RELATED APPLICATIONS

[0001] The present disclosure claims benefit of and priority to U.S. provisional patent application no. 63/418,909, filed October 24, 2022, and entitled, “SYSTEMS, METHODS, AND DEVICES FOR TREATING A DISEASED OR OTHERWISE DAMAGED TRICUSPID VALVE”, and is also related to PCT Application No. PCT/IB2017/050534, filed February 1, 2017, and PCT Application No. PCT/IL2019/050658, filed June 7, 2019. Each of these foregoing disclosures is herein incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

[0002] The present disclosure generally relates to medical systems, apparatuses, devices, and methods for implantation in the heart thereof, and particularly, but not only, to a stent-based device for treating diseases and/or malfunctions of the tricuspid valve.

BACKGROUND

[0003] The tricuspid valve prevents back flow of blood from the right ventricle into the right atrium when it closes during ventricular systole and allows blood to flow from the right atrium into the right ventricle upon opening during ventricular diastole.

[0004] An insufficient tricuspid valve causing tricuspid regurgitation may occur from tricuspid annular dilation and right ventricular enlargement. Tricuspid regurgitation is typically divided into two main etiologies: primary and secondary (also known as functional). Primary tricuspid regurgitation accounts for approximately 10%-20% of cases and is associated with valve insufficiency that originates from the valve leaflets or chordae tendineae. Examples for primary tricuspid regurgitation include flail or perforated valve leaflets, ruptured chordae, pacemaker lead induction induced TR, degenerated surgical tricuspid valve replacement and more. However, tricuspid regurgitation is most often secondary to other causes as can be seen in dilated cardiomyopathy, atrial fibrillation and annular dilation, right ventricular volume or pressure overload and more.

[0005] Tricuspid regurgitation causes right atrial overload that is transmitted to the superior and inferior vena cava and their tributaries. Eventually, this leads to hepatic congestion, ascites, anasarca, peripheral edema, and other clinical symptoms of congestive heart failure. If untreated, significant tricuspid regurgitation frequently leads to heart failure and death.

[0006] Clinically available treatments for tricuspid regurgitation include open heart surgery and/or medication. However, open heart surgery for the replacement and/or repair of the tricuspid valve is rarely carried out, mainly due to its high mortality and morbidity rates. Medication, alternatively, may not solve the problem and may allow the disease to progress, leaving patients with a deteriorated quality of life and cardiac function.

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

[0008] While extensive efforts have been made to develop and clinically approve transcatheter device solutions for tricuspid regurgitation (e.g., Transcatheter Tricuspid Valve Replacements (TTVR), and Transcatheter Edge to Edge Repair (TEER)), such solutions, however, do not address challenges and restrictions related to the anatomy of individual patient’s tricuspid valve. For example, patients who present with a large regurgitant gap (the distance between the malcoapting valve leaflets), typically of more than 10mm, cannot be treated with TEER. In the same manner, patients with large tricuspid annulus diameter, typically of more than 52mm, are usually found inadequate for treatment with TTVR devices. Additional excluding criteria for TTVR and TEER exist, such as indwelling pacemaker or defibrillator leads crossing the tricuspid valve, previously failed tricuspid valve leaflet procedures and more.

[0009] TTVR and TEER are also demanding in terms of procedural complexity and duration, and typically mandate the use of multiple imaging modalities for the purpose of implantation such as trans-esophageal echocardiography, in addition to the standard fluoroscopy.

[0010] Given these challenges, a caval valve implantation (CAVI) treatment option has emerged which makes use of the vena cava (inferior, or inferior and superior) for positioning transcatheter valves. While CAVI is fairly simple to perform and is unaffected by complex tricuspid valve anatomy and failed prior procedures on the tricuspid valve, CAVI, nevertheless, also comes with challenges. For example, typically, tricuspid regurgitation patients present with dilated right heart chambers. While this generally refers to the right ventricle (RV) and the right atrium (RA), it can also refer to the inferior and superior vena cava (IVC and SVC). For example, dilated IVC and SVC can have diameters of up to 55mm. In addition, the high compliance of the IVC and SVC makes anchoring of transcatheter CAVI valves extremely difficult and valve migration more likely.

[0011] Moreover, IVC and SVC bifurcations, such as the proximate hepatic and azygos veins respectively, make the anchoring and sealing of CAVI devices more complex in light of the need to keep the inflow from the hepatic and azygos veins unblocked and undisturbed.

SUMMARY

[0012] Accordingly, with respect to at least some of the embodiments of the disclosure, a cross- caval tricuspid device (CCTD) for treating tricuspid valve insufficiency is provided. Such a CCTD, according to some embodiments, includes many benefits, improvements and features over existing technologies such as TTVR, TEER and current CAVI concepts, and addresses many of the still remaining challenges in transcatheter tricuspid valve regurgitation treatments. [0013] In some embodiments of the present disclosure, when compared to prior art devices, the CCTD provides at least one of, in some embodiments, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of the following: a single device; a single implantation procedure; improved anchoring and correspondingly, migration resistance, improved sealing (including, in some embodiments, no blocking/disturbance to the hepatic and azygos vein inflow), a simpler, more straight-forward implantation procedure, an ability to be implanted with the use of fluoroscopy only (e.g., no need for transesophageal echo guidance in the implantation procedure), improved fitting to unique tricuspid regurgitation vena cava and RA anatomies of different individuals (including, in some embodiments, a size, a shape, SVC to IVC translation and/or angulation), improved mechanical durability of the stent structures along with a-traumatic device ends an ability to recapture the device post device deployment/release, and filtering of the IVC/SVC blood flow, to prevent thrombi/debris from reaching the right heart and lungs.

[0014] Additionally, in some embodiments, the CCTD includes the ability to carry out future procedures (post CCTD implantation) such as, for example, pacemaker lead implantation, transseptal procedures, right heart catheterization, and valve-in-valve implantations (within the CCTD).

[0015] In some embodiments of the disclosure, a single, cross-caval tricuspid device (CCTD) for treating tricuspid valve insufficiency is provided and includes at least one stent structure, a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC (the first end optionally is at least partially covered). The device can also include a second end configured for implantation in the superior vena cava (SVC) and anchoring the device therein (the second end also optionally can be at least partially covered), a first valve connected to at least a portion of the first end, such that the first valve is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, so that it does not block the inflow of blood coming from the hepatic veins, a second valve connected to at least a portion of the second end, such that the second valve is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein, a middle portion (which can be at least partially covered or non-covered) which spans the RA and the distance between the IVC and SVC device valves and sealing means configured to prevent or, at a minimum, reduce backflow of blood coming from the RA to enter the IVC and SVC.

[0016] In some embodiments, the middle portion is optionally configured to rotate at least one of the first valve and the second valve relative to the at least one of the first end and the second end a desired amount of rotation. Such a rotation, in some embodiments, assists with shortening of the entire device length so it would fit different patient anatomies.

[0017] In some embodiments, the middle portion is constructed of alternating stent sections and soft/flexible material such as but not restricted to (for example) fabric, biological tissue, polymer, or composite material, such that by pushing the two device ends towards each other, the device shortens, and/or elongates by pulling the two device ends away from each other. This feature assists with shortening or elongating of the entire device length so it would fit different patient anatomies.

[0018] In some embodiments of the disclosure, a prosthetic heart valve device is provided and includes at least one stent structure, at least one valve, and at least one sealing means.

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

[0020] In some embodiments of the disclosure, a cross-caval tricuspid device for treating tricuspid valve insufficiency is provided and comprises 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, further a first sealing means including a first skirt attached to the outer diameter of the first end, and a second end of the stent structure configured for implantation in the superior vena cava (SVC) and for anchoring the device in the SVC. A first valve is connected to the first end, and a second valve is connected to the second end wherein the position of the first valve along 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.

[0021] In the above-noted embodiment a second sealing means may be provided including 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 stent 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. [0022] The longitudinal direction of the stent structure extends along the length of the stent structure.

[0023] 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 a ring-like portion which has a smaller longitudinal extension than the valve. Accordingly, the larger-extension cylinder shape may overlap with the smaller-extension ring shape when viewed from the side.

[0024] Each of the above-noted embodiments may further include one and/or another of the following structures, features, functionality, functions, steps, and clarifications, and in some embodiments, if such structures, features, functionality, functions, steps, and clarifications are not mutually exclusive, a plurality of, a majority of, substantially all of, or all of, the following structures, features, functionality, functions, steps, and clarifications:

- the middle portion or connector comprises a length which is sufficient to span between the first end and the second end, or, the first stent and the second stent, as applicable;

- the middle portion can be configured as and/or for at least one of: rotation, modular, straight (or in some embodiments none of the above);

- the middle portion may have a weaker structure than the first end and the second end of the stent structure in order to allow for localized rotation in the middle portion;

- the/at least one valve, and optionally a plurality or all valves, is/are an intraluminal valve; at least one of the first stent, the second stent, the first valve, the second valve, the IVC and/or SVC sealing means, and the connector, are changeable to different sizing to accommodate different anatomies of a patients;

- the sealing means comprises at least one skirt;

- the sealing means comprises a plurality of skirts;

- the sealing means comprises at least two skirts;

- the sealing means comprises at least three skirts;

- the sealing means is configured to prevent a backflow of blood from any and all of the right atrium to at least one of the inferior vena cava (IVC) and from the right atrium to the superior vena cava (SVC), leaks around any and all of one and/or another components of the device, without (in some embodiments) blocking the hepatic vein and azygos vein inflow by using a sealing means comprising a supra hepatic IVC skirt and an infra azygos SVC skirt, respectively; an exterior diameter of at least a portion of the device is between 15-70 mm, 15-60 mm, 15-50 mm, 15-40 mm, 15-30 mm, 15-20 mm, 20-70 mm, 20-60 mm, 20-50 mm, 20-40 mm, 20-30 mm, 30-70 mm, 30-60 mm, 30-50 mm, 30-40 mm, 40-70 mm, 40-60 mm, 40-50 mm, 50-70 mm, 50-60 mm, and 60-70 mm, and ranges therebetween;

- the sealing means comprises one or more respective sealing structures arranged on or adjacent any and all of, and as applicable, each of the elements of the device, and wherein one or more of sealing structures is sized and shaped to specifically accommodate anatomical structure arranged opposite and/or adjacent to the respective element; o respective sealing structures surround only a portion of any and all of the elements of the device; o respective sealing structures surround a majority of any and all of the elements of the device; o respective sealing structures surround any and all of the elements of the device; a first sealing structure is arranged along a different plane than that of a second sealing structure; a/the first structure can be arranged to seal against a wall of the RA and/or the IVC, and a/the second structure is arranged to seal against the SVC or the SVC inlet of the RA;

- the sealing means comprises a plurality of layers;

- the sealing means includes a reinforcement structure, where the reinforcement structure can comprise a wire or stent;

- the sealing means comprises a parachute structure, where the parachute structure can be configured to open the sealing means during deployment of the device;

- the sealing means comprises a first perforated layer and a second sealed layer, where: o the first perforated layer and second sealed layer can be configured to establish a pocket, o the established pocket is sized and shaped to promote tissue growth therein, and/or o the first perforated layer is arranged so as to be adjacent tissue;

- the sealing structure comprises a skirt and includes an inflatable balloon structure, where the balloon structure can be donut shaped;

- the sealing structure comprises a stretchable skirt; a/the sealing structure comprises a stretchable skirt reversibly adherable to an outer surface of an inflatable balloon structure; each/the sealing structure comprises a 3-dimensional skirt; each/the sealing structure comprises a stent structure (which can be made from nitinol), optionally covered by a sealing material;

- the sealing means material comprises a skirt including a flange shape and having an inner diameter for attachment to the outer diameter of at least one structure or element of the device, proximate to a first end of the skirt, and an outer diameter for interfacing with an inner diameter of any and all of an implantation site anatomies, the IVC, the SVC, or RA, in a direction toward a second end of the skirt; o the skirt includes a straight edge, and/or o the skirt includes a curved edge;

- the sealing means comprises a skirt including a donut shape with an outer diameter configured to interface with surrounding tissue, the IVC, SVC, or RA, and an inner diameter radially spaced away from the outer diameter and configured for attachment to a stent structure; the sealing means comprises a skirt attached to the outer diameter of the stent structure, wherein the outer diameter of the skirt is at least the double of the outer diameter of the stent structure; at least one portion of the device (e.g., a first portion), or an element thereof, includes a rigidity greater than a rigidity of another portion of the device (e.g., a second portion of the device or element thereof), where the at least one portion can comprise an area of the device or element thereof which accommodates at least a portion of a valve; o with respect to rigidity (any, a plurality of, or all of):

■ rigidity can vary due to stent thickness (in some embodiments, a range of O.lmm-1.5 mm, and in some embodiments preferably 0.2-lmm);

■ rigidity can vary due to stent strut width (in some embodiments, a range of O.lmm-1.5 mm, and in some embodiments preferably 0.2-lmm);

■ rigidity can vary due to the configuration of the stent structure (e.g., cell size/area 0.25-10 cm ² , and in some embodiments preferably 2.5 cm ² ;

■ rigidity can vary due to stent surface treatment (e.g., electro/chemical polishing, sand blasting, passivation, and the like); o with respect to the noted portions:

■ the other (e.g., second) portion can comprise a remainder of the device or an element thereof, and/or

■ the other (e.g., second) portion can comprise a/the middle portion of the device or an element thereof; at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts; at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts, and wherein one or more plurality of interconnected struts associated with a first portion which includes a thickness of between 0.2 mm and 1.0 mm; at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells; at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells, and where an area of each cell associated with the first portion is between 0.25 cm ² and 10 cm ² , and preferably, between 2-5 cm ² ; at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells, and wherein an area of each cell associated with the first portion is configured with a size and shape to allow passage of a catheter, where the catheter can be sized up to approximately 15 mm in diameter (e.g., in some embodiments, so that a transcatheter procedure such as transseptal procedures, pacemaker lead placement and right heart catheterization may be performed after CCTD implantation); at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality of interconnected struts, and wherein one or more of the plurality interconnected struts associated with a first portion of the device which are sized, shaped, and/or arranged so as to impart radial forces than a second portion of the device (which results, according to some embodiments, in any CCTD portion is affected only by forces directly acting on it and not by forces acting on another portion of the CCTD, which assists with the mechanical durability of the CCTD structure as well as with its anatomical contact safety). at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality of interconnected struts, and wherein one or more of the plurality interconnected struts associated with the first portion are sized, shaped, and/or arranged so as to impart a first diameter different from a second diameter of the second portion (in some embodiments, the CCTD can fit different sizes and shapes of anatomies along its longitudinal axis, so that a portion of an anatomy acting on one part of the device will not inflict a diameter change on another portion of the device); each of the valves includes 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 number of degrees from the rotational position of the commissures of the second valve when connected to the second end, wherein the offset may be determined when the stent structure is not twisted (in some embodiments, during valve(s)-opening and closing, the forces acting on any of the SVC and I VC commissures are not aligned in one longitudinal line of the stent structure so as to improve the mechanical durability of the stent structure); each valve includes a plurality of commissures, and wherein the commissures of the first valve are offset from the commissures of the second valve by a predetermined number of degrees (in some embodiments, during valve(s)-opening and closing, the forces acting on any of the SVC and IVC commissures are not aligned in one longitudinal line of the device so as to improve the mechanical durability of the CCTD and/or reduce corresponding diameter increase and decrease in diastole and systole, respectively); o the plurality of commissures comprise 2, and the predetermined number of degrees is selected from the group consisting of: between 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, o the plurality of commissures comprises 3, and the predetermined number of degrees is selected from the group consisting of comprises 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, o the plurality of commissures comprises 3, and the predetermined number of degrees comprises approximately 60°; a/the stent structure, first stent, and/or second stent includes a plurality of cells established by a plurality of interconnected struts each configured as a rhombus shape; at least one thrombus filter (e.g., to prevent thrombi/debris from entering the CCTD and/or reaching the heart and lungs), where: o the filter can comprise a plurality of arches, and where the plurality of arches can be established between adjacent apexes of an end of at least one of the first stent and the second stent, or the at least one stent structure, and/or o the filter comprises a net positioned on at least one of a stent end and configured for device/filter re-capture after the device is implanted; - the device is sized and shaped for recapture;

- the device is sized and shaped for recapture by a DS hook;

- the device includes a length of between 60 mm and 280mm;

- the device is configured to translate between the IVC and SVC up to approximately 60mm and at an angle of between 0 and 45 degrees; a covering which covers an end of at least one of the first stent and the second stent, or the at least one stent structure;

- the covering includes one or more openings configured to be adjacent one or more leaflets of the valve;

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

- the valve material is selected from the group consisting of: fabric, polymer, composites, biological tissue, and combinations of the foregoing; any and all of the sealing means and a/the cover are configured to be arranged or otherwise positioned on the device on a portion thereof, including on the first stent, the second stent, or the stent structure, on at least one of the inside, the outside; any and all of the sealing means and a/the cover comprise a material selected from the group consisting of: fabric, biological tissue, synthetic materials, composite materials, polymers, and combinations of the foregoing; one or more ports configured for placement of pacemaker and/or defibrillator leads post-implantation of the device; one or more ports configured for placement of pacemaker leads post-implantation of the device, such that, the one or more ports do not interfere with the svc valve function; at least one of the first stent and the second stent, or the stent structure, includes one or more struts arranged above or below an outflow area of a valve positioned within or connected to the a/the first and/or a/the second strut, or a/the strut component, where: o the one or more struts can be positioned between two leaflets of the valve, o the one or more struts are positioned within the middle of a/the valve, and/or o the one or more ports are arranged on a wall of at least one of a/the first stent and a/the second stent, or a/the stent structure; connections between elements of the device comprise a fabric; a majority of the device is flexible; a majority of the device is rigid; 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 includes one or more hooks for connection to another element, where an end of the hook can be accommodated by an opening of another element for attachment;

- the/a cover is arranged or otherwise positioned on the device so as to prevent one or more blood jets coming from a native valve from impacting the device or elements thereof; a middle portion of the device is configured for arrangement within the RA and includes no more than a partial covering (so that, in some embodiments, blood inflow into the RA, and the passage of catheters are enabled, while still maintaining the benefits of one structure - one operation implantation, migration resistance and mechanical strength of the device); one or more radio-opaque materials are included on one or more portions or locations of any and all of the first stent, the second stent, the stent structure, a valve, a/the first valve, a/the second valve, a/the connector, a/the middle portion, and one or more leaflets of a valve; a/the first valve, a/the second valve, and/or a/the valve is configured to receive a transcatheter self-expanding or mechanically expanding (including balloon expanding) replacement valve, such that the replacement valve is arranged therein (in some embodiments, this allows the CCTD valve(s) to be percutaneously replaced in case of valve malfunction/deterioration. a/the first valve, a/the second valve, and/or a/the valve include a diameter range, in some embodiments, of 18mm-30mm, and in some embodiments, in the range of 25mm- 29mm (allowing, for example, an interventional cardiologist will be able to use the vast majority of commercially available transcatheter valves) a/the first valve, a/the second valve, and/or a/the valve having at least one of a rigid perimeter, an hourglass shape, upper/lower stoppers, and additional features for the purpose of stabilizing a transcatheter valve-within a CCTD valves embodiment; and

- the middle portion or connector is configured to twist to effect a change in length of the device, where the middle portion or connector can comprise a plurality of linear structures for connecting ends of the device and/or first and second stents of the device, which upon twisting in a first direction, shorten the length of the device, and upon twisting in a second direction opposite to the first direction, lengthen the length of the device.

[0025] In some embodiments, a method of implanting a cross-caval tricuspid device (CCTD) for treating tricuspid valve insufficiency is provided. In some embodiments, the method includes providing the CCTD according to any of the disclosed CCTD embodiments, removably attaching the CCTD to a distal end of a delivery catheter, directing the distal end of the delivery catheter to a site of implantation adjacent at least one of the IVC, SVC, RA or RV via any of a femoral approach, and a jugular approach, deploying or otherwise releasing the CCTD at the implantation site, and removing the delivery catheter. Optionally, the method can also include retrieving a deployed CCTD (either being fully or partially deployed).

[0026] Such method embodiments may further include any and all of adjusting of the CCTD length (e.g., via rotation and/or foreshortening); a modular CCTD, in particular, one or more of SVC, IVC and RA sections being connected together either prior to the insertion of the (modular) device into the catheter or, alternatively in the patient’s body; if the construction of the modular device is accomplished in a patient’s body, the implantation can be via a femoral approach, a jugular approach or a femoral and jugular approach (that is, in some embodiments, where separate catheters (femoral and jugular) carry at least one portion of the modular device. [0027] These and other objects, advantages, and benefits of embodiments of the disclosure will become even more apparent by reference to the figures and detailed description below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The skilled artisan will understand that the drawings primarily are for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structural similar elements).

[0029] FIG. 1 is a side view of a CCTD implanted within the right atrium (in section), as well as portions thereof positioned in the SVC and IVC, according to some embodiments of the present disclosure;

[0030] FIGs. 2-3 are side views of a CCTD implanted within the right atrium (in section), as well as portions thereof positioned in the SVC and IVC, according to some embodiments of the present disclosure, illustrating the rotation functionality of a CCTD;

[0031] FIGs. 4-5 are side views of a CCTD implanted within the right atrium (in section), as well as portions thereof positioned in the SVC and IVC, according to some embodiments of the present disclosure, illustrating foreshortening functionality of a CCTD;

[0032] Figs. 6A-B is side views of a CCTD according to some embodiments of the present disclosure (Fig. 1 corresponds to the CCTD of Fig. 6A implanted);

[0033] Figs. 7A-8D illustrate various skirt structures for a sealing means for a CCTD, according to some embodiments of the disclosure;

[0034] Figs. 9-10 are side views of a CCTD according to some embodiments of the present disclosure (Fig. 9 being a CCTD alone and Fig. 10 illustrating a CCTD implanted in the right atrium/IVC/SVC, illustrating a multiplane skirt structure for a sealing means for a CCTD, according to some embodiments of the disclosure;

[0035] Fig. 11 illustrates a CCTD, according to some embodiments, with two valves, where the commissures of a first valve are offset from the commissures of the second valve; [0036] Fig. 12 illustrates a CCTD, according to some embodiments, having at least one thrombus filter for blocking emboli from proceeding through the CCTD;

[0037] Figs. 13A-B illustrate additional features of a thrombus filter for a CCTD (showing both side and end views), according to some embodiments, which can be arranged on the stent structure of the CCTD on or adjacent an end thereof, in proximity or in the IVC or SVC;

[0038] Figs. 14A-B, illustrate a CCTD, according to some embodiments, configured with functionality to enable conformity to an anatomy of a particular patient;

[0039] Figs. 14C-D illustrate a CCTD, according to some embodiments, having structure/functionality (e.g., covering) to prevent one or more blood jets coming from a native valve from impacting the device or elements thereof;

[0040] Figs. 15A-B, illustrates a CCTD, according to some embodiments, having a stent including one or more struts arranged above and/or below an outflow area of a valve positioned within or connected to a first and/or a second strut, or a strut component;

[0041] Figs. 16A-B illustrate a CCTD, according to some embodiments, having a stent including one or more struts arranged above and/or below an outflow area of a valve positioned within or connected to a first and/or a second strut, or a strut component, in which a pacemaker lead or the like can be directed through and lie within the CCTD;

[0042] Fig. 17 illustrates a side view of a CCTD, according to some embodiments, having a port receiving and/or placement of a pacemaker lead(s) and/or the like;

[0043] Fig. 18 illustrates a side view of a CCTD according to some embodiments, having attachment means for connecting components of the CCTD together;

[0044] Figs. 19A-B illustrate a CCTD, according to some embodiments of the present disclosure, which include functionality for enabling replacement of a previous prosthetic valve with another prosthetic valve.

DETAILED DESCRIPTION

[0045] As shown in Fig. 1, which illustrates in some embodiments of the disclosure, a cross- caval tricuspid device (CCTD) 100 for treating tricuspid valve insufficiency is provided. In some embodiments, device may be a single, integral device, and in some embodiments, device 100 can comprise two or more components that are interconnected. Accordingly, device 100 can include at least one stent structure 102 (in some embodiments, a single stent structure), a first end 104 configured for implantation in the inferior vena cava (IVC) 200 and anchoring the device in the IVC (where the first end optionally at least partially covered). The device also includes a second end 106 configured for implantation in the superior vena cava (SVC) 202 and anchoring the device in the SVC 202, the second end optionally at least partially covered. [0046] A first valve 108 connected to at least a portion of the first end 104, such that the first valve 108 is arranged within at least a portion of the right atrium (RA) 204 of the heart 201 above the IVC 200 when the CCTD is implanted.

[0047] Device 100 can further include a second valve 110 connected to at least a portion of the second end 106, such that the second valve 110 is partially arranged within the right atrium 204 below or at least partially within the SVC 202 and below the azygos vein 206.

[0048] Device 100 can further include sealing means 112.

[0049] Optionally, device 100 can further include a middle portion 114 between the first end 104 and the second end 106, the middle portion 114 can be configured to rotate (in some embodiments) at least one of the first valve 108 and the second valve 110 relative to the at least one of the first end 104 and the second end 106 a desired amount of rotation 120, which is illustrated in Figs. 2-3 (Fig. 2 illustrating device 100 being straight, and Fig. 3 illustrating device 100 being rotated relative to first end 104 and second end 106).

[0050] Each valve (and any valve according to other disclosed embodiments), can be considered an intraluminal valve. An end result of the rotational functionality can be had (or furthered) via foreshortening of device 100 (see Figs. 4-5).

[0051] In some embodiments, the sealing means comprises an IVC skirt configured with a size and shape so as to protrude outwards, and arranged on the RA floor, as well as an SVC skirt configured with a size and shape so as to protrude outwards and situated on the RA roof.

[0052] In some embodiments of the disclosure, the prosthetic heart valve device 100 CCTD can be merely the at least one stent structure 102, at least one valve (e.g., valve 108 and/or valve 110), and at least one sealing means 112. One and/or another of the valves can include material including a fabric, polymer, composites, biological tissue, and combinations of the foregoing.

[0053] In some embodiments, an exterior diameter of at least a portion of the CCTD device (single or modular) can be between 15-70 mm, 15-60 mm, 15-50 mm, 15-40 mm, 15-30 mm, 15-20 mm, 20-70 mm, 20-60 mm, 20-50 mm, 20-40 mm, 20-30 mm, 30-70 mm, 30-60 mm, 30-50 mm, 30-40 mm, 40-70 mm, 40-60 mm, 40-50 mm, 50-70 mm, 50-60 mm, and 60-70 mm, and ranges therebetween.

[0054] As indicated above, in some embodiments, the CCTD can be a modular, CCTD 116 for treating tricuspid valve insufficiency, as shown in Figs. 4-5. In these embodiments, the first end can be configured as a first stent 118 configured for implantation in the inferior vena cava (IVC) 200 and anchoring the device in the IVC, the first stent optionally at least partially covered, a second stent 120 configured for implantation in the superior vena cava (SVC) 204 and optionally anchoring the device in the SVC. The second stent 120 can be at least partially covered. Device 116, a first valve (not shown) connected to at least a portion of the first stent 118, such that the first valve is arranged within at least a portion of the right atrium (RA) 204 above the IVC 200 when the CCTD 116 is implanted. A second valve (not shown) connected to at least a portion of the second stent 120, such that the second valve 124 is arranged within at least a portion of the right atrium (RA) 206 below or at least partially within the SVC 204 and below the azygos vein 208. The modular device, like the single device, can include sealing means, and optionally, a middle portion 114 (which can also be referred to as a connector) arranged between the first valve and/or first stent 118 and the second valve and/or the second stent 120.

[0055] Similar to the middle portion 114 of the CCTD 100, connector 114 optionally can be configured to rotate at least one of the first valve and/or first stent 118, and the second valve 124 and/or the second stent 120, relative to the at least one of the first valve/first stent 118 and the second valve/second stent 120 an amount of rotation (which can be predetermined according to a desired amount). For example, in some embodiments, the amount of rotation can be preferably between 0 and 180 deg. See Figs. 2-3.

[0056] The middle portion 114 or connector can include a length which is sufficient to span between the first end and the second end, or, the first stent and the second stent, as applicable. In some embodiments, the span is between about 30 and 120mm, and ranges there between, and in some embodiments, preferably between 40-90mm).

[0057] At least one of stent of the CCTD (and/or the connector/middle portion) can be made from a shape-memory material, a self-expandable material, mechanically expandable material, composite materials, polymers, and combinations of the foregoing. [0058] With respect to some embodiments, and in particular, embodiments related to a modular CCTD, components thereof can be configured for specific human anatomies, including, for example, different sizing, shapes, lengths, and the like, so as to correspond to specific human anatomies. To this end, in some embodiments, a kit can be provided which includes a plurality of different components, for example different sized first stents (e.g., diameter, shape, and/or length) for position in the IVC, different sized second stents (e.g., diameter, shape, and/or length) for positing in the SVC, different sized (e.g., diameter, and/or length) valves, different sized connectors (e.g., diameter, and/or length), and any and/or all of the forgoing with sealing means (e.g., covers, skirts, and the like).

[0059] In some module CCTD embodiments, the interface between components, can be, in some embodiments, considered a joining material 128 or structure, as shown in Fig. 4-5. For example, a fabric material (which can be a natural or synthetic material) can be arranged between the first stent and the connector, and the second stent and the connector. As shown in Fig- 5, the joining material 128, in some embodiments, can be flexible, such that it can compress and extend (i.e., changing the length of either a portion and/or all of the CCTD). In some embodiments, the joining material can be, tissue, including, for example, pericardium tissue.

[0060] In some embodiments, any of the stents can be configured to be flexible or rigid, or a combination (e.g., a portion of a stent being flexible and a portion of the stent being rigid, a first stent being flexible and a second stent being rigid).

[0061] In some embodiments, the CCTD, whether modular or a single device, and as mentioned above, can include a sealing means. Such sealing means can include one or more fluid impervious (which includes sealing means which are nearly or substantially fluid impervious) skirts 130, and in some embodiments, a plurality of fluid impervious skirts 130 (e.g., two skirts, three skirts). Such skirts can comprise a material, such as, for example, fabric, biological tissue, polymer, and composite materials.

[0062] As shown in Figs. 6A-B (see also, Fig. 1), the sealing means, in some embodiments, is configured to prevent a backflow of blood from any and all of the right atrium 206 to at least one of the IVC 202 and from the right atrium 206 to the SVC 204, leaks around any and all of one and/or another components of the device, and still allow hepatic and azygos vein inflow (e.g., a supra hepatic IVC skirt and infra azygos SVC skirt, respectively). Fig. 6A illustrates a single sealing means/skirt on the IVC portion of the CCTD, and Fig. 6B illustrates two (2) sealing means/skirts 112/130. Moreover, one or more respective sealing structures arranged on or adjacent any and all of, and as applicable, elements of the device, and can be sized and shaped to specifically accommodate anatomical structure arranged opposite and/or adjacent to the respective element.

[0063] As can be seen in Fig. 6A, a first sealing means 112 includes a first skirt 130 attached to the outer diameter of the first end 104 and the first valve 108 is connected to the first end 104. The position of the first valve 108 along the longitudinal direction of the stent structure 102 overlaps with 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 in which the first skirt 130 is attached to the first end 104.

[0064] Alternatively, and not shown in Fig. 6A, the position of the first valve 108 along the longitudinal direction of the stent structure may be located between the position of the first skirt 130 and the position of the second valve 110.

[0065] Furthermore, as can be seen in Fig. 6A, a second sealing means 112 includes a second skirt 130 attached to the outer diameter of the second end 106 and the second valve 110 is connected to the second end 106. The position of the second valve 110 along the longitudinal direction of the stent structure overlaps with 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 in which the second skirt 130 is attached to the second end 106.

[0066] Alternatively, and not shown in Fig. 6A, the position of the second valve 110 along the longitudinal direction of the stent structure may be located between the position of the second skirt 130 and the position of the first valve 108.

[0067] Accordingly, in some embodiments, one or more respective sealing structures can be configured to surround at least a portion, and in some embodiments, only a portion of any and all of the elements of the device, a majority of any and all of the elements of the device, and/or surrounding any and all of the elements of the device. For example, a sealing structure (skirt 144) can be arranged on different planes of the CCTD device and RA 204, according to some embodiments, as shown in Figs. 9-10. [0068] In some embodiments, the sealing means (e.g., skirt) can include a plurality of layers, as shown in Fig. 6B, which can include a reinforcement structure such as a wire or stent. For example, a wire can outline a perimeter of at least a portion of a skirt sealing structure to help give the structure more rigidity (for example), according to some embodiments. Such materials to provide such structure can be nitinol or a material having similar properties.

[0069] Figs. 7A-8D illustrate various skirt structures for the sealing means. To this end, one or more skirts for some embodiments may include be arranged or configured (size, shape, and/or dimensions) as a flange shape and/or inverted 138a/b (Figs. 7A-B, 8A), include a curved portion, convex or concave, which can include or be configured as a parachute structure 138c (Figs. 7A, 8D), oblong, bulbous shape 142 (Fig. 8B), and/or tube shaped 144 (Fig. 8C). The tube-shaped skirt of Fig. 8C, may be or considered as an inflatable balloon structure, which can be donut shaped. Donut shaped skirts can include an outer diameter configured to interface with surrounding tissue, the IVC, SVC, or RA, and an inner diameter radially spaced away from the outer diameter and configured for attachment to a stent structure.

[0070] In some embodiments, a perforated layer having one or more perforations 146, and/or the establishment of one or more “pockets” 139 (see Figs. 7A-B) can be included. In some embodiments, perforations and pockets are provided such that, for one or more pockets, they are sized and shaped to promote tissue growth therein. Accordingly, such perforations and/or pockets can be between, in some embodiments, 0.5 mm and 5 mm.

[0071] In some embodiments, the skirt sealing structures can be configured as a stretchable material (e.g., silicon, rubber, and materials having similar properties of the foregoing), which 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 a straight edge (see e.g., edge 138d, or a curved or undulating edge 140b).

[0072] In some embodiments, at least one first portion of the CCTD, or an element thereof, includes a rigidity greater than a rigidity of a second portion of the device or element thereof. Such a feature allows for at least one of:

- the fitting of different device portions to different functions such as IVC and SVC tenderness when in contact with, for example, the phrenic nerve and/or the delicate SVC and IVC while maintaining strong commissural structure so that the valves do not collapse under large systolic pressure gradients, and flexibility of the middle portion to allow translation and angular differences between the SVC and IVC while still maintaining migration resistance.

The at least one first portion can comprise an area of the device or element thereof which accommodates at least a portion of a valve. The second portion can comprise a remainder of the area of the device or element thereof, or a middle portion of the device or element thereof.

[0073] The CCTD, or one or more elements thereof (e.g., stent structure, first stent, second stent) includes a structure including a plurality of interconnected struts, where one or more plurality of interconnected struts associated with a first portion which includes a thickness of between 0.2 mm and 1.0 mm. Such interconnected struts can form a plurality of cells 148 (Fig. 12). In some embodiments, an area of each cell associated with at least a portion of the CCTD, can be between 0.25 cm ² and 10 cm ² , and preferably (in some embodiments), between 2-5 cm ² . In some embodiments, each cell associated with at least a first portion of the CCTD is configured with a size and shape to allow passage of a catheter, for example, which is sized up to approximately 15 mm in diameter (in some embodiments). The cells may include any shape, and in some embodiments, a plurality of the cells each include a rhombus shape.

[0074] In some embodiments, the plurality of interconnected struts associated with a first portion of the device can be sized, shaped, and/or arranged so as to impart radial forces than a second portion of the device. In some embodiments, some of the interconnected struts corresponding with the first portion are sized, shaped, and/or arranged so as to impart a first diameter different from a second diameter of a second portion of the CCTD as to accommodate different IVC, SVC and RA anatomical sizes with one device.

[0075] In some embodiments of the CCTD 100, one or more of the valves include a plurality of commissures, and in some embodiments which include two valves (Fig- 11), the commissures 150a of a first valve 150b are offset from the commissures 152a of the second valve 152b by a predetermined number of degrees. The offset of the commissures of the two valves are beneficial, in some embodiments, as it distinguishes between the forces that the SVC and IVC CCTD valves exert on the entire device structure across any one longitudinal line (i.e., no IVC and SVC commissure are situated on one longitudinal CCTD line).

[0076] 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 stent structure is offset by a predetermined number of degrees from the rotational position of the commissures 152a of the second valve 152b when connected to the second end of the stent structure, wherein preferably the offset is determined when the stent structure is not twisted.

[0077] Accordingly, various embodiments where the valves include two (2) commissures, have offset values can be between: 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. Various embodiments where the valves include three (3) commissures, have offset values can 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 number of offset degrees is preferably approximately 60°.

[0078] In some embodiments, as shown in Fig. 12, the CCTD includes at least one thrombus filter 154, which can be arranged on the stent structure on an end which is adjacent or in the IVC 202 or SVC. The filter 154 can include a plurality of arches 156 and a net or net-like structure (not shown), configured for capturing thrombus from the IVC or SVC. The plurality of arches, in some embodiments, are established between adjacent apexes of an end of at least one of the first stent and the second stent, or the at least one stent structure. The filter, or the net component 158, can be configured for device/filter re-capture after the device is implanted. To this end, in some embodiments, the CCTD, and/or components or portions thereof, can be sized and shaped for recapture by a catheter either during implantation or retrieval after implantation. In such embodiments, recapture can be accomplished by using a hook device 160, as shown in Figs. 13A-B.

[0079] As shown in Figs. 14A-B, the CCTD can include a length (in some embodiments, between 60 mm and 280 mm). In addition, the CCTD 100 (and/or components thereof), in some embodiments, and as shown in these figures, are configured (e.g., via the interconnecting struts of one or more stents of the CCTD) so as to be able to conform to the anatomy of a particular patient. To this end, the CCTD can be configured to translate between the IVC and SVC up to approximately 60mm and/or at an angle of between 0 and 45 degrees. According [0080] In some embodiments, the CCTD or components thereof can include a covering 162 which covers an end of at least one of the first stent and the second stent, or at least one stent structure. In some embodiments, the covering 162 can include one or more openings configured to be adjacent one or more leaflets of the valve. In some embodiments, such covering 162 (and/or sealing means) can be configured to be arranged or otherwise positioned on the device on a portion thereof, including on any stent, on at least one of the inside, the outside. Any and all of the sealing means and/or covering, according to some embodiments, can be made of a material including biological tissue, synthetic materials, composite materials, polymers, and combinations of the foregoing.

[0081] The covering 162, in some embodiments, can be configured or otherwise arranged or positioned, as shown in Figs. 14C-D, so as to prevent one or more blood jets coming from a native valve from impacting the device or elements thereof. For example, in some embodiments, the covering 162 covers a middle portion of the CCTD device, which is configured for arrangement within the RA. Fig. 14C illustrates no covering to protect against possible blood jets, and Fig. 14D illustrates covering 162 blocking the jets (the jets being illustrated as dashed arrows).

[0082] As shown in Figs. 15A-16B, in some embodiments, a stent of the CCTD 100 includes one or more struts 170 arranged above and/or below an outflow area of a valve positioned within or connected to a first and/or a second strut, or a strut component. Such struts or components can be positioned between two leaflets of the valve, and in some embodiments, the one or more struts are position within the middle of a/the valve. In some embodiments, the purpose of such struts is to allow the passage of pacemaker or defibrillator leads 172 without interfering with the proper valve function. In some embodiments, one or more struts direct passing of a lead or catheter between the leaflets.

[0083] As shown in Fig. 17, in some embodiments, one or more stents of the CCTD, the cover, and/or sealings means, can be configured with one or more ports 164 for placement of, for example, a pacemaker lead(s) 166 post-implantation of the device. For such stents, the one or more ports can correspond to areas or openings for placement of pacemaker leads 172 postimplantation of the device. In some embodiments, such ports do not interfere with any valve included with the CCTD. For example, the one or more ports can be arranged on a wall of a stent(s) of the CCTD. In some embodiments, a port directs passing of a lead or catheter to the outside of the valve.

[0084] In some embodiments, and as illustrated in Fig. 18, any stent of the CCTD, especially those can include attachment means, which can include one or more hooks 168 for connection to other components of the CCTD (one and/or another of the stents, valves, and the like), and/or, in some embodiments, one or more sutures. This feature can allow for each connection of elements of the CCTD so that components can be easily interchanged (e.g., for anatomical purposes to customize the CCTD for a particular patient), and/or for enabling delivery/implantation of one or more components for connection to previously implanted components. An end of such hooks 168 and can be accommodated by an opening 171 of another element for attachment.

[0085] The CCTD device can include one or more radio-opaque materials are included on one or more portions or locations of any and all of any stent of the device, a valve, a connector, a middle portion, and one or more leaflets of a valve, for example, and according to some embodiments.

[0086] In some embodiments, as shown in Figs. 19A-B, one or more valves of the CCTD 100 is configured to receive a replacement valve 180, such that the replacement valve is arranged therein. For example, the replacement valve 170 can be delivered to the one and/or another valve of the CCTD which was previously implanted. For example, to replace a CCTD valve which is degenerated or malfunctioning.

[0087] Example Aspects and Embodiments of the Disclosure

[0088] Example 1 : A single, cross-caval tricuspid device for treating tricuspid valve insufficiency including at least one stent structure, a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first end optionally at least partially covered, a second end configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, the second end optionally at least partially covered, a first valve connected to at least a portion of the first end, such that the first valve is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, a second valve connected to at least a portion of the second end, such that the second valve is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein, and sealing means.

[0089] Example 2: A single, cross-caval tricuspid device for treating tricuspid valve insufficiency including at least one stent structure, a first end configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first end optionally at least partially covered, a second end configured for implantation in the superior vena cava (SVC) and anchoring the device in the SVC, the second end optionally at least partially covered, a first valve connected to at least a portion of the first end, such that the first valve is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, a second valve connected to at least a portion of the second end, such that the second valve is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein, sealing means, and optionally, a middle portion between the first end and the second end, the middle portion optionally configured to at least one of: rotate at least one of the first valve and the second valve relative to the at least one of the first end and the second end a desired amount of rotation, and foreshorten the device.

[0090] Example 3: A modular, cross-caval tricuspid device for treating tricuspid valve insufficiency including a first stent configured for implantation in the inferior vena cava (IVC) and anchoring the device in the IVC, the first stent optionally at least partially covered, a second stent configured for implantation in the superior vena cava (SVC) and optionally anchoring the device in the SVC, the second stent optionally at least partially covered, a first valve connected to at least a portion of the first end, such that the first valve is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, a second valve connected to at least a portion of the second end, such that the second valve is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein, sealing means, and optionally a connector arranged between the first valve and the second valve, the connector optionally configured to at least one of: rotate at least one of the first valve and the second valve relative to the at least one of the first stent and the second stent a desired amount of rotation, and foreshorten the device.

[0091] Example 4: A prosthetic heart valve device including: at least one stent structure, at least one valve, and at least one sealing means.

[0092] Example 5 : The device of any of examples 2-3, wherein the middle portion or connector comprises a length which is sufficient to span between the first end and the second end, or, the first stent and the second stent, as applicable.

[0093] Example 6: The device of any of examples 1-4, wherein the/at least one valve, and optionally a plurality or all valves, is/are an intraluminal valve.

[0094] 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 means, and the connector, are changeable to different sizing to accommodate different anatomies of patients.

[0095] Example 8: The device of any of examples 1-7, wherein the sealing means comprises at least one skirt.

[0096] Example 9: The device of any of examples 1-7, wherein the sealing means comprises a plurality of skirts.

[0097] Example 10: The device of any of examples 1-7, wherein the sealing means comprises at least two skirts.

[0098] Example 11 : The device of any of examples 1-7, wherein the sealing means comprises at least three skirts.

[0099] Example 12: The device of any of examples 1-11, wherein the sealing means is configured to prevent a backflow of blood from any and all of the right atrium to at least one of the inferior vena cava (IVC) and from the right atrium to the superior vena cava (SVC), leaks around any and all of one and/or another components of the device, and/or allowing hepatic vein inflow, wherein the sealing means comprises a supra hepatic IVC skirt. [0100] Example 13: The device of any of examples 1-12, wherein an exterior diameter of at least a portion of the device is between 15-70 mm, 15-60 mm, 15-50 mm, 15-40 mm, 15-30 mm, 15-20 mm, 20-70 mm, 20-60 mm, 20-50 mm, 20-40 mm, 20-30 mm, 30-70 mm, 30-60 mm, 30-50 mm, 30-40 mm, 40-70 mm, 40-60 mm, 40-50 mm, 50-70 mm, 50-60 mm, and 60- 70 mm, and ranges therebetween.

[0101] Example 14: The device of examples 1-13, wherein the sealing means comprises one or more respective sealing structures arranged on or adjacent any and all of, and as applicable, each of the elements of the device, and wherein one or more of sealing structures is sized and shaped to specifically accommodate anatomical structure arranged opposite and/or adjacent to the respective element.

[0102] Example 15: The device of example 14, wherein respective sealing structures surround only a portion of any and all of the elements of the device.

[0103] Example 16: The device of example 14, wherein respective sealing structures surround a majority of any and all of the elements of the device.

[0104] Example 17: The device of example 14, wherein respective sealing structures surround any and all of the elements of the device.

[0105] Example 18: The device of example 17, wherein a first sealing structure is arranged along a different plane than that of a second sealing structure.

[0106] Example 19: The device of any of examples 14-18, wherein a/the first structure is arranged to seal against a wall of the RA, and a/the second structure is arranged to seal against a vessel inlet of the RA.

[0107] Example 20: The device of any of examples 1-19, wherein the sealing means comprises a plurality of layers.

[0108] Example 21 : The device of any of example 1-20, wherein the sealing means includes a reinforcement structure.

[0109] Example 22: The device of example 21, wherein the reinforcement structure comprises a wire or stent.

[0110] Example 23: The device of any of examples 1-22, wherein the sealing means comprises a parachute structure. [0111] Example 24: The device of example 23, wherein the parachute structure is configured to open the sealing means during deployment of the device.

[0112] Example 25: The device of any of examples 1-24, wherein the sealing means comprises a first perforated layer and a second sealed layer.

[0113] Example 26: The device of example 25, wherein the first perforated layer and second sealed layer are configured to establish a pocket.

[0114] Example 27: The device of example 26, wherein the established pocket is sized and shaped to promote tissue growth therein.

[0115] Example 28: The device of any of examples 25-27, wherein the first perforated layer is arranged so as to be adjacent tissue.

[0116] Example 29: The device of any of examples 14-28, wherein the sealing means comprises a skirt and includes an inflatable balloon structure.

[0117] Example 30: The device of example 29, wherein the balloon structure is donut shaped.

[0118] Example 31 : The device of any of examples 14-28, wherein a/the sealing structure comprises a stretchable skirt.

[0119] Example 32: The device of any of examples 14-28, wherein a/the sealing structure comprises a stretchable skirt reversibly adherable to an outer surface of an inflatable balloon structure.

[0120] Example 33: The device of any of examples 14-28, wherein each/the sealing structure comprises a 3-dimensional skirt.

[0121] Example 34: The device of example 33, wherein each/the sealing structure comprises a nitinol structure, optionally covered by a sealing material.

[0122] Example 35: The device of any of examples 1-8 and 12-28 wherein the sealing means material comprises a skirt including a flange shape and having an inner diameter for attachment to the outer diameter of at least one structure or element of the device, proximate to a first end of the skirt, and an outer diameter for interfacing with an inner diameter of any and all of an implantation site, the IVC, the SVC, or RA, in a direction toward a second end of the skirt.

[0123] Example 36: The device of example 35, wherein the skirt includes a straight edge. [0124] Example 37: The device of example 35, wherein the skirt includes a curved edge.

[0125] Example 38: The device of any of example 1-8 and 12-28, wherein the sealing means comprises a skirt including a donut shape with an outer diameter configured to interface with surrounding tissue, the IVC, SVC, or RA, and an inner diameter radially spaced away from the outer diameter and configured for attachment to a stent structure.

[0126] Example 39: The device of any of examples 1-38, wherein at least one first portion of the device or an element thereof includes a rigidity greater than a rigidity of a second portion of the device or element thereof.

[0127] Example 40: The device of example 39, wherein the at least one first portion comprises an area of the device or element thereof which accommodates at least a portion of a valve.

[0128] Example 41 : The device of example 40, wherein the second portion comprises a remainder of the area of the device or element thereof.

[0129] Example 42: The device of example 41, wherein the second portion comprises a/the middle portion of the device or element thereof.

[0130] Example 43: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts.

[0131] Example 44: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprises a structure including a plurality of interconnected struts, and wherein one or more plurality of interconnected struts associated with a first portion which includes a thickness of between 0.2 mm and 1.0 mm.

[0132] Example 45: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells.

[0133] Example 46: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells, and wherein an area of each cell associated with the first portion is between 0.25 cm ² and 10 cm ² , and preferably, between 2-5cm2. [0134] Example 47: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality interconnected struts forming a plurality of cells, and wherein an area of each cell associated with the first portion is configured with a size and shape to allow passage of a catheter.

[0135] Example 48: The device of example 47, wherein the catheter is sized up to approximately 15 mm in diameter.

[0136] Example 49: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality of interconnected struts, and wherein one or more of the plurality interconnected struts associated with a first portion of the device which are sized, shaped, and/or arranged so as to impart radial forces than a second portion of the device.

[0137] Example 50: The device of any of examples 1-42, wherein at least one of the first stent and the second stent, or the at least one stent structure, comprise a structure including a plurality of interconnected struts, and wherein one or more of the plurality interconnected struts associated with the first portion are sized, shaped, and/or arranged so as to impart a first diameter different from a second diameter of the second portion.

[0138] Example 51 : The device of any of examples 1-50, wherein each valve includes a plurality of commissures, and wherein the commissures of the first valve are offset from the commissures of the second valve by a predetermined number of degrees.

[0139] Example 52: The device of example 51, wherein the plurality of commissures comprises 2, and the predetermined number of degrees is selected from the group consisting of: between 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.

[0140] Example 53: The device of example 51, wherein the plurality of commissures comprises 3, and the predetermined number of degrees is selected from the group consisting of comprises 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. [0141] Example 54: The device of example 51, wherein the plurality of commissures comprises 3, and the predetermined number of degrees comprises approximately 60°.

[0142] Example 55: The device of any of examples 1-54, wherein a/the stent structure, first stent, and/or second stent includes a plurality of cells established by a plurality of interconnected struts each configured as a rhombus shape.

[0143] Example 56: The device of any of examples 1-55, further comprising at least one thrombus filter.

[0144] Example 57: The device of example 56, wherein the filter comprises a plurality of arches.

[0145] Example 58: The device of example 57, wherein the plurality of arches are established between adjacent apexes of an end of at least one of the first stent and the second stent, or the at least one stent structure.

[0146] Example 59: The device of any of examples 56-58, wherein the filter comprises a net positioned on at least one of a stent end and configured for device/filter re-capture after the device is implanted.

[0147] Example 60: The device of any of examples 1-59, wherein the device is sized and shaped for recapture.

[0148] Example 61 : The device of any of examples 1-59, wherein the device is sized and shaped for recapture by a DS hook.

[0149] Example 62: The device of any of examples 1-59, wherein the device includes a length of between 60 mm and 280mm.

[0150] Example 63: The device of any of examples 1-62, wherein the device is configured to translate between the IVC and SVC up to approximately 60mm and/or at an angle of between 0 and 45 degrees.

[0151] Example 64: The device of any of examples 1-63, further comprising a covering which covers an end of at least one of the first stent and the second stent, or the at least one stent structure.

[0152] Example 65: The device of example 64, wherein the covering includes one or more openings configured to be adjacent one or more leaflets of the valve. [0153] Example 66: The device of any of examples 1-65, wherein the first stent, the second stent, or stent structure composition is selected from the group consisting of: a shape-memory material, a self-expandable material, mechanically expandable material, composite materials, polymers, and combinations of the foregoing.

[0154] Example 67: The device of any of examples 1-66, wherein the valve material is selected from the group consisting of: fabric, polymer, composites, biological tissue, and combinations of the foregoing.

[0155] Example 68: The device of any of examples 1-67, wherein any and all of the sealing means and a/the cover are configured to be arranged or otherwise positioned on the device on a portion thereof, including on the first stent, the second stent, or the stent structure, on at least one of the inside, the outside.

[0156] Example 69: The device of any of examples 1-68, wherein any and all of the sealing means and a/the cover comprise a material selected from the group consisting of: biological tissue, synthetic materials, composite materials, polymers, and combinations of the foregoing.

[0157] Example 70: The device of any of examples 1-69, further comprising one or more ports configured for placement of pacemaker leads post-implantation of the device.

[0158] Example 71 : The device of any of examples 1-69, further comprising one or more ports configured for placement of pacemaker leads post-implantation of the device, such that, the one or more ports do not interfere with the svc valve.

[0159] Example 72: The device of example 71, wherein at least one of the first stent and the second stent, or the stent structure, includes one or more struts arranged above an outflow area of a valve positioned within or connected to the a/the first and/or a/the second strut, or a/the strut component.

[0160] Example 73: The device of example 72, wherein the one or more struts are positioned between two leaflets of the valve.

[0161] Example 74: The device of any of examples 72 or 73, wherein the one or more struts are position within the middle of a/the valve.

[0162] Example 75: The device of example 71, wherein the one or more ports are arranged on a wall of at least one of a/the first stent and a/the second stent, or a/the stent structure. [0163] Example 76: The device of any of examples 1-75, wherein connections between elements of the device comprise a fabric.

[0164] Example 77: The device of any of examples 1-76, wherein a majority of the device is flexible.

[0165] Example 78: The device of any of examples 1-76, wherein a majority of the device is rigid.

[0166] Example 79: The device of examples 1-78, 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 includes one or more hooks for connection to another element.

[0167] Example 80: The device of example 79, wherein an end of the hook is accommodated by an opening of another element for attachment.

[0168] Example 81 : The device of any of examples 1-80, wherein the/a cover is arranged or otherwise positioned on the device so as to prevent one or more blood jets coming from a native valve from impacting the device or elements thereof.

[0169] Example 82: The device of any of examples 1-81, wherein a middle portion of the device is configured for arrangement within the RA and includes no more than a partial covering.

[0170] Example 83 : The device of any of examples 1-82, further comprising one or more radioopaque materials are included on one or more portions or locations of any and all of the first stent, the second stent, the stent structure, a valve, a/the first valve, a/the second valve, a/the connector, a/the middle portion, and one or more leaflets of a valve.

[0171] Example 84: The device of any of examples 1-83, wherein a/the first valve, a/the second valve, and/or a/the valve is configured to receive a replacement valve, such that the replacement valve is arranged therein.

[0172] Example 85: The device of any of examples 1-3 and 5-84, wherein the middle portion or connector is configured to twist to effect a change in length of the device.

[0173] Example 86: The device of example 85, wherein the middle portion or connector comprises a plurality of linear structures for connecting ends of the device and/or first and second stents of the device, which upon twisting in a first direction, shorten the length of the device, and upon twisting in a second direction opposite to the first direction, lengthen the length of the device.

[0174] Example 87 : A method of implanting a cross-caval tricuspid device (CCTD) for treating tricuspid valve insufficiency including providing the CCTD according to any of the CCTD embodiments disclosed herein, removably attaching the CCTD to a distal end of a delivery catheter, directing the distal end of the delivery catheter to a site of implantation adjacent at least one of the IVC, SVC, RA or RV via any of a femoral approach, and a jugular approach, releasing the CCTD at the implantation site, and removing the delivery catheter.

[0175] The following examples include reference numbers corresponding to those of the disclosure’s figures.

[0176] Example 88: A cross-caval tricuspid device (100) for treating tricuspid valve insufficiency including at least one stent structure (102), a first end (104) of the stent structure (102) configured for implantation in the inferior vena cava (IVC)(200) and anchoring the device in the IVC (200), a first sealing means (112) including a first skirt (130) attached to the outer diameter of the first end (104), a second end (106) of the stent structure (102) configured for implantation in the superior vena cava (SVC)(202) and anchoring the device in the SVC (202), a first valve (108) connected to the first end (104), a second valve (110) connected to the second end (106), wherein the position of the first valve (108) along longitudinal direction of the stent 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).

[0177] Example 89: The device (100) of example 88 further including a second sealing means (112) 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 stent 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).

[0178] Example 90: The device (100) of 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. [0179] Example 91 : The device (100) of any one of examples 88-90, wherein the first skirt (130) and/or the second skirt (130) has an outer diameter for interfacing with an inner diameter of any and all of an implantation site, the IVC, the SVC, or RA, in a direction toward a second end of the skirt (130).

[0180] Example 92: The device (100) of any one of examples 88-91, wherein the first sealing means (112) includes at least two skirts (130) and/or the second sealing means (112) includes at least two skirts (130).

[0181] Example 93: The device (100) of any one of examples 88-92, wherein at least one of the skirts (112) includes a plurality of layers, and/or includes a reinforcement structure, preferably a reinforcement structure comprising a wire or stent, and/or includes a parachute structure, and/or includes a first perforated layer and a second sealed layer, preferably wherein the first perforated layer and second sealed layer are configured to establish a pocket, preferably wherein the established pocket is sized and shaped to promote tissue growth therein, wherein preferably the first perforated layer is arranged so as to be adjacent tissue, and/or includes an inflatable balloon structure, preferably wherein the balloon structure is donut shaped, and/or is stretchable, wherein preferably the stretchable skirt is reversibly adherable to an outer surface of an inflatable balloon structure, and/or comprises a 3-dimensional skirt structure, and/or is arranged to seal against a 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 which is at least double of the outer diameter of the stent structure, and/or has an outer diameter of at least 70mm.

[0182] Example 94: The device (100) of any one of examples 88-93, wherein the stent structure (102) is unitary and/or formed in one piece.

[0183] Example 95: The device (100) of any one of examples 88-94, wherein between the first end (104) and the second end (106) a middle portion (114) is arranged, wherein the middle portion (114) is configured to rotate the first end (104) relative to the second end (106) a desired amount of rotation (120) to effect a change in length of the stent structure (102), wherein preferably the middle portion (114) has a weaker structure than the first end (104) and the second end (106) in order to allow for rotation in the middle portion (114).

[0184] Example 96: The device (100) of any one of examples 88-95, wherein the stent structure (102) includes a first stent (118) including the first end (104) and a second stent (120) including the second end (106) and a connector connecting the first stent (118) and the second stent (120). [0185] Example 97: The device (100) of example 96, wherein the connector is configured to rotate the first end (104) relative to the second end (106) a desired amount of rotation (120).

[0186] Example 98: The device (100) of any one of examples 95 to 97, wherein the middle portion (114) or the connector comprises a plurality of linear structures for connecting the first end (104) to the second end (106) and/or the first stent (118) and the second stent (120), which upon twisting in a first direction, shorten the length of the stent structure (102), and upon twisting in a second direction opposite to the first direction, lengthen the length of the stent structure (102).

[0187] Example 99: The device (100) of any one of examples 88-98, 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 number of degrees from 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 stent structure (102) is not twisted.

[0188] Example 100: The device (100) of example 99, wherein each of the valves (108, 110) comprises two commissures, and the predetermined number of degrees is selected from the group consisting of: between 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.

[0189] Example 101 : The device (100) of example 99, wherein each of the valves (1138, 110) comprises three commissures, and the predetermined number of degrees is selected from the group consisting of comprises 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, wherein preferably the predetermined number of degrees comprises approximately 60°.

[0190] Example 102: The device (100) of any one of examples 88-101, wherein the position of the first valve (108) in the first end (104) is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, and/or wherein the position of the second valve (110) in the second end (106) is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein. [0191] Example 103: A cross-caval tricuspid device (100) for treating tricuspid valve insufficiency including: at least one stent structure (102), a first end (104) of the stent structure (102) configured for implantation in the inferior vena cava (IVC)(200) and anchoring the device in the IVC (200), a first sealing means (112) including a first skirt (130) attached to the outer diameter of the first end (104), a second end (106) of the stent structure (102) configured for implantation in the superior vena cava (SVC)(202) and anchoring the device in the SVC (202), a first valve (108) connected to the first end (104), a second valve (110) connected to the second end (106), wherein the position of the first valve (108) along longitudinal direction of the stent 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).

[0192] Example 104: The device (100) of example 103 further including a second sealing means (112) 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 stent 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).

[0193] Example 105: The device (100) of 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.

[0194] Example 106: The device (100) of any one of examples 103-105, wherein the first skirt (130) and/or the second skirt (130) has an outer diameter for interfacing with an inner diameter of any and all of an implantation site, the IVC, the SVC, or RA, in a direction toward a second end of the skirt (130).

[0195] Example 107: The device (100) of any one of examples 103-106, wherein the first sealing means (112) includes at least two skirts (130) and/or the second sealing means (112) includes at least two skirts (130).

[0196] Example 108: The device (100) of any one of examples 103-107, wherein at least one of the skirts (112) includes a plurality of layers, and/or includes a reinforcement structure, preferably a reinforcement structure comprising a wire or stent, and/or includes a parachute structure, and/or includes a first perforated layer and a second sealed layer, preferably wherein the first perforated layer and second sealed layer are configured to establish a pocket, preferably wherein the established pocket is sized and shaped to promote tissue growth therein, wherein preferably the first perforated layer is arranged so as to be adjacent tissue, and/or includes an inflatable balloon structure, preferably wherein the balloon structure is donut shaped, and/or is stretchable, wherein preferably the stretchable skirt is reversibly adherable to an outer surface of an inflatable balloon structure, and/or includes a 3-dimensional skirt structure, and/or is arranged to seal against a wall of the RA and/or the I VC, and/or is arranged to seal against the SVC and/or the SVC inlet of the RA, and/or has an outer diameter which is at least double of the outer diameter of the stent structure, and/or has an outer diameter of at least 70mm.

[0197] Example 109: The device (100) of any one of examples 103-108, wherein the stent structure (102) is unitary and/or formed in one piece.

[0198] Example 110: The device (100) of any one of examples 103-109, wherein between the first end (104) and the second end (106) a middle portion (114) is arranged, wherein the middle portion (114) is configured to rotate the first end (104) relative to the second end (106) a desired amount of rotation (120) to effect a change in length of the stent structure (102), wherein preferably the middle portion (114) has a weaker structure than the first end (104) and the second end (106) in order to allow for rotation in the middle portion (114).

[0199] Example 111 : The device (100) of any one of examples 103-108, wherein the stent structure (102) includes a first stent (118) including the first end (104) and a second stent (120) including the second end (106) and a connector connecting the first stent (118) and the second stent (120).

[0200] Example 112: The device (100) of example 111, wherein the connector is configured to rotate the first end (104) relative to the second end (106) a desired amount of rotation (120).

[0201] Example 113: The device (100) of any one of examples 110 to 112, wherein the middle portion (114) or the connector comprises a plurality of linear structures for connecting the first end (104) to the second end (106) and/or the first stent (118) and the second stent (120), which upon twisting in a first direction, shorten the length of the stent structure (102), and upon twisting in a second direction opposite to the first direction, lengthen the length of the stent structure (102).

[0202] Example 114: The device (100) of any one of examples 103-113, 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 number of degrees from 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 stent structure (102) is not twisted.

[0203] Example 115: The device (100) of example 114, wherein each of the valves (108, 110) comprises two commissures, and the predetermined number of degrees is selected from the group consisting of: between 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.

[0204] Example 116: The device (100) of example 114, wherein each of the valves (1138, 110) comprises three commissures, and the predetermined number of degrees is selected from the group consisting of comprises 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, wherein preferably the predetermined number of degrees comprises approximately 60°.

[0205] Example 117: The device (100) of any one of examples 103-116, wherein the position of the first valve (108) in the first end (104) is arranged within at least a portion of the right atrium (RA) above the IVC when the CCTD is implanted, and/or wherein the position of the second valve (110) in the second end (106) is arranged within at least a portion of the right atrium (RA) below or at least partially within the SVC and below the azygos vein.

[0206] General Considerations

[0207] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all structure, parameters, dimensions, materials, functionality, and configurations described herein are meant to be an example and that the actual structure, parameters, dimensions, materials, functionality, and configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the claims supported by the present disclosure, and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. 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, structure, materials, kits, functionalities, steps, and methods, if such are not mutually inconsistent, is included within the inventive scope of the present disclosure. Some embodiments may be distinguishable from the prior art for specifically lacking one or more features/elements/functionality (i.e., claims directed to such embodiments may include negative limitations).

[0208] Also, as noted, various inventive concepts are embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0209] Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[0001] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The terms “can” and “may” are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to) for a particular embodiment s).

[0210] The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined.

[0211] Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0212] As used herein 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” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” [0213] “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0214] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. 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”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, 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); etc.

[0215] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.