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 include an artificial atrioventricular valve for replacing a defective bicuspid and / or tricuspid valve. The present invention relates to a valve and methods and devices for delivering and implanting the same into the human heart.

[0002] The present invention relates to an artificial object to be inserted into a cavity or body cavity and a delivery system for the artificial object. In particular, in some embodiments, the prosthesis and delivery system include a prosthetic heart valve device, For example, with respect to replacement atrioventricular valves. [Background technology]

[0003] Incomplete closure of the atrioventricular valves and incomplete or ineffective closure of the bicuspid and / or tricuspid valves Also known as incomplete functioning, the atrioventricular valves (bicuspid and / or tricuspid) fail to close normally In a healthy human heart, both the bicuspid and tricuspid valves are composed of a fibrous ring. Attached onto it are flexible and resilient leaflets that are capable of closing when the ventricle contracts. The free ends of each flexible leaflet are connected to chordae tendineae, which attach the leaflets to the papillary muscles within the ventricle. The valves are then fitted with a valve stud, which controls the movement of the free ends of the valve leaflets throughout the cardiac cycle. Various cardiac or degenerative diseases must be treated with the proper circulation of blood throughout the body. The disease affects various parts of the atrioventricular valve, causing the valve to close improperly. This causes abnormal leakage. The blood passes through the valve into the atria and peripheral vascular system. This can lead to a number of cardiovascular complications, including congestive heart failure.

[0004] Traditionally, patients with bicuspid valves that do not close completely have already undergone invasive cardiac surgery to correct the bicuspid valve. Treatment includes repair or replacement. Generally, these procedures produce good clinical results. However, due to its invasive nature and long recovery period, many potential patients are hesitant to accept such therapy. Therefore, many patients are not treated and are given medical therapy. Patients suffering from reflux have been treated to a lesser extent by surgery, and therefore There are more and more medical patients suffering from tricuspid regurgitation due to the current trend. Patients who undergo this procedure have a poor quality of life and adverse long-term outcomes, with many experiencing a 50% 5-year mortality rate. It could be more than that.

[0005] Over the years, the development of minimally invasive catheter valve therapy has made serious progress, and here The greatest advances have been made in treating aortic and pulmonary valve disease. The invention relates to the subject matter described in U.S. Patent No. 7,892,281, all of which are incorporated herein by reference for all purposes. The contents of which are incorporated herein by reference. Some progress has been made in the field of treatment. U.S. Patent No. 8652203 is an exemplary This application is hereby incorporated by reference in its entirety for all purposes, to disclose the work. Also, U.S. Patent No. 9,034,032 discloses an exemplary prosthesis and is incorporated herein by reference. No. 6,399,433, the entire contents of which are incorporated herein by reference for all purposes. However, due to limitations in current technology, a large number of potential patients remain unavailable for such treatment. These limitations are not suitable for therapy and remain untreated or produce adverse outcomes. and results include, but are not limited to: Surgical reduction of atrial blood flow stagnation and prolongation Adverse events and / or radiation exposure to patients and surgeons may result in outflow obstruction, thrombus formation, and It may cause thromboembolic events. Overall progress in treatment has been very limited due to limitations in current technology and the large number of untreated patients. In view of this, there remains an easier, more accurate and repeatable method for treating atrioventricular valve dysfunction. There is a need for improved apparatus, systems and methods that can Summary of the Invention

[0006] The embodiments disclosed herein refer to devices, systems and methods, e.g., for treating a defective atrioventricular and more particularly, but not exclusively, for use in replacing valves in the heart of a human patient. Replacement prosthetic heart valve devices and systems for replacing defective native tricuspid and / or bicuspid valves in be.

[0007] Yet another embodiment involves the insertion of a prosthetic heart valve device (such as, but not limited to, a replacement heart valve device) into the body. A delivery system, device and / or method for delivering and / or controllably deploying a relates to a method.

[0008] In some embodiments, the replacement prosthetic heart valve device and the replacement prosthetic heart valve device are coupled to a native heart. A method for delivery to a valve, such as an atrioventricular valve, is 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, comprising a delivery system and a prosthetic heart valve. The device includes two typical operating configurations: The radial compression maneuver is then performed through the structure, followed by radial expansion to finally implant the target defective atrioventricular valve. The purpose is to facilitate tension operation and placement.

[0012] (Embodiment 2)

[0013] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. The catheter can be implanted in the bicuspid valve of the femoral vein, passing through the patient's vascular system and into the inferior vena cava. and through the space between the chambers to reach its final implantation location within the bicuspid valve. In the exemplary embodiment, a delivery conduit having a controlled deployment step is utilized to deliver the artificial Accurate alignment of the prosthetic heart valve device by delivering the heart valve device to the desired implantation location The alignment, positioning and fixation can be ensured.

[0014] (Embodiment 3)

[0015] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. It can be implanted within the tricuspid valve and passes through the patient's vascular system from the femoral vein to the inferior vein and and through the right atrium to its final implantation location within the tricuspid valve. In an exemplary embodiment, a delivery conduit having a controlled deployment step is utilized to create an artificial heart. Accurate alignment of the prosthetic heart valve device by delivering the valve device to the desired implantation location , placement and fixation can be ensured.

[0016] (Embodiment 4)

[0017] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. The device can be implanted in the bicuspid valve of the patient's subclavian vein, through the patient's vascular system, and into the superior venous system. The vein is then passed through the vein to reach its final implantation location within the bicuspid valve. In an embodiment, a prosthetic heart valve device is delivered utilizing a delivery conduit having a controlled deployment step. The valve prosthesis can be precisely aligned and positioned by delivering the valve prosthesis to the desired implantation site. and fixation can be ensured.

[0018] (Embodiment 5)

[0019] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. It can be implanted within the tricuspid valve and passes through the patient's vascular system from the subclavian vein to the superior venous 1 through the tricuspid valve to reach its final implantation location within the tricuspid valve. In an embodiment, a delivery conduit having a controlled deployment step is utilized to deliver a prosthetic heart valve device. By delivering the prosthetic heart valve device to the desired implantation site, precise alignment, positioning and and fixation can be ensured.

[0020] (Embodiment 6)

[0021] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. The device can be implanted in the bicuspid valve of the left ventricle, penetrates the patient's anatomy via the apical entry tract, and enters the left ventricle. 1 through the bicuspid valve to reach its final implantation location within the bicuspid valve. In an embodiment, a delivery conduit having a controlled deployment step is utilized to deliver a prosthetic heart valve device. By delivering the prosthetic heart valve device to the desired implantation site, precise alignment, positioning and and fixation can be ensured.

[0022] (Embodiment 7)

[0023] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural heart valve. It can be implanted within the tricuspid valve, penetrates the patient's anatomy via the apical entry tract, and enters the right ventricle. 2 through the tricuspid valve to reach its final implantation location. In one embodiment, a delivery conduit having a controlled deployment step is utilized to deliver a prosthetic heart valve device. By delivering the valve prosthesis to the desired implantation site, precise alignment, positioning and Fixation can be ensured.

[0024] (Embodiment 8)

[0025] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural The device can be implanted in the bicuspid valve of the left atrium, through the atrial entry tract into the patient's anatomy, and into the left atrium. 1 through the bicuspid valve to reach its final implantation location within the bicuspid valve. In an embodiment, a delivery conduit having a controlled deployment step is utilized to deliver a prosthetic heart valve device. By delivering the prosthetic heart valve device to the desired implantation site, precise alignment, positioning and and fixation can be ensured.

[0026] (Embodiment 9)

[0027] The artificial heart valve device according to embodiment 1, wherein the artificial heart valve device is a defective natural The device can be implanted in the bicuspid valve of the femoral artery, through the aortic entry and into the patient's anatomy. The aorta is then passed through the aorta and into its final implantation location within the bicuspid valve. In the exemplary embodiment, a delivery conduit having a controlled deployment step is utilized to deliver the drug to a human. The prosthetic heart valve device can be delivered to the desired implantation location, thereby allowing accurate positioning of the prosthetic heart valve device. The alignment, positioning and fixation can be ensured.

[0028] (Embodiment 10)

[0029] The artificial heart valve device according to any one of embodiments 2 to 9, wherein the artificial heart valve The device is concentrically aligned with the valve frame, radially adjacent thereto, and directly connected to and attached to the valve frame. The surrounding differentially deformable anchor structure is included.

[0030] (Embodiment 11)

[0031] 11. The prosthetic heart valve device of embodiment 10, wherein the deformable anchor structure is atrial region having a stiffness of 1 and a plurality of alignment structures; is intended to assist with rotational orientation during implantation.

[0032] (Embodiment 12)

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

[0034] (Embodiment 13)

[0035] 13. The prosthetic heart valve device of embodiment 12, wherein the differentially deformable anchor structure The ring region includes a ring anchor element for preventing reverse migration. In addition, it generally has a second stiffness that is suitable for deformation and conforms to the natural anatomy.

[0036] (Embodiment 14)

[0037] 14. The prosthetic heart valve device of embodiment 13, wherein the deformable anchor structure is a ventricular region, which generally has a third stiffness and includes a plurality of ventricular anchor elements; The ventricular anchor element has a plurality of ventricular region connecting elements and is disposed adjacent the outflow region of the connecting member of the valve frame. abutting and in contact with it.

[0038] (Embodiment 15)

[0039] 15. The prosthetic heart valve device according to embodiment 14, wherein the differentially deformable anchor structure The device is further arranged to be covered with a leak-proof membrane in the atrial region and the ring region. This prevents leakage around the valve.

[0040] (Embodiment 16)

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

[0042] (Embodiment 17)

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

[0044] (Embodiment 18)

[0045] 18. The prosthetic heart valve device of embodiment 17, wherein the inflow region of the valve frame further comprises and a connecting member for connecting the inflow region directly to the atrial region of the differentially deformable anchor structure. will be placed in.

[0046] (Embodiment 19)

[0047] 19. The prosthetic heart valve device according to embodiment 18, wherein the connecting member is further bendably deformable. The geometry of the part that can be used includes the mechanical damping force and the torsional an Located in the transmission from the car structure to the valve frame while maintaining a rigid connection therebetween; and The valve frame allows it to retain a generally cylindrical geometry and improves valve performance. Optimize.

[0048] (Embodiment 20)

[0049] 20. The prosthetic heart valve device of embodiment 19, wherein the inflow region of the valve frame further comprises The valve frame is attached to the anchor structure along the connecting member. Straddle the structure.

[0050] (Embodiment 21)

[0051] 21. The prosthetic heart valve device of embodiment 20, wherein the intermediate region of the valve frame further comprises The valve frame includes a plurality of valve leaflets supported by a leaflet support structure extending to an intermediate region of the valve frame body. The valve assembly is supported by a one-way valve and has a leak-proof membrane, which together form a one-way valve for allowing blood to flow through the prosthetic valve assembly. Form.

[0052] (Embodiment 22)

[0053] 22. The prosthetic heart valve device according to 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, The exit region connecting member extends from the boundary region of the valve frame.

[0054] (Embodiment 23)

[0055] 23. The prosthetic heart valve device according to embodiment 22, wherein the outflow region connecting member is further curved. The geometric shape of the deformable portion is included, which is the force distribution between the anchor structure and the valve frame. The actuator is arranged to mechanically damp the transmission.

[0056] (Embodiment 24)

[0057] 24. The prosthetic heart valve device according to embodiment 23, wherein the geometry of the bendable portion The target shape further includes suture filaments, which range from relatively stiff to relatively flexible. It has elasticity or tensile properties within the range.

[0058] (Embodiment 25)

[0059] 25. The prosthetic heart valve device according to embodiment 24, wherein the prosthetic heart valve device further comprises different The guided rotational orientation of the atrial alignment structure within the deformable anchor structure allows for It is used to align any leaflet of the prosthetic valve with the anterior leaflet of the native atrioventricular valve and avoid ventricular outflow tract obstruction. It is arranged so that

[0060] (Embodiment 26)

[0061] 26. The prosthetic heart valve device of embodiment 25, wherein the inflow region and the outflow region of the valve frame are The geometry of the bendable deformable portion contained within the exit region further defines a circulatory shuttle for the valve prosthesis. are positioned to allow

[0062] (Embodiment 27)

[0063] 27. The prosthetic heart valve device of embodiment 26, wherein the bendable member in the valve frame is The geometry of the valve prosthesis is designed to allow the valve prosthesis to move toward the atrium. The catheter is positioned so that as it contracts during systole it displaces it from a potentially obstructed ventricular outflow tract. During systole, the increase in ventricular pressure opens the leaflets of the artificial valve and helps the ventricular output. to a closed position, thereby increasing back pressure on the valve.

[0064] (Embodiment 28)

[0065] 28. The prosthetic heart valve device of embodiment 27, wherein when the ventricle expands, the atrium and the ventricle expand. As the pressure difference between the atria and the ventricles decreases, blood flows from the atria through the artificial valve and into the ventricles. and the geometry of the bendable deformation portion within the valve frame that is used for ventricular filling. further permitting the valve frame to return to its original position within the ventricle and reducing its atrial projection, Positioned to reduce the chance of diastolic flow obstruction, blood stagnation, and optimize ventricular filling will be done.

[0066] (Embodiment 29)

[0067] 29. The artificial heart valve device according to embodiment 28, wherein the radially compressed artificial heart The valve device also allows the patient to traverse tight curvatures according to the demands of the anatomy. Does not impair the progression of the anatomical pathway of the structure.

[0068] (Embodiment 30)

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

[0070] (Embodiment 31)

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

[0072] (Embodiment 32)

[0073] 32. The prosthetic heart valve device according to embodiment 31, wherein the differentially deformable anchor structure The artificial heart valve device is designed to provide a long compression that advances along the tight curve of the artificial heart. Enables optimized and controlled advancement and delivery of valve devices to desired target implantation sites. do.

[0074] (Embodiment 33)

[0075] 33. The delivery system of embodiment 32, wherein the delivery system comprises an elongated first a conduit having a first diameter and including a primary cavity, a first bendable portion, and It includes one or more secondary cavities radially adjacent the primary cavity.

[0076] (Embodiment 34)

[0077] The delivery system of embodiment 33 further comprises one or more tethers, which may be attached to a human a second cavity or cavities of the first conduit connected to a portion of the cardiac valve device and translating the second cavity or cavities of the first conduit; The obstacles are positioned so that they move and pass through the obstacles.

[0078] (Embodiment 35)

[0079] 35. The delivery system of embodiment 34, further comprising a second elongated conduit, a cavity having a second diameter smaller than the first diameter, a second bendable portion, and a or a plurality of connecting elements of a portion connectable to a prosthetic heart valve device, wherein the second conduit is further disposed in translation within the primary cavity of the first conduit.

[0080] (Embodiment 36)

[0081] The delivery system of embodiment 35 may further include a second conduit connected to the delivery system and communicating with the second conduit and an artificial heart. The valve device includes a compensation mechanism for controllably effecting a change in configuration of the valve device.

[0082] (Embodiment 37)

[0083] 37. The delivery system of embodiment 36, wherein the one or more tethers and one or more The plurality of connecting elements together provide tension that provides radial restraint for delivery of the prosthetic heart valve device. Maintain a controllable bundle structure.

[0084] (Embodiment 38)

[0085] 38. The delivery system of embodiment 37, wherein the compensation mechanism comprises a second conduit comprising an artificial heart. The valve device is controlled to translate into the first conduit during radial expansion to release tension. This allows you to release the

[0086] (Embodiment 39)

[0087] 39. The delivery system of embodiment 38, further comprising an elongated third conduit, a third diameter smaller than the second diameter and including a cavity, a third bendable portion, and a distal the distal end covering having a fourth diameter greater than the third diameter and having a human body therein. The artificial heart valve device is arranged so as to radially restrain the artificial heart valve device portion by the portion including the artificial heart valve device. do.

[0088] (Embodiment 40)

[0089] 40. The delivery system of embodiment 39, wherein the third conduit further comprises a second conduit. The cavity is arranged for translation within the cavity.

[0090] (Embodiment 41)

[0091] 41. The delivery system of embodiment 40, wherein the distal end jacket further comprises a second conductive layer. It is positioned to embed a portion of the prosthetic heart valve device by contacting the connecting element of the tube.

[0092] (Embodiment 42)

[0093] 42. The delivery system of embodiment 41, wherein the compensation mechanism further comprises a third conduit. and a third conduit is disposed in a position to be connected and communicated therewith, and wherein the distal end covering of the third conduit is a portion of the compensation mechanism. Actuation provides controllable translation.

[0094] (Embodiment 43)

[0095] 43. The delivery system of embodiment 42, further comprising a fourth elongate conduit, a fifth diameter greater than the first diameter and including a cavity and a proximal end covering; The covering includes a portion of the prosthetic heart valve device therein, thereby radially supporting the portion of the prosthetic heart valve device. The device is configured to restrain the

[0096] (Embodiment 44)

[0097] 44. The delivery system of embodiment 43, wherein the fourth conduit further comprises a first conduit. The sensor 10 is arranged so as to move in parallel above the sensor 10.

[0098] (Embodiment 45)

[0099] 45. The delivery system of embodiment 44, wherein the first and second bendable members The article further includes a section of laser cut nickel titanium knowtube.

[0100] (Embodiment 46)

[0101] As in the delivery system of embodiment 44, here the first and second bendable portions are Also includes sections of laser cut steel tubing.

[0102] (Embodiment 47)

[0103] As in the delivery system of embodiment 44, here the first and second bendable portions are Additionally, the laser cut polymer tubing section.

[0104] (Embodiment 48)

[0105] 45. The delivery system of embodiment 44, wherein the first and second bendable members The portion further includes a portion of a fiber reinforced tube.

[0106] (Embodiment 49)

[0107] The transport system according to any one of embodiments 45 to 48, wherein the second guide The tube is further arranged to be deflected by applying tension to an internally biased guy wire. can be. 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. Includes seal cover, The valve includes a plurality of leaflets, and the valve frame is expandable and configured to support the valve. and having an inlet region, an intermediate region and an outlet region downstream of the inlet region, The inflow region further comprises a plurality of inflow region connecting members, and the intermediate region further comprises 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 prevents leakage around the valve. are arranged to prevent wherein the valve is configured to convert between a permissive state and a blocking state; The anchor structure is deformable and is concentrically aligned with and radially adjacent to the valve frame. and surrounding the valve frame and including an atrial region, a ring region and a ventricular region, The atrial region generally has a first stiffness and includes a plurality of atrial region connecting elements, the plurality of atrial region connecting elements being The region connecting element is adjacent to and in contact with the inlet region connecting member of the valve frame, The ring region generally has a second stiffness and is configured to prevent retrograde displacement of the device. the ventricular region generally having a third stiffness and a plurality of ventricular region connecting elements the plurality of ventricular region connecting elements are adjacent to the outflow region connecting members of the valve frame; And also connected and contacted, The anchor seal cover extends between the atrial and ventricular regions and surrounds the valve. It is arranged to prevent leakage. wherein the prosthetic heart valve device is disposed for delivery in a radially minimized, compressed state and filled 3. A method for controlling transition between radially maximizing and expanded states, comprising: And, The anchor structure is adapted to anchor the heart valve when the device is in the expanded state and implanted. The device is positioned to permanently anchor within the atrial valve of the heart. (Item 2) During implantation of the device, any leaflet is aligned with the native anterior leaflet of the atrioventricular valve of the heart, and the device is 2. The prosthetic heart valve device according to item 1, which avoids ventricular outflow tract obstruction after implantation. (Item 3) During implantation of the device, any leaflet is aligned with the native anterior leaflet of the atrioventricular valve of the heart, and the device is The method according to claim 1, which allows the native anterior leaflet to move freely after implantation. Artificial heart valve devices. (Item 4) The expandable valve frame further provides positioning and fixation between adjacent valve leaflets. and each outlet region connecting member of the valve frame includes a boundary member for connecting the outlet region of the valve frame to the outlet region of the outlet region. 2. The prosthetic heart valve device of claim 1 extending from the material. (Item 5) Each inlet region connecting member further includes a bendable portion geometric shape, which is and arranged to mechanically damp the transmission of said forces between said anchor structure and said valve frame. 2. The prosthetic heart valve device of item 1. (Item 6) Each outflow area connecting member further includes a bendable portion geometric shape, which is and arranged to mechanically damp the transmission of said forces between said anchor structure and said valve frame. 2. The prosthetic heart valve device of item 1. (Item 7) The geometric shape of the bendable deformable portion of each inlet region connecting member further determines whether the valve flap is deflected during deflation. configured to allow the frame to be translationally displaced from the anchor structure. 2. The prosthetic heart valve device of item 1. (Item 8) The geometric shape of the bendable deformable portion of each outlet region connecting member further determines whether the valve flap is deflected during deflation. configured to allow the frame to be translationally displaced from the anchor structure. 2. The prosthetic heart valve device of item 1. (Item 9) The geometric shape of the bendable deformable portion of each inlet region connecting member further determines whether the valve flap is in a position to deflect the inlet region during expansion. The frame is configured to allow counter rotation to translate and displace from the anchor structure. 2. The artificial heart valve device according to item 1. (Item 10) The geometric shape of the bendable deformable portion of each outlet region connecting member further determines whether the valve flap is in a position to deflect the outlet region connecting member during expansion. The frame is configured to allow counter rotation to translate and displace from the anchor structure. 2. The artificial heart valve device according to item 1. (Item 11) The geometric shape of the bendable deformation portion of each inlet region connecting member is furthermore a radially bendable deformation portion. The geometric shape of the inlet region and the radially curvature of the inlet region when compressed. Item 1, wherein the portion is configured to bend radially in response to an applied force. The artificial heart valve device. (Item 12) The geometric shape of the bendable deformation portion of each outlet area connecting member is furthermore a radially bendable deformation. The geometric shape of the shaped portion and the radially curvature-able deformation of the outflow region when compressed. Item 1, wherein the portion is configured to bend radially in response to an applied force. The artificial heart valve device. (Item 13) Each outflow area connecting member further includes a rigid geometric shape that is in contact with the anchor structure. The artificial heart according to item 1, which is arranged to resist bending or displacement between the valve frame and the artificial heart. Valvular apparatus. (Item 14) Each inlet region connecting member further includes a rigid geometric shape that is in contact with the anchor structure. The artificial heart according to item 1, which is arranged to resist bending or displacement between the valve frame and the artificial heart. Valvular apparatus. (Item 15) The atrial region of the anchor includes a plurality of atrial retaining members terminating in a releasably captured atrial retaining member. wherein the support structure has a first stiffness when implanted. Item 1, which is arranged to coincide with the bottom of the natural atrium of the atrium valve adjacent to the heart. Artificial heart valve device. (Item 16) The releasably captured atrial retention member is releasably attached to a delivery system of a prosthetic heart valve device. Item 16. The prosthetic heart valve device according to item 15, configured to be connected. (Item 17) When viewed in standard imaging mode, 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 natural rings and outflow tract of the heart. 2. The artificial heart valve device according to item 1. (Item 18) The plurality of support structures in the atrial region of the anchor may be formed by a number of radially bendable deformable portions. a radially deflectable deformable portion of said atrial region further comprising a geometric shape and capable of being radially deflected when compressed. 2. The method according to claim 1, wherein the bending moment is arranged to allow the bending moment to bend radially in response to a force applied thereto. Artificial heart valve devices. (Item 19) The atrial region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent the atrial region and a second diameter greater than the first diameter and adjacent the atrial region. 2. The prosthetic heart valve device according to item 1, comprising: (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) The ring region of the anchor further has a diameter when implanted based on the second stiffness. The present invention relates to a method and apparatus for providing an atrioventricular valve for a heart, comprising: 2. The prosthetic heart valve device according to item 1, (Item 23) 2. The prosthetic heart valve device of claim 1, wherein the ring anchor element comprises a tissue piercing structure. (Item 24) The ring anchor element further comprises one or more rows of tissue piercing structures, wherein each 24. The prosthetic heart valve device of item 23, wherein the structures are oriented in the same direction. (Item 25) The ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures 24. The prosthetic heart valve device of item 23, wherein the woven puncture structures are generally oriented toward one another. (Item 26) The ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures 24. The prosthetic heart valve device of claim 23, wherein the woven puncture structures are generally oriented away from each other. 。 (Item 27) The ventricular region of the anchor further comprises a third stiffness when implanted. 2. The prosthetic heart valve device of item 1, positioned to coincide with a native ventricle of the heart. (Item 28) The ventricular region connecting member of the anchor includes an elongated structural member, A distal end extends away from the ring region of the anchor and toward the ventricle and is released. 2. The prosthetic heart valve device of item 1 terminating in a potentially captured ventricular retention member. (Item 29) The releasably captured ventricular retention member is releasably attached to a delivery system of a prosthetic heart valve device. 30. The prosthetic heart valve device according to item 28, configured to be connected to (Item 30) The ventricular region connecting member of the anchor has a geometric shape of a radially bendable deformable portion. and a radially deflectable deformation portion of the ventricular region that is adapted to respond to a force when compressed. Item 1, the prosthetic heart valve being arranged to allow the valve to bend radially in response to the Device. (Item 31) The ventricular region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent the ventricular region and a second diameter greater than the first diameter and adjacent the ventricular region; 2. The prosthetic heart valve device according to item 1, comprising: (Item 32) The ventricular region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent said ventricular region and a second diameter smaller than said first diameter and adjacent said ventricular region; 2. The prosthetic heart valve device according to item 1, comprising: (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) The device is delivered to the atrioventricular valve of the heart through a percutaneous incision in the femoral artery or femoral vein. 2. The prosthetic heart valve device according to item 1, (Item 37) The device can be delivered to the atrioventricular valve of the heart through a percutaneous incision at the apex of the heart. 2. The artificial heart valve device according to item 1. (Item 38) The device can be delivered to the atrioventricular valves of the heart via a percutaneous incision in the corresponding atrium. 2. The artificial heart valve device according to item 1. (Item 39) The device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the subclavian vein. 2. The artificial heart valve device according to item 1. (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. Includes a roller cover. The valve includes a plurality of leaflets, and the valve frame is expandable and configured to support the valve. and having an inlet region, an intermediate region and an outlet region downstream of the inlet region, The inflow region further comprises a plurality of inflow region connecting members, and the intermediate region further comprises 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 prevents leakage around the valve. are arranged to prevent wherein the valve is configured to convert between a permissive state and a blocking state; the anchor structure is deformable and concentrically aligned with and radially adjacent to the valve frame; a valve frame surrounding the atrial cavity and including an atrial region, a D-shaped ring region and a ventricular region; The atrial region generally has a first stiffness and includes a plurality of atrial region connecting elements, the plurality of atrial region connecting elements being The region connecting element is adjacent to and in contact with the inlet region connecting member of the valve frame, The D-ring region generally has a second stiffness and is a ring to prevent retrograde displacement of the device. The ventricular region generally has a third stiffness and includes a plurality of ventricular region interfaces. the plurality of ventricular region connection elements are connected to the outflow region connection member of the valve frame; adjacent and connected in contact; The anchor seal cover extends between the atrial and ventricular regions and surrounds the valve. It is arranged to prevent leakage. wherein the prosthetic heart valve device is disposed for delivery in a radially minimized, compressed state and filled 3. A method for controlling transition between radially maximizing and expanded states, comprising: And, The anchor structure is adapted to anchor the heart valve when the device is in the expanded state and implanted. The device is positioned to permanently anchor within the atrial valve of the heart. (Item 41) During implantation of the device, the plane of the D-shaped ring region of the anchor structure is aligned with the chamber of the heart. Align with the native anterior leaflet of the valve and avoid ventricular outflow tract obstruction after device implantation 41. The prosthetic heart valve device according to claim 40. (Item 42) During implantation of the device, the plane of the D-shaped ring region of the anchor structure is aligned with the chamber of the heart. Aligns with the valve's native anterior leaflet, allowing the native leaflet to move freely after implantation of the device 41. The prosthetic heart valve device according to item 40, which enables (Item 43) The expandable valve frame further provides positioning and fixation between adjacent valve leaflets. and each outlet region connecting member of the valve frame includes a boundary member for connecting the outlet region of the valve frame to the outlet region of the outlet region. 41. The prosthetic heart valve device of item 40 extending from the material. (Item 44) Each inlet area connecting member further includes a bendable portion geometric shape, which is and arranged to mechanically damp the transmission of said forces between said anchor structure and said valve frame. 41. The prosthetic heart valve device of item 40. (Item 45) Each outflow area connecting member further includes a bendable portion geometric shape, which is and arranged to mechanically damp the transmission of said forces between said anchor structure and said valve frame. 41. The prosthetic heart valve device of item 40. (Item 46) The geometric shape of the bendable deformable portion of each inlet region connecting member further determines whether the valve flap is deflected during deflation. configured to allow the frame to be translationally displaced from the anchor structure. 41. The prosthetic heart valve device of item 40. (Item 47) The geometric shape of the bendable deformable portion of each outlet region connecting member further determines whether the valve flap is deflected during deflation. configured to allow the frame to be translationally displaced from the anchor structure. 41. The prosthetic heart valve device of item 40. (Item 48) The geometric shape of the bendable deformable portion of each inlet region connecting member further determines whether the valve flap is in a position to deflect the inlet region during expansion. The frame is configured to allow counter rotation to translate and displace from the anchor structure. 41. The artificial heart valve device according to item 40. (Item 49) The geometric shape of the bendable deformable portion of each outlet region connecting member further determines whether the valve flap is in a position to deflect the outlet region connecting member during expansion. The frame is configured to allow counter rotation to translate and displace from the anchor structure. 41. The artificial heart valve device according to item 40. (Item 50) The geometric shape of the bendable deformation portion of each inlet area connection member is a radially bendable deformation portion. The inlet region further includes a geometric shape and a radially deflectable variable shape when compressed. Item 40 configured to allow the shaped portion to bend radially in response to an applied force. 2. The artificial heart valve device according to claim 1 . (Item 51) The geometric shape of the bendable deformation portion of each outlet area connection member is a radially bendable deformation portion. The geometry of the outlet region further includes a radially deflectable deformation region when compressed. Item 40, the shaped portion being arranged to allow it to bend radially in response to an applied force. 2. The artificial heart valve device according to claim 1 . (Item 52) Each outflow region connecting member further includes a rigid geometric shape, and the anchor structure and the valve frame are 41. The prosthetic heart valve according to item 40, which is arranged to resist bending or displacement between the frame and the prosthetic heart valve. Device. (Item 53) Each inflow region connecting member further includes a rigid geometric shape, and the anchor structure and the valve flange are 41. The prosthetic heart valve according to item 40, which is arranged to resist bending or displacement between the frame and the prosthetic heart valve. Device. (Item 54) The atrial region of the anchor is further terminated with a releasably captured atrial retention member. a plurality of support structures, wherein the support structures have a first stiffness when implanted, Item 40, wherein the atrial valve is arranged to coincide with the bottom of the natural atrium of the adjacent atrium of the heart. Artificial heart valve device. (Item 55) The releasably captured atrial retention member is releasably attached to a delivery system of a prosthetic heart valve device. Item 55. The prosthetic heart valve device of item 54, configured to be connected. (Item 56) When viewed in standard imaging mode, 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 natural rings and outflow tract of the heart. 41. The artificial heart valve device according to item 40. (Item 57) The plurality of support structures in the atrial region of the anchor further comprises a radially bendable deformation portion and when compressed, the radially bendable deformation portion of the atrial region includes a geometric shape of Item 40. The method according to item 40, wherein the bending member is arranged to bend radially in response to a force applied thereto. Artificial heart valve devices. (Item 58) The atrial region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent the atrial region and a second diameter greater than the first diameter and adjacent the atrial region. 41. The prosthetic heart valve device according to item 40, comprising: (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) The ring region of the anchor further has a diameter when implanted based on the second stiffness. The present invention relates to a method and apparatus for providing an atrioventricular valve for a heart, comprising: 41. The prosthetic heart valve device according to item 40, (Item 62) 41. The prosthetic heart valve device of claim 40, wherein the ring anchor element comprises a tissue piercing structure. (Item 63) The ring anchor element further comprises one or more rows of tissue piercing structures, wherein each 63. The prosthetic heart valve device of item 62, wherein the structures are oriented in the same direction. (Item 64) The ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures 63. The prosthetic heart valve device of item 62, wherein the woven puncture structures are generally oriented toward one another. (Item 65) The ring anchor element further comprises two rows of tissue piercing structures, and wherein the two rows of tissue piercing structures 63. The prosthetic heart valve device of claim 62, wherein the woven puncture structures are generally oriented away from each other. 。 (Item 66) The ventricular region of the anchor further comprises a third stiffness when implanted. 41. The prosthetic heart valve device of item 40, positioned to coincide with a native ventricle of the heart. (Item 67) The ventricular region connecting member of the anchor includes an elongated structural member, A distal end extends away from the ring region of the anchor and toward the ventricle and is released. 41. The prosthetic heart valve device of item 40 terminating in a potentially captured ventricular retention member. (Item 68) The releasably captured ventricular retention member is releasably attached to a delivery system of a prosthetic heart valve device. Item 70. The prosthetic heart valve device of item 67, configured to be connected (Item 69) The ventricular region connecting member of the anchor has a geometric shape of a radially bendable deformable portion. and a radially deflectable deformation portion of the ventricular region that is adapted to respond to a force when compressed. 41. The artificial heart according to item 40, which is arranged so as to be able to bend radially in response to the Valve gear. (Item 70) The ventricular region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent the ventricular region and a second diameter greater than the first diameter and adjacent the ventricular region; 41. The prosthetic heart valve device according to item 40, comprising: (Item 71) The ventricular region of the anchor is generally frusto-conical in shape and adjacent to the ring region a first diameter adjacent the ventricular region and a second diameter smaller than the first diameter and adjacent the ventricular region; 41. The prosthetic heart valve device according to item 40, comprising: (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) The device is delivered to the atrioventricular valve of the heart through a percutaneous incision in the femoral artery or femoral vein. 41. The prosthetic heart valve device according to item 40, which can (Item 76) The device can be delivered to the atrioventricular valve of the heart through a percutaneous incision at the apex of the heart. 41. The artificial heart valve device according to item 40. (Item 77) The device can be delivered to the atrioventricular valves of the heart via a percutaneous incision in the corresponding atrium. 41. The artificial heart valve device according to item 40. (Item 78) The device can be delivered to the atrioventricular valve of the heart via a percutaneous incision in the subclavian vein. 41. The artificial heart valve device according to item 40. (Item 79) 1. A delivery system for a prosthetic heart valve device, comprising: The device includes an elongated first conduit, one or more tethers, an elongated second conduit, and a compensation mechanism. fruit, 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 to the one or arranged to translate through a plurality of secondary cavities; The elongated second conduit has a second diameter smaller than the first diameter and includes a lumen, a second The prosthetic heart valve includes a bendable portion and a connecting element of a portion connectable to one or more of the prosthetic heart valve devices. wherein the second conduit is further translated into the primary cavity of the first conduit. It is arranged so that The compensation mechanism is connected to the second conduit in communication with the second conduit and is capable of controlling the prosthetic heart valve device. and the one or more tethers together with the one or more connection elements can be shortened to 4, the tensioning being capable of controllably positioning the prosthetic heart valve device in a radially constrained configuration for delivery. and wherein the compensation mechanism maintains the second conduit in a radial expansion state of the prosthetic heart valve device. allowing tension to be released by controllably translating within said first conduit; 。 (Item 80) and a third elongated conduit, the third elongated conduit having a diameter smaller than the second diameter. a third diameter and including a lumen, a third bendable portion, and a distal end covering; The covering has a fourth diameter greater than the third diameter and has the prosthetic heart valve device disposed therein. a portion including a portion of the artificial heart valve device that is radially constrained by the portion including the Item 7. The third conduit is further disposed so as to translate within the lumen of the second conduit. 10. A transport system as described in claim 9. (Item 81) The distal end jacket further contacts the connecting element of the second conduit to connect the human Item 81. The delivery system of item 80 configured to implant a portion of a prosthetic heart valve device. (Item 82) The compensation mechanism is further disposed in communication with the third conduit, and The distal end covering of the third conduit is controllably translated by actuation of the compensation mechanism. The transport system according to claim 81. (Item 83) a fourth elongated conduit, the fourth elongated conduit having a second diameter larger than the first diameter; 5 and includes a lumen and a proximal end covering, the proximal end covering having the artificial The prosthetic heart valve device includes a portion of the prosthetic heart valve device to support radial restraint of the portion of the prosthetic heart valve device. The fourth conduit is further arranged to move in parallel above the first conduit. 83. The transport system according to item 82. (Item 84) The first and second bendable sections are further comprised of sections of laser cut nickel titanium tubing. 84. The delivery system of item 83, comprising: (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) The second conduit can be further deflected by applying tension to an internally biased wire. The conveying system according to any one of items 84 to 87, which is configured to:

[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 a summary of several embodiments of replacement prosthetic heart valve devices, systems and methods. Aspects and features of the present disclosure are provided in the text, and these replacement prosthetic heart valve devices, systems, The system and method are disposed in the vascular system of a patient, for example, a native heart valve of the patient. These embodiments are intended to be combined and replaced with a particular valve (e.g., a patient's bicuspid or tricuspid valve). However, it will be understood that the features and The concepts may be applied to products other than prosthetic heart valve devices. For example, The controlled positioning, deployment and fixation features may be used in medical implants, e.g., other types of deployable It can be applied to other parts of the body, such as arteries, veins or other body cavities or parts. In addition, certain features of a prosthetic heart valve device, system, or method may be considered limitations. and the features of any embodiment discussed herein may be modified as appropriate. The features of the present invention may be combined with those of other embodiments in any suitable manner. Although some embodiments are described in conjunction with specific delivery routes, it should be understood that these embodiments It will be appreciated that the embodiments may be used with other delivery routes. Certain features described in combination with one embodiment may be combined with other embodiments, The different transport paths are combined and include those described.

[0111] Reference is made to FIG. 1, which illustrates an anterior portion of an exemplary heart 100, in accordance with some applications of the present invention. FIG. 1 is a schematic diagram showing a front view of an exemplary heart 100. The exemplary heart 100 generally has four main chambers: the right ventricle, Atrium 140, right ventricle 146, left atrium 110 and left ventricle 147, which form a pumping system. They work in a coordinated way to circulate blood throughout the vascular system. The annulus (not shown) directs deoxygenated blood to the superior and inferior veins (125 and 145 respectively). During diastole (the ventricular expansion portion of the cardiac cycle), deoxygenated blood is pumped into the right atrium 140 via the right ventricle. It is forced through the leaflet valve (245, FIG. 2B) and into the right ventricle 146. The right ventricle 146 and the right atrium 140 contract during systole (the ventricular contraction portion of the cardiac cycle). The pressure gradient between the right and left ventricles closes the tricuspid valve (245, FIG. 2B) and blood enters the right ventricular outflow tract (520, FIG. 5A), passing through the pulmonary valve (515, FIG. 5A) and into the left pulmonary artery and The pulmonary trunk 114 by proceeding along the right pulmonary artery (115, 130, respectively) The blood travels along the pulmonary arteries until it flows into the lungs (not shown). It is then transported by the left and right pulmonary veins (105 and 135, respectively). Then, the diastolic expansion is stopped by the open bicuspid valve (210, FIG. 2B). 100% of the oxygen-containing blood is drawn into the left ventricle 147, resulting in the filling of the left ventricle 147. Finally, the systolic ventricle The pressure gradient between the left ventricle 147 and the left atrium 110 drives contraction, forming a bicuspid valve (210, FIG. 2B). and oxygenated blood in the left ventricle of the heart 147 passes through the left ventricular outflow tract (455, FIG. 4A). 2B, passes through the aortic valve (205, FIG. 2B), and circulates through the system along the aorta 120. The heart 100 further includes the circumflex artery 155 and the left and right coronary arteries 156 and 158. Arteries (160 and 150 respectively) provide oxygenated blood to the heart throughout the cardiac cycle The branch arteries of the aorta 120, such as the left subclavian artery, the left common carotid artery, and the cephalic and brachial arteries (each of which is 21, 122, 123) provide oxygen-containing blood to the brain and upper extremities of the body.

[0112] Reference is now made to FIG. 2A, which illustrates an exemplary heart 100 in accordance with some applications of the present invention. 1 is a schematic diagram of the posterior portion of an exemplary heart 100; FIG. 2 shows section line A-A200, which illustrates a cross-section of an exemplary heart 100; Explain where you can cut to arrive at the view shown in Figure 2B.

[0113] FIG. 2B is a schematic diagram illustrating a cross-sectional view of an exemplary heart 100 in accordance with some applications of the present invention. , which highlights the anatomical features presented from an apical perspective. The heart generally has four main chambers: right atrium 140, right ventricle 146, left atrium 110, and left ventricle 147. Between the right atrium (140, FIG. 1) and the right ventricle (146, FIG. 1) The inner wall of the right ventricle 240 is an air gap through which blood is pushed out during systolic contraction. The tricuspid valve 245 is a tricuspid valve having an anterior leaflet 255, a posterior leaflet 250 and an intermediate leaflet 252. 60, which come together when the right ventricle (146, Figure 1) is under pressure during contraction. The anterior leaflet 255 and the posterior leaflet 250 are closed and generally prevent retrograde blood flow. There are papillary muscles 256 that support the two leaflets by the chordae tendineae 261. Between and below the tricuspid valve leaflet 260 is the posterior papillary muscle 257, which is attached to the tricuspid valve chordae tendineae 261. The anterior septal papillary muscle 258 is located between and below the septal leaflet 260 and the anterior leaflet 255. , which supports the two leaflets by the tricuspid valve chordae tendineae 261.

[0114] The right ventricle 241 is connected to the pulmonary valve 235 along the outer wall thereof, and the pulmonary valve 235 and the tricuspid valve 245 are It shares the right ventricle (146, FIG. 1) and the right ventricular outflow tract (520, FIG. 5A). Pulmonary valve 235 The right ventricle (146) is a tricuspid valve, consisting of a left leaflet 236, a right leaflet 238 and an anterior leaflet 237. When the endovascular valves (Figure 1) are decompressed during diastole, they close together and generally prevent retrograde blood flow. Stop.

[0115] The left ventricle 231 is connected to the aortic valve 205 along the outer wall thereof, and the aortic valve 205 and the bicuspid valve 210 are It shares the left ventricle (147, Fig. 1) and the left ventricular outflow tract (455, Fig. 4A). Aortic valve 205 The left ventricle (147) is a tricuspid valve, consisting of a left cusp 206, a right cusp 207 and a posterior cusp 208. When the endovascular valves (Fig. 1) decompress during systole, they close together and generally prevent retrograde blood flow. Stop.

[0116] Between the left atrium (110, FIG. 1) and the left ventricle (147, FIG. 1) there is a bicuspid valve 210. The inner wall of the left ventricle 230 defines the space through which blood is pumped during systolic contraction. 210 is a bicuspid valve, consisting of an anterior leaflet 212 and a posterior leaflet 211, and is connected to the left ventricle (147, FIG. 1 When the ventricles 14a-14c are subjected to pressure during systole, they close and generally prevent retrograde blood flow. Between the posterior leaflet 211 and the anterior leaflet 212 and at the rear is the posterior medial papillary muscle 215, which is the chordae tendineae of the bicuspid valve. The two leaflets are supported by 225. The posterior leaflet 211 and the anterior leaflet 212 are supported on the outer side and the posterior side. There is a papillary muscle 220 that supports the two leaflets by chordae tendineae 225. 2 extends from the bicuspid valve ring (335, FIG. 3A) into the central chamber in a sub-ring shape. At the corner where the cusps intersect, the anterior leaflet 212 is an apparent rigid region of fibrous tissue (the fibrous trigones 213 and 214). The fibrous trigone 216 is a structural region of the heart 100 and originates from the adjacent valve annulus (called the fibrous trigone 16). 20 and 210, and function as a valve guiding mechanism for the bicuspid valve 210 and the aortic valve 205 during the dynamic motions generated throughout the cardiac cycle. Provide a supporting base for the

[0117] Reference is now made to FIG. 3A, which illustrates the valve leaflets (anterior 310, posterior 311) in accordance with some applications of the present invention. 315), bicuspid valve chordae tendineae (320), and papillary muscles (anterolateral 305, posteromedial 301). FIG. 1 is a front view of a representative 300 of a typical native bicuspid valve surrounding unfolded and spread out flat for selection. As can be seen, both the anterior leaflet 310 and the posterior leaflet 315 are bicuspid. Originating from the annulus 335 and extending downward (towards the left ventricle, not shown) and into the left atrium (not shown). The representative body 300 is separated from the posterior medial border region 30 along the edge of the bicuspid ring 335. 6 and anterior-lateral boundary region 307 (divided in half in this figure). Extending below the border regions (posterior medial 306, anterolateral 307) are the arteries of the bicuspid valve chordae tendineae 320. It further communicates with the corresponding papillary muscles (posterior medial 301, anterolateral 305). The bicuspid valve chordae also extend directly from the anterior leaflet 310 and the posterior leaflet 315 themselves, Each of them continues until it reaches the area without tendons called the anterior free edge (325 and 330, respectively). In a healthy heart with intact anatomical structure, the function of the chordae tendineae is The function of the valve is to provide tension between the leaflets and the papillary muscles, preventing the leaflets from being excessively coapted to the atrium during systole and causing atrial fibrillation. The goal of this study is to prevent the vascular endothelium from migrating toward the atrium, which can ultimately lead to valve dysfunction and backflow. , which can lead to heart failure and poor health.

[0118] Similar to FIG. 3A, FIG. 3B illustrates a valve leaflet (partition 350, anterior ventricular occlusion 352, lateral ventricular occlusion 354, lateral ventricular occlusion 356, lateral ventricular occlusion 358, lateral ventricular occlusion 359, lateral ventricular occlusion 360, lateral ventricular occlusion 362, lateral 360, posterior 370), tricuspid valve chordae (380) and papillary muscles (posterior partition 385, anterior partition 39 0, anterior and posterior 395) of an exemplary native tricuspid valve surrounding unfolded and flattened to select As can be seen, the anterior leaflet 360, the posterior leaflet 370, and the The tricuspid valve leaflets 345 and 350 extend downward (towards the right ventricle) and 3. The representative body is located along the edge of the tricuspid ring 345 and away from the right atrium (not shown). 340 is divided into a front partition boundary region 382, ​​a front and rear boundary region 383, and a rear partition boundary region 381 (the same In the figure, the boundary area is divided into two parts (front partition 382, ​​front and rear partition 383, and rear partition 384). Extending below the partition 381) are the arches of the tricuspid chordae 380, which in turn are The papillary muscles are extended until they communicate with the corresponding papillary muscles (front partition 390, front and rear partition 395, and rear partition 385). The tricuspid valve chordae 380 also extend directly from the segmental leaflets 350, anterior leaflet 360, and posterior leaflet 370 themselves. Extending and defining the edges of each corresponding leaflet, the segment free edge, the anterior free edge and the posterior free edge (355, The valves stop at the area called the chordae tendon (365, 375). The leaflets of the cusp valve, the chordae tendineae and the corresponding papillary muscles also work in unison to prevent retrograde and reverse flow of blood. All associated diseases and complications related to can be prevented.

[0119] Reference is now made to Figures 4A and 4B, which show a left ventricular stenosis in accordance with some applications of the present invention. Normal forward blood flow on the left and right sides (centralized on the left) through the cardiac cycle, including diastole and systole. 4A shows an exemplary illustration of a cross-section of the anterior portion of an exemplary heart 400. 4 shows a schematic diagram of the normal direction of blood flow from the left atrium 445 to the left ventricle 425 during diastole. (indicated by arrow 430). It should be understood that during diastole, the bicuspid valve 440 opens. The bicuspid valve leaflets 435 extend completely into the left ventricle 425, allowing fresh oxygen-containing Allows blood to fill the left ventricle 425. During diastole, the aortic valve 450 The right side of the heart is also depicted in FIG. 4A during diastole. On the right side, blood is released from the right atrium 405 in a manner similar to what occurs on the left side of the heart. 410 and past the fully extended tricuspid valve leaflets 415. The blood enters the right ventricle 420 and then passes through the right ventricular outflow tract (not shown) and the pulmonary valve and then the pulmonary artery. During the cardiac cycle, the two ventricles of the heart diastole. The anterior portion of the exemplary heart 400 expands in a consistent manner and then contracts in a consistent manner. 4 shows a schematic cross-sectional view of the left ventricle 425 passing through the left ventricular outflow tract 455 during systole. The normal direction of blood flow (indicated by arrow 460) through the aortic valve 465 is shown. During systole, the bicuspid valve 470 closes and the bicuspid leaflets 471 fully contract, allowing blood to flow through the valve. This prevents fluid from flowing back into the left atrium 445 and allows fresh oxygen-containing blood to flow into the aorta 47. During systole, the aortic valve 465 is forced open. Also depicted in Figure 4B is the right side of the heart during systole. On the right side, blood flows from the right ventricle 420 into the right ventricular outflow tract (not shown) in a manner similar to that occurring in the right ventricle. ) into the pulmonary valve (not shown). The tricuspid valve 475 closes and the tricuspid valve leaflets 476 are fully extended. It was found that the complete contraction of the ventricle prevents blood from flowing backward into the right atrium 405. do.

[0120] In contrast to FIGS. 4A and 4B, FIGS. 4C and 4D show the cardiac Abnormally directed blood flow with some retrograde flow on the left and right sides (centred on the left side) during the systolic phase FIG. 4C is a schematic diagram of an exemplary illustration of the flow of blood through an exemplary heart 400. A schematic cross-sectional view of the anterior portion of the aorta 465 is shown, showing the blood flowing through the aorta 465 during contraction as well as the blood flowing through the damaged aorta 465 during contraction. The direction of abnormal blood flow (arrows 480 and 483) through the bicuspid valve 485 and into the left atrium 445 1), in which a damaged bicuspid valve 485 has successive leaflets that cannot coapt properly. The associated leaflet may be due to ruptured chordae (not shown) or degenerated bicuspid annulus tissue. This can lead to further damage to tissue structures, loss of strength and degeneration. For this type of damaged bicuspid valve 485, the ejection flow through the aorta 465 The majority of the scores should have successfully left and reintroduced into the left atrium 445, as indicated by arrow 480. FIG. 4D is a schematic cross-sectional view of an exemplary heart 400, showing large blood vessels during systole. Not only does it pass through the artery 465, but it also passes through the damaged bicuspid valve 495 and into the left atrium 445. The direction of abnormal blood flow into the damaged aorta is shown (indicated by arrows 490 and 481). Bicuspid valves495 suffer from tentorial leaflets that do not coapt properly. Tentorial leaflets prevent ventricular remodeling. This may be due to the formation of vascular endothelial cells, 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 contracts excessively. The valve is then compressed, causing localized hypertrophy and deformation of the surrounding anatomical structures (e.g., chordae tendineae and associated leaflets). vinegar.

[0121] Reference is now made to Figures 5A and 5B, which show a bicuspid and and prosthetic heart valve devices implanted in the bicuspid position (535 in the bicuspid position, 555 in the tricuspid position) FIG. 1 is a schematic diagram showing a cross-sectional view of the anterior portion of an exemplary heart (500, 550) according to an embodiment of the present invention. Generally, FIG. 5A illustrates a schematic diagram of an exemplary heart 500, which includes a pulmonary trunk 501, Along a plane dividing the right atrium 502, the left atrium 503, the right ventricle 510 and the left ventricle 505 into two The heart cavities (right atrium 405, left atrium 445, right ventricle 42 0 and left ventricle 425) and exposes the internal features and details of these internal features and details already known from the DESIGN OF AN EXEMPLARY EMBODIMENT OF A PROSTHETIC HEART VALVE DEVICE 535 DESIGNED FOR IMPLANTATION IN THE CUSPIDATE POSITION The exemplary embodiment of the prosthetic heart valve device 535 is configured to have an inflow (left atrium 445 or right atrium 446) and an outflow (left atrium 447) A minimum contour extending into the atrium 405) region and the outflow (right ventricle 420 or left ventricle 425) region is and a ventricular outflow tract obstruction (left ventricular outflow tract 512, right ventricular outflow tract 5 20) and prevent reduced ejection scores in the event of outflow obstruction, and Prevents blood flow obstruction and stagnation in the event of blockage. Further, the anterior and posterior regions of the natural anatomical structures, such as the bicuspid valve ring (514, FIG. 5B), (545 and 540, respectively) can be used, and a radially outward force can be applied The device was anchored to the bottom of the atrium (left, 445) and the apex of the ventricle (left, 4 25) By having a load-bearing surface that can abut the natural valve ring, These features prevent the device from migrating into the left atrium 445 or left ventricle 425. will be further explained.

[0122] Similar to FIG. 5A, FIG. 5B illustrates an exemplary heart 550, in accordance with some applications of the present invention. The heart 550 is shown as having a pulmonary trunk 501, a right atrium 502, a left atrium 503, a right ventricle 510, and along a plane dividing the left ventricle 505 in two, thereby revealing the heart cavity ( The right atrium 405, the left atrium 445, the right ventricle 420 and the left ventricle 425 are shown exposing internal features and details. These internal features and details are of a prosthetic heart valve designed for implantation in the tricuspid position. The present invention relates to design features of an exemplary embodiment of the device 555. The embodiments provide advantages similar to those found in the bicuspid position device described and designed above. For example, an exemplary embodiment of the prosthetic heart valve device 555 may further include a natural Anatomical structures, such as the anterior, partition and posterior regions of the tricuspid valve ring (513, FIG. 5A) 565 and 560, respectively), and a radially outward force is used. to aid in anchoring the device and to provide a catheter to the bottom of the atrium (right, 405) and the apex of the ventricle (right, 42 0) to effectively clamp onto the natural valve ring and The device is prevented from migrating into the right atrium 405 or right ventricle 420.

[0123] Reference is now made to FIGS. 6A-6H, which are illustrative diagrams of exemplary cardiac 6 is a schematic diagram of a cross-sectional front view of 600 illustrating various percutaneous delivery pathways for an exemplary prosthetic heart valve device. FIG. 6A shows a corresponding percutaneous passageway in an apical implanted bicuspid valve location, with directional arrow 605 FIG. 6B shows a corresponding percutaneous passageway within the apical implanted tricuspid valve location, indicated by directional arrow 615. FIG. 6C shows the corresponding percutaneous pathway within the femoral vein graft tricuspid valve location, with directional arrow 6 FIG. 6D shows the corresponding percutaneous pathway in a transfemoral / transinterval implanted bicuspid valve location. FIG. 6E illustrates a bicuspid valve in a subclavian implanted position, indicated by directional arrow 635. FIG. 6F shows a percutaneous pathway through which the catheter is inserted into the subclavian tricuspid valve, indicated by directional arrow 645. FIG. 6G shows the corresponding percutaneous pathway within the device, indicated by directional arrow 655. FIG. 6H shows the corresponding percutaneous pathway within the bicuspid valve position shown, indicated by directional arrow 665. indicates a corresponding percutaneous pathway within the bicuspid valve location inserted by the atrium, and directional arrow 675 indicates Some embodiments of the exemplary prosthetic heart valve devices described herein include Although described in conjunction with a transdermal delivery route, it will be understood that these embodiments may be used in conjunction with other transdermal It should also be understood that in some applications of the present invention, Thus, certain features that are described in combination with some embodiments may also be combined with other embodiments. It is possible to combine different transdermal transport routes, including those described above.

[0124] Reference is now made to Figures 7A-7D, which may be modified in different ways in accordance with some applications of the present invention. An exemplary self-expanding valve frame is arranged to mate with a removable anchor structure (800, FIG. 8A). FIG. 7A is a schematic diagram illustrating an embodiment of a self-expanding frame 700. 7 shows a perspective view of an embodiment of a valve frame 700, which may be generally cylindrical. The blood inlet region 701 and the blood outlet region 702 facing the blood inlet region 701 are provided. These regions typically illustrate the directions blood may flow through the device during normal operation. The illustrated embodiment of the exemplary self-expanding valve frame 700 is generally superelastic and shape-memory. It may be made of any alloy having the properties, for example nickel titanium or any other superconductor. Elastic, shape memory metals or other alloys, polymers or compositions of materials capable of exhibiting self-expanding properties In general, the exemplary self-expanding valve frame 700 embodiment has a valve frame inflow region (715, FIG. 7C), which is adjacent to the blood inflow area 701 and around the valve. Features to prevent leakage and an exemplary self-expanding valve frame 700 and adjacent valve frame inflow region (715, FIG. 7C) between the exemplary differential deformable anchor structure (800, FIG. 8A) The frame is arranged to provide features that allow for a mating connection. 00 and an exemplary differential deformable anchor structure (800, FIG. 8A) A further feature of the present invention is the inclusion of a plurality of (736, FIG. 7B) elongated inlet region connecting members 735. They can be arranged to be flexible, movable and bendable, allowing deformation of the structure and absorbing forces. The inlet area connecting member 7 is formed of a material that is highly flexible and can be used for connecting the inlet area to the outlet of the inlet. 35 may be further arranged in a geometric shape 740 including a bendable portion, which may It allows for structural deformation and force absorption. The inlet region connecting member 735 further comprises an inlet region connecting element 7 45, which acts as a positioning feature and may be positioned to 735 and a corresponding atrial connection element (825, FIG. 8A). and the corresponding atrial connection element (825, FIG. 8A) is an exemplary differentially deformable anchor structure. (800, FIG. 8A) embodiment. Features that allow for preventing paravalvular leakage include a valve seal cover (780, FIG. 7D). It can be made of e.g. polyester, nylon, PTFE, ePTFE, treated Any material that may be used to construct pericardial tissue, polymer fabrics, or durable prosthetic heart valve devices. and other materials, and is arranged to separate the valve frame inlet area (715, FIG. 7C) from the valve frame. The flow path is positioned so that it extends to the flow path outflow area (725, FIG. 7C, as described below). In addition, the exemplary embodiment of the self-expanding valve frame 700 further includes a valve frame ring region (72 0, FIG. 7C), which includes a valve frame inlet region (715, FIG. 7C) and a valve frame inlet region (720, FIG. 7C). adjacent to and between the ram spill area (725, FIG. 7C, as follows); and arranged to provide a location for connecting a suture and a fabric, the fabric being, for example, poly. polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics, or The same applies to any other material used to construct a durable prosthetic heart valve device. The exemplary self-expanding valve frame 700 is fabricated in the valve frame ring area (720, FIG. 7C). The feature allows for providing locations for connecting sutures and fabric thereon. The leaflet attachment connection rail 730 and the geometric shape of the bendable deformation portion of the leaflet attachment connection rail The geometry may include a shape (775, FIG. 7C) that is also adapted to receive sutures and fabric. and further providing flexibility (not shown) which aids in the crimping process. It can be loaded into a delivery system (not shown) for percutaneous or other implantation. The embodiment of the self-expanding valve frame 700 further includes a valve frame outflow region (725, FIG. 7C). The valve frame outflow region may be adjacent to and adjacent to the valve annulus region (720, FIG. 7C). Downstream and showing the exemplary self-expanding valve frame 700 and the adjacent valve frame outflow area (7 25, FIG. 7C) between the exemplary differential deformable anchor structure (800, FIG. 8A). The valve frame 700 is configured to provide features that allow for connection to the valve frame 700. and an exemplary differential deformable anchor structure (725, FIG. 7C) in the adjacent valve frame outflow region ( The features that enable a mating connection between the stator 800 (FIG. 8A) and the stator 820 (FIG. 7C) are elongated The outflow region connection member (750, FIG. 7C) may include a leaflet attachment rail (730 , FIG. 7C) and adjacent to and extending from the valve boundary attachment region (765, FIG. 7A) The attachment area (765, Fig. 7A) is attached by means of sutures and a boundary leaflet attachment part (770, Fig. 7A). The valve is arranged to support the attachment of a plurality of leaflets (790, FIG. 7D). (750, FIG. 7C) may further include a series of outflow region connecting elements (755, FIG. 7C). 7C) and a corresponding ventricular region connection element (845, 8A) and serve as matable positioning features between the corresponding ventricular region connection elements (845, FIG. 8A) is adjacent to the ventricular conformal structural support strut (836, FIG. 8A), which is e.g. An exemplary embodiment of the differential deformable anchor structure (800, FIG. 8A) is shown. The area connecting member (750, FIG. 7C) further defines the geometric shape of the bendable portion (760, FIG. 7C), which is arranged to be flexible, movable and bendable, allowing deformation of the structure. to provide a stable and durable support between the members. do.

[0125] Referring now to FIG. 7D, an illustration of a self-expanding valve frame 777, in accordance with some applications of the present invention, is shown. FIG. 1 illustrates a schematic diagram of a front view of an exemplary embodiment of a tissue valve leaflet for preventing leakage around the valve. and a fabric covering (valve seal cover) 780. The embodiment includes a leaflet attachment rail 730, which provides a location for a plurality of leaflets 790. The leaves are chemically treated and biocompatible intrapericardial tissue material or biocompatible Polymeric materials or any material that is biocompatible and can be used to manufacture the leaflet structure of an artificial heart valve. Other configurations may also be used. Each leaflet 790 extends between valve boundaries 795. The leaflet attachment rails 730 are adjacent to and between the leaflet attachment rails 730, and the valve boundary 795 is further defined as the boundary Includes covering 786 and attachment sutures 785.

[0126] Reference is now made to Figures 8A-8D, which are illustrative diagrams of exemplary differentials in accordance with certain applications of the present invention. 1 is a schematic diagram illustrating various views of an embodiment of a heteromorphic anchor structure 800. The exemplary embodiment of the differentially deformable anchor structure 800 shown in FIGS. 8A-8B is an anchor The anchor atrial region 805 may include a generally diamond shaped unit structure. The atrial region includes a plurality of elongated struts that together define a first structure and generally have a first stiffness. 805 is positioned to coincide with the atrial surface of the native atrioventricular valve of the heart (see Figures 5A-5B). and provide resistance to the movement of the atrioventricular valves of the heart from the atria toward the corresponding ventricles. The atrial region 805 may further include a plurality of atrial ejection members 830, each of which may include a The material 830 is adjacent to and extends from the atrial conforming structure 820, which is Further, an exemplary delivery system conduit (not shown) is arranged to provide a smooth surface. The lubricated surface can be pulled against the lubricated surface to capture and seat the prosthetic heart valve device of the present disclosure. The atrial release member 830 is arranged to include an atrial release member geometry 831. 8, which may include a differential deformable anchor structure 800 and an exemplary transport system (not shown) Attachment of an exemplary differentially deformable anchor structure 800 The additional features can include the atrial region connection element 825, which is the geometric shape 826, which is the inflow region of the exemplary self-expanding heart valve frame (700, FIG. 7A). The contact area 745 is disposed to be connectably mated with the contact area 745 .

[0127] The exemplary embodiment of the differentially deformable anchor structure 800 of FIGS. 8A-8B further includes an anchor - Fixed valve ring area 810, which generally includes multiple long and wide valve ring areas fastened 8. The struts 862, which together define an annular circumferential structure, are exemplary variants of this embodiment. The ring region traverses the circumference of the possible anchor structure 800 and generally has a second stiffness. Region 810 is configured to correspond to the natural atrioventricular rings of the heart (see FIGS. 5A-5B ); Movement away from the ring can be resisted by radial expansion forces. In addition, the embodiment of the exemplary differentially deformable anchor structure 800 shown in FIGS. 8A-8B further It may further include an anchored ventricular region 815, the anchored ventricular region 815 being Generally having a third stiffness and generally including a plurality of long and wide ventricular conformal structures 835. , which has a heel 860 (see FIGS. 5A-5B ) for abutting the apical surface of the native ventricle; and a plurality of elongated ventricular conformal structural support struts 836, which terminate in a ventricular ejection member 840. The ventricular ejection member 840 has a ventricular ejection member geometry 850 that is differentially deformable. 10 is a perspective view of an exemplary delivery system (not shown) for releasably connecting the anchor structure 800 to an exemplary delivery system (not shown). Each ventricular conformity structure 835 further includes a plurality of ventricular region connection elements 845. ventricular region connection element geometry 855, which are exemplary Provides a mating connection with the outflow region connection element 755 of the 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. 4, which penetrates the ring tissue and increases the anchoring force of the differentially deformable anchor structure 800. Finally, the ventricular region 815 is positioned to reinforce the ventricular walls and ribs of the heart's native atrioventricular valves. 5A-5B), and heel 860 The valve is then moved away from the natural ring by contacting the apical surface of the ventricle adjacent to the lower surface of the natural ring. The first stiffness of the atrial region 805, the second stiffness of the ring region 810, The second stiffness and the third stiffness of the ventricular region 815 can be related in this manner, all i.e. providing the right combination of optimized stiffness to avoid device migration while at the same time providing a natural core The stiffnesses may be generally equal. Alternatively, the first stiffness may be generally The stiffness is greater than or less than one or two of the second stiffness and the third stiffness. , the second stiffness is generally greater than one or two of the first and third stiffnesses. Finally, the third stiffness is generally one of the first and second stiffnesses. The stiffness may be greater or less than one or two of the stiffnesses.

[0128] Reference is now made to FIG. 8D, which illustrates a fabric covering 867, in accordance with some applications of the present invention. FIG. 1 is a schematic diagram of an embodiment having a deformable anchor structure. The anchor structure may include the differentially deformable anchor structure 800 described above, and may further include an anchor structure 802. A car seal cover 870 is included, which is positioned to prevent leakage around the valve and is e.g. Polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics or any other material of a durable prosthetic heart valve device. The ring area seal cover 870 further includes a ring area seal cover 871 and a ring area seal cover diamond. The ring may include a shaped feature 872 to provide maximized fabric surface area, thereby Finally, the three sets of ventricular region outflow openings 875 each provide maximum resistance to leakage. A plurality of ventricular conformal structures 835 are joined together at the boundary of the valve annulus region seal cover 871 to form the ventricular conformal structures 835. and utilizing the available space below and embedded in an embodiment of a prosthetic heart valve device. The catheter is positioned to maximize the ventricular outflow tract (see Figures 5A-5B). Reduces the occurrence of blockages.

[0129] 9A-9F, which are illustrative diagrams of an exemplary artificial heart in accordance with some applications of the present invention. 9A is a schematic diagram showing various views of an embodiment of a valve device 900. FIG. 9B shows a front view of a typical embodiment of a prosthetic heart valve device 900; 9C shows a perspective top (inflow) view of the prosthetic heart valve device 900, and FIG. 9D shows a perspective top (inflow) view of the prosthetic heart valve device 900. A front view of the prosthetic heart valve device with the covering 915 is shown. Finally, FIG. 9E shows an exemplary prosthetic heart. 9A shows a cross-sectional view of a valve device 900. As shown in FIG. Example of a deformable anchor structure (800, FIG. 8A) different from the embodiment of (700, FIG. 7A) A mating connection at the outflow end 910 between the exemplary embodiment can be seen. In the embodiment of the exemplary self-expanding heart valve frame (700, FIG. 7A), different variations are shown. 8A)。 8A) at the inflow end 905 between the exemplary embodiment of the anchor structure (800). As shown in FIG. 9D, according to some applications of the present invention, 9 shows a schematic representation of an exemplary embodiment of a prosthetic heart valve device having a covering 915, where the valve seal Shown is cover 780, leaflets 790 and anchor seal cover 870. Referring now to FIG. 9 is a cross-sectional view of an exemplary embodiment of a prosthetic heart valve device 900 in accordance with some applications of the present invention. The projected curve describing the anchor cross section 925 is a projected curve describing the valve frame cross section 930. An embodiment of the prosthetic heart valve device 900 depicts an anchor cross section 925. The overall length of the protruding curve is equal to the overall length of the protruding curve describing the valve frame cross section 930. 9D, each curve may be designed to be When connected to the jacket 915 (connected at the inlet 935 and connected at the outlet 940), the inlet For example, an exemplary embodiment of a delivery system conduit may be used when the delivery system conduit is left with tension applied to both the outflow end and outflow end. When loaded into the embodiment (described further below), a heart valve frame (700, FIG. 7A ) conforms to the differentially deformable anchor structure (800, FIG. 8A) and contracts uniformly.

[0130] Finally, FIG. 9F illustrates the geometry of the ventricular region connection element of the anchor (855, FIG. 8A) in a valve-like configuration. Various alternative embodiments for connecting to the connection structure of the outflow area connection element 755 of the frame Specifically, the detailed cross-sectional circles 945, 973 and 974 are the same as the corresponding enlarged cross-sectional circles (9 Five reference lines (946, 947, 945, 950, 955, 960, 965, 964) 8, 963, and 962) are shown, and the embodiments for selecting the connection structure are explained. The light line 946 leads from the first detailed cross-sectional circle 945 to the enlarged cross-sectional circle 950 and is a suture line or flute. 9 shows an embodiment including a connection structure of filament-type material 951, which already has an anchor The geometric shape of the ventricular region connection element (855, FIG. 8A) and the outflow region connection element of the valve frame 755, which are interleaved with each other to provide a rigid connection. The thread-like or filament-like material 951 is a fabric or polymer having elasticity or flexibility. The suture-like or filament-like material 951 may include a flexible or elastic metal alloy. The suture-like or filament-like material 951 may further include a rigid and inflexible The material may include a material having a specific surface area, a polymer, a fabric, or an alloy. From circle 945 to enlarged cross-sectional circle 955 and at the junction of suture-like or filament-type material 956 9 illustrates an embodiment including a connecting structure, where the material 956 has already been adapted to the geometry of the ventricular region connecting element of the anchor. The valve frame is connected between the target feature (855, FIG. 8A) and the outflow region connection element 755 of the valve frame. The suture or line of material 956 may be arranged to provide a connection, which may be an anchor. The geometric shape of the ventricular region connection element of the valve frame (855, FIG. 8A) and the outflow region connection element of the valve frame The suture line or filamentous material 956 allows some displacement between the ligaments 755. The may include elastic or flexible fabrics or polymers. The material 956 may further include a flexible or elastic metal alloy. The bolster material 956 may include a rigid and inflexible material, polymer, fabric, or alloy. A reference line 948 leads from the first detailed cross-section circle 945 to the enlarged cross-section circle 960 and 9 shows an embodiment of a connection structure including a coil of material 961, which is already part of the anchor. The geometric shape of the ventricular region connection element (855, FIG. 8A) and the outflow region connection element 7 of the valve frame 55. The coiled material 961 may be arranged to provide the connection. , the connection being based on the geometric shape of the ventricular region connection element of the anchor (855, FIG. 8A) and the valve frame. The coiled material 961 is stretched to allow maximum displacement between the outlet region connection element 755 and the outlet region connection element 755. The coiled material 961 may comprise a flexible or compliant fabric or polymer. Alternatively, the coiled material 961 may be a rigid and non-rigid metal alloy. It may include a flexible material, a polymer, a fabric, or an alloy.

[0131] The reference line 962 leads from the second detail cross-sectional circle 974 to the enlarged cross-sectional circle 964 and is 9 shows an alternative embodiment including a connection structure for the suture material 971, the suture material 971 being an anchor Between the geometric shape 975 of the ventricular region connection element of the valve frame and the outflow region connection element 755 of the valve frame (adjacent to and extending from heel 860). In this case, one or more of the ventricular conformal structural support struts 836 are directly connected to the suture material 971. by means of a tension connection, or a rigid connection, or any other connection between the connection elements. The connection depicted in the specific alternative embodiment is capable of absorbing some displacement. The structure may be implemented in one or more valve coaptation areas, or in any valve coaptation area. 7D. The connecting structure is designed to prevent any affected valve coaptation area (795 , FIG. 7D). In addition, the connection configuration described in this embodiment may be The total curl height of the device (the vertical distance between members 830 and 850 as shown in FIG. 10A) The design may be such that the distance (distance in the direction of the arrow) is small.

[0132] The reference line 963 extends from the third detailed cross-sectional circle 973 to the enlarged cross-sectional circle 965 and is a suture line. The opposite end of the above selected embodiment including the connection structure of the material 971 (connected to the outflow area connection member 750) A view of the ventricular region of the anchor is drawn, which is the geometric shape of the ventricular region connecting element. and the valve frame outflow region connection element 755 (adjacent to and extending from the heel 860 The NI 8116 is connected directly to the

[0133] Reference is now made to Figures 10A and 10B, which show the crimping effect of some applications of the present invention. 1 is a schematic diagram of an exemplary embodiment of a prosthetic heart valve device 900 in a configuration 1000 and an expanded configuration 1020. It is a schematic diagram of a front view. Specifically, FIG. 10A shows the crimped structure 1000, and the artificial heart valve device 900 is crimped and appears in an exemplary embodiment of a delivery system conduit when loaded in a radially compressed or axially tensioned form. The crimped structure 1000 (further described below) appears. The atrial region 1005, the ring region 1010, and the ventricular region 1015 when in the crimped structure 1000 are also visible. Similarly, FIG. 10B shows the expanded structure 1020, which appears when the artificial heart valve device 900 is fully released and implanted within the native atrioventricular valve. visible. Similarly, FIG. 10B shows the expanded structure 1020, which appears when the artificial heart valve device 900 is fully released and implanted within the native atrioventricular valve.

[0134] Referring to FIGS. 11A - 11C, which are schematic diagrams showing the typical deployment process sequence of an exemplary embodiment of an artificial heart valve device 900 deployed by an exemplary embodiment of a delivery system 1100 according to some applications of the present invention. FIG. 11A shows a pre - deployment configuration example of a portion of the conduit 1104 adjacent to the proximal capsule portion 1101 and the distal capsule portion 1102. The proximal end capsule portion 1101 can have a proximal end marker tape 1106, and the distal end capsule portion 1102 can have a distal end marker tape 1107, thereby serving as an imaging guide for the insertion program. An exemplary embodiment of the delivery system 1100 may be arranged to travel on the guide wire 1103, thereby tracking the device as it enters position during the program - embedding period. FIG. 11B shows an in - deployment configuration of an exemplary portion of the conduit 1104 of an exemplary embodiment of the delivery system 1105, which shows that the proximal end capsule portion 1109 is translated away from the distal end capsule portion 1102, exposing the atrial portion of an exemplary embodiment of the artificial heart valve device 1108. Some applications of the present invention show an in - deployment configuration of an exemplary portion of the conduit 1104 of an exemplary embodiment of the delivery system 1105, which shows that the proximal end capsule portion 1109 is translated away from the distal end capsule portion 1102, exposing the atrial portion of an exemplary embodiment of the artificial heart valve device 1108. Some applications of the present invention 11C is an illustration of a conduit 1104 of an exemplary embodiment of a delivery system 1110. 1 shows a fully deployed configuration of the proximal capsule portion 1112 and the distal capsule portion 1113. 111 are completely separated from each other in translation, and an exemplary implementation of the prosthetic heart valve device 900 is shown. It is shown that the ventricular 1113 and ventricular 1114 portions of the ventricle are fully exposed. In this exemplary embodiment of the prosthetic heart valve device 900, the atrium 1113 and the ventricle 1114 The problem is that some parts are not released completely.

[0135] 12A-12B, which are diagrams showing diastole and systole in accordance with some applications of the present invention. FIG. 1 is a schematic diagram showing the transition sequence between the diastolic and diastolic heart cycles. 200, systolic 1240, as shown in Figures 12A and 12B, respectively) and in situ An exemplary implanted prosthetic heart valve device (diastolic embodiment 1230, systolic embodiment 1260) 12A and 12B, respectively). Specifically, FIG. 12A shows 1 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 are In response to blood flowing from the left atrium 1206 (cross section 1205) toward the left ventricle 1215, Similarly, the atretic leaflets of the exemplary aortic valve 1225 respond to diastolic ventricular filling by The left ventricular outflow tract 1220 and the left ventricular septum 1222 are located just below the atretic leaflet of the exemplary aortic valve 1225. A cross-section 1210 of the chamber wall can be seen, which is in an expanded state. An arrow 1221 can be seen just above the exemplary diastolic embodiment of FIG. 1231, which corresponds to the diastolic position of the exemplary embodiment of the differentially deformable anchor. The exemplary diastolic embodiment of the structure 1229 moves in position relative to the native valve ring in place. In the exemplary expanded embodiment adjacent to the prosthetic heart valve device 1230, the native anterior leaflet 1201 can be seen, which is depicted as a free, open and unconstrained position. Thus, the exemplary embodiment of the native anatomical structure and prosthetic heart valve device shown in FIG. Additionally, the anatomy of selected atrioventricular valves, such as the tricuspid valve and its corresponding native tricuspid valve anatomy, It can be realized for the method of biological structure.

[0136] Reference is now made to FIG. 12B, which illustrates, in accordance with some applications of the present invention, a valve already in a bicuspid position. FIG. 1 is a schematic diagram of an exemplary systolic embodiment of a prosthetic heart valve device 1260 implanted in a patient, currently With particular reference to the cross-sectional heart during systole 1240. Exemplary systole of a prosthetic heart valve device 1260 The closing leaflet 1255 of the present embodiment acts in response to pressurization of the left ventricle 1215 and therefore During systolic ventricular contraction, blood is pumped from the left ventricle 1215 (cross section 1250) to the left ventricle. The blood can be allowed to flow out through the outflow tract 1220 and through the open aortic valve 1245. 1 shows an illustration of a prosthetic heart valve device 1260 with the unconstrained native anterior leaflet 1202 in a closed position. 1. The prosthetic heart valve device 126 can be seen abutting the front of the exemplary systolic embodiment. Just above the exemplary systolic embodiment of FIG. 12, an arrow 1265 can be seen, which indicates the heart valve frame. 1261, which corresponds to the pose of the exemplary systolic embodiment of the differentially deformable anchors. The exemplary systolic embodiment of structure 1259 is displaced toward the atrium relative to the native ring in which it resides. It should be understood that the example of the natural anatomical structure and prosthetic heart valve device shown in FIG. Exemplary embodiments further include the use of selected atrioventricular valve anatomies, such as the tricuspid valve and its corresponding The present invention can be implemented in accordance with the principles of native tricuspid valve anatomy.

[0137] Reference is now made to FIG. 13A, which illustrates an exemplary transport system 1 according to some applications of the present invention. 3 is a perspective view of a detail 1315 of an embodiment of an exemplary prosthetic heart valve device 1340 loaded onto 300. 13 is a schematic diagram illustrating an exemplary embodiment of a load-transporting system 1300 in a curved configuration. 13A is a proximal end portion of the capsule 1310 adjacent to the proximal neck 1305, and 0, where each capsule portion can include a distal end portion of the capsule 1325 adjacent The capsule portion is arranged to move in parallel with the capsule portion during deployment, away from the opposing capsule portion. 13 is a schematic diagram of an exemplary load carrying system 1300 in a curved configuration prior to the introduction of the conduits of the system 1300. The embodiment is secured in anatomical position by a guide rail over the top of the guidewire 1330. The guidewire 1330 may be positioned to move to a predetermined position by a program. The cut cross-sectional view window 1315 is an example of a prosthetic heart valve device. A cross section 1340 of the exposed portion of the stent can be seen, which is a bendable portion. 13 shows an embodiment of a bendable portion geometry 1316. It will be appreciated that certain portions of the exemplary embodiment of the heart valve device 1340 may be bent in certain directions and bend radii. The catheter may be positioned to allow the catheter to pass through the natural anatomical vessels, veins and arteries. The cut-out window is then enlarged and the cut-out window is then used to track the location of the endothelial cell membrane passing through the endothelial cell membrane and entering the native atrioventricular valve. 320 details the geometrical properties 1345 of the enlarged and partially exposed bendable deformation portion. Now, by following the drawing, the image is turned to FIG. 13B with reference to the arrow 1335 in FIG. 13B. In accordance with some applications of the present invention, it is an exemplary prosthetic heart valve device stent flat pattern. A fragment of an exemplary prosthetic heart valve device stent flat pattern 1350 is shown. 0 may include an exemplary embodiment of an atrial region curved element 1351, which is a prosthetic heart valve. A bending element 13 in the ventricular region is arranged to allow the device to bend specifically in the atrial region. 52, which is an exemplary embodiment of a prosthetic heart valve device having a particular curvature in the ventricular region. are positioned to allow

[0138] Please refer to FIG. 14, which shows the remote control of an exemplary embodiment of a transport system (1500, FIG. 15A). FIG. 14 is a schematic diagram of the distal end portion 1405 of a loaded prosthetic heart valve device 1400, showing partial deployment thereof. The exemplary embodiment of the structure is used for illustrative purposes. As mentioned above, the prosthetic heart valve The device 1400 is illustrative of some applications of the present invention. 15A) may include an assembly of concentrically aligned and radially adjacent flexible conduits. , a first conduit 1420, at least partially extending through the first conduit 1420. a second conduit 1430 disposed at least partially through the second conduit 1430; a third conduit 1445 disposed to pass through the first conduit 1442 and extending at least partially through the first conduit 1442. The fourth conduit 1450 is disposed over the tube 1420. The fourth conduit 1450 The third duct 1445 may have a proximal outer cover portion 1415. The second conduit 1430 may have a connecting element 1435. and is used to connect to portions of the exemplary prosthetic heart valve device 1400. The tube 1420 can house a number of tethers 1440, which are located in the atrial region. The tether is further configured to be matingly connected to a portion of the valve device 1400. -connector structure 1455 by which the tether can be attached to the prosthetic heart valve device A mating connection scheme can be provided, the details of which are provided further below. provides additional details regarding the conduit.

[0139] 15A-B, which are in a compressed delivery state according to some applications of the present invention. FIG. 15 is a schematic diagram of an exemplary delivery system 1500 for a loaded prosthetic heart valve device 1535.

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

[0141] The handle portion 1520 has a generally elongated shape and is generally cylindrical, with a proximal end The distal end region 1505 has a distal end region 1515 and a middle region 1510 therebetween. .

[0142] The conduit portion 1525 extends distally from the distal end region 1515 of the handle portion 1520. One or more flexible conduits, such as a first conduit 1420 and a second conduit 1430. It can extend through the first conduit 1420 to form the second conduit 143. The flexible distal end portion of the second conduit 140 is disposed outside the distal end of the first conduit 1420. The distal end portion of 30 may further include a connecting element 1435, which may be a pressure The prosthetic heart valve device 1535 is adapted to be releasably attached to at least a portion of the prosthetic heart valve device 1535. It will be placed.

[0143] The conduit portion 1525 of the delivery system 1500 further includes a third conduit 1445. The conduit 1445 extends through a second conduit 1430 to form an outer cover portion at the distal end. The portion 1425 is disposed out of the distal end of the second conduit 1430 .

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

[0145] The conduit portion 1525 of the delivery system 1500 further includes a holding area 1530, which is The third prosthetic heart valve device 1535 may be configured to hold and transport a contracted prosthetic heart valve device 1535. A distal end outer covering portion 1425 of the conduit 1445 and a proximal end outer covering portion of the fourth conduit 1450 The portion 1415 can function as a restraining member, and both of them are compressed prosthetic heart valve device 1 535 in a compressed delivery state, thereby radially constraining the compressed The prosthetic heart valve device 1535 is held in place.

[0146] The distal end region 1515 of the handle portion 1520 generally includes a first dial wheel 154 5, the first dial wheel 1545 being a mechanical interfacing element within the distal end region 1515. The fourth conduit 1450 is in controllable communication with the fourth conduit 1450 via a valve 1460 (described in more detail below). Actuation of one dial wheel 1545 moves the fourth conduit 1450 from the first position (proximal end) to the Controlling the translation to a second location (distal end) downstream from the first location and back. When in the second position (distal end), the proximal end overcoat portion of the fourth conduit 1450 1415 is in a favorable position to secure at least one of the compressed prosthetic heart valve device 1535. When in the first position (proximal end), the fourth conduit 1450 can be partially constrained. The proximal overmold portion 1415 can be advantageously located to provide a secure, compact prosthesis. At least a portion of the heart valve device 1535 is released from radial constraint.

[0147] The distal end region 1515 of the handle portion 1520 generally includes a saline flush port 1540a. and removing trapped air between concentric adjacent conduits during device preparation. This is particularly useful for allowing, for example, the injection of sterile saline between the conduits 1420 and 1450. By doing so, air is removed from between the fourth conduit 1450 and the first conduit 1420, and This removes trapped air and prevents air bubble emboli from introducing blood flow.

[0148] As can be seen with reference to FIGS. 16A-B and 17A-E, the middle of the handle portion 1520 Area 1510 generally includes a saltwater wash port 1540b and a tether shuttle assembly 1560. Salt water wash port 1540 in mid-region 1510, details of which are provided further below. b is useful for removing trapped air between adjacent concentric ducts during device preparation For example, sterile saline can be injected between the first conduit 1420 and the second conduit 1430. This removes the air between the first conduit 1420 and the second conduit 1430, This helps to remove trapped air and prevent air bubbles from introducing blood flow. In the middle region 1510 of the handle portion 1520, the first duct 1420 is mechanically connected to the handle portion 1520. The device may include a location for mounting the device to a target object.

[0149] The proximal end region 1505 of the handle portion 1520 generally includes a second dial wheel 155 0, the second dial wheel 1550 being mechanically interacting within the proximal end region 1505. The second conduit 1430 is in controllable communication with the second conduit 1430 via a pressure sensor (described in more detail below). Actuation of the second dial wheel 1550 places the second conduit 1430 in the first position (proximal end). to a second position (distal end) downstream of the first position and back. When in the second position (the distal end), the compressed prosthetic heart valve device 1535 It may be in a more distally positioned location (e.g., within the ventricle of the heart). , and simultaneously loaded for delivery. When in the first position (proximal end), the compressed artificial heart The valve device 1535 can be in a proximal position and simultaneously loaded for delivery. I can.

[0150] The proximal end region 1505 of the handle portion 1520 further includes a third dial wheel 1555 the third dial wheel 1555 can include a mechanical The third conduit 1445 is in controllable communication with the third conduit 1445 via electrical interaction (described in more detail below). Actuation of the third dial wheel 1555 moves the third conduit 1445 to the first position (proximal to a second location (the distal end) downstream of the first location and back. When in the first position (proximal end), the third conduit 1445 can be The side covering portion 1425 is advantageously located to prevent the compressed prosthetic heart valve device 1535 from being damaged. When in the second position (the distal end), the third conduit can be at least partially constrained. The outer jacket portion 1425 at the distal end of 1445 can be advantageously located to prevent compression. At least a portion of the assembled prosthetic heart valve device 1535 is released from radial constraint.

[0151] The proximal end region 1505 of the handle portion 1520 generally includes a saline flush port 1540c. and removing trapped air between concentric adjacent conduits during device preparation. This is useful, for example, to allow for the injection of sterile saline between conduits 1430 and 1445. This removes air from between the second conduit 1430 and the third conduit 1445, This removes trapped air and prevents air bubble emboli from introducing blood flow. The proximal end region 1505 of the rod portion 1520 further includes a saline flush port 1540d, which Helps remove trapped air from within the guidewire cavity The cavity extends from a first end of the third conduit 1445 to a second end opposite the first end, By allowing sterile saline to be injected into the Prevents emboli from introducing blood flow.

[0152] The proximal end region 1505 of the handle portion 1520 can further include a compensation mechanism, such as For example, the internal mechanism (described in more detail below and referring to Figures 19A-C, 18A-I, and 20A-C) It is a second dial wheel 1550 and a third dial wheel 15 55 provides a common lead screw system (shown in FIGS. 8A-C) and thus The actuation of the second dial wheel 1550 mechanically displaces a third dial wheel 1555. That is, the actuation of the second dial wheel 1550 can occur at the same time and at the same time. The second conduit 1430, the third dial wheel 1555 and the third conduit 14 45 can be displaced because they are mechanically connected as a system.

[0153] The enlarged view section pane 1570 shows a magnified view of the object in the detailed view section pane 1565, The compressed prosthetic heart valve device 1535, the distal end covering portion 1425 of the third conduit 1445 and 14 includes an enlarged view of the proximal end covering portion 1415 of the fourth conduit 1450, the view being clearly is provided accurately.

[0154] Reference is now made to FIGS. 16A-B, which illustrate a transport system in accordance with some applications of the present invention. 1500. A schematic diagram of a distal end region 1515, a middle region 1520, and a handle portion 1520. 15 provides further detail of 1510 and proximal end region 1505.

[0155] Specifically, the distal end handle region 1515 further comprises a distal end region handle cap 160. 0, which is connected to a holding system (not shown) and a transport system 15 16. The device according to claim 15, further comprising: a support surface 1605 for allowing relative rotation between the 00 part and the holding system. The first dial wheel 1545 can be attached to a plurality of dial wheel covers 1 610, these dial wheel covers 1610 may be included in the first dial wheel 1545 while maintaining the cylindrical (or other) shape of the distal handle region 1515 The translation grooves 1515 on the distal handle region 1515 are used to fasten the parts together. 615 can provide clearance for translation of the saltwater wash port 1540a, The fourth conduit 1450 is controllably movable relative to the first dial wheel 1540a. The reason is that the screw 1545 can rotate in a first direction or a second direction and face the first direction. do.

[0156] The proximal end handle region 1505 may further include a proximal end region handle cap 1630. 1500, which is connected to a holding system (not shown) and is part of the transport system 1500. A support surface 1635 can be provided to allow relative rotation between the support system. The second dial wheel 1550 is contained within a plurality of dial wheel covers 1610. These dial wheel covers 1610 may be attached to the second dial wheel 15. 50, while at the same time preserving the cylindrical (or other shaped) shape of the proximal handle region 1505. The translation groove 1625 on the proximal handle region 1505 is saline flushable. The clearance can be provided for translation of the cleaning port 1540c, and the salt water flush port 1540c The second dial wheel 1550 controllably moves with the second conduit 1430. It is for being rotatably operable in one direction or a second direction and opposing the first.

[0157] Referring to FIG. 16B, as previously described, the mid-handle region 1510 further includes a saline flush port. 1540b, which is concentrically adjacent to the device preparation stage. This can be useful for removing trapped air from between adjacent conduits.

[0158] As shown, the central handle region 1510 is configured to include multiple tie bars, as described in more detail below. These tether shuttles 1640 can be used to Controllable tension between the valve device (not shown) and a plurality of tie tethers (1440, FIG. 14) These tethers are then placed in a way that optimizes the placement of the prosthetic heart valve. The tether shuttle holder 1640 is arranged to be connected to the tether shuttle holder 1640. The tether may include a tether body 1645 and a tether shuttle latch buckle 1650. The shuttle latch buckle 1650 is centered around the tether shuttle latch hinge 1655. The device is arranged to be controllably rotated from a first position to a second position, which It is rotated and displaced and is mechanically attached to the proximal end portion of the tether protection sleeve 1660. Activating the tether shuttle latch 1650 activates the tether protection The internal connection in communication with the proximal end portion of the sleeve 1660 is the proximal end of the tether protection sleeve 1660. The end portion is concentrically (from the distal end position to the proximal end position opposite the distal end position) inside the tether cable. The tether (1440, FIG. 14) can then be retracted to the top of the bull (not shown). to controllably connect and release from portions of the prosthetic heart valve device (as described further below); See Figures 17A-F).

[0159] The tether shuttle body 1645 is generally rectangular and fits within the tether shuttle groove 1665. tether shuttle groove 1665 from a first end to a second end opposite the first end. The tether shuttle piece body 1645 corresponds to a first end of the tether shuttle groove 1665. The first proximal end position is spring biased (not shown) and is manually operable by push. It can translate dynamically or translate automatically, for example when placed under a tensile load. , delivered along a tether (1440, FIG. 14) from the prosthetic heart valve device.

[0160] 17A-F, which show the artificial structure of a transport system according to some applications of the present invention. FIG. 17A is a schematic diagram of a prosthetic heart valve device holding area 1530. 10 provides a close-up view of the distal end outer cover 1425. The retention area 1530 can include a distal end outer cover 1425, Its distal end is connected to a third conduit 1445, which in turn is connected to the second conduit 1430. 14, the second conduit 1430 may extend therethrough, with the second conduit 1430 having a guidewire catheter extending therethrough. The fourth conduit 1450 has a cavity 1760 and a proximal outer cover 1415 extending therefrom. As described above, the distal end and proximal end outer covers (1425 and 141, respectively) can be 5 ) together provide a position for the compressed prosthetic heart valve device 1535 .

[0161] More specifically, the prosthetic heart valve device retaining region 1530 further comprises a plurality of closure structures 1700. The closure structure 1700 may include a number of tether connector structures 1455. The connector structure 1455 is concentric with the second conduit 1430 and has the same diameter as the second conduit 1430. 1430. The second conduit 1430 is disposed adjacent to the longitudinal axis of the second conduit 1430 (not shown) and generally parallel to the longitudinal axis of the second conduit 1430. The tether connector structure 1455 forms a straight line. 1535, and the prosthetic heart valve device 1535 is radially and radially in contact with the prosthetic heart valve device 1535. and provide a tension restraining force, thereby holding it in a closed and compressed configuration and allowing it to be transported. More specifically, the tether connector structure 1455 is a closed and compressed A connection element of the artificial cardiac valve device 1535 (e.g., an atrial connection element having an atrial connection pull tab 1730) The tether link connector structure 1455 can be connected to and contacted by a tether link connector 1720. Mates and contacts the far end of the Zarlink sheath 1740 and the inner cable 1775 This relationship is shown diagrammatically in FIG. 17F, with hidden lines.

[0162] More specifically, see the link system connector structure 1455 and the link system protective sleeve 17 The distal end portion of 40 can be mated with a link system connector cover 1715 (link The rope connector cover 1715 is connected to the rear of the The link system connector 1725 is arranged to be slidably fitted thereto, and the link system connector 1725 is arranged therein. The link system connector 1725 further includes a first connector 1725 in the link system protective sleeve. The distal end of the inner cable 1775 extends from the distal end to the second end of the inner cable 1775. The proximal end portion of the protective sleeve 1660 mates with the actuable portion of the shuttle mechanism 1705. The shuttle mechanism 1705 may be connected to an internal tether connector 1725. Controlling the tether connector cover 1715 to a first or second position (opposite the first position) The tether connector can be further arranged to be movable and translatable. The cable 1775 is connected to the fixed part of the shuttle mechanism 1705 and keeps it stationary. The devices are positioned so that

[0163] As shown diagrammatically in FIG. 17C, a tether connector cover 1715 is offset at the distal end. When the tether connector 1725 is closed (in the first position), it preferentially covers the tether connector 1725. 15, so that a compressed portion of the prosthetic heart valve device 1535, e.g., a connecting element, The atrial connection element 1720 having an atrial connection pull tab 1730 is disconnected. 17 is a perspective view of a shuttle mechanism 1705 corresponding to a first closed position of the ink connector cover 1715. Schematically shown.

[0164] Referring now to FIG. 17C, additional features of the second conduit 1430 are described. Extending from the distal end of the second conduit 1430 is a distal stiffness 17, then a distal stiffness transition region 1750, and finally a distal flexible region 1760. The inherent stiffness of the distal end region of the second conduit 1430 is the stiffness portion (1745 ) to the softest part (1755), providing enhanced flexibility and narrower half This allows for bending through the diameter (e.g., experienced during the implant period).

[0165] As shown diagrammatically in FIG. 17E, a tether connector cover 1715 is offset at the proximal end. If the second position is opposite to the first position and opens, it indicates a translation. tether connector 1725 (indicated by arrow 1770 ) can be preferentially exposed. The part of the artificial heart valve device 1535 compressed thereby, e.g., as a connecting element, the atrial connecting The atrial connection element 1720 having a pull tab 1730 is released. The second open position of the tether shuttle latch 1650 (after the tether shuttle latch 1650 has rotated) is indicated by arrow 17 17. A perspective view of a shuttle mechanism 1710 corresponding to the actuator 1700 (designated 65) is shown diagrammatically.

[0166] 18A-I, which show some applications of the present invention, using a conveying system. 18A-B are a series of schematic diagrams illustrating the expansion of a deployed prosthetic heart valve device. 18A , showing a prosthetic heart valve device retention region 1530, which has a first, closed state ( FIG. 18A ); Here, the proximal end outer sheath 1415 of the fourth conduit 1450 is in a closed position, and the compressed prosthesis The prosthetic heart valve device retaining area 1530 also covers at least a portion of the prosthetic heart valve device 1535. 18C, in which the proximal end outer cover of the fourth conduit 1450 is shown. 1415 is in the open position and displaced a distance Dl from the closed position to the proximal end, thereby being compressed. At least a portion of the prosthetic heart valve device 1535 and the plurality of tether connector structures 1700 are expanded. Prior to tensioning, the multiple tether connector structures 1700 are exposed in a closed configuration.

[0167] As discussed above and as shown in FIG. 18B, the proximal end outer cover 1415 of the fourth conduit 1450 is The operating displacement distance D1 (indicated by the rotation arrow 1830) of one dial wheel 1545 is The proximal outer jacket 1415 of the fourth conduit 1450 extends in the opposite direction. D1, thereby actuating the same first dial wheel 1545. Pressing the lever returns it to the closed state as described above (FIG. 18A).

[0168] When in the open state (FIG. 18C), a compressed portion of the prosthetic heart valve device 1535 (e.g., Before the atrial region 1410 expands, the atrial region 1410 may have a first diameter d1. The portion of the prosthetic heart valve device 1535 that is compressed (e.g., the atrial region 1410) can expand. After this, the atrial region 1410 has a second diameter d2 (FIG. 18D) that is greater than the first diameter and The atrial fibrillation may be in a configuration (not shown) that is compatible with the atrial surface attachment of the native heart. A tether 1800 is also present in FIG. 18D.

[0169] Referring to FIG. 18E, the distal end outer cover 1425 is in a closed state before being transitioned to an open state. 18. A partially expanded cardiac chamber having a partially expanded atrial region 1805. The artificial heart valve device 1835 is actuated by the operation of the third dial wheel 1555 (indicated by arrow 1865). 18F), a distal end outer cover 1425 of the third conduit 1445 is attached to the distal end of the third conduit 1445 at least It can be further deployed by displacing it a distance D2 (FIG. 18G), thereby partially deploying it. At least a portion of the prosthetic heart valve device 1835, e.g., a compressed ventricular portion 1845 and an engagement groove 1825 disposed to releasably engage the ventricular anchor engagement groove 1825. The outer cover 1425 of the distal end of the third conduit 1445 is turned in the opposite direction to expose the dowel 1820. It can be moved a distance D2, thereby returning it to the closed state as described above (FIG. 18E ).

[0170] In a partially deployed state (Fig. 18E), but before final expansion (Fig. 18G), The portion of the contraction ventricular region 1845 can have a third diameter d3. After expansion of the ventricle 18, the expanded ventricular region 1840 has a fourth diameter d4 (FIG. 18) that is larger than the third diameter. G) and is of a structure (not shown) suitable for joining with the ventricular surface of the native heart. can be done.

[0171] 18H-I, the following is a diagram showing a method for producing a conveyance system and a final product according to some applications of the present invention. 1A-1D show a series of schematic diagrams of a deployed prosthetic heart valve device.

[0172] FIG. 18I illustrates a fully expanded atrial region 1850, in accordance with some applications of the present invention. A schematic diagram of a fully expanded ring region 1855 and a fully expanded ventricular region 1860 is shown. The fully expanded atrial region 1850 is shown in FIG. The fully expanded limb is positioned so that it is in contact with the atrial surface (see Figures 5A-5B). The ring region 1855 is adapted to interface with a native heart ring tissue surface, e.g., a bicuspid valve ring surface. (See Figures 5A-5B.) A fully expanded ventricular region 1860 is a natural Any combination of ventricular tissue surfaces of the heart, e.g., the left ventricle, bicuspid valve leaflets, and / or chordae tendineae, and / or The electrodes are arranged so as to be in contact with each other (see FIGS. 5A to 5B).

[0173] The control, final release and permanent implantation of the prosthetic heart valve device 1810 is controlled by each tether shuttle. This can be achieved by the controlled actuation of the tether shaft 1640 (FIGS. 16B and 18H). The control actuation of the torque 1640 (FIGS. 16B, 18H) is Activating the shuttle lock 1650 (FIGS. 16B and 18H) releases the tether shuttle 1 640 is in an open configuration 1710. According to some applications of the present invention, A fully released, permanently implanted prosthetic heart valve device 1810 is shown diagrammatically in FIG. Each tether shuttle 1640 is actuated and the tether connectors 1815 are fully opened. Then, each atrial connection pull tab 1730 can be released from the constraint, thereby allowing each atrial region Allows 1850 to fully expand, completely released and permanently implanted A prosthetic heart valve device 1810 is provided.

[0174] 19A-D, according to some applications of the present invention, a second conduit and a third 1 provides a schematic diagram illustrating the mechanism of compositional change of the outer coating layer of a conduit.

[0175] Specifically, FIG. 19A shows a partially expanded atrial region 1805 of a prosthetic heart valve device. urged into contact with the native atrial floor (not shown) and exerts a seating force on the first conduit 1420. When applied, the compensation mechanism within the delivery system provides an overall compression force to the anchor structure of the prosthetic heart valve device. 1805 and the natural atrial floor. In FIG. 19A, the first conduit 1420 and the fourth conduit 14 50 is displaced distally, creating tension in link 1920 and the connection therebetween. It can be seen that the first conduit 1420 and the second conduit 1430 generate a seating force for the atrial region 1805 for partial deployment. Such distal displacement of the fourth conduit 1450 may be achieved by a compensation mechanism in the delivery system, The details will now be described with reference to Figs. 19B to 19D. As shown in Fig. 19B, 19 provides a simplified diagram of the distal end portion of the delivery system 1910. An embodiment is not shown in FIG. 19B whereby the conduit is concerned during this stage of device operation. The element D5 is the most distal end of the first duct 1420. A first distance between the far end region and a reference point of the second duct (near the stiffness transition region 1750) is shown. A third dial wheel (1550, FIG. 19C ) is indicated by a rotating arrow 1900 (FIG. 19C ). ) to release the distal end retention region 1905 and the partially deployed prosthetic heart valve device. In each of the locations (not shown), the second distance indicated by element D6 is the distal most position of the first conduit 1420. until the same reference point on the end region and the second conduit (adjacent to the stiffness transition region 1750) is reached. The proximal end is translated to the proximal end at 1915, which is illustrated in FIG. There are also embodiments of tethers and prosthetic heart valve devices herein, whereby the device, as it relates to the conduit, This section describes more clearly the mechanical interactions that exist during this stage of the placement operation. Such a change in position of the distal end holding region 1905 activated by the compensation mechanism of the artificial heart The delivery of the valve can be better controlled. The compensation mechanism in the delivery system is an anchor structure. It allows for the assisted control of the structural changes experienced, allowing for a better approximation of the ventricular anatomy and a more human-like The gap between the artificial heart valve and the ventricular region structure can be improved, and a reversible artificial heart can be formed. Repositioning and reapproximation of the valve is necessary.

[0176] 20A-C, cross-sectional views of exemplary conveying devices according to some applications of the present invention are shown. 20A provides a schematic diagram illustrating an embodiment of a system. 15 shows an embodiment of the middle and proximal regions of the stem. Also shown is the third dial wheel 1555. The lead screw 2015 and the lead screw 20 of the second dial wheel 1550 20 is shown. Finally, a cross-sectional view of the tether tension adjustment mechanism 2030 is provided.

[0177] FIG. 20B illustrates an embodiment of a distal end region of a delivery system shown in cross section 2005. , the lead screw 2025 of the first dial wheel 1545 is shown. 2 shows an example of a holding area of ​​a transport system shown in cross section 2010.

[0178] While the subject matter of the present disclosure has been described in its preferred embodiments, it should be understood that the use The problem is that the words used are descriptive rather than limiting. Changes may be made in the appended claims without departing from the actual scope of the present invention.

[0179] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described above. On the contrary, the scope of the present invention includes any combination or subcombination of the various features described above. It does not belong to the changes and modifications of the prior art, and those skilled in the art would have realized them after reading the above content. It is possible.

[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 is concentrically aligned with, radially adjacent to, and directly connected to the valve frame. a differentially deformable anchor structure; The delivery system includes a first conduit, one or more tether assemblies, a second conduit, and a control an assembly; The first conduit has a first diameter and includes a primary cavity, a first bendable portion, and a front 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 to the first lead. a second cavity disposed in a second direction and arranged to translate through the second cavity or cavities of the tube; The second conduit is dimensioned to be assembled and translated into the primary cavity of the first conduit. the second conduit having a cavity, a second bendable portion and a prong includes a connecting element of a portion connectable to a plurality of prosthetic heart valve devices, The control assembly includes a compensation mechanism connected in fluid communication with the second conduit, The control assembly controllably provides translation of the second conduit and permits configuration changes of the prosthetic heart valve. The The system has a delivery state, in which the prosthetic heart valve device is released from the tether assembly. the connecting elements are in a compressed elongated configuration; and The delivery system is advanced to propel the artificial valve through the femoral access to the native atrioventricular valve. The valve is controllably implanted by a compensation mechanism within the control assembly.

Claims

1. A prosthetic heart valve device, comprising: The prosthetic heart valve device includes a valve, a valve seal cover, a differentially deformable anchor structure, and an anchor seal cover; The valve includes a plurality of leaflets and an expandable valve frame for supporting the valve, the expandable valve frame having an inflow region, an intermediate region, and an outflow region downstream of the inflow region, the inflow region further includes a plurality of flexible inflow region connecting members (735), the flexible plurality of inflow region connecting members (735) allowing the expandable valve frame to bend or curve radially, the intermediate region further includes a leaflet support structure, and the outflow region further includes a plurality of rigid outflow region connecting members (750); the valve seal cover extends between the inflow region and the outflow region, the valve seal cover configured to prevent leakage around the valve, and the valve configured to transition between a flow-permitting state and a flow-blocking state; The differentially deformable anchor structure is concentrically aligned with, radially adjacent to, and surrounds the expandable valve frame, the differentially deformable anchor structure including an atrial region, a ring region, and a ventricular region, the atrial region having approximately a first stiffness and including a plurality of atrial region connection elements (825), the plurality of atrial region connection elements (825) adjacent to and adjacent to the plurality of flexible inflow region connection members (735) of the expandable valve frame. a plurality of ventricular region connection elements (845) that are adjacent to and in connecting contact with the plurality of rigid outflow region connection members (750) of the expandable valve frame, the plurality of flexible ventricular region connection elements (845) allowing the differentially deformable anchor structure to bend or curve radially; the anchor seal cover extends between the atrial region and the ventricular region, the anchor seal cover configured to prevent perivalve leakage; 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 differentially deformable anchor structure is configured to permanently anchor the prosthetic heart valve device within an atrium valve of the heart when the prosthetic heart valve device is in the expanded state and implanted; a prosthetic heart valve device, wherein the connections between the plurality of flexible inflow region connection members (735) and the plurality of atrial region connection elements (825), and the connections between the plurality of rigid outflow region connection members (750) and the plurality of flexible ventricular region connection elements (845) are configured to absorb displacement between the differentially deformable anchor structure and the expandable valve frame.

2. The prosthetic heart valve device of claim 1, wherein the differentially deformable anchor structure is configured to deform to enable the expandable valve frame to retain an approximately cylindrical geometric shape.

3. The flexible inflow area connecting members (735) extend radially, The plurality of rigid outflow region connecting members (750) extend axially; The plurality of atrial region connecting elements (825) extend radially; 2. The prosthetic heart valve device of claim 1, wherein said plurality of flexible ventricular region connecting elements (845) extend axially.

4. There are up to nine flexible inflow area connecting members, 3. The prosthetic heart valve device of claim 2, wherein there are up to three stiff outflow region connecting members.

5. The artificial heart valve device of claim 1, wherein the connection contact between the plurality of atrial region connection elements (825) and the plurality of flexible inflow region connection members (735), and the connection contact between the plurality of flexible ventricular region connection elements (845) and the plurality of rigid outflow region connection members (750) are maintained while transitioning between a radially minimized compressed state configured for delivery and a radially maximized expanded state configured for implantation.

6. The artificial heart valve device of claim 1, wherein the distances between connection contacts between the plurality of atrial region connection elements (825) and the plurality of flexible inflow region connection members (735) and between connection contacts between the plurality of flexible ventricular region connection elements (845) and the plurality of rigid outflow region connection members (750) are equal.

7. The artificial heart valve device of claim 1, wherein the differentially deformable anchor structure includes a plurality of elongated and wide ventricular conforming structures (835), the plurality of elongated and wide ventricular conforming structures (835) including a heel (860) for abutting the top surface of the native ventricle and a plurality of elongated ventricular conforming structure support struts (836).

8. The prosthetic heart valve device of claim 7, wherein the plurality of elongated ventricular conformal structural support struts (836) terminate in a ventricular ejection member (840).

9. The prosthetic heart valve device of claim 7, wherein each of the flexible ventricular region connection elements (845) is at least partially formed by filaments interwoven between the elongated ventricular conformal structural support struts (836) and the rigid outflow region connection members (750).

10. The prosthetic heart valve device of claim 1, wherein each flexible inflow region connecting member is configured to mechanically dampen the transmission of forces between the differentially deformable anchor structure and the expandable valve frame.

11. The prosthetic heart valve device of claim 1, wherein each flexible inflow region connecting member is configured to allow the inflow region to flex radially.

12. The prosthetic heart valve device of claim 1, wherein each rigid outflow region connecting member is configured to resist bending or displacement between the differentially deformable anchor structure and the expandable valve frame.

13. The prosthetic heart valve device of claim 1, wherein each of the flexible inflow region connecting members is configured to allow the ventricular region to flex radially.

14. The prosthetic heart valve device of claim 1, wherein the expandable valve frame further includes a plurality of boundary members for providing positioning and fixation between adjacent valve leaflets, each rigid outflow region connecting member of the expandable valve frame extending from a boundary member.

15. The prosthetic heart valve device of claim 1, wherein the atrial region of the differentially deformable anchor structure further includes a plurality of support structures terminating within a releasably captureable atrial retaining member, the plurality of support structures being configured, when implanted, to conform to the bottom of the natural atrium adjacent the atrial valve of the heart in accordance with the first stiffness.

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