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

Abstract

A single trans-vena tricuspid valve device (CCTD) for use in the treatment of a tricuspid valve insufficiency, comprising at least one stent structure; a first end configured for implantation in an inferior vena cava (IVC) and anchoring the device in the IVC, the first end optionally being at least partially covered; a second end configured for implantation in a superior vena cava (SVC) and anchoring the device in the SVC, the second end optionally being at least partially covered; a first valve connected to at least a portion of the first end such that when the CCTD is implanted, the first valve 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 the second valve is disposed under the SVC or within at least a portion of the right atrium (RA) located at least partially within the SVC and under the odd vein; and a sealing member.

Description

[0001] Related Applications

[0002] This disclosure claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 418,909, filed on October 24, 2022, entitled “SYSTEMS, METHODS, AND DEVICES FORTREATING A DISEASED OR OTHERWISE DAMAGED TRICUSPID VALVE,” and is also related to PCT Application No. PCT / IB2017 / 050534, filed on February 1, 2017, and PCT Application No. PCT / IL2019 / 050658, filed on June 7, 2019. Each of these disclosures is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to medical systems, devices, apparatuses and methods thereof for cardiac implantation, and particularly, but not limited to, stent-based devices for treating disease and / or dysfunction of the tricuspid valve. Background Art

[0004] The tricuspid valve prevents blood from flowing back from the right ventricle into the right atrium when closed during ventricular systole, and allows blood to flow from the right atrium into the right ventricle when opened during ventricular diastole.

[0005] Tricuspid regurgitation leading to tricuspid regurgitation may be caused by tricuspid annular dilatation and right ventricular enlargement. Tricuspid regurgitation is typically divided into two main etiologies: primary and secondary (also called functional). Primary tricuspid regurgitation accounts for approximately 10%-20% of cases and is associated with valvular regurgitation originating from the valve leaflets or chordae tendineae. Examples of primary tricuspid regurgitation include flail or perforated valve leaflets, ruptured chordae tendineae, pacemaker lead-induced TR, degenerated surgical tricuspid valve replacement, etc. However, tricuspid regurgitation is most often secondary to other etiologies, such as can be seen in conditions such as dilated cardiomyopathy, atrial fibrillation, and annular dilatation, right ventricular volume or pressure overload.

[0006] TR causes right atrial overload, which is transmitted to the superior and inferior vena cava and their tributaries. This eventually leads to hepatic congestion, ascites, generalized edema, peripheral edema, and other clinical symptoms of congestive heart failure. If untreated, severe TR often leads to heart failure and death.

[0007] Clinically available treatments for tricuspid regurgitation include open-heart surgery and / or drug therapy. However, open-heart surgery for tricuspid valve replacement and / or repair is rarely performed, primarily due to its high mortality and morbidity rates. Alternatively, drug therapy may not resolve the problem and may allow the disease to progress, worsening the patient's quality of life and heart function.

[0008] Currently, most patients with tricuspid regurgitation are considered inoperable due to the high surgical risks of tricuspid valve replacement and / or repair. This results in a very large number of untreated patients with significant tricuspid regurgitation.

[0009] Although significant efforts have been made to develop and clinically approve transcatheter device solutions for the treatment of tricuspid regurgitation, such as transcatheter tricuspid valve replacement (TTVR) and transcatheter edge-to-edge repair (TEER), such solutions still fail to address the challenges and limitations associated with the anatomy of the individual patient's tricuspid valve. For example, patients with a large regurgitant gap (i.e., the distance between the mal-approximated valve leaflets, typically greater than 10 mm) cannot be treated with TEER. In the same manner, patients with a large tricuspid annulus diameter (typically greater than 52 mm) are generally not suitable for treatment with a TTVR device. There are additional exclusion criteria for TTVR and TEER, such as indwelling pacemaker or defibrillator leads passing through the tricuspid valve, previous failed tricuspid valve leaflet surgery, etc.

[0010] TTVR and TEER are also demanding in terms of procedural complexity and duration, and typically require the use of multiple imaging modalities for implantation, such as transesophageal echocardiography, in addition to standard fluoroscopy.

[0011] In light of these challenges, the treatment option of caval valve implantation (CAVI) has emerged, which utilizes the vena cava (the inferior vena cava, or the inferior and superior vena cava) to position a transcatheter valve. While CAVI is fairly simple to perform and is not affected by the complex tricuspid valve anatomy and failed previous surgeries on the tricuspid valve, CAVI also presents challenges. For example, typically, patients with tricuspid regurgitation present with dilated right heart chambers. While this usually refers to the right ventricle (RV) and right atrium (RA), it can also refer to the inferior and superior vena cava (IVC and SVC). For example, the diameter of a dilated IVC and SVC can be as high as 55 mm. In addition, the high compliance of the IVC and SVC makes anchoring of a transcatheter CAVI valve extremely difficult and the potential for valve migration is greater.

[0012] Furthermore, the branches of the IVC and SVC, such as the nearby hepatic vein and azygos vein, respectively, further complicate the anchoring and sealing of the CAVI device by maintaining blood inflow from the hepatic vein and azygos vein without obstruction or disturbance. Summary of the invention

[0013] Therefore, with respect to at least some embodiments of the present disclosure, a transcatheter tricuspid valve device (CCTD) for treating tricuspid valve regurgitation is provided. According to some embodiments, such a CCTD includes many benefits, improvements, and features over prior art technologies such as TTVR, TEER, and current CAVI concepts, and addresses many challenges that still exist in transcatheter tricuspid valve regurgitation treatment.

[0014] In some embodiments of the present disclosure, the CCTD provides at least one, in some embodiments more, in some embodiments most, in some embodiments substantially all, and in some embodiments all of the following when compared to prior art devices:

[0015] - Single device,

[0016] - Single implantation procedure;

[0017] - improved anchorage and corresponding resistance to migration,

[0018] - Enhanced sealing (including, in some embodiments, no obstruction / disturbance of hepatic vein and azygos vein inflow),

[0019] - A simpler and more straightforward implant procedure,

[0020] - Ability to be implanted by fluoroscopy alone (i.e., no need for transesophageal echo guidance during the implantation procedure),

[0021] - Improved fit to individual unique tricuspid regurgitant caval and RA anatomy (including, in some embodiments, size, shape, SVC to IVC translation and / or angulation),

[0022] - Enhanced mechanical durability of the stent structure and atraumatic device ends

[0023] - Ability to recapture the device after it has been deployed / released, and

[0024] - Filters IVC / SVC blood flow to prevent thrombi / debris from reaching the right heart and lungs.

[0025] Additionally, in some embodiments, the CCTD includes the ability 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).

[0026] In some embodiments of the present disclosure, a single transcaval tricuspid device (CCTD) for treating tricuspid valve regurgitation is provided, which includes at least one stent structure, a first end, and the first end is configured to be implanted in the inferior vena cava (IVC) and anchor the device in the IVC (the first end is optionally at least partially covered). The device may also include a second end configured for implantation in the superior vena cava (SVC) and anchoring the device therein (the second end may also optionally be at least partially covered); a first valve connected to at least a portion of the first end such that when the CCTD is implanted, the first valve is disposed within at least a portion of the right atrium (RA) above the IVC so that it does not block the inflow of blood from the hepatic vein; a second valve connected to at least a portion of the second end such that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein; an intermediate portion (which may be at least partially covered or uncovered) that bridges the RA and the distance between the IVC and SVC device valves; and a sealing member configured to prevent or at least reduce the backflow of blood from the RA into the IVC and SVC.

[0027] In some embodiments, the middle portion is optionally configured to rotate at least one of the first valve and the second valve relative to at least one of the first end and the second end by a desired rotation amount. In some embodiments, this rotation helps to shorten the entire device length so that it will fit different patient anatomies.

[0028] In some embodiments, the middle portion is composed of alternating stent segments and soft / flexible materials such as, but not limited to, fabrics, biological tissues, polymers, or composite materials, such that the device is shortened by pushing the two device ends toward each other, and / or lengthened by pulling the two device ends away from each other. This feature helps shorten or lengthen the overall device length, thereby adapting it to different patient anatomies.

[0029] In some embodiments of the present disclosure, a prosthetic heart valve device is provided that includes at least one stent structure, at least one valve, and at least one sealing member.

[0030] In some embodiments of the present disclosure, a modular transcaval tricuspid valve device for treating tricuspid valve regurgitation is provided, the device comprising: a first stent configured to be implanted in the inferior vena cava (IVC) and anchor the device in the IVC, the first stent being optionally at least partially covered; a second stent configured to be implanted in the superior vena cava (SVC) and optionally anchor the device in the SVC, the second stent being 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, the first valve is arranged 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 the second valve is arranged below the SVC or at least partially within the SVC and at least a portion of the right atrium (RA) below the azygos vein; an IVC and SVC sealing member; and optionally a connector arranged between the first valve and the second valve, the connector being optionally configured to rotate at least one of the first valve and the second valve relative to at least one of the first stent and the second stent by a desired amount of rotation.

[0031] In some embodiments of the present disclosure, a transcaval tricuspid valve device for treating tricuspid valve regurgitation is provided, and it includes at least one stent structure, wherein a first end of the stent structure is configured for implantation in the inferior vena cava (IVC) and for anchoring the device in the IVC, and a first sealing member includes a first skirt attached to the outer diameter of the first end; and a second end of the stent structure is 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, and a second valve is connected to the second end, wherein the position of the first valve along the longitudinal direction of the stent structure overlaps with the position of the first skirt, or the position of the first valve is located between the position of the first skirt and the position of the second valve.

[0032] In the above embodiment, a second sealing member can be provided, which includes a second skirt attached to the outer diameter of the second end, wherein the position of the second valve along the longitudinal direction of the support structure overlaps with the position of the second skirt, or the position of the second valve is located between the position of the second skirt and the position of the first valve.

[0033] The longitudinal direction of the support structure extends along the length of the support structure.

[0034] The first valve and the second valve may have an extension in the longitudinal direction and may have a cylindrical outer shape. The skirt may be attached to the outer diameter along an annular portion having a smaller longitudinal extension than the valve. Thus, when viewed from the side, the cylindrical shape of the larger extension may overlap the annular shape of the smaller extension.

[0035] Each of the above embodiments may further include one and / or another of the following structures, features, functionalities, functions, steps, and clarifications, and in some embodiments, if these structures, features, functionalities, functions, steps, and clarifications are not mutually exclusive, multiple, most, substantially all, or all of the following structures, features, functionalities, functions, steps, and clarifications are included:

[0036] - the intermediate portion or connector has a length sufficient to bridge between the first end and the second end or between the first bracket and the second bracket, depending on the application;

[0037] - the middle section may be configured and / or used to be at least one of: rotatable, modular, straight (or in some embodiments, none of the above);

[0038] - the middle section may have a weaker structure than the first and second ends of the support structure in order to allow local rotation in the middle section;

[0039] - the at least one valve / at least one valve and optionally a plurality or all valves are endoluminal valves;

[0040] - at least one of the first stent, the second stent, the first valve, the second valve, the IVC and / or SVC sealing member, and the connector can be changed to different sizes to accommodate different anatomies of the patient;

[0041] - the sealing member comprises at least one skirt;

[0042] - the sealing member comprises a plurality of skirts;

[0043] - the sealing member comprises at least two skirts;

[0044] - the sealing member comprises at least three skirts;

[0045] - the sealing member is configured to prevent blood backflow from the right atrium to at least one of the inferior vena cava (IVC) and from the right atrium to the superior vena cava (SVC), leaking around any and all of one and / or another component of the device, without (in some embodiments) blocking hepatic vein and azygos vein inflow by using a sealing member including a suprahepatic IVC skirt and an infraazygos SVC skirt, respectively;

[0046] - an outer diameter of at least a portion of the device is between the following values: - 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, - 60-70 mm and ranges therebetween;

[0047] - the sealing means comprises one or more respective sealing structures disposed on or adjacent any and all elements of the device and, as the case may be, on or adjacent each element, and wherein one or more of the sealing structures are sized and shaped to specifically accommodate an anatomical structure to which the respective element is disposed opposite and / or adjacent;

[0048] o The corresponding sealing structure only surrounds a portion of any and all elements of the device;

[0049] o A corresponding sealing structure surrounds a substantial portion of any and all components of the device;

[0050] ○ Appropriate sealing structures surround any and all components of the device;

[0051] - the first sealing structure is arranged along a plane different from the plane of the second sealing structure;

[0052] - the first structure / the first structure may be arranged to seal against a wall of the RA and / or IVC, and the second structure / the second structure is arranged to seal against the SVC or the SVC inlet of the RA;

[0053] - the sealing member comprises a plurality of layers;

[0054] - the sealing member comprises a reinforcement structure, wherein the reinforcement structure may comprise a wire or a bracket;

[0055] - the sealing member comprises a parachute-shaped structure, wherein the parachute-shaped structure can be configured to open the sealing member during deployment of the device;

[0056] - The sealing member comprises a first perforated layer and a second sealing layer, wherein:

[0057] ○ The first perforated layer and the second sealing layer may be configured to create a recess,

[0058] o The size and shape of the created pocket is designed to promote tissue growth therein, and / or

[0059] ○ The first perforated layer is arranged adjacent to the tissue;

[0060] - the sealing structure comprises a skirt and comprises an inflatable balloon structure, wherein the balloon structure may be donut-shaped;

[0061] - the sealing structure comprises a stretchable skirt;

[0062] - a sealing structure / the sealing structure comprises a stretchable skirt reversibly adhered to an outer surface of an inflatable balloon structure;

[0063] - each sealing structure / the sealing structure comprises a three-dimensional skirt;

[0064] - Each sealing structure / the sealing structure comprises a support structure (which may be made of Nitinol), optionally covered by a sealing material;

[0065] - the sealing member material comprises a skirt, the skirt comprising a flange shape and having an inner diameter proximate a first end of the skirt, an outer diameter for attachment to at least one structure or element of the device, and having an outer diameter for interfacing with an inner diameter of any and all of the implantation site anatomy, the IVC, the SVC, or the RA in a direction toward a second end of the skirt;

[0066] ○ The skirt includes a straight edge, and / or

[0067] ○ The skirt includes a curved edge;

[0068] - the sealing member comprises a skirt, the skirt comprising a donut shape having an outer diameter configured to interface with surrounding tissue, the IVC, SVC, or RA and an inner diameter radially spaced from the outer diameter and configured for attachment to the stent structure;

[0069] - the sealing member comprises a skirt attached to an outer diameter of the stent structure, wherein the outer diameter of the skirt is at least twice the outer diameter of the stent structure;

[0070] - at least a portion of the device (e.g., a first portion) or an element thereof comprises a stiffness that is greater than a stiffness of another portion of the device (e.g., a second portion of the device or an element thereof), wherein the at least a portion may comprise a region of the device or an element thereof that accommodates at least a portion of a valve;

[0071] ○ Regarding stiffness (any, several, or all of the following):

[0072] ■ Stiffness may vary with stent thickness (in some embodiments, range of 0.1 mm-1.5 mm, and in some embodiments, preferably 0.2-1 mm);

[0073] ■ Stiffness may vary due to stent strut width (in some embodiments, range of 0.1 mm-1.5 mm, and in some embodiments, preferably 0.2-1 mm);

[0074] ■ Stiffness can vary depending on the configuration of the support structure (e.g., cell size / area 0.25-10 cm 2 and in some embodiments preferably 2.5 cm 2 ) and changes;

[0075] ■ Stiffness can vary due to stent surface treatment (e.g., electro / chemical polishing, sandblasting, passivation, etc.);

[0076] ○ Regarding the mentioned parts:

[0077] ■ another (eg second) part may include the remainder of the device or elements thereof, and / or

[0078] ■ another (e.g. second) part may comprise a middle part of the device / the middle part or an element thereof;

[0079] - at least one of the first support and the second support or at least one of the support structures comprises a structure comprising a plurality of interconnected struts;

[0080] - at least one of the first stent and the second stent or at least one stent structure comprises a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts is associated with a first portion having a thickness comprised between 0.2 mm and 1.0 mm;

[0081] - at least one of the first support and the second support or at least one of the support structures comprises a structure comprising a plurality of interconnected struts, the plurality of interconnected struts forming a plurality of cells;

[0082] - at least one of the first and second supports or at least one of the support structures comprises a structure comprising a plurality of interconnected struts, the plurality of interconnected struts forming a plurality of cells, and wherein the area of ​​each cell associated with the first portion is within 0.25 cm 2 With 10 cm 2 Between and preferably between 2-5 cm 2 between;

[0083] - at least one of the first stent and the second stent or at least one stent structure comprises a structure comprising a plurality of interconnected struts, the plurality of interconnected struts forming a plurality of cells, and wherein an area of ​​each cell associated with the first portion is configured to have a size and shape to allow passage of a catheter, wherein the size of the catheter may be at most approximately 15 mm in diameter (e.g., in some embodiments, so that transcatheter procedures such as transseptal surgery, pacemaker lead placement, and right heart catheterization may be performed after CCTD implantation);

[0084] - At least one of the first stent and the second stent or at least one stent structure comprises a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts are associated with a first portion of the device, and the size, shape and / or arrangement of one or more of the plurality of interconnected struts associated with the first portion compared to the second portion of the device are designed to be suitable for imparting radial forces (according to some embodiments, this results in any CCTD portion being only affected by forces acting directly thereon and not by forces acting on another portion of the CCTD, which contributes to the mechanical durability of the CCTD structure and its anatomical contact safety).

[0085] - at least one of the first stent and the second stent or at least one of the stent structures comprises a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts associated with the first portion are sized, shaped and / or arranged to impart a first diameter that is different from a second diameter of the second portion (in some embodiments, the CCTD can conform to anatomical structures of different sizes and shapes along its longitudinal axis such that one portion of the anatomical structure acting on one portion of the device does not cause a diameter change on another portion of the device);

[0086] - each of the valves comprises at least two commissures, and wherein the rotational position of the commissures of the first valve when connected to the first end is offset by a predetermined degree relative to the rotational position of the commissures of the second valve when connected to the second end, wherein the offset can be determined when the stent structure is not twisted (in some embodiments, during opening and closing of the valve(s), the forces acting on either of the SVC and IVC commissures are not aligned on a longitudinal line of the stent structure so as to enhance the mechanical durability of the stent structure);

[0087] - each valve comprises a plurality of commissures, and wherein the commissures of a first valve are offset by a predetermined degree relative to the commissures of a second valve (in some embodiments, during opening and closing of the valve(s), the forces acting on either of the SVC and IVC commissures are misaligned in a longitudinal line of the device so as to improve the mechanical durability of the CCTD and / or reduce the corresponding diameter increase and decrease in diastole and systole, respectively);

[0088] o The plurality of commissures comprises 2, and the predetermined degree is selected from the group consisting of 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, 2 0-50, 20-40, 20-30, 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, 60-70 and ranges therebetween.

[0089] o the plurality of commissures comprises 3 and the predetermined degree is selected from the group consisting of 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 ranges therebetween,

[0090] o the plurality of commissures comprises 3, and the predetermined degree comprises approximately 60°;

[0091] - the support structure / the support structure, the first support and / or the second support comprises a plurality of cells established by a plurality of interconnected struts, each cell being configured in a diamond shape;

[0092] - At least one thrombus filter (e.g. to prevent thrombi / debris from entering the CCTD and / or reaching the heart and lungs), where:

[0093] o The filter may include a plurality of arches, and wherein the plurality of arches may be established between adjacent vertices of at least one of the first and second supports or an end of at least one support structure, and / or

[0094] o the filter comprises a mesh positioned on at least one of the stent ends and configured for recapture of the device / filter after implantation of the device;

[0095] - the size and shape of the device is designed to be suitable for recapture;

[0096] - The size and shape of the device is designed to be suitable for recapture by DS hooks;

[0097] - the device comprises a length between 60 mm and 280 mm;

[0098] - the device is configured to translate between the IVC and SVC up to approximately 60 mm and an angle between 0 and 45 degrees;

[0099] - a cover covering at least one of the first bracket and the second bracket or an end of at least one bracket structure;

[0100] - the cover comprises one or more openings, the one or more openings being configured to be adjacent to one or more leaflets of the valve;

[0101] - the first stent, the second stent or the stent structure composition is selected from the group consisting of: shape memory materials, self-expanding materials, mechanically expandable materials, composite materials, polymers and combinations of the foregoing;

[0102] - the valve material is selected from the group consisting of: fabric, polymer, composite material, biological tissue and combinations of the foregoing;

[0103] - any and all of the sealing member and / or the covering / the covering is configured to be arranged or otherwise positioned on a portion thereof on the device, including on at least one of the first support, the second support or the support structure, on the inside, on the outside;

[0104] - any and all of the sealing member and / or the covering comprise a material selected from the group consisting of: a fabric, a biological tissue, a synthetic material, a composite material, a polymer, and combinations of the foregoing;

[0105] - one or more ports configured for placement of pacemaker and / or defibrillator leads after implantation of the device;

[0106] - one or more ports, the one or more ports configured for placement of a pacemaker lead after implantation of the device such that the one or more ports do not interfere with SVC valve function;

[0107] - at least one of the first and second stents or the stent structure comprises one or more struts arranged above or below the outflow region of the valve, the valve being positioned within or connected to the first strut / the first strut and / or the second strut / the second strut or strut component / the strut component, wherein:

[0108] ○ One or more struts may be positioned between the two leaflets of the valve,

[0109] o One or more struts are positioned within the middle portion of the valve, and / or

[0110] o one or more ports are arranged on a wall of at least one of the first support / the first support and the second support / the second support or the support structure / the support structure;

[0111] - the connections between the elements of the device comprise fabric;

[0112] - The majority of the device is flexible;

[0113] - The majority of the device is rigid;

[0114] - any and all of the first stent, the second stent, the first valve, the second valve, the at least one stent structure and the at least one valve comprise one or more hooks for connecting to another element, wherein an end of the hook can be received by an opening of the other element for attachment;

[0115] - the covering / covering is arranged or otherwise positioned on the device so as to prevent one or more blood jets from the native valve from impacting the device or its elements;

[0116] - The middle portion of the device is configured for placement within the RA and includes no more than a partial cover (so as to, in some embodiments, allow blood flow into the RA and passage of catheters while still maintaining the benefits of one-step implantation, resistance to migration, and mechanical strength of the device);

[0117] - comprising one or more radiopaque materials on one or more portions or locations of any and all of the first stent, the second stent, the stent structure, the valve, the first valve / the first valve, the second valve / the second valve, the connector / the connector, the middle portion / the middle portion and one or more leaflets of the valve;

[0118] - the first valve / the first valve, the second valve / the second valve and / or the valve / the valve is configured to receive a transcatheter self-expanding or mechanically expandable (including balloon expandable) replacement valve such that the replacement valve is disposed therein (in some embodiments, this allows percutaneous replacement of (one or more) CCTD valves in the event of valve dysfunction / deterioration).

[0119] - In some embodiments, the first valve / the first valve, the second valve / the second valve and / or valve / the valve comprises a diameter range of 18 mm-30 mm, and in some embodiments, a range of 25 mm-29 mm (e.g., allowing interventional cardiologists to use the vast majority of commercially available transcatheter valves).

[0120] - in CCTD valve embodiments, the first valve / the first valve, the second valve / the second valve and / or the valve / the valve has at least one of a rigid perimeter, an hourglass shape, an upper / lower stop and additional features for stabilizing the transcatheter valve; and

[0121] - The middle portion or connector is configured to be twisted to achieve a change in the length of the device, wherein the middle portion or connector may include a plurality of linear structures for connecting the ends of the device and / or the first bracket and the second bracket of the device, which shortens the length of the device when twisted in a first direction, and extends the length of the device when twisted in a second direction opposite to the first direction.

[0122] In some embodiments, a method of implanting a transcaval tricuspid device (CCTD) for treating tricuspid regurgitation is provided. In some embodiments, the method includes providing a CCTD according to any of the disclosed CCTD embodiments, removably attaching the CCTD to the distal end of a delivery catheter, guiding the distal end of the delivery catheter to an implantation site adjacent to at least one of the IVC, SVC, RA, or RV via any of the following: femoral access and jugular access, deploying or otherwise releasing the CCTD at the implantation site, and removing the delivery catheter. Optionally, the method may also include retrieving the deployed CCTD (fully or partially deployed).

[0123] Such method embodiments may further include any and all of the following:

[0124] - Adjusting CCTD length (e.g., via rotation and / or constriction);

[0125] - A modular CCTD, in particular one or more of the SVC, IVC and RA segments are connected together before inserting the (modular) device into a catheter or alternatively into a patient;

[0126] - If construction of the modular device is completed in the patient, implantation can be via a femoral approach, a jugular approach, or a femoral and jugular approach (i.e., in some embodiments, where separate catheters (femoral and jugular) deliver at least a portion of the modular device).

[0127] These and other objects, advantages and benefits of the embodiments of the present disclosure will become more apparent with reference to the accompanying drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0128] Those skilled in the art will appreciate that the drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily drawn to scale; in some cases, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate understanding of different features. In the drawings, similar reference numerals generally refer to similar features (e.g., functionally similar and / or structurally similar elements).

[0129] Figure 1 is a side view of a CCTD implanted in the right atrium (cross-section) and portions thereof positioned in the SVC and IVC according to some embodiments of the present disclosure;

[0130] Figures 2 to 3 is a side view of a CCTD implanted within the right atrium (cross-section) and portions thereof within the SVC and IVC, illustrating the rotational functionality of the CCTD, according to some embodiments of the present disclosure;

[0131] Figures 4 to 5 is a side view of a CCTD implanted in the right atrium (cross-section) and portions thereof located in the SVC and IVC, illustrating the foreshortening functionality of the CCTD, according to some embodiments of the present disclosure;

[0132] FIG. 6A to FIG. 6B is a side view of a CCTD according to some embodiments of the present disclosure ( Figure 1 Corresponding to the implant Fig. 6A CCTD);

[0133] 7A to 8D Various skirt structures of a sealing member for a CCTD according to some embodiments of the present disclosure are illustrated;

[0134] Figures 9 and 10 is a side view of a CCTD according to some embodiments of the present disclosure ( Fig. 9 is a separate CCTD, and Fig.10 illustrates a CCTD implanted in the right atrium / IVC / SVC according to some embodiments of the present disclosure), illustrating a multi-planar skirt structure of a sealing member for the CCTD;

[0135] Fig.11 illustrates a CCTD having two valves, wherein the commissures of a first valve are offset relative to the commissures of a second valve, according to some embodiments;

[0136] Fig.12 illustrates a CCTD having at least one thrombus filter for preventing emboli from advancing through the CCTD, according to some embodiments;

[0137] FIG. 13A to FIG. 13BAdditional features of a thrombus filter for CCTD according to some embodiments are illustrated (side and end views are shown). Figure 2 ), which may be arranged on the support structure of the CCTD, on or adjacent to its ends, near or in the IVC or SVC;

[0138] FIG. 14A to FIG. 14B Figure 1 illustrates a CCTD configured with functionality that can conform to a specific patient's anatomy, according to some embodiments;

[0139] FIG. 14C to FIG. 14D illustrates a CCTD according to some embodiments having structure / functionality (eg, a cover) that prevents one or more blood jets from the native valve from impacting the device or components thereof;

[0140] FIG. 15A to FIG. 15B A CCTD according to some embodiments is illustrated having a stent including one or more struts disposed above and / or below an outflow region of a valve, the valve being positioned within or connected to a first strut and / or a second strut or strut component;

[0141] FIG. 16A to FIG. 16B illustrates a CCTD according to some embodiments having a stent including one or more struts disposed above and / or below an outflow region of a valve, with the valve positioned within or connected to a first strut and / or a second strut or strut component, wherein a pacemaker lead or the like may be guided through and within the CCTD;

[0142] Fig.17 illustrates a side view of a CCTD having a port for receiving and / or placing pacemaker lead(s) or the like in accordance with some embodiments;

[0143] Fig.18 illustrates a side view of a CCTD having attachment members for connecting components of the CCTD together according to some embodiments;

[0144] FIG. 19A to FIG. 19B A CCTD according to some embodiments of the present disclosure is illustrated that includes functionality that enables replacement of a previous prosthetic valve with another prosthetic valve. DETAILED DESCRIPTION

[0145] like Figure 1As shown in , which illustrates some embodiments of the present disclosure, a transcaval tricuspid device (CCTD) 100 for treating tricuspid valve regurgitation is provided. In some embodiments, the device can be a single integral device, and in some embodiments, the device 100 can include two or more interconnected components. Thus, the device 100 can include at least one stent structure 102 (in some embodiments, a single stent structure), a first end 104, the first end being configured for implantation in the inferior vena cava (IVC) 200 and anchoring the device in the IVC (wherein the first end is optionally at least partially covered). The device also includes a second end 106, the second end being 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.

[0146] The first valve 108 is coupled to at least a portion of the first end 104 such that when the CCTD is implanted, the first valve 108 is disposed within at least a portion of a right atrium (RA) 204 of the heart 201 above the IVC 200 .

[0147] The device 100 may also include a second valve 110 connected to at least a portion of the second end 106 such that the second valve 110 is disposed partially beneath the SVC 202 or at least partially within the SVC 202 and within the right atrium 204 beneath the azygos vein 206 .

[0148] The device 100 may also include a sealing member 112 .

[0149] Optionally, the device 100 may further include an intermediate portion 114 between the first end 104 and the second end 106, which may be configured (in some embodiments) to rotate at least one of the first valve 108 and the second valve 110 relative to at least one of the first end 104 and the second end 106 by a desired rotation amount 120. Figures 2 to 3 Middle diagram ( Figure 2 The device 100 is shown to be straight, and Figure 3 The device 100 is shown rotated relative to the first end 104 and the second end 106).

[0150] Each valve (and any valve according to other disclosed embodiments) can be considered an intraluminal valve. The end result of the rotational function can be achieved (or further achieved) via the contraction of the device 100 (see Figures 4 to 5 ).

[0151] In some embodiments, the sealing member includes an IVC skirt configured to have an outwardly protruding size and shape and disposed on the RA bottom and an SVC skirt configured to have an outwardly protruding size and shape and disposed on the RA top.

[0152] In some embodiments of the present disclosure, the prosthetic heart valve device 100 CCTD may be simply at least one stent structure 102, at least one valve (e.g., valve 108 and / or valve 110), and at least one sealing member 112. One and / or the other of the valves may include materials including fabrics, polymers, composite materials, biological tissue, and combinations of the foregoing.

[0153] In some embodiments, the outer diameter of at least a portion of a CCTD device (single or modular) can be between the following values: 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 and ranges therebetween.

[0154] As indicated above, in some embodiments, the CCTD may be a modular CCTD 116 for treating tricuspid valve regurgitation, such as Figures 4 to 5 In these embodiments, the first end can be configured as a first stent 118 configured to be implanted in an inferior vena cava (IVC) 200 and anchor the device in the IVC, the first stent is optionally at least partially covered, and the second stent 120 is configured to be implanted in a superior vena cava (SVC) 204 and optionally anchor the device in the SVC. The second stent 120 can be at least partially covered. 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, the first valve is arranged in at least a portion of the right atrium (RA) 204 above the IVC 200. The second valve (not shown) is connected to at least a portion of the second stent 120 so that the second valve 124 is arranged below the SVC 204 or at least partially within the SVC 204 and within at least a portion of the right atrium (RA) 206 below the azygos vein 208. Similar to a single device, a modular device may include a sealing member and optionally an intermediate portion 114 (which may also be referred to as a connector) disposed between a first valve and / or first stent 118 and a second valve and / or second stent 120 .

[0155] Similar to the middle portion 114 of the CCTD 100, the connector 114 can optionally be configured to rotate the first valve and / or the first support 118 and the second valve 124 and / or the second support 120 relative to at least one of the first valve / first support 118 and the second valve / second support 120 by a certain amount of rotation (which can be predetermined according to the desired amount). For example, in some embodiments, the amount of rotation can preferably be between 0 degrees and 180 degrees. See Figures 2 to 3 .

[0156] The middle portion 114 or connector has a length sufficient to span between the first end and the second end or between the first bracket and the second bracket, depending on the application. In some embodiments, the span is between about 30 mm and 120 mm, and in some embodiments, preferably between 40-90 mm.

[0157] At least one of the stents (and / or connectors / mid-portion) of the CCTD may be made of shape memory materials, self-expanding materials, mechanically-expanding materials, composite materials, polymers, and combinations of the foregoing.

[0158] With respect to some embodiments, and in particular with respect to embodiments of modular CCTDs, components thereof may be configured for specific human anatomy, including, for example, different sizes, shapes, lengths, etc., so as to correspond to specific human anatomy. To this end, in some embodiments, a kit may be provided that includes a plurality of different components, such as a first stent of different sizes (e.g., diameter, shape, and / or length) for positioning in the IVC, a second stent of different sizes (e.g., diameter, shape, and / or length) for positioning in the SVC, a valve of different sizes (e.g., diameter and / or length), a connector of different sizes (e.g., diameter and / or length), and any and / or all of the foregoing components with a sealing member (e.g., a cover, a skirt, etc.).

[0159] In some modular CCTD embodiments, the interface between components, in some embodiments, can be considered as a bonding material 128 or structure, such as Figures 4 to 5 For example, a fabric material (which may be a natural or synthetic material) may be disposed between the first bracket and the connector and between the second bracket and the connector. Figure 5 As shown in , in some embodiments, the bonding material 128 can be flexible so that it can compress and extend (ie, change the length of part and / or all of the CCTD). In some embodiments, the bonding material can be tissue, including, for example, pericardial tissue.

[0160] In some embodiments, any of the stents may be configured to be flexible or rigid, or a combination (eg, a portion of the stent is flexible and a portion of the stent is rigid, a first stent is flexible and a second stent is rigid).

[0161] In some embodiments, the CCTD, whether modular or a single device, and as mentioned above, can include a sealing member. Such a sealing member can include one or more fluid-impermeable (including a sealing member that is almost or substantially fluid-impermeable) skirts 130, and in some embodiments, multiple fluid-impermeable skirts 130 (e.g., two skirts, three skirts). Such skirts can include materials such as, for example, fabrics, biological tissues, polymers, and composite materials.

[0162] like FIG. 6A to FIG. 6B As shown in (see also Figure 1 ), in some embodiments, the sealing member is configured to prevent backflow of blood from at least one of the right atrium 206 to the IVC 202 and from the right atrium 206 to any and all of the SVC 204, prevent leakage around any and all of one and / or another component of the device, and still allow inflow into the hepatic vein and the azygos vein (e.g., the IVC skirt above the hepatic vein and the SVC skirt below the azygos vein, respectively). Fig. 6A A single sealing member / skirt on the IVC portion of the CCTD is illustrated, and Figure 6B Two (2) sealing members / skirts 112 / 130 are shown. In addition, one or more corresponding sealing structures are disposed on or adjacent to any and all elements of the device and, as applicable, may be sized and shaped to specifically accommodate the anatomical structure to which the corresponding element is disposed opposite and / or adjacent.

[0163] As in Fig. 6A 104, the first sealing member 112 includes a first skirt 130 attached to the outer diameter of the first end portion 104, and the first valve 108 is connected to the first end portion 104. The position of the first valve 108 along the longitudinal direction of the support structure 102 overlaps the position of the first skirt 130. In other words, if viewed from the side, a portion of the first valve 108 can be seen above and below the portion of the first skirt 130 attached to the first end portion 104.

[0164] Alternatively, and in Fig. 6A Not shown in the figure, 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 .

[0165] In addition, as in Fig. 6A106, 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 overlaps the position of the second skirt 130. In other words, if viewed from the side, a portion of the second valve 110 can be seen above and below the portion of the second skirt 130 attached to the second end 106.

[0166] Alternatively, and Fig. 6A Not shown in the figure, 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 .

[0167] Thus, in some embodiments, one or more corresponding sealing structures can be configured to surround at least a portion of any and all elements of the device, and in some embodiments, surround only a portion of any and all elements of the device, and / or surround any and all elements of the device. For example, according to some embodiments, the sealing structure (skirt 144) can be arranged on different planes of the CCTD device and RA 204, such as Figures 9 and 10 as shown in .

[0168] In some embodiments, the sealing member (eg, skirt) may include multiple layers, such as Figure 6B As shown in , it can include a reinforcing structure such as a wire or a bracket. For example, according to some embodiments, the wire can circle the perimeter of at least a portion of the skirt sealing structure to help give the structure greater rigidity (for example). Such a material providing such a structure can be Nitinol or a material with similar properties.

[0169] 7A to 8D Various skirt configurations for sealing members are illustrated. To this end, one or more skirts for some embodiments may include a flange-shaped and / or inverted 138a / b ( FIG. 7A to FIG. 7B , Fig. 8A ), including a convex or concave curved portion, which may include or be configured as a parachute-shaped structure 138c ( Fig. 7A , Fig.8D ), oblong, bulbous shape 142 ( Figure 8B ) and / or tubular 144 ( Figure 8C ). Figure 8C The tubular skirt may be or be considered to be an inflatable balloon structure, which may be donut-shaped. The donut-shaped skirt may include an outer diameter and an inner diameter, the outer diameter being configured to interface with surrounding tissue, IVC, SVC or RA, and the inner diameter being radially spaced apart from the outer diameter and configured for attachment to a stent structure.

[0170] In some embodiments, a perforated layer having one or more perforations 146 may be included, and / or the creation of one or more "recesses" 139 (see FIG. 7A to FIG. 7B ). In some embodiments, perforations and recesses are provided such that for one or more recesses, their size and shape are designed to be suitable for promoting tissue growth therein. Thus, in some embodiments, such perforations and / or recesses may be between 0.5 mm and 5 mm.

[0171] In some embodiments, the skirt sealing structure can be configured as a stretchable material (e.g., silicon, rubber, and materials having similar properties as described above) that can be configured to cover the exterior of another element, including, for example, an inflatable balloon structure. In some embodiments, one or more skirts can include straight edges (see, for example, edge 138d or curved or undulating edge 140b).

[0172] In some embodiments, at least one first portion of the CCTD or an element thereof comprises a stiffness greater than a stiffness of a second portion of the device or an element thereof. Such a feature allows at least one of the following:

[0173] - tailoring different device parts to different functions, such as IVC and SVC flexibility when contacting, for example, the phrenic nerve and / or the delicate SVC and IVC, while maintaining a strong commissural structure so that the valve does not collapse under large systolic pressure gradients, and

[0174] - Flexibility in the midsection to allow for translational and angular differences between the SVC and IVC while still maintaining resistance to migration.

[0175] At least one first portion may include a region of the device or component thereof housing at least a portion of the valve. The second portion may include the remainder of the region of the device or component thereof, or an intermediate portion of the device or component thereof.

[0176] The CCTD or one or more elements thereof (e.g., the support structure, the first support, the second support) includes a structure including a plurality of interconnected struts, wherein one or more of the plurality of interconnected struts is associated with a first portion including a thickness between 0.2 mm and 1.0 mm. Such interconnected struts may form a plurality of cells 148 ( Fig.12 In some embodiments, the area of ​​each cell associated with at least a portion of the CCTD may be within 0.25 cm 2 With 10 cm 2 Between and preferably (in some embodiments) between 2-5 cm 2In some embodiments, each cell associated with at least a first portion of the CCTD is configured to have a size and shape that allows passage of a catheter, for example, the catheter is sized to have a diameter of at most about 15 mm (in some embodiments). The cells can include any shape, and in some embodiments, multiple cells each include a diamond shape.

[0177] In some embodiments, the size, shape, and / or arrangement of a plurality of interconnected struts associated with a first portion of the device can be designed to be suitable for imparting radial forces as compared to a second portion of the device. In some embodiments, the size, shape, and / or arrangement of some of the interconnected struts corresponding to the first portion are designed to be suitable for imparting a first diameter that is different from a second diameter of a second portion of the CCTD in order to accommodate different IVC, SVC, and RA anatomical structure sizes with one device.

[0178] In some embodiments of CCTD 100, one or more of the valves includes multiple commissures, and in some embodiments, two valves ( Fig.11 ), the commissures 150a of the first valve 150b are offset by a predetermined degree relative to the commissures 152a of the second valve 152b. In some embodiments, the offset of the commissures of the two valves is beneficial because it differentiates the forces exerted on the overall device structure by the SVC and IVC CCTD valves across any one longitudinal line (i.e., no IVC and SVC commissures lie on one longitudinal CCTD line).

[0179] In some embodiments, each of the valves 150b, 152b includes at least two commissures 150a, 152a, and wherein the rotational position of the commissures of the first valve 150b when connected to the first end of the support structure is offset by a predetermined degree relative to the rotational position of the commissures 152a of the second valve 152b when connected to the second end of the support structure, wherein the offset is preferably determined when the support structure is not twisted.

[0180] Thus, various embodiments of valves including two (2) commissures have offset values ​​that may be between the following values: 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, 20-6 0, 20-50, 20-40, 20-30, 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, 60-70 and ranges therebetween. In various embodiments where the valve includes three (3) commissures, the offset value 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 ranges therebetween. In some embodiments where the plurality of commissures includes three (3), the predetermined degree of offset is preferably about 60°.

[0181] In some embodiments, Fig.12 As shown in , the CCTD includes at least one thrombus filter 154, which can be arranged on a stent structure adjacent to or at an end in the IVC 202 or SVC. The filter 154 may include a plurality of arches 156 and a net or mesh structure (not shown) that is configured to capture thrombi from the IVC or SVC. In some embodiments, the plurality of arches are established between adjacent vertices of at least one of the first stent and the second stent or at least one of the stent structures' ends. The filter or mesh component 158 ​​can be configured for recapture of the device / filter after implantation of the device. To this end, in some embodiments, the size and shape of the CCTD and / or its components or portions can be designed to be suitable for recapture by a catheter during implantation or during retrieval after implantation. In such an embodiment, the thrombus can be captured by using a hook device 160 (such as FIG. 13A to FIG. 13B ) to achieve recapture.

[0182] like FIG. 14A to FIG. 14BAs shown in the figures, the CCTD can include a certain length (in some embodiments, between 60 mm and 280 mm). In addition, in some embodiments, and as shown in these figures, the CCTD 100 (and / or its components) is configured to conform to the anatomy of a particular patient (e.g., via the interconnecting struts of one or more stents of the CCTD). To this end, the CCTD can be configured to translate between the IVC and the SVC up to approximately 60 mm and / or at an angle between 0 and 45 degrees.

[0183] In some embodiments, the CCTD or a component thereof may include a cover 162 that covers at least one of the first and second stents or an end of at least one stent structure. In some embodiments, the cover 162 may include one or more openings configured to be adjacent to one or more leaflets of the valve. In some embodiments, such a cover 162 (and / or a sealing member) may be configured to be arranged or otherwise positioned on a portion thereof on the device, including on any stent, on at least one of the inside, the outside. According to some embodiments, any and all sealing members and / or covers may be made of materials including biological tissue, synthetic materials, composite materials, polymers, and combinations of the foregoing.

[0184] In some embodiments, the cover 162 may be configured or otherwise arranged or positioned, such as FIG. 14C to FIG. 14D , to prevent one or more blood jets from the native valve from impacting the device or its components. For example, in some embodiments, the cover 162 covers the middle portion of the CCTD device (which is configured for placement within the RA). Fig. 14C The figure shows no cover to prevent possible blood ejection, and Fig.14D The cover 162 is shown blocking the jet (the jet is illustrated as a dashed arrow).

[0185] like FIG. 15A to FIG. 16B As shown in, in some embodiments, the stent of CCTD 100 includes one or more struts 170 arranged above and / or below the valve outflow area, and the valve is positioned in or connected to the first strut and / or the second strut or strut component. Such a strut or component can be positioned between the two leaflets of the valve, and in some embodiments, one or more struts are positioned in the middle of the valve / the valve. In some embodiments, the purpose of such a strut is to allow a pacemaker or defibrillator lead 172 to pass through without interfering with proper valve function. In some embodiments, one or more struts guide a guide wire or catheter to pass between the leaflets.

[0186] like Fig.17As shown in , in some embodiments, one or more stents, coverings and / or sealing members of a CCTD may be configured with one or more ports 164 for placement of, for example, (one or more) pacemaker leads 166 after device implantation. For such a stent, one or more ports may correspond to an area or opening for placement of a pacemaker lead 172 after device implantation. In some embodiments, such ports do not interfere with any valve included in the CCTD. For example, one or more ports may be arranged on the wall of (one or more) stents of the CCTD. In some embodiments, the port guides a guide wire or catheter through the outside of the valve.

[0187] In some embodiments, and as Fig.18 , any stent of the CCTD, particularly those that may include attachment members, may include one or more hooks 168 for connection to other components of the CCTD (one and / or another of the stent, valve, etc.), and / or in some embodiments, one or more sutures. This feature may allow each connection of the elements of the CCTD so that the components may be easily interchanged (e.g., to customize the CCTD for a particular patient for anatomical purposes), and / or enable delivery / implantation of one or more components for connection to previously implanted components. The end of such a hook 168 may be accommodated by an opening 171 of another element for attachment.

[0188] The CCTD device may include one or more radiopaque materials, for example and according to some embodiments, which are included in one or more portions or locations of any and all of, for example, any stent, valve, connector, intermediate portion, and one or more leaflets of the valve of the device.

[0189] In some embodiments, FIG. 19A to FIG. 19B As shown in , one or more valves of CCTD 100 are configured to receive replacement valve 180 so that the replacement valve is disposed therein. For example, replacement valve 170 can be delivered to one and / or another valve of a previously implanted CCTD. For example, to replace a degenerated or dysfunctional CCTD valve.

[0190] Example aspects and embodiments of the present disclosure

[0191] Example 1: A single transcaval tricuspid valve device for treating tricuspid valve regurgitation, comprising: at least one stent structure; a first end, the first end being configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first end being optionally at least partially covered; a second end, the second end being configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, the second end being optionally at least partially covered; a first valve, the first valve being connected to at least a portion of the first end so that when the CCTD is implanted, the first valve is arranged in at least a portion of the right atrium (RA) above the IVC; a second valve, the second valve being connected to at least a portion of the second end so that the second valve is arranged below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein; and a sealing member.

[0192] Example 2: A single transcaval tricuspid valve device for treating tricuspid valve regurgitation, comprising: at least one stent structure; a first end portion, the first end portion is configured to be implanted in the inferior vena cava (IVC) and anchor the device in the IVC, the first end portion is optionally at least partially covered; a second end portion, the second end portion is configured to be implanted in the superior vena cava (SVC) and anchor the device in the SVC, the second end portion is optionally at least partially covered; a first valve, the first valve is connected to at least a portion of the first end portion so that when the CCTD is implanted, the first valve is arranged in the IVC a second valve connected to at least a portion of the second end so that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein; a sealing member; and optionally, an intermediate portion between the first end and the second end, the intermediate portion optionally being configured to at least one of: rotate at least one of the first valve and the second valve relative to at least one of the first end and the second end by a desired amount of rotation, and contract the device.

[0193] Example 3: A modular transcaval tricuspid valve device for treating tricuspid valve regurgitation, comprising: a first stent, the first stent is configured to be implanted in the inferior vena cava (IVC) and anchor the device in the IVC, the first stent is optionally at least partially covered; a second stent, the second stent is configured to be implanted in the superior vena cava (SVC) and optionally anchor the device in the SVC, the second stent is optionally at least partially covered; a first valve, the first valve is connected to at least a portion of the first end, so that when the CCTD is implanted, the first valve is arranged on the IVC a second valve connected to at least a portion of the second end so that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein; a sealing member; and an optional connector disposed between the first valve and the second valve, the connector optionally being configured to at least one of: rotate at least one of the first valve and the second valve relative to at least one of the first stent and the second stent by a desired amount of rotation, and constrict the device.

[0194] Example 4: A prosthetic heart valve device comprising: at least one stent structure, at least one valve, and at least one sealing member.

[0195] Example 5: A device according to any of Examples 2 to 3, wherein the intermediate portion or connector has a length sufficient to bridge between the first end and the second end or between the first bracket and the second bracket depending on the application.

[0196] Example 6: A device according to any of Examples 1 to 4, wherein the / at least one valve and optionally multiple or all valves are intraluminal valves.

[0197] Example 7: The device of Example 3, wherein at least one of the first stent, the second stent, the first valve, the second valve, the sealing member, and the connector can be changed to different sizes to accommodate different anatomical structures of the patient.

[0198] Example 8: The device according to any one of Examples 1 to 7, wherein the sealing member includes at least one skirt.

[0199] Example 9: A device according to any one of Examples 1 to 7, wherein the sealing member includes a plurality of skirts.

[0200] Example 10: A device according to any of Examples 1 to 7, wherein the sealing member includes at least two skirts.

[0201] Example 11: A device according to any of Examples 1 to 7, wherein the sealing member includes at least three skirts.

[0202] Example 12: A device according to any of Examples 1 to 11, wherein the sealing member is configured to prevent blood backflow from the right atrium to any and all of at least one inferior vena cava (IVC) and from the right atrium to the superior vena cava (SVC), prevent leakage around any and all of one component and / or another component of the device, and / or allow hepatic vein inflow, wherein the sealing member includes an IVC skirt above the hepatic vein.

[0203] Example 13: A device according to any one of Examples 1 to 12, wherein the outer diameter of at least a portion of the device is between the following values: 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 and ranges therebetween.

[0204] Example 14: A device according to Examples 1 to 13, wherein the sealing member includes one or more corresponding sealing structures, which are arranged on or adjacent to any and all of each element of the device depending on the specific application, and wherein the size and shape of one or more of the sealing structures are designed to specifically adapt to anatomical structures arranged opposite and / or adjacent to the corresponding element.

[0205] Example 15: The device of Example 14, wherein the corresponding sealing structure only surrounds a portion of any and all elements of the device.

[0206] Example 16: The device of Example 14, wherein the corresponding sealing structure surrounds a majority of any and all elements of the device.

[0207] Example 17: The device of Example 14, wherein a corresponding sealing structure surrounds any and all elements of the device.

[0208] Example 18: The device of Example 17, wherein the first sealing structure is arranged along a plane different from a plane of the second sealing structure.

[0209] Example 19: A device according to any of Examples 14 to 18, wherein the first structure / the first structure is arranged to seal against a wall of the RA, and the second structure / the second structure is arranged to seal against a blood vessel entrance of the RA.

[0210] Example 20: A device according to any one of Examples 1 to 19, wherein the sealing member includes multiple layers.

[0211] Example 21: A device according to any of Examples 1 to 20, wherein the sealing member includes a reinforcement structure.

[0212] Example 22: The device of Example 21, wherein the reinforcing structure comprises a wire or a bracket.

[0213] Example 23: A device according to any one of Examples 1 to 22, wherein the sealing member includes a parachute-shaped structure.

[0214] Example 24: The device of Example 23, wherein the parachute-shaped structure is configured to open the sealing member during deployment of the device.

[0215] Example 25: A device according to any one of Examples 1 to 24, wherein the sealing member includes a first perforated layer and a second sealing layer.

[0216] Example 26: The device of Example 25, wherein the first perforated layer and the second sealing layer are configured to establish a recess.

[0217] Example 27: The device of Example 26, wherein the size and shape of the created recess are designed to be suitable for promoting tissue growth therein.

[0218] Example 28: A device according to any of Examples 25 to 27, wherein the first perforated layer is arranged to be adjacent to the tissue.

[0219] Example 29: A device according to any of Examples 14 to 28, wherein the sealing member includes a skirt and includes an inflatable balloon structure.

[0220] Example 30: A device according to Example 29, wherein the balloon structure is donut-shaped.

[0221] Example 31: A device according to any one of Examples 14 to 28, wherein the sealing structure / the sealing structure includes a stretchable skirt.

[0222] Example 32: A device according to any of Examples 14 to 28, wherein the sealing structure / the sealing structure includes a stretchable skirt reversibly adhered to the outer surface of the inflatable balloon structure.

[0223] Example 33: A device according to any of Examples 14 to 28, wherein each / the sealing structure includes a three-dimensional skirt.

[0224] Example 34: A device according to Example 33, wherein each / the sealing structure comprises a nitinol structure, optionally covered by a sealing material.

[0225] Example 35: A device according to any of Examples 1 to 8 and 12 to 28, wherein the sealing member material includes a skirt, the skirt including a flange shape and having an inner diameter proximate a first end of the skirt, an outer diameter for attachment to at least one structure or element of the device, and an outer diameter for docking with the inner diameter of any and all of the implantation site, the IVC, the SVC or the RA in a direction toward the second end of the skirt.

[0226] Example 36: The device of Example 35, wherein the skirt includes a straight edge.

[0227] Example 37: An apparatus according to Example 35, wherein the skirt includes a curved edge.

[0228] Example 38: A device according to any of Examples 1 to 8 and 12 to 28, wherein the sealing member includes a skirt, the skirt including a donut shape having an outer diameter configured to interface with surrounding tissue, the IVC, SVC or RA and an inner diameter radially spaced from the outer diameter and configured for attachment to a support structure.

[0229] Example 39: A device according to any of Examples 1 to 38, wherein at least one first portion of the device or an element thereof comprises a stiffness greater than the stiffness of a second portion of the device or an element thereof.

[0230] Example 40: The device of Example 39, wherein the at least one first portion comprises a region of the device or an element thereof that houses at least a portion of a valve.

[0231] Example 41: An apparatus according to Example 40, wherein the second portion includes the remainder of the area of ​​the apparatus or an element thereof.

[0232] Example 42: An apparatus according to Example 41, wherein the second portion comprises a middle portion / the middle portion of the apparatus or an element thereof.

[0233] Example 43: A device according to any one of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure comprises a structure including a plurality of interconnected struts.

[0234] Example 44: A device according to any of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure comprises a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts is associated with a first portion comprising a thickness between 0.2 mm and 1.0 mm.

[0235] Example 45: A device according to any one of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure includes a structure comprising a plurality of interconnected struts, and the plurality of interconnected struts form a plurality of units.

[0236] Example 46: The device of any one of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure comprises a structure comprising a plurality of interconnected struts, the plurality of interconnected struts forming a plurality of cells, and wherein the area of ​​each cell associated with the first portion is within 0.25 cm 2 With 10 cm 2 and preferably between 2 and 5 cm 2 between.

[0237] Example 47: A device according to any one of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure comprises a structure comprising a plurality of interconnected struts, the plurality of interconnected struts forming a plurality of units, and wherein an area of ​​each unit associated with the first portion is configured to have a size and shape that allows a catheter to pass through.

[0238] Example 48: The device of Example 47, wherein the catheter is sized to be approximately 15 mm in diameter.

[0239] Example 49: A device according to any one of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure includes a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts are associated with a first portion of the device, and the size, shape and / or arrangement of one or more of the plurality of interconnected struts associated with the first portion compared to the second portion of the device is designed to be suitable for imparting radial force.

[0240] Example 50: A device according to any of Examples 1 to 42, wherein at least one of the first support and the second support or the at least one support structure includes a structure comprising a plurality of interconnected struts, and wherein the size, shape and / or arrangement of one or more of the plurality of interconnected struts associated with the first portion is designed to be suitable for imparting a first diameter that is different from a second diameter of the second portion.

[0241] Example 51: A device according to any of Examples 1 to 50, wherein each valve includes a plurality of commissures, and wherein the commissures of the first valve are offset by a predetermined degree relative to the commissures of the second valve.

[0242] Example 52: The device of Example 51, wherein the plurality of commissures comprises 2, and the predetermined degree is selected from the group consisting of: 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, 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, 60-70 and ranges therebetween.

[0243] Example 53: A device according to Example 51, wherein the plurality of joints include 3 and the predetermined degree is selected from the group consisting of: 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 ranges therebetween.

[0244] Example 54: A device according to Example 51, wherein the plurality of commissures includes 3 and the predetermined degree includes approximately 60°.

[0245] Example 55: An apparatus according to any one of Examples 1 to 54, wherein the support structure / the support structure, the first support and / or the second support includes a plurality of units established by a plurality of interconnected struts, each unit being configured in a diamond shape.

[0246] Example 56: The device according to any one of Examples 1 to 55 also includes at least one thrombus filter.

[0247] Example 57: The device of Example 56, wherein the filter comprises a plurality of arches.

[0248] Example 58: The device of Example 57, wherein the plurality of arches are established between adjacent vertices of at least one of the first and second supports or an end of the at least one support structure.

[0249] Example 59: A device according to any of Examples 56 to 58, wherein the filter includes a mesh positioned on at least one of the stent ends and configured for recapture of the device / filter after the device is implanted.

[0250] Example 60: The device of any one of embodiments 1 to 59, wherein the size and shape of the device is designed to be suitable for recapture.

[0251] Example 61. The device of any of Examples 1 to 59, wherein the device is sized and shaped to be suitable for recapture by a DS hook.

[0252] Example 62: A device according to any of Examples 1 to 59, wherein the device comprises a length between 60 mm and 280 mm.

[0253] Example 63: An apparatus according to any of Examples 1 to 62, wherein the apparatus is configured to translate between the IVC and the SVC by up to approximately 60 mm and / or an angle between 0 and 45 degrees.

[0254] Example 64: The device according to any one of Examples 1 to 63 further includes a cover that covers at least one of the first bracket and the second bracket or an end of the at least one bracket structure.

[0255] Example 65: The device of Example 64, wherein the cover comprises one or more openings configured to be adjacent to one or more leaflets of the valve.

[0256] Example 66: A device according to any one of Examples 1 to 65, wherein the first stent, the second stent or the stent structure composition is selected from the group consisting of: shape memory materials, self-expanding materials, mechanically expanding materials, composite materials, polymers and combinations of the foregoing.

[0257] Example 67: A device according to any of Examples 1 to 66, wherein the valve material is selected from the group consisting of: fabrics, polymers, composites, biological tissues, and combinations of the foregoing.

[0258] Example 68: A device according to any of Examples 1 to 67, wherein any and all of the sealing members and / or the coverings are configured to be arranged or otherwise positioned on a portion thereof on the device, including on the first bracket, the second bracket or the bracket structure, or on at least one of the inner side and the outer side.

[0259] Example 69: A device according to any of Examples 1 to 68, wherein any and all of the sealing member and / or the covering comprises a material selected from the group consisting of: biological tissue, synthetic materials, composite materials, polymers, and combinations of the foregoing.

[0260] Example 70: The device of any one of Examples 1 to 69 further comprises one or more ports configured for placement of pacemaker leads after implantation of the device.

[0261] Example 71: The device of any one of Examples 1 to 69 further comprises one or more ports configured for placement of pacemaker leads after implantation of the device such that the one or more ports do not interfere with the SVC valve.

[0262] Example 72: A device according to Example 71, wherein at least one of the first stent and the second stent or the stent structure includes one or more struts, and the one or more struts are arranged above the outflow area of ​​the valve, and the valve is positioned in or connected to the first strut / the first strut and / or the second strut / the second strut or the strut component / the strut component.

[0263] Example 73: The device of Example 72, wherein the one or more struts are positioned between two leaflets of the valve.

[0264] Example 74: A device according to any of Examples 72 or 73, wherein the one or more struts are positioned within the valve / the middle portion of the valve.

[0265] Example 75: A device according to Example 71, wherein the one or more ports are arranged on at least one of the first bracket / the first bracket and the second bracket / the second bracket or the bracket structure / the wall of the bracket structure.

[0266] Example 76: A device according to any of Examples 1 to 75, wherein the connection between the elements of the device includes a fabric.

[0267] Example 77: A device according to any of Examples 1 to 76, wherein a majority of the device is flexible.

[0268] Example 78: A device according to any of Examples 1 to 76, wherein a majority of the device is rigid.

[0269] Example 79: A device according to Examples 1 to 78, wherein any and all of the first stent, the second stent, the first valve, the second valve, the at least one stent structure and the at least one valve include one or more hooks for connecting to another element.

[0270] Example 80: The device of Example 79, wherein the end of the hook is received by an opening of another element for attachment.

[0271] Example 81: A device according to any of Examples 1 to 80, wherein the covering / covering is arranged or otherwise positioned on the device so as to prevent one or more blood jets from the native valve from impacting the device or an element thereof.

[0272] Example 82: A device according to any of Examples 1 to 81, wherein the intermediate portion of the device is configured for placement within the RA and includes no more than one partial cover.

[0273] Example 83: The device according to any one of Examples 1 to 82 further includes one or more non-radiopaque materials, which are included in one or more parts or locations of any and all of the first stent, the second stent, the stent structure, the valve, the first valve / the first valve, the second valve / the second valve, the connector / the connector, the middle part / the middle part and one or more leaflets of the valve.

[0274] Example 84: A device according to any one of Examples 1 to 83, wherein the first valve / the first valve, the second valve / the second valve and the valve / or the valve are configured to receive a replacement valve so that the replacement valve is arranged therein.

[0275] Example 85: A device according to any of Examples 1 to 3 and 5 to 84, wherein the intermediate portion or connector is configured to be twisted to achieve a change in the length of the device.

[0276] Example 86: A device according to Example 85, wherein the middle portion or connector includes a plurality of linear structures for connecting the ends of the device and / or the first bracket and the second bracket of the device, and the plurality of linear structures shorten the length of the device when twisted in a first direction and extend the length of the device when twisted in a second direction opposite to the first direction.

[0277] Example 87: A method of implanting a transcaval tricuspid device (CCTD) for treating tricuspid regurgitation, comprising providing a CCTD according to any of the CCTD embodiments disclosed herein; removably attaching the CCTD to the distal end of a delivery catheter; guiding the distal end of the delivery catheter to an implantation site adjacent to at least one of the IVC, SVC, RA, or RV via any of the following: a femoral approach and a jugular approach; releasing the CCTD at the implantation site; and removing the delivery catheter.

[0278] The following examples include reference numerals that correspond to the drawings of the present disclosure.

[0279] Example 88: A transcaval tricuspid valve device (100) for treating tricuspid valve regurgitation, comprising: at least one stent structure (102); a first end (104) of the stent structure (102), the first end being configured to be implanted in the inferior vena cava (IVC) (200) and anchor the device in the IVC (200); a first sealing member (112), the first sealing member comprising a first skirt (130) attached to the outer diameter of a first end (104); a second end (106) of the support structure (102), the second end being configured to be implanted in the superior vena cava (SVC) (202) and to anchor the device in the SVC (202); a first valve (108), the first valve being connected to the first end (104); and a second valve (110), the second valve being connected to the second end (106), wherein a position of the first valve (108) along the longitudinal direction of the support structure (102) overlaps with a position of the first skirt (130), or a position of the first valve (108) is between a position of the first skirt (130) and a position of the second valve (110).

[0280] Example 89: The device (100) according to Example 88 further includes a second sealing member (112), the second sealing member including the second skirt (130) attached to the outer diameter of the second end (106), wherein the position of the second valve (110) along the longitudinal direction of the support structure (102) overlaps 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).

[0281] Example 90: A device (100) according to Example 88 or 89, wherein the first end (104) is at least partially covered and / or the second end (106) is at least partially covered.

[0282] Example 91: A device (100) according to any of Examples 88 to 90, wherein the first skirt (130) and / or the second skirt (130) has an outer diameter, which is used to interface with the inner diameter of any and all of the implantation site, the IVC, the SVC or the RA in a direction toward the second end of the skirt (130).

[0283] Example 92: A device (100) according to any of Examples 88 to 91, wherein the first sealing member (112) includes at least two skirts (130) and / or the second sealing member (112) includes at least two skirts (130).

[0284] Example 93: A device (100) according to any of Examples 88 to 92, wherein at least one of the skirts (112) comprises a plurality of layers, and / or comprises a reinforcement structure, preferably a reinforcement structure of a wire or a stent, and / or comprises a parachute-shaped structure, and / or comprises a first perforated layer and a second sealing layer, preferably wherein the first perforated layer and the second sealing layer are configured to establish a recess, preferably wherein the size and shape of the established recess are designed to promote tissue growth therein, wherein preferably the first perforated layer is arranged adjacent to the tissue, and / or comprises an inflatable balloon structure, preferably wherein the balloon structure is donut-shaped, and / or is stretchable, wherein 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 arranged to seal against the wall of the RA and / or the IVC, and / or is arranged to seal against the SVC and / or the SVC inlet of the RA, and / or has an outer diameter at least twice the outer diameter of the stent structure, and / or has a diameter of at least 70 mm outer diameter.

[0285] Example 94: The device (100) of any one of Examples 88 to 93, wherein the support structure (102) is integral and / or formed as one piece.

[0286] Example 95: A device (100) according to any one of Examples 88 to 94, wherein an intermediate portion (114) is arranged between the first end (104) and the second end (106), wherein the intermediate portion (114) is configured to rotate (120) the first end (104) relative to the second end (106) by a desired amount of rotation to achieve a change in the length of the support structure (102), wherein preferably the intermediate portion (114) has a weaker structure than the first end (104) and the second end (106) to allow rotation in the intermediate portion (114).

[0287] Example 96: An apparatus (100) according to any one of Examples 88 to 95, wherein the support structure (102) includes a first support (118) having the first end (104) and a second support (120) having the second end (106), and a connector connecting the first support (118) and the second support (120).

[0288] Example 97: The apparatus (100) of Example 96, wherein the connector is configured to rotate (120) the first end (104) relative to the second end (106) by a desired amount of rotation.

[0289] Example 98: A device (100) according to any one of Examples 95 to 97, wherein the middle portion (114) or the connector includes a plurality of linear structures for connecting the first end (104) to the second end (106) and / or the first bracket (118) and the second bracket (120), and the plurality of linear structures shorten the length of the bracket structure (102) when twisted in a first direction, and extend the length of the bracket structure (102) when twisted in a second direction opposite to the first direction.

[0290] Example 99: A device (100) according to any one of Examples 88 to 98, wherein each of the valves (108, 110) includes at least two commissures, and wherein the rotational position of the commissures of the first valve (108) when connected to the first end (104) is offset by a predetermined degree relative to the rotational position of the commissures of the second valve (110) when connected to the second end (106), wherein the offset is preferably determined when the support structure (102) is not twisted.

[0291] Example 100: The device (100) of Example 99, wherein each of the valves (108, 110) comprises two commissures, and the predetermined degree is selected from the group consisting of: 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, 10-3 0, 10-20, 20-70, 20-60, 20-50, 20-40, 20-30, 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, 60-70 and ranges therebetween.

[0292] Example 101: A device (100) according to Example 99, wherein each of the valves (108, 110) includes three joints, and the predetermined angle number is selected from the group consisting of the following values: 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 sub-ranges therebetween; wherein, preferably, the predetermined angle number is approximately 60°.

[0293] Example 102: A device (100) according to any one of Examples 88 to 101, wherein, when the CCTD is implanted, the first valve (108) in the first end (104) is positioned within at least a portion of the right atrium (RA) above the IVC; and / or the second valve (110) in the second end (106) is positioned 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.

[0294] Example 103: A transcaval tricuspid valve device (100) for treating tricuspid valve regurgitation, comprising: at least one stent structure (102); a first end (104) of the stent structure (102), the first end being configured to be implanted in an inferior vena cava (IVC) (200) and anchor the device in the IVC (200); a first sealing member (112), the first sealing member comprising a first skirt (130) attached to an outer diameter of the first end (104); a second end (106) of the stent structure (102), the The second end is configured to be implanted in the superior vena cava (SVC) (202) and anchor the device in the SVC (202); a first valve (108), the first valve being connected to the first end (104); and a second valve, the second valve being connected to the second end (106), wherein the position of the first valve (108) along the longitudinal direction of the support structure (102) overlaps with the position of the 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).

[0295] Example 104: The device (100) according to Example 103 further includes a second sealing member (112), the second sealing member including a second skirt (130) attached to the outer diameter of the second end (106), wherein the position of the second valve (110) along the longitudinal direction of the support structure (102) overlaps 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).

[0296] Example 105: A device (100) according to Example 103 or 104, wherein the first end (104) is at least partially covered and / or the second end (106) is at least partially covered.

[0297] Example 106: A device (100) according to any of Examples 103 to 105, wherein the first skirt (130) and / or the second skirt (130) has an outer diameter for docking with an inner diameter of any and all of the implantation site, the IVC, the SVC or the RA in a direction toward the second end of the skirt (130).

[0298] Example 107: A device (100) according to any of Examples 103 to 106, wherein the first sealing member (112) includes at least two skirts (130) and / or the second sealing member (112) includes at least two skirts (130).

[0299] Example 108: A device (100) according to any of Examples 103 to 107, wherein at least one of the skirts (112) comprises a plurality of layers, and / or comprises a reinforcement structure, preferably a reinforcement structure of a wire or a stent, and / or comprises a parachute-shaped structure, and / or comprises a first perforated layer and a second sealing layer, preferably wherein the first perforated layer and the second sealing layer are configured to establish a recess, preferably wherein the size and shape of the established recess are designed to promote tissue growth therein, wherein preferably the first perforated layer is arranged adjacent to the tissue, and / or comprises an inflatable balloon structure, preferably wherein the balloon structure is donut-shaped, and / or is stretchable, wherein 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 arranged to seal against the wall of the RA and / or IVC, and / or is arranged to seal against the SVC and / or the 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.

[0300] Example 109: The device (100) of any one of Examples 103 to 108, wherein the support structure (102) is integral and / or formed as one piece.

[0301] Example 110: A device (100) according to any one of Examples 103 to 109, wherein an intermediate portion (114) is arranged between the first end (104) and the second end (106), wherein the intermediate portion (114) is configured to rotate (120) the first end (104) relative to the second end (106) by a desired rotation amount to achieve a change in the length of the support structure (102), wherein preferably, the intermediate portion (114) has a weaker structure than the first end (104) and the second end (106) to allow rotation in the intermediate portion (114).

[0302] Example 111: A device (100) according to any one of Examples 103 to 108, wherein the support structure (102) includes a first support (118) having the first end (104) and a second support (120) including the second end (106), and a connector connecting the first support (118) and the second support (120).

[0303] Example 112: The device (100) of Example 111, wherein the connector is configured to rotate (120) the first end (104) relative to the second end (106) by a desired amount of rotation.

[0304] Example 113: A device (100) according to any one of Examples 110 to 112, wherein the middle portion (114) or the connector includes a plurality of linear structures for connecting the first end (104) to the second end (106) and / or the first bracket (118) and the second bracket (120), and the plurality of linear structures shorten the length of the bracket structure (102) when twisted in a first direction, and extend the length of the bracket structure (102) when twisted in a second direction opposite to the first direction.

[0305] Example 114: A device (100) according to any one of Examples 103 to 113, wherein each of the valves (108, 110) includes at least two commissures, and wherein the rotational position of the commissures of the first valve (108) when connected to the first end (104) is offset by a predetermined angle relative to the rotational position of the commissures of the second valve (110) when connected to the second end (106), wherein preferably, the offset is determined when the support structure (102) is not twisted.

[0306] Example 115: The device (100) of Example 114, wherein each of the valves (108, 110) comprises two commissures, and the predetermined degree is selected from the group consisting of: 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, 10-3 0, 10-20, 20-70, 20-60, 20-50, 20-40, 20-30, 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, 60-70 and subranges therebetween.

[0307] Example 116: A device (100) according to Example 114, wherein each of the valves (108, 110) includes three commissures, and the predetermined degree is selected from a group consisting of the following values: 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 sub-ranges therebetween; wherein, preferably, the predetermined degree includes approximately 60°.

[0308] Example 117: A device (100) according to any of Examples 103 to 116, wherein when the CCTD is implanted, the first valve (108) in the first end (104) is positioned within at least a portion of the right atrium (RA) above the IVC, and / or wherein the second valve (110) in the second end (106) is positioned 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.

[0309] General considerations

[0310] Although various inventive embodiments have been described and illustrated herein, it will be readily apparent to those of ordinary skill in the art that various other components and / or structures for performing functions and / or obtaining results and / or one or more advantages described herein will be readily conceived, and each of these variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, it will be readily understood by those skilled in the art that all structures, parameters, dimensions, materials, functionality, and configurations described herein are examples, and that the actual structures, parameters, dimensions, materials, functionality, and configurations will depend on one or more specific applications taught using the present invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific inventive embodiments described herein using only experiments that do not exceed routine. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and within the scope of the claims supported by the present disclosure and their equivalents, the inventive embodiments may be practiced in a manner different from that specifically described and required. The inventive embodiments of the present disclosure are also directed to each individual feature, system, article, structure, material, kit, functionality, step, and method described herein. In addition, any combination of two or more such features, systems, articles, structures, materials, kits, functionality, steps, and methods, if they are not mutually contradictory, is included within the scope of the invention disclosed herein. Certain embodiments may be distinguished from the prior art by the specific absence of one or more features / elements / functionality (ie, claims directed to such embodiments may include a negative limitation).

[0311] Furthermore, as noted, various inventive concepts are embodied as one or more methods, examples of which have been provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in an order different from that illustrated, which may include performing some actions simultaneously, even though shown as sequential actions in an illustrative embodiment.

[0312] Any and all references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., appearing anywhere in this application are incorporated herein by reference in their entirety. In addition, all definitions defined and used herein should be understood to take precedence over dictionary definitions, definitions incorporated by reference in the literature, and / or the ordinary meaning of the defined terms.

[0313] Unless expressly indicated to the contrary, the indefinite articles "a" and "an" as used in the specification and claims should be understood to mean "at least one". In the present disclosure, "can" and "may" are used interchangeably and indicate that the referenced element, component, structure, function, functionality, object, advantage, operation, step, process, device, system, means, result, or clarifying description has the ability to be used, included, produced, or otherwise represents the claim indicated in the statement using (or referring to) the term in (one or more) specific embodiments.

[0314] The phrase "and / or" used in the specification and claims should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in conjunction in some cases and separate in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., it means "one or more" of the elements so combined.

[0315] In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising," a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; and so forth.

[0316] As used in the specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one of a plurality of elements or a list of elements, but also including more than one, and optionally additional unlisted items. Only terms that clearly indicate the opposite (such as "only one of..." or "exactly one of..." or "consisting of..." when used in the claims) will refer to including exactly one element in a plurality of elements or a list of elements. In general, when there are exclusive terms such as "any", "one of...", "only one of..." or "exactly one of..." in front, the term "or" used should only be interpreted as indicating an exclusive alternative (i.e., "one or the other, but not both").

[0317] When used in a claim, "consisting essentially of shall have its ordinary meaning as used in the art of patent law.

[0318] As used in the specification and claims, when referring to a list of one or more elements, the phrase "at least one" should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than the elements specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting 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 refer to at least one (optionally including more than one) A, without B (and optionally including elements other than B) in one embodiment; may refer to at least one (optionally including more than one) B, without A (and optionally including elements other than A) in another embodiment; may refer to at least one (optionally including more than one) A and at least one (optionally including more than one) B (and optionally including other elements) in yet another embodiment; and so on.

[0319] In the claims and the above description, all transitional phrases such as "includes," "comprising," "carrying," "having," "containing," "involving," "maintaining," "consisting of," etc. should be understood as open-ended, i.e., meaning including but not limited to. As set forth in Section 2111.03 of the U.S. Patent Office Manual of Patent Examining Procedures, only the transitional phrases "consisting of" and "consisting essentially of" are closed or semi-closed transitional phrases, respectively.

Claims

1. A single transcaval tricuspid valve device for treating tricuspid valve regurgitation, wherein include: at least one support structure; a first end portion configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first end portion optionally being at least partially covered; a second end portion configured for implantation in a superior vena cava (SVC) and anchoring the device in the SVC, the second end portion optionally being at least partially covered; a first valve connected to at least a portion of the first end portion such that when the transcaval tricuspid valve device is implanted, the first valve 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 portion such that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein, as well as Sealing member.

2. A single transcaval tricuspid valve device for treating tricuspid valve regurgitation, wherein include: at least one support structure; a first end portion configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first end portion optionally being at least partially covered; a second end portion configured for implantation in a superior vena cava (SVC) and anchoring the device in the SVC, the second end portion optionally being at least partially covered; a first valve connected to at least a portion of the first end portion such that when the transcaval tricuspid valve device is implanted, the first valve 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 portion such that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein, Sealing member; as well as An optional intermediate portion between the first end and the second end, the intermediate portion is optionally configured to perform at least one of the following: rotating at least one of the first valve and the second valve relative to at least one of the first end and the second end by a desired amount of rotation, and The device is deflated.

3. A modular transcaval tricuspid valve device for treating tricuspid valve regurgitation, wherein include: a first stent configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first stent optionally being at least partially covered; a second stent configured for implantation in the superior vena cava (SVC) and optionally anchoring the device in the SVC, the second stent optionally being at least partially covered; a first valve connected to at least a portion of the first end portion such that when the transcaval tricuspid valve device is implanted, the first valve 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 portion such that the second valve is disposed below the SVC or at least partially within the SVC and within at least a portion of the right atrium (RA) below the azygos vein, Sealing member; as well as An optional connector disposed between the first valve and the second valve, the connector optionally configured to do at least one of the following: rotating at least one of the first valve and the second valve relative to at least one of the first stent and the second stent by a desired amount of rotation, and The device is deflated.

4. A prosthetic heart valve device, include: at least one support structure; at least one valve; as well as At least one sealing member.

5. The device according to any one of claims 2 to 3, in, The intermediate portion or connector has a length sufficient to bridge between the first end and the second end or between the first bracket and the second bracket, depending on the application.

6. The device according to any one of claims 1 to 4, in, The / at least one valve and optionally a plurality or all valves are endoluminal valves.

7. The device according to claim 3, in, At least one of the first stent, the second stent, the first valve, the second valve, the sealing member, and the connector can be changed to different sizes to accommodate different anatomies of patients.

8. The device according to any one of claims 1 to 7, in, The sealing member includes at least one skirt.

9. The device according to any one of claims 1 to 7, in, The sealing member includes a plurality of skirts.

10. The device according to any one of claims 1 to 7, in, The sealing member includes at least two skirts.

11. The device according to any one of claims 1 to 7, in, The sealing member includes at least three skirts.

12. The device according to any one of claims 1 to 11, in, The sealing member is configured to prevent blood backflow from any and all of the right atrium to at least one inferior vena cava (IVC) and from the right atrium to the superior vena cava (SVC), prevent leakage around any and all of one and / or another component of the device, and / or allow hepatic vein inflow, wherein the sealing member includes an IVC skirt above the hepatic vein.

13. The device according to any one of claims 1 to 12, in, The outer diameter of at least a portion of the device is between the following values: 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 and ranges therebetween.

14. The device according to claims 1 to 13, in, The sealing member includes one or more corresponding sealing structures, which are arranged on or adjacent to any and all elements of the device and on or adjacent to each element as the case may be, and wherein the size and shape of one or more of the sealing structures are designed to specifically adapt to the anatomical structure arranged opposite and / or adjacent to the corresponding element.

15. The device according to claim 14, in, The corresponding sealing structure only surrounds a portion of any and all elements of the device.

16. The device according to claim 14, in, A corresponding sealing structure surrounds a substantial portion of any and all components of the device.

17. The device according to claim 14, in, A corresponding sealing structure surrounds any and all elements of the device.

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

19. The device according to any one of claims 14 to 18, in, A first structure / the first structure is arranged to seal against a wall of the RA and a second structure / the second structure is arranged to seal against a blood vessel entrance of the RA.

20. The device according to any one of claims 1 to 19, in, The sealing member includes a plurality of layers.

21. The device according to any one of claims 1 to 20, in, The sealing member includes a reinforcement structure.

22. The device according to claim 21, in, The reinforcement structure includes a wire or a bracket.

23. The device according to any one of claims 1 to 22, in, The stiffness of at least a first portion of the device or a component thereof is greater than the stiffness of a second portion of the device or a component thereof.

24. The device according to any one of claims 1 to 23, in, At least one of the first stent and the second stent or the at least one stent structure comprises a structure comprising a plurality of interconnected struts, and wherein one or more of the plurality of interconnected struts are associated with a first portion of the device, and wherein the size, shape and / or arrangement of one or more of the plurality of interconnected struts associated with the first portion are designed to impart radial force compared to a second portion of the device.

25. The device according to any one of claims 1 to 24, in, At least one of the first and second stents or the at least one stent structure comprises a structure comprising a plurality of interconnected struts, and wherein the size, shape and / or arrangement of one or more of the plurality of interconnected struts associated with the first portion is designed to impart a first diameter that is different from a second diameter of the second portion.

26. The device according to any one of claims 1 to 25, in, Each valve comprises a plurality of commissures, and wherein the commissures of the first valve are offset a predetermined degree relative to the commissures of the second valve.

27. The device according to claim 26, in, The plurality of commissures comprises three, and the predetermined degree comprises approximately 60°.

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

29. The device according to any one of claims 1 to 28, in, The intermediate portion of the device is configured for placement within the RA and includes no more than one partial cover.

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

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