Built-in prosthesis with interlocking stent with variable stiffness

Abstract

This document discloses an embedded prosthesis having a length, a first end, a second end, and a longitudinal axis, wherein the embedded prosthesis can expand from a compact delivery configuration to an enlarged deployment configuration. The embedded prosthesis includes multiple rows of support elements along its length, wherein the multiple rows include a first row and a second row adjacent to the first row. The first row of support elements has a first plurality of alternating vertices, while the second row of support elements has a second plurality of alternating vertices. The first plurality of alternating vertices and the second plurality of alternating vertices define spaced-apart interlocking structures. The embedded prosthesis also includes a discontinuous mesh material comprising multiple mesh elements spaced apart from each other and interconnecting the first plurality of alternating vertices and the second plurality of alternating vertices. The multiple mesh elements are arranged along a first common periphery such that, when the embedded prosthesis is in the enlarged deployment configuration, the multiple mesh elements restrict torsional and axial compression of the embedded prosthesis between the first row of support elements and the second row of support elements.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of provisional patent application No. 62 / 963917, filed on January 21, 2020, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to implantable medical devices, and more specifically to implantable stents having adjacent stent elements with flexible connections. Background Technology

[0004] Implantable stents typically need to have a small, compact diameter for insertion into the intended body conduit, usually via a catheter to the desired site for expansion, where the stent expands to a larger diameter. Capsule-expandable stents utilize an inflatable capsule for expansion. Self-expanding stents are confined to a compact diameter by a restraining sleeve or other means and spring open upon release. Self-expanding stents are typically formed from biocompatible shape-memory materials or hyperelastic materials. Nickel-titanium alloy stents are a commonly used material for self-expanding stents.

[0005] The development of implantable stents includes the use of tubular coverings fitted onto the stent. Covered stents are generally referred to as stent grafts. As an alternative to continuous or substantially continuous coverings (e.g., substantially fluid-impermeable coverings), flexible elements (e.g., membrane or diaphragm materials) can be used to interconnect stent elements while leaving openings between the flexible elements. U.S. Patent No. 8,926,688 to Burkart et al., entitled "Stent Having Adjacent Elements Connected by Flexible Webs," describes such an alternative to covered stents. Burkart et al. describe a stent encompassing flexible, preferably aggregated connecting elements, wherein these elements connect adjacent, spaced-apart stent elements.

[0006] Generally, a fully covered scaffold graft can be considered to have a surface area equal to the periphery of the expanded scaffold multiplied by the scaffold length (hereinafter referred to as A). 最大 For a conventional open-frame scaffold (unlike scaffold grafts), the surface area represented by all scaffold elements is only the maximum surface area A. 最大 A small portion. The actual surface area covered by the support, that is, the area covered by all components of the support (including connecting elements) in its deployed state, is A. 支架The porosity index, or PI, describes the open (or unopened) area (the portion of the largest surface area not covered by all the components of the support assembly) as a percentage of the maximum surface area, where: PI = 1 - (A) 支架 / A 最大 ))×100%.

[0007] Measure the actual surface area covered by the support (A) 支架 Some methods involve the use of machines supplied by Visicon Inspection Technologies, LLC (Napa, California). Visicon Finescan TM The scaffold inspection system (Visicon Finescan model 85) uses a 6000-pixel line scan camera to generate a planar unfolded view of the scaffold. In operation, the scaffold is mounted on a sapphire mandrel with a finely diffused surface. This mandrel is held below the line scan camera and rotated by the system electronics to trigger the camera to collect one line of image data precisely, line by line. After a complete rotation, the entire image of the scaffold is acquired. Once the entire scaffold has been imaged, the software distinguishes the scaffold with its covering from the background. The total number of image elements (pixels) is compared to the total number of pixels related to the scaffold and its covering to determine A. 支架 The basic settings used on such a defined machine are (for example): light, 100%; exposure, 0.3 ms / line; gain, 5; threshold, 50; noise filter, 20; smoothness (flattening), 4.

[0008] An open (opening) region can be a continuous single space, such as the space between the windings of a single helically wound support element. Similarly, an open (opening) region can be represented by the space between multiple individual annular or loop-shaped support elements. An open (opening) region can also be a single support element (e.g., the one granted to Palmaz in U.S. Patent No. 4,776,337). Figure 1B and 2B The area is represented by the total area of ​​the multiple holes provided by multiple support elements (as shown) or multiple holes provided. If multiple holes are provided, they can be the same or different sizes. In addition to metal support elements, the use of perforated graft coverings or polymer elements can also reduce the opening (open area).

[0009] A stent with a porosity index greater than 50% is considered to be a substantially open (open) stent.

[0010] In addition to the porosity index, if the aim is to cover only a portion of the stent area for a specific stent application, the size of any pores providing open areas must be considered. For multiple pores, the maximum size of any single pore must generally be considered, especially if the pores are to provide a "filtration" effect, thereby controlling or restricting the flow space of biomaterial from the lumen wall into the body's tubular space.

[0011] Various support devices combining metal support elements with polymer connecting elements are known; see, for example, U.S. Patent No. 5,507,767 to Maeda et al. Another is a support with a flexible knitted sleeve having small openings in the form of chain-link fences, from InspireMD Ltd. (4 Derech Hashalom Street, Tel Aviv 67892, Israel). Summary of the Invention

[0012] According to one example (“Example 1”), an embedded prosthesis has a length, a first end, a second end, and a longitudinal axis, wherein the embedded prosthesis can expand from a compact delivery configuration to an enlarged deployment configuration. The embedded prosthesis includes multiple rows of support elements along its length, wherein the multiple rows include a first row and a second row adjacent to the first row. The first row of support elements has a first plurality of alternating vertices, and the second row of support elements has a second plurality of alternating vertices. The first plurality of alternating vertices and the second plurality of alternating vertices define spaced-apart interlocking structures (configurations). The embedded prosthesis also includes a discontinuous mesh material (material mesh) comprising a plurality of mesh elements spaced apart from each other and interconnecting the first plurality of alternating vertices and the second plurality of alternating vertices. The plurality of mesh elements are arranged along a first common periphery such that, when the embedded prosthesis is in the enlarged deployment configuration, the plurality of mesh elements restrict torsional and axial compression of the embedded prosthesis between the first row of support elements and the second row of support elements.

[0013] According to another example (“Example 2”) further relative to Example 1, the discontinuous mesh material also includes a second plurality of mesh elements spaced apart from each other and interconnecting the first plurality of alternating vertices and the second plurality of alternating vertices. The second plurality of mesh elements are arranged along a second common perimeter longitudinally spaced from the first common perimeter, such that when the implanted prosthesis is in an expanded unfolded configuration, the second plurality of mesh elements restrict the twisting and elongation of the implanted prosthesis between the first row of support elements and the second row of support elements.

[0014] According to another example (“Example 3”) that is further than Example 1 or 2, the discontinuous mesh material is a polymer film that defines a plurality of pores between the first row of support elements and the second row of support elements.

[0015] According to another further example (“Example 4”) relative to any of Examples 1 to 3, a plurality of mesh elements and an optional second plurality of mesh elements each extend at an angle offset relative to the periphery of the built-in prosthesis (extending at an angle offset).

[0016] According to another further example (“Example 5”) relative to any of Examples 1 to 4, circumferentially adjacent mesh elements in a plurality of mesh elements extend relative to each other at alternating opposite angles.

[0017] According to another further example (“Example 6”) relative to any of Examples 1 to 5, when the built-in prosthesis is in an expanded unfolded configuration, a plurality of mesh elements and an optional second plurality of mesh elements each extend at an acute angle relative to the periphery of the built-in prosthesis.

[0018] According to another further example (“Example 7”) relative to any of Examples 1 to 6, when the built-in prosthesis is in an expanded unfolded configuration, a plurality of mesh elements each extend at an obtuse angle relative to the longitudinal axis of the built-in prosthesis.

[0019] According to another further example (“Example 8”) relative to any of Examples 1 to 3, a plurality of mesh elements and an optional second plurality of mesh elements each extend along the periphery of the built-in prosthesis.

[0020] According to another further example (“Example 9”) relative to any of Examples 1 to 7, a first row of support elements and a second row of support elements, along with a plurality of mesh elements interconnecting a first plurality of alternating vertices and a second plurality of alternating vertices of the first row of support elements and the second row of support elements, are located within a first segment along the length of the implant. Furthermore, a second segment of the implant along the length of the implant includes a third row of support elements having alternating vertices and a fourth row of support elements having alternating vertices. When the implant is in an expanded deployment configuration, the third and fourth rows define a spaced-apart arrangement. The implant includes a second discontinuous mesh material interconnecting the third and fourth rows of support elements, such that when the implant is in an expanded deployment configuration, the implant is axially compressible between the third and fourth support elements.

[0021] According to another example (“Example 10”) that is further relative to Example 9, the second discontinuous mesh material includes a plurality of mesh elements, each mesh element extending at an acute angle relative to the longitudinal axis of the built-in prosthesis.

[0022] According to another example (“Example 11”) that is further than Example 9 or 10, the first segment is adjacent to the first end of the implant, and the second segment is located closer to the midpoint between the first end and the second end of the implant than the first segment.

[0023] According to another further example (“Example 12”) relative to any of Examples 9 to 11, when the built-in prosthesis is in an expanded unfolded configuration, the built-in prosthesis has greater axial stiffness (rigidity) in the first section than in the second section.

[0024] According to another further example (“Example 13”) relative to any of Examples 9 to 12, the implanted prosthesis also includes a third segment toward a second end of the implanted prosthesis, the third segment having the same axial stiffness as the first segment (the third segment is as axially stiff as the first segment).

[0025] According to another further example (“Example 14”) relative to any of Examples 9 to 13, when the built-in prosthesis is in an expanded unfolded configuration, the third and fourth rows define a spaced-apart interlocking structure (set).

[0026] According to another further example (“Example 15”) relative to any of Examples 9 to 13, when the built-in prosthesis is in an expanded unfolded configuration, the third and fourth rows define a spaced-apart non-interlocking structure (set).

[0027] According to another further example (“Example 16”) relative to any of Examples 1 to 15, the multi-row support element is formed of an elastically deformable material, optionally formed of a nickel-titanium alloy.

[0028] According to another further example (“Example 17”) relative to any of Examples 1 to 16, the multi-row support element is formed of a plastically deformable material, optionally formed of a stainless steel alloy.

[0029] According to another further example (“Example 18”) relative to any of Examples 1 to 17, the discontinuous mesh material includes a thin film.

[0030] According to another further example (“Example 19”) relative to any of Examples 1 to 18, the discontinuous mesh material includes an ePTFE membrane.

[0031] According to another further example (“Example 20”) relative to any of Examples 1 to 19, the first plurality of alternating vertices are axially aligned with the second plurality of alternating vertices to define a plurality of interlocking peaks and a plurality of interlocking valleys.

[0032] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. Although several examples have been disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. Attached Figure Description

[0033] The accompanying drawings are included to provide a further understanding of the present disclosure, and the drawings are incorporated in and form a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0034] Figure 1A This is a three-dimensional view of a built-in prosthesis based on some embodiments.

[0035] Figure 1B This is another view of the built-in prosthesis according to some embodiments.

[0036] Figure 2A Two adjacent support elements of an embedded prosthesis in an expanded, unfolded configuration according to some embodiments are shown, with flexible bridging portions not shown.

[0037] Figure 2B Two adjacent support elements of an embedded prosthesis in a compact delivery configuration according to some embodiments are shown, with flexible bridging not shown.

[0038] Figure 3A Two adjacent support elements of an enlarged, unfolded prosthesis according to some embodiments are shown, wherein a flexible bridging portion connects the adjacent support elements along a common periphery.

[0039] Figure 3B A compact delivery configuration according to some embodiments is shown. Figure 3A The two adjacent support elements of the built-in prosthesis.

[0040] Figure 3C Two adjacent support elements of another built-in prosthesis in an expanded unfolded configuration according to some embodiments are shown, wherein a flexible bridging portion connects the adjacent support elements along two common peripheries.

[0041] Figure 4A Two adjacent support elements of an implanted prosthesis in an expanded, unfolded configuration according to some embodiments are shown, wherein the bridging portion extends at an acute angle relative to the longitudinal axis of the implanted prosthesis.

[0042] Figure 4B Illustrations are shown according to some embodiments Figure 4A The adjacent support elements, in which the built-in prosthesis is situated within a compact delivery profile.

[0043] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting. Detailed Implementation

[0044] Figure 1A and 1B An implantable medical device, or more specifically an implantable prosthesis 100, is shown having a first end 102, a second end 104, and an intermediate portion 103 extending therebetween, the intermediate portion including a midpoint located between the first end 102 and the second end 104. The implantable prosthesis 100 has a longitudinal length 106 measured from the first end 102 to the second end 104. The implantable prosthesis 100 has multiple rows of support elements 108 along its length 106 and a mesh material (material mesh) or mesh 110 (e.g., a flexible polymer material) connecting adjacent rows of support elements 108. As further explained below, the support elements 108 interlock with each other. The implantable prosthesis 100 also defines a longitudinal axis 107 extending along the length of the implantable prosthesis 100.

[0045] In some examples, each row of support elements 108 is formed by a serpentine or wavy length (serpentine or wavy segment) of an elongated element (e.g., filament or wire) extending along the length of the prosthesis 100 around its periphery in a helical path. As shown, each turn, each loop, or each winding (each coil) of the elongated element 109 in sequence results in spaced-apart adjacent rows of support elements 108. In some examples, the elongated element 109 extends continuously between opposite ends (first end 102 and second end 104) of the prosthesis 100. While continuous helical winding is contemplated, other configurations are also contemplated. For example, discrete (separate) (e.g., circumferential) loops may also be used to define adjacent rows of support elements 108. In some examples, the support elements 108 may be formed of an elastically deformable material such as a nickel-titanium alloy. In some examples, the support element 108 may be formed of a plastically deformable material such as a stainless steel alloy, and / or otherwise configured to be plastically deformable during deployment.

[0046] Due to the multiple holes or openings 116 formed therein, the mesh 110 is discontinuous in its length. This discontinuity in the mesh 110 allows it to provide sufficient flexibility to allow the support elements 108 to move relative to each other. The movement of the support elements 108 relative to each other results in an increase or decrease in the total length 106 of the implanted prosthesis 100, allowing the implanted prosthesis 100 to present a compact delivery profile with a smaller length 106 or an expanded unfolding profile with a larger length 106.

[0047] The stent element 108 also includes a first segment 112 adjacent to the first end 102 and / or the second end 104. In the first segment 112, the mesh 110 is configured to restrict movement of the stent element 108 relative to each other. That is, the first segment 112 is configured to be relatively stiffer than some other segments of the implant 100, such as the middle portion of the implant 100.

[0048] Figure 1A A first segment 112, a second segment 113 adjacent to the first end 102, and a third segment 115 adjacent to the second end 104 are shown, wherein the second segment 113 is located between the first segment 112 and the third segment 115, such that the mesh 110 at the first segment 112 and the third segment 115 is configured such that the relative movement of the support element 108 in the third segment is restricted relative to each other.

[0049] The first segment 112 and / or the third segment 115 may be stiffer or more axially rigid than the second segment 113, which is closer to the midpoint of the implanted prosthesis 100 than the other segments. The first segment 112 and the third segment 115 may be similar to each other in terms of stiffness and axial stiffness, or they may be different as desired.

[0050] The mesh 110 has multiple holes or openings 116A and 116B along the length 106 of the implant 100. As shown, the mesh 110 in the first segment 112 and / or the third segment 115 has a larger surface area covered or contains fewer openings (open areas) compared to other portions of the implant 100 (e.g., the second segment 113). In some examples, the opening group 116A is uniformly located along the entire length 106 of the implant 100, but the first segment 112 and / or the third segment 115 may include fewer or smaller openings (e.g., no additional openings 116B) than in the second segment 113 of the implant 100.

[0051] like Figure 1B As shown, the smaller opening area in mesh 110 allows for wider interconnecting members or mesh elements, also referred to as bridging portions 118A. As shown, the first segment 112 has a first set of mesh elements or bridging portions 118A, which differs from the second set of mesh elements or bridging portions 118B found in the second segment 113. Mesh elements or bridging portions 118A and 118B can be polymer films defining opening groups 116A and / or 116B. In some examples, mesh elements or bridging portions 118A and 118B can be made of films with thicknesses ranging from about 0.001 mm to 0.1 mm, 0.1 mm to 0.2 mm, 0.2 mm to 0.5 mm, or any other suitable thickness thereof. Figure 1BIn this configuration, the width of the first bridging portion 118A is wider than that of the second bridging portion 118B because the first segment 112 does not have a second set of openings 116B between the first set of openings 116A. In this case, the first segment 112 is defined by a set of four support elements 108A, 108B, 108C, and 108D, but in other examples, fewer or more support elements may be present in the first segment 112. A second support element 108B may be adjacent to a first support element 108A, a third support element 108C may be adjacent to a second support element 108B, and so on.

[0052] Each support element 108 (e.g., support elements 108A, 108B, 108C, 108D) may extend at an angle relative to the periphery (e.g., centerline AA) of the implanted prosthesis 100. In some examples, when the implanted prosthesis 100 is in an expanded deployment configuration, the third support element 108C and the fourth support element 108D may define a spaced-apart structure. A second discontinuous mesh material (second discontinuous material mesh) may also be present to interconnect the third support element 108C and the fourth support element 108D, such that the implanted prosthesis 100 is axially compressible between the third support element 108C and the fourth support element 108D when the implanted prosthesis 100 is in the expanded deployment configuration. Furthermore, in some examples, when the implanted prosthesis 100 is in the expanded deployment configuration, the rows of support elements 108A and 108B may be in an interlocked structure spaced apart from each other, and the rows of support elements 108C and 108D may be in a spaced-apart, non-interlocked structure.

[0053] Figure 2A and 2B This illustrates when the built-in prosthesis 100 is in an expanded unfolded profile or configuration or a compact delivery profile or configuration. Figure 1A and 1B Details of the elongated element 109 are shown. Opposite vertices 200A and 200B are interconnected by straight or relatively straight elongated element segments 202. Vertices generally "point" in a direction substantially parallel to the longitudinal axis 107 of the built-in prosthesis 100 (e.g., within 10 degrees of parallelism), with alternating vertices 200A and 200B pointing in opposite directions. That is, alternating vertices 200A and 200B point to opposite ends of the built-in prosthesis 100. In some examples, vertices pointing in one direction (e.g., vertex 200A) are aligned along a first common line, while vertices pointing in the opposite direction (e.g., vertex 200B) are aligned along a second common line parallel to the first common line. For example, alternating vertices 200A may be axially aligned with each other to define a plurality of interlocking valleys, and alternating vertices 200B may also be axially aligned with each other to define a plurality of interlocking peaks, or vice versa.

[0054] As previously described, some or all rows of the support elements 108 along at least a portion of the length 106 of the implanted prosthesis 100 are interlocked with each other. In the context of this disclosure, the term "interlocked" or "interlocked" is defined as follows: when the implanted prosthesis 100 is in its expanded, extended profile, portions of two adjacent or neighboring support elements (e.g., 108A and 108B as shown) traverse (span) a centerline or perimeter (A-A) located between the two support elements and extending or oriented perpendicularly to the longitudinal axis 107. That is, as... Figure 2A As shown, centerline A-A passes through support elements 108A and 108B, such that a left-pointing vertex 200A (which may be referred to as a valley) from support element 108B and a right-pointing vertex 200B (which may be referred to as a peak) from support element 108A cross (across) centerline A-A. Furthermore, in some examples, adjacent rows of support elements 108 may interlock with each other along the entire length 106 of the implanted prosthesis 100. Alternatively, one or more rows of support elements 108 may exist along one or more portions of the length 106 of the implanted prosthesis 100 without interlocking with other (one or more) adjacent rows.

[0055] Figure 2A The diagram illustrates two adjacent support elements when the built-in prosthesis 100 is in an expanded unfolded profile (108A and 108B), for example, when the rows of support elements 108 are spaced further apart than in a compact delivery profile. Dimension 204 is considered to be the height (amplitude) of adjacent relative vertices, while dimension 206 is the width of adjacent relative vertices. Dimension 208 describes a complete cycle of the serpentine shape (form). The elongated element diameter 210 and bend angle 212 of vertices 200A and 200B can be suitably chosen. Furthermore, vertices 200A and 200B can have any suitable radius of curvature. Dimension 214A describes the distance between adjacent rows of support elements 108 when the built-in prosthesis 100 is in an expanded unfolded profile, a distance that can be measured, for example, from the vertex 200A of the first support element 108A to the nearest vertex 200A of the second support element 108B (not the vertex 200B pointing in the opposite direction to vertex 200A). Figure 2B The diagram shows the built-in prosthesis 100 in a compact delivery profile, where dimension 214B is the distance between adjacent row support elements 108A and 108B when the built-in prosthesis 100 is in a compact deployment profile.

[0056] Figure 3A and 3B Examples are shown of how opening 116A and bridging portion 118A can be constructed in first section 112 and / or third section 115 according to some embodiments. Figure 3AThe opening 116A and bridging portion 118A are shown when the built-in prosthesis 100 is in its expanded unfolded profile, wherein the support elements 108A and 108B are more than in Figure 3B The compact delivery profiles shown are further apart from each other. The bridging portions 118A are formed such that each of the bridging portions 118A formed between the support elements 108A and 108B is oriented around a circumferential reference line or perimeter (circumference) 300 oriented substantially perpendicular to the longitudinal axis 107 of the implanted prosthesis 100. In some examples, the circumferential reference line defining the perimeter of the implanted prosthesis 100 extends circumferentially around the longitudinal axis 107. Thus, in some examples, the perimeter 300 passes through all the bridging portions 118A, making it a common perimeter 300 between the bridging portions 118A, such that when the implanted prosthesis 100 is in an expanded, unfolded configuration, the bridging portions 118A restrict torsion and axial compression of the implanted prosthesis 100 between the first row of support elements and the second row of support elements (e.g., Figures 108A and 108B). In some examples, the angle formed between the perimeter 300 and the longitudinal axis 107 may be between approximately 75° and 90°, approximately 80° and 90°, approximately 85° and 90°, or any other suitable range of obtuse angles in between. Furthermore, in some examples, the perimeter 300 may be aligned with the previously... Figure 2A The center lines A-A shown in the diagram overlap.

[0057] exist Figure 3B In this configuration, two adjacent support elements 108A and 108B are brought closer together, causing the bridging portion 118A to be stretched or tensioned. When the mesh 110 is made of a flexible, relatively inextensible polymeric material, the bridging portion 118A resists this axial compression. However, in the example where the mesh 110 is made of an elastic, extensible material, the bridging portion 118A stores potential energy during this axial compression, resisting the compression and biasing the rows of support elements 108A and 108B back to their original positions. Figure 3A The original position is shown. Therefore, in some examples, the bridging portion 118A may restrict the movement of the support elements 108A and 108B relative to each other. It is worth noting that when the rows of support elements 108A and 108B collapse radially (e.g., when the implanted prosthesis is in a compact delivery profile), the bridging portion 118A is free to bend or angle (change angle) and does not prevent or resist axial compression between the rows of support elements 108A and 108B.

[0058] Figure 3C Examples are shown of how bridging portions 302A and 302B, according to some embodiments, can be constructed in the first segment 112 and / or the third segment 115. Figure 3A and 3BUnlike the bridging portion 118A, bridging portions 302A and 302B encompass multiple peripheries that are substantially parallel to each other. Specifically, bridging portions 302A share a common first periphery 300A, and bridging portions 302B include a common second periphery 300B, wherein the first periphery (boundary) 300A and the second periphery 300B are parallel to each other. Therefore, when the implanted prosthesis 100 is in an expanded deployment configuration, the first plurality of bridging portions 302A and the second plurality of bridging portions 302B restrict the twisting and elongation of the implanted prosthesis 100 between the first row of support elements and the second row of support elements 108. The positions of bridging portions 302A and 302B can be described as being in an “interlaced” configuration relative to each other, since no straight line passes through all bridging portions 302A and 302B. In some examples, when the implanted prosthesis 100 is in the expanded, unfolded configuration, each bridging portion 118A (or 302A and 302B) may extend at an acute angle relative to the periphery 300 of the implanted prosthesis 100. In some examples, when the implanted prosthesis 100 is in the expanded, unfolded configuration, each bridging portion 118A (or 302A and 302B) may extend at an obtuse angle relative to the longitudinal axis 107 of the implanted prosthesis 100.

[0059] Figure 4A and 4B Examples of how opening 116B and bridging portion 118B can be constructed in the second section 113 according to some embodiments are shown. In some examples, circumferentially adjacent bridging portions 118B extend relative to each other at alternating opposite angles. Figure 4A The openings 116A and 116B, and the bridging portion 118B, are shown when the implanted prosthesis 100 is in its expanded, unfolded profile. Each bridging portion 118B is formed to include (enclose) a line 400 positioned at a different angle than that of the bridging portion 118A. For example, each bridging portion 118B is positioned at an acute angle 402 relative to the longitudinal axis 107 of the implanted prosthesis 100. In some examples, the acute angle 402 may range from approximately 5° to 10°, approximately 5° to 20°, approximately 5° to 30°, approximately 5° to 45°, or any other suitable angular range between them.

[0060] like Figure 4B As shown, when the support elements 108A and 108B move closer to each other, the length of each bridging portion 118B decreases. Therefore, in this state, no tension is applied to the bridging portion 118B, and thus there is no stretching, tensioning, or other considerable (large) potential energy stored in the bridging portion 118B to restrict the movement of the support elements 108A and 108B relative to each other.

[0061] While various polymer membranes may be suitable as scaffold coverings (or coatings) for this device, and as mesh materials for defining bridging portions in built-in prostheses, FEP (fluorinated ethylene propylene) membranes for use in combination with ePTFE membranes or diaphragms are conceivable. ePTFE membranes used with scaffold elements are membranes with multiaxial fiber orientation, as shown in the scanning electron micrograph of Figure 3. It can be seen how the fibrils are oriented in all directions within the plane of the ePTFE membrane. This type of ePTFE membrane can be manufactured as taught in U.S. Patent No. 7,306,729 to Bacino et al. and U.S. Patent Publication No. 2007 / 0012624. Membranes of the same type can optionally have a partial covering of a thin FEP layer (with openings through the FEP membrane covering; i.e., a discontinuous covering). FEP-coated ePTFE membranes with discontinuous (porous) or continuous (non-porous) FEP coverings (coatings) can generally be manufactured as taught in U.S. Patent No. 5,735,892 to Myers et al.

[0062] In some examples, the stiffness of the bridging portion 118A in the first segment 112 and / or the third segment 115 can be increased by applying one or more additional materials to the bridging portion 118A. For example, in addition to the mesh 110, a second material, such as another layer of polymer or fiber material as described above, and any other suitable material, can be attached to the bridging portion 118A to limit the movement of the rows of support elements 108 relative to each other in the first segment 112 and / or the third segment 115. In some examples, the additional material applied to the bridging portion 118A can be the same material used to manufacture the mesh 110.

[0063] The advantage of increasing stiffness to limit the movement of the support elements relative to each other at or near the ends includes preventing the support elements from shortening as they deform during expansion. In some examples, the implant is mounted on a capsule for subsequent deployment and expansion, but if the capsule expands unevenly, the support elements of the implant may shorten or fold in the region proximal to the ends of the implant. Making the region proximal to the ends of the implant harder or more rigid during expansion reduces the likelihood of this undesirable change in the shape of the implant.

[0064] The embodiments have been generally described above, with particular embodiments also described. It will be apparent to those skilled in the art that various modifications and alterations can be made to the embodiments without departing from the scope of this disclosure. Therefore, the embodiments are intended to cover various changes and alterations to the embodiments falling within the scope of the appended claims and their equivalents.

Claims

1. An embedded prosthesis having a length, a first end, a second end, and a longitudinal axis, said embedded prosthesis being expandable from a compact delivery configuration to an enlarged deployment configuration, said embedded prosthesis comprising: A multi-row support element along the length of the implanted prosthesis, the multi-row support element comprising a first row of support elements and a second row of support elements parallel and adjacent to the first row of support elements, the first row of support elements having a plurality of first alternating vertices, and the second row of support elements having a plurality of second alternating vertices, the first alternating vertices and the second alternating vertices defining a spaced-apart interlocking structure, wherein, when the implanted prosthesis is in the enlarged unfolded configuration, the spaced-apart interlocking structure is defined by the first alternating vertices and the second alternating vertices crossing a centerline located midway between the first row of support elements and the second row of support elements and extending perpendicular to the longitudinal axis; and A discontinuous mesh material comprising a plurality of mesh elements spaced apart from each other, wherein the plurality of mesh elements form a bridging portion between a first alternating vertex and a second alternating vertex, the bridging portion defining with a first row of support elements and a second row of support elements: (a) a first opening, each of the first openings being located at one of the first alternating vertex and the second alternating vertex; and (b) a second opening, each of the second openings being located between two circumferentially adjacent first openings, and wherein, when the implanted prosthesis is in an enlarged unfolded configuration, the bridging portion restricts the torsion and axial compression of the implanted prosthesis between the first row of support elements and the second row of support elements.

2. The built-in prosthesis as described in claim 1, characterized in that, Each bridging portion is located between a first opening in the first opening and a second opening in the second opening that is circumferentially adjacent to the first opening.

3. The built-in prosthesis as described in claim 1, characterized in that, The discontinuous mesh material is a polymer film that defines the first opening and the second opening between the first row of support elements and the second row of support elements.

4. The built-in prosthesis as described in claim 1, characterized in that, Each bridging portion extends at alternating opposite angles relative to another bridging portion circumferentially adjacent to it.

5. The built-in prosthesis as described in claim 1, characterized in that, When the built-in prosthesis is in an expanded unfolded configuration, each bridging portion includes a line that extends from one of the first alternating vertices and the second alternating vertices at an acute angle relative to the longitudinal axis of the built-in prosthesis, and extends at an acute angle offset relative to the periphery of the built-in prosthesis.

6. The built-in prosthesis as described in claim 1, characterized in that, The multi-row support elements are formed of an elastically deformable material.

7. The built-in prosthesis as described in claim 6, characterized in that, The elastically deformable material is a nickel-titanium alloy.

8. The built-in prosthesis as described in claim 1, characterized in that, The multi-row support elements are formed from a plastically deformable material.

9. The built-in prosthesis as described in claim 8, characterized in that, The material that can be plastically deformed is a stainless steel alloy.

10. The built-in prosthesis as described in claim 1, characterized in that, The discontinuous mesh material includes a thin film.

11. The built-in prosthesis as described in claim 1, characterized in that, The discontinuous mesh material includes an ePTFE membrane.

12. The built-in prosthesis as described in claim 1, characterized in that, The first alternating vertex and the second alternating vertex are axially aligned to define multiple interlocking peaks and multiple interlocking valleys.

13. The implanted prosthesis as described in any one of claims 1-12, characterized in that, In the compact delivery configuration and in the expanded unfolding configuration, the first alternating vertex and the second alternating vertex axially define the spaced-apart interlocking structure.

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