example herein, particularly example 79, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets. [0317] Example 82. The prosthetic valve of any example herein, particularly any one of examples 77 - 81, wherein one of the trapezoid shaped struts has a chamfered surface at one or more edges thereof.
[0318] Example 83. The prosthetic valve of any example herein, particularly example 82, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a width of the respective trapezoid shaped strut.
[0319] Example 84. The prosthetic valve of any example herein, particularly example 82, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a thickness of the respective trapezoid shaped strut.
[0320] Example 85. The prosthetic valve of any example herein, particularly any one of examples 82 - 84, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the chamfered surface comprise edges of the wide base of the trapezoid shape.
[0321] Example 86. The prosthetic valve of any example herein, particularly any one of examples 82 - 85, wherein, for each of the chamfered surfaces, a pair of edges thereof are rounded.
[0322] Example 87. The prosthetic valve of any example herein, particularly example 86, wherein, for each of the pair of rounded edges of each of the chamfered surfaces, a width of each rounded edge is at least 20% of a width of the chamfered surface.
[0323] Example 88. The prosthetic valve of any example herein, particularly any one of examples 82 - 85, wherein, for each of the chamfered surfaces, a pair of edges thereof are blunted.
[0324] Example 89. The prosthetic valve of any example herein, particularly example 88, wherein, for each of the pair of blunted edges of each of the chamfered surfaces, a width of each blunted edge is at least 20% of a width of the chamfered surface. [0325] Example 90. The prosthetic valve of any example herein, particularly any one of examples 77 - 81, wherein one of the trapezoid shaped struts has a rounded surface at one or more edges thereof.
[0326] Example 91. The prosthetic valve of any example herein, particularly example 90, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a width of the respective trapezoid shaped strut.
[0327] Example 92. The prosthetic valve of any example herein, particularly example 90, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a thickness of the respective trapezoid shaped strut.
[0328] Example 93. The prosthetic valve of any example herein, particularly any one of examples 90 - 92, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the rounded surface comprise edges of the wide base of the trapezoid shape.
[0329] Example 94. The prosthetic valve of any example herein, particularly any one of examples 77 - 81, wherein one of the trapezoid shaped stmts has a blunted surface at one or more edges thereof.
[0330] Example 95. The prosthetic valve of any example herein, particularly example 94, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a width of the respective trapezoid shaped stmt.
[0331] Example 96. The prosthetic valve of any example herein, particularly example 94, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a thickness of the respective trapezoid shaped stmt.
[0332] Example 97. The prosthetic valve of any example herein, particularly any one of examples 94 - 96, wherein, for each of the first subset of the trapezoid shaped stmts, the one or more edges having the blunted surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the blunted surface comprise edges of the wide base of the trapezoid shape. [0333] Example 98. The prosthetic valve of any example herein, particularly any one of examples 77 - 97, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a chamfered surface at a portion thereof.
[0334] Example 99. The prosthetic valve of any example herein, particularly example 98, wherein, for each of the inflow apices, the chamfered surface faces away from the longitudinal axis of the frame.
[0335] Example 100. The prosthetic valve of any example herein, particularly example 99, wherein, for each of the inflow apices, a width of the chamfered surface is at least 20% of a thickness of the inflow apex.
[0336] Example 101. The prosthetic valve of any example herein, particularly any one of examples 77 - 97, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a rounded surface at a portion thereof.
[0337] Example 102. The prosthetic valve of any example herein, particularly example 101, wherein, for each of the inflow apices, the rounded surface faces away from the longitudinal axis of the frame.
[0338] Example 103. The prosthetic valve of any example herein, particularly example 102, wherein, for each of the inflow apices, a width of the rounded surface is at least 20% of a thickness of the inflow apex.
[0339] Example 104. The prosthetic valve of any example herein, particularly any one of examples 77 - 97, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a blunted surface at a portion thereof.
[0340] Example 105. The prosthetic valve of any example herein, particularly example 104, wherein, for each of the inflow apices, the blunted surface faces away from the longitudinal axis of the frame.
[0341] Example 106. The prosthetic valve of any example herein, particularly example 105, wherein, for each of the inflow apices, a width of the blunted surface is at least 20% of a thickness of the inflow apex. [0342] Example 107. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the frame further comprises a plurality of inflow apices at an inflow end of the frame, wherein each of the inflow apices has a chamfered surface at a first portion thereof.
[0343] Example 108. The prosthetic valve of any example herein, particularly example 107, wherein, for each of the inflow apices, the first portion faces away from the longitudinal axis of the frame.
[0344] Example 109. The prosthetic valve of any example herein, particularly example 108, wherein, for each of the inflow apices, the respective inflow apex consists essentially of the first portion and a second portion, wherein the second portion does not have a chamfered surface.
[0345] Example 110. The prosthetic valve of any example herein, particularly any one of examples 107 - 109, wherein, for each of the inflow apices, a width of the chamfered surface is at least 20% of a thickness of the inflow apex.
[0346] Example 111. The prosthetic valve of any example herein, particularly any one of examples 107 - 110, wherein each of a first subset of the struts has a chamfered surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, wherein each of a second subset of the struts does not have a chamfered surface at any edges thereof, and wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0347] Example 112. The prosthetic valve of any example herein, particularly example 111, wherein, for each of the chamfered surfaces of the first subset of the struts, a width of the respective chamfered surface is at least 20% of a width of the respective strut.
[0348] Example 113. The prosthetic valve of any example herein, particularly example 111, wherein, for each of the chamfered surfaces of the first subset of the struts, a width of the respective chamfered surface is at least 20% of a thickness of the respective strut.
[0349] Example 114. The prosthetic valve of any example herein, particularly any one of examples 111 - 113, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the leaflets are secured to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second struts.
[0350] Example 115. The prosthetic valve of any example herein, particularly any one of examples 111 - 114, wherein, for each of the first subset of struts, the respective strut has a chamfered surface at each of a pair of the edges thereof.
[0351] Example 116. The prosthetic valve of any example herein, particularly example 115, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0352] Example 117. The prosthetic valve of any example herein, particularly example 116, wherein, for each of the first subset of stmts, the respective stmt does not have chamfered surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0353] Example 118. The prosthetic valve of any example herein, particularly any one of examples 111 - 117, wherein the first subset of the stmts comprises one or more of the angled stmts.
[0354] Example 119. The prosthetic valve of any example herein, particularly example 118, wherein each of the one or more angled stmts of the first subset of stmts extends from a respective one of the axially extending stmts.
[0355] Example 120. The prosthetic valve of any example herein, particularly any one of examples 112 - 117, wherein each of the first subset of stmts has a trapezoid shaped cross section.
[0356] Example 121. The prosthetic valve of any example herein, particularly example 120, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame. [0357] Example 122. The prosthetic valve of any example herein, particularly example 121, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0358] Example 123. The prosthetic valve of any example herein, particularly any one of examples 121 - 122, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0359] Example 124. The prosthetic valve of any example herein, particularly any one of examples 121 - 123, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the wide base of the trapezoid shape.
[0360] Example 125. The prosthetic valve of any example herein, particularly example 111, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0361] Example 126. The prosthetic valve of any example herein, particularly example 125, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0362] Example 127. The prosthetic valve of any example herein, particularly example 126, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0363] Example 128. The prosthetic valve of any example herein, particularly any one of examples 126 - 127, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame. [0364] Example 129. The prosthetic valve of any example herein, particularly any one of examples 127 - 128, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0365] Example 130. The prosthetic valve of any example herein, particularly any one of examples 126 - 129, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the chamfered surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the chamfered surface comprise edges of the wide base of the trapezoid shape.
[0366] Example 131. The prosthetic valve of any example herein, particularly any one of examples 111 - 130, wherein, for each of the chamfered surfaces of the first subset of the stmts, a pair of edges thereof are rounded.
[0367] Example 132. The prosthetic valve of any example herein, particularly example 131, wherein, for each of the pair of rounded edges of each of the chamfered surfaces, a width of each rounded edge is at least 20% of a width of the chamfered surface.
[0368] Example 133. The prosthetic valve of any example herein, particularly any one of examples 111 - 130, wherein, for each of the chamfered surfaces, a pair of edges thereof are blunted.
[0369] Example 134. The prosthetic valve of any example herein, particularly example 133, wherein, for each of the pair of blunted edges of each of the chamfered surfaces, a width of each blunted edge is at least 20% of a width of the chamfered surface.
[0370] Example 135. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of stmts forming a plurality of cells, wherein the stmts comprise: a plurality of axially extending stmts; and a plurality of angled stmts, wherein the frame further comprises a plurality of inflow apices at an inflow end of the frame, wherein each of the inflow apices has a rounded surface at a first portion thereof.
[0371] Example 136. The prosthetic valve of any example herein, particularly example 135, wherein, for each of the inflow apices, the first portion faces away from the longitudinal axis of the frame. [0372] Example 137. The prosthetic valve of any example herein, particularly example 136, wherein, for each of the inflow apices, the respective inflow apex consists essentially of the first portion and a second portion, wherein the second portion does not have a chamfered surface.
[0373] Example 138. The prosthetic valve of any example herein, particularly any one of examples 135 - 137, wherein, for each of the inflow apices, a width of the rounded surface is at least 20% of a thickness of the inflow apex.
[0374] Example 139. The prosthetic valve of any example herein, particularly any one of examples 135 - 138, wherein each of a first subset of the struts has a rounded surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the struts does not have a rounded surface at any edges thereof.
[0375] Example 140. The prosthetic valve of any example herein, particularly example 139, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0376] Example 141. The prosthetic valve of any example herein, particularly any one of examples 139 - 140, wherein, for each of the rounded surfaces of the axially extending struts, a width of the respective rounded surface is at least 20% of a width of the respective strut.
[0377] Example 142. The prosthetic valve of any example herein, particularly any one of examples 139 - 140, wherein, for each of the rounded surfaces of the axially extending struts, a width of the respective rounded surface is at least 20% of a thickness of the respective strut.
[0378] Example 143. The prosthetic valve of any example herein, particularly any one of examples 139 - 142, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the leaflets are secured to the plurality of axially extending second stmts, and wherein the second subset of stmts comprises the plurality of axially extending second stmts. [0379] Example 144. The prosthetic valve of any example herein, particularly any one of examples 139 - 143, wherein, for each of the first subset of struts, the respective strut has a rounded surface at each of a pair of the edges thereof.
[0380] Example 145. The prosthetic valve of any example herein, particularly example 144, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0381] Example 146. The prosthetic valve of any example herein, particularly example 145, wherein, for each of the first subset of struts, the respective strut does not have rounded surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0382] Example 147. The prosthetic valve of any example herein, particularly any one of examples 139 - 146, wherein the first subset of the struts comprises one or more of the angled struts.
[0383] Example 148. The prosthetic valve of any example herein, particularly example 147, wherein each of the one or more angled struts of the first subset of struts extends from a respective one of the axially extending struts.
[0384] Example 149. The prosthetic valve of any example herein, particularly any one of examples 140 - 146, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0385] Example 150. The prosthetic valve of any example herein, particularly example 149, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0386] Example 151. The prosthetic valve of any example herein, particularly example 150, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0387] Example 152. The prosthetic valve of any example herein, particularly any one of examples 150 - 151, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0388] Example 153. The prosthetic valve of any example herein, particularly any one of examples 150 - 152, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the wide base of the trapezoid shape.
[0389] Example 154. The prosthetic valve of any example herein, particularly example 139, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0390] Example 155. The prosthetic valve of any example herein, particularly example 154, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0391] Example 156. The prosthetic valve of any example herein, particularly example 155, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0392] Example 157. The prosthetic valve of any example herein, particularly any one of examples 155 - 156, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0393] Example 158. The prosthetic valve of any example herein, particularly any one of examples 155 - 157, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0394] Example 159. The prosthetic valve of any example herein, particularly any one of examples 155 - 158, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped struts, the one or more edges having the rounded surface comprise edges of the wide base of the trapezoid shape. [0395] Example 160. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the frame further comprises a plurality of inflow apices at an inflow end of the frame, wherein each of the inflow apices has a blunted surface at a first portion thereof.
[0396] Example 161. The prosthetic valve of any example herein, particularly example 160, wherein, for each of the inflow apices, the first portion faces away from the longitudinal axis of the frame.
[0397] Example 162. The prosthetic valve of any example herein, particularly example 161, wherein, for each of the inflow apices, the respective inflow apex consists essentially of the first portion and a second portion, wherein the second portion does not have a chamfered surface.
[0398] Example 163. The prosthetic valve of any example herein, particularly any one of examples 160 - 162, wherein, for each of the inflow apices, a width of the chamfered blunted surface is at least 20% of a thickness of the inflow apex.
[0399] Example 164. The prosthetic valve of any example herein, particularly any one of examples 160 - 163, wherein each of a first subset of the struts has a blunted surface at one or more edges thereof the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the axially extending struts does not have a blunted surface at any edges thereof.
[0400] Example 165. The prosthetic valve of any example herein, particularly example 164, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0401] Example 166. The prosthetic valve of any example herein, particularly any one of examples 164 - 165, wherein, for each of the blunted surfaces of the axially extending struts, a width of the respective blunted surface is at least 20% of a width of the respective strut.
[0402] Example 167. The prosthetic valve of any example herein, particularly any one of examples 164 - 165, wherein, for each of the blunted surfaces of the axially extending struts, a width of the respective blunted surface is at least 20% of a thickness of the respective strut. [0403] Example 168. The prosthetic valve of any example herein, particularly any one of examples 164 - 167, further comprising a plurality of leaflets, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the leaflets are secured to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second struts.
[0404] Example 169. The prosthetic valve of any example herein, particularly any one of examples 164 - 168, wherein, for each of the first subset of struts, the respective strut has a blunted surface at each of a pair of the edges thereof.
[0405] Example 170. The prosthetic valve of any example herein, particularly example 169, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0406] Example 171. The prosthetic valve of any example herein, particularly example 170, wherein, for each of the first subset of struts, the respective strut does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0407] Example 172. The prosthetic valve of any example herein, particularly any one of examples 164 - 171, wherein the first subset of the struts comprises one or more of the angled struts.
[0408] Example 173. The prosthetic valve of any example herein, particularly example 172, wherein each of the one or more angled struts of the first subset of struts extends from a respective one of the axially extending struts.
[0409] Example 174. The prosthetic valve of any example herein, particularly any one of examples 165 - 171, wherein each of the first subset of struts has a trapezoid shaped cross section.
[0410] Example 175. The prosthetic valve of any example herein, particularly example 174, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0411] Example 176. The prosthetic valve of any example herein, particularly example 175, wherein each of the second subset of the trapezoid shaped struts is positioned between a pair of the first subset of the trapezoid shaped struts.
[0412] Example 177. The prosthetic valve of any example herein, particularly any one of examples 175 - 176, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
[0413] Example 178. The prosthetic valve of any example herein, particularly any one of examples 175 - 177, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the blunted surface comprise edges of the wide base of the trapezoid shape.
[0414] Example 179. The prosthetic valve of any example herein, particularly example 164, wherein each of the first subset of stmts has a trapezoid shaped cross section.
[0415] Example 180. The prosthetic valve of any example herein, particularly example 179, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0416] Example 181. The prosthetic valve of any example herein, particularly example 180, wherein each of the second subset of the trapezoid shaped stmts is positioned between a pair of the first subset of the trapezoid shaped stmts.
[0417] Example 182. The prosthetic valve of any example herein, particularly any one of examples 180 - 181, wherein the trapezoid shaped stmts of the first subset of trapezoid shaped stmts and the trapezoid shaped stmts of the second subset of trapezoid shaped stmts are alternately arranged around a circumference of the frame. [0418] Example 183. The prosthetic valve of any example herein, particularly any one of examples 180 - 182, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped struts faces a center of a respective one of the leaflets.
[0419] Example 184. The prosthetic valve of any example herein, particularly any one of examples 180 - 183, wherein, for each of the first subset of the trapezoid shaped struts, the one or more edges having the blunted surface comprise edges of the narrow base of the trapezoid shape, and wherein, for each of the second subset of the trapezoid shaped stmts, the one or more edges having the blunted surface comprise edges of the wide base of the trapezoid shape.
[0420] Example 185. The prosthetic valve of any example herein, particularly any one of examples 107 - 109, wherein each of a subset of axially extending stmts has a trapezoid shaped cross section.
[0421] Example 186. The prosthetic valve of any example herein, particularly example 185, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0422] Example 187. The prosthetic valve of any example herein, particularly example 186, wherein each of the second subset of the trapezoid shaped stmts is positioned between a pair of the first subset of the trapezoid shaped stmts.
[0423] Example 188. The prosthetic valve of any example herein, particularly any one of examples 186 - 187, wherein the trapezoid shaped stmts of the first subset of trapezoid shaped stmts and the trapezoid shaped stmts of the second subset of trapezoid shaped stmts are alternately arranged around a circumference of the frame.
[0424] Example 189. The prosthetic valve of any example herein, particularly any one of examples 186 - 188, further comprising a plurality of leaflets, wherein each of the second subset of the trapezoid shaped stmts faces a center of a respective one of the leaflets.
[0425] Example 190. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises forming a plurality of struts, the plurality of stmts forming a plurality of cells, wherein the stmts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the method further comprises, for each of a first subset of the struts, using a 5-axis laser to form a chamfered surface at one or more edges thereof, wherein each of a second subset of the struts does not have a chamfered surface at any edges thereof.
[0426] Example 191. The method of any example herein, particularly example 190, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0427] Example 192. The method of any example herein, particularly any one of examples 190 - 191, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a width of the respective strut.
[0428] Example 193. The method of any example herein, particularly any one of examples 190 - 191, wherein, for each of the chamfered surfaces, a width of the respective chamfered surface is at least 20% of a thickness of the respective strut.
[0429] Example 194. The method of any example herein, particularly any one of examples 190 - 193, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of struts comprising the plurality of axially extending first struts, wherein the method further comprises securing a plurality of leaflets to the plurality of axially extending second struts, and wherein the second subset of struts comprises the plurality of axially extending second struts.
[0430] Example 195. The method of any example herein, particularly any one of examples 190 - 194, wherein, for each of the first subset of struts, the using the 5-axis laser to form the chamfered surface at one or more edges thereof comprising using the 5-axis laser to form a chamfered surface at each of a pair of the edges thereof.
[0431] Example 196. The method of any example herein, particularly example 195, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
[0432] Example 197. The method of any example herein, particularly example 196, wherein, for each of the first subset of struts, the respective strut does not have chamfered surfaces at each of a pair of edges facing away from the longitudinal axis of the frame. [0433] Example 198. The method of any example herein, particularly any one of examples 190 - 197, further comprising using the 5-axis laser to round a pair of edges of each of the chamfered surfaces.
[0434] Example 199. The method of any example herein, particularly example 198, wherein, for each of the pair of rounded edges of each of the chamfered surfaces, a width of each rounded edge is at least 20% of a width of the chamfered surface.
[0435] Example 200. The method of any example herein, particularly any one of examples 190 - 197, further comprising electropolishing a pair of edges of each of the chamfered surfaces to be rounded.
[0436] Example 201. The method of any example herein, particularly any one of examples 190 - 197, further comprising using the 5-axis laser to blunt a pair of edges of each of the chamfered surfaces.
[0437] Example 202. The method of any example herein, particularly example 201, wherein, for each of the pair of blunted edges of each of the chamfered surfaces, a width of each blunted edge is at least 20% of a width of the chamfered surface.
[0438] Example 203. The method of any example herein, particularly any one of examples 190 - 197, further comprising electropolishing a pair of edges of each of the chamfered surfaces to be blunted.
[0439] Example 204. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises forming a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the method further comprises, for each of a first subset of the struts, using a 5-axis laser to form a rounded surface at one or more edges thereof, wherein each of a second subset of the struts does not have a rounded surface at any edges thereof.
[0440] Example 205. The method of any example herein, particularly example 204, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame. [0441] Example 206. The method of any example herein, particularly any one of examples 204 - 205, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a width of the respective strut.
[0442] Example 207. The method of any example herein, particularly any one of examples 204 - 205, wherein, for each of the rounded surfaces, a width of the respective rounded surface is at least 20% of a thickness of the respective strut.
[0443] Example 208. The method of any example herein, particularly any one of examples 204 - 207, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of stmts comprising the plurality of axially extending first stmts, wherein the method further comprises securing a plurality of leaflets to the plurality of axially extending second stmts, and wherein the second subset of stmts comprises the plurality of axially extending second struts.
[0444] Example 209. The method of any example herein, particularly any one of examples 204 - 208, wherein, for each of the first subset of stmts, the using the 5 -axis laser to form the rounded surface at one or more edges thereof comprising using the 5-axis laser to form a rounded surface at each of a pair of the edges thereof.
[0445] Example 210. The method of any example herein, particularly example 209, wherein, for each of the first subset of stmts, the pair of edges face the longitudinal axis of the frame.
[0446] Example 211. The method of any example herein, particularly example 210, wherein, for each of the first subset of stmts, the respective stmt does not have rounded surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0447] Example 212. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises forming a plurality of stmts, the plurality of stmts forming a plurality of cells, wherein the stmts comprise: a plurality of axially extending stmts; and a plurality of angled stmts, wherein the method further comprises, for each of a first subset of the stmts, using a 5-axis laser to form a blunted surface at one or more edges thereof, wherein each of a second subset of the stmts does not have a blunted surface at any edges thereof. [0448] Example 213. The method of any example herein, particularly example 212, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
[0449] Example 214. The method of any example herein, particularly any one of examples 212 - 213, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a width of the respective strut.
[0450] Example 215. The method of any example herein, particularly any one of examples 212 - 213, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a thickness of the respective strut.
[0451] Example 216. The method of any example herein, particularly any one of examples 212 - 215, wherein the plurality of axially extending struts comprises a plurality of axially extending first struts and a plurality of axially extending second struts, the one or more axially extending struts of the first subset of stmts comprising the plurality of axially extending first struts, wherein the method further comprises securing a plurality of leaflets to the plurality of axially extending second stmts, and wherein the second subset of stmts comprises the plurality of axially extending second struts.
[0452] Example 217. The method of any example herein, particularly any one of examples 212 - 216, wherein, for each of the first subset of stmts, the using the 5-axis laser to form the blunted surface at one or more edges thereof comprising using the 5-axis laser to form a blunted surface at each of a pair of the edges thereof.
[0453] Example 218. The method of any example herein, particularly example 217, wherein, for each of the first subset of stmts, the pair of edges face the longitudinal axis of the frame.
[0454] Example 219. The method of any example herein, particularly example 218, wherein, for each of the first subset of stmts, the respective stmt does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
[0455] Example 220. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises: forming a plurality of stmts, the plurality of struts forming a plurality of cells; forming a plurality of inflow apices at an inflow end of the frame; and for each of the inflow apices, using a 5-axis laser to form a chamfered surface at a portion thereof, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0456] Example 221. The method of any example herein, particularly example 220, wherein, for each of the inflow apices, the chamfered surface faces away from the longitudinal axis of the frame.
[0457] Example 222. The method of any example herein, particularly any one of examples 220 - 221, wherein, for each of the inflow apices, the chamfered surface extends along at least 20% of a thickness of the angled strut.
[0458] Example 223. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises: forming a plurality of struts, the plurality of struts forming a plurality of cells; forming a plurality of inflow apices at an inflow end of the frame; and for each of the inflow apices, using a 5-axis laser to form a rounded surface at a portion thereof, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0459] Example 224. The method of any example herein, particularly example 223, wherein, for each of the inflow apices, the rounded surface faces away from the longitudinal axis of the frame.
[0460] Example 225. The method of any example herein, particularly any one of examples 223 - 224, wherein, for each of the inflow apices, the rounded surface extends along at least 20% of a thickness of the angled strut.
[0461] Example 226. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises: forming a plurality of struts, the plurality of struts forming a plurality of cells; forming a plurality of inflow apices at an inflow end of the frame; and for each of the inflow apices, using a 5-axis laser to form a blunted surface at a portion thereof, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts.
[0462] Example 227. The method of any example herein, particularly example 226, wherein, for each of the inflow apices, the blunted surface faces away from the longitudinal axis of the frame. [0463] Example 228. The method of any example herein, particularly any one of examples 226 - 227, wherein, for each of the inflow apices, the blunted surface extends along at least 20% of a thickness of the angled strut.
[0464] Example 229. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises using a 5-axis laser to form a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled stmts, and wherein each of the axially extending stmts has a trapezoid shaped cross section.
[0465] Example 230. The method of any example herein, particularly example 229, wherein each of a first subset of the trapezoid shaped stmts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped stmts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
[0466] Example 231. The method of any example herein, particularly example 230, wherein each of the second subset of the trapezoid shaped stmts is positioned between a pair of the first subset of the trapezoid shaped stmts.
[0467] Example 232. The method of any example herein, particularly example 231, further comprising securing a plurality of leaflets to the frame, wherein each of the second subset of the trapezoid shaped stmts faces a center of a respective one of the leaflets.
[0468] Example 233. A prosthetic valve can include a radially compressible and expandable frame that can include a longitudinal axis and a plurality of stmts forming a plurality of cells. The plurality of stmts can include a plurality of axially extending stmts and a plurality of angled stmts. The plurality of axially extending stmts can include a subset of axially extending commissure stmts, and each one of the subset of axially extending commissure stmts can include a commissure window and one or more blunted edges.
[0469] Example 234. The prosthetic valve of any example herein, particularly example 233, wherein each one of the subset of axially extending commissure stmts can extend along a respective axis that is parallel to the longitudinal axis of the frame. [0470] Example 235. The prosthetic valve of any example herein, particularly any one of examples 233-234, wherein each commissure strut in the subset of axially extending commissure struts can include a plurality of circumferentially inwards facing edges and a plurality of circumferentially outwards facing edges.
[0471] Example 236. The prosthetic valve of any example herein, particularly example 235, wherein the blunted edge can be one or more of the plurality of circumferentially inwards facing edges.
[0472] Example 237. The prosthetic valve of any example herein, particularly example 236, wherein the blunted edge can be only one or more of the plurality of circumferentially inwards facing edges.
[0473] Example 238. The prosthetic valve of any example herein, particularly example 235, wherein the blunted edge can be one or more of the plurality of circumferentially outwards facing edges.
[0474] Example 239. The prosthetic valve of any example herein, particularly any one of examples 233-238, wherein the blunted edge can be rounded.
[0475] Example 240. The prosthetic valve of any example herein, particularly any one of examples 233-239, wherein each blunted edge can include a projected width in a circumferential direction of the frame, and wherein the projected width of the blunted edge can be less than or equal to 10% of a projected width of a corresponding one of the subset of axially extending commissure struts.
[0476] Example 241. A prosthetic valve can include a frame having a longitudinal axis. The frame can include a plurality of struts forming a plurality of cells. The struts can include a plurality of axially extending struts, each including four edges, and a plurality of angled struts. Each one of a subset of the axially extending struts can include two strut portions defining a commissure window therebetween, and one or more blunted edges on one or more of the two strut portions.
[0477] Example 242. The prosthetic valve of any example herein, particularly example 241, wherein each strut portion can include two circumferentially inwards facing edges and two circumferentially outwards facing edges, and wherein the blunted edge can be formed on one or more of the circumferentially inwards facing edges of the two strut portions.
[0478] Example 243. The prosthetic valve of any example herein, particularly example 242, wherein each one of the circumferentially inwards facing edges can be blunted.
[0479] Example 244. The prosthetic valve of any example herein, particularly any one of examples 241-243, wherein the two circumferentially inwards facing edges can include a radially inwards facing edge and a radially outwards facing edge, and wherein the radially inwards facing edge can be blunted.
[0480] Example 245. The prosthetic valve of any example herein, particularly example 244, wherein the commissure window edges can extend in a longitudinal direction of the frame.
[0481] Example 246. The prosthetic valve of any example herein, particularly any one of examples 244-245, wherein the prosthetic heart valve can further include a plurality of leaflets, wherein adjacent ones of the plurality of leaflets can be connected form a plurality of commissure tabs, and wherein each commissure tab can be secured to a corresponding commissure window of the subset of the axially extending struts.
[0482] Example 247. The prosthetic valve of any example herein, particularly any one of examples 241-246, wherein each rounded surface can include a projected width in a circumferential direction of the frame, and wherein the projected width of the rounded surface can be less than or equal to 10% of a projected width of a corresponding one of the subset of axially extending struts.
[0483] Example 248. A prosthetic valve can include a frame having a longitudinal axis. The frame can include a plurality of struts forming a plurality of cells. The struts can include a plurality of axially extending struts and a plurality of angled struts. The plurality of axially extending struts can include a subset of axially extending commissure struts. Each commissure strut in the subset of axially extending commissure struts can include an open commissure window and one or more radially inwards facing blunted edges. The prosthetic valve can further include a plurality of leaflets secured to the subset of axially extending struts.
[0484] Example 249. The prosthetic valve of any example herein, particularly example 248, wherein each radially inwards facing edge of the commissure strut can be blunted. [0485] Example 250. The prosthetic valve of any example herein, particularly any one of examples 246-249, wherein only the radially inwards facing edges are blunted.
[0486] Example 251. The prosthetic valve of any example herein, particularly example 248, wherein each strut in the subset of axially extending struts can include one or more radially outwards facing blunted edges.
[0487] Example 252. The prosthetic valve of any example herein, particularly any one of examples 248-251, wherein one or more blunted edges can have a projected width in a circumferential direction of the frame, and wherein the projected width of the blunted edge can be less than or equal to 10% of a projected width of a corresponding one of the subset of axially extending struts.
[0488] Example 253. The prosthetic valve of any example herein, particularly any one of examples 248-252, wherein each one of the plurality of axial struts can connect to two corresponding ones of the plurality of angled stmts at a corresponding one of a plurality of junctions, and wherein at least one of the plurality of junctions can include a blunted edge.
[0489] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.
[0490] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims and their equivalents.

Claims

1. A prosthetic valve comprising a frame having a longitudinal axis, the frame comprising a plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein each of a first subset of the struts has a blunted surface at one or more edges thereof, the first subset of the struts comprising one or more of the axially extending struts, and wherein each of a second subset of the struts does not have a blunted surface at any edges thereof.
2. The prosthetic valve of claim 1, wherein each of the plurality of axially extending struts extends along a respective axis that is parallel to the longitudinal axis of the frame.
3. The prosthetic valve of any one of claims 1-2, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a width of the respective strut.
4. The prosthetic valve of any one of claims 1-2, wherein, for each of the blunted surfaces, a width of the respective blunted surface is at least 20% of a thickness of the respective strut.
5. The prosthetic valve of any one of claims 1-4, wherein, for each of the first subset of struts, the respective strut has a blunted surface at each of a pair of the edges thereof.
6. The prosthetic valve of claim 5, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
7. The prosthetic valve of claim 6, wherein, for each of the first subset of struts, the respective strut does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
8. The prosthetic valve of any one of claims 1-7, wherein the first subset of the struts comprises one or more of the angled struts.
9. The prosthetic valve of claim 8, wherein each of the one or more angled struts of the first subset of struts extends from a respective one of the axially extending struts.
10. The prosthetic valve of claim 1, wherein each of the first subset of struts has a trapezoid shaped cross section.
11. The prosthetic valve of claim 10, wherein each of a first subset of the trapezoid shaped struts is oriented such that a narrow base of the trapezoid shape faces the longitudinal axis of the frame and each of a second subset of the trapezoid shaped struts is oriented such that a wide base of the trapezoid shape faces the longitudinal axis of the frame.
12. The prosthetic valve of claim 11, wherein the trapezoid shaped struts of the first subset of trapezoid shaped struts and the trapezoid shaped struts of the second subset of trapezoid shaped struts are alternately arranged around a circumference of the frame.
13. The prosthetic valve of any one of claims 1-12, wherein the frame comprises a plurality of inflow apices at an inflow end of the frame, and wherein each of the inflow apices has a blunted chamfered surface at a portion thereof.
14. A method of producing a frame of a prosthetic valve, the frame having a longitudinal axis, wherein the method comprises forming a plurality of struts, the plurality of struts forming a plurality of cells, wherein the struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the method further comprises, for each of a first subset of the struts, using a 5- axis laser to form a blunted surface at one or more edges thereof, wherein each of a second subset of the struts does not have a blunted surface at any edges thereof.
15. The method of claim 14, wherein, for each of the first subset of struts, the using the 5 -axis laser to form the blunted surface at one or more edges thereof comprising using the 5-axis laser to form a blunted surface at each of a pair of the edges thereof.
16. The method of claim 15, wherein, for each of the first subset of struts, the pair of edges face the longitudinal axis of the frame.
17. The method of claim 16, wherein, for each of the first subset of struts, the respective strut does not have blunted surfaces at each of a pair of edges facing away from the longitudinal axis of the frame.
18. A prosthetic valve comprising: a radially compressible and expandable frame comprising a longitudinal axis and a plurality of struts forming a plurality of cells, wherein the plurality of struts comprise: a plurality of axially extending struts; and a plurality of angled struts, wherein the plurality of axially extending struts comprises a subset of axially extending commissure struts, and wherein each one of the subset of axially extending commissure struts comprises a commissure window and one or more blunted edges.
19. The prosthetic valve of claim 18, wherein each commissure strut in the subset of axially extending commissure struts comprises a plurality of circumferentially inwards facing edges and a plurality of circumferentially outwards facing edges.
20. The prosthetic valve of claim 19, wherein the blunted edge is one or more of the plurality of circumferentially inwards facing edges.
21. The prosthetic valve of claim 20, wherein the blunted edge is only one or more of the plurality of circumferentially inwards facing edges.
22. The prosthetic valve of claim 19, wherein the blunted edge is one or more of the plurality of circumferentially outwards facing edges.
23. The prosthetic valve of any one of claims 18-22, wherein each blunted edge has a projected width in a circumferential direction of the frame, and wherein the projected width of the blunted edge is less than or equal to 10% of a projected width of a corresponding one of the subset of axially extending commissure struts.
PCT/US2024/0560612023-11-162024-11-15Prosthetic valve framePendingWO2025106770A1 (en)

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US202363599631P2023-11-162023-11-16
US63/599,6312023-11-16
US202463701979P2024-10-012024-10-01
US63/701,9792024-10-01

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