Artificial heart valve devices, systems 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 generally relates to an artificial heart valve device for repairing and / or replacing a natural heart valve. . In particular, some embodiments relate to an artificial atrioventricular valve for replacing a defective mitral and / or tricuspid valve, and methods and devices for delivering and implanting it within the human heart.

[0002] The present invention relates to an artificial object inserted into a cavity or body cavity and a delivery system for the artificial object. In particular, in some embodiments, the artificial object and the delivery system relate to an artificial heart valve device, <S for example, a replacement atrioventricular valve.

Background Art

[0003] Incomplete closure of the atrioventricular valve, also known as incomplete closure or malfunction of the mitral and / or tricuspid valve, is a heart disease in which the atrioventricular valve (mitral and / or tricuspid valve) cannot close properly. The mitral and tricuspid valves of a healthy human heart are both composed of a fibrous ring, on which flexible and elastic valve leaflets are attached that can close when the ventricles contract. The free end of each flexible valve leaflet is connected to a chordae tendineae, which attach the valve leaflet to the papillary muscle in the ventricle and thereby control the movement of the free end of the valve leaflet throughout the cardiac cycle. Each part of the valve must move synchronously, and various heart diseases or degenerative disorders that result in appropriate systemic blood circulation affect each part of the atrioventricular valve, causing the valve to close inappropriately. This results in abnormal leakage of blood that passes through the valve and enters the atrium and the peripheral vascular system. Persistent atrioventricular valve insufficiency can cause numerous cardiovascular complications, including congestive heart failure.

[0004] Traditionally, patients whose bicuspid valves do not close completely have undergone invasive cardiac surgery to correct the bicuspid valve. Treatment includes repair or replacement. Generally, these methods produce good clinical outcomes. However, due to its invasive nature and long recovery period, many potential patients do not accept such therapies. It does not meet the criteria. Therefore, many patients are not treated and receive drug therapy. Tricuspid valve Patients suffering from reflux can receive even less severe treatment through surgery, therefore There are more medical and nursing patients suffering from tricuspid valve regurgitation. Treatment of atrioventricular valve disease with medication. Patients receiving this treatment have a lower quality of life and unfavorable long-term outcomes, with a five-year mortality rate of 50% for many. It is possible that this is the case.

[0005] Over the years, the development of minimally invasive catheter valve therapy has made significant progress, and here we see a major development. It achieves the greatest progress in the treatment of pulse valve and pulmonary valve diseases. Exemplary artifacts are Including artifacts described in U.S. Patent No. 7892281, all of them for all purposes. The contents of this document are incorporated herein by reference. Catheter treatment for bicuspid valve regurgitation We have made some progress in the area of ​​treatment. U.S. Patent No. 8652203 is an exemplary person The details of the work are disclosed, and for all purposes, all of its contents are cited in their entirety in this specification. It is incorporated into the book. Also, U.S. Patent No. 9034032 discloses an exemplary prosthesis, and all For the purposes of this document, all of its contents are incorporated herein by whole quotation. However, due to the limitations of current technology, a large number of potential patients still cannot be treated in this way. Unsuitable for therapy and still untreated or producing unfavorable results. These limitations And the results include, but are not limited to, the following: surgical treatment of atrial blood flow stagnation and prolongation. As a result of adverse events and / or radiation exposure to the patient and operator, outflow tract obstruction, thrombus formation and It can cause thromboembolic events. Tricuspid valve closure failure due to catheter valve replacement therapy. Overall progress in treatment is very small. This is due to limitations of current technology and the large number of untreated patients. In light of this, there is still a need for easier, more accurate, and repeatable treatment of atrioventricular valve dysfunction. This requires improved devices, systems, and methods. [Overview of the Initiative]

[0006] Embodiments disclosed herein refer to apparatus, systems, and methods, such as those for a defective atrioventricular ventricle. It is used to replace valves, but is not limited to that; more specifically, in the heart of a human patient. Replacement artificial heart valve device and system for replacing a missing natural tricuspid and / or bicuspid valve. be.

[0007] Further embodiments include an artificial heart valve device (not limited to, for example, a replacement heart valve device) inside the body. A transport system, apparatus and / or for transporting to a desired position and / or unfolding in a controllable manner. This concerns the method.

[0008] In some embodiments, a replacement artificial heart valve device and a replacement artificial heart valve device are used with a natural heart The present invention provides a method for transporting to a valve, such as the atrioventricular valve.

[0009] The present invention includes, but is not limited to, embodiments numbered below.

[0010] (Embodiment 1)

[0011] A system for replacing a missing natural atrioventricular valve, comprising a transport system and an artificial heart valve. The device includes two typical operating configurations. Catheter transport allows for the desired anatomical position. A radial compression operation configuration for passing through the structure and a radial expansion operation configuration for finally implanting the target-deficient atrioventricular valve are targeted.

[0012] (Embodiment 2)

[0013] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device can be implanted into the defective natural mitral valve, passes through the patient's vascular system from the femoral vein, and reaches the final implantation position within the mitral valve through the inferior vena cava and the interatrial space. Thereby, In this exemplary embodiment, by using a delivery catheter having a controlled deployment step to deliver the artificial heart valve device to the desired implantation position, accurate alignment of the artificial heart valve device can be achieved, and placement and fixation can be ensured.

[0014] (Embodiment 3)<00​​​​​​​​​​​​​​​​​​​​​​​​It passes through the vein and reaches its final implantation site within the bicuspid valve. In one embodiment, an artificial heart valve device is used with a transport conduit having a controlled deployment step. By transporting it to the desired implantation position, the artificial heart valve device can be precisely positioned and placed. And it is possible to ensure that it is fixed in place.

[0018] (Embodiment 5)

[0019] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device is a missing natural heart valve. It can be implanted within the tricuspid valve, passing through the patient's vascular system from the subclavian vein to the superior vascular vein. It passes through and reaches the final implantation position within the tricuspid valve. In the implementation configuration, an artificial heart valve device is deployed using a transport conduit with controlled deployment steps. By transporting the artificial heart valve device to the desired implantation location, precise positioning and placement are achieved. It can be secured and fixed in place.

[0020] (Embodiment 6)

[0021] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device is a missing natural heart valve. It can be implanted within the bicuspid valve, penetrates the patient's anatomical structure through the apical entry tract, and leads to the left ventricle. It passes through and reaches the final implantation position within the bicuspid petal. In the implementation configuration, an artificial heart valve device is deployed using a transport conduit with controlled deployment steps. By transporting the artificial heart valve device to the desired implantation location, precise positioning and placement are achieved. It can be secured and fixed in place.

[0022] (Embodiment 7)

[0023] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device is a missing natural heart valve. It can be implanted within the tricuspid valve, penetrates the patient's anatomical structure via the apical entry tract, and enters the right ventricle. It passes through and reaches the final implantation position within the tricuspid valve. This allows the exemplary implementation to In its form, the artificial heart valve device is provided using a transport conduit with controlled deployment steps. By transporting the artificial heart valve device to the desired implantation location, precise positioning and placement of the device are achieved. It can be secured.

[0024] (Embodiment 8)

[0025] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device is a missing natural heart valve. It can be implanted within the bicuspid valve, passes through the atrial entry tract and the patient's anatomical structure, and enters the left atrium. It passes through and reaches the final implantation position within the bicuspid petal. In the implementation configuration, an artificial heart valve device is deployed using a transport conduit with controlled deployment steps. By transporting the artificial heart valve device to the desired implantation location, precise positioning and placement are achieved. It can be secured and fixed in place.

[0026] (Embodiment 9)

[0027] An artificial heart valve device according to Embodiment 1, wherein the artificial heart valve device is a missing natural heart valve. It can be implanted within the bicuspid valve, penetrates the patient's anatomical structure via the aortic entry tract, and enters the femoral cavity. It passes through the arteries and aorta to reach its final implantation site within the bicuspid valve. In this exemplary embodiment, a transport conduit having a controlled deployment step is used to transport a person By transporting the artificial heart valve device to the desired implantation position, the precise positioning of the artificial heart valve device is achieved. Alignment, positioning, and fixing can be ensured.

[0028] (Embodiment 10)

[0029] An artificial heart valve device according to any one of Embodiments 2 to 9, wherein the artificial heart valve The device is aligned concentrically with the valve frame, radially adjacent, and directly connected to the valve frame. Includes a surrounding, deformable anchor structure.

[0030] (Embodiment 11)

[0031] An artificial heart valve device according to Embodiment 10, wherein the deformable anchor structure is It includes an atrial region having rigidity 1 and multiple alignment structures, and multiple alignment structures This is intended to assist in rotational orientation during the planting period.

[0032] (Embodiment 12)

[0033] An artificial heart valve device according to Embodiment 11, wherein the atrial region is adjacent to the atrioventricular valve. The internal valve frame is positioned to coincide with the base of the natural atrium and connected by an inflow region connecting member. It can be connected directly.

[0034] (Embodiment 13)

[0035] An artificial heart valve device according to Embodiment 12, wherein a differentially deformable anchor structure It includes a ring region, and the ring region includes a ring anchor element to prevent reverse transition. Furthermore, it possesses a second rigidity that is generally suitable for deformation and consistent with natural anatomical structures.

[0036] (Embodiment 14)

[0037] An artificial heart valve device according to Embodiment 13, wherein the deformable anchor structure is the heart It includes a ventricular region, which generally has a third rigidity and includes multiple ventricular anchor elements, The ventricular anchor element has multiple ventricular region connecting elements adjacent to the outflow region of the valve frame connecting member. To be in contact with and to be in contact with it.

[0038] (Embodiment 15)

[0039] An artificial heart valve device according to Embodiment 14, wherein a differentially deformable anchor structure Furthermore, the atrial region and ring region are positioned to be covered by a leak-proof membrane. This further prevents leakage around the valve.

[0040] (Embodiment 16)

[0041] An artificial heart valve device according to Embodiment 15, wherein the artificial heart valve device is a valve frame It also includes.

[0042] (Embodiment 17)

[0043] An artificial heart valve device according to Embodiment 16, wherein the valve frame has an inflow region and an intermediate region. This includes the region and the outflow region downstream of the inflow region.

[0044] (Embodiment 18)

[0045] An artificial heart valve device according to Embodiment 17, wherein the inlet region of the valve frame is further It is directly connected to the atrial region of an anchor structure that can be deformed by an inflow region connecting member. It will be placed there.

[0046] (Embodiment 19)

[0047] An artificial heart valve device according to Embodiment 18, wherein the connecting member is further bendable It includes the geometric shape of the functional part, which is mechanically damped (dampen) and torsion. It is positioned to transmit from the car structure to the valve frame, while simultaneously maintaining a robust connection between them, The valve frame allows it to maintain a generally cylindrical geometric shape, and the valve performance Optimize.

[0048] (Embodiment 20)

[0049] An artificial heart valve device according to Embodiment 19, wherein the inlet region of the valve frame is further It is positioned to include a leak-proof membrane, which is anchored from the valve frame along the connecting member. To straddle a structure.

[0050] (Embodiment 21)

[0051] An artificial heart valve device according to Embodiment 20, wherein the intermediate region of the valve frame is further It includes multiple valve leaves, which are supported by a valve leaf support structure extending into the intermediate region of the valve frame body. It is equipped with a leak-proof membrane, and together they are one-way valves for blood to flow through the artificial valve assembly. It forms.

[0052] (Embodiment 22)

[0053] An artificial heart valve device according to Embodiment 21, wherein the outflow region of the valve frame is further It includes a plurality of outflow region connecting members directly connected to the ventricular region of the anchor structure, where, The outlet region connecting member extends from the boundary region of the valve frame.

[0054] (Embodiment 23)

[0055] An artificial heart valve device according to Embodiment 22, wherein the outflow region connecting member is further curved. It includes the geometric shape of the deformable part, which is the force between the anchor structure and the valve frame. It is positioned to mechanically attenuate the transmission.

[0056] (Embodiment 24)

[0057] An artificial heart valve device according to Embodiment 23, wherein the geometry of the bendable portion The target shape further includes suture-like filaments, which range from relative rigidity to relative flexibility. It has internal elasticity or tensile properties.

[0058] (Embodiment 25)

[0059] An artificial heart valve device according to Embodiment 24, wherein the artificial heart valve device is further different The guide rotational orientation method of the atrial alignment structure within the deformable anchor structure allows for the implantation period. To align any leaflet of the prosthetic valve with the anterior leaflet of the natural atrioventricular valve and avoid ventricular outflow tract obstruction, They are positioned so that they can stay there.

[0060] (Embodiment 26)

[0061] An artificial heart valve device according to Embodiment 25, wherein the inlet region and flow of the valve frame The geometric shape of the bendable deformable portion included within the exit region is further a circulatory shuttle of the valve artifact. It will be configured to allow this.

[0062] (Embodiment 27)

[0063] An artificial heart valve device according to Embodiment 26, wherein the valve frame is bendable The geometric shape of that part allows the internal artificial valve to be displaced toward the atrium. It is positioned and thereby displaces it from the potentially obstructive ventricular outflow tract when it contracts during systole. It helps with ventricular output, and when the ventricular pressure increases during systole, the prosthetic valve leaves open and move into position. The valve is then displaced to the closed position, thereby increasing the back pressure above the valve.

[0064] (Embodiment 28)

[0065] An artificial heart valve device according to Embodiment 27, wherein when the ventricle expands, the atrium and heart As the pressure difference between the atria and ventricles decreases, blood flows from the atria through the artificial valve and into the ventricles. It is permitted to be used for ventricular filling, and the geometric shape of the bendable deformable portion inside the valve frame Furthermore, it allows the valve frame to return to its original position within the ventricle, reducing its atrial projection. The placement is designed to reduce the possibility of diastolic blood flow obstruction and blood stagnation, and to optimize ventricular filling. It will be done.

[0066] (Embodiment 29)

[0067] An artificial heart valve device according to Embodiment 28, wherein the artificial heart is compressed radially The valve apparatus further allows for traversing tightly curved curvatures in accordance with requirements, and anatomically... It does not damage the advancement of the anatomical pathway of the structure.

[0068] (Embodiment 30)

[0069] An artificial heart valve device according to Embodiment 29, wherein the artificial heart is radially compressed The internal valve system is transported using a hinged connection.

[0070] (Embodiment 31)

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

[0072] (Embodiment 32)

[0073] An artificial heart valve device according to Embodiment 31, wherein a differentially deformable anchor structure By providing a residual volume to the artificial heart valve device of long compression that advances along the close curve, the artificial heart This enables optimized control of the advancement and transport of the internal valve device to the desired target implantation site. do.

[0074] (Embodiment 33)

[0075] A transport system according to Embodiment 32, wherein the transport system comprises an elongated first It includes a conduit having a first diameter and a primary cavity, a first bendable portion and It includes one or more secondary cavities radially adjacent to the primary cavity.

[0076] (Embodiment 34)

[0077] The transport system described in Embodiment 33 further includes one or more tethers, which are used by people Connected to a portion of the heart valve apparatus and parallel shifting one or more secondary cavities of the first conduit. They are positioned to move and pass through.

[0078] (Embodiment 35)

[0079] The transport system according to Embodiment 34 further includes an elongated second conduit, which Having a second diameter smaller than the first diameter, and a cavity, a second flexible portion and one or includes a connecting element for a portion that can be connected to a plurality of artificial heart valve devices, wherein the second conduit Furthermore, it is positioned to be translated parallel to the primary cavity of the first conduit.

[0080] (Embodiment 36)

[0081] The transport system described in Embodiment 35 is further connected to and communicates with a second conduit and an artificial heart It includes a compensation mechanism that enables controllable changes in the configuration of the internal valve device.

[0082] (Embodiment 37)

[0083] A transport system according to Embodiment 36, wherein one or more tethers and one or Multiple connecting elements together provide tension, which provides radial restraint for transporting the artificial heart valve device. Maintain the bundle structure in a controllable manner.

[0084] (Embodiment 38)

[0085] The transport system according to Embodiment 37, wherein the compensation mechanism is such that the second conduit is an artificial heart The tension is relieved by the controllable parallel movement within the first conduit during the radial expansion period of the internal valve device. It makes it possible to release.

[0086] (Embodiment 39)

[0087] The transport system according to Embodiment 38, further comprising an elongated third conduit, which Having a third diameter smaller than the second diameter, and a cavity, a third flexible portion and a distal Including an end covering, the distal end covering has a fourth diameter that is larger than the third diameter and contains a person The portion containing the artificial heart valve device is arranged to radially restrain the portion of the artificial heart valve device. ru.

[0088] (Embodiment 40)

[0089] The transport system according to Embodiment 39, wherein the third conduit is further a second conduit It is positioned to be translated parallel within the cavity.

[0090] (Embodiment 41)

[0091] A transport system according to Embodiment 40, wherein the distal end covering further comprises a second guide It is positioned to embed the portion of the artificial heart valve device by contacting the connecting element of the tube.

[0092] (Embodiment 42)

[0093] The transport system according to Embodiment 41, wherein the compensation mechanism further comprises a third conduit. They are arranged to be connected and communicate, and the distal end covering of the third conduit is a compensating mechanism It moves in a controllable manner through operation.

[0094] (Embodiment 43)

[0095] The transport system according to Embodiment 42 further includes a fourth elongated conduit, which It has a fifth diameter that is larger than the first diameter and includes a cavity and a proximal end covering, The covering includes the portion of the artificial heart valve device, thereby shaping the portion of the artificial heart valve device radially. It is configured to be restrained.

[0096] (Embodiment 44)

[0097] The transport system according to Embodiment 43, wherein the fourth conduit is further the first conduit It is positioned so as to be shifted parallel to the above.

[0098] (Embodiment 45)

[0099] A transport system according to Embodiment 44, wherein the first and second curved parts The portion further includes laser-cut nickel-titanium knot tubing.

[0100] (Embodiment 46)

[0101] As in the transport system of Embodiment 44, here the first and second flexible parts are It also includes the laser-cut steel pipe portion.

[0102] (Embodiment 47)

[0103] As in the transport system of Embodiment 44, here the first and second flexible parts are It also includes a portion of a laser-cut polymer tube.

[0104] (Embodiment 48)

[0105] A transport system according to Embodiment 44, wherein the first and second curved parts The portion further includes the reinforced fiber tube section.

[0106] (Embodiment 49)

[0107] A transport system according to any one of embodiments 45 to 48, wherein a second guide The tube is further positioned to be steered by applying tension to biased support wires inside. It can be done. The present invention provides, for example, the following items: (Item 1) A system of natural atrioventricular valves for treating heart defects, Including an artificial heart valve device and transport system, The artificial heart valve device comprises a valve, a valve frame, a valve seal cover, an anchor structure, and an anchor Including the seal cover, The valve includes a plurality of valve leaves, and the valve frame is expandable and supports the valve. It is used for and has an inflow region, an intermediate region and an outflow region downstream of the inflow region, The aforementioned inflow region further includes a plurality of inflow region connecting members, and the aforementioned intermediate region further supports the valve leaf. The structure includes, and the outflow region further includes a plurality of outflow region connecting members, The valve seal cover extends between the inlet region and the outlet region and leaks around the valve. It is positioned to prevent this, Here, the valve is configured to switch between a blood flow-allowing state and a blood flow-blocking state. The anchor structure is deformable and is aligned concentrically with the valve frame and adjacent in the radial direction. Furthermore, surrounding the valve frame, and including the atrial region, the ring region and the ventricular region, the heart The atrial region generally has a first rigidity and includes a plurality of atrial region connecting elements, and the plurality of atrial The region connecting element is adjacent to and connected to the inflow region connecting member of the valve frame, and in front The ring region generally has a second rigidity and a ring to prevent reverse displacement of the device. Including a nuclear element, the ventricular region generally has a third rigidity and a plurality of ventricular region connecting elements Including the child, the plurality of ventricular region connecting elements are adjacent to the outflow region connecting member of the valve frame. And connect and make contact, The anchor seal cover extends between the atrial region and the ventricular region and around the valve. It is positioned to prevent leakage, Here, the artificial heart valve device is arranged for transport in a radially minimized, compressed state and embedded. Arranged to allow controllable transitions between radially maximized and expanded states, which are positioned for integration. And so, The anchor structure is such that when the device is in the expanded state and embedded, the heart valve The device is positioned to be permanently anchored within the atrial valve of the heart. (Item 2) During the period of implantation of the device, any valve leaf is aligned with the natural anterior valve leaf of the atrioventricular valve of the heart, and the device is installed. An artificial heart valve device described in item 1 that avoids ventricular outflow tract obstruction after implantation. (Item 3) During the period of implantation of the device, any valve leaf is aligned with the natural anterior valve leaf of the atrioventricular valve of the heart, and the device is installed. The item described in item 1 allows the natural anterior petal to move freely after the implantation. Artificial heart valve device. (Item 4) The expandable valve frame further provides positioning and fixing between adjacent valve leaves. It includes a plurality of boundary members for the purpose of, and each outlet region connecting member of the valve frame is a boundary An artificial heart valve device as described in item 1, extending from the material. (Item 5) Each inflow region connecting member further includes the geometric shape of a bendable portion, which is the a The force transmission between the ignition structure and the valve frame is arranged to be mechanically dampened. Artificial heart valve device as described in item 1. (Item 6) Each outflow region connecting member further includes the geometric shape of a bendable portion, which is the a The force transmission between the ignition structure and the valve frame is arranged to be mechanically dampened. Artificial heart valve device as described in item 1. (Item 7) The geometric shape of the bendable deformable portion of each inflow region connecting member is further reduced during the contraction period of the valve The frame is configured to allow displacement by translation away from the anchor structure. Artificial heart valve device as described in item 1. (Item 8) The geometric shape of the bendable deformable portion of each outlet region connecting member is further reduced during the contraction period of the valve The frame is configured to allow displacement by translation away from the anchor structure. Artificial heart valve device as described in item 1. (Item 9) The geometric shape of the bendable deformable portion of each inflow region connecting member is further extended during the valve The frame is configured to allow reverse rotation, which is displaced by parallel movement from the anchor structure. The artificial heart valve device described in item 1. (Item 10) The geometric shape of the bendable deformable portion of each outlet region connecting member is further extended during the valve The frame is configured to allow reverse rotation, which is displaced by parallel movement from the anchor structure. The artificial heart valve device described in item 1. (Item 11) The geometric shape of the bendable deformable portion of each inflow region connecting member is further radially bendable The geometric shape of the shaped portion and the radially curved deformation of the inflow region when compressed. Item 1 describes how the part is configured to allow the part to bend radially in response to a force. An artificial heart valve device. (Item 12) The geometric shape of the bendable deformable portion of each outflow region connecting member is further radially bendable The geometric shape of the shaped portion and the radially curved deformation of the outflow region when compressed. Item 1 describes how the part is configured to allow the part to bend radially in response to a force. An artificial heart valve device. (Item 13) Each outflow region connecting member further includes a rigid geometric shape, which is the anchor structure and front The artificial heart described in item 1 is positioned to resist bending or displacement between itself and the valve frame. Internal valve apparatus. (Item 14) Each inflow region connecting member further includes a rigid geometric shape, which is the anchor structure and front The artificial heart described in item 1 is positioned to resist bending or displacement between itself and the valve frame. Internal valve apparatus. (Item 15) The atrial region of the anchor is terminated by a plurality of atrial retaining members that are releasably captured. The support structure further includes, wherein the support structure, when planted, is based on the first rigidity As described in item 1, the atrial valve adjacent to the heart is positioned to coincide with the base of the natural atrium. An artificial heart valve device. (Item 16) The releasably captured atrial retaining member is releasably accessible to the transport system of the artificial heart valve device. An artificial heart valve device as described in item 15, configured to be connected. (Item 17) When observed in standard imaging mode, the plurality of support structures in the atrial region of the anchor are This provides clear indication of the relative position and orientation of the device with respect to the natural ring and outflow tract of the heart. An artificial heart valve device as described in item 1. (Item 18) The plurality of support structures in the atrial region of the anchor have a radially flexible deformable portion. A deformable portion of the atrial region that further includes some kind of geometric shape and is radially bendable when compressed. The item described in item 1 is arranged to allow it to bend radially in response to a force. Artificial heart valve device. (Item 19) The shape of the atrial region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the atrial region, and a second diameter that is larger than the first diameter and adjacent to the atrial region. An artificial heart valve device as described in item 1, having the following: (Item 20) The shape of the atrial region of the anchor is generally disc-shaped, as described in item 1. Heart valve apparatus. (Item 21) The shape of the atrial region of the anchor is generally bowl-shaped, as described in item 1 of the artificial heart valve. Device. (Item 22) The ring region of the anchor, when further embedded, has a diameter based on the second rigidity. The system is configured to apply an outward anchoring force to a natural ring that contacts the atrioventricular valve of the heart. An artificial heart valve device as described in item 1. (Item 23) The artificial heart valve device according to item 1, which includes a ring anchor element and a tissue puncture structure. (Item 24) The ring anchor element further includes one or more rows of tissue puncture structures, and each The structure is an artificial heart valve device as described in item 23, oriented in the same direction. (Item 25) The ring anchor element further includes two rows of tissue puncture structures, and here the two rows Artificial heart valve devices as described in item 23, where the woven puncture structures generally point toward each other. (Item 26) The ring anchor element further includes two rows of tissue puncture structures, and here the two rows Artificial heart valve device as described in item 23, in which the woven puncture structures are generally oriented to move away from each other. 。 (Item 27) The ventricular region of the anchor is further embedded based on the third rigidity. An artificial heart valve device as described in item 1, positioned to match the natural ventricle of the heart. (Item 28) The ventricular region connecting member of the anchor includes an elongated structural member, and the elongated structural member The distal end is separate from the ring region of the anchor and extends toward the ventricle, and is open. An artificial heart valve device as described in item 1, which terminates with a ventricular retaining member that can be captured. (Item 29) The releasably captured ventricular retaining member is releasably accessible to the transport system of the artificial heart valve device. An artificial heart valve device as described in item 28, configured to be connected. (Item 30) The ventricular region connecting member of the anchor has a geometric shape of a radially curveable deformable portion. Furthermore, when compressed, the radially flexible deformable portion of the ventricular region responds to the force. Artificial heart valve as described in item 1, which is arranged to allow for radial curvature. Device. (Item 31) The shape of the ventricular region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the ventricular region, and a second diameter that is larger than the first diameter and adjacent to the ventricular region. An artificial heart valve device as described in item 1, having the following characteristics. (Item 32) The shape of the ventricular region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the ventricular region and a second diameter that is smaller than the first diameter and adjacent to the ventricular region. An artificial heart valve device as described in item 1, having the following characteristics. (Item 33) The shape of the ventricular region of the anchor is generally bowl-shaped, as described in item 1 of the artificial heart valve. Device. (Item 34) The shape of the ventricular region of the anchor is generally disc-shaped, as described in item 1. Heart valve apparatus. (Item 35) The shape of the ventricular region of the anchor is generally cylindrical, as described in item 1 of the artificial heart Valve device. (Item 36) The device is delivered to the atrioventricular valve of the heart by percutaneous incision in the femoral artery or femoral vein. An artificial heart valve device as described in item 1, which may be used. (Item 37) The device can be delivered to the atrioventricular valve of the heart by percutaneous incision at the tip of the heart. Artificial heart valve device as described in item 1. (Item 38) The device can be delivered to the atrioventricular valve of the heart by percutaneous incision in the corresponding atrium. Artificial heart valve device as described in item 1. (Item 39) The device can be delivered to the atrioventricular valve of the heart by a percutaneous incision in the subclavian vein. The artificial heart valve device described in item 1. (Item 40) An artificial heart valve device for treating a natural atrioventricular valve defect, The artificial heart valve device comprises a valve, a valve frame, a valve seal cover, an anchor structure, and an anchor seal Includes a cover, The valve includes a plurality of valve leaves, and the valve frame is expandable and supports the valve. It is used for and has an inflow region, an intermediate region and an outflow region downstream of the inflow region, The aforementioned inflow region further includes a plurality of inflow region connecting members, and the aforementioned intermediate region further supports the valve leaf. The structure includes, and the outflow region further includes a plurality of outflow region connecting members, The valve seal cover extends between the inlet region and the outlet region and leaks around the valve. It is positioned to prevent this, Here, the valve is configured to switch between a blood flow-allowing state and a blood flow-blocking state. The anchor structure is deformable, is aligned concentrically with the valve frame, and is adjacent in the radial direction. The valve frame is surrounded and includes the atrial region, the D-ring region and the ventricular region, and the heart The atrial region generally has a first rigidity and includes a plurality of atrial region connecting elements, and the plurality of atrial The region connecting element is adjacent to and connected to the inflow region connecting member of the valve frame, and in front The D-type ring region generally has a second rigidity and prevents reverse displacement of the device. The system includes a guan anchor element, and the ventricular region generally has a third rigidity and multiple ventricular region connections. The connection elements include a plurality of ventricular region connecting elements, and the plurality of ventricular region connecting elements are connected to the outflow region connecting member of the valve frame. Adjacent and connected and in contact, The anchor seal cover extends between the atrial region and the ventricular region and around the valve. It is positioned to prevent leakage, Here, the artificial heart valve device is arranged for transport in a radially minimized, compressed state and embedded. Arranged to allow controllable transitions between radially maximized and expanded states, which are positioned for integration. And so, The anchor structure is such that when the device is in the expanded state and embedded, the heart valve The device is positioned to be permanently anchored within the atrial valve of the heart. (Item 41) During the period of implantation of the device, the plane of the D-shaped ring region of the anchor structure is aligned with the atrioventricular region of the heart. This involves aligning the device with the natural anterior valve lobe and preventing ventricular outflow tract obstruction after implantation. Artificial heart valve device as described in 40. (Item 42) During the period of implantation of the device, the plane of the D-shaped ring region of the anchor structure is aligned with the atrioventricular region of the heart. The device is aligned with the natural anterior valve leaf, and after the device is embedded, the natural anterior valve leaf can move freely. An artificial heart valve device as described in item 40, which enables the use of artificial heart valves. (Item 43) The expandable valve frame further provides positioning and fixing between adjacent valve leaves. It includes a plurality of boundary members for the purpose of, and each outlet region connecting member of the valve frame is a boundary An artificial heart valve device as described in item 40, which is extended from the material. (Item 44) Each inflow region connecting member further includes the geometric shape of a bendable portion, which is the a The force transmission between the ignition structure and the valve frame is arranged to be mechanically dampened. Artificial heart valve device as described in item 40. (Item 45) Each outflow region connecting member further includes the geometric shape of a bendable portion, which is the a The force transmission between the ignition structure and the valve frame is arranged to be mechanically dampened. Artificial heart valve device as described in item 40. (Item 46) The geometric shape of the bendable deformable portion of each inflow region connecting member is further reduced during the contraction period of the valve The frame is configured to allow displacement by translation away from the anchor structure. Artificial heart valve device as described in item 40. (Item 47) The geometric shape of the bendable deformable portion of each outlet region connecting member is further reduced during the contraction period of the valve The frame is configured to allow displacement by translation away from the anchor structure. Artificial heart valve device as described in item 40. (Item 48) The geometric shape of the bendable deformable portion of each inflow region connecting member is further extended during the valve The frame is configured to allow reverse rotation, which is displaced by parallel movement from the anchor structure. Artificial heart valve device as described in item 40. (Item 49) The geometric shape of the bendable deformable portion of each outlet region connecting member is further extended during the valve The frame is configured to allow reverse rotation, which is displaced by parallel movement from the anchor structure. Artificial heart valve device as described in item 40. (Item 50) The geometric shape of the bendable deformable portion of each inflow region connecting member is a radially bendable deformable portion The geometric shape of the portion further includes a radially curved shape of the inflow region when compressed. Item 40 is configured to allow the shaped portion to bend radially in response to a force. The artificial heart valve device described above. (Item 51) The geometric shape of the bendable deformable portion of each outflow region connecting member is a radially bendable deformable portion The geometric shape of the portion further includes a radially curved shape of the outflow region when compressed. Item 40 is positioned to allow the shaped portion to bend radially in response to the applied force. The artificial heart valve device described above. (Item 52) Each outflow region connecting member further includes a rigid geometric shape, and the anchor structure and the valve Artificial heart valve as described in item 40, which is positioned to resist bending or displacement between itself and the frame. Device. (Item 53) Each inflow region connecting member further includes a rigid geometric shape, and the anchor structure and the valve Artificial heart valve as described in item 40, which is positioned to resist bending or displacement between itself and the frame. Device. (Item 54) The atrial region of the anchor is further terminated by a releasably captured atrial retaining member. It includes multiple support structures, wherein the support structures are based on the first rigidity when planted. As described in item 40, the atrial valve adjacent to the heart is positioned to coincide with the base of the natural atrium. An artificial heart valve device. (Item 55) The releasably captured atrial retaining member is releasably accessible to the transport system of the artificial heart valve device. An artificial heart valve device as described in item 54, configured to be connected. (Item 56) When observed in standard imaging mode, the plurality of support structures in the atrial region of the anchor are This provides clear indication of the relative position and orientation of the device with respect to the natural ring and outflow tract of the heart. An artificial heart valve device as described in item 40. (Item 57) The plurality of support structures in the atrial region of the anchor further have radially bendable deformable portions The geometric shape includes and the radially curveable deformable portion of the atrial region when compressed Item 40, which is arranged to allow for radial curvature in response to a force. Artificial heart valve device. (Item 58) The shape of the atrial region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the atrial region, and a second diameter that is larger than the first diameter and adjacent to the atrial region. An artificial heart valve device as described in item 40, having the following: (Item 59) The shape of the atrial region of the aforementioned anchor is generally disc-shaped, as described in item 40. Heart valve device. (Item 60) The shape of the atrial region of the anchor is generally bowl-shaped, as described in item 40 of the artificial heart. Valve device. (Item 61) The ring region of the anchor, when further embedded, has a diameter based on the second rigidity. The system is configured to apply an outward anchoring force to a natural ring that contacts the atrioventricular valve of the heart. An artificial heart valve device as described in item 40. (Item 62) The artificial heart valve device according to item 40, which includes a ring anchor element and a tissue puncture structure. (Item 63) The ring anchor element further includes one or more rows of tissue puncture structures, and each The structure is an artificial heart valve device as described in item 62, oriented in the same direction. (Item 64) The ring anchor element further includes two rows of tissue puncture structures, and here the two rows Artificial heart valve devices as described in item 62, where the woven puncture structures generally point toward each other. (Item 65) The ring anchor element further includes two rows of tissue puncture structures, and here the two rows Artificial heart valve apparatus as described in item 62, in which the woven puncture structures are generally oriented to move away from each other. 。 (Item 66) The ventricular region of the anchor is further embedded based on the third rigidity. An artificial heart valve device as described in item 40, positioned to match the natural ventricle of the heart. (Item 67) The ventricular region connecting member of the anchor includes an elongated structural member, and the elongated structural member The distal end is separate from the ring region of the anchor and extends toward the ventricle, and is open. An artificial heart valve device as described in item 40, which terminates with a potentially captured ventricular retaining member. (Item 68) The releasably captured ventricular retaining member is releasably accessible to the transport system of the artificial heart valve device. An artificial heart valve device as described in item 67, configured to be connected. (Item 69) The ventricular region connecting member of the anchor has a geometric shape of a radially curveable deformable portion. Furthermore, when compressed, the radially flexible deformable portion of the ventricular region responds to the force. Artificial heart described in item 40, which is positioned to allow for radial curvature. Valve device. (Item 70) The shape of the ventricular region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the ventricular region, and a second diameter that is larger than the first diameter and adjacent to the ventricular region. An artificial heart valve device as described in item 40, having the following characteristics. (Item 71) The shape of the ventricular region of the anchor is generally truncated cone, adjacent to the ring region. A first diameter that is in contact with the ventricular region, and a second diameter that is smaller than the first diameter and adjacent to the ventricular region. An artificial heart valve device as described in item 40, having the following: (Item 72) The shape of the ventricular region of the anchor is generally bowl-shaped, as described in item 40 of the artificial heart. Valve device. (Item 73) The shape of the ventricular region of the anchor is generally disc-shaped as described in item 40. Heart valve device. (Item 74) The shape of the ventricular region of the anchor is generally cylindrical, as described in item 40. Internal valve apparatus. (Item 75) The device is delivered to the atrioventricular valve of the heart by percutaneous incision in the femoral artery or femoral vein. Artificial heart valve devices as described in item 40. (Item 76) The device can be delivered to the atrioventricular valve of the heart by percutaneous incision at the tip of the heart. Artificial heart valve device as described in item 40. (Item 77) The device can be delivered to the atrioventricular valve of the heart by percutaneous incision in the corresponding atrium. Artificial heart valve device as described in item 40. (Item 78) The device can be delivered to the atrioventricular valve of the heart by a percutaneous incision in the subclavian vein. Artificial heart valve device as described in item 40. (Item 79) A transport system for an artificial heart valve device, It includes a slender first conduit, one or more tethers, a slender second conduit, and a compensation mechanism. fruit, The elongated first conduit has a first diameter and a primary cavity, a first flexible portion and includes one or more secondary cavities radially adjacent to the primary cavity, The tether is connected to the portion of the artificial heart valve device and to one or the first conduit. It is positioned to pass through multiple secondary cavities in parallel, The elongated second conduit has a second diameter smaller than the first diameter and a lumen, second Includes a flexible portion and a connecting element for a portion that can be connected to one or more artificial heart valve devices. Here, the second conduit is further translated into the primary cavity of the first conduit. They are arranged in such a way. The compensation mechanism is connected to and communicates with the second conduit and is capable of controlling the artificial heart valve device. This can be shortened, and the one or more tethers can be used together with the one or more connecting elements. This provides tension, and the tension allows the artificial heart valve device to be controlled into a radial restraint structure for transport. Maintain, and the compensation mechanism ensures that the second conduit is in the radial expansion period of the artificial heart valve device. This makes it possible to release tension by controllingly translating it within the first conduit. 。 (Item 80) It further includes an elongated third conduit, the elongated third conduit having a smaller diameter than the second conduit. Having a third diameter and including a lumen, a third bendable portion and a distal end covering, the distal end The covering has a fourth diameter that is larger than the third diameter and contains the artificial heart valve device The portion including the portion is arranged to restrain the portion of the artificial heart valve device in the radial direction, Item 7: The third conduit is further positioned to move parallel to the lumen of the second conduit. The transport system described in section 9. (Item 81) The distal end covering further comes into contact with the connecting element of the second conduit, thereby the person A transport system according to item 80, configured to embed a portion of a cardiac valve apparatus. (Item 82) The compensation mechanism is further arranged to be connected to and communicate with the third conduit, and The distal end covering of the third conduit is controlled to move in parallel by the operation of the compensation mechanism. The transport system described in item 81. (Item 83) It further includes a fourth elongated conduit, the fourth elongated conduit having a diameter larger than the first It has a diameter of 5 and includes a lumen and a proximal end covering, the proximal end covering containing the artificial By including the portion of the heart valve device, the radial restraint of the portion of the artificial heart valve device is supported. The fourth conduit is positioned such that it is moved parallel to the first conduit. The transport system described in item 82. (Item 84) The first and second bendable portions are further laser-cut nickel-titanium tube portions. The transport system described in item 83, including minutes. (Item 85) The first and second bendable portions further include, in item 83, portions of laser-cut steel pipe. The transport system described. (Item 86) The first and second bendable portions further include portions of laser-cut polymer tubes. The transport system described in 83. (Item 87) The first and second bendable portions further include reinforced fiber tube portions as described in item 83. Conveyor system. (Item 88) The second conduit can be redirected by applying tension to a biased wire inside. A transport system as described in any one of items 84 to 87, configured to such an extent.

[0108] The present invention, with reference to its applications, is described below. [Brief explanation of the drawing]

[0109] [Figure 1] This is a schematic diagram of a front view of the anterior part of the heart, illustrating some examples of applications of the present invention. [Figure 2A]This is a schematic diagram of an exemplary front view of the posterior part of a heart, showing cross-sectional lines according to several applications of the present invention. [Figure 2B] This is a schematic cross-sectional view of an exemplary basic form of the heart according to several 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] This is a front view of the expanded and flattened periphery of an exemplary natural bicuspid valve apparatus, including the lobules, chordae tendineae, and papillary muscles, according to several applications of the present invention. [Figure 3B] This is a front view of the expanded and flattened periphery of an exemplary natural tricuspid valve apparatus, including the lobules, chordae tendineae, and papillary muscles, according to several applications of the present invention. [Figure 4A] This is a schematic diagram of an exemplary anterior cross-sectional view of the heart, illustrating the direction of normal blood flow in the left ventricle during diastole, according to several applications of the present invention. [Figure 4B] This is a schematic diagram of an exemplary anterior cross-sectional view of the heart according to several applications of the present invention, showing the direction of normal blood flow in the left ventricle during contraction. [Figure 4C] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing the direction of blood flow returning to the left ventricle by the posterior lobe during contraction. [Figure 4D] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing the direction of blood flow permeating the left ventricle via the lobular prominence during contraction. [Figure 5A] This is a schematic cross-sectional view of the anterior part of the heart, illustrating an embodiment of an artificial heart valve device implanted in the bicuspid valve position according to several applications of the present invention. [Figure 5B] This is a schematic diagram of an exemplary anterior cross-sectional view of the heart according to several applications of the present invention, showing an embodiment of an artificial heart valve device implanted within the tricuspid valve location. [Figure 6A] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous pathway corresponding to transapical transplantation within the bicuspid valve location. [Figure 6B]This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous pathway corresponding to transapical transplantation within the tricuspid valve location. [Figure 6C] This is a schematic diagram of an exemplary anterior cross-sectional view of the heart according to several applications of the present invention, showing a percutaneous route corresponding to a transfemoral vein transplant within the tricuspid valve location. [Figure 6D] This is a schematic diagram of an exemplary anterior cross-sectional view of the heart according to several applications of the present invention, showing a percutaneous pathway corresponding to a septal implantation within the bicuspid valve location. [Figure 6E] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous route corresponding to a subclavian graft within the bicuspid valve location. [Figure 6F] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous route corresponding to a subclavian graft within the tricuspid valve location. [Figure 6G] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous passage corresponding to a cortical graft within the bicuspid valve location. [Figure 6H] This is a schematic diagram of an exemplary anterior cross-section of the heart according to several applications of the present invention, showing a percutaneous passage corresponding to a percutaneous graft within the bicuspid valve location. [Figure 7A] This is a schematic perspective view of an exemplary self-expanding valve frame embodiment according to several applications of the present invention. [Figure 7B] This is a schematic plan view (inlet) of an exemplary embodiment of a self-expanding valve frame according to several applications of the present invention. [Figure 7C] This is a schematic front view of an exemplary embodiment of a self-expanding valve frame according to several applications of the present invention. [Figure 7D] This is a front view of an exemplary embodiment of a self-expanding valve frame including tissue lobes and fabric covering according to several applications of the present invention. [Figure 8A] This is a schematic perspective view of an exemplary embodiment of a differentially deformable anchor structure according to several applications of the present invention. [Figure 8B]This is a schematic cross-sectional view of an exemplary embodiment of a differentially deformable anchor structure according to several applications of the present invention. [Figure 8C] This is a schematic plan view (inflow) of an exemplary differential deformable anchor structure embodiment according to several applications of the present invention. [Figure 8D] This is a schematic cross-sectional view of an exemplary embodiment of a differentially deformable anchor structure, including a woven fabric cover, according to some applications of the present invention. [Figure 9A] This is a schematic front view of an exemplary embodiment of an artificial heart valve device according to several applications of the present invention. [Figure 9B] This is a schematic perspective view of an exemplary embodiment of an artificial heart valve device according to several applications of the present invention. [Figure 9C] This is a schematic plan (inflow) perspective view of an exemplary embodiment of an artificial heart valve device according to several applications of the present invention. [Figure 9D] This is a schematic front view of an exemplary embodiment of an artificial heart valve device, including a fabric covering, according to some applications of the present invention. [Figure 9E] This is a schematic diagram of a cross-sectional contour of an exemplary embodiment of an artificial heart valve device according to several applications of the present invention. [Figure 9F] This is a schematic diagram of an exemplary embodiment of an artificial heart valve device, and an alternative embodiment of the curved geometric coupling will be described in detail. [Figure 10A] This is a schematic front view of an exemplary embodiment of an artificial heart valve device with a curl structure according to several applications of the present invention. [Figure 10B] Figure 10B is a schematic front view of an exemplary embodiment of an artificial heart valve device configured in an extended manner according to several applications of the present invention. [Figure 11A] This is a front view of an embodiment of an exemplary artificial heart valve device developed from an exemplary delivery system according to several applications of the present invention. [Figure 11B] This is a schematic front view of an exemplary embodiment of an artificial heart valve device developed from an exemplary delivery system according to several applications of the present invention. [Figure 11C]This is a schematic front view of an exemplary embodiment of an artificial heart valve device developed from an exemplary delivery system according to several applications of the present invention. [Figure 12A] Figure 12A is a side cross-sectional view of an exemplary embodiment of an artificial heart valve device according to several applications of the present invention, which is implanted in the bicuspid valve position during the diastolic phase of the cardiac cycle. [Figure 12B] Figure 12B is a side cross-sectional view of an exemplary embodiment of an artificial heart valve device implanted in the bicuspid valve position during the systolic phase of the cardiac cycle, according to some applications of the present invention. [Figure 13A] These are schematic diagrams of perspective views and detail views of an exemplary artificial heart valve device mounted in an exemplary delivery system according to several applications of the present invention. [Figure 13B] This is a front view of a segment of an embodiment of the frame planar pattern of an exemplary artificial heart valve device according to several applications of the present invention. [Figure 14] This is an enlarged schematic diagram of the distal portion of a femoral artery delivery device having an artificial object in a partially unfolded configuration, according to some applications of the present invention. [Figure 15A-B] Figure 15A is a schematic diagram of a femoral artery delivery device having an artificial heart valve device in a loading configuration, according to some applications of the present invention. Figure 15B is a schematic diagram of the distal end of a femoral artery delivery device having an artificial heart valve device in a loading configuration, according to some applications of the present invention. [Figure 16A] This is a schematic diagram of a femoral artery delivery device according to several application examples of the present invention. [Figure 16B] This is a schematic diagram of a femoral artery delivery device according to several application examples of the present invention. [Figure 17A] This is a schematic diagram of the artificial heart valve device holding area of ​​a femoral artery delivery device according to several application examples of the present invention. [Figure 17B] This is a schematic diagram of the tether shuttle mechanism of a femoral artery delivery device according to some applications of the present invention, in which the tether shuttle is in a closed configuration. [Figure 17C]This is a schematic diagram of multiple tether connectors in a femoral artery delivery device in a joint configuration according to several applications of the present invention. [Figure 17D] This is a schematic diagram of the tether shuttle mechanism of a femoral artery delivery device according to some applications of the present invention, in which the tether shuttle is in an open configuration. [Figure 17E] This is a schematic diagram of multiple tether connectors in an offset-configured strand distribution system according to some application examples of the present invention. [Figure 17F] This is a hidden line diagram of a tethered connector in a strand distribution system according to several applications of the present invention. [Figure 18A] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18B] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18C] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18D] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18E] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18F] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18G] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18H] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 18I] These are a series of schematic diagrams illustrating the arrangement of an artificial heart valve device in several applications of the present invention. [Figure 19A] This is a sequence of schematic diagrams illustrating the three-dimensional structure of the outer covering in the second conduit and retaining region according to several applications of the present invention. [Figure 19B]This is a sequence of schematic diagrams illustrating the three-dimensional structure of the outer covering in the second conduit and retaining region according to several applications of the present invention. [Figure 19C] This is a sequence of schematic diagrams illustrating the three-dimensional structure of the outer covering in the second conduit and retaining region according to several applications of the present invention. [Figure 19D] This is a sequence of schematic diagrams illustrating the three-dimensional structure of the outer covering in the second conduit and retaining region according to several applications of the present invention. [Figure 20A] These are a series of schematic diagrams of a femoral artery delivery device drawn in cross-section according to some applications of the present invention. [Figure 20B] These are a series of schematic diagrams of a femoral artery delivery device drawn in cross-section according to some applications of the present invention. [Figure 20C] These are a series of schematic diagrams of a femoral artery delivery device drawn in cross-section according to some applications of the present invention. [Modes for carrying out the invention]

[0110] This specification and the drawings describe several embodiments of replacement artificial heart valve devices, systems and methods. The text provides aspects and features of this disclosure, and these replacement artificial heart valve devices, systems The system and method are placed in the patient's vascular system, for example, the patient's natural heart valve. These embodiments involve combining and replacing specific valves (e.g., the patient's bicuspid or tricuspid valve) for discussion. It can be discussed. However, as can be understood, the features and The concept can be applied to products other than artificial heart valve devices. For example, the control described herein The controlled positioning, deployment, and fixation features are applicable to medical implants, for example, other types of deployable implants. It can be applied to artificial structures, and to other parts of the body, such as arteries, veins, or other body cavities or parts It is used in this context. Furthermore, it considers certain characteristics of an artificial heart valve device, system, or method as limitations. It should not be, and any feature of any embodiment discussed herein may be appropriate as needed. In such cases, it can be combined with features of other embodiments. Several of the embodiments described herein While this embodiment is described by combining a specific transport inlet, it should be understood that these practical aspects The example may be used for other transport access routes. Also, to make it clear, several Some features described in conjunction with the embodiments can be combined with other embodiments. This includes those described by combining different transport routes.

[0111] Referring to Figure 1, it shows the anterior part of an exemplary heart 100 according to some applications of the present invention. This is a schematic diagram showing a front view. The exemplary heart 100 generally has four main chambers (right heart). This includes the atrium (140), right ventricle (146), left atrium (110), and left ventricle (147), and these are pumping cells. As a system, it works harmoniously to circulate blood throughout the entire vascular system. In a normal state, systemic circulation The ring (not shown) delivers deoxygenated blood to the superior and inferior veins (125 and 145, respectively). The right atrium is returned to 140. During diastole (the ventricular diastolic portion of the cardiac cycle), deoxygenated blood is three It forcibly passes through the cusp valve (245, Figure 2B) and enters the right ventricle 146. And, the right ventricle 146 and right atrium 140, which are driven to contract during systole (the ventricular contraction portion of the heart cycle) The pressure gradient between them closes the tricuspid valve (245, Figure 2B) and blood flows into the right ventricular outflow tract (520, Figure 2B). It is forced to pass through 5A), and through the pulmonary valve (515, Figure 5A) and the left pulmonary artery and By progressing along the right pulmonary artery (which is 115 and 130 respectively), the pulmonary trunk 114 It stops along the way until it flows into the lungs (not shown). Blood flows into the lungs (not shown) during respiration. It contains more oxygen, and then it is released into the left and right pulmonary veins (105 and 135 respectively). Then it returns to the left atrium 110. Next, diastole is performed by the opened bicuspid valve (210, Figure 2B) It draws in oxygenated blood, resulting in filling of the left ventricle 147. Finally, the systolic ventricle The pressure gradient between the left ventricle 147 and the left atrium 110 is driven to contraction, and the bicuspid valve (210, Figure 2B) The valve closes and oxygenated blood in the left ventricle of the heart 147 passes through the left ventricular outflow tract (455, Figure 4A) It passes through the aortic valve (205, Figure 2B) and circulates in the system along the aorta 120. It is forced to do so (not shown). The heart 100 is further connected to the circumflex arteries 155 and the left and right coronary arteries The arteries (160 and 150 respectively) provide oxygenated blood to themselves throughout the entire cardiac cycle. . The branch arteries of the aorta 120, for example, the left subclavian artery, the left carotid artery and the cranial brachial artery (each 1 (21, 122, 123) provide oxygenated blood to the brain and upper limbs of the body.

[0112] Now, referring to Figure 2A, there is an exemplary heart 100, which is one of several applications of the present invention. This is a schematic diagram of the rear. It shows the cross-sectional line A-A200, which represents the cross-section of an exemplary heart 100. This explains where the cut can be made to reach the view shown in Figure 2B.

[0113] Figure 2B is a schematic diagram showing an exemplary cross-sectional view of a heart 100 according to several applications of the present invention. Yes, and it emphasizes the anatomical features presented in the apical perspective view. As mentioned above, an exemplary heart The heart generally has four main chambers (right atrium 140, right ventricle 146, left atrium 110 and left ventricle). Includes ventricle 147 (Figure 1). Between the right atrium (140, Figure 1) and the right ventricle (146, Figure 1) The tricuspid valve 245 is present. The inner wall of the right ventricle 240 is a cavity through which blood is pushed out during systolic contraction. It defines the interval. The tricuspid valve 245 is a tricuspid valve, with an anterior leaflet 255, a posterior leaflet 250, and an intervening leaflet 2 It is composed of 60, and when the right ventricle (146, Figure 1) is subjected to pressure during systole, they act as a single unit. It closes and generally prevents retrograde blood flow. Between and below the anterior and posterior leaflets 255 and 250. The papillary muscle 256 is present and supports the two lobes of the tricuspid valve by the chordae tendineae 261. Posterior leaflet 25 Between and below the septal apex 260 is the posterior septal papillary muscle 257, which connects to the tricuspid valve chordae tendineae 261. It supports two more lobes. Between and below the septal apex 260 and the anterior apex 255 is the anterior septal papillary muscle 258. It exists and supports the two lobes of the tricuspid valve by the tricuspid chordae tendineae 261.

[0114] The right ventricle 241 runs along its outer wall to the pulmonary valve 235, and the pulmonary valve 235 and the tricuspid valve 245 The right ventricle (146, Figure 1) and the right ventricular outflow tract (520, Figure 5A) are shared. Pulmonary valve 235 It is also a tricuspid valve, consisting of the left cusp 236, the right cusp 238, and the anterior cusp 237, and the right ventricle (146 (Figure 1) When decompression occurs during diastole, they close together and generally prevent retrograde blood flow. Stop.

[0115] The left ventricle 231 runs along its outer wall to the aortic valve 205, and the aortic valve 205 and the bicuspid valve 210 are The left ventricle (147, Figure 1) and the left ventricular outflow tract (455, Figure 4A) are shared. Aortic valve 205 It is also a tricuspid valve, consisting of the left leaflet 206, the right leaflet 207, and the posterior leaflet 208, and the left ventricle (147 When the pressure is reduced during systole (Figure 1), they close together and generally prevent retrograde blood flow. Stop.

[0116] A bicuspid valve 210 is located between the left atrium (110, Figure 1) and the left ventricle (147, Figure 1). The inner wall of the left ventricle 230 defines the space through which blood is pumped during systolic contraction. (Bicuspid valve) 210 is a bifocal valve, consisting of an anterior leaflet 212 and a posterior leaflet 211, and is located in the left ventricle (147, Figure 1) When pressure is applied during systole, they close and generally prevent retrograde blood flow. The posteromedial papillary muscle 215 is located midway between the posterior leaflet 211 and the anterior leaflet 212, and is part of the bicuspid valve chordae tendineae. The two lobes are supported by 225. The posterior and posterior portions of the posterior and anterior leaflets 211 and 212 are anterolateral. The papillary muscle 220 is present, which supports the two lobes of the bicuspid valve by chordae tendineae 225. Anterior leaflet 21 2 extends in a sub-ring shape into the central chamber from the bicuspid valve ring (335, Figure 3A). Boundary edge At the angle where the cusp valves intersect, the anterior cusp 212 is a clearly rigid region of fibrous tissue (fibrous triangle 2 It originates from the valve ring near (called 16). The fibrous triangle 216 is a structural region of the heart 100 and The bicuspid valve 210 and aortic valve 205 function as the dynamic motion period generated throughout the cardiac cycle. It provides a supporting foundation.

[0117] Currently, referring to Figure 3A, it shows some application examples of the present invention, with the petals (front 310, rear 310) Examples include (315), the bicuspid chordae tendineae (320), and the papillary muscles (anterolateral 305, posteromedial 301). Front view of representative body 300 for selection, showing the unfolded and flattened area around the natural bicuspid valve. This is a schematic diagram. As can be seen, both the anterior lobe 310 and the posterior lobe 315 are bicuspid lobes. It originates from ring 335 and extends downward (facing the left ventricle, not shown) and the left atrium (not shown) The representative body 300 moves away from the zo. The representative body 300 moves along the edge of the bicuspid ring 335 to the posteromedial boundary region 30 It is divided into 6 and the anterolateral boundary region 307 (divided in half in this figure). The bicuspid chordae tendineae 320 extends downward from the border region (postomidular 306, anterolateral 307). It is a ch, and it further communicates with the corresponding papillary muscles (posterior medial 301, anterolateral 305) It extends. The bicuspid chordae tendineae also extend directly from the anterior lobe 310 and posterior lobe 315 themselves, and posteriorly and Each It defines the margin of the corresponding valve leaflet. In a healthy heart with complete anatomical structure, the chordae tendineae function The ability provides tension between the valve lobe and the papillary muscle, preventing the valve lobe from being excessively attached to the atrium during systole and the heart This prevents movement towards the atrium, which ultimately leads to valve dysfunction and blood flow regurgitation. This can lead to heart failure and poor health.

[0118] Similar to Figure 3A, Figure 3B shows some application examples of the present invention, including the leaflets (partition 350, front 360, posterior 370), tricuspid valve chordae tendineae (380) and papillary muscles (posterior partition 385, anterior partition 39) Exemplary natural tricuspid valves, including 0, 395 (front and rear), are unfolded and flattened around the selected area. This is a schematic diagram of representative specimen 340. As can be seen from this, the anterior lobe 360 ​​and the posterior lobe 37 The 0 and choke lobe 350 originate from the tricuspid annulus 345 and extend downward (towards the right ventricle, (Not shown) and away from the right atrium (Not shown). Representative body along the edge of the tricuspid valve ring 345. 340 is the front partition boundary area 382, ​​the front and rear boundary areas 383 and the rear partition boundary area 381 (same Divide the area into two sections (in the diagram, it is shown as being divided in half). Each boundary area (front partition 382, ​​front and back partition 383 and rear partition) is divided into two sections. Extending below partition 381) is the arch of the tricuspid valve chordae tendineae 380, which further opposes Extend until it connects to the corresponding papillary muscles (anterior partition 390, anterior and posterior partition 395, and posterior partition 385). The tricuspid valve chordae tendineae (380) also directly derive from the segmented lobes (350), anterior lobes (360), and posterior lobes (370) themselves. Extend, define the margins of each corresponding leaf, and define the free side, anterior free side and posterior free side (355, It stops until it reaches the tendonless cord region called 365, 375). Similar to the bicuspid valve, three The cusp valve lobes, chordae tendineae, and corresponding papillary muscles also work in harmony, preventing retrograde and reverse blood flow. It can prevent all related diseases and complications.

[0119] Now, referring to Figures 4A and 4B, which illustrate some applications of the present invention, the left side of the heart Normal anterior blood flow on the lateral and right side (concentrated on the left side) passes through the cardiac cycle, including diastole and systole. This figure illustrates a typical explanation. Specifically, Figure 4A shows an anterior cross section of an exemplary heart 400. A schematic diagram is shown, illustrating the normal blood flow direction from the left atrium (445) to the left ventricle (425) during diastole. (Indicated by arrow 430) What needs to be understood is that during the diastolic period, the bicuspid valve 440 opens The bicuspid valve lobe 435 extends completely toward the left ventricle 425, thereby allowing fresh oxygen to be absorbed. This allows blood to fill the left ventricle 425. During diastole, the aortic valve 450 It remains closed. Figure 4A also depicts the right side of the heart during diastole. Diastole In a similar manner to what happens on the left side of the heart, blood is released from the right atrium 405 on the right side. It is guided to pass through the extended tricuspid valve 410, and then through the fully extended tricuspid valve lobe 415. It enters the right ventricle 420, and then proceeds through the right ventricular outflow tract (not shown), the pulmonary valve, and subsequently the pulmonary artery It is expelled through the pulse valves (none of which are shown). During the cardiac cycle, the two ventricles of the heart expand. The heart expands in conjunction with the systole and then contracts in conjunction with the systole. Figure 4B shows an exemplary heart 400 in front of the heart. A schematic cross-sectional view of the ventricle is shown, illustrating that during systole, the blood flows from the left ventricle 425 through the left ventricular outflow tract 455. This shows the normal blood flow direction through arterial valve 465 (indicated by arrow 460). What needs to be understood is: During systole, the bicuspid valve 470 closes and the bicuspid valve lobe 471 completely contracts, causing blood to flow. This prevents the fluid from flowing backward into the left atrium 445, and ensures that fresh, oxygenated blood flows into the aorta 47. 2 allows for discharge. During systole, the aortic valve 465 is forcibly opened. Figure 4B also shows the right side of the heart during contraction. In a manner similar to the situation in which it occurs, on the right side, blood flows from the right ventricle 420 to the right ventricular outflow tract (not shown). It is guided to the pulmonary valve (not shown) by the tricuspid valve 475, and the tricuspid lobe 476 closes completely. It has been found that by contracting completely, blood is prevented from flowing backward into the right atrium 405. ru.

[0120] Conversely to Figures 4A and 4B, Figures 4C and 4D show some applications of the present invention for the heart. The left and right sides (concentrated on the left) exhibit abnormal blood flow with some retrograde regurgitation during systole. This diagram provides a schematic explanation of a typical flow. Specifically, Figure 4C shows an exemplary heart 400. A schematic cross-sectional view of the anterior portion is shown, illustrating that the aorta 465 not only passes through during systole but is also damaged. The direction of abnormal blood flow passing through the bicuspid valve 485 and entering the left atrium 445 (arrows 480 and 48) (As shown in 1). In this figure, the damaged bicuspid valve 485 has continuous leaves that cannot be properly joined. It has. The associated lobe may be caused by a ruptured chordae tendineae (not shown) or degenerated bicuspid annular tissue. This has the potential to cause further damage to tissue structure, loss of strength, and degeneration. For this type of damaged bicuspid valve 485, the ejection through the aorta 465 Most of the score should be normal and re-entered into the left atrium at 445, as indicated by arrow 480. Figure 4D schematically shows a cross-sectional view of the anterior part of an exemplary heart 400, and during systole, It not only passes through artery 465, but also through the damaged bicuspid valve 495 and within the left atrium 445. The direction of abnormal blood flow entering is shown (indicated by arrows 490 and 481). In this figure, the damaged The bicuspid valve 495 suffers from tent-like lobes that cannot be properly joined. Tent-like lobes are involved in ventricular reconstruction. This may be caused by a heart attack or other ischemic event. There is a condition where, if the ventricular portion (due to ischemia) loses its function, the remaining healthy portion of the ventricle becomes excessively compressed. It shrinks, causing local hypertrophy and deformation of surrounding anatomical structures (e.g., chordae tendineae and associated leaflets). vinegar.

[0121] Now, referring to Figures 5A and 5B, they illustrate some applications of the present invention, including a bicuspid valve and Artificial heart valve device implanted within the tricuspid valve location (bicuspid valve location 535, tricuspid valve location 555) This is a schematic diagram showing a cross-sectional view of the anterior part of an exemplary heart (500, 550) in an embodiment. Specifically, Figure 5A schematically shows an exemplary heart 500, the heart 500 is the pulmonary artery trunk 501, Along the plane that divides the right atrium 502, left atrium 503, right ventricle 510, and left ventricle 505 into two parts. By cutting, the cardiac cavity (right atrium 405, left atrium 445, right ventricle 42) The internal features and details of the 0 and left ventricle (425) are exposed, and these internal features and details have already been revealed. Design of an exemplary embodiment of an artificial heart valve device 535 designed for implantation within the cusp valve location Related to the features. An exemplary embodiment of the artificial heart valve device 535 is inflow (left atrium 445 or right The minimum contour extending to the atrial (405) region and the outflow (right ventricle 420 or left ventricle 425) region It may be designed to have ventricular outflow tract obstruction (left ventricular outflow tract 512, right ventricular outflow tract 5 20) To prevent the outflow area from becoming blocked and to prevent the ejection score from decreasing in the case of outflow area blockage, and to prevent the inflow area from becoming blocked In the event of blockage, blood flow impairment and stagnation are prevented. Exemplary embodiment of artificial heart valve device 535 Furthermore, natural anatomical structures, such as the anterior and posterior regions of the bicuspid valve ring (514, Figure 5B) (These are 545 and 540 respectively) can be used, and the radially outward force It is used to assist in anchoring the device, and at the atrial floor (left, 445) and ventricular apex (left, 4 25) By having a load-bearing surface adjacent to it, it is effectively sandwiched between the natural valve rings. This prevents the device from moving to the left atrium 445 or left ventricle 425. The following are its features: Let me explain further.

[0122] Similar to Figure 5A, Figure 5B schematically illustrates an exemplary heart 550 in several applications of the present invention. The heart 550 is shown to consist of the pulmonary trunk 501, right atrium 502, left atrium 503, and right ventricle 510. And the left ventricle 505 is cut along the plane that divides it into two, thereby revealing the cavity of the heart ( The internal characteristics and details of the right atrium (405), left atrium (445), right ventricle (420), and left ventricle (425) are revealed. These internal features and details are from an artificial heart valve designed to be implanted within the tricuspid valve location. This relates to the design features of an exemplary embodiment of the device 555. The embodiments offer advantages similar to those found in the devices for bicuspid valve positions described and designed above. It can be provided. For example, an exemplary embodiment of the artificial heart valve device 555 is further natural Anatomical structures, such as the anterior, periphery, and posterior regions of the tricuspid valve ring (513, Figure 5A) (These are 565 and 560 respectively) and can utilize radially outward forces This assists in anchoring the device, and also in the base of the atrium (right, 405) and the apex of the ventricle (right, 42) Having a load-bearing surface adjacent to 0), it is effectively sandwiched by the natural valve ring and This prevents the device from moving to the right atrium 405 or the right ventricle 420.

[0123] Now, referring to Figures 6A-6H, there is an exemplary heart according to some application examples of the present invention. This is a schematic diagram of the front cross-section of the 600, illustrating various percutaneous transport pathways for an exemplary artificial heart valve device. Figure 6A shows the corresponding percutaneous passage within the apical bicuspid valve site, indicated by directional arrow 605. This is shown in Figure 6B, which shows the corresponding percutaneous passage within the apical tricuspid valve site, indicated by the directional arrow 615. Figure 6C shows the corresponding percutaneous route within the tricuspid valve site of the femoral vein graft, indicated by the directional arrow 6. Figure 25 shows the corresponding percutaneous pathway within the transfemoral vein / transintercalated bicuspid valve site. This is indicated by the directional arrow 635. Figure 6E corresponds to the location of the bicuspid valve embedded under the clavicle. The percutaneous pathway is shown and indicated by the directional arrow 645. Figure 6F shows the tricuspid valve transplanted subclavianally. Figure 6G shows the corresponding percutaneous pathway within the device, indicated by directional arrows 655. The corresponding percutaneous pathway within the bicuspid valve location is shown and indicated by the directional arrow 665. Figure 6H This indicates the percutaneous pathway corresponding to the bicuspid valve position inserted by the atrium, indicated by directional arrow 675. As shown herein, some embodiments of the exemplary artificial heart valve devices described herein are specific Although described in conjunction with transdermal delivery entry routes, as to be understood, these embodiments are other transdermal It can be used in delivery entry paths. Furthermore, it should be understood that in some applications of the present invention... Furthermore, some features described by combining several embodiments can be combined with other embodiments. This can include those described by combining different transdermal transport pathways.

[0124] Currently, please refer to Figures 7A to 7D, which are variations that can be modified based on several application examples of the present invention. An exemplary self-expanding valve positioned to mate with a functional anchor structure (800, Figure 8A) This is a schematic diagram illustrating an embodiment of frame 700. Specifically, Figure 7A shows an exemplary self-expanding frame. A perspective view of an embodiment of the tension valve frame 700 is shown, and the valve frame may be substantially cylindrical in shape. It has a blood inflow region 701 and a blood outflow region 702 facing the blood inflow region 701, The area described here explains the possible directions in which blood may flow through the device during normal operation. See Figure 7A. The described exemplary self-expanding valve frame 700 embodiment is generally superelastic and shape-memory. It may be composed of any alloy having the properties, for example, nickel-titanium or any other superalloy. Compositions of materials capable of exhibiting elastic, shape memory, or other alloys, polymers, or self-expanding properties. Generally, an exemplary embodiment of the self-expanding valve frame 700 is the valve frame inlet region. (715, Figure 7C) may have a valve adjacent to the blood inflow area 701 and around the valve. Features and exemplary self-expanding valve frame 700 and adjacent valve frame inlet area for preventing leakage. Between (715, Figure 7C) and an exemplary differentially deformable anchor structure (800, Figure 8A) Arranged to provide features that enable mating connection. Exemplary self-expanding valve frame 7 Enables a mating connection between 00 and an exemplary differentially deformable anchor structure (800, Figure 8A). A further feature is that it includes multiple (736, Figure 7B) elongated inlet region connecting members 735. These are arranged to be flexible, movable, and bendable, allowing for structural deformation and force absorption. It receives and, at the same time, still provides secure and lasting support between the members. Inflow area connecting member 7 35 may be further arranged in a geometric shape 740 which includes a bendable portion, This enables structural deformation and force absorption. The inflow region connecting member 735 further has an inflow region connecting element 7 45 may be positioned to provide a positioning feature and inflow area contact Used for a connectable mating between the connecting member 735 and the corresponding atrial connecting element (825, Figure 8A) The corresponding atrial connector (825, Figure 8A) is an exemplary differentially deformable anchor structure. Located in the embodiment of (800, Figure 8A). Around the exemplary self-expanding valve frame 700 Features that enable prevention of leakage around the valve include a valve seal cover (780, Figure 7D). It can be made from materials such as polyester, nylon, PTFE, ePTFE, and processed materials. Any application to constructing pericardial tissue, polymer fabrics, or durable artificial heart valve devices It is made of a fabric of other materials, and from the valve frame inlet region (715, Figure 7C) to the valve frame It is positioned to extend to the outflow area (725, Figure 7C, as shown below). Furthermore, an exemplary embodiment of the self-expanding valve frame 700 further comprises a valve frame ring region (72 0 (Figure 7C) can have a valve frame inlet region (715, Figure 7C) and valve frame Located adjacent to and between the Rehm outflow region (725, Figure 7C, as shown below), Furthermore, it is arranged to provide a position for connecting the suture thread and the fabric, and the fabric is, for example, poly Polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics, or This applies to constructing any other material for durable artificial heart valve devices. Sutures and Self-expanding valve frame 700 exemplifying the woven fabric in the valve frame ring region (720, Figure 7C) The feature allows for providing a position for connecting sutures and fabrics to it. Geometric shape of the valve leaf attachment connecting rail 730 and the bendable deformable portion of the valve leaf attachment connecting rail It may include shapes (775, Figure 7C), and the geometric shape may also receive sutures and fabrics. This allows for and further provides flexibility (not shown) that is useful in the crimping process, and the apparatus is then illustrated. It is used for transdermal or other transplantation by being loaded onto a transport system (not shown). Furthermore, the illustrative images are... The embodiment of the self-expanding valve frame 700 further has a valve frame outflow region (725, Figure 7C) The valve frame outflow region is adjacent to the valve ring region (720, Figure 7C) and Located downstream, and an exemplary self-expanding valve frame 700 and adjacent valve frame outflow region (7 25. Fitting with an exemplary differentially deformable anchor structure (800, Figure 8A) as shown in Figure 7C. Arranged to provide features that enable connection. Exemplary self-expanding valve frame 700 And an exemplary differential deformable anchor structure in the adjacent valve frame outflow region (725, Figure 7C) The feature that enables a matched connection between 800 (Figure 8A) is multiple (749, Figure 7C) elongated It may include an outflow area connecting member (750, Figure 7C), which is a valve leaf attachment rail (730 Adjacent to and extending from the valve boundary attachment region (765, Figure 7A) (Figure 7C), and attached to the valve boundary The attachment area (765, Figure 7A) is formed using a method involving sutures and a boundary flap attachment component (770, Figure 7A). The connections of each outflow region member are positioned to support the attachment of multiple valve leaves (790, Figure 7D). (750, Figure 7C) may further include a series of outflow region connecting elements (755, Figure 7C) It is the outflow region connecting member (750, Figure 7C) and the corresponding ventricular region connecting element (845, It functions as a positioning feature that can be connected and mated between Figure 8A) and the corresponding ventricular region connecting element. (845, Figure 8A) is adjacent to the ventricular-coordinated structural support column (836, Figure 8A), and the column is, for example Located in an embodiment of an exemplary differentially deformable anchor structure (800, Figure 8A). Each outflow region The regional connecting member (750, Figure 7C) has a geometric shape of a part that can be further bent and deformed (760, Figure 7C). 7C) may include, and it is arranged to be flexible, movable and bendable, allowing deformation of the structure. Moreover, it absorbs force while simultaneously providing reliable and lasting support between the components. ru.

[0125] Refer to Figure 7D for an illustration of a self-expanding valve frame 777 in some applications of the present invention. A schematic front view of a typical embodiment is illustrated, which shows the tissue valve leaf for preventing leakage around the valve. and includes a fabric covering (valve seal cover) 780. Self-expanding valve frame 777 in Figure 7D The embodiment includes a valve leaf attachment rail 730, which provides positioning for a plurality of valve leaves 790. The leaves are chemically treated and biocompatible intrapericardial tissue material, or biocompatible Polymer materials, or any biocompatible materials applicable to the manufacture of valve leaflets for artificial heart valves It may be composed of other structures. Each valve leaf 790 extends between the valve boundaries 795, and the valve boundaries 795 The valve boundary 795 is adjacent to and between the ranges of each valve leaf attachment rail 730, and the valve boundary 795 is further a boundary Includes a covering 786 and an attached suture line 785.

[0126] Currently, please refer to Figures 8A-8D, which are illustrative examples of some applications of the present invention. This is a schematic diagram illustrating various views of an embodiment of the deformable anchor structure 800. The exemplary differentially deformable anchor structure 800 shown in 8A-8B is an anchor It may include an atrial region 805, and the anchor atrial region 805 is generally a rhomboid unit structure. It includes multiple elongated supports that define the structure and generally has a first rigidity. Atrial region 805 is positioned to coincide with the atrial surface of the heart's natural atrioventricular valve (see Figures 5A-5B). (and also provides resistance to the movement of the cardiac atrioventricular valves from the atria towards the corresponding ventricles.) The atrial region 805 may further include a plurality of atrial discharge members 830, and each atrial discharge portion Material 830 is adjacent to and extends from the atrial-constant structure 820, and the atrial-constant structure 820 is Furthermore, it is positioned to provide a smoother surface, and is an exemplary transport system conduit (not shown). The smooth surface can be pulled to capture and fit the artificial heart valve device of this disclosure. The atrial release member 830 is arranged to include the geometric shape 831 of the atrial release member. It also has a differentially deformable anchor structure 800 and an exemplary transport system (not shown). Allows for a releaseable connection between the two. Exemplary differential deformable anchor structure 800 Additional features may include an atrial region connector 825, which has a geometric shape. It has a shape 826, and it is the inlet region of an exemplary self-expanding heart valve frame (700, Figure 7A) It is positioned to be connectably mated with the region connection element 745.

[0127] The exemplary differentially deformable anchor structure 800 embodiments shown in Figures 8A-8B are further anchored - Includes a fixed valve ring region 810, which generally has multiple long and wide valve ring regions fastening. Including the support columns 862, they together define the annular circumferential structure and are exemplary variants of this embodiment. Possible anchor structure traverses the circumference of 800 and generally has second rigidity. Ring region Region 810 is configured to coincide with the natural atrioventricular ring of the heart (see Figures 5A-5B). The radial expansion force can provide resistance to movement away from the above-mentioned ring. Furthermore, the exemplary differentially deformable anchor structure 800 shown in Figures 8A-8B is Furthermore, it may include an anchor-fixed ventricular region 815, and the anchor-fixed ventricular region 815 is Generally, it has a third rigidity and generally includes multiple long and wide ventricular-coordinate structures 835. It has a heel of 860 (see Figures 5A-5B) adjacent to the apex of the natural ventricle, It includes a plurality of elongated ventricular coherence structure support columns 836, which terminate at a ventricular release member 840. The ventricular discharge member 840 has a geometric shape 850 of the ventricular discharge member, and it has a different deformation. The possible anchor structure 800 is connected in a dischargeable manner to an exemplary transport system (not shown). They are arranged in such a way. Each ventricular consistency structure 835 further includes multiple ventricular region connecting elements 845. It is possible to have the geometric shape 855 of each ventricular region connecting element, and it is exemplary Provides a mating connection between the self-expanding heart valve frame (700, Figure 7) and the outflow region connecting element 755. The heel of the ventricular region-consistent structure 860 may further include a ring anchor element 865. It is possible to achieve an anchor force of the ring structure 800 that penetrates the ring structure and is differentially deformable. It is positioned to reinforce. Finally, the ventricular region 815 is the ventricular wall and ri of the heart's natural atrioventricular valve. It may be positioned to coincide with the ng (see Figures 5A-5B), and heel 860 As a result, the natural ring contacts the apex of the ventricle at a position adjacent to the lower surface of the valve, and separates from the aforementioned ring. It provides resistance to movement into the atria. The first rigidity of the atrial region 805, the ring region 810 The second stiffness and the third stiffness of the ventricular region 815 can be related in this manner. In other words, it provides an optimized and appropriate combination of rigidity to avoid equipment shifts, while simultaneously providing a natural core. It matches the natural structure of the organ. The rigidity may generally be equal. Or, the first rigidity is generally It is greater than or less than one or two of the second and third stiffnesses. The second stiffness is generally greater than one or two of the first and third stiffnesses. Or it may be small. Finally, the third stiffness is generally one of the first and second stiffnesses. The rigidity may be greater than or less than one or two of the rigidities.

[0128] Now, referring to Figure 8D, it shows a woven covering 867 according to some applications of the present invention. This is a schematic diagram of an embodiment having a deformable anchor structure. The anchor has a woven fabric covering 867. The anchor structure may include the above-mentioned deformable anchor structure 800, and further an Includes car seal cover 870, which is positioned to prevent leakage around the valve and for example Polyester, nylon, PTFE, ePTFE, treated pericardial tissue, polymer fabrics Alternatively, it is composed of any other material such as a fabric for a durable artificial heart valve device. The Lucabar 870 further consists of the ring area seal cover 871 and the diamond ring area seal cover. It can include a shape 872, providing the maximum fabric surface area, thereby around the ring It provides maximum resistance to prevent leakage. Finally, the three sets of ventricular outflow openings 875 each Multiple ventricular consistency structures 835 are joined together at the boundary of the annular region seal cover 871. This is possible, and the available space below the embodiment of the artificial heart valve device and the device embedded in the device The ventricular outflow tract is positioned to maximize the amount of ventricular outflow tract space (see Figures 5A-5B), Reduces the occurrence of blockages.

[0129] Refer to Figures 9A-9F, which illustrate an exemplary artificial heart based on several applications of the present invention. This is a schematic diagram showing various views of an embodiment of the valve device 900. Specifically, Figure 9A is an example. Figure 9B shows a front view of an embodiment of the artificial heart valve device 900. Figure 9C shows a perspective view of the artificial heart valve device 900 from the inflow side, and Figure 9D shows the Figure 9E shows a front view of an artificial heart valve device with a cover 915. Finally, Figure 9E shows an exemplary artificial heart A cross-sectional view of the valve apparatus 900 is shown. As shown in Figure 9A, an exemplary self-expanding heart valve frame. An example of a deformable anchor structure (800, Figure 8A) that differs from the embodiment (700, Figure 7A). The mating connection at the outlet end 910 between the exemplary embodiment can be seen. Similarly, Figure 9B In this example, a variant differs from the embodiment of the self-expanding heart valve frame (700, Figure 7A). Fitting at the inlet end 905 between an exemplary embodiment of a possible anchor structure (800, Figure 8A) The combined connection can be seen. As shown in Figure 9D, according to some applications of the present invention, An exemplary embodiment of an artificial heart valve device having a cover 915 is schematically shown, where the valve seal The cover 780, valve leaf 790, and anchor seal cover 870 are shown. Now refer to Figure 9E. Cross-sectional view of an exemplary embodiment of an artificial heart valve device 900, based on several applications of the present invention. This is shown in general terms. The projection curve that traces the anchor section 925 traces the projection that traces the valve frame section 930. This indicates that it is adjacent to the curve. The embodiment of the artificial heart valve device 900 depicts the anchor cross section 925. The overall length of the protruding curve is equal to the overall length of the protruding curve that traces the valve frame cross section 930. It may be designed in such a way that each curve in the assembly device is as shown in Figure 9D. If the covering 915 is connected (connected at the inlet 935 and connected at the outlet 940), Examples of situations where tension is applied to both the end and the outflow end include, for example, a conduit in a transport system. When loaded into the embodiment (as further described below), the heart valve frame (700, Figure 7A) ) conforms to and uniformly contracts with the differentially deformable anchor structure (800, Figure 8A).

[0130] Finally, Figure 9F shows the geometric shape of the anchor's ventricular region connecting element (855, Figure 8A). Various selectable implementations for connecting to the connection structure of the frame outflow region connection element 755 This shows the state. Specifically, detail section circles 945, 973 and 974 correspond to the enlarged section circle (9 Five reference lines (946, 947, 94) leading to 50, 955, 960, 965, 964 References 8, 963, and 962) are shown, and embodiments for selecting the connection structure are described for each. The line 946 extends from the first detailed section circle 945 to the enlarged section circle 950, and is in the form of a suture or f An embodiment is shown that includes a connection structure for a filament-type material 951, wherein the material 951 is already anchored Geometric shape of the ventricular region connector (855, Figure 8A) and the outflow region connector of the valve frame Interleaved between 755 and it is positioned to achieve a rigid connection. Suture The thread-like or filamentous material 951 is a fabric or polymer that is stretchable or flexible. It may also contain: The suture-like or filamentous material 951 is a flexible or elastic metal alloy. It may further include the following: The suture-like or filament-like material 951 is rigid and inflexible. It may contain materials, polymers, textiles, or alloys. Reference line 947 is the first detailed section. A connection from circle 945 to enlarged cross-section circle 955, and a suture line or filament-type material 956. An embodiment including a continuation structure is shown, in which the material 956 already has the geometry of the ventricular region connecting element of the anchor It is connected between the target shape (855, Figure 8A) and the outlet region connecting element 755 of the valve frame. The suture line or linear material 956 may be arranged to provide a connection, and the connection is anchored - Geometric shape of the ventricular region connecting element (855, Figure 8A) and the outflow region connecting element of the valve frame Allows for some displacement between child 755 and the suture linear or filamentous material 956. It may include elastic or flexible fabrics or polymers. It may be suture-like or filament-like. Material 956 may further contain a flexible or elastic metal alloy. Suture-like or filam The stencil material 956 includes rigid and non-flexible materials, polymers, textiles, or alloys. This is also good. Reference line 948 passes from the first detailed section circle 945 to the enlarged section circle 960, and the carp An embodiment of a connection structure including a coil-shaped material 961 is shown, wherein the coil-shaped material 961 is already an anchor Geometric shape of the ventricular region connecting element (855, Figure 8A) and the outflow region connecting element 7 of the valve frame It is connected between 55 and the coiled material 961. The connection is between the geometric shape of the anchor's ventricular region connecting element (855, Figure 8A) and the valve frame. The coiled material 961 allows for maximum displacement between the outflow region connecting element 755 and the coiled material 961. It may also contain a fabric or polymer that is flexible or pliable. The coiled material 961 is pliable Alternatively, it may be an elastic metal alloy. Furthermore, the coiled material 961 is rigid and impermeable. It may contain flexible materials, polymers, textiles, or alloys.

[0131] Reference line 962 extends from the second detail section circle 974 to the enlarged section circle 964, and is a suture line material. The following are optional embodiments including a connection structure for material 971, wherein the suture linear material 971 is an anchor Between the geometric shape 975 of the ventricular region connecting element and the outflow region connecting element 755 of the valve frame It is directly connected to (adjacent to and extending from heel 860). In this particular embodiment, Furthermore, one or more ventricular-coordinated structural support struts 836 are directly connected to the suture material 971. This allows for replacement, thereby creating tensile connections, rigid connections, or connections between connecting elements. To achieve a connection that can absorb several displacements. The connection depicted in the particular selectable embodiment. The structure may be implemented in one or more valve joint regions, or in any valve joint region. This does not have to be realized (795, Figure 7D). The connection structure is affected by any valve joint region (795) due to valve ring changes caused by the anchor. The configuration may be designed to isolate (Figure 7D). Also, the connection configuration described in this embodiment is , the total curl height of the device (as shown in Figure 10A, the vertical distance between member 830 and member 850) The design may be made to minimize the distance between the two.

[0132] Reference line 963 extends from the third detail section circle 973 to the enlarged section circle 965, and is a suture line material. The opposing end (outflow region connecting member 750) of the above selected embodiment, including the connection structure of material 971 The view (focused) is drawn, and it is the geometric shape of the anchor ventricular region connecting element 975 Between the valve frame and the outlet region connecting element 755 (adjacent to and extending from the heel 860) It is directly connected to ( ).

[0133] Now, referring to Figures 10A and 10B, they show some application examples of the present invention, specifically crimping. Exemplary embodiments of the artificial heart valve device 900 located in structure 1000 and extension structure 1020 This is a schematic diagram of the view. Specifically, Figure 10A shows the crimped structure 1000, and the artificial heart valve device. 900 is crimped and subjected to radial compression or axial tension to exemplify the implementation of a transport system conduit. When subjected to a specific form, the crimped structure 1000 (which will be further described below) appears. The atrial region 1005, ring region 1010, and ventricular region 1015 when in position 1000 are also It can be seen. Similarly, Figure 10B shows the expanded structure 1020, and the artificial heart valve device 900 is completely The expanded structure 1020 appears when it is released and embedded within the natural atrioventricular valve.

[0134] Refer to Figures 11A-11C, which show some application examples of the present invention in a transport system. Exemplary Embodiment of Artificial Heart Valve Device 900 as Developed by Exemplary Embodiment 1100 This is a schematic diagram showing the typical sequence of development processes. Figure 11A shows the proximal capsule portion 1101 The diagram also shows an example of the configuration of the conduit 1104 adjacent to the distal capsule portion 1102 before deployment. The proximal capsule portion 1101 may have a proximal mark tape 1106, and the far The distal end capsule portion 1102 may have a distal end mark tape 1107, and thereafter This is useful for imaging guidance in the insertion program. An exemplary embodiment of the transport system 1100 is It may be positioned to run on the Idwire 1103, thereby embedding the program. The device is tracked to ensure it is in position during the loading period. Figure 11B shows an exemplary transport system 1105. An example of the configuration of a conduit 1104 in an embodiment is shown, which has a proximal end capsule portion. The part 1109 is translated so that it moves away from the distal end capsule portion 1102, and the artificial heart valve is mounted. This shows an exemplary embodiment of the present invention exposing the atrial portion. According to the example, Figure 11C shows an example of a conduit 1104 in an exemplary embodiment of the transport system 1110. This shows the fully deployed configuration of the main part, which consists of a near-end capsule portion 1112 and a far-end capsule portion 1 111 are both completely parallel to each other and separated, illustrating an exemplary implementation of the artificial heart valve device 900. This shows complete exposure of the morphological portions of ventricles 1113 and 1114. What needs to be understood is In this exemplary embodiment of the artificial heart valve device 900, the atrium 1113 and the ventricle 1114 The part is not completely released.

[0135] Refer to Figures 12A-12B, which illustrate the expansion and contraction phases in some application examples of the present invention. This is a schematic diagram showing the transition sequence between the heart cycle phases, specifically the cross-sectional view of the heart (diastolic phase 1). (200°C, 1240°C during systole, as shown in Figures 12A and 12B, respectively) and buried in the original position. An example of an artificial heart valve device embedded (diastolic embodiment 1230, systolic embodiment 1260) (See Figures 12A and 12B, respectively). Specifically, Figure 12A is This shows an exemplary diastolic embodiment of an artificial heart valve device 1230 implanted within the bicuspid valve position. The open valve leaflet 1235 of the diastolic embodiment of the artificial heart valve device 1230 opens during diastolic ventricular filling. In response to blood flowing from the left atrium 1206 (section 1205) towards the left ventricle 1215 It functions in the same way. Similarly, the closure leaf of the exemplary aortic valve 1225 also responds to diastolic ventricular filling. It acts. Directly below the closure lobe of the exemplary aortic valve 1225 are the left ventricular outflow tract 1220 and the left heart A cross-section 1210 of the ventricular wall can be seen, and it is in an expanded state. Artificial heart valve device 123 You can see arrow 1221 directly above the exemplary diastolic embodiment, which is the heart valve frame. Corresponding to the posture of an exemplary extended embodiment of Room 1231, the posture is a differentially deformable anchor - The exemplary expansion embodiment of structure 1229 moves in position relative to the natural valve ring where it is located. No. In an exemplary extended embodiment adjacent to the artificial heart valve device 1230, the natural anterior lobe 1201 It can be seen, and it is depicted as a free, open, and unrestricted position. As shown in Figure 12A, an exemplary embodiment of the natural anatomical structure and artificial heart valve device is Furthermore, the anatomical structure of selected atrioventricular valves, such as the tricuspid valve and its corresponding natural tricuspid valve anatomy. This can be achieved for academic structures.

[0136] Now, referring to Figure 12B, it shows some application examples of the present invention, already within the bicuspid valve position This is a schematic diagram of an exemplary systolic embodiment of an artificial heart valve device 1260 implanted in the present. Specifically, refer to a cross-sectional view of the heart at systole 1240. Exemplary systole of the artificial heart valve device 1260. In this embodiment, the closure valve leaflet 1255 acts in response to the pressurization of the left ventricle 1215, and therefore During the systolic period when the ventricle contracts, blood is transferred from the left ventricle (1215 in transverse plane, 1250 in left ventricular region) to the left ventricle. It can be discharged into the outflow tract 1220 and also discharged by the open aortic valve 1245. The unrestrained natural anterior valve lobe 1202 is in the closed position, illustrating the artificial heart valve device 1260. It can be seen that it abuts against the anterior part of the typical systolic embodiment. Artificial heart valve device 126 You can see the arrow in Figure 1265 directly above the exemplary systolic embodiment, which is the heart valve frame. Corresponding to the posture of the exemplary contraction embodiment of the 1261, the posture is a differentially deformable anchor The exemplary systolic embodiment of structure 1259 is repositioned in the atrial direction relative to the natural ring where it is located. To understand this, see the example of natural anatomical structures and artificial heart valve devices shown in Figure 12B. The exemplary embodiment further includes selected atrioventricular valve anatomical structures, such as the tricuspid valve and its corresponding This can be achieved using the anatomical structure of the natural tricuspid valve.

[0137] Referring to Figure 13A, it is an exemplary transport system 1 according to some applications of the present invention. Perspective view of detail 1315 of an exemplary embodiment of an artificial heart valve device 1340 loaded onto 300 This is a schematic diagram illustrating an exemplary embodiment of a load transport system 1300 in a curved structure. The proximal end portion of the capsule 1310 adjacent to the proximal end neck 1305, and the proximal end portion 131 It may include the distal end portion of capsule 1325 adjacent to 0, where each capsule portion During the deployment period, it is positioned so that it moves parallel to the opposite capsule section and moves away from it. An example of a load transport system 1300 in a curved structure before introducing the conduit of M1300. In this embodiment, the guide wire 1330 is fixed to an anatomical position above its top by a guide rail. They may be arranged in such a way that the guide wire 1330 is positioned in a predetermined position by program. It may be placed in the sectioned view window 1315 which shows an exemplary artificial heart valve assembly. You can see the exposed cross-section 1340 of the stent, which is a bendable portion. An embodiment of the geometric shape 1316 is shown. Geometric shape 1316 of the bendable portion A particular part of an exemplary embodiment of the heart valve apparatus 1340 is bent in a specific direction and with a specific bending radius. They may be arranged to allow access through natural anatomical blood vessels, veins, and arteries. Suitable for tracking the position where the ventricular valve passes through and enters the natural atrioventricular valve. Enlarged view of the cross-sectional window 1 320 details the geometric properties 1345 of the enlarged and partially exposed curved deformable portion. Let me explain in detail. Currently, due to tracking drawing, we are referring to arrow 1335 in Figure 13B and turning to Figure 13B. Based on several applications of the present invention, it is an exemplary artificial heart valve device stent planar pattern. A schematic representation of fragment 1350 is shown. Exemplary artificial heart valve device stent planar pattern 135 0 may include exemplary embodiments of an atrial region bending element 1351, which is an artificial heart valve The device is positioned to allow for specific bending in the atrial region, and the ventricular region bending element 13 52 Exemplary embodiments thereof, in which the artificial heart valve device curves in a particular manner in the ventricular region. It will be configured to allow this.

[0138] Referring to Figure 14, it shows an exemplary embodiment of the transport system (1500, Figure 15A). This is a schematic diagram of the terminal portion 1405, showing a partial deployment of the artificial heart valve device 1400 that is loaded here. Exemplary embodiments of the structure are used to illustrate the purpose. As described above, artificial heart valve Apparatus 1400 is one of several applications based on the present invention. Exemplary delivery system (1500) Figure 15A) can include an assembly of flexible conduits that are concentrically aligned and radially adjacent. , the first conduit 1420, at least partially extended and passing through the first conduit 1420 A second conduit 1430 is positioned, and at least partially extends through the second conduit 1430. A third conduit 1445 is positioned to pass through, and at least partially extends to the first conduit It includes a fourth conduit 1450 positioned to extend beyond pipe 1420. The fourth conduit 1450 is It may have a proximal end outer cover portion 1415. The third duct 1445 has a tip side cover - It may have a section 1425. The second conduit 1430 has a connecting element 1435. This can be done and is used to connect to a part of the example artificial heart valve device 1400. The tube 1420 can accommodate multiple tethers 1440, which are located in the atrial region of the heart. It is positioned to be mated and connected to a portion of the internal valve device 1400. The tether can be further divided into multiple tethers. - Connector structure 1455 may include a tether that thereby connects to the artificial heart valve device. A mating connection method can be provided, and further details are provided below. This provides additional details regarding the above conduit.

[0139] Refer to Figures 15A-B, which show a compressed transport state according to some application examples of the present invention. This is a schematic diagram of an exemplary transport system 1500 for a load artificial heart valve device 1535.

[0140] The transport system 1500 is used for intracardiac transport of the compressed artificial heart valve device 1535, The handle portion 1520 and the portion adjacent to the handle portion 1520 and from the handle portion 1520 It is arranged to include a conduit portion 1525 that extends to the distal end.

[0141] The handle portion 1520 generally has an elongated shape and is generally cylindrical, with the proximal end It has a region 1505, a distal end region 1515, and an intermediate region 1510 located between them. .

[0142] The conduit portion 1525 extends from the distal end region 1515 of the handle portion 1520 to the distal end. One or more flexible conduits, for example, a first conduit 1420 and a second conduit 1430 It can extend and penetrate the first conduit 1420, thereby passing through the second conduit 143 The flexible distal end portion of 0 is placed outside the distal end of the first conduit 1420. Second conduit 14 The distal end portion of 30 may further include a connecting element 1435, which is pressure Arranged to be releasably attached to at least a portion of the reduced artificial heart valve device 1535 It is placed.

[0143] The conduit section 1525 of the conveying system 1500 further includes a third conduit 1445, and the third The conduit 1445 extends and passes through the second conduit 1430, thereby reaching the outer cover portion at the distal end. Section 1425 is installed outside the distal end of the second conduit 1430.

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

[0145] The conduit portion 1525 of the conveying system 1500 further includes a holding area 1530, which is pressure It is positioned to hold and transport the retracted artificial heart valve device 1535. For example, the third The distal end outer covering portion 1425 of conduit 1445 and the proximal end outer covering portion of the fourth conduit 1450 Part 1415 can function as a restraining member, and both are compressed artificial heart valve devices 1 At least a portion of 535 is constrained radially to be in a compressed transport state, thereby compressing It holds the artificial heart valve device 1535.

[0146] The distal end region 1515 of the handle portion 1520 is generally the first dial wheel 154 Including 5, the first dial wheel 1545 is a mechanical interaction within the distal end region 1515 It is controlled to communicate with the fourth conduit 1450 (as described in more detail below). The operation of the dial wheel 1545 moves the fourth conduit 1450 from the first position (proximal end) Controlling the movement to move parallel to a second position (distal end) downstream from the first position, and then to move back. This is possible. When it is in the second position (distal end), the outer covering portion of the proximal end of the fourth conduit 1450 1415 is at least of the compressed artificial heart valve device 1535 due to being in a favorable position A portion can be restrained. When in the first position (proximal end), the fourth conduit 1450 The proximal outer covering portion 1415 can be in an advantageous position, thereby compressing the artificial At least a portion of the heart valve apparatus 1535 is released from radial constraint.

[0147] The distal end region 1515 of the handle portion 1520 is generally a saltwater washing port 1540a It also contains, which removes trapped air from between concentrically adjacent conduits during the device preparation period. This is useful in that it allows, for example, the injection of sterile saline solution between the conduits 1420 and 1450. By enabling this, air is removed from between the fourth conduit 1450 and the first conduit 1420, This removes the blocked air and prevents the air bubble embolism from introducing blood flow.

[0148] As can be seen by referring to Figures 16A-B and 17A-E, the middle of the handle portion 1520 Region 1510 generally includes saltwater washing port 1540b and tether shuttle assembly 1560. This includes, and further details are provided below. Intermediate region 1510 saltwater washing port 1540 b helps remove trapped air from between concentrically adjacent conduits during the equipment preparation period. For example, sterile saline solution can be injected between the first conduit 1420 and the second conduit 1430. By doing so, the air between the first conduit 1420 and the second conduit 1430 is removed, and It removes trapped air and prevents air bubbles from introducing blood flow. Handle section In the intermediate region 1510 of 1520, the first duct 1420 is connected to the handle section 1520 by a machine. The position for mounting to the target may be included.

[0149] The proximal end region 1505 of the handle portion 1520 is generally the second dial wheel 155 Including 0, the second dial wheel 1550 is a mechanical interaction within the proximal end region 1505 It is controlled to communicate with the second conduit 1430 as needed (this will be explained in more detail below). The operation of the second dial wheel 1550 moves the second conduit 1430 to the first position (proximal end). Control it to move parallel to a second position (distal end) downstream of the first position and then return to its original position. It is possible. When in the second position (distal end), the compressed artificial heart valve device 1535 It can be located in a more distal position (for example, within the ventricles of the heart). At the same time, it is loaded for transport. When in the first position (proximal end), the compressed artificial heart The internal valve device 1535 can be positioned at the proximal end and simultaneously loaded for transport. I can stay.

[0150] The proximal end region 1505 of the handle portion 1520 is further a third dial wheel 1555 This may include the third dial wheel 1555 being a machine inside the proximal end region 1505. Through interaction, it is controllably connected to the third conduit 1445 (explained in more detail below). The operation of the third dial wheel 1555 moves the third conduit 1445 to the first position (proximal). Controlled to move parallel from the first position to a second position (distal end) downstream of the first position, and then back. It is possible. When in the first position (proximal end), the distal end of the third conduit 1445 is outside. The side covering portion 1425 is in an advantageous position, which compresses the artificial heart valve device 1535. At least a portion can be restrained. When in the second position (distal end), the third conduit The outer covering portion 1425 at the distal end of 1445 can be in an advantageous position, thereby compressing At least a portion of the artificial heart valve device 1535 is released from radial restraint.

[0151] The proximal end region 1505 of the handle portion 1520 is generally a saltwater washing port 1540c It also contains, which removes trapped air from between concentrically adjacent conduits during the device preparation period. This is useful in, for example, allowing the injection of sterile saline solution between conduits 1430 and 1445. By doing so, air is removed from between the second conduit 1430 and the third conduit 1445, This removes the blocked air and prevents the air bubble embolism from introducing blood flow. The proximal end region 1505 of the portion 1520 further includes a saltwater washing port 1540d, which It helps to remove trapped air from inside the guidewire cavity, and guidewire The cavity extends from the first end of the third conduit 1445 to the second end opposite the first end, and By allowing sterile saline solution to be injected into it, trapped air and bubbles are removed. The embolus prevents blood flow from entering the system.

[0152] The proximal end region 1505 of the handle portion 1520 may further include a compensation mechanism, for example The internal mechanism (which will be explained in more detail below; please refer to Figures 19A-C, 18A-I, and 20A-C) is also explained below. (to illuminate) and it is the second dial wheel 1550 and the third dial wheel 15 55 provides a shared lead screw system (shown in Figures 8A-C), and therefore the The operation of the second dial wheel 1550 mechanically displaces the third dial wheel 1555. It is possible that the operation of the second dial wheel 1550 is the same time and the same In the same direction, 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 frame 1570 shows an enlarged view of the subject of the detailed view section frame 1565, The compressed artificial heart valve device 1535, the distal end covering portion 1425 of the third conduit 1445 and The view includes a magnified view of the proximal end covering portion 1415 of the fourth conduit 1450, and the view is clear. It will definitely be provided.

[0154] Currently, referring to Figures 16A-B, there are several application examples of the present invention, specifically a conveying system. This is a schematic diagram of 1500. The distal end region 1515 and intermediate region relative to the handle portion 1520. Further details of region 1510 and the proximal region 1505 are provided.

[0155] Specifically, the distal end handle region 1515 is further divided into the distal end region handle cap 160 It may contain 0, and it is connected to a holding system (not shown) and a transport system 15 Provides a support surface 1605 to allow relative rotation between part 00 and the retaining system. It is possible. The first dial wheel 1545 has multiple dial wheel covers 1 These dial wheel covers 1610 may be included within 610, and the first dial Includes wheel 1545 and simultaneously cylindrical (or other shape) distal end handle region 1515 Used to fasten parts together as a single unit. Parallel movement groove 1 on the distal end handle area 1515 615 can provide a gap for parallel movement of the saltwater washing port 1540a, saltwater washing port The conduit 1540a moves controllably in conjunction with the fourth conduit 1450, and the first dial wheel The 1545 is rotatably operated in a first or second direction, in order to face the first direction. ru.

[0156] The proximal end handle region 1505 further includes the proximal end region handle cap 1630. This can be done, and it is connected to a holding system (not shown) and part of the transport system 1500. A support surface 1635 is provided to allow relative rotation between the holding system and the support surface. The second dial wheel 1550 is included within a plurality of dial wheel covers 1610. These dial wheel covers 1610 may be placed on the second dial wheel 15 Used to include 50, and at the same time the cylindrical (or other shape) of the near-end handle region 1505 The ) portion is fastened as a single unit. The parallel movement groove 1625 on the proximal end handle region 1505 is saltwater washed. This can provide a gap for the parallel movement of the cleaning port 1540c, and the saltwater washing port 1540c The second conduit 1430 moves in a controllable manner, and the second dial wheel 1550 moves It is designed to operate so as to be rotatable in one direction or a second direction, and to face the first direction.

[0157] Referring to Figure 16B, as described above, the intermediate handle region 1510 further has a saltwater washing port. It may include an exit groove 1620 for 1540b, which is concentric and adjacent during the apparatus preparation period. This can help remove trapped air from between the conduits.

[0158] As shown in the figure, and as detailed below, the central handle region 1510 has multiple tie tesers - It can include the shuttle 1640, and these tethered shuttle 1640s are artificial hearts The tension between the valve device (not shown) and multiple tie tethers (1440, Figure 14) can be controlled. Positioned to optimize their placement, these tie tethers are tightened by a tightening mechanism for the artificial heart valve device. It is positioned to be connected to the part. The tether shuttle holder 1640 is the tether shuttle holder It may include the rod body 1645 and the tether shuttle latch buckle 1650, The shuttle latch buckle 1650 is centered around the tethered shuttle latch hinge 1655. It is positioned to rotate controllably from position 1 to position 2, and it is positioned from position 1 to position 2. It rotates and displaces, and is mechanically attached to the proximal end portion of the tether protection sleeve 1660. It is positioned as follows. By activating the tether shuttle latch 1650, tether protection The internal connection communicating with the proximal end portion of sleeve 1660 is the proximal end of tether protection sleeve 1660 The end portion is concentrically positioned (from the distal end position to the proximal end position opposite the distal end position) and the internal tether cable The top of the bull (not shown) can be retracted, thereby tethering (1440, Figure 14) It provides controllable connection and release from the artificial heart valve device (as further explained below). (See Figures 17A-F).

[0159] The tether shuttle body 1645 is roughly rectangular in shape, and within the tether shuttle groove 1665 The tether shuttle groove 1665 may then transition from its first end to its second end, which is opposite to the first end. The tether shuttle piece body 1645 corresponds to the first end of the tether shuttle groove 1665. It is biased by a spring (not shown) at the first proximal end position and is operated by a push mechanism. It can be moved in translation, or, for example, automatically moves in translation when placed under a tensile load. The artificial heart valve is then transported along a tether (Figure 1440, 14).

[0160] Refer to Figures 17A-F, which illustrate some application examples of the present invention, specifically the artificial transport system. This is a schematic diagram of the heart valve device holding area 1530. Figure 17A shows the artificial heart valve device holding area 153 An enlarged view of 0 is provided. The retaining area 1530 may include the distal end outer cover 1425. Its distal end is connected to a third conduit 1445, and the third conduit 1445 is connected to the second conduit 1430 The second conduit 1430 can extend through it, and a guide wire passes through it. It has a cavity 1760 and a proximal end outer cover 1415 extending from the fourth conduit 1450. This is possible. As described above, the distal end and proximal end outer covers (1425, 141, respectively) (5) together provides position to the compressed artificial heart valve device 1535.

[0161] More specifically, the artificial heart valve device holding area 1530 is further located in the closed structure 1700. A number of tether connector structures 1455 may be included. In the closed structure 1700, the tether - The connector structure 1455 is concentric with the second conduit 1430 and has a diameter relative to the second conduit 1430. They are installed adjacent to each other in the direction and generally along the long axis (not shown) of the second conduit 1430 Forms a straight line. The tether connector structure 1455 is closed and compressed artificial heart valve device. The artificial heart valve device 1535 is connected to and in contact with the part 1535 and is compressed radially. It provides tensile restraint force, thereby holding it in a closed and compressed structure during transport. Applies. More specifically, the tether connector structure 1455 is closed and compressed. Connecting elements of the cardiac valve device 1535 (for example, atrial connection element having an atrial connection pull tab 1730) It can be connected to and made contact with the child 1720). The tether link connector structure 1455 is The outermost ends of the Zerlink sheath 1740 and inner cable 1775 mate and make contact. This is possible, and the relationship is schematically shown in Figure 17F, which has hidden lines.

[0162] More specifically, refer to link connector structure 1455 and link protective sleeve 17 The distal end portion of 40 can be mated and connected to the link connector cover 1715 (link (Connected via the system connector cover 1735), the rope connector cover 1715 is The link connector 1725 is positioned to slidably mate with the link connector inside Includes TA1725. Link system connector 1725 further contains the first within the link system protective sleeve It mates in contact with the internal cable 1775 that extends from one end to the second end. The proximal end portion of the ser protection sleeve 1660 is fitted with the operable portion of the shuttle mechanism 1705. The shuttle mechanism 1705 may be connected to the internal tether connector 1725. Control the tether connector cover 1715 to the first or second position (opposite the first position). It can be positioned in a way that allows for parallel movement. The tether connector also has an inner case. Cable 1775 engages and connects with the fixed part of the shuttle mechanism 1705, and maintains its position. They are arranged in such a way.

[0163] As schematically shown in Figure 17C, the tether connector cover 1715 is offset to the distal end. If you do this (closed in the first position), it will preferentially cover the tether connector 1725. This results in a compressed portion of the artificial heart valve device 1535, for example, as a connecting element, The atrial connection element 1720 having the atrial connection pull tab 1730 is disconnected. Figure 17B shows A perspective view of the shuttle mechanism 1705 corresponding to the first closed position of the link connector cover 1715 is shown. It is shown in a simplified form.

[0164] Referring to Figure 17C, the additional features of the second conduit 1430 are described. Specifically, a series This explains the different regions of stiffness. The distal end extends from the distal end of the second conduit 1430, which is the distal end stiffness. The first region is rigidity region 1745, followed by distal end rigidity transition region 1750, and finally distal end flexibility region. The region is 1755. The inherent stiffness of the distal end region of the second conduit 1430 is the stiff portion (1745). ) converts to the softest part (1755), and provides reinforced flexibility, and narrow half This allows the material to pass through the diameter and curve (for example, as experienced during implantation).

[0165] As schematically shown in Figure 17E, the tether connector cover 1715 is offset to the proximal end. If it is in the second position (which is the opposite of the first position and is open), then it indicates a translation. The tether connector 1725 (indicated by arrow 1770) can be preferentially exposed. As a result, the compressed portion of the artificial heart valve device 1535, for example as a connecting element, is the atrial connection. Release the atrial connector element 1720 having a pull tab 1730. Figure 17D shows the tether connector The second open position of Kuta 1725 (after the tether shuttle latch 1650 has rotated, arrow 17 A schematic perspective view of the shuttle mechanism 1710 corresponding to (indicated by 65) is shown.

[0166] Refer to Figures 18A-I, which illustrate some applications of the present invention, by conveying a transport system These are a series of schematic diagrams showing the expansion of the deployed artificial heart valve device, as shown in Figures 18A-B. The artificial heart valve device holding region 1530 is shown, which has a first closed state (Figure 18A). Here, the proximal end outer covering 1415 of the fourth conduit 1450 is in a closed position, and the compressed artificial It covers at least a portion of the heart valve apparatus 1535. The artificial heart valve apparatus holding area 1530 is also second It is drawn to have an open state (Figure 18C), where the proximal end outer cover of the fourth conduit 1450 is located. -1415 is in the open position and displaced by a distance Dl from the closed position to the proximal end, thereby being compressed. At least a portion of the artificial heart valve device 1535 and a plurality of tether connector structures 1700 are expanded. Before tensioning, expose the multiple tether connector structures 1700 that are in a closed structure.

[0167] As described above and as shown in Figure 18B, the proximal end outer cover 1415 of the fourth conduit 1450 is The operating displacement distance D1 of dial wheel 1545 (indicated by rotation arrow 1830) It can pass through. The proximal end outer covering 1415 of the fourth conduit 1450 is spaced in the opposite direction. The D1 can be moved, thereby activating the same first dial wheel 1545. This returns it to the closed state as described above (Figure 18A).

[0168] When in the open position (Figure 18C), the compressed portion of the artificial heart valve device 1535 (for example, the heart Before the atrial region 1410 expands, the atrial region 1410 may have a first diameter d1. The compressed portion of the artificial heart valve device 1535 (e.g., the atrial region 1410) expands. Subsequently, the atrial region 1410 has a second diameter d2 (Figure 18D) that is larger than the first diameter and It can be in a structure (not shown) suitable for atrial surface junction of a natural heart. A certain tether 1800 is also present in Figure 18D.

[0169] Referring to Figure 18E, the distal end outer cover 1425 is in the closed position before it is displaced to the open position. It is depicted as follows: A partially developed person with a partially developed atrial region 1805 The heart valve apparatus 1835 operates the third dial wheel 1555 (indicated by arrow 1865) As shown in Figure 18F, the distal end outer cover 1425 of the third conduit 1445 is at least at the distal end. It can be further expanded by displacing it by a distance D2 (Figure 18G), thereby partially expanding. At least a portion of the artificial heart valve device 1835, for example, the compressed ventricular portion 1845 A component is exposed and positioned to releasably engage with the ventricular anchor engagement groove 1825. The interlocking nail 1820 is exposed. The distal end outer cover 1425 of the third conduit 1445 is in the opposite direction. It is possible to move the distance D2, thereby returning it to the closed state as described above (Figure 18E). ).

[0170] It is in a partially unfolded state (Figure 18E), but before it is fully expanded (Figure 18G), pressure The constricted ventricular region 1845 may have a third diameter d3. Compressed ventricular region 184 After dilation, the expanded ventricular region 1840 has a fourth diameter d4 that is larger than the third diameter (Figure 18). Having G) and having a structure (not shown) suitable for bonding with the ventricular surface of a natural heart. It is possible.

[0171] Refer to Figures 18H-I, which illustrate several application examples of the present invention, from a transport system to a final A series of schematic diagrams of the deployed artificial heart valve device are shown.

[0172] Figure 18I shows a fully extended atrial region 1850, according to some applications of the present invention. Schematic diagrams of the fully expanded ring region 1855 and the fully expanded ventricular region 1860. The fully dilated atrial region 1850 is the surface of the atrial tissue of a natural heart, for example, the left of the bicuspid valve. It is positioned to junction with the atrial surface (see Figures 5A-5B). The ring region 1855 is bonded to the ring tissue surface of the natural heart, for example, the ring surface of the bicuspid valve. It is positioned as shown (see Figures 5A-5B). The fully dilated ventricular region 1860 is natural The surface of the ventricular tissue of the heart, for example, the left ventricle, bicuspid lobe and / or any combination of chordae tendineae and joints. They are arranged in this manner (see Figures 5A-5B).

[0173] Control, final release, and permanent implantation of the artificial heart valve device 1810 are performed by each tethered shuttle. This can be achieved by the control operation of L1640 (Figures 16B and 18H), and each tethersha The control operation of Tor 1640 (Figures 16B, 18H) is controlled by the tether of each tether shuttle 1640 By activating the shuttle locking device 1650 (Figures 16B and 18H), the tether shuttle 1 640 results in the opening structure 1710. According to some applications of the present invention, complete The fully open and permanently implanted artificial heart valve device 1810 is schematically shown in Figure 18I. Each tether shuttle 1640 is activated and the tether connector 1815 is fully open. Then, each atrial connecting pull tab 1730 can be released from restraint, thereby allowing each atrial region This made it possible to fully extend 1850, and it was completely freed and permanently embedded. This brings us to the artificial heart valve device 1810.

[0174] Referring to Figures 19A-D, according to some applications of the present invention, a second conduit and a third This provides a schematic diagram illustrating the mechanism of structural changes in the outer covering layer of a conduit.

[0175] Specifically, Figure 19A shows the partially deployed atrial region 1805 of the artificial heart valve device already The device is propelled to make contact with the natural atrial floor (not shown) and to impart a seating force to the first conduit 1420. When added, the compensation mechanism within the transport system affects the overall anchor structure of the artificial heart valve device. The effect is explained, and the resulting partial expansion of the contact between the atrial region 1805 and the natural atrial floor. Maintain contact (not shown). In Figure 19A, the first conduit 1420 and the fourth conduit 14 50 is displaced to the distal end, generating tension in link 1920, and the connection between them creates a single It is found that the seating force of the atrial region 1805 for partial dissection is generated. The first conduit 1420 and Such distal end displacement of the fourth conduit 1450 is achieved by the compensation mechanism of the transport system. Now, please refer to Figures 19B to 19D to explain the details. As shown in Figure 19B, the displacement is predetermined. A simplified diagram of the furthest end portion of the transport system 1910 is provided. (Tether and artificial heart valve device) The embodiment is not shown in Figure 19B, and therefore, in the case of conduits, during this stage of the device operation This provides a clearer explanation of the mechanical interactions present in the first duct 1420. Element D5 is the most important part of the first duct 1420. This indicates the first distance between the far end region and the reference point of the second duct (near the rigidity transition region 1750). The third dial wheel (1550, Figure 19C) is indicated by the rotating arrow 1900 (Figure 19C). By activating the distal end holding area 1905 and the partially deployed artificial heart valve In all cases (not shown), the second distance indicated by element D6 is the furthest point of the first conduit 1420. Until the same reference point on the end region and the second conduit (proximity to the rigid transition region 1750) is reached. It is then translated parallel to the proximal end. The proximal end orientation position (after displacement) 1915 is explained in Figure 19D. Here, there are no embodiments of tethers and artificial heart valve devices, and therefore, in the case of conduits, This provides a clearer explanation of the mechanical interactions that occur during this stage of the placement operation within the transport system. Such a positional change of the distal end holding region 1905, activated by the compensation mechanism, is an artificial heart Valve transport can be controlled more effectively. The compensation mechanism within the transport system is an anchor structure. It can assist in controlling the structural changes experienced, and it can get closer to the anatomical structure of the ventricle, and human It is possible to improve the gap between the artificial heart valve portion and the ventricular region structure, and to create a reversible artificial heart. Repositioning and repositioning of the internal valves are necessary.

[0176] Referring to Figures 20A-C, the cross-sectional view illustrates the transport in several application examples of the present invention. A schematic diagram illustrating an embodiment of the system is provided. Figure 20A shows a conveying system shown in cross-section 2000. Embodiments of the middle and near-end regions of the stem are shown. Also, the third dial wheel 1555 Lead screw 2015 and 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] Figure 20B shows an embodiment of the distal end region of the transport system, as indicated in section 2005. The lead screw 2025 of the first dial wheel 1545 is shown in Figure 20C. This shows an example of the holding region of the transport system, as indicated in section 2010.

[0178] The subject matter of this disclosure has been described in its preferred embodiments, but it should be understood that the use The words used are descriptive words, not restrictive words. Therefore, this subject The attached claims may be modified without departing from the actual scope of the invention.

[0179] As will be understood by those skilled in the art, the present invention is not limited to what has been specifically shown and described above. Conversely, the scope of the present invention includes combinations and subcombinations of the various features described above, and This does not constitute a change or modification of prior art, and a person skilled in the art would conceive of these after reading the above. It is possible.

[0180] The following is a list of selectable claim sets.

[0181] 1. A system including an artificial heart valve device, Including an artificial heart valve device and transport system, The artificial heart valve device is aligned concentrically with the valve frame, radially adjacent, and directly connected. Includes a differentially deformable anchor structure, The transport system comprises a first conduit, one or more tether assemblies, a second conduit, and control Including the assembly, The first conduit has a first diameter, a primary cavity, a first bendable portion, and a front The primary cavity includes one or more secondary cavities radially adjacent to it. The tether assembly is releasably connected to the portion of the artificial heart valve device and the first guide It is arranged to pass through one or more secondary cavities of the pipe in parallel, The dimensions of the second conduit are assembled and parallel moved within the primary cavity of the first conduit. Designed to move, the second conduit is a cavity, a second bendable portion and one or It includes a connecting element for a portion that can be connected to multiple artificial heart valve devices. The control assembly includes a compensation mechanism that is connected to and communicates with the second conduit, where the control The assembly enables controllable parallel movement of the second conduit and allows for configuration changes of the artificial heart valve. They are arranged in such a way, The system is in a transport state, where the artificial heart valve device is released from the tether assembly. They are connectable and the connecting elements are in a compressed, elongated structure, By propelling the aforementioned transport system, the artificial valve is pushed to the natural atrioventricular valve via the femoral entry tract. The valve is embedded in a way that allows it to be controlled by a compensation mechanism within the advanced control assembly.

Claims

1. An artificial heart valve device, The artificial heart valve device includes a valve, a valve seal cover, a deformable anchor structure, and an anchor seal cover. The valve comprises a plurality of valve leaves and an expandable valve frame for supporting the valve, the expandable valve frame having an inlet region, an intermediate region and an outlet region downstream of the inlet region, the inlet region further comprising a plurality of flexible inlet region connecting members (735) which allow the expandable valve frame to bend or curve radially, the intermediate region further comprising a valve leaf support structure, and the outlet region further comprising a plurality of rigid outlet region connecting members (750). The valve seal cover extends between the inlet region and the outlet region, and is configured to prevent leakage around the valve, and the valve is configured to transition between a blood flow-allowing state and a blood flow-blocking state. The differentially deformable anchor structure is concentrically aligned with the expandable valve frame, radially adjacent to the expandable valve frame, and surrounds the expandable valve frame, and the differentially deformable anchor structure includes an atrial region, a ring region, and a ventricular region, the atrial region having substantially a first rigidity and including a plurality of atrial region connecting elements (825), the plurality of atrial region connecting elements (825) adjacent to the plurality of flexible inflow region connecting members (735) of the expandable valve frame, and the plurality of flexible inflow region connecting members (735) of the expandable valve frame Connected to and in contact with the connecting member (735), the ring region substantially has a second rigidity, the ventricular region substantially has a third rigidity, and includes a plurality of flexible ventricular region connecting elements (845), the plurality of flexible ventricular region connecting elements (845) are adjacent to and in contact with the plurality of rigid outflow region connecting members (750) of the expandable valve frame, and the plurality of flexible ventricular region connecting elements (845) enable the differentially deformable anchor structure to bend or curve radially. The anchor seal cover extends between the atrial region and the ventricular region, and is configured to prevent leakage around the valve. The artificial heart valve device is configured to transition controllly between a radially minimized compressed state configured for transport and a radially maximized extended state configured for implantation. The deformable anchor structure is configured to permanently anchor the artificial heart valve device within the atrial valve of the heart when the artificial heart valve device is in the expanded state and implanted. An artificial heart valve device wherein the connections between the plurality of flexible inflow region connecting members (735) and the plurality of atrial region connecting elements (825), and the connections between the plurality of rigid outflow region connecting members (750) and the plurality of flexible ventricular region connecting elements (845), are configured to absorb forces between the differentially deformable anchor structure and the expandable valve frame.

2. The artificial heart valve device according to claim 1, wherein the differentially deformable anchor structure is configured to match the natural structure of the heart, and the expandable valve frame is configured to maintain a substantially cylindrical geometric shape.

3. The aforementioned flexible multiple inflow region connecting members (735) extend in the radial direction, The aforementioned rigid multiple outflow region connecting members (750) extend in the axial direction. The plurality of atrial region connecting elements (825) extend in the radial direction, The artificial heart valve device according to claim 1, wherein the plurality of flexible ventricular region connecting elements (845) extend in the axial direction.

4. There are up to nine flexible inflow area connecting members. The artificial heart valve device according to claim 2, wherein there are up to three outflow region connecting members with a maximum rigidity.

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

6. The artificial heart valve device according to claim 1, wherein the differentially deformable anchor structure has an anchor cross section, and the expandable valve frame has a valve frame cross section, and the anchor cross section and the valve frame cross section are of equal length so as to contract uniformly together when the anchor structure and the valve frame are subjected to tension in the inlet and outlet regions while being loaded into the transport system.

7. The artificial heart valve device according to claim 1, wherein the differentially deformable anchor structure comprises a plurality of elongated and broad ventricular-identical structures (835), the plurality of elongated and broad ventricular-identical structures (835) comprising a heel (860) for adjacency to the apex of a natural ventricle and a plurality of elongated ventricular-identical structure support struts (836).

8. The artificial heart valve device according to claim 7, wherein the plurality of elongated ventricular-coordinated structural support columns (836) are terminated by ventricular discharge members (840).

9. The artificial heart valve device according to claim 7, wherein each of the plurality of flexible ventricular region connecting elements (845) is at least partially formed by a filament woven between the geometric shape (855) of the ventricular region connecting element and the outflow region connecting member (755) of the plurality of rigid outflow region connecting members (750).

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

11. The artificial heart valve device according to claim 1, wherein each flexible inlet region connecting member is configured to allow the inlet region to bend radially.

12. The artificial heart valve device according to 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 artificial heart valve device according to claim 1, wherein each of the plurality of flexible inflow region connecting members is configured to allow the ventricular region to bend radially.

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

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

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