Artificial Heart Valve Devices, Systems and Methods

Abstract

This invention relates to artificial heart valve devices and delivery systems for artificial heart valve devices. The artificial heart valve device includes a valve with multiple leaflets, an expandable valve stent, a valve seal, a differentially deformable anchoring structure, and an anchor seal. The delivery system includes an elongated first catheter, one or more tethers, an elongated second catheter, and a compensation mechanism.

Description

Invention Field

[0001] This technology generally relates to artificial heart valve devices for repairing and / or replacing natural heart valves. In particular, several embodiments relate to artificial atrioventricular valves for replacing defective mitral and / or tricuspid valves, and methods and apparatus for delivering and implanting them into the human heart.

[0002] Some embodiments disclosed herein generally relate to prostheses for implantation within a lumen or body cavity and delivery systems for the prostheses. In particular, in some embodiments, the prosthesis and delivery system relate to artificial heart valve devices, such as replacement atrioventricular valves. Background of the Invention

[0004] Atrioventricular valvular insufficiency, also known as mitral and / or tricuspid valvular insufficiency or dysfunction, is a heart condition in which the atrioventricular valves (mitral and / or tricuspid valves) fail to close properly. In a healthy human heart, both the mitral and tricuspid valve apparatus consist of fibrous rings to which flexible, resilient leaflets are attached to close during ventricular contraction. The free end of each flexible leaflet is attached to a chordae tendineae, which anchor the leaflet to papillary muscles within the ventricle, thus controlling the movement of the free end of the leaflet throughout the cardiac cycle. All these components of the valve apparatus must function synchronously to achieve proper systemic blood circulation. Various heart diseases or degenerative conditions can affect any component of the atrioventricular valves, leading to improper closure. This results in abnormal leakage of blood through the valves into the atria and peripheral vascular system. Persistent atrioventricular valvular insufficiency can lead to numerous cardiovascular complications, including congestive heart failure.

[0005] Traditionally, patients with mitral regurgitation have been treated with invasive open-heart surgery, including surgical repair or replacement of the mitral valve apparatus. These methods often produce good clinical outcomes, but due to their invasiveness and long recovery periods, a large proportion of potential patients do not meet the inclusion criteria for such treatments. Therefore, many patients do not receive treatment and instead receive medication. Patients with tricuspid regurgitation receive even less invasive treatment through surgery, resulting in a larger number of patients under medical management for tricuspid regurgitation. Patients receiving medication for atrioventricular valve disease may have a poor quality of life and a poor long-term prognosis; many have a five-year mortality rate of 50% or higher.

[0006] Significant progress has been made in the development of minimally invasive transcatheter valve therapy over the years, with the greatest advancements in the treatment of aortic and pulmonary valve diseases. Exemplary prostheses include those described in U.S. Patent No. 7,892,281, the entire contents of which are incorporated herein by reference for all purposes. Some progress has been made in the treatment of mitral regurgitation via transcatheter therapy. Exemplary prostheses include those described in U.S. Patent No. 8,652,203, the entire contents of which are incorporated herein by reference for all purposes. Further exemplary prostheses include those described in U.S. Patent No. 9,034,032, the entire contents of which are incorporated herein by reference for all purposes. However, due to limitations of current technology, a large number of potential patients remain unsuitable for this therapy and have not yet received treatment or have experienced adverse outcomes. These limitations and outcomes include, but are not limited to, adverse events due to atrial stasis and prolonged surgery and / or radiation exposure to patients and surgical personnel, potentially leading to outflow tract obstruction, thrombosis, and thromboembolic events. Progress in treating tricuspid regurgitation via transcatheter valve replacement therapy has been minimal. Given the limitations of current technology and the large number of untreated patients, there remains a need for easier, more precise, and reproducible improved devices, systems, and methods for treating atrioventricular valvular dysfunction.

[0007] Invention Summary

[0008] The embodiments disclosed herein refer to devices, systems, and methods; for example, but not limited to, for replacing defective atrioventricular valves, and more specifically, for replacing defective natural tricuspid and / or mitral valves in the hearts of human patients with artificial heart valves.

[0009] Further embodiments relate to delivery systems, devices, and / or methods for delivering and / or controllably deploying artificial heart valve devices (e.g., but not limited to replacement heart valve devices) to desired locations within the body.

[0010] In some embodiments, a replacement artificial heart valve device and a method for delivering the replacement artificial heart valve device to a natural heart valve, such as an atrioventricular valve, are provided.

[0011] This disclosure includes, but is not limited to, the embodiments numbered below.

[0012] Implementation Method 1

[0013] Systems for replacing defective natural atrioventricular valves, including delivery systems and artificial heart valve devices, have two typical operating configurations: a radial compression operating configuration designed for transcatheter delivery through the intended anatomical structure, and a radial expansion operating configuration designed for eventual implantation of the target defective atrioventricular valve.

[0014] Implementation Method 2

[0015] The artificial heart valve device of Embodiment 1 is implantable into a defective natural mitral valve, passing through the patient's vascular system via the femoral vein, through the inferior vena cava and the interatrial septum to reach its final implantation site within the mitral valve apparatus. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement and fixation of the artificial heart valve device.

[0016] Implementation Method 3

[0017] The artificial heart valve device of Embodiment 1 is implantable into a defective natural tricuspid valve, passing through the patient's vascular system via the femoral vein, through the inferior vena cava and the right atrium to reach its final implantation site within the tricuspid valve apparatus. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement and fixation of the artificial heart valve device.

[0018] Implementation Method 4

[0019] The artificial heart valve device of Embodiment 1 is implantable into the defective natural mitral valve, passing through the patient's vascular system via the subclavian vein and through the superior vena cava to the final implantation site within the mitral valve apparatus. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0020] Implementation Method 5

[0021] The artificial heart valve device of Embodiment 1 is implantable into a defective natural tricuspid valve, passing through the patient's vascular system via the subclavian vein and through the superior vena cava to the final implantation site within the tricuspid valve apparatus. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0022] Implementation Method 6

[0023] The artificial heart valve device of Embodiment 1 is implantable into the defective natural mitral valve, passing through the patient's anatomy via an apical approach, and reaching the final implantation site within the mitral valve apparatus through the left ventricle. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0024] Implementation Method 7

[0025] The artificial heart valve device of Embodiment 1 is implantable into a defective natural tricuspid valve, passing through the patient's anatomy via an apical approach and through the right ventricle to reach the final implantation site within the tricuspid valve apparatus. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0026] Implementation Method 8

[0027] The artificial heart valve device of Embodiment 1 is implantable into the defective natural mitral valve, passing through the patient's anatomy via an atrial approach, and reaching the final implantation site within the mitral valve apparatus through the left atrium. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0028] Implementation Method 9

[0029] The artificial heart valve device of Embodiment 1 is implantable into the defective natural mitral valve, passing through the patient's anatomy via an aortic approach, and reaching the final implantation site within the mitral valve apparatus via the femoral artery and aorta. Thus, in this exemplary embodiment, the artificial heart valve device can be delivered to the intended implantation site using a delivery catheter with controlled deployment steps to ensure precise alignment, placement, and fixation of the artificial heart valve device.

[0030] Implementation Method 10

[0031] An artificial heart valve device according to any one of embodiments 2 to 9, wherein the artificial heart valve device includes a differentially deformable anchoring structure concentrically aligned with and radially adjacent to the valve stent, directly connected to and surrounding the valve stent.

[0032] Implementation Method 11

[0033] The artificial heart valve device of embodiment 10, wherein the differentially deformable anchoring structure includes an atrial region having a first stiffness and a plurality of alignment structures designed to assist rotational orientation during implantation.

[0034] Implementation Method 12

[0035] The artificial heart valve device of embodiment 11 has its atrial region configured to coincide with the bottom of the natural atrium of the adjacent atrioventricular valve, and can be directly connected to the internal valve stent via the inflow region connecting member.

[0036] Implementation Method 13

[0037] The artificial heart valve device of embodiment 12, wherein the differentially deformable anchoring structure includes a valve annulus region, which, in addition to including valve annulus anchoring elements for preventing retrograde migration, generally has a second stiffness suitable for deformation and consistent with the natural anatomical structure.

[0038] Implementation Method 14

[0039] The artificial heart valve device of embodiment 13, wherein the differentially deformable anchoring structure includes a ventricular region, which generally has a third stiffness and includes a plurality of ventricular anchoring elements, each having a plurality of ventricular region connecting elements adjacent to and in contact with the outflow region of the connecting member of the valve stent.

[0040] Implementation Method 15

[0041] The artificial heart valve device of embodiment 14, wherein the differentially deformable anchoring structure is further configured to be covered by a leak-proof membrane in the atrial region and the annular region to prevent paravalvular leakage.

[0042] Implementation Method 16

[0043] The artificial heart valve device of embodiment 15, wherein the artificial heart valve device further includes a valve stent.

[0044] Implementation Method 17

[0045] The artificial heart valve device of embodiment 16, wherein the valve stent includes an inflow region, an intermediate region and an outflow region downstream of the inflow region.

[0046] Implementation Method 18

[0047] The artificial heart valve device of embodiment 17, wherein the inflow region of the valve stent is further configured to be directly connected to the atrial region of a differentially deformable anchoring structure via an inflow region connecting member.

[0048] Implementation Method 19

[0049] The artificial heart valve device of embodiment 18 includes a connecting member further comprising a flexture geometry configured to mechanically dampen the transmission of forces and torsions from the anchoring structure to the valve stent, while maintaining a secure connection therebetween and allowing the valve stent to retain its generally cylindrical geometry to optimize valve performance.

[0050] Implementation Method 20

[0051] The artificial heart valve device of embodiment 19, wherein the inflow area of ​​the valve stent is further configured to include a leak-proof membrane that extends along the connecting member from the valve stent to the anchoring structure.

[0052] Implementation Method 21

[0053] The artificial heart valve device of embodiment 20 includes a plurality of leaflets in the middle region of the valve stent, which are supported by a leaflet support structure extending throughout the middle region of the valve stent body, and a leak-proof membrane, which together form a one-way valve for blood to flow through the artificial valve assembly.

[0054] Implementation Method 22

[0055] The artificial heart valve device of embodiment 21 further includes multiple outflow region connecting members that are directly connected to the ventricular region of the anchoring structure in the outflow region of the valve stent, wherein the outflow region connecting members extend from the commissure region of the valve stent.

[0056] Implementation Method 23

[0057] The artificial heart valve device of embodiment 22, wherein the outflow region connecting member further includes a geometry of a flexible deformable portion configured to mechanically dampen the transmission of force between the anchoring structure and the valve stent.

[0058] Implementation Method 24

[0059] The artificial heart valve device of embodiment 23 further includes a suture-like filament in the geometry of the flexible deformable portion, which has elasticity or tensile properties ranging from relatively rigid to relatively flexible.

[0060] Implementation Method 25

[0061] The artificial heart valve device of embodiment 24, wherein the artificial heart valve device is further configured to align any leaflet of the artificial valve with the anterior leaflet of the natural atrioventricular valve during implantation by guided rotational orientation of the atrial alignment structure within a differentially deformable anchoring structure, in order to avoid obstruction of the ventricular outflow tract.

[0062] Implementation Method 26

[0063] The artificial heart valve device of embodiment 25 includes a flexible deformable portion in the inflow and outflow regions of the valve stent whose geometry is also configured to allow cyclic shuttle of the valve prosthesis.

[0064] Implementation Method 27

[0065] The artificial heart valve device of embodiment 26, wherein the geometry of the flexible deformable portion within the valve stent is configured to allow the internal artificial valve to displace toward the atrium, thereby displacing it from a potentially obstructed ventricular outflow tract during systolic contraction and facilitating ventricular output. The increase in ventricular pressure during systolic contraction displaces the artificial valve leaflet from an open position to a closed position, thereby increasing the back pressure on the valve.

[0066] Implementation Method 28

[0067] The artificial heart valve device of embodiment 27, wherein during ventricular dilation, as the pressure difference between the atrium and ventricle decreases, blood is allowed to flow from the atrium through the artificial valve and into the ventricle for ventricular filling. The geometry of the flexible deformable portion inside the valve stent is also configured to allow the valve stent to return to its original position within the ventricular cavity, reduce its atrial projection, reduce the possibility of diastolic blood flow obstruction and blood stagnation, and optimize ventricular filling.

[0068] Implementation Method 29

[0069] The artificial heart valve device of embodiment 28, wherein the radially compressed artificial heart valve device also allows for advancement along anatomical paths that require traversing tight tortuous curvatures without compromising the anatomical structure.

[0070] Implementation Method 30

[0071] The artificial heart valve device of embodiment 29, wherein the radially compressed artificial heart valve device is delivered in the form of an articulated section.

[0072] Implementation Method 31

[0073] The artificial heart valve device of embodiment 30, wherein the radially compressed artificial heart valve device further includes a flexible geometric region.

[0074] Implementation Method 32

[0075] The artificial heart valve device of embodiment 31, wherein the differentially deformable anchoring structure allows for optimized control of the advancement and delivery of the artificial heart valve device toward the intended target implantation site by providing leeway for the longer, compressed artificial heart valve device that advances along a tight tortuous path.

[0076] Implementation Method 33

[0077] The delivery system of embodiment 32 includes an elongated first conduit having a first diameter and including a main lumen, a first flexible portion and one or more auxiliary lumens radially adjacent to the main lumen.

[0078] Implementation Method 34

[0079] The delivery system of embodiment 33 further includes one or more tethers that can be connected to portions of the artificial heart valve device and are configured to translate through one or more auxiliary lumens of the first catheter.

[0080] Implementation Method 35

[0081] The delivery system of embodiment 34 further includes an elongated second catheter having a second diameter smaller than the first diameter and including a lumen, a second flexible portion, and one or more connecting elements that can be connected to the portion of the artificial heart valve device; wherein the second catheter is also configured to translate within the main lumen of the first catheter.

[0082] Implementation Method 36

[0083] The delivery system of embodiment 35 further includes a compensation mechanism that is connected to the second catheter and controllably realizes conformational changes of the artificial heart valve device.

[0084] Implementation Method 37

[0085] The delivery system of embodiment 36, wherein one or more tethers and one or more connecting elements together provide tension that controllably maintains the artificial heart valve device in a radially constrained configuration for delivery.

[0086] Implementation Method 38

[0087] Delivery system of embodiment 37, wherein a compensation mechanism allows the second catheter to release tension by controllable translation within the first catheter during radial expansion of the artificial heart valve device.

[0088] Implementation Method 39

[0089] The delivery system of embodiment 38 further includes an elongated third catheter having a third diameter smaller than the second diameter and including a lumen, a third flexible portion, and a distal cover having a fourth diameter larger than the third diameter and configured to radially constrain a portion of the artificial heart valve device, including the portion comprising the artificial heart valve device.

[0090] Implementation Method 40

[0091] The delivery system of embodiment 39, wherein the third conduit is further configured to translate within the lumen of the second conduit.

[0092] Implementation Method 41

[0093] The delivery system of embodiment 40, wherein the distal cover is also configured to entrap a portion of the artificial heart valve device by contacting the connecting element of the second catheter.

[0094] Implementation Method 42

[0095] The delivery system of embodiment 41, wherein the compensation mechanism is further configured to be connected and communicated with the third conduit, and wherein the distal end cover of the third conduit is controllably translated by actuation of the compensation mechanism.

[0096] Implementation Method 43

[0097] The delivery system of embodiment 42 further includes a fourth elongated catheter having a fifth diameter greater than the first diameter and including a lumen and a proximal cover, the proximal cover being configured to support a portion of the artificial heart valve device that includes the portion of the artificial heart valve device for radial constraint.

[0098] Implementation Method 44

[0099] The delivery system of embodiment 43, wherein the fourth conduit is further configured to translate over the first conduit.

[0100] Implementation Method 45

[0101] The conveying system of embodiment 44, wherein the first and second flexible portions further include portions of laser-cut nitinol tubes.

[0102] Implementation Method 46

[0103] The conveying system of embodiment 44, wherein the first and second flexible portions further include portions of laser-cut steel pipes.

[0104] Implementation Method 47

[0105] The conveying system of embodiment 44, wherein the first and second flexible portions further include portions of a laser-cut polymer tube.

[0106] Implementation Method 48

[0107] The conveying system of embodiment 44, wherein the first and second flexible portions further include portions of reinforcing fiber tubes.

[0108] Implementation Method 49

[0109] The delivery system of any one of embodiments 45-48, wherein the second conduit is further configured to be deflected by applying tension to an internally biased draw wire.

[0110] The invention will be more fully understood from the following detailed description of its applications, taken in conjunction with the accompanying drawings, wherein:

[0111] Brief description of the attached figures

[0112] Figure 1 This is a schematic diagram of an exemplary frontal view of the anterior part of the heart, according to some applications of the present invention.

[0113] Figure 2A This is a schematic diagram of an exemplary front view of the posterior portion of a heart with cross-section lines, according to some applications of the present invention.

[0114] Figure 2B This is a schematic cross-sectional view of the basic parts of an exemplary heart, according to some applications of the present invention, showing an exemplary aortic valve, an exemplary mitral valve, an exemplary pulmonary valve, and an exemplary tricuspid valve.

[0115] Figure 3A This is a schematic diagram of the front view of the unfolded and flattened periphery of an exemplary natural mitral valve apparatus, including leaflets, chordae tendineae, and papillary muscles, according to some applications of the present invention.

[0116] Figure 3B This is a schematic diagram of the unfolded and flattened periphery of an exemplary natural tricuspid valve apparatus, including leaflets, chordae tendineae, and papillary muscles, according to some applications of the present invention.

[0117] Figure 4A This is a schematic diagram of a cross-sectional view of an exemplary anterior portion of the heart, illustrating the direction of normal blood flow in the left ventricle during diastole, according to some applications of the present invention.

[0118] Figure 4B This is a schematic diagram of a cross-sectional view of an exemplary anterior portion of the heart, illustrating the direction of normal blood flow in the left ventricle during systole, according to some applications of the present invention.

[0119] Figure 4C This is a schematic diagram of a cross-sectional view of an exemplary anterior portion of the heart, illustrating the direction of left ventricular regurgitation during systole due to the flail posterior leaflet, according to some applications of the present invention.

[0120] Figure 4D This is a schematic diagram of an exemplary cross-sectional view of the anterior part of the heart, illustrating the direction of left ventricular regurgitation during systole due to valve leaflet bulging, according to some applications of the present invention.

[0121] Figure 5A This is a schematic diagram of a cross-sectional view of an exemplary anterior portion of the heart, illustrating an embodiment of an artificial heart valve device implanted in the mitral valve location, according to some applications of the present invention.

[0122] Figure 5B This is a schematic diagram of a cross-sectional view of an exemplary anterior portion of the heart, illustrating an embodiment of an artificial heart valve device implanted in the tricuspid valve location, according to some applications of the present invention.

[0123] Figure 6AThis is a schematic diagram of an exemplary anterior sectional view of the heart, showing a percutaneous access corresponding to the transapical mitral valve implantation site, according to some applications of the present invention.

[0124] Figure 6B This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous approach corresponding to the location of a tricuspid valve implanted via the apex, according to some applications of the present invention.

[0125] Figure 6C This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous approach corresponding to the location of a tricuspid valve implanted via the femoral vein, according to some applications of the present invention.

[0126] Figure 6D This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous access corresponding to the transseptal mitral valve implantation site, according to some applications of the present invention.

[0127] Figure 6E This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous approach corresponding to the subclavian mitral valve implantation site, according to some applications of the present invention.

[0128] Figure 6F This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous approach corresponding to the subclavian tricuspid valve implantation site, according to some applications of the present invention.

[0129] Figure 6G This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous access corresponding to the location of a transaortic mitral valve implantation, according to some applications of the present invention.

[0130] Figure 6H This is a schematic diagram of an exemplary anterior sectional view of the heart, illustrating a percutaneous access corresponding to the location of a transatrial mitral valve implantation, according to some applications of the present invention.

[0131] Figure 7A This is a schematic perspective view of an exemplary embodiment of a self-expanding valve stent according to some applications of the present invention.

[0132] Figure 7B This is a schematic top view (inflow) of an exemplary embodiment of a self-expanding valve stent according to some applications of the present invention.

[0133] Figure 7C This is a schematic diagram of a front view of an exemplary embodiment of a self-expanding valve stent according to some applications of the present invention.

[0134] Figure 7D This is a schematic front view of an exemplary self-expanding valve stent embodiment according to some applications of the present invention, including tissue leaflets and fabric coverings.

[0135] Figure 8A This is a perspective view of an embodiment of an exemplary differentially deformable anchoring structure according to some applications of the present invention.

[0136] Figure 8B This is a schematic outline diagram of an exemplary embodiment of a differentially deformable anchoring structure according to some applications of the present invention.

[0137] Figure 8C This is a schematic top (flow) view of an embodiment of an exemplary differentially deformable anchoring structure according to some applications of the present invention.

[0138] Figure 8D This is a schematic outline diagram of an embodiment of an exemplary differentially deformable anchoring structure for fabric coverings, according to some applications of the present invention.

[0139] Figure 9A This is a schematic diagram of a front view of an exemplary embodiment of an artificial heart valve device according to some applications of the present invention.

[0140] Figure 9B This is a schematic perspective view of an exemplary embodiment of an artificial heart valve device according to some applications of the present invention.

[0141] Figure 9C This is a schematic perspective top view (inflow) of an exemplary embodiment of an artificial heart valve device according to some applications of the present invention.

[0142] Figure 9D This is a schematic diagram of a front view of an exemplary artificial heart valve device, including a fabric covering, according to some applications of the present invention.

[0143] Figure 9E This is a schematic cross-sectional view of an exemplary embodiment of an artificial heart valve device according to some applications of the present invention.

[0144] Figure 9F This is a schematic diagram of an exemplary artificial heart valve device, detailing alternative embodiments of geometric connections of the flexible deformable portion.

[0145] Figure 10A This is a schematic diagram of a front view of an exemplary artificial heart valve device in a coiled configuration, according to some applications of the present invention.

[0146] Figure 10B This is a schematic diagram of a front view of an exemplary artificial heart valve device in an expanded configuration, according to some applications of the present invention.

[0147] Figure 11A This is a schematic diagram of a front view of an embodiment of an exemplary artificial heart valve device, developed from an exemplary delivery system, according to some applications of the present invention.

[0148] Figure 11B This is a schematic diagram of a front view of an exemplary artificial heart valve device, developed from an exemplary delivery system, according to some applications of the present invention.

[0149] Figure 11C This is a schematic diagram of a front view of an embodiment of an exemplary artificial heart valve device, developed from an exemplary delivery system, according to some applications of the present invention.

[0150] Figure 12A This is a schematic side sectional view of an embodiment of an exemplary artificial heart valve device implanted in the mitral valve location during the diastolic phase of the cardiac cycle, according to some applications of the present invention.

[0151] Figure 12B This is a schematic side sectional view of an embodiment of an exemplary artificial heart valve device implanted in the mitral valve location during the systolic phase of the cardiac cycle, according to some applications of the present invention.

[0152] Figure 13A This is a perspective view schematic diagram with detailed views of an embodiment of an exemplary artificial heart valve device loaded into an exemplary delivery system, according to some applications of the present invention.

[0153] Figure 13B This is a schematic diagram of a partial front view of an exemplary embodiment of a planar pattern of an artificial heart valve device stent, according to some applications of the present invention.

[0154] Figure 14 This is a schematic enlarged view of the distal portion of a prosthesis via a femoral delivery device, according to some applications of the present invention, wherein the prosthesis is in a partially deployed configuration.

[0155] Figure 15A This is a schematic diagram of a femoral delivery device for an artificial heart valve device in a load configuration, according to some applications of the present invention.

[0156] Figure 15B This is a schematic diagram of the distal portion of an artificial heart valve device with a femoral delivery device in a load configuration, according to some applications of the present invention.

[0157] Figure 16A This is a schematic diagram of a femoral delivery device according to some applications of the present invention.

[0158] Figure 16B This is a schematic diagram of a femoral delivery device according to some applications of the present invention.

[0159] Figure 17A This is a schematic diagram of the retention area of ​​an artificial heart valve device via a femoral delivery device, according to some applications of the present invention.

[0160] Figure 17B This is a schematic diagram of a tethered shuttle mechanism via a femoral transport device, according to some applications of the present invention, wherein the tethered shuttle is in a closed configuration.

[0161] Figure 17C This is a schematic diagram of multiple tethered connectors via a femoral delivery device according to some applications of the present invention, wherein the connectors are in an engaging configuration.

[0162] Figure 17D This is a schematic diagram of a tethered shuttle mechanism via a femoral transport device, according to some applications of the present invention, wherein the tethered shuttle is in an open configuration.

[0163] Figure 17E This is a schematic diagram of multiple chain connectors in a strand conveying system according to some applications of the present invention, wherein the connectors are in a disengaged configuration.

[0164] Figure 17F This is a schematic diagram of a chain connector of a stranded conveyor system in a hidden line view, according to some applications of the present invention.

[0165] Figure 18A -I is a series of schematic diagrams depicting the deployment of an artificial heart valve device according to some applications of the present invention.

[0166] Figure 19A -D is a series of schematic diagrams depicting the conformational mechanics of the second catheter and the outer covering at the retention area according to some applications of the present invention.

[0167] Figure 20A -C is a series of schematic diagrams depicting a femoral delivery device in cross-section, according to some applications of the present invention.

[0168] Detailed description of preferred embodiments

[0169] This specification and accompanying drawings provide aspects and features of the present disclosure in the context of several embodiments of replacement artificial heart valve devices, systems, and methods configured for use in a patient's vascular system, such as for replacing a patient's natural heart valve. These embodiments may be discussed in conjunction with the replacement of a specific valve (e.g., a patient's mitral or tricuspid valve). However, it should be understood that the features and concepts discussed herein can be applied to products other than artificial heart valve devices. For example, the controlled positioning, deployment, and fixation features described herein can be applied to medical implants, such as other types of deployable prostheses, for use in other parts of the body, such as arteries, veins, or other body cavities or sites. Furthermore, specific features of artificial heart valve devices, systems, or methods should not be considered limiting, and features of any embodiment discussed herein may be combined with features of other embodiments as needed and where appropriate. Although some embodiments described herein are described in conjunction with specific delivery routes, it should be understood that these embodiments can be used with other delivery routes. Furthermore, it should be understood that certain features described in conjunction with some embodiments may be combined with other embodiments, including those described in conjunction with different delivery routes.

[0170] refer to Figure 1 According to some applications of the present invention, it is a schematic diagram showing a frontal view of an exemplary heart 100. The exemplary heart 100 typically includes four main chambers (right atrium 140, right ventricle 146, left atrium 110, and left ventricle 147), which harmoniously act as a pumping system to circulate blood throughout the vascular system. Normally, systemic circulation (not shown) returns deoxygenated blood to the right atrium 140 via the superior vena cava and inferior vena cava (125, 145, respectively). During diastole (the ventricular dilation portion of the cardiac cycle), deoxygenated blood is forced through the tricuspid valve (245, 145). Figure 2B And enters the right ventricle 146. Once inside the right ventricle 146, the pressure gradient between the right ventricle 146 and the right atrium 140, driven by systolic contraction (the ventricular systolic portion of the cardiac cycle), closes the tricuspid valve (245, Figure 2B And force blood to flow through the right ventricular outflow tract (520, Figure 5A ), through the pulmonary valve (515, Figure 5A The blood travels along the pulmonary trunk 114 through the left and right pulmonary arteries (115 and 130, respectively) until it flows out into the lungs (not shown). The blood becomes oxygenated through respiration in the lungs (not shown) and then returns to the left atrium 110 via the left and right pulmonary veins (105 and 135, respectively). It then dilates during diastole through the open mitral valve (210, ...). Figure 2BThe ventricular 147 is filled by the suction of oxygenated blood. Finally, systolic ventricular contraction drives the pressure gradient between ventricular 147 and left atrium 110, closing the mitral valve (210). Figure 2B This forces oxygenated blood in the left ventricle of the heart (447) to flow through the left ventricular outflow tract (455). Figure 4A ), through the aortic valve (205, Figure 2B The blood flows along the aorta 120 into the systemic circulation (not shown). The heart 100 also supplies itself with oxygenated blood throughout the cardiac cycle via the circumflex artery 155 and the left and right coronary arteries (160 and 150, respectively). Branch arteries of the aorta 120, such as the left subclavian artery, the left common carotid artery, and the brachiocephalic artery (121, 122, and 123, respectively), supply oxygenated blood to the brain and upper limbs.

[0171] Now turn to reference Figure 2A According to some applications of the present invention, it is a schematic diagram of the rear portion of an exemplary heart 100. Section line AA 200 is shown, illustrating where a section of the exemplary heart 100 can be cut to reach... Figure 2B The view depicted in the image.

[0172] Figure 2B This is a schematic diagram showing a cross-sectional view of an exemplary heart 100, illustrating some applications of the present invention, highlighting anatomical features presented from a top perspective view. As previously described, the exemplary heart typically includes four main chambers (right atrium 140, right ventricle 146, left atrium 110, and left ventricle 147). Figure 1 ); right atrium (140, Figure 1 ) and right ventricle (146, Figure 1 There is a tricuspid valve 245 between the right ventricle and the right ventricular 240. The inner wall of the right ventricle 240 defines the space through which blood is pumped during systole. The tricuspid valve 245 is a three-leaved valve composed of anterior apex 255, posterior apex 250, and septal apex 260. When the right ventricle (146, Figure 1 When compressed during systole, they close together and generally prevent retrograde blood flow. Between and below the anterior apex 255 and posterior apex 250 lie the anterior and posterior papillary muscles 256, which support the two leaflets via the tricuspid valve chordae tendineae 261. Between and below the posterior apex 250 and septal apex 260 lies the posterior septal papillary muscle 257, which supports the two leaflets via the tricuspid valve chordae tendineae 261. Between and below the septal apex 260 and anterior apex 255 lies the anterior septal papillary muscle 258, which supports the two leaflets via the tricuspid valve chordae tendineae 261.

[0173] The pulmonary valve 235 extends along the outer wall of the right ventricle 241. The pulmonary valve 235 shares the right ventricle with the tricuspid valve 245 (146). Figure 1 ) and right ventricular outflow tract (520, Figure 5AThe pulmonary valve 235 is also a three-leaved valve, composed of the left apex 236, right apex 238, and anterior apex 237. When the right ventricle (146, Figure 1 During diastole, when the pressure is reduced, they close together and usually prevent retrograde blood flow.

[0174] The aortic valve 205 is located along the outer wall of the left ventricle 231. The aortic valve 205 and the mitral valve 210 share the left ventricle (147, Figure 1 ) and left ventricular outflow tract (455, Figure 4A The aortic valve 205 is also a three-leaved valve, composed of the left apex 206, right apex 207, and posterior apex 208. When the left ventricle (147, Figure 1 During systole, when the pressure is reduced, they close together and usually prevent retrograde blood flow.

[0175] Left atrium (110, Figure 1 ) and left ventricle (147, Figure 1 There is a mitral valve 210 between the left ventricle and the left ventricle 230. The inner wall of the left ventricle 230 defines the space through which blood is pumped during systole. The mitral valve 210 is a bicuspid valve composed of an anterior apex 212 and a posterior apex 211. When the left ventricle (147, Figure 1 When compressed during systole, they close together and generally prevent retrograde blood flow. The posteromedial papillary muscles 215 are located between and posterior to the posterior apex 211 and the anterior apex 212, supporting the two leaflets via the mitral valve chordae tendineae 225. The anterolateral papillary muscles 220 are located lateral to and posterior to the posterior apex 211 and the anterior apex 212, supporting the two leaflets via the mitral valve chordae tendineae 225. The anterior apex 212 extends from the mitral valve annulus (335, Figure 3A The anterior apex 212 extends sub-annularly into the ventricle. At the junctional margin (the angle where the mitral valves intersect), the anterior apex 212 originates from the valve annulus near a distinctly rigid region of fibrous tissue (called the fibrous triangle 216). The fibrous triangle 216 serves as a structural region of the heart 100, providing a supporting base for the mitral valve 210 and the aortic valve 205 during the dynamic motion generated throughout the cardiac cycle.

[0176] Now for reference Figure 3AAccording to some applications of the invention, it is a schematic front view of an optional representative 300, unfolded and tiled, of the periphery of an exemplary natural mitral valve apparatus, including leaflets (anterior 310, posterior 315), chordae tendineae (320), and papillary muscles (anterolateral 305, posteromedial 301). It can be seen that both the anterior leaflet 310 and the posterior leaflet 315 originate from the mitral annulus 335 and extend downward (towards the left ventricle, not shown) and away from the left atrium (not shown). The representative 300 is divided along the edge of the mitral annulus 335 into a posteromedial commissural region 306 and an anterolateral commissural region 307 (divided in half in this view). Extending below each commissural region (posteromedial 306, anterolateral 307) is a connecting arch of the chordae tendineae 320, which further extends to communicate with the corresponding papillary muscles (posteromedial 301, anterolateral 305). The chordae tendineae of the mitral valve also extend directly from the anterior leaflet 310 and the posterior leaflet 315 themselves, defining the edge of each corresponding leaflet until reaching the chordae tendineae-free areas known as the posterior and anterior free edges (325 and 330, respectively). In a healthy heart with intact anatomy, the function of the chordae tendineae is to provide tension between the leaflets and papillary muscles, preventing the leaflets from over-engaging with and moving toward the atria during systole, which can ultimately lead to valvular dysfunction, regurgitation, heart failure, and poor health.

[0177] Similar to Figure 3A According to some applications of the present invention, Figure 3B This is a schematic diagram of an unfolded and laid-out alternative representative 340 of the periphery of an exemplary natural tricuspid valve apparatus, including leaflets (septum 350, anterior 360, posterior 370), tricuspid chordae tendineae (380), and papillary muscles (posterior septum 385, anterior septum 390, anterior and posterior 395). It can be seen that the anterior leaflet 360, posterior leaflet 370, and septal leaflet 350 originate from the tricuspid annulus 345 and extend downward (towards the right ventricle, not shown) and away from the right atrium (not shown). The representative 340 is divided along the edge of the tricuspid annulus 345 into anterior septal junction 382, ​​anterior and posterior junction 383, and posterior septal junction 381 (divided in half in this view). Extending below each junction (anterior septum 382, ​​anterior and posterior 383, and posterior septum 381) is a connecting arch of the tricuspid chordae tendineae 380, which further extends to communicate with the corresponding papillary muscles (anterior septum 390, anterior and posterior 395, and posterior septum 385). The tricuspid valve chordae tendineae 380 extend directly from the septal leaflet 350, anterior leaflet 360, and posterior leaflet 370 themselves, defining the edge of each corresponding leaflet until reaching the chordae tendineae-free areas known as the septal free edge, anterior free edge, and posterior free edge (355, 365, 375). Like the mitral valve, the leaflets, chordae tendineae, and corresponding papillary muscles of the tricuspid valve function harmoniously to prevent retrograde and regurgitation of blood flow, as well as all associated diseases and complications related to retrograde flow.

[0178] Now for reference Figure 4A and 4BAccording to some aspects of the invention, it is a typical description showing normal forward blood flow on the left and right sides of the heart (concentrated on the left) through a cardiac cycle including diastolic and systolic phases. Specifically, Figure 4A A schematic cross-sectional view of the anterior portion of an exemplary heart 400 is shown, illustrating the direction of normal blood flow from the left atrium 445 to the left ventricle 425 during diastole (indicated by arrow 430). It should be understood that during diastole, the mitral valve 440 opens, and the mitral valve leaflets 435 extend fully toward the left ventricle 425 to allow fresh, oxygenated blood to fill the left ventricle 425. During diastole, the aortic valve 450 remains closed. Figure 4A The right side of the heart during diastole is also depicted. In a manner similar to what occurs on the left side of the heart during diastole, on the right side, blood is directed from the right atrium 405 through the open tricuspid valve 410, past the fully extended tricuspid valve leaflets 415, and into the right ventricle 420, where it is then expelled from the right ventricular outflow tract (not shown) and the pulmonary valve, and subsequently the pulmonary valve (both not shown). During the cardiac cycle, both ventricles of the heart will expand co-existingly during diastole and then contract co-existingly during systole. Figure 4B A schematic cross-sectional view of the anterior portion of an exemplary heart 400 is shown, illustrating the normal direction of blood flow during systole from the left ventricle 425 through the left ventricular outflow tract 455 and toward the aortic valve 465 (indicated by arrow 460). It should be understood that during systole, the mitral valve 470 closes, and the mitral valve leaflets 471 fully contract to prevent retrograde blood flow toward the left atrium 445 and allow fresh, oxygenated blood to be expelled through the aorta 472. During systole, the aortic valve 465 is forced to open. Figure 4B The right side of the heart during systole is also depicted. In a manner similar to what occurs on the left side of the heart during systole, on the right side, blood is guided from the right ventricle 420 through the right ventricular outflow tract (not shown) to the pulmonary valve (not shown). It can be seen that the tricuspid valve 475 is closed, and the tricuspid valve leaflets 476 are fully contracted to prevent retrograde blood flow into the right atrium 405.

[0179] and Figure 4A and 4B Conversely, according to some applications of the present invention, Figure 4C and 4D This schematically illustrates a typical description of abnormal blood flow with partial retrograde regurgitation on both the left and right sides of the heart (focused on the left) during the systolic phase. Specifically, Figure 4CA schematic cross-sectional view of the anterior portion of an exemplary heart 400 is shown, illustrating the direction of abnormal blood flow during systole that passes through the aorta 465 and returns through the damaged mitral valve 485 into the left atrium 445 (indicated by arrows 480 and 481). In this illustration, the damaged mitral valve 485 suffers from a flail leaflet that cannot properly engage. The flail leaflet may be caused by a ruptured chordae tendineae (not shown) or degenerated mitral annular tissue, which can lead to further structural damage, reduced strength, and degeneration. For this type of damaged mitral valve 485, a large portion of the ejection fraction that should normally exit through the aorta 465 is redirected back into the left atrium 445, as indicated by arrow 480. Figure 4D A schematic cross-sectional view of the anterior portion of an exemplary heart 400 is shown, illustrating the direction of abnormal blood flow during systole, both through the aorta 465 and back through the damaged mitral valve 495 into the left atrium 445 (indicated by arrows 490 and 481). In this illustration, the damaged mitral valve 495 suffers from tented leaflets that cannot properly engage. Tented leaflets can be caused by ventricular remodeling, which may occur after ischemic events such as a heart attack. When a portion of the ventricle loses function (due to ischemia), the remaining healthy portion of the ventricle is forced to contract excessively, resulting in localized hypertrophy and deformation of surrounding anatomical structures such as chordae tendineae and associated leaflets.

[0180] Now for reference Figure 5A and 5B According to some applications of the present invention, it is a schematic diagram of an anterior cross-sectional view of an exemplary heart (500, 550) showing an embodiment of an artificial heart valve device (mitral valve position 535, tricuspid valve position 555) implanted in the mitral and tricuspid valve positions. Specifically, Figure 5AAn exemplary heart 500 is schematically illustrated, having been bisected along a plane bisecting the pulmonary trunk 501, right atrium 502, left atrium 503, right ventricle 510, and left ventricle 505 to expose the internal features and details of the heart's chambers (right atrium 405, left atrium 445, right ventricle 420, and left ventricle 425). These internal features and details relate to design features of an exemplary embodiment of an artificial heart valve device 535 designed for implantation in the mitral valve location. An exemplary embodiment of the artificial heart valve device 535 may be designed to have a minimal profile extending into the inflow (left atrium 445 or right atrium 405) and outflow (right ventricle 420 or left ventricle 425) regions to prevent obstruction of the ventricular outflow tract (left ventricular outflow tract 512, right ventricular outflow tract 520) and, in the event of obstruction of the outflow region, to prevent reduced ejection fraction, and, in the event of obstruction of the inflow region, to prevent flow obstruction and stasis. Exemplary embodiments of the artificial heart valve device 535 can also utilize natural anatomical structures, such as the mitral valve annulus (514, Figure 5B The device is anchored in the anterior and posterior regions (545 and 540, respectively) using radially outward forces, and is effectively clamped onto the natural valve annulus and prevented from migrating toward the left atrium 445 or left ventricle 425 by load-bearing surfaces that are adjacent to the atrial base (left, 445) and ventricular roof (left, 425). These features will be further described below.

[0181] Similar to Figure 5A According to some applications of the present invention, Figure 5B An exemplary heart 550 is schematically illustrated, having been bisected along a plane bisecting the pulmonary trunk 501, right atrium 502, left atrium 503, right ventricle 510, and left ventricle 505 to expose the internal features and details of the heart's chambers (right atrium 405, left atrium 445, right ventricle 420, and left ventricle 425). These internal features and details relate to design features of an exemplary embodiment of an artificial heart valve device 555 designed for implantation in the tricuspid valve location. The exemplary embodiment of the artificial heart valve device 555 can provide the same advantages found in devices described and designed above for the mitral valve location. For example, the exemplary embodiment of the artificial heart valve device 555 can also utilize natural anatomical structures, such as the tricuspid valve annulus (513, Figure 5A The device is anchored in the anterior, septal, and posterior regions (565 and 560, respectively) using radially outward forces, and is effectively clamped onto the natural valve annulus and prevented from migrating toward the right atrium 405 or right ventricle 420 by having load-bearing surfaces that are adjacent to the atrial base (right, 405) and ventricular top (right, 420).

[0182] Now for reference Figures 6A-6H According to some applications of the present invention, it is a schematic cross-sectional view of the front portion of an exemplary heart 600, showing various percutaneous delivery paths of an exemplary artificial heart valve device. Figure 6A The percutaneous access corresponding to the transapical mitral valve implantation site is shown, indicated by directional arrow 605. Figure 6B The percutaneous access corresponding to the location of the tricuspid valve implanted at the apex is shown, indicated by directional arrow 615. Figure 6C The percutaneous access corresponding to the tricuspid valve implantation site via the femoral vein is shown, indicated by directional arrow 625. Figure 6D The percutaneous access corresponding to the mitral valve implantation site via the femoral vein / septum is shown, indicated by directional arrow 635. Figure 6E The percutaneous access corresponding to the subclavian mitral valve implantation site is shown, indicated by directional arrow 645. Figure 6F The percutaneous access corresponding to the subclavian tricuspid valve implantation site is shown, indicated by directional arrow 655. Figure 6G The percutaneous access corresponding to the mitral valve implantation site via the aorta is shown, indicated by directional arrow 665. Figure 6H The percutaneous access corresponding to the transatrial implantation of the mitral valve is shown, indicated by directional arrow 675. While some embodiments of the exemplary artificial heart valve devices described herein are described in conjunction with specific percutaneous delivery approaches, it should be understood that these embodiments can be used with other percutaneous delivery approaches. Furthermore, it should be understood that, according to some applications of the invention, certain features described in conjunction with some embodiments can be combined with other embodiments, including those described in conjunction with different percutaneous delivery approaches.

[0183] Now for reference Figures 7A-7D According to some applications of the invention, it describes an anchoring structure (800) configured to be differentially deformable. Figure 8A A schematic diagram illustrating an exemplary embodiment of a self-expanding valve stent 700 that cooperates with [the valve]. Specifically, Figure 7A A perspective view of an exemplary embodiment of a self-expanding valvular stent 700 is shown. The stent may be generally cylindrical and has a blood inflow region 701 and a blood outflow region 702 opposite to the blood inflow region 701, the regions generally describing the direction in which blood may flow through the device during normal operation. Figure 7A The exemplary self-expanding valve stent 700 described herein can typically be composed of any alloy having superelasticity and shape memory properties, such as nitinol or any other superelastic, shape memory metal or other alloy, polymer, or composition of materials that can exhibit self-expanding properties. Typically, the exemplary self-expanding valve stent 700 embodiment may have a valve stent inflow region (715, Figure 7C), which is adjacent to the blood inflow area 701 and is configured to provide features to prevent paravalvular leakage and to provide features to allow the exemplary self-expanding valve stent 700 and the adjacent valve stent inflow area (715, Figure 7C An exemplary differentially deformable anchoring structure (800, ) Figure 8A Features that allow for the connection between the exemplary self-expanding valve stent 700 and the exemplary differentially deformable anchoring structure (800). Figure 8A The features connecting the 736 and 736 can also include multiple (736, Figure 7B The elongated inflow area connecting members 735 are configured to be flexible and bendable, allowing structural deformation and force absorption while still providing reliable and durable support between the members. The inflow area connecting members 735 can also be configured to include a geometry 740 with a bendable deformable portion, allowing structural deformation and force absorption. The inflow area connecting members 735 can also be configured to provide an inflow area connecting element 745, which acts as a positioning feature for the inflow area connecting member 735 and the corresponding atrial connecting element (825). Figure 8A The mating connections between these elements correspond to the atrial connecting elements (825, ...). Figure 8A ) located in an exemplary differentially deformable anchoring structure (800, Figure 8A The implementation of the 700 model can include features that allow prevention of paravalvular leakage around the exemplary self-expanding valve stent 700, such as a valve seal (780). Figure 7D It can be made of fabrics such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics, or any other material suitable for constructing durable artificial heart valve devices, and is configured to flow from the valve stent inlet region (715, Figure 7C ) extends to the valve stent outflow area (725, Figure 7C (as described below). Furthermore, an exemplary embodiment of the self-expanding valve stent 700 may also have a valve stent annular region (720, Figure 7C ), its adjacent valve stent inflow area (715, Figure 7C ) and valve stent outflow area (725, Figure 7C (as described below) and between the two, and configured to provide a location for the connection of sutures and fabric, such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabric, or any other material suitable for constructing a durable artificial heart valve device. Allows for the provision of sutures and fabric in the valve stent annulus region (720, Figure 7C Features at the location where it connects to the exemplary self-expanding valve stent 700 may include a leaflet attachment rail 730 to which sutures and fabric are attached, and the geometry of the flexible, deformable portion of the leaflet attachment rail (775). Figure 7CThe geometry of the device can also accept sutures and fabrics, and further provides flexibility (not shown) to facilitate the coiling process, after which the device is loaded onto an exemplary delivery system (not shown) for percutaneous or other implantation. Furthermore, embodiments of the exemplary self-expanding valve stent 700 may also have a valve stent outflow region (725, Figure 7C The valve stent outflow area is adjacent to the valve annulus region (720, Figure 7C And in its downstream direction, and configured to provide an outflow region (725) allowing the exemplary self-expanding valve stent 700 and adjacent valve stents to flow out. Figure 7C An exemplary differentially deformable anchoring structure (800, ) Figure 8A Features that allow for connection between the exemplary self-expanding valve stent 700 and the adjacent valve stent outflow region (725). Figure 7C An exemplary differentially deformable anchoring structure (800, ) Figure 8A The features of matching connections between (749, ) can include multiple (749, Figure 7C ) Slender outflow area connecting component (750, Figure 7C ), its adjacent leaflet is attached to the rail (730, Figure 7C ) and the valve junction attachment area (765, Figure 7A ) and extending from it, the valvular junctional attachment area (765, Figure 7A ) is configured to couple the element (770, ) via the suture and the junctional leaflet. Figure 7A This method supports multiple leaflets (790, Figure 7D ) attachment. Each outflow area connection component (750, Figure 7C It may also include a series of outflow area connection elements (755, Figure 7C ), which acts as a connecting component for the outflow area (750, Figure 7C ) and the corresponding ventricular region connection element (845, Figure 8A The positioning features that allow for connection and mating between ) and the corresponding ventricular region connecting elements (845, Figure 8A Adjacent ventricular congruent structural support struts (836, Figure 8A The support is located in an exemplary differentially deformable anchoring structure (800, Figure 8A The implementation method of ) is as follows. Each outflow area connecting component (750, Figure 7C It can also include the geometry of the bendable deformable portion (760, Figure 7C It is configured to be flexible and bendable, allowing the structure to deform and absorb forces, while still providing reliable and durable support between components.

[0184] refer to Figure 7DAccording to some applications of the present invention, a schematic front view of an exemplary embodiment of a self-expanding valve stent 777 is described, which includes tissue leaflets and fabric covering (valve seal 780) for preventing paravalvular leakage. Figure 7D Embodiments of the self-expanding valvular stent 777 include leaflet attachment rails 730 that provide location for a plurality of leaflets 790. The leaflets may be composed of chemically treated and biocompatible pericardial tissue material, or a biocompatible polymeric material, or any other biocompatible structure suitable for fabricating artificial heart valve leaflet structures. Each leaflet 790 extends between valvular junctions 795, which are adjacent to and between the extent of each leaflet attachment rail 730, and also include a junctional cover 786 and attachment sutures 785.

[0185] Now for reference Figures 8A-8D According to some applications of the present invention, it is a schematic diagram of various views illustrating embodiments of an exemplary differentially deformable anchoring structure 800. Depicted in Figures 8A-8B An exemplary embodiment of the differentially deformable anchoring structure 800 may include an anchor atrial region 805, which typically includes a plurality of elongated struts that collectively define a rhomboid unit structure and typically has a first stiffness. The atrial region 805 may be configured to conform to the atrial surface of the heart's natural atrioventricular valves (see [link to original text]). Figures 5A-5B The atrioventricular region 805 may also include a plurality of atrial release members 830, each atrial release member 830 adjacent to and extending therefrom an atrial congruence structure 820, the atrial congruence structure 820 being configured to also provide a smooth surface on which an exemplary delivery system catheter (not shown) may be pulled out to capture and sheath the artificial heart valve device of this disclosure. The atrial release members 830 may also be configured to include a geometry 831 of the atrial release members that allows a releasable connection between the differentially deformable anchoring structure 800 and the exemplary delivery system (not shown). Additional features of the exemplary differentially deformable anchoring structure 800 may include an atrial region connecting element 825 having a geometry 826 of an atrial connecting element, which is configured to connect with an exemplary self-expanding heart valve stent (700, Figure 7A The inflow area connecting element 745 can be connected and mated.

[0186] schematically shown in Figures 8A-8BAn embodiment of the exemplary differentially deformable anchoring structure 800 also includes an anchoring annular region 810, which typically includes a plurality of elongated and wide annular regions fastening struts 862, collectively defining an annular circumferential structure traversing the circumference of the exemplary differentially deformable anchoring structure 800 of this embodiment, and typically having a second stiffness. The annular region 810 can be configured to conform to the natural atrioventricular valve annulus of the heart (see [link to original text]). Figures 5A-5B Furthermore, it provides resistance to migration away from the aforementioned annulus through radial expansion force. Additionally, it is depicted in... Figures 8A-8B An exemplary embodiment of the differentially deformable anchoring structure 800 may further include an anchoring ventricular region 815, which typically has a third stiffness and typically includes a plurality of elongated and wide ventricular conforming structures 835, including a heel portion 860 for abutting the natural ventricular roof (see [link to previous document]). Figures 5A-5B The ventricular congruence structure 835 includes multiple elongated ventricular congruence support struts 836 terminating at a ventricular release member 840; the ventricular release member 840 has a ventricular release member geometry 850 configured to releasably connect a differentially deformable anchoring structure 800 to an exemplary delivery system (not shown). Each ventricular congruence structure 835 may also include multiple ventricular region connection elements 845, each having a ventricular region connection element geometry 855 providing mating connection with an outflow region connection element 755 of an exemplary self-expanding cardiac valve stent (700, FIG. 7). The base of the ventricular region congruence structure 860 may also include an annular anchoring element 865 configured to pass through annular tissue and enhance the anchoring force of the differentially deformable anchoring structure 800. Finally, the ventricular region 815 may be configured to conform to the ventricular wall and annulus of the heart's natural atrioventricular valves (see [link to relevant documentation]). Figures 5A-5B The device, via its heel 860, abuts against the top of the ventricle at a location adjacent to the lower surface of the natural valve annulus, providing resistance to migration away from the valve annulus and toward the atrium. The first stiffness of the atrial region 805, the second stiffness of the valve annulus region 810, and the third stiffness of the ventricular region 815 can be related in such a way that an optimized combination of stiffness is provided to prevent device migration while conforming to the natural structure of the natural heart. The stiffnesses can generally be equal; or, the first stiffness can generally be greater or less than one or both of the second and third stiffnesses. Furthermore, the second stiffness can generally be greater or less than one or both of the first and third stiffnesses. Finally, the third stiffness can generally be greater or less than one or both of the first and second stiffnesses.

[0187] Now for reference Figure 8DAccording to some applications of the invention, this is a schematic diagram of an embodiment of a differentially deformable anchoring structure having a fabric cover 867. The anchoring structure having a fabric cover 867 may include the aforementioned differentially deformable anchoring structure 800, and further include an anchor seal 870 configured to prevent paravalvular leakage and composed of fabrics such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics, or any other material suitable for constructing a durable artificial heart valve device. The anchor seal 870 may also include a valve annular region seal 871 and a rhomboid shape 872 of the valve annular region seal 871 to provide maximized fabric surface area, thereby providing maximum resistance to paravalvular leakage. Finally, three sets of ventricular region outflow openings 875 may be formed, each free from the boundary of the valve annular region seal 871, in conjunction with multiple ventricular consistency structures 835, and are configured to maximize the available space below the embodiment of the artificial heart valve device and the ventricular outflow tract to which the device is implanted (see [link to documentation]). Figures 5A-5B This is to reduce the occurrence of ventricular outflow tract obstruction.

[0188] refer to Figures 9A-9F According to some applications of the present invention, it is a schematic diagram depicting various views of an embodiment of an exemplary artificial heart valve device 900. Specifically, Figure 9A A front view of an embodiment of an exemplary artificial heart valve device 900 is shown, while Figure 9B A perspective view of an artificial heart valve device 900 is shown. Figure 9C A perspective top view (inflow) of the artificial heart valve device 900 is shown, while Figure 9D A front view of an artificial heart valve device with a cover 915 is shown. Finally, Figure 9E A cross-sectional view of an exemplary artificial heart valve device 900 is shown. (Reference) Figure 9A As can be seen in the exemplary self-expanding heart valve stent (700, Figure 7A The implementation method of ) and the anchoring structure with differential deformation (800, Figure 8A The mating connection at the outlet end 910 between exemplary embodiments of ) . Similarly, in Figure 9B In the image, an exemplary self-expanding heart valve stent (700) can be seen. Figure 7A The implementation method of ) and the anchoring structure with differential deformation (800, Figure 8A The mating connection at the inflow end 905 between exemplary embodiments of the present invention. (See reference...) Figure 9D According to some applications of the invention, an exemplary embodiment of an artificial heart valve device having a cover 915 is schematically shown, wherein a valve seal 780, a leaflet 790, and an anchor seal 870 are illustrated. Referring now to... Figure 9EAccording to some applications of the present invention, a cross-sectional view of an exemplary embodiment of an artificial heart valve device 900 is schematically shown. A protruding curve depicting the anchor cross-section 925 is shown adjacent to a protruding curve depicting the valve stent cross-section 930. Embodiments of the artificial heart valve device 900 may be designed such that the overall length of the protruding curve depicting the anchor cross-section 925 is equal to the overall length of the protruding curve depicting the valve stent cross-section 930, such that... Figure 9D As shown, when each curve is connected to the cover 915 in the assembly device (connected at the inflow 935 and at the outflow 940), when placed under tension applied together at the inflow and outflow ends, such as when loaded onto an exemplary embodiment of a delivery system catheter (described further below), the heart valve stent (700, Figure 7A ) and differentially deformable anchor structures (800, Figure 8A They shrink uniformly and evenly.

[0189] at last, Figure 9F The geometry of the elements used to connect the ventricular region of the anchor is depicted (855, Figure 8A Various alternative embodiments of the connection configuration connected to the outflow region connection element 755 of the valve stent are shown. Specifically, detailed section circles 945, 973, and 974 illustrate five reference lines (946, 947, 948, 963, 962) leading to the corresponding enlarged section circles (950, 955, 960, 965, 964), each describing an alternative embodiment of the connection configuration. Reference line 946 extends from the first detailed section circle 945 to the enlarged section circle 950 and depicts an embodiment of the connection configuration including a suture-like or filamentous material 951 interwoven into the geometry of the anchored ventricular region connection element (855, 855, 960, 965, 964). Figure 8A Between the ventricular region connecting element 755 and the valve stent, which is configured to achieve a rigid connection. The suture thread or filament material 951 may comprise an elastic or flexible textile or polymer. The suture thread or filament material 951 may also comprise a flexible or elastic metal alloy. The suture thread or filament material 951 may also comprise a rigid and non-flexible material, polymer, fabric, or alloy. Reference line 947 extends from the first detailed section circle 945 to the enlarged section circle 955 and depicts an embodiment including a connection structure comprising a suture thread or filament material 956, which has been connected to the geometry (855, ) of the anchor ventricular region connecting element. Figure 8A Between the ventricular region connecting element 755 and the valve stent. A suture-like or filamentous material 956 can be configured to provide a connection that allows for the anchoring of the ventricular region connecting element geometry (855, Figure 8ASome displacement between the ventricular region connecting element 755 and the valve stent. The suture thread or filament material 956 may include elastic or flexible textiles or polymers. The suture thread or filament material 956 may also include flexible or elastic metal alloys. The suture thread or filament material 956 may also include rigid and non-flexible materials, polymers, fabrics, or alloys. Reference line 948 extends from the first detailed section circle 945 to the enlarged section circle 960 and depicts an embodiment including a connection structure containing a coil-like material 961 connected to the geometry (855, ) of the anchor ventricular region connecting element. Figure 8A Between the ventricular region connecting element 755 and the valve stent. A coiled material 961 can be configured to provide a connection that allows for the anchoring of the ventricular region connecting element geometry (855, ...). Figure 8A The maximum displacement between the valve stent and the outflow region connecting element 755. The coiled material 961 may include elastic or flexible textiles or polymers. The coiled material 961 may also include flexible or elastic metal alloys. The coiled material 961 may also include rigid and non-flexible materials, polymers, fabrics, or alloys.

[0190] Reference line 962 extends from the second detailed section circle 974 to the enlarged section circle 964 and depicts an alternative embodiment of a connection configuration including a suture-like material 971 directly connected to the geometry 975 of the anchor ventricular region connection element and the outflow region connection element 755 of the valve stent (adjacent to and extending from the heel 860). In this particular embodiment, one or more ventricular coherence structural support struts 836 can be replaced by a direct connection with the suture-like material 971, thereby achieving a tensile connection, or a rigid connection, or a connection that can absorb some displacement between the connection elements. The connection configuration depicted in this particular alternative embodiment can be implemented in one or more valve engagement regions, or not in any valve engagement region (795, Figure 7D The connection configuration depicted in this particular alternative embodiment can be designed to accommodate any affected valve engagement regions (795, ) arising from valve annular deformation induced at the anchor. Figure 7D Isolation. The connection configuration depicted in this particular alternative embodiment can also be designed to reduce the overall crimped height of the device (e.g., Figure 10A (The vertical distance between parts 830 and 850 depicted in the image).

[0191] Reference line 963 extends from third detailed section circle 973 to enlarged section circle 965 and depicts a view of the opposite ends (focused on the outflow region connecting member 750) of the above-described alternative embodiment, including the connection structure of suture thread material 971, which is directly connected between the geometry 975 of the anchor ventricular region connecting element and the outflow region connecting element 755 of the valve stent (adjacent to and extending from the heel 860).

[0192] Now for reference Figure 10A and 10B According to some applications of the present invention, it is a schematic front view of an exemplary embodiment of an artificial heart valve device 900 in a coiled configuration 1000 and an expanded configuration 1020. Specifically, Figure 10A A coiled configuration 1000 is shown, which occurs in an exemplary embodiment when the artificial heart valve device 900 has been coiled and loaded onto the delivery system catheter by radial compression or axial tension (described further below). The atrial region 1005, the annular region 1010, and the ventricular region 1015 are also visible in the coiled configuration 1000. Similarly, Figure 10B The expansion configuration 1020 is shown, which occurs when the artificial heart valve device 900 has been fully deployed and implanted into the natural atrioventricular valve.

[0193] refer to Figure 11A-11C According to some applications of the present invention, it is a schematic diagram depicting the sequence of a typical deployment process of an exemplary embodiment of an artificial heart valve device 900 deployed by an exemplary embodiment of the delivery system 1100. Figure 11A A pre-deployed configuration of exemplary portions of the catheter 1104 adjacent to the proximal capsule portion 1101 and the distal capsule portion 1102 is shown. The proximal capsule portion 1101 may have a proximal marking band 1106, and the distal capsule portion 1102 may have a distal marking band 1107 to aid in imaging guidance during the implantation procedure. An exemplary embodiment of the delivery system 1100 may be configured to travel on the guidewire 1103 to track the device's entry position during the implantation procedure. Figure 11B A moderately deployed configuration of an exemplary portion of a catheter 1104, illustrating an exemplary embodiment of the delivery system 1105, shows the proximal capsule portion 1109 translated away from the distal capsule portion 1102, exposing the atrial portion of an exemplary embodiment of the artificial heart valve device 1108. According to some applications of the invention, Figure 11CThe diagram illustrates a fully deployed configuration of an exemplary portion of the catheter 1104, representing an exemplary embodiment of the delivery system 1110, showing that both the proximal capsule portion 1112 and the distal capsule portion 1111 have been fully translated away from each other, fully exposing the ventricular portions 1113 and 1114 of an exemplary embodiment of the artificial heart valve device 900. It should be understood that in this exemplary embodiment of the artificial heart valve device 900, the atrial portions 1113 and ventricular portions 1114 are not yet fully deployed.

[0194] refer to Figure 12A-12B According to some applications of the invention, it is a schematic diagram illustrating the sequence of transitions between the diastolic and systolic phases of the cardiac cycle, specifically with reference to a cross-section of the heart (diastolic 120°, systolic 124°, see respective figures). Figure 12A , 12B ( ), and exemplary artificial heart valve devices implanted in situ (diastolic embodiment 1230, systolic embodiment 1260, see respectively) Figure 12A , 12B Specifically, Figure 12A An exemplary diastolic embodiment of an artificial heart valve device 1230 implanted in the mitral valve location is shown. The opening leaflet 1235 of the exemplary diastolic embodiment of the artificial heart valve device 1230 functions in response to blood flow from the left atrium 1206 (cross-section 1205) toward the left ventricle 1215 during diastolic ventricular filling. Similarly, the closing leaflet of the exemplary aortic valve 1225 also functions in response to diastolic ventricular filling. Directly below the closing leaflet of the exemplary aortic valve 1225, a cross-section 1210 of the left ventricular outflow tract 1220 and the left ventricular wall, in an expanded state, is visible. Directly above the exemplary diastolic embodiment of the artificial heart valve device 1230, an arrow 1221 is visible, corresponding to the posture of the exemplary diastolic embodiment of the heart valve stent 1231, which remains stationary relative to the natural valve annulus where the exemplary diastolic embodiment of the differentially deformable anchoring structure 1229 is located. The natural anterior leaflet 1201 can be seen at an exemplary diastolic embodiment adjacent to the artificial heart valve device 1230, depicted in a free, open, and unrestrained position. It should be understood that... Figure 12A The exemplary embodiments of the natural anatomical structures and artificial heart valve devices depicted can also be implemented relative to the anatomical structures of alternative atrioventricular valves, such as the tricuspid valve and its corresponding natural tricuspid valve anatomy.

[0195] Now for reference Figure 12BAccording to some applications of the invention, this is a schematic diagram of an exemplary systolic embodiment of an artificial heart valve device 1260 implanted in the mitral valve location, with specific reference now to a cross-section of the heart at systolic 1240. The closed leaflet 1255 of the exemplary systolic embodiment of the artificial heart valve device 1260 functions in response to pressure in the left ventricle 1215, and thus allows blood to flow from the left ventricle 1215 (cross-section 1250) to the left ventricular outflow tract 1220 during systolic ventricular contraction, and out through the open aortic valve 1245. The unconstrained natural anterior leaflet 1202 can be seen in the closed position, immediately adjacent to the anterior portion of the exemplary systolic embodiment of the artificial heart valve device 1260. Arrow 1265 can be seen directly above the exemplary systolic embodiment of the artificial heart valve device 1260, corresponding to the posture of the exemplary systolic embodiment of the heart valve stent 1261, which is moved in the atrial direction relative to the natural valve annulus where the exemplary systolic embodiment of the differentially deformable anchoring structure 1259 is located. It should be understood that... Figure 12B The exemplary embodiments of the natural anatomical structures and artificial heart valve devices depicted can also be implemented in this manner relative to the anatomical structures of alternative atrioventricular valves, such as the tricuspid valve and its corresponding natural tricuspid valve anatomy.

[0196] refer to Figure 13A According to some applications of the invention, this is a schematic perspective view of a detailed portion 1315 illustrating an embodiment of an exemplary artificial heart valve device 1340 loaded into an exemplary delivery system 1300. An exemplary embodiment of the load delivery system 1300 in a curved configuration may include a proximal portion of a capsule 1310 located adjacent to a proximal neck 1305, and a distal portion of a capsule 1325 adjacent to the proximal portion 1310, wherein each capsule portion is configured to translate away from the opposing capsule portion during deployment. Prior to the introduction of a catheter into the delivery system 1300, the exemplary embodiment of the load delivery system 1300 in a curved configuration may be configured to be secured in an anatomical position by a guidewire 1330, which can be programmed into place, above the top of the guidewire 1330. The detached cross-sectional view window 1315 allows a view of a partially exposed section 1340 of the exemplary artificial heart valve device stent, showing an embodiment of the geometry 1316 of the flexible deformable portion. The geometry 1316 of the flexible deformable portion can be configured to allow specific portions of an exemplary embodiment of the heart valve device 1340 to be bent to specific directions and radii of curvature, suitable for tracing locations through natural anatomical vessels, veins, and arteries and entering within natural atrioventricular valves. An enlarged view 1320 of a broken cross-sectional window details the enlarged and partially exposed geometry 1345 of the flexible deformable portion. This is now illustrated by following the depicted reference. Figure 13BArrow 1335 turns Figure 13B According to some applications of the present invention, a fragment of an exemplary artificial heart valve device stent planar pattern 1350 is schematically shown. The exemplary artificial heart valve device stent planar pattern 1350 may include an exemplary embodiment of an atrial region bending element 1351 configured to allow specific bending of the artificial heart valve device in the atrial region, and an exemplary embodiment of a ventricular region bending element 1352 configured to allow specific bending of the artificial heart valve device in the ventricular region.

[0197] refer to Figure 14 It is a conveying system (1500, Figure 15A A schematic diagram of the distal portion 1405 of an exemplary embodiment of the artificial heart valve device 1400, wherein the exemplary embodiment of the partially deployed configuration of the loaded artificial heart valve device 1400 is for illustrative purposes. As previously stated, the artificial heart valve device 1400 is one application of the present invention. Exemplary delivery system (1500, Figure 15A The device may include an assembly of concentrically aligned and radially adjacent flexible catheters, including a first catheter 1420, a second catheter 1430 configured to at least partially extend through the first catheter 1420, a third catheter 1445 configured to at least partially extend through the second catheter 1430, and a fourth catheter 1450 configured to at least partially extend beyond the first catheter 1420. The fourth catheter 1450 may have a proximal outer covering portion 1415. The third catheter 1445 may have a distal outer covering portion 1425. The second catheter 1430 may have a connecting element 1435 for connection to a portion of an exemplary artificial heart valve device 1400. The first catheter 1420 may accommodate a plurality of tethers 1440 configured to mate with a portion of the heart valve device 1400 located in the atrial region. The tethers may also include a plurality of tether connector structures 1455 providing a manner through which the tethers mate with the artificial heart valve device, details of which are further provided below. Additional details regarding the aforementioned catheters are also provided below.

[0198] refer to Figure 15A -B, according to some applications of the present invention, is a schematic diagram of an exemplary delivery system 1500 for a loaded artificial heart valve device 1535 in a compressed delivery state.

[0199] The delivery system 1500 is configured for intracardiac delivery of a compressed artificial heart valve device 1535 and includes a handle portion 1520 and a catheter portion 1525 adjacent to and extending distally from the handle portion 1520.

[0200] The handle portion 1520 typically has an elongated shape and is generally cylindrical, having a proximal region 1505, a distal region 1515, and an intermediate region 1510 located between them.

[0201] The catheter portion 1525 extends distally from the distal region 1515 of the handle portion 1520 and may include one or more flexible catheters, such as a first catheter 1420 and a second catheter 1430, extending through the first catheter 1420 such that the flexible distal portion of the second catheter 1430 is disposed outside the distal end of the first catheter 1420. The distal portion of the second catheter 1430 may also include a connecting element 1435 configured for releasable attachment to at least a portion of the compressed artificial heart valve device 1535.

[0202] The conduit portion 1525 of the delivery system 1500 also includes a third conduit 1445 that extends through the second conduit 1430, such that the distal outer cover portion 1425 is disposed outside the distal end of the second conduit 1430.

[0203] The catheter portion 1525 of the delivery system 1500 also includes a fourth catheter 1450 that covers a portion of the first catheter 1420 and includes a proximal outer cover portion 1415 that can extend over at least a portion of the compressed artificial heart valve device 1535.

[0204] The catheter portion 1525 of the delivery system 1500 also includes a holding region 1530 configured to hold the compressed artificial heart valve device 1535 for delivery. For example, the distal outer covering portion 1425 of the third catheter 1445 and the proximal outer covering portion 1415 of the fourth catheter 1450 can act as restraint members, each radially restraining at least a portion of the compressed artificial heart valve device 1535 in a compressed delivery state, thereby holding the compressed artificial heart valve device 1535.

[0205] The distal region 1515 of the handle portion 1520 typically includes a first thumbwheel 1545, which is controllably communicated with the fourth catheter 1450 (described in further detail below) via mechanical interaction within the distal region 1515. Actuation of the first thumbwheel 1545 can controllably translate the fourth catheter 1450 from a first position (proximal) to a second position (distal) further downstream than the first position and back. When in the second position (distal), the proximal outer cover portion 1415 of the fourth catheter 1450 can be advantageously positioned to restrain at least a portion of the compressed artificial heart valve device 1535. When in the first position (proximal), the proximal outer cover portion 1415 of the fourth catheter 1450 can be advantageously positioned to release at least a portion of the compressed artificial heart valve device 1535 from radial restraint.

[0206] The distal region 1515 of the handle portion 1520 typically also includes a saline flushing port 1540a, which can help remove trapped air from between concentric adjacent catheters during device preparation, for example by allowing the injection of sterile saline between the fourth catheter 1450 and the first catheter 1420, thereby removing trapped air and preventing air embolism from being introduced into the bloodstream.

[0207] refer to Figure 16A -B and Figure 17A -E, The intermediate region 1510 of the handle portion 1520 typically includes a saline flushing port 1540b and a tethered shuttle assembly 1560, details of which will be provided further below. The saline flushing port 1540b of the intermediate region 1510 can help remove trapped air from between concentric adjacent catheters during device preparation, for example, by allowing the injection of sterile saline between the first catheter 1420 and the second catheter 1430 to remove trapped air and prevent air embolism from being introduced into the bloodstream. The intermediate region 1510 of the handle portion 1520 may also include a location for mechanically attaching the internal components of the first catheter 1420 to the handle portion 1520.

[0208] The proximal region 1505 of the handle portion 1520 typically includes a second knob 1550, which is controllably connected to the second catheter 1430 via mechanical interaction within the proximal region 1505 (described in further detail below). Actuation of the second knob 1550 can controllably translate the second catheter 1430 from a first position (proximal) to a second position (distal) further downstream than the first position and back. When in the second position (distal), the compressed artificial heart valve device 1535 can be positioned more distally (e.g., when in the ventricle of the heart) while being loaded for delivery. When in the first position (proximal), the compressed artificial heart valve device 1535 can be positioned more proximally while being loaded for delivery.

[0209] The proximal region 1505 of the handle portion 1520 may further include a third knob 1555, which is controllably connected to the third catheter 1445 via mechanical interaction within the proximal region 1505 (described in further detail below). Actuation of the third knob 1555 can controllably translate the third catheter 1445 from a first position (proximal) to a second position (distal) further downstream than the first position and back. When in the first position (proximal), the distal outer covering portion 1425 of the third catheter 1445 may be advantageously positioned to restrain at least a portion of the compressed artificial heart valve device 1535. When in the second position (distal), the distal outer covering portion 1425 of the third catheter 1445 may be advantageously positioned to release at least a portion of the compressed artificial heart valve device 1535 from radial restraint.

[0210] The proximal region 1505 of the handle portion 1520 typically also includes a saline flushing port 1540c, which can help remove trapped air from between concentric adjacent catheters during device preparation, for example, by allowing the injection of sterile saline between catheters 1430 and 1445, thereby removing trapped air and preventing air embolism from being introduced into the bloodstream. The proximal region 1505 of the handle portion 1520 also includes a saline flushing port 1540d, which can help remove trapped air from within the guidewire lumen, which extends from a first end of the third catheter 1445 to a second end opposite the first end, by allowing the injection of sterile saline therein, thereby removing trapped air and preventing air embolism from being introduced into the bloodstream.

[0211] The proximal region 1505 of the handle portion 1520 may also include a compensation mechanism, such as an internal mechanism (described in more detail below, see reference). Figure 19A -C、 Figure 18A -I、 Figure 20A-C), which provides a lead screw system shared by the second knob 1550 and the third knob 1555 (see reference). Figure 8A (As shown in -C), therefore, actuation of the second knob 1550 can mechanically displace the third knob 1555. That is, actuation of the second knob 1550 can simultaneously displace the second conduit 1430, the third knob 1555, and the third conduit 1445 in the same time and in the same direction, because they are mechanically connected as a system.

[0212] The enlarged view section frame 1570 shows an enlarged view of the object in the detailed view section frame 1565, and includes an enlarged view of the compressed artificial heart valve device 1535, the distal cover portion 1425 of the third catheter 1445 and the proximal cover portion 1415 of the fourth catheter 1450, and this view is provided for clarity.

[0213] Now for reference Figure 16A -B, a schematic diagram of a delivery system 1500 according to some applications of the invention. Further details will be provided for the distal region 1515, the intermediate region 1510, and the proximal region 1505 of the handle portion 1520.

[0214] Specifically, the distal handle region 1515 may further include a distal handle cap 1600, which provides a support surface 1605 for coupling to a holding system (not shown) and allowing relative rotation between a portion of the delivery system 1500 and the holding system. A first knob 1545 may be included within a plurality of knob covers 1610 for including the first knob 1545 while simultaneously securing the cylindrical (or other shaped) portion of the distal handle region 1515 together. A translation groove 1615 on the distal handle region 1515 may provide clearance for the translation of a brine flushing port 1540a, which is controllably moved with the fourth conduit 1450, as the first knob 1545 is rotatably actuated in a first or second direction, opposite to the first.

[0215] The proximal handle region 1505 may also include a proximal handle cap 1630, which provides a support surface 1635 for coupling to a holding system (not shown) and allowing relative rotation between a portion of the delivery system 1500 and the holding system. A second knob 1550 may be included within a plurality of knob covers 1610 for including the second knob 1550 while simultaneously securing the cylindrical (or other shaped) portion of the proximal handle region 1505 together. A translation groove 1625 on the proximal handle region 1505 may provide clearance for the translation of the brine flushing port 1540c, which is controllably moved with the second conduit 1430, as the second knob 1550 is rotatably actuated in a first or second direction, opposite to the first.

[0216] refer to Figure 16B As described above, the intermediate handle area 1510 may also include an outlet groove 1620 for the brine flushing port 1540b, which can help remove trapped air from between concentric adjacent conduits during device preparation.

[0217] As shown in the figure and detailed below, the central handle region 1510 may include multiple tether shuttles 1640, which are configured to controllably optimize the artificial heart valve device (not shown) and multiple tethers (1440, Figure 14 The tension between the tethers is such that these tethers are configured to be connected to portions of the artificial heart valve device via a fastening mechanism. The tether shuttle 1640 may include a tether shuttle body 1645 and a tether shuttle latch 1650, the tether shuttle latch 1650 being configured to controllably rotate about the tether shuttle latch hinge 1655 from a first position to a second position, which is rotatably displaced from the first position, and is also configured to be mechanically attached to the proximal portion of the tether sheath 1660. By actuating the tether shuttle latch 1650, the internal connection communicating with the proximal portion of the tether sheath 1660 can concentrically retract the proximal portion of the tether sheath 1660 (from the distal position to the proximal position opposite to the distal position) to the top of the internal tether cable (not shown), thereby providing the tether (1440, Figure 14 The controllable connection and release of portions of the artificial heart valve device (described further below, see reference) Figure 17A -F).

[0218] The tether shuttle body 1645 may be generally rectangular in shape and may transition from a first end of the tether shuttle slot 1665 to a second end opposite to the first end within the tether shuttle slot 1665. The tether shuttle body 1645 may be spring-biased (not shown) at a first proximal position corresponding to the first end of the tether shuttle slot 1665 and may be manually translated by pushing, or automatically translated, for example, when placed under tensile load, from the artificial heart valve device along the tether (1440). Figure 14 )transmission.

[0219] refer to Figure 17A -F, according to some applications of the invention, is a schematic diagram of the artificial heart valve device holding region 1530 of the delivery system. Figure 17AAn enlarged view of the artificial heart valve device retention region 1530 is provided. The retention region 1530 may include a distal outer cover 1425 distally connected to a third catheter 1445 which may extend through a second catheter 1430 which may have a guidewire lumen 1760 therethrough, and a proximal outer cover 1415 extending from a fourth catheter 1450; as described above, the distal and proximal outer covers (1425 and 1415, respectively) together provide location for the compressed artificial heart valve device 1535.

[0220] More specifically, the artificial heart valve device holding region 1530 may also include a plurality of tether connector structures 1455 in a closed configuration 1700. In the closed configuration 1700, the tether connector structures 1455 are concentric with and configured to be radially adjacent to the second catheter 1430, and generally aligned with the long axis (axis not shown) of the second catheter 1430. The tether connector structures 1455 are schematically shown as closed and in partial contact with the compressed artificial heart valve device 1535, and provide radial and tensile restraints to the compressed artificial heart valve device 1535, thereby holding it in a closed and compressed configuration suitable for delivery. More specifically, the tether connector structures 1455 may be closed and in contact with a connecting element of the compressed artificial heart valve device 1535 (e.g., an atrial connecting element 1720 with an atrial connecting tab 1730). The tether connector structure 1455 can mate and contact the furthest portion of the tether sheath 1740 and the inner cable 1775, as schematically shown in [the diagram]. Figure 17F There is a hidden line in it.

[0221] More specifically, referring to the tether connector structure 1455, the distal portion of the tether sheath 1740 can engage with a tether connector cover 1715 (connected via a tether connector cover sleeve 1735), the rope connector cover 1715 being configured to slidably engage with and internally include the tether connector 1725; the tether connector 1725 further engages with an inner cable 1775 extending from a first end to a second end within the tether sheath. The proximal portion of the tether sheath 1660, opposite the distal end, can engage with an actuated portion of a shuttle mechanism 1705, which can controllably and translatably position the tether connector cover 1715 in a first or second position (opposite to the first position) relative to the internal tether connector 1725; the tether connector also engages with a fixed portion of the shuttle mechanism 1705 via the inner cable 1775 and is configured to remain stationary.

[0222] like Figure 17CThe diagram schematically illustrates that when the tether connector cover 1715 is biased distally (first position, closed), it can preferentially cover the tether connector 1725, thereby trapping a portion of the compressed artificial heart valve device 1535, such as the connecting element, like the atrial connecting element 1720 with the atrial connecting pull tab 1730. Figure 17B A perspective view of the shuttle mechanism 1705 corresponding to the first closed position of the chain connector cover 1715 is schematically shown.

[0223] refer to Figure 17C Additional features of the second catheter 1430 are described. Specifically, a series of regions with different stiffnesses are described. Extending from the distal end of the second catheter 1430 is a distal rigid region 1745, followed by a distal rigid transition region 1750, and finally a distal flexible region 1755. The inherent stiffness of the distal region of the second catheter 1430 transitions from the stiffer portion (1745) to the softest portion (1755), providing enhanced flexibility and allowing passage through narrow radius bends (e.g., those experienced during implantation).

[0224] like Figure 17E The diagram schematically shows that when the tether connector cover 1715 is biased proximally (second position, opposite to the first position and open), it can preferentially expose (indicated by arrow 1770 indicating translation) the tether connector 1725, thereby releasing compressed portions of the artificial heart valve device 1535, such as connecting elements, like the atrial connecting element 1720 with atrial connecting pull tab 1730. Figure 17D The diagram schematically shows a perspective view of the shuttle mechanism 1710 corresponding to the second open position of the chain connector 1725 (indicated by arrow 1765 after the chain shuttle latch 1650 has rotated).

[0225] refer to Figure 18A -I, according to some applications of the invention, is a series of schematic diagrams depicting the expansion of an artificial heart valve device deployed by a delivery system. Turn Figure 18A -B, depicts the artificial heart valve device holding region 1530, which has a first closed state ( Figure 18A The fourth catheter 1450 has a proximal outer covering 1415 in a closed position, covering at least a portion of the compressed artificial heart valve device 1535. The artificial heart valve device holding region 1530 is also depicted having a second open state. Figure 18C The proximal outer covering 1415 of the fourth catheter 1450 is in the open position and displaced proximally by a distance Dl from the closed position, thereby exposing the plurality of tether connector structures 1700 in the closed configuration before at least a portion of the compressed artificial heart valve device 1535 and the plurality of tether connector structures 1700 expand.

[0226] As mentioned above and Figure 18B The proximal outer cover 1415 of the fourth catheter 1450 can be displaced a distance D1 (indicated by the rotating arrow 1830) by actuating the first knob 1545. The proximal outer cover 1415 of the fourth catheter 1450 can also be moved a distance D1 in the opposite direction, thereby returning it to the closed state as described above by actuating the same first knob 1545. Figure 18A ).

[0227] Once in the open state ( Figure 18C Before the compressed portion of the artificial heart valve device 1535 (e.g., atrial region 1410) expands, the atrial region 1410 may have a first diameter d1. After the compressed portion of the artificial heart valve device 1535 (e.g., atrial region 1410) expands, the atrial region 1410 may have a second diameter d2 larger than the first diameter. Figure 18D And it is situated in a structure suitable for the atrial surface engagement of the natural heart (not shown). The tibia 1800, in a fully expanded state, is also present. Figure 18D middle.

[0228] refer to Figure 18E The distal outer covering 1425 is depicted as being in a closed state before being displaced to the open state. The partially deployed artificial heart valve device 1835, with a partially deployed atrial region 1805, can be actuated by a third knob 1555 (indicated by arrow 1865). Figure 18F The distal outer covering 1425 of the third catheter 1445 is displaced distally by at least a distance D2. Figure 18G The device is further unfolded to expose at least a portion of the partially unfolded artificial heart valve device 1835, such as the ventricular portion 1845 in a compressed configuration, and to expose the mating pin 1820 configured to releasably engage with the ventricular anchor mating groove 1825. The distal outer cover 1425 of the third catheter 1445 can also be moved a distance D2 in the opposite direction, thereby returning it to the closed state as described above. Figure 18E ).

[0229] In a partially unfolded state ( Figure 18E ) after, however, just before the final expansion ( Figure 18G The compressed ventricular region 1845 may have a third diameter d3. After the compressed ventricular region 1845 expands, the expanded ventricular region 1840 may have a fourth diameter d4, which is larger than the third diameter. Figure 18G And it is in a configuration suitable for engaging with the ventricular surface of the natural heart (not shown).

[0230] refer to Figure 18H-I, according to some applications of the present invention, depicts a series of schematic diagrams of an artificial heart valve device that is ultimately deployed from a delivery system.

[0231] According to some applications of the present invention, Figure 18I A schematic diagram shows a fully dilated atrial region 1850, a fully dilated annular region 1855, and a fully dilated ventricular region 1860. The fully dilated atrial region 1850 is configured to engage with the surface of atrial tissue in the natural heart, such as the left atrial surface of the mitral valve (see [reference]). Figures 5A-5B The fully dilated annular region 1855 was configured to engage with the annular tissue surface of the natural heart, such as the annular surface of the mitral valve (see [link]). Figures 5A-5B The fully dilated ventricular region 1860 was configured to engage with the surface of the natural heart's ventricular tissues, such as the left ventricle, mitral valve leaflets, and / or chordae tendineae (see [link to relevant documentation]). Figures 5A-5B )

[0232] The controlled, eventual release, and permanent implantation of the artificial heart valve device 1810 can be achieved through each tether shuttle 1640 ( Figure 16B , Figure 18H Controlled actuation is achieved for each of the 1640 (system shuttle components). Figure 16B , Figure 18H The controlled actuation of the chain shuttle latch 1650 of each chain shuttle 1640 is achieved by actuating the chain shuttle latch 1650 of each chain shuttle 1640. Figure 16B , Figure 18H This results in the tether shuttle 1640 being in the open configuration 1710. According to some applications of the invention, a fully released, permanently implanted artificial heart valve device 1810 is schematically shown... Figure 18I Once each tether shuttle 1640 has been actuated and the tether connector is fully open 1815, each atrial connecting pull tab 1730 can be released from restraint, thereby allowing each atrial region to fully expand 1850, resulting in the fully released and permanently implanted artificial heart valve device 1810.

[0233] refer to Figure 19A -D, according to some applications of the present invention, provides a schematic diagram depicting the conformational change mechanism of the outer sheath of the second and third catheters.

[0234] Specifically, Figure 19A The overall effect of the compensating mechanism within the delivery system on the anchoring structure of the artificial heart valve device is described when the partially deployed atrial region 1805 of the artificial heart valve device has been advanced into contact with the natural atrial floor (not shown) and a seating force has been applied to the first catheter 1420, thereby maintaining contact (not shown) between the partially deployed atrial region 1805 and the natural atrial floor. Figure 19AAs can be seen, the first catheter 1420 and the fourth catheter 1450 have been displaced distally, generating tension on the tether 1920 and, due to their connection, creating a seating force for the partially unfolded atrial region 1805. This distal displacement of the first catheter 1420 and the fourth catheter 1450 is achieved by a compensation mechanism of the delivery system, now referred to... Figure 19B -D describes its details. For example... Figure 19B The description provides a simplified view of the distal portion of the pre-displaced delivery system 1910. The implementation of the tether and artificial heart valve device is not described in the text. Figure 19B Presented in this way, in cases involving conduits, to more clearly illustrate the mechanical interactions present during this phase of device operation. Element D5 represents the first distance between the distal region of the first conduit 1420 and the reference point of the second conduit (adjacent to the stiffness transition region 1750). This is achieved by actuation via rotating arrow 1900 (… Figure 19C The third knob (1550) indicates... Figure 19C The distal holding region 1905 and the partially deployed artificial heart valve device (not shown) are both translated proximally until a second distance, indicated by element D6, reaches the distal region of the first catheter 1420 and the same reference point on the second catheter (adjacent stiffness transition region 1750). This proximal orientation position (after displacement) 1915 is described in Figure 19D The implementation of tethers and artificial heart valve devices is also omitted to more clearly illustrate the mechanical interactions present during this phase of device operation, especially when catheters are involved. This positional change of the distal holding region 1905, activated by a compensating mechanism within the delivery system, allows for better control of artificial heart valve delivery. The compensating mechanism within the delivery system can assist in controlling the conformational changes experienced by the anchor structure to better approximate the ventricular anatomy, improving the gap between the portion of the artificial heart valve and the ventricular regional structures, and necessitating reversible repositioning and re-approximation of the artificial heart valve.

[0235] refer to Figure 20A -C, According to some applications of the present invention, schematic diagrams depicting embodiments of an exemplary conveying system in cross-sectional view are provided. Figure 20A An embodiment of the conveying system, shown in cross-section 2000, depicts the middle and proximal regions. The guide screw 2015 of the third knob 1555 and the guide screw 2020 of the second knob 1550 are also shown. Finally, a cross-sectional view of the chain tension adjustment mechanism 2030 is provided.

[0236] Figure 20B An embodiment of the conveying system's distal region, shown in cross-section 2005, is depicted. The lead screw 2025 of the first knob 1545 is also shown. Figure 20CAn embodiment of the holding area of ​​the conveying system, shown in cross-section 2010, is depicted.

[0237] Although the subject matter of this disclosure has been described in its preferred embodiments, it should be understood that the terms used are descriptive rather than restrictive. Therefore, changes may be made in the appended claims without departing from the true scope of the subject matter.

[0238] Those skilled in the art will understand that this invention is not limited to what has been specifically shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications that are not part of the prior art, which will come to mind for those skilled in the art upon reading the foregoing.

[0239] Optional claim set

[0240] 1. A system, comprising:

[0241] Artificial heart valve devices include:

[0242] A differentially deformable anchoring structure concentrically aligned with, radially adjacent to, and directly connected to the valve stent; and

[0243] The conveying system includes:

[0244] A first conduit having a first diameter, the first conduit including a main lumen, a first flexible portion, and one or more auxiliary lumens radially adjacent to the main lumen;

[0245] One or more tethering assemblies, releasably connected to portions of the artificial heart valve device and configured to translate through the one or more auxiliary lumens of the first catheter.

[0246] The second catheter, sized to fit and translate within the main lumen of the first catheter, includes a lumen, a second flexible portion, and one or more connecting elements for connection to an artificial heart valve device.

[0247] A control assembly, the control assembly including a compensation mechanism connected in communication with the second catheter, wherein the control assembly is configured to controllably realize translation of the second catheter and allow conformational changes of the artificial heart valve;

[0248] The system is in a delivery state, wherein the artificial heart valve device is releasably connected to the tether assembly and the connecting element is in a compressed, elongated configuration;

[0249] Specifically, the artificial valve is advanced to the natural atrioventricular valve via the femoral access through the delivery system and implanted controllably via a compensation mechanism within the control assembly.

Claims

1. An artificial heart valve device, comprising: An expandable valve stent comprising multiple leaflets for supporting the valve and having an inflow region, an intermediate region and an outflow region downstream of the inflow region; The inflow area further includes multiple inflow area connecting components, the intermediate area further includes a leaflet support structure, and the outflow area further includes multiple outflow area connecting components. and A valve sealing cover that extends between the inflow region and the outflow region and is configured to prevent paravalvular leakage; The valve is configured to switch between a flow-allowing state and a flow-blocking state; A differentially deformable anchoring structure, which is concentrically aligned with, radially adjacent to and surrounds the valve stent, and includes an atrial region, annular region and ventricular region; The atrial region typically has a first stiffness and includes a plurality of atrial region connecting elements, which are adjacent to and in contact with the inflow region connecting member of the valve stent; the annular region typically has a second stiffness and includes annular anchoring elements for preventing retrograde displacement of the device; the ventricular region typically has a third stiffness and includes a plurality of ventricular region connecting elements, which are adjacent to and in contact with the outflow region connecting member of the valve stent. and An anchor seal that extends between the atrial and ventricular regions and is configured to prevent paravalvular leakage; The artificial heart valve device is configured to controllably transition between a radially minimized, compressed state configured for delivery and a radially maximized, expanded state configured for implantation, wherein the expandable valve stent and the differentially deformable anchoring structure are configured to contract uniformly together; and The anchoring structure is configured to permanently anchor the heart valve device within the atrioventricular valve of the heart when the device is in the expanded state and implanted. The connection between the inflow region connecting member and the atrial region connecting element, and the connection between the outflow region connecting member and the ventricular region connecting element, are configured to absorb displacement between the anchoring structure and the internal valve stent.

2. The artificial heart valve device of claim 1, wherein during device implantation, any valve leaflet is aligned with the natural anterior leaflet of the atrioventricular valve of the heart to avoid obstruction of the ventricular outflow tract after device implantation; The anchoring structure includes multiple elongated and wide ventricular congruence structures, each including a base for abutting the natural ventricular roof and multiple slender ventricular congruence structure support struts; and The plurality of the connecting elements define three sets of outflow openings located between the ventricular concordance structures.

3. The artificial heart valve device of claim 1, wherein any valve leaflet is aligned with the natural anterior leaflet of the atrioventricular valve of the heart during device implantation, allowing the natural anterior leaflet to move freely after device implantation.

4. The artificial heart valve device of claim 1, wherein the expandable valve stent further comprises a plurality of junctional members for providing positioning and fixation between adjacent leaflets, and wherein each outflow region connecting member of the valve stent extends from the junctional members.

5. The artificial heart valve device of claim 1, wherein each inflow region connecting member further includes a geometry of a flexible deformable portion configured to mechanically dampen the transmission of forces between the anchoring structure and the valve stent.

6. The artificial heart valve device of claim 1, wherein each outflow region connecting member further includes a geometry of a flexible deformable portion configured to mechanically dampen the transmission of forces between the anchoring structure and the valve stent.

7. The artificial heart valve device of claim 1, wherein the geometry of the flexible deformable portion of each inflow region connecting member is further configured to allow the valve stent to translate from the anchoring structure during contraction.

8. The artificial heart valve device of claim 1, wherein the geometry of the flexible deformable portion of each inflow region connecting member is further configured to allow the reversal of the translational displacement of the valve stent from the anchoring structure during diastole.

9. The artificial heart valve device of claim 1, wherein the anchoring structure comprises a plurality of elongated and wide ventricular concordance structures, the ventricular concordance structures including a root portion for abutting the top surface of the natural ventricle and a plurality of elongated ventricular concordance structure support struts.

10. The artificial heart valve device of claim 1, wherein the geometry of the flexible deformable portion of each inflow region connecting member further includes the geometry of a radially flexible deformable portion, and is further configured to allow the radially flexible deformable portion of the inflow region to bend radially in response to force when compressed.

11. The artificial heart valve device of claim 9, wherein the plurality of elongated ventricular congruent structure support struts terminate at the ventricular release member.

12. The artificial heart valve device of claim 1, wherein each outflow region connection member further comprises a rigid geometry configured to resist bending or displacement between the anchoring structure and the valve stent.

13. The artificial heart valve device of claim 9, wherein each of the plurality of ventricular region connecting elements is at least partially formed by filaments interwoven between the plurality of elongated ventricular consistency structure support struts and the plurality of outflow region connecting members.

14. The artificial heart valve device of claim 1, wherein the atrial region of the anchor further comprises a plurality of support structures terminating in a releasably captured atrial retaining member, wherein, The support structure is configured, upon implantation, to align with the base of the natural atrium of the atrioventricular valve adjacent to the heart, according to the first stiffness.

15. The artificial heart valve device of claim 14, wherein the releasably captured atrial retaining member is configured to be releasably connected to the delivery system of the artificial heart valve device.

16. The artificial heart valve device of claim 1, wherein, when viewed in standard imaging mode, the plurality of support structures in the atrial region of the anchor provide a clear indication of the relative position and orientation of the device with respect to the natural valve annulus and outflow tract of the heart.

17. The artificial heart valve device of claim 1, wherein the plurality of support structures of the atrial region of the anchor further include a geometry of a radially flexible deformable portion and are further configured to allow the radially flexible deformable portion of the atrial region to bend radially in response to force when compressed.

18. The artificial heart valve device of claim 1, wherein the atrial region of the anchor is generally truncated conical in shape, having a first diameter adjacent to the annular region and a second diameter greater than the first diameter and adjacent to the atrial region.

19. The artificial heart valve device of claim 1, wherein the atrial region of the anchor is generally disc-shaped.

20. The artificial heart valve device of claim 1, wherein the atrial region of the anchor is generally bowl-shaped.

21. The artificial heart valve device of claim 1, wherein the annular region of the anchor is further configured to apply a radial anchoring force outward against the natural annulus of the atrioventricular valve of the heart according to the second stiffness when implanted.

22. The artificial heart valve device of claim 1, wherein the valve annulus anchoring element comprises a tissue puncture structure.

23. The artificial heart valve device of claim 22, wherein the valve annulus anchoring element further comprises one or more rows of tissue puncture structures, and wherein each structure points in the same direction.

24. The artificial heart valve device of claim 22, wherein the valve annulus anchoring element further comprises two rows of tissue puncture structures, and wherein the two rows of tissue puncture structures generally point toward each other.

25. The artificial heart valve device of claim 1, wherein the differentially deformable anchoring structure is configured to deform to allow the valve stent to maintain a substantially cylindrical geometry.

26. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is further configured to conform to the natural ventricle of the heart according to the third stiffness when implanted.

27. The artificial heart valve device of claim 1, wherein the ventricular region connection member of the anchor comprises an elongated structural member, the distal end of the elongated structural member being disposed from the annular region of the anchor and extending toward the ventricle, and terminating in a releasably captured ventricular retaining member.

28. The artificial heart valve device of claim 27, wherein the releasably captured ventricular retaining member is configured to be releasably connected to the delivery system of the artificial heart valve device, wherein, The differentially deformable anchoring structure has an anchor cross section, and the expandable valve stent has a valve stent cross section. The anchor cross section and the valve stent cross section have equal lengths, such that during the loading of the delivery system of the artificial heart valve device, when placed under tension in the inflow and outflow regions, the anchoring structure and the valve stent contract uniformly together.

29. The artificial heart valve device of claim 1, wherein the ventricular region connecting member of the anchor further includes a geometry of a radially flexible deformable portion and is further configured to allow the radially flexible deformable portion of the ventricular region to bend radially in response to force when compressed.

30. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is generally truncated conical in shape, having a first diameter adjacent to the annular region and a second diameter greater than the first diameter and adjacent to the ventricular region.

31. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is generally truncated conical in shape, having a first diameter adjacent to the annular region and a second diameter smaller than the first diameter and adjacent to the ventricular region.

32. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is generally bowl-shaped.

33. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is generally disc-shaped.

34. The artificial heart valve device of claim 1, wherein the ventricular region of the anchor is generally cylindrical in shape.

35. The artificial heart valve device of claim 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the femoral artery or femoral vein.

36. The artificial heart valve device of claim 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision at the apex of the heart.

37. The artificial heart valve device of claim 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision at the corresponding atrium.

38. The artificial heart valve device of claim 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the subclavian vein.

39. A delivery system for an artificial heart valve device according to any one of claims 1 to 38, comprising: An elongated first conduit having a first diameter and including a main lumen, a first flexible portion and one or more auxiliary lumens radially adjacent to the main lumen; One or more tethers, which may be connected to portions of the artificial heart valve device and are configured to translate through the one or more auxiliary lumens of the first catheter; An elongated second catheter having a second diameter smaller than the first diameter and including a lumen, a second flexible portion, and one or more connecting elements for connection to the artificial heart valve device; wherein the second catheter is also configured to translate within the main lumen of the first catheter; and A compensation mechanism, which is connected to the second catheter and enables the artificial heart valve device to be controllably shortened; wherein the one or more tethers and the one or more connecting elements together provide tension that controllably maintains the artificial heart valve device in a radially constrained configuration for delivery, and wherein the compensation mechanism allows the second catheter to release tension by controllably translating within the first catheter during radial expansion of the artificial heart valve device.

40. The delivery system of claim 39 further includes an elongated third catheter having a third diameter smaller than the second diameter and including a lumen, a third flexible portion, and a distal end cover, the distal end cover having a fourth diameter larger than the third diameter and configured to radially constrain a portion of the artificial heart valve device including the portion thereof, the third catheter further being configured to translate within the lumen of the second catheter.

41. The delivery system of claim 40, wherein the distal cover is further configured to encapsulate a portion of the artificial heart valve device by contacting the connecting element of the second catheter.

42. The delivery system of claim 41, wherein the compensation mechanism is further configured to communicate with the third conduit, and wherein the distal end cover of the third conduit is controllably translated by actuation of the compensation mechanism.

43. The delivery system of claim 42 further includes an elongated fourth catheter having a fifth diameter greater than the first diameter and including a lumen and a proximal cover, the proximal cover being configured to provide radial constraint on a portion of the artificial heart valve device that includes the portion thereof; wherein the fourth catheter is further configured to translate over the first catheter.

44. The conveying system of claim 43, wherein the first and second flexible portions further comprise portions of laser-cut nitinol tubes.

45. The conveying system of claim 43, wherein the first and second flexible portions further include portions of laser-cut steel pipes.

46. ​​The delivery system of claim 43, wherein the first and second flexible portions further include portions of a laser-cut polymer tube.

47. The conveying system of claim 43, wherein the first and second flexible portions further include portions of reinforcing fiber tubes.

48. The delivery system of any one of claims 44-47, wherein the second conduit is further configured to be deflected by applying tension to an internally biased drawwire.

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