Ventricular control of artificial atrioventricular valves

Abstract

According to one aspect of the present disclosure, an artificial heart valve system comprises a foldable and expandable artificial atrioventricular valve having an atrial disc, a ventricular disc, a central portion, and a plurality of artificial valve leaflets. The system may include a delivery device comprising a catheter having a valve cover configured to maintain the artificial heart valve in a folded state for delivery. The delivery device may include an expansion limiting mechanism and a shaft device having an atrial tube and a ventricular tube. In the delivery state, the artificial heart valve is folded within the valve cover, and a plurality of sutures can limit and control the expansion of the ends of the artificial heart valve by connecting the atrial tube and ventricular tube to the atrial disc and ventricular disc, respectively.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 500,993, filed on May 9, 2023. The disclosure of this application is hereby incorporated by reference in its entirety.

Background Art

[0002] Cardiac valve disease is one of the major causes of morbidity and mortality. One treatment for this disease is valve replacement. One form of replacement device is a bioprosthetic valve. Folding these valves into a smaller size or placing them within a delivery system enables a less invasive delivery technique compared to conventional open - chest surgery, open - heart surgery. By folding the implant into a smaller size and using a smaller delivery system, the size of the access site is minimized and the number of potential complications during and after the procedure is reduced.

[0003] The size to which an implant can be folded is limited by the volume of the materials used in the implant, the strength and shape of those materials, and the need to function after expansion (or re - expansion). Using multiple steps and / or multiple delivery system devices can increase the time and complexity of the procedure.

[0004] Natural atrioventricular valves (i.e., tricuspid and mitral valves) are typically larger in size and / or diameter compared to natural aortic and pulmonary valves. Among natural atrioventricular valves, regurgitant tricuspid valves are typically larger in size and / or diameter than regurgitant mitral valves. For example, in patients with severe tricuspid regurgitation, the diameter of the tricuspid valve can range from approximately 30 mm to 70 mm (including approximately 40 mm to 66 mm). However, these figures are illustrative only. Consequently, the design and considerations of prosthetic heart valves used to replace various natural heart valves are not the same. For example, to accommodate the larger sizes of mitral and tricuspid valves, recent prosthetic heart valve designs have a large outer frame that engages with the natural mitral or tricuspid annulus, and a smaller, generally cylindrical inner frame located within the outer frame, which houses the leaflets of the prosthetic valve. However, this dual-stent design generally increases the volume of the artificial heart valve, resulting in a larger external shape when folded within the delivery device. This necessitates that the delivery device (e.g., the catheter housing the artificial heart valve folded for delivery) be larger to accommodate the larger valve. Typically, the catheter for transcatheter heart valve delivery devices is desirable to be smaller, as it may need to pass through the vascular system to reach the natural heart valve in a minimally invasive manner.

[0005] When delivering a foldable and expandable atrioventricular valve prosthesis via a fully endovascular approach (e.g., via the femoral vein and inferior vena cava), a portion of the tip of the delivery device housing or otherwise enclosing the prosthesis valve typically needs to be at least partially positioned within the ventricle to properly align with the natural valve annulus. For example, in some self-expanding mitral valve prostheses, before expansion, approximately one-third of the folded length of the prosthesis valve is positioned on the atrial side of the mitral annulus, and approximately two-thirds of the folded length is positioned on the ventricular side of the mitral annulus. This may require a large amount of space to position the delivery device within the left ventricle for successful valve implantation. This positioning may make implantation difficult in at least some situations, but prosthesis tricuspid valves, especially those with a single support frame, can be quite long when folded. Furthermore, the right ventricle is often shorter in available length compared to the left ventricle. Therefore, while artificial tricuspid valve implantation can be particularly challenging, it should be understood that the disclosures herein can be applied to both the implantation and procedures of mitral and tricuspid valves. However, it should be understood that the devices and methods described herein, which enable better control and / or release of self-expanding artificial heart valves during deployment, can be applied to heart valve replacements including aortic, pulmonary, mitral, and tricuspid valves, and furthermore, to any other self-expanding devices delivered intravascularly where more controlled deployment would be beneficial. [Overview of the project]

[0006] According to one aspect of the present disclosure, an artificial heart valve system comprises an artificial heart valve for replacement of a native atrioventricular valve. The artificial heart valve may comprise a frame that is foldable and expandable, having an atrial disc, a ventricular disc, and a central portion extending between the atrial and ventricular discs, and a plurality of artificial valve leaflets arranged within the frame. The system may comprise a delivery device for delivering and deploying the artificial heart valve, the delivery device may comprise a catheter having a valve cover at its distal end, the valve cover being configured to keep the artificial heart valve folded for delivery. The delivery device may comprise an expansion restriction mechanism and a shaft device, the shaft device comprising an atrial tube and a ventricular tube, the expansion restriction mechanism comprising a first pair of rings fixed to the atrial tube and a second pair of rings fixed to the ventricular tube. In the delivery state of this system, the artificial heart valve is folded within the valve cover with the atrial disc positioned adjacent to the atrial tube and the ventricular disc positioned adjacent to the ventricular tube, and a plurality of first sutures connect a first pair of rings and extend through the atrial disc, and a plurality of second sutures connect a second pair of rings and extend through the ventricular disc.

[0007] In the partially deployed state of this system, (i) the valve cover can be withdrawn relative to the prosthetic heart valve so as not to restrict the expansion of the prosthetic heart valve; (ii) a plurality of first sutures can be wrapped around the atrial tube so as to restrict the inflow portion of the atrial disc from self-expanding; (iii) a plurality of second sutures can be wrapped around the ventricular tube so as to restrict the outflow portion of the ventricular disc from self-expanding; and (iv) the outflow portion of the atrial disc, the inflow portion of the ventricular disc, and the central portion of the frame are all at least partially expanded.

[0008] In the partially deployed state of this system, the artificial heart valve may have a peanut shape, wherein at least the partially expanded inflow portion of the ventricular disc has a larger diameter than at least the partially expanded outflow portion of the atrial disc, and at least the partially expanded outflow portion of the atrial disc has a larger diameter than at least the partially expanded central portion of the frame.

[0009] This system may include a gear mechanism coupled to a delivery device, the gear mechanism having a first connector coupled to the atrial tube, a second connector coupled to the ventricular tube, and a knob operably coupled to the first and second connectors, such that rotation of the knob in a first rotational direction causes the first and second connectors, and consequently the atrial and ventricular tubes, to rotate simultaneously in opposite directions. The first connector can be directly coupled to the atrial tube, and the second connector can be directly coupled to a central rod that passes through the atrial tube and directly connects to the ventricular tube.

[0010] The first pair of rings may include a first mounting ring and a first suture ring, and the second pair of rings may include a second mounting ring and a second suture ring, wherein the first plurality of sutures are fixedly coupled to the first mounting ring and relentlessly coupled to the first suture ring, and the second plurality of sutures are fixedly coupled to the second mounting ring and relentlessly coupled to the second suture ring. The first suture ring may have a plurality of first fingers, each having a free end facing a first rotational direction, and the second suture ring may have a plurality of second fingers, each having a free end facing a second rotational direction opposite to the first rotational direction.

[0011] The first pair of rings may include a first mounting ring and a second mounting ring, the second pair of rings may include a third mounting ring and a fourth mounting ring, the first plurality of sutures are fixedly coupled to both the first and second mounting rings, and the second plurality of sutures are fixedly coupled to both the third and fourth mounting rings. The system may comprise a first pull rod extending through the first pair of rings, wherein in the delivery state of the system, the eyelets of the first plurality of sutures receive the first pull rod through the eyelets, and a second pull rod extending through the second pair of rings, wherein in the delivery state of the system, the eyelets of the second plurality of sutures receive the second pull rod through the eyelets, each of the first and second pull rods is configured to be pulled out toward the respective pair of rings to release the respective eyelets from the respective pull rod.

[0012] The atrial disk may have a plurality of atrial openings formed at each of the inflow ends of the atrial disk, and the ventricular disk may have a plurality of openings formed at each of the outflow ends of the ventricular disk, and in the delivery state of the system, a plurality of first sutures may pass through each of the atrial openings, and a plurality of second sutures may pass through each of the ventricular openings.

[0013] According to another aspect of the present disclosure, a method for implanting an artificial heart valve comprises loading the artificial heart valve into a delivery device, the artificial heart valve comprising a foldable and expandable frame having an atrial disc, a ventricular disc, and a central portion extending between the atrial and ventricular discs, and a plurality of artificial valve leaflets positioned within the frame. The delivery device can be advanced into the patient's natural heart valve while the artificial heart valve is kept folded by the valve cover of the delivery device. Deployment of the artificial heart valve can be initiated by withdrawing the valve cover so that the frame begins to expand, while the delivery device is positioned in or adjacent to the natural heart valve. Once the frame begins to expand, the outflow end portion of the ventricular disc can be restricted from expanding by a connection between the outflow end portion of the ventricular disc and a ventricular tube positioned inside the frame, so that the ventricular disc is partially expanded after the valve cover is withdrawn. After the valve cover has been withdrawn and the ventricular disc has partially expanded, the desired position of the artificial heart valve relative to the natural heart valve can be confirmed. After confirming the desired position of the artificial heart valve relative to the natural heart valve, the connection between the outflow end of the ventricular disc and the ventricular tube can be released to expand the ventricular disc and engage with the natural heart valve.

[0014] When the frame begins to expand, the inlet portion of the atrial disc can be restricted from expanding by the connection between the inlet portion of the atrial disc and the atrial tube positioned inside the frame, so that the atrial disc is partially expanded after the valve cover is withdrawn. Even after the valve cover is withdrawn, while the connection between the outlet portion of the ventricular disc and the ventricular tube is maintained, and while the connection between the inlet portion of the atrial disc and the atrial tube is maintained, the artificial heart valve can have a peanut shape in which the outlet portion of the atrial disc is at least partially expanded and the inlet portion of the ventricular disc is at least partially expanded. When the artificial heart valve has a peanut shape, the at least partially expanded atrial disc may have a first diameter, the at least partially expanded ventricular disc may have a second diameter, and the central portion of the frame may have a third diameter, where the second diameter is larger than the first diameter and the first diameter is larger than the third diameter.

[0015] After confirming the desired position of the prosthetic heart valve relative to the natural heart valve, the connection between the inlet portion of the atrial disc and the atrial tube can be released to expand the atrial disc and engage with the natural heart valve. The connection between the outlet portion of the ventricular disc and the ventricular tube can be formed by a first set of sutures, and the connection between the inlet portion of the atrial disc and the atrial tube can be formed by a second set of sutures. In a partially expanded state of the ventricular disc, the first set of sutures can be wrapped around the ventricular tube, and in a partially expanded state of the atrial disc, the second set of sutures can be wrapped around the atrial tube. Releasing the connection between the outlet portion of the ventricular disc and the ventricular tube can include unwinding the first set of sutures from the ventricular tube, and releasing the connection between the inlet portion of the atrial disc and the atrial tube can include unwinding the second set of sutures from the atrial tube. Unwinding the first set of sutures from the ventricular tube and the second set of sutures from the atrial tube may include rotating the atrial tube in a first rotational direction while simultaneously rotating the ventricular tube in a second rotational direction opposite to the first rotational direction. Disconnecting the outflow end of the ventricular disk from the ventricular tube and disconnecting the inflow end of the atrial disk from the atrial tube may include (i) allowing the first set of sutures and the second set of sutures to slide off their respective connection points to the respective tubes, or (ii) actively withdrawing the first pull rod to disconnect the first set of sutures from the ventricular tube and actively withdrawing the second pull rod to disconnect the second set of sutures from the atrial tube. [Brief explanation of the drawing]

[0016] [Figure 1A] This is a perspective view of an artificial atrioventricular valve according to one aspect of the present disclosure. [Figure 1B] Figure 1A shows the cutting pattern of a stent used with an artificial heart valve. [Figure 1C] Figure 1A is a diagram of an artificial heart valve, with some structural elements omitted from the original diagram for clarity. [Figure 1D] It is a schematic side view of a part of the tubular instrument of the delivery device. [Figure 1E] It is an enlarged view of one end of the tubular instrument in FIG. 1D. [Figure 1F] It is a longitudinal sectional view of the tubular assembly of the tubular instrument in FIG. 1D. [Figure 1G] It is a longitudinal sectional view of the tubular assembly of the tubular instrument in FIG. 1D. [Figure 1H] It is a side view of FIG. 1E in a state where the wire structure is radially contracted. [Figure 2A] It is a view showing the frame of the artificial heart valve in a partially expanded state, with other components of the artificial heart valve omitted for clarity. [Figure 2B] It is a top view of the gear device used to control the partial expansion of the frame in FIG. 2A. [Figure 2C] It is a very schematic view of the components of the gear device in FIG. 2B coupled to the shaft device and frame in FIG. 2A. [Figure 3A] It is a perspective view of an expansion control mechanism that can be used with the system of FIGS. 2A - 2C. [Figure 3B] It is a perspective view of an expansion control mechanism that can be used with the system of FIGS. 2A - 2C. [Figure 3C] It is a view showing an alternative suture loop structure used with the expansion control mechanism of FIGS. 3A and 3B. [Figure 3D] It is a view showing an alternative suture loop structure used with the expansion control mechanism of FIGS. 3A and 3B. [Figure 4] It is a perspective view of an additional alternative control mechanism having features common to the expansion control mechanisms of FIGS. 3A and 3B. [Figure 5] It is a perspective view of an additional alternative control mechanism having features common to the expansion control mechanisms of FIGS. 3A and 3B. [Figure 6A] It is a view of a part of the cutting pattern of the stent used with the artificial heart valve in FIG. 1A. [Figure 6B] It is an enlarged view of the ventricular cell of the frame in FIG. 6A during the use of the tine control mechanism. [Figure 7A] A very schematic diagram of a plurality of steps for implanting an artificial tricuspid valve using the expansion control mechanism of the present disclosure. [Figure 7B] A very schematic diagram of a plurality of steps for implanting an artificial tricuspid valve using the expansion control mechanism of the present disclosure. [Figure 7C] A very schematic diagram of a plurality of steps for implanting an artificial tricuspid valve using the expansion control mechanism of the present disclosure. [Figure 7D] A very schematic diagram of a plurality of steps for implanting an artificial tricuspid valve using the expansion control mechanism of the present disclosure.

Mode for Carrying Out the Invention

[0017] As used herein, when used in connection with an artificial heart valve, the term inflow refers to the end of the artificial heart valve where blood first flows when flowing in the forward direction, and the term outflow refers to the end of the artificial heart valve where blood last flows when flowing in the forward direction. Further, although the present disclosure focuses on artificial tricuspid valve replacement, the present disclosure can be applied to artificial mitral valve replacement. Thus, unless otherwise explicitly specified, even if a particular embodiment may be more suitable for replacement of either the native tricuspid valve or the native mitral valve, the embodiments described herein can be used for replacement of either the native tricuspid valve or the native mitral valve (with or without additional modifications specific to the heart valve being replaced). However, as described above, the devices and methods described herein that enable better control and / or release of a self-expanding artificial heart valve during deployment can be applied to heart valve replacement including aortic valve, pulmonary valve, mitral valve, and tricuspid valve, and furthermore, it should be understood that they can also be applied to any other self-expanding device delivered into a blood vessel where more controlled deployment would be beneficial.

[0018] As described in the background art of this disclosure, artificial heart valves comprising a fixed frame and a valve frame nested within the fixed frame typically become large in size when folded within a delivery device. For example, this type of artificial heart valve can only be fitted into delivery devices having catheters of 24 to 40 French (diameter 8 mm to 13.33 mm) or larger, including those with an outer diameter of 30 to 33 French (diameter 10 mm to 11 mm) or larger. In the case of transcatheter artificial mitral or tricuspid valves delivered intravascularly via the femoral vein, delivery catheters with an outer diameter of 30 to 33 French or larger increase the potential for complications at the access site and may require intervention by a vascular surgeon. The artificial heart valves disclosed herein have features and configurations intended to allow the artificial heart valve to be securely fixed within a larger annulus of a tricuspid valve (or mitral valve) and to be foldable into a delivery catheter with an inner diameter of 30 to 33 French or smaller (including smaller ones of about 24 French (8 mm)). In this specification, the unit "French" refers to the inner diameter of a catheter when describing the performance of a valve fitted within the catheter, while it refers to the outer diameter of a catheter when describing how the size of the catheter may cause problems with vascular access.

[0019] As will be discussed later, one way to achieve this functionality is to design an artificial heart valve with a single support stent (e.g., a single stent layer or a non-nesting frame configuration) that can span the large atrioventricular annular diameter seen in patients with heart failure. The geometric shape of the support stent can allow the artificial valve leaflets to be fixed inward using atrial flanges or discs and / or ventricular flanges or discs having a diameter or outer shape large enough to sandwich, clamp, or cover the natural annular tissue between them. To provide proper sealing between the support stent and the natural annular tissue, a fabric material(s) may span the gap between the atrial and ventricular discs, in which case the fabric material(s) may be stretchable to mitigate the effects of stretching when housing the artificial heart valve in the catheter. The embodiments described later may be suitable for the replacement of either the tricuspid valve or the mitral valve, but these embodiments are most suitable for the replacement of the tricuspid valve because the right ventricular pressure is lower than the left ventricular pressure, and the need for a nested stent design may be reduced. The terms “frame” and “stent” are used interchangeably in this specification, but it should be understood that the term “stent” does not imply any special structure or function beyond the frame.

[0020] Figure 1A shows an artificial heart valve 10 according to one embodiment of the present disclosure. The artificial heart valve 10 may be particularly suitable for the replacement of a congenital atrioventricular valve, in particular a congenital tricuspid valve. The artificial heart valve 10 may generally comprise four components, including a stent or frame 100, a sealing skirt 200, artificial valve leaflets (not visible in Figure 1A), and a commissure support member 300 (shown in Figure 1C), which may also be referred to as a reinforcing structure. In addition to these four components, other components may be provided, such as sutures for sewing a fabric-like material (e.g., the sealing skirt 200) and / or tissue (e.g., the artificial valve leaflets) to the frame 100 and / or the commissure support member 300. In Figure 1A, the artificial heart valve 10 is shown in an expanded or deployed state, with the atrial or inlet end of the valve oriented upward in the diagram of Figure 1A.

[0021] Figure 1B shows a portion of the cutting pattern of a stent frame 100 that can be used with an artificial heart valve 10. In Figure 1B, the frame 100 has the same orientation as shown in Figure 1A. In other words, in the diagram of Figure 1B, the inlet end or atrial end of the frame 100 is oriented towards the top of the viewpoint. The frame 100 is preferably formed from a shape memory material, such as a nickel-titanium alloy such as nitinol, and can be made from a single tube by laser cutting a nitinol tube, for example. In the cutting pattern shown in Figure 1B, the frame 100 generally comprises an atrial portion 110 and a ventricular portion 120 separated by a central portion 130. After the frame 100 has been cut and set into the desired shape, the central portion 130 can be very short, for example, as illustrated and described in more detail in relation to Figure 1C.

[0022] The frame 100 may comprise a row of the most atrial or most inflow-side atrial cells 112, which may be roughly diamond-shaped cells that expand radially outward from a central portion 130 in the expanded state. A pin 114 may be formed at the inflow apex of one or more of the most atrial cells 112 or each of the most atrial cells 112. The pin 114 extends a short distance toward the outflow side to its free end. Each pin 114 may be sized and shaped such that the suture loop of the delivery device slides over the pin 114, keeping the frame 100 connected to the delivery device during delivery and deployment. During deployment of the artificial heart valve 10, each suture loop may be pushed forward or distally to disengage from the corresponding pin 114, thereby completely detaching the artificial heart valve 10 from the delivery device. Similar pins and suture loops are described in detail in U.S. Patent No. 10,874,512, the disclosure of which is incorporated herein by reference. The atrial cell 112 may terminate at an inflection point 132 at its outflow end. If the frame 100 is shaped to a desired form which may be substantially similar to that shown in Figure 1C, the inflection point 132 may define the minimum diameter of the central portion 130. It should be understood that the term “inflection point” is not necessarily used according to its mathematical definition, but rather refers to the point where the frame 100 changes from a decrease in diameter to an increase in diameter.

[0023] Referring further to Figure 1B, the multiple transition cells 116 may be arranged in a row adjacent to the atrial cell 112 on the outflow side. The multiple transition cells 116 can be generally diamond-shaped. The transition cell 116 may have an inflow portion on the inflow side of the central portion 130 and an outflow portion on the outflow side of the central portion 130. In some embodiments, the transition cells 116 may be arranged axially around an inflection point 132. The row of transition cells 116 may comprise three expansion transition cells 117 (or four or more or two or fewer depending on the number of artificial valve leaflets included in the artificial heart valve 10) terminating at the commissure attachment feature (CAF) 140. The expansion transition cells 117 are preferably positioned at approximately equal circumferential intervals around the frame 100. The sides of the atrial cell 112 (which may extend to the inflow apex of the transition cells 116 and expansion transition cells 117) may comprise elongated beams 115. These elongated beams 115 can impart additional flexibility to the atrial portion 110 (sometimes referred to as the atrial disk). For example, the length of the beams 115 can be adjusted depending on the number of cells included in the atrial portion 110 and the desired diameter that the atrial portion spans. As the desired diameter of the atrial portion 110 increases, the (axial) length of the diamond-shaped cells forming the atrial portion 110 may need to increase if a specific opening angle of the diamond-shaped cells (e.g., about 90 degrees) is desired. As the axial length of the diamond-shaped cells increases in valve frames of various sizes, the length of the beams 115 can be increased or decreased accordingly. However, in some embodiments, the beams 115 can be omitted, and the entire atrial row of cells 112 can be a "complete" diamond-shaped cell.

[0024] Each CAF140 can function as an attachment point to an artificial valve leaflet. For example, each CAF140 may have multiple holes, and a pair of adjacent valve leaflets can be joined to the CAF140 through the holes using sutures. The illustrated CAF140 has four small holes in a 2x2 arrangement and one elongated hole, but other specific CAF configurations may be more suitable for use than those shown.

[0025] The outflow-side portion of the frame 100 at the inflection point 132 may comprise a plurality of ventricular cells. For example, a group of first ventricular cells 124a may be roughly diamond-shaped, with their inflow apex at the inflection point 132. A group of second ventricular cells 124b may extend to the outflow-side outermost portion of the frame 100, with the inflow apex of the second ventricular cells connecting to the outflow apex of the transition cell 116. Some or all of the second ventricular cells 124b may comprise tines 126 that act as frictional engagement members that frictionally engage with the natural tissue to reinforce the fixation of the frame 100 within the natural annulus, or none of the second ventricular cells 124b may comprise tines 126. A group of third ventricular cells 124c may be positioned between some pairs of second ventricular cells 124b and may comprise struts that extend from the inflection point 132 to the terminal outflow end of the ventricular portion 120. The third ventricular cell 124c can be larger than the other ventricular cells and can be partially formed by struts of an expanding transition cell 117 terminating at CAF 140. In this configuration, CAF 140 can be considered to be nested within the third ventricular cell 124c or to form the boundary of the third ventricular cell 124c.

[0026] In addition to the tines 126 located on some or all of the second ventricular cells 124b, or not located on any of them, some or all of the third ventricular cells 124c may have tines 126, or none of them may have tines 126. In the illustrated embodiment, each third ventricular cell 124c has a single tine 126 extending upward from the cell's outflow apex, and only a portion of the second ventricular cells 124b have tines 126, so that each second ventricular cell 124b having tines 126 has a single tine 126 extending upward from the cell's outflow apex. All tines 126 may extend to a free end, and the free end may have a pointed or blunt tip for the purpose of puncturing tissue or frictionally engaging with tissue without puncturing it. It should be understood that the number and positioning of the tines 126 may differ from those shown in Figure 1B, or may be the specific number and position shown in Figure 1B.

[0027] In the illustrated embodiment, the tine 126 can be connected at the outflow end of the tine, with its free end positioned at the inflow end. This orientation of the tine allows for smoother and easier deployment of the valve from the delivery catheter compared to a tine connected at the inflow end and having a free end at the outflow end. In other words, when the valve begins to self-expand upon release from the delivery catheter, the tine does not begin to expand until the entire tine is released from the delivery device. In the opposite orientation, the tine would begin to expand radially outward, potentially contacting the end of the delivery sheath and making deployment more difficult. However, it should be understood that the illustrated orientation of the tine may make the loading process slightly more difficult compared to the opposite orientation. However, typically, smooth and easy deployment is more important than smooth and easy loading. The loading process is highly controllable and performed outside the patient, while the deployment process is performed inside the patient.

[0028] After forming the frame 100 using the cutting pattern shown in Figure 1B or another substantially similar cutting pattern, the frame 100 can be shaped into the desired form, for example, by heat treatment. Figure 1C shows an example of a frame 100 having a cutting pattern similar to that shown in Figure 1A, after it has been shaped and connected to the connecting support section 300, which will be described in more detail later.

[0029] As can be seen in Figure 1C, when the frame 100 is expanded or deployed, the bottom of the atrial portion 110 can be substantially straight with a slight upward angle, while the upper half of the atrial portion 110 can flare upward so that the tips of the atrial cells 112 are generally facing the inflow side. The above contour may differ from that precisely described, as long as it is suitable for use with the artificial heart valve 10.

[0030] Referring further to Figure 1C, the ventricular portion 120 can form a roughly "bell" shape with a more rounded and less flattened contour compared to the atrial portion 110. The smoother contour of the ventricular portion 120 allows it to drape against the ventricle, applying only light pressure to assist in attaching or otherwise securing the artificial heart valve 10 to the natural annulus. This light pressure or draping action may be the first mechanism by which the artificial heart valve 10 achieves fixation within the natural annulus.

[0031] The various tines 126 described above can be shaped such that the free end of the tine 126 is located away from the surface defined by the cell on which the tine 126 is situated. In other words, the tip of the tine 126 can be bent or shaped to be available for puncturing or frictionally engaging with tissue without puncturing, providing a second mechanism for the artificial heart valve 10 to achieve fixation within the innate annulus. The tines 126 can be oriented at various angles to achieve various purposes. For example, in some embodiments, some or all of the tines 126 can be oriented or angled such that their free end faces toward the atrial portion 110 at an acute angle with respect to the longitudinal axis passing through the center of the artificial heart valve 10. Tines 126 oriented at an acute angle may be less likely to puncture tissue in the innate annulus compared to those oriented at a right or obtuse angle. Patients who may require an artificial atrioventricular valve, particularly an artificial tricuspid valve, are likely to have very thin inner walls within the ventricles, and an acutely angled tine 126 can reduce the likelihood of the inner wall being perforated by the tine 126. Having an acutely angled tine 126 compared to a tine 126 with a larger angle (e.g., right or obtuse) may offer additional benefits in relation to the loading and deployment of the artificial heart valve 10. For example, if the tine 26 is angled more acutely, it may provide less resistance when loading or deploying the artificial heart valve 10 into or from the delivery catheter. Less resistance makes the load easier to manage, which, all else equal, may allow the use of a smaller size delivery catheter. However, this is only one option. Alternatively, some or all of the tines 126 can be shaped to be more lateral with respect to the central longitudinal axis of the artificial heart valve 10, for example, at a relatively large acute angle, or at a right or obtuse angle. While the tine 126 may be entirely optional, if it is included, whether acutely or laterally oriented, it can provide a second mechanism for the artificial heart valve 10 to achieve fixation within the innate annulus.

[0032] Before describing the support member 300 in more detail, an exemplary sealing skirt 200 that can be used with the artificial heart valve 10 is described. Referring to Figure 1A, the outer sealing skirt 200 can be provided on the outside of the frame 100. In some embodiments, the sealing skirt 200 can be the same as or similar to any of the embodiments described in U.S. Provisional Patent Application No. 63 / 384,521, filed November 21, 2022, for the invention entitled “Transcatheter Prosthetic Atrioventricular Valve with Stiffening Structure,” the disclosure thereof is incorporated herein by reference. In the particular example shown in Figure 1A, the sealing skirt 200 can be a single piece of material (however, in some embodiments, it can be designed as a plurality of pieces of material), and the pieces of material can be formed from any suitable material, for example, polyethylene terephthalate ("PET"), polytetrafluoroethylene ("PTFE"), ultra-high molecular weight polyethylene ("UHMWPE"), polyester, or similar materials or combinations of such materials. The sealing skirt 200 may preferably be formed as a woven fabric skirt, but other options, including being formed as a knitted fabric skirt, may be suitable in some embodiments. In the embodiment shown in Figure 1A, the sealing skirt 200 may be formed from woven PET and have an atrial skirt portion 210 and a ventricular skirt portion 220. The atrial skirt portion 210 can be joined to the atrial portion 110 of the frame 100 by a relatively tight connection, for example, by suturing along the struts of the atrial portion 110 of the frame 100. In some embodiments, including those shown in Figure 1A, the inflow edge of the atrial skirt portion 210 may be positioned away from the atrial apex of the atrial cell 112. For example, in some embodiments where the atrial end of the frame 100 curves toward the atrium (not shown in Figure 1A), the outer sealing skirt 200 may be terminated away from the atrial end so that no thrombus-forming outline is present at the inflow end of the frame 100.As used herein, the term “thrombus-forming shape” refers to a shape or shape that may promote blood stagnation. In other embodiments, the inflow edge of the atrial skirt portion 210 may be positioned to coincide with or cover the atrial apex of the atrial cell 112. It should be understood that for various tines 126, it is preferable to puncture the sealing cloth material 200 so that the free end of the tine 126 is available for frictional engagement with the innate tissue at the time of implantation.

[0033] Referring further to Figure 1A, the ventricular skirt portion 220 can be connected more loosely to the ventricular portion 120 of the frame 100 than the atrial skirt portion 210 is connected to the atrial portion 110. For example, the outflow edge of the ventricular skirt portion 220 can be connected relatively tightly to the outflow end of the ventricular portion 120 of the frame 100, while the connection of the sealing skirt 200 can be relatively loose between the central portion 130 of the frame 100 and the distal end of the ventricular portion 120. This configuration allows the ventricular skirt portion 220 to inflate, expand, or open like a parachute due to the pressure difference during ventricular systole (for example, when the ventricle contracts, the prosthetic valve leaflets close, and the pressure inside the ventricle becomes greater than the pressure inside the atrium). As the ventricular skirt portion 220 opens parachute-like during ventricular systole, it can fill any gaps, voids, or openings between the prosthetic valve 10 and the natural valve annulus that could cause blood to leak out around the outside of the prosthetic valve 10 and flow back into the atrium (i.e., perivalvular leakage or "PV" leakage). Typically, sealing of a self-expanding prosthetic valve is achieved by "oversizing" the prosthesis relative to the annulus, at least partially, to ensure that the prosthesis is pressed firmly against the annulus with a force that assists sealing. However, particularly with tricuspid valves, it may be desirable to avoid excessive stretching of the natural annulus, which can occur if the prosthesis is oversized. By achieving sealing using this expanded skirt action, the prosthesis can be made not oversized, or not significantly oversized, relative to the natural tricuspid annulus.

[0034] Referring briefly to Figure 1C, the illustrated configuration of frame 100 can provide a levering effect that can further assist in sealing against PV leakage. For example, when frame 100 is in the expanded or unfolded state shown in Figure 1C, the deformation of the ventricular portion 120 may have a tendency to move the atrial portion 110 toward the ventricular portion 120. Therefore, referring back to Figure 1A, when the ventricular skirt portion 220 expands or opens like a parachute during ventricular systole (which may slightly deform the ventricular portion 120 of frame 100), the atrial portion 110 of frame 100 may be gently pulled downward relative to the atrial side of the natural valve annulus. This "pinching" effect can further seal against any PV leakage and reduce the possibility of embolization. For example, particularly in low-flow environments of the right heart, a gap or space remaining between the artificial heart valve 10 and the natural anatomical structure may create a thrombosis risk zone. Furthermore, the presence of gaps or spaces increases the risk of PV leakage, which tends to accelerate the outflow of blood through the gaps and spaces, potentially causing additional shear stress on red blood cells and damaging them. The aforementioned lever or clamping effect can reduce or eliminate such gaps or spaces, thereby reducing the risk of thrombus formation. In one particular case, a patient may have a prominent septal prominence, and some patients may have a septal prominence in the right ventricle that protrudes over the tricuspid annulus. This anatomical structure can be an exclusion criterion for transcatheter prosthetic tricuspid valve replacement. However, the aforementioned clamping or levering effect makes it possible to implant the prosthetic heart valve 10 in patients with relatively prominent septal prominences.

[0035] Referring again to Figure 1C, in the deployed or expanded state of frame 100, the bottom strut of the expanding transition cell 117 to which the CAF 140 is attached extends toward the outflow side substantially parallel to the central longitudinal axis of the artificial heart valve 10. This arrangement allows the CAF 140 to be aligned, or approximately aligned, with the smallest diameter portion of frame 100 in the central portion 130. In other words, the CAF 140 of frame 100 is substantially cantilevered. If additional support is not provided, this cantilevered state of the CAF 140 may result in certain disadvantages. As described above, the artificial valve leaflets are coupled to the CAF 140. As a result, during ventricular systole, when the artificial valve leaflets are closed and pressure is applied from the ventricle toward the atrium, the CAF 140 and the strut of the expanding transition cell 117 to which the CAF 140 is attached may flex radially inward toward each other. While a certain degree of deflection may be desirable, the length of the CAF140 (which can extend approximately 20-30 mm from the central portion 130) may be such that there is a risk of excessive deflection. If the CAF140 deflects too much during ventricular systole, the prosthetic valve leaflets may not coapt properly, potentially leading to inefficient valve function. Another disadvantage of a large amount of CAF140 deflection is that the strut from which the CAF140 extends may fatigue rapidly, potentially leading to frame 100 failure.

[0036] If the CAF140 of frame 100 does not have additional support, other potential disadvantages may arise. For example, during deployment of the prosthetic heart valve 10, the ventricular or outflow end of the prosthetic heart valve 10 tends to over-expand, while the atrial or inflow end of the prosthetic heart valve 10 remains folded within the delivery device. This over-expanding or spreading may put stress on the prosthetic valve leaflets coupled to frame 100. The commissure support 300, described later, may help prevent such over-expanding or spreading.

[0037] To address one or more of the potential disadvantages of the CAF140 without additional support members, a cross-support member 300 (which may be referred to herein as a CAF support or simply a support member) can be provided. Figure 1C illustrates the CAF support member 300 assembled to the frame 100. The CAF support member 300 can take various forms, but in some embodiments, it can be an expandable and foldable ring-shaped structure. In the illustrated embodiment, the CAF support member 300 is formed from a shape memory material such as nitinol and can be laser-cut from a nitinol tube using a diamond-like pattern similar to that shown in Figure 1C. After cutting the CAF support member 300, the resulting structure can be shaped (e.g., by heat treatment) such that, in the absence of applied force, the CAF support member 300 forms a generally circular or cylindrical ring having a single row of diamond-like cells. In the expanded or unbiased state, the inner diameter of the CAF support portion 300 is approximately equal to the diameter of the circle that aligns with the outer surface of the CAF 140 when the frame 1100 is in the expanded or unbiased state.

[0038] The CAF support 300 is located outside the CAF 140 (and / or the cell struts to which the CAF 140 extends) and can be coupled to the frame 100 via any suitable mechanism. For example, in some embodiments, the CAF support 300 can be simply sewn onto the CAF 140 and / or the cell struts to which the CAF 140 extends. In other embodiments, either or both of the CAF support 300 and the CAF 140 (or their associated struts) may be provided with a mechanism to assist in fastening. For example, referring back to Figure 1B, one or both of the two struts leading to the CAF 140 may have one or more holes 142 that can be used to assist in sewing the CAF support 300 to the frame 100 (for example, at the intersection where two adjacent diamond-shaped cells of the CAF support 300 meet). In the frame 100 shown in Figure 1B, each strut leading to the CAF 140 has a single hole in the same axial position. However, in the example shown in Figure 1C, each strut connected to each CAF 140 has two holes, and the holes on one strut may or may not be axially aligned with the holes on the other strut that form the pair. It should be understood that the number, shape, and arrangement of the holes 142 can be other than those shown in the figure, as long as they provide the desired functionality. While suturing is described as one structure for securing the CAF support 300 to the frame 100, it should be understood that other methods such as adhesives, rivets (or other mechanical fasteners) may be equally suitable. Furthermore, other designs of the CAF support 300 are described in U.S. Provisional Patent Application No. 63 / 384,521, filed November 21, 2022, with the title of the invention, “Transcatheter Prosthetic Atrioventricular Valve with Stiffening Structure,” the disclosures of which are incorporated herein by reference. The CAF support disclosed in that application may be used in connection with the disclosures herein.While the CAF support portion 300 may not be essential for use with the artificial heart valve 10, it should be understood that if used, it can provide benefits, including better support for the artificial heart valve 10 without adding a significant additional volume to the valve.

[0039] The artificial heart valve 10 can be provided in various sizes to treat a variety of patients. In some embodiments, the largest artificial heart valve 10 may comprise an atrial disc 110 and / or ventricular disc 120 having a diameter of approximately 75 mm in the expanded state, and when the artificial heart valve 10 is in a crimped or folded state within the delivery device, it will have a length of approximately 40 mm to approximately 70 mm (including maximums of approximately 45 mm, 50 mm, 55 mm, 60 mm, or 65 mm). In some embodiments, the delivery device may comprise a distal tip (e.g., a non-traumatic nose cone) having a length of approximately 15 mm to approximately 20 mm. Therefore, if it is desirable to fold approximately two-thirds of the artificial heart valve within the ventricle before deployment, as described above, a total length of up to approximately 65 mm within the ventricle may be required (the folded valve length of approximately 44 mm plus the maximum length of the nose cone of 20 mm). The ventricles of at least some patients, particularly the right ventricle, may simply be too short to accommodate this length. It should be understood that the diameter (in the expanded state) and length (in the folded state) of the artificial heart valve 10 (and its portion) described above are illustrative, and even if specific dimensions differ from the specific examples listed above, the invention described herein may still provide similar benefits. However, it should be understood that as the folded length of the artificial heart valve increases, the ventricular control described herein may become correspondingly more desirable.

[0040] One option to address this potential sizing problem while using similar or identical artificial heart valves 10 and delivery devices is to have more precise control over how the artificial heart valve 10, and in at least some cases particularly the ventricular end of the artificial heart valve 10, unfolds when the sheath covering the delivery device (which may alternatively be referred to as a capsule or valve cover) is withdrawn, removing the constraint that kept the artificial heart valve 10 in a fully folded state. For example, as will be described in more detail later, the ventricular and atrial ends of the artificial heart valve 10 can be individually restricted from expanding by mechanisms other than the valve cover, such that the artificial heart valve 10 expands only partially by an additional expansion restriction mechanism when the valve cover is withdrawn. When this partial expansion occurs, the artificial heart valve 10 can expand to have a "peanut" shape (or a shape with two bulges or a shape with the partial spheres joined together). While the artificial heart valve 10 has this peanut shape, the ventricular portion of the valve cannot fully expand due to an additional mechanism limiting the expansion of the artificial heart valve 10, and can expand to a diameter of approximately 25 mm to 35 mm. Due to the partial radial expansion, the artificial heart valve 10 is also partially shortened, so that the axial length of the artificial heart valve 10 is shorter than the length of the artificial heart valve 10 when fully folded or wavy. Tests have shown that this type of limiting mechanism allows the artificial heart valve 10 (and similar designs) to be properly deployed into the innate valve annulus without having to be positioned as deeply into the ventricle as would be the case if the artificial heart valve 10 did not have an additional mechanism (other than a valve cover) to limit its self-expansion. Furthermore, by enabling partial expansion, it can be significantly easier to evaluate and confirm the desired position of the artificial heart valve relative to the innate valve annulus before actually fully deploying the artificial heart valve 10. This then allows for easier adjustment and repositioning of the artificial heart valve 10 before full deployment. In fact, the artificial heart valve 10 can be partially or potentially completely refolded using the mechanism described herein, and then repositioned and redeployed to achieve the desired final positioning of the artificial heart valve 10.Certain mechanisms described herein can provide a method for safely disconnecting the artificial heart valve 10 from a delivery device once its positioning is confirmed, and / or a method for adjusting the position of the artificial heart valve 10 even after one or more tines 126 have been exposed.

[0041] Figure 1D is a schematic side view of a tubular instrument 2000 of a delivery device that enables controlled expansion of a self-expanding device, such as a self-expanding artificial heart valve, indicated by the wire structure 2006 in Figure 1D. It should be understood that the term “wire structure” encompasses not only braided stents / frames but also stents / frames laser-cut from tubing (e.g., hypotube), and any other style of expandable and foldable stents / frames. Figure 1E is a magnified view of the distal end of the tubular instrument 2000 in Figure 1D. Additional details of a system similar to that shown in Figure 1D are described in detail in International Patent Application Publication No. 2022 / 029111, the disclosures of which are incorporated herein by reference. The tubular instrument 2000 may comprise a tubular assembly 2001 having a first handling tube 2002, a second handling tube 2003, and one or more retaining devices 2007. Two handling tubes 2002 and 2003 extend from the proximal operating region 2004.

[0042] In the illustrated embodiment, the handling tubes 2002 and 2003 are arranged coaxially, i.e., their longitudinal axes LR1 and LR2 coincide, respectively, forming a common longitudinal axis of the tubular assembly 2001. The tubular assembly 2001 comprising the handling tubes 2002 and 2003 preferably has the desired flexibility or bendability and can be made from any flexible tubular material known to those skilled in the art for intravascular delivery. Although only a portion of the tubular assembly 2001 is shown as exhibiting flexibility, it should be understood that the majority or all of the tubular assembly 2001 between the control interface 2008 and one or more connection points to the wire structure 2006 (both described in more detail later) may have the desired flexibility.

[0043] The handling tubes 2002 and 2003 are arranged to be rotatable relative to each other. In particular, in the illustrated example, the handling tubes 2002 and 2003 can change their relative rotational positions with respect to the common longitudinal axis of the tubular assembly 2001. In the proximal operating region 2004, the tubular instrument 2000 has a control interface 2008 for operating the relative rotational motion of the first handling tube 2002 and the second handling tube 2003. The control interface 2008 can be configured as desired to achieve the desired rotation, and is therefore only schematically shown in Figure 1D. For example, the control interface 2008 may comprise a gearbox 2020 for driving the rotation of both handling tubes 2002 and 2003, and an operation control unit 2021 for activating the gearbox 2020, for example, by electric or manual operation. The two handling tubes 2002, 2003 and the control interface 2008 are configured such that, in order to achieve a desired relative rotation, only the first handling tube 2002, only the second handling tube 2003, or both handling tubes 2002, 2003 actively rotate around their respective longitudinal axes LR1 and LR2 (or a common longitudinal axis), preferably in opposite directions to each other.

[0044] As shown in Figure 1F, the first handling tube 2002 can cover the second handling tube 2003. The first handling tube 2002 can be fixedly coupled (e.g., axially and rotationally) to the proximal holding device 2007 (on the right in the diagram of Figure 1E), and the second handling tube 2003 can be fixedly coupled to the distal holding device 2007 (on the left in the diagram of Figure 1E). These holding devices 2007 are configured to hold the wire structure 2006 in the distal region of the tubular assembly 2001. As shown in Figure 1G, which illustrates the proximal holding device 2007, the proximal end of the wire structure 2006 can be fixedly coupled to the proximal holding device 2007. For example, the wire of the wire structure can be fixed within a recess of the holding device 2007. In other embodiments, the connector 2010 (e.g., a suture) can be fixed within a recess of the holding device 2007, and the other end of the connector 2010 can be coupled to the wire structure 2006. It should be understood that the distal holding structure 2007 can generally be a mirror image of the one shown in Figure 1G, except that the distal holding structure 2007 is fixedly connected to the second handling tube 2003 instead of the first handling tube 2002.

[0045] In some embodiments, the first handling tube 2002 can be an outer tube and is formed as a wound coil (or a stack of coils wound in opposite directions) defining an open central channel. For example, the outer tube can be formed from a first strand wound clockwise (or counterclockwise) to form the tube and a second strand wound counterclockwise (or clockwise) in opposite directions to form the covering tube. Although two coils forming the tube are described, it is possible to provide more coils, for example, including a third strand wound in the same direction as the first strand and covering the second strand to form the tube. Examples of suitable tubes include Helical Hollow Strand (HHS) from Fort Wayne Metals, BiFlex or TriFlex coils from Heraeus, Torque Coil from Asahi, or other similar products. In some embodiments, the second handling tube 2003 can be an inner tube or a rod and is formed as a laser-cut hypo tube to impart flexibility, including, for example, a puzzle cut (sometimes also referred to as a ball and socket cut). However, it should be understood that other combinations may be suitable. For example, the inner tube can be formed as the wound torque coil described above, and the outer tube can be formed as a puzzle-cut hypo tube. In yet another embodiment, both tubes may be formed as the wound torque coil described above, or both may be formed as the puzzle-cut hypo tube described above. However, in practice, forming the first handling tube 2002 (or outer tube) as a wound torque coil and the second handling tube 2003 (or inner tube) as a puzzle-cut hypo tube provides superior results compared to the other options described herein.

[0046] Referring to Figure 1H, the operation of the control interface 2008 causes the first handling tube 2002 to rotate in the first rotational direction RD1, and the second handling tube 2003 to rotate in the second rotational direction RD2, opposite to the first rotational direction RD1. This causes the two holding devices 2007 to rotate in opposite directions to each other, and consequently, the connector 2010 to wrap around each of the handling tubes 2002 and 2003 in opposite directions. This then pulls the wire structure 2006 inward toward the tubular assembly 2001, effectively folding the first structure. The operation of the control interface 2008 can also cause the handling tubes 2002 and 2003 to rotate in the opposite direction to that shown in Figure 1H, thereby unwinding the connector 2010 and causing the wire structure 2006 to begin self-expanding toward the state shown in Figure 1E. According to the tubular device 2000 described above, the self-expanding artificial heart valve can be better controlled with respect to expansion and contraction compared to a self-expanding artificial heart valve controlled solely by a covering sheath that is withdrawn to deploy the artificial heart valve. However, the tubular device 2000 described above does not address one important feature: the ability to release the artificial heart valve from the tubular assembly 2001 for complete deployment.

[0047] In some embodiments, as the wire structure 2006 is folded radially (i.e., as the wire structure 2006 approaches the tubular assembly), the wire structure 2006 tends to elongate axially. In some embodiments, to adapt to the natural tendency for the axial ends of the wire structure 2006 to move away from each other as the wire structure 2006 is folded radially, it is preferable that the retaining devices 2007 move away from each other. This can be achieved in various ways, including, for example, by advancing the second handling tube 2003 distally as the second handling tube 2003 rotates, by retracting the first handling tube 2002 proximal as the first handling tube 2002 rotates, or both. This axial movement can be performed manually, but it is more preferable that the axial movement is driven by the gearbox 2020 such that a set amount of linear translation is achieved for each set amount of rotation. In other words, by pegging the axial translation of one or more handling tubes to the rotation of one or more handling tubes, a precise desired distance can always exist between the two holding devices 2007, depending on the precise amount of rotation received by the one or more handling tubes. This movement works equally well in reverse; as handling tubes 2002, 2003 rotate to re-expand wire structure 2006, the two holding devices 2007 can be drawn together in a direction toward closer proximity as the wire structure 2006 shortens axially. This feature can be provided (or omitted) in any of the embodiments described later.

[0048] In some embodiments, the outer diameter of the first handling tube 2002 at the connection point to the corresponding retaining device 2007 is the same as the outer diameter of the second handling tube 2003 at the connection point to the corresponding retaining device 2007. In this embodiment, it is preferable that the gear ratio of the gearbox 2020 rotates the two handling tubes 2002 and 2003 at the same speed (in opposite directions) so that the wire structure 2006 (or the connection point that connects the wire structure 2006 to the corresponding retaining device 2007) wraps around the corresponding handling tubes 2002 and 2003 at the same speed, or unwinds from the handling tubes 2002 and 2003 at the same speed. However, in other embodiments, the outer diameter of the first handling tube 2002 at the connection point to the retaining device 2007 can be larger or smaller than the outer diameter of the second handling tube 2003. For example, since the second handling tube 2003 passes inside the first handling tube 2002, at least a portion of the second handling tube 2003 has an outer diameter smaller than the outer diameter of the first handling tube 2002. If the outer diameters of the handling tubes 2002 and 2003 are not equal at the connection point to the holding device 2007, the gearbox 2020 can have a gear ratio that rotates the two handling tubes 2002 and 2003 at different speeds. For example, the handling tube with the larger outer diameter will have a greater length of connection wrapped around the tube in one rotation compared to the handling tube with the smaller outer diameter. Since it is desirable for the connection to wrap around each tube at the same speed (e.g., length of winding per unit time), the gear ratio can be set so that the tangential speeds of each handling tube are similar or identical. In other words, in order to wrap the same length of connection around the tubes per unit time, the smaller tube needs to rotate at a larger angular velocity than the larger tube. This concept will be applied to the embodiments described later.

[0049] Figure 2A shows the frame 100' of the artificial heart valve in a partially expanded state having a peanut shape. The frame 100' can be substantially similar to the frame 100, although there may be some specific differences. Referring to Figure 2A, the frame 100' comprises an atrial end 110' which can be substantially similar to the atrial end 110, a ventricular portion 120' which is substantially similar to the ventricular portion 120, and a central portion 130' which is substantially similar to the central portion 130. A commissure support 135' which is similar to or identical to the commissure support 300 may be provided on the frame 100'. In this partially expanded state, the inlet end portion of the atrial disc 110' is maintained in a fully or nearly fully folded state via a suture connection to the shaft device 400 of the delivery device, and the outlet end portion of the ventricular disc 120' is maintained in a fully or nearly fully folded state via a suture connection to the shaft device 400. The shaft device 400 may be the same as or identical to the tubular assembly 2001 described above. For example, the shaft device 400 may include an atrial tube 410 which is the same as or identical to the first handling tube 2002, and a central rod 430 and a ventricular tube 420 which are both the same as or identical to the second handling tube 2003.

[0050] For example, referring to Figure 2A, the shaft device 400 may comprise an atrial tube 410, which has a first end terminating at or near the atrial disk 110' and a second opposite end coupled in a manner that it is fixed in the rotational direction to a component of the gear device, such as the gearbox 2020 of the control interface 2008. Figure 2B shows a particular gear device 500, primarily intended to conceptually illustrate one type of system capable of producing a desired rotation. For example, the second opposite end of the atrial tube 410 can be fixed in the rotational direction to the first pin vise 510 of the gear device 500. Although Figure 2B shows the gear device 500 disconnected from all other components, it should be understood that a conceptually similar device can replace the gearbox 2020 shown in Figure 1D. Referring back to Figure 2A, a central rod 430, smaller in diameter than the atrial tube 410, passes through the center of the atrial tube 410. The central rod 430 has a first end that is rotatably fixed (e.g., via laser welding) to a ventricular tube 420 which may have a diameter similar to that of the atrial tube 410. Both the central rod 430 and the ventricular tube 420 may be similar to or identical to the second handling tube 2003 in Figure 1E. In other words, the atrial tube 410, the ventricular tube 420, and the central rod 430 are generally shown as rigid rods, but are preferably flexible catheter members as described in relation to the tubular assembly 2001. The central rod 430 can pass through the atrial tube 410 and through the box of the gear device 500, in which case the second end of the central rod 430 is coupled to the second pin vise 520 of the gear device 500 in a manner that is rotatably fixed. Similar to the first pin vise 510, the second pin vise 520 is merely one example of a fixed connection between the second handling tube 2003 and the gearbox 2020 in Figure 1D.

[0051] Referring to Figure 2B, each pin vise 510, 520 may have a geared end that meshes with the geared end of the knob 530. The geared ends mesh with each other, and when the knob 530 is rotated in a first direction, these gears interact so that the two pin vises 510, 520 rotate in opposite directions to each other. The knob 530 may be an example of a manual operation control unit 2021 of the control interface 2008. Similar to the pin vises 510, 520 which represent specific examples of fixed connections, the knob 530 corresponds to a specific type of manual operation control unit 2021. Figure 2C is a very schematic diagram of the connections between the second pin vise 520 and the central rod 430, the connection between the central rod 430 and the ventricular tube 420, and the connection between the atrial tube 410 and the first pin vise 510, with other components of the gear device 500 omitted. Figure 2C schematically shows the frame 100', the connection between the atrial disc 110' and the first end of the atrial tube 410, and the connection between one end of the ventricular tube 420 and the ventricular disc 120'. As will be described in more detail later, by rotating the knob 530 in one direction, the atrial tube 410 rotates in a first direction at the connection point to the atrial disc 110', while the central rod 430 and the ventricular tube 420 rotate in a second direction (opposite to the first direction) at the connection point to the ventricular disc 120'. It should be understood that the shaft device 400 and the gear device 500 are merely examples of the control interface 2008 and the tubular assembly 1, and that the embodiments described herein should generally be considered as examples of modifications that may be made to the tubular device 2000. As mentioned above, one function that the tubular device 2000 lacks is the ability to easily and accurately release the artificial heart valve (or wire structure 2006) from the tubular device 2000. However, it should be understood that various different mechanisms can be used in combination with an atrial tube 410 (or first handling tube 2002) and a ventricular tube 420 (or second handling tube 2003) that rotate in opposite directions to bring the atrial disc 110' and ventricular disc 120' into close contact with (or maintain close contact with) the shaft device 400.Examples of these mechanisms (to be understood as examples of the retaining device 2007), and examples of additional mechanisms that enable complete disconnection between the shaft assembly 400 and the frame 100', will be described in more detail later. In other words, the various control mechanisms described later are generally described in relation to the shaft assembly 400, but it should be understood that such mechanisms, including specific examples of its retaining device 2007, can be used with the tubular assembly 2001.

[0052] Figure 3A shows a portion of the ventricular tube 420, and Figure 3B shows a portion of the atrial tube 410. Each tube 410, 420 may be provided with mounting rings 610, 620 fixedly connected to the respective tube 410, 420. Generally, the various rings described herein are described as being "fixed" to the respective tubes, but it should be understood that this includes situations in which the rings are integrally formed with the respective tubes. Each mounting ring 610, 620 is preferably fixed to its associated tube 410, 420 such that no movement (axial or rotational) occurs between the mounting ring 610, 620 and its associated tube 410, 420. For example, each mounting ring 610, 620 can be laser welded to its associated tube 410, 420. Each mounting ring 610, 620 may be similar or identical, and may have a generally circular or cylindrical outer surface, and have inwardly facing projections 612, 622 alternating with recesses or notches 614, 624. Each notch 614, 624 may be positioned between two circumferentially adjacent projections 612 or 622, and each projection 612, 622 may be positioned between two circumferentially adjacent notches 614, 624. The projections 612, 622 may be in direct contact with the outer surface of the associated tubes 410, 420, such that the notches 614, 624 form a gap between the outside of the tubes 410, 420 and the inner surface of the mounting rings 610, 620. With this configuration, each notch 614, 624 may function as a place for the first end 814, 824 of the associated sutures 810, 820 to be attached to the mounting rings 610, 620. Although the term suture is used, it should be understood that other strings or wire-like devices can be used instead of sutures. As shown in Figures 3A and 3B, the first ends 814, 824 of each suture 810, 820 can be secured to the associated mounting rings 610, 620 at the notches 614, 624 via knots or any other fastening mechanism that ensures the first ends 814, 824 of the sutures 810, 820 cannot be detached from the mounting rings 610, 620.Furthermore, the placement of the notches 614, 624 between adjacent protrusions 612, 622 ensures that the first ends 814, 824 of each suture 810, 820 can only slide a short distance around the outer circumference of the mounting rings 610, 620, thereby ensuring that the first ends 814, 824 of each suture are constrained within the area of ​​the notches 614, 624. Although only one suture 810, 820 is shown in Figures 3A and 3B, it should be understood that multiple sutures may be provided on each mounting ring 610, 620 such that there is one or more sutures per notch 614, 624. The term “suture” is used throughout in relation to the sutures 810, 820 and related components, but it should be understood that in these contexts, the term “suture” includes cables, wires, or other strand-like members.

[0053] Referring further to Figures 3A and 3B, each tube 410, 420 may be provided with suture rings 710, 720 fixedly connected to the respective tube 410, 420. Each suture ring 710, 720 is preferably fixed to its associated tube 410, 420 so that no movement (axial or rotational) occurs between the suture ring 710, 720 and its associated tube 410, 420. For example, each suture ring 710, 720 can be laser-welded to its associated tube 410, 420. Each suture ring 710, 720 may be similar or identical, but they can be attached to their associated tubes 410, 420 in opposite rotational directions. Each suture ring 710, 720 may have a generally circular or cylindrical inner surface that is in direct contact with the outer surface of the associated tube 410, 420. Multiple teeth or fingers 712, 722 may extend from each suture ring 710, 720, and each finger 712, 722 has a generally "L" shape having a first portion extending radially outward from the center of the associated ring 710, 720 and a second portion extending generally circumferentially around a central axis passing through the ring 710, 720. The second portion of each finger 712, 722 terminates at a free end, and due to the different rotational mounting configurations of the two suture rings 710, 720, each free end of each finger 712 of ring 710 faces counterclockwise, and each free end of each finger 722 of ring 720 faces clockwise. It should be understood that the clockwise and counterclockwise directions are merely conventions, and the important feature is that all free ends of finger 712 point in one direction around the outer circumference of ring 710, and all free ends of finger 722 point in the opposite direction around the outer circumference of ring 720. With the above configuration, each finger 712, 722 can serve as a place for attaching the second loop-shaped ends 812, 822 or eyelets of the associated sutures 810, 820 to the suture rings 710, 720 by placing them over the fingers 712, 722.When each suture ring 710, 720 rotates in the direction in which the free ends of each finger 712, 722 face the direction of rotation or become the leading edge of the direction of rotation, the suture eyelets 812, 822 tend to remain connected to the associated fingers 712, 722. When each suture ring 710, 720 rotates in the opposite direction to the direction in which the free ends of each finger 712, 722 face, such that the free ends are at the trailing edge of the rotation (rather than becoming the leading edge), the suture eyelets 812, 822 tend to slip off the fingers 712, 722 and become disconnected from the suture ring 710, 720.

[0054] Continuing to refer to Figures 3A and 3B, each suture 810, 820 has a central portion extending between a first end 814, 824 and an eyelet or second loop-shaped end 812, 822. When in use, the frame 100' can be positioned such that the atrial disc 110' is positioned on or adjacent to the atrial mounting ring 610 and the suture ring 710, and the ventricular disc 120' is positioned on or adjacent to the ventricular mounting ring 620 and the suture ring 720. With this arrangement, the central portion of each suture 810 can form a loop through the inside of a cell in the atrial disc 110' (for example, at or near the inflow end vertex), and the central portion of each suture 820 can form a loop through the inside of a cell in the ventricular disc 120' (for example, at or near the outflow end vertex). For example, if frame 100' has the same structure as frame 100, the atrial suture can form a loop through the atrial cell 112, and the ventricular suture can form a loop through the ventricular cells 124b, 124c. According to this configuration, as long as the eyelets 812, 822 of the sutures 810, 820 remain connected to the associated fingers 712, 722, frame 100' will remain connected to the associated tubes 410, 420. As the knob 530 rotates in one direction, the tube 410 and suture ring 710 rotate in the first direction while the tube 420 and suture ring 720 rotate in the opposite direction, causing the associated sutures 810, 820 to pull the atrial disc 110' and ventricular disc 120' toward the associated tubes 410, 420, pressing and folding the ends of the frame 100', or maintaining the ends of the frame 100' in a folded state, thereby causing the frame 100' to take on the "peanut" shape shown in Figure 2A. When the artificial heart valve is in the desired position relative to the natural annulus, rotating the knob 530 in the opposite direction releases the tension on the sutures 810, 820, expanding the end of the frame 100', and ultimately allowing the eyelets 812, 822 of the sutures 810, 820 to slide off their associated fingers 712, 722, thereby completely freeing the frame 100' (and thus the entire artificial heart valve) from the delivery shaft device 400.It should be understood that by rotating tubes 410 and 420 in opposite directions, the sutures 810 and 820 can more effectively pull the frame 100' toward the shaft device 400 as the sutures 810 and 820 wrap around their respective tubes 410 and 420 (in opposite directions).

[0055] The sutures 810 and 820 shown in Figures 3A and 3B have eyelets 812 and 822 formed by simply making a knot at the end of the suture, but the eyelets or loops can be formed in other ways. For example, as shown in Figure 3C, one of the sutures 810' can be formed as a suture or cord that is wound around a center line to form an eyelet 812' at its distal end. In another embodiment, as shown in Figure 3D, one of the sutures 810'' can be braided to form an eyelet 812'' at its distal end. For example, suture 810" has a larger body portion than the suture forming eyelet 812", and the transition between the body portion and eyelet 812" is smooth. If a knot is used to form the eyelet, for example, the knots shown in Figures 3A and 3B for eyelets 812 and 822, the knot may interfere with the stent or frame structure (such as a cell apex), or if the suture is passed through a hole (as described in other embodiments below), the knot may get caught in such a hole. It should be understood that any of the eyelet options may be suitable for use.

[0056] Figure 4 shows an alternative system for controlling the deployment of frame 100'. Although Figure 4 shows an atrial tube 410, it should be understood that the same system can also be provided on a ventricular tube 420. As shown in Figure 4, the atrial tube 410 comprises two mounting rings 610 spaced apart from each other, each mounting ring 610 being similar to or identical to the mounting ring 610 in Figure 3A. One or more sutures 810 can be secured to the mounting rings 610 in the same manner as illustrated and described in Figures 3A and 3B. However, instead of the eyelets 812 of the sutures 810 being connected to the suture rings as in Figures 3A and 3B, all eyelets 812 can be wrapped around a single pull rod 900. As shown in Figure 4, the pull rod 900 can pass through a notch in one mounting ring 610 and a notch in the other mounting ring 610, as long as the pull rod 900 extends between both mounting rings 610, so that the eyelet 812 wrapped around the pull rod 900 cannot slip off the pull rod 900. The atrial tube 412 may have a notch or cutout 412 to provide space for the eyelet 812 of the suture 810 between the pull rod 900 and the atrial tube 410. The ventricular tube may similarly have a pair of mounting rings, a notch, and a separate pull rod. Similar to the embodiments in Figures 3A to 3D, the suture 810 on the atrial tube 410 can pass through the atrial disc 110', and the suture on the ventricular tube can pass through the ventricular disc 120'. By rotating the knob 530, the atrial tube 410 and the ventricular tube 420 rotate in opposite directions to each other, causing the suture to wrap around the tubes (or unwrap depending on the direction of rotation). When the user is ready to completely release the frame 100' from the shaft device 400, the pull rod 900 can be pulled proximal until the eyelet 812 slides off the distal end of the pull rod 900. Although the eyelet 812 is shown as being formed by a knot, it should be understood that the other suture loop alternatives described above can also be applied to this embodiment.

[0057] Figure 5 shows a slightly different alternative embodiment compared to Figure 4. The only difference between the embodiment in Figure 5 and the embodiment in Figure 4 is that the suture 810 does not terminate in an eyelet 812 wound around the pull rod 900. Rather, each suture 810 has a first knotted end that connects to the mounting ring 610, the central portion of the suture 810 is wound around the pull rod 900, and the second end of the suture forms another knot next to the first knotted end, which is secured to the mounting ring 610. Except for the way the ends of the suture 810 in Figure 5 are secured to the mounting ring 610 and the pull rod 900, the structure and function of the embodiment in Figure 5 are identical to those in Figure 4. In some embodiments, the pull rod 900 can be connected to a flexible suture wound around a rotating shaft. The number of times the suture is wound around the shaft can be similar to the number of rotations required to open the ventricular and atrial disks. After the disc is fully released, the suture loop can be released as described above by pulling back the suture connected to rod 900.

[0058] The embodiments described above generally rely on sutures passing through the cells of frame 100 or 100', but in other embodiments, the frame may have a dedicated mechanism for connecting to the sutures. For example, Figure 6A shows a portion of the cutting pattern of frame 1100 which is generally similar to frame 100. Frame 1100 can be used with the artificial heart valve 10 and / or can be used in place of frame 100'. Like frames 100 and 100', frame 1100 may comprise an atrial disc 1110, a ventricular disc 1120, and a central lumbar region 1130. In the expanded state, frame 1100 may have a shape similar to that shown in Figure 1C. The description of frame 100 generally applies to frame 1100, except for the differences which will be discussed later. Therefore, for brevity, only the differences will be described. One difference in frame 1100 is that CAF 1140 has a generally dog-boned shape, having a single row of eyelets and a pair of eyelets aligned at both ends of this row. This structure can assist in coupling to the commissure support 300, as described in detail in U.S. Provisional Patent Application No. 63 / 384,521, filed November 21, 2022, with the title of the invention, "Transcatheter Prosthetic Atrioventricular Valve with Stiffening Structure," the disclosures of which are incorporated herein by reference. Another difference is that the atrial cell may have a hole 1112a formed at the tip of the atrial cell, the hole 1112a being sized to receive a suture passing through the hole 1112a. Similarly, a hole 1124a may be formed at the tip of the ventricular cell, and if the ventricular cell is provided with tines, a hole 1126a may be provided in those tines. Hole 1112a can be used to receive the central portion of the atrial suture 810 passing through it, and hole 1124a can be used to receive the central portion of the ventricular suture 820 passing through it.Because the knot may interfere with the suture being pulled through the hole, it may be preferable, but not essential, to use sutures similar to sutures 810' or 810'' with knotless eyelets 812' or 812''. Thus, by using the frame 1100 of Figure 6A together with the artificial heart valve 10, the peanut shape shown in Figure 2A can be achieved by connecting the atrial disc 1110 to the atrial tube 410 via hole 1112a with the atrial suture 810, and the ventricular disc 1120 to the ventricular tube 420 via hole 1124a with the ventricular suture 820, and by using the gear device 500 to rotate the atrial tube 410 and the ventricular tube 420 in opposite directions. By using any suitable expansion limiting mechanism, including those shown in Figures 3A, 3B, 4 and 5, not only expansion control but also controlled release of the frame 1100 from the shaft device 400 when it is confirmed that the artificial heart valve 10 is in the desired position can be achieved.

[0059] One potential problem with achieving the peanut shape of the artificial heart valve 10 (and in particular its frames 100, 100', 1100) as shown in Figure 2A is that even while the frame is otherwise constrained to this peanut shape, the tines (e.g., tines 126 or 1126) may tend to protrude radially outward when in the set shape. These outwardly extending tines 126, 1126 may interfere with natural tissue, for example, by engaging with or becoming entangled with subvalvular devices such as chordae tendineae. This potential problem can be avoided by utilizing holes 1126a provided in the tines. For example, Figure 6B shows a magnified view of one of the ventricular cells 1124 of frame 1100, which has a tine 1126 with a hole 1126a. As shown in Figure 6B, the tine suture 830 may have an end that terminates in an eyelet (with or without a knot, as in the embodiments of Figures 3C and 3D), the eyelet may extend at least partially through hole 1126a to the radially outer surface of frame 1100. The opposite end of the tine suture 830 may be coupled to a ventricular expansion control mechanism (e.g., the mounting ring 610 shown in Figure 3A, or the ventricular plate in the embodiments of Figures 4 and 5). A separate wire 1200 may pass through the eyelet of the suture 830 on the radially outer surface of tine 1126, but may extend across the struts forming the apex of the ventricular cell 1124 on the radially inner surface of cell 1124. The wire 1200 may be a flexible wire formed from, for example, nitinol or other similar material. Furthermore, in some embodiments, the wire 1200 may have a relatively thick portion 1210 to provide maximum support at the contact point with the frame 1100, while having a relatively thin portion 1220 located away from the contact point (e.g., by polishing) to provide maximum flexibility in the non-contact area. Instead of the thick and thin portions, the wire may have a metal portion instead of the thick portion 1220, and a suture (or suture-like) material instead of the thin portion 1220.The suture is connected to the metal part by any suitable mechanism, which includes swaging or other methods similar to those typically used to connect the suture to a needle. For example, the metal part may be a nitinol tube swaged at both ends to the suture or the portion of the suture. In another example, the wire 1200 may be formed as a monofilament suture that is thinned (e.g., stretched) to have a thicker region (neither thinned nor stretched) if desired and a thinner region if desired. Regardless of the specific method by which the wire 1200 is formed, while tension is maintained on the tine suture 830, the wire 1200 pulls the tine 1126 radially inward so that the wire 1200 does not interfere with the subvalve device. Once the position of the artificial heart valve 10 is confirmed while the frame 1100 is still in the controlled peanut shape shown in Figure 2A, the wire 1200 is withdrawn and the tine suture 830 is no longer connected to the tine 1126, so that the tine 1126 takes on a set shape (with the tine facing radially outward) and can engage with the natural tissue as the artificial heart valve 10 expands into its final deployed configuration.

[0060] Although only a portion of the flexible wire 1200 is shown in Figure 6B, the flexible wire is longer than shown and can form a loop around the outer circumference of the frame 1100, thereby allowing each tine 1126 to be controlled by a single wire 1200. It should be understood that both ends of the wire 1200 extend through the channels of the delivery system in order to maintain a closed loop with respect to the wire 1200. When the user is ready to detach the wire 1200 from the tine suture 830 and move the tines 1126 outward, one end of the wire 1200 can be pulled proximally from the delivery system until the other end is pulled through all the eyelets of the suture 830.

[0061] Figures 7A to 7D illustrate the steps of an exemplary delivery of the artificial heart valve 10 using the expansion control mechanism described herein. Prior to delivery, the artificial heart valve 10 is loaded in a folded state within the valve cover 1310 of the delivery catheter 1300. As part of this loading process, the artificial heart valve 10 is positioned on the shaft device 400 (or on the tubular assembly 2001), allowing the atrial suture 810 to pass through the atrial disc 1110 (through either the cells or holes 1112a) and the ventricular suture 820 to pass through the ventricular disc 1120 (through either the cells or holes 1124a). Any of the above-described expansion limiting mechanisms can be used (for example, instead of the holding device 2007) to activate the gear device 500 (or control interface 2008) to wrap the sutures 810, 820 around their respective tubes (for example, the handling tubes 2002, 2003) and pull the atrial disk 1110 and ventricular disk 1120 toward their respective tubes. If tine sutures 830 are used, the tine sutures 830 can be positioned through the tine holes 1126, and by passing the wire 1200 through the eyelets, a closed loop can be formed that can maintain the tines 1126 in an inward position.

[0062] Referring to Figure 7A, the artificial heart valve 10 is folded within the valve cover 1310, and after various control sutures are positioned, the delivery catheter 1300 can be advanced in the patient, for example, through the femoral vein, with the nose cone 1320 leading this advance. The delivery catheter 1300 can enter the right atrium via the inferior vena cava, and with the assistance of operational control, the valve cover 1310 can be positioned through the natural tricuspid valve.

[0063] Once the valve cover 1310 is positioned as desired, it is withdrawn, and the artificial heart valve 10 begins to expand on its own. However, because the atrial sutures 810 and ventricular sutures 820 are wrapped around their associated tubes on the shaft device 400, the atrial and ventricular discs are restricted from expanding. As shown in Figure 7B, this can result in the artificial heart valve 10 expanding to a peanut shape. Furthermore, as described above, this partial expansion reduces the axial range of the artificial heart valve 10 (compared to the fully wavy state), thereby eliminating the need for the delivery catheter 1300 to extend as deeply into the right ventricle as it might otherwise require. While the artificial heart valve 10 is in this partially expanded state, with the valve cover 1310 withdrawn, the user can verify that the artificial heart valve 10 is in the desired position for full expansion. If the artificial heart valve 10 is not in the desired position for full expansion, its position and / or orientation can be changed until the user is satisfied. Furthermore, when the tine suture 830 is implemented in this method, it should be understood that while the artificial heart valve 10 is in the state shown in Figure 7B, the tine 1126 is restricted from facing outward and engaging with the subvalvular apparatus, or from becoming entangled in any other way.

[0064] Even if the artificial heart valve 10 is positioned too deep within the ventricle, correction of the artificial heart valve 10 during expansion should be easily achieved. For example, when unwinding the sutures from their respective tubes, the artificial heart valve 10 is shortened (axially) at both the atrial and ventricular discs. While this shortening is occurring, the artificial heart valve 10 can be pulled further back (towards the atrium). Desirably, due to the simultaneous expansion of the ventricular and atrial discs during unwinding (and final release), the artificial heart valve 10 tends to self-center. While self-centering is known with respect to sequential deployment (e.g., ventricular deployment followed by atrial deployment), the simultaneous deployment enabled by the system described herein can greatly improve self-centering. Furthermore, it should be understood that in the “peanut” shape, the actual valve leaflets (or valve assembly) are not folded, or only slightly folded. As a result, the valve leaflets of the artificial valve are already functioning at the moment the atrial and ventricular discs are partially released. This is in contrast to known artificial heart valves, where the valve is released sequentially, and the valve only begins to function after the final deployment of the atrial disc.

[0065] Once the user confirms that the artificial heart valve 10 is in the desired position, the user can fully expand the artificial heart valve 10. To achieve this full expansion, the user can rotate the knob 530 of the gear device 500 to unwind the atrial sutures 810 and ventricular sutures 820 from the shaft device 400, thereby releasing the tension that the atrial sutures 810 and ventricular sutures 820 have created on the artificial heart valve 10. Furthermore, once this tension is released, the atrial sutures 810 and ventricular sutures 820 are disconnected from the artificial heart valve 10. When the expansion control mechanism of Figures 3A and 3B is used, the suture eyelets slide off the fingers of the suture ring. When the expansion control mechanism of Figure 4 is used, the pull rod 900 is pulled proximal, thereby causing the suture eyelets to slide off the pull rod 900. When the expansion control mechanism shown in Figure 5 is used, when the pull rod 900 is pulled proximal, the central portion of the suture is separated from the pull rod 900 and pulled through the artificial heart valve 10. When the flexible wire 1200 is used, immediately before, immediately after, or simultaneously with the release of the atrial sutures 810 and ventricular sutures 820, the user can pull the flexible wire 1200 proximal through the delivery catheter 1300. This allows the tine 1126 to move outward and frictionally engage with the tissue to assist in fixation. The fully released state is shown in Figure 7C.

[0066] After fully releasing the artificial heart valve 10, the shaft device 400 and nose cone 1320 can be withdrawn through the deployed artificial heart valve 10 (for example, until the nose cone 1310 abuts against the distal end of the valve cover 1310), and the delivery catheter 1300 can be removed from the patient. At this point, the artificial heart valve 10 is fully deployed as shown in Figure 7D, and the procedure can be considered complete.

[0067] While the disclosures herein are generally described in the context of the delivery and deployment of artificial tricuspid valves, it should be understood that similar or identical features may also be used for artificial mitral valves, and even for artificial aortic valves or artificial pulmonary valves. Although various rings are described herein as pairs of rings (e.g., rings 610 and 710 as a pair, rings 620 and 720 as a pair, two rings 610 as a pair, etc.), it should be understood that in some embodiments, these pairs of rings can be provided as a single ring having the respective features of both rings constituting the pair. For example, in some embodiments, rings 620 and 720 can be provided as a single component having the projections 622 and notches 624 of ring 620, and the fingers 722 of ring 720. Other pairs of rings described herein can, where appropriate, be provided as a single composite ring.

[0068] While the present invention has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present invention. Therefore, it should be understood that numerous modifications can be made to the exemplary embodiments, and that other configurations can be devised without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. An artificial heart valve system, An artificial heart valve for replacing the natural atrioventricular valve, A foldable and expandable frame comprising an atrial disc, a ventricular disc, and a central portion extending between the atrial disc and the ventricular disc, A plurality of artificial valve leaflets arranged within the frame, An artificial heart valve equipped with, A delivery device for delivering and deploying the artificial heart valve, The delivery device is equipped with, A catheter having a valve cover at its distal end, wherein the valve cover is configured to maintain the artificial heart valve in a folded state for delivery, An expansion restriction mechanism and a shaft device, wherein the shaft device comprises an atrial tube and a ventricular tube, and the expansion restriction mechanism comprises a first pair of rings fixed to the atrial tube and a second pair of rings fixed to the ventricular tube, Equipped with, An artificial heart valve system in which, in the delivery state of the system, the artificial heart valve is folded within the valve cover such that the atrial disc is positioned adjacent to the atrial tube and the ventricular disc is positioned adjacent to the ventricular tube, and a plurality of first sutures connect the first pair of rings and extend through the atrial disc, and a plurality of second sutures connect the second pair of rings and extend through the ventricular disc.

2. In the partially deployed state of the aforementioned system, The valve cover is withdrawn from the artificial heart valve so as not to restrict the expansion of the artificial heart valve. The plurality of first sutures are wrapped around the atrial tube so as to restrict the inflow portion of the atrial disk from self-expanding. The plurality of second sutures are wrapped around the ventricular tube so as to restrict the outflow portion of the ventricular disk from self-expanding. The artificial heart valve system according to claim 1, wherein the outflow portion of the atrial disk, the inflow portion of the ventricular disk, and the central portion of the frame are all at least partially enlarged.

3. The artificial heart valve system according to claim 2, wherein in the partially deployed state of the system, the artificial heart valve has a peanut shape, wherein at least the partially expanded inlet portion of the ventricular disc has a larger diameter than at least the partially expanded outlet portion of the atrial disc, and at least the partially expanded outlet portion of the atrial disc has a larger diameter than at least the partially expanded central portion of the frame.

4. The delivery device further comprises a gear device coupled to the aforementioned delivery device, The artificial heart valve system according to claim 2, wherein the gear device comprises a first connector connected to the atrial tube, a second connector connected to the ventricular tube, and a knob operably connected to the first connector and the second connector, and the rotation of the knob in a first rotational direction causes the first connector and the second connector, and consequently the atrial tube and the ventricular tube, to rotate simultaneously in opposite directions.

5. The first connection is directly connected to the atrial tube, The artificial heart valve system according to claim 4, wherein the second connection portion is directly connected to a central rod that passes through the atrial tube and directly connects to the ventricular tube.

6. The first pair of rings includes a first mounting ring and a first suture ring, The aforementioned second pair of rings includes a second mounting ring and a second suture ring, The first plurality of sutures are fixedly connected to the first mounting ring and are also releasably connected to the first suture ring. The artificial heart valve system according to claim 1, wherein the second plurality of sutures are fixedly connected to the second mounting ring and are also releasably connected to the second suture ring.

7. The first suture ring has a plurality of first fingers, each having a free end facing a first direction of rotation. The artificial heart valve system according to claim 6, wherein the second suture ring has a plurality of second fingers, each having a free end facing a second rotation direction opposite to the first rotation direction.

8. The first pair of rings includes a first mounting ring and a second mounting ring, The aforementioned second pair of rings includes a third mounting ring and a fourth mounting ring, The first set of sutures are fixedly connected to both the first mounting ring and the second mounting ring. The artificial heart valve system according to claim 1, wherein the second plurality of sutures are fixedly connected to both the third mounting ring and the fourth mounting ring.

9. A first pull rod extending through the first pair of rings, wherein, in the delivery state of the system, the eyelets of the first plurality of sutures receive the first pull rod passing through the eyelets, The system further comprises a second pull rod extending through the second pair of rings, wherein, in the delivery state of the system, the eyelets of the second plurality of sutures receive the second pull rod through the eyelets, The artificial heart valve system according to claim 8, wherein each of the first pull rod and the second pull rod is configured to be pulled out from each of the pair of rings to release each of the eyelets from each of the pull rods.

10. The atrial disk has a plurality of atrial holes formed at each of the inflow tips of the atrial disk, The ventricular disk has a plurality of holes formed at each of the outflow ends of the ventricular disk, The artificial heart valve system according to claim 1, wherein in the delivery state of the system, the plurality of first sutures pass through each of the atrial foramina, and the plurality of second sutures pass through each of the ventricular foramina.

11. A method for implanting an artificial heart valve, The artificial heart valve is loaded into a delivery device, wherein the artificial heart valve comprises a foldable and expandable frame having an atrial disc, a ventricular disc, a central portion extending between the atrial disc and the ventricular disc, and a plurality of artificial valve leaflets disposed within the frame. The delivery device is advanced onto the patient's natural heart valve while the artificial heart valve is kept folded by the valve cover of the delivery device. The deployment of the artificial heart valve is initiated by positioning the delivery device within or adjacent to the natural heart valve, and withdrawing the valve cover so that the frame begins to self-expand. When the frame begins to self-expand, the outflow end portion of the ventricular disk is restricted from self-expanding by the connection between the outflow end portion of the ventricular disk and the ventricular tube positioned inside the frame, so that the ventricular disk partially expands after the valve cover is withdrawn. After the valve cover is removed and the ventricular disc is partially expanded, the desired position of the artificial heart valve relative to the original heart valve is confirmed, After confirming the desired position of the artificial heart valve relative to the natural heart valve, the connection between the outflow end portion of the ventricular disc and the ventricular tube is released to expand the ventricular disc and engage it with the natural heart valve. Methods that include...

12. The method according to claim 11, wherein when the frame begins to expand, the inlet portion of the atrial disk is restricted from expanding by a connection between the inlet portion of the atrial disk and an atrial tube positioned inside the frame, so that the atrial disk partially expands after the valve cover is withdrawn.

13. The method according to claim 12, wherein, even after the valve cover has been removed, the artificial heart valve has a peanut shape in which the outflow portion of the atrial disc is at least partially expanded and the inflow portion of the ventricular disc is at least partially expanded, while maintaining the connection between the outflow portion of the ventricular disc and the ventricular tube, and maintaining the connection between the inflow portion of the atrial disc and the atrial tube.

14. The method according to claim 13, wherein, when the artificial heart valve has the peanut shape, at least the partially expanded atrial disc has a first diameter, at least the partially expanded ventricular disc has a second diameter, the central portion of the frame has a third diameter, the second diameter is greater than the first diameter, and the first diameter is greater than the third diameter.

15. The method according to claim 12, wherein after confirming the desired position of the artificial heart valve relative to the congenital heart valve, the connection between the inlet end portion of the atrial disc and the atrial tube is released to expand the atrial disc and engage with the congenital heart valve.

16. The connection between the outflow end portion of the ventricular disk and the ventricular tube is formed by a first set of sutures. The method according to claim 15, wherein the connection between the inlet end portion of the atrial disk and the atrial tube is formed by a second plurality of sutures.

17. In the partially expanded state of the ventricular disk, the first plurality of sutures are wrapped around the ventricular tube. The method according to claim 16, wherein, in the partially dilated state of the atrial disk, the second plurality of sutures are wrapped around the atrial tube.

18. Disconnecting the outflow end portion of the ventricular disk from the ventricular tube includes unwinding the first plurality of sutures from the ventricular tube. The method according to claim 17, wherein releasing the connection between the inlet end portion of the atrial disk and the atrial tube includes unwinding the second plurality of sutures from the atrial tube.

19. The method according to claim 18, wherein unwinding the first plurality of sutures from the ventricular tube and unwinding the second plurality of sutures from the atrial tube includes rotating the atrial tube in a first rotational direction and simultaneously rotating the ventricular tube in a second rotational direction opposite to the first rotational direction.

20. Disconnecting the outflow end portion of the ventricular disk from the ventricular tube and disconnecting the inflow end portion of the atrial disk from the atrial tube is, (i) The first plurality of sutures and the second plurality of sutures are made to slide off from their respective connection points to the respective tubes, or (ii) Actively withdrawing the first pull rod to disconnect the first set of sutures from the ventricular tube, and actively withdrawing the second pull rod to disconnect the second set of sutures from the atrial tube, The method according to claim 19, comprising any of the following:

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