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

Abstract

Embodiments of the present disclosure relate to tricuspid valve treatment devices and methods for treating and / or replacing diseased or otherwise damaged tricuspid valves, such as utilizing the devices and systems of the present disclosure, in some embodiments, the devices include a lateral outflow port configured for placement after implantation into the right atrium or right atrium and right ventricle, and configured for securing a surgical or transcatheter valve, which may be placed in the lateral outflow port after implantation of the tricuspid valve treatment device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 149,555, filed February 15, 2021, the contents of which are incorporated herein by reference in their entirety.

[0002] Additionally, this disclosure is related to PCT application PCT / IB2017 / 050534, filed February 1, 2017, and PCT application PCT / IL2019 / 050658, filed June 7, 2019, the disclosures of both of which are incorporated herein by reference in their entireties.

[0003] The present disclosure relates generally to medical systems, apparatus, devices, and methods for implanting medical devices in the heart, and particularly, but not exclusively, to stent-based devices for treating tricuspid valve disease and / or tricuspid valve dysfunction. [Background technology]

[0004] The tricuspid valve closes during ventricular systole to prevent backflow of blood from the right ventricle to the right atrium, and opens during ventricular diastole to allow blood to flow from the right atrium to the right ventricle.

[0005] Tricuspid insufficiency, which causes tricuspid regurgitation, may result from tricuspid annular dilation and right ventricular enlargement. Tricuspid regurgitation is often secondary to myocardial or valvular heart failure, right ventricular volume or pressure overload, and chamber dilation. Tricuspid regurgitation causes right atrial overload, which is propagated to the superior and inferior vena cava and their tributaries. Ultimately, this overload leads to hepatic congestion, ascites, anasarca, peripheral edema, and other clinical symptoms of congestive heart failure. If untreated, significant tricuspid regurgitation often leads to heart failure and death.

[0006] Clinically available treatments for tricuspid regurgitation include open-heart surgery and / or medical therapy. However, open-heart surgery for tricuspid valve replacement and / or tricuspid valve repair is rarely performed, mainly due to its high mortality and morbidity rates. Meanwhile, medical therapy does not solve the problem and may allow the disease to progress, resulting in a decline in the quality of life and cardiac function of the patient.

[0007] Due to the high surgical risks of tricuspid valve replacement and / or tricuspid valve repair, most patients with tricuspid regurgitation are currently considered inoperable, resulting in a significant number of untreated patients with significant tricuspid regurgitation. Summary of the Invention [Means for solving the problem]

[0008] According to one embodiment, the present disclosure relates to a stent graft device configured for implantation into the inferior and superior vena cava of a patient to treat a tricuspid valve that has been damaged due to disease or other reasons in the patient, the device comprising a tubular body having a longitudinal axis and configured for implantation into the superior and inferior vena cava (SVC) and the inferior and inferior vena cava (IVC), where upon implantation a first end and an associated first end portion of the tubular body are disposed within the inferior and superior vena cava, and a first outflow port configured for placement after implantation within the right atrium and right ventricle and configured for anchoring a surgical or transcatheter valve, the first outflow port being disposed transversely to the longitudinal axis and optionally automatically deploying upon exiting a delivery catheter.

[0009] In one embodiment, the first outflow port is disposed transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, the first outflow port is disposed transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, with a distal end of the first outflow port facing toward the base of the heart and / or with a distal end of the first outflow port facing toward the apex of the heart.

[0010] In one embodiment, the device further comprises a material configured to at least partially cover the tubular body, the material being disposed on the tubular body to prevent blood flow through at least a side portion of the tubular body, the placement of the material on the tubular body being configured to allow blood flow from the azygos / brachiocephalic and / or hepatic veins.

[0011] In one embodiment, the device further comprises a pacemaker / ICD lead port and / or valve (PLP) configured to receive the passage of a pacemaker / ICD lead. The PLP is disposed on a side of the tubular body. The first outflow port comprises at least one of a first restriction and a second restriction, each of which is configured to prevent the movement of a valve disposed within the first outflow port. The first outflow port comprises at least one restriction configured as a bottleneck structure, the bottleneck structure being located within the first outflow port or configured with an hourglass shape such that the bottleneck structure is located within the hourglass structure, the bottleneck structure being configured to prevent the movement of a valve disposed within the first outflow port. The first outflow port comprises a first stopper portion disposed on a distal end of the first outflow port, the first stopper portion configured to prevent the movement of a valve disposed within the first outflow port away from the tubular body. The first outflow port comprises a first stopper portion disposed on a proximal end of the first outflow port, the first stopper portion configured to prevent movement of a valve disposed within the first outflow port toward the tubular body. The first outflow port comprises a first stopper portion disposed on a distal end of the first outflow port, the first stopper portion configured to prevent movement of a valve disposed within the first outflow port away from the tubular body, and a second stopper portion disposed on a proximal end of the first outflow port, the second stopper portion configured to prevent movement of a valve disposed within the first outflow port toward the tubular body. The first outflow port comprises a limiting structure disposed on a distal end of the first outflow port, the limiting structure configured to prevent movement of a valve disposed within the first outflow port away from the tubular body. At least one of the proximal and distal ends of the first outflow port has a diameter less than a diameter of a central portion of the first outflow port, which diameter less than the diameter of the central portion of the first outflow port is configured to prevent movement of a valve disposed within the first outflow port, and / or the first outflow port comprises a stent structure configured as a spring and configured to apply a radially inward force against the first outflow port.

[0012] In one embodiment, the device further comprises a skirt made of a sealing material and disposed at least one of within and around the tubular body. The skirt is configured to prevent blood backflow from the right atrium into the inferior vena cava. The skirt comprises a flange-shaped portion having an inner diameter attached to the tubular body proximal to the first end and an outer diameter for bordering the inferior vena cava, the outer diameter being longitudinally spaced from the inner diameter in a direction toward the second end, the outer diameter comprising a straight edge. The skirt comprises an outer diameter for bordering the inferior vena cava and an inner diameter longitudinally spaced from the outer diameter in a direction toward the second end, the outer diameter comprising a curved edge. The skirt comprises a donut-shaped portion having an outer diameter configured to border the inferior vena cava and an inner diameter radially spaced from the outer diameter and configured to mount against the tubular body. The skirt comprises a flange feature, the flange feature comprising an outer diameter disposed proximal to the first end and for bordering the inferior vena cava, and an inner diameter attached to the tubular body and spaced longitudinally from the inner diameter in a direction toward the second end, the outer diameter comprising a straight edge. The first port is self-expanding and / or comprises a predetermined shape. The device is configured to be delivered to the inferior / superior vena cava via a sheath delivery device, and is optionally configured to be re-covered by the sheath delivery device for at least one of repositioning, redeployment, and removal. At least the first outflow port is configured to be re-covered within the sheath device. The first outflow port comprises a stent structure configured to support a valve device disposed in, on, or near the first outflow port. The first outflow port is configured with a length and / or shape such that the first port reaches the right atrium upon implantation. The first outflow port has at least one fenestration along the first contour (right atrial contour) or a shape that allows flow from the side of a valve located in, on, or near the first outflow port. The first outflow port is designed to prevent retrograde jet flow from reaching a valve located in, on, or near the first outflow port.Upon implantation of the device, at least a portion of the first port is disposed within the RA and optionally at least a portion of the first outflow port projects into the right ventricle via the tricuspid valve. The tubular body comprises a stent with a scaffolding structure configured to operate in a first compressed mode such that the device fits within a delivery catheter and a second expanded mode such that the device is configured to self-expand or balloon-expand within the implantation site upon placement of the device at the implantation site, and / or the tubular body has varying stiffness in different portions.

[0013] According to one embodiment, the present disclosure relates to a method of delivering the devices disclosed herein via a transcatheter delivery device and / or a transapical delivery device.

[0014] According to one embodiment, the present disclosure relates to a method of implanting a valve in a tubular stent, the method comprising the steps of delivering a stent graft device to a patient's heart, the tubular body having a first end and an associated first end portion disposed in the IVC, the tubular body having a second end and an associated second end portion disposed in the SVC, and a first outflow port disposed in at least the right atrium, delivering the stented valve through one of the IVC and the SVC to be disposed in at least a portion of the first outflow port, and balloon expanding the stented valve in the first outflow port. In one embodiment, the balloon expanding the stented valve in the first outflow port comprises expanding at least one first portion of the stented valve further than other portions of the stented valve. The first portion comprises at least one or optionally two of a proximal portion, a middle portion, and a distal portion of the stented valve.

[0015] According to an embodiment, the present disclosure relates to a system, device, apparatus, or method according to any of the embodiments disclosed herein.

[0016] Those skilled in the art will appreciate that the drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale, and in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the figures to facilitate an understanding of each feature. In the drawings, like reference numerals generally indicate like features (e.g., functionally similar and / or structurally similar elements, etc.). [Brief description of the drawings]

[0017] [Figure 1A] FIG. 1 is a side view of a tricuspid valve treatment device implanted in the inferior vena cava, superior vena cava, and right atrium according to some embodiments. [Figure 1B] FIG. 1 is a side view of a tricuspid valve treatment device according to some embodiments. [Diagram 2] FIG. 1 illustrates a side / perspective view of a tricuspid valve treatment device according to some embodiments. [Diagram 3] FIG. 1 is a side view of a tricuspid valve treatment device implanted in the inferior and superior vena cava and right atrium, according to some embodiments, and also shows a sealing structure. [Figure 4A] 1A-1C illustrate one configuration of a skirt closure structure according to some embodiments. [Figure 4B] 1A-1C illustrate one configuration of a skirt closure structure according to some embodiments. [Figure 5A] 1A-1C illustrate one configuration of a skirt closure structure according to some embodiments. [Figure 5B] 1A-1C illustrate one configuration of a skirt closure structure according to some embodiments. [Figure 6A] FIG. 13 is a side view of a port or valve configured for placement of other devices through the wall of a tricuspid valve treatment device, according to some embodiments. [Figure 6B] FIG. 13 is a side view of a port or valve configured for placement of other devices through the wall of a tricuspid valve treatment device, according to some embodiments. [Figure 6C] FIG. 13 is a side view of a port or valve configured for placement of other devices through the wall of a tricuspid valve treatment device, according to some embodiments. [Figure 6D] FIG. 13 is a side view of a port or valve configured for placement of other devices through the wall of a tricuspid valve treatment device, according to some embodiments. [Figure 7A] FIG. 13 is a side view of a tricuspid valve treatment device with an opening at the outflow port, according to some embodiments. [Figure 7B] FIG. 13 is a side view of a tricuspid valve treatment device with an opening at the outflow port, according to some embodiments. [Figure 8] 1A-1D are side cross-sectional views of a tricuspid valve treatment device and a stopper device positioned adjacent to the outflow port, according to some embodiments. [Figure 9] FIG. 1 is a side view of a tricuspid valve treatment device implanted in the inferior vena cava, superior vena cava, right atrium, and right ventricle, according to some embodiments. [Figure 10A] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 10B] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 11A] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 11B] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 11C] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 11D] FIG. 13 is a side view of a tricuspid treatment device showing one configuration of the outflow port and its components, according to some embodiments. [Figure 11E]1A-1D show images of an implantable tricuspid valve treatment device during implantation, according to some embodiments. [Figure 11F] 1A-1D show images of an implantable tricuspid valve treatment device during implantation, according to some embodiments. [Figure 11G] 1A-1D show images of an implantable tricuspid valve treatment device during implantation, according to some embodiments. [Figure 12] FIG. 13 is a side view of a tricuspid treatment device showing one component included in the outflow port, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The term "a" or "an" refers to one or more of its entities, i.e., it can refer to a plurality of referents. Thus, the terms "a," "one or more," and "at least one" are used interchangeably herein. Furthermore, reference to "an element" with the indefinite article "a" or "an" does not exclude the possibility that there are two or more of that element, unless the context clearly requires that there is one and only one of that element.

[0019] 1A is a side view of the heart including the inferior vena cava 102, superior vena cava 104, and right atrium 106 of a heart 1000. The superior vena cava 104 returns blood from the upper half of the body and opens into the superior posterior region of the right atrium 106 via a valveless orifice directed inferiorly and anteriorly. The inferior vena cava 102, which is generally larger than the superior vena cava 104, returns blood from the lower half of the body and opens into the inferior region of the right atrium 106 near the interatrial septum. The orifice of the inferior vena cava 102 is directed superiorly and posteriorly and is protected by a valve of the inferior vena cava 102 (called the Oistahii valve).

[0020] The tricuspid valve 128 is located between the right atrium 106 and the right ventricle 122. The coronary sinus opens into the right atrium 106 between the orifice of the inferior vena cava 102 and the atrioventricular opening. The coronary sinus returns blood from a substantial portion of the heart 1000 and is protected by the semicircular or coronary sinus valve (also called the Thebesian valve).

[0021] During ventricular systole, pressure within the ventricles rises. Under normal conditions, such as on the right side of the heart, pressure within the right ventricle 122 rises to a level that exceeds the pressure in the right atrium 106, thus closing the tricuspid valve 128. However, if the tricuspid valve 128 cannot close completely during ventricular systole, such as in a patient suffering from heart disease, tricuspid regurgitation occurs and blood flow from the right ventricle 122 returns to the right atrium 106, allowing deoxygenated blood to return to the venous circulation via the superior vena cava 104 and / or inferior vena cava 102.

[0022] While other valves of the heart (e.g., the mitral valve, aortic valve, etc.) can be easily replaced and / or repaired during open-heart surgery, the tricuspid valve 128 is difficult to surgically repair. The tissue surrounding the tricuspid valve 128 is highly mobile, thus making repair or replacement technically challenging, and the mortality and morbidity of the procedure in general are sufficient reasons to consider other approaches.

[0023] According to some embodiments, the present disclosure describes an implantable tricuspid valve treatment device located in the right atrium 106, the inferior vena cava 102, and the superior vena cava 104, which provides the benefits of repair and / or replacement of the tricuspid valve 128 without the risks associated with surgery. Additionally, the implantable tricuspid valve treatment device may be delivered via a catheter, thus further minimizing complications of cardiac intervention.

[0024] Referring now to the drawings, and in light of the above description, FIG. 1A is a side view of an implanted tricuspid treatment device (TTD) 100 positioned in the inferior vena cava 102, the superior vena cava 104, and the right atrium 106 of a heart 1000, in accordance with some embodiments.

[0025] In some embodiments, the TTD 100 comprises a tubular body 108 covered with a material (see, for example, the gray shaded areas in the figures, e.g., FIGS. 4A-4B, 5A-5B, 6A-6D, 7A-7B, 8, 10A-10B, 11A-11D, 12) and having a longitudinal axis 110. Upon implantation, a first end 112 and associated first end portion 114 of the tubular body 108 are disposed within the inferior vena cava 102 and a second end 116 and associated second end portion 118 of the tubular body 108 are disposed within the superior vena cava 104. The TTD 100 also includes at least one outflow port 120 (which may be referred to as a first outflow port) that is configured for placement after implantation within the right atrium 106 or within the right atrium 106 and right ventricle 122. The first outflow port 120 of the TTD 100 may be configured for fixation of a surgical or transcatheter valve (see, for example, FIGS. 11A-11B, which show a valve 121 positioned therein in cross-section).

[0026] In some embodiments, the first outflow port 120 is one of multiple outflow ports disposed along the tubular body 108 of the TTD 100, as shown in FIG. 1B. In some embodiments, one or more of the multiple outflow ports may be disposed along the tubular body 108 and positioned within the right atrium 106. In some embodiments, the number of outflow ports can be based on the size of each outflow port and takes into account the magnitude of tricuspid regurgitation and pressure gradients within the heart 1000. For example, if the basal pressure in the right atrium 106 is significantly elevated due to tricuspid regurgitation from the right ventricle 122, the number of outflow ports and / or the size of each outflow port may need to be adjusted to accommodate and function within this elevated pressure environment.

[0027] In some embodiments, the first outflow port 120 is disposed transversely (but may even be at an oblique angle, see e.g., FIGS. 10A-10B) relative to the longitudinal axis 110, and optionally automatically deploys upon exiting the delivery catheter (not shown). FIG. 1A further illustrates the hepatic vein 124, the pulmonary artery 126, and the azygos vein 127. The TTD 100 may further include a valve or port 138 (for example) disposed on one side of the TTD 100 to provide access to portions of the heart, which may include a flap or cover that may be biased to a closed position in some embodiments. Such access may be configured for, for example, a pacing lead of a pacemaker device. FIG. 3 is another side view of an implanted TTD 100, such as FIG. 1A, showing the implanted TTD 100 positioned, for example, in the inferior vena cava 102, the superior vena cava 104, and the right atrium 106. FIG. 3 also illustrates a sealing structure corresponding to the skirt element 136. In some embodiments, each of the upper and lower ends of the TTD 100, and particularly the stent structure, may be curved inward (e.g., toward the longitudinal axis 110) to avoid damage to the superior vena cava 104 and inferior vena cava 102, respectively (see curved portions of each end throughout all figures).

[0028] In some embodiments, the TTD 100 is configured as an anchoring device / mechanism for the surgeon to implant and is used within the transverse axial outflow port 120 (of the device / tubular body 108) as a housing and / or anchor for a new prosthetic valve (e.g., to replace the function of a diseased or defective tricuspid valve) that is not implanted after implantation of the TTD 100. In yet other embodiments, the TTD 100 can be delivered with the prosthetic valve pre-positioned / anchored within the first outflow port 120. Indeed, in embodiments with a pre-positioned prosthetic valve, the TTD 100 can be configured such that the pre-positioned valve is configured to be later removable / replaceable. To this end, the new prosthetic valve can be substituted for the pre-positioned valve. In other embodiments, the new prosthetic valve can be placed within a previously prepared pre-positioned prosthetic valve without removing the pre-positioned prosthetic valve. In some embodiments, the above-described functionality may be achieved by either the TTD 100 being an anchoring device for later receiving a valve or the TTD 100 including a valve pre-located in place.

[0029] As will be appreciated by those skilled in the art, the stent structure of the TTD 100 may comprise a series of connected (integral or otherwise fixed to one another) struts that form a series of apertures. Such structures may be made from Nitinol material. In some embodiments, the Nitinol material allows the stent structure to be compressed at least radially to a small fraction of its expanded diameter, thereby fitting within the sheath of a delivery device and self-expanding after removal from the sheath. In some embodiments, such expansion may be assisted (or may replace self-expansion) by balloon expansion.

[0030] FIG. 2 is a side / perspective view of a TTD 100 according to some embodiments. This view shows the stent structure 130, the inflow 132 from the inferior vena cava, the inflow 134 from the superior vena cava, and the portions of the device corresponding to the implantation location (e.g., superior vena cava (SVC), right atrium (RA), inferior vena cava (IVC)). Also shown is a skirt 136 (which may include a corresponding reinforcing structure 125, which may be a stent structure and may be interconnected or integral with the stent structure or the tubular body of the device itself). The skirt 136 may be located at the junction between the right atrium and the inferior vena cava and may be shaped such that pressure generated within the right atrium will force a flange of the skirt 136 against the heart wall, thus sealing the TTD 100 and further minimizing backflow of reflux blood in the venous system.

[0031] In some embodiments, and as previously described, the outflow port is configured to receive a valve (e.g., in some embodiments, a natural tricuspid valve, or similar) to control blood flow from the inferior and superior vena cava into the right atrium and / or right ventricle. This valve in the outflow port can be an artificial valve or an allograft or xenograft (e.g., human, bovine, porcine). In some embodiments, the outflow port can be configured so that the valve implanted in the port is replaceable (in some embodiments, by removing the previously placed valve, and in some embodiments, by fixing or otherwise placing a new valve into the previously placed valve).

[0032] In some embodiments, the TTD may be mounted within and deployed out of a transcatheter delivery system.

[0033] 4A-4B and 5A-5B show various configurations of skirt sealing structures 140a-140d according to some embodiments. FIG. 4A shows skirt 140a having a first flange-shaped portion with inner diameter 141a attached to the tubular body proximal to first end 401, outer diameter 141b, and a material portion connected between inner diameter 141a and outer diameter 141b that interfaces with the wall of the right atrium. In some embodiments, outer diameter 141b may be spaced longitudinally (relative to longitudinal axis 110) away from inner diameter 141a in a direction toward second end 402, and outer diameter 141b includes a straight edge. In some embodiments, the skirt structure is configured to prevent backflow from the right atrium into the inferior vena cava.

[0034] In some embodiments, the skirt structure is designed to prevent backflow from the right atrium into the inferior vena cava toward the first end 401, while allowing unimpeded flow from the hepatic vein into the inferior vena cava, taking advantage of the proximity of the hepatic vein to the inferior vena cava. If the structure were to perform the same function as a skirt structure deployed distal to the right atrium and along the inferior vena cava, as shown in FIG. 1A, the hepatic vein may be occluded. To avoid this, the present disclosure shows the skirt structure in FIGS. 4A-5B. In some embodiments, the skirt material can be made from any biocompatible woven fabric, biocompatible sheet fiber or biocompatible polymer, and / or biological tissue.

[0035] 4B shows skirt 140b comprising an outer diameter 142b for bordering the inferior vena cava at first end 401 and an inner diameter 142a spaced longitudinally (with respect to longitudinal axis 110) away from outer diameter 142b in a direction toward second end 402, outer diameter 142b comprising curved edge 142c.

[0036] 5A shows a skirt 140c with a donut-shaped portion 144 having an outer diameter 144b configured to interface with the inferior vena cava and an inner diameter 144a radially spaced (with respect to the longitudinal axis 110) away from the outer diameter 144b and configured to fit over the tubular body of the TTD 100.

[0037] 5B shows skirt 140d with a flange feature 146 comprising an outer diameter 146b disposed proximal to first end 501 and for bordering the inferior vena cava, and an inner diameter 146a attached to the tubular body and spaced longitudinally (with respect to longitudinal axis 110) away from inner diameter 146a in a direction toward second end 502, with outer diameter 146b comprising a straight edge.

[0038] 6A-6D are side views of a port or valve 138 configured for placement of other devices through the wall of the TTD 100, according to some embodiments. In some embodiments, the port or valve 138 may be configured to receive leads 148 from a pacemaker, cardiac resynchronization therapy (CRT) device, or defibrillation device. For example, such leads 148 may be inserted into such port 138 without the need to pass such leads through a working valve, which can lead to inefficiencies and potential damage.

[0039] According to some embodiments, the port / valve 138 can be configured to allow antegrade lead insertion into the right atrium and right ventricle while preventing retrograde flow.

[0040] This port / valve 138 may be referred to as a PM port. In some embodiments, the port / valve 138 can be an opening, a flapped opening (which may simply be an overlapping portion of the sidewall of the TTD 100, which may be curved (FIG. 6D)), straight (FIG. 6C), a slot in the side of the TTD 100, a slot in the side of the outflow port 120 (FIG. 6B), and / or a covered opening (FIG. 6A).

[0041] 7A and 7B are side views of the TTD 100, and specifically the outflow port 120. In some embodiments, as shown, all or a portion of the side wall 123 of the outflow port 120 can include openings / windows 150 that can be configured to allow the retrograde blood flow to reach the valve 121 located within the outflow port (i.e., such valve contacts the blood flow via the side, rather than just "head-on" / directly). In other words, the openings / windows 150 can be located on the atrial side of the valve 121. Such a location allows the valve 121 to open and close due to pressure changes within the heart and in light of the effects of tricuspid regurgitation.

[0042] 8 is a side cross-sectional view of the TTD 100 and a blocking feature 152 disposed adjacent the outflow port 120 of the TTD 100, according to some embodiments. In some embodiments, the blocking feature 152 is configured to assist in blocking blood flow (and in some embodiments, blood jets) from the native tricuspid valve 128. For example, the blocking feature 152 redirects backflow of blood that would otherwise flow directly into the outflow port 120 and prevent proper function of the valve 121 when located within the outflow port 120. Such a blocking feature, or stopper device, can be, for example, a flap of flexible or rigid material disposed at the distal end of the outflow port 120.

[0043] 9 is a side view of the TTD 100 implanted in the inferior vena cava 102, the superior vena cava 104, the right atrium 106, and the right ventricle 122. As shown, in some embodiments, the distal end of the outflow port 120 protrudes beyond the native tricuspid valve 128 into the right ventricle 122.

[0044] 10A-10B show side views of the TTD 100 illustrating various configurations of the outflow port 120 and its components, in particular the outflow port 120, in some embodiments, being angled such that its distal end projects toward the apex of the heart (i.e., protruding upwards) and in some embodiments, the outflow port 120, being angled such that its distal end projects toward the base of the heart (i.e., protruding downwards).

[0045] 11A-11D show side views of the TTD 100 illustrating various configurations of the outflow port 120 and its components following delivery and / or implantation of a valve 121 into the outflow port 120. Examples of delivery and / or implantation of a valve 121 into the outflow port 120 of the TTD 100 are illustrated in FIGS. 11E-11G and described below.

[0046] The TTD 100 is positioned in the superior vena cava, inferior vena cava, and right atrium immediately after delivery to the heart via the catheter. Once delivered, the TTD 100 is deployed or expanded to fill the luminal space of the superior vena cava and inferior vena cava and ejected into the right atrium via the outflow port (OP) as shown in FIG. 11E. Once the TTD 100 is expanded, a valve (V) can be delivered to the TTD 100 as shown in FIG. 11F, where the V is oriented toward the OP. Once in place, the V can be deployed to occupy the luminal space of the OP as shown in FIG. 11G. Deployment of the V can include self-expansion of the V and balloon expansion of the V, etc. In FIG. 11G, the V is expanded by balloon expansion by inflation of the balloon (B).

[0047] In view of the above, an embodiment of the present disclosure includes a method of implanting a valve within a tubular stent, the method including the steps of delivering a TTD 100 to a patient's heart such that, upon implantation, a first end of the tubular body and an associated first end portion are disposed within the inferior vena cava, a second end of the tubular body and an associated second end portion are disposed within the superior vena cava, and a first outflow port OP is disposed within at least the right atrium, delivering the stented valve within the TTD 100 and through one of the inferior vena cava and superior vena cava to position within at least a portion of the first outflow port OP, and balloon expanding the stented valve V within the first outflow port OP. In one embodiment, expanding the stented valve V within the first outflow port OP includes expanding at least a first portion of the stented valve V further than other portions of the stented valve V. In some embodiments, the first portion comprises at least one, and optionally two, of a proximal portion, a central portion, and a distal portion of the stented valve V.

[0048] While a valve can be provided as an integral component of the TTD 100 or implanted at the time of deployment of the TTD 100, it should be understood that the TTD 100 can also be deployed without a valve and can be modified later as desired. In some embodiments, it may be determined during or after the procedure to deploy the TTD 100 that a valve is not needed in the outflow port. To this end, any type of valve may be delivered to and implanted in the outflow port during or after the procedure to deploy the TTD 100. The valve of Figures 11E-11G is an example of any generic valve used for cardiac applications (e.g., SAPIEN 3 transcatheter heart valve) and is used only to illustrate how a valve may be delivered in the TTD 100.

[0049] In view of the above, and now referring to FIG. 11A, the outflow port 120 may be configured with at least one restriction, configured as a bottleneck structure 156 according to some embodiments. The bottleneck structure 156 may be located between the proximal and distal ends of the outflow port 120, and in some embodiments may be configured as an hourglass shape (i.e., a wall of the outflow port) with the bottleneck structure 156 located within the hourglass structure. As such, the bottleneck structure 156 may be configured to prevent movement of the valve 121 disposed within the outflow port 120. To this end, during deployment of the valve 121 as in FIG. 11G, a middle region of the valve 121 may be pinched by the bottleneck structure 156 to prevent translational movement of the valve 121 within the outflow port 120.

[0050] In some embodiments, and referring now to FIG. 11B, the outflow port 120 can include at least one of a first proximal constriction (located at the base of the outflow port 120 and not shown) and a second distal constriction 155, each of which is configured to prevent movement of the valve 121 disposed within the outflow port 120 (in some embodiments, the outflow port can include a single proximal or distal constriction).

[0051] In one embodiment, the restrictors as described in connection with Figure 11B may be configured as terminal portions of the sidewalls of the outflow port 120 as shown in Figure 11D. To this end, the TTD 100 of Figure 11D is configured such that the outflow port 120 includes a balloon-like central 158c portion having a diameter greater than at least one of the diameters of its proximal and distal ends 158a, 158b, which are configured relative to the diameter of the valve 121 to prevent translational movement of the valve 121.

[0052] FIG. 11C illustrates a blocking structure (which may also be referred to as a restricting structure) according to some embodiments, which may be configured as a cross member 160 spanning the diameter (or a portion thereof) of the distal end of the outflow port 120 (in some embodiments, such a cross member may also be configured on the proximal end of the outflow port 120 instead of or in addition to a cross member disposed on the distal end). The cross member may be a wire structure (which may be coupled to the stent structure of the tubular body 108 and / or to the stent structure of the outflow port 120) or other material secured relative to the outflow port 120 (its distal and / or proximal ends). As with the blocking structure of FIG. 8, this feature is intended to modify blood flow and pressure gradients applied directly to the valve 121 in the outflow port 120, which may affect the function of the valve 121.

[0053] 12 is a side view of the TTD 100 illustrating one component included within the outflow port 120 of the TTD 100. Specifically, in some embodiments, the walls of the outflow port may include a spring structure 162 (which may be configured as a stent-like structure and / or may be configured as part of the stent structure of the tubular body and / or outflow port). According to some embodiments, such spring structure 162 is configured to apply a radially inward force against the outflow port 120, which may be utilized, for example, to help retain a valve within the outflow port 120.

[0054] Although various embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions described herein and / or achieving the results described herein and / or achieving one or more of the advantages described herein. Any such variations and / or modifications are deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that any structures, parameters, dimensions, materials, functions, and configurations described herein are intended as examples, and that the actual structures, parameters, dimensions, materials, functions, and configurations will depend on the specific application in which the teachings of the present invention are used. Many equivalents to the specific embodiments of the present invention described herein will be recognized or discernible by those skilled in the art using no more than routine experimentation. Thus, the foregoing embodiments have been presented by way of example only, and it will be understood that within the scope of the claims supported by this disclosure and their equivalents, the embodiments of the present invention may be practiced in ways other than as specifically described and claimed. Additionally, the inventive embodiments of the present disclosure relate to each and every individual feature, system, article, structure, material, kit, function, step, and method described herein. Moreover, any combination of two or more of such features, systems, articles, structures, materials, kits, functions, steps, and methods, if they are not mutually inconsistent, is included within the inventive scope of the present disclosure. Some embodiments may be distinguishable from the prior art by specifically lacking one or more features / elements / functions (i.e., claims relating to such embodiments may include negative limitations).

[0055] Also, as noted above, various inventive concepts may be embodied as one or more methods, examples of which are provided. The acts performed as part of a method may be ordered in any suitable manner. Thus, embodiments are contemplated in which acts are performed in an order different from that illustrated, which may include, for example, performing some acts simultaneously even though the illustrated embodiment shows them as sequential acts.

[0056] Any references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., mentioned anywhere in this application are incorporated herein by reference in their entirety. Furthermore, any definition as defined and used herein will be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or subsequent general meanings as defined.

[0057] The indefinite article "a" or "an" as used in the specification and claims of this application should be understood to mean "at least one" unless clearly indicated to the contrary. The words "can" and "may" are used interchangeably in this disclosure to suggest that an element, component, structure, feature, functionality, object, advantage, operation, step, process, apparatus, system, device, outcome, or clarification referred to has the ability to be used, included, or produced, or otherwise express the suggestion implied in the statement in which the term is used (or referenced) for a particular embodiment.

[0058] The term "and / or" as used in the specification and claims of this application should be understood to mean "either or both" of the elements so conjointly present, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., as "one or more" of the elements so conjointly present.

[0059] Other elements may optionally be present other than the elements specifically implied by the "and / or" clause, whether or not related to the specifically implied elements. Thus, as a non-limiting example, a reference to "A and / or B," when used in combination with open-ended language such as "comprising," can in some embodiments refer to only A (optionally including elements other than B), in other embodiments refer to only B (optionally including other elements other than A), in yet other embodiments refer to both A and B (optionally including other elements), etc.

[0060] When used in the specification and claims of this application, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as non-exclusive, i.e., including at least one of a plurality of elements or a list of elements, but also including two or more, and optionally including additional items not listed. Conversely, clearly indicated limiting expressions, such as "only one of" or "exactly one of," or "consisting of" when used in the claims, indicate the inclusion of exactly one of a plurality of elements or a list of elements. In general, the word "or" as used herein, when used with an exclusive expression, such as "either," "one of," "only one of," or "exactly one of," should only be interpreted as suggesting mutually exclusive alternatives (i.e., "one or the other, but not both").

[0061] When used in the claims, "consisting essentially of" shall have its ordinary meaning as used in the field of patent law.

[0062] As used in the specification and claims of this application, the phrase "at least one" referring 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 all elements specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically set forth in the list of elements to which the phrase "at least one" refers, whether or not related to the specifically set forth elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can in one embodiment refer to at least one, optionally including two or more, with no B (and optionally including elements other than B), in other embodiments refer to at least one, optionally including two or more B, with no A (and optionally including elements other than A), in yet other embodiments refer to at least one, optionally including two or more A and at least one, optionally including two or more B (and optionally including other elements), etc.

[0063] In the claims, all transitional phrases in the above specification, such as "comprising," "including," "bearing," "having," "containing," "accompanying," "holding," and "consisting of" are to be understood as open-ended, i.e., having the meaning of including but not limited to. "Consisting of" and "consisting essentially of" are closed or semi-closed transitional phrases, respectively, as set forth in the U.S. Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0064] Incorporation by Reference All references, articles, publications, patents, published patent applications, and patent applications cited herein are hereby incorporated by reference in their entirety for all purposes. However, the statement of any reference, article, publication, patent, published patent application, or patent application cited herein is not, and should not be construed as, an admission or in any manner suggesting that they constitute valid prior art or part of the common general knowledge in any country in the world.

[0065] Numbering of the embodiments of the present invention Separate from the appended claims, this disclosure presents the following numbered embodiments.

[0066] (1) A stent graft device configured for implantation into the inferior and superior vena cava of a patient to treat a tricuspid valve that has been damaged due to a disease or other reason in the patient, the stent graft device comprising: a tubular body having a longitudinal axis and configured for implantation into the superior vena cava (SVC) and inferior vena cava (IVC), wherein, upon implantation, a first end and an associated first end portion of the tubular body are disposed within the IVC and a second end and an associated second end portion of the tubular body are disposed within the SVC; and a first outflow port configured for placement after implantation within the right atrium and right ventricle and configured for anchoring a surgical or tricuspid valve, the first outflow port being disposed transverse to the longitudinal axis and optionally automatically deploying upon exiting a delivery catheter.

[0067] (2) The device of (1), wherein the first outflow port is positioned transversely to the longitudinal axis and at an oblique angle to the longitudinal axis.

[0068] (3) The device of (1) or (2), wherein the first outflow port is positioned transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, with the distal end of the first outflow port facing toward the bottom of the heart.

[0069] (4) A device described in any of (1) to (3), wherein the first outflow port is arranged transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, and a distal end of the first outflow port faces toward the apex of the heart.

[0070] (5) The device of any of (1) to (4), further comprising a material configured to at least partially cover the tubular body.

[0071] (6) A device as described in any of (1) to (5), wherein the material is positioned on the tubular body so as to prevent blood flow through at least a side portion of the tubular body.

[0072] (7) A device described in any of (1) to (6), wherein disposing the material portion on the tubular body is configured to allow blood inflow from the azygos / brachiocephalic vein and / or hepatic vein.

[0073] (8) The device of any of (1) to (7), further comprising a pacemaker / ICD lead port and / or valve (PLP) configured to receive the passage of a pacemaker / ICD lead.

[0074] (9) A device described in any of (1) to (8), wherein the PLP is positioned on the side of the tubular body.

[0075] (10) A device described in any of (1) to (9), wherein the first outflow port includes at least one of a first constriction portion and a second constriction portion, each of which is configured to prevent movement of a valve disposed within the first outflow port.

[0076] (11) A device described in any of (1) to (10), wherein the first outflow port has at least one restriction configured as a bottleneck structure, the bottleneck structure being located within the first outflow port or configured with an hourglass shape such that the bottleneck structure is located within the hourglass structure, and the bottleneck structure is configured to prevent movement of a valve located within the first outflow port.

[0077] (12) A device described in any of (1) to (11), wherein the first outflow port comprises a first stopper portion disposed on a distal end of the first outflow port, the first stopper portion configured to prevent movement of a valve disposed within the first outflow port away from the tubular body.

[0078] (13) A device described in any of (1) to (12), wherein the first outflow port comprises a first stopper portion disposed on a proximal end of the first outflow port, the first stopper portion configured to prevent movement of a valve disposed within the first outflow port toward the tubular body.

[0079] (14) The device of any of (1) to (13), wherein the first outflow port comprises a first stopper portion disposed on a distal end of the first outflow port, the first stopper portion configured to prevent movement away from the tubular body of a valve disposed within the first outflow port, and a second stopper portion disposed on a proximal end of the first outflow port, the second stopper portion configured to prevent movement toward the tubular body of a valve disposed within the first outflow port.

[0080] (15) A device described in any of (1) to (14), wherein the first outflow port comprises a restricting structure disposed on a distal end of the first outflow port, the restricting structure configured to prevent movement of a valve disposed within the first outflow port away from the tubular body.

[0081] (16) A device described in any of (1) to (15), wherein at least one of the proximal and distal ends of the first outflow port has a diameter less than a diameter of a central portion of the first outflow port, which is configured to prevent movement of a valve disposed within the first outflow port.

[0082] (17) The device of any of (1) to (16), wherein the first outflow port comprises a stent structure configured as a spring and configured to apply a radially inward force to the first outflow port.

[0083] (18) The device of (17), further comprising a skirt comprised of a sealing material and disposed within and / or around the tubular body.

[0084] (19) A device described in any of (1) to (18), wherein the skirt is configured to prevent blood backflow from the right atrium into the inferior vena cava.

[0085] (20) The device of any of (1) to (19), wherein the skirt comprises a flange-shaped portion having an inner diameter attached to the tubular body proximal to the first end and an outer diameter for bordering the inferior vena cava, the outer diameter being longitudinally spaced from the inner diameter in a direction toward the second end, the outer diameter comprising a straight edge.

[0086] (21) A device as described in any of (1) to (20), wherein the skirt comprises an outer diameter portion for bordering the inferior vena cava and an inner diameter portion longitudinally spaced from the outer diameter portion in a direction toward the second end, the outer diameter portion comprising a curved edge.

[0087] (22) The device of any of (1) to (21), wherein the skirt comprises a donut-shaped portion having an outer diameter configured to interface with the inferior vena cava and an inner diameter radially spaced from the outer diameter and configured to mount to the tubular body.

[0088] (23) The device of any of (1) to (22), wherein the skirt comprises a flanged portion having an outer diameter disposed proximal to the first end and for bordering the inferior vena cava, and an inner diameter attached to the tubular body and spaced longitudinally from the inner diameter in a direction toward the second end, the outer diameter having a straight edge.

[0089] (24) The device of any one of (1) to (23), wherein the first port is self-expanding and / or has a predetermined shape.

[0090] (25) The device of any of (1) to (24), configured to be delivered to the IVC / SVC via a sheath delivery device and, optionally, configured to be re-covered by the sheath delivery device for at least one of repositioning, redeployment, and removal.

[0091] (26) A device described in any of (1) to (25), wherein at least the first outflow port is configured to be re-covered within a sheath device.

[0092] (27) The device of any of (1) to (26), wherein the first outflow port comprises a stent structure configured to support a valve device positioned in, on, or near the first outflow port.

[0093] (28) A device described in any of (1) to (27), wherein the first outflow port is configured with a length and / or shape such that the first port reaches the right atrium when implanted.

[0094] (29) A device described in any of (1) to (28), wherein the first outflow port has at least one window along the first contour (RA contour) or has a shape that allows flow from a side of the valve located in, on, or near the first port.

[0095] (30) A device described in any of (1) to (29), wherein the first outflow port is designed to prevent the retrograde jet flow from reaching a valve located in, on, or near the first outflow port.

[0096] (31) A device described in any of (1) to (30), wherein, upon implantation of the device, at least a portion of the first port is positioned within the RA, and optionally, at least a portion of the first outflow port protrudes into the right ventricle via the tricuspid valve.

[0097] (32) The device of any of (1) to (31), wherein the tubular body comprises a stent having a scaffolding structure configured to operate in a first compressed mode such that the device fits within a delivery catheter and a second expanded mode such that when the device is placed at the implantation site, the device is configured to self-expand or be balloon-expanded within the implantation site.

[0098] (33) A device described in any one of (1) to (32), wherein the tubular body has varying stiffness in different portions.

[0099] (34) A method of delivering the device described in any of (1) to (33) by at least one of a transcatheter delivery device and a transapical delivery device.

[0100] (35) A method of implanting a valve in a tubular stent, comprising the steps of delivering a stent graft device according to any one of (1) to (33) to a patient's heart, wherein, upon implantation, a first end and an associated first end portion of the tubular body are disposed in the IVC, a second end and an associated second end portion of the tubular body are disposed in the SVC, and a first outflow port is disposed in at least the right atrium; delivering the stented valve through one of the IVC and the SVC to position it within at least a portion of the first outflow port; and balloon expanding the stented valve within the first outflow port.

[0101] (36) The method of (35), wherein the step of balloon expanding the stented valve in the first outflow port includes expanding at least a first portion of the stented valve more than other portions of the stented valve.

[0102] (37) The method of (35) or (36), wherein the first portion consists of at least one or optionally two of the proximal portion, the central portion, and the distal portion of the stented valve.

[0103] (38) A system, device, apparatus, or method according to any of the embodiments of the present disclosure. [Explanation of symbols]

[0104] 100 Tricuspid Valve Therapy Device, TTD 102 Inferior vena cava 104 Superior vena cava 106 Right atrium 108 Tubular body 110 Longitudinal axis 112 First end 114 First end portion 116 Second End 118 Second end portion 120 Outlet port, first outlet port, transverse outlet port 121 Valve 122 Right ventricle 123 Side wall 124 Hepatic vein 125 Reinforcement structure 126 Pulmonary Artery 127 Azygos vein 128 Tricuspid valve, natural tricuspid valve 130 Stent structure 132 Inlet 134 Inlet 136 Skirt elements, skirt 138 Ports / Valves 140a skirt sealing structure, skirt 140b skirt sealing structure, skirt 140c skirt sealing structure, skirt 140d skirt sealing structure, skirt 141a Inner diameter part 141b Outer diameter part 142a Inner diameter 142b Outer diameter 142c curved edge 144 Donut-shaped part 144a Inner diameter 144b Outer diameter 146 Flange-shaped part 146a Inner diameter part 146b Outer diameter 148 Lead Wire 150 openings / windows 152 Blocking Features 155 Second distal constriction 156 Bottleneck Structure 158a Proximal end 158b Distal end 158c Balloon-shaped center 160 Cross member 162 Spring structure 401 First end 402 Second End 501 first end 502 Second End 1000 Heart

Claims

1. 1. A stent graft device configured for implantation within a patient's inferior and superior vena cava to repair a tricuspid valve that has been damaged due to disease or otherwise in the patient, comprising: a tubular body having a longitudinal axis and configured for implantation within a superior vena cava (SVC) and an inferior vena cava (IVC), wherein, upon implantation, a first end and an associated first end portion of the tubular body are disposed within the IVC and a second end and an associated second end portion of the tubular body are disposed within the SVC; 1. A first outflow port configured for placement after implantation in the right atrium and right ventricle and configured for securing a surgical or transcatheter valve, the first outflow port comprising: oriented transversely to the longitudinal axis; Optionally, it automatically deploys upon exiting the delivery catheter. a first outlet port; A stent graft device comprising:

2. The device of claim 1 , wherein the first outflow port is disposed transversely to the longitudinal axis and at an oblique angle to the longitudinal axis.

3. the first outflow port is disposed transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, with a distal end of the first outflow port pointing toward the base of the heart; or 3. The device of claim 1 or 2, wherein the first outflow port is disposed transversely to the longitudinal axis and at an oblique angle to the longitudinal axis, with a distal end of the first outflow port pointing toward the apex of the heart.

4. The device of claim 1 , further comprising a material configured to at least partially cover the tubular body.

5. The device of claim 4 , wherein the material is disposed on the tubular body to prevent blood flow through at least a side portion of the tubular body.

6. 6. The device of claim 4 or 5, wherein the placement of the material on the tubular body is configured to allow inflow of blood from the azygos / brachiocephalic and / or hepatic veins.

7. 7. The device of claim 1, further comprising a pacemaker / ICD lead port and / or valve (PLP) configured to receive the passage of a pacemaker / ICD lead.

8. The device of claim 7 , wherein the PLP is disposed on a side of the tubular body.

9. 9. The device of claim 1, wherein the first outflow port comprises at least one of a first restriction and a second restriction, each of the restriction portions configured to prevent movement of a valve disposed within the first outflow port.

10. the first outlet port includes at least one restriction configured as a bottleneck structure located within the first outlet port or configured with an hourglass shape such that the bottleneck structure is located within the hourglass structure, the bottleneck structure configured to prevent movement of a valve located within the first outlet port; or the first outflow port comprises a first stop portion disposed on a distal end of the first outflow port, the first stop portion configured to prevent movement of a valve disposed within the first outflow port away from the tubular body; or the first outflow port comprises a first stop portion disposed on a proximal end of the first outflow port, the first stop portion configured to prevent movement of a valve disposed within the first outflow port toward the tubular body; or the first outflow port comprises a first stop portion disposed on a distal end of the first outflow port, the first stop portion configured to prevent movement of a valve disposed within the first outflow port away from the tubular body, and a second stop portion disposed on a proximal end of the first outflow port, the second stop portion configured to prevent movement of a valve disposed within the first outflow port towards the tubular body; or the first outflow port includes a restriction structure disposed on a distal end of the first outflow port, the restriction structure configured to prevent movement of a valve disposed within the first outflow port away from the tubular body; or At least one of the proximal and distal ends of the first outflow port has a diameter less than a diameter of a central portion of the first outflow port, the diameter less than the diameter of the central portion configured to prevent movement of a valve disposed within the first outflow port; or 9. The device of any one of claims 1 to 8, wherein the first outflow port comprises a stent structure configured as a spring and configured to apply a radially inward force to the first outflow port.

11. The device of claim 1 , further comprising a skirt comprised of a sealing material disposed within and / or around the tubular body.

12. The device of claim 11 , wherein the skirt is configured to prevent blood backflow from the right atrium into the inferior vena cava.

13. the skirt comprises a flanged portion having an inner diameter attached to the tubular body proximal to the first end and an outer diameter for bordering the inferior vena cava, the outer diameter being longitudinally spaced from the inner diameter in a direction toward the second end, the outer diameter comprising a straight edge; or the skirt comprises an outer diameter for bordering the inferior vena cava and an inner diameter longitudinally spaced from the outer diameter in a direction toward the second end, the outer diameter comprising a curved edge; or the skirt comprises a donut-shaped portion having an outer diameter configured to interface with the inferior vena cava and an inner diameter radially spaced from the outer diameter and configured to mount against the tubular body; or 13. The device of claim 11 or 12, wherein the skirt comprises a flange feature comprising an outer diameter disposed proximal to the first end and for bordering the inferior vena cava, and an inner diameter attached to the tubular body and spaced longitudinally from the inner diameter in a direction toward the second end, the outer diameter comprising a straight edge.

14. the first port is self-expanding and / or has a predetermined shape; and / or configured to be delivered to the IVC / SVC via a sheath delivery device, and optionally re-covered by said sheath delivery device for at least one of repositioning, redeployment, and removal; and / or At least the first outlet port is configured to be resheathed within a sheath device; and / or the first outflow port comprises a stent structure configured to support a valve device disposed in, on, or near the first outflow port; and / or the first outflow port is configured with a length and / or shape such that, upon implantation, the first port reaches the right atrium; and / or the first outflow port comprises at least one window along a first contour (the RA contour) or has a shape that allows flow from a side of the valve located in, on, or near the first port; and / or the first outlet port is designed to prevent a retrograde jet flow from reaching a valve / valve located in, on or near the first outlet port; and / or Upon implantation of the device, at least a portion of the first port is disposed within the RA, and optionally at least a portion of the first outflow port projects through the tricuspid valve into the right ventricle; and / or the tubular body comprises a stent comprising a scaffolding structure configured to operate in a first compressed mode such that the device fits within a delivery catheter and a second expanded mode such that upon placement of the device at an implantation site, the device is configured to self-expand or be balloon-expanded within the implantation site; and / or 14. The device of claim 1, wherein the tubular body has varying stiffness in different sections.

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