Support structure of an implantable device with enhanced compression rigidity region

Abstract

To provide excellent support structures and the like.SOLUTION: Various examples address support structures (e.g., prosthetic valve support structures or frames) that incorporate a frame that, upon transitioning to a deployed configuration, include a proximal section having increased stiffness, or resistance to deformation in a transverse plane to a longitudinal axis of a device, including resistance to a change in shape, size, or both. Such an increase in transverse deformation resistance may be measured as an increase in radial compressive resistance or an increase in flat plate stiffness, for example, or both. Such increases in transverse deformation resistance may be realized through a reduction in length of the increased stiffness region of the support structure, such as through longitudinal compression of the region following an initial radial expansion of the region.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 62 / 951,292, filed December 20, 2020, and is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Field Implantable medical devices including prosthetic valves and related support structures.

[0003] Background Various types of support structures are implemented for implantable medical devices. Self - expanding nitinol frames are often used as support structures for replacement heart valves. These devices can be placed in the calcified aortic valve annulus for treatment. In various situations, such support structures either have insufficient plate stiffness to function effectively or exert undesirable chronic radial forces on the surrounding tissue.

Summary of the Invention

[0004] Summary Various examples relate to a support structure (e.g., a prosthetic valve structure) that incorporates a frame in which a proximal section has increased stiffness, or resistance to deformation including a change in shape, size, or both, in a cross - section with respect to the longitudinal axis of the device when transitioning to a deployed configuration. Such an increase in transverse deformation resistance can be measured, for example, as an increase in radial compression resistance or an increase in plate stiffness, or both. Such an increase in transverse deformation resistance can be achieved by reducing the length of the increased - stiffness region of the support structure, such as by longitudinal compression of the region following an initial radial expansion of the region.

[0005] According to one example (Example 1), the support structure of an implantable device includes a tubular body having a longitudinal axis, the tubular body including a first region having an annular shape and a first transverse deformation resistance (e.g., a first radial compression resistance and / or a first plate stiffness), and a second region having an annular shape and a second transverse deformation resistance (e.g., a second radial compression resistance and / or a second plate stiffness). The second region can include a plurality of frame elements that define the annular shape of the second region. The plurality of frame elements can have a shape / geometry (e.g., curvature) and / or a cross-section (e.g., a region of relatively reduced cross-section) such that the second region exhibits a relatively high degree of compression in the longitudinal direction compared to the radial or transverse direction.

[0006] In some examples, at least a portion of each of the plurality of frame elements has a region of reduced cross-section including a radial width transverse to the longitudinal axis of the tubular body and a longitudinal thickness parallel to the longitudinal axis of the tubular body, and the width of the region of reduced cross-section is greater than the thickness (e.g., at least 2 times, 4 times, 6 times or other multiple of the thickness) such that the second region exhibits a relatively high degree of compression in the longitudinal direction compared to the radial direction.

[0007] According to another example (Example 2), in addition to Example 1, the second transverse deformation resistance (e.g., radial and / or plate stiffness) is greater than the first transverse deformation resistance (e.g., radial and / or plate stiffness).

[0008] According to another example (Example 3), in addition to Example 1, the first region includes a plurality of frame elements that define the annular shape of the first region, and further, at least a portion of each of the plurality of frame elements of the first region has a radial width transverse to the longitudinal axis of the tubular body and a longitudinal thickness parallel to the longitudinal axis of the tubular body, and the width of each of the plurality of frame elements of the first region is less than 4 times the thickness of each of the plurality of frame elements of the first region.

[0009] According to another example (“Example 4”), in addition to Example 1, the support structure includes one or more valve tips coupled to the first region.

[0010] According to another example (“Example 5”), in addition to Example 4, the one or more valve tips are formed from a natural material.

[0011] According to another example (“Example 6”), in addition to Example 4, the one or more valve tips are formed from a synthetic material.

[0012] According to another example (“Example 7”), the support structure of an implantable device includes a tubular body having a longitudinal axis, the implantable device being movable between a delivery configuration and a deployed configuration, the tubular body including a first region that is annular in shape and characterized by a first transverse deformation resistance, and a second region that is annular in shape and characterized by a second transverse deformation resistance, the second region including a plurality of frame elements that define the annular shape of the second region, the plurality of frame elements intersecting each other to form a plurality of cells, each of the plurality of cells defining a longitudinal apex that is directed longitudinally along the longitudinal axis of the support structure and a lateral apex that crosses the longitudinal apex and is directed along the perimeter of the support structure, and further, in the deployed configuration, the longitudinal apex defines an obtuse angle and the circumferential apex defines an acute angle.

[0013] According to another example (“Example 8”), in addition to Example 7, each of the plurality of cells defines a pair of longitudinal apices that are directed longitudinally and a pair of lateral apices that are directed circumferentially, and further, in the deployed configuration, each of the longitudinal apices defines an obtuse angle and each of the lateral apices defines an acute angle.

[0014] According to another example ("Example 9"), in addition to Example 8, each pair of lateral direction vertices of the plurality of cells defines a circumferential center line of a plurality of cells extending between the pairs of lateral direction vertices of each of the plurality of cells, and further, at least a part of each of the intersecting frame members defines a pair of longitudinal direction vertices of each of the plurality of cells intersecting the circumferential center line of each of the plurality of cells.

[0015] According to another example ("Example 10"), in addition to Example 9, the obtuse angle defined by each longitudinal direction vertex of the deployed configuration exceeds 100 degrees, 130 degrees, 150 degrees or 170 degrees, or is any value or range between the above-mentioned values.

[0016] According to another example ("Example 11"), in addition to Example 9, the obtuse angle defined by each longitudinal axis is 100 degrees to 170 degrees.

[0017] According to another example ("Example 12"), in addition to Example 9, the second transverse direction deformation resistance is greater than the first transverse direction deformation resistance.

[0018] According to another example (Example 13), a method of implanting an artificial valve includes advancing the artificial valve in a delivery configuration, in which the artificial valve has a first compressed delivery diameter, into a target region within a patient's anatomical structure, where the artificial valve includes a support structure having a first region with an annular shape and characterized by a first transverse deformation resistance, and a second region with an annular shape and characterized by a second transverse deformation resistance, the second region including a plurality of frame elements that intersect each other to form a plurality of cells, each of the plurality of cells defining a longitudinal apex that is longitudinally directed along a longitudinal axis of the support structure and a lateral apex that crosses the longitudinal apex and is directed along a perimeter of the support structure, where, when the artificial valve is in the delivery configuration, the longitudinal apex defines an acute angle and the circumferential apex defines an obtuse angle, and deploying the artificial valve such that the longitudinal apex defines an obtuse angle and the circumferential apex defines an acute angle. In some embodiments, deploying the artificial valve further includes axially or longitudinally compressing the second region and locking the second region in the axially compressed configuration.

[0019] According to another example (Example 14), in addition to Example 13, the obtuse angle of the longitudinal apex is at least 180 degrees.

[0020] According to another example (Example 15), in addition to Example 13, the obtuse angle of the longitudinal apex exceeds 180 degrees.

[0021] According to another example (``Example 16''), a method of forming a support structure for an artificial valve includes cutting out a pattern of closed cells from a tube to form a support structure having a first diameter and a first length, where each closed cell is defined by a plurality of frame members, expanding the first diameter of the support structure from the first diameter to a second diameter, axially compressing a portion shorter than all of the lengths of the support structure to form a first region and a second region, where the first region includes a first plurality of cells and the second region includes a second plurality of cells, the shape of the cells in the second plurality of cells being different from the shape of the cells in the first plurality of cells, and heat setting the support structure in a geometry having the first region and the second region such that the first region is characterized by a first transverse deformation resistance and the second region is characterized by a second transverse deformation resistance different from the first transverse deformation resistance.

[0022] According to another example (``Example 17''), in addition to Example 16, the cells of the support structure each have the same shape (e.g., each being generally diamond-shaped) before axially compressing a portion shorter than all of the lengths of the support structure to form the first region and the second region. In various embodiments, the cells of the second region have a relatively longer shape in the longitudinal direction than in the transverse direction in an initial delivery configuration.

[0023] According to another example ("Example 18"), the support structure of an implantable device includes a framework having a first region configured to support one or more valve leaflets and a second region configured to provide enhanced resistance to transverse deformation. The second region defines a plurality of cells, each of the plurality of cells having a first height and width when the second region is in a delivery configuration, a second height and width when the second region is expanded from the delivery configuration to an initial expanded configuration, and a third height and width when the second region is longitudinally compressed from the initial expanded configuration to a final deployed configuration having enhanced resistance to transverse deformation compared to the initial expanded configuration. The support structure includes at least one locking mechanism configured to lock one or more of the plurality of cells at the third height and width.

[0024] The locking mechanism optionally includes a first locking component that projects into a corresponding cell. The first locking component includes a first sliding surface and a first protrusion, defines a first receiver, and also includes a second locking component that projects toward the first locking component. The second locking component includes a second sliding surface and a second protrusion and defines a second receiver.

[0025] In some examples, the first locking component and the second locking component are configured such that during collapse of the corresponding cell, the first and second sliding surfaces slide relative to each other to facilitate receipt of the first protrusion in the second receiver and the second protrusion in the first receiver, locking the locking mechanism and holding the corresponding cell in the collapsed configuration.

[0026] According to another example ("Example 19"), in addition to Example 18, the support structure is included as part of an artificial valve.

[0027] According to another example ("Example 20"), in addition to Example 18, the support structure is a stent structure.

[0028] According to another example ("Example 21"), in addition to any one of Examples 18 - 20, the optional first sliding surface and second sliding surface elastically deflect the first locking component and the second locking component during the collapse of the corresponding cell.

[0029] According to another example ("Example 22"), in addition to any one of Examples 18 - 21, the optional first locking component and second locking component are symmetric in shape.

[0030] According to another example ("Example 23"), in addition to any one of Examples 18 - 22, the optional first locking component and second locking component are integrally formed with the support structure.

[0031] According to another example ("Example 24"), an implantable device support structure, the support structure defining a longitudinally compressible portion having a distal end and a locking mechanism associated with the support structure, the locking mechanism including a body having a first end and a second end, and a fixing portion disposed at the second end of the body, the fixing portion being operable to selectively engage the distal end of the longitudinally compressible portion of the support structure.

[0032] According to another example ("Example 25"), in addition to Example 24, the locking mechanism further includes a compression member retainer configured to hold a compression member.

[0033] According to another example ("Example 26"), in addition to Example 25, the compression member retainer is configured to release the compression member when the fixing portion engages the distal end of the longitudinally compressible portion of the support structure.

[0034] According to another example ("Example 27"), in addition to any one of Examples 24 - 26, the fixing portion is disposed at an acute angle with respect to the body of the locking mechanism.

[0035] According to another example (Example 28), in addition to any one of Examples 24 to 27, the locking mechanism further includes a coupling portion disposed at a first end of the main body of the locking mechanism.

[0036] According to another example (Example 29), in addition to any one of Examples 24 to 28, the coupling portion is configured to couple to the support structure.

[0037] The above examples are merely examples and should not be read as limiting or narrowing the scope of the concepts of the invention provided by the present disclosure. Although multiple examples are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description that sets forth exemplary examples. Accordingly, the drawings and the detailed description are to be considered as being essentially non-limiting and essentially exemplary.

Brief Description of the Drawings

[0038] Brief Description of the Drawings The accompanying drawings are included to provide a further understanding of the embodiments of the invention of the present disclosure, are incorporated herein, form a part thereof, and serve to illustrate, together with the description, various principles of the invention.

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[0057] Definitions and Terms This disclosure is not intended to be read restrictively. For example, the terms used in this application should be read broadly in the sense of the relationships that terms in the art ascribe to such terms.

[0058] Regarding the term of inaccuracy, the terms "about" and "substantially" can be used interchangeably to refer to a measurement value that includes the stated measurement value and also includes measurement values that are reasonably close to the stated measurement value. A measurement value that is reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount, as would be understood and readily confirmed by a person of ordinary skill in the relevant art. Such deviations can be due to measurement errors, differences in calibration of measurement and / or manufacturing equipment, human error in reading and / or setting measurement values, minor adjustments made to optimize performance and / or structural parameters in consideration of differences in measurement values related to other components, specific implementation scenarios, such as inaccurate adjustment and / or operation of an object by a person or machine, etc. If it is determined that a person of ordinary skill in the relevant art cannot readily confirm such values of reasonably small differences, the terms "about" and "substantially" can be understood to mean ±10% of the stated value.

[0059] In this specification, certain terms are used for convenience only. For example, words such as "proximal", "distal", "top", "bottom", "upper", "lower", "left", "right", "horizontal", "vertical", "upward" or "downward" represent the relative configuration shown in the figures or the orientation of components in the mounting position. The components being referred to may be oriented in any of various directions. Similarly, throughout this disclosure where a process or method is shown or described, unless it is clear from the context that the method depends on a particular operation being performed first, the method can be performed in any order or simultaneously.

[0060] As used herein, the term "transverse deformation resistance" refers to the resistance to deformation in a substantially cross-sectional plane with respect to the longitudinal axis of a support structure. Examples of measurements of transverse compression resistance include, for example, radial compression resistance and the rigidity of a flat plate.

[0061] Detailed Description Those skilled in the art will readily understand that the various embodiments of the inventive concepts provided in this disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying figures referred to herein are not necessarily drawn to scale and may be exaggerated in order to illustrate the various aspects of the disclosure, and in that regard, the drawings should not be construed as limiting.

[0062] The various examples deal with expandable support structures having one or more regions of enhanced transverse deformation resistance (e.g., enhanced planar stiffness and / or radial compression resistance). Various examples include configurations that help minimize drawbacks associated with high levels of chronic outward radial forces. Support structures having enhanced transverse deformation resistance can be advantageous in promoting and / or maintaining the reshaping of the tissue structures into which they are implanted. For example, when an expandable support structure consistent with the various examples discussed herein is used in an artificial valve implanted at a valve orifice, the artificial valve opens the valve orifice with a stent and recircumscribes the valve annulus, and as a result, the ability of the valve leaflets to operate in a kinematically optimal deployed shape is maximized because the function of the valve leaflets is not impeded, which can be desirable to provide a support structure.

[0063] In various examples, the regions of enhanced transverse deformation resistance expand fully radially by compressing them longitudinally. The regions of enhanced transverse deformation resistance can first expand to an intermediate deployment diameter and then be longitudinally compressed to a fully deployed diameter at which the regions exhibit the desired transverse deformation resistance. Such expansion techniques and associated support structure configurations can facilitate expansion to a known / preselected diameter and help reduce wrinkles / deformations in the post-deployment valve leaflet shape that would otherwise lead to suboptimal valve leaflet motion. Such expansion mechanisms and enhanced transverse deformation resistance can also help ensure uniform cell expansion / configuration and more consistent performance (e.g., fatigue resistance, deployment shape, stiffness, etc.) after deployment.

[0064] The transverse deformation resistance (e.g., radial compression resistance and / or plate stiffness) of many conventional self-expanding artificial organ support structures may not need to be high enough to overcome the stiffness / resistance of the surrounding tissue (e.g., the tissue of a calcified valve annulus) to reshape the surrounding tissue or otherwise maintain a desired shape. The design (e.g., expandable or self-expanding) of a relatively expandable artificial organ support structure (e.g., an extra-large self-expanding structure) with a high outward radial force to overly compensate for a relatively low transverse deformation resistance may exert chronic outward forces on the surrounding tissue, which may cause other problems including problems with the conduction system (e.g., bundle branch block, complete heart block, the need for pacemaker implant procedures, etc.).

[0065] FIG. 1 shows an artificial valve 1000 including a support structure 2000 and one or more valve leaflets 3000. In some examples, the artificial valve 1000 may be implemented as a blood valve, including, for example, a heart valve. In some examples, the artificial valve 1000 includes a graft material 4000. The graft material may be disposed around the artificial valve 1000, either inside or outside the support structure 2000. Examples of the graft material 4000 can include any known biocompatible material, including but not limited to polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or other suitable polymers or natural materials.

[0066] As shown in FIG. 1, the support structure 2000 includes a first region 2100 and a second region 2200. In various examples, the first region 2100 is configured to house, contain, or support one or more valve tips 3000. The first region 2100 (also referred to herein as the valve tip support portion) can define or otherwise be present at the outflow end 1002 of the artificial valve 1000. In some examples, the outflow end 1002 corresponds to the outflow portion of the artificial valve 1000. That is, in various examples, blood or fluid entering the artificial valve 1000 can enter or first encounter the artificial valve 1000 at the inflow end 1004 of the artificial valve 1000. The fluid or blood generally moves through the artificial valve 1000 at the inflow end 1004 and exits the artificial valve 1000 at the outflow end 1002 of the artificial valve 1000. When flowing through the artificial valve 1000, the fluid or blood encounters the valve tip 3000 that controls the direction of flow through the artificial valve 1000.

[0067] As described above, in various embodiments, one or more valve tips 3000 are coupled to the first region 2100, which can also be described as a valve tip frame, to provide a one-way valve structure. Any of various mechanical valve, biological valve tip, and synthetic valve tip designs can be used as needed. Generally, the valve tip 3000 is coupled to the first region 2100 such that it is operable to open to allow flow to pass from the inflow region, also referred to as the forward flow direction, through the valve tip frame subcomponent outflow region, and is coupled to the first region 2100 such that it is operable to close to restrict flow from the outflow region, also referred to as the reverse flow direction, through the inflow region. One or more valve tips 3000 can be coupled to, for example, the inner and / or outer surfaces of the support structure 2000, to a film associated with the support structure 2000, and / or can be wrapped around one or more portions of the support structure 2000, and various suitable attachment mechanisms including mechanical fasteners can also be contemplated.

[0068] In some embodiments, the prosthetic valve 1000 has a central longitudinal axis Xv. Similarly, the central longitudinal axis Xf of the support structure 2000 is coaxial with the central axis Xv of the prosthetic valve 1000 and can be described as interchangeable with the central longitudinal axis Xv of the prosthetic valve 1000, as shown in FIG. 2. Continuing to refer to FIG. 2, in various examples, the support structure 2000 includes a distal end 2002, a proximal end 2004, and an intermediate region 2006 defined between the distal and proximal ends 2002, 2004. In some examples, the distal end 2002 of the support structure 2000 defines or otherwise corresponds to the outflow end 1002 of the prosthetic valve 1000. Similarly, in some examples, the proximal end 2004 of the support structure 2000 defines or otherwise corresponds to the inflow end 1004 of the prosthetic valve 1000. As described above, in various examples, the support structure 2000 includes a first region 2100 and a second region 2200, and the second region 2200 is generally configured to include enhanced transverse deformation resistance. In some examples, the transverse deformation resistance of the second region 2200 is enhanced compared to the first region 2100. In other words, in some examples, the first region 2100 includes a first transverse deformation resistance (e.g., radial compression resistance and / or flat resistance), while the second region 2200 includes a second transverse deformation resistance (e.g., radial compression resistance and / or flat stiffness) that is greater than the transverse deformation resistance of the first region 2100.

[0069] The prosthetic valve 1000, and thus the support structure 2000, can collapse, together with one or more valve leaflets 3000 and graft material 4000, into a delivery configuration that is of a reduced profile and can then be expanded in situ (e.g., self-expanding or expanded by the application of an internal force such as balloon expansion or other expansion mechanisms discussed herein). As shown in FIG. 2, the support structure 2000 can, optionally, define an annular, at least partially tapered cylinder (e.g., a cone), also described as a tapered cylinder, although the support structure 2000 can be fully conical or non-conical (e.g., a non-tapered constant cross-section such as a right circular cylinder). In the case of a conical shape, the support structure 2000 can include a relatively constant (linear) taper, although non-constant tapers (e.g., varying by one or more curved or angled segments) are contemplated. As shown in FIG. 1A, the valve leaflets 3000 can be attached to the support structure 2000 at a first region 2100 and at the boundary between the first and second regions 2100, 2200. However, leaflet attachment can occur at various locations on the support structure 2000, including the first region 2100, the second region 2200, or a combination of the first and second regions 2100, 2200.

[0070] The support structure 2000 generally defines a circular cross-section in the unloaded state (e.g., when no transverse load is applied), although any of a variety of cross-sections (e.g., elliptical or rectangular) are contemplated. The support structure 2000 has an inner side 2008 and an outer side 2010 opposite the inner side 2008. The inner side 2008 is directed toward the central longitudinal axis Xf, and the outer side 2010 is directed outwardly or away from the central longitudinal axis Xf. The support structure 2000 generally extends from a distal end 2002 (also referred to as the outflow end) to a proximal end 2004 (also referred to as the inflow end). As shown in FIG. 1, the support structure 2000 can include one or more struts 2012 configured to interface with and provide support for one or more valve leaflets 3000.

[0071] Figure 3 shows another configuration of the first region 2100 of the support structure 2000 that can be combined with (e.g., integrally formed or coupled to) the second region 2200. As shown, the support structure 2000 according to Figure 3 can include one or more cross-linking posts 2012 that project distally from the remainder of the support structure and are configured to interface with one or more valve tips 3000 to provide support. Three cross-linking posts 2012 are shown in Figure 3, but any number of cross-linking posts are contemplated. The plurality of cross-linking posts 2012 define those that are circumferentially adjacent or simply adjacent among the plurality of cross-linking posts 2012 that move around the support structure 2000.

[0072] In some examples, the transverse deformation resistance of the second region 2200 is enhanced (e.g., via selective strain hardening) by one or more material properties of various structural components of the second region 2200 as compared to the transverse deformation resistance of the first region 2100. In some examples, the transverse deformation resistance of the second region 2200 is enhanced additionally or alternatively to the transverse deformation resistance of the first region 2100 due to the orientation and / or configuration of various structural elements of the second region 2200.

[0073] For example, as shown in Figure 2, the first region 2100 of the support structure 2000 includes a plurality of frame members that include one or more strut elements 2102. The strut elements 2102 can be joined together or configured to interface at one or more interface regions 2104 (referred to herein as intersection locations Pd). The strut elements 2102 include a plurality of valve tip attachment struts 2103 to which one or more valve tips can be coupled.

[0074] In some embodiments, the plurality of strut elements 2102 define a collapsible (e.g., elastically) and expandable (e.g., self-expanding, or expandable via a balloon or other suitable mechanism discussed herein) framework and also serve to support one or more valve tips as described above. As shown in FIGS. 2 and 3, the plurality of strut elements 2102 define a plurality of rows of closed cells 2118 (e.g., rows 2106, 2108, and 2109) that define an alternating pattern of proximally-directed vertices 2112 that point in the proximal direction and distally-directed vertices 2110 that point in the distal direction. As shown in FIGS. 2 and 3, there are two rows of closed cells 2118, and the third row 2109 has a relatively flat set of distally-directed vertices 2110. Although three are shown, more or fewer numbers are contemplated (e.g., 1, 2, 4, 12, or 20).

[0075] In various examples, each apex angle 2114 of the distally-directed vertices 2110 can have substantially the same value, or a value that varies as desired, in two or more of the plurality of rows of closed cells 2118 (e.g., 2106 and 2108). In some embodiments, each apex angle 2114 of the distally-directed vertices 2110 defined by rows 2106 and 2108 is within 10% of a common apex angle defined by those distally-directed vertices 2110. In particular, it can be advantageous to have distally-directed vertices 2110 in the region where the valve tip is attached to the support structure 2000 and approaches the common apex angle. For example, the distally-directed vertices 2110 that include the valve tip attachment struts 2103 can approach the common apex angle or, alternatively, be within a desired range of the common apex angle. Although a range of 10% is given, in other embodiments, each of those apex angles is within a range of 5%, 15%, 20%, or some other value of the common apex angle. In some examples, the common apex angle described above is 30 degrees, although various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees, and ranges between those values).

[0076] In various examples, each apex angle 2116 of the proximally-directed apexes 2112 can have approximately the same value, or a value that varies as desired, in two or more of a plurality of rows (e.g., 2108 and 2109) of the closed cells 2118. In some embodiments, each apex angle 2116 of the proximally-directed apexes 2112 defined by rows 2108 and 2109 is within 10% of a common apex angle defined by those proximally-directed apexes 2112. In particular, it can be advantageous to have proximally-directed apexes 2112 in a region where the valve tip is attached to the support structure 2000 and approaches the common apex angle. For example, the proximally-directed apexes 2112 including the valve tip attachment struts 2103 can approach the common apex angle or, alternatively, be within a desired range of the common apex angle. While a range of 10% is given, in other embodiments, each of those apex angles is within a range of 5%, 15%, 20% or some other value of the common apex angle. In some examples, the common apex angle above is 30 degrees, but various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between those values).

[0077] In some examples, the apex angles 2114 and / or apex angles 2116 of one or more columns of the closed cells 2118 defined by the plurality of closed cells 2118 are approximately the same as another of the columns of the closed cells 2118. For example, the apex angles of one or more columns can, in some cases, be within 10% of a common apex angle defined by one or more columns of the closed cells 2118 of the proximally-directed apexes 2112 and / or distally-directed apexes 2110. In particular, it can be advantageous to have an apex in a region where it is attached to the support structure 2000 and approaches the common apex angle. For example, an apex including a valve tip attachment strut can approach the common apex angle or, alternatively, be within a desired range of the common apex angle. While a range of 10% is given, in other embodiments, each apex angle is within a range of 5%, 15%, 20% or some other value of the common apex angle. In some examples, the common apex angle is 30 degrees, but various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between those values).

[0078] The closed cells 2118 of the first region 2100 of the support structure 2000 generally intersect each other at the intersection position Pd. As shown in the example of FIG. 4, each closed cell 2118 of the first region 2100 of the support structure 2000 has a cell height 2120 and a cell width 2122, where the cell width 2122 is generally understood to be perpendicular to the cell height 2120. Each closed cell 2118 has a first laterally directed vertex 2124 that defines an apex angle 2128, and a second laterally directed vertex 2126 that is on the opposite side of the first laterally directed vertex 2124 and defines an apex angle 2130.

[0079] Similar to the apex angles 2114 and 2116, in various examples, one or more of the apex angles 2128 and / or apex angles 2130 have approximately the same value among one or more of the plurality of closed cells 2118 (e.g., within 10% of a common apex angle, but other values such as within 5%, 15%, 20% of a common apex angle, or some other value). In particular, as described above, it can be advantageous for there to be a vertex in the region where the valve tip is attached to the support structure 2000 and approaches a common apex angle. For example, a vertex including a valve tip attachment strut can approach a common apex angle or, otherwise, be within a desired range of a common apex angle. In some examples, the common apex angle is 30 degrees, but various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of them).

[0080] In various examples, the cell height 2120 of the closed cell 2118 can be the same or different for different rows and / or columns of the closed cells 2118 in the first region 2100 of the support structure 2000. Similarly, the cell width 2122 of the closed cell 2118 can be the same or different for different rows and / or columns of the closed cells 2118 in the first region 2100 of the support structure 2000.

[0081] ​In various examples, varying the proximal- and distal-directed vertices 2112, 2110 and / or the first- and second-laterally-directed apex angles 2124, 2126 that are proximal and distal to the closed cell can serve to control the compressive force (e.g., the force required to radially compress the prosthetic valve 1000 into a compact delivery configuration), as well as the transverse deformation resistance of a particular region of the support structure 2000 upon deployment. It should also be appreciated that other factors, including material selection, strut geometry (cross-section and curvature), and other properties, can be selected to vary the transverse deformation resistance of the first region 2100. Thus, in various examples, the support structure 2000 can be configured such that the transverse deformation resistance of the first region 2100 is different from the transverse deformation resistance of the second region 2200.

[0082] For example, referring now to FIGS. 2, 4, and 4A, the second region 2200 of the support structure 2000 includes a plurality of frame members that include one or more strut elements 2202. The strut elements 2102 can be joined together or configured to interface at one or more interface regions 2204.

[0083] In some embodiments, the plurality of strut elements 2202 define a framework that is collapsible (e.g., elastically) and expandable (e.g., self-expanding or expandable via a balloon or other suitable mechanism discussed herein) and, as described above, serves to support one or more valve leaflets. As shown, the plurality of strut elements 2202 define a plurality of rows (e.g., rows 2206 and 2208) of closed cells 2218 that define a wavy alternating pattern of proximal-directed vertices 2212 that point in the proximal direction and distal-directed vertices 2210 that point in the distal direction. As shown in FIG. 4, there are 15 rows of closed cells 2218, although more or fewer numbers, including odd and even rows (e.g., 1, 2, 4, 12, 20), are contemplated.

[0084] In various examples, each of the apex angles 2214 of the distally-directed apex 2210 has substantially the same value in two or more of the plurality of rows of closed cells 2218 (e.g., 2206 and 2208). For example, in some embodiments, each apex angle 2214 is within 10% of a common apex angle defined by a plurality of rows of the distally-directed apex 2210. In other embodiments, each apex angle is within a range of 5%, 15%, 20% or some other value of the common apex angle. In some examples, the common apex angle is 30 degrees, although various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values).

[0085] In various examples, each of the apex angles 2216 of the proximally-directed apex 2212 has substantially the same value in two or more of the plurality of rows of closed cells 2218 (e.g., 2206 and 2208). For example, in some embodiments, each apex angle 2216 is within 10% of a common apex angle defined by a plurality of rows of the proximally-directed apex 2212. In other embodiments, each apex angle is within a range of 5%, 15%, 20% or some other value of the common apex angle. In some examples, the common apex angle is 30 degrees, although various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values).

[0086] In some examples, the apex angles 2214 and / or 2216 of one or more columns of the closed cells 2218 defined by the plurality of closed cells 2218 are substantially the same as another one of the columns of the closed cells 2218. For example, the apex angles of one or more columns are, optionally, within 10% of a common apex angle defined by one or more columns of the closed cells 2218 of the proximally-directed vertex 2212 and / or the distally-directed vertex 2210. In other embodiments, each apex angle is within a range of 5%, 15%, 20% or some other value of the common apex angle. In some examples, the common apex angle is 30 degrees, although various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values).

[0087] The closed cells 2218 of the second region 2200 of the support structure 2000 generally intersect each other at the intersection location Pp. As shown in the example of FIG. 4, each closed cell 2218 of the second region 22200 of the support structure 2000 has a cell height 2220 and a cell width 2222, and the cell width 2222 is generally understood to be perpendicular to the cell height 2220. Further, each closed cell 2218 has a first laterally-directed vertex 2224 that defines an apex angle 2228, and a second laterally-directed vertex 2226 that is on the opposite side of the first laterally-directed vertex 2224 and defines an apex angle 2230.

[0088] Similar to the apex angles 2214 and 2216, in various examples, each of the apex angles 2228 and / or 2230 has substantially the same value among one or more of the plurality of closed cells 2218 (e.g., within 10% of the common apex angle, although other values such as within 5%, 15%, 20% of the common apex angle, or some other value are contemplated). In some examples, the common apex angle is 30 degrees, although various common apex angles are contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values).

[0089] In various examples, the cell height 2220 of the closed cell 2218 can be the same or different for different rows and / or columns of the closed cell 2218 in the second region 2200 of the support structure 2000. Similarly, the cell width 2222 of the closed cell 2218 can be the same or different for different rows and / or columns of the closed cell 2218 in the second region 2200 of the support structure 2000.

[0090] In some embodiments, varying the apex angles of the proximal-directed apex and the distal-directed apexes 2210, 2212 and the lateral-directed apexes 2224, 2226 of the closed cell can serve to control the compressive force (e.g., the force required to radially compress the artificial valve 1000 into a compact delivery configuration), as well as the transverse deformation resistance of a particular region of the support structure 2000 upon deployment. Thus, in various examples, the support structure 2000 can be configured such that the transverse deformation resistance of the second region 2200 is different from the transverse deformation resistance of the second region 2200.

[0091] Figures 5A-5C are schematic diagrams showing the support structure 2000 through a deployment sequence using the delivery system 6000, according to some examples. The delivery system 6000 optionally includes a circumferential restraint 6010 for holding the support structure 2000 in a radially compressed state and a longitudinal restraint 6020 for applying a longitudinal compressive force to the second region 2200. FIG. 5A shows the support structure 2000 in an initial state including that the first region 2100 and the second region 2200 are maintained at a delivery diameter or profile compressed by the delivery system 6000. FIG. 5B shows the support structure 2000 in an intermediate state where the first region 2100 and the second region 2200 are radially expanded to an intermediate diameter or profile. In some examples, the support structure 2000 is configured to self-expand to an intermediate state when the circumferential restraint 6010 is released. FIG. 5C shows the support structure 2000 in a deployed state, where the support structure including the first region 2100 and the second region 2200 is radially expanded to a deployed diameter or profile. As shown in FIG. 5C, the second region is longitudinally compressed. In some examples, a longitudinal compressive force is applied to the second region 2200. For example, the longitudinal compressive force can be applied via the longitudinal restraint 6020 associated with the delivery system 6000. In some examples, features can be included for locking the second region 2200 in a longitudinally compressed state.

[0092] During longitudinal compression, the strut element 2202 is deformed, which includes changing the various apex angles of the second region 2200. FIG. 6 shows, according to some examples, a row of closed cells of the second region 2200 in an initial state, including row 2206 which is representative of the remaining rows of the second region 2200. FIGS. 7A - 7C show row 2206 when transitioning from an intermediate state to a deployed state, including the change in the apex angles of the proximal - directed apex and distal - directed apexes 2210, 2212 and the first - laterally - directed apex and second - laterally - directed apexes 2224, 2226 of the closed cells during the transition of the second region from the intermediate state to the deployed state. FIGS. 8A - 8C show a single closed cell of row 2206 in more detail. In some examples, the second region 2200 self - expands from an initial state (e.g., FIG. 6) to an intermediate state (e.g., FIGS. 7A and 8A) and is longitudinally compressed to a deployed state (FIGS. 7C and 8C). As shown in the various figures, the apex angles of the proximal - directed apex and distal - directed apexes 2210, 2212 and the first - laterally - directed apex and second - laterally - directed apexes 2224, 2226 of the closed cell 2218 are generally equal, although various configurations are possible.

[0093] As shown in FIGS. 7A - 7C, in the intermediate state of FIGS. 7A and 8A, the cell height 2220 of the closed cell 2218 of row 2206 is decreased relative to the initial state of FIG. 6 (while the cell width 2222 is increased), and as a result, the apex angles 2214, 2216 of the proximal - directed apex and distal - directed apexes 2210, 2212 are increased compared to those shown in FIG. 6, and the apex angles 2214, 2216 of the laterally - directed apexes 2224, 2226 of the closed cell 2218 of row 2206 are decreased compared to those shown in FIG. 6. It should be understood that the apex angles referred to herein can be defined as the relative angle between adjacent strut elements 2202 intersecting at point Pp (such as between the longitudinal axes of adjacent strut elements).

[0094] As shown in FIGS. 7B and 7C (and FIGS. 8B and 8C), the cell height 2220 of the closed cell 2218 in row 2206 further decreases during the transition to the deployed state such that the apex angles 2214, 2216 of the proximally-directed apex and the distally-directed apexes 2210, 2212 increase as compared to those shown in FIGS. 6 and 7A, and the apex angles 2228, 2230 of the laterally-directed apexes 2224, 2226 of the closed cell 2218 in row 2206 decrease as compared to those shown in FIGS. 6 and 7A (while the cell width 2222 further increases). In various embodiments, as the cell height 2220 further decreases, the angles 2214, 2216 of the proximally-directed apex and the distally-directed apexes 2210, 2212 approach (and in some examples, breach) 180 degrees (also referred to as centering). For example, the configurations shown in FIGS. 7B and 8B show angles 2214, 2216 of the proximally-directed apex and the distally-directed apexes 2210, 2212 of approximately 180 degrees, while the configurations shown in FIGS. 7C and 8C show angles 2214, 2216 of the proximally-directed apex and the distally-directed apexes 2210, 2212 that exceed 180 degrees (also referred to herein as over-centering).

[0095] Increasing the apex angles 2214, 2216 of the proximally-directed apex and the distally-directed apexes 2210, 2212 (e.g., increasing the angle between adjacent strut elements 2202) operates to increase the transverse deformation resistance of row 2206 of closed cells 2218, thereby increasing the transverse deformation resistance of the region of the support structure 2000 in which row 2206 of closed cells 2218 is disposed (e.g., in this case, the second region 2200). It should also be understood that other factors, including the material selection, strut geometry (cross-section and curvature), and other properties, can be selected to vary the transverse deformation resistance of the second region 2200.

[0096] In various examples, the intersections (e.g., Pd and Pp) define hinge regions for various strut elements (e.g., 2102 and 2202) that intersect each other at the intersections (e.g., Pd and Pp) or otherwise form an interface with each other. In some examples, the strut elements (e.g., 2102 and / or 2202) of the support structure 2000 can include one or more sections configured to deform to facilitate or correspond to the change in the apex angle discussed above. These deformations of one or more sections of the strut element can include elastic deformation, plastic deformation, or a combination thereof. For example, as shown in FIGS. 7A - 8C, the strut element 2202 includes a first deformed section and a second deformed section 2232, 2234 having a reduced cross-sectional area configured to deform to facilitate or correspond to the change in the apex angle described above. It should be understood that the deformation of one or more sections of the strut element can be achieved by additionally or alternatively reducing the stiffness of the deformable section (e.g., by reducing the modulus of elasticity or hardness).

[0097] Returning now to FIG. 4, in various examples, the second region 2200 includes a proximal end region 2236 and a distal end region 2238. In various examples, the distal end region 2238 includes a distal edge 2240 that is coupled to the proximal edge 2136 (see FIG. 2) of the first region 2100. The first region and the second region 2100, 2200 are optionally coupled by being integrally formed (e.g., during an etching or cutting operation) or by being attached in other ways (e.g., by welding, an adhesive, or other means). In some examples, the distal end 2240 of the second region 2200 is at least partially defined by the most distal apex of the closed cell 2218 of the second region 2200, and the proximal end 2136 of the first region 2100 is at least partially defined by the most proximal apex of the closed cell 2118 of the first region 2100.

[0098] In various examples, reducing the cell height 2220 of the closed cell 2218 of the second region 2200 can be achieved by pulling the proximal and distal end regions 2236, 2238 of the second region 2200 of the support structure 2000 together. For example, in a delivery configuration, the proximal and distal end regions 2236, 2238 may be separated from each other by a first distance (see FIG. 6), and upon deployment of the prosthetic valve 1000, the proximal and distal end regions 2236, 2238 of the second region 2200 of the support structure 2000 are pulled together such that the proximal and distal end regions 2236, 2238 are closer in the deployed configuration (FIGS. 2, 5C, 7C, and 8C) than in the delivery configuration (FIGS. 5A and 6).

[0099] In some examples, as shown in FIG. 6, in a delivery configuration, the cell height 2220 of the closed cell 2218 is increased or even maximized such that the apex angles 2214, 2216 of the proximally-directed apex and distally-directed apex 2210, 2212 are reduced relative to those shown in FIGS. 2, 5C, 7C, and 8C, and the apex angles 2228, 2230 of the laterally-directed apex 2224, 2226 of the closed cell 2218 are increased relative to those shown in FIG. 4 (while the cell width 2222 is decreased or even minimized).

[0100] In some examples, pulling together the proximal and distal regions 2236, 2238 of the second region 2200 of the support structure 2000 during or after deployment to the expanded diameter has the further effect of increasing the radial dimension of the second region from the first diameter to the second, larger diameter. For example, the diameter of the second region 2200 shown in FIG. 2 is larger than the diameter of the second region 2200 shown in FIG. 6, while the distance between the proximal and distal regions 2236, 2238 shown in FIG. 2 is smaller than the distance between the proximal and distal regions 2236, 2238 shown in FIG. 6. As noted above, when the cell height 2220 of the closed cell 2218 is decreased and the cell width 2222 is increased, the apex angles 2214, 2216 of the proximal-directed and distal-directed apices 2210, 2212 of the closed cell 2218 increase, and the apex angles 2228, 2230 of the laterally-directed apices 2224, 2226 decrease. In some examples, it should also be understood that when the cell height 2220 of the closed cell 2218 is decreased and the cell width 2222 is increased, the curvature of the deformed sections (e.g., sections 2232, 2234) of the strut element (e.g., strut element 2202) increases. Such an increase in curvature is shown in the comparison of FIGS. 5A - 7A. As shown, the curvature of the deformed sections 2232, 2234 is increased (i.e., more curved) in FIG. 6A compared to FIG. 5A. Similarly, as shown, the curvature of the deformed sections 2232, 2234 is increased (i.e., more curved) in FIG. 7A compared to FIG. 6A. Similarly, in some examples, it should also be understood that when the cell height 2220 of the closed cell 2218 is decreased and the cell width 2222 is increased, the relative angle between the strut element 2202 and the transverse datum 5000 extending along the width profile of the closed cell 2218 between the laterally-directed apices transitions from a non-parallel positive angle 5002 to a zero angle 5004 (e.g., parallel relationship) and a non-parallel negative angle 5006.

[0101] In some examples, the deformed sections (e.g., 2232 and 2234) of the strut elements (e.g., 2102 and 2202) act as living hinges in that these deformed regions allow the strut elements to pivot or change angle with respect to the intersection regions (e.g., Pd and Pp), and also allow the strut elements to change angle with respect to each other. In some examples, one or more of the first and second regions 2100, 2200 of the support structure 2000 are formed by laser cutting a tube such as a nitinol tube. In various examples, the second region 2200 (and optionally the first region 2100) is shape set in an intermediate state such that the second region 2200 is configured to self-expand towards an intermediate diameter or profile in the intermediate state. According to one example, the support structure 2000 is cut from a nitinol tube with an outer diameter of 6 mm and shape set to an outer diameter of 24 mm. The support structure 2000 is collapsed to a delivery diameter of 24 mm to 6 mm. The final deployed diameter of the support structure 2000 can be 29 mm or more. These dimensions are intended to be merely examples and various shapes and sizes are contemplated.

[0102] In some examples, one or more of the first and second regions 2100, 2200 of the support structure 2000 can be formed such that the intersection points (e.g., Pd and Pp) define an intersection hub to which the strut elements are coupled. For example, in some examples, one or more strut elements forming each of the first and second regions 2100, 2200 of the support structure 2000 are coupled to the hub at a reduced cross-section region (e.g., an end section) such that the strut elements are operable to pivot around the hub without requiring substantial deformation of the more central sections of the strut elements, thereby reducing strain on the strut elements. This feature can be particularly useful during longitudinal compression, and such a feature can also serve to minimize or reduce elastic rebound from a longitudinally compressed configuration due to the energy accumulated in the strut elements by longitudinal compression of the second region 2200.

[0103] It should also be understood that the support structure 2000 can be shaped into any of the configurations discussed herein, initially including a delivery configuration, a deployed configuration, or any configuration therebetween (e.g., a partially deployed configuration). For example, in some instances, the support structure 2000 can be shaped into a partially deployed configuration, where the prosthetic valve 1000 is compressed into a delivery configuration (e.g., stored potential energy), and the fully deployed configuration requires mechanically expanding the prosthetic valve 1000 beyond the shaping configuration. In some instances, mechanically expanding the prosthetic valve 1000 beyond the shaping configuration requires one or more of radially expanding a first region 2100 and radially expanding and axially compressing a second region 2200. In some instances, radially expanding and axially compressing the second region 2200 requires mechanical intervention, such as one or more axial tension screws, to engage one or more portions of the prosthetic valve and move the proximal and distal end regions 2236, 2238 of the support structure 2000 closer to each other as they are in the delivery configuration. Additionally or alternatively, the mechanical intervention can include using one or more suture elements or tethers to pull the proximal and distal end regions 2236, 2238 of the support structure 2000 together. In some instances, the mechanical intervention means described above can be used to secure the support structure 2000 (and thus the prosthetic valve 1000) in the fully deployed configuration.

[0104] In various examples, the prosthetic valve 1000 includes a locking mechanism for securing the second region 2200 in an axially or longitudinally compressed state. The locking mechanism can include components (e.g., integrally formed therewith) secured to the second region 2200 of the support structure 2000 that interact with each other during collapse of the cells formed by the second region 2200 of the support structure 2000. A locking mechanism associated with a cell or set of cells can lock and hold the corresponding cells in a collapsed configuration. Additional exemplary locking mechanisms are contemplated. In some designs, the locking mechanism is configured to engage the first region 2100, the second region 2200, or both the first region 2100 and the second region 2200. Various systems and methods are contemplated for securing or maintaining at least a portion of the prosthetic valve 1000 in a longitudinally compressed state.

[0105] FIG. 9 shows a locking mechanism 7000 that can be incorporated into one or more rows of one or more cells of the second region 2200 to lock the second region 2200 longitudinally in a longitudinally compressed state. As shown, the locking mechanism 7000 includes a first locking component 7010 and a second locking component 7020. The first locking mechanism and the second locking components 7010, 7020 each project inwardly, optionally, from opposing vertices within the cell. The first locking component 7010 includes a first sliding surface 7012 and the second locking component 7020 includes a second sliding surface 7022. The first component 7010 and the second component 7020 slide relative to each other and elastically flex outwardly relative to each other during longitudinal compression of the second region 2200.

[0106] As shown, first and second locking components 7010, 7020 each form a first receiver 7014 and a second receiver 7024. And as shown, first and second locking components 7010, 7020 each include a first protrusion 7016 and a second protrusion 7026. When the first and second locking components 7010, 7020 slide far enough, the first and second protrusions 7016, 7026 slide past each other such that the first and second locking components 7010, 7020 can return towards each other, with the first protrusion 7016 sliding into the first receiver 7014 and the second protrusion 7026 sliding into the second receiver 7024, thereby locking the first and second locking components 7010, 7020 together and locking the associated cells in a longitudinally compressed state. As previously referenced, any number of locking mechanisms 7000 can be incorporated into the second region 2200 to facilitate locking various rows of closed cells in a more closed or longitudinally compressed state.

[0107] FIG. 10 shows another embodiment of a locking mechanism 7000 that can be incorporated into an artificial valve 1000 (not shown), either as an integrated component or as a separate component that can be coupled to the support structure 2000, as described with reference to several embodiments. As shown, the locking mechanism 7000 includes a proximal end 7102, a distal end 7104, and a body 7106. The distal end 7104 of the locking mechanism 7000 can include a coupling portion 7108 operable to be coupled or connected to the artificial valve 1000. In some embodiments, the locking mechanism 7000 is integrated with the artificial valve 1000 and the distal end 7104 extends from the artificial valve 1000 (e.g., extends from the support structure 2000). The proximal end 7102 of the locking mechanism 7000 includes a fixed portion 7110 operable to engage a second region 2200 of the artificial valve 1000. As shown, the fixed portion 7110 engages a portion of the second region 2200 and is thus operable to hold the second region 2200 in a longitudinally compressed configuration.

[0108] As shown in FIG. 10, in one embodiment, the coupling portion 7108 of the locking mechanism 7000 can extend from the body 7106 to form an aperture 7112. In some embodiments, the aperture 7112 is completely surrounded (as shown in FIG. 12), or in other examples, the aperture 7112 is partially surrounded (as shown in FIG. 13). In some examples, the distal tip is disposed adjacent to or adjacent to the body 7106 (e.g., the aperture 7112 is partially surrounded). In other words, the coupling portion 7106 includes a profile that is operable to engage or couple with the prosthetic valve 1000. The profile of the coupling portion 7106 corresponds to the profile of the portion of the prosthetic valve 1000 to which the coupling portion 7106 is fixed. Further, the coupling portion 7106 can include a fixing structure such as a barb to fix the locking mechanism 7000 to the prosthetic valve 1000, for example, when a winding frame is provided on the prosthetic valve 1000. For example, the barb can extend around a portion of the winding frame such that the longitudinal movement of the coupling portion 7106 relative to the winding frame at the coupling portion is restricted. In other examples, the distal tip is coupled to the body 7106 (e.g., welded, adhered, or otherwise coupled to the body), or the aperture 7112 is formed directly in the body 7106 of the locking mechanism 7000 at the distal end 7104.

[0109] In some embodiments, the aperture 7112 can have a shape complementary to the cross-sectional shape of the strut element 2202. For example, the aperture 7112 can have a shape that is substantially rectangular or square. However, it should be apparent that the aperture can take various shapes suitable for facilitating the coupling with the support structure 2000. In some embodiments, the coupling portion 7108, and in some embodiments, the aperture 7112, can be in the form of a hook or any other operable shape as shown with reference to the fixing portion 7110.

[0110] Referring further to FIG. 10, in some embodiments, the proximal end 7102 includes a fixed portion 7110 operable to selectively engage or couple to a second region 2200 of the artificial valve 1000. As shown, the fixed portion 7110 can include a fixed arm 7113. The fixed arm 7113 can extend from the body 7106 such that an angle 7114, for example, greater than 0 degrees and less than 180 degrees, is formed between the body 7106 and the fixed arm 7113. In some embodiments, the angle 7114 is an acute angle or a right angle. In some embodiments, the angle 7114 is from about 1 degree to about 90 degrees. In some embodiments, the angle 7114 is about 15 degrees, about 20 degrees, about 22.5 degrees, 25 degrees, about 30 degrees, about 31.5 degrees, about 35 degrees, about 37.5 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 62.5 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees. In some embodiments, the intersection of the body 7106 and the fixed arm 7113 can include a linear profile or a curved profile.

[0111] In some embodiments, the fixed arm 7113 includes a compression member retainer 7116. The compression member retainer 7116 is operable to hold or couple a portion of a support structure 2000 (not shown) for compressing the second region 2200 of the artificial valve 1000. The compression member retainer 7116 can include a hook, an eyelet, a groove, or a wall for engaging a compression member 7500, and the compression member 7500 engages the support structure 2000 during compression. As seen in FIG. 10, the compression member retainer can include a hook, where an inner wall 7118 of the hook is formed under an inner surface 7120 of the fixed arm 7113, and the difference between the inner surface 7120 of the fixed arm 7113 and the inner wall 7118 of the hook forms a notch 7122 having a notch depth 7124. The hook can extend around an inner arc. In some embodiments, the inner arc is completely enclosed (e.g., when the compression member retainer 7116 includes an eyelet).

[0112] Referring now to FIG. 12, the locking mechanism 7000 can be coupled to the prosthetic valve 1000. For example, the coupling portion 7108 of the locking mechanism 7000 can be coupled to the strut element 2202 of the second region 2200 of the prosthetic valve 1000, although the locking mechanism 7000 can be coupled to other portions, such as being coupled to the first region 2100 or being coupled to the prosthetic valve 1000 at the boundary between the first and second regions 2100, 2200. The locking mechanism 7000 can be disposed relative to the prosthetic valve 1000 such that the body 7106 of the locking mechanism 7000 is outside of the portion of the prosthetic valve 1000 where the locking mechanism 7000 is disposed (e.g., so as to keep the locking mechanism 7000 out of the internal blood flow path of the prosthetic valve 1000). In other embodiments, the locking mechanism 7000 is disposed inside the prosthetic valve 1000, as seen in FIGS. 14 and 15. In some embodiments, the coupling portion 7108 is coupled to the strut element 2202 disposed at the boundary between the first and second regions 2100, 2200. The fixing portion 7110 can engage the proximal end 2004 of the second region 2200 of the prosthetic valve 1000. When the fixing portion 7110 engages the proximal end 2004 of the second region 2200 of the prosthetic valve 1000, the second region 2200 is held in a longitudinally compressed configuration by the locking mechanism 7000.

[0113] Figures 16a - 16e show, according to some examples, a compression sequence for longitudinally compressing the second region 2200 of the prosthetic valve 1000 and holding the second region 2200 in a compressed configuration when implementing the locking mechanism 7000. As shown, the locking mechanism 7000 is coupled to the strut element 2202 of the prosthetic valve 1000 via the coupling portion 7108. A compression member 7500, such as a string, fiber, line, or cord having a distal end (not shown) and a proximal end 7504, is coupled to the compression member retainer 7116. The compression member 7500 can include fibers that are doubled back on themselves such that the distal or proximal end represents the central portion of the length of the fiber, meaning that the distal or proximal end represents the position of the compression member 7500 relative to the system (e.g., the fiber can be looped over the locking mechanism). For example, the proximal end 7504 is coupled to the locking mechanism 7000 and the distal end is held, tensioned, pulled, or otherwise actuated by an operator of the deployment system. The compression member 7500 can be disposed within the notch 7122 of the compression member retainer 7116 or, in other embodiments including an eyelet or the like, at an appropriate position on the compression member retainer 7116, as seen in FIGS. 16a - 16e. The compression member 7500 is operable to extend from the compression member retainer 7116 toward the proximal end 2004 of the second region 2200 of the prosthetic valve 1000 that is internal to the prosthetic valve 1000. In some examples, the compression member 7500 is disposed around the end of the proximal end 2004 of the second region 2200 of the prosthetic valve 1000 and then extends toward and beyond the outflow end 1002 of the prosthetic valve 1000 to the operator of the delivery system.

[0114] When the distal end of the compression member 7500 advances away from the artificial valve 1000, the portion of the compression member 7500 that contacts the proximal end 2004 of the second region 2200 of the artificial valve 1000 compresses the second region 2200 longitudinally. As seen in FIG. 16a, the inner wall 7118 of the notch 7122 can, more generally, help maintain the engagement of the compression member retainer 7116 with the notch 7122 and the fixed portion 7110, even when the compression member retainer 7116 is disposed at an acute angle relative to the fixed portion 7110.

[0115] As also seen in FIG. 16A, the force applied across the compression member 7500 can deflect the body 7106 of the locking mechanism 7000 away from the inner surface of the artificial valve 1000. This facilitates displacement such that the fixed portion 7110 moves away from the second region 2200 during the compression process, and thus the locking mechanism 7000 can advance or compress the second region 2200 without interference. Further, in some examples, the force applied across the compression member 7500 is transmitted to the locking mechanism 7000 and the fixed portion 7110 can also deflect relative to the body 7106 (as seen, for example, in FIG. 16C). Thus, the compression member retainer 7116 can be shaped to ensure that the compression member 7500 is not released from engagement before the compression member 7500 locks. Note that the locking mechanism 7000, and more specifically the fixed portion 7110, is shaped to allow deflection and relative sliding of the fixed portion 7110 with respect to the second region 2200 of the artificial valve 1000. This can include a curved profile / or an inclined or angled surface. It is understood that the compression member 7500 can also function as an inclined path or guide while the second region 2200 is being compressed, allowing the locking mechanism 7000 to engage properly with the artificial valve 1000.

[0116] Referring now to FIGS. 16C and 16D, when the compression member 7500 is actuated such that the proximal end 2004 of the second region 2200 of the artificial valve 1000 moves toward the outflow end 1002 of the artificial valve 1000, the second region 2200 is compressed. When the distal end of the compression member 7500 is disposed in proximity to the proximal end 2004 of the second region 2200, the outer surface of the compression member 7500 and / or the fixed portion 7110 enables the fixed portion to slide beyond the inner edge of the proximal end 2004 of the second region 2200 of the artificial valve 1000. The compression member retainer 7116 can be shaped to maintain engagement with the compression member 7500 until the fixed portion 7110 is fully secured to the proximal end 2004 of the second region 2200. Thus, as the compression member 7500 continues to be actuated and the fixed portion 7110 moves beyond the inner edge of the proximal end 2004 of the second region 2200, the fixed portion 7110 is moved outwardly of the second region 2200. At least a portion of the compression member retainer 7116 can act to engage or secure to the outside of the second region 2200. In some embodiments, the compression member retainer 7116 is configured to release the compression member 7500 such that the fixed portion 7110 engages the proximal end 2004 of the second region 2200, such that the proximal end 2004 seats within or against the fixed portion 7110. In other embodiments, the compression member 7500 can be manually released by removing one of the looped ends of the compression member 7500 to enable the compression member to slide through the compression member retainer 7116. As described above, the locking mechanism 7000 can be disposed external to the second region 2200 along with the body 7106. Thus, the above process is also applicable except that the locking mechanism 7000 is actuated such that the compression member 7500 engages by moving inwardly beyond the outside of the second region 2200.

[0117] Figures 17A - 17C provide another view of the second region 2200 during compression. A plurality of compression members 7500 can be implemented at various points around the artificial valve 1000 in combination with a plurality of locking mechanisms 7000 at various points around the artificial valve 1000. For example, the locking mechanisms 7000 can be disposed at various locations around the artificial valve 1000, where the locking mechanisms are implemented in multiples of 3 (e.g., 3, 6, 9, 12, or 24 locking mechanisms). It should be understood that any number of locking mechanisms 7000, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, or more, can be implemented with the artificial valve 1000. The guide member 8000 can be used in combination to provide stability, directionality, and controllability of the compression members 7500 during compression of the second region 2200. As can be seen in Figures 17A - 17C, when the second region 2200 is compressed, the second region 2200 expands radially outwardly, which, in some embodiments, occurs starting from the longitudinal center of the second region 2200. It is within the scope of the present disclosure to include various compression members 7500 and locking mechanisms having different lengths and coupled at various positions along the length of the second region 2200, such that when the compression members 7500 are actuated, radial expansion of the second region 2200 begins and continues to occur. For example, compression can first occur at the proximal end 2004 of the second region 2200.

[0118] As described above, the first region 2100 and the second region 2200 are joined together. Thus, when the second region 2200 is compressed longitudinally and as a result expands radially, the first region 2100 is also adjusted. In some embodiments, this can result in a first region 2100 having a tapered shape in which a first diameter of the first region 2100 at the location where the first region and the second region 2100, 2200 are joined is larger than a second diameter of the first region 2100 at the outflow end 1002 of the artificial valve 1000, as can be seen in FIG. 15. Thus, when the valve tip attachment region is fully contained within the first region 2100, the operation and engagement of the valve tip is enhanced during operation at the first region 2100 at the boundary of the first and second regions 2100, or in both the first and second regions.

[0119] It is understood that the locking mechanism 7000 can be formed from any suitable material including, but not limited to, nitinol, metal alloys, polymers, etc. The compression member 7500 can function in combination with or separately from the locking mechanism 7000 to maintain the second region 2200 in a longitudinally compressed state, i.e., to maintain the second region 2200 in a longitudinally compressed position when the compression member is locked to the artificial valve 1000.

[0120] Although the locking mechanism 7000 is shown and described in connection with an artificial valve, it is to be understood that the locking mechanism is applicable to any of a variety of expandable (e.g., self-expanding) and expandable support structures, including a tubular framework defining a pattern of cells.

[0121] Valve tip material

[0122] In various examples, the valve tip or valve tip construct is formed from a biocompatible synthetic material (e.g., ePTFE and ePTFE composite materials, or including other materials as desired). In other examples, the valve tip construct 104 is formed from natural materials such as reclaimed tissue including bovine tissue, porcine tissue, etc.

[0123] As used herein, the term "elastomer" refers to a polymer or mixture of polymers having the ability to be stretched to at least 1.3 times its original length and rapidly contract to approximately its original length when released. The term "elastomeric material" refers to a polymer or mixture of polymers that exhibits elongation and recovery characteristics similar to those of an elastomer, although not necessarily to the same degree of elongation and / or recovery. The term "non-elastomeric material" refers to a polymer or mixture of polymers that does not resemble either an elastomer or an elastomeric material, i.e., is considered not to be an elastomer or an elastomeric material, and exhibits elongation and recovery characteristics.

[0124] According to some embodiments of the present specification, the valve tip includes a composite material having at least one porous synthetic polymer membrane layer having a plurality of pores and / or spaces, and an elastomer and / or an elastomeric material filling the pores and / or spaces of the at least one synthetic polymer membrane layer. According to another example, the valve tip further includes a layer of an elastomer and / or an elastomeric material and / or a non-elastomeric material on the composite material. According to an example, the composite material includes a porous synthetic polymer membrane in the range of about 10% to 90% by mass.

[0125] Examples of the porous synthetic polymer membrane include expanded (expanded, expanded, stretched or foamed) fluoropolymer membranes having a node and fibril structure defining pores and / or spaces. In some examples, the expanded fluoropolymer membrane is an expanded polytetrafluoroethylene (ePTFE) membrane. Another example of the porous synthetic polymer membrane includes a microporous polyethylene membrane.

[0126] Examples of elastomers and / or elastomeric materials and / or non-elastomeric materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymers), (per)fluoroalkyl vinyl ethers (PAVE), urethanes, silicones (organopolysiloxanes), silicon-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and respective copolymers or mixtures thereof. In some examples, the TFE / PMVE copolymer is an elastomer essentially comprising 60 to 20 weight percent tetrafluoroethylene and 40 to 80 weight percent perfluoromethyl vinyl ether, respectively. In some examples, the TFE / PMVE copolymer is an elastomeric material essentially comprising 67 to 61 weight percent tetrafluoroethylene and 33 to 39 weight percent perfluoromethyl vinyl ether, respectively. In some examples, the TFE / PMVE copolymer is a non-elastomeric material essentially comprising 73 to 68 weight percent tetrafluoroethylene and 27 to 32 weight percent perfluoromethyl vinyl ether, respectively. The TFE and PMVE components of the TFE-PMVE copolymer are expressed in wt%. For reference, 40, 33 - 39, and 27 - 32 wt% of PMVE correspond to 29, 23 - 28, and 18 - 22 mol%, respectively.

[0127] In some examples, the TFE-PMVE copolymer exhibits elastomeric, elastomeric and / or non-elastomeric properties.

[0128] In some examples, the composite material further comprises a layer or coating of a TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and from about 27 to about 32 weight percent perfluoromethyl vinyl ether, respectively.

[0129] In some examples, the valve tip is an expanded polytetrafluoroethylene (ePTFE) membrane that has absorbed a TFE-PMVE copolymer comprising from about 60 to about 20 weight percent tetrafluoroethylene and from about 40 to about 80 weight percent perfluoromethyl vinyl ether, respectively, and the valve tip further comprises a coating of a TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and from about 27 to about 32 weight percent perfluoromethyl vinyl ether, respectively, on the blood contact surface.

[0130] As described above, the elastomer and / or elastomeric material can be combined with the expanded fluoropolymer membrane such that the elastomer and / or elastomeric material occupies substantially all of the void spaces or pores within the expanded fluoropolymer membrane.

[0131] Frame material

[0132] The frame can be formed by, among other suitable processes, etching, cutting, laser cutting, stamping, three-dimensional printing, or winding. The frame can be self-expanding or balloon-expandable (e.g., when configured for a transcatheter implant procedure) or non-expandable (e.g., when configured for a surgical implant procedure). The various frames can include any metal or polymer material, such as, but not limited to, an elastic (e.g., nitinol) or plastic (e.g., stainless steel) deformable metal or polymer material that is generally biocompatible. Other materials suitable for any of the frames described herein include, but are not limited to, other titanium alloys, stainless steels, cobalt nickel alloys, polypropylene, acetyl homopolymers, acetyl copolymers, extruded filled tubes (e.g., nitinol wire having a platinum core), or other alloys or polymers or any other material that is generally biocompatible and has sufficient physical and mechanical properties to function as a frame as described herein.

[0133] The embodiments and examples illustrated and described above are generally described in connection with a transcatheter approach, but it should be understood that various additional well-known delivery procedures can be utilized without departing from the spirit or scope of the present application, including surgical and laparoscopic approaches. Non-limiting delivery procedures include, among others, transseptal, transapical, left atriotomy, and transaortic approaches.

[0134] Furthermore, the concepts of the invention addressed herein have been described above both generally and with respect to specific examples. It will be apparent to those skilled in the art that various changes and modifications can be made in the examples without departing from the scope of the present disclosure. Similarly, various components described in the examples can be combined. Accordingly, it is intended that the examples be viewed as a whole to suggest various changes and modifications to these specific examples. (Aspect) (Aspect 1) A support structure for an implantable device, the support structure including a tubular body having a longitudinal axis, the tubular body including a first region that is annular in shape and characterized by a first transverse deformation resistance, and a second region that is annular in shape and characterized by a second transverse deformation resistance, wherein the second region includes a plurality of frame elements that define the annular shape of the second region, at least a portion of each of the plurality of frame elements having a reduced cross-sectional region including a radial width transverse to the longitudinal axis of the tubular body and a longitudinal thickness parallel to the longitudinal axis of the tubular body, the width of the reduced cross-sectional region being at least four times the thickness such that the second region exhibits a relatively higher degree of compressibility in the longitudinal direction than in the radial direction. (Aspect 2) The support structure according to aspect 1, wherein the second transverse deformation resistance is greater than the first transverse deformation resistance. (Aspect 3) The first region includes a plurality of frame elements that define an annular shape of the first region. Further, at least a part of each of the plurality of frame elements of the first region has a radial width that crosses the longitudinal axis of the tubular body and a longitudinal thickness parallel to the longitudinal axis of the tubular body. The width of each of the plurality of frame elements of the first region is less than four times the thickness of each of the plurality of frame elements of the first region. The support structure according to any one of aspects 1 to 2. (Aspect 4) The support structure according to any one of aspects 1 to 3, further comprising one or more valve tips coupled to the first region. (Aspect 5) The support structure according to aspect 4, wherein the one or more valve tips are formed from a natural material. (Aspect 6) The support structure according to aspect 4, wherein the one or more valve tips are formed from a synthetic material. (Aspect 7) A support structure for an implantable device, the support structure including a tubular body having a longitudinal axis, the implantable device being movable between a delivery configuration and a deployment configuration, the tubular body comprising a first region that is annular in shape and characterized by a first transverse deformation resistance, and a second region that is annular in shape and characterized by a second transverse deformation resistance, comprising The second region includes a plurality of frame elements that define an annular shape of the second region. The plurality of frame elements intersect each other to form a plurality of cells. Each of the plurality of cells defines a longitudinal apex that is longitudinally directed along the longitudinal axis of the support structure and a lateral apex that crosses the longitudinal apex and is directed along the perimeter of the support structure. Further, in the deployment configuration, the longitudinal apex defines an obtuse angle and the lateral apex defines an acute angle. The support structure. (Aspect 8) Each of the plurality of cells defines a pair of longitudinal vertices that point in the longitudinal direction and a pair of lateral vertices that point along the circumferential direction. Further, in the deployed configuration, each of the longitudinal vertices defines an obtuse angle, and each of the lateral vertices defines an acute angle, the support structure according to Aspect 7. (Aspect 9) Each pair of lateral vertices of the plurality of cells defines a circumferential center line of the plurality of cells that extends between the pairs of lateral vertices of each of the plurality of cells. Further, at least a portion of the frame element defines a pair of longitudinal vertices of each of the plurality of cells that intersect the circumferential center line of each of the plurality of cells, the support structure according to Aspect 8. (Aspect 10) The obtuse angle defined by each longitudinal vertex of the deployed configuration exceeds 150 degrees, the support structure according to Aspect 9. (Aspect 11) The obtuse angle defined by each longitudinal axis exceeds 180 degrees, the support structure according to Aspect 9. (Aspect 12) The second transverse deformation resistance is greater than the first transverse deformation resistance, the support structure according to any one of Aspects 9 to 11. (Aspect 13) A method of implanting an artificial valve, Advancing an artificial valve to a target region within a patient's anatomical structure in a delivery configuration, where the artificial valve includes a support structure having an annular shape and a first region characterized by a first transverse deformation resistance, and an annular shape and a second region characterized by a second transverse deformation resistance, the second region including a plurality of frame elements, the plurality of frame elements intersecting each other to form a plurality of cells, each of the plurality of cells defining a longitudinal vertex that points longitudinally along the longitudinal axis of the support structure, and a lateral vertex that traverses the longitudinal vertex and points along the perimeter of the support structure, where, in the delivery configuration, the longitudinal vertex defines an acute angle and the lateral vertex defines an obtuse angle, and, Deploying the artificial valve such that the longitudinal vertex defines an obtuse angle and the lateral vertex defines an acute angle A method comprising (Aspect 14) The method according to aspect 13, wherein the obtuse angle of the longitudinal vertex is at least 180 degrees. (Aspect 15) The method according to aspect 13, wherein the obtuse angle of the longitudinal vertex exceeds 180 degrees. (Aspect 16) A method of forming a support structure for an artificial valve, comprising: Cutting out a pattern of closed cells from a tube to form a support structure having a first diameter and a length; Expanding the first diameter of the support structure from the first diameter to a second diameter; Axially compressing a portion shorter than the entire length of the support structure to form a first region and a second region; and Heat setting the support structure having the first region and the second region such that the first region is characterized by a first transverse deformation resistance and the second region is characterized by a second transverse deformation resistance different from the first transverse deformation resistance. Including Each closed cell is defined by a plurality of frame members, The first region includes a first plurality of cells and the second region includes a second plurality of cells, and the shape of the cells in the second plurality of cells is different from the shape of the cells in the first plurality of cells. (Aspect 17) The method according to aspect 16, wherein the cells of the support structure have the same shape before axially compressing a portion shorter than the entire length of the support structure to form the first region and the second region. (Aspect 18) A support structure for an implantable device, the support structure including a framework defining a plurality of cells and at least one locking mechanism disposed within a corresponding one of the plurality of cells, the locking mechanism including: A first locking component protruding into the corresponding cell; and A second locking component protruding toward the first locking component. including the first locking component includes a first sliding surface and a first protrusion, defining a first receiver, the second locking component includes a second sliding surface and a second protrusion, defining a second receiver, the first locking component and the second locking component are configured such that during collapse of the corresponding cell, the first sliding surface and the second sliding surface slide relative to each other to facilitate receipt of the first protrusion in the second receiver and the second protrusion in the first receiver, locking the locking mechanism and holding the corresponding cell in the collapsed configuration, a support structure. (Aspect 19) the support structure according to aspect 18, wherein the support structure is included as part of an artificial valve. (Aspect 20) the support structure according to aspect 18, wherein the support structure is a stent structure. (Aspect 21) the support structure according to any one of aspects 18 to 20, wherein the first sliding surface and the second sliding surface elastically deflect the first locking component and the second locking component during collapse of the corresponding cell. (Aspect 22) the support structure according to any one of aspects 18 to 21, wherein the first locking component and the second locking component are symmetric in shape. (Aspect 23) the support structure according to any one of aspects 18 to 22, wherein the first locking component and the second locking component are integrally formed with the support structure. (Aspect 24) A support structure for an implantable device, the support structure defining a longitudinally compressible portion having a distal end and a locking mechanism associated with the support structure, the locking mechanism comprising a body having a first end and a second end, a fixed portion disposed at the second end of the body, A support structure including the same, wherein the fixed portion is operable to selectively engage the distal end of a longitudinally compressible portion of the support structure. (Aspect 25) The support structure according to aspect 24, wherein the locking mechanism further includes a compression member retainer configured to hold a compression member. (Aspect 26) The support structure according to aspect 25, wherein the compression member retainer is configured to release the compression member when the fixed portion engages the distal end of the longitudinally compressible portion of the support structure. (Aspect 27) The support structure according to any one of aspects 24 to 26, wherein the fixed portion is disposed at an acute angle with respect to the body of the locking mechanism. (Aspect 28) The support structure according to any one of aspects 24 to 27, wherein the locking mechanism further includes a coupling portion disposed at a first end of the body of the locking mechanism. (Aspect 29) The support structure according to aspect 28, wherein the coupling portion is configured to couple to the support structure. (Aspect 30) A method for treating a human patient having a diagnostic condition or disease associated with mitral valve regurgitation or valvular insufficiency, the method comprising implanting the prosthetic valve according to any one of aspects 1 to 12, 18 to 29 at or adjacent to the position of the native valve.

Claims

1. A support structure for an implantable device, the support structure including a tubular body having a longitudinal axis, the implantable device being movable between a delivery configuration and a deployed configuration, the tubular body including: a first region that is annular in shape and characterized by a first transverse deformation resistance, and a second region that is annular in shape and characterized by a second transverse deformation resistance, wherein the second region includes a plurality of frame elements that define the annular shape of the second region, the plurality of frame elements intersecting each other to form a plurality of cells, each of the plurality of cells defining a longitudinal vertex that extends longitudinally along the longitudinal axis of the support structure and a lateral vertex that crosses the longitudinal vertex and extends along the perimeter of the support structure, and further, in the deployed configuration, the longitudinal vertex defines an angle greater than 180 degrees and the lateral vertex defines an acute angle. A support structure.

2. Each of the plurality of cells defines a pair of longitudinal vertices that extend longitudinally and a pair of lateral vertices that extend circumferentially, and further, in the deployed configuration, each of the longitudinal vertices defines an angle greater than 180 degrees and each of the lateral vertices defines an acute angle. The support structure according to claim 1.

3. Each pair of lateral vertices of the plurality of cells defines a circumferential centerline of the plurality of cells that extends between the pairs of lateral vertices of each of the plurality of cells, and further, at least a portion of the frame elements defines a pair of longitudinal vertices of each of the plurality of cells that intersects the circumferential centerline of each of the plurality of cells. The support structure according to claim 2.

4. The second transverse deformation resistance is greater than the first transverse deformation resistance. The support structure according to any one of claims 2 to 3.

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