Artificial valve system and apparatus

Abstract

Systems, devices, and methods for an artificial valve having one or more bioabsorbable components are described. The bioabsorbable components are absorbable over time and enable ingrowth of tissue in and around the artificial valve. Systems, devices, and methods for an artificial valve to reduce stasis of blood flow are also described. Generally, various alternative mechanisms are described that encourage stagnant blood to move away from the wall near the tip of the valve and near the lumen wall so that it can flow through the outflow end of the artificial valve.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 358,774, filed on July 6, 2022, which is incorporated herein by reference.

[0002] This application generally relates to devices and systems for artificial valves, and more specifically to valve devices and systems that provide bioabsorbable components or improved blood flow.

Background Art

[0003] Artificial devices are available for treating various heart diseases and circulatory disorders. For example, artificial heart valves are available for treating valvular diseases such as valvular insufficiency or aortic valve stenosis. Transcatheter methods can be used to introduce and implant artificial devices in a way that is less invasive and can reduce complications compared to surgical procedures (e.g., open - heart surgery). In transcatheter methods, an artificial valve is mounted in a crimped state on the distal end of a delivery catheter and can be advanced through a patient's blood vessel until the artificial device reaches the implantation site. Next, the artificial device at the catheter tip can be expanded to its functional size at the treatment site, for example, by inflating a balloon or by using a self - expanding stent or frame. The artificial valve can have a balloon - expandable, self - expandable, mechanically expandable frame, and / or a frame expandable in multiple ways or combinations of ways. Artificial devices used in this way include transcatheter heart valves (THVs).

[0004] Existing artificial heart valves provide effective treatment, but there can be complications resulting from undesirable forces arising from the implantation of the artificial heart valve within the native heart. There can also be complications related to non - uniform crimping, which can cause damage and / or impairment to the frame during implantation. Artificial heart valves can also pose a risk of thrombus formation. Therefore, further improvements and refinements to existing technologies are needed.

SUMMARY OF THE INVENTION

[0005] Systems and devices can be implantable within a vasculature and can provide a variety of benefits including, but not limited to, improved absorption, crimping, blood flow, and manufacturing.

[0006] In some implementations, the frame is for use with an artificial valve. The frame includes a plurality of interconnected struts that form a tubular frame. The frame further includes a plurality of bioabsorbable elements. The bioabsorbable elements may be located within a portion of the struts that form the frame.

[0007] The bioabsorbable 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 at initial implantation but changes over time to different sizes. By adjusting over time, it may be possible to reduce or eliminate the force on the heart or other surrounding tissue. As the tissue ingrows, a strong fixation is provided, thereby reducing the need to anchor the mechanisms on the frame, and in some cases, a portion of the frame may become unnecessary over time.

[0008] For example, an artificial valve may include a plurality of interconnected struts for forming a tubular frame. The artificial valve may further include an anchor system attached to the tubular frame. The anchor system may take the form of anchor arms that anchor to surrounding tissue, such as capturing a native valve leaflet. Over time, the anchor arms may become unnecessary. Thus, the anchor arms may be constructed to be bioabsorbable. Alternatively, the anchor arms may have bioabsorbable tips.

[0009] In other embodiments, the prosthetic valve includes a plurality of interconnected struts that form a tubular frame. The prosthetic valve further includes a skirt attached to the tubular frame. The skirt is bioabsorbable. The skirt may be attached to the inside or outside of the frame. The skirt may also be attached to both the inside and outside of the frame.

[0010] In some embodiments, the prosthetic valve includes a plurality of interconnected struts that form a tubular frame. The prosthetic valve further includes a bioabsorbable band that surrounds the tubular frame. The band may be constructed to control frame expansion in a delayed release manner.

[0011] In some embodiments, the prosthetic valve includes a plurality of interconnected struts that form a tubular frame. The prosthetic valve further includes an anchor system attached to the tubular frame. The prosthetic valve further includes one or more bioabsorbable barbs attached to the tubular frame or to the anchor system. The barbs may provide a temporary anchoring mechanism that is absorbed over time.

[0012] In some embodiments, the plurality of interconnected struts includes a shape memory material that provides a radial force.

[0013] In some embodiments, the frame further includes a plurality of bioabsorbable elements within a portion of the struts that form the tubular frame.

[0014] In some embodiments, at least a portion of the plurality of bioabsorbable elements is located at an interconnect point of two or more struts.

[0015] In some embodiments, the absorption of the bioabsorbable elements results in weakening of the radial force of the tubular frame.

[0016] In some embodiments, the tubular frame further includes a plurality of appendages that extend away from the tubular frame. Each appendage of the plurality of appendages is formed by a portion of a plurality of interconnected struts.

[0017] In some embodiments, at least a portion of the plurality of bioabsorbable elements is located within one or more of the plurality of appendages.

[0018] In some embodiments, the tubular frame is compressible for placement within a catheter of a transcatheter delivery system.

[0019] In some embodiments, the frame further includes a series of valve leaflets within the tubular frame. The series of valve leaflets are attached to the tubular frame or to an inner skirt.

[0020] In some embodiments, the frame is sterilized and packaged.

[0021] In some embodiments, the prosthetic valve includes a plurality of interconnected struts for forming a self-expanding tubular frame. The tubular frame includes a shape memory material. The prosthetic valve includes a contractile bioabsorbable band surrounding the self-expanding tubular frame.

[0022] In some embodiments, the prosthetic valve is within a catheter of a transcatheter delivery system.

[0023] In some embodiments, the prosthetic valve includes a series of columnar segments. Each columnar segment includes a plurality of interconnected struts. The prosthetic valve includes a series of bioabsorbable connectors. The series of bioabsorbable connectors connect the series of columnar segments to form a tubular frame. Each columnar segment is connected to two adjacent columnar sections via one or more of the set of bioabsorbable connectors.

[0024] In some embodiments, the frame is for use in an artificial valve. The frame comprises a plurality of interconnected struts that form a tubular frame having a plurality of cells. At least some of the plurality of cells are asymmetric. The asymmetry of each cell of a portion of the plurality of cells that are asymmetric can be formed by at least one intersecting strut that is asymmetric.

[0025] In some embodiments, the asymmetry of at least one intersecting strut is formed by two curved portions that intersect at a central vertex. The first curved portion of the two curved portions has a greater radius and length than the second curved portion of the two curved portions.

[0026] In some embodiments, the frame is for use in an artificial valve. The frame includes a plurality of interconnected struts that form a tubular frame. The tubular frame has an inflow end and an outflow end. The frame further includes a plurality of bioabsorbable portions within a portion of the struts that form the tubular frame. The bioabsorbable portions are on or near the outflow side.

[0027] In some embodiments, absorption of the bioabsorbable elements at or near the outflow side results in a segmented outflow end having the ability to bend.

[0028] In some embodiments, the frame is configured such that when the frame is subjected to the flow and pressure of a liquid passing through the frame, the segmented outflow end can bend outwardly to convert the outflow end from a narrow linear shape to a shape that flares out like a trumpet.

[0029] In some embodiments, an artificial valve is provided for improving stagnant blood flow. The artificial valve includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inlet side and an outlet side. The artificial valve further includes a lumen wall attached to the tubular frame. The artificial valve further includes a series of valve leaflets within the tubular frame. The series of valve leaflets are attached to the tubular frame or the lumen wall and separate the inlet side and the outlet side of the tubular frame. The artificial valve further includes one or more expandable bags attached to the lumen wall on the outlet side of the frame.

[0030] In some embodiments, each bag of the one or more expandable bags of the series is composed of a biocompatible flexible material.

[0031] In some embodiments, each bag of the one or more expandable bags of the series is filled with a compressible fluid component that changes volume based on pressure.

[0032] In some embodiments, the one or more expandable bags of the series are configured such that each bag of the one or more expandable bags can expand to an expanded state when the artificial valve is subjected to the flow and pressure of a liquid passing through the lumen wall.

[0033] In some embodiments, the artificial valve is implanted within the vascular structure of an animal, and the flow and pressure of the liquid are systolic blood flow and pressure.

[0034] In some implementations, an artificial valve is provided for improving stagnant blood flow. The artificial valve includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow side and an outflow side. The artificial valve further includes a lumen wall attached to the tubular frame. The artificial valve further includes a series of valve leaflets within the tubular frame. The series of valve leaflets are attached to the tubular frame or the lumen wall and separate the inflow side and the outflow side of the tubular frame. The artificial valve further includes one or more fluidity sheets attached to the lumen wall on the outflow side of the frame. Each fluidity sheet of the one or more fluidity sheets has at least one free end.

[0035] In some implementations, each fluidity sheet of the one or more fluidity sheets is composed of a biocompatible flexible material.

[0036] In some implementations, the one or more fluidity sheets of the series are configured such that each fluidity sheet of the one or more fluidity sheets can move with the flow of the liquid when the artificial valve is subjected to the flow and pressure of the liquid through the lumen wall.

[0037] In some implementations, the artificial valve is for improving stagnant blood flow. The artificial valve includes a plurality of interconnected struts forming a tubular frame. The tubular frame has an inflow side and an outflow side. The artificial valve further includes a lumen wall attached to the tubular frame. The artificial valve further includes a series of valve leaflets within the tubular frame. The series of valve leaflets are attached to the tubular frame or the lumen wall and separate the inflow side and the outflow side of the tubular frame. The artificial valve further includes a plurality of flexible magnetically driven microprojections that are linearly aligned in the direction of flow and attached to the lumen wall. Each flexible magnetically driven microprojection of the plurality of flexible magnetically driven microprojections has a positive magnetic pole and a negative magnetic pole at the tip of the microprojection.

[0038] In some implementations, the plurality of flexible magnetically driven microprojections include larger driven microprojections.

[0039] In some embodiments, each tip of the plurality of flexible magnetically driven microprojections has a specific pole alignment such that the pole faces of each tip have the same charge as the adjacent tip pole faces, respectively.

[0040] In some embodiments, the larger driven microprojections can stimulate the bending of the remaining portions of the plurality of flexible magnetically driven microprojections.

[0041] In some embodiments, the frame system is for use within an artificial valve. The frame system comprises a plurality of interconnected struts that form a self-expanding tubular frame. The frame system includes a plurality of anti-torsion elements. Each anti-torsion element is a protrusion that extends laterally from at least a portion of the plurality of interconnected struts.

[0042] In some embodiments, each anti-torsion element is attached to a strut within a region of the frame having low-density struts.

[0043] In some embodiments, each anti-torsion element is fabricated as part of the frame design.

[0044] In some embodiments, each anti-torsion element is attached to and fixed to the strut by attachment means.

[0045] In some embodiments, at least a portion of the plurality of anti-torsion elements abut or substantially abut adjacent struts when the frame is crimped.

[0046] In some embodiments, each anti-torsion element extends laterally for a length that is about 1.1 to 5 times the lateral width of the strut.

[0047] In some embodiments, each anti-torsion element has a vertical length that is about 2% to 20% of the length of the strut.

[0048] In some implementations, at least a portion of the plurality of anti-torsion elements includes markers for visualization.

[0049] In some implementations, the frame system further includes a catheter. The catheter houses a tubular frame. Each anti-torsion element reduces the ability of the struts to twist or bend during loading of the tubular frame into the catheter.

[0050] In some implementations, the catheter includes an inner surface having a polygonal contour.

[0051] In some implementations, the tubular frame includes a number of columnar segments, and the number of columnar segments is equal to the number of sides of the polygonal contour.

[0052] In some implementations, at least a portion of the plurality of interconnected struts abuts or substantially abuts against the sides of the polygonal contour.

[0053] In some implementations, the method is for releasing a frame by a transcatheter method. The method includes delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be deployed. The tubular frame is loaded within the catheter. The tubular frame includes a shape memory material for providing a 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 portion of the plurality of interconnected struts. The method includes advancing the tubular frame distally from the catheter to effect expansion of the tubular frame. The method further includes reloading the tubular frame proximally within the catheter to effect curling of the tubular frame.

[0054] In some implementations, each anti-torsion element is attached to a strut within a region of the frame having a low density of struts.

[0055] In some embodiments, each anti-torsion element extends laterally for a length that is about 1.1 to 5 times the lateral width of the strut.

[0056] In some embodiments, at least some of the plurality of anti-torsion elements include markers for visualization. The method further includes visualizing the distal advancement or proximal reloading of the self-expanding tubular frame by markers for visualization and visualization techniques.

[0057] In some embodiments, the frame system is for use within an artificial valve. The frame system includes a plurality of interconnected struts that form a self-expanding tubular frame. The tubular frame includes a shape memory material for providing a radial force. The frame system includes a catheter. The catheter houses the tubular frame. The catheter includes an inner surface having a polygonal contour.

[0058] In some embodiments, the tubular frame includes a plurality of columnar segments. The number of columnar segments is equal to the number of sides of the polygonal contour.

[0059] In some embodiments, at least some of the plurality of interconnected struts abut or substantially abut against the sides of the polygonal contour.

[0060] In some embodiments, the frame system further includes a plurality of anti-torsion elements. Each anti-torsion element is a protrusion that extends laterally from at least a portion of the plurality of interconnected struts.

[0061] In some embodiments, each anti-torsion element is attached to a strut within a region of the frame having low-density struts.

[0062] In some embodiments, at least some of the plurality of anti-torsion elements abut or substantially abut against adjacent struts when the frame is crimped.

[0063] In some embodiments, each torsional resistance element extends laterally for a length that is about 1.1 to 5 times the lateral width of the strut.

[0064] In some embodiments, each torsional resistance element has a vertical length that is about 2% to 20% of the length of the strut.

[0065] In some embodiments, the method is for releasing a frame by a transcatheter method. The method includes delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be placed. The tubular frame is loaded within the catheter. The catheter includes an inner surface having a polygonal contour. 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 from the catheter to effect expansion of the tubular frame. The method includes reloading the tubular frame proximally within the catheter to effect crimping of the tubular frame.

[0066] In some embodiments, the frame includes a plurality of columnar segments, and the number of columnar segments is equal to the number of sides of the polygonal contour.

[0067] In some embodiments, at least a portion of the plurality of interconnected struts abuts or substantially abuts against the sides of the polygonal contour.

[0068] In some embodiments, the tubular frame further includes a plurality of torsional resistance elements. Each torsional resistance element is a protrusion that extends laterally from at least a portion of the plurality of interconnected struts.

[0069] In some embodiments, the cover is for the fabrication of a tubular frame having a plurality of peripheries along the proximal-distal axis of the frame. The cover includes a pre-cut sheet that includes a plurality of columnar segments forming a flower shape. Each columnar segment has a first end, a second end, and two side edges. Each columnar segment is laterally connected to two adjacent segments at the first end. Each columnar segment is not laterally connected from two adjacent segments at the second end and for most of each of the two side edges. In some embodiments, the pre-cut sheet is composed of cloth, tissue paper, or film.

[0070] In some embodiments, the 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 pre-cut sheet in a flower shape. The cover includes a plurality of columnar segments. Each columnar segment has a first end, a second end, and two side edges. The two side edges of each columnar segment are laterally connected to the side edges of two adjacent segments at the first end by the pre-cut flower shape. The two side edges of each columnar segment are laterally connected to the side edges of two adjacent segments at the second end by attachment means.

[0071] In some embodiments, most of each of the two side edges of each columnar segment is laterally connected to the side edges of two adjacent segments by attachment means. In some embodiments, the attachment means includes one of stitching, stapling, or an adhesive.

[0072] In some embodiments, 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.

[0073] In some embodiments, 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.

[0074] In some embodiments, the side edges of each columnar segment of the cover are contoured to conform to a plurality of peripheries along the proximal-distal axis of the frame.

[0075] In some embodiments, the number of columnar segments of the plurality of segments of the cover matches the number of columnar segments of the frame.

[0076] This specification and the claims will be more fully understood with reference to the following figures and data graphs, which are presented as exemplary embodiments of the invention and should not be construed as a complete enumeration of the scope of the disclosure.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0078] Referring now to the drawings, various valve systems and devices are described for improving functionality, host interaction, blood flow, artificial organ delivery, and / or artificial organ manufacturing. The valve systems and devices are available as an artificial organ (or as part of an artificial organ delivery and fixation system) for replacing the function of any of the four heart valves: the aortic valve, mitral valve, tricuspid valve, or pulmonary valve. In some implementations, the valve system or device has one or more bioabsorbable components. In some implementations, the valve system or device has one or more components for improving blood flow. In some implementations, the valve system or device has one or more components for improving the crimping of the valve onto a catheter and / or the release from the catheter. In some implementations, the valve system or device has one or more components for improving the attachment of a cover to a frame.

[0079] The systems, devices, and methods described should never be construed as limiting. Instead, this disclosure is directed to all novel and non-obvious features and aspects of the various disclosed components, alone and in various combinations and sub-combinations with each other. The disclosed systems, devices, and methods are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, devices, and methods require the presence of any one or more particular advantages or problems to be solved.

[0080] Systems, devices, and various components of the embodiments of the artificial valve or transcatheter valve are disclosed herein, and any combination of these options is executable unless specifically excluded. For example, any of the disclosed bioabsorbable components can be used with any other type of other bioabsorbable components even if a specific combination is not explicitly described. Similarly, different structures and features of components of devices, methods, and systems, such as elements for reducing torsion (e.g.) and bioabsorbable components, can be mixed and matched. As another example, any bioabsorbable component type / feature, valve type / feature, tissue cover type / feature, catheter type / feature, etc. can be combined even if not explicitly disclosed. In short, the individual components of the disclosed systems and devices are combinable unless mutually exclusive or physically impossible.

[0081] Some of the operations of the disclosed methods are described in a particular sequential order for the convenience of presentation, but it should be understood that this description method includes permutations unless a particular order is required by the specific words described below. For example, the operations described sequentially may, in some cases, be rearranged or executed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed systems, devices, and methods can be used in combination with other systems, devices, and methods.

[0082] As used throughout this specification, the terms "proximal" and "distal" relate to the axis of the catheter system, where the end where the treatment is performed is the distal end, and the opposite end where the catheter system is controlled is the proximal end. Thus, the distal end of the catheter system is the tip that first traverses the body and first reaches the treatment site. Conversely, the proximal end of the catheter system is the portion that remains outside the body. Similarly, distal movement along the catheter axis is movement in the direction towards the treatment site of the component, and proximal movement along the catheter axis is movement in the opposite direction of the component. These terms have a relationship with the treatment site, but it should be understood that these terms can be used for reference and when interpreting the components or movements of the devices and systems described in this specification, the treatment site need not be present.

[0083] Various systems and devices for repair are utilized for the purpose of performing treatments within a recipient. Recipients include, but are not limited to, patients, animal models, cadavers, or human-shaped phantoms. Thus, in addition to methods of treating patients, the systems and devices are available for training or practice of other treatments on animal models, cadavers, or human-shaped phantoms. Further, techniques, methods, operations, steps, etc. as described or suggested herein can be performed on live animals or are possible on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where parts of the body, tissues, etc. are simulated).

[0084] The systems and devices described are sterilizable, which can be achieved using gamma irradiation, gas plasma, aldehydes, ethylene oxide, and / or electron beam. The system or device can be further processed in a formaldehyde bioburden reduction process. After preparation, the systems and devices can be hermetically sealed or stored in a container that remains sterilized by other means.

[0085] Figure 1 is a cutaway view of a human heart during systole. The right ventricle (RV) and the left ventricle (LV) are separated from the right atrium (RA) and the left atrium (LA), respectively, by the tricuspid valve 101 and the mitral valve 103, i.e., the atrioventricular valves. 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 valve leaflets that extend inwardly across the individual valve orifices and that come together or "join" in the flow to form a surface that blocks one-way fluid flow.

[0086] The RA receives deoxygenated blood from the venous system through the SVC and the IVC, the former entering the RA from above and the latter from below. During diastole or relaxation, the deoxygenated blood from the IVC and SVC collected in the RA passes through the tricuspid valve 101 and enters the RV as the RV expands. Similarly, the oxygenated blood from the pulmonary veins collected in the LA passes through the mitral valve 103 and enters the LV as the LV expands. During systole or contraction, the RV contracts to pump the deoxygenated blood collected in the RV through the pulmonary valve 107 into the pulmonary artery and the lungs. Similarly, the LV contracts to pump the deoxygenated blood collected in the LV through the aortic valve 105 into the aorta and the peripheral cardiovascular system.

[0087] The systems and devices described within this application are described for illustrative purposes and can be used for the replacement or repair of any native valve or for use within the cardiac system. Native valves may require replacement or repair, for example, if the valve is stenotic and / or suffers from insufficiency and / or regurgitation. The systems and devices described herein can be used in a variety of areas for the treatment of defective native valves or other cardiovascular disorders, whether or not explicitly described herein.

[0088] Various artificial valve systems and devices can have one or more bioabsorbable components that can provide various improved functions, such as the ability to improve integration at the implantation site (for example). Typically, when an artificial valve is implanted, some components, such as (for example) a frame, an anchor, and a skirt, provide benefits that enable the placement of the prosthesis and / or valve function immediately after implantation. However, some of these components become unnecessary over time when the valve integrates with the local anatomical structure. Additionally, some of these components may be harmful to the local anatomical structure. Therefore, after implantation, one or more components can be bioabsorbable such that one or more components are absorbed over a period of time, resulting in a valve without various components such as (for example) a frame, an anchor, and a skirt. Thus, the local tissue at the implantation site can grow more freely within and around the valve and the valve can integrate with the host tissue.

[0089] An artificial valve that includes a bioabsorbable portion can be a replacement artificial valve for replacing any of the heart valves, namely, the tricuspid valve, the pulmonary valve, the mitral valve, or the aortic valve. The replacement valve can further include one or more of an inner skirt, an outer skirt, and a series of valve leaflets. To provide one-way blood flow through the valve, the tubular frame can have an inlet end portion and an outlet end portion, and between them and within the lumen of the artificial tubular frame, a series of valve leaflets are disposed. The series of valve leaflets can include two, three, four, or more valve leaflets that can be composed of pericardial tissue derived from a bovine, porcine, or human donor.

[0090] To deliver the tubular frame, the prosthetic valve can be crimped and accommodated within the sheath of a transcatheter system. In some embodiments, the prosthetic heart valve is crimped and accommodated within the sheath of a transcatheter system. The prosthetic valve can be delivered to the implantation site by any suitable approach including, but not limited to, a transfemoral, transjugular, subclavian, transapical, or transaortic approach. In some embodiments, the prosthetic valve can replace the tricuspid valve and be delivered into the right atrium via the femoral vein and inferior vena cava or via the jugular vein and superior vena cava. In some embodiments, the prosthetic valve can replace the mitral valve and be delivered into the right atrium via the femoral vein, through the inferior vena cava, and can transverse through the atrial septum into the left atrium.

[0091] A bioabsorbable component means that the component is biodegradable over time such that the component undergoes a chemical change and decomposes within the body. Any biocompatible material can be utilized 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-co-glycolic acid) (PGLA), poly(β-hydroxybutyrate-co-β-hydroxyvalerate) (PHBV), poly(hydroxybutyrate) (PHB), polycaprolactone (PCL), polycyanoacrylate (e.g., poly(octyl cyanoacrylate) (POCA)), polyanhydride (e.g., poly(fumaric acid-co-sebacic acid) (P(FASA)), and poly(propylene fumarate) (PPF). The composition of bioabsorbable materials by various combinations and percentages can be controlled to yield desired results. For example, the degradation time is controllable by the material selection and composition, i.e., PGA is absorbed within 1 - 2 months, PLA / PGA (80 / 20) is absorbed within 1 - 2 years, and PLLA is absorbed after more than 5 years.

[0092] In FIGS. 2A and 2B, non-exhaustive examples are provided showing the bioabsorbable portion of the frame of the prosthetic valve. The tubular frame 151 can be composed of a shape memory material (e.g., nitinol) and can 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 several appendages 157. It should be understood that any frame design is contemplated and any interconnectivity of the struts to form cells and / or appendages is available. FIG. 2B further includes an inner skirt 159, an outer skirt 161, and several anchor arms 163 that can accommodate a series of valve leaflets on the inner skirt to form and install a prosthetic valve. The valve leaflets can be composed 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 anchor arms 163 can be utilized as anchors to fix the replacement valve. By utilizing the curved portion of each anchor arm 163, it can adhere to the chordae tendineae of the tricuspid valve or mitral valve, resist the movement of the atrium and ventricle, and help hold the replacement valve in place during installation.

[0093] A frame composed of a shape memory material such as nitinol can continuously provide a radial force based on its shape memory. The radial force can push outwardly against the host tissue at the installation site. At the time of installation, the radial force of the frame combined with the contractile force of the local tissue helps the frame to firmly settle and maintain the prosthetic valve in its installation position. However, over a period of time, since the local tissue can grow into the prosthetic valve, be rounded and settled, and maintain its position, the radial force is no longer needed. The continuous radial force may cause discomfort, or cause injury, or result in undesirable anatomical remodeling, or have an adverse effect on cardiac function, as it attempts to consistently suppress the contractile force of the inner tissue and tissue ingrowth.

[0094] To address the problem of continuous radial forces, the frame can comprise several struts 153 having bioabsorbable elements. For example, frame 151 can comprise several struts 153 having bioabsorbable elements 165 and 167 that can be absorbed over time. That is, the bioabsorbable elements can be part of the strut itself and / or bioabsorbable connectors that connect one or more struts. As can be inferred from the illustrated example, bioabsorbable element 165 is located at the center of frame 151 (e.g., at a central connection point between struts) and thus can be decomposable after implantation, thereby weakening the radially expanding frame and reducing the radial forces exerted by the frame. Any method of expanding the frame can be utilized, including expansion by balloon, mechanical expansion, or utilization of a shape memory material (e.g., nitinol).

[0095] Similarly, bioabsorbable element 167 is located at the periphery of frame 151 (e.g., on a peripheral strut appendage) and decomposes after implantation to weaken the expanded appendage, remove the most expanded part of the frame, and reduce its overall size. Of course, various parts of the frame can be bioabsorbable to weaken the radial forces of the frame or the expanded appendage and are not limited to the exact locations shown in FIGS. 2A and 2B. In particular, any central part of a strut or any connection point between struts can be composed of a bioabsorbable material.

[0096] Frame 151 can also be entirely composed of a bioabsorbable material. Thus, when the artificial valve is implanted at the implantation site, the bioabsorbable frame can be absorbed as tissue ingrowth occurs. Tissue ingrowth can provide the structure necessary to support the valve function of the valve implantation, and thus the frame is no longer needed. In some implementations, the frame entirely composed of a bioabsorbable material is detachable.

[0097] When installing an artificial valve, an anchor can be utilized to fix the artificial object at the installed location. Over a certain period after installation, the ingrowth of tissue can hold and maintain the artificial object at the installed location, such that the anchor and barb required to provide the necessary function are no longer needed. Further, the anchor and barb may cause an obstruction to local tissue because their bulkiness or sharp tips can be pushed into the tissue wall or other local anatomical structures.

[0098] Figure 3A provides an example of an artificial valve in which the anchor system includes a bioabsorbable portion. Similar to FIGS. 2A and 2B, the frame 151 can be formed at least partially of a shape memory material (e.g., nitinol) and includes several struts 153 interconnected to form several cells 155 that can form a frame base 157. The struts 153 can also extend from the base 157 to form several appendages 157. The artificial valve further includes an inner skirt 159, an outer skirt 161, and an anchor system 163. The artificial valve can further include a series of valve leaflets. Here, the anchor system 163 includes a plurality of anchor arms having bioabsorbable anchor tips 169. The bioabsorbable anchor tips 169 can hold the self-valve leaflets and help maintain the artificial valve at its installation location as the tissue grows into the artificial object.

[0099] FIGS. 3B and 3C provide an example of the usefulness of the bioabsorbable anchor tip. For example, it has been found that when an artificial valve is installed, the anchor tip 169 may cause problems by protruding into the local tissue 171 (FIG. 3B). To solve this problem, the bio-valve anchor tip 169 is absorbable over time such that it no longer protrudes into the local tissue 171 (FIG. 3C), thereby preventing damage and / or remodeling of the local tissue.

[0100] Figure 4A shows an enlarged view of a portion of an artificial valve showing an anchor arm 163 having an anchor and a portion of the frame 151 behind the outer skirt 161. Also shown are several bioabsorbable barbs 173 extending from the frame 151 and / or the anchor arm 163. The bioabsorbable barbs 173 can serve to fix the valve in the implantation site by engaging the local tissue 171 (Figure 4B). Similar to the anchor, the barbs are not required when the tissue grows into the artifact and the valve is fixed by tissue ingrowth. As the bioabsorbable barbs 173 are absorbed over time, the barbs disappear from the local tissue 171 (Figure 4C), allowing for better healing and ingrowth.

[0101] Generally, skirts are utilized on artificial valves that serve to promote one-way flow and prevent perivalvular leakage. Figure 5 provides an artificial valve having an inner skirt 175 and an outer skirt 177 made of a bioabsorbable material that can be impermeable or semipermeable to the blood and components of the circulatory system. The bioabsorbable inner skirt 175 can be impermeable so that blood can flow through the valve without leakage. The bioabsorbable outer skirt 177 can integrate with the local tissue to promote tissue regrowth and re-endothelialization. After implantation, the bioabsorbable inner skirt 175 and the bioabsorbable outer skirt 177 are absorbed as the tissue grows into the valve, providing a sealing effect with the local tissue. Figure 5 shows both an artificial valve having both a bioabsorbable inner skirt and a bioabsorbable outer skirt, but various artificial valves can be constructed with either only a bioabsorbable inner skirt or only a bioabsorbable outer skirt, and thus should not be limited to an artificial valve having both a bioabsorbable inner skirt and an outer skirt.

[0102] To promote blood flow and prevent tissue ingrowth, the bioabsorbable material on the inner surface of the inner skirt can be fluorinated or otherwise made more hydrophobic.

[0103] To promote tissue ingrowth, the outer valve skirt can be composed of a fluffy material having a thickness and a high porosity, which enables blood integration and coagulation, which can help prevent perivalvular leakage and create a seal to promote tissue ingrowth. Therefore, the outer skirt 177 can be composed of a bioabsorbable fluffy material. Alternatively or additionally, 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). The fluffy bioabsorbable outer band 179 can completely or partially surround the artificial valve to promote blood integration and coagulation. After implantation of the artificial valve, the fluffy bioabsorbable outer skirt 177 or the fluffy bioabsorbable outer band 179 can be absorbable as the tissue grows into the prosthesis and a seal is formed. In some implementations, the outer surface of the outer skirt and / or the outer band is coated with a biomaterial that induces re-endothelialization, such as (for example) amino acids (for example, lysine or ornithine), saccharides (for example, hyaluronic acid, fibronectin, chitosan), structural proteins (for example, collagen, elastin), growth factors (for example, VEGF), and combinations thereof.

[0104] Bioabsorbable materials can also be utilized to help control the expansion and / or contraction of the valve frame. Figure 7A shows a frame 151 that is expandable and a bioabsorbable band 181 that surrounds the frame. The bioabsorbable band 181 can prevent the frame 151 from expanding beyond its perimeter and ensure that the frame is positioned at the perimeter set by the bioabsorbable band. After being placed at the implantation site, the bioabsorbable band 181 can be absorbable so that the frame does not contract. In some implementations, the frame 151 is composed of a shape memory material (for example, nitinol) and self-expands. Therefore, when the bioabsorbable band 181 is absorbed, the frame expands freely outwards (Figure 7B).

[0105] In response to corrected valve leakage, the local anatomical structure of the patient's anatomical structure tends to return to normal dimensions (commonly referred to as positive remodeling). The remodeling process contracts the atrium, annulus, and ventricle, thereby providing relaxation to the heart and restoring a more sustainable physiological function. Since many artificial valve frames are self-expanding, the radial force due to expansion reduces this natural positive remodeling. Therefore, it would be desirable to provide a frame that provides radial expansion during implantation and later stops providing the radial force to enable positive remodeling. In some implementations, the artificial valve frame can include a plurality of segments along the outer diameter. Each of the segments can be connectable via a bioabsorbable material such that the frame provides a radial force during implantation and later reduces that force as the material is absorbed. The selection and application of materials in combination with the frame design can allow the absorption of the bioabsorbable material to reduce the radial force, as the artifact is properly integrated within the local anatomical structure and further enables healing of the implant and adhesion to the natural anatomical structure.

[0106] Figure 8A provides an example of a frame 151 that can be contracted. In this example, the frame 151 is divided into a plurality of segments (151a, 151b, 151c), which together result in a circular frame. Each frame segment is joined to its adjacent frame segment via a bioabsorbable connector 183. Any bioabsorbable connector that can join adjacent segments can be utilized, such as (for example) a small band (shown in Figure 8A), a knot, a hook, a rivet, a staple, or a row of a plurality of biocompatible elements (shown in Figure 2A). After being placed at the implantation site, the bioabsorbable connector 183 can be absorbed, removing the restrictions on the plurality of segments. The local anatomical structure at the implantation site can provide a contracting force to slide the segments relative to each other such that the segments overlap, resulting in a contracted frame and an artificial valve (Figure 8B). When installing the frame, it can be expandable via a balloon or mechanical means, or be composed of a shape memory material (such as nitinol).

[0107] The artificial valve can include one or more of any of the bioabsorbable components and / or elements described herein. Therefore, the various described bioabsorbable components can be combined in any manner. In various artificial valves, 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 expansion of the frame, and a frame including segments connected via a bioabsorbable connector.

[0108] An artificial valve having one or more bioabsorbable components can be loaded within a transcatheter delivery device. The artificial valve is crimped and loaded within a catheter so that the artifact can be delivered to the site of implementation by a transcatheter approach. Any suitable transcatheter delivery system can be used, such as that described in U.S. Patent Publication No. 2017 / 0231756, the disclosure of which is incorporated herein by reference in its entirety. Thus, the delivery system can comprise a transcatheter having one or more bioabsorbable components and / or an artificial valve having elements. The artificial valve and delivery system having one or more bioabsorbable components / elements can be sterilized and stored.

[0109] In another aspect, the frame is constructed for improved crimping. A typical frame is constructed such that the cells formed by the frame struts generally have a symmetric shape. However, symmetry can cause crimping problems due to equivalent struts and connectors that are designed to be symmetric such that each tries to crimp inwardly at the same force simultaneously. Problems with symmetric designs include kinking of the non-uniform struts that lead to elliptical and saddle-shaped frame configurations during crimping and placement.

[0110] Figure 9 provides a frame design in which each cell includes an asymmetric shape. It has been found that asymmetric struts can provide improved crimping ability. Frame 901 consists of interconnected struts 903 that form several cells 905. For each cell, at least one strut 907 extending in a direction along the perimeter of the frame has a left - right asymmetric design lacking reflection symmetry across the central mid - line of the strut. The lack of reflection symmetry can be formed by the unequal lengths and / or curvatures on each side of the mid - line. Each strut 907 has two curved portions (909a and 909b) that intersect at a central vertex 911 and mark the central mid - line of the asymmetric strut. Curved portion 909a has a larger radius and length than curved portion 909b. This left - right asymmetric design allows one side of the cell to crimp or approach circumferentially in front of the other side of the cell, enabling predictable loading by keeping all vertices in the same direction during the crimping process. Similarly, this asymmetric bias provides more predictable valve crimping and expansion, reducing irregularities. Figure 9 shows a frame cell with asymmetric curved portions, but various other left - right asymmetric designs can be utilized to improve crimping, including the use of multiple struts that result in a left - right asymmetric design along the perimeter of the frame.

[0111] Frames having asymmetric cells and struts are available for use as stents or within artificial valves. When in the process of forming a crimp, the frame can be filled into a trans - catheter delivery device and thus is usable in trans - catheter procedures. Therefore, the delivery system can include a trans - catheter having a crimped frame with one or more cells with a left - right asymmetric design. A crimped frame and / or a delivery system having one or more cells with a left - right asymmetric design can be sterilized and stored.

[0112] When delivered to the site, any method of expanding the frame can be utilized that includes balloon-mediated expansion, mechanical expansion, or utilization of a shape memory material (e.g., nitinol). Thus, in some implementations, the frame is crimped with a balloon or other means for mechanical expansion.

[0113] In another aspect, the prosthetic device is provided with features that reduce blood stasis and thereby reduce the likelihood of clotting. In an artificial heart valve, blood flow can stagnate in the space between the valve leaflets and the surrounding lumen wall. Stagnant blood can cause clotting, increasing the risk of embolism and other problems and potentially limiting the lifespan of the valve. Thus, solutions are needed to improve blood flow and / or washout on the outflow side of the valve leaflets.

[0114] One implementation that has been found to improve stagnant blood flow is to utilize an artificial valve having an outflow end that flares out like a trumpet. However, there may be a need to deliver and / or deploy an artificial valve straight shape onto the outflow end in a manner that improves delivery by reducing interaction with the delivery system. FIGS. 10A - 10C provide a system for delivering and deploying a valve frame having a straight shape onto an outflow end and providing for conversion of that outflow end to an outward flare. FIG. 10A shows an example of a valve frame 1001 for use in an artificial valve. The frame 1001 has an inflow side 1003 and an outflow side 1005. The frame 1001 further includes several bioabsorbable elements 1007 on or near the outflow side 1005. The bioabsorbable elements 1007 are absorbed over time, resulting in a frame 1001 having a segmented outflow side 1005 that has the ability to bend. After absorption, the outflow side 1005 will be able to bend outward when local blood pressure and blood flow are high. This results in a frame that will bend outward during diastole (see FIGS. 10B and 10C), and as a result, an artificial valve with an outflow end that flares out like a trumpet is obtained that helps prevent blood flow stagnation by facilitating outward flow.

[0115] Using various implementations of the bioabsorbable element, a wrapper-shaped outflow end can be obtained. In some implementations, the bioabsorbable element is provided at the outflow end of each vertical strut. In some implementations, the bioabsorbable element is provided at the outflow end for every three vertical struts. In some implementations, the bioabsorbable element is provided at the outflow end for every four vertical struts. In some implementations, the bioabsorbable element is provided at the outflow end for every five vertical struts. Various implementations can be combined, such as an implementation where for the first set of struts, each strut has a bioabsorbable element, and for the second set of struts, there is a bioabsorbable element for every three struts.

[0116] Figures 11A and 11B provide an example of an artificial valve for improving stagnant blood flow using a gap-filling member such as an inflatable bag. The artificial valve 1101 has a series of valve tips 1103 and a lumen wall 1105. Below the valve tips 1103, the lumen wall 1105 has attached thereto a series of one or more gap-filling members that move the blood, thereby reducing blood stasis. In one example, the inflatable bag 1107 is filled with a compressible fluid component (e.g., a compressible liquid or gas component) that changes volume based on pressure. When the valve is closed, there is no flow through the valve lumen, and the series of inflatable bags 1107 can be placed in a basically unexpanded state (Figure 11B). When the valve tips 1103 open to allow blood flow through the valve, the flow increases, and the inflatable bags 1107 expand with the outward flow, creating a drum shape within the valve lumen (Figure 11A). The expansion of the bags can encourage stagnant blood along the lumen wall 1105, towards the center of the artificial valve 1101, and through the outflow end assisted by the drum shape of the valve cavity. The inflatable bag can be composed of any biocompatible flexible material such as (for example) PET.

[0117] FIG. 12 provides an example of an artificial valve for improving stagnant blood flow using a fluidity sheet. The artificial valve 1201 has a series of valve tips 1203 and a lumen wall 1205. Immediately below the valve tips 1203, the lumen wall 1205 has attached thereto a series of one or more fluidity sheets 1207 each having one edge attached to the lumen wall. During systole when local pressure and flow are low, the series of fluidity sheets 1207 can be placed along or near the lumen wall 1205 (FIG. 12). As flow and pressure increase, the valve tips 1203 open to allow blood to flow and the free edges of the series of sheets 1207 are able to move with the outward flow (FIG. 12). The movement of the sheets can encourage any stagnating blood along the lumen wall 1205, towards the center of the artificial valve 1201, and through the outflow end.

[0118] Figures 13A and 13B provide an example of an artificial valve that utilizes movable microprojections to improve stagnant blood flow. The artificial valve 1301 has a series of valve leaflets 1303 and a lumen wall 1305. Immediately below the valve leaflets 1303, a series of microprojections 1307 that project from the lumen wall are attached to the lumen wall 1305. In one example, the microprojections are magnetically driven and each has a positive and a negative magnetic pole at the tip of the microprojection. Each microprojection can bend in the direction towards the valve leaflet. The series of magnetically driven microprojections 1307 can include one or more larger driven microprojections 1307a that can stimulate the bending of the remaining portions of the series of microprojections within the range of a linear array in the direction of flow. Further, each microprojection tip has a specific pole alignment such that the pole faces of each tip are each the same charge as the adjacent tip pole faces. For example, as shown in Figure 13B, the larger driven microprojection tip 1307a has a negative / positive pole tip and the adjacent tip 1307b has a positive / negative pole tip such that the negative pole face of the microprojection tip 1307a is directly adjacent to the negative pole face of the microprojection tip 1307b. Thus, when the driven microprojection tip 1307a bends towards the microprojection tip 1307b, the driven microprojection tip 1307a pushes the microprojection tip 1307b to bend towards the valve leaflet. Each adjacent microprojection tip having opposite polarities along the linear array allows the driven microprojection tip to sequentially induce the bending of each microprojection. The bending of the microprojections can encourage any stagnant blood along the lumen wall 1305, towards the center of the artificial valve 1301, and through the outflow end.

[0119] In another aspect, the frame and catheter are provided to prevent or limit strut torsion. A problem with a tubular frame is that the struts tend to twist and kink when loaded into the sheath. This is especially true for struts in the less dense portions of the frame, which have more space to allow torsion to occur. Torsion can damage the frame and / or cause problems during placement and installation, so it is best case to load the frame into the sheath such that torsion does not occur. Generally, to prevent strut torsion, the frame is crimped with a device that prevents the struts from twisting by individually restraining each strut. However, this device is generally only used during the initial crimping and loading of the frame. Its use is limited to an external load only and generally is not available at the bedside.

[0120] Clinicians desire to have the ability to proximally reload the structural frame back into the sheath after advancing the frame distally at the implantation site during a transcatheter procedure. Placement and installation of the frame needs to be extremely precise at the implantation site within the patient's body. Since reloading the structural frame can cause strut torsion, the clinician has only one chance to place and install the frame, which can be difficult when relying on ultrasound or fluoroscopy. At the implantation site, the clinician desires to be able to adjust and reposition the sheath by proximally reloading the frame back into the sheath and then advancing and placing the frame distally again at the repositioned site. This allows for a better implantation procedure since a perfectly exact placement is not required on the first attempt. The frame can be expanded when placed to result in a self-expanding frame by utilization of a balloon, mechanical expansion, or a shape memory material (e.g., nitinol).

[0121] To prevent kinking of the struts during crimping and loading (and reloading) of the valve frame into the sheath, the frame can include one or more anti-kink elements on a series of struts. The anti-kink elements are small protrusions that extend laterally from the struts in a direction that coincides with the perimeter of the frame. The anti-kink elements prevent kinking by providing a wide lateral profile that makes it impossible for the struts to bend or twist as they are loaded into the sheath. The anti-kink elements can be separate from the frame design such as when the frame is made of the elements. Alternative anti-kink elements can be attached onto the frame, and the frame can be attached and secured to the struts by attachment means (e.g., by rivets, screws, adhesives, or fitting in place).

[0122] In some embodiments, the anti-torsion element extends laterally for a length that prevents twisting during loading such that it can be determined by the lateral width and the radial depth of the strut. In some embodiments, the anti-torsion element extends laterally for a length such that the protrusion abuts or substantially abuts the adjacent strut. In some embodiments, the anti-torsion element extends laterally for a length that is about 1.1 to 5 times the lateral width of the strut. In various embodiments, the anti-torsion element extends laterally for a length that is 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 substantially 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 so long as to prevent the flexibility of the strut and the expandability of the frame. In some implementations, the vertical length of the anti-torsion element is about 2% to 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.

[0123] One or more anti-twist elements can be provided on each strut of the frame, or on each strut of a series of struts. In some implementations, one or more anti-twist elements are provided on struts within a low-density portion of the frame (as determined by the density along the perimeter of the frame). The density can be determined by the abutment (or near abutment) of the struts in the crimped state. When crimped, adjacent struts that are abutting or within a distance that prevents the struts from twisting may not require anti-twist elements as this density prevents the struts from bending. The distance that prevents twisting can potentially be determined by the lateral width and radial depth of the strut. Additionally, a high lateral density may not allow for the addition of anti-twist elements that would expand the lateral profile of the strut.

[0124] The anti-twist portion can further include other components. In some implementations, the anti-twist element includes markers for visualization by ultrasound examination, radiography, or any other visualization technique for monitoring during trans-catheter procedures. In some implementations, an aperture is provided within the anti-twist element, which can be utilized as a marker for visualization.

[0125] Alternatively, or in addition to a frame having anti-twist elements, the sheath can be designed so that the struts of the frame cannot twist and bend. The sheath is generally tubular in design with a lumen. The inner surface of the sheath (i.e., the surface within the lumen of the sheath) has a circular profile. To prevent twisting and bending, the inner surface of the sheath can have a polygonal profile instead of a conventional circular profile. The flat profile of each side of the polygon reduces the amount of space between the strut and the inner surface of the sheath, so that the strut does not have space to twist and bend.

[0126] The valve frame often includes a pattern that repeats struts and cells, resulting in multiple repetitions of columnar segments (e.g., each segment extends along a proximal-distal axis). The number of columnar segments can vary, but is generally 5 to 15 columnar segments depending on the frame design. The inner surface of the sheath can be contoured polygonal to match the columnar segments of the frame. For example, the contour of the inner surface of the sheath can be a polygon having a number of sides that matches the number of columnar segments of the frame. Therefore, in various implementations, the inner contour of the sheath is a pentagon for a frame having 5 columnar segments, a hexagon for a frame having 6 columnar segments, a heptagon for a frame having 7 columnar segments, an octagon for a frame having 8 columnar segments, a nonagon for a frame having 9 columnar segments, a decagon for a frame having 10 columnar segments, a hendecagon for a frame having 11 columnar segments, a dodecagon for a frame having 12 columnar segments, a tridecagon for a frame having 13 columnar segments, a tetradecagon for a frame having 14 columnar segments, or a pentadecagon for a frame having 15 columnar segments.

[0127] In some implementations for preventing strut kinking, when the crimped frame is within a sheath having an inner surface with a polygonal contour, the strut is within a range proximate to a side of the polygon. In some implementations, when the crimped frame is within a sheath having an inner surface with a polygonal contour, the strut abuts or nearly abuts against one side of the polygon. Measurements of the strut width and the nearly abutting distance will be made at the same location of the strut.

[0128] Figures 14A and 14B provide an example of a frame having a plurality of anti-torsion elements. Frame 1401 includes a plurality of anti-torsion elements 1403. Frame 1401 includes a plurality of struts 1405 that are connected at a plurality of connection points 1407 and form a plurality of cells 1409, with each cell surrounded by two or more connected struts. The plurality of struts 1405 form nine columnar segments, and each columnar segment 1411 is laterally adjacent to another columnar segment and forms the entire perimeter.

[0129] Each columnar segment 1411 includes three cells having two cells at the distal end of the frame and a single cell at the proximal end. As can be easily understood, when crimped, the distal end has a higher density of struts along the lateral perimeter. Due to the lack of strut density at the proximal end, these struts (e.g., struts 1405a and 1405b) tend to twist and bend during crimping. To reduce the twist on these struts, each strut at the proximal end includes an anti-torsion element 1403.

[0130] As shown, each anti-torsion element 1403 extends into the proximal cell, but the anti-torsion element may extend away from the cell or in any lateral direction from the strut. In some implementations, two or more anti-torsion elements extend toward the same lateral axis, and each anti-torsion element is provided on a different longitudinal axis to prevent the anti-torsion elements from contacting when the frame is crimped. For example, anti-torsion element 1403a and anti-torsion element 1403b each extend toward the same lateral axis 1402. Anti-torsion element 1403a extends from strut 1405a along a longitudinal axis that is longitudinally proximal to the longitudinal axis along which anti-torsion element 1403b extends so as to extend from strut 1405b. When frame 1401 is crimped, anti-torsion element 1403a and anti-torsion element 1403b do not contact.

[0131] Each anti-torsion element 1403 includes an opening 1413, which is available for visualizing the element and the frame 1401 by a visualization technique for monitoring the arrangement of the frame. Each anti-torsion element 1403 is illustrated as a quadrilateral, but any shape can be utilized.

[0132] Figures 15A and 15B show an example of a frame crimped within a sheath. The frame includes a continuous series of columnar segments, but the figure shows only a single columnar segment for clarity and explanation. The frame 1501 includes a columnar segment 1503 within a sheath 1505. Struts 1507a and 1507b are located in a section of the frame 1501 with a low density of struts such that there is sufficient space for the struts to twist and bend, and thus these struts tend to twist and bend when the frame is crimped and loaded within the sheath (see arrow 1508 in Figure 15B).

[0133] Figures 16A and 16B show an example of a frame including anti-torsion elements crimped within a sheath. The frame includes a continuous series of columnar segments, but the figure shows only a single columnar segment for clarity and explanation. The frame 1601 includes a columnar segment 1603 within a sheath 1605. Struts 1607a and 1607b are located in a section of the frame 1601 with a low density of struts such that there is sufficient space for the struts to twist and bend. To reduce twisting and bending, struts 1607a and 1607b include a series of anti-torsion elements. As shown, each of struts 1607a and 1607b includes two anti-torsion elements, but of course, a series can be one or more and can vary in dimensions and shape as described herein. The anti-torsion element 1609 limits the ability of struts 1607a and 1607b to twist and bend, reducing the torsion on the struts (Figure 16B).

[0134] Figures 17A and 17B show an example of a frame crimped within a sheath that includes an inner surface having a polygonal shape. The frame includes a continuous series of columnar segments, although the figure shows only a single columnar segment for clarity and explanation. Frame 1701 includes columnar segment 1703 within sheath 1605. Struts 1707a and 1707b are located in a section of frame 1701 with a low density of struts that has sufficient space to twist and bend. To reduce twisting and bending, the inner surface 1711 of sheath 1701 is polygonal. As shown, columnar segment 1703 abuts or substantially abuts one side of the polygonal contour. The polygonal contour of inner surface 1711 limits the ability of struts 1707a and 1707b to twist and bend, reducing strut twist (Figure 16B).

[0135] In some implementations, the frame includes an anti-twist element (e.g., Figure 16A), is crimped, and is loaded into a catheter that includes an inner surface having a polygonal contour (e.g., Figure 17B).

[0136] In another aspect, an improved manufacturing procedure is provided such that the cover can be applied more efficiently and economically over the frame. A common problem with the manufacture of valve frame covers is that it can be difficult to wrap and attach the cover around the frame. The cover is generally a sheet of cloth, tissue paper, film, or some other flat material, and the frame is typically tubular in shape with multiple peripheries of various lengths. When wrapping and securing the cover around the frame, excess cover may be gathered and further trimmed and fitted as necessary. To solve this problem, the cover is pre-cuttable prior to assembly. The pre-cut cover can be repeated and improved to an industrial manufacturing level, facilitating the production of a frame with a cover.

[0137] FIG. 18A provides an example of a pre-cut cover for assembly onto a frame. Cover 1801 includes a plurality of segments 1803. The number of segments can vary depending on the frame design. Cover 1801 is for a frame that includes nine columnar segments, and in some implementations, the cover includes the same number of segments as the columnar segments of the frame. Segment 1803 is cut so as to appropriately cover each columnar segment of the frame. In this example, each segment 1803 is connected to an adjacent segment at a first end 1805 of cover 1801 (i.e., the first end is one of the proximal or distal ends). At a second end 1807 opposite the first end, each segment 1803 is not connected from an adjacent segment so that cover 1801 is pre-cut in a flower-like shape. The side edges of each segment 1803 include a portion connected at or near the first end and a portion not connected (e.g., an intermediate portion and a portion at or near the second end) that is not at or near the first end. As shown, most of each side edge of each segment 1803 is not connected from an adjacent segment.

[0138] Cover 1801 is for a tubular frame that includes a plurality of circumferential lengths along a proximal-distal axis. FIG. 18A shows four circumferential lengths (1802a, 1802b, 1802c, and 1802d) of the frame. Accordingly, each segment 1803 is cut to a specification having side edges of the contour of each segment 1803 to provide a segment width that matches a plurality of perimeters of the frame. As shown, the first end 1805 is cut to a size that matches the circumferential length 1802a. Each segment 1803 extends laterally from the first circumferential length 1802a to the second circumferential length 1802b and then maintains a similar lateral width to the third perimeter 1803c. The width of each segment 1803 decreases laterally from the third circumferential length 1802c to the fourth circumferential length 1802d, which is the second end of the cover. Each side edge is available for use in sewing the cover onto the frame.

[0139] Figure 18B provides an exemplary cover of Figure 18A mounted on a frame. Cover 1801 conforms to the frame so as to overlap each segment 1803 on the columnar segments of the frame. Each segment 1803 is sewn along its side to each of its adjacent segments via stitches 1809, resulting in a plurality of seams. Therefore, the side edges of each segment 1803 are connected at a first end 1805 to the side edges of each adjacent section by a pre-cut flower shape (see Figure 18A) and are connected at a second end 1807 to the side edges of each adjacent section by attachment means such as stitches 1809. Most of the side edges of each columnar segment are connected to the side edges of each adjacent section by attachment means such as stitches 1809. Although stitches are shown, any number of attachment means can be utilized, such as (for example) stitches, staples, adhesives, etc.

[0140] The following examples are included within the scope of the present invention.

[0141] Example 1. A frame for use in an artificial valve, comprising a plurality of interconnected struts forming a tubular frame and a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0142] Example 2. The frame according to Example 1, wherein the plurality of interconnected struts comprise a shape memory material that provides a radial force.

[0143] Example 3. The frame according to Example 2, wherein the absorption of the bioabsorbable elements results in weakening the radial force of the tubular frame.

[0144] Example 4. The frame according to Example 1, 2, or 3, wherein at least a portion of the plurality of bioabsorbable elements is located at the interconnection points of two or more struts.

[0145] Example 5. The tubular frame further includes a plurality of appendages extending away from the tubular frame, and each appendage of the plurality of appendages is formed by a part of a plurality of interconnected struts, and the frame according to any one of Examples 1 to 4.

[0146] Example 6. At least a part of the plurality of bioabsorbable elements is located within one or more of the plurality of appendages, and the frame according to Example 5.

[0147] Example 7. The tubular frame is crimped, and the frame according to any one of Examples 1 to 6.

[0148] Example 8. The tubular frame is within the catheter of a transcatheter delivery system, and the frame according to Example 7.

[0149] Example 9. The frame further includes an inner skirt attached to the tubular frame, and the frame according to any one of Examples 1 to 8.

[0150] Example 10. The inner skirt is bioabsorbable, and the frame according to Example 9.

[0151] Example 11. The tubular frame further includes a series of valve tips, and the series of valve tips are attached to the tubular frame or to the inner skirt, and the frame according to any one of Examples 1 to 10.

[0152] Example 12. The frame further includes an outer skirt attached to the tubular frame, and the frame according to any one of Examples 1 to 11.

[0153] Example 13. The outer skirt is bioabsorbable, and the frame according to Example 12.

[0154] Example 14. The frame further includes a fluffy bioabsorbable band surrounding the tubular frame, and the frame according to any one of Examples 1 to 13.

[0155] Example 15. The frame according to any one of Examples 1 to 14, further comprising an anchor system attached to the tubular frame.

[0156] Example 16. The frame according to Example 15, wherein the anchor system includes a bioabsorbable portion.

[0157] Example 17. The frame according to Example 16, further comprising a series of bioabsorbable barbs attached to the tubular frame or to the anchor system.

[0158] Example 18. The frame according to any one of Examples 1 to 17, wherein the frame is sterilized and packaged.

[0159] Example 19. An artificial valve comprising a plurality of interconnected struts forming a tubular frame, and an anchor system attached to the tubular frame, the anchor system including a plurality of anchor arms having bioabsorbable anchor tips.

[0160] Example 20. The artificial valve according to Example 19, wherein the absorption of at least one of the bioabsorbable anchor tips results in a reduction in invasion of the local tissue at the implantation site when implanted.

[0161] Example 21. The artificial valve according to Example 19 or 20, further comprising a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0162] Example 22. The artificial valve according to Example 21, wherein at least a portion of the plurality of bioabsorbable elements is located at the interconnecting points of two or more struts.

[0163] Example 23. The tubular frame further comprises a plurality of appendages extending away from the tubular frame, each appendage of the plurality of appendages being formed by a portion of the plurality of interconnected struts, and at least a portion of the plurality of bioabsorbable portions being located within one or more of the plurality of appendages. The artificial valve according to Example 21 or 22.

[0164] Example 24. An artificial valve that is crimped, the artificial valve according to any one of Examples 19 to 23.

[0165] Example 25. The crimped artificial valve that is within a catheter of a transcatheter delivery system, the artificial valve according to Example 24.

[0166] Example 26. An artificial valve further comprising an inner skirt attached to a tubular frame, the artificial valve according to any one of Examples 19 to 25.

[0167] Example 27. The artificial valve according to Example 26, wherein the inner skirt is bioabsorbable.

[0168] Example 28. An artificial valve further comprising a series of valve leaflets within a tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt, the artificial valve according to any one of Examples 19 to 27.

[0169] Example 29. An artificial valve further comprising an outer skirt attached to a tubular frame, the artificial valve according to any one of Examples 19 to 28.

[0170] Example 30. The artificial valve according to Example 29, wherein the outer skirt is bioabsorbable.

[0171] Example 31. An artificial valve further comprising a fluffy bioabsorbable band surrounding the tubular frame, the artificial valve according to any one of Examples 19 to 30.

[0172] Example 32. An artificial valve further comprising a series of bioabsorbable barbs, the artificial valve according to any one of Examples 19 to 31.

[0173] Example 33. The artificial valve according to any one of Examples 19 to 32, wherein the artificial valve is sterilized and packaged.

[0174] Example 34. An artificial valve comprising: a plurality of interconnected struts forming a tubular frame; and an inner skirt attached to the tubular frame, the inner skirt being bioabsorbable.

[0175] Example 35. The artificial valve according to Example 34, further comprising a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0176] Example 36. The artificial valve according to Example 35, wherein at least a portion of the plurality of bioabsorbable elements is located at an interconnect point of two or more struts.

[0177] Example 37. The tubular frame further comprises a plurality of appendages extending away from the tubular frame, each appendage of the plurality of appendages being formed by a portion of the plurality of interconnected struts, and at least a portion of the plurality of bioabsorbable elements is located within one or more of the plurality of appendages. The artificial valve according to Example 35 or 36.

[0178] Example 38. The artificial valve according to any one of Examples 34 to 37, wherein the artificial valve is crimped.

[0179] Example 39. The crimped artificial valve according to Example 38, wherein the crimped artificial valve is within a catheter of a transcatheter delivery system.

[0180] Example 40. The artificial valve according to any one of Examples 34 to 39, further comprising a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt.

[0181] Example 41. The artificial valve according to any one of Examples 34 to 40, further comprising an outer skirt attached to the tubular frame.

[0182] Example 42. The artificial valve according to Example 41, wherein the outer skirt is bioabsorbable.

[0183] Example 43. An artificial valve according to any one of Examples 34 to 42, further comprising a woolly bioabsorbable band surrounding the tubular frame.

[0184] Example 44. An artificial valve according to any one of Examples 34 to 43, further comprising an anchor system attached to the tubular frame.

[0185] Example 45. An artificial valve according to Example 44, wherein the anchor system includes a bioabsorbable portion.

[0186] Example 46. An artificial valve according to Example 45, further comprising a series of bioabsorbable barbs attached to the tubular frame or to the anchor system.

[0187] Example 47. An artificial valve according to any one of Examples 34 to 46, wherein the artificial valve is sterilized and packaged.

[0188] Example 48. An artificial valve comprising a plurality of interconnected struts forming a tubular frame and an outer skirt attached to the tubular frame, the outer skirt being bioabsorbable.

[0189] Example 49. An artificial valve according to Example 48, wherein the outer skirt is a woolly bioabsorbable outer skirt.

[0190] Example 50. An artificial valve according to Example 48 or 49, further comprising a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0191] Example 51. An artificial valve according to Example 50, wherein at least a portion of the plurality of bioabsorbable elements is located at the intersection points of two or more struts.

[0192] Example 52. The tubular frame further comprises a plurality of appendages extending away from the tubular frame, each appendage of the plurality of appendages being formed by a part of a plurality of interconnected struts, and at least a part of the plurality of bioabsorbable elements being located within one or more of the plurality of appendages, the artificial valve according to Example 50 or 51.

[0193] Example 53. The artificial valve is crimped, the artificial valve according to any one of Examples 48 to 52.

[0194] Example 54. The crimped artificial valve is within a catheter of a transcatheter delivery system, the artificial valve according to Example 53.

[0195] Example 55. The artificial valve according to any one of Examples 48 to 54, further comprising an inner skirt attached to the tubular frame.

[0196] Example 56. The inner skirt is bioabsorbable, the artificial valve according to Example 55.

[0197] Example 57. The artificial valve according to any one of Examples 48 to 56, further comprising a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt.

[0198] Example 58. The artificial valve according to any one of Examples 48 to 57, further comprising an anchor system attached to the tubular frame.

[0199] Example 59. The anchor system includes a bioabsorbable portion, the artificial valve according to Example 58.

[0200] Example 60. The artificial valve according to Example 59, further comprising a series of bioabsorbable barbs attached to the tubular frame or to the anchor system.

[0201] Example 61. The artificial valve is sterilized and packaged, the artificial valve according to any one of Examples 48 to 60.

[0202] Example 62. An artificial valve comprising a plurality of interconnected struts forming a tubular frame and a fluffy bioabsorbable band surrounding the tubular frame.

[0203] Example 63. The artificial valve according to Example 62, further comprising a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0204] Example 64. The artificial valve according to Example 63, wherein at least a portion of the plurality of bioabsorbable elements is located at the connection points of two or more struts.

[0205] Example 65. The tubular frame further comprises a plurality of appendages extending away from the tubular frame, each appendage of the plurality of appendages being formed by a portion of the plurality of interconnected struts, and at least a portion of the plurality of bioabsorbable elements is located within one or more of the plurality of appendages. The artificial valve according to Example 63 or 64.

[0206] Example 66. The artificial valve according to any one of Examples 62 to 65, wherein the artificial valve is crimped.

[0207] Example 67. The crimped artificial valve according to Example 66, which is within a catheter of a transcatheter delivery system.

[0208] Example 68. The artificial valve according to any one of Examples 62 to 67, further comprising an inner skirt attached to the tubular frame.

[0209] Example 69. The artificial valve according to Example 68, wherein the inner skirt is bioabsorbable.

[0210] Example 70. The artificial valve according to any one of Examples 62 to 69, further comprising a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt.

[0211] Example 71. The artificial valve according to any one of Examples 62 to 70, further comprising an outer skirt attached to the tubular frame.

[0212] Example 72. The artificial valve according to Example 71, wherein the outer skirt is bioabsorbable.

[0213] Example 73. The artificial valve according to any one of Examples 62 to 72, further comprising an anchor system attached to the tubular frame.

[0214] Example 74. The artificial valve according to Example 73, wherein the anchor system includes a bioabsorbable portion.

[0215] Example 75. The artificial valve according to Example 74, further comprising a series of bioabsorbable barbs attached to the tubular frame or to the anchor system.

[0216] Example 76. The artificial valve according to any one of Examples 62 to 75, wherein the artificial valve is sterilized and packaged.

[0217] Example 77. An artificial valve comprising a plurality of interconnected struts for forming a tubular frame, an anchor system attached to the tubular frame, and a series of bioabsorbable barbs attached to the tubular frame or to the anchor system.

[0218] Example 78. The artificial valve according to Example 77, further comprising a plurality of bioabsorbable elements within a portion of the struts forming the tubular frame.

[0219] Example 79. The artificial valve according to Example 78, wherein at least a portion of the plurality of bioabsorbable elements is located at the interconnecting points of two or more struts.

[0220] Example 80. The tubular frame further comprises a plurality of appendages extending away from the tubular frame, each appendage of the plurality of appendages being formed by a part of a plurality of interconnected struts, and at least a part of the plurality of bioabsorbable elements being located within one or more of the plurality of appendages, the artificial valve according to Example 78 or 79.

[0221] Example 81. The artificial valve is crimped, the artificial valve according to any one of Examples 77 to 80.

[0222] Example 82. The crimped artificial valve is within the catheter of a transcatheter delivery system, the artificial valve according to Example 81.

[0223] Example 83. The anchor system includes a bioabsorbable portion, the artificial valve according to any of Examples 77 to 82.

[0224] Example 84. The artificial valve further comprises an inner skirt attached to the tubular frame, the artificial valve according to any one of Examples 77 to 83.

[0225] Example 85. The inner skirt is bioabsorbable, the artificial valve according to Example 84.

[0226] Example 86. The tubular frame further comprises a series of valve leaflets, the series of valve leaflets being attached to the tubular frame or to the inner skirt, the artificial valve according to any one of Examples 77 to 85.

[0227] Example 87. The artificial valve further comprises an outer skirt attached to the tubular frame, the artificial valve according to any one of Examples 77 to 86.

[0228] Example 88. The outer skirt is bioabsorbable, the artificial valve according to Example 87.

[0229] Example 89. The artificial valve further includes a fluffy bioabsorbable band surrounding the tubular frame, the artificial valve according to any one of Examples 77 to 88.

[0230] Example 90. An artificial valve that is sterilized and packaged, the artificial valve according to any one of Examples 77 to 89.

[0231] Example 91. A plurality of interconnected struts for forming a self-expanding tubular frame, the tubular frame including a shape memory material, the plurality of interconnected struts, and a shrinkable bioabsorbable band surrounding the self-expanding tubular frame, an artificial valve comprising.

[0232] Example 92. The artificial valve according to Example 91, further including an inner skirt attached to the tubular frame.

[0233] Example 93. The artificial valve according to Example 91 or 92, further comprising a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt.

[0234] Example 94. The artificial valve according to Example 91, 92, or 93, further including an outer skirt attached to the tubular frame.

[0235] Example 95. The artificial valve according to any one of Examples 91 to 94, further including an anchor system attached to the tubular frame.

[0236] Example 96. The artificial valve according to any one of Examples 91 to 95, wherein the tubular frame is crimped.

[0237] Example 97. The artificial valve according to Example 96, wherein the artificial valve is within a catheter of a transcatheter delivery system.

[0238] Example 98. An artificial valve that is sterilized and packaged, the artificial valve according to any one of Examples 91 to 97.

[0239] Example 99. An artificial valve comprising a series of columnar segments, each columnar segment comprising a plurality of interconnected struts and a series of bioabsorbable connectors, the series of bioabsorbable connectors connecting the series of columnar segments to form a tubular frame, each columnar segment being connected to two adjacent columnar segments via one or more of the series of bioabsorbable sections.

[0240] Example 100. The artificial valve according to Example 99, further comprising an inner skirt attached to the tubular frame.

[0241] Example 101. The artificial valve according to Example 99 or 100, further comprising a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner skirt.

[0242] Example 102. The artificial valve according to Example 99, 100, or 101, further comprising an outer skirt attached to the tubular frame.

[0243] Example 103. The artificial valve according to any one of Examples 99 to 102, further comprising an anchor system attached to the tubular frame.

[0244] Example 104. The artificial valve according to any one of Examples 99 to 103, wherein the tubular frame is crimped.

[0245] Example 105. The artificial valve according to Example 104, wherein the artificial valve is within a catheter of a transcatheter delivery system.

[0246] Example 106. The artificial valve according to any one of Examples 99 to 105, wherein the artificial valve is sterilized and packaged.

[0247] Example 107. A frame for use with an artificial valve, comprising a plurality of interconnected struts forming a tubular frame having a plurality of cells, at least some of the plurality of cells being asymmetric.

[0248] Example 108. The asymmetry of each cell of a plurality of asymmetric cells is the frame according to Example 107, formed by at least one asymmetric cross strut.

[0249] Example 109. The asymmetry of at least one cross strut is formed by two curved portions intersecting at a central vertex, and the first curved portion of the two curved portions has a larger radius and length than the second curved portion of the two curved portions, the frame according to Example 108.

[0250] Example 110. A plurality of interconnected struts forming a tubular frame, the tubular frame having an inlet end and an outlet end, a plurality of biocompatible elements within a portion of the struts forming the tubular frame, the biocompatible elements being on or near the outlet side, a frame for use in an artificial valve.

[0251] Example 111. Absorption of the biocompatible element on or near the outlet side results in a segmented outlet end having the ability to bend, the frame according to Example 110.

[0252] Example 112. The frame is configured such that when the frame is subjected to the flow and pressure of a liquid passing through the frame, the segmented outlet end can bend outward to convert the outlet end from a narrow linear shape to a shape that spreads out like a trumpet, the frame according to Example 111.

[0253] Example 113. The frame is implanted within the vascular structure of an animal, and the liquid flow and pressure are systolic blood flow and blood pressure, the frame according to Example 112.

[0254] Example 114. An artificial valve 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; a lumen wall attached to the tubular frame; a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the lumen wall and separating the inflow side and the outflow side of the tubular frame; and a series of one or more inflatable bags attached to the lumen wall on the outflow side of the frame.

[0255] Example 115. The artificial valve according to Example 114, wherein each bag of the series of one or more inflatable bags is composed of a biocompatible flexible material.

[0256] Example 116. The artificial valve according to Example 114 or 115, wherein each bag of the series of one or more inflatable bags is filled with a compressible fluid component that changes volume based on pressure.

[0257] Example 117. The artificial valve according to Example 116, wherein each bag of the series of one or more inflatable bags is configured to expand to an inflated state when the artificial valve is subjected to liquid flow and pressure through the lumen wall.

[0258] Example 118. The artificial valve according to Example 117, wherein the artificial valve is implanted within the vascular structure of an animal, and the liquid flow and pressure are systolic blood flow and blood pressure.

[0259] Example 119. An artificial valve 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; a lumen wall attached to the tubular frame; a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the lumen wall and separating the inflow side and the outflow side of the tubular frame; and a series of one or more fluidity sheets attached to the lumen wall on the outflow side of the frame, each fluidity sheet of the series of one or more fluidity sheets having at least one free edge.

[0260] Example 120. The artificial valve according to Example 119, wherein each fluidity sheet of the series of one or more fluidity sheets is composed of a biocompatible flexible material.

[0261] Example 121. The artificial valve according to Example 120, wherein the series of one or more fluidity sheets are configured such that each fluidity sheet of the series of one or more fluidity sheets can move with the flow of liquid when the artificial valve is subjected to the flow and pressure of liquid through the lumen wall.

[0262] Example 122. The artificial valve according to Example 121, wherein the artificial valve is implanted within the vascular structure of an animal, and the flow and pressure of the liquid are the systolic blood flow and blood pressure.

[0263] Example 123. An artificial valve 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 cavity wall attached to the tubular frame; a series of valve leaflets within the tubular frame, the series of valve leaflets being attached to the tubular frame or to the inner cavity wall and separating the inflow side and the outflow side of the tubular frame; and a plurality of flexible magnetically driven microprojections linearly aligned in the direction of flow and attached to the inner cavity wall, each of the plurality of flexible magnetically driven microprojections having a positive magnetic pole and a negative magnetic pole at the tip of the microprojection.

[0264] Example 124. The artificial valve according to Example 123, wherein the plurality of flexible magnetically driven microprojections include larger driven microprojections.

[0265] Example 125. The artificial valve according to Example 123 or 124, wherein each microprojection tip of the plurality of flexible magnetically driven microprojections has a specific pole alignment such that the pole faces of each tip have the same electric charge as the adjacent tip pole faces.

[0266] Example 126. The artificial valve according to Example 124 or 125, wherein the larger driven microprojections can stimulate the bending of the remaining portions of the plurality of flexible magnetically driven microprojections.

[0267] Example 127. A frame system for use within an artificial valve, the frame system comprising a plurality of interconnected struts forming a self-expanding tubular frame, the tubular frame including a shape memory material for providing a radial force; and a plurality of anti-torsion elements, each anti-torsion element being a protrusion extending laterally from at least a portion of the plurality of interconnected struts.

[0268] Example 128. The frame system according to Example 127, wherein each anti-torsion element is attached to a strut within a region of the frame having low-density struts.

[0269] Example 129. The frame system according to Example 127 or 128, wherein each anti-torsion element is fabricated as part of the frame design.

[0270] Example 130. The frame system according to Example 127 or 128, wherein each anti-torsion element is attached and fixed to a strut by attachment means.

[0271] Example 131. The frame system according to any one of Examples 127 to 130, wherein at least a part of the plurality of anti-torsion elements abuts or substantially abuts adjacent struts when the frame is coiled.

[0272] Example 132. The frame system according to any one of Examples 127 to 131, wherein each anti-torsion element extends laterally by a length that is about 1.1 to 5 times the lateral width of the strut.

[0273] Example 133. The frame system according to any one of Examples 127 to 132, wherein each anti-torsion element has a vertical length that is about 2% to 20% of the length of the strut.

[0274] Example 134. The frame system according to any one of Examples 127 to 133, wherein at least a part of the plurality of anti-torsion elements includes markers for visualization.

[0275] Example 135. Further comprising a catheter, the catheter accommodating a tubular frame, and each anti-torsion element reducing the ability of the strut to kink or twist during loading of the tubular frame into the catheter. The frame system according to any one of Examples 127 to 134.

[0276] Example 136. The frame system according to Example 135, wherein the catheter includes an inner surface having a polygonal contour.

[0277] Example 137. The frame system according to Example 136, wherein the tubular frame includes a plurality of columnar segments, and the number of columnar segments is equal to the number of sides of the polygonal contour.

[0278] Example 138. The frame system according to Example 136 or 137, wherein at least a part of the plurality of interconnected struts abuts or substantially abuts one side of the polygonal contour.

[0279] Example 139. The frame system according to any one of Examples 127 to 138, wherein the tubular frame is sterilized and packaged.

[0280] Example 140. A method for releasing a frame by a transcatheter method, comprising delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be installed, wherein the tubular frame is loaded into the catheter, and the tubular frame comprises a shape memory material for providing a radial force, a plurality of interconnected struts, and a plurality of anti-torsion elements, each anti-torsion element being a protrusion extending laterally from at least a part of the plurality of interconnected struts; advancing the tubular frame distally from the catheter to cause expansion of the tubular frame; and reloading the tubular frame proximally into the catheter, resulting in crimping of the tubular frame.

[0281] Example 141. The method according to Example 140, wherein each anti-torsion element is attached to a strut within a region of the frame having a low density of struts.

[0282] Example 142. The frame system according to Example 140 or 141, wherein each anti-torsion element extends laterally by a length of about 1.1 to 5 times the lateral width of the strut.

[0283] Example 143. Each anti-torsion element has a vertical length of about 2% to 20% of the length of the strut, and the method described in Example 140, 141, or 142.

[0284] Example 144. At least some of the plurality of anti-torsion elements include markers for visualization, and the method further includes visualizing the distal advancement or proximal reload of the self-expanding tubular frame by the markers for visualization and visualization techniques, and the method described in any one of Examples 140 to 143.

[0285] Example 145. A frame system for use within an artificial valve, comprising a plurality of interconnected struts forming a self-expanding tubular frame, the tubular frame including a shape memory material for providing a radial force, the plurality of interconnected struts, and a catheter, the catheter accommodating the tubular frame, the catheter including an inner surface having a polygonal contour.

[0286] Example 146. The frame system according to Example 145, wherein the tubular frame includes several columnar segments, and the number of columnar segments is equal to the number of sides of the polygonal contour.

[0287] Example 147. The frame system according to Example 145 or 146, wherein at least some of the plurality of interconnected struts abut or substantially abut against the sides of the polygonal contour.

[0288] Example 148. Further comprising a plurality of anti-torsion elements, each anti-torsion prevention element being a protrusion extending laterally from at least a part of the plurality of interconnected struts, and the frame system described in Example 145, 146, or 147.

[0289] Example 149. Each anti-torsion element is attached to a strut within a region of the frame having a low-density strut, and the frame system described in Example 148.

[0290] Example 150. The frame system according to Example 148 or 149, wherein at least a part of the plurality of anti-torsion elements abuts or substantially abuts an adjacent strut when the frame is crimped.

[0291] Example 151. The frame system according to Example 149 or 150, wherein each anti-torsion element extends laterally by a length that is about 1.1 to 5 times the lateral width of the strut.

[0292] Example 152. The frame system according to any one of Examples 148 to 151, wherein each anti-torsion element has a vertical length that is about 2% to 20% of the length of the strut.

[0293] Example 153. The frame system according to any one of Examples 145 to 152, wherein the tubular frame is sterilized and packaged.

[0294] Example 154. A method for releasing a frame by a transcatheter method, comprising delivering a catheter and a self-expanding tubular frame to a site where the tubular frame is to be installed, wherein the tubular frame is loaded within the catheter, the catheter includes an inner surface having a polygonal contour, the tubular frame includes a shape memory material for providing a radial force and a plurality of interconnected struts; advancing the tubular frame distally from the catheter to cause expansion of the tubular frame; and reloading the tubular frame proximally within the catheter, resulting in crimping of the tubular frame.

[0295] Example 155. The method according to Example 154, wherein the frame includes a plurality of columnar segments, and the number of columnar segments is equal to the number of sides of the polygonal contour.

[0296] Example 156. The method according to Example 154 or 155, wherein at least a part of the plurality of interconnected struts abuts or substantially abuts one side of the polygonal contour.

[0297] Example 157. The method according to Example 154, 155, or 156, wherein the tubular frame further comprises a plurality of anti-torsion elements, and each anti-torsion element is a protrusion extending laterally from at least a part of the plurality of interconnected struts.

[0298] Example 158. A cover for manufacturing a tubular frame, the tubular frame having a plurality of peripheries along the proximal-distal axis of the frame, the cover comprising a pre-cut sheet including a plurality of columnar segments forming a flower shape, each columnar segment having a first end, a second end, and two side edges, each columnar segment being laterally connected to two adjacent segments at the first end, and each columnar segment not being laterally connected from two adjacent segments at the second end and for most of each of the two side edges.

[0299] Example 159. The cover according to Example 158, wherein the side edges of each columnar segment are contoured to match a plurality of peripheries along the proximal-distal axis of the frame.

[0300] Example 160. The cover according to Example 158 or 159, wherein the number of columnar segments of the plurality of segments of the cover matches the number of columnar segments of the frame.

[0301] Example 161. The cover according to Example 158, 159, or 160, wherein the first end is the proximal end and the second end is the distal end.

[0302] Example 162. The cover according to Example 158, 159, or 160, wherein the first end is the distal end and the second end is the proximal end.

[0303] Example 163. The cover according to any one of Examples 158 to 162, wherein the pre-cut sheet is composed of cloth, tissue paper, or film.

[0304] Example 164. A system of a frame and a cover, comprising a tubular frame extending only by the length of the proximal-distal axis, the tubular frame being 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, the tubular frame, and a cover surrounding the tubular frame, the cover being composed of a pre-cut sheet in a flower shape, the cover including a plurality of columnar segments, each columnar segment having a first end, a second end, and two side edges, the two side edges of each columnar segment being horizontally connected to the side edges of two adjacent segments at the first end by the pre-cut flower shape, and the two side edges of each columnar segment being horizontally connected to the side edges of two adjacent segments at the second end by attachment means.

[0305] Example 165. The system according to Example 164, wherein most of each of the two side edges of each columnar segment is horizontally connected to the side edges of two adjacent segments by attachment means.

[0306] Example 166. The system according to Example 164 or 165, wherein the attachment means includes one of stitching, stapling, or an adhesive.

[0307] Example 167. The 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.

[0308] Example 168. The 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.

[0309] Example 169. The system according to any one of Examples 164 to 168, wherein the side edges of each columnar segment of the cover are contoured to match a plurality of peripheries along the proximal-distal axis of the frame.

[0310] Example 170. The system according to any one of Examples 164 to 169, wherein the number of columnar segments of the plurality of segments of the cover matches the number of columnar segments of the frame.

[0311] Example 171. The system according to any one of Examples 164 to 170, wherein the pre-cut sheet is composed of cloth, tissue paper, or film.

[0312] The above description includes many specific implementations of various systems, devices, and methods, but these should not be construed as limitations on the scope of these systems, devices, and methods, but rather as examples thereof. Therefore, the scope of the claims should be determined by the appended examples, the described alternatives, and their equivalents, rather than by the embodiments shown.

Claims

1. An artificial heart valve for replacing the native mitral valve or native tricuspid valve, A support frame having an inlet end portion and an outlet end portion, comprising a plurality of interconnecting struts, A valve portion positioned within the lumen of the support frame, wherein the valve portion includes a plurality of valve leaflets including pericardial tissue, and the valve portion provides a unidirectional flow of blood through the lumen to replace the function of the self-valve, An artificial heart valve comprising one or more bioabsorbable elements disposed on or within the support frame.

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

3. The artificial valve according to claim 1, wherein the one or more bioabsorbable elements include bioabsorbable elements located at the interconnection points of two or more struts.

4. The artificial valve according to claim 1, wherein the support frame further comprises a plurality of attachments extending away from the support frame, and the one or more bioabsorbable elements are located within one or more attachments of the plurality of attachments.

5. The artificial valve according to claim 1, further comprising an inner skirt attached to the support frame.

6. The artificial valve according to claim 5, wherein the inner skirt is bioabsorbable.

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

8. The artificial valve according to claim 1, further comprising an outer skirt attached to the support frame.

9. The artificial valve according to claim 8, wherein the outer skirt is bioabsorbable.

10. The artificial valve according to claim 1, further comprising a bioabsorbable band surrounding the support frame.

11. The artificial valve according to claim 10, wherein the bioabsorbable band is coated with a biomaterial that induces reendothelialization.

12. The artificial valve according to claim 1, further comprising an anchor system attached to the support frame.

13. The artificial valve according to claim 12, wherein the anchor system includes a bioabsorbable portion.

14. The artificial valve according to claim 12, wherein the anchor system comprises a plurality of anchor arms having curved portions that can extend between chordae tendineae.

15. The artificial valve according to claim 14, wherein at least one anchor arm is bioresorbable.

16. The artificial valve according to claim 12, further comprising a series of bioabsorbable barbs attached to the support frame or to the anchor system.

17. The artificial valve according to claim 1, further comprising a bioabsorbable, retractable band surrounding the support frame.

18. The artificial valve according to claim 1, wherein the support frame comprises a series of columnar segments and a series of bioabsorbable connectors, the series of bioabsorbable connectors connecting the series of columnar segments to form the support frame, and each columnar segment is connected to two adjacent columnar sections via the series of one or more bioabsorbable connectors.

19. The artificial valve according to claim 1, wherein the support frame is compressible for placement within the sheath of a transcatheter delivery system.

20. The artificial valve according to claim 1, wherein the support frame is sterilized and packaged.

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