Compact prosthetic heart valve device

Abstract

The devices and methods of the present disclosure relate to heart valve prostheses configured to be implanted within a native heart valve having a generally oval shape with a smaller circumference.

Description

Technical Field

[0001] This technology relates in general to prosthetic heart valve devices, and more specifically, to prosthetic heart valve devices for percutaneous repair and / or replacement of natural mitral valves. Background Technology

[0002] The human heart is a four-chambered muscular organ that circulates blood throughout the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle, which supply circulation to the lungs, and the left atrium and left ventricle, which supply oxygenated blood received from the lungs to the systemic circulation. To ensure blood flows through the heart in one direction, atrioventricular valves (tricuspid and mitral valves) are located between the atria and ventricles, and semilunar valves (pulmonary and aortic valves) control the exits of the ventricles to the lungs and the rest of the body. These valves contain leaflets or tips that open and close in response to changes in blood pressure caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart to open and allow blood to flow downstream of the valve, and close upstream to close and prevent backflow.

[0003] Heart valve-related diseases (such as those caused by damage or defects) can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to narrow and harden, which can prevent blood flow to the downstream chambers of the heart from occurring at the proper rate and can make it harder for the heart to work to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backward, resulting in reduced cardiac efficiency. Diseased or damaged valves, which can be congenital, age-related, drug-induced, or in some cases caused by infection, can lead to an enlarged, thickened heart that loses its elasticity and efficiency. Some symptoms of heart valve disease can include weakness, shortness of breath, dizziness, fatigue, palpitations, anemia, and edema, as well as blood clots that can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to debilitate and / or endanger life.

[0004] Heart valve prostheses have been developed for the repair and replacement of diseased and / or damaged heart valves. These prostheses can be delivered via the skin and deployed at the site of the diseased heart valve using a catheter-based delivery system. They can also be delivered in a radially compressed configuration, allowing the prosthesis to advance through the patient's vascular system. Once positioned at the treatment site, the prosthesis can be inflated to engage with tissue in the region of the diseased heart valve, for example, to hold the prosthesis in place.

[0005] While these valve prostheses offer a minimally invasive approach to heart valve repair and / or replacement, providing heart valve prostheses to patients with smaller natural heart valves than the general population remains challenging, for example, due to the smaller size of adults or because they are children or adolescents. Among adult patients who could benefit from mitral valve prostheses for treating mitral regurgitation, up to 7% may be screened out due to natural mitral valves with annular circumferences between 89 mm and 101 mm (currently considered too small for known mitral valve prostheses), the sizes of which are designed for implantation in natural mitral valves with annular circumferences between 101 mm and 119 mm. These smaller annular valves tend to be more elliptical in shape compared to those with larger annular circumferences, making currently known mitral valve prostheses unsuitable for implantation in smaller annular circumferences because they are too large in the anteroposterior direction.

[0006] Therefore, there is a need for a mitral valve prosthesis that can be delivered through the skin and deployed at the site of the diseased mitral valve in a patient with a natural mitral valve that is too small to accept known mitral valve prostheses. Summary of the Invention

[0007] The apparatus and method disclosed herein generally relate to a heart valve prosthesis configured for implantation within a natural heart valve having a generally elliptical annulus with a small circumference.

[0008] In one aspect, this disclosure provides a heart valve prosthesis including a valve support having an upstream segment and a downstream segment relative to blood flow through a natural heart valve in a human heart. The upstream segment of the valve support is configured to support a prosthetic valve component and defines an inflow end of the valve support having a first outer diameter. The downstream segment of the valve support defines an outflow end of the valve support having a second outer diameter greater than the first outer diameter. The heart valve prosthesis also includes an anchoring element surrounding the valve support. A plurality of connectors form a downstream portion of the anchoring element, the connectors being angled inward toward the valve support to attach to the outflow end of the valve support. The anchoring element is spaced apart from the upstream segment of the valve support to mechanically isolate the upstream segment of the valve support from the anchoring element.

[0009] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a first outer diameter of an upstream segment of a valve support that is constant from a first end to a second end of the upstream segment, the first end defining an inflow end of the valve support.

[0010] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a downstream end of an upstream segment of a valve support adjacent to an upstream end of a downstream segment of the valve support, such that the upstream end of the downstream segment has a first outer diameter and a longitudinally opposing downstream end of the downstream segment has a second outer diameter greater than the first outer diameter, the longitudinally opposing downstream end defining an outflow end of the valve support.

[0011] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a downstream section of a valve support extending outward from a first end to a second end, wherein the first end of the downstream section has a first outer diameter and the second end of the downstream section has a second outer diameter greater than the first outer diameter, the second end defining an outflow end of the valve support.

[0012] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having an upstream segment of a valve support that tapers from a first end of the upstream segment having a first outer diameter to a second end of the upstream segment, the first end defining an inflow end of the valve support, and the second end having a second outer diameter smaller than the first outer diameter.

[0013] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having an upstream segment of a valve support that tapers inward from its upstream end to its downstream end, such that a downstream end of the upstream segment of the valve support having a first outer diameter is adjacent to an upstream end of the downstream segment of the valve support having a first outer diameter. The downstream segment expands outward from the upstream end to its downstream end, wherein the downstream end of the downstream segment has a second outer diameter greater than the first outer diameter, the downstream end defining an outflow end of the valve support.

[0014] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having a tissue fixation ring forming an upstream portion of an anchoring element, the tissue fixation ring being configured to engage heart tissue at or below the natural annulus of a natural heart valve.

[0015] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having an anchoring element having a tissue fixation ring radially spaced S from an upstream segment of a valve support in the undeployed state. The tissue fixation ring is configured to deform, at least partially, into a non-circular shape in the deployed state to accommodate the shape of the implantation site, such that the tissue fixation ring does not contact the upstream segment of the valve support, thereby mechanically isolating the upstream segment of the valve support from the anchoring element during implantation in vivo.

[0016] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a plurality of connectors for an anchoring element, the plurality of connectors being angled inward from a tissue fixation ring of the anchoring element.

[0017] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having a plurality of connectors to an anchoring element angled inward from a tissue fixation ring of the anchoring element, the plurality of connectors being configured to flex upward after implantation to accommodate any radial expansion of the tissue fixation ring caused by an increase in the size of the implantation site (such as the natural valve annulus) that may occur after deployment.

[0018] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having an anchoring element having a tissue fixation ring including one or more wedges extending outwardly from the tissue fixation ring to engage cardiac tissue upon implantation.

[0019] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a prosthetic valve component disposed within an upstream segment of a valve support such that the leaflets of the prosthetic valve component open into a downstream segment of the valve support during diastole.

[0020] In another aspect that may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a prosthetic valve component disposed within an upstream segment of a valve support, such that the leaflets of the prosthetic valve component achieve a position greater than about 1.6 cm during diastole. 2 The open state of the effective orifice area.

[0021] In another aspect which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a frame having a valve support formed by a scaffold-like structure having one of a honeycomb unit and a closed rhomboid unit.

[0022] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having a frame having anchoring elements formed by a scaffold-like structure having rhomboid units.

[0023] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having an outflow end of a valve support member attached to a plurality of connectors of an anchoring element via a plurality of rivets.

[0024] In another aspect which may be combined with any other aspect noted herein, this disclosure provides a heart valve prosthesis having an anchoring element provided with a plurality of connectors, wherein each of these connectors has an inwardly curved, substantially V-shaped shape.

[0025] In another aspect, which may be combined with any other aspect pointed out herein, this disclosure provides a heart valve prosthesis having a first outer diameter and a second outer diameter. In one embodiment, the first outer diameter at the outflow end of the heart valve prosthesis is about 30 mm, and the second outer diameter at the upstream end of the anchoring element is about 36 mm, such that the heart valve prosthesis is sized for implantation in a patient with a smaller natural valve annulus.

[0026] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0027] The foregoing and other features and advantages of the present invention will become apparent from the following description of embodiments as illustrated in the accompanying drawings. The drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable those skilled in the art to make and use the invention. The drawings are not drawn to scale.

[0028] Figure 1 A schematic cross-sectional view of a heart with natural valve structures is depicted.

[0029] Figure 2 A schematic cross-sectional view of the left ventricle of the heart is depicted, showing the anatomy and the natural mitral valve.

[0030] Figure 2AA schematic diagram of the natural mitral valve of the heart is depicted, showing the normal closure of the natural mitral valve leaflets.

[0031] Figure 3 A perspective view of a heart valve prosthesis according to one aspect of this disclosure is depicted.

[0032] Figure 3A It depicts the section intercepted along its line AA. Figure 3 A cross-sectional view of a heart valve prosthesis.

[0033] Figure 3B A prosthetic valve component having a fixed therein is depicted according to one aspect of this disclosure. Figure 3 A perspective view of the valve support component of a heart valve prosthesis.

[0034] Figure 3C One aspect of this disclosure is described Figure 3 A view of the atrium of a prosthetic heart valve.

[0035] Figure 3D One aspect of this disclosure is described Figure 3 A ventricular view of a prosthetic heart valve shown.

[0036] Figure 4 A side view of the frame of a heart valve prosthesis in an undeployed state, according to one aspect of this disclosure, is depicted.

[0037] Figure 4A The image depicts an unfolded state according to one aspect of this disclosure. Figure 4 The side view of the frame.

[0038] Figure 4B The image depicts an unfolded state according to one aspect of this disclosure. Figure 4A A cross-sectional view of a portion of the frame.

[0039] Figure 5 A side view of a frame of a heart valve prosthesis according to one aspect of this disclosure is shown. Detailed Implementation

[0040] Specific embodiments of the invention will now be described with reference to the accompanying drawings, wherein similar reference numerals indicate identical or functionally similar elements. When used in the following description to refer to natural blood vessels, natural valves, or devices to be implanted into natural blood vessels or natural valves, such as prosthetic heart valves, the terms "distal" and "proximal" are relative to the direction of blood flow. Thus, "distal" and "distal" refer to a position in the downstream direction relative to the direction of blood flow, and the terms "proximal" and "proximal" refer to a position in the upstream direction relative to the direction of blood flow.

[0041] The following detailed description is merely exemplary in nature and is not intended to limit the invention or its application and uses. While the embodiments described herein are in the context of treating heart valves (such as pulmonary valves, aortic valves, mitral valves, or tricuspid valves), the invention can also be used for any other bodily pathways that are considered useful. Furthermore, one is not intended to be bound by any express or implied theory presented in the foregoing technical field, background art, summary of the invention, or the following detailed description.

[0042] The prosthetic heart valve device and method described herein provide a heart valve replacement device sized to fit within a natural mitral valve that has been screened as too small and potentially too elliptical in shape to accommodate known mitral valve prostheses. According to embodiments of the invention, the prosthetic heart valve device can be configured for implantation within a natural mitral valve having a diameter between approximately 89 mm and approximately 101 mm. The prosthetic heart valve device described herein possesses the necessary flexibility to adapt to and conform to such natural mitral valve anatomy while mechanically isolating the prosthetic heart valve from the device's anchoring portion, particularly addressing the problem of oversized dimensions that may occur in the anteroposterior direction of a smaller, elliptical natural mitral valve. The prosthetic heart valve device described herein effectively absorbs torsional forces exerted by the natural anatomy with sufficient structural strength and integrity to withstand the dynamic conditions of the heart over time. The prosthetic heart valve device described herein is also configured for delivery in a less invasive transcatheter procedure.

[0043] Figure 1 It is a schematic cross-sectional view of the heart H depicting the four cardiac chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and the natural valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV). Figure 2 A schematic cross-sectional view of the left ventricle (LV) of the heart, showing the anatomical structure and natural mitral valve (MV). (Common Reference) Figure 1 and Figure 2 The heart (H) includes the left atrium (LA), which receives oxygenated blood from the lungs via pulmonary veins. During ventricular diastole, the left atrium (LA) pumps oxygenated blood through the mitral valve (MV) and into the left ventricle (LV). During cardiac systole, the left ventricle (LV) contracts, and blood flows out through the aortic valve (AV), into the aorta, and to the rest of the body.

[0044] In a healthy heart, the leaflets of the mitral valve (MV) converge or "tighten" at their free edges to close during left ventricular (LV) systole and prevent backflow of blood. (Reference) Figure 2The mitral valve leaflets (LF) are attached to surrounding cardiac structures via a dense fibrous ring of connective tissue called the annulus (AN), which is distinct from both the leaflet tissue (LF) and the adjacent muscular tissue of the heart wall. Generally, the connective tissue at the annulus (AN) is more fibrous, tougher, and stronger than the leaflet tissue. The flexible leaflet tissue of the mitral valve leaflets (LF) is connected to the papillary muscles (PM) via branching tendons called chordae tendineae (CT), which extend upwards from the inferior wall of the left ventricle (LV) and the interventricular septum (IVS). In a heart (H) with a mitral valve (MV) in which the leaflets (LF) are not adequately closed or confluent, leakage will occur from the left ventricle (LV) to the left atrium (LA). Several structural defects can cause mitral valve leaflet (LF) prolapse in this manner, followed by backflow, including CT rupture, PM damage (e.g., due to ischemic heart disease), and enlargement of the heart and / or the mitral valve annulus (AN) (e.g., cardiomyopathy).

[0045] Figure 2A The shape and relative size of the mitral valve leaflets (LF) are also shown, and it can be seen that the overall valve has a roughly "D" or kidney-shaped shape, with a long axis (LA) and a short axis (SA). The cleavage line (C) of the leaflets (LF) is curved or C-shaped, thus defining the relatively larger anterior leaflet (AL) and the significantly smaller posterior leaflet (PL). The two leaflets appear roughly crescent-shaped when viewed from the superior or atrial side, with the anterior leaflet (AL) significantly wider than the posterior leaflet in the middle of the valve. Figure 2A As shown, the valvular leaflets LF join together at opposite ends of the suture line C at the corners called the anterolateral commissure AC and the posteromedial commissure PC.

[0046] For healthy adults, refer to Figure 2A The long-axis LA and short-axis SA are shown. The long-axis LA typically ranges from about 33.6 ± 6.0 mm to about 42.2 ± 2.6 mm, with a standard deviation of 2.6 mm to 6.0 mm, and the short-axis SA typically ranges from about 23.8 ± 4.0 mm to about 33.7 ± 3.5 mm, with a standard deviation of 2.2 mm to 4.0 mm. However, in adult patients with diseased mitral valve function, these values ​​can be larger; for example, LA can range from about 38.5 ± 3.2 mm to about 52.7 ± 3.9 mm, with a standard deviation of 2.9 mm to 6.0 mm, and SA can range from about 26.7 ± 2.8 mm to about 37.2 ± 0.4 mm, with a standard deviation of 0.4 mm to 6.4 mm. For patients with a diseased, smaller natural mitral valve who are to be treated with the prosthetic heart valve device described herein, these values ​​may be, for example, LA in the range of about 30 mm to 34 mm and SA in the range of about 24 mm to about 32 mm.

[0047] A perspective view of a heart valve prosthesis 100 according to one aspect of this disclosure. Figure 3 As shown in the figure, and along Figure 3 A cross-sectional view of a 100mm heart valve prosthesis taken from line AA. Figure 3A As shown in the figure. The heart valve prosthesis 100 is configured to be compressed into a delivery configuration with a reduced diameter (not shown) and return to an expanded deployment configuration, as... Figure 3A As shown. According to an embodiment of the invention, when in delivery configuration, the heart valve prosthesis 100 has a low profile suitable for delivery to and deployment within the natural mitral valve via a suitable delivery catheter that can be traced to the deployment site of the natural mitral valve of the heart via any of a transseptal approach, a retrograde approach, or a transapical approach.

[0048] In one aspect of this disclosure, a heart valve prosthesis 100 includes a valve support 102 at least partially surrounded by an anchoring element 104. The valve support 102 is a hollow, support-like structure defining a lumen 109 from an inflow end 101 to an outflow end 103 of the valve support 102. In another aspect of this disclosure, the valve support 102 has a first or upstream segment 102A and a second or downstream segment 102B, wherein “upstream” and “downstream” refer to the intended deployment location of the respective segments within the natural mitral valve of the heart relative to the blood flow passing through it.

[0049] The upstream segment 102A of the valve support 102 is configured to support the prosthetic valve component 108 therein, as will be described in more detail below. The upstream segment 102A can be described as having a substantially cylindrical shape, wherein a first or upstream end portion 301 of the upstream segment 102A defines an inflow end portion 101 of the valve support 102. A second or downstream end portion 311 of the upstream segment 102A of the valve support 102 extends co-existingly with the first or upstream end portion 311 of the downstream segment 102B of the valve support 102, and a second or downstream end portion 303 of the downstream segment 102B defines an outflow end portion 103 of the valve support 102.

[0050] In one aspect of this disclosure, the first end 301 of the inflow end 101 of the defining valve support 102 of the upstream segment 102A has an outer diameter D1, and the second end 303 of the outflow end 103 of the defining valve support 102 of the downstream segment 102B has an outer diameter D2 that is greater than the outer diameter D1. In various aspects of this disclosure, the second end 311 of the upstream segment 102A and the common first end 311 of the downstream segment 102B have an outer diameter D3 that may be equal to or less than the outer diameter D1.

[0051] In an embodiment of the valve support 102 in which outer diameters D1 and D3 are equal to each other, the outer diameter D1 of the upstream segment 102A can be described as constant along its entire length from the first end 301 to its second end 311. In such an embodiment, the outer diameter D3 of the downstream segment 102B extending from its first end 311 is also equal to the outer diameter D1, such that the downstream segment 102B expands outward from its outer diameter D1 at its first end 311 to its outer diameter D2 at its second end 303, wherein, as described above, the outer diameter D2 is greater than the outer diameter D1. In one aspect of this disclosure, the upstream segment 102A, having a constant outer diameter D1 along its entire length, can be described as having a hollow, substantially cylindrical form, and the downstream segment 102B, expanding radially outward from its first end 311 with outer diameter D1 to its second end with outer diameter D2, can be described as having a hollow, substantially truncated conical form. On the other hand, the upstream section 102A, which has a constant outer diameter D1 along its entire length, can be described as having a hollow, substantially cylindrical form, and the downstream section 102B, which expands radially outward from the first end 311 with an outer diameter D1 to the second end with an outer diameter D2, can be described as having a hollow, substantially trumpet-shaped form.

[0052] In an embodiment where the outer diameter D3 of the valve support 102 is smaller than the outer diameter D1, the upstream segment 102A gradually tapers along its length from a first end 301 having an outer diameter D1 to a second end 311 having an outer diameter D3. In one aspect of this disclosure, the valve support 102 with a tapering inflow distribution can improve hemodynamics because the tapering inflow distribution can promote transvalvular blood flow and reduce the likelihood of paravalvular leakage. In the aforementioned embodiment, the common first end 311 of the downstream segment 102B also has an outer diameter D3 smaller than the outer diameter D1, such that the downstream segment 102B expands radially outward from its first end 311 at the outer diameter D3 to its second end 303 at the outer diameter D2, wherein the outer diameter D2 is larger than each of the outer diameters D1 and D3.

[0053] In one aspect of this disclosure, the anchoring element 104 of the heart valve prosthesis 100 is configured to mechanically isolate the upstream segment 102A of the valve support 102 from the anchoring element 104 when the heart valve prosthesis 100 is deployed within a small, generally elliptical, natural mitral valve annulus. In another aspect of this disclosure, the anchoring element 104 is a hollow, support-like structure including a tissue fixation ring 112 and a plurality of connectors 106. The tissue fixation ring 112 is a generally cylindrical structure configured to engage cardiac tissue at or below the annulus of a natural heart valve (such as the annulus of a natural mitral valve). The tissue fixation ring 112 may be configured to engage subvalve annular tissue, such as the inward-facing surface of a valve leaflet, as... Figure 4AAs shown. The tissue fixation ring 112 serves as an anchor for the heart valve prosthesis 100 to secure it in its deployed position within the natural valve annulus. In one aspect of this disclosure, the tissue fixation ring 112 includes one or more wedges or pins 114 extending outward from the outside of the tissue fixation ring 113 to engage cardiac tissue. In another aspect of this disclosure, the tissue fixation ring 113 may employ barbs, spikes, or other tissue fixation mechanisms for engaging heated tissue.

[0054] In one aspect of this disclosure, in the undeployed state, the tissue fixation ring 112 is radially spaced apart from the upstream segment 102A of the valve support 102 by a distance S, such as... Figure 3 and Figure 3A As shown, and in the deployed state, it can at least partially deform into a non-circular shape to adapt to the shape of the implantation site, such as deforming into a substantially elliptical shape when deployed within a smaller natural mitral valve annulus. In one aspect of this disclosure, the dimensions of the tissue fixation ring 112 and the upstream segment 102A of the annulus support 102 are set relative to each other to provide a distance S between them, so as to be configured to prevent contact between them when the heart valve prosthesis is deployed, and thereby mechanically isolating the upstream segment 102A of the valve support 102 from the anchoring element 104.

[0055] refer to Figure 3 , Figure 3A and Figure 4 A plurality of connectors 106 are radially angled inward from the downstream end 105 of the tissue fixation ring 112 to attach to the outflow end 103 of the valve support 102. In one aspect of this disclosure, the outflow end 103 of the valve support 102 may be attached to the downstream end 115 of the plurality of connectors 106 by a plurality of rivets 120. In other aspects of this disclosure, the plurality of connectors 106 of the valve support 102 and the fixation ring 112 may be coupled to each other by any of a variety of methods known in the art, by way of example and not limitation, including suturing, soldering, welding, nailing or other fasteners, mechanical interlocking, snap-fit, friction fit or interference fit, or any combination thereof.

[0056] Each connector in the connectors 106 of the fixation ring 112 can be described as having an inwardly curved, generally V-shaped shape, wherein the downstream ends 115 of the plurality of connectors 106 are the respective apexes of the V-shape. In one aspect of this disclosure, the plurality of connectors 106 may be formed by inwardly bending or flexing the downstream portion or downstream half of the last row of units of the support-like structure of the anchoring element 104. In one aspect of this disclosure, the plurality of connectors 106 may extend radially inward and downward from a respective upstream end coexisting with the downstream end 105 of the tissue fixation ring to their respective downstream end 115, and are configured to allow the plurality of connectors 106 to flex upward after implantation to accommodate any radial expansion of the tissue fixation ring 112, which may occur after unfolding due to an increase in the size of the natural valve annulus, such an increase may occur, for example, due to tissue remodeling after valve replacement, natural growth up to adulthood, and / or potential disease progression.

[0057] Figure 4 A frame 430 of a heart valve prosthesis 100 according to an embodiment of the present invention is depicted, the frame 430 including a valve support 102 and an anchoring element 104. Figure 4 In one embodiment, the valve support 102 of the frame 430 is formed of a support-like structure with honeycomb units, and the anchoring element 104 of the frame 430 is formed of a support-like structure with closed rhomboid units. Figure 5 In another embodiment shown, each of the valve support 502 and the anchoring element 104 of the frame 530 is formed by a scaffold-like structure having closed rhomboid units.

[0058] refer to Figure 4 In one aspect of this disclosure, the outer diameter OD1 of the outflow end 432 of the frame 430 is a measurement of the distance between the outer sides of the downstream ends 115A, 115B of the corresponding connectors 106 on opposite sides of the anchoring element 104. (See reference...) Figure 4 In another aspect of this disclosure, the outer diameter OD2 of the upstream end 107 of the anchoring element 104 is a measurement of the distance between the outer sides of the upstream ends 107 on opposite sides of the anchoring element 104, and is the widest point of the anchoring element 104. According to one embodiment of the invention, the heart valve prosthesis 100, having a frame 430 with an outer diameter OD1 of approximately 30 + / - 0.5 mm and an outer diameter OD2 of approximately 36 + / - 0.5 mm, is sized for implantation in a patient with a smaller natural mitral valve annulus.

[0059] Additionally, refer to Figure 4 , Figure 4A and Figure 4BAccording to an embodiment of the invention, the frame 430 for a compact transcatheter heart valve prosthesis has a shorter overall height H1 and a reduced cone height H2 than conventional heart valve prostheses, which reduces the protrusion of the compact transcatheter heart valve prosthesis into the left ventricle below the valvular plane of the natural mitral valve. According to an embodiment of the invention, the heart valve prosthesis 100 having the frame 430 is sized for implantation in a patient with a smaller natural mitral valve annulus, thereby reducing or preventing left ventricular outflow tract (LVOT) obstruction; this frame has a shorter overall height H1 of approximately 16.2 mm + / - 0.5 mm and a reduced cone height H2 of approximately 5.4 mm + / - 0.5 mm. In one aspect of this disclosure, despite this lower profile, the compact transcatheter heart valve prosthesis exhibits equivalent or, in some cases, improved hemodynamic performance compared to its larger and taller counterparts. To demonstrate the benefits of the shortened overall height H1 and reduced cone height H2, as well as other features, Figure 4A The image depicts an expanded state located within the annulus AN of the natural mitral valve MV, according to one aspect of this disclosure. Figure 4 The side view of frame 430, and Figure 4B The image depicts an unfolded state according to one aspect of this disclosure. Figure 4A A cross-sectional view of a portion of frame 430. For ease of illustration, Figure 4A Only the frame 430 deployed within the mitral valve MV is shown, and those skilled in the art will readily recognize how this illustration applies to the reference. Figure 3 and Figures 3A to 3D The deployment state of the compact heart valve prosthesis 100 shown and described.

[0060] The cone height H2 of frame 430 refers to the measurement between the downstream end 105 of tissue fixation ring 112 and the outflow end 432 of frame 430. The cone height H2 encompasses multiple connectors 106 of anchoring element 104. In one aspect of this disclosure, the cone height H2 is relatively short, and the remainder of frame 430 is located at or near the valvular plane of the annulus AN, wherein the fully deployed compact cardiac valve prosthesis 100 is displaced upward toward the left atrium LA, thereby reducing or preventing left ventricular outflow tract (LVOT) obstruction. In one aspect of this disclosure, the reduced cone height H2 of frame 430 also minimizes contact and / or interaction with chordae tendineae CT and papillary muscles, and provides advantages in patients with small left ventricles who may be excluded from receiving mitral valve prostheses due to their small annulus or excessive LVOT obstruction.

[0061] As described above and referenced Figure 4 and Figure 4BIn one aspect of this disclosure, the tissue fixation ring 112 of the frame 430, in its undeployed state, is radially spaced by a distance S from the upstream segment 102A of the valve support 102, and is capable of at least partially deforming into a non-circular shape to accommodate the shape of the natural mitral valve annulus in its deployed state. Although the distance S decreases once deformed when the frame 430 is deployed within the natural mitral valve annulus, the tissue fixation ring 112 does not contact the upstream segment 102A of the valve support 102, as... Figure 4B As shown, mechanical isolation between the upstream segment 102A of the valve support 102 and the anchoring element 104 is maintained when the compact heart valve prosthesis 100 is implanted in the body.

[0062] Continue to refer to Figure 3 and Figure 3A According to various aspects of this disclosure, the prosthetic heart valve 100 includes a rim or edge element 110 extending outward from the upstream end 107 of the anchoring element 104. The edge element 110 comprises an overlapping, 180-degree out-of-phase sinusoidal form that is attached to and hinged to the anchoring element 104 via a suitable biocompatible low-profile fabric 119 (such as woven polyethylene terephthalate (PET) fabric) used in bioprosthetic implants, i.e., intravascular grafts, heart valves, or left atrial appendages, to facilitate biointegration. The edge element 110 may act as an atrial retainer (if present), and to achieve this function, the edge element 110 may be configured to engage tissue above the natural valve annulus AN, such as the upper surface of the annulus or some other tissue in the left atrium, thereby inhibiting, for example, downstream migration of the prosthetic heart valve 100 during atrial contraction.

[0063] The heart valve prosthesis 100 according to various aspects of this disclosure includes a prosthetic valve component 108, as previously described above. Figure 3B A perspective view of a valve support 102 having a prosthetic valve component 108 fixed therein is depicted for ease of explanation. Figure 3B The valve support 102 shown in the figure is from Figure 3 The remainder of the heart valve prosthesis 100 shown is removed. Figure 3C Depicting Figure 3 The atrial view of the heart valve prosthesis 100 shown, and Figure 3D Depicting Figure 3The diagram shows a ventricular view of a prosthetic heart valve 100. The prosthetic valve component 108 includes valve leaflets 117, such as three leaflets 117, arranged to clasp within a narrow upstream segment 102A of a valve support 102, wherein commissures 117A, 117B, and 117C of the valve leaflets 117 are secured within a wider downstream segment 102B of the valve support 102, such that the leaflets 117 open into the wider downstream segment 102B of the valve support 102 during diastole. In one aspect of this disclosure, the leaflet commissures 117A, 117B, and 117C arranged within the wider downstream segment 102B provide a larger effective orifice area (EOA) for the prosthetic valve component 108 by allowing the valve leaflets 117 to open further without interacting with the valve support 102. In one aspect of this disclosure, in the open state during diastole, the prosthetic valve component 108 may have a diameter greater than approximately 1.6 cm. 2 The effective orifice area.

[0064] Valve leaflet 117 can be formed from a variety of flexible materials, including but not limited to natural pericardial materials (such as tissues derived from cattle, horses, or pigs) or synthetic materials (such as polytetrafluoroethylene (PTFE)). Polyester, pyrolytic carbon, or other biocompatible materials. For some prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is also desirable that the prosthetic leaflet material is durable and resistant to stretching, deformation, or fatigue.

[0065] In one aspect of this disclosure, Figure 5 A prosthetic valve component 108 is depicted fixed within a valve support 502 of a frame 530. The valve component 108 includes valve leaflets 117 configured to close within a narrow upstream segment 502A of the valve support 502, and commissures 117A, 117B, 117C of the valve leaflets 117 are fixed within a wider downstream segment 502B of the valve support 502, such that the valve leaflets 117 open to the wider downstream segment 502B of the valve support 502 during diastole.

[0066] In one aspect of this disclosure, the valve support 102 and the tissue fixation ring 112 may be fully lined with a low-profile fabric 119 designed to provide a seal, such as fabrics used in bioprosthetic implants (i.e., intravascular grafts, heart valves, or atrial appendages) to facilitate biointegration, such as woven polyethylene terephthalate (PET) fabric. In one aspect of this disclosure, a woven textile that will serve as a platform for subsequent tissue inward growth may be employed. In one aspect of this disclosure, the low-profile fabric 119 for attachment to the valve support 102 and the tissue fixation ring 104 may be two separate fabric sheets or fabric types to reduce leakage and manufacturing time.

[0067] The components described herein as the frame, valve support, tissue fixation ring, multiple connectors, etc., of the heart valve prosthesis 100 can be made of any number of suitable biocompatible materials, such as stainless steel, nickel-titanium alloys such as Nitinol. TM Cobalt-chromium alloys such as MP35N, and other alloys such as (Elgin, Ill.), various polymers, pyrolytic carbon, silicone resins, polytetrafluoroethylene (PTFE), or any number of other materials or combinations thereof. Suitable biocompatible materials will be selected to provide the heart valve prosthesis 100, which is configured to compress into a delivery configuration with a reduced diameter for transcatheter delivery to the natural valve, whereby release from the delivery catheter allows the prosthesis to return to an expanded configuration.

[0068] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, and may be completely added, combined, or omitted (e.g., performing the described technique may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

Claims

1. A heart valve prosthesis, comprising: A valve support having upstream and downstream sections relative to the blood flow through the natural heart valves of the human heart. The upstream section is configured to support the prosthetic valve component therein and define an inflow end of the valve support, the inflow end having a first outer diameter, and The downstream section defines the outflow end of the valve support, the outflow end having a second outer diameter greater than the first outer diameter. Anchoring element, the anchoring element surrounding the valve support, The anchoring element has a plurality of connectors forming its downstream portion, the plurality of connectors being angled inward toward the valve support and attached to the outflow end of the valve support, and The anchoring element is spaced apart from the upstream section of the valve support to mechanically isolate the upstream section of the valve support from the anchoring element.

2. The heart valve prosthesis of claim 1, wherein the first outer diameter of the upstream segment is constant from the first end of the upstream segment to the second end of the upstream segment, and the first end of the upstream segment defines the inflow end of the valve support.

3. The heart valve prosthesis of claim 2, wherein the second end of the upstream segment is adjacent to the first end of the downstream segment such that the first end of the downstream segment has the first outer diameter and the second end of the downstream segment has the second outer diameter, the second end of the downstream segment defining the outflow end of the valve support.

4. The heart valve prosthesis of claim 2, wherein the downstream segment extends outward from a first end of the downstream segment to a second end of the downstream segment, wherein the first end of the downstream segment has the first outer diameter and the second end of the downstream segment has the second outer diameter, the second end of the downstream segment defining the outflow end of the valve support.

5. The heart valve prosthesis of claim 1, wherein the upstream segment tapers from a first end having the first outer diameter to a second end of the upstream segment, the first end of the upstream segment defining the inflow end of the valve support, and the second end of the upstream segment having a third outer diameter smaller than the first outer diameter and the second outer diameter.

6. The heart valve prosthesis of claim 5, wherein the second end of the upstream segment is adjacent to the first end of the downstream segment such that the first end of the downstream segment has the third outer diameter, the downstream segment extending outward from the first end of the downstream segment to the second end of the downstream segment, wherein the second end of the downstream segment has the second outer diameter, the second end of the downstream segment defining the outflow end of the valve support.

7. The heart valve prosthesis of claim 1, wherein the anchoring element comprises a tissue fixation ring forming an upstream portion of the anchoring element, the upstream portion of the anchoring element being configured to engage cardiac tissue at or below the natural annulus of the natural heart valve.

8. The heart valve prosthesis according to claim 7, wherein the tissue fixation ring is radially spaced from the upstream segment of the valve support in the undeployed state, and is at least partially deformable into a non-circular shape in the deployed state to adapt to the shape of the implantation site without contacting the upstream segment of the valve support, so as to mechanically isolate the upstream segment of the valve support from the anchoring element.

9. The heart valve prosthesis of claim 7, wherein the plurality of connectors are angled inward from the tissue fixation ring.

10. The heart valve prosthesis of claim 9, wherein the plurality of connectors are configured to flex upward after implantation to accommodate any radial expansion of the tissue fixation ring due to the increase in size of the natural valve annulus as the patient grows.

11. The heart valve prosthesis of claim 7, wherein the tissue fixation ring includes one or more wedges extending outward therefrom to engage the heart tissue.

12. The heart valve prosthesis of claim 1, further comprising a prosthetic valve component disposed within the upstream section of the valve support, such that the leaflets of the prosthetic valve component open to the downstream section of the valve support during diastole.

13. The heart valve prosthesis of claim 12, wherein, in the open state during diastole, the prosthetic valve component has a diameter greater than approximately 1.6 cm. 2 The effective orifice area.

14. The heart valve prosthesis of claim 1, wherein the outflow end of the valve support is attached to the plurality of connectors by a plurality of rivets.

15. The heart valve prosthesis of claim 1, wherein each of the plurality of connectors has an inwardly curved, substantially V-shaped form.

16. The heart valve prosthesis of claim 1, wherein the valve support and the anchoring element comprise the frame of the heart valve prosthesis.

17. The heart valve prosthesis of claim 16, wherein the valve support of the frame is formed of a scaffold structure having honeycomb units, and the anchoring element is formed of a scaffold structure having closed rhomboid units.

18. The heart valve prosthesis of claim 16, wherein each of the valve support and the anchoring element of the frame is formed of a scaffold-like structure having closed rhomboid units.

19. The heart valve prosthesis of claim 16, wherein the frame has an outer diameter of 30 mm at the outflow end of the frame and an outer diameter of 36 mm at the upstream end of the anchoring element, thereby sizing the heart valve prosthesis for implantation in a patient with a smaller natural mitral valve annulus.

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