Systems and devices for valve prosthesis

Abstract

Systems, devices, and methods of valve prostheses having one or more bioabsorbable components are described. The bioabsorbable component may be absorbed over time, allowing tissue to grow inward in and around the valve prosthesis. Systems, devices, and methods for valve prostheses that mitigate blood flow stagnation are also described. Generally, various alternative mechanisms are described that push stagnant blood beneath the leaflet and near the lumen wall away from the wall such that the stagnant blood can flow through the outflow end of the valve prosthesis.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 358,774, filed on July 6, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present application relates generally to valve prosthesis devices and systems, and more particularly to valve devices and systems that provide bioresorbable components or improve blood flow. Background Art

[0004] Prosthetic devices can be used to treat various heart and circulatory diseases. For example, prosthetic heart valves can be used to treat valvular diseases, such as valvular insufficiency or aortic stenosis. Transcatheter technology can be used to introduce and implant prosthetic devices in a less invasive manner, and can reduce complications compared to surgery (e.g., open heart surgery). In transcatheter technology, the prosthetic device can be mounted on the distal portion of a delivery catheter in a curled state and advanced through the patient's vascular system until the prosthetic device arrives at the implantation site. Then, the prosthetic device at the catheter tip can be expanded to its functional size at the treatment site, such as by inflating a balloon or utilizing a self-expanding intravascular stent or framework. The prosthetic device can have a balloon expansion, self-expanding, mechanical expansion framework, and / or a framework that can be expanded in a variety of ways or in combination. The prosthetic device used in this way comprises a transcatheter heart valve (THV).

[0005] Existing prosthetic heart valves provide effective treatment; however, complications may exist due to undesirable forces generated by implanting the prosthetic heart valve within the native heart. There may also be complications related to uneven curling, which may cause damage to the frame and / or difficulties during implantation. Prosthetic heart valves may also form blood clots. Therefore, there is a need for further improvement and refinement of the existing technology. Summary of the invention

[0006] The systems and devices may be implanted within the vasculature and provide various benefits including, but not limited to, absorption, improved crimping, improved blood flow, and improved manufacturing.

[0007] In some embodiments, a frame is used in a valve prosthesis. The frame includes a plurality of interconnected struts forming a tubular frame. The frame also includes a plurality of bioresorbable elements. The bioresorbable elements may be located within a subset of the struts forming the frame.

[0008] Bioresorbable elements provide the ability to change the size or shape of the frame after implantation. For example, it may be advantageous to provide a frame that has a fixed size upon initial implantation but changes to a different size over time. By making adjustments over time, forces on the heart or other surrounding tissues may be reduced or eliminated. Over time, certain portions of the frame may become unnecessary as tissue ingrowth creates a secure fixation, thereby reducing the need for anchoring mechanisms on the frame.

[0009] For example, the valve prosthesis may include a plurality of interconnected struts to form a tubular frame. The valve prosthesis may also include an anchoring system attached to the tubular frame. The anchoring system may take the form of an anchoring arm that is anchored to surrounding tissue, such as capturing a native valve leaflet. Over time, the anchoring arm may become unnecessary. Therefore, the anchoring arm may be configured to be bioabsorbable. Alternatively, the anchoring arm may have a bioabsorbable tip.

[0010] In other embodiments, a valve prosthesis includes a plurality of interconnected struts forming a tubular frame. The valve prosthesis also includes a skirt attached to the tubular frame. The skirt is bioabsorbable. The skirt can be mounted inside the frame or outside the frame. The skirt can also be mounted to both the inside and outside of the frame.

[0011] In some embodiments, a valvular prosthesis includes a plurality of interconnected struts forming a tubular frame. The valvular prosthesis also includes a bioabsorbable band surrounding the tubular frame. The band can be configured to control expansion of the frame in a delayed release manner.

[0012] In some embodiments, a valve prosthesis includes a plurality of interconnected struts forming a tubular frame. The valve prosthesis also includes an anchoring system attached to the tubular frame. The valve prosthesis also includes one or more bioabsorbable barbs attached to the tubular frame or to the anchoring system. The barbs can provide a temporary anchoring mechanism that absorbs over time.

[0013] In some embodiments, the plurality of interconnected struts include a shape memory material that provides a radial force.

[0014] In some embodiments, the framework further comprises a plurality of bioresorbable elements within a subset of the struts forming the tubular framework.

[0015] In some embodiments, at least a subset of the plurality of bioresorbable elements are located at the interconnection points of two or more struts.

[0016] In some embodiments, absorption of the bioresorbable element causes a reduction in radial forces of the tubular framework.

[0017] In some embodiments, the tubular frame further comprises a plurality of appendages extending away from the tubular frame.Each appendage of the plurality of appendages is formed by a subset of the plurality of interconnected struts.

[0018] In some embodiments, at least a subset of the plurality of bioresorbable elements is located within one or more appendages of the plurality of appendages.

[0019] In some embodiments, the tubular frame is compressible for placement within a catheter of a transcatheter delivery system.

[0020] In some embodiments, the frame further comprises a set of leaflets within the tubular frame. The set of leaflets is attached to the tubular frame or to the inner skirt.

[0021] In some embodiments, the frame is sterilized and packaged.

[0022] In some embodiments, a valve prosthesis includes a plurality of interconnected struts to form a self-expanding tubular frame. The tubular frame includes a shape memory material. The valve prosthesis includes a contracted bioabsorbable band surrounding the self-expanding tubular frame.

[0023] In some embodiments, the valve prosthesis is within a catheter of a transcatheter delivery system.

[0024] In some embodiments, a valve prosthesis includes a group of columnar segments. Each columnar segment includes a plurality of interconnected struts. The valve prosthesis includes a group of bioabsorbable connectors. The group of bioabsorbable connectors connects the group of columnar segments to form a tubular frame. Each columnar segment is connected to two adjacent columnar segments via one or more bioabsorbable connectors in the group.

[0025] In some embodiments, a frame is used in a valve prosthesis. The frame includes a plurality of interconnected struts forming a tubular frame having a plurality of cells. At least a subset of the plurality of cells is asymmetric. The asymmetry of each cell in the subset of the plurality of cells can be formed by at least one asymmetric transverse strut.

[0026] In some embodiments, the asymmetry of at least one transverse strut is formed by two curved portions that meet in a central vertex. A first curved portion of the two curved portions has a larger radius and length than a second curved portion of the two curved portions.

[0027] In some embodiments, a frame is used in a valve prosthesis. The frame includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow end and an outflow end. The frame also includes a plurality of bioabsorbable portions within a subset of the struts forming the tubular frame. The bioabsorbable portions are at or near the outflow side.

[0028] In some embodiments, absorption of the bioresorbable element is at or near the outflow side, creating a segmented outflow end with flexing capabilities.

[0029] In some embodiments, the frame is configured such that when the frame is subjected to liquid flow and pressure through the frame, the segmented outflow end can flex outwardly to transform the outflow end from a slightly linear shape to a flared shape.

[0030] In some embodiments, a valve prosthesis for improving stagnant blood flow is provided. The valve prosthesis includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow side and an outflow side. The valve prosthesis also includes an inner lumen wall attached to the tubular frame. The valve prosthesis also includes a set of leaflets within the tubular frame. The set of leaflets is attached to the tubular frame or to the inner lumen wall and separates the inflow side of the tubular frame from the outflow side. The valve prosthesis also includes a set of one or more inflatable bags attached to the inner lumen wall on the outflow side of the frame.

[0031] In some embodiments, each bag in the set of one or more inflatable bags is constructed of a biocompatible flexible material.

[0032] In some embodiments, each bag in the set of one or more inflatable bags is filled with a compressed fluid component that changes volume based on pressure.

[0033] In some embodiments, the set of one or more inflatable bags is configured such that each bag in the set of one or more inflatable bags is capable of expanding to an inflated state when the valve prosthesis is subjected to fluid flow and pressure across the inner luminal wall.

[0034] In some embodiments, the valve prosthesis is implanted within the vasculature of an animal, and wherein the fluid flow and pressure are systolic blood flow and pressure.

[0035] In some embodiments, a valve prosthesis for improving stagnant blood flow is provided. The valve prosthesis includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow side and an outflow side. The valve prosthesis also includes an inner lumen wall attached to the tubular frame. The valve prosthesis also includes a group of leaflets within the tubular frame. The group of leaflets is attached to the tubular frame or to the inner lumen wall and separates the inflow side of the tubular frame from the outflow side. The valve prosthesis also includes a group of one or more free-flow sheets attached to the inner lumen wall on the outflow side of the frame. Each free-flow sheet in the group of one or more free-flow sheets has at least one free edge.

[0036] In some embodiments, each free-flowing sheet in the set of one or more free-flowing sheets is comprised of a biocompatible flexible material.

[0037] In some embodiments, the set of one or more free-flow sheets is configured such that when the valve prosthesis experiences liquid flow and pressure across the inner luminal wall, each free-flow sheet in the set of one or more free-flow sheets can move with the liquid flow.

[0038] In some embodiments, a valve prosthesis is used to improve stagnant blood flow. The valve prosthesis includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow side and an outflow side. The valve prosthesis also includes an inner lumen wall attached to the tubular frame. The valve prosthesis also includes a group of leaflets within the tubular frame. The group of leaflets is attached to the tubular frame or to the inner lumen wall and separates the inflow side of the tubular frame from the outflow side. The valve prosthesis also includes a plurality of flexible magnetically driven micro-protrusions linearly aligned in the flow direction and attached to the inner lumen wall. Each of the plurality of flexible magnetically driven micro-protrusions has a positive magnetic pole and a negative magnetic pole at the tip of the micro-protrusion.

[0039] In some embodiments, the plurality of flexible magnetically actuated microprojections comprises a larger actuator microprojection.

[0040] In some embodiments, each microprojection tip of a plurality of flexible magnetically actuated microprojections has a specific polar alignment such that each pole face of each tip has the same charge as an adjacent tip pole face.

[0041] In some embodiments, a larger actuator microprojection can stimulate deflection of the remainder of the plurality of flexible magnetically actuated microprojections.

[0042] In some embodiments, a frame system is used in a valve prosthesis. The frame system includes a plurality of interconnected struts forming a self-expanding tubular frame. The frame system includes a plurality of anti-torsion elements. Each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0043] In some embodiments, each anti-torsion element is attached to a strut that is in a region of the frame having a low density of struts.

[0044] In some embodiments, each anti-torsion element is manufactured as part of the frame design.

[0045] In some embodiments, each anti-torsion element is attached and secured to the strut by an attachment member.

[0046] In some embodiments, when the frame is curled, at least a subset of the plurality of anti-torsion elements abut or nearly abut an adjacent strut.

[0047] In some embodiments, each anti-torsion element extends laterally a length between about 1.1 and 5 times the lateral width of the strut.

[0048] In some embodiments, each anti-torsion element has a vertical length between about 2% and 20% of the length of the strut.

[0049] In some embodiments, at least a subset of the plurality of anti-torsion elements includes indicia for visualization.

[0050] In some embodiments, the frame system further comprises a catheter. The catheter houses the tubular frame. Each anti-torsion element mitigates the ability of the struts to twist or distort during loading of the tubular frame into the catheter.

[0051] In some embodiments, the catheter comprises an inner surface having a polygonal profile.

[0052] In some embodiments, the tubular frame comprises a plurality of cylindrical segments, and wherein the number of cylindrical segments is equal to the number of sides of the polygonal profile.

[0053] In some embodiments, at least a subset of the plurality of interconnected struts abuts or nearly abuts a side of the polygonal outline.

[0054] In some embodiments, a method is used to release a frame via a transcatheter technique. The method includes delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be installed. The tubular frame is loaded into the catheter. The tubular frame includes a shape memory material for providing radial force, a plurality of interconnected struts, and a plurality of anti-torsion elements. Each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts. The method includes advancing the tubular frame distally out of the catheter so that the tubular frame expands. The method also includes reloading the tubular frame proximally into the catheter so that the tubular frame curls.

[0055] In some embodiments, each anti-torsion element is attached to a strut that is in a region of the frame having a low density of struts.

[0056] In some embodiments, each anti-torsion element extends laterally a length between about 1.1 and 5 times the lateral width of the strut.

[0057] In some embodiments, at least a subset of the plurality of anti-torsion elements comprises a marker for visualization.The method further comprises visualizing the distal advancement or proximal reloading of the self-expanding tubular frame via the marker for visualization and the visualization technique.

[0058] In some embodiments, a frame system is used in a valve prosthesis. The frame system includes a plurality of interconnected struts forming a self-expanding tubular frame. The tubular frame includes a shape memory material for providing radial force. The frame system includes a catheter. The catheter receives the tubular frame. The catheter includes an inner surface having a polygonal profile.

[0059] In some embodiments, the tubular frame comprises a plurality of cylindrical segments. The number of cylindrical segments is equal to the number of sides of the polygonal profile.

[0060] In some embodiments, at least a subset of the plurality of interconnected struts abuts or nearly abuts a side of the polygonal outline.

[0061] In some embodiments, the frame system further comprises a plurality of anti-torsion elements. Each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0062] In some embodiments, each anti-torsion element is attached to a strut that is in a region of the frame having a low density of struts.

[0063] In some embodiments, when the frame is curled, at least a subset of the plurality of anti-torsion elements abut or nearly abut an adjacent strut.

[0064] In some embodiments, each anti-torsion element extends laterally a length between about 1.1 and 5 times the lateral width of the strut.

[0065] In some embodiments, each anti-torsion element has a vertical length between about 2% and 20% of the length of the strut.

[0066] In some embodiments, a method is used to release a frame via a transcatheter technique. The method includes delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be installed. The tubular frame is loaded within the catheter. The catheter includes an inner surface having a polygonal profile. The tubular frame includes a shape memory material for providing a radial force and includes a plurality of interconnected struts. The method includes advancing the tubular frame distally out of the catheter so that the tubular frame expands. The method includes reloading the tubular frame proximally into the catheter so that the tubular frame curls.

[0067] In some embodiments, the frame comprises a plurality of columnar segments, and wherein the number of columnar segments is equal to the number of sides of the polygonal profile.

[0068] In some embodiments, at least a subset of the plurality of interconnected struts abuts or nearly abuts a side of the polygonal outline.

[0069] In some embodiments, the tubular frame further comprises a plurality of anti-torsion elements. Each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0070] In some embodiments, a cover is used to make a tubular frame having multiple circumferences along the proximal-distal axis of the frame. The cover includes a pre-cut sheet, which includes multiple columnar segments forming a flower shape. Each columnar segment has a first end, a second end and two lateral edges. Each columnar segment is laterally connected to two adjacent segments at the first end. At the second end and for most of each of the two lateral edges, each columnar segment is not laterally connected to two adjacent segments. In some embodiments, the pre-cut sheet is composed of fabric, tissue or film.

[0071] In some embodiments, a system includes a tubular frame extending along a proximal-distal axis. The tubular frame includes a plurality of columnar segments, each segment extending along the proximal-distal axis. The tubular frame includes a plurality of circumferential lengths along the proximal-distal axis. The tubular frame includes a proximal end and a distal end. The system includes a cover surrounding the tubular frame. The cover is composed of a sheet pre-cut into a flower shape. The cover includes a plurality of columnar segments. Each columnar segment has a first end, a second end and two lateral edges. The two lateral edges of each columnar segment are laterally connected to the lateral edges of two adjacent segments at the first end by the pre-cut flower shape. The two lateral edges of each columnar segment are laterally connected to the lateral edges of two adjacent segments at the second end by an attachment member.

[0072] In some embodiments, a majority of each of the two lateral edges of each columnar segment is laterally connected to the lateral edges of two adjacent segments by an attachment member. In some embodiments, the attachment member comprises one of the following: a suture, a staple, or an adhesive.

[0073] In some embodiments, a first end of the cap surrounds the proximal end of the tubular frame and a second end of the cap surrounds the distal end of the tubular frame.

[0074] In some embodiments, a first end of the cap surrounds the distal end of the tubular frame and a second end of the cap surrounds the proximal end of the tubular frame.

[0075] In some embodiments, the lateral edges of each cylindrical segment of the cover are contoured to match a plurality of circumferences along the proximal-distal axis of the frame.

[0076] In some embodiments, the number of column segments in the plurality of segments of the cover matches the number of column segments of the frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The specification and claims will be more fully understood with reference to the following figures and data graphs, which present exemplary embodiments of the invention and should not be construed as a complete recitation of the scope of the invention.

[0078] Figure 1 Provides an illustration of the human heart.

[0079] Figure 2A and Figure 2B An example of a tubular frame having a bioresorbable portion for use in a valve prosthesis is provided.

[0080] Figure 3A Examples of bioresorbable anchoring systems for use in valve prostheses are provided.

[0081] Figure 3B and 3C An exemplary schematic diagram of a bioabsorbable anchor system in the context of a local implantation site is provided.

[0082] Figure 4A An example of a set of bioresorbable barbs for use in a valve prosthesis is provided.

[0083] Figure 4B and 4C An exemplary schematic diagram of a set of bioabsorbable barbs in the context of a local implantation site is provided.

[0084] Figure 5 Examples of bioabsorbable outer skirts and bioabsorbable inner skirts for use in valve prostheses are provided.

[0085] Figure 6 An example of a fluffy bioabsorbable outer band for use in a valve prosthesis is provided.

[0086] Fig. 7A An example of a bioabsorbable band for use in a valve prosthesis for controlling frame expansion is provided.

[0087] Figure 7B An exemplary schematic diagram is provided to control the expansion of the framework after the bioresorbable band has been absorbed.

[0088] Fig. 8A An example of a set of bioabsorbable connectors for joining multiple frame segments for use in a valve prosthesis is provided.

[0089] Figure 8B An exemplary schematic diagram of a tubular frame having a plurality of segments joined by a set of bioabsorbable connectors after the set of bioabsorbable connectors have been absorbed is provided.

[0090] Fig. 9 An example of a frame having an asymmetric strut design for use in a valve prosthesis is provided.

[0091] Fig. 10A An example of a frame having a bioabsorbable portion proximate the outflow portion for use in a valve prosthesis is provided.

[0092] Fig. 10B and 10C Exemplary schematic illustrations of a valve prosthesis having a frame with a bioresorbable portion that absorbs adjacent to the outflow portion during systole and diastole are provided.

[0093] Fig.11A and 11B Exemplary schematic diagrams of a valve prosthesis having a set of one or more inflatable pockets for improving stagnant blood flow are provided.

[0094] Fig.12 An exemplary schematic diagram of a valve prosthesis having a set of sheets with free edges for improving stagnant blood flow is provided.

[0095] Fig.13A and 13B An exemplary schematic diagram of a valve prosthesis having a set of magnetic microprotrusions for improving stagnant blood flow is provided.

[0096] Fig.14A and 14B An example of a frame having multiple elements to prevent torsion is provided.

[0097] Fig.15A and 15B An example of a framework within a catheter is provided, focusing on a single cylindrical segment of the framework. Fig. 15B supply Fig.15A Cross-sectional view of the conduit and frame.

[0098] Fig.16A and 16B An example of a frame including an anti-torsion element within a catheter is provided, focusing on a single cylindrical segment of the frame. Fig. 16B supply Fig.16A Cross-sectional view of the conduit and frame.

[0099] Fig.17A and 17B An example of a frame within a catheter including an inner surface having a polygonal profile is provided, focusing on a single cylindrical segment of the frame. Fig. 17B supply Fig.17A Cross-sectional view of the conduit and frame.

[0100] Fig.18A and 18B Examples of pre-cut covers are provided to facilitate attachment of the cover to the frame. DETAILED DESCRIPTION

[0101] Turning now to the drawings, various valve systems and devices are described to improve function, host interaction, blood flow, prosthesis delivery and / or prosthesis manufacturing. The valve systems and devices can be used as a prosthesis (or as part of a prosthesis delivery and fixation system) to replace the function of any of the following four heart valves: the aortic valve, the mitral valve, the tricuspid valve, or the pulmonary valve. In some embodiments, the valve system or device has one or more bioresorbable components. In some embodiments, the valve system or device has one or more components for improving blood flow. In some embodiments, the valve system or device has one or more components for improving valve curling into a catheter and / or release from a catheter. In some embodiments, the valve system or device has one or more components for improving the attachment of the cover to the frame.

[0102] The described systems, devices, and methods should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed components, individually and in various combinations and sub-combinations with each other. The disclosed systems, devices, and methods are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, devices, and methods require the presence of any one or more specific advantages or the resolution of any one or more specific problems.

[0103] Various components of systems and devices and examples of artificial valves or transcatheter valves are disclosed herein, and any combination of these options can be made unless specifically excluded. For example, any bioabsorbable component disclosed can be used with other bioabsorbable components of any other type, even if a specific combination is not explicitly described. Similarly, different configurations and features of components of devices, methods, and systems, such as (for example) elements and bioabsorbable components for reducing torsion, can be mixed and matched. As another example, any bioabsorbable component type / feature, valve type / feature, tissue covering type / feature, catheter type / feature, etc. can be combined even if not explicitly disclosed. In short, the various components of the disclosed systems and devices can be combined unless mutually exclusive or physically impossible.

[0104] Although the operations of some of the disclosed methods are described in a particular sequential order for ease of presentation, it should be understood that unless specific language set forth below requires a particular ordering, this description encompasses rearrangements. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, devices, and methods can be used in conjunction with other systems, devices, and methods.

[0105] The terms "proximal" and "distal" used throughout the specification refer to the catheter system axis, wherein the end performing the operation is the distal end, and the opposite end controlling the catheter system is the proximal end. Thus, the distal end of the catheter system is the front end, which first traverses into the body and first reaches the surgical site. In contrast, the proximal end of the catheter system is the portion that remains outside the body. Likewise, distal movement along the catheter axis will be movement of the component in a direction toward the surgical site, and proximal movement along the catheter axis will be movement of the component in the opposite direction. Although these terms are related to the surgical site, it should be understood that these terms are used for reference, and the surgical site does not need to be presented when explaining the components or movements of the devices and systems described herein.

[0106] Various systems and devices for repair are used to perform surgery in a recipient. The recipient includes (but is not limited to) a patient, an animal model, a corpse, or an anthropomorphic phantom. Therefore, in addition to the method of treating a patient, the system and device can also be used for training or other practice procedures in an animal model, a corpse, or an anthropomorphic phantom. In addition, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or a non-living simulation, such as a corpse, a corpse heart, an anthropomorphic ghost, a simulated body (e.g., using a simulated body part, tissue, etc.), etc.

[0107] The described systems and devices can be sterilized, which can be performed using gamma radiation, gas plasma, aldehydes, ethylene oxide, and / or electron beams. The systems or devices can be further treated with a formaldehyde bioburden reduction process. After preparation, the systems and devices can be stored in containers that can be hermetically sealed or otherwise maintained sterile.

[0108] Figure 1 1 is a cross-sectional view of a human heart in the systolic phase. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA) by the tricuspid valve 101 and the mitral valve 103 (i.e., the atrioventricular valves), respectively. In addition, the aortic valve 105 separates the LV from the ascending aorta (AO), and the pulmonary valve 107 separates the RV from the pulmonary artery (PA). Each of these valves has flexible leaflets extending inwardly through respective orifices that meet or "combine" in the flow stream to form a one-way fluid blocking surface.

[0109] The RA receives deoxygenated blood from the venous system through the SVC and IVC, the former entering the RA from above and the latter entering the RA from below. During the diastolic phase, or diastole, deoxygenated blood from the IVC and SVC that has collected in the RA crosses the tricuspid valve 101 and enters the RV as the RV expands. Likewise, oxygenated blood from the pulmonary veins that has collected in the LA crosses the mitral valve 103 and enters the LV as the LV expands. During the systolic phase, or systole, the RV contracts to force the deoxygenated blood that has collected in the RV through the pulmonary valve 107 into the pulmonary artery and lungs. Likewise, the LV contracts to force the deoxygenated blood that has collected in the LV through the aortic valve 105 into the aorta and to the peripheral cardiovascular system.

[0110] For illustration, the systems and devices described in this application are described as being useful for replacement or repair of any native valve or for use within a cardiac system. A native valve may need to be replaced or repaired if, for example, the valve is stenotic and / or suffers from insufficiency and / or regurgitation. Whether or not explicitly described herein, the systems and devices described herein may be used in a variety of fields as a treatment for a defective native valve or another cardiovascular disease.

[0111] Various valve prosthesis systems and devices can have one or more bioresorbable components that can provide various improved functions, such as (for example) providing the ability to improve integration at the implant site. Typically, when a valve prosthesis is implanted, several components such as (for example) a frame, anchors, and skirts provide the benefit of achieving prosthetic installation and / or valve function immediately after implantation. However, as the valve is integrated with the local anatomy, over time, several of these components are not required. In addition, some of these components may cause damage to the local anatomy. Therefore, after implantation, one or more components can be bioresorbable, so that the one or more components are absorbed over a period of time, thereby producing a valve that does not contain various components such as (for example) a frame, anchors, and skirts. Therefore, local tissue at the implant site can grow more freely in and around the valve, thereby integrating the valve with the host tissue.

[0112] The valve prosthesis including the bioresorbable portion can be a replacement valve prosthesis for replacing any of the following valves of the heart: the tricuspid valve, the pulmonary valve, the mitral valve, or the aortic valve. The replacement valve can also include one or more of the following: an inner skirt, an outer skirt, and a set of leaflets. The tubular frame can have an inlet end portion and an outlet end portion, wherein a set of leaflets is disposed between the inlet end portion and the outlet end portion and is disposed within the interior lumen of the prosthetic tubular frame for providing unidirectional blood flow through the valve. A set of leaflets can include 2, 3, 4 or more leaflets, and the leaflets can be composed of pericardial tissue derived from bovine, porcine, or human donors.

[0113] The valve prosthesis can be curled and contained within a sheath of a transcatheter system for delivering a tubular frame. In some embodiments, the prosthetic heart valve is curled and contained within a sheath of a transcatheter system. The valve prosthesis can be delivered to the installation site by any appropriate method, including, but not limited to, a transfemoral, transjugular, subclavian, transapical, or transaortic method. In some embodiments, the valve prosthesis replaces the tricuspid valve and can be delivered to the right atrium via the femoral vein and inferior vena cava or via the jugular vein and superior vena cava. In some embodiments, the valve prosthesis replaces the mitral valve and can be delivered to the right atrium via the femoral vein through the inferior vena cava and into the left atrium through the atrial septum.

[0114] A bioresorbable component means that the component is biodegradable over time, such that the component breaks down and degrades within the body.Any biocompatible material may be used for the various components described herein. Examples of biocompatible and biodegradable materials for use as bioabsorbable components include, but are not limited to, poly(glycolic acid) (PGA), poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), poly(D,L-lactic acid) (PDLLA), poly(lactic acid-co-glycolic acid) (PGLA), poly(β-hydroxybutyrate-co-β-hydroxyvalerate) (PHBV), poly(hydroxybutyrate) (PHB), polycaprolactone (PCL), polycyanoacrylates (e.g., poly(octylcyanoacrylate) (POCA)), polyanhydrides (e.g., poly(fumaric acid-co-sebacic acid) (p(FASA)), and poly(propylene fumarate) (PPF). The composition of the bioabsorbable material can be controlled by various combinations and percentages to produce the desired results. For example, the degradation time can be controlled through the selection and composition of the material: PGA is absorbed within one to two months, PLA / PGA (80 / 20) is absorbed within one to two years, and PLLA is absorbed over five years.

[0115] Figure 2A and 2B A non-exhaustive example of a bioabsorbable portion of a frame of a valvular prosthesis is provided in . Tubular frame 151 can be constructed of a memory shape material (e.g., nitinol) and include a plurality of struts 153 interconnected to form cells 155 that can form a frame base 157. The struts 153 can also extend from the base 157 to form a plurality of appendages 157. It should be understood that any frame design is contemplated and any interconnection of struts to form cells and / or appendages can be utilized. Figure 2BAlso included is an inner skirt 159, an outer skirt 161, and a plurality of anchoring arms 163 that can hold a set of leaflets on the inner skirt to form a valve prosthesis for installation. The leaflets can be made of any suitable material such as (for example) bovine pericardium, porcine pericardium, or human donor pericardium. When replacing the tricuspid valve or mitral valve, the anchoring arms 163 can be used as anchors for anchoring the replacement valve. The curve of each anchoring arm 163 can be used to latch onto the chordae tendineae of the tricuspid valve or mitral valve, resist atrial and ventricular migration, and help keep the replacement valve in place when installed.

[0116] A frame constructed of a shape memory material such as nitinol can continuously provide radial force based on its shape memory. The radial force can push the host tissue at the installation site outward. During installation, the radial force of the frame combined with the contractile force of the local tissue helps to ensure that the frame anchors and maintains the valve prosthesis in its installed position. However, after a period of time, the radial force is no longer required because the local tissue can grow into and around the valve prosthesis to anchor and maintain the position. Continuous radial force may cause discomfort, or cause damage, or drive undesirable anatomical remodeling, or adversely affect heart function because it always resists the contractile force of the internal tissue and the inward growth of tissue.

[0117] In order to deal with the problem of continuous radial force, the framework may include multiple pillars 153 with bioabsorbable elements. For example, the framework 151 includes multiple pillars 153 with bioabsorbable elements 165 and 167 that can be absorbed over time. The bioabsorbable element can be a part of the pillar itself and / or a bioabsorbable connector connecting one or more pillars. As can be inferred from the depicted example, the bioabsorbable element 165 is located at a central position on the framework 151 (e.g., on the central connection point between the pillars), and can therefore be decomposed after installation, which can weaken the radial expansion framework and reduce the radial force it provides. Any method for expanding the framework can be utilized, including expansion via balloon, mechanical expansion or the utilization of shape memory materials (e.g., nitinol).

[0118] In a similar manner, bioabsorbable elements 167 are located on the periphery of the frame 151 (e.g., on the peripheral strut attachments) and can be disassembled after installation to weaken the extended attachments, thereby removing the most extended portion of the frame and reducing its overall size. It should be understood that various portions of the frame can be bioabsorbable to weaken the radial forces of the frame or extended attachments, and are not limited to Figure 2A and 2B In particular, any central portion of the struts or any connection points between struts may be constructed of bioabsorbable material.

[0119] The frame 151 may also be constructed entirely of bioabsorbable material. Thus, once the valve prosthesis is installed at the implant site, the bioabsorbable frame may be absorbed as tissue grows inward. Tissue ingrowth may provide the structure required to support the valve function of the valve implant, making the frame no longer necessary. In some embodiments, the frame constructed entirely of bioabsorbable material is removable.

[0120] When the valve prosthesis is installed, the anchors may be used to secure the prosthesis in its installed position. For a period of time after installation, tissue ingrowth may hold and maintain the prosthesis in the installed position, and therefore, the anchors and barbs are no longer required to provide the desired function. In addition, anchors and barbs may interfere with local tissue because their bulk or sharp points may push into tissue walls or other local anatomical structures.

[0121] Figure 3A An example of a valve prosthesis is provided in which the anchoring system includes a bioresorbable portion. Figure 2A and 2B , the frame 151 can be at least partially formed of a memory shape material (e.g., nitinol) and includes a plurality of struts 153 interconnected to form a plurality of cells 155 that can form a frame base 157. The struts 153 can also extend from the base 157 to form a plurality of appendages 157. The valve prosthesis also includes an inner skirt 159, an outer skirt 161, and an anchoring system 163. The valve prosthesis can also include a set of leaflets. Here, the anchoring system 163 includes a plurality of anchoring arms with bioabsorbable anchoring tips 169. When tissue grows into the prosthesis, the bioabsorbable anchoring tips 169 can help retain the native leaflets and maintain the valve prosthesis in its installed position.

[0122] Figure 3B and 3C Provide an example of the utility of a bioabsorbable anchoring tip. For example, it has been found that when a valve prosthesis is installed, the anchoring tip 169 may protrude into the local tissue 171 ( Figure 3B ) and cause problems. To solve this problem, the bioprosthesis anchoring tip 169 can be absorbed over time so that it no longer protrudes into the local tissue 171 ( Figure 3C ), and thereby prevent damage and / or remodeling of local tissue.

[0123] Figure 4A An enlarged view of a portion of a valve prosthesis is provided, showing an anchoring arm 163 with an anchor and a portion of a frame 151 behind an outer skirt 161. Also shown are a plurality of bioabsorbable barbs 173 extending from the frame 151 and / or the anchoring arm 163. The bioabsorbable barbs 173 can be attached to the local tissue 171 ( Figure 4B) to help secure the valve at the implant site. Similar to anchors, barbs are not required as tissue grows into the prosthesis and the valve is secured via tissue ingrowth. Over time, the bioresorbable barbs 173 can be absorbed, leaving the local tissue 171 free of barbs ( Figure 4C ), and allows for better healing and ingrowth.

[0124] Typically, a skirt is used over a valve prosthesis to help promote unidirectional flow and prevent paravalvular leak. Figure 5 A valve prosthesis is provided having an inner skirt 175 and an outer skirt 177 made of a bioabsorbable material that can be impermeable or semi-permeable to blood and circulatory system components. The bioabsorbable inner skirt 175 can be impermeable so that blood can flow through the valve without any leakage. The bioabsorbable outer skirt 177 can integrate with local tissue to promote tissue re-growth and re-endothelialization. After implantation, the bioabsorbable inner skirt 175 and the bioabsorbable outer skirt 177 can be absorbed as tissue grows into the valve to provide a sealing effect with the local tissue. Although Figure 5 A valve prosthesis having both a bioabsorbable inner skirt and a bioabsorbable outer skirt is depicted, but various valve prostheses may be constructed with only a bioabsorbable inner skirt or only a bioabsorbable outer skirt, and thus should not be limited to valve prostheses having both a bioabsorbable inner skirt and an outer skirt.

[0125] To promote blood flow and prevent tissue ingrowth, the bioabsorbable material of the inner surface of the inner skirt may be fluorinated or otherwise made more hydrophobic.

[0126] To promote tissue ingrowth, the outer valve skirt can be composed of a fluffy material having thickness and high porosity, which allows blood integration and clotting, which can help form a seal to prevent paravalvular leakage and also promote tissue ingrowth. Therefore, the outer skirt 177 can be composed of a bioabsorbable fluffy material. Alternatively or in addition, an outer band 179 composed of a bioabsorbable fluffy material can be utilized, which can be placed on top of the outer skirt 161 ( Figure 6 ). A fluffy bioabsorbable outer band 179 can completely or partially surround the valve prosthesis to promote blood integration and clotting. After implantation of the valve prosthesis, the fluffy bioabsorbable outer skirt 177 or the fluffy bioabsorbable outer band 179 can be absorbed as tissue grows into the prosthesis and forms a seal. In some embodiments, the outer surface of the outer skirt and / or outer band has been coated with a biologic that induces re-endothelialization, such as (for example) amino acids (e.g., lysine or ornithine), carbohydrates (e.g., hyaluronic acid, fibronectin, chitosan), structural proteins (e.g., collagen, elastin), growth factors (e.g., VEGF), and combinations thereof.

[0127] Bioresorbable materials may also be used to help control expansion and / or contraction of the valve frame. Fig. 7A An expandable frame 151 and a bioresorbable band 181 surrounding the frame are provided. The bioresorbable band 181 can prevent the frame 151 from expanding beyond its circumference, thereby ensuring that the frame is installed at the circumference set by the bioresorbable band. After installation at the implantation site, the bioresorbable band 181 can be absorbed, thereby preventing the frame from shrinking. In some embodiments, the frame 151 is made of a shape memory material (e.g., nitinol) and is self-expanding. Therefore, when the bioresorbable band 181 is absorbed, the frame is free to expand outward ( Figure 7B ).

[0128] In response to the corrected valve leakage, the local anatomy of the patient's anatomy has a tendency to return to normal size (commonly referred to as positive remodeling). The remodeling process shrinks the atria, annulus, and ventricles, thereby providing relief to the heart and restoring more sustainable physiological function. Because many valve prosthesis frames are self-expanding, the radial forces caused by expansion mitigate this natural positive remodeling. Therefore, it is ideal to provide a frame that provides radial expansion during installation, and the frame later stops providing radial forces to allow positive remodeling. In some embodiments, the valve prosthesis frame may include multiple segments along the outer diameter. Each segment can be connected via a bioabsorbable material so that the frame provides radial force during installation and reduces the force later as the material is absorbed. Material selection and application combined with frame design can enable the absorption of bioabsorbable materials to reduce radial forces as the prosthesis is fully integrated into the local anatomy, and further allow healing and implant adhesion to the autologous anatomy.

[0129] Fig. 8A An example of a frame 151 that can be collapsed is provided. In this example, the frame 151 is divided into a plurality of segments (151a, 151b, 151c) that combine to create a circular frame. Each frame segment is abutted to its adjacent frame segment via a bioabsorbable connector 183. Any bioabsorbable connector capable of abutting adjacent segments may be utilized, such as, for example, a plurality of biocompatible elements (e.g., Figure 2A The small band (as shown in Fig. 8A ), knots, hooks, rivets, staples or posts. After installation at the implant site, the bioabsorbable connector 183 can be absorbed to remove the constraints on the multiple segments. The local anatomical structure at the implant site can provide a contraction force, causing the segments to slide between each other so that they overlap, thereby creating a contracted frame and valve prosthesis ( Figure 8B ). When the frame is installed, the frame can be expanded via a balloon or mechanical member, or composed of a shape memory material (e.g., Nitinol).

[0130] The valve prosthesis may include one or more of any bioabsorbable components and / or elements described herein. Thus, the various described bioabsorbable components may be combined in any manner. In various valve prostheses, one or more of the following are combined: a frame having one or more bioabsorbable elements, one or more bioabsorbable anchors, one or more bioabsorbable barbs, a bioabsorbable inner skirt, a bioabsorbable outer skirt, a fluffy bioabsorbable outer skirt, one or more fluffy bioabsorbable outer bands, a bioabsorbable band for preventing frame expansion, and a frame comprising segments connected via bioabsorbable connectors.

[0131] A valve prosthesis having one or more bioabsorbable components can be loaded into a transcatheter delivery device. The valve prosthesis is curled and loaded into a catheter so that the prosthesis can be delivered to the implementation site via a transcatheter method. Any suitable transcatheter delivery system can be used, such as the system described in U.S. Patent Publication No. 2017 / 0231756, the disclosure of which is incorporated herein by reference in its entirety. Therefore, the delivery system may include a transcatheter having a valve prosthesis with one or more bioabsorbable components and / or elements. The valve prosthesis and delivery system having one or more bioabsorbable components / elements can be sterilized and stored.

[0132] In another aspect, the frame is configured to improve curling. Typical frames are configured so that the cells formed by the frame struts have a generally symmetrical shape. However, symmetry can lead to curling problems because equivalent struts and connectors with a symmetrical design each attempt to curl inward at the same time with the same force. Problems with symmetrical designs include uneven strut torsion during curling and unfolding that lead to oval and saddle-shaped frame configurations.

[0133] Fig. 9A framework design is provided in which each unit includes an asymmetric shape. It has been found that asymmetric struts can provide improved curling capabilities. The frame 901 is composed of interconnected struts 903 forming a plurality of units 905. For each unit, at least one strut 907 extending in a direction along the circumference of the frame has an asymmetric design that lacks reflective symmetry on the central midline of the strut. The lack of reflective symmetry can be formed by inconsistent lengths and / or curvatures on each side of the midline. The struts 907 each have two curved portions (909a and 909b) that meet in the middle vertex 911, thereby marking the central midline of the asymmetric strut. Curved portion 909a has a larger radius and length than curved portion 909b. This asymmetric design allows one side of the unit to curl or close circumferentially before the other side of the unit, and allows predictable loading by forcing all vertices to the same direction during the curling process. Similarly, this asymmetric bias provides more predictable valve curling and expansion, thereby reducing randomness. Although Fig. 9 A frame unit with an asymmetric curved portion is depicted, but various other asymmetric designs may be utilized to improve curling, including using multiple struts to create an asymmetric design along the circumference of the frame.

[0134] The frame with asymmetric cells and struts can be used as a stent or in a valve prosthesis. When in a curled configuration, the frame can be packaged into a transcatheter delivery device so that the frame can be used in a transcatheter procedure. Therefore, a delivery system can include a transcatheter with a curled frame having one or more cells with an asymmetric design. The curled frame and / or delivery system with one or more cells with an asymmetric design can be sterilized and stored.

[0135] When delivered to the site, any method of expanding the frame may be utilized, including expansion via a balloon, mechanical expansion, or utilization of a shape memory material (eg, nitinol). Thus, in some embodiments, the frame is crimped with a balloon or other means for mechanical expansion.

[0136] In another aspect, a prosthetic device is provided with features that reduce blood stagnation and thereby reduce the likelihood of clotting. In a prosthetic heart valve, blood flow can stagnate in the space between the leaflets and the surrounding lumen wall. Stagnant blood can lead to clotting, increase the risk of embolism and other problems, and can limit the life of the valve. Therefore, a solution to improve blood flow and / or flushing on the outflow side of the leaflets is needed.

[0137] One embodiment found to improve stagnant blood flow is to utilize a valve prosthesis with a flared outflow end. However, it may be desirable to deliver and / or install a valve prosthesis with a straight shape on the outflow end, which may improve delivery by reducing interaction with the delivery system. Figures 10A to 10C A system is provided for providing a valve frame having a rectilinear shape on the outflow end for delivery and installation, the system converting the outflow end thereof to flare outwardly. Fig. 10A An example of a valve frame 1001 for use in a valve prosthesis is depicted. The frame 1001 has an inflow side 1003 and an outflow side 1005. The frame 1001 also includes a plurality of bioabsorbable elements 1007 at or near the outflow side 1005. The bioabsorbable elements 1007 will absorb over time, thereby creating a frame 1001 with a segmented outflow side 1005 that has the ability to flex. After absorption, when local blood pressure and flow are high, the outflow side 1005 will be able to flex outward. This will create a frame that flexes outward during diastole (see Fig. 10B and 10C ), thereby creating a valve prosthesis with a flared outflow end to help ease outward flow and thus prevent blood stagnation.

[0138] Various embodiments of bioabsorbable elements can be used to produce an open outflow end. In some embodiments, the bioabsorbable element is arranged at the outflow end of every other vertical pillar. In some embodiments, the bioabsorbable element is arranged at the outflow end of every two vertical pillars. In some embodiments, the bioabsorbable element is arranged at the outflow end of every three vertical pillars. In some embodiments, the bioabsorbable element is arranged at the outflow end of every four vertical pillars. Various embodiments can be combined, such as (for example) for the first group of pillars, every other pillar has a bioabsorbable element and for the second group of pillars, every two pillars have an embodiment of a bioabsorbable element.

[0139] Fig.11A and 11B An example of a valve prosthesis that utilizes gap filling members, such as inflatable bags, to improve stagnant blood flow is provided. A vascular prosthesis 1101 has a set of leaflets 1103 and an inner lumen wall 1105. A set of one or more gap filling members are beneath the leaflets 1103 and attached to the inner lumen wall 1105, displacing blood and thereby reducing blood stagnation. In one example, the inflatable bag 1107 is filled with a compressed fluid component (e.g., a compressed liquid or gas component) that changes volume based on pressure. When the valve is closed, there is no flow through the lumen of the valve, and the set of inflatable bags 1107 can be left in a substantially unexpanded state ( Fig. 11B When the leaflets 1103 open to allow blood to flow through the valve, the flow increases and the inflatable bag 1107 expands with the outward flow, creating an hourglass shape in the lumen of the valve ( Fig.11A). Inflation of the bag can push stagnant blood along the lumen wall 1105 toward the center of the valve prosthesis 1101 and through the outflow end, which is aided by the hourglass shape of the valve lumen. The inflatable bag can be made of any biocompatible flexible material such as, for example, PET.

[0140] Fig.12 An example of a valve prosthesis utilizing a free-flowing sheet to improve stagnant blood flow is provided. A vascular prosthesis 1201 has a set of leaflets 1203 and an inner luminal wall 1205. A set of one or more free-flowing sheets 1207 are below the leaflets 1203 and attached to the inner luminal wall 1205, with one edge of the free-flowing sheet attached to the luminal wall. During systole when local pressure and flow are low, a set of free-flowing sheets 1207 can rest along or near the luminal wall 1205 ( Fig.12 ). As flow and pressure increase, the leaflets 1203 open to allow blood to flow through, and the free edges of a set of sheets 1207 move with the outward flow ( Fig.12 ). The movement of the sheet can push any stagnant blood along the luminal wall 1205 toward the center of the valve prosthesis 1201 and through the outflow end.

[0141] Fig.13A and 13B An example of a valve prosthesis that utilizes movable microprotrusions to improve stagnant blood flow is provided. The valve prosthesis 1301 has a set of leaflets 1303 and an inner lumen wall 1305. A set of microprotrusions 1307 protruding from the lumen wall are below the leaflets 1303 and attached to the inner lumen wall 1305. In one example, the microprotrusions are magnetically driven, wherein each microprotrusion has a positive magnetic pole and a negative magnetic pole at the tip of the microprotrusion. Each microprotrusion can be deflected in a direction toward the leaflet. The set of magnetically driven microprotrusions 1307 may include one or more larger driver microprotrusions 1307a, which can stimulate the rest of the set of microprotrusions to deflect in a linear alignment in the direction of flow. In addition, each microprotrusion tip has a specific pole alignment such that each pole face of each tip has the same charge as the adjacent tip pole face. For example, as Fig. 13B As shown in , the larger driver microprojection tip 1307a has a negative-positive tip, and the adjacent tip 1307b has a positive-negative tip, so that the negative side of microprojection tip 1307a is in close proximity to the negative side of microprojection tip 1307b. Therefore, when driver microprojection tip 1307a flexes toward microprojection tip 1407b, it pushes microprojection tip 1307b to flex toward the leaflet. Aligning each adjacent microprojection tip with opposite polarity along a linear line allows the driver microprojection tip to cause flexure of each microprojection in sequence. The flexure of the microprojections can push any stagnant blood along the lumen wall 1305 toward the center of the valve prosthesis 1301 and through the outflow end.

[0142] In another aspect, a frame and catheter are provided to prevent or limit strut twisting. A problem with tubular frames is that the struts tend to twist and twist when loaded into a sheath. This is particularly true for struts in less dense portions of the frame, which have more space to allow twisting to occur. Since twisting may damage the frame and / or create problems during deployment and installation, it is best to load the frame into the sheath so that twisting does not occur. Typically, to prevent the struts from twisting, the frame is crimped with a device that individually constrains each strut so that the strut cannot twist. However, this device is typically used only during the initial crimping and loading of the frame. The use of this device is limited to in vitro loading and is typically not used at the bedside.

[0143] Clinicians wish to be able to reload the frame proximally back into the sheath after advancing the structural frame distally at the installation site during a transcatheter procedure. The deployment and installation of the frame requires extremely high precision at the installation site in the patient's body. Because reloading of the structural frame may cause the struts to twist, the clinician only has one opportunity to deploy and install the frame, which may be difficult when relying on ultrasound echography or radiography. When at the installation site, the clinician wishes to reload the frame proximally back into the sheath so that they can adjust and reposition the sheath, and then advance the frame distally again at the repositioning site and deploy. This will allow for a better installation procedure because a completely accurate deployment is not required on the first attempt. When deployed, the frame can expand via a balloon, mechanical expansion, or the use of a shape memory material (e.g., Nitinol) to produce a self-expanding frame.

[0144] To prevent twisting of the struts during crimping and loading (and reloading) of the valve frame into the sheath, the frame may include one or more anti-torsion elements on a set of struts. The anti-torsion elements are small protrusions that extend laterally from the struts in a direction consistent with the circumference of the frame. The anti-torsion elements prevent twisting by providing a laterally wider profile that does not allow the struts to twist or twist when loaded into the sheath. The anti-torsion elements can be separate from the frame design so that the frame is manufactured together with the elements. Alternative anti-torsion elements can be attached to the frame, which can be attached and secured to the struts via attachment members (e.g., via rivets, screws, adhesives, or snaps in place).

[0145] In some embodiments, the anti-torsion element extends laterally for a length that prevents twisting when loaded and can be determined by the lateral width and radial depth of the strut. In some embodiments, the anti-torsion element extends laterally for a length such that the protrusion abuts or nearly abuts an adjacent strut. In some embodiments, the anti-torsion element extends laterally for a length between about 1.1 and 5 times the lateral width of the strut. In various embodiments, the anti-torsion element extends laterally for a length of about 1.1 times the lateral width of the strut, about 1.5 times the lateral width of the strut, about 2 times the lateral width of the strut, about 2.5 times the lateral width of the strut, about 3 times the lateral width of the strut, about 3.5 times the lateral width of the strut, about 4 times the lateral width of the strut, about 4.5 times the lateral width of the strut, or about 5 times the lateral width of the strut. In some embodiments, the anti-torsion element has the same (or nearly the same) radial depth as the strut. In some embodiments, the anti-torsion element has a vertical length (i.e., a length parallel to the longitudinal axis of the strut) that is a fraction of the length of the strut. The vertical length can vary, but should not be too long to prevent flexibility of the strut and expandability of the framework. In some implants, the vertical length of the anti-torsion element is between about 2% and 20% of the length of the strut. In various embodiments, the vertical length of the anti-torsion element is about 2% of the length of the strut, about 2.5% of the length of the strut, about 3% of the length of the strut, about 5% of the length of the strut, about 10% of the length of the strut, or about 20% of the length of the strut. The anti-torsion element can have any shape.

[0146] One or more anti-torsion elements may be disposed on each strut of the frame, or on each strut in a group of struts. In some embodiments, one or more anti-torsion elements are disposed on struts within a less dense portion of the frame (as determined by the density along the circumference of the frame). The density may be determined by the abutment (or near abutment) of the struts in a curled state. When curled, adjacent struts that are adjacent or within a distance that prevents the ability of the struts to twist may not require anti-torsion elements because this density prevents the struts from twisting. The distance to prevent twisting may be determined by the lateral width and radial depth of the struts. In addition, a high lateral density may not allow the addition of anti-torsion elements that would widen the lateral profile of the struts.

[0147] The anti-torsion may also include other components. In some embodiments, the anti-torsion element includes a marker for visualization via ultrasound echography, radiography, or any other visualization technique for monitoring during a transcatheter procedure. In some embodiments, an orifice is provided in the anti-torsion element that may be used as a marker for visualization.

[0148] Alternatively or in addition to a frame having an anti-torsion element, the sheath can be designed so that the struts of the frame cannot twist and twist. The sheath is typically tubular in design, having an inner lumen. The inner surface of the sheath (i.e., the surface inside the lumen of the sheath) has a circular profile. To prevent twisting and twisting, the inner surface of the sheath can have a polygonal profile instead of a traditional circular profile. The flat profile on each side of the polygon reduces the amount of space between the struts and the inner surface of the sheath, and thus the struts do not have room to twist and twist.

[0149] The valve frame typically includes a repeating pattern of struts and cells, resulting in a plurality of repeating columnar segments (e.g., each segment extending along a proximal-distal axis). The number of columnar segments can vary, but typically is between 5 and 15 columnar segments, depending on the frame design. The inner surface of the sheath can be contoured in a polygonal shape to match the columnar segments of the frame. For example, the inner surface contour of the sheath can be a polygon with a certain number of sides that match the number of columnar segments of the frame. Thus, in various embodiments, the inner profile of the sheath is: a pentagon for a frame having five columnar segments; a hexagon for a frame having six columnar segments; a heptagon for a frame having seven columnar segments; an octagon for a frame having eight columnar segments; a nonagon for a frame having nine columnar segments; a decagon for a frame having ten columnar segments; an eleventh sided for a frame having eleven columnar segments; a dodecagon for a frame having twelve columnar segments; a thirteenth sided for a frame having thirteen columnar segments; a tetradecagon for a frame having fourteen columnar segments; or a pentagon for a frame having fifteen columnar segments.

[0150] In some embodiments, to prevent the struts from twisting, the struts are closely adjacent to one side of the polygon when the curled frame is within a sheath comprising an inner surface having a polygonal profile. In some embodiments, the struts abut or nearly abut one side of the polygon when the curled frame is within a sheath comprising an inner surface having a polygonal profile. The strut width and near abutment distance measurements will be measured at the same location of the struts.

[0151] Fig.14A and 14B An example of a frame with multiple anti-torsion elements is provided in . Frame 1401 includes multiple anti-torsion elements 1403. Frame 1401 includes multiple struts 1405, which are connected at multiple connection points 1407 and form multiple units 1409, each unit perimeter includes two or more connected struts. Multiple struts 1405 form nine column segments, each column segment 1411 is laterally adjacent to another column segment and integrally forms a circumference.

[0152] Each columnar segment 1411 includes three units, two of which are at the distal end of the frame and a single unit at the proximal end. As can be easily appreciated, when curled, the distal end will have a greater density of struts along the lateral circumference. Due to the lack of strut density at the proximal end, these struts (e.g., struts 1405a and struts 1405b) have a tendency to twist and twist when curled. To mitigate the twisting on these struts, each strut at the proximal end includes an anti-twist element 1403.

[0153] As depicted, each anti-torsion element 1403 extends into the proximal cell, but the anti-torsion element can extend away from the cell or extend from the pillar in any lateral direction. In some embodiments, two or more anti-torsion elements extend toward the same transverse axis, each anti-torsion element is arranged on a different longitudinal axis, which can prevent the anti-torsion elements from contacting when the frame is curled. For example, anti-torsion element 1403a and anti-torsion element 1403b each extend toward the same transverse axis 1402. Anti-torsion element 1403a extends from pillar 1405a along a longitudinal axis that is close to the longitudinal axis along which anti-torsion element 1403b extends, and the longitudinal axis extends from pillar 1405b. When frame 1401 is curled, anti-torsion element 1403a and anti-torsion element 1403b will not contact.

[0154] Each anti-torsion element 1403 includes an aperture 1413 that can be used to visualize the element and frame 1401 via a visualization technique used to monitor deployment of the frame. Each anti-torsion element 1403 is depicted as a quadrilateral, but any shape may be utilized.

[0155] Fig.15A and 15B An example of a frame crimped within a sheath is depicted. The frame comprises a series of columnar segments, but for clarity and explanation, the figure depicts only a single columnar segment. Frame 1501 comprises columnar segment 1503 within sheath 1505. Struts 1507a and 1507b are located in a section of frame 1501 where the strut density is low and there is ample room for twisting and distortion, and therefore when the frame is crimped and loaded into the sheath, these struts have a tendency to twist and distort (see Fig. 15B 1508).

[0156] Fig.16A and 16BAn example of a frame including an anti-torsion element curled within a sheath is depicted. The frame includes a series of columnar segments, but for clarity and explanation, the figure only depicts a single columnar segment. Frame 1601 includes columnar segment 1603 within sheath 1605. Struts 1607a and 1607b are located in a section of the frame 1601 with a lower density of struts that has sufficient room for twisting and twisting. To mitigate twisting and twisting, struts 1607a and 1607b include a set of anti-torsion elements. As depicted, each of struts 1607a and 1607b includes two anti-torsion elements, but it is understood that a set can be one or more and can vary in size and shape, as described herein. Anti-torsion element 1609 limits the ability of struts 1607a and 1607b to twist and twist, thereby reducing the torsion on the struts ( Fig. 16B ).

[0157] Fig.17A and 17B An example of a frame curled within a sheath including an inner surface having a polygonal shape is depicted. The frame includes a series of columnar segments, but for clarity and explanation, the figure only depicts a single columnar segment. Frame 1701 includes columnar segment 1703 within sheath 1605. Struts 1707a and 1707b are located in a section of the frame 1701 with a lower density of struts that has sufficient room for twisting and distortion. To reduce twisting and distortion, the inner surface 1711 of sheath 1701 is polygonal. As shown, columnar segment 1703 abuts or nearly abuts one side of the polygonal profile. The polygonal profile of inner surface 1711 limits the ability of struts 1707a and 1707b to twist and distort, thereby reducing the torsion of the struts ( Fig. 16B ).

[0158] In some embodiments, the frame includes an anti-torsion element (e.g., Fig.16A ), and is crimped and loaded into a catheter including an inner surface having a polygonal contour (e.g., Fig. 17B ).

[0159] On the other hand, an improved manufacturing procedure is provided in which a cover can be applied to a frame in a more efficient and economical manner. A common problem in manufacturing valve frame covers is that it can be difficult to wrap and attach the cover around the frame. The cover is typically a sheet of fabric, tissue, film, or some other flattened material, and the frame is typically tubular in shape with a circumference of many different lengths. When the cover is wrapped and secured to the frame, excess cover may bunch up and require further trimming and assembly. To address this issue, the cover can be pre-cut prior to assembly. The pre-cut cover can be repeated and scaled to industrial manufacturing levels, thereby facilitating the manufacture of frames with covers.

[0160] Fig.18A1801 includes a plurality of segments 1803. The number of segments can vary and depends on the frame design. The cover 1801 is used for a frame including nine columnar segments, and according to some embodiments, the cover includes the same number of segments as the columnar segments of the frame. The segments 1803 are cut in a manner that fully covers each columnar segment of the frame. In this example, each segment 1803 is connected to an adjacent segment at a first end 1805 of the cover 1801 (i.e., the first end is one of the proximal end or the distal end). At a second end 1807 opposite to the first end, each segment 1803 is not connected to an adjacent segment, so that the cover 1801 is pre-cut into a shape similar to a flower. The lateral edges of each segment 1803 include a portion connected at or near the first end and a portion (e.g., a middle portion and a portion at or near the second end) that is not connected at or near the first end. As shown, most of each lateral edge of each segment 1803 is not connected from an adjacent segment.

[0161] Cap 1801 is for use with a tubular frame that includes multiple circumferential lengths along a proximal-distal axis. Fig.18A Describe the four circumference lengths (1802a, 1802b, 1802c and 1802d) of the framework. Therefore, each segment 1803 is cut into certain specifications, wherein the lateral edge profile of each segment 1803 is formed to produce a segment width to match with multiple circumferences of the framework. As shown in the figure, the first end 1805 is cut into a size that matches the circumference length 1802a. Each segment 1803 expands laterally from the first circumference length 1802a to the second circumference length 1802b, and then maintains a similar lateral width until the third circumference 1803c. The width of each segment 1803 is laterally reduced to the fourth circumference length 1802d from the third circumference length 1802c, and the fourth circumference length is the second end of the cover. Each lateral edge can be used to sew the cover to the framework.

[0162] Fig.18B Provides attachment to the frame Fig.18A An exemplary cover of FIG. 1801 is assembled to the frame, covering each segment 1803 over the cylindrical segment of the frame. Each segment 1803 is sewn to each of its adjacent segments along its lateral sides via stitching 1809, thereby creating a plurality of seams. Thus, the lateral edges of each segment 1803 are formed by pre-cutting flower shapes (see FIG. 1804 ). Fig.18A ) is connected to the lateral edge of each adjacent segment at a first end 1805 and to the lateral edge of each adjacent segment at a second end 1807 by an attachment member, such as a suture 1809. A majority of the lateral edge of each columnar segment is connected to the lateral edge of each adjacent segment by an attachment member, such as a suture 1809. Although sutures are shown, any of a number of attachment members may be utilized, such as, for example, sutures, staples, and adhesives.

[0163] The following examples are included within the scope of the present invention.

[0164] Example 1. A frame for use in a valve prosthesis, comprising a plurality of interconnected struts forming a tubular frame, and a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0165] Example 2. The frame of Example 1, wherein the plurality of interconnected struts comprises a shape memory material that provides a radial force.

[0166] Example 3. A framework according to Example 2, wherein absorption of the bioresorbable element causes a reduction in radial force of the tubular framework.

[0167] Example 4. The framework of example 1, 2 or 3, wherein at least a subset of the plurality of bioresorbable elements are located at the interconnection points of two or more struts.

[0168] Example 5. A frame according to any one of Examples 1 to 4, wherein the tubular frame further comprises a plurality of appendages extending away from the tubular frame; and wherein each appendage of the plurality of appendages is formed by a subset of the plurality of interconnected struts.

[0169] Example 6. The frame of Example 5, wherein at least a subset of the plurality of bioresorbable elements are located within one or more of the plurality of appendages.

[0170] Example 7. The frame of any one of Examples 1 to 6, wherein the tubular frame is curled.

[0171] Example 8. The frame of Example 7, wherein the tubular frame is within a catheter of a transcatheter delivery system.

[0172] Example 9. The frame of any one of Examples 1 to 8 further comprises an inner skirt attached to the tubular frame.

[0173] Example 10. A frame according to Example 9, wherein the inner skirt is bioabsorbable.

[0174] Example 11. A frame according to any one of Examples 1 to 10, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0175] Example 12. The frame of any one of Examples 1 to 11 further comprising an outer skirt attached to the tubular frame.

[0176] Example 13. A frame according to Example 12, wherein the outer skirt is bioresorbable.

[0177] Example 14. The frame of any one of Examples 1 to 13, further comprising a fluffy bioresorbable band surrounding the tubular frame.

[0178] Example 15. The frame of any one of Examples 1 to 14, further comprising an anchoring system attached to the tubular frame.

[0179] Example 16. A framework according to Example 15, wherein the anchoring system includes a bioresorbable portion.

[0180] Example 17. The framework of Example 16 further comprising a set of bioabsorbable barbs attached to the tubular framework or to the anchoring system.

[0181] Example 18. A frame according to any one of Examples 1 to 17, wherein the frame is sterilized and packaged.

[0182] Example 19. A valve prosthesis comprising: a plurality of interconnected struts forming a tubular frame; and an anchor system attached to the tubular frame, the anchor system comprising a plurality of anchor arms having bioabsorbable anchor tips.

[0183] Example 20. The valve prosthesis of Example 19, wherein, when implanted, absorption of at least one of the bioresorbable anchoring tips causes reduced invasiveness to local tissue at the implantation site.

[0184] Example 21. The valve prosthesis of Example 19 or 20 further comprising a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0185] Example 22. The valve prosthesis of Example 21 wherein at least a subset of the plurality of bioresorbable elements are located at an interconnection point of two or more struts.

[0186] Example 23. A valve prosthesis according to Example 21 or 22, wherein the tubular frame further includes a plurality of attachments extending away from the tubular frame; wherein each of the plurality of attachments is formed by a subset of the plurality of interconnected struts; and wherein at least a subset of the plurality of bioresorbable portions is located within one or more of the plurality of attachments.

[0187] Example 24. The valve prosthesis of any of Examples 19 to 23, wherein the valve prosthesis is curled.

[0188] Example 25. The valve prosthesis of Example 24, wherein the curled valve prosthesis is within a catheter of a transcatheter delivery system.

[0189] Example 26. The valve prosthesis of any of Examples 19 to 25, further comprising an inner skirt attached to the tubular frame.

[0190] Example 27. A valve prosthesis according to Example 26, wherein the inner skirt is bioresorbable.

[0191] Example 28. The valve prosthesis of any one of Examples 19 to 27, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0192] Example 29. The valve prosthesis of any of Examples 19 to 28 further includes an outer skirt attached to the tubular frame.

[0193] Example 30. The valve prosthesis of Example 29, wherein the outer skirt is bioresorbable.

[0194] Example 31. The valve prosthesis of any of Examples 19 to 30, further comprising a fluffy bioresorbable band surrounding the tubular frame.

[0195] Example 32. The valve prosthesis of any one of Examples 19 to 31, further comprising a set of bioresorbable barbs.

[0196] Example 33. The valve prosthesis of any one of Examples 19 to 32, wherein the valve prosthesis is sterilized and packaged.

[0197] Example 34. A valve prosthesis comprising: a plurality of interconnected struts forming a tubular frame; and an inner skirt attached to the tubular frame, the inner skirt being bioabsorbable.

[0198] Example 35. The valve prosthesis of Example 34 further includes a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0199] Example 36. The valve prosthesis of Example 35 wherein at least a subset of the plurality of bioresorbable elements are located at a point of interconnection of two or more struts.

[0200] Example 37. A valve prosthesis according to Example 35 or 36, wherein the tubular frame further includes a plurality of appendages extending away from the tubular frame, wherein each of the plurality of appendages is formed by a subset of the plurality of interconnected struts, and wherein at least a subset of the plurality of bioresorbable elements is located within one or more of the plurality of appendages.

[0201] Example 38. The valve prosthesis of any of Examples 34 to 37, wherein the valve prosthesis is curled.

[0202] Example 39. The valve prosthesis of Example 38, wherein the curled valve prosthesis is within a catheter of a transcatheter delivery system.

[0203] Example 40. The valve prosthesis of any one of Examples 34 to 39, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0204] Example 41. The valve prosthesis of any of Examples 34 to 40, further comprising an outer skirt attached to the tubular frame.

[0205] Example 42. A valve prosthesis according to Example 41, wherein the outer skirt is bioresorbable.

[0206] Example 43. The valve prosthesis of any of Examples 34 to 42 further comprising a fluffy bioresorbable band surrounding the tubular frame.

[0207] Example 44. The valve prosthesis of any of Examples 34 to 43 further includes an anchoring system attached to the tubular frame.

[0208] Example 45. A valve prosthesis according to Example 44, wherein the anchoring system includes a bioresorbable portion.

[0209] Example 46. The valve prosthesis of Example 45 further includes a set of bioabsorbable barbs attached to the tubular frame or to the anchoring system.

[0210] Example 47. The valve prosthesis of any of Examples 34 to 46, wherein the valve prosthesis is sterilized and packaged.

[0211] Example 48. A valve prosthesis comprising: a plurality of interconnected struts forming a tubular frame; and an outer skirt attached to the tubular frame, the outer skirt being bioabsorbable.

[0212] Example 49. The valve prosthesis of Example 48 wherein the outer skirt is a fluffy bioresorbable outer skirt.

[0213] Example 50. The valve prosthesis of Example 48 or 49 further includes a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0214] Example 51. The valve prosthesis of Example 50, wherein at least a subset of the plurality of bioresorbable elements are located at the interconnection point of two or more struts.

[0215] Example 52. A valve prosthesis according to Example 50 or 51, wherein the tubular frame further includes a plurality of appendages extending away from the tubular frame; wherein each of the plurality of appendages is formed by a subset of the plurality of interconnected struts; and wherein at least a subset of the plurality of bioresorbable elements is located within one or more of the plurality of appendages.

[0216] Example 53. The valve prosthesis of any of Examples 48 to 52, wherein the valve prosthesis is curled.

[0217] Example 54. The valve prosthesis of Example 53, wherein the curled valve prosthesis is within a catheter of a transcatheter delivery system.

[0218] Example 55. The valve prosthesis of any of Examples 48 to 54 further includes an inner skirt attached to the tubular frame.

[0219] Example 56. The valve prosthesis of Example 55, wherein the inner skirt is bioresorbable.

[0220] Example 57. The valve prosthesis of any one of Examples 48 to 56, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0221] Example 58. The valve prosthesis of any of Examples 48 to 57 further includes an anchoring system attached to the tubular frame.

[0222] Example 59. The valve prosthesis of Example 58, wherein the anchoring system includes a bioresorbable portion.

[0223] Example 60. The valve prosthesis of Example 59 further includes a set of bioabsorbable barbs attached to the tubular frame or to the anchoring system.

[0224] Example 61. The valve prosthesis of any of Examples 48 to 60, wherein the valve prosthesis is sterilized and packaged.

[0225] Example 62. A valve prosthesis comprising: a plurality of interconnected struts forming a tubular frame; and a fluffy bioresorbable band surrounding the tubular frame.

[0226] Example 63. The valve prosthesis of Example 62 further includes a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0227] Example 64. The valve prosthesis of Example 63 wherein at least a subset of the plurality of bioresorbable elements are located at a point of interconnection of two or more struts.

[0228] Example 65. A valve prosthesis according to Example 63 or 64, wherein the tubular frame further includes a plurality of appendages extending away from the tubular frame; wherein each of the plurality of appendages is formed by a subset of the plurality of interconnected struts; and wherein at least a subset of the plurality of bioresorbable elements is located within one or more of the plurality of appendages.

[0229] Example 66. The valve prosthesis of any of Examples 62 to 65, wherein the valve prosthesis is curled.

[0230] Example 67. The valve prosthesis of Example 66 wherein the curled valve prosthesis is within a catheter of a transcatheter delivery system.

[0231] Example 68. The valve prosthesis of any of Examples 62 to 67 further includes an inner skirt attached to the tubular frame.

[0232] Example 69. The valve prosthesis of Example 68, wherein the inner skirt is bioresorbable.

[0233] Example 70. The valve prosthesis of any one of Examples 62 to 69, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0234] Example 71. The valve prosthesis of any of Examples 62 to 70 further includes an outer skirt attached to the tubular frame.

[0235] Example 72. A valve prosthesis according to Example 71, wherein the outer skirt is bioresorbable.

[0236] Example 73. The valve prosthesis of any of Examples 62 to 72 further includes an anchoring system attached to the tubular frame.

[0237] Example 74. The valve prosthesis of Example 73, wherein the anchoring system includes a bioresorbable portion.

[0238] Example 75. The valve prosthesis of Example 74 further includes a set of bioabsorbable barbs attached to the tubular frame or to the anchoring system.

[0239] Example 76. The valve prosthesis of any of Examples 62 to 75, wherein the valve prosthesis is sterilized and packaged.

[0240] Example 77. A valve prosthesis comprising: a plurality of interconnected struts forming a tubular frame; an anchoring system attached to the tubular frame; and a set of bioresorbable barbs attached to the tubular frame or to the anchoring system.

[0241] Example 78. The valve prosthesis of Example 77 further includes a plurality of bioresorbable elements within a subset of the struts forming the tubular frame.

[0242] Example 79. The valve prosthesis of Example 78 wherein at least a subset of the plurality of bioresorbable elements are located at a point of interconnection of two or more struts.

[0243] Example 80. A valve prosthesis according to Example 78 or 79, wherein the tubular frame further includes a plurality of appendages extending away from the tubular frame; wherein each of the plurality of appendages is formed by a subset of the plurality of interconnected struts; and wherein at least a subset of the plurality of bioresorbable elements is located within one or more of the plurality of appendages.

[0244] Example 81. The valve prosthesis of any of Examples 77 to 80 wherein the valve prosthesis is curled.

[0245] Example 82. The valve prosthesis of Example 81 wherein the curled valve prosthesis is within a catheter of a transcatheter delivery system.

[0246] Example 83. A valve prosthesis according to any of Examples 77 to 82, wherein the anchoring system includes a bioresorbable portion.

[0247] Example 84. The valve prosthesis of any of Examples 77 to 83 further includes an inner skirt attached to the tubular frame.

[0248] Example 85. The valve prosthesis of Example 84, wherein the inner skirt is bioresorbable.

[0249] Example 86. The valve prosthesis of any of Examples 77 to 85, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0250] Example 87. The valve prosthesis of any of Examples 77 to 86 further includes an outer skirt attached to the tubular frame.

[0251] Example 88. The valve prosthesis of Example 87, wherein the outer skirt is bioresorbable.

[0252] Example 89. The valve prosthesis of any of Examples 77 to 88 further comprising a fluffy bioresorbable band surrounding the tubular frame.

[0253] Example 90. The valve prosthesis of any of Examples 77 to 89, wherein the valve prosthesis is sterilized and packaged.

[0254] Example 91. A valve prosthesis comprising: a plurality of interconnected struts for forming a self-expanding tubular frame; wherein the tubular frame comprises a shape memory material; and a contracting bioresorbable band surrounding the self-expanding tubular frame.

[0255] Example 92. The valve prosthesis of Example 91 further includes an inner skirt attached to the tubular frame.

[0256] Example 93. The valve prosthesis of Example 91 or 92 further includes a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0257] Example 94. The valve prosthesis of Example 91, 92, or 93 further includes an outer skirt attached to the tubular frame.

[0258] Example 95. The valve prosthesis of any of Examples 91 to 94 further comprising an anchoring system attached to the tubular frame.

[0259] Example 96. The valve prosthesis of any of Examples 91 to 95 wherein the tubular frame is curled.

[0260] Example 97. The valve prosthesis of Example 96, wherein the valve prosthesis is within a catheter of a transcatheter delivery system.

[0261] Example 98. The valve prosthesis of any of Examples 91 to 97, wherein the valve prosthesis is sterilized and packaged.

[0262] Example 99. A valve prosthesis comprising: a group of columnar segments, each columnar segment comprising a plurality of interconnected struts; and a group of bioabsorbable connectors, wherein the group of bioabsorbable connectors connect the group of columnar segments to form a tubular frame, wherein each columnar segment is connected to two adjacent columnar segments via one or more bioabsorbable connectors in the group.

[0263] Example 100. The valve prosthesis of Example 99 further includes an inner skirt attached to the tubular frame.

[0264] Example 101. The valve prosthesis of Example 99 or 100, further comprising a set of leaflets within the tubular frame; wherein the set of leaflets is attached to the tubular frame or to the inner skirt.

[0265] Example 102. The valve prosthesis of Examples 99, 100, or 101 further comprising an outer skirt attached to the tubular frame.

[0266] Example 103. The valve prosthesis of any of Examples 99 to 102 further comprising an anchoring system attached to the tubular frame.

[0267] Example 104. The valve prosthesis of any of Examples 99 to 103, wherein the tubular frame is curled.

[0268] Example 105. The valve prosthesis of Example 104, wherein the valve prosthesis is within a catheter of a transcatheter delivery system.

[0269] Example 106. The valve prosthesis of any of Examples 99 to 105, wherein the valve prosthesis is sterilized and packaged.

[0270] Example 107. A frame for use in a valve prosthesis, comprising: a plurality of interconnected struts forming a tubular frame having a plurality of cells; wherein at least a subset of the plurality of cells are asymmetric.

[0271] Example 108. A frame according to Example 107, wherein the asymmetry of each unit in the subset of the plurality of units is formed by at least one asymmetric lateral strut.

[0272] Example 109. A frame according to Example 108, wherein the asymmetry of at least one of the lateral struts is formed by two curved portions connected at a central vertex, wherein a first curved portion of the two curved portions has a larger radius and length than a second curved portion of the two curved portions.

[0273] Example 110. A frame for use in a valve prosthesis, comprising: a plurality of interconnected struts forming a tubular frame, the tubular frame having an inflow end and an outflow end; and a plurality of bioresorbable elements within a subset of the struts forming the tubular frame, wherein the bioresorbable elements are at or near the outflow side.

[0274] Example 111. The frame of Example 110, wherein absorption of the bioabsorbable element at or near the outflow side creates a segmented outflow end with flexing capabilities.

[0275] Example 112. A frame according to Example 111, wherein the frame is configured such that when the frame is subjected to liquid flow and pressure passing through the frame, the segmented outflow end can flex outward to transform the outflow end from a slight linear shape to an open shape.

[0276] Example 113. A framework of Example 112, wherein the framework is implanted within the vascular system of an animal, and wherein the fluid flow and pressure are systolic blood flow and pressure.

[0277] Example 114. A valve prosthesis for improving stagnant blood flow, comprising: a plurality of interconnected struts forming a tubular frame, the tubular frame having an inflow side and an outflow side; an inner lumen wall attached to the tubular frame; a group of leaflets within the tubular frame, the group of leaflets attached to the tubular frame or to the inner lumen wall and separating the inflow side of the tubular frame from the outflow side; and a group of one or more inflatable bags attached to the inner lumen wall on the outflow side of the frame.

[0278] Example 115. The valve prosthesis of Example 114 wherein each bag in the set of one or more inflatable bags is comprised of a biocompatible flexible material.

[0279] Example 116. The valve prosthesis of Example 114 or 115 wherein each bag in the set of one or more inflatable bags is filled with a compressed fluid component that changes volume based on pressure.

[0280] Example 117. A valve prosthesis according to Example 116, wherein the set of one or more inflatable bags is configured such that each bag in the set of one or more inflatable bags is capable of expanding into an inflated state when the valve prosthesis is subjected to liquid flow and pressure through the inner lumen wall.

[0281] Example 118. The valve prosthesis of Example 117, wherein the valve prosthesis is implanted within the vasculature of an animal, and wherein the fluid flow and pressure are systolic blood flow and pressure.

[0282] Example 119. A valve prosthesis for improving stagnant blood flow, comprising: a plurality of interconnected struts forming a tubular frame, the tubular frame having an inflow side and an outflow side; an inner lumen wall attached to the tubular frame; a group of leaflets within the tubular frame, the group of leaflets being attached to the tubular frame or to the inner lumen wall and separating the inflow side of the tubular frame from the outflow side; and a group of one or more free-flow sheets attached to the inner lumen wall on the outflow side of the frame, each free-flow sheet in the group of one or more free-flow sheets having at least one free edge.

[0283] Example 120. The valve prosthesis of Example 119, wherein each free-flowing sheet in the set of one or more free-flowing sheets is comprised of a biocompatible flexible material.

[0284] Example 121. A valve prosthesis according to Example 120, wherein the set of one or more free-flow sheets is configured such that when the valve prosthesis is subjected to liquid flow and pressure through the inner lumen wall, each free-flow sheet in the set of one or more free-flow sheets is able to move with the liquid flow.

[0285] Example 122. The valve prosthesis of Example 121, wherein the valve prosthesis is implanted within the vasculature of an animal, and wherein the fluid flow and pressure are systolic blood flow and pressure.

[0286] Example 123. A valve prosthesis for improving stagnant blood flow, comprising: a plurality of interconnected struts forming a tubular frame, the tubular frame having an inflow side and an outflow side; an inner lumen wall attached to the tubular frame; a group of leaflets within the tubular frame, the group of leaflets being attached to the tubular frame or to the inner lumen wall and separating the inflow side of the tubular frame from the outflow side; and a plurality of flexible magnetically actuated microprotrusions linearly aligned in the direction of flow and attached to the inner lumen wall, wherein each of the plurality of flexible magnetically actuated microprotrusions has a positive magnetic pole and a negative magnetic pole at the tip of the microprotrusion.

[0287] Example 124. A valve prosthesis according to Example 123, wherein the plurality of flexible magnetically actuated microprotrusions includes larger actuator microprotrusions.

[0288] Example 125. A valve prosthesis according to Example 123 or 124, wherein each microprotrusion tip of the plurality of flexible magnetically actuated microprotrusions has a specific polar alignment such that each pole face of each tip has the same charge as the pole face of an adjacent tip.

[0289] Example 126. The valve prosthesis of Example 124 or 125 wherein the larger actuator microprotrusion stimulates deflection of the remainder of the plurality of flexible magnetically actuated microprotrusions.

[0290] Example 127. A frame system for use in a valve prosthesis, the frame system comprising: a plurality of interconnected struts forming a self-expanding tubular frame, wherein the tubular frame comprises a shape memory material for providing radial force; and a plurality of anti-torsion elements, wherein each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0291] Example 128. A frame system as described in Example 127, wherein each anti-torsion element is attached to a strut that is in an area of ​​the frame having a low density of struts.

[0292] Example 129. A frame system according to Example 127 or 128, wherein each anti-torsion element is manufactured as part of the frame design.

[0293] Example 130. A frame system according to Example 127 or 128, wherein each anti-torsion element is attached and secured to the support post by an attachment member.

[0294] Example 131. A frame system as described in any of Examples 127 to 130, wherein when the frame is curled, at least a subset of the plurality of anti-torsion elements abut or nearly abut an adjacent post.

[0295] Example 132. A frame system as described in any of Examples 127 to 131, wherein each anti-torsion element extends laterally a length between about 1.1 times and 5 times the lateral width of the support.

[0296] Example 133. A frame system as described in any of Examples 127 to 132, wherein each anti-torsion element has a vertical length between about 2% and 20% of the length of the support.

[0297] Example 134. A frame system as described in any of Examples 127 to 133, wherein at least a subset of the plurality of anti-torsion elements includes markings for visualization.

[0298] Example 135. A frame system according to any one of Examples 127 to 134, further comprising a conduit wherein the conduit accommodates the tubular frame, wherein each anti-torsion element reduces the ability of the struts to twist or twist during loading of the tubular frame into the conduit.

[0299] Example 136. A frame system according to Example 135, wherein the conduit includes an inner surface having a polygonal profile.

[0300] Example 137. A frame system according to Example 136, wherein the tubular frame includes a plurality of columnar segments, and wherein the number of columnar segments is equal to the number of sides of the polygonal profile.

[0301] Example 138. A frame system as described in Example 136 or 137, wherein at least a subset of the plurality of interconnected struts abut or nearly abut a side of the polygonal profile.

[0302] Example 139. A frame system according to any of Examples 127 to 138, wherein the tubular frame is sterilized and packaged.

[0303] Example 140. A method for releasing a frame via a transcatheter technique, the method comprising: a delivery catheter and a tubular frame, the tubular frame self-expanding to a site where the tubular frame is to be installed, wherein the tubular frame is loaded within the catheter, wherein the tubular frame comprises: a shape memory material for providing radial force; a plurality of interconnected struts; and a plurality of anti-torsion elements, wherein each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts; advancing the tubular frame distally out of the catheter, thereby causing expansion of the tubular frame; and reloading the tubular frame proximally into the catheter, thereby causing curling of the tubular frame.

[0304] Example 141. A method according to Example 140, wherein each anti-torsion element is attached to a strut that is in an area of ​​the frame having a low density of struts.

[0305] Example 142. A method according to Example 140 or 141, wherein each anti-torsion element extends laterally a length between about 1.1 times and 5 times the lateral width of the strut.

[0306] Example 143. A method as described in Example 140, 141 or 142, wherein each anti-torsion element has a vertical length between about 2% and 20% of the length of the strut.

[0307] Example 144. A method according to any one of Examples 140 to 143, wherein at least a subset of the plurality of anti-torsion elements includes markers for visualization, the method further comprising: visualizing distal advancement or proximal reloading of the self-expanding tubular frame via the markers for visualization and visualization technology.

[0308] Example 145. A frame system for use in a valve prosthesis, the frame system comprising: a plurality of interconnected struts forming a self-expanding tubular frame, wherein the tubular frame comprises a shape memory material for providing radial force; and a catheter, wherein the catheter accommodates the tubular frame, wherein the catheter comprises an inner surface having a polygonal profile.

[0309] Example 146. A frame system according to Example 145, wherein the tubular frame includes a plurality of columnar segments, and wherein the number of columnar segments is equal to the number of sides of the polygonal profile.

[0310] Example 147. A frame system as described in Example 145 or 146, wherein at least a subset of the plurality of interconnected struts abut or nearly abut a side of the polygonal profile.

[0311] Example 148. The frame system of Example 145, 146 or 147 further includes a plurality of anti-torsion elements, wherein each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0312] Example 149. A frame system as described in Example 148, wherein each anti-torsion element is attached to a strut that is in an area of ​​the frame having a low density of struts.

[0313] Example 150. A frame system as described in Example 148 or 149, wherein when the frame is curled, at least a subset of the plurality of anti-torsion elements abut or nearly abut an adjacent support post.

[0314] Example 151. A frame system as described in Example 148, 149 or 150, wherein each anti-torsion element extends laterally a length between about 1.1 times and 5 times the lateral width of the support.

[0315] Example 152. A frame system as described in any of Examples 148 to 151, wherein each anti-torsion element has a vertical length between approximately 2% and 20% of the length of the support.

[0316] Example 153. A frame system according to any of Examples 145 to 152, wherein the tubular frame is sterilized and packaged.

[0317] Example 154. A method for releasing a frame via a transcatheter technique, the method comprising: a delivery catheter and a tubular frame, the tubular frame self-expanding to a site where the tubular frame is to be installed, wherein the tubular frame is loaded within the catheter, wherein the catheter comprises an inner surface having a polygonal profile, wherein the tubular frame comprises a shape memory material for providing radial force and a plurality of interconnected struts; advancing the tubular frame distally out of the catheter, thereby causing expansion of the tubular frame; and reloading the tubular frame proximally into the catheter, thereby causing curling of the tubular frame.

[0318] Example 155. A method according to Example 154, wherein the frame includes a plurality of columnar segments, and wherein the number of columnar segments is equal to the number of sides of the polygonal profile.

[0319] Example 156. A method according to Example 154 or 155, wherein at least a subset of the plurality of interconnected pillars abut or nearly abut a side of the polygonal contour.

[0320] Example 157. A method according to Example 154, 155 or 156, wherein the tubular frame further includes a plurality of anti-torsion elements, wherein each anti-torsion element is a protrusion extending laterally from at least a subset of the plurality of interconnected struts.

[0321] Example 158. A cover for manufacturing a tubular frame having multiple circumferences along the proximal-distal axis of the frame, the cover comprising: a pre-cut sheet comprising a plurality of columnar segments forming a flower shape, wherein each columnar segment has a first end, a second end, and two lateral edges, wherein each columnar segment is laterally connected to two adjacent segments at the first end, wherein each columnar segment is not laterally connected to the two adjacent segments at the second end and for a majority of each of the two lateral edges.

[0322] Example 159. The cover of Example 158, wherein the lateral edge profile of each columnar segment is formed to match the multiple circumferences along the proximal-distal axis of the frame.

[0323] Example 160. A cover as described in Example 158 or 159, wherein the number of columnar segments in the plurality of segments of the cover matches the number of columnar segments of the frame.

[0324] Example 161. The cover of Example 158, 159, or 160, wherein the first end is a proximal end and the second end is a distal end.

[0325] Example 162. The cover of Example 158, 159, or 160, wherein the first end is a distal end and the second end is a proximal end.

[0326] Example 163. The cover of any one of Examples 158 to 162, wherein the pre-cut sheet is comprised of a fabric, a tissue, or a film.

[0327] Example 164. A system of a frame and a cover, comprising: a tubular frame extending along a proximal-distal axis, wherein the tubular frame comprises: a plurality of columnar segments, each segment extending along the proximal-distal axis; a plurality of circumferential lengths along the proximal-distal axis; and a proximal end and a distal end; a cover surrounding the tubular frame, wherein the cover is formed from a pre-cut sheet in a flower shape, wherein the cover comprises a plurality of columnar segments, wherein each columnar segment has a first end, a second end and two lateral edges, wherein the two lateral edges of each columnar segment are laterally connected to the lateral edges of two adjacent segments at the first end through the pre-cut flower shape, wherein the two lateral edges of each columnar segment are laterally connected to the lateral edges of two adjacent segments at the second end through an attachment member.

[0328] Example 165. A system according to Example 164, wherein a majority of each of the two lateral edges of each columnar segment is laterally connected to the lateral edges of two adjacent segments by the attachment members.

[0329] Example 166. A system according to Example 164 or 165, wherein the attachment member comprises one of: a suture, a staple, or an adhesive.

[0330] Example 167. A system according to Example 164, 165, or 166, wherein the first end of the cover surrounds the proximal end of the tubular frame and the second end of the cover surrounds the distal end of the tubular frame.

[0331] Example 168. A system according to Example 164, 165 or 166, wherein the first end of the cover surrounds the distal end of the tubular frame and the second end of the cover surrounds the proximal end of the tubular frame.

[0332] Example 169. The system of any of Examples 164 to 168, wherein the lateral edge profile of each cylindrical segment of the cover is formed to match the multiple circumferences along the proximal-distal axis of the frame.

[0333] Example 170. A system according to any of Examples 164 to 169, wherein the number of columnar segments in the plurality of segments of the cover matches the number of columnar segments of the frame.

[0334] Example 171. A system according to any of Examples 164 to 170, wherein the pre-cut sheet is composed of a fabric, a tissue, or a film.

[0335] Although the above description contains many specific embodiments of various systems, devices and methods, these should not be interpreted as limitations on the scope of these systems, devices and methods, but as examples thereof. Therefore, the scope of the claims should not be determined by the embodiments shown, but by the accompanying examples, the described alternatives and their equivalents.

Claims

1. A prosthetic heart valve for replacing a native mitral valve or tricuspid valve, the prosthetic heart valve comprising: a support frame having an inlet end portion and an outlet end portion, the support frame comprising a plurality of interconnected struts; a valve portion positioned within the lumen of the support frame, wherein the valve portion includes a plurality of leaflets, the plurality of leaflets including pericardial tissue, wherein the valve portion provides a unidirectional flow of blood through the lumen to replace the function of the native valve; as well as One or more bioabsorbable elements are disposed on or within the support frame.

2. The prosthetic valve of claim 1 , wherein the support frame comprises a self-expanding frame that provides a radial force for anchoring to surrounding tissue, wherein absorption of the bioresorbable element reduces the radial force.

3. The prosthetic valve of claim 1 or 2, wherein the one or more bioresorbable elements include a bioresorbable element located at a point of interconnection of two or more struts.

4. The prosthetic valve of claim 1, 2 or 3, wherein the support frame further comprises a plurality of appendages extending away from the support frame, and wherein the one or more bioresorbable elements are located within one or more of the plurality of appendages.

5. The prosthetic valve of any one of claims 1 to 4, further comprising an inner skirt attached to the support frame.

6. The prosthetic valve of claim 5, wherein the inner skirt is bioresorbable.

7. The prosthetic valve of claim 5, wherein the plurality of leaflets are attached to the inner skirt.

8. The prosthetic valve of any one of claims 1 to 7, further comprising an outer skirt attached to the support frame.

9. The prosthetic valve of claim 8, wherein the outer skirt is bioresorbable.

10. The prosthetic valve of any one of claims 1 to 9, further comprising a bioresorbable band surrounding the support frame.

11. The prosthetic valve of claim 10, wherein the bioresorbable band is coated with a biologic that induces re-endothelialization.

12. The prosthetic valve of any one of claims 1 to 11, further comprising an anchoring system attached to the support frame.

13. The prosthetic valve of claim 12, wherein the anchoring system comprises a bioresorbable portion.

14. The prosthetic valve of claim 12 or 13, wherein the anchoring system comprises a plurality of anchoring arms having curved portions that are capable of extending between chordae tendineae.

15. The prosthetic valve of claim 14, wherein at least one anchoring arm is bioresorbable.

16. The prosthetic valve of any one of claims 12 to 15, further comprising a set of bioabsorbable barbs attached to the support frame or to the anchoring system.

17. The prosthetic valve of any one of claims 1 to 17, further comprising a bioabsorbable contraction band surrounding the support frame.

18. A prosthetic valve according to any one of claims 1 to 18, wherein the support frame comprises a group of columnar segments and a group of bioabsorbable connectors, and wherein the group of bioabsorbable connectors connect the group of columnar segments to form the support frame, and wherein each columnar segment is connected to two adjacent columnar segments via one or more bioabsorbable connectors in the group.

19. The prosthetic valve of any one of claims 1 to 19, wherein the support frame is compressible for placement within a sheath of a transcatheter delivery system.

20. The prosthetic valve of claim 1, wherein the support frame is sterilized and packaged.

21. A prosthetic heart valve for replacing a native mitral valve or tricuspid valve, the prosthetic heart valve comprising: a support frame having an inlet end portion and an outlet end portion, the support frame comprising a plurality of interconnected struts; a valve portion positioned within the lumen of the support frame, wherein the valve portion includes a plurality of leaflets, the plurality of leaflets including pericardial tissue, wherein the valve portion provides a unidirectional flow of blood through the lumen to replace the function of the native valve; as well as One or more anti-torsion elements, wherein each anti-torsion element includes a protrusion extending laterally from at least one of the interconnected struts and configured to engage an inner surface of the sheath to prevent the struts from twisting when received in a compressed state within the sheath.

22. The prosthetic valve of claim 21, wherein each anti-torsion element is attached to a strut that is in a region of the frame having a low density of struts.

23. The prosthetic valve of claim 21 or 22, wherein each anti-torsion element is manufactured as part of the frame design.

24. The prosthetic valve of claim 21, 22 or 23, wherein each anti-torsion element is attached and secured to a strut by an attachment member.

25. The prosthetic valve of any one of claims 21 to 24, wherein at least a subset of the plurality of anti-torsion elements abut or nearly abut adjacent struts when the frame is crimped.

26. The prosthetic valve of any one of claims 21 to 25, wherein each anti-torsion element extends laterally a length between about 1.1 and 5 times the lateral width of the strut.

27. The prosthetic valve of any one of claims 21 to 26, wherein each anti-torsion element has a vertical length between about 2% and 20% of the length of the strut.

28. The prosthetic valve of any one of claims 21 to 27, wherein at least a subset of the plurality of anti-torsion elements comprises markings for visualization.

29. The prosthetic valve of any one of claims 21 to 28, further comprising a sheath, the support frame crimped within the sheath, and wherein each anti-torsion element mitigates twisting or torsion of struts during loading of the support frame into the sheath.

30. The prosthetic valve of claim 29, wherein the sheath comprises an inner surface having a polygonal contour.

31. The prosthetic valve of claim 30, wherein the support frame comprises a plurality of columnar segments, and wherein the number of columnar segments is equal to the number of sides of the polygonal profile.

32. The prosthetic valve of claim 30 or 31, wherein at least a subset of the plurality of interconnected struts abut or nearly abut a side of the polygonal profile.

33. The prosthetic valve of any one of claims 21 to 32, wherein the support frame comprises a shape memory material.

34. The prosthetic valve of any one of claims 21 to 33, wherein the support frame is self-expanding.

35. The prosthetic valve of any one of claims 21 to 34, further comprising an outer skirt and an inner skirt attached to the support frame.

36. The prosthetic valve of claim 35, wherein the plurality of leaflets are attached to the inner skirt.

37. The prosthetic valve of any one of claims 21 to 36, wherein the support frame is sterilized and packaged.

38. A prosthetic heart valve for replacing a native heart valve, the prosthetic heart valve comprising: a support frame having a tubular shape having an inlet end portion and an outlet end portion, the support frame comprising a plurality of interconnected struts forming a plurality of cells, wherein each cell of at least a subset of the plurality of cells has an asymmetric shape formed by at least one asymmetric strut extending in a direction along a circumference of the frame; as well as A valve portion is positioned within the lumen of the support frame, wherein the valve portion includes a plurality of leaflets including pericardial tissue, wherein the valve portion allows blood to flow unidirectionally through the lumen to replace the function of the native valve.

39. The prosthetic valve of claim 38, wherein the at least one asymmetric strut extending in a direction along the circumference lacks reflection symmetry on the central midline of the at least one strut.

40. The prosthetic valve of claim 39, wherein the central midline divides the at least one asymmetric strut into a first portion and a second portion, wherein the first portion has a greater length than the second portion.

41. The prosthetic valve of claim 39 or 40, wherein the central midline divides the at least one strut into a first portion and a second portion, wherein the radius of curvature of the first portion is greater than the radius of curvature of the second portion.

42. The prosthetic valve of any one of claims 38 to 41, wherein the asymmetric shape of each cell in at least a subset of the plurality of cells allows one side of the cell to curl circumferentially prior to another side of the cell to produce predictable curling of the support frame.

43. The prosthetic valve of any one of claims 38 to 42, wherein the support frame comprises a shape memory material.

44. The prosthetic valve of any one of claims 38 to 43, wherein the support frame is self-expanding.

45. The prosthetic valve of any one of claims 38 to 44, further comprising an outer skirt and an inner skirt attached to the support frame.

46. ​​The prosthetic valve of claim 45, wherein the plurality of leaflets are attached to the inner skirt.

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