Prosthetic heart valve device, system, and methods

Abstract

To provide a prosthetic heart valve device, system, and methods.SOLUTION: A system is provided, comprising a prosthetic heart valve device (535, 555, 900, 1108, 1230, 1260, 1400, 1535), and a delivery system (1100, 1105, 1110, 3000, 1500). The prosthetic heart valve device (535, 555, 900, 1108, 1230, 1260, 1400, 1535) comprises a differentially deformable anchoring structure (800, 1229, 1259) concentrically aligned with, radially adjacent to, and in direct connection with a valve frame (700). The atrial region (805, 1005, 1410, 1805, 1850) of the differentially deformable anchoring structure (800, 1229, 1259) comprises a plurality of alignment structures intended to aid in rotational orientation. This atrial region (805, 1005, 1410, 1805, 1850) is in direct connection with the valve frame (700) through inflow region connection elements (745).SELECTED DRAWING: Figure 8D

Description

[Technical field]

[0001] The present invention relates generally to prosthetic heart valve devices for repairing and / or replacing native heart valves. In particular, some embodiments relate to prosthetic atrioventricular valves for replacing defective bicuspid and / or tricuspid valves, and methods and devices for delivering and implanting the same into the human heart.

[0002] The present invention relates to prostheses and delivery systems for prostheses for insertion into cavities or body lumen, and in particular, in some embodiments, the prostheses and delivery systems relate to prosthetic heart valve devices, such as replacement atrioventricular valves. [Background technology]

[0003] Incomplete atrioventricular valve closure, also called incomplete bicuspid and / or tricuspid valve closure or incomplete function, is a heart disease in which the atrioventricular valves (bicuspid and / or tricuspid) fail to close normally. Both bicuspid and tricuspid valves in a healthy human heart are composed of a fibrous ring onto which are attached flexible and elastic leaflets that can close when the ventricle contracts. The free ends of each flexible leaflet are connected to chordae tendineae, which attach the leaflets to papillary muscles in the ventricle, thereby controlling the movement of the free ends of the leaflets throughout the cardiac cycle. The parts of the valve must work in sync to achieve proper systemic blood circulation. Various cardiac or degenerative diseases affect the parts of the atrioventricular valves, causing the valves to close improperly. This allows abnormal leakage of blood past the valve into the atria and peripheral vascular system. Persistent atrioventricular valve regurgitation can lead to a myriad of cardiovascular complications, including congestive heart failure.

[0004] Traditionally, patients with bicuspid valves that do not completely close have already been treated with invasive cardiac surgery, including surgical repair or replacement of the bicuspid valve. Generally, these methods produce good clinical results, but due to their invasiveness and long recovery period, many potential patients do not meet the acceptance criteria for such therapy. Thus, many patients are not treated and are treated with medication. Patients suffering from tricuspid regurgitation are treated to a much lesser extent with surgery, and therefore there are many more medically-needed patients suffering from tricuspid regurgitation. Patients who are treated with medication for atrioventricular valve disease have a poor quality of life and adverse long-term outcomes, with many individuals experiencing a five-year mortality rate of 50% or more.

[0005] Over the years, the development of minimally invasive catheter valve therapy has made significant progress, with the greatest progress being made in the direction of treating aortic and pulmonary valve disease. Exemplary prostheses include those described in U.S. Patent No. 7,892,281, the entire contents of which are incorporated herein by reference for all purposes. Some progress has been made in the direction of treating bicuspid regurgitation by catheter therapy. U.S. Patent No. 8,652,203 discloses exemplary prostheses, the entire contents of which are incorporated herein by reference for all purposes. Also, U.S. Patent No. 9,034,032 discloses exemplary prostheses, the entire contents of which are incorporated herein by reference for all purposes. However, due to limitations of current technology, a large number of potential patients remain unsuitable for such therapy and remain untreated or produce adverse outcomes. These limitations and outcomes include, but are not limited to: Adverse surgical events of stagnation and prolongation of atrial blood flow and / or radiation exposure to the patient and operator, which can lead to outflow tract obstruction, thrombus formation and thromboembolic events. Progress in treating tricuspid regurgitation with catheter valve replacement therapy has been very small. Given the limitations of current technology and the large number of untreated patients, there remains a need for improved devices, systems, and methods that are easier, more accurate, and repeatable to treat atrioventricular valve insufficiency. Summary of the Invention

[0006] The embodiments disclosed herein refer to devices, systems and methods, such as, but not limited to, used to replace defective atrioventricular valves, and more specifically, replacement prosthetic heart valve devices and systems for replacing defective native tricuspid and / or bicuspid valves in the heart of a human patient.

[0007] Still other embodiments relate to delivery systems, devices and / or methods for delivering and / or controllably deploying a prosthetic heart valve device (such as, but not limited to, a replacement heart valve device) to a desired location within the body.

[0008] In some embodiments, a replacement prosthetic heart valve device and a method for delivering the replacement prosthetic heart valve device to a native heart valve, such as an atrioventricular valve, are provided.

[0009] The present invention includes, but is not limited to, the following number of embodiments.

[0010] (Embodiment 1)

[0011] A system for replacing a defective native atrioventricular valve includes a delivery system and a prosthetic heart valve device, and has two typical operation configurations: a radial compression operation configuration for passage through a desired anatomical structure by catheter delivery, and a radial expansion operation configuration for final implantation of the target defective atrioventricular valve.

[0012] (Embodiment 2)

[0013] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native bicuspid valve and passes through the patient's vascular system from the femoral vein, through the inferior vena cava and the space between the chambers to reach the final implantation location in the bicuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0014] (Embodiment 3)

[0015] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native tricuspid valve and passes through the patient's vascular system from the femoral vein, through the inferior vena cava and through the right atrium to reach the final implantation location in the tricuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0016] (Embodiment 4)

[0017] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native bicuspid valve and passes through the patient's vascular system from the subclavian vein and through the superior vein to reach the final implantation location in the bicuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0018] (Embodiment 5)

[0019] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native tricuspid valve and passes through the subclavian vein, through the patient's vascular system, through the superior vein, and to the final implantation location in the tricuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0020] (Embodiment 6)

[0021] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native bicuspid valve, penetrates the patient's anatomy via the apical entry tract, passes through the left ventricle to reach the final implantation location in the bicuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device in the exemplary embodiment by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step.

[0022] (Embodiment 7)

[0023] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native tricuspid valve, passing through the patient's anatomy via the apical tract and through the right ventricle to reach the final implantation location in the tricuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to the desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0024] (Embodiment 8)

[0025] A prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native bicuspid valve, passing through the patient's anatomy via an atrial entry tract and through the left atrium to reach a final implantation location in the bicuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device in the exemplary embodiment by delivering the prosthetic heart valve device to a desired implantation location using a delivery conduit with a controlled deployment step.

[0026] (Embodiment 9)

[0027] The prosthetic heart valve device according to embodiment 1, wherein the prosthetic heart valve device can be implanted in a defective native bicuspid valve, and penetrates the patient's anatomy via an aortic access, passing through the femoral artery and the aorta to reach a final implantation location in the bicuspid valve, thereby ensuring accurate alignment, placement and fixation of the prosthetic heart valve device by delivering the prosthetic heart valve device to a desired implantation location using a delivery conduit with a controlled deployment step in the exemplary embodiment.

[0028] (Embodiment 10)

[0029] A prosthetic heart valve device according to any one of embodiments 2 to 9, wherein the prosthetic heart valve device comprises a differentially deformable anchor structure concentrically aligned with, radially adjacent to, directly connected to and surrounding the valve frame.

[0030] (Embodiment 11)

[0031] A prosthetic heart valve device as described in embodiment 10, wherein the deformable anchor structure includes an atrial region having a first stiffness and a plurality of alignment structures, the plurality of alignment structures intended to assist with rotational orientation during implantation.

[0032] (Embodiment 12)

[0033] 12. A prosthetic heart valve device as described in embodiment 11, wherein the atrial region is positioned to coincide with the bottom of the native atrium adjacent to the atrioventricular valve and can be directly connected to the internal valve frame by an inflow region connecting member.

[0034] (Embodiment 13)

[0035] A prosthetic heart valve device as described in embodiment 12, wherein the differentially deformable anchor structure includes a ring region, the ring region including a ring anchor element for preventing reverse migration and having a second stiffness generally suitable for deformation and consistent with a native anatomical structure.

[0036] (Embodiment 14)

[0037] A prosthetic heart valve device as described in embodiment 13, wherein the deformable anchor structure includes a ventricular region, which generally has a third stiffness and includes a plurality of ventricular anchor elements, the ventricular anchor elements having a plurality of ventricular region connecting elements, adjacent to and in contact with the outflow region of the connecting member of the valve frame.

[0038] (Embodiment 15)

[0039] A prosthetic heart valve device as described in embodiment 14, wherein the differentially deformable anchor structures are further arranged to be covered by a leak-proof membrane in the atrial region and the ring region to prevent circumferential leakage of the valve.

[0040] (Embodiment 16)

[0041] 16. The prosthetic heart valve device according to embodiment 15, wherein the prosthetic heart valve device further comprises a valve frame.

[0042] (Embodiment 17)

[0043] 17. The prosthetic heart valve device of embodiment 16, wherein the valve frame includes an inflow region, an intermediate region, and an outflow region downstream of the inflow region.

[0044] (Embodiment 18)

[0045] 18. The prosthetic heart valve device according to embodiment 17, wherein the inflow region of the valve frame is further arranged to be directly connected to the atrial region of the differentially deformable anchor structure by an inflow region connecting member.

[0046] (Embodiment 19)

[0047] An artificial heart valve device as described in embodiment 18, wherein the connecting member further comprises a bendable portion geometry that is arranged to transfer mechanical damping forces and torsion from the anchor structure to the valve frame while maintaining a rigid connection therebetween and allowing the valve frame to retain its generally cylindrical geometry, optimizing valve performance.

[0048] (Embodiment 20)

[0049] 20. The prosthetic heart valve device of embodiment 19, wherein the inflow region of the valve frame is further configured to include a leak-proof membrane, which spans from the valve frame along the connecting member to the anchor structure.

[0050] (Embodiment 21)

[0051] A prosthetic heart valve device as described in embodiment 20, wherein the intermediate region of the valve frame further includes a plurality of leaflets, which are supported by a leaflet support structure extending to the intermediate region of the valve frame body, and have a leak-proof membrane, which together form a one-way valve for blood flow through the prosthetic valve assembly.

[0052] (Embodiment 22)

[0053] 22. The prosthetic heart valve device of embodiment 21, wherein the outflow region of the valve frame further comprises a plurality of outflow region connecting members directly connected to the ventricular region of the anchor structure, wherein the outflow region connecting members extend from the boundary region of the valve frame.

[0054] (Embodiment 23)

[0055] 23. The prosthetic heart valve device of embodiment 22, wherein the outflow region connecting member further comprises a bendable portion geometric shape that is arranged to mechanically damp the transmission of forces between the anchor structure and the valve frame.

[0056] (Embodiment 24)

[0057] 24. The prosthetic heart valve device of embodiment 23, wherein the geometry of the bendable portion further comprises a suture filament, which has an elasticity or tensile property within a relatively stiff to relatively soft range.

[0058] (Embodiment 25)

[0059] 25. The prosthetic heart valve device of embodiment 24, wherein the prosthetic heart valve device is further configured to be used to align any leaflet of the prosthetic valve with the anterior leaflet of the native atrioventricular valve during implantation by a guided rotational orientation manner of the atrial alignment structure within the different deformable anchor structures to avoid ventricular outflow tract obstruction.

[0060] (Embodiment 26)

[0061] 26. A prosthetic heart valve device as described in embodiment 25, wherein the geometry of the bendable deformation portions contained within the inflow and outflow regions of the valve frame is further configured to permit circulatory shuttle of the valve prosthesis.

[0062] (Embodiment 27)

[0063] A prosthetic heart valve device as described in embodiment 26, wherein the geometry of the bendable portion in the valve frame is arranged to allow the internal prosthetic valve to displace toward the atrium, thereby displacing it from a potentially obstructed ventricular outflow tract and aiding in ventricular output when contracting during systole, and an increase in ventricular pressure when contracting during systole displaces the prosthetic valve leaflets from an open position to a closed position, thereby increasing the back pressure on the valve.

[0064] (Embodiment 28)

[0065] A prosthetic heart valve device as described in embodiment 27, wherein when the ventricle expands, as the pressure difference between the atrium and the ventricle becomes smaller, blood is allowed to flow from the atrium through the prosthetic valve and enter the ventricle for ventricular filling, and the geometric shape of the bendable deformation portion inside the valve frame is further arranged to allow the valve frame to return to its original position within the ventricle, reducing its atrial projection, reducing the possibility of diastolic blood flow obstruction, blood stagnation, and optimizing ventricular filling.

[0066] (Embodiment 29)

[0067] The prosthetic heart valve device according to embodiment 28, wherein the radially compressed prosthetic heart valve device further allows traversing tight bend curvatures as required and does not impair the advancement of the anatomical path of the anatomical structure.

[0068] (Embodiment 30)

[0069] 30. The prosthetic heart valve device according to embodiment 29, wherein the radially compressed prosthetic heart valve device is delivered in the form of a hinge connection.

[0070] (Embodiment 31)

[0071] The prosthetic heart valve device according to embodiment 30, wherein the radially compressed prosthetic heart valve device further comprises a flexible geometric region.

[0072] (Embodiment 32)

[0073] A prosthetic heart valve device as described in embodiment 31, wherein the differentially deformable anchor structure provides a residual amount of compression to the prosthetic heart valve device to advance along tight curves, thereby enabling optimized and controlled advancement and delivery of the prosthetic heart valve device to a desired target implantation site.

[0074] (Embodiment 33)

[0075] A delivery system as described in embodiment 32, wherein the delivery system includes an elongated first conduit having a first diameter and including a primary cavity, a first bendable portion, and one or more secondary cavities radially adjacent to the primary cavity.

[0076] (Embodiment 34)

[0077] The delivery system of embodiment 33 further includes one or more tethers connected to portions of the prosthetic heart valve device and arranged to translate through one or more secondary cavities of the first conduit.

[0078] (Embodiment 35)

[0079] A delivery system as described in embodiment 34, further comprising an elongated second conduit having a second diameter smaller than the first diameter and comprising a cavity, a second bendable portion and a connecting element of a portion connectable to one or more artificial heart valve devices, wherein the second conduit is further arranged for translation within the primary cavity of the first conduit.

[0080] (Embodiment 36)

[0081] The delivery system of embodiment 35 further includes a compensation mechanism connected in fluid communication with the second conduit and adapted to controllably effect a configuration change of the prosthetic heart valve device.

[0082] (Embodiment 37)

[0083] 37. A delivery system as described in embodiment 36, wherein the one or more tethers and the one or more connecting elements together provide tension that controllably maintains the prosthetic heart valve device in a radially constrained configuration for delivery.

[0084] (Embodiment 38)

[0085] A delivery system as described in embodiment 37, wherein the compensation mechanism allows the second conduit to release tension by controllably translating into the first conduit during radial expansion of the prosthetic heart valve device.

[0086] (Embodiment 39)

[0087] A delivery system as described in embodiment 38, further comprising a third elongated conduit having a third diameter smaller than the second diameter and comprising a cavity, a third bendable portion and a distal end covering, the distal end covering having a fourth diameter larger than the third diameter and arranged to radially constrain a portion of the prosthetic heart valve device by a portion including the prosthetic heart valve device therein.

[0088] (Embodiment 40)

[0089] 40. A delivery system as described in embodiment 39, wherein the third conduit is further disposed for translation within the cavity of the second conduit.

[0090] (Embodiment 41)

[0091] 41. The delivery system of embodiment 40, wherein the distal end jacket is further configured to contact a connecting element of the second conduit thereby embedding a portion of the prosthetic heart valve device.

[0092] (Embodiment 42)

[0093] A delivery system as described in embodiment 41, wherein the compensation mechanism is further arranged to be connected and in communication with a third conduit, and wherein the distal end covering of the third conduit is controllably translated by operation of the compensation mechanism.

[0094] (Embodiment 43)

[0095] The delivery system of embodiment 42 further comprises a fourth elongate conduit having a fifth diameter greater than the first diameter and comprising a cavity and a proximal end covering configured to contain the portion of the prosthetic heart valve device therein and thereby radially constrain the portion of the prosthetic heart valve device.

[0096] (Embodiment 44)

[0097] 44. A delivery system as described in embodiment 43, wherein the fourth conduit is further disposed in translation above the first conduit.

[0098] (Embodiment 45)

[0099] 45. The delivery system of embodiment 44, wherein the first and second bendable portions further comprise sections of laser cut nickel titanium knowtube.

[0100] (Embodiment 46)

[0101] Like the delivery system of embodiment 44, here the first and second bendable portions further comprise sections of laser cut steel tubing.

[0102] (Embodiment 47)

[0103] Like the delivery system of embodiment 44, here the first and second bendable portions further comprise sections of laser cut polymer tubing.

[0104] (Embodiment 48)

[0105] 45. The delivery system of embodiment 44, wherein the first and second bendable portions further comprise portions of reinforced fiber tubes.

[0106] (Embodiment 49)

[0107] 49. The delivery system of any one of embodiments 45-48, wherein the second conduit is further arranged to be deflected in a manner that applies tension to the inwardly biased guy wire. The present invention provides, for example, the following items. (Item 1) 1. A native atrioventricular valve system for treating a cardiac defect, comprising: Prosthetic heart valve devices and delivery systems, The prosthetic heart valve device includes a valve, a valve frame, a valve seal cover, an anchor structure, and an anchor seal cover; the valve includes a plurality of leaflets, the valve frame is expandable and is used to support the valve, and has an inflow region, a middle region, and an outflow region downstream of the inflow region; the inflow region further comprises a plurality of inflow region connecting members, the intermediate region further comprises a leaflet support structure, and the outflow region further comprises a plurality of outflow region connecting members; the valve seal cover extends between the inlet and outlet regions and is positioned to prevent leakage around the valve; wherein the valve is configured to convert between a permissive state and a blocking state; the anchor structure is deformable, concentrically aligned with, radially adjacent to and surrounding the valve frame, and includes an atrial region, a ring region and a ventricular region, the atrial region generally having a first stiffness and including a plurality of atrial region connection elements adjacent to and connecting and contacting the inflow region connection members of the valve frame, the ring region generally having a second stiffness and including a ring anchor element for preventing retrograde displacement of the device, the ventricular region generally having a third stiffness and including a plurality of ventricular region connection elements adjacent to and connecting and contacting the outflow region connection members of the valve frame, the anchor seal cover extends between the atrial region and the ventricular region and is positioned to prevent leakage around the valve; wherein the prosthetic heart valve device is configured to controllably transition between a radially minimized, compressed state configured for delivery and a radially maximized, expanded state configured for implantation; The anchor structure is positioned to permanently anchor the heart valve device within an atrium valve of the heart when the device is in the expanded state and implanted. (Item 2) 2. The prosthetic heart valve device of item 1, wherein any leaflets are aligned with the native anterior leaflets of the atrioventricular valves of said heart during implantation of the device, avoiding ventricular outflow tract obstruction after implantation of the device. (Item 3) The method according to item 1, wherein any leaflet is aligned with the native anterior leaflet of the atrioventricular valve of the heart during implantation of the device, and the native anterior leaflet is allowed to move freely after implantation of the device. Artificial heart valve devices. (Item 4) 2. The prosthetic heart valve device of claim 1, wherein the expandable valve frame further comprises a plurality of boundary members for providing positioning and fixation between adjacent valve leaflets, and each outflow region connecting member of the valve frame extends from a boundary member. (Item 5) 2. The prosthetic heart valve device of claim 1, wherein each inflow region connecting member further comprises a bendable portion geometry that is configured to mechanically damp the transmission of forces between the anchor structure and the valve frame. (Item 6) 2. The prosthetic heart valve device of claim 1, wherein each outflow region connecting member further comprises a bendable portion geometric shape that is arranged to mechanically damp the transmission of forces between the anchor structure and the valve frame. (Item 7) 2. The prosthetic heart valve device of claim 1, wherein the geometry of the bendable deformation portion of each inflow region connecting member is further configured to permit translational displacement of the valve frame from the anchor structure during systole. (Item 8) 2. The prosthetic heart valve device of claim 1, wherein the geometry of the bendable deformation portion of each outflow region connecting member is further configured to permit translational displacement of the valve frame from the anchor structure during systole. (Item 9) 2. The prosthetic heart valve device of claim 1, wherein the geometry of the bendable deformation portion of each inflow region connecting member is further configured to permit counter-rotational translational displacement of the valve frame from the anchor structure during expansion. (Item 10) 2. The prosthetic heart valve device of claim 1, wherein the geometry of the bendable deformation portion of each outflow region connecting member is further configured to permit counter-rotational translational displacement of the valve frame from the anchor structure during expansion. (Item 11) The geometric shape of the bendable deformation portion of each inlet region connecting member further includes a geometric shape of a radially bendable deformation portion, and is configured to allow the radially bendable deformation portion of the inlet region to bend radially in response to an applied force when compressed, as described in item 1. The artificial heart valve device. (Item 12) The geometric shape of the bendable deformation portion of each outflow region connecting member further includes a geometric shape of a radially bendable deformation portion, and is configured to allow the radially bendable deformation portion of the outflow region to bend radially in response to an applied force when compressed, as described in item 1. The artificial heart valve device. (Item 13) 2. The cardiac prosthesis of claim 1, wherein each outflow region connecting member further comprises a rigid geometric shape that is arranged to resist bending or displacement between the anchor structure and the valve frame. Valvular apparatus. (Item 14) 2. The cardiac prosthesis of claim 1, wherein each inflow region connecting member further comprises a rigid geometric shape that is arranged to resist bending or displacement between the anchor structure and the valve frame. Valvular apparatus. (Item 15) The atrial region of the anchor further comprises a plurality of support structures terminated in a releasably captured atrial retention member, wherein the support structures are positioned to coincide with the bottom of a native atrium of an atrial valve adjacent to the heart based on the first stiffness when implanted. Artificial heart valve device. (Item 16) Item 16. The prosthetic heart valve device of item 15, wherein the releasably captured atrial retention member is configured for releasable connection to a delivery system of the prosthetic heart valve device. (Item 17) 2. The prosthetic heart valve device of claim 1, wherein when viewed in standard imaging modes, the plurality of support structures of the atrial region of the anchor provide a clear indication of the relative position and orientation of the device with respect to the native rings and outflow tract of the heart. (Item 18) 2. The method of claim 1, wherein the plurality of support structures of the atrial region of the anchor further includes a radially bendable deformation portion geometry and is arranged to allow the radially bendable deformation portion of the atrial region to bend radially in response to an applied force when compressed. Artificial heart valve devices. (Item 19) 2. The prosthetic heart valve device of claim 1, wherein the atrial region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter larger than the first diameter adjacent the atrial region. (Item 20) 2. The artificial heart according to claim 1, wherein the atrial region of the anchor has a generally disk-like shape. Heart valve apparatus. (Item 21) 2. The prosthetic heart valve of claim 1, wherein the atrial region of the anchor is generally bowl-shaped. Device. (Item 22) 2. The prosthetic heart valve device of claim 1, wherein the ring region of the anchor is further configured, when implanted, to apply a radial anchoring force outwardly against a native ring abutting an atrioventricular valve of the heart based on the second stiffness. (Item 23) 2. The prosthetic heart valve device of claim 1, wherein the ring anchor element comprises a tissue piercing structure. (Item 24) 24. The prosthetic heart valve device of claim 23, wherein said ring anchor element further comprises one or more rows of tissue piercing structures, and wherein each structure is oriented in the same direction. (Item 25) 24. The prosthetic heart valve device of claim 23, wherein said ring anchor element further comprises two rows of tissue piercing structures, and wherein said two rows of tissue piercing structures are generally oriented toward one another. (Item 26) 24. The prosthetic heart valve device of claim 23, wherein the ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures are generally oriented away from each other. . (Item 27) 2. The prosthetic heart valve device of claim 1, wherein the ventricular region of the anchor is further configured to conform to a native ventricle of the heart when implanted based on the third stiffness. (Item 28) 2. The prosthetic heart valve device of claim 1, wherein the ventricular region connecting member of the anchor comprises an elongated structural member, a distal end of the elongated structural member extending away from the ring region of the anchor and toward the ventricle and terminating in a releasably captured ventricular retaining member. (Item 29) 30. The prosthetic heart valve device of item 28, wherein the releasably captured ventricular retention member is configured for releasable connection to a delivery system of the prosthetic heart valve device. (Item 30) 2. The prosthetic heart valve according to claim 1, wherein the ventricular region connecting member of the anchor further comprises a radially bendable deformation portion geometric shape and is arranged such that when compressed, the radially bendable deformation portion of the ventricular region is allowed to bend radially in response to an applied force. Device. (Item 31) 2. The prosthetic heart valve device of claim 1, wherein the ventricular region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter larger than the first diameter adjacent the ventricular region. (Item 32) 2. The prosthetic heart valve device of claim 1, wherein the ventricular region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter smaller than the first diameter adjacent the ventricular region. (Item 33) 2. The prosthetic heart valve of claim 1, wherein the ventricular region of the anchor is generally bowl-shaped. Device. (Item 34) 2. The artificial heart according to claim 1, wherein the ventricular region of the anchor has a generally disk-like shape. Heart valve apparatus. (Item 35) 2. The artificial heart according to claim 1, wherein the shape of the ventricular region of the anchor is generally cylindrical. Valve gear. (Item 36) 2. The prosthetic heart valve device of item 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the femoral artery or femoral vein. (Item 37) 2. The prosthetic heart valve device of claim 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision at the tip of the heart. (Item 38) 2. The prosthetic heart valve device of item 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the corresponding atrium. (Item 39) 2. The prosthetic heart valve device of item 1, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the subclavian vein. (Item 40) 1. A prosthetic heart valve device for treating a heart defect comprising: The prosthetic heart valve device includes a valve, a valve frame, a valve seal cover, an anchor structure, and an anchor seal cover; the valve includes a plurality of leaflets, the valve frame is expandable and is used to support the valve, and has an inflow region, a middle region, and an outflow region downstream of the inflow region; the inflow region further comprises a plurality of inflow region connecting members, the intermediate region further comprises a leaflet support structure, and the outflow region further comprises a plurality of outflow region connecting members; the valve seal cover extends between the inlet and outlet regions and is positioned to prevent leakage around the valve; wherein the valve is configured to convert between a permissive state and a blocking state; the anchor structure is deformable, concentrically aligned with, radially adjacent to and surrounding the valve frame, and includes an atrial region, a D-shaped ring region and a ventricular region, the atrial region generally having a first stiffness and including a plurality of atrial region connection elements adjacent to and connecting and contacting the inflow region connection member of the valve frame, the D-shaped ring region generally having a second stiffness and including a ring anchor element for preventing retrograde displacement of the device, the ventricular region generally having a third stiffness and including a plurality of ventricular region connection elements adjacent to and connecting and contacting the outflow region connection member of the valve frame, the anchor seal cover extends between the atrial region and the ventricular region and is positioned to prevent leakage around the valve; wherein the prosthetic heart valve device is configured to controllably transition between a radially minimized, compressed state configured for delivery and a radially maximized, expanded state configured for implantation; The anchor structure is positioned to permanently anchor the heart valve device within an atrium valve of the heart when the device is in the expanded state and implanted. (Item 41) aligning the plane of the D-shaped ring region of the anchor structure with the native anterior leaflet of an atrioventricular valve of the heart during device implantation to avoid ventricular outflow tract obstruction after device implantation. 41. The prosthetic heart valve device according to claim 40. (Item 42) 41. The prosthetic heart valve device according to item 40, wherein the plane of the D-shaped ring region of the anchor structure is aligned with the native anterior leaflet of the atrioventricular valve of the heart during implantation of the device and allows the native anterior leaflet to move freely after implantation of the device. (Item 43) 41. The prosthetic heart valve device of claim 40, wherein the expandable valve frame further comprises a plurality of boundary members for providing positioning and fixation between adjacent leaflets, and wherein each outflow region connecting member of the valve frame extends from a boundary member. (Item 44) Item 41. The prosthetic heart valve device of item 40, wherein each inflow region connecting member further includes a bendable portion geometry that is arranged to mechanically damp the transmission of forces between the anchor structure and the valve frame. (Item 45) Item 41. The prosthetic heart valve device of item 40, wherein each outflow region connecting member further comprises a bendable portion geometry that is arranged to mechanically damp the transmission of forces between the anchor structure and the valve frame. (Item 46) 41. The prosthetic heart valve device of claim 40, wherein the geometry of the bendable deformation portion of each inflow region connecting member is further configured to permit translational displacement of the valve frame from the anchor structure during systole. (Item 47) Item 41. The prosthetic heart valve device of item 40, wherein the geometry of the bendable deformation portion of each outflow region connecting member is further configured to allow translational displacement of the valve frame from the anchor structure during systole. (Item 48) 41. The prosthetic heart valve device of claim 40, wherein the geometry of the bendable deformation portion of each inflow region connecting member is further configured to permit counter-rotational translational displacement of the valve frame from the anchor structure during expansion. (Item 49) 41. The prosthetic heart valve device of claim 40, wherein the geometry of the bendable deformation portion of each outflow region connecting member is further configured to permit counter-rotational translational displacement of the valve frame from the anchor structure during expansion. (Item 50) Item 40. The geometric shape of the bendable deformation portion of each inlet region connecting member further includes a geometric shape of a radially bendable deformation portion and is configured to allow the radially bendable deformation portion of the inlet region to bend radially in response to an applied force when compressed. 2. The artificial heart valve device according to claim 1 . (Item 51) Item 40. The geometric shape of the bendable deformation portion of each outflow region connecting member further includes a geometric shape of a radially bendable deformation portion and is arranged to allow the radially bendable deformation portion of said outflow region to bend radially in response to an applied force when compressed. 2. The artificial heart valve device according to claim 1 . (Item 52) 41. The prosthetic heart valve of claim 40, wherein each outflow region connecting member further comprises a rigid geometric shape and is arranged to resist bending or displacement between the anchor structure and the valve frame. Device. (Item 53) 41. The prosthetic heart valve of claim 40, wherein each inflow region connecting member further comprises a rigid geometric shape and is arranged to resist bending or displacement between the anchor structure and the valve frame. Device. (Item 54) Item 40. The atrial region of the anchor further comprises a plurality of support structures terminated with a releasably captured atrial retention member, wherein the support structures are positioned to coincide with the floor of a native atrium of an atrial valve adjacent the heart based on the first stiffness when implanted. Artificial heart valve device. (Item 55) 55. The prosthetic heart valve device of item 54, wherein the releasably captured atrial retention member is configured to be releasably connected to a delivery system of the prosthetic heart valve device. (Item 56) 41. The prosthetic heart valve device of claim 40, wherein when viewed in standard imaging modes, the plurality of support structures of the atrial region of the anchor provide a clear indication of the relative position and orientation of the device with respect to the native rings and outflow tract of the heart. (Item 57) 41. The prosthetic heart valve device of claim 40, wherein the plurality of support structures of the atrial region of the anchor further comprises a radially deflectable deformation portion geometry and is arranged, when compressed, to enable the radially deflectable deformation portion of the atrial region to bend radially in response to an applied force. (Item 58) 41. The prosthetic heart valve device of claim 40, wherein the atrial region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter larger than the first diameter adjacent the atrial region. (Item 59) 41. The method of claim 40, wherein the atrial region of the anchor is generally disk-shaped. Artificial heart valve apparatus. (Item 60) 41. The artificial heart according to claim 40, wherein the shape of the atrial region of the anchor is generally bowl-shaped. Valve gear. (Item 61) 41. The prosthetic heart valve device of claim 40, wherein the ring region of the anchor is further configured when implanted to apply a radial anchoring force outwardly against a native ring abutting an atrioventricular valve of the heart based on the second stiffness. (Item 62) 41. The prosthetic heart valve device of claim 40, wherein the ring anchor element comprises a tissue piercing structure. (Item 63) 63. The prosthetic heart valve device of claim 62, wherein said ring anchor element further comprises one or more rows of tissue piercing structures, and wherein each structure is oriented in the same direction. (Item 64) 63. The prosthetic heart valve device of claim 62, wherein said ring anchor element further comprises two rows of tissue piercing structures, and wherein said two rows of tissue piercing structures are generally oriented toward one another. (Item 65) 63. The prosthetic heart valve device of claim 62, wherein the ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures are generally oriented away from each other. . (Item 66) 41. The prosthetic heart valve device of claim 40, wherein the ventricular region of the anchor is further configured to conform to a native ventricle of the heart when implanted based on the third stiffness. (Item 67) 41. The prosthetic heart valve device of claim 40, wherein the ventricular region connecting member of the anchor comprises an elongated structural member, a distal end of the elongated structural member extending away from the ring region of the anchor and toward the ventricle and terminating in a releasably captured ventricular retaining member. (Item 68) Item 68. The prosthetic heart valve device of item 67, wherein the releasably captured ventricular retention member is configured for releasable connection to a delivery system of the prosthetic heart valve device. (Item 69) 41. The cardiac prosthesis according to claim 40, wherein the ventricular region connecting member of the anchor further comprises a radially bendable deformation portion geometric shape and is arranged such that when compressed, the radially bendable deformation portion of the ventricular region is allowed to bend radially in response to an applied force. Valve gear. (Item 70) 41. The prosthetic heart valve device of claim 40, wherein the ventricular region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter larger than the first diameter adjacent the ventricular region. (Item 71) 41. The prosthetic heart valve device of claim 40, wherein the ventricular region of the anchor is generally frusto-conical in shape and has a first diameter adjacent the ring region and a second diameter smaller than the first diameter adjacent the ventricular region. (Item 72) 41. The artificial heart according to claim 40, wherein the shape of the ventricular region of the anchor is generally bowl-shaped. Valve gear. (Item 73) 41. The method of claim 40, wherein the ventricular region of the anchor is generally disk-shaped. Artificial heart valve apparatus. (Item 74) 41. The cardiac prosthesis according to claim 40, wherein the shape of the ventricular region of the anchor is generally cylindrical. Valvular apparatus. (Item 75) 41. The prosthetic heart valve device according to item 40, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the femoral artery or femoral vein. (Item 76) 41. The prosthetic heart valve device of item 40, wherein the device can be delivered to the atrioventricular valve of the heart through a percutaneous incision at the tip of the heart. (Item 77) 41. The prosthetic heart valve device of item 40, wherein the device is deliverable to the atrioventricular valve of the heart via a percutaneous incision in the corresponding atrium. (Item 78) 41. The prosthetic heart valve device of item 40, wherein the device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the subclavian vein. (Item 79) 1. A delivery system for a prosthetic heart valve device, comprising: a first elongated conduit, one or more tethers, a second elongated conduit, and a compensation mechanism; the elongated first conduit has a first diameter and includes a primary cavity, a first bendable portion, and one or more secondary cavities radially adjacent the primary cavity; the tether is connected to a portion of the prosthetic heart valve device and is disposed to translate through the one or more secondary cavities of the first conduit; the elongated second conduit has a second diameter smaller than the first diameter and includes a lumen, a second bendable portion, and a connection element of a portion connectable to one or more of the prosthetic heart valve devices, wherein the second conduit is further disposed for translation within the primary cavity of the first conduit; The compensation mechanism is connected in fluid communication with the second conduit and is capable of controllably shortening the prosthetic heart valve device, the one or more tethers together with the one or more connection elements providing tension that controllably maintains the prosthetic heart valve device in a radially constrained configuration for delivery, and the compensation mechanism allows the second conduit to release the tension by controllably translating into the first conduit during radial expansion of the prosthetic heart valve device. (Item 80) Item 7 further includes an elongated third conduit, the elongated third conduit having a third diameter smaller than the second diameter and including a lumen, a third bendable portion, and a distal end jacket, the distal end jacket having a fourth diameter larger than the third diameter and arranged to radially constrain a portion of the prosthetic heart valve device with a portion including the prosthetic heart valve device therein, the third conduit further arranged to translate within the lumen of the second conduit. 10. A transport system as described in claim 9. (Item 81) 81. The delivery system of claim 80, wherein the distal end jacket is further configured to contact the connecting element of the second conduit thereby embedding a portion of the prosthetic heart valve device. (Item 82) 82. The delivery system of claim 81, wherein the compensation mechanism is further disposed in communication with and connected to the third conduit, and the distal end jacket of the third conduit is controllably translated by actuation of the compensation mechanism. (Item 83) Item 83. The delivery system of item 82, further comprising a fourth elongate conduit, the fourth elongate conduit having a fifth diameter greater than the first diameter and comprising a lumen and a proximal end jacket, the proximal end jacket being arranged to contain the portion of the prosthetic heart valve device therein and thereby support radial restraint of the portion of the prosthetic heart valve device, the fourth conduit being further arranged for translation above the first conduit. (Item 84) Item 84. The delivery system of item 83, wherein the first and second bendable portions further comprise sections of laser cut nickel titanium tubing. (Item 85) Item 83. The first and second bendable sections further comprise sections of laser cut steel tubing. The transport system described herein. (Item 86) the first and second bendable portions further comprise sections of laser cut polymer tubing. 84. A transport system as described in claim 83. (Item 87) Item 84. The method according to item 83, wherein the first and second bendable portions further comprise reinforced fiber tube portions. Conveying system. (Item 88) 88. The delivery system of any one of items 84 to 87, wherein the second conduit is further configured to be deflected in a manner that applies tension to an internally biased wire.

[0108] The present invention will be described below with reference to application examples thereof in conjunction with the drawings. [Brief description of the drawings]

[0109] [Figure 1] FIG. 1 is a schematic diagram of an anterior frontal view of an exemplary heart, in accordance with some applications of the present invention. [Figure 2A] FIG. 2 is a schematic diagram of a front view of the posterior portion of an exemplary heart with section lines in accordance with some applications of the present invention. [Figure 2B] FIG. 1 is a schematic diagram of a cross-sectional view of basic aspects of an exemplary heart in accordance with some applications of the present invention, showing an exemplary aortic valve, an exemplary bicuspid valve, an exemplary pulmonary valve, and an exemplary tricuspid valve. [Figure 3A] FIG. 1 is a front view of the deployment and flattened periphery of an exemplary bicuspid natural valve apparatus including leaflets, chordae tendineae, and papillary muscles, in accordance with some applications of the present invention. [Figure 3B] FIG. 1 is a front view of the deployment and flattened periphery of an exemplary native tricuspid valve apparatus including leaflets, chordae tendineae, and papillary muscles, in accordance with some applications of the present invention. [Figure 4A] 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart illustrating the direction of normal blood flow in the left ventricle during diastole, in accordance with some applications of the present invention. [Figure 4B] 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart illustrating the normal direction of blood flow in the left ventricle during contraction, in accordance with some applications of the present invention; [Figure 4C] 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart illustrating the direction of blood flow returning to the left ventricle by the attached posterior lobe during systole, in accordance with some applications of the present invention; [Figure 4D] 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart illustrating the direction of blood flow returning the left ventricle through the leaflet ridges during systole, in accordance with some applications of the present invention; [Figure 5A] FIG. 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart illustrating an embodiment of a prosthetic heart valve device implanted in a bicuspid position, in accordance with some applications of the present invention. [Figure 5B] FIG. 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart showing an embodiment of a prosthetic heart valve device implanted in the tricuspid position, in accordance with some applications of the present invention. [Figure 6A] FIG. 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart, illustrating a percutaneous pathway for transapical implantation in a bicuspid position, in accordance with some applications of the present invention. [Figure 6B] FIG. 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart illustrating a percutaneous pathway for transapical implantation in the tricuspid position in accordance with some applications of the present invention. [Figure 6C] FIG. 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart showing a percutaneous pathway corresponding to a transfemoral venous graft in the tricuspid position in accordance with some applications of the present invention. [Figure 6D] FIG. 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart illustrating a percutaneous pathway for septal implantation in a bicuspid valve position in accordance with some applications of the present invention. [Figure 6E] FIG. 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart showing a percutaneous pathway for subclavian implantation in a bicuspid position in accordance with some applications of the present invention. [Figure 6F] FIG. 1 is a schematic diagram of an exemplary anterior cross-sectional view of a heart showing a percutaneous pathway for subclavian implantation in the tricuspid position in accordance with some applications of the present invention. [Figure 6G]FIG. 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart showing percutaneous pathways for cortical implantation in a bicuspid valve position in accordance with some applications of the present invention. [Figure 6H] FIG. 1 is a schematic diagram of an anterior cross-sectional view of an exemplary heart showing percutaneous pathways corresponding to percutaneous implantation in a bicuspid valve position, in accordance with some applications of the present invention. [Figure 7A] FIG. 2 is a schematic diagram of a perspective view of an exemplary self-expanding valve frame embodiment in accordance with some applications of the present invention. [Figure 7B] 1 is a schematic diagram of a top view (inflow) of an exemplary self-expanding valve frame embodiment in accordance with some applications of the present invention. [Figure 7C] FIG. 2 is a schematic diagram of a front view of an exemplary self-expanding valve frame embodiment in accordance with some applications of the present invention. [Figure 7D] 1 is a front view of an exemplary self-expanding valve frame embodiment including tissue leaflets and a fabric covering, in accordance with some applications of the present invention. [Figure 8A] 1A-1C are schematic diagrams of perspective views of exemplary differentially deformable anchor structure embodiments in accordance with some applications of the present invention; [Figure 8B] 1A-1C are schematic diagrams of cross-sectional views of exemplary differentially deformable anchor structure embodiments, in accordance with some applications of the present invention. [Figure 8C] 1A-1C are schematic diagrams of top views (inflow) of exemplary differentially deformable anchor structure embodiments, in accordance with some applications of the present invention. [Figure 8D] 1 is a schematic diagram of a cross-sectional view of an exemplary embodiment of a differentially deformable anchor structure including a fabric cover according to some applications of the present invention. FIG. [Figure 9A] FIG. 1 is a schematic diagram of a front view of an exemplary embodiment of a prosthetic heart valve device, in accordance with some applications of the present invention. [Figure 9B] 1 is a schematic diagram of a perspective view of an exemplary embodiment of a prosthetic heart valve device, in accordance with some applications of the present invention. [Figure 9C] FIG. 1 is a schematic diagram of a top (inflow) perspective view of an exemplary prosthetic heart valve device embodiment, in accordance with some applications of the present invention. [Figure 9D]FIG. 1 is a schematic diagram of a front view of an exemplary embodiment of a prosthetic heart valve device including a fabric covering, according to some applications of the present invention. [Figure 9E] 1 is a schematic diagram of a cross-sectional profile view of an exemplary embodiment of a prosthetic heart valve device, in accordance with some applications of the present invention. [Figure 9F] 1 is a schematic diagram of an exemplary embodiment of a prosthetic heart valve device, detailing an alternative embodiment of a curved geometric coupling. [Figure 10A] FIG. 1 is a schematic diagram of a front view of an exemplary prosthetic heart valve device embodiment in a curl configuration, in accordance with certain applications of the present invention. [Figure 10B] FIG. 10B is a schematic diagram of a front view of an exemplary prosthetic heart valve device embodiment in an expanded configuration, in accordance with some applications of the present invention. [Figure 11A] 1 is a front view of an exemplary embodiment of a prosthetic heart valve device deployed from an exemplary delivery system, in accordance with some applications of the present invention. [Figure 11B] 1 is a schematic diagram of a front view of an exemplary embodiment of a prosthetic heart valve device deployed from an exemplary delivery system, in accordance with some applications of the present invention. [Figure 11C] 1 is a schematic diagram of a front view of an exemplary embodiment of a prosthetic heart valve device deployed from an exemplary delivery system, in accordance with some applications of the present invention. [Figure 12A] FIG. 12A is a side cross-sectional view of an exemplary embodiment of a prosthetic heart valve device according to some applications of the present invention implanted in a bicuspid position during the diastole of the cardiac cycle. [Figure 12B] FIG. 12B is a side cross-sectional view of an exemplary embodiment of a prosthetic heart valve device implanted in a bicuspid position during the systolic phase of the cardiac cycle, in accordance with some applications of the present invention. [Figure 13A] 1A-1C are schematic diagrams of perspective and detailed views of an exemplary embodiment of a prosthetic heart valve device mounted on an exemplary delivery system, in accordance with some applications of the present invention. [Figure 13B] 1A-1C are front views of segments of an embodiment of a frame flat pattern of an exemplary prosthetic heart valve device, in accordance with some applications of the present invention. [Figure 14]1 is an enlarged schematic diagram of a distal portion of a transfemoral delivery device having a prosthesis in a partially deployed configuration, according to some applications of the present invention. [Figure 15A] 1 is a schematic diagram of a transfemoral delivery apparatus having a prosthetic heart valve device in a loading configuration, in accordance with some applications of the present invention. [Figure 15B] 1 is a schematic diagram of a distal end of a transfemoral delivery apparatus having a loaded prosthetic heart valve device, in accordance with some applications of the present invention. FIG. [Figure 16A] 1 is a schematic diagram of a transfemoral delivery device according to some applications of the present invention. [Figure 16B] 1 is a schematic diagram of a transfemoral delivery device according to some applications of the present invention. [Figure 17A] 1 is a schematic diagram of a prosthetic heart valve device retention region of a transfemoral delivery apparatus according to some applications of the present invention. [Figure 17B] 1 is a schematic diagram of a tether shuttle mechanism of a transfemoral delivery device according to some applications of the present invention, with the tether shuttle in a closed configuration. [Figure 17C] 1 is a schematic diagram of multiple tether connectors of a transfemoral delivery device in a joined configuration in accordance with some applications of the present invention. [Figure 17D] 1 is a schematic diagram of a tether shuttle mechanism of a transfemoral delivery device according to some applications of the present invention, with the tether shuttle in an open configuration. [Figure 17E] 1 is a schematic diagram of multiple tether connectors of an offset configured strand delivery system, according to some applications of the present invention. [Figure 17F] 1 is a hidden line view of a tether connector of a strand delivery system according to some applications of the present invention. [Fig. 18A-I] 1A-1C are a series of schematic diagrams illustrating the deployment of prosthetic heart valve devices in accordance with some applications of the present invention. [Figure 19A-D] 1 is a sequence of schematic diagrams illustrating the configuration of the second conduit and the outer coating in the retention region according to some applications of the present invention. [Figure 20A-C]1A-1C are a series of schematic illustrations of a transfemoral delivery device taken in cross-section in accordance with certain applications of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0110] The present specification and drawings provide aspects and features of the present disclosure in the context of several embodiments of replacement prosthetic heart valve devices, systems, and methods that are placed in a patient's vascular system, e.g., the patient's native heart valve. These embodiments may be discussed in conjunction with and replace a particular valve, e.g., the patient's bicuspid or tricuspid valve. However, it will be understood that the features and concepts discussed herein may be applied to products other than prosthetic heart valve devices. For example, the controlled positioning, deployment, and fixation features described herein may be applied to medical implants, e.g., other types of deployable prostheses, and used in other locations of the body, e.g., arteries, veins, or other body cavities or locations. Additionally, the specific features of the prosthetic heart valve devices, systems, or methods should not be considered limiting, and features of any embodiment discussed herein may be combined with features of other embodiments, where appropriate. Although several embodiments described herein are described in conjunction with a particular delivery entry, it will be understood that these examples may be used with other delivery entries. It will also be understood that some features described in combination with some embodiments can be combined with other embodiments, including those described in combination with different transport paths.

[0111] Reference is now made to FIG. 1, which is a schematic diagram illustrating a frontal view of an exemplary heart 100, in accordance with some applications of the present invention. The exemplary heart 100 generally includes four main chambers (right atrium 140, right ventricle 146, left atrium 110, and left ventricle 147) that work in unison as a pumping system to circulate blood throughout the vascular system. Normally, the systemic circulation (not shown) returns deoxygenated blood to the right atrium 140 via the superior and inferior veins (125, 145, respectively). During diastole (the ventricular expansion portion of the cardiac cycle), the deoxygenated blood is forced through the tricuspid valve (245, FIG. 2B) and into the right ventricle 146. Upon entering the right ventricle 146, the pressure gradient between the contraction-driven right ventricle 146 and the right atrium 140 during systole (the ventricular contraction portion of the cardiac cycle) closes the tricuspid valve (245, FIG. 2B) and forces the blood to pass through the right ventricular outflow tract (520, FIG. 5A), passing through the pulmonary valve (515, FIG. 5A) and proceeding along the left and right pulmonary arteries (115, 130, respectively) until it exits along the pulmonary trunk 114 to the lungs (not shown). The blood becomes oxygenated by inhalation in the lungs (not shown) and then returns to the left atrium 110 by the left and right pulmonary veins (105, 135, respectively). Diastolic expansion then draws in the now oxygenated blood through the open bicuspid valve (210, FIG. 2B), resulting in the filling of the left ventricle 147. Finally, the systolic ventricle drives the pressure gradient between the left ventricle 147 and the left atrium 110 to contract, closing the bicuspid valve (210, FIG. 2B) and forcing oxygenated blood in the left ventricle of the heart 147 to pass through the left ventricular outflow tract (455, FIG. 4A), through the aortic valve (205, FIG. 2B), and circulate through the system along the aorta 120 (not shown). The heart 100 further provides itself with oxygenated blood throughout the cardiac cycle through the circumflex artery 155 and the left and right coronary arteries (160, 150, respectively). Branching arteries of the aorta 120, such as the left subclavian artery, the left common carotid artery, and the cephalic and brachial arteries (121, 122, 123, respectively), provide oxygenated blood to the brain and upper extremities of the body.

[0112] Reference is now made to Figure 2A, which is a schematic diagram of the posterior portion of an exemplary heart 100, in accordance with some applications of the present invention. Section line A-A200 is shown, which illustrates where a section of the exemplary heart 100 can be cut to arrive at the view shown in Figure 2B.

[0113] FIG. 2B is a schematic diagram showing a cross-section of an exemplary heart 100 in accordance with some applications of the present invention, highlighting anatomical features presented from an apical perspective. As previously mentioned, the exemplary heart generally includes four main chambers (right atrium 140, right ventricle 146, left atrium 110, and left ventricle 147, FIG. 1). Between the right atrium (140, FIG. 1) and the right ventricle (146, FIG. 1) is the tricuspid valve 245. The inner wall of the right ventricle 240 defines the space through which blood is pumped during systolic contraction. The tricuspid valve 245 is a tricuspid valve, and is comprised of anterior leaflet 255, posterior leaflet 250, and interspaced leaflet 260, which close together when the right ventricle (146, FIG. 1) is under pressure during contraction and generally prevent retrograde blood flow. Between and below the anterior and posterior leaflets 255, 250 are the anterior and posterior papillary muscles 256, which support the two leaflets by the tricuspid valve chordae tendineae 261. Between and below the posterior leaflet 250 and the septal leaflet 260 is the posterior septal papillary muscle 257, which supports the two leaflets by the tricuspid chordae tendineae 261. Between and below the septal leaflet 260 and the anterior leaflet 255 is the anterior septal papillary muscle 258, which supports the two leaflets by the tricuspid chordae tendineae 261.

[0114] Opening along the outer wall of the right ventricle 241 is the pulmonary valve 235, which and the tricuspid valve 245 share the right ventricular outflow tract (520, FIG. 5A) with the right ventricle (146, FIG. 1). The pulmonary valve 235 is also a tricuspid valve, consisting of a left cusp 236, a right cusp 238 and an anterior cusp 237, which close together and generally prevent retrograde blood flow when the right ventricle (146, FIG. 1) decompresses during diastole.

[0115] Opening along the outer wall of the left ventricle 231 is the aortic valve 205, which and the bicuspid valve 210 share a left ventricular outflow tract (455, FIG. 4A) with the left ventricle (147, FIG. 1). The aortic valve 205 is also a tricuspid valve, consisting of a left cusp 206, a right cusp 207 and a posterior cusp 208, which close together and generally prevent retrograde blood flow when the left ventricle (147, FIG. 1) decompresses during systole.

[0116] Between the left atrium (110, FIG. 1) and the left ventricle (147, FIG. 1) is a bicuspid valve 210. The inner wall of the left ventricle 230 defines a space into which blood is pumped during systolic contraction. The bicuspid valve 210 is a bicuspid valve, consisting of an anterior leaflet 212 and a posterior leaflet 211, which close when the left ventricle (147, FIG. 1) is under pressure during contraction and generally prevent retrograde blood flow. Between and behind the posterior leaflet 211 and the anterior leaflet 212 is a posteromedial papillary muscle 215, which supports the two leaflets by the bicuspid valve chordae tendineae 225. Outside and behind the posterior leaflet 211 and the anterior leaflet 212 is an anteriorlateral papillary muscle 220, which supports the two leaflets by the bicuspid valve chordae tendineae 225. The anterior leaflet 212 extends from the bicuspid valve ring (335, FIG. 3A) into the central chamber in a subring-like manner. At the border (the corner where the cusps intersect), the anterior leaflet 212 arises from the valve annulus adjacent to a distinctly rigid area of ​​fibrous tissue, called the fibrous trigon 216. The fibrous trigon 216 serves as a structural area for the heart 100, providing a base of support for the bicuspid valve 210 and the aortic valve 205 during the dynamic motions produced throughout the cardiac cycle.

[0117] Reference is now made to Figure 3A, which is a schematic diagram of a front view of a representative 300 of an exemplary native bicuspid valve periphery, including leaflets (anterior 310, posterior 315), bicuspid chordae tendineae (320), and papillary muscles (anterolateral 305, posteromedial 301), unfolded and flattened for selection, according to some applications of the present invention. As can be seen, both the anterior leaflet 310 and the posterior leaflet 315 originate from the bicuspid annulus 335 and extend downward (towards the left ventricle, not shown) and away from the left atrium (not shown). The representative 300 is segmented (in half in this view) along the edge of the bicuspid ring 335 into a posteromedial boundary region 306 and an anteriorlateral boundary region 307. Extending below each border region (posterior medial 306, anterolateral 307) are arches of bicuspid chordae tendineae 320, which further extend to communicate with the corresponding papillary muscle (posterior medial 301, anterolateral 305). The bicuspid chordae tendineae also extend directly from the anterior 310 and posterior 315 leaflets themselves, defining the edge of each corresponding leaflet until they reach chordae-free regions called the posterior and anterior free margins (325, 330, respectively). In a healthy heart with intact anatomy, the function of the chordae tendineae is to provide tension between the leaflets and the papillary muscles, preventing the leaflets from becoming too coapted and moving toward the atrium during systole, which can ultimately cause valve dysfunction, regurgitation, heart failure, and poor health.

[0118] Similar to Fig. 3A, Fig. 3B is a schematic diagram of an exemplary representative 340 of a native tricuspid valve periphery, including leaflets (partitions 350, anterior 360, posterior 370), tricuspid chordae tendineae (380), and papillary muscles (posterior partitions 385, anterior partitions 390, anterior and posterior 395), unfolded and flattened for selection, according to some applications of the present invention. As can be seen, the anterior leaflet 360, posterior leaflet 370, and cut-off leaflet 350 originate from the tricuspid ring 345 and extend downward (towards the right ventricle, not shown) and away from the right atrium (not shown). Along the edge of the tricuspid ring 345, the representative 340 is divided into an anterior partition boundary region 382, ​​an anterior-posterior boundary region 383, and a posterior partition boundary region 381 (divided in half in this figure). Extending beneath each border region (anterior partition 382, ​​anterior / posterior partition 383, and posterior partition 381) are arches of tricuspid chordae tendineae 380, which further extend until they communicate with the corresponding papillary muscles (anterior partition 390, anterior / posterior partition 395, and posterior partition 385). Tricuspid chordae tendineae 380 also extend directly from the segment leaflets 350, anterior leaflet 360, and posterior leaflet 370 themselves, defining the edges of each corresponding leaflet and terminating at the tendonless chordae areas called segment free margins, anterior free margins, and posterior free margins (355, 365, 375). As with the bicuspid valve, the tricuspid valve leaflets, chordae tendineae, and corresponding papillary muscles also work in unison to prevent blood flow retrograde and all associated diseases and complications related to blood flow retrograde and retrograde.

[0119] Reference is now made to Figures 4A and 4B, which are diagrams illustrating exemplary illustrations of normal forward blood flow on the left and right sides of the heart (centred on the left side) through a cardiac cycle including diastole and systole, in accordance with some applications of the present invention. Specifically, Figure 4A illustrates a schematic cross-sectional view of an anterior portion of an exemplary heart 400, showing the normal direction of blood flow (indicated by arrow 430) from the left atrium 445 to the left ventricle 425 during diastole. It should be understood that during diastole, the bicuspid valve 440 opens and the bicuspid valve leaflets 435 extend completely toward the left ventricle 425, thereby allowing fresh oxygen-containing blood to fill the left ventricle 425. During diastole, the aortic valve 450 remains closed. Also depicted in Figure 4A is the right side of the heart during diastole. In a manner similar to what occurs on the left side of the heart during diastole, on the right side, blood is directed from the right atrium 405 through the open tricuspid valve 410, through the fully extended tricuspid leaflets 415, into the right ventricle 420, and then out the right ventricular outflow tract (not shown) and the pulmonary valve and then the pulmonary valve (neither shown). During a cardiac cycle, the two ventricles of the heart expand in unison during diastole, and then contract in unison during systole. FIG. 4B is a schematic anterior cross-sectional view of an exemplary heart 400, showing the normal direction of blood flow (indicated by arrow 460) from the left ventricle 425 through the left ventricular outflow tract 455 to the aortic valve 465 during systole. It should be understood that during systole, the bicuspid valve 470 closes and the bicuspid leaflets 471 fully contract, preventing blood from flowing backwards into the left atrium 445, and allowing fresh oxygenated blood to be expelled by the aorta 472. During systole, the aortic valve 465 is forced open. Figure 4B also illustrates the right side of the heart during systole. In a manner similar to what occurs on the left side of the heart during systole, on the right side, blood is directed from the right ventricle 420 by the right ventricular outflow tract (not shown) to the pulmonary valve (not shown). It can be seen that the tricuspid valve 475 closes and the tricuspid leaflets 476 fully contract, preventing blood from flowing backwards into the right atrium 405.

[0120] Contrary to Figures 4A and 4B, Figures 4C and 4D are schematic diagrams illustrating exemplary illustrations of abnormally directed blood flow in the left and right sides of the heart (centred on the left side) with some retrograde flow during systole, according to some applications of the present invention. Specifically, Figure 4C is a schematic cross-sectional view of the anterior part of an exemplary heart 400, showing the direction of abnormal blood flow (indicated by arrows 480 and 481) not only passing through the aorta 465 during systole, but also passing through a damaged bicuspid valve 485 and into the left atrium 445. In this figure, the damaged bicuspid valve 485 has continuous leaflets that cannot be coapted correctly. The associated leaflets may be due to torn chordae tendineae (not shown) or degenerated bicuspid annulus tissue, which may cause further tissue structure damage, reduced strength and degeneration. For such type of damaged bicuspid valve 485, most of the ejection score passing through the aorta 465 should normally leave and be reintroduced into the left atrium 445, as indicated by arrow 480. 4D is a schematic cross-sectional view of an anterior portion of an exemplary heart 400, showing the direction of abnormal blood flow (indicated by arrows 490 and 481) through the aorta 465 during systole, as well as through a damaged bicuspid valve 495 and into the left atrium 445. In the figure, the damaged bicuspid valve 495 suffers from tented leaflets that cannot coapt properly. Tented leaflets may result from ventricular remodeling, which may occur after an ischemic event, such as a cardiac attack. When a portion of the ventricle loses function (due to ischemia), the remaining healthy portion of the ventricle is forced to contract excessively, causing localized hypertrophy and deformation of the surrounding anatomical structures (e.g., chordae tendineae and associated leaflets).

[0121] Reference is now made to Figures 5A and 5B, which are schematic diagrams showing cross-sectional views of the anterior portion of an exemplary heart (500, 550) of an embodiment of a prosthetic heart valve device implanted in the bicuspid and tricuspid positions (bicuspid position 535, tricuspid position 555), according to some applications of the present invention. In particular, Figure 5A shows a schematic diagram of an exemplary heart 500 cut along a plane that bisects the pulmonary trunk 501, the right atrium 502, the left atrium 503, the right ventricle 510, and the left ventricle 505, thereby exposing internal features and details of the heart cavities (right atrium 405, left atrium 445, right ventricle 420, and left ventricle 425), which are already related to the design features of an exemplary embodiment of a prosthetic heart valve device 535 designed for implantation in the bicuspid position. Exemplary embodiments of the prosthetic heart valve device 535 may be designed to have a minimal profile extending into the inflow (left atrium 445 or right atrium 405) and outflow (right ventricle 420 or left ventricle 425) regions to prevent ventricular outflow tract obstruction (left ventricular outflow tract 512, right ventricular outflow tract 520) and reduced ejection scores in the event of outflow area obstruction, and to prevent blood flow obstruction and stagnation formation in the event of inflow area obstruction. Exemplary embodiments of the prosthetic heart valve device 535 may further utilize native anatomical structures, such as the anterior and posterior regions (545 and 540, respectively) of the bicuspid ring (514, FIG. 5B), and may use an outward radial force to aid in anchoring the device, and may have load bearing surfaces adjacent the atrial base (left, 445) and ventricular apex (left, 425) to effectively pinch the native valve ring and prevent the device from migrating into the left atrium 445 or left ventricle 425. These features are further described below.

[0122] 5B, in accordance with some applications of the present invention, shows a schematic diagram of an exemplary heart 550 cut along a plane that bisects the pulmonary trunk 501, the right atrium 502, the left atrium 503, the right ventricle 510, and the left ventricle 505, thereby exposing internal features and details of the heart cavities (right atrium 405, left atrium 445, right ventricle 420, and left ventricle 425) that relate to design features of an exemplary embodiment of a prosthetic heart valve device 555 designed for implantation in the tricuspid position. The exemplary embodiment of the prosthetic heart valve device 555 can provide similar advantages as those described and discovered above for devices designed for the bicuspid position. For example, an exemplary embodiment of the prosthetic heart valve device 555 can further utilize native anatomical structures, such as the anterior, partition, and posterior regions (565 and 560, respectively) of the tricuspid ring (513, FIG. 5A ), and can use a radially outward force to help anchor the device, and have load-bearing surfaces that can abut the atrial base (right, 405) and ventricular apex (right, 420), effectively pinching against the native valve ring and preventing the device from migrating into the right atrium 405 or right ventricle 420.

[0123] Reference is now made to Figures 6A-6H, which are schematic diagrams of cross-sectional views of an anterior portion of an exemplary heart 600, according to some applications of the present invention, illustrating various percutaneous delivery pathways of an exemplary prosthetic heart valve device. Figure 6A illustrates a percutaneous pathway corresponding to an apical implanted bicuspid valve position, indicated by directional arrow 605. Figure 6B illustrates a percutaneous pathway corresponding to an apical implanted tricuspid valve position, indicated by directional arrow 615. Figure 6C illustrates a percutaneous pathway corresponding to a femoral vein implanted tricuspid valve position, indicated by directional arrow 625. Figure 6D illustrates a percutaneous pathway corresponding to a transfemoral vein / transinterseptal implanted bicuspid valve position, indicated by directional arrow 635. Figure 6E illustrates a percutaneous pathway corresponding to a subclavian implanted bicuspid valve position, indicated by directional arrow 645. Figure 6F illustrates a percutaneous pathway corresponding to a subclavian implanted tricuspid valve position, indicated by directional arrow 655. Figure 6G illustrates a percutaneous pathway corresponding to an aortically interposed bicuspid valve position, indicated by directional arrow 665. 6H shows a corresponding percutaneous pathway in a bicuspid valve position inserted by the atrium, indicated by directional arrow 675. Although some embodiments of the exemplary prosthetic heart valve devices described herein are described in conjunction with a particular percutaneous delivery pathway, it will be understood that these embodiments can be used with other percutaneous delivery pathways. It will also be understood that, depending on some applications of the invention, some features described in conjunction with some embodiments can be combined with other embodiments, including those described in conjunction with different percutaneous delivery pathways.

[0124] Reference is now made to Figures 7A-7D, which are schematic diagrams illustrating an embodiment of an exemplary self-expanding valve frame 700 arranged to mate with a differentially deformable anchor structure (800, Figure 8A), in accordance with some applications of the present invention. Specifically, Figure 7A shows a perspective view of an exemplary embodiment of a self-expanding valve frame 700, which may be generally cylindrical and have a blood inflow region 701 and a blood outflow region 702 opposite the blood inflow region 701, which generally illustrate the direction in which blood may flow through the device during normal operation. The exemplary self-expanding valve frame 700 embodiment illustrated in Figure 7A may generally be constructed of any alloy having superelastic and shape memory properties, such as nickel titanium or any other superelastic, shape memory metal or other alloy, polymer, or composition of material capable of exhibiting self-expanding properties. In general, an exemplary embodiment of a self-expanding valve frame 700 may have a valve frame inflow region (715, FIG. 7C) adjacent to the blood inflow region 701 and arranged to provide features that prevent leakage around the valve and features that allow for a mating connection between the exemplary self-expanding valve frame 700 and the exemplary differentially deformable anchor structure (800, FIG. 8A) of the adjacent valve frame inflow region (715, FIG. 7C). The features that allow for a mating connection between the exemplary self-expanding valve frame 700 and the exemplary differentially deformable anchor structure (800, FIG. 8A) may further include a plurality (736, FIG. 7B) of elongated inflow region connecting members 735 that are flexibly, moveably, and bendably arranged to allow for structural deformation and to absorb forces while still providing a secure and persistent support between the members. The inflow region connecting members 735 may further be arranged in a geometric shape 740 that includes a bendable portion, which allows for structural deformation and force absorption. The inflow region connection member 735 may be further configured to provide an inflow region connection element 745, which acts as a positioning feature and is used for a connectable engagement between the inflow region connection member 735 and a corresponding atrial connection element (825, FIG. 8A) that is located in an exemplary embodiment of the differentially deformable anchor structure (800, FIG. 8A).Features that allow for preventing paravalvular leakage around the exemplary self-expanding valve frame 700 can include a valve seal cover (780, FIG. 7D), which is constructed of a fabric, such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymeric fabric, or any other material adapted to construct a durable prosthetic heart valve device, and is positioned to extend from the valve frame inflow region (715, FIG. 7C) to the valve frame outflow region (725, FIG. 7C, as follows). Additionally, the exemplary self-expanding valve frame 700 embodiment can further include a valve frame ring region (720, FIG. 7C), which is adjacent to and between the valve frame inflow region (715, FIG. 7C) and the valve frame outflow region (725, FIG. 7C, as follows), and is positioned to provide a location for connecting sutures and fabric, such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymeric fabric, or any other material adapted to construct a durable prosthetic heart valve device. Features that allow for providing locations for connecting sutures and fabric to the exemplary self-expanding valve frame 700 at the valve frame ring region (720, FIG. 7C) can include leaflet attachment connection rails 730 and bendable deformable portion geometry of the leaflet attachment connection rails (775, FIG. 7C) that can also receive the sutures and fabric and provide flexibility (not shown) that aids in the crimping process and then loading the device onto an exemplary delivery system (not shown) for percutaneous or other implantation. Additionally, the exemplary self-expanding valve frame 700 embodiment can further include a valve frame outflow region (725, FIG. 7C) that is adjacent and downstream of the valve annulus region (720, FIG. 7C) and that is positioned to provide features that allow for a mating connection between the exemplary self-expanding valve frame 700 and the exemplary differentially deformable anchor structure (800, FIG. 8A) of the adjacent valve frame outflow region (725, FIG. 7C).Features enabling a matching connection between the exemplary self-expanding valve frame 700 and the exemplary differentially deformable anchor structure (800, FIG. 8A) of the adjacent valve frame outflow region (725, FIG. 7C) can include a plurality (749, FIG. 7C) of elongated outflow region connection members (750, FIG. 7C) adjacent to and extending from the leaflet attachment rails (730, FIG. 7C) and the valve boundary attachment region (765, FIG. 7A) that are arranged to support attachment of a plurality of leaflets (790, FIG. 7D) by way of sutures and boundary leaflet attachment components (770, FIG. 7A). Each outflow region connection member (750, FIG. 7C) may further include a series of outflow region connection elements (755, FIG. 7C) that serve as matable positioning features between the outflow region connection member (750, FIG. 7C) and a corresponding ventricular region connection element (845, FIG. 8A) that is adjacent to a ventricular conformal structure support strut (836, FIG. 8A) that is located in an exemplary embodiment of a differentially deformable anchor structure (800, FIG. 8A). Each outflow region connection member (750, FIG. 7C) may further include a bendable portion geometry (760, FIG. 7C) that is flexibly and bendably arranged to allow deformation of the structure and absorb forces while still providing reliable and persistent support between the members.

[0125] Referring to FIG. 7D, a schematic diagram of a front view of an exemplary embodiment of a self-expanding valve frame 777, according to some applications of the present invention, is illustrated, which includes a tissue leaflet and fabric covering (valve seal cover) 780 to prevent leakage around the valve. The self-expanding valve frame 777 embodiment of FIG. 7D includes a leaflet attachment rail 730, which provides a location for a plurality of leaflets 790. The leaflets may be made of chemically treated and biocompatible intrapericardial tissue material, or a biocompatible polymeric material, or any other structure that is biocompatible and adapted for manufacturing of a prosthetic heart valve leaflet structure. Each leaflet 790 extends between a valve boundary 795 adjacent and between the extent of each leaflet attachment rail 730, which further includes a boundary covering 786 and an attachment suture 785.

[0126] Reference is now made to Figures 8A-8D, which are schematic diagrams illustrating various views of an exemplary embodiment of a differentially deformable anchor structure 800, according to some applications of the present invention. The exemplary embodiment of the differentially deformable anchor structure 800 shown in Figures 8A-8B can include an anchor atrial region 805, which includes a plurality of elongated struts that together define a generally diamond-shaped unit structure and has a generally first stiffness. The atrial region 805 is arranged to conform to an atrial surface of a native atrioventricular valve of the heart (see Figures 5A-5B), and provides resistance to the atrioventricular valve of the heart moving from the atrium toward the corresponding ventricle. The atrial region 805 can further include a plurality of atrial ejection members 830, each atrial ejection member 830 adjacent to and extending from an atrial conforming structure 820, which is further arranged to provide a smooth surface over which an exemplary delivery system conduit (not shown) can be pulled to capture and engage a prosthetic heart valve device of the present disclosure. The atrial release member 830 may be arranged to include an atrial release member geometry 831, which allows for a releasable connection between the differentially deformable anchor structure 800 and an exemplary delivery system (not shown). Additional features of the exemplary differentially deformable anchor structure 800 may include an atrial region connection element 825, which has an atrial connection element geometry 826, which is arranged to connectively mate with the inflow region connection element 745 of the exemplary self-expanding heart valve frame (700, FIG. 7A).

[0127] 8A-8B further includes an anchored valve ring region 810, which generally includes a plurality of long and wide valve ring region fastening struts 862 that together define an annular circumferential structure that traverses the circumference of the exemplary differentially deformable anchor structure 800 of this embodiment and generally has a second stiffness. The ring region 810 is configured to conform to the native atrioventricular ring of the heart (see FIGS. 5A-5B) and can provide resistance to movement away from the ring by radial expansion forces. The exemplary differentially deformable anchor structure 800 embodiment shown in FIGS. 8A-8B can also further include an anchored ventricular region 815, which generally has a third stiffness and generally includes a plurality of long and wide ventricular conforming structures 835, which generally include a heel 860 (see FIGS. 5A-5B) for abutting the apex of the native ventricle and a plurality of elongated ventricular conforming structure support struts 836 that terminate in a ventricular ejection member 840. The ventricular ejection member 840 has a ventricular ejection member geometry 850 that is arranged to releasably connect the differentially deformable anchor structure 800 to an exemplary delivery system (not shown). Each ventricular conformity structure 835 may further include a plurality of ventricular region connection elements 845, each having a ventricular region connection element geometry 855 that provides a mating connection with the outflow region connection element 755 of the exemplary self-expanding heart valve frame (700, FIG. 7). The heel of the ventricular region conformity structure 860 may further include a ring anchor element 865 that is arranged to penetrate the ring tissue and enhance the anchoring force of the differentially deformable anchor structure 800. Finally, the ventricular region 815 may be arranged to conform to the ventricular wall and ring of a native atrioventricular valve of the heart (see FIGS. 5A-5B), and abuts the apical surface of the ventricle adjacent the undervalvular surface of the native ring with the heel 860 to provide resistance to migration away from the ring and into the atrium. The first stiffness of the atrial region 805, the second stiffness of the ring region 810, and the third stiffness of the ventricular region 815 may be related in this manner, i.e., to provide an appropriate combination of optimized stiffness to avoid device migration while at the same time matching the native structure of the native heart. The stiffnesses may be generally equal.Alternatively, the first stiffness may be generally greater or less than one or two of the second stiffness and the third stiffness. Also, the second stiffness may be generally greater or less than one or two of the first and third stiffness. Finally, the third stiffness may be generally greater or less than one or two of the first and second stiffness.

[0128] Reference is now made to Figure 8D, which is a schematic diagram of an embodiment having a deformable anchor structure with a fabric covering 867, according to some applications of the present invention. The anchor structure with fabric covering 867 may include the differential deformable anchor structure 800 described above, and may further include an anchor seal cover 870, which is arranged to prevent perivalve leakage and is comprised of a fabric such as polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabric, or any other material of a durable prosthetic heart valve device. The anchor seal cover 870 may further include a ring area seal cover 871 and a diamond shape of the ring area seal cover 872, which provides maximized fabric surface area and therefore provides maximum resistance to prevent peri-ring leakage. Finally, three sets of ventricular region outflow openings 875 may each be formed by combining multiple ventricular conformal structures 835 at the boundary of the valve annulus region sealing cover 871 and are positioned to maximize the available space beneath an embodiment of the prosthetic heart valve device and the ventricular outflow tract implanted therein (see Figures 5A-5B), thereby reducing the occurrence of ventricular outflow tract obstruction.

[0129] Reference is now made to Figures 9A-9F, which are schematic diagrams illustrating various views of an exemplary embodiment of a prosthetic heart valve device 900, according to some applications of the present invention. Specifically, Figure 9A illustrates a front view of the exemplary embodiment of the prosthetic heart valve device 900, Figure 9B illustrates a perspective view of the prosthetic heart valve device 900, Figure 9C illustrates a perspective top (inflow) view of the prosthetic heart valve device 900, and Figure 9D illustrates a front view of the prosthetic heart valve device with a covering 915. Finally, Figure 9E illustrates a cross-sectional view of the exemplary prosthetic heart valve device 900. As shown in Figure 9A, a mating connection at the outflow end 910 between an exemplary embodiment of a self-expanding heart valve frame (700, Figure 7A) and an exemplary embodiment of a different deformable anchor structure (800, Figure 8A) can be seen. Similarly, in Figure 9B, a mating connection at the inflow end 905 between an exemplary embodiment of a self-expanding heart valve frame (700, Figure 7A) and an exemplary embodiment of a different deformable anchor structure (800, Figure 8A) can be seen. As shown in Fig. 9D, in accordance with certain applications of the present invention, an exemplary embodiment of a prosthetic heart valve device having a covering 915 is shown, including a valve seal cover 780, a valve leaflet 790, and an anchor seal cover 870. Referring now to Fig. 9E, a cross-sectional view of an exemplary embodiment of a prosthetic heart valve device 900 is shown, in accordance with certain applications of the present invention. The protruding curve describing the anchor cross section 925 is shown adjacent to the protruding curve describing the valve frame cross section 930. An embodiment of the prosthetic heart valve device 900 may be designed such that the overall length of the protruding curve describing the anchor cross section 925 is equal to the overall length of the protruding curve describing the valve frame cross section 930, so that when each curve is connected to the covering 915 in an assembly device (connected at inflow 935 and connected at outflow 940), as shown in FIG. 9D, when left with tension applied to both the inflow and outflow ends, for example when loaded onto an exemplary embodiment of a delivery system conduit (described further below), the heart valve frame (700, FIG. 7A) will conform to the differentially deformable anchor structure (800, FIG. 8A) and contract uniformly.

[0130] Finally, FIG. 9F shows various selectable embodiments for connecting the geometric shape of the ventricular region connection element of the anchor (855, FIG. 8A) to the connection structure of the outflow region connection element of the valve frame 755. Specifically, the detail cross-sectional circles 945, 973 and 974 show five reference lines (946, 947, 948, 963, 962) leading to the corresponding enlarged cross-sectional circles (950, 955, 960, 965, 964), each illustrating an embodiment for selecting a connection structure. The reference line 946 leads from the first detail cross-sectional circle 945 to the enlarged cross-sectional circle 950 and shows an embodiment including a connection structure of a suture-line or filament-type material 951, which is already interleaved between the geometric shape of the ventricular region connection element of the anchor (855, FIG. 8A) and the outflow region connection element of the valve frame 755, which is arranged to achieve a rigid connection. The suture or filamentary material 951 may include elastic or flexible fabrics or polymers. The suture or filamentary material 951 may further include flexible or elastic metal alloys. The suture or filamentary material 951 may include rigid and inflexible materials, polymers, fabrics or alloys. Reference line 947 leads from the first detailed cross-sectional circle 945 to the enlarged cross-sectional circle 955 and shows an embodiment including a connection structure of a suture line or filamentary material 956, which is already connected between the geometry of the ventricular region connection element of the anchor (855, FIG. 8A) and the outflow region connection element 755 of the valve frame. The suture line or filamentary material 956 may be arranged to provide a connection that allows some displacement between the geometry of the ventricular region connection element of the anchor (855, FIG. 8A) and the outflow region connection element 755 of the valve frame. The suture or filamentary material 956 may include elastic or flexible fabrics or polymers. The suture or filamentary material 956 may further include flexible or elastic metal alloys. The suture or filamentary material 956 may include rigid and inflexible materials, polymers, fabrics or alloys.Reference line 948 leads from the first detailed cross-sectional circle 945 to the enlarged cross-sectional circle 960 and shows an embodiment of a connection structure including a coiled material 961, which is already connected between the geometry of the ventricular region connection element of the anchor (855, FIG. 8A) and the outflow region connection element of the valve frame 755. The coiled material 961 may be arranged to provide a connection that allows maximum displacement between the geometry of the ventricular region connection element of the anchor (855, FIG. 8A) and the outflow region connection element of the valve frame 755. The coiled material 961 may include a stretchable or flexible fabric or polymer. The coiled material 961 may be a flexible or elastic metal alloy. The coiled material 961 may also include a rigid and inflexible material, polymer, fabric, or alloy.

[0131] Reference line 962 leads from second detail cross-sectional circle 974 to enlarged cross-sectional circle 964 and shows an alternative embodiment including a connection structure of suture line material 971, which is directly connected between the geometry 975 of the ventricular region connection element of the anchor and the outflow region connection element 755 of the valve frame (adjacent to and extending from the heel 860). In this particular embodiment, one or more ventricular conformal structural support struts 836 can be replaced by a direct connection with suture line material 971, thereby realizing a tensile connection, or a rigid connection, or a connection that can absorb some displacement between the connection elements. The connection structure depicted in this particular alternative embodiment may be realized in one or more valve coaptation regions, or may not be realized in any valve coaptation region (795, FIG. 7D). The connection structure shown in this particular alternative embodiment may be designed to isolate any affected valve coaptation region (795, FIG. 7D) from valve ring changes caused by the anchor. Additionally, the connection configuration described in this embodiment may be designed to reduce the total curl height of the device (the vertical distance between members 830 and 850 as shown in FIG. 10A).

[0132] Reference line 963 leads from the third detailed cross-sectional circle 973 to the enlarged cross-sectional circle 965 and depicts a view of the opposite end (concentrated on the outflow region connection member 750) of the above selected embodiment including a connection structure of suture line material 971, which is directly connected between the geometric shape 975 of the anchor's ventricular region connection element and the outflow region connection element 755 of the valve frame (adjacent to and extending from the heel 860).

[0133] Reference is now made to Figures 10A and 10B, which are schematic diagrams of front views of an exemplary embodiment of the prosthetic heart valve device 900 in a crimped configuration 1000 and an expanded configuration 1020, according to some applications of the present invention. Specifically, Figure 10A shows the crimped configuration 1000, which appears when the prosthetic heart valve device 900 is crimped and loaded onto an exemplary embodiment of a delivery system conduit by radial compression or axial tension (discussed further below). Also seen are the atrial region 1005, the ring region 1010 and the ventricular region 1015 when in the crimped configuration 1000. Similarly, Figure 10B shows the expanded configuration 1020, which appears when the prosthetic heart valve device 900 is fully released and implanted into a native atrioventricular valve.

[0134] 11A-11C, which are schematic diagrams illustrating a typical deployment sequence of an exemplary embodiment of a prosthetic heart valve device 900 deployed by an exemplary embodiment of a delivery system 1100, according to some applications of the present invention. FIG. 11A illustrates an exemplary pre-deployment configuration of a portion of a conduit 1104 adjacent a proximal capsule portion 1101 and a distal capsule portion 1102. The proximal capsule portion 1101 can have a proximal end marking tape 1106, and the distal capsule portion 1102 can have a distal end marking tape 1107, to aid in imaging guidance of the insertion program. The exemplary embodiment of the delivery system 1100 can be positioned to run over a guidewire 1103, to track the device as it is put into position during the implant program. FIGURE 11B illustrates a mid-deployment configuration of an exemplary portion of the conduit 1104 of an exemplary embodiment of a delivery system 1105, showing the proximal capsule portion 1109 translated away from the distal capsule portion 1102, exposing the atrial portion of an exemplary embodiment of a prosthetic heart valve device 1108. According to some applications of the present invention, FIGURE 11C illustrates a fully-deployed configuration of an exemplary portion of the conduit 1104 of an exemplary embodiment of a delivery system 1110, showing both the proximal capsule portion 1112 and the distal capsule portion 1111 fully translated away from each other, fully exposing the ventricular 1113 and ventricular 1114 portions of an exemplary embodiment of a prosthetic heart valve device 900. It should be understood that in the exemplary embodiment of a prosthetic heart valve device 900, the atrial 1113 and ventricular 1114 portions are not fully expelled.

[0135] Reference is now made to Figures 12A-12B, which are schematic diagrams illustrating the transition sequence between diastolic and systolic cardiac cycles according to some applications of the present invention, specifically with reference to a cross-sectional view of a heart (diastolic 1200, systolic 1240, as shown in Figures 12A and 12B, respectively) and an exemplary prosthetic heart valve device implanted in situ (diastolic embodiment 1230, systolic embodiment 1260, as shown in Figures 12A and 12B, respectively). Specifically, Figure 12A illustrates an exemplary diastolic embodiment of a prosthetic heart valve device 1230 implanted in a bicuspid position. The open leaflets 1235 of the diastolic embodiment of the prosthetic heart valve device 1230 function in response to blood flow from the left atrium 1206 (cross-section 1205) towards the left ventricle 1215 during diastolic ventricular filling. Similarly, the closed leaflets of the exemplary aortic valve 1225 also function in response to diastolic ventricular filling. A left ventricular outflow tract 1220 and a cross-section 1210 of the left ventricular wall can be seen just below the atretic leaflet of the exemplary aortic valve 1225, which is in an expanded state. An arrow 1221 can be seen just above the exemplary diastolic embodiment of the prosthetic heart valve device 1230, which corresponds to the position of the exemplary diastolic embodiment of the heart valve frame 1231, which does not move in position relative to the native valve ring in which the exemplary diastolic embodiment of the differentially deformable anchor structure 1229 is located. A native anterior leaflet 1201 can be seen in the exemplary expanded embodiment adjacent to the prosthetic heart valve device 1230, which is depicted in a free, open and unconstrained position. As will be appreciated, the exemplary embodiment of the natural anatomy and prosthetic heart valve device shown in FIG. 12A can also be implemented for selected atrioventricular valve anatomy, such as the tricuspid valve and the corresponding pattern of the native tricuspid valve anatomy.

[0136] Reference is now made to Figure 12B, which is a schematic diagram of an exemplary systolic embodiment of a prosthetic heart valve device 1260 already implanted in a bicuspid position, according to some applications of the present invention, and now specifically referring to a cross-sectional heart in systole 1240. The closed leaflet 1255 of the exemplary systolic embodiment of the prosthetic heart valve device 1260 acts in response to pressurization of the left ventricle 1215, and thus allows blood to flow out of the left ventricle 1215 (cross-section 1250) into the left ventricular outflow tract 1220 and out through the opened aortic valve 1245 during systolic ventricular contraction. The unconstrained native anterior leaflet 1202 can be seen in a closed position, abutting the front of the exemplary systolic embodiment of the prosthetic heart valve device 1260. An arrow 1265 can be seen just above the exemplary systolic embodiment of the prosthetic heart valve device 1260, which corresponds to the position of the exemplary systolic embodiment of the heart valve frame 1261, which is displaced in the atrial direction relative to the native ring in which the exemplary systolic embodiment of the differentially deformable anchor structure 1259 resides. It should be understood that the exemplary embodiment of the native anatomy and prosthetic heart valve device shown in FIG. 12B can also be implemented for selected atrioventricular valve anatomy, such as the tricuspid valve and corresponding native tricuspid valve anatomy.

[0137] 13A, which is a schematic diagram illustrating a perspective view of a detail 1315 of an embodiment of an exemplary prosthetic heart valve device 1340 loaded onto an exemplary delivery system 1300, according to some applications of the present invention. The exemplary embodiment of the load-carrying system 1300 in the curved configuration can include a proximal end portion of the capsule 1310 adjacent the proximal end neck 1305, and a distal end portion of the capsule 1325 adjacent the proximal end portion 1310, where each capsule portion is arranged to translate away from the opposing capsule portion during deployment. Prior to introducing the conduit of the delivery system 1300, the exemplary embodiment of the load-carrying system 1300 in the curved configuration can be arranged to be fixed in an anatomical position by a guide rail over the top of the guide wire 1330, which can be programmatically placed in place. A cutaway cross-section view window 1315 allows viewing of a partially exposed cross-section 1340 of the exemplary prosthetic heart valve device stent, which shows an embodiment of a bendable portion geometry 1316. The bendable portion geometry 1316 may be arranged to allow a particular portion of the exemplary embodiment of the heart valve device 1340 to bend in a particular direction and bend radius, suitable for tracking through the natural anatomical vessels, veins and arteries and into the native atrioventricular valve. A close-up of the cut section window 1320 details the enlarged and partially exposed bendable portion geometry 1345. Now turning to FIG. 13B with reference to the arrow 1335 in FIG. 13B, which shows a schematic fragment of an exemplary prosthetic heart valve device stent flat pattern 1350, according to some applications of the present invention. The exemplary prosthetic heart valve device stent flat pattern 1350 may include an exemplary embodiment of an atrial region bending element 1351, which is arranged to allow the prosthetic heart valve device to bend in a particular manner in the atrial region, and an exemplary embodiment of a ventricular region bending element 1352, which is arranged to allow the prosthetic heart valve device to bend in a particular manner in the ventricular region.

[0138] 14, which is a schematic diagram of a distal end portion 1405 of an exemplary embodiment of a delivery system (1500, FIG. 15A), in which an exemplary embodiment of a partially deployed structure of a loaded prosthetic heart valve device 1400 is used for illustrative purposes. As mentioned above, the prosthetic heart valve device 1400 is several applications according to the present invention. The exemplary delivery system (1500, FIG. 15A) can include an assembly of concentrically aligned and radially adjacent flexible conduits, including a first conduit 1420, a second conduit 1430 arranged to extend at least partially through the first conduit 1420, a third conduit 1445 arranged to extend at least partially through the second conduit 1430, and a fourth conduit 1450 arranged to extend at least partially beyond the first conduit 1420. The fourth conduit 1450 can have a proximal end outer cover portion 1415. The third duct 1445 may have a distal cover portion 1425. The second conduit 1430 may have a connecting element 1435 and is used to connect to a portion of the exemplary prosthetic heart valve device 1400. The first conduit 1420 may accommodate a number of tethers 1440, which are arranged to matingly connect to a portion of the heart valve device 1400 located in the atrial region. The tethers may further include a number of tether connector structures 1455, which may provide a manner by which the tethers are matingly connected to the prosthetic heart valve device, details of which are provided further below. The following further provides additional details regarding the above conduits.

[0139] Reference is now made to Figures 15A-B, which are schematic diagrams of an exemplary delivery system 1500 for a loaded prosthetic heart valve device 1535 in a compressed delivery state, in accordance with certain applications of the present invention.

[0140] The delivery system 1500 is used for intracardiac delivery of a compressed prosthetic heart valve device 1535 and is configured to include a handle portion 1520 and a conduit portion 1525 adjacent to and extending distally from the handle portion 1520 .

[0141] Handle portion 1520 has a generally elongated shape and is generally cylindrical, having a proximal end region 1505, a distal end region 1515 and an intermediate region 1510 located therebetween.

[0142] The conduit portion 1525 extends distally from the distal end region 1515 of the handle portion 1520 and can include one or more flexible conduits, such as a first conduit 1420 and a second conduit 1430, that extend through the first conduit 1420 such that a flexible distal end portion of the second conduit 1430 is located outside the distal end of the first conduit 1420. The distal end portion of the second conduit 1430 can further include a connecting element 1435 arranged to be releasably attached to at least a portion of the compressed prosthetic heart valve device 1535.

[0143] The conduit portion 1525 of the delivery system 1500 further includes a third conduit 1445 which extends and passes through the second conduit 1430 such that the distal end outer cover portion 1425 is positioned outside the distal end of the second conduit 1430.

[0144] The conduit portion 1525 of the delivery system 1500 further includes a fourth conduit 1450 which covers a portion of the first conduit 1420 and includes a proximal end outer cover portion 1415 which can extend over at least a portion of the compressed prosthetic heart valve device 1535.

[0145] The conduit portion 1525 of the delivery system 1500 further includes a retention area 1530 that is arranged to retain and deliver a compressed prosthetic heart valve device 1535. For example, the distal end overmolding portion 1425 of the third conduit 1445 and the proximal end overmolding portion 1415 of the fourth conduit 1450 can function as restraining members, both of which radially restrain at least a portion of the compressed prosthetic heart valve device 1535 in a compressed delivery state, thereby retaining the compressed prosthetic heart valve device 1535.

[0146] The distal end region 1515 of the handle portion 1520 generally includes a first dial wheel 1545 that is in controllable communication with the fourth conduit 1450 through mechanical interaction within the distal end region 1515 (described in more detail below). Actuation of the first dial wheel 1545 can control the fourth conduit 1450 to translate from a first position (proximal end) to a second position (distal end) downstream from the first position and back. When in the second position (distal end), the proximal end overmold portion 1415 of the fourth conduit 1450 can be in an advantageous position to constrain at least a portion of the compressed prosthetic heart valve device 1535. When in the first position (proximal end), the proximal end overmold portion 1415 of the fourth conduit 1450 can be in an advantageous position to release at least a portion of the compressed prosthetic heart valve device 1535 from radial constraint.

[0147] The distal end region 1515 of the handle portion 1520 generally further includes a saline flush port 1540a which serves to remove trapped air from between concentric adjacent conduits during device preparation, for example, by allowing injection of sterile saline between said conduits 1420 and 1450 to remove air from between the fourth conduit 1450 and the first conduit 1420, thereby removing trapped air and preventing air bubble emboli from introducing blood flow.

[0148] 16A-B and 17A-E, the intermediate region 1510 of the handle portion 1520 generally includes a saline flush port 1540b and a tether shuttle assembly 1560, the details of which are provided further below. The saline flush port 1540b of the intermediate region 1510 can be useful for removing trapped air from between concentric adjacent conduits during device preparation, for example, by injecting sterile saline between the first conduit 1420 and the second conduit 1430, thereby removing trapped air and preventing air bubble emboli from introducing blood flow. The intermediate region 1510 of the handle portion 1520 may include a location for mechanically attaching the first duct 1420 to the handle portion 1520.

[0149] The proximal end region 1505 of the handle portion 1520 generally includes a second dial wheel 1550 that is in controllable communication with the second conduit 1430 through mechanical interaction within the proximal end region 1505 (described in more detail below). Actuation of the second dial wheel 1550 can control the second conduit 1430 to translate from a first position (proximal end) to a second position (distal end) downstream from the first position and back. When in the second position (distal end), the compressed prosthetic heart valve device 1535 can be in a more distally positioned position (e.g., within a ventricle of the heart) and simultaneously loaded for delivery. When in the first position (proximal end), the compressed prosthetic heart valve device 1535 can be in a proximal positioning position and simultaneously loaded for delivery.

[0150] The proximal end region 1505 of the handle portion 1520 may further include a third dial wheel 1555 that is in controllable communication with the third conduit 1445 through mechanical interaction within the proximal end region 1505 (described in further detail below). Actuation of the third dial wheel 1555 may control the third conduit 1445 to translate from a first position (proximal end) to a second position (distal end) downstream from the first position and back. When in the first position (proximal end), the outer sheath portion 1425 at the distal end of the third conduit 1445 may be in an advantageous position to constrain at least a portion of the compressed prosthetic heart valve device 1535. When in the second position (distal end), the outer sheath portion 1425 at the distal end of the third conduit 1445 may be in an advantageous position to release at least a portion of the compressed prosthetic heart valve device 1535 from radial constraint.

[0151] The proximal end region 1505 of the handle portion 1520 generally further includes a saline flush port 1540c, which serves to remove trapped air from between concentrically adjacent conduits during device preparation, for example, between the second conduit 1430 and the third conduit 1445 by permitting injection of sterile saline between the conduits 1430 and 1445, thereby removing trapped air and preventing air bubble emboli from introducing blood flow. The proximal end region 1505 of the handle portion 1520 generally further includes a saline flush port 1540d, which serves to remove trapped air from within the guidewire cavity, which extends from a first end of the third conduit 1445 to a second end opposite the first end, and into which sterile saline is permitted to be injected to remove trapped air and prevent air bubble emboli from introducing blood flow.

[0152] The proximal end region 1505 of the handle portion 1520 can further include a compensation mechanism, such as an internal mechanism (described in more detail below and with reference to FIGS. 19A-C, 18A-I, 20A-C) that provides a lead screw system (shown in FIGS. 8A-C) shared by the second dial wheel 1550 and the third dial wheel 1555 such that actuation of the second dial wheel 1550 can mechanically displace the third dial wheel 1555. That is, actuation of the second dial wheel 1550 can displace the second conduit 1430, the third dial wheel 1555, and the third conduit 1445 together at the same time and in the same direction because they are mechanically connected as a system.

[0153] The enlarged view cross section frame 1570 shows an enlarged view of the subject of the detailed view cross section frame 1565 and includes an enlarged view of the compressed prosthetic heart valve device 1535, the distal end covering portion 1425 of the third conduit 1445 and the proximal end covering portion 1415 of the fourth conduit 1450, which views are clearly presented.

[0154] 16A-B, which are schematic diagrams of a delivery system 1500, in accordance with some applications of the present invention, providing further details of a distal end region 1515, an intermediate region 1510, and a proximal end region 1505 relative to a handle portion 1520.

[0155] Specifically, the distal handle region 1515 may further include a distal handle cap 1600, which may be connected to a holding system (not shown) and may provide a support surface 1605 for enabling relative rotation between a portion of the delivery system 1500 and the holding system. The first dial wheel 1545 may be included in a number of dial wheel covers 1610, which may include the first dial wheel 1545 and may be used to fasten together the cylindrical (or other shaped) portion of the distal handle region 1515. A translation groove 1615 on the distal handle region 1515 may provide clearance for translation of the saline flush port 1540a, which controllably moves with the fourth conduit 1450, such that the first dial wheel 1545 is rotatably actuated in a first direction or a second direction to face the first.

[0156] The proximal handle region 1505 may further include a proximal handle cap 1630, which may be connected to a holding system (not shown) and may provide a support surface 1635 to allow relative rotation between a portion of the delivery system 1500 and the holding system. The second dial wheel 1550 may be contained within a number of dial wheel covers 1610, which are used to contain the second dial wheel 1550 while fastening together the cylindrical (or other shaped) portion of the proximal handle region 1505. The translation groove 1625 on the proximal handle region 1505 may provide clearance for translation of the saline flush port 1540c, which controllably moves with the second conduit 1430, such that the second dial wheel 1550 is rotatably actuated in a first direction or a second direction to oppose the first.

[0157] Referring to FIG. 16B, as discussed above, the intermediate handle region 1510 can further include an exit groove 1620 for a saline flush port 1540b, which can aid in removing trapped air from between concentric adjacent conduits during device preparation.

[0158] As shown, and as described in more detail below, the central handle region 1510 can include a plurality of tie tether shuttles 1640 arranged to controllably optimize tension between a prosthetic heart valve device (not shown) and a plurality of tie tethers (1440, FIG. 14) arranged to be connected to portions of the prosthetic heart valve device by a tightening mechanism. The tether shuttle holder 1640 can include a tether shuttle holder body 1645 and a tether shuttle latch buckle 1650 arranged to controllably rotate from a first position to a second position about a tether shuttle latch hinge 1655 that is arranged to be rotationally displaced from the first position and mechanically attached to a proximal end portion of a tether protector sleeve 1660. By actuating the tether shuttle latch 1650, an internal connection communicating with the proximal end portion of the tether protection sleeve 1660 can retract the proximal end portion of the tether protection sleeve 1660 concentrically (from a distal end position to a proximal end position opposite the distal end position) onto the top of an internal tether cable (not shown), thereby providing a tether (1440, FIG. 14) to controllably connect and release from portions of the prosthetic heart valve device (described further below and with reference to FIGS. 17A-F).

[0159] The tether shuttle body 1645 may be generally rectangular and transition within the tether shuttle groove 1665 from a first end of the tether shuttle groove 1665 to a second end opposite the first end. The tether shuttle piece body 1645 is spring biased (not shown) at a first proximal end location corresponding to the first end of the tether shuttle groove 1665, and may be manually translated by push or automatically translated when placed under a tensile load, for example, to carry the tether (1440, FIG. 14) from the prosthetic heart valve device.

[0160] 17A-F, which are schematic diagrams of a prosthetic heart valve device retention area 1530 of a delivery system, according to some applications of the present invention. FIG. 17A provides an enlarged view of the prosthetic heart valve device retention area 1530. The retention area 1530 can include a distal outer cover 1425, the distal end of which is connected to a third conduit 1445, which can extend through a second conduit 1430, which can have a guidewire cavity 1760 extending therethrough, and a proximal outer cover 1415 extending from a fourth conduit 1450. As previously mentioned, the distal and proximal outer covers (1425, 1415, respectively) together provide a position for the compressed prosthetic heart valve device 1535.

[0161] More specifically, the prosthetic heart valve device retaining region 1530 may further include a plurality of tether connector structures 1455 in the closed structure 1700. In the closed structure 1700, the tether connector structures 1455 are concentric with and radially adjacent to the second conduit 1430, and generally form a straight line with the long axis (not shown) of the second conduit 1430. The tether connector structures 1455 connect to and contact portions of the closed and compressed prosthetic heart valve device 1535, and provide radial and tensile restraining forces to the compressed prosthetic heart valve device 1535, thereby holding it in the closed and compressed configuration and adapted for transport. More specifically, the tether connector structures 1455 may connect to and contact connecting elements of the closed and compressed prosthetic heart valve device 1535 (e.g., the atrial connecting element 1720 with the atrial connecting pull tab 1730). The tether link connector structure 1455 can mate and contact the farthest end of the tether link sheath 1740 and the inner cable 1775, the relationship of which is shown diagrammatically in FIG. 17F with hidden lines.

[0162] More specifically, referring to the link system connector structure 1455, a distal end portion of the link system protection sleeve 1740 may be matingly connected to a link system connector cover 1715 (connected via a link system connector cover 1735) which is arranged to slidably mate with and includes a link system connector 1725 therein. The link system connector 1725 is further in mating contact with an internal cable 1775 which extends within the link system protection sleeve from a first end to a second end. A proximal end portion of the tether protection sleeve 1660 opposite the distal end may be matingly connected to an actuatable portion of a shuttle mechanism 1705 which may controllably and translationally position the tether connector cover 1715 in a first or second position (opposite the first position) relative to the internal tether connector 1725. The tether connector is further matingly connected to a fixed portion of the shuttle mechanism 1705 by an inner cable 1775 and is arranged to hold it stationary.

[0163] As shown diagrammatically in Figure 17C, when the tether connector cover 1715 is offset distally (first position, closed), it can preferentially cover the tether connector 1725, thereby blocking portions of the compressed prosthetic heart valve device 1535, such as the atrial connection element 1720 having the atrial connection pull tab 1730 as a connection element. Figure 17B shows a perspective view of the shuttle mechanism 1705 corresponding to the first closed position of the link connector cover 1715.

[0164] 17C, additional features of the second conduit 1430 are described. Specifically, a series of regions of differing stiffness are described. Extending from the distal end of the second conduit 1430 is a distal stiffness region 1745, then a distal stiffness transition region 1750, and finally a distal flexible region 1755. The inherent stiffness of the distal region of the second conduit 1430 transitions from the stiffest portion (1745) to the softest portion (1755) and provides enhanced flexibility and allows bending through tight radii (e.g., experienced during implantation).

[0165] As shown diagrammatically in Fig. 17E, when the tether connector cover 1715 is offset proximally (second position, opposite to the first position and open), it can preferentially expose the tether connector 1725 (indicated by the translation arrow 1770), thereby releasing the compressed part of the prosthetic heart valve device 1535, for example the atrial connection element 1720 having the atrial connection pull tab 1730 as the connection element. Fig. 17D shows a perspective view of the shuttle mechanism 1710 corresponding to the second open position of the tether connector 1725 (indicated by the arrow 1765 after the tether shuttle latch 1650 has rotated).

[0166] 18A-I, which are a series of schematic diagrams illustrating the expansion of a prosthetic heart valve device deployed by a delivery system, according to some applications of the present invention. As shown in FIGS. 18A-B, the prosthetic heart valve device retention area 1530 is depicted having a first closed state (FIG. 18A), where the proximal end outer covering 1415 of the fourth conduit 1450 is in a closed position and covers at least a portion of the compressed prosthetic heart valve device 1535. The prosthetic heart valve device retention area 1530 is also depicted having a second open state (FIG. 18C), where the proximal end outer covering 1415 of the fourth conduit 1450 is in an open position and displaced a distance Dl from the closed position to the proximal end, thereby exposing at least a portion of the compressed prosthetic heart valve device 1535 and the multiple tether connector structures 1700 in a closed configuration before the multiple tether connector structures 1700 expand.

[0167] As discussed above and as shown in FIG. 18B, the proximal end outer covering 1415 of the fourth conduit 1450 can move through an actuation displacement distance D1 (indicated by rotation arrow 1830) of the first dial wheel 1545. The proximal end outer covering 1415 of the fourth conduit 1450 can move a distance D1 in the opposite direction, thereby returning it to the closed state as previously described (FIG. 18A), by actuating the same first dial wheel 1545.

[0168] When in an open state (FIG. 18C), before the portion of the compressed prosthetic heart valve device 1535 (e.g., the atrial region 1410) expands, the atrial region 1410 can have a first diameter d1. After the portion of the compressed prosthetic heart valve device 1535 (e.g., the atrial region 1410) expands, the atrial region 1410 can have a second diameter d2 (FIG. 18D) that is larger than the first diameter and can be in a configuration suitable for atrial surface coaptation of the native heart (not shown). The tether 1800 in a fully expanded state is also shown in FIG. 18D.

[0169] With reference to FIG. 18E, the distal outer cover 1425 is depicted in a closed state prior to displacement to an open state. The partially deployed prosthetic heart valve device 1835 having a partially deployed atrial region 1805 can be further deployed by displacing the distal outer cover 1425 of the third conduit 1445 at least a distance D2 (FIG. 18G) distally by actuation of the third dial wheel 1555 (indicated by arrow 1865, FIG. 18F), thereby exposing at least a portion of the partially deployed prosthetic heart valve device 1835, such as the compressed ventricular portion 1845 and exposing the engagement peg 1820 arranged to releasably engage with the ventricular anchor engagement groove 1825. The distal outer cover 1425 of the third conduit 1445 can be moved a distance D2 in the opposite direction, thereby returning it to the closed state as described above (FIG. 18E).

[0170] While in a partially deployed state (FIG. 18E), but prior to final expansion (FIG. 18G), the portion of the compressed ventricular region 1845 can have a third diameter d3. After the compressed ventricular region 1845 expands, the expanded ventricular region 1840 can have a fourth diameter d4 (FIG. 18G) that is larger than the third diameter and can be in a configuration (not shown) suitable for mating with the ventricular surface of the native heart.

[0171] 18H-I, a series of schematic diagrams of a prosthetic heart valve device finally deployed from a delivery system are shown, in accordance with some applications of the present invention.

[0172] FIG. 18I shows a schematic diagram of a fully expanded atrial region 1850, a fully expanded ring region 1855, and a fully expanded ventricular region 1860, according to some applications of the present invention. The fully expanded atrial region 1850 is positioned to interface with an atrial tissue surface of a native heart, e.g., a left atrial surface of a bicuspid valve (see FIGS. 5A-5B). The fully expanded ring region 1855 is positioned to interface with a ring tissue surface of a native heart, e.g., a ring surface of a bicuspid valve (see FIGS. 5A-5B). The fully expanded ventricular region 1860 is positioned to interface with any combination of ventricular tissue surfaces of a native heart, e.g., the left ventricle, bicuspid valve leaflets, and / or chordae tendineae (see FIGS. 5A-5B).

[0173] Control, final release and permanent implantation of the prosthetic heart valve device 1810 can be achieved by controlled actuation of each tether shuttle 1640 (FIGS. 16B, 18H) which actuates the tether shuttle lock 1650 (FIGS. 16B, 18H) of each tether shuttle 1640, resulting in the tether shuttle 1640 being in the open configuration 1710. According to some applications of the present invention, a fully released and permanently implanted prosthetic heart valve device 1810 is shown diagrammatically in FIG. 18I. Once each tether shuttle 1640 is actuated and the tether connectors 1815 are fully open, each atrial connection pull tab 1730 can be released from restraint, thereby allowing each atrial region 1850 to fully expand, resulting in a fully released and permanently implanted prosthetic heart valve device 1810.

[0174] Referring to Figures 19A-D, schematic diagrams illustrating the composition change mechanism of the outer coating layer of the second conduit and the third conduit are provided, according to some applications of the present invention.

[0175] Specifically, Figure 19A illustrates the overall effect of the compensation mechanism within the delivery system on the anchor structure of the prosthetic heart valve device when the partially deployed atrial region 1805 of the prosthetic heart valve device has already been urged into contact with the native atrial floor (not shown) and applies a seating force to the first conduit 1420, thereby maintaining contact (not shown) between the partially deployed atrial region 1805 and the native atrial floor. In Figure 19A, it can be seen that the first conduit 1420 and the fourth conduit 1450 are distally displaced, creating tension in the link 1920 and the connection therebetween creating a seating force for the partially deployed atrial region 1805. Such distal displacement of the first conduit 1420 and the fourth conduit 1450 is achieved by the compensation mechanism of the delivery system, which will now be described in more detail with reference to Figures 19B-D. As shown in Figure 19B, a simplified diagram of the distal most portion of a pre-displaced delivery system 1910 is provided. The embodiment of the tether and the prosthetic heart valve device are not shown in FIG. 19B, thereby more clearly illustrating the mechanical interactions present during this stage of device operation when it is related to the conduit. Element D5 indicates a first distance between the most distal region of the first duct 1420 and a reference point on the second duct (near the stiffness transition region 1750). By actuating the third dial wheel (1550, FIG. 19C), indicated by the rotating arrow 1900 (FIG. 19C), the distal end holding region 1905 and the partially deployed prosthetic heart valve device (not shown) are both translated proximally until a second distance indicated by element D6 reaches the most distal region of the first conduit 1420 and the same reference point on the second conduit (near the stiffness transition region 1750). The proximal end orientation position (after displacement) 1915 is illustrated in FIG. 19D, where the embodiment of the tether and the prosthetic heart valve device are also not shown, thereby more clearly illustrating the mechanical interactions present during this stage of device operation when it is related to the conduit. Such positional changes of the distal retention region 1905 activated by a compensation mechanism within the delivery system can provide better control over delivery of the prosthetic heart valve. The compensation mechanism within the delivery system can assist in controlling the structural changes experienced by the anchor structure, better approximating the ventricular anatomy, improving the clearance between portions of the prosthetic heart valve and the ventricular region structures, and allowing for reversible repositioning and reapproximation of the prosthetic heart valve where necessary.

[0176] 20A-C, schematic diagrams are provided illustrating exemplary delivery system embodiments in cross-section, according to some applications of the present invention. FIG. 20A illustrates an embodiment of a mid and proximal region of a delivery system shown in cross-section 2000. Also shown are lead screw 2015 of third dial wheel 1555 and lead screw 2020 of second dial wheel 1550. Finally, a cross-sectional view of tether tension adjustment mechanism 2030 is provided.

[0177] Figure 20B shows an embodiment of a distal end region of the delivery system shown in cross section 2005. Also shown is the lead screw 2025 of the first dial wheel 1545. Figure 20C shows an example of a retention region of the delivery system shown in cross section 2010.

[0178] Although the subject matter of the present disclosure has been described in its preferred embodiments, it should be understood that the words used are descriptive rather than limiting, and therefore changes may be made in the appended claims without departing from the true scope of the subject matter.

[0179] As will be understood by those skilled in the art, the present invention is not limited to what has been specifically shown and described above.On the contrary, the scope of the present invention includes combinations and subcombinations of the various features described above, which do not belong to the changes and modifications of the prior art, which may occur to those skilled in the art after reading the above content.

[0180] The optional claim set is as follows:

[0181] 1. A system including a prosthetic heart valve device, comprising: Prosthetic heart valve devices and delivery systems, The prosthetic heart valve device includes a differentially deformable anchor structure concentrically aligned with, radially adjacent to, and directly connected to a valve frame; the delivery system includes a first conduit, one or more tether assemblies, a second conduit, and a control assembly; the first conduit has a first diameter and includes a primary cavity, a first bendable portion, and one or more secondary cavities radially adjacent the primary cavity; the tether assembly is releasably connected to a portion of the prosthetic heart valve device and is disposed to translate through the one or more secondary cavities of the first conduit; the dimensions of the second conduit are designed to assemble and translate within the primary cavity of the first conduit, the second conduit including a cavity, a second bendable portion, and a connection element of a portion connectable to one or more prosthetic heart valve devices; the control assembly including a compensation mechanism connected in fluid communication with the second conduit, wherein the control assembly is arranged to controllably effect translation of the second conduit and to permit configurational changes of the prosthetic heart valve; the system has a delivery state, in which the prosthetic heart valve device is releasably connected to the tether assembly and the connecting element is in a compressed elongated configuration; and The delivery system is advanced to advance the prosthetic valve through a femoral access into the native atrioventricular valve and a compensation mechanism within a control assembly controllably implants the valve.

Claims

[Claim 1] The invention as depicted in the drawings of this application.

Images