Systems, methods, and devices for treating diseased or otherwise damaged tricuspid valves

Abstract

A single vena cava crossing tricuspid valve device comprises at least one stent structure; a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, optionally at least partially covered; a second end configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, optionally at least partially covered; a first valve connected to at least a portion of the first end so that when the CCTD is implanted, it is located in at least a portion of the right atrium (RA) above the IVC; a second valve connected to at least a portion of the second end so that it is located in at least a portion of the right atrium (RA) below the SVC or at least partially within the SVC, below the azygos vein; and sealing means.

Description

[Technical Field]

[0001] Related applications This disclosure claims benefit and priority to U.S. Provisional Patent Application No. 63 / 418,909, filed October 24, 2022, and is also related to PCT Application No. PCT / IB2017 / 050534, filed February 1, 2017, and PCT Application No. PCT / IL2019 / 050658, filed June 7, 2019. Each of these disclosures is incorporated herein by reference in whole.

[0002] This disclosure relates, in general, to medical systems, apparatus, devices, and methods for implantation into the heart, and in more detail, to stent-based devices for treating tricuspid valve disease and / or dysfunction. [Background technology]

[0003] The tricuspid valve closes during ventricular systole to prevent the backflow of blood from the right ventricle to the right atrium, and opens during ventricular diastole to allow blood to flow from the right atrium to the right ventricle.

[0004] Tricuspid regurgitation can arise from tricuspid annular dilation and right ventricular enlargement. Tricuspid regurgitation is typically classified into two main etiologies: primary and secondary (also known as functional). Primary tricuspid regurgitation accounts for approximately 10-20% of cases and is associated with valve insufficiency originating from the valve or chordae tendineae. Examples of primary tricuspid regurgitation include loose or perforated valves, torn tendons, TR induced by pacemaker leads, degenerated surgical tricuspid valve replacement, and many others. However, in most cases, tricuspid regurgitation is secondary to other causes, as seen in dilated cardiomyopathy, atrial fibrillation and annular dilation, right ventricular volume or pressure overload, and many others.

[0005] Tricuspid regurgitation causes right atrial overload transmitted to the superior vena cava, inferior vena cava, and their branches. Ultimately, this leads to hepatic congestion, ascites, generalized edema, peripheral edema, and other clinical manifestations of congestive heart failure. If left untreated, significant tricuspid regurgitation often leads to heart failure and death.

[0006] Clinically available treatments for tricuspid regurgitation include open cardiac surgery and / or drug therapy. However, open cardiac surgery for tricuspid valve replacement and / or repair is rarely performed, mainly due to its high mortality and morbidity. Instead, drug therapy may fail to resolve the problem, may even cause the disease to progress, leaving patients with a deteriorated quality of life and impaired cardiac function.

[0007] Due to the high surgical risks of tricuspid valve replacement and / or repair, most patients with tricuspid regurgitation are currently considered inoperable. This results in a very large number of untreated patients with significant tricuspid regurgitation.

[0008] Significant effort has been made to develop and clinically approve transcatheter-device solutions for tricuspid regurgitation (e.g., transcatheter tricuspid valve replacement (TTVR) and transcatheter edge-to-edge repair (TEER)), but such solutions do not address the challenges and limitations associated with the biomechanism of the tricuspid valve in individual patients. For example, patients exhibiting large regurgitant gaps (distance between poorly joined valve leaflets), typically exceeding 10 mm, cannot be treated with TEER. Similarly, patients with large tricuspid annulus diameters, typically exceeding 52 mm, are generally known to be unsuitable for treatment with TTVR devices. Additional exclusion criteria for TTVR and TEER exist, including the presence of pacemaker or defibrillator leads crossing the tricuspid valve, previous failed treatment of tricuspid valve leaflets, and many others.

[0009] TTVR and TEER are also demanding in terms of procedure complexity and duration, typically requiring the use of multiple imaging techniques for transplantation purposes, such as transesophageal echocardiography in addition to standard fluoroscopy.

[0010] Given these difficulties, a treatment option has emerged: vena cava valve implantation (CAVI), which utilizes the superior vena cava (inferior vena cava, or both inferior and superior vena cava) to position the transcatheter valve. While CAVI is relatively straightforward to perform and unaffected by the complex biomechanics of the tricuspid valve or previous failed attempts on the tricuspid valve, it still presents its own set of challenges. For example, patients with tricuspid regurgitation typically exhibit a dilated right heart lumen. This generally refers to the right ventricle (RV) and right atrium (RA), but may also refer to the inferior and superior vena cava (IVC and SVC). For instance, the dilated IVC and SVC can have a diameter of up to 55 mm. Furthermore, the high compliance of the IVC and SVC makes anchoring the transcatheter CAVI valve extremely difficult and increases the likelihood of valve migration.

[0011] Furthermore, the branching of the IVC and SVC, including the adjacent hepatic vein and azygos vein, respectively, complicates the anchoring and sealing of the CAVI device, considering the need to avoid obstructing or disrupting the inflow from the hepatic vein and azygos vein. [Overview of the project] [Means for solving the problem]

[0012] Accordingly, in relation to at least some embodiments of the present disclosure, a cross-caval tricuspid device (CCTD) for treating tricuspid insufficiency is provided. Such CCTDs in some embodiments offer many advantages, improvements, and features over existing technologies such as TTVR, TEER, and current CAVI concepts, and address many of the remaining challenges in transcatheter tricuspid regurgitation treatment.

[0013] In some embodiments of this disclosure, when compared to prior art devices, the CCTD is as follows: - Single device, - Single transplant procedure, - Improved anchoring and corresponding anti-slip properties, - Improved sealing (in some embodiments, no obstruction / disturbance to inflow from the hepatic vein and azygos vein), - A simpler and more concise transplant procedure, - Ability to perform transplantation solely using fluorescence fluoroscopy (e.g., transesophageal echocardiography is not required in transplantation procedures), - Improved fit to the unique tricuspid regurgitation biostructure of the superior vena cava and RA of separate individuals (including, in some embodiments, dimensions, shape, transition from SVC to IVC, and / or angles), - Improved mechanical durability of stent structures with traumatic device ends, - The ability to recapture the device after it has been deployed / released, and - Filtration of blood flow in the IVC / SVC to prevent thrombi / fragments from reaching the right heart and lungs. We provide at least one of them, several in some embodiments, most in some embodiments, substantially all in some embodiments, and all in some embodiments.

[0014] In some embodiments, the CCTD also includes the capability to perform future procedures (after CCTD implantation), such as pacemaker lead implantation, transseptal procedures, right heart catheterization, and valve-in-valve implantation (within the CCTD).

[0015] In some embodiments of the present disclosure, a single crossed tricuspid valve device (CCTD) for treating tricuspid valve insufficiency is provided, comprising at least one stent structure and a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC (the first end is optionally at least partially covered). The device may also be configured for implantation in the superior vena cava (SVC) and comprises a second end (the second end may also be at least partially covered, optionally) that anchors the device in the superior vena cava; a first valve connected to at least part of the first end so as to be positioned above the IVC and within at least a portion of the right atrium (RA) when the CCTD is implanted, so as not to obstruct the inflow of blood coming from the hepatic veins; a second valve connected to at least part of the second end so as to be positioned below the SVC or at least partially within the SVC, below the azygos vein, within at least a portion of the right atrium (RA); an intermediate portion (which may or may not be covered) widened by the RA and the distance between the IVC device valve and the SVC Davis valve; and sealing means configured to prevent, or at least reduce, the backflow of blood coming from the RA into the IVC and SVC.

[0016] In some embodiments, the intermediate portion is optionally configured to rotate at least one of the first and second valves by a desired amount of rotation relative to at least one of the first and second ends. Such rotation helps to shorten the overall length of the device in some embodiments, so that the device can be adapted to the different patient biomechanics.

[0017] In some embodiments, the intermediate portion is constructed from the stent area and a soft / flexible material such as (e.g.) fibers, biological tissue, polymer, or composite material, so that the device is shortened by pushing the two device ends toward each other and / or elongated by pulling the two device ends toward each other. This feature helps to shorten or elongate the overall length of the device, so that the device can conform to different patient biostructures.

[0018] In some embodiments of the present disclosure, an artificial heart valve device is provided, comprising at least one stent structure, at least one valve, and at least one sealing means.

[0019] In some embodiments of the present disclosure, a modular inferior vena cava crossing tricuspid valve device for treating tricuspid regurgitation is provided. The modular inferior vena cava crossing tricuspid valve device is configured for implantation in the inferior vena cava (IVC) and includes a first stent configured to anchor the device in the IVC, optionally at least partially covered; a second stent configured for implantation in the superior vena cava (SVC) and optionally anchoring the device in the SVC, optionally at least partially covered; a first valve connected to at least a portion of the first end such that when the CCTD is implanted, it is disposed within at least a portion of the right atrium (RA) above the IVC; a second valve connected to at least a portion of the second end such that it is disposed within at least a portion of the right atrium (RA) below the SVC or at least partially within the SVC and below the azygos vein; sealing means for the IVC and SVC; and an optional connector disposed between the first valve and the second valve, optionally configured to rotate at least one of the first valve and the second valve by a desired amount of rotation relative to at least one of the first stent and the second stent.

[0020] In some embodiments of the present disclosure, a vena cava crossing tricuspid valve device for treating tricuspid regurgitation is provided. The vena cava crossing tricuspid valve device includes at least one stent structure, a first end of the stent structure configured for implantation in the inferior vena cava (IVC) and for anchoring the device in the IVC, and further includes first sealing means including a first skirt attached to the outer diameter of the first end. The vena cava crossing tricuspid valve device also includes a second end of the stent structure configured for implantation in the superior vena cava (SVC) and for anchoring the device in the SVC. A first valve is connected to the first end, a second valve is connected to the second end, and the position of the first valve along the longitudinal direction of the stent structure overlaps the position of the first skirt or is positioned between the position of the first skirt and the position of the second valve.

[0021] In the above embodiment, second sealing means including a second skirt attached to the outer diameter of the second end may be provided, and the position of the second valve along the longitudinal direction of the stent structure may overlap the position of the second skirt, or the position of the second valve may be positioned between the position of the second skirt and the position of the first valve.

[0022] The longitudinal direction of the stent structure extends along the length of the stent structure.

[0023] The first valve and the second valve can have an extension in the longitudinal direction and can have a cylindrical outer shape. The skirt can be attached to the outer diameter along an annular portion having a smaller longitudinal extension of the valve. Thus, when viewed from the side, the shape of the cylinder with a larger extension can overlap the shape of the ring with a smaller extension.

[0024] Each of the previously described embodiments can further include one and / or the other of the following structures, features, functionalities, functions, steps, and clarifications, and in some embodiments, if such structures, features, functionalities, functions, steps, and clarifications are not mutually exclusive, can include a plurality, a majority, substantially all, or all of the following structures, features, functionalities, functions, steps, and clarifications. - The intermediate portion or connector has a length sufficient to extend between the first end and the second end, or, where applicable, sufficient to extend between the first stent and the second stent. - The intermediate portion can be configured as rotational, modular, linear, and / or can be configured for at least one of rotational, modular, linear (or, in some embodiments, none of these). - The intermediate portion can have a structure weaker than the first and second ends of the stent structure to allow for local rotation in the intermediate portion. - At least one valve and any optional plurality or all valves are intraluminal valves. - The first stent, the second stent, the first valve, the second valve, the sealing means for the IVC and / or SVC, and the connectors are configurable to different dimensions to accommodate different patient biomechanisms. - The sealing means comprises at least one skirt. - The sealing means comprises multiple skirts. - The sealing means comprises at least two skirts. - The sealing means comprises at least three skirts. - The sealing means is configured to prevent backflow of blood from all of the right atrium to at least one of the inferior vena cava (IVC) and superior vena cava (SVC), and leakage around all of one and / or other components of the device, without obstructing the inflow into the hepatic vein and azygos vein by using sealing means that (in some embodiments) comprises a suprahepatic IVC skirt and a subzygos SVC skirt, respectively. - The outer diameter of at least a portion of the device is between 15-70mm, 15-60mm, 15-50mm, 15-40mm, 15-30mm, 15-20mm, 20-70mm, 20-60mm, 20-50mm, 20-40mm, 20-30mm, 30-70mm, 30-60mm, 30-50mm, 30-40mm, 40-70mm, 40-60mm, 40-50mm, 50-70mm, 50-60mm, and 60-70mm, as well as in the range between them. - The sealing means comprises one or more sealing structures positioned on or adjacent to every element of the device, and, where applicable, on or adjacent to each element of the device, one or more of the sealing structures being sized and shaped to clearly accommodate anatomical structures positioned opposite and / or adjacent to each element. Each sealing structure encloses only a portion of every element of the device. Each sealing structure encloses the majority of all elements of the device. Each sealing structure encloses every element of the device. - The first sealing structure is positioned along a plane different from the plane of the second sealing structure. - The first structure may be positioned to seal in contact with the walls of the RA and / or IVC, and / or the second structure may be positioned to seal in contact with the SVC or SVC inlet of the RA. - The sealing means comprises multiple layers. - The sealing means includes a reinforcing structure, which may include wires or stents. - The sealing means may include a parachute structure, which may be configured to open the sealing means during the deployment of the device. - The sealing means comprises a first perforated layer and a second sealing layer, where, The first perforated layer and the second sealing layer may be configured to establish a pocket. • Established pockets are to have dimensions and shapes that promote tissue growth therein, and / or The first perforated layer is positioned adjacent to the tissue. - The sealing structure includes a skirt and contains an inflatable balloon structure, the balloon structure may be donut-shaped. - The sealing structure includes an expandable skirt. - The sealing structure includes an elastic skirt that can be reversibly adhered to the outer surface of the inflatable balloon structure. - Each sealing structure is equipped with a three-dimensional skirt. - Each sealing structure comprises a stent structure (which may be made from nitinol) that is optionally covered by a sealing material. - The sealing means material comprises a skirt having a flange shape and an inner diameter adjacent to the first end of the skirt for attachment to the outer diameter of at least one structure or element of the device, and an outer diameter toward the second end of the skirt for bonding with any and all inner diameters of the implantation site biostructure, IVC, SVC, or RA. • The skirt includes a straight edge, and / or • The skirt includes a curved edge. - The sealing means comprises a skirt including a donut shape, having an outer diameter configured to bond with the surrounding tissue, IVC, SVC, or RA, and an inner diameter radially spaced from the outer diameter and configured for attachment to a stent structure. - The sealing means comprises a skirt attached to the outer shape of the stent structure, the outer diameter of the skirt being at least twice the outer diameter of the stent structure. - At least one portion of the device (e.g., a first portion) or an element thereof may have a stiffness greater than that of another portion of the device (e.g., a second portion of the device) or an element thereof, and at least one portion may include a region of the device or an element thereof that receives at least one portion of a valve. Regarding rigidity (including one, more, or all of the following): - The rigidity may vary due to the stent thickness (in some embodiments, it ranges from 0.1 mm to 1.5 mm, and in some embodiments, it is preferably 0.2 mm to 1 mm). - The rigidity may vary due to the stent column width (in some embodiments, it ranges from 0.1 mm to 1.5 mm, and in some embodiments, it is preferably 0.2 mm to 1 mm). - Stiffness may vary due to the configuration of the stent structure (e.g., cell dimensions / area are 0.25-10 cm²). 2 In some embodiments, it is preferably 2.5 cm. 2 (That is.) - Stiffness may change due to stent surface treatment (e.g., electrolytic / chemical polishing, sandblasting, passivation, etc.). Regarding the portion that was written, - The other (second) part may comprise the rest of the device, or elements of the rest of the device, and / or - The other (second) part may comprise an intermediate part of the device, or an element of an intermediate part. - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected supports. - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts, one or more of the plurality of interconnected struts associated with the first part having a thickness between 0.2 mm and 1.0 mm. - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected supports that form a plurality of cells. - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts forming a plurality of cells, the area of ​​each cell associated with the first part being 0.25 cm² 2 10cm 2 It is between 2 and 5 cm. 2 It is between these two points. - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts forming a plurality of cells, the region of each cell associated with the first portion being configured in dimensions and shape to allow the passage of a catheter, the catheter may be up to approximately 15 mm in diameter (for example, in some embodiments, so that transcatheter procedures such as transseptal procedures, pacemaker lead placement, and right heart catheterization can be performed after CCTD implantation). - At least one of the first and second stents, or at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first part of the device are sized, shaped, and / or arranged to impart radial forces, unlike the second part of the device (this results in, according to some embodiments, in any CCTD, one part is affected only by forces acting directly upon it and not by forces acting on other parts of the CCTD, which not only aids in the mechanical durability of the CCTD structure but also in the safety of its anatomical contact). - At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts, one or more of the plurality of interconnected struts associated with the first portion, which are sized, shaped, and / or arranged to impart a first diameter different from the second diameter of the second portion (in some embodiments, the CCTD can adapt to different dimensions and shapes of biostructures along its longitudinal axis so that a portion of the biostructure acting on a portion of the device does not impose a change in diameter in the other portion of the device). - Each valve includes at least two commissations, and the rotational position of the first valve commissations when connected to the first end is offset by a predetermined numerical angle from the rotational position of the second valve commissations when connected to the second end, the offset can be determined when the stent structure is not twisted (in some embodiments, the forces acting on both the SVC and IVC commissations while opening and closing the valve are not aligned along one longitudinal line of the stent structure so as to improve the mechanical durability of the stent structure). - Each valve comprises multiple commissures, the commissures of the first valve being offset from the commissures of the second valve by a predetermined numerical angle (in some embodiments, the forces acting on both the SVC and IVC commissures during opening and closing of the valve are not aligned along one longitudinal line of the device to improve the mechanical durability of the CCTD and / or to reduce the corresponding increase and decrease in diameter during cardiac diastole and cardiac systole, respectively). • Multiple commissars consist of two, and the angles of the given numerical values ​​are: 5-90°, 5-80°, 5-70°, 5-60°, 5-50°, 5-40°, 5-30°, 5-20°, 5-10°, 10-90°, 10-80°, 10-70°, 10-60°, 10-50°, 10-40°, 10-30°, 10-20°, 20-70°, 20-60°, 20-50°, 20-40°, and 20° The range is selected from the group consisting of ~30°, 30°~90°, 30°~80°, 30°~70°, 30°~60°, 30°~50°, 30°~50°, 30°~40°, 40°~90°, 40°~80°, 40°~70°, 40°~60°, 40°~50°, 50°~90°, 50°~80°, 50°~70°, 50°~60°, 60°~90°, 60°~80°, and the range between 60° and 70°. • There are three multiple commissarions, and the angles of a given numerical value are selected from a group consisting of the ranges between 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~60°, 20°~50°, 20°~40°, 20°~30°, 30°~60°, 30°~50°, 30°~40°, 40°~60°, 40°~50°, and the ranges between them. • There are three multiple crosses, and the angles of the given numerical values ​​include approximately 60°. - The stent structure, the first stent, and / or the second stent comprises multiple cells established by multiple interconnected struts, each configured as a rhomboid. - At least one thrombus filter (e.g., to prevent thrombi / fragments from entering the CCTD and / or reaching the heart and lungs), where, The filter may have multiple arches, which may be established between adjacent ends of at least one of the first stent and the second stent, and / or The filter is positioned at at least one of the stent ends and includes a mesh configured for device / filter recapture after the device has been implanted. - The device is dimensionally determined and molded for recapture. - The device is dimensionally determined and shaped for recapture by a DS hook. - The device includes lengths between 60mm and 280mm. - The device is configured to translate between the IVC and SVC at an angle between 0 and 45 degrees, with a maximum length of approximately 60 mm. - The covering covers at least one of the first stent and the second stent, or the end of at least one stent structure. - The covering includes one or more openings configured to be adjacent to one or more valve leaflets of the valve. - The first stent, the second stent, or the stent structure configuration is selected from the group consisting of shape memory materials, self-expandable materials, mechanically expandable materials, composite materials, polymers, and combinations thereof. - The valve material is selected from the group consisting of fibers, polymers, composite materials, biological tissues, and combinations thereof. - All sealing means and covers, including a first stent, a second stent, or a stent structure, are configured to be positioned or otherwise located on the device, either internally or externally, within a portion of the device. - All sealing means and covers include materials selected from the group consisting of fibers, biological tissues, synthetic materials, composite materials, polymers, and combinations thereof. - One or more ports are configured for the placement of pacemaker and / or defibrillator leads after device implantation. - One or more ports are configured for the placement of pacemaker leads after device implantation and do not interfere with the SVC valve. - At least one of the first stent and the second stent, or the stent structure, comprises one or more columns positioned above or below the outflow area of ​​the valve located within the first column and / or the second column or column component, or the valve connected to the first column and / or the second column or column component. One or more supports may be positioned between the two valve leaflets of the valve. • One or more supports are positioned in the middle of the valve, and / or • One or more ports are located in at least one of the first stent and the second stent, or in the wall of the stent structure. - The connections between the elements of the device include fibers. - The majority of devices are flexible. - The majority of the device is rigid. - All of the first stent, the second stent, the first valve, the second valve, at least one stent structure, and at least one valve include one or more hooks for connection to other elements, the ends of which are received by openings in other elements for attachment. - The cover is positioned on or elsewhere on the device to prevent one or more blood jets coming from the self-valve from striking the device or its elements. - The intermediate portion of the device is configured for placement within the RA and has only partial coverage (in some embodiments, this allows for blood inflow into the RA and passage of the catheter, while still maintaining the benefits of a single structure, namely, implantation in a single surgery, resistance to migration, and mechanical strength of the device). - One or more radiopaque materials are included in the first stent, the second stent, the stent structure, the valve, the first valve, the second valve, the connector, the intermediate portion, and all one or more parts or locations of one or more valve leaflets of the valve. - The first valve, the second valve, and / or the valve are configured to accept a replacement valve for transcatheter self-expansion or mechanical expansion (including balloon expansion) so as to be placed therein (in some embodiments, this can percutaneously replace the CCTD valve in case of valve dysfunction / deterioration). - The first valve, second valve, and / or valves include a diameter range of 18mm to 30mm in some embodiments, and a range of 25mm to 29mm in some embodiments (for example, the interventional cardiologist can use most commercially available transcatheter valves). - The first valve, the second valve, and / or the valve have at least one of the following features for the purpose of stabilizing the transcatheter valve in the CCTD valve embodiment: rigid perimeter, hourglass shape, upper / lower stop section, and additional features. - The intermediate section or connector is configured to cause a change in the length of the device by twisting, and the intermediate section or connector comprises multiple linear structures for connecting the ends of the device and / or connecting the first stent and the second stent of the device, wherein twisting in a first direction shortens the length of the device, and twisting in a second direction opposite to the first direction lengthens the length of the device.

[0025] In some embodiments, a method is provided for implanting a crossed tricuspid vena cava device (CCTD) to treat tricuspid valve insufficiency. In some embodiments, the method includes the steps of: providing a CCTD according to one of the disclosed embodiments of a CCTD; removably attaching the CCTD to the distal end of a delivery catheter; directing the distal end of the delivery catheter toward an implantation site adjacent to at least one of the IVC, SVC, RA, or RV via either a femoral or cervical technique; deploying or releasing the CCTD at the implantation site; and removing the delivery catheter. Optionally, the method may also include the step of retrieving the deployed CCTD (which may be deployed fully or partially).

[0026] Such embodiments of the method may further include all of the following: - A step to adjust the length of the CCTD (e.g., by rotation and / or shortening). - The modular CCTD, specifically the SVC, IVC, and RA regions, are connected together either before or as an alternative to the insertion of the (modular) device into the catheter. - When the construction of the modular device is carried out in the patient's body, implantation may be via a femoral approach, a cervical approach, or a femoral and cervical approach (i.e., in some embodiments, separate catheters (femoral and cervical) carry at least one part of the modular device).

[0027] These and other purposes, advantages, and benefits of the embodiments of this disclosure will become even clearer with reference to the figures and the detailed description below.

[0028] Those skilled in the art will understand that the drawings are for illustrative purposes only and are not intended to limit the scope of the subject matter of the inventions described herein. The drawings are not necessarily to a constant scale, and in some instances, different aspects of the subject matter of the inventions disclosed herein may be shown in the drawings in an exaggerated or enlarged manner to facilitate the understanding of different features. In the drawings, similar reference numerals refer to generally similar features (e.g., functionally similar elements and / or structurally similar elements). [Brief explanation of the drawing]

[0029] [Figure 1] The images show a CCTD implanted in the right atrium (in cross-section) and a side view of a portion of the CCTD positioned in the SVC and IVC, according to some embodiments of the present disclosure. [Figure 2] The images show, according to several embodiments of the present disclosure, a CCTD implanted in the right atrium (in cross-section), and a side view of a portion of a CCTD positioned in the SVC and IVC, demonstrating the rotational functionality of the CCTD. [Figure 3] The images show, according to several embodiments of the present disclosure, a CCTD implanted in the right atrium (in cross-section), and a side view of a portion of a CCTD positioned in the SVC and IVC, demonstrating the rotational functionality of the CCTD. [Figure 4] The images show a CCTD implanted in the right atrium (in cross-section) and a side view of a portion of a CCTD positioned in the SVC and IVC, according to some embodiments of the present disclosure, demonstrating the shortening functionality of the CCTD. [Figure 5] The images show a CCTD implanted in the right atrium (in cross-section) and a side view of a portion of a CCTD positioned in the SVC and IVC, according to some embodiments of the present disclosure, demonstrating the shortening functionality of the CCTD. [Figure 6A] This is a side view of a CCTD according to several embodiments of the present disclosure (Figure 1 corresponds to the ported CCTD in Figure 6A). [Figure 6B] This is a side view of a CCTD according to several embodiments of the present disclosure (Figure 1 corresponds to the ported CCTD in Figure 6A). [Figure 7A] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 7B] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 8A] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 8B] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 8C] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 8D] This diagram shows various skirt structures for sealing means for CCTD according to some embodiments of the present disclosure. [Figure 9] This is a side view of a CCTD alone, according to some embodiments of the present disclosure. [Figure 10] This is a side view of a CCTD, according to some embodiments of the present disclosure, showing a CCTD implanted in the right atrium / IVC / SVC and illustrating a multiplane skirt structure for sealing means for the CCTD. [Figure 11] This is a diagram of a CCTD with two valves, in which the commissure of the first valve is offset from the commissure of the second valve, according to several embodiments. [Figure 12] This is a diagram of a CCTD having at least one thrombus filter to prevent an embolus from advancing through the CCTD, according to several embodiments. [Figure 13A] This figure shows additional thrombus filter features for CCTDs according to several embodiments, which may be positioned in or near the IVC or SVC, at the end of the CCTD, or adjacent to the CCTD, or within the stent structure of the CCTD (both side and end views are shown). [Figure 13B] This figure shows additional thrombus filter features for CCTDs according to several embodiments, which may be positioned in or near the IVC or SVC, at the end of the CCTD, or adjacent to the CCTD, or within the stent structure of the CCTD (both side and end views are shown). [Figure 14A] This is a diagram of CCTD, which consists of functionalities that enable adaptation to the biological structure of a particular patient, according to several embodiments. [Figure 14B] This is a diagram of CCTD, which consists of functionalities that enable adaptation to the biological structure of a particular patient, according to several embodiments. [Figure 14C] This is a diagram of a CCTD having a structure / functionality (e.g., coating) for preventing one or more blood jets coming from a self-valve from colliding with the device or its elements, according to several embodiments. [Figure 14D] This is a diagram of a CCTD having a structure / functionality (e.g., coating) for preventing one or more blood jets coming from a self-valve from colliding with the device or its elements, according to several embodiments. [Figure 15A]This is a diagram of a CCTD having a stent that includes a first and / or second support, or a valve positioned within a support component, or one or more supports positioned above and / or below the outlet area of ​​a valve connected thereto, according to some embodiments. [Figure 15B] This is a diagram of a CCTD having a stent that includes a first and / or second support, or a valve positioned within a support component, or one or more supports positioned above and / or below the outlet area of ​​a valve connected thereto, according to some embodiments. [Figure 16A] This is a diagram of a CCTD having a stent that includes first and / or second struts, or valves positioned within strut components, or one or more struts positioned above and / or below the outflow area of ​​valves connected thereto, to which pacemaker leads and the like can be directed through the CCTD and positioned within the CCTD. [Figure 16B] This is a diagram of a CCTD having a stent that includes first and / or second struts, or valves positioned within strut components, or one or more struts positioned above and / or below the outflow area of ​​valves connected thereto, to which pacemaker leads and the like can be directed through the CCTD and positioned within the CCTD. [Figure 17] This is a side view of a CCTD having ports for receiving and / or arranging pacemaker leads, etc., according to several embodiments. [Figure 18] This is a side view of a CCTD having mounting means for connecting the components of the CCTD together, according to several embodiments. [Figure 19A] This is a diagram of a CCTD, including functionality to enable the replacement of a previous prosthetic valve with other prosthetic valves, according to some embodiments of the present disclosure. [Figure 19B] This is a diagram of a CCTD, including functionality to enable the replacement of a previous prosthetic valve with other prosthetic valves, according to some embodiments of the present disclosure. [Modes for carrying out the invention]

[0030] As shown in Figure 1, in some embodiments of the present disclosure, a crossed tricuspid vena cava (CCTD) device 100 for treating tricuspid valve insufficiency is provided. In some embodiments, the device may be a single, integrated device, and in some embodiments, the device 100 may comprise two or more interconnected components. Thus, the device 100 may comprise at least one stent structure 102 (in some embodiments, a single stent structure) and a first end 104 configured for implantation in the inferior vena cava (IVC) 200 and anchoring the device in the IVC (in the IVC, the first end is optionally at least partially covered). The device also comprises a second end 106 configured for implantation in the superior vena cava (SVC) 202 and anchoring the device in the SVC 202, the second end being optionally at least partially covered.

[0031] The first valve 108 is connected to at least a portion of the first end 104 so that when the CCTD is implanted, it is located above the IVC 200 within at least a portion of the right atrium (RA) 204 of the heart 201.

[0032] The device 100 may further include a second valve 110 connected to at least a portion of the second end 106 so as to be partially located in the right atrium 204, below the azygos vein 206, or at least partially within the SVC 202, or below the azygos vein 206.

[0033] Device 100 may further include sealing means 112.

[0034] Optionally, the device 100 may further comprise an intermediate portion 114 between the first end 104 and the second end 106, the intermediate portion 114 may be configured to rotate at least one of the first valve 108 and the second valve 110 by a desired amount of rotation 120 relative to at least one of the first end 104 and the second end 106, as shown in Figures 2 and 3 (Figure 2 shows the device 100 in a straight position, and Figure 3 shows the device 100 rotated relative to the first end 104 and the second end 106).

[0035] Each valve (and any valve according to other disclosed embodiments) can be considered an intraluminal valve. The final result of rotational functionality may be achieved (or advanced) through shortening of device 100 (see Figures 4-5).

[0036] In some embodiments, the sealing means comprises an IVC skirt configured to protrude outward and positioned on the RA floor surface, and an SVC skirt configured to protrude outward and positioned on the RA top surface.

[0037] In some embodiments of the present disclosure, the CCTD of the artificial heart valve device 100 may simply be at least one stent structure 102, at least one valve (e.g., valve 108 and / or valve 110), and at least one sealing means 112. One of the valves and / or the others may be made of a material including fibers, polymers, composites, biological tissues, and combinations thereof.

[0038] In some embodiments, the outer diameter of at least a portion of the CCTD device (single or modular) may be between 15-70 mm, 15-60 mm, 15-50 mm, 15-40 mm, 15-30 mm, 15-20 mm, 20-70 mm, 20-60 mm, 20-50 mm, 20-40 mm, 20-30 mm, 30-70 mm, 30-60 mm, 30-50 mm, 30-40 mm, 40-70 mm, 40-60 mm, 40-50 mm, 50-70 mm, 50-60 mm, and 60-70 mm, as well as in the range between these.

[0039] As previously indicated, in some embodiments, the CCTD may be a modular CCTD 116 for treating tricuspid valve insufficiency, as shown in Figures 4-5. In these embodiments, the first end may be configured as a first stent 118, which is configured for implantation in the inferior vena cava (IVC) 200 and anchors the device in the IVC, and is optionally at least partially covered, and a second stent 120, which is configured for implantation in the superior vena cava (SVC) 202 and anchors the device in the SVC, and is optionally at least partially covered. In the device 116, a first valve (not shown) is connected to at least a portion of the first stent 118 so that when the CCTD 116 is implanted, it is located in at least a portion of the right atrium (RA) 204 above the IVC 200. A second valve (not shown) is connected to at least a portion of the second stent 120 so as to be located in at least a portion of the right atrium (RA) 204, below or at least partially within the SVC 204, below the azygos vein 206. The modular device may, like a single device, comprise sealing means and an optional intermediate portion 114 (which may also be referred to as a connector) positioned between the first valve and / or first stent 118 and the second valve and / or second stent 120.

[0040] Similar to the intermediate section 114 of the CCTD100, the connector 114 may optionally be configured to rotate at least one of the first valve and / or first stent 118 and the second valve and / or second stent 120 by a certain amount of rotation (which may be predetermined according to a desired amount). For example, in some embodiments, the amount of rotation may preferably be between 0 and 180 degrees, as seen in Figures 2 and 3.

[0041] The intermediate portion 114 or connector may include a length sufficient to spread between the first and second ends, or, where applicable, sufficient to spread between the first and second stents. In some embodiments, the spread is between approximately 30 mm and 120 mm, and in some embodiments, preferably between 40 and 90 mm.

[0042] At least one of the CCTD stents (and / or connectors / intermediate parts) may be made from shape memory materials, self-expandable materials, mechanically expandable materials, composite materials, polymers, and combinations thereof.

[0043] With respect to some embodiments, and more specifically with respect to a modular CCTD, the components may be configured for a particular person's biostructure, including, for example, different dimensions, shapes, lengths, etc., to correspond to the biostructure of that particular person. To this end, in some embodiments, a kit may be provided that includes several different components, such as a first stent of different dimensions (e.g., diameter, shape, and / or length) for positioning in the IVC, a second stent of different dimensions (e.g., diameter, shape, and / or length) for positioning in the SVC, a valve of different dimensions (e.g., diameter and / or length), a connector of different dimensions (e.g., diameter and / or length), and any and / or all of the above, along with sealing means (e.g., cover, skirt, etc.).

[0044] In some embodiments of modular CCTDs, the joints between components can be considered as a binding material 128 or structure, as shown in Figures 4-5. For example, a fibrous material (which may be a natural or synthetic material) may be placed between the first stent and the connector, and between the second stent and the connector. As shown in Figure 5, the binding material 128 may be flexible in some embodiments so that it can be compressed and stretched (i.e., the length of any part or / or all of the CCTD can be changed). In some embodiments, the binding material may be a tissue, such as pericardial tissue.

[0045] In some embodiments, one of the stents may be configured to be flexible, rigid, or a combination of both (for example, a flexible portion of the stent and a rigid portion of the stent, where the first stent is flexible and the second stent is rigid).

[0046] In some embodiments, the CCTD may include sealing means, whether it is a modular or monolithic device, and as described above. Such sealing means may comprise one or more fluid-impermeable (including sealing means that are mostly or substantially fluid-impermeable) skirts 130, and in some embodiments, may comprise multiple fluid-impermeable skirts 130 (e.g., two skirts, three skirts). Such skirts may include materials such as fibers, biological tissues, polymers, and composite materials.

[0047] As shown in Figures 6A and 6B (see also Figure 1), the sealing means are configured in some embodiments to prevent backflow of blood from all over the right atrium 206 to at least one of the IVC 200 and SVC 202, leakage around all over one and / or other components of the device, while still allowing inflow from the hepatic vein and azygos vein (e.g., the suprahepatic IVC skirt and the subzygos SVC skirt, respectively). Figure 6A shows a single sealing means / skirt in the IVC portion of the CCTD, and Figure 6B shows two sealing means 112 / skirts 130. Furthermore, one or more of each sealing structures located on or adjacent to all elements of the device, and, where applicable, on or adjacent to each element of the device, may be sized and shaped to clearly accommodate anatomical structures located opposite and / or adjacent to each element.

[0048] As can be seen in Figure 6A, the first sealing means 112 includes a first skirt 130 attached to the outer diameter of the first end 104, and the first valve 108 is connected to the first end 104. The position of the first valve 108 along the longitudinal direction of the stent structure 102 coincides with the position of the first skirt 130. In other words, when viewed from the side, portions of the first valve 108 may be seen above and below the portion to which the first skirt 130 is attached to the first end 104.

[0049] Alternatively, although not shown in Figure 6A, the position of the first valve 108 along the longitudinal direction of the stent structure may be located between the position of the first skirt 130 and the position of the second valve 110.

[0050] Furthermore, as can be seen in Figure 6A, the second sealing means 112 includes a second skirt 130 attached to the outer diameter of the second end 106, and the second valve 110 is connected to the second end 106. The position of the second valve 110 along the longitudinal direction of the stent structure coincides with the position of the second skirt 130. In other words, when viewed from the side, portions of the second valve 110 may be seen above and below the portion to which the second skirt 130 is attached to the second end 106.

[0051] Alternatively, although not shown in Figure 6A, the position of the second valve 110 along the longitudinal direction of the stent structure may be located between the position of the second skirt 130 and the position of the first valve 108.

[0052] Therefore, in some embodiments, one or more sealing structures can be configured to surround at least a portion, and in some embodiments, they can be configured to surround only a portion of all elements of the device, most of all elements of the device, and / or all elements of the device. For example, the sealing structures (skirts 130) may be positioned in different planes of the CCTD device and RA204, depending on some embodiments, as shown in Figures 9-10.

[0053] In some embodiments, the sealing means (e.g., skirt) may include multiple layers that may include reinforcing structures such as wires or stents, as shown in Figure 6B. For example, according to some embodiments, wires may contour around at least a portion of the skirt sealing structure to help (e.g.) give greater rigidity to the structure. Such materials for providing such a structure may be nitinol or materials having similar properties.

[0054] Figures 7A to 8D show various skirt structures for sealing means. For this purpose, one or more skirts for some embodiments may be arranged or configured (dimensions, shape, and / or size) as flange-shaped and / or inverted 138a, 138b (Figures 7A to 7B, 8A), and may include or be configured as curved portions, convex portions, or concave portions, including or configured as parachute structures 138c (Figures 7A, 8D), elliptical, bulbous shapes 142 (Figure 8B), and / or tubular shapes 144 (Figure 8C). The tubular skirt in Figure 8C may be or can be considered as an inflatable balloon structure that can be donut-shaped. The donut-shaped skirt may include an outer diameter configured to bond with the surrounding tissue, IVC, SVC, or RA, and an inner diameter radially spaced from the outer diameter and configured for attachment to the stent structure.

[0055] In some embodiments, this may include the establishment of a perforated layer having one or more perforations 146 and / or one or more “pockets” 139 (see Figures 7A-7B). In some embodiments, the perforations and pockets are provided such that, for one or more pockets, they are sized and shaped to promote tissue growth therein. Thus, such perforations and / or pockets may be between 0.5 mm and 5 mm in some embodiments.

[0056] In some embodiments, the skirt sealing structure may be made of an elastic material (e.g., silicone, rubber, and materials having similar properties) that can be configured to cover the outside of other elements, including an inflatable balloon structure. In some embodiments, one or more skirts may include a straight edge (e.g., edge 138d, or a curved or wavy edge 140b).

[0057] In some embodiments, at least one first portion of the CCTD or its elements has a stiffness greater than that of a second portion of the device or its elements. Such features include, - Adapting different device parts to different functions, such as maintaining a strong commissure structure to prevent the valve from collapsing under large systolic pressure gradients, while also considering the flexibility of the IVC and SVC when in contact with the phrenic nerve and / or delicate SVC and IVC, and, - While maintaining resistance to wandering, the flexibility of the intermediate section allows for translational and angular differences between the SVC and IVC. To enable at least one of the following. At least one first part may include a region of the device or element that receives at least a portion of the valve. The second part may include the remaining portion of the region of the device or element, or an intermediate portion of the device or element.

[0058] The CCTD, or one or more elements thereof (e.g., stent structure, first stent, second stent), comprises a structure including a plurality of interconnected struts, one or more of which are interconnected struts associated with the first part, and which have a thickness between 0.2 mm and 1.0 mm. Such interconnected struts can form a plurality of cells 148 (Figure 12). In some embodiments, the area of ​​each cell associated with at least a portion of the CCTD is 0.25 cm². 2 10cm 2 It can be between, preferably (in some embodiments), 2 to 5 cm 2 This is possible. In some embodiments, each cell associated with at least a first portion of the CCTD is configured with dimensions and a shape that allows the passage of a catheter, for example, having dimensions of up to approximately 15 mm in diameter in some embodiments. The cells can include any shape, and in some embodiments, multiple cells each include a rhomboid shape.

[0059] In some embodiments, the interconnected struts associated with the first part of the device may be sized, shaped, and / or arranged to impart radial forces, unlike the second part of the device. In some embodiments, some of the interconnected struts associated with the first part may be sized, shaped, and / or arranged to impart a first diameter different from the second diameter of the second part of the CCTD, so as to accommodate different anatomical dimensions of the IVC, SVC, and RA in a single device.

[0060] In some embodiments of the CCTD100, one or more of the valves have multiple commutations, and in some embodiments involving two valves (Figure 11), the commutation 150a of the first valve 150b is offset by a predetermined numerical angle from the commutation 152a of the second valve 152b. The offset of the commutations of the two valves is useful in some embodiments to distinguish between the force exerted by the CCTD valve of the SVC and the force exerted by the CCTD valve of the IVC across the entire device structure along any one longitudinal line (i.e., the IVC commutation and the SVC commutation are not installed along one longitudinal line of the CCTD).

[0061] In some embodiments, each of the valves 150b, 152b includes at least two joints 150a, 152a, and the rotational position of the joint of the first valve 150b when connected to the first end of the stent structure is offset by a predetermined numerical angle from the rotational position of the joint 152a of the second valve 152b when connected to the second end of the stent structure, preferably the offset is determined when the stent structure is not twisted.

[0062] Therefore, various embodiments in which the valve includes two commissars are 5°~90°, 5°~80°, 5°~70°, 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~90°, 10°~80°, 10°~70°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~70°, 20°~60°, 20°~50°, 20°~40°, 20 It has possible deviation values ​​between °~30°, 30°~90°, 30°~80°, 30°~70°, 30°~60°, 30°~50°, 30°~50°, 30°~40°, 40°~90°, 40°~80°, 40°~70°, 40°~60°, 40°~50°, 50°~90°, 50°~80°, 50°~70°, 50°~60°, 60°~90°, 60°~80°, and 60°~70°, and within the range between them. Therefore, various embodiments in which the valve includes three commissars have deviation values ​​that may be between 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~60°, 20°~50°, 20°~40°, 20°~30°, 30°~60°, 30°~50°, 30°~40°, 40°~60°, 40°~50°, and in the range between them. In some embodiments, there are three commissars, and the angle of deviation for a given numerical value is preferably approximately 60°.

[0063] In some embodiments, as shown in Figure 12, the CCTD can be positioned within a stent structure and includes at least one thrombus filter 154 at an end located in or adjacent to the IVC 200 or SVC. The filter 154 may comprise a plurality of arches 156 and a mesh or mesh-like structure (not shown) configured for capturing thrombi from the IVC or SVC. In some embodiments, the plurality of arches are established between adjacent ends of at least one of the first and second stents, or at least one stent structure. The filter, or mesh component 158, may be configured for device / filter recapture after the device has been implanted. To this end, in some embodiments, the CCTD, and / or its components or parts, may be sized and shaped for recapture by catheter either during implantation or during retrieval after implantation. In such embodiments, recapture may be performed using a hook device 160, as shown in Figures 13A–13B.

[0064] As shown in Figures 14A and 14B, the CCTD may include a length (between 60 mm and 280 mm in some embodiments). Furthermore, the CCTD (and / or its components) may be configured in some embodiments to adapt to the specific patient's biostructure (e.g., via interconnected struts of one or more stents in the CCTD), as shown in these figures. For this purpose, the CCTD may be configured to translate between the IVC and SVC with a maximum length of approximately 60 mm and / or at an angle between 0 and 45 degrees.

[0065] In some embodiments, the CCTD or its components may include a covering 162 that covers at least one of the first and second stents, or the end of at least one stent structure. In some embodiments, the covering 162 may include one or more openings configured to be adjacent to one or more valve leaflets of a valve. In some embodiments, such covering 162 (and / or sealing means) may be configured to be positioned in or otherwise located in a portion of the device, either inside or outside, and including any stent. All of the sealing means and / or coverings according to some embodiments may be made from materials including biological tissues, synthetic materials, composite materials, polymers, and combinations thereof.

[0066] In some embodiments, the covering 162 may be configured, as shown in Figures 14C–14D, or otherwise positioned or configured to prevent one or more blood jets coming from the self-valve from striking the device or its elements. For example, in some embodiments, the covering 162 covers the middle portion of the CCTD device configured for placement in the RA. Figure 14C shows the absence of the covering to protect against possible blood jets, and Figure 14D shows the covering 162 obstructing the jets (jets are shown as dashed arrows).

[0067] As shown in Figures 15A to 16B, in some embodiments, the CCTD stent 100 includes a valve positioned within a first and / or second strut or strut component, or one or more struts 170 positioned above and / or below the outflow area of ​​the valve connected thereto. Such struts or components can be positioned between the two valve leaflets, and in some embodiments, one or more struts are positioned in the middle of the valve. In some embodiments, the purpose of such struts is to allow the passage of a pacemaker or defibrillator lead wire 172 without interfering with proper valve function. In some embodiments, one or more struts direct the passage of a lead wire or catheter between the valve leaflets.

[0068] As shown in Figure 17, in some embodiments, one or more stents, covers, and / or sealing means of the CCTD may consist of one or more ports 164 for the placement of pacemaker leads 166 or the like after device implantation. For such a stent, one or more ports may correspond to areas or openings for the placement of pacemaker leads 172 after device implantation. In some embodiments, such ports do not interfere with any valves in which the CCTD is contained. For example, one or more ports may be located on the wall of the CCTD stent. In some embodiments, the ports direct the passage of the lead or catheter to the outside of the valve.

[0069] In some embodiments, as shown in Figure 18, any stent of the CCTD, in particular the CCTD stent, may be equipped with attachment means that may include one or more hooks 168 for connection to other components of the CCTD (one or other of the stent, valve, etc.), and / or, in some embodiments, one or more sutures. This feature may allow connection to each of the elements of the CCTD so that the components are easily replaceable (for example, for anatomical purposes to customize the CCTD for a particular patient), and / or allow delivery / implantation of one or more components for connection to a previously implanted component. The ends of such hooks 168 may be received by openings 171 of other elements for attachment.

[0070] According to some embodiments, the CCTD device may include, for example, one or more radiopaque materials included in any one or more parts or locations of any stent, valve, connector, intermediate portion, and one or more valve leaflets of the device.

[0071] In some embodiments, as shown in Figures 19A to 19B, one or more valves of the CCTD 100 are configured to accept a replacement valve 180 so that a replacement valve can be placed therein. For example, a replacement valve 170 can be delivered to one and / or other valves of a previously implanted CCTD, for example, to replace a degenerated CCTD valve or a malfunctioning CCTD valve.

[0072] Examples and embodiments of the present disclosure Example 1: A single vena cava-crossing tricuspid valve device for treating tricuspid valve insufficiency, comprising: at least one stent structure; a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, optionally at least partially covered; a second end configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, optionally at least partially covered; a first valve connected to at least a portion of the first end so as to be located in at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted; a second valve connected to at least a portion of the second end so as to be located in at least a portion of the right atrium (RA) below the SVC or at least partially within the SVC, below the azygos vein; and sealing means.

[0073] Example 2: A single crossed tricuspid valve device for treating tricuspid valve insufficiency, comprising at least one stent structure, a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, and optionally at least partially covered, and a second end configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, and optionally at least partially covered, and at least a portion of the first end connected so that when the CCTD is implanted, it is positioned in at least a portion of the right atrium (RA) above the IVC. A single vena cava crossing tricuspid valve device comprising: a first valve; a second valve connected to at least a portion of the second end so as to be located in at least a portion of the right atrium (RA) below or at least partially within the SVC, below the azygos vein; sealing means; and an optional intermediate portion between the first and second ends, optionally configured to perform at least one of the following: rotating at least one of the first and second valves with respect to at least one of the first and second ends by a desired amount of rotation; and shortening the device.

[0074] Example 3: A modular vena cava crossing tricuspid valve device for treating tricuspid valve insufficiency, comprising: a first stent configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, optionally at least partially covered; a second stent configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, optionally at least partially covered; and a second stent connected to at least a portion of the first end, such that when the CCTD is implanted, it is positioned in at least a portion of the right atrium (RA) above the IVC. A modular tricuspid vena cava crossing valve device comprising: a valve; a second valve connected to at least a portion of the second end so as to be located in at least a portion of the right atrium (RA) below or at least partially within the SVC, below the azygos vein; sealing means; and an optional connector positioned between the first valve and the second valve, optionally configured to rotate at least one of the first valve and the second valve by a desired amount of rotation relative to at least one of the first stent and the second stent, and shorten the device.

[0075] Example 4: An artificial heart valve device comprising at least one stent structure, at least one valve, and at least one sealing means.

[0076] Example 5: The device according to Example 2 or 3, wherein the intermediate portion or connector has a length sufficient to spread between the first end and the second end, or, where applicable, sufficient to spread between the first stent and the second stent.

[0077] Example 6: A device from any of Examples 1 to 4, comprising at least one valve and an optional number or all of the valves, the valves being intraluminal valves.

[0078] Example 7: The device of Example 3, in which the first stent, second stent, first valve, second valve, sealing means, and connector are configurable to different dimensions to accommodate different patient biostructures.

[0079] Example 8: A device according to any of Examples 1 to 7, wherein the sealing means comprises at least one skirt.

[0080] Example 9: A device according to any of Examples 1 to 7, wherein the sealing means comprises multiple skirts.

[0081] Example 10: A device according to any of Examples 1 to 7, wherein the sealing means comprises at least two skirts.

[0082] Example 11: A device according to any of Examples 1 to 7, wherein the sealing means comprises at least three skirts.

[0083] Example 12: A device from any of Examples 1 to 11, wherein the sealing means is configured to prevent backflow of blood from all of the right atrium into at least one of the inferior vena cava (IVC) and superior vena cava (SVC), leakage around all of one and / or other components of the device, and / or hepatic vein inflow, and the sealing means comprises a hepatic IVC skirt.

[0084] Example 13: Any device from Examples 1 to 12, wherein the outer diameter of at least a portion of the device is between 15-70mm, 15-60mm, 15-50mm, 15-40mm, 15-30mm, 15-20mm, 20-70mm, 20-60mm, 20-50mm, 20-40mm, 20-30mm, 30-70mm, 30-60mm, 30-50mm, 30-40mm, 40-70mm, 40-60mm, 40-50mm, 50-70mm, 50-60mm, and 60-70mm, as well as in the range between them.

[0085] Example 14: The devices of Examples 1 to 13, wherein the sealing means comprises one or more respective sealing structures located on or adjacent to every element of the device, and, where applicable, on or adjacent to each element of the device, and one or more of the sealing structures are sized and shaped to clearly accommodate anatomical structures located opposite and / or adjacent to each element.

[0086] Example 15: The device of Example 14, where each sealing structure encloses only a portion of every element of the device.

[0087] Example 16: The device from Example 14, where each sealing structure encloses most of all elements of the device.

[0088] Example 17: The device from Example 14, where each sealing structure encloses every element of the device.

[0089] Example 18: The device according to Example 17, wherein the first sealing structure is arranged along a plane different from the plane of the second sealing structure.

[0090] Example 19: Any device from Examples 14 to 18, wherein the first structure is positioned to seal in contact with the wall of the RA, and the second structure is positioned to seal in contact with the tube inlet of the RA.

[0091] Example 20: A device from any of Examples 1 to 19, wherein the sealing means comprises multiple layers.

[0092] Example 21: A device from any of Examples 1 to 20, wherein the sealing means comprises a reinforcing structure.

[0093] Example 22: The device of Example 21, wherein the reinforcing structure comprises wires or stents.

[0094] Example 23: A device from any of Examples 1 to 22, wherein the sealing means comprises a parachute structure.

[0095] Example 24: The device of Example 23, wherein the parachute structure is configured to open the sealing means during the deployment of the device.

[0096] Example 25: A device according to any of Examples 1 to 24, wherein the sealing means comprises a first perforated layer and a second sealing layer.

[0097] Example 26: The device of Example 25, wherein the first perforated layer and the second sealing layer are configured to establish a pocket.

[0098] Example 27: The device of Example 26, wherein the established pocket is of a size and shape that promotes tissue growth therein.

[0099] Example 28: A device from any of Examples 25 to 27, in which the first perforated layer is positioned adjacent to the tissue.

[0100] Example 29: The sealing means is a device from any of Examples 14 to 28, comprising a skirt and an inflatable balloon structure.

[0101] Example 30: The balloon structure is described as donut-shaped, as in the device from Example 29.

[0102] Example 31: A device from any of Examples 14 to 28, wherein the sealing structure includes an elastic skirt.

[0103] Example 32: A device from any of Examples 14 to 28, wherein the sealing structure comprises a reversibly adhesive stretchable skirt on the outer surface of the inflatable balloon structure.

[0104] Example 33: Any device from Examples 14 to 28, each encapsulation structure having a three-dimensional skirt.

[0105] Example 34: The device of Example 33, wherein each encapsulation structure comprises a nitinol structure optionally covered by an encapsulation material.

[0106] Example 35: A device of any of Examples 1 to 8 and Examples 12 to 28, wherein the sealing means material comprises a skirt having a flange shape and an inner diameter adjacent to a first end of the skirt for attachment to the outer diameter of at least one structure or element of the device, and an outer diameter toward a second end of the skirt for bonding with all the inner diameters of the graft site, IVC, SVC, or RA.

[0107] Example 36: The device from Example 35, with a skirt that includes a straight edge.

[0108] Example 37: The device from Example 35, with a skirt that includes a curved edge.

[0109] Example 38: A device from any of Examples 1 to 8 and 12 to 28, wherein the sealing means comprises a skirt including a donut shape with an outer diameter configured to bond with surrounding tissue, IVC, SVC, or RA, and an inner diameter radially spaced from the outer diameter and configured for attachment to a stent structure.

[0110] Example 39: A device according to any of Examples 1 to 38, wherein at least one first part of the device or its elements has a stiffness greater than the stiffness of a second part of the device or its elements.

[0111] Example 40: The device of Example 39, wherein at least one first part includes an area of ​​a device or element that accepts at least a portion of a valve.

[0112] Example 41: The device of Example 40, wherein the second part includes the remaining portion of the area of ​​the device or its elements.

[0113] Example 42: The device of Example 41, wherein the second part includes an intermediate part of the device or its elements.

[0114] Example 43: A device according to any of Examples 1 to 42, wherein at least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts.

[0115] Example 44: At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first portion include a thickness between 0.2 mm and 1.0 mm, a device according to any of Examples 1 to 42.

[0116] Example 45: At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts forming a plurality of cells, a device according to any of Examples 1 to 42.

[0117] Example 46: At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts forming a plurality of cells, and the area of each cell associated with the first portion is between 0.25 cm 2 and 10 cm 2 and preferably between 2 and 5 cm 2 a device according to any of Examples 1 to 42.

[0118] Example 47: At least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts forming a plurality of cells, and each cell region associated with the first portion is configured in dimensions and shape to permit passage of a catheter, a device according to any of Examples 1 to 42.

[0119] Example 48: The catheter is sized to have a maximum diameter of approximately 15 mm, a device of Example 47.

[0120] Example 49: A device of any of Examples 1 to 42, wherein at least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first part of the device are dimensionally, shaped, and / or arranged to impart radial force, unlike the second part of the device.

[0121] Example 50: A device from any of Examples 1 to 42, wherein at least one of the first stent and the second stent, or at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first portion are determined to be dimensional, shaped, and / or arranged to give the first portion a different diameter from the second portion.

[0122] Example 51: Any device from Examples 1 to 50, wherein each valve has multiple commutations, and the commutation of the first valve is offset from the commutation of the second valve by a predetermined angle.

[0123] Example 52: There are two multiple commissars, and the angles of the given numerical values ​​are 5~90°, 5°~80°, 5°~70°, 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~90°, 10°~80°, 10°~70°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~70°, 20°~60°, 20°~50°, 20°~40°, 20°~30° A device of Example 51, selected from the group consisting of the ranges between 30°~90°, 30°~80°, 30°~70°, 30°~60°, 30°~50°, 30°~50°, 30°~40°, 40°~90°, 40°~80°, 40°~70°, 40°~60°, 40°~50°, 50°~90°, 50°~80°, 50°~70°, 50°~60°, 60°~90°, 60°~80°, and between them.

[0124] Example 53: The device of Example 51, wherein the multiple commissars are three, and the angles of a given numerical value are selected from the group consisting of between 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~60°, 20°~50°, 20°~40°, 20°~30°, 30°~60°, 30°~50°, 30°~40°, 40°~60°, 40°~50°, and the ranges in between.

[0125] Example 54: The device of Example 51, with three multiple cross joints, and the angles of a given numerical value include approximately 60°.

[0126] Example 55: A stent structure, a first stent, and / or a second stent, comprising multiple cells established by multiple interconnected struts, each configured as a rhomboid, as a device of any of Examples 1 to 54.

[0127] Example 56: Any device from Examples 1 through 55, further comprising at least one thrombus filter.

[0128] Example 57: The device from Example 56, where the filter has multiple arches.

[0129] Example 58: The device of Example 57, wherein multiple arches are established between adjacent ends of at least one of the first stent and the second stent, or at least one stent structure.

[0130] Example 59: A device from any of Examples 56 to 58, wherein the filter is positioned at at least one of the stent ends and comprises a mesh configured for device / filter recapture after the device has been implanted.

[0131] Example 60: A device from any of Examples 1 through 59, which is sized and molded for recapture.

[0132] Example 61: A device from any of Examples 1 through 59, which is sized and shaped for recapture by a DS hook.

[0133] Example 62: The device is one of the devices from Examples 1 through 59, with a length ranging from 60 mm to 280 mm.

[0134] Example 63: Any of the devices from Examples 1 to 62, the device is configured to translate between the IVC and SVC by a maximum of approximately 60 mm and / or at an angle between 0 and 45 degrees.

[0135] Example 64: Any device from Examples 1 to 63, further comprising a covering that covers at least one of the first stent and the second stent, or the end of at least one stent structure.

[0136] Example 65: The device of Example 64, wherein the covering includes one or more openings configured to be adjacent to one or more valve leaflets of the valve.

[0137] Example 66: A device according to any of Examples 1 to 65, wherein the first stent, the second stent, or the stent structure configuration is selected from the group consisting of shape memory materials, self-expandable materials, mechanically expandable materials, composite materials, polymers, and combinations thereof.

[0138] Example 67: A device from any of Examples 1 to 66, in which the valve material is selected from the group consisting of fibers, polymers, composite materials, biological tissues, and combinations thereof.

[0139] Example 68: A device of any of Examples 1 to 67, wherein all of the sealing means and cover, including a first stent, a second stent, or a stent structure, are configured to be positioned on or otherwise located on the device in a portion of the device, at least on the inside or outside.

[0140] Example 69: A device according to any of Examples 1 to 68, wherein all of the sealing means and cover are made of a material selected from the group consisting of biological tissues, synthetic materials, composite materials, polymers, and combinations thereof.

[0141] Example 70: Any device from Examples 1 to 69, further comprising one or more ports configured for the placement of pacemaker leads after device implantation.

[0142] Example 71: Any device from Examples 1 to 69, configured for the placement of pacemaker leads after device implantation and further comprising one or more ports that do not interfere with the SVC valve.

[0143] Example 72: The device of Example 71, wherein at least one of the first stent and the second stent, or the stent structure, comprises one or more struts positioned above the outflow area of ​​the first strut and / or the second strut, or a valve positioned within the strut component, or a valve connected to the first strut and / or the second strut, or a strut component.

[0144] Example 73: The device of Example 72, in which one or more struts are positioned between the two valve leaflets of the valve.

[0145] Example 74: A device of Example 72 or 73 in which one or more supports are positioned in the middle of the valve.

[0146] Example 75: The device of Example 71, wherein one or more ports are located in at least one of the first stent and the second stent, or in the wall of the stent structure.

[0147] Example 76: Any device from Examples 1 through 75, in which the connections between the elements of the device include fibers.

[0148] Example 77: Any device from Examples 1 through 76, where the majority of the device is flexible.

[0149] Example 78: Any device from Examples 1 through 76, where the majority of the device is rigid.

[0150] Example 79: Any device from Examples 1 to 78, wherein all of the first stent, second stent, first valve, second valve, at least one stent structure, and at least one valve include one or more hooks for connection to other elements.

[0151] Example 80: The device of Example 79, in which the end of the hook is received by an opening in another element for mounting.

[0152] Example 81: A device from any of Examples 1 to 80, wherein a cover is positioned on or otherwise on the device to prevent one or more blood jets coming from the self-valve from striking the device or its elements.

[0153] Example 82: A device from any of Examples 1 to 81, wherein the intermediate portion of the device is configured for placement within the RA and has only partial covering.

[0154] Example 83: Any device of Examples 1 to 82, further comprising a first stent, a second stent, a stent structure, a valve, a first valve, a second valve, a connector, an intermediate portion, and one or more radiopaque materials included in all one or more parts or locations of one or more valve leaflets of the valve.

[0155] Example 84: A device from any of Examples 1 through 83, wherein the first valve, the second valve, and / or valve are configured to accept a replacement valve to which a replacement valve is to be placed.

[0156] Example 85: A device from Examples 1 to 3 and Examples 5 to 84, in which the intermediate section or connector is configured to cause a change in the length of the device by twisting.

[0157] Example 86: The intermediate section or connector comprises multiple linear structures for connecting the ends of the devices and / or connecting the first stent and the second stent of the device, wherein twisting the multiple linear structures in a first direction shortens the length of the device, and twisting them in a second direction opposite to the first direction lengthens the length of the device, as in the device of Example 85.

[0158] Example 87: A method for implanting a crossed tricuspid vena cava device (CCTD) to treat tricuspid valve insufficiency, comprising the steps of: providing a CCTD according to any embodiment of a CCTD disclosed herein; removably attaching the CCTD to the distal end of a delivery catheter; directing the distal end of the delivery catheter toward a site for implantation adjacent to at least one of the IVC, SVC, RA, or RV via either a femoral or cervical approach; releasing the CCTD at the implantation site; and removing the delivery catheter.

[0159] The following examples include reference numerals corresponding to the numerals in the figures of this disclosure.

[0160] Example 88: A vena cava crossing tricuspid valve device (100) for treating tricuspid valve insufficiency, comprising at least one stent structure (102), a first end (104) of the stent structure (102) configured for implantation in the inferior vena cava (IVC) (200) and anchoring the device in the IVC (200), a first sealing means (112) including a first skirt (130) attached to the outer diameter of the first end (104), and a first sealing means configured for implantation in the superior vena cava (SVC) (202) and in the SVC (202) A tricuspid vena cava crossing valve device (100) comprising a second end (106) of a stent structure (102) that anchors the device, a first valve (108) connected to a first end (104), and a second valve (110) connected to the second end (106), wherein the position of the first valve (108) along the longitudinal direction of the stent structure (102) coincides with the position of a first skirt (130), or the position of the first valve (108) is located between the position of the first skirt (130) and the position of the second valve (110).

[0161] Example 89: The device (100) of Example 88, further comprising a second sealing means (112) including a second skirt (130) attached to the outer diameter of a second end (106), wherein the position of the second valve (110) along the longitudinal direction of the stent structure (102) coincides with the position of the second skirt (130), or the position of the second valve (110) is located between the position of the second skirt (130) and the position of the first valve (108).

[0162] Example 90: Device (100) of Example 88 or 89, where the first end (104) is at least partially covered, and / or the second end (106) is at least partially covered.

[0163] Example 91: A device (100) from any one of Examples 88 to 90, wherein the first skirt (130) and / or second skirt (130) have an outer diameter for bonding with any and all inner diameters of the graft site, IVC, SVC, or RA in the direction toward the second end of the skirt (130).

[0164] Example 92: A device (100) from any one of Examples 88 to 91, wherein the first sealing means (112) comprises at least two skirts (130), and / or the second sealing means (112) comprises at least two skirts (130).

[0165] Example 93: At least one of the skirts (112) comprises multiple layers and / or a reinforcing structure, preferably a reinforcing structure comprising wires or stents and / or a parachute structure and / or a first perforated layer and a second sealing layer, preferably configured such that the first perforated layer and the second sealing layer establish a pocket, preferably the established pocket having dimensions and shape that promote tissue growth therein, preferably the first perforated layer is positioned adjacent to the tissue and / or comprises an inflatable balloon structure, preferably The rune structure is donut-shaped and / or stretchable, preferably the stretchable skirt is reversibly adhered to the outer surface of the inflatable balloon structure and / or comprises a three-dimensional skirt structure and / or is positioned to seal in contact with the walls of the RA and / or IVC and / or is positioned to seal in contact with the SVC and / or SVC inlet of the RA and / or has an outer diameter that is at least twice the outer diameter of the stent structure and / or has an outer diameter of at least 70 mm, one device (100) of Examples 88 to 92.

[0166] Example 94: The stent structure (102) is a single device (100) from any of Examples 88 to 93, and / or formed from a single component.

[0167] Example 95: A device (100) from any one of Examples 88 to 94, wherein an intermediate portion (114) is positioned between a first end (104) and a second end (106), and the intermediate portion (114) is configured to rotate the first end (104) relative to the second end (106) by a desired amount of rotation (120) to result in a change in the length of the stent structure (102), preferably the intermediate portion (114) has a weaker structure than the first end (104) and the second end (106) to allow the rotation of the intermediate portion (114).

[0168] Example 96: A stent structure (102) is a device (100) from any one of Examples 88 to 95, comprising a first stent (118) including a first end (104), a second stent (120) including a second end (106), and a connector connecting the first stent (118) and the second stent (120).

[0169] Example 97: The connector is the device (100) of Example 96, configured to rotate the first end (104) relative to the second end (106) by a desired amount of rotation (120).

[0170] Example 98: The intermediate section (114) or connector comprises multiple linear structures for connecting a first end (104) to a second end (106) and / or connecting a first stent (118) and a second stent (120), wherein the multiple linear structures shorten the length of the stent structure (102) when twisted in a first direction and lengthen the length of the stent structure (102) when twisted in a second direction opposite to the first direction, one device (100) of Examples 95 to 97.

[0171] Example 99: Each of the valves (108, 110) includes at least two commutations, and the rotational position of the commutation of the first valve (108) when connected to the first end (104) is offset by a predetermined numerical angle from the rotational position of the commutation of the second valve (110) when connected to the second end (106), preferably the offset is determined when the stent structure (102) is not twisted, one device (100) of Examples 88 to 98.

[0172] Example 100: Each valve (108, 110) has two commissar, and the angles of the given numerical values ​​are 5~90°, 5°~80°, 5°~70°, 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~90°, 10°~80°, 10°~70°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~70°, 20°~60°, 20°~50°, 20°~40°, 20°~ A device (100) of Example 99, selected from the group consisting of 30°, 30°~90°, 30°~80°, 30°~70°, 30°~60°, 30°~50°, 30°~50°, 30°~40°, 40°~90°, 40°~80°, 40°~70°, 40°~60°, 40°~50°, 50°~90°, 50°~80°, 50°~70°, 50°~60°, 60°~90°, 60°~80°, between 60° and 70°, and the ranges in between.

[0173] Example 101: Device (100) of Example 99, each of the valves (108, 110) has three commissar, and the angle of a predetermined numerical value is selected from the group consisting of between 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~60°, 20°~50°, 20°~40°, 20°~30°, 30°~60°, 30°~50°, 30°~40°, 40°~60°, 40°~50°, and the range in between, preferably the angle of a predetermined numerical value includes approximately 60°.

[0174] Example 102: The location of the first valve (108) at the first end (104) is such that when the CCTD is implanted, it is located in at least a portion of the right atrium (RA) above the IVC, and / or the location of the second valve (110) at the second end (106) is such that it is located in at least a portion of the right atrium (RA) below the SVC or at least partially within the SVC, below the azygos vein, one of the devices (100) from Examples 88 to 101.

[0175] Example 103: A vena cava crossing tricuspid valve device (100) for treating tricuspid valve insufficiency, comprising at least one stent structure (102), a first end (104) of the stent structure (102) configured for implantation in the inferior vena cava (IVC) (200) and anchoring the device in the IVC (200), a first sealing means (112) including a first skirt (130) attached to the outer diameter of the first end (104), and a first sealing means configured for implantation in the superior vena cava (SVC) (202) and in the SVC (202) A vena cava crossing tricuspid valve device (100) comprising a second end (106) of a stent structure (102) that anchors the device, a first valve (108) connected to a first end (104), and a second valve (110) connected to the second end (106), wherein the position of the first valve (108) along the longitudinal direction of the stent structure (102) coincides with the position of a first skirt (130), or the position of the first valve (108) is located between the position of the first skirt (130) and the position of the second valve (110).

[0176] Example 104: The device (100) of Example 103, further comprising a second sealing means (112) including a second skirt (130) attached to the outer diameter of a second end (106), wherein the position of the second valve (110) along the longitudinal direction of the stent structure (102) coincides with the position of the second skirt (130), or the position of the second valve (110) is located between the position of the second skirt (130) and the position of the first valve (108).

[0177] Example 105: Device (100) of Example 103 or 104, where the first end (104) is at least partially covered, and / or the second end (106) is at least partially covered.

[0178] Example 106: A device (100) from any one of Examples 103 to 105, wherein the first skirt (130) and / or second skirt (130) have an outer diameter for bonding with any and all inner diameters of the graft site, IVC, SVC, or RA in the direction toward the second end of the skirt (130).

[0179] Example 107: A device (100) from any one of Examples 103 to 106, wherein the first sealing means (112) comprises at least two skirts (130), and / or the second sealing means (112) comprises at least two skirts (130).

[0180] Example 108: At least one of the skirts (112) comprises multiple layers and / or a reinforcing structure, preferably comprising a reinforcing structure comprising wires or stents and / or a parachute structure and / or comprising a first perforated layer and a second sealing layer, preferably configured such that the first perforated layer and the second sealing layer establish a pocket, preferably having dimensions and shape that promote tissue growth therein, preferably the first perforated layer is positioned adjacent to the tissue and / or comprises an inflatable balloon structure, preferably a balloon The stent structure is donut-shaped and / or stretchable, preferably the stretchable skirt is reversibly adhered to the outer surface of the inflatable balloon structure and / or comprises a three-dimensional skirt structure and / or is positioned to seal in contact with the walls of the RA and / or IVC and / or is positioned to seal in contact with the SVC and / or SVC inlet of the RA and / or has an outer diameter that is at least twice the outer diameter of the stent structure and / or has an outer diameter of at least 70 mm, one device (100) of Examples 103 to 107.

[0181] Example 109: The stent structure (102) is a single device (100) from Examples 103 to 108, which is and / or formed from one part.

[0182] Example 110: A device (100) from any one of Examples 103 to 109, wherein an intermediate portion (114) is positioned between a first end (104) and a second end (106), and the intermediate portion (114) is configured to rotate the first end (104) relative to the second end (106) by a desired amount of rotation (120) to result in a change in the length of the stent structure (102), preferably the intermediate portion (114) has a weaker structure than the first end (104) and the second end (106) to allow the rotation of the intermediate portion (114).

[0183] Example 111: A device (100) from any one of Examples 103 to 108, comprising a stent structure (102) a first stent (118) including a first end (104), a second stent (120) including a second end (106), and a connector connecting the first stent (118) and the second stent (120).

[0184] Example 112: The connector is the device (100) of Example 111, configured to rotate the first end (104) relative to the second end (106) by a desired amount of rotation (120).

[0185] Example 113: The intermediate section (114) or connector comprises multiple linear structures for connecting a first end (104) to a second end (106) and / or connecting a first stent (118) to a second stent (120), wherein the multiple linear structures shorten the length of the stent structure (102) when twisted in a first direction and lengthen the length of the stent structure (102) when twisted in a second direction opposite to the first direction, one device (100) of Examples 110 to 112.

[0186] Example 114: Each of the valves (108, 110) includes at least two commutations, and the rotational position of the commutation of the first valve (108) when connected to the first end (104) is offset by a predetermined numerical angle from the rotational position of the commutation of the second valve (110) when connected to the second end (106), preferably the offset is determined when the stent structure (102) is not twisted, one of the devices (100) of Examples 103 to 113.

[0187] Example 115: Each valve (108, 110) has two commissar, and the angles of the given numerical values ​​are 5~90°, 5°~80°, 5°~70°, 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~90°, 10°~80°, 10°~70°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~70°, 20°~60°, 20°~50°, 20°~40°, 20°~3 Device (100) of Example 114, selected from the group consisting of 0°, 30°~90°, 30°~80°, 30°~70°, 30°~60°, 30°~50°, 30°~50°, 30°~40°, 40°~90°, 40°~80°, 40°~70°, 40°~60°, 40°~50°, 50°~90°, 50°~80°, 50°~70°, 50°~60°, 60°~90°, 60°~80°, between 60°~70°, and ranges in between.

[0188] Example 116: Device (100) of Example 114, each of the valves (108, 110) has three commissar, and the angles of a predetermined numerical value are selected from the group consisting of between 5°~60°, 5°~50°, 5°~40°, 5°~30°, 5°~20°, 5°~10°, 10°~60°, 10°~50°, 10°~40°, 10°~30°, 10°~20°, 20°~60°, 20°~50°, 20°~40°, 20°~30°, 30°~60°, 30°~50°, 30°~40°, 40°~60°, 40°~50°, and the range in between, preferably the angles of a predetermined numerical value include approximately 60°.

[0189] Example 117: The location of the first valve (108) at the first end (104) is such that when the CCTD is implanted, it is located in at least a portion of the right atrium (RA) above the IVC, and / or the location of the second valve (110) at the second end (106) is such that it is located in at least a portion of the right atrium (RA) below the SVC or at least partially within the SVC, below the azygos vein, one of the devices (100) from Examples 103 to 116.

[0190] General Considerations While various embodiments of the invention have been described and illustrated herein, those skilled in the art will readily imagine various other means and / or structures to carry out the function and / or to obtain one or more of the results and / or benefits described herein, and each of such variations and / or improvements will be considered to fall within the scope of the embodiments of the invention described herein. More generally, those skilled in the art will readily understand that all structures, parameters, sizes, materials, functionalities, and configurations described herein are meant to be illustrative, and that the actual structures, parameters, sizes, materials, functionalities, and configurations will depend on the specific application in which the teachings of the invention are used. Those skilled in the art will recognize, or can confirm by using only the given experiments, many equivalents to the specific embodiments of the invention described herein. Thus, it will be understood that the embodiments described herein are shown only by example, and that embodiments of the invention can be carried out in ways other than those explicitly described and claimed within the scope of the claims supported by this disclosure and their equivalents. Embodiments of the invention in this disclosure are also directed to each of the individual features, systems, articles, structures, materials, kits, functionalities, steps, and methods described herein. Furthermore, any combination of two or more such features, systems, articles, structures, materials, kits, functionalities, steps, and methods is included within the scope of the invention of this disclosure, provided that they are not inconsistent with each other. Such embodiments can be distinguished from the prior art by clearly lacking one or more features / elements / functionalities (i.e., claims directed to such embodiments may contain negative limitations).

[0191] As also stated, various inventive concepts are embodied in one or more methods for which examples are provided. The actions performed as part of the method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in a different order than those exemplified, which may include performing several actions simultaneously, although these are shown as sequential actions in the exemplary embodiments.

[0192] All references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., indicated anywhere in this application, are incorporated herein by reference in their entirety. Furthermore, all definitions as defined and used herein should be understood to be governed by dictionary definitions, definitions in documents incorporated by reference, and / or the ordinary meaning of the defined terms.

[0193] The indefinite article “a, an” as used herein and in the claims should be understood to mean “at least one” unless explicitly indicated as incompatible. The terms “may” and “may” are used interchangeably in this disclosure, indicating that references to elements, components, structures, functions, features, purposes, benefits, actions, steps, processes, apparatus, systems, devices, results, or clarifications have the ability to be used, included, or made for or to express otherwise the opinion indicated in the concluding (or referred to) wording used for a particular embodiment.

[0194] The phrase "and / or" as used herein and in the claims should be understood to mean "either or both" of the elements thus combined, that is, elements that are sometimes connected and sometimes disconnected. Multiple elements listed with "and / or" should be interpreted in the same manner, that is, "one or more" of the elements thus combined.

[0195] Other elements may be of optional nature, whether related to the explicitly identified elements or not, and may exist in addition to the elements explicitly identified by the “and / or” clause. Thus, as a non-restrictive example, when a reference to “A and / or B” is used in conjunction with open-ended phrases such as “equipped with,” in one embodiment it may refer to A only (optionally including elements other than B), in another embodiment it may refer to B only (optionally including elements other than A), and in yet another embodiment it may refer to both A and B (optionally including other elements), and so on.

[0196] As used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as previously defined. For example, when dividing items in an enumerated list, “or” or “and / or” is interpreted as inclusive, meaning that it includes several elements or at least one of the enumerated elements, but also two or more, and optionally includes additional items not enumerated. Only terms that are explicitly indicated as incompatible, such as “one of” or “exactly one of” or, when used in the claims, “consisting of” refer to including several elements or exactly one of the enumerated elements. In general, the term “or” as used herein is interpreted only as indicating an exclusive choice (i.e., “one or the other, but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “one of,” or “exactly one of.”

[0197] When used in patent claims, "essentially consisting of" takes on its usual meaning as it does in the field of patent law.

[0198] As used herein and in the claims, the phrase “at least one” in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each element explicitly listed in the list of elements and all of the elements, nor excluding any combination of elements in the list of elements. This definition also allows for the presence of elements other than those explicitly identified in the list of elements referred to by the phrase “at least one,” whether relating to those explicitly identified elements or not, at the discretion of the list. Therefore, as a non-restrictive example, “at least one of A and B” (or equivalently “at least one of A or B” or equivalently “at least one of A and / or B”) may, in one embodiment, refer to at least one which optionally includes two or more A's but does not include B (and optionally includes elements other than B); in another embodiment, refer to at least one which optionally includes two or more B's but does not include A (and optionally includes elements other than A); and in yet another embodiment, refer to at least one which optionally includes two or more A's and at least one which optionally includes two or more B's (and optionally includes other elements), and so on.

[0199] In the claims as well as in the specification, all transitional clauses such as “equipped with,” “includes,” “carrying,” “having,” “contains,” “accompanying,” “holding,” and “composed of” are understood to be open-ended, meaning they include not being limited to them. Only the transitional clauses “consist of” and “essentially consist of” are considered closed or semi-closed transitional clauses, respectively, as stated in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03. [Explanation of symbols]

[0200] 100 Crossed tricuspid valve devices for vena cava, CCTD 102 Stent Structure 104 The first end 106 The second end 108 First valve 110 Second valve 112 Sealing means 114 Intermediate section, connector 116 Modular CCTD 118 First stent 120 Desired amount of rotation 120 Second stent 128 Bonding materials 130 Skirt 138a, 138b Inverted 138c Parachute structure 138d Edge 139 pockets 140b Curved or wavy edge 142 Bulb shape 144 Tube shape 146 Perforation 148 cells 150a commissure 150b First valve 152a commissure 152b Second valve 154 Thrombosis filter 156 Arch 158 Network Components 160 Hook Devices 162 Covering 164 ports 166 Pacemaker lead wires 168 hooks 170 Post 172 Lead wires 180 Replacement valve 200 Inferior vena cava, IVC 201 Heart 202 Superior Vena Cava, SVC 204 Right atrium, RA 206 Azygos vein

Claims

1. A single-type vena cava crossing tricuspid valve device for treating tricuspid valve insufficiency, At least one stent structure, A first end configured for implantation in the inferior vena cava (IVC), which anchors the device in the IVC, and optionally at least partially covers the first end, A second end configured for implantation in the superior vena cava (SVC), which anchors the device in the SVC, and optionally has at least a partial coverage of the second end, When the CCTD is implanted, a first valve connected to at least a portion of the first end is positioned above the IVC and within at least a portion of the right atrium (RA), A second valve connected to at least a portion of the second end, so as to be located in at least a portion of the right atrium (RA) below or at least partially within the SVC, below the azygos vein, Sealing means and A single-type vena cava crossing tricuspid valve device.

2. A single-type vena cava crossing tricuspid valve device for treating tricuspid valve insufficiency, At least one stent structure, A first end configured for implantation in the inferior vena cava (IVC), which anchors the device in the IVC, and optionally at least partially covers the first end, A second end configured for implantation in the superior vena cava (SVC), which anchors the device in the SVC, and optionally has at least a partial coverage of the second end, When the CCTD is implanted, a first valve connected to at least a portion of the first end is positioned above the IVC and within at least a portion of the right atrium (RA), A second valve connected to at least a portion of the second end, so as to be located in at least a portion of the right atrium (RA) below or at least partially within the SVC, below the azygos vein, Sealing means and An optional intermediate portion between the first end and the second end, Rotating at least one of the first valve and the second valve by a desired amount of rotation relative to at least one of the first end and the second end, To shorten the aforementioned device, An optional intermediate part consisting of an optional choice to perform at least one of the following, A single-type vena cava crossing tricuspid valve device.

3. A modular vena cava crossing tricuspid valve device for treating tricuspid valve insufficiency, A first stent configured for implantation in the inferior vena cava (IVC) and for anchoring the device in the IVC, the first stent being optionally at least partially covered, A second stent configured for implantation in the superior vena cava (SVC), which optionally anchors the device in the SVC, comprising a second stent that optionally covers at least partially, When the CCTD is implanted, a first valve is connected to at least a portion of the first stent so as to be positioned in at least a portion of the right atrium (RA) above the IVC, A second valve connected to at least a portion of the second stent, so as to be located in at least a portion of the right atrium (RA) below or at least partially within the SVC, below the azygos vein, Sealing means and An optional connector disposed between the first valve and the second valve, Rotating at least one of the first valve and the second valve by a desired amount of rotation relative to at least one of the first stent and the second stent, To shorten the aforementioned device, An optional connector, optionally configured to perform at least one of the following: A modular tricuspid vena cava crossing valve device equipped with the following features.

4. At least one stent structure, At least one valve, At least one sealing means, An artificial heart valve device equipped with the following features.

5. The device according to claim 2 or 3, wherein the intermediate portion or connector has a length sufficient to spread between the first end and the second end, or, where applicable, sufficient to spread between the first stent and the second stent.

6. The device according to any one of claims 1 to 4, wherein the valve or at least one valve and any number or all of the valves are intraluminal valves.

7. The device according to claim 3, wherein the first stent, the second stent, the first valve, the second valve, the sealing means, and the connector are configurable to different dimensions to accommodate different biological structures of a patient.

8. The device according to any one of claims 1 to 7, wherein the sealing means comprises at least one skirt.

9. The device according to any one of claims 1 to 7, wherein the sealing means comprises a plurality of skirts.

10. The device according to any one of claims 1 to 7, wherein the sealing means comprises at least two skirts.

11. The device according to any one of claims 1 to 7, wherein the sealing means comprises at least three skirts.

12. The device according to any one of claims 1 to 11, wherein the sealing means is configured to prevent backflow of blood from all of the right atrium to at least one of the inferior vena cava (IVC) and superior vena cava (SVC), leakage around all of one and / or other components of the device, and / or hepatic vein inflow, and the sealing means comprises a hepatic IVC skirt.

13. The device according to any one of claims 1 to 12, wherein the outer diameter of at least a portion of the device is between 15 and 70 mm, 15 and 60 mm, 15 and 50 mm, 15 and 40 mm, 15 and 30 mm, 15 and 20 mm, 20 and 70 mm, 20 and 60 mm, 20 and 50 mm, 20 and 40 mm, 20 and 30 mm, 30 and 70 mm, 30 and 60 mm, 30 and 50 mm, 30 and 40 mm, 40 and 70 mm, 40 and 60 mm, 40 and 50 mm, 50 and 70 mm, and in the range between thereof.

14. The device according to any one of claims 1 to 13, wherein the sealing means comprises one or more sealing structures disposed on or adjacent to all elements of the device, and, where applicable, on or adjacent to each element of the device, and one or more of the sealing structures are sized and shaped to clearly accommodate anatomical structures disposed opposite and / or adjacent to each element.

15. The device according to claim 14, wherein each sealing structure surrounds only a portion of all elements of the device.

16. The device according to claim 14, wherein each sealing structure encloses most of all elements of the device.

17. The device according to claim 14, wherein each sealing structure surrounds every element of the device.

18. The device according to claim 17, wherein the first sealing structure is arranged along a plane different from the plane of the second sealing structure.

19. The device according to any one of claims 14 to 18, wherein the first structure or the first structure is arranged to seal in contact with the wall of the RA, and the second structure or the second structure is arranged to seal in contact with the tube inlet of the RA.

20. The device according to any one of claims 1 to 19, wherein the sealing means comprises a plurality of layers.

21. The device according to any one of claims 1 to 20, wherein the sealing means comprises a reinforcing structure.

22. The device according to claim 21, wherein the reinforcing structure comprises a wire or a stent.

23. The device according to any one of claims 1 to 22, wherein at least one first portion of the device or its elements has a stiffness greater than the stiffness of a second portion of the device or its elements.

24. The device according to any one of claims 1 to 23, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first part of the device are, unlike the second part of the device, determined to be sized, shaped, and / or arranged to impart radial force.

25. The device according to any one of claims 1 to 24, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts, and one or more of the plurality of interconnected struts associated with the first portion are determined to be sized, shaped, and / or arranged to give a first diameter different from the second diameter of the second portion.

26. The device according to any one of claims 1 to 25, wherein each valve comprises a plurality of commutations, and the commutations of the first valve are offset from the commutations of the second valve by an angle of a predetermined value.

27. The device according to claim 26, wherein the plurality of crossings are three, and the angle of the predetermined numerical value includes approximately 60°.

28. The device according to any one of claims 1 to 27, further comprising one or more ports configured for the placement of pacemaker leads after implantation of the device.

29. The device according to any one of claims 1 to 28, wherein the intermediate portion of the device is configured for placement within the RA and comprises only partial covering.

30. The device according to any one of claims 1 to 29, wherein a first valve or the first valve, a second valve or the second valve, and / or a valve or the valve is configured to receive a replacement valve to be disposed therein.

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