Reinforcement member for the outer skirt of an artificial heart valve

Abstract

A reinforcing member for an outer skirt of an artificial heart valve is disclosed. As an example, the artificial heart valve can include an annular frame and an outer skirt disposed around the outer surface of the frame, and the outer skirt includes a sealing layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and a deformable reinforcing member attached to the sealing layer. The reinforcing member extends circumferentially along the sealing layer and is configured to extend radially outward from the frame such that when the frame is radially expanded from a radially compressed state to a radially expanded state, the sealing layer bulges radially outward and away from the frame. The reinforcing member includes a circumferentially extending cell row or undulating shape.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 366,799, filed on June 22, 2022, which is hereby incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates to an artificial heart valve, and more particularly, to an outer cover or outer skirt having a deformable seal member for an artificial heart valve.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require repairing the native valve or replacing the native valve with an artificial valve. Many repair devices (e.g., stents) and artificial valves are known, and many methods for implanting these devices and valves into the human body are also known. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations within the body that are not easily accessible surgically or to locations within the body where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a compressed state on the end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The artificial valve can then be radially expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, or by driving a mechanical actuator that applies an expanding force to the artificial valve, or by self - expanding the artificial valve from the sheath of the delivery device to its functional size.

[0004] Most expandable artificial heart valves include a cylindrical metal frame, i.e., a stent, and an artificial valve leaflet attached within the frame. Those valves can also include one or more covers (i.e., skirts) spanning the periphery of the frame on the inner or outer surface of the frame. Those covers can be configured to establish a seal against native tissue when the artificial heart valve is placed at the implantation site (and thus can be referred to as a sealing member). However, while the frame of the artificial heart valve is generally cylindrical, native tissue (e.g., native tissue at the native valve annulus or native tissue at the arterial wall surrounding the native valve) can have an irregular shape. As a result, even when a cover is provided on the artificial heart valve, a gap can be formed between the artificial heart valve and the native heart valve annulus when the artificial heart valve is implanted within the native heart valve annulus.

[0005] Accordingly, there is a need for an improved cover, i.e., an outer skirt, for an artificial heart valve that can better fill the gap between the native tissue and the artificial heart valve. SUMMARY OF THE INVENTION

[0006] What is described herein are artificial heart valves, delivery devices, and methods for implanting artificial heart valves. In particular, what is described herein are examples of covers for artificial heart valves and methods for manufacturing and using such covers. An artificial heart valve can include a frame and a valve leaflet assembly disposed on the inner surface of the frame. The artificial heart valve can include a cover (i.e., an outer skirt) disposed on the outer surface of the frame around the periphery of the frame. The outer skirt can be deformable (i.e., flexible) and can include one or more reinforcing members (i.e., seal members) configured to bulge radially outwardly and away from the frame. In some examples, one or more of the reinforcing members can extend circumferentially around the frame. The one or more reinforcing members can be configured such that the implanted artificial heart valve better conforms to the shape of the surrounding native tissue. Thus, the skirts and artificial heart valves disclosed herein can, among other things, overcome one or more drawbacks of typical artificial heart valves.

[0007] An artificial heart valve can include a frame and a valve membrane structure coupled to the frame. In addition to these components, the artificial heart valve can further include one or more components disclosed herein.

[0008] In some examples, the artificial heart valve can include a seal member configured to reduce paravalvular leakage.

[0009] An artificial heart valve can include a frame and a seal member configured to reduce paravalvular leakage. In addition to these components, the artificial heart valve can further include one or more components disclosed herein.

[0010] In some examples, the seal member is an outer skirt disposed around the outer surface of the frame.

[0011] In some examples, the outer skirt can include a seal layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and a deformable reinforcing member attached to the seal layer.

[0012] In some examples, the reinforcing member extends circumferentially along the seal layer.

[0013] In some examples, the reinforcing member can include a circumferentially extending cell row or undulating shape.

[0014] In some examples, the reinforcing member can include a shape memory material and is configured to transition between a first shape and a second shape.

[0015] In some examples, the reinforcing member can include a circumferentially extending cell row.

[0016] In some examples, an artificial heart valve includes an annular frame and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a seal layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and a deformable reinforcing member attached to the seal layer, the reinforcing member extending circumferentially along the seal layer. The reinforcing member is configured to extend radially outward from the frame such that when the frame is radially expanded from a radially compressed state to a radially expanded state, the seal layer bulges radially outward and away from the frame. The reinforcing member includes a circumferentially extending cell row or undulating shape.

[0017] In some examples, the prosthetic heart valve is an annular frame that is radially expandable and radially compressible, and an annular frame configured to transition between a radially compressed configuration and a radially expanded configuration, and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a seal layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the inflow end of the frame, and a reinforcing member coupled to the seal layer, the reinforcing member extending circumferentially along the seal layer at an axial position between the outflow edge portion and the inflow edge portion. The reinforcing member includes a shape memory material and is capable of transitioning between a first shape and a second shape. In the first shape, the reinforcing member is elongated axially and is disposed closer to the frame compared to the second shape. In the second shape, the reinforcing member is shortened axially compared to the first shape and protrudes radially outwardly and away from the frame.

[0018] In some examples, the prosthetic heart valve includes an annular frame and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a seal layer disposed around the outer surface of the frame and a deformable reinforcing member coupled to the seal layer, the reinforcing member extending circumferentially along the seal layer and including a circumferentially extending cell row.

[0019] In some examples, the prosthetic heart valve includes an annular frame and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a seal layer disposed around the outer surface of the frame and a shape memory reinforcing wire including a circumferentially extending cell row supported by the seal layer.

[0020] In some examples, an artificial heart valve includes an annular frame and an outer skirt disposed around the outer surface of the frame. The outer skirt is a seal layer disposed around the outer surface of the frame and a deformable reinforcement member coupled to the seal layer, extends circumferentially along the seal layer, and includes a plurality of axially extending members spaced apart from each other circumferentially around the outer skirt, the reinforcement member.

[0021] In some examples, the artificial heart valve includes one or more components described in Examples 1-50, Examples 57-64, and Examples 66-68 below.

[0022] The method is to radially expand an artificial valve from a radially compressed configuration to a radially expanded configuration within a natural anatomical structure, the artificial heart valve including an annular frame and an outer skirt disposed around the outer surface of the frame, the outer skirt including a seal layer fixed to the frame, and can include. The method can further include transitioning a reinforcement member embedded within a portion of the seal layer not attached to the frame from a first configuration to a second configuration, in the first configuration the reinforcement member being disposed adjacent to the frame and in the second configuration the reinforcement member extending radially outwardly and away from the frame.

[0023] In some examples, the method is to radially expand an artificial heart valve from a radially compressed configuration to a radially expanded configuration inside the natural valve annulus of the heart, the artificial heart valve including an annular frame, a plurality of valve leaflets fixed inside the frame, and an outer skirt disposed around the outer surface of the frame and including a seal layer, the seal layer being fixed to the frame at the outflow edge portion of the seal layer and at the inflow edge portion of the seal layer. The method further includes, during radial expansion, shifting a reinforcing member embedded into a portion of the seal layer not attached to the frame from a first configuration to a second configuration, in the first configuration, the reinforcing member being disposed adjacent to the frame and being longer axially compared to the second configuration, and in the second configuration, the reinforcing member extending radially outwardly and away from the frame.

[0024] The above method can be implemented on a living animal or on a non-biological simulation such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a part of the body, the heart, tissue, etc. is simulated).

[0025] In some examples, the method includes one or more features described in Examples 51 - 56 and Example 65 below.

[0026] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of various concepts that will be further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

[0028] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limited in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects related to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect, feature, or combination thereof, and the methods, apparatuses, and systems do not require the presence of any one or more specific advantages, nor do they require problems to be solved.

[0029] Although the operations in some of the disclosed examples are described in a particular sequential order for the sake of presentation, it should be understood that this manner of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be executed simultaneously. Additionally, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods may be used in conjunction with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions related to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those skilled in the art.

[0030] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupling or connecting and does not exclude the presence of intervening elements between the coupled or associated members unless a specific contrary statement is made.

[0031] As used herein, the term "proximal" refers to the position, orientation, or portion of a device that is closer to the user and spaced from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of a device that is spaced from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and towards the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and towards the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal-distal direction unless otherwise explicitly defined.

[0032] As used herein, "e.g." means "for example" and "i.e." means "that is".

[0033] Summary of the Disclosed Technology The prosthetic valve disclosed herein can be compressible in the radial direction and can be expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be placed in a radially compressed state and compressed or held by an implant delivery device, and can be advanced through the patient's vasculature on the delivery device. After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It is understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures. Examples of various delivery procedures will be described in more detail below.

[0034] FIG. 1 illustrates an exemplary prosthetic device (e.g., a prosthetic heart valve) that can be advanced through the patient's vasculature, e.g., to a native heart valve, by a delivery device such as the exemplary delivery device shown in FIG. 2. The prosthetic heart valve can include an outer cover or outer skirt disposed around the outer surface of the prosthetic heart valve frame. The outer skirt can include one or more seal members or reinforcing members that are deformable and bulge radially outward from the frame. Thus, such an outer skirt is configured to improve the sealing of the prosthetic heart valve against native tissue at the implantation site. Various examples of deformable reinforcing or seal members for the outer skirt, and methods for forming such reinforcing members, are shown in FIGS. 3-9.

[0035] Examples of the Disclosed Technology FIG. 1 shows an exemplary artificial valve 10 according to one example. Although any artificial valve disclosed herein is configured to be implanted within the native aortic valve annulus, in other examples, the artificial valve can be configured to be implanted within other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valve can also be implanted within a blood vessel in communication with the heart, such as the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed artificial valve can also be implanted within a previously implanted artificial valve (which can be an artificial surgical valve or an artificial transcatheter heart valve) in a valve-in-valve procedure.

[0036] In some examples, the disclosed artificial valve can be implanted within a docking device or anchor device that is implanted within a native heart valve or blood vessel. For example, in one example, the disclosed artificial valve can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in, for example, U.S. Patent Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed artificial valve can be implanted within a docking device implanted within or adjacent to the native mitral valve, as disclosed in, for example, PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed artificial valve can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in, for example, U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0037] The artificial valve 10 can have four main components, namely, a stent or frame 12, a valve leaflet structure 14, an inner skirt 16, and a perivalvular outer seal member or outer skirt 18. The artificial valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19.

[0038] The valve structure 14 can include a plurality of leaflets 40 that collectively form a leaflet structure, which can be configured to collapse in a tricuspid arrangement, although in other examples, more or fewer leaflets can be provided (e.g., one or more leaflets 40). The leaflets 40 can be fixed to each other at adjacent sides so as to form commissures 22 of the valve leaflet (e.g., leaflet) structure 14. The lower edge of the valve structure 14 can have a curved scalloped shape as if having undulations and can be fixed to the inner skirt 16 by a suture (not shown). In some examples, the leaflets 40 can be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from various other suitable natural or synthetic materials as known in the art and as described in U.S. Patent No. 6,730,118, which is hereby incorporated by reference herein.

[0039] Frame 12 can be formed to have a plurality of circumferentially spaced slots or commissural windows 20, and the slots or commissural windows 20 are configured to attach the commissures 22 of the valve leaflet structure 14 to the frame. Frame 12 can be formed from either a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi) such as nitinol), as is known in the art. When constructed from a plastically expandable material, frame 12 (and thus, artificial valve 10) can be compressed on the delivery catheter into a radially crimped configuration (or radially compressed configuration) and then, within the patient, can be expanded into a radially expanded configuration by an inflatable balloon or an equivalent expansion mechanism. When constructed from a self-expandable material, frame 12 (and thus, artificial valve 10) can be compressed into a radially crimped configuration by insertion into the sheath of the delivery catheter or an equivalent mechanism and can be constrained in that crimped configuration. Inside the body, the artificial valve can be advanced from the delivery sheath, thereby expanding the artificial valve to its functional size.

[0040] Suitable plastically deformable materials that can be used to form the frame 12 include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, the frame 12 can include stainless steel. In some examples, the frame 12 can include cobalt chromium. In some examples, the frame 12 can include nickel-cobalt-chromium. In some examples, the frame 12 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trademark name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 includes 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0041] Additional details regarding the artificial valve 10 and its various components are described in WIPO Patent Application Publication No. WO2018 / 222799, which is incorporated herein by reference for reference purposes.

[0042] The frame 12 can include a plurality of interconnected struts 32 that form open cells within the frame.

[0043] In some examples, as shown in FIG. 1, the upper edge portion 28 (also referred to as the outflow edge portion) of the outer skirt 18 can be fixed to the frame 12 by stitches 24, and the lower edge portion 30 (also referred to as the inflow edge portion) of the outer skirt 18 can be fixed to the frame 12 by stitches 26 extending along the inflow end portion 15 of the artificial valve 10. For example, the stitch 24 can be wound around the strut 32 of the frame 12 such that the stitch 24 forms a row of struts 32 extending circumferentially at the middle portion 17 of the artificial valve 10. Further, in some examples, the stitch 26 can be wound around the strut 32 of the frame 12 such that the stitch 26 forms a row of struts 32 extending circumferentially at the inflow end portion 15 of the artificial valve 10.

[0044] FIG. 2 shows a delivery device 100 according to an example, and this delivery device 100 can be used to implant an expandable artificial heart valve (e.g., artificial valve 10) or another type of expandable artificial medical device (e.g., a stent). In some examples, the delivery device 100 is specifically configured for use when introducing an artificial valve into the heart.

[0045] In the example illustrated in FIG. 2, the delivery device 100 is a balloon catheter, which includes a handle 102, a manipulable outer shaft 104 extending from the handle 102, an intermediate shaft extending from the handle 102 and coaxially through the manipulable outer shaft 104, an inner shaft 106 extending from the handle 102 and coaxially through the intermediate shaft and the manipulable outer shaft 104, an inflatable balloon (e.g., balloon) 108 extending from the distal end of the intermediate shaft, and a nose cone 110 disposed at the distal end of the delivery device 100. The distal end portion 112 of the delivery device 100 includes the balloon 108, the nose cone 110, and a balloon shoulder assembly. An artificial medical device such as an artificial heart valve may be attached on the valve holding portion of the balloon 108. The balloon shoulder assembly is configured to maintain an artificial heart valve or other medical device at a fixed position on the balloon 108 during delivery through a patient's vasculature. In some examples, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0046] The balloon 108 can include a central portion (which can be substantially cylindrical when inflated, as shown in FIG. 2), and two tapered end portions connected to the delivery device 100 (e.g., connected to one or more shafts of the delivery device and / or to the nose cone).

[0047] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device. In the illustrated example, for instance, the handle 102 includes an adjustment member such as the illustrated rotatable knob 134, and this adjustment member is operably coupled to the proximal end portion of a tension wire (not shown). The tension wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion fixed to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 is effective in increasing or decreasing the tension of the tension wire, whereby the curvature of the distal end portion of the delivery device is adjusted.

[0048] The delivery device 100 can be configured to be advanced through a guide wire that can be received within a guide wire lumen defined by the innermost shaft of the delivery device 100.

[0049] In some examples, the delivery device (or another similar delivery device) can be configured to deploy and implant an artificial heart valve (e.g., the artificial valve 10 of FIG. 1) within the native aortic valve annulus of the native aortic valve. Further details regarding such a delivery device can be found in International Application No. PCT / US2021 / 047056, which is incorporated herein by reference for reference purposes.

[0050] As an example, during a implantation procedure for implanting an expandable artificial heart valve (e.g., the artificial valve 10 of FIG. 1), the distal end portion of the delivery device 100 (or another similar delivery device or balloon catheter) can be advanced (through the guide wire) to the target implantation site (e.g., the native valve annulus). Thereafter, by inflating the balloon 108, the artificial heart valve can be expanded radially and implanted within the native valve annulus.

[0051] The native valve annulus and / or surrounding anatomical structures (such as the arterial wall) at the implantation site may have an irregular shape that includes recessed regions, calcified nodules, and / or alternating protrusions. However, because the artificial heart valve may have a generally cylindrical shape, when the artificial heart valve is implanted within the native valve annulus, a gap (e.g., void or channel) may be formed between the artificial heart valve and the native valve annulus. Such a gap may increase the likelihood of paravalvular leakage occurring through the artificial heart valve.

[0052] Therefore, it may be desirable to provide an outer skirt having a reinforcing member configured to extend or bulge radially outward from the frame of the artificial heart valve and into the recessed region of the native valve annulus to increase the sealing against paravalvular leakage with respect to the native valve annulus.

[0053] Figs. 3-4B illustrate an example of an outer skirt 200 (also referred to as a seal member) for an artificial device 250 (such as the artificial heart valve 10 of FIG. 1), the outer skirt 200 including a reinforcing member 202 configured to extend radially outwardly from a frame 220 of the artificial device 250 when the artificial device 250 is radially expanded (e.g., when implanted at a native valve annulus or alternative implantation site). The outer skirt 200, as well as other outer skirts disclosed herein, can be used in mechanically expandable artificial valves, balloon-expandable artificial valves (e.g., the artificial valve 10 of FIG. 1), and / or self-expandable artificial valves. Additional details regarding balloon-expandable artificial valves can be found in U.S. Patent No. 9,393,110, U.S. Provisional Application No. 63 / 178,416, filed April 22, 2021, U.S. Provisional Application No. 63 / 194,830, filed May 28, 2021, and U.S. Provisional Application No. 63 / 279,096, filed November 13, 2021, all of which are incorporated herein by reference for their disclosures. Additional details regarding mechanically expandable artificial valves can be found in International Application No. PCT / US2021 / 052745, filed September 30, 2021, which is incorporated herein by reference for its disclosure. Additional details regarding self-expanding artificial valves can be found in U.S. Patent No. 8,652,202, which is incorporated herein by reference for its disclosure.

[0054] FIG. 3 shows the outer skirt 200 in a flattened configuration, and FIGS. 4A and 4B show the outer skirt 200 in an annular configuration disposed around and fixed to the outer surface of the frame 220 of an artificial device (e.g., an artificial heart valve). In FIG. 4A, the frame 220 is in a radially compressed configuration, which may be the configuration of the artificial device when attached onto a delivery device such as that shown in FIG. 2. In FIG. 4B, the frame 220 is in a radially expanded configuration, which may be the configuration of the artificial device (e.g., the configuration of the artificial heart valve 10 shown in FIG. 1) when the artificial device is radially expanded and implanted at the implantation site within the patient. Although the frame 220 is schematically shown in FIGS. 4A-4B, the frame can have any of a variety of configurations such as the frame 12 of FIG. 1, or can have any of a variety of balloon-expandable, self-expandable, or mechanically expandable frames such as those disclosed in each of the applications referenced above. Also, the artificial device 250 can be an artificial valve that includes one or more of the components described above with respect to the artificial valve 10, including the valve leaflets 40 and the inner skirt 16. In some examples, the artificial device 250 can be the artificial valve 10 except that the outer skirt 18 is replaced by the outer skirt 200.

[0055] The outer skirt 200 can include a base material 204 (which can also be referred to as a base layer or a seal layer). The base material 204 in the outer skirt 200, and also in other skirts or covers described herein, can include various synthetic materials, including a fabric (e.g., a polyethylene terephthalate fabric (PET) fabric) or an ultra-high molecular weight polyethylene (UHMWPE) fabric, polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), a hybrid material including one or more fabrics or polymer materials (e.g., PET coated with TPU), or a natural tissue (e.g., pericardial tissue). In some examples, the base material 204 of the outer skirt 200 can include a fabric material (such as fabric PET) formed by weaving together two or more sets of fabric fibers, strands, or yarns.

[0056] The reinforcing member 202 can be formed from one or more of suture, yarn, cord, or wire (e.g., shape memory wire such as nitinol wire), and can be attached to the base material 204 (also referred to as "material") of the outer skirt 200. In other examples, the reinforcing member 202 can be a self-expanding stent or ring, such as one made of nitinol, that can be formed, for example, by laser cutting the reinforcing member from a metal tube or by other techniques known in the art for forming stents. Thus, the reinforcing member 202 can be supported by the base material 204 of the outer skirt 200. In some examples, the reinforcing member 202 can be embedded within the base material 204 of the outer skirt or woven into the base material 204 of the outer skirt. For example, when the base material 204 includes a fiber weave, the suture, yarn, cord, or wire that constitutes the reinforcing member 202 can be woven into the fiber weave that constitutes the base material 204. In alternative examples, the reinforcing member 202 can be attached to the base material 204 by one or more fastening members such as suture or by an adhesive. In such examples, the reinforcing member 202 can be secured to the inner surface of the base material 204 or to the outer surface of the base material.

[0057] The outer skirt 200 can include a first edge portion 206 and a second edge portion 208 (which can also be referred to as short edges or edge portions) located on opposite sides of each other, each of these edge portions extending between an outflow edge portion 210 (also referred to herein as the "upper edge portion") and an inflow edge portion 212 (also referred to herein as the "lower edge portion") of the outer skirt 200.

[0058] Although the first edge portion 206 and the second edge portion 208 are shown in FIG. 3 as being perpendicular to the inflow edge portion 212, in an alternative example, the first edge portion 206 and the second edge portion 208 can be non-perpendicular to the inflow edge portion 212. For example, in an alternative example, the first edge portion 206 and the second edge portion 208 can extend at an angle of about 45 degrees (or in the range of 40 degrees to 50 degrees) with respect to the inflow edge portion 212. Thus, the overall shape of the outer skirt 200 can be in the overall shape of a rhombus, a parallelogram, or a rectangle (as shown in FIG. 3).

[0059] When the outer skirt 200 is converted to its annular configuration (e.g., when attached around the frame of an artificial device as shown in FIGS. 4A and 4B), the first edge portion 206 and the second edge portion 208 can be arranged adjacent to or overlapping each other, and then can be fixed together via one or more fastening members (e.g., suture threads).

[0060] As shown in FIGS. 4A and 4B, when the outer skirt 200 is disposed around the frame 220 of the artificial device, the outflow edge portion 210 of the outer skirt 200 can be disposed closer to the outflow end 222 of the frame 220 of the artificial device compared to the inflow edge portion 212. FIGS. 3-4B illustrate an outflow edge portion 210 that is relatively straight and parallel to the inflow edge portion 212. However, in an alternative example, the outflow edge portion 210 can have an alternative shape, such as being formed with a plurality of protrusions that define a wavy shape that generally follows the shape or contour of the struts of the frame to which the outflow edge portion 210 is fixed.

[0061] The inflow edge portion 212 of the outer skirt 200 can be disposed at the inflow end 224 of the frame 220 of the artificial device (FIGS. 4A and 4B). In this way, although the outer skirt 200 can extend from the inflow end 224 of the frame 220 toward the outflow end 222 of the frame 220, it is spaced apart from the outflow end 222.

[0062] Both the outflow edge portion 210 and the inflow edge portion 212 of the outer skirt 200 can be fixed to the frame 220 (e.g., to the struts of the frame via sutures, as shown in FIG. 1) (directly), and the remaining portion of the outer skirt 200 disposed between the inflow edge portion 212 and the outflow edge portion 210 is not adhered to the frame 220 (FIGS. 4A and 4B). In some examples, the reinforcement member 202 can be attached to an intermediate portion 214 (or central portion) of the outer skirt 200 disposed between the inflow edge portion 212 and the outflow edge portion 210 (and spaced apart from the inflow edge portion 212). Thus, the reinforcement member 202 is also not attached to the frame 220 and can freely extend radially outward from the frame 220 with respect to the central longitudinal axis 226 of the frame 220.

[0063] The frame 220 is preferably configured to shorten when the frame is expanded from a radially compressed state (FIG. 4A) to a radially expanded state (FIG. 4B). Thus, when the frame is radially expanded, the outflow edge portion 210 and the inflow edge portion 212 can move closer to each other, thereby creating slack or excess material in the base material 204 between the inflow edge portion and the outflow edge portion.

[0064] In some examples, the reinforcing member 202 can be referred to as a deformable reinforcing member 202 due to its ability to change or deform from a first shape or first configuration 230 when the frame 220 is in a radially compressed configuration (shown in FIG. 4A) to a second shape or second configuration 232 when the frame 220 is in a radially expanded configuration (as shown in FIG. 4B).

[0065] In its first configuration 230 (FIG. 4A), the reinforcing member 202 can be axially elongated and can be disposed closer to the frame 220 in the radial direction (compared to when it is in the second configuration 232). For example, when the reinforcing member 202 is in its first configuration 230, the height 216 (in the axial direction) of the reinforcing member 202 can be greater compared to when it is in the second configuration 232. In some examples, the height 216 of the reinforcing member 202 can be specified such that the reinforcing member 202 is spaced apart from the outflow edge portion 210 and the inflow edge portion 212 in both the first configuration 230 and the second configuration 232.

[0066] In contrast, when the reinforcing member 202 is in the second configuration 232 (FIG. 4B), the height 216 of the reinforcing member 202 can be shorter compared to when it is in the first configuration 230. Further, in the second configuration 232, the reinforcing member 202 can project radially outwardly and away from the outer surface of the frame 220, thereby causing a slack or excess of the base material 204 along the intermediate portion 214 of the outer skirt 200 (to which or within which the reinforcing member 202 is attached) and extending or bulging radially outwardly from the frame 220 (FIG. 4B).

[0067] The ability of the reinforcing member 202 to vary across the first configuration 230 and the second configuration 232 can be due to the material of the reinforcing member 202. For example, as introduced above, the reinforcing member 202 can include a stent, a suture, a knitted structure, or a wire (or a plurality of sutures, knitted structures, and / or wires integrated together), and can include, for example, a shape memory knitted structure or wire (e.g., a knitted structure or wire made of nitinol), such that when the frame 220 is radially compressed and the outer skirt 200 elongates axially with the frame 220, it assumes the first configuration 230 (FIG. 4A), and further, when the frame 220 is radially expanded and the outer skirt 200 shortens axially with the frame 220, it can be configured to deform into the second configuration 232.

[0068] As an example, the reinforcing member 202 can be shaped to protrude or bulge radially outwardly when the frame 220 is in a radially expanded configuration (FIG. 4B). This can be referred to as the "free state" of the reinforcing member 202. The material of the reinforcing member 202 can be configured such that when the frame is radially compressed, the reinforcing member 202 can deform into the first configuration 230. As introduced above, in this deformed first configuration 230, the reinforcing member can elongate axially and press closer to the frame 220, thereby clamping or pressing the intermediate portion 214 of the outer skirt 200 against the outer surface of the frame 220. This can assist in reducing the overall compression profile of the radially compressed artificial device when it is radially compressed around a delivery device (e.g., as shown in FIG. 2).

[0069] When the frame 220 is radially expanded (e.g., when deployed by a delivery device at the implantation site), the reinforcement member 202 can return to its free state, i.e., to the second configuration 232. In some examples, the reinforcement member 202 can be adjusted to have a specific amount of radial strength and / or a specific amount of radial elongation spaced from the frame 220. In this way, the reinforcement member 202 can have a more predictable and reproducible behavior by being formed from a shape memory material and further by adjusting the behavior of the shape memory material.

[0070] In some examples, as shown in FIGS. 3 - 4B, the reinforcement member 202 can include circumferentially extending rows of cells 234 that are arranged end - to - end around the outer skirt 200. Each cell 234 can have an axial height 216 that is the height of the reinforcement member 202 and a width 218 (in the circumferential direction). The height 216 of each cell 234 can be longer in the first configuration 230 (FIG. 4A) and shorter in the second configuration 232 (FIG. 4B). Further, the width 218 of each cell 234 can be narrower in the first configuration 230 compared to the width in the second configuration 232. In the illustrated example, the cell 234 is a rhombus - shaped cell having four sides. In other examples, the cell 234 can have any of a variety of other shapes such as hexagonal, elliptical, circular, or combinations thereof.

[0071] The reinforcement member 202 can have a thickness 228. This thickness 228 can be selected such that when the frame 220 is in the radially expanded configuration (FIG. 4B), the reinforcement member 202 extends radially outward from the frame 220 of the artificial device 250 by a predetermined amount.

[0072] The reinforcing member 202 can also form a closed ring around the periphery of the outer skirt 200, as shown in FIGS. 4A and 4B. By being formed as a closed ring and from a deformable material (e.g., as described above, a metal wire or a shape memory material), the reinforcing member 202 can better conform to the natural anatomical structure (e.g., the natural valve annulus) during implantation. For example, as illustrated in FIGS. 5 and 6, when one region of the reinforcing member 202 is radially inwardly pressed by a portion of the natural anatomical structure at the natural valve annulus 300, the adjacent region of the reinforcing member 202 can be configured to bulge, i.e., extend further radially outwardly (e.g., to maintain the outer periphery of the ring formed by the reinforcing member 202). As shown in FIGS. 5 and 6, this enables the reinforcing member 202 to conform to the surrounding anatomical shape at the natural valve annulus 300 (or an alternative implantation site for an artificial device).

[0073] In FIGS. 5 and 6, the artificial device 250 is an artificial heart valve, which includes a frame 220, valve leaflets 252 attached inside the frame, and an outer skirt 200 disposed around the outer surface of the frame. Further, FIGS. 5 and 6 show a cross-section of the artificial heart valve illustrated along the intermediate portion 314 within the region of the reinforcing member 202.

[0074] Turning to FIG. 5, the artificial device 250 is implanted (radially expanded) within a native valve annulus 300 that includes an exemplary recess 302 therein. Such irregularities within the native valve annulus 300 can be caused by calcification of the native valve annulus. The portion of the native valve annulus 300 adjacent to the recess 302 can be made narrower and can press the reinforcing member 202 radially inwardly, whereby the portion or region 304 of the reinforcing member 202 that is not pressed inwardly by the native valve annulus 300 extends radially outwardly into the recess 302, whereby the outer skirt can seal the native tissue within the recess. As a result, the gap between the artificial device 250 and the native valve annulus 300 can be reduced, thereby minimizing paravalvular leakage.

[0075] As another example, as shown in FIG. 6, the native valve annulus 300 may include one or more calcific nodules 306. When one or more calcific nodules 306 press the first portion 308 (or first segment) of the reinforcing member 202 radially inwardly, the second portion 310 (or second segment) of the reinforcing member 202 disposed adjacent to the first portion 308 bulges further radially outwardly to fill the gap within the native valve annulus 300 around the calcific nodule 306.

[0076] Thus, the reinforcing member 202 provides improved sealing with respect to paravalvular leakage of the artificial device 250 against the native anatomical structure without applying unnecessary force to the calcific nodule 306.

[0077] In some examples, the reinforcing member 202 can include a plurality of circumferentially extending cell rows. In some implementations, each cell forming a row can be connectable to one or more cells in an adjacent row. In other implementations, each row of cells can be spaced apart axially (along the height of the base material 204). In this way, each row of cells can be a separate reinforcing member coupled to the base layer.

[0078] In some examples, the reinforcing member 202 can have an alternative shape (a shape other than an annular array of closed cells) that extends circumferentially along (and around) the outer skirt, for example, a zigzag shape, a plurality of straight lines extending axially, a circumferentially extending ring, a plurality of circles, an eight - shape, a triangle, or the like, such that the ends are arranged in contact with each other around the circumference of the outer skirt.

[0079] Figures 7 - 9 illustrate additional examples of reinforcing members for the outer skirt of an artificial device. The reinforcing members shown in Figures 7 - 9 can be similar to the reinforcing member 202 described above with reference to Figures 3 - 4B. Similar to the reinforcing member 202, the reinforcing members shown in Figures 7 - 9 can be attached to the base material 204 of the outer skirt by stitching, weaving, adhesion, or other means of embedding the reinforcing member 202 within the base material 204. The outer skirts 400, 500, and 600 shown in Figures 7, 8, and 9 respectively are shown in a configuration that has been removed from the frame of the artificial device and flattened. However, the outer skirts 400, 500, and 600 can be attached to the frame of the artificial device in the same manner as shown in Figures 4A and 4B with respect to the outer skirt 200.

[0080] Turning first to Figure 7, the outer skirt 400 can include one or more reinforcing members 402 (two are shown in the example of Figure 7), and each reinforcing member 402 is formed as a straight line extending horizontally (or circumferentially after being wound around the cylindrical frame of the artificial device) or as a ring along the outer skirt 400. For example, as shown in Figure 7, each reinforcing member 402 can be formed as a straight line having a thickness 404. The thickness 404 can be selected such that when the frame is in a radially expanded configuration (e.g., a configuration similar to that shown in Figure 4B), the reinforcing member 402 extends radially outward from the frame of the artificial device to which the outer skirt 400 is attached.

[0081] In some examples, as shown in FIG. 7, each reinforcing member 402 can extend from the first edge portion 206 of the outer skirt 400 to the second edge portion 208 such that when the reinforcing member 402 is in an annular configuration around the frame of the artificial device, the reinforcing member 402 forms a ring around the outer skirt 400.

[0082] In some examples, as shown in FIG. 7, the outer skirt 400 can include a plurality of (e.g., two, three, four, five, or the same number of) reinforcing members 402 that are axially spaced apart from each other. Similar to the outer skirt 200, the reinforcing members 402 can be disposed in the middle portion 214 of the outer skirt 400 and can be spaced apart from the inflow edge portion 212 and from the outflow edge portion 210.

[0083] FIG. 8 shows another exemplary outer skirt 500 that includes a reinforcing member 502 and has a undulating shape such as the illustrated zigzag pattern or a sine wave shape that extends circumferentially along the outer skirt 500. In some examples, the reinforcing member 502 can extend from the first edge portion 206 of the outer skirt 500 to the second edge portion 208 such that when it is in an annular configuration around the frame of the artificial device, it forms a (closed) ring around the outer skirt 500.

[0084] The undulating shape of the reinforcing member 502 can include a plurality of peaks 504 (i.e., outflow side vertices) and a plurality of valleys 506 (i.e., inflow side vertices) that are spaced apart from each of the outflow edge portion 210 and the inflow edge portion 212 of the outer skirt 500.

[0085] The thickness 508 of the reinforcing member 502 can be selected such that when the frame is in a radially expanded configuration (e.g., a configuration similar to that shown in FIG. 4B), the reinforcing member 502 extends radially outward from the frame of the artificial device to which the outer skirt 500 is attached.

[0086] Figure 9 shows another exemplary outer skirt 600 that includes a plurality of reinforcing members 602, which are spaced apart from each other circumferentially along the outer skirt 600 from a first edge portion 206 to a second edge portion 208 of the outer skirt 600. Each reinforcing member 602 can be formed as a vertical line, i.e., a rectangle extending axially, having a thickness 604. In an alternative example, each reinforcing member 602 can be configured as an axially extending member having an alternative shape such as an elliptical shape, a curved shape, or an S-shaped, and its longest dimension is oriented axially.

[0087] The thickness 604 of the reinforcing member 602 can be selected such that the reinforcing member 602 extends radially outward from a frame of an artificial device to which the outer skirt 500 is attached when the frame is in a radially expanded configuration (e.g., a configuration similar to that shown in FIG. 4B). Further, the spacing 606 (circumferential) between adjacent reinforcing members 602 can be selected such that the base material 204 of the outer skirt 600 at the intermediate portion 214 bulges radially outward across the periphery of the outer skirt 600 when the artificial device is in a radially expanded configuration.

[0088] The height 608 (defined axially) of each reinforcing member 602 can be selected such that the ends of each reinforcing member 602 are spaced apart from an inlet edge portion 212 and an outlet edge portion 210 of the outer skirt 610 and each reinforcing member 602 is disposed within the intermediate portion 214 of the outer skirt 600. In other examples, one or more of the reinforcing members 602 can extend across the entire height of the outer skirt from the inlet edge to the outlet edge.

[0089] Thus, by arranging one or more deformable reinforcing members circumferentially along the outer skirt, an artificial device (such as an artificial heart valve) can better conform to an irregular shape at the implantation site (such as a native valve annulus), thereby providing an improved seal against the native anatomical structure. In some examples, by being formed as a closed ring, a portion of the reinforcing member can extend radially outward into a recess within the native valve annulus when other portions of the reinforcing member are radially inwardly pressed by a protrusion within the native valve annulus. Still further, in examples where the reinforcing member is formed from a shape memory material (such as a wire), the reinforcing member of the outer skirt can be configured to be axially elongate and disposed closer to the frame of the artificial device when the artificial device is in a radially compressed configuration, and then can be configured to extend radially outward from the frame when the artificial device is in a radially expanded configuration. As a result, the outer skirt of the artificial device can increase the seal against perivalvular leakage while reducing the overall compression profile of the artificial device (such as when attached around a delivery device).

[0090] Delivery Technology To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by driving one or more actuators of the delivery device, or by deploying the artificial valve from the sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0091] To implant an artificial valve into the native mitral valve via a transseptal delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and the inferior vena cava, into the right atrium, across the atrial septum (through a puncture performed within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted into the native mitral valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0092] To implant an artificial valve inside a native tricuspid valve, the artificial valve is attached in a radially compressed state along a distal end portion of a delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside a native pulmonary valve or pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0093] Another delivery approach is the transatrial approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the atrial wall (the atrial wall of the right atrium or left atrium) to access any of the native heart valves. Atrial delivery can also be performed from inside a blood vessel, such as from a pulmonary vein, for example. Yet another delivery approach is the transventricular approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0094] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0095] Any system, device, apparatus, etc. described herein can be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for a patient, and any method described herein can include sterilizing the associated system, device, apparatus, etc. as one of the steps in the method. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be carried out, for example, using hydrogen peroxide plasma.

[0096] Treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the documents incorporated herein by reference, can be carried out on a live animal or on a non-living simulation such as a cadaver, a cadaver's heart, an anthropomorphic ghost, a simulator (e.g., where a body part, tissue, etc. is simulated), etc.

[0097] Additional Examples Relating to the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional embodiments listed below. It should be noted that one individual feature in one embodiment, or two or more features in combination in that embodiment, and optionally in combination with one or more features in one or more further embodiments, are also further embodiments that fall within the disclosure of this application.

[0098] Example 1. An artificial heart valve, comprising an annular frame and an outer skirt disposed around the outer surface of the frame, wherein the outer skirt includes a sealing layer having an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and a deformable reinforcing member attached to the sealing layer, the reinforcing member extending circumferentially along the sealing layer and configured to extend radially outward from the frame such that when the frame is radially expanded from a radially compressed state to a radially expanded state, the sealing layer bulges radially outward and away from the frame, and further includes a cell row or undulating shape extending circumferentially, the artificial heart valve comprising the reinforcing member.

[0099] Example 2. The artificial heart valve according to any embodiment described herein, particularly the artificial heart valve described in Example 1, wherein the reinforcing member includes a shape memory material.

[0100] Example 3. The artificial heart valve according to any embodiment described herein, particularly the artificial heart valve described in Example 1 or 2, wherein the reinforcing member includes a knitted structure made of nitinol or a nitinol wire.

[0101] Example 4. The artificial heart valve according to any embodiment described herein, particularly any one of Examples 1 to 3, wherein the sealing layer includes a fabric.

[0102] Example 5. The artificial heart valve according to any embodiment described herein, particularly any one of Examples 1 to 4, wherein the reinforcing member is woven into the sealing layer.

[0103] Example 6. The artificial heart valve according to any embodiment described herein, particularly any one of Examples 1 to 5, wherein the reinforcing member forms a closed ring around the periphery of the outer skirt.

[0104] Example 7. The reinforcing member is disposed at a distance from the outflow edge portion and the inflow edge portion of the seal layer, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 6.

[0105] Example 8. The reinforcing member is not attached to the outer surface of the frame and is disposed at a radial distance from the outer surface of the frame, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 7.

[0106] Example 9. The reinforcing member includes a circumferentially extending row of diamond-shaped cells arranged with ends in contact with each other around the outer skirt, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 8.

[0107] Example 10. The reinforcing member is sutured to the seal layer, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 8.

[0108] Example 11. The reinforcing member forms a zigzag pattern around the outer skirt, and the peaks and valleys of the reinforcing member are disposed at a distance from the outflow edge portion and the inflow edge portion of the seal layer, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 8.

[0109] Example 12. The inflow edge portion and the outflow edge portion of the seal layer move closer to each other when the frame is radially expanded, thereby forming a slack along the middle portion of the seal layer, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 8.

[0110] Example 13. The artificial heart valve further includes a plurality of valve tips disposed inside the frame, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 1 to 12.

[0111] Example 14. An artificial heart valve, comprising an annular frame that is radially expandable and radially compressible, the annular frame being configured to transition between a radially compressed configuration and a radially expanded configuration, and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a sealing layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the inflow end of the frame, and a reinforcing member coupled to the sealing layer, the reinforcing member extending circumferentially along the sealing layer at an axial position between the outflow edge portion and the inflow edge portion. The reinforcing member includes a shape memory material and is capable of transitioning between a first shape and a second shape. In the first shape, the reinforcing member is elongated axially and is disposed closer to the frame compared to the second shape. In the second shape, the reinforcing member is shortened axially compared to the first shape and protrudes radially outward and away from the frame.

[0112] Example 15. The artificial heart valve according to any one of the embodiments described herein, particularly the artificial heart valve described in Example 14, wherein when the frame is in the radially compressed configuration, the reinforcing member is in the first shape, and when the frame is in the radially expanded configuration, the reinforcing member is in the second shape.

[0113] Example 16. The artificial heart valve according to any one of the embodiments described herein, particularly the artificial heart valve described in Example 14 or 15, wherein the sealing layer includes a fabric and the reinforcing member is woven into the fabric.

[0114] Example 17. The artificial heart valve according to any one of the embodiments described herein, particularly any one of the embodiments described in Examples 14 to 16, wherein the reinforcing member includes nitinol.

[0115] Example 18. The first shape is a deformed configuration of the reinforcement member, and the second shape is a free configuration of the reinforcement member. An artificial heart valve described in any embodiment of this specification, particularly in any one of Embodiments 14 to 17.

[0116] Embodiment 19. The reinforcement member forms a ring around the periphery of the seal layer. An artificial heart valve described in any embodiment of this specification, particularly in any one of Embodiments 14 to 18.

[0117] Embodiment 20. The reinforcement member includes a circumferentially extending row of cells with ends in contact with each other around the outer skirt. An artificial heart valve described in any embodiment of this specification, particularly in any one of Embodiments 14 to 19.

[0118] Embodiment 21. The width of each cell is larger in the second shape compared to the first shape. An artificial heart valve described in any embodiment of this specification, particularly in Embodiment 20.

[0119] Embodiment 22. The reinforcement member includes a plurality of rings spaced apart axially from each other around the periphery of the outer skirt. An artificial heart valve described in any embodiment of this specification, particularly in any one of Embodiments 14 to 19.

[0120] Embodiment 23. The reinforcement member forms a zigzag pattern around the outer skirt, and the peaks and valleys of the reinforcement member are spaced apart from the outflow edge portion and the inflow edge portion of the outer skirt. An artificial heart valve described in any embodiment of this specification, particularly in any one of Embodiments 14 to 19.

[0121] Embodiment 24. The reinforcing member includes a plurality of axially extending members that are circumferentially spaced apart from each other around the outer skirt, and the ends of each axially extending member are spaced apart from the outflow edge portion and the inflow edge portion of the outer skirt. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 14 to 19.

[0122] Example 25. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 14 to 24, further including a plurality of valve leaflets disposed inside the frame.

[0123] Example 26. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 14 to 25, wherein the entire reinforcing member is radially spaced apart from the frame when the reinforcing member is in the second shape.

[0124] Example 27. An artificial heart valve including an annular frame and an outer skirt disposed around the outer surface of the frame. The outer skirt includes a seal layer disposed around the outer surface of the frame and a deformable reinforcing member coupled to the seal layer. The reinforcing member extends circumferentially along the seal layer and includes a row of cells extending circumferentially.

[0125] Example 28. An artificial heart valve according to any embodiment described herein, particularly Example 27, wherein the cells are in a rhombus shape.

[0126] Example 29. An artificial heart valve according to any embodiment described herein, particularly Example 27 or 28, wherein the cells are arranged with ends in contact with each other and form a closed ring around the periphery of the seal layer.

[0127] Example 30. The reinforcing member is an intermediate portion of the seal layer disposed between the outflow edge portion and the inflow edge portion of the seal layer and is spaced apart from the outflow edge portion and the inflow edge portion of the seal layer, and is disposed in an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 29.

[0128] Embodiment 31. The reinforcing member is not attached to the outer surface of the frame, and is an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 30.

[0129] Embodiment 32. The reinforcing member includes a shape memory material, and is an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 31.

[0130] Embodiment 33. The reinforcing member includes a knitted structure made of nitinol, a nitinol wire, or a nitinol stent, and is an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 32.

[0131] Embodiment 34. The seal layer includes a fabric, and is an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 33.

[0132] Embodiment 35. The reinforcing member is woven into the fabric, and is an artificial heart valve according to any embodiment described herein, particularly the one described in Embodiment 34.

[0133] Embodiment 36. When the frame is radially expanded, the reinforcing member and the part of the seal layer to which the reinforcing member is attached bulge radially outward and away from the frame, and is an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 35.

[0134] Embodiment 37. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 36, further including a plurality of valve tips disposed inside the frame.

[0135] Embodiment 38. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 37, wherein the frame includes a plurality of interconnected struts forming open cells within the frame, and the frame is configured to compress radially and expand radially between a radially compressed configuration and a radially expanded configuration.

[0136] Embodiment 39. An artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 38, wherein the seal layer includes an inflow edge portion and an outflow edge portion that are fixed to the frame by sutures.

[0137] Embodiment 40. An artificial heart valve including an annular frame and an outer skirt disposed around the outer surface of the frame, the outer skirt including a seal layer disposed around the outer surface of the frame and a shape memory reinforcing wire including a circumferentially extending cell row supported by the seal layer.

[0138] Embodiment 41. An artificial heart valve according to any embodiment described herein, particularly Embodiment 40, wherein the cells are rhombic in shape.

[0139] Embodiment 42. An artificial heart valve according to any embodiment described herein, particularly Embodiment 40 or 41, wherein the cells are arranged with ends in contact with each other and form a closed ring around the periphery of the outer skirt.

[0140] Embodiment 43. The reinforcing wire is an intermediate portion of the seal layer, which is disposed between the outflow edge portion and the inflow edge portion of the seal layer and is spaced apart from the outflow edge portion and the inflow edge portion of the seal layer, and is disposed in an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 40 to 42.

[0141] Embodiment 44. The reinforcing wire is not attached to the outer surface of the frame, and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 40 to 43.

[0142] Embodiment 45. The seal layer includes surplus material between the outflow edge portion and the inflow edge portion of the seal layer. When the frame is radially expanded, the material of the seal layer to which the reinforcing wire is attached bulges radially outward and away from the frame together with the reinforcing wire. This is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 40 to 44.

[0143] Embodiment 46. The reinforcing wire contains nitinol and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 40 to 45.

[0144] Embodiment 47. The seal layer includes a fabric and is an artificial heart valve according to any embodiment described in this specification, particularly any one of Embodiments 40 to 46.

[0145] Embodiment 48. The reinforcing wire is woven into the fabric and is an artificial heart valve according to any embodiment described in this specification, particularly Embodiment 47.

[0146] Embodiment 49. An artificial heart valve further including a plurality of valve tips disposed inside the frame, according to any embodiment described in this specification, particularly any one of Embodiments 40 to 48.

[0147] Example 50. The frame includes a plurality of interconnected struts that form open cells within the frame, and the frame is configured to compress radially and expand radially over a range between a radially compressed configuration and a radially expanded configuration, an artificial heart valve according to any embodiment herein, particularly according to any one of Embodiments 40 to 49.

[0148] Example 51. A method of radially expanding an artificial heart valve from a radially compressed configuration to a radially expanded configuration within the native valve annulus of the heart, the artificial heart valve including an annular frame, a plurality of valve leaflets fixed within the frame, and an outer skirt disposed around the outer surface of the frame and including a seal layer, the seal layer being fixed to the frame at the outflow edge portion of the seal layer and at the inflow edge portion of the seal layer, and an outer skirt, and, upon radial expansion, transitioning a reinforcement member embedded into a portion of the seal layer not attached to the frame from a first configuration to a second configuration, in the first configuration, the reinforcement member being disposed adjacent to the frame and being more elongated axially compared to the second configuration, and in the second configuration, the reinforcement member extending radially outwardly and away from the frame.

[0149] Example 52. The portion of the seal layer not attached to the frame is a central portion disposed axially between the outflow edge portion and the inflow edge portion, and further includes, upon radial expansion, bulging the central portion of the seal layer radially outwardly to conform to the shape of the native valve annulus as the reinforcement member transitions to the second configuration, a method according to any embodiment herein, particularly according to Example 51.

[0150] Example 53. When radially expanding, when the first segment of the reinforcing member and the central portion of the seal layer are compressed radially inwardly by the protruding feature of the native valve annulus, further extending the second segment of the reinforcing member and the central portion of the seal layer radially into the gap formed adjacent to the protruding feature within the native valve annulus, further included in any embodiment described herein, particularly in embodiment 52, method.

[0151] Example 54. In response to the first portion of the reinforcing member being compressed radially inwardly, further extending the adjacent second portion of the reinforcing member radially outwardly, further included in any embodiment described herein, particularly in embodiment 51 or 52, method.

[0152] Example 55. The reinforcing member includes a circumferentially extending row of diamond-shaped cells arranged with ends touching around the outer skirt, and each diamond-shaped cell is shorter axially and longer circumferentially in the second configuration compared to the first configuration, in any embodiment described herein, particularly in any one of embodiments 51 - 54, method.

[0153] Example 56. Radially expanding the artificial heart valve includes shortening the seal layer axially and expanding the seal layer radially outwardly, in any embodiment described herein, particularly in any one of embodiments 51 - 55, method.

[0154] Example 57. An artificial heart valve including an annular frame and an outer skirt disposed around the outer surface of the frame, the outer skirt being a seal layer disposed around the outer surface of the frame and a deformable reinforcing member coupled to the seal layer, extending circumferentially along the seal layer, and including a plurality of axially extending members spaced apart circumferentially around the outer skirt, the reinforcing member.

[0155] Example 58. The seal member includes an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and the end portions of each axially extending member are spaced apart from the outflow edge portion and the inflow edge portion of the seal layer. An artificial heart valve according to any embodiment described herein, particularly embodiment 57.

[0156] Example 59. The reinforcing member is an intermediate portion disposed between the outflow edge portion and the inflow edge portion of the seal layer and is coupled to the intermediate portion spaced apart from the outflow edge portion and the inflow edge portion of the seal layer. An artificial heart valve according to any embodiment described herein, particularly embodiment 57 or 58.

[0157] Example 60. The seal layer includes surplus material between the outflow edge portion and the inflow edge portion of the seal layer, and the material to which the reinforcing member of the seal layer is coupled bulges radially outward and away from the frame together with the reinforcing member when the frame is radially expanded. An artificial heart valve according to any embodiment described herein, particularly any one of embodiments 57 to 59.

[0158] Example 61. The reinforcing member includes nitinol. An artificial heart valve according to any embodiment described herein, particularly any one of embodiments 57 to 60.

[0159] Example 62. The seal layer includes a fabric. An artificial heart valve according to any embodiment described herein, particularly any one of embodiments 57 to 61.

[0160] Example 63. An artificial heart valve according to any embodiment described herein, particularly any one of embodiments 57 to 62, further including a plurality of valve leaflets disposed inside the frame.

[0161] Example 64. The frame includes a plurality of interconnected struts that form open cells within the frame, and the frame is configured to compress radially and expand radially across a radially compressed configuration and a radially expanded configuration, of any embodiment described herein, particularly any one of embodiments 57-63, an artificial heart valve.

[0162] Example 65. A method comprising sterilizing an artificial heart valve, device, and / or assembly in any embodiment.

[0163] Example 66. An artificial heart valve according to any one of embodiments 1-64, wherein the artificial heart valve is sterilized.

[0164] Example 67. The method is performed on a living animal or on a non-biological simulation such as a cadaver, a cadaver heart, an anthropomorphic ghost, or a simulator, according to any one of embodiments 51-56.

[0165] Example 68. A method for treating the heart on a simulation, the method comprising the method according to any one of embodiments 51-56.

[0166] Each feature described herein with respect to any embodiment can be combined with any other feature described in any one or more other embodiments, unless otherwise stated. For example, any one or more features regarding a certain skirt, cover, seal member, or reinforcing member can be combined with any one or more features regarding another skirt, cover, seal member, or reinforcing member. As another example, any one or more features regarding a certain artificial heart valve can be combined with any one or more features regarding another artificial heart valve.

[0167] Considering the many possible aspects to which the principles of the present disclosure may be applied, it will be appreciated that the illustrated configurations are illustrative of examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. An artificial heart valve, comprising: an annular frame; and an outer skirt disposed around the outer surface of the frame, the outer skirt comprising: a seal layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame; and a deformable reinforcing member attached to the seal layer, the reinforcing member extending circumferentially along the seal layer and configured to extend radially outward from the frame such that when the frame is expanded radially from a radially compressed state to a radially expanded state, the seal layer bulges radially outward and away from the frame, and further the reinforcing member includes a circumferentially extending row of cells or a corrugated shape, the artificial heart valve comprising the reinforcing member.

2. The artificial heart valve according to claim 1, wherein the reinforcing member includes a shape memory material.

3. The artificial heart valve according to claim 1 or 2, wherein the reinforcing member includes a knitted structure made of nitinol or nitinol wire.

4. The artificial heart valve according to any one of claims 1 to 3, wherein the seal layer includes a fabric.

5. The artificial heart valve according to any one of claims 1 to 4, wherein the reinforcing member is woven into the seal layer.

6. The artificial heart valve according to any one of claims 1 to 5, wherein the reinforcing member forms a closed ring around the periphery of the outer skirt.

7. The artificial heart valve according to any one of claims 1 to 6, wherein the reinforcing member is disposed spaced apart from the outflow edge portion and the inflow edge portion of the seal layer.

8. The artificial heart valve according to any one of claims 1 to 7, wherein the reinforcing member is not attached to the outer surface of the frame and is disposed radially spaced apart from the outer surface of the frame.

9. The artificial heart valve according to any one of claims 1 to 8, wherein the reinforcing member includes a circumferentially extending row of diamond-shaped cells having ends in contact with each other around the periphery of the outer skirt.

10. An artificial heart valve, comprising: an annular frame; and an outer skirt disposed around the outer surface of the frame, the outer skirt comprising: a seal layer disposed around the outer surface of the frame; and a shape memory reinforcing wire including a circumferentially extending row of cells supported by the seal layer, the artificial heart valve comprising the shape memory reinforcing wire.

11. The artificial heart valve according to claim 10, wherein the cell has a rhombic shape.

12. The artificial heart valve according to claim 10 or 11, wherein the cells are arranged end to end with each other and form a closed ring around the periphery of the outer skirt.

13. The artificial heart valve according to any one of claims 10 to 12, wherein the reinforcing wire is an intermediate portion of the seal layer disposed between the outflow edge portion and the inflow edge portion of the seal layer and spaced apart from the outflow edge portion and the inflow edge portion of the seal layer.

14. The artificial heart valve according to any one of claims 10 to 13, wherein the reinforcing wire is not attached to the outer surface of the frame.

15. The seal layer includes surplus material between the outflow edge portion and the inflow edge portion of the seal layer, and the material to which the reinforcing wire is attached in the seal layer bulges radially outward and away from the frame together with the reinforcing wire when the frame is radially expanded. The artificial heart valve according to any one of claims 10 to 14.

16. A method comprising: radially expanding an artificial heart valve from a radially compressed configuration to a radially expanded configuration inside the natural valve annulus of the heart, the artificial heart valve comprising an annular frame, a plurality of valve tips fixed inside the frame, and an outer skirt disposed around the outer surface of the frame, the outer skirt including a seal layer, the seal layer being fixed to the frame at the outflow edge portion of the seal layer and at the inflow edge portion of the seal layer; expanding; during the radial expansion, transitioning a reinforcing member embedded in a portion of the seal layer not attached to the frame from a first configuration to a second configuration, in the first configuration, the reinforcing member being disposed adjacent to the frame and being more elongated axially compared to the second configuration, and in the second configuration, the reinforcing member extending radially outward and away from the frame; transitioning.

17. The portion of the seal layer that is not attached to the frame is a central portion disposed axially between the outflow edge portion and the inflow edge portion. When expanding in the radial direction, as the reinforcing member transitions to the second configuration, further includes bulging the central portion of the seal layer radially outward so as to conform to the shape of the natural valve ring. The method according to claim 16.

18. Further includes extending a second adjacent portion of the reinforcing member further radially outward in response to the first portion of the reinforcing member being compressed radially inward. The method according to claim 16 or claim 17.

19. The reinforcing member includes a circumferentially extending row of diamond-shaped cells disposed end-to-end around the outer skirt. Each diamond-shaped cell is shorter in the axial direction and longer in the circumferential direction in the second configuration compared to the first configuration. The method according to any one of claims 16 to 18.

20. Expanding the artificial heart valve radially includes shortening the seal layer in the axial direction and expanding the seal layer radially outward. The method according to any one of claims 16 to 19.

Images