Systems, methods and devices for treating tricuspid insufficiency

Abstract

Embodiments of the present disclosure provide for tricuspid insufficiency treatment devices and associated systems and methods thereof and include a tubular vena cava member which includes graft material, the member being implantable in a vena cava of a patient, one or more fenestrations and associated one or more blocking members arranged to block and unblock the fenestration and normally open thereto.

Description

SYSTEMS, METHODS AND DEVICESFOR TREATING TRICUSPID INSUFFICIENCYRELATED APPLICATIONS

[0001] This disclosure claims benefit of and priority to U.S. provisional patent application no. 63 / 726,191, filed November 27, 2024, entitled, SYSTEMS, METHODS AND DEVICES FOR TREATING TRICUSPID INSUFFICIENCY, the entire disclosure of which is incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE

[0002] Embodiments of the present disclosure generally relates to medical devices for implantation in the heart, and particularly, but not only, to a stent-based device for treating an incompetent or regurgitant tricuspid (atrioventricular) valve.BACKGROUND OF THE DISCLOSURE

[0003] The tricuspid valve (TV) allows blood flow during diastole from the right atrium (RA) into the right ventricle (RV) and, during systole, prevents blood from back-flowing into the atrium and veins.

[0004] Tricuspid regurgitation (TR) is a cardiac disorder in which the tricuspid valve does not close tightly, leading to reverse blood flow into the atrium during systole. TR decreases the forward flow of blood pumped from the right ventricle and increases the blood pressure in the right atrium and veins near the heart. TR is typically divided into primary and secondary TR which are different from each other mainly in their etiology. Primary TR affects approximately 10% of the TR patientpopulation and is caused by direct damage to the valve structures such as the valve leaflets or chordae tendineae. Secondary TR, affects approximately 90% of the TR patient population and is caused by atrial or ventricular dilatation which in turn widen the tricuspid valve annulus or the sub-valvular apparatus, leading to the pulling of the chordae on the valve leaflets also known as valve tethering.

[0005] TR is the most common valvular heart disease, affecting 65% to 85% of the global population in its mild form. Traditionally, TR is graded as mild, moderate, and severe, however, given the wide range of valve leakage within severe TR, this TR grade was sub-divided into 3 grades now known as severe, massive and torrential (severe<massive<torrential). While mild TR is generally regarded as harmless, moderate and especially severe or greater TR can severely affect multiple organs, such as the liver, spleen, colon, and kidneys. If left untreated, severe or greater TR can eventually lead to heart failure and death. The prevalence of severe or greater TR significantly increases with age, affecting millions of men and especially women, in the EU and the US. Although evident in different forms also in children and young adults, TR is much more prevalent in the aging population and presents a challenge to patients and their cardiologists / surgeons.

[0006] The TV typically operates in a low-pressure environment. A typical systolic pressure in the right ventricle, which is the chamber downstream from the valve, is below 40 mmHg, and the typical pressure in the right atrium, which is the chamber upstream from the valve, is below 10 mmHg. However, in the presence of tricuspid regurgitation this environment can present with a much higher and more fluctuating hemodynamic pressure regime. This requires any TR treating device / procedure to be able to function well in a wide range of pressure and flow regimes.

[0007] The low filling pressures acting on the tricuspid valve are derived from multiple factors among which are RA contraction and relaxation, compression of the vena cava by the lungs as part of the inhalation-exhalation cycle, and the expansion of the RV as part of the cardiac cycle. All of these factors create a highly mobile anatomical environment that changes in size and shape every heartbeat / breath.

[0008] Since TR is represented by elevated systolic pressure in the RA and venous system, longstanding TR typically leads to RAVena-cava stretching and expansion. Although patients with no / mild TR usually have Vena cava diameters between 15-30 mm, patients who have been livingwith severe or greater TR for an extended period of time can present with vena cava that are noncircular and / or non-symmetric with perimeter derived diameters of up to 65 mm.

[0009] Moreover, while RAs of healthy individuals are typically not more than 200 ml in volume, TR patients can reach, in advanced stages of their disease, volumes of one (1) liter or even more. This correlates with RA lengths that range from 40 mm in healthy patients to up to 150 mm in TR patients.

[0010] As part of the IVC / SVC stretching and expansion, adjacent up-stream vascular anatomies are also affected. For example, the hepatic veins (veins exiting the liver and delivering blood to the IVC) tend to stretch significantly under the presence of TR and increase their diameter over the expense of their distance from the RA. This is why the vast majority of severe or greater TR patients will have a short distance between the superior hepatic vein and the inferior part of the RA. Such distances can range from 30mm on the large side of the range to virtually 1-2 mm on the lower side of the range. Such expansions can also be viewed with the Azygos vein entering the SVC.

[0011] The SVC and IVC stretching can be manifested by ballooning of these vessels or by a funnel shape that gets wider towards the RA. These indications are clearly illustrated in Figs. 11- 13.

[0012] The pharmacotherapy used in the treatment of TR is directed toward treating the symptoms of heart failure. Drugs include diuretics to address volume overload, digoxin to help the cardiac muscle pump, and angiotensin-converting enzyme (ACE) inhibitors to reduce elevated blood pressure. Medical management is likely to provide only temporary symptom relief but does not halt the progression of the disease.

[0013] Clinically available treatments for TR are open heart surgery or medication. However, open heart surgery for the replacement / repair of the tricuspid valve is rarely conducted, mainly due to its high mortality and morbidity rates.

[0014] Mortality rates after surgical tricuspid valve replacement are considered to be extremely high, exceeding 10% in the severe or greater TR patient population. One of the most common causes for these high mortality rates is the inability of the RV to continue to pump effectively in the presence of elevated RV pressure which is the result of no TV leakage. For an RV with adeteriorated function, the absence of TR post the surgical TV replacement and the sudden elevation in RV systolic pressures, results in RV failure and death. Thus, in most cases, surgical repair of the TV, which typically results mild TR post procedure is considered superior to surgical TV replacement, which typically results in full TR abolition.

[0015] Therefore, in the TR patient population, where RV dysfunction is highly prevalent, allowing a mild form of TR post treatment is considered to be safer than completely blocking the backflow on the TV

[0016] Due to the high surgical risk of tricuspid valve treatment, currently, the vast majority of TR patients are deemed inoperable. This results in an extremely large number of untreated patients with significant TR.SUMMARY OF THE DISCLOSURE

[0017] Embodiments of the present disclosure seek to disclose a stent-based device for treating an incompetent or regurgitant tricuspid valve, as described in more detail hereinbelow. Unlike the prior art, the embodiments of the present disclosure do not attempt to mimic the structure of the tricuspid valve, rather embodiments of the present disclosure provide a blocking member to selectively unblock or block flow into or out of the right atrium. The device is intended for the functional replacement of a regurgitant tricuspid valve, while avoiding the complex anatomy of the right ventricle and atrioventricular valve. Although not restricted for percutaneous implantations, the device can improve the transcatheter functional replacement of the tricuspid valve. Embodiments of the present disclosure treat the regurgitant tricuspid valve without having to deal with the complex anatomy of the tricuspid valve. Embodiments of the present disclosure obviate the need for complex imaging modalities such as (Trans Esophageal Echocardiography, Intra cardiac echocardiography, and others). Implantation of the device of embodiments of the present disclosure involve a simple deployment of a single stent structure.

[0018] Embodiments of the present disclosure present a tricuspid insufficiency device. The device should be constructed from materials capable of maintaining functionality and durability under repetitive and strenuous conditions, enduring hundreds of millions of force-generating cardiac cycles. Nitinol material is not best suited for such significant, constant and repeated deformations;rather, sutures, pliable materials and reinforced structures together allow mechanical / fatigue endurance, for the disclosed embodiments. For example, pericardium reinforced with nitinol wire where the pericardium valve receives its structural integrity from the nitinol wire. However, the Nitinol does not deform, and the bending areas of the valve are pericardium and suture based.

[0019] For reliable sealing of the device, the device includes a rigid infrastructure (e.g., a stent) covered by a graft material (e.g., fabric / polymer, biological tissue, and the like) which serves as a fluid tight barrier between a patient’s venous system and the right atrium and right ventricle of the patient’s heart. In the portion of the device adjacent the right atrium, one or more fenestrations are provided and covered by corresponding blocking members (which can also be referred to as covers or flaps) to create unidirectional flow from the vena cava into the right atrium and right ventricle. In some embodiments, there can be no vessel or tube support immediately adjacent the right atrium such that the overall device can accommodate angulations for anatomical reasons.

[0020] Accordingly, the device can be a stent graft with a valved wall. In some embodiments, the stent graft extends from the superior vena cava to the inferior vena cava (or vice versa) and may be anchored to the tubular structure of the vena cava using the stent radial force or any other anchoring means, such as sutures, barbs, diverging stent graft ends or elements inserted into the SVC / IVC tributary vessels (such as, but not limited to, the hepatic and azygos veins). The portion of the device which is in the right atrium (between the SVC and IVC) has one or more apertures in the graft material and one or more blocking members which cover the apertures and selectively prevent back-flow through them. Depending on the pressure gradient across the blocking members, the blocking members can either open (such as by being pushed away from the apertures by inner pressure directed through the apertures) to allow flow from within the stent graft towards its outer environment or can close (such as by being pushed towards the apertures by outer pressure directed towards the device) to prevent the fluid backflow from the outer device environment towards its inner lumen.

[0021] Accordingly, the graft material can be provided on the portion of the tricuspid valve as follows:With respect to the portion of the tricuspid insufficiency apparatus for positioning adjacent to the superior vena cava (SVC), in some embodiments, at least substantially fully or fully covered;With respect to the portion of the tricuspid insufficiency apparatus for positioning adjacent to the right atrium (RA), in some embodiments, fully covered; andWith respect to the portion of the tricuspid insufficiency apparatus for positioning adjacent the inferior vena cava (IVC), in some embodiments, only the section of the apparatus close to the RA is covered, which, in some embodiments, is between: o l-20mm; l-15mm; l-10mm; l-5mm; 2-20mm; 2-15mm; 2-10mm; 2-5mm; 3- 20mm; 3-15mm; 3-10mm; 3-5mm; 4-20mm; 4-15mm; 4-10mm; 4-5mm; 5-20mm; 5-15mm; 5-10mm; 6-20mm; 6-15mm; 6-10mm; 7-20mm; 7-15mm; 7-10mm; 8- 20mm; 8-15mm; 8- 10mm; 9-20mm; 9-15mm; 9- 10mm; 10-20mm; 10- 15mm; 11- 20mm; ll-15mm; 12-20mm; 12-15mm; 13-20mm; 13-15mm; 14-20mm; 14- 15mm; 15-20mm; 16-20mm; 17-20mm; 18-20mm; 19-20mm, and ranges therebetween.

[0022] In some embodiments, in place of a graft material with respect to the IVC or SVC portion of the tricuspid insufficiency device, a skirt can be used.

[0023] The graft material preferably inhibits tissue growth across some areas of the device but preferably induces tissue growth where the device touches portions of the SVC / IVC. Specifically, graft material does not touch the right atrium anatomy so that tissue growth is restrained (i.e., is slowed down). In some embodiments, graft material in the area of a valve (i.e., the blocking member and / or the fenestration), can be non-porous (such as with biological tissue or PTFE) to reduce tissue growth.

[0024] In some embodiments, one or more valves of the tricuspid insufficiency device correspond to an open valve area (which can be referred to as a fenestration area) of between (in cm2):1-20; 1-15; 1-10; 1-5; 5-20; 5-15; 5-10; 10-20; 10-15; and ranges there-between.

[0025] Thus, the one or more fenestrations and corresponding blocking members include sizes (and shapes) to produce the valve area according to the ranges listed above. In some embodiments, the blocking members may include a perimeter which is slightly larger than the fenestration such that the blocking member cannot freely enter a fenestration.

[0026] In an optional embodiment, the blocking members can be normally open, meaning thatwhen not subjected to any pressure or force, the blocking members maintain a certain distance from at least part of the apertures. This serves TR patients by requiring higher closing pressure / force and allowing a controlled amount of backflow during the beginning / end of the systolic phase. Thus, backflow is not totally abolished and there is some pressure release from the RV and RA into the vena cava for the benefit of weak RVs.

[0027] Examples for mechanisms for a normally open valve are, but not limited to:Tension of the suture / connector which connects the blocking member(s) to the graft material and / or stent, and / or a total number of sutures and / or a number of sutures per distance of connection (e.g., per mm), for connecting the blocking member(s) (in some embodiments, the resulting tension of the suture / connection can pull the blocking member open in a controlled manner);The distance of the hinge from the fenestration, which defines the angle between the blocking member and the fenestration. Accordingly, by increasing the distance of the hinge from the fenestration on the circular cross section of the generally tubular device, the normally open angle increases as well; andPositioning at least one of the stent structure struts between the hinge and fenestration.

[0028] In some embodiments, in the suggested position of the vena cava and right atrium, the device is typically subjected to pressure gradients that open the blocking members during diastole, when the venous pressure is higher than the ventricular and atrial pressure, and to oppositely directed pressure gradients during ventricular systole when the ventricular and atrial pressures (both chambers being at similar pressures due to the incompetent native tricuspid valve) are higher than the venous pressure. Thus, in this anatomical position, the blocking members are open to allow forward blood flow during diastole and are closed to prevent back flow of blood during ventricular systole. In this anatomical position the device acts as a second valve above the native tricuspid valve which is left untouched. The stent element in the stent graft may be a selfexpandable material such as medical grade shape memory alloys or polymers; it can also be a balloon expandable material such as a medical grade metal alloy or polymer. The stent structure may be a woven or braided mesh, it may be independent or interconnected stent wires with the typical M or Z shape, and it may also be laser cut from a tube. Additionally, the stent structure, insome embodiments, may also be cut from a tube, including, for example, laser cutting, chemical or electrical etching, and any and all methods of cutting a stent structure out of a tube familiar to those of skill in the art.

[0029] The graft material is a flow barrier that significantly restricts the passage of body fluids (e.g., blood) through it. The graft material may be a fabric, either braided or woven, it may be a polymer either braided, woven, injected or immersed, and it may also be a biological material either from human or animal source. With time, in the body, the graft material may become covered with tissue, this tissue itself may function as a flow barrier.

[0030] Connecting of the stent and graft material may be done using sutures, adhesives, embedding of the stent material within the graft material, and passing of the stent material through the graft material.

[0031] Although the device is not restricted to percutaneous methods of delivery, transcatheter is the preferred method of delivery into the relevant anatomy. It is noted that in the closed state of the blocking members, the device is generally tubular and has no element protruding outwards or inwards from the stent graft body. This construction is advantageous for transcatheter delivery because the simple shape of a tube can be easily mounted in, and deployed out of, a catheter. When deployed out of a catheter, the blocking members respond to the pressure gradient and start performing as a valve. This structure allows for sheathing and un-sheathing of the device with no device preparation or constraints. There is no need for additional stent bodies that are off-axis or parallel to the device tubular axis, which can hinder the straight- forward sheathing or deployment of the device.

[0032] It is contemplated that the device may be useful in other applications other than tricuspid insufficiency, such as but not limited to, treating mitral regurgitation, for example.

[0033] In some embodiments, a tricuspid valve insufficiency device is provided and includes a tubular vena cava member implantable in a vena cava of a patient, at least one fenestration formed in a side wall of the tubular vena cava member, at least one blocking member arranged to block and unblock the at least one fenestration, and a graft material arranged to cover at least a portion of the tubular vena cava member. In some such embodiments, the at least one blocking member is normally open with respect to said at least one fenestration by means of one or more sutures orconnectors (and optionally, suture or connector tension), the suture or connector corresponding to a hinge, and the at least one blocking member is normally open with respect to said at least one fenestration by means of predetermined distance from the hinge forming a hinge distance from the fenestration.

[0034] In some embodiments, a tricuspid valve insufficiency treatment device is provided and includes a tubular vena cava member implantable in a vena cava of a patient, the tubular vena cava member comprising a stent structure and a graft material covering at least a portion thereof, at least one fenestration formed in a side wall of the tubular vena cava member, at least one blocking member arranged to block and unblock the at least one fenestration and having an end affixed to the tubular vena cava member proximate a first end of the fenestration forming a hinge, where the at least one fenestration and blocking member form a valve. In some such embodiments, the blocking member is configured to be normally open relative to the fenestration, the at least one blocking member is normally open with respect to said at least one fenestration by means of suture(s) or connector(s), and optionally, tension thereof, and the at least one blocking member is normally open with respect to said at least one fenestration by means of predetermined hinge distance from the fenestration.

[0035] Such embodiments (as well as other embodiments disclosed herein) may additionally including one and / or another of the following functions, functionality, structure, step, and / or clarifications (and if not mutually exclusive, in some embodiments a plurality of, and in some embodiments, a majority of, and in some embodiments, substantially all of, and in some embodiments, all of): the hinge distance is between: 1-10mm, l-9mm, I -8mm, l-7mm, l-6mm, I -5mm, 1- 4mm, l-3mm, l-2mm, 1-1.5mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm,2-4mm, 2-3mm, 2-2.5mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3-6mm, 3-5mm, 3-4mm,3-3.5mm, 4-10mm, 4-9mm, 4-8mm, 4-7mm, 4-6mm, 4-5mm, 4-4.5mm, 5-10mm, 5- 9mm, 5-8mm, 5-7mm, 5-6mm, 5-5.5mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm, 6-6.5mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-10mm, 8-9mm, 8-8.5mm, 9-10mm, 9-9.5mm, and ranges therebetween; an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is less than 20 degrees from the fenestration end;an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is between 5-45 degrees, 5-40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10- 30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15-35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges there-between; the graft material is configured to cover or at least substantially cover a first portion of the tubular member configured to be positioned upon implantation adjacent the superior vena cava (SVC); the graft material is configured to fully cover a second portion of the tubular member configured to be positioned upon implantation adjacent to the right atrium (RA); the graft material is configured to cover at least part of a third portion of the tubular member configured to be positioned adjacent the inferior vena cava (IVC) in immediate proximity to the RA; the part of the third portion comprises a distance or length along the tubular vena cava member, the distance of length is selected from the group consisting of between: 1 - 20mm; l-15mm; l-10mm; l-5mm; 2-20mm; 2-15mm; 2-10mm; 2-5mm; 3-20mm; 3- 15mm; 3-10mm; 3-5mm; 4-20mm; 4-15mm; 4-10mm; 4-5mm; 5-20mm; 5-15mm; 5- 10mm; 6-20mm; 6-15mm; 6-10mm; 7-20mm; 7-15mm; 7-10mm; 8-20mm; 8-15mm; 8- 10mm; 9-20mm; 9- 15mm; 9- 10mm; 10-20mm; 10- 15mm; 11 -20mm; 11-15mm; 12- 20mm; 12- 15mm; 13 -20mm; 13-15mm; 14-20mm; 14- 15mm; 15-20mm; 16-20mm; 17-20mm; 18-20mm; 19-20mm, and ranges therebetween; the tubular vena cava member comprises an expandable stent body; the at least one blocking member comprises at least one flap or cover pivoted to a portion of said vena cava member; the at least one blocking member is normally open with respect to said at least one fenestration; the at least one blocking member is normally open with respect to the at least one fenestration by means of at least one stent strut between the hinge and the fenestration;the at least one fenestration faces in a direction of an orifice of a superior vena cava of the patient; the at least one fenestration faces in a direction of an orifice of an inferior vena cava of the patient; the at least one blocking member comprises a plurality of blocking members where the at least one fenestration comprises a plurality of fenestrations, where a respective blocking member corresponds to a respective fenestration; one or more of the blocking members face in a first direction and one or more of the blocking members face in one or more different directions from the first direction; the at least one blocking member comprises a plurality of blocking members and the at least one fenestration comprises a plurality of fenestrations equal to the number of the plurality of blocking members, a respective blocking member corresponding to a respective fenestration, and wherein the plurality of blocking members and plurality of fenestrations are circumferentially spaced around at least a portion of the circumference of the tubular vena cava member; the tubular vena cava member includes one or more barbs; the at least one blocking member includes reinforcing structure; the tubular vena cava member includes diverging stent graft ends; one or both of the diverging stent graft ends are at least partially covered by graft material; a first end of the at least one the blocking member is secured to a first end of the at least one fenestration; securing of the first end of the at least one blocking member and the first end of the at least one fenestration via a plurality of sutures; the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration;the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to the surface of the tubular vena cava member and / or the surface of the tubular vena cava member; the plurality of sutures are configured or installed to correspond to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to the surface of the tubular vena cava member and / or the surface of the tubular vena cava member; a / the stent of the tubular vena cava member does not comprise nitinol; the graft material is configured to inhibit tissue growth along different areas of the device; the tubular vena cava member does not provide support in and around the right atrium, such that the device accommodates angulation; and a skirt in either or both of portions of the device arranged in the IVC and SVC.

[0036] In some embodiments, a method of connection between a blocking member and a fenestration of a prosthetic heart valve is provided and includes providing a stent structure and a graft material forming a prosthetic heart valve that is generally tubular, the prosthetic heart valve having at least one fenestration, and suturing with one more sutures at least a portion of at least one edge of a blocking member to at least one of the stent structure and graft material of the prosthetic heart valve at a predetermined location of the at least one fenestration spaced a predetermined distance from the edge of the at least one fenestration, where a tension of the one or more sutures, a total number of sutures, and / or a number of sutures per a distance of connection (e.g., per mm), is configured to pull the blocking member open in a controlled manner, the one or more sutures form a hinge between the at least one blocking member and the at least one fenestration at the predetermined distance which defines an angle between the at least one blocking member and the at least one fenestration and increasing the predetermined distance increases anormally open angle relative to a circular cross section of the generally tubular device, and / or at least one strut of the stent structure is positioned between the hinge and fenestration.

[0037] Such embodiments (as well as other embodiments disclosed herein) may additionally including one and / or another of the following functions, functionality, structure, step, and / or clarifications (and if not mutually exclusive, in some embodiments a plurality of, and in some embodiments, a majority of, and in some embodiments, substantially all of, and in some embodiments, all of): the number of sutures is between 1-20, 5-20, 10-20, 15-20, 1-15, 5-15, 5-10, 1-10, 2- 10, 3-10, 4-10, 5-10, 6-10, 7-10, 8-10, 9-10 and ranges there between; the number of sutures per distance is between 1 suture per 5 mm, 1 suture per 4 mm, 1 suture per 3 mm, 1 suture per 2 mm, 1 suture per 1 mm, 1 suture per 0.5 mm, 1 suture per 0.25 mm, and ranges therebetween; the hinge distance is between: l-20mm, 1-15mm, l-12mm, 1-10mm, l-9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1-1.5mm, 2-20mm, 2-15mm, 2- 12mm, 2-10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm, 2-4mm, 2-3mm, 2-2.5mm, 3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3-6mm, 3-5mm, 3- 4mm, 3-3.5mm, 4-20mm, 4-15mm, 4-12mm, 4-10mm, 4-9mm, 4-8mm, 4-7mm, 4- 6mm, 4-5mm, 4-4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm, 5- 7mm, 5-6mm, 5-5.5mm, 6-20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6- 7mm, 6-6.5mm, 7-20mm, 7-15mm, 7-12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8- 20mm, 8-15mm, 8- 12mm, 8- 10mm, 8-9mm, 8-8.5mm, 9-20mm, 9- 15mm, 9- 12mm, 9- 10mm, 9-9.5mm, and ranges therebetween; the angle is less than 20 degrees from the end of the fenestration; and the angle is between 5-45 degrees, 5-40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15-35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges there-between.

[0038] It is worth noting that embodiments of the present disclosure that while the disclosure discusses “tricuspid insufficiency devices” (i.e., a prosthetic heart valve for taking over the function of the native tricuspid valve - or at least some of the functionality thereof), the teachings of the disclosure are equally applicable to prosthetic heart valves in general, including, for example, aortic prosthetic heart valves / devices and prosthetic mitral valve / devices. Thus, the disclosure supports claims directed to a prosthetic heart valve(s).

[0039] These and other embodiments, objects, features and advantages are presented below in the detailed description and the provided for drawings, a brief description of which is provided below.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Embodiments of the present disclosure will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

[0041] Figs. 1A and IB are simplified illustrations of a heart at diastole and ventricular systole, respectively, wherein during ventricular systole, the tricuspid valve is not properly closed, such that there is tricuspid regurgitation;

[0042] Fig. 2 is a simplified illustration of a percutaneous venous path for implantation of the device according to embodiments of the present disclosure, either from lower or upper extremities;

[0043] Figs. 3A and 3B are simplified illustrations of a tricuspid insufficiency treatment device, constructed and operative with a flap valve in blocked and unblocked positions, respectively (Fig. 3A a flap valve is open and in Fig. 3B the flap valve is closed);

[0044] Figs. 4 A and 4B are simplified illustrations of a tricuspid insufficiency treatment device implanted in the vasculature (IVC / SVC), respectively in diastole and systole;

[0045] Fig. 5 is a simplified illustration of a tricuspid insufficiency treatment device, constructed and operative with the flap valve being connected to the stent graft using a relatively small portion of its perimeter;

[0046] Fig. 6 is a simplified illustration of a tricuspid insufficiency treatment device, constructed and operative with more than one aperture and blocking member;

[0047] Fig. 7 is a simplified illustration of a tricuspid insufficiency treatment device, constructedand operative to include multiple fenestrations and blocking members all around (or almost all around) the stent graft perimeter;

[0048] Fig. 8 is a simplified illustration of a tricuspid insufficiency treatment device, constructed and operative to including barbs on the vena cava member and reinforcing struts on the blocking member;

[0049] Fig. 9 is a simplified illustration of a tricuspid insufficiency treatment device, constructed and operative with diverging stent graft ends, which may be covered, partially covered or not covered by graft material.

[0050] Figs. 10A-E are cross-sectional illustrations for a tricuspid insufficiency treatment devices according to some embodiments, detailing hinge lines with associated structure for securing and movement of blocking members, and using mechanisms for controlling the degree of normally open (the distance of the blocking member from the at least part of the fenestration);

[0051] Fig. 10F is a perspective illustrations of a tricuspid insufficiency treatment device according to some embodiments, illustrating a hinge suture / connection structure; and

[0052] Figs. 11-13 are 3D scans of actual anatomical images of the heart illustrating anatomical features of TR patients illustrating balloon effects due to tricuspid valve insufficiency.DETAILED DESCRIPTION

[0053] The anatomy of the heart is presented with reference to Figs. 1 A and IB. The superior vena cava 1 returns blood from the upper half of the body and opens into the upper and back part of the right atrium 2 via a valve-less orifice which is directed downward and forward. The inferior vena cava 3, typically larger than the superior, returns blood from the lower half of the body, and opens into the lowest part of the atrium 2, near the atrial septum. Its orifice is directed upward and backward and protected by the inferior vena cava valve (called the Eustachian valve). The tricuspid valve 4 is located between the right atrium 2 and the right ventricle 5.

[0054] The coronary sinus 6 opens into the right atrium 2, between the orifice of the inferior vena cava and the atrioventricular opening. It returns blood from the substance of the heart and is protected by a semicircular valve, the valve of the coronary sinus (also called the valve ofThebesius). The mitral valve 7 is between the left ventricle 8 and the left atrium 9.

[0055] Ventricular systole induces increased pressure in the right and left ventricles 5 and 8. Pressure in the ventricles rises to a level above that of the atria 2 and 9, thus closing the tricuspid and mitral valves 4 and 7. Fig. IB shows that the tricuspid valve 4 is not properly closed, such that there is tricuspid regurgitation.

[0056] Reference is now made to Fig. 3A, which illustrates a tricuspid insufficiency treatment device 10, which includes a vena cava member 12 implantable in the superior vena cava (SVC) and / or inferior vena cava (IVC). The side wall of vena cava member 12 is formed with a right atrium aperture 14 (also referred to as a fenestration 14) and also includes a blocking member 16 arranged to block and unblock the right atrium aperture 14. For example, the blocking member 16 may be a flap valve, in which blocking member 16, in some embodiments, is a flap or cover having one end which pivots relative to a portion of vena cava member 12. The blocking member can open outwards away from the side wall of the vena cava member, or in other embodiments, can open sideways or other directions.

[0057] The blocking member 16 can be normally open (Fig. 3 A) or normally closed (Fig. 3B) with respect to the one or more apertures 14. The mechanism of a normally open or closed blocking member can be of further assistance in controlling the degree of the device regurgitation or stenosis, respectively. For example, a normally open blocking member requires a certain measurable and controlled closing force. Thus, a normally open blocking member can create a measurable and controlled level of regurgitation. Conversely, a normally closed blocking member can create a measurable and controlled level of stenosis.

[0058] The device can be implanted so that the right atrium aperture 14 is aligned with (faces in a direction of) the orifice of the SVC or with the orifice of the IVC or it can face in other directions, such as sideways (anteriorly / posteriorly). Thus, the blocking member 16 may have its open portion (right atrium aperture 14) directed towards the superior, inferior, anterior or posterior part of the right atrium.

[0059] In Figs. 3A-3B and 5, one right atrium aperture 14 and one blocking member 16 are provided; in Figs. 6 and 7, more than one right atrium aperture 14 is provided, each one with its blocking member 16. The vena cava member 12 may be a stent graft, which can be self-expanding(e.g., shape memory alloy, polymer and the like) or balloon expandable (e.g., steel alloys, polymers and the like). The blocking member 16 may be made from the same graft material as the vena cava member or from other graft materials. It may be free of, or include, reinforcing structure, such as wires, rods, tubes, sutures or a mesh. The stent graft and blocking members may be immersed, sprayed or covered by anti-coagulant agents, anti-platelet agents, tissue growth accelerating or inhibiting agents, antibiotics, statins, anti-inflammatory agents and other materials or medications. The stent structure may include, without limitation, stent rings, independent or interconnected, a braided or laser-cut mesh, a braided or laser cut tubular structure and others. The device 10 may be fixed in-situ, for example, by the radial force of the expandable members, barbs, diverging vena cava member ends, stent or other members deployed in the tributaries, or other suitable means. Any subsequent tissue growth on the device may also help in fixation.

[0060] In some embodiments, sutures can create a normally open valve (e.g., see Figs. 10A-D) by pulling on an area of the valve which is beyond a hinge line (i.e., closer to the fenestration end; the fenestration end being the opposite end / side of the fenestration from the end / side that corresponds to the hinge line). The hinge line, according to some embodiments, may be a substantially linear line where the blocking member rotates or otherwise moves around and / or relative to. In some embodiments, as long as the normally open angle is below approximately 20 degrees from the fenestration end, and correspondingly, the closing volumes and pressures align with what is considered to be the clinical manifestation of a properly functioning valve. Generally, 20-30 degrees corresponds to a native tricuspid valve with mild TR. To this end, in embodiments having a normally open angle of 5-45 degrees (or more, according to some embodiments):5-40 degrees; 5-35 degrees; 5-30 degrees; 5-25 degrees; 5-20 degrees; 10-45 degrees; 10- 40 degrees; 10-35 degrees; 10-30 degrees; 10-25 degrees; 10-20 degrees; 15-45 degrees; 15-40 degrees; 15-35 degrees; 15-30 degrees; 15-25 degrees; 15-20 degrees; and ranges there-between.

[0061] In some embodiments, the specific angle is achieved by holding the blocking member at the desired angle (e.g., see above) while the blocking member is sutured at the hinge line. Accordingly, the suture / hinge line distance from the opposite end of the fenestration determine a controlled and measurable level of normally open / closed for the benefit of controlling the valve’s closing volume / pressure (which allows patients with reduced right-ventricle function to be treatedas well). The hinge line (which may also be referred to as a hinge, these terms used interchangeably throughout) in some embodiments, can include a range of distances between the hinge line and a side of the fenestration proximate thereto, such ranges can include: l-20mm, 1-15mm, l-12mm,1-1 Omm, l-9mm, l-8mm, l-7mm, I -6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1-1.5mm, 2-20mm,2-15mm, 2- 12mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm, 2-4mm, 2-3mm, 2-2.5mm,3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3-6mm, 3-5mm, 3-4mm, 3- 3.5mm, 4-20mm, 4-15mm, 4- 12mm, 4- 10mm, 4-9mm, 4-8mm, 4-7mm, 4-6mm, 4-5mm, 4- 4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm, 5-7mm, 5-6mm, 5-5.5mm, 6- 20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm, 6-6.5mm, 7-20mm, 7-15mm, 7- 12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-20mm, 8-15mm, 8-12mm, 8-10mm, 8-9mm, 8- 8.5mm, 9-20mm, 9-15mm, 9- 12mm, 9- 10mm, 9-9.5mm, and ranges therebetween.

[0062] In some embodiments, sutures are sued to control the function of the one or more valves, since that the sutures determine how much the one or more valves are “normally open,” and / or the force that is required for closing the one or more valves. In some embodiments, this is important since there is a clinical meaning to the amount of force needed for a “closing volume” (approximately 5-20 ml). This can be achieved by sutures, and or heat treatment, and / or the like.

[0063] The blocking member 16 may be connected to the vena cava member 12 by any suitable means, such as but not limited to, sutures, adhesives, polymer embedding, welding, ultrasonic welding, a unified graft and blocking member material, and others. The vena cava member 12 may be generally cylindrical but alternatively may be non-cylindrical. The term "cylindrical" as used throughout the specification and claims includes not only a circular cross-section, but also elliptical and other curved cross- sections. The diameter of vena cava member 12 may be uniform over its axial length. Alternatively, the diameter of vena cava member 12 may vary over its axial length (see background information). The blocking member 16 may have a triangular shape with rounded corners as shown. Alternatively, it may have an oval, rectangular, circular or other shape.

[0064] To this end, in some embodiments, the tricuspid insufficiency treatment device can include a diameter of between 20mm and 60mm, and in some embodiments, between:20-50mm; 20-40mm; 20-30mm; 30-60mm; 30-50mm; 30-40mm; 40-60mm; 40-50mm; and ranges therebetween.

[0065] The device may be delivered percutaneously or by surgical means. For example, the device may be delivered percutaneously through the IVC in a transcatheter femoral / iliac approach (Fig. 2), or through the SVC in a transcatheter jugular / radial / subclavian approach (Fig. 2).

[0066] Radio-opaque markers may be provided on the device for axial and rotational positioning within the body lumen. Typically, radio-opaque markers can be in the shape of the letters 'L', 'E' or 'C to mark the rotational position of the device, these or other markers can be placed on various axial positions on the device, so that the implanting operator can understand and control the device axial position.

[0067] Reference is now made to Figs. 4 A and 4B, which illustrate the tricuspid insufficiency treatment device 10 implanted in the vasculature. Fig. 4 A shows diastole, in which the pressure in the right ventricle 5 drops (e.g., to 0 mm Hg) and the blood pressure in the vena cava causes the blocking member 16 to open and allow flow through the right atrium aperture 14.

[0068] Systole is shown in Fig. 4B, in which the pressure in the right ventricle 5 increases. The inadequate tricuspid valve 4 does not completely prevent back flow of blood from the right ventricle 5 into the right atrium 2 because it cannot close completely. The systole pressure causes the blocking member 16 to close and prevent flow through the right atrium aperture 14 (blocked from view in Fig. 4B). This helps diminish back flow of blood from the right ventricle and atrium into the venous system. As seen in Fig. 4B, when blocking member 16 blocks fenestration 14, the tubular vena cava member and the blocking member together have a closed cylindrical outer shape. This structure is advantageous for sheathing and un-sheathing the device in a delivery catheter. Reference is now made to Fig. 5 which illustrates a tricuspid insufficiency treatment device 50, constructed and operative in accordance with another non-limiting embodiment of the present disclosure. Device 50 includes a blocking member 56 connected to a vena cava member (stent graft) 52 in a relatively small portion of its perimeter, thus enabling large volume flow with relatively low resistance in every diastole. During ventricular systole, the blocking member 56 fully impedes back flow of blood as in other device embodiments.

[0069] Reference is now made to Fig. 6, which illustrates a tricuspid insufficiency treatment device 60, constructed and operative in accordance with another non-limiting embodiment of the present disclosure. Device 60 includes more than one blocking member 16 and more than one fenestration 14. Some of the blocking members 16 face in the same directions and others face indifferent directions.

[0070] The embodiment of Fig. 6, with its multiple fenestrations 14 and blocking members 16 may provide improved hemodynamics, with a small chance of valve clogging and insufficient blood supply. It may reduce turbulence and diminish no-flow areas and other insufficient blood flows that could occur with a single opening. In addition, the device deployment is less sensitive to axial position of the flap valves (fenestrations 14 and blocking members 16) since there are many of them. Accordingly, in some embodiments, the sizes, angle of the valves (that is, the angle that the blocking member forms with respect to the surface of the device / fenestration) can be configured as desired and can be provided along two or more levels along the surface of the device (e.g., along two different circumference positions which can be immediately adjacent or spaced apart).

[0071] The embodiment of Fig. 6 enables performing future interventions with access to reach anywhere in the right atrium. For example, some of the flap valves retain their function even during interventions such as puncturing of the fossa ovalis, implanting a pacemaker or defibrillator or other procedures. Even if the procedure interferes with the function of some of the flap valves, the rest (majority) of the flap valves maintain their function for the benefit of the interventional procedure and the patient.

[0072] In case of tissue growth, thrombi or other causes of device deterioration, the multiple flap valves significantly improve the chances of an efficient and safe blood flow.

[0073] In this and any other embodiment of the disclosure, each fenestration 14 can have one dedicated blocking member 16 or several blocking members 16, and the blocking members 16 can either cover the entire fenestration 14 or a portion thereof.

[0074] Reference is now made to Fig. 7, which illustrates a tricuspid insufficiency treatment device 70, constructed and operative in accordance with another non-limiting embodiment of the present disclosure, including multiple fenestrations 14 circumferentially all around (or partially around) the vena cava member 12. This embodiment eliminates any need for a specific rotational orientation of the device.

[0075] Reference is now made to Fig. 8, which illustrates a tricuspid insufficiency treatment device 80, constructed and operative in accordance with another non-limiting embodiment of thepresent disclosure. Device 80 includes barbs 82 on the vena cava member 12, which may assist in anchoring the device at the implantation site. Device 80 may also include reinforcing structure such as struts 84 on the blocking member (or members) 16, which may increase the strength of the blocking member (or members) 16 against the flow impinging on it (or them).

[0076] Reference is now made to Fig. 9, which illustrates a tricuspid insufficiency treatment device 90, constructed and operative in accordance with another non-limiting embodiment of the present disclosure. Device 90 includes diverging stent graft ends 92, which may be covered, partially covered or not covered by graft material 94 (shown partially in the figure in broken lines). The diverging stent graft ends 92 may assist in anchoring the device at the implantation site.

[0077] Accordingly, the tricuspid insufficiency treatment device 10 provides benefits for a patient suffering from tricuspid regurgitation. The device may be implanted surgically and percutaneously (e.g., via femoral jugular, or subclavian approach).

[0078] The tricuspid insufficiency treatment device 10 has a smooth tubular shape when in the closed condition. This has the advantage of easy installation of the device into a catheter and deployment to site at the heart and even provides the possibility of re- sheathing the device into the catheter during the procedure.

[0079] Figs. 10A-E illustrate cross-sections of a tricuspid valve insufficiency device illustrating positions of a hinge 1002 for the blocking member / flap 1006 with respect to the tubular vena cava member (TVCM) 1004, the fenestration 1008, and the blocking member / flap 1006. In each figure, the hinge 1002 can be one or more sutures (of a material known to those of skill in the art, e.g., adhesive, a staple, and / or the like). Please note, the dashed line in Figs. 10A-B represents the cover / flap 1008 closed which, in some embodiments, forms a closed cylindrical shape with the TVCM (i.e., forms a curve corresponding substantially to the outer curve of the tubular member when closed), while the straight line represents the cover / flap normally open by the hinge (which in some embodiments, represents a suture / distance mechanism for enabling normally open). As shown in the figures, the hinge 1002 can be at one side of the fenestration (as shown in Fig. 10C, according to some embodiments), and in some embodiments, and preferred, spaced circumferentially apart from a closest side various predetermined distances (although it is evident to those of skill in the art that the hinge is spaced apart from both sides), as shown in Figs. 10A, 10B, 10D and 10E. This provides different levels of normally opening functionality desired. It isworth noting that while Figs. 10A-E appear to illustrate a specific structure (e.g., a “hinge” be it of flexible material or metallic in nature), such structure also corresponds to one or more sutures or other type device (e.g., one or more staples, clips, adhesive, and / or a combination thereof, and the like; see also Fig. 10F).

[0080] Accordingly, Fig. 10A illustrates a stent strut 1001 which is arranged between the hinge 1002 and the fenestration 1006, according to some embodiments. This arrangement assists a normally open valve (i.e., fenestration plus flap 1008 corresponding to a valve). Specifically, the stent strut 1001 assists in creating and controlling the level of normally open functionality. As shown, in some embodiments, the struts 1001 are spaced apart substantially equally around the circumference. Fig. 10B illustrates a tricuspid valve insufficiency device where the hinge is beyond the stent strut, according to some embodiments at a predetermined distance.

[0081] Figs. 10C-10E illustrate different sized fenestration opening, as well as different hinge 1002 positions (according to some embodiments). It is worth noting that the hinge position may stay the same while the fenestration size changes, depending upon the functionality desired according to some embodiments). Fig. 10C illustrates a tricuspid valve insufficiency device having a fenestration / opening 1008 which is of a first size, Fig. 10D illustrates a tricuspid valve insufficiency device having a fenestration / opening 1008 which is of a second size, and Fig. 10E illustrates a tricuspid valve insufficiency device having a fenestration / opening 1008 which is of a third size. Each sized opening in Figs. 10C-E is a different size than the prior (e.g., small, medium, large, which is readily apparent in the figures. Hinge distance is also applicable to at least some such embodiments, such that the hinge, depending up the level of normally opening functionality desired, can be placed either on / at a side of the fenestration, or spaced apart therefrom (e.g., Figs. 10D and 10E). Thus, with respect to Figs. 10A-E, hinge distance from the fenestration can be a mechanism of controlling a level of normally open.

[0082] Fig. 10F is a perspective view of a tricuspid insufficiency device illustrating a connection between a blocking member / flap 1006 relative to the tubular member 1004 of the device, and the fenestration 1008. As illustrated, the connection can include one or more connectors 1009, including sutures, clips, stables, a combination thereof, and the like. In this figure, the hinge distance 1010 is shown. In some embodiments, the number of sutures can be between 1-20, 5-20, 10-20, 15-20, 1-15, 5-15, 5-10, 1-10, 2-10, 3-10, 4-10, 5-10, 6-10, 7-10, 8-10, 9-10 and rangesthere between. Moreover, the number of sutures per distance is between 1 suture per 5 mm, 1 suture per 4 mm, 1 suture per 3 mm, 1 suture per 2 mm, 1 suture per 1 mm, 1 suture per 0.5 mm, 1 suture per 0.25 mm, and ranges therebetween. Additionally, the hinge distance can be between: l-20mm, 1-15mm, 1-12mm, l-10mm, l-9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1-1.5mm, 2-20mm, 2- 15mm, 2- 12mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2- 5mm, 2-4mm, 2-3mm, 2-2.5mm, 3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3-6mm, 3-5mm, 3-4mm, 3-3.5mm, 4-20mm, 4-15mm, 4-12mm, 4-10mm, 4-9mm, 4-8mm, 4- 7mm, 4-6mm, 4-5mm, 4-4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm, 5-7mm, 5-6mm, 5-5.5mm, 6-20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm, 6-6.5mm, 7- 20mm, 7-15mm, 7-12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-20mm, 8-15mm, 8-12mm, 8- 10mm, 8-9mm, 8-8.5mm, 9-20mm, 9-15mm, 9-12mm, 9-10mm, 9-9.5mm, and ranges therebetween.

[0083] Accordingly, in some embodiments, the structure illustrated in Figs. 10A-E support a method of connection between a blocking member and a fenestration of a prosthetic heart valve includes providing a stent structure and a graft material forming a prosthetic heart valve that is generally tubular. The prosthetic heart valve includes at least one fenestration, and suturing with one more sutures at least a portion of at least one edge of a blocking member to at least one of the stent structure and graft material of the prosthetic heart valve at a predetermined location of the at least one fenestration spaced a predetermined distance from a / the edge of the at least one fenestration, where a tension of the one or more sutures, a total number of sutures, and / or a number of sutures per a distance of connection (e.g., per mm), can be configured to pull the blocking member open in a controlled manner. The one or more sutures form a / the hinge between the at least one blocking member and the at least one fenestration at the predetermined distance which defines an angle between the at least one blocking member and the at least one fenestration and increasing the predetermined distance increases a normally open angle relative to a circular cross section of the generally tubular device, and / or at least one strut of the stent structure is positioned between the hinge and fenestration. In some embodiments, the angle can be less than 20 degrees from the end of the fenestration, in some embodiments, the angle can be between 5-45 degrees, 5- 40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15-35degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges there-between.Additional Considerations

[0084] Anatomical features. The embodiments according to the present disclosure address the anatomical problems caused by TR. Specifically, embodiments of the present disclosure address the non-circular and / or non-symmetric vena cava with perimeter derived diameters of up to 65 mm or more, RA changes in length and / or volume, as well as changes in size and shape of hepatic veins. Accordingly, the tricuspid insufficiency device, according to some embodiments, is configured with a size and / or shape to coordinate with specific anatomical features of the implantation site and / or right atrium.

[0085] Accordingly, in some embodiments, the one or more valves of the tricuspid insufficiency device are situated above the IVC (in the RA), and below the one or more valves, a flanged skirt, which may comprise struts covered by graft material (preferably, in some embodiments, having an approximately 70 mm outer diameter) that is situated on the RA floor above the IVC. Accordingly, this allows inflow from the hepatic veins while blocking TR backflow into the IVC.

[0086] In some embodiments, the tricuspid insufficiency device is constructed such that the entire blood flow received from the IVC and SVC (in some embodiments, substantially the entire blood flow), the flow being in opposite directions from both the IVC and SVC, is directed into the right atrium.

[0087] The tricuspid insufficiency device according to the disclosed embodiments, is configured to address TR related at least one or more of, and preferably a plurality of, issues with respect to the native tricuspid valve and vena cava, involving:Hemodynamic issues including: o low and high pressure surrounding the tricuspid valve; o high flow volume; and o flow speed and directions.Vessel structure issues including:o the thin and compliant vena cava wall; o the large diameters of the vena cava in TR patients and their dynamic change in shape and size due to respiration and the cardiac cycle;Backflow of blood caused by the TR (i.e., the tricuspid insufficiency device should manage the problem of reflux while maintaining venous inflow to the heart);Blocking members / Flaps: o flexible and / or requiring specific opening and closing force;Mechanical durability, hence, the ability to withstand repeated strains with little or no structural fatigue; andBalanced between controlling regurgitation while allowing forward flow.Examples:

[0088] The following are examples according to some embodiments of the disclosure:Example 1 : A tricuspid valve insufficiency device including a tubular vena cava member implantable in a vena cava of a patient, at least one fenestration formed in a side wall of the tubular vena cava member, at least one blocking member arranged to block and unblock the at least one fenestration, and a graft material arranged to cover at least a portion of the tubular vena cava member, where the at least one blocking member is normally open with respect to said at least one fenestration by means of one or more sutures or connectors, and optionally tension thereof, the suture or connector corresponding to a hinge, and the at least one blocking member is normally open with respect to said at least one fenestration by means of predetermined distance from the hinge forming a hinge distance from the fenestration.Example 2: A tricuspid valve insufficiency treatment device including a tubular vena cava member implantable in a vena cava of a patient, the tubular vena cava member comprising a stent structure and a graft material covering at least a portion thereof, at least one fenestration formed in a side wall of the tubular vena cava member, at least one blocking member arranged to blockand unblock the at least one fenestration and having an end affixed to the tubular vena cava member proximate a first end of the fenestration forming a hinge, wherein the at least one fenestration and blocking member form a valve, where the blocking member is configured to be normally open relative to the fenestration, the at least one blocking member is normally open with respect to said at least one fenestration by means of one or more sutures or connectors, and optionally, tension thereof, and the at least one blocking member is normally open with respect to said at least one fenestration by means of predetermined hinge distance from the fenestration.Example 3: The device of any of examples 1-2, where the hinge distance is between: 1-1 Omm, 1- 9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1-1.5mm, 2- 10mm, 2-9mm, 2- 8mm, 2-7mm, 2-6mm, 2-5mm, 2-4mm, 2-3mm, 2-2.5mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3- 6mm, 3-5mm, 3-4mm, 3-3.5mm, 4-10mm, 4-9mm, 4-8mm, 4-7mm, 4-6mm, 4-5mm, 4-4.5mm, 5- 10mm, 5-9mm, 5-8mm, 5-7mm, 5-6mm, 5-5.5mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm, 6-6.5mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-10mm, 8-9mm, 8-8.5mm, 9-10mm, 9-9.5mm, and ranges therebetween.Example 4: The device of any of examples 1-3, where an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is less than 20 degrees from the fenestration end.Example 5: The device of any of examples 1-3, where an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is between 5-45 degrees, 5-40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10- 40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15-35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges therebetween.Example 6: The device of any of examples 1 -5, where the graft material is configured to cover or at least substantially cover a first portion of the tubular member configured to be positioned upon implantation adjacent the superior vena cava (SVC).Example 7: The device of any of examples 1-6, where the graft material is configured to fully cover a second portion of the tubular member configured to be positioned upon implantation adjacent to the right atrium (RA).Example 8: The device of any of examples 1-7, where the graft material is configured to cover atleast part of a third portion of the tubular member configured to be positioned adjacent the inferior vena cava (I VC) in immediate proximity to the RA.Example 9: The device of example 8, where the part of the third portion comprises a distance or length along the tubular vena cava member, the distance of length is selected from the group consisting of between: l-20mm; 1-15mm; 1-1 Omm; l-5mm; 2-20mm; 2- 15mm; 2- 10mm; 2-5mm; 3-20mm; 3-15mm; 3-10mm; 3-5mm; 4-20mm; 4-15mm; 4-10mm; 4-5mm; 5-20mm; 5-15mm; 5- 10mm; 6-20mm; 6-15mm; 6-10mm; 7-20mm; 7-15mm; 7-10mm; 8-20mm; 8-15mm; 8-10mm; 9- 20mm; 9-15mm; 9-10mm; 10-20mm; 10-15mm; ll-20mm; ll-15mm; 12-20mm; 12-15mm; 13- 20mm; 13-15mm; 14-20mm; 14-15mm; 15-20mm; 16-20mm; 17-20mm; 18-20mm; 19-20mm, and ranges therebetween.Example 10: The device of any of examples 1-9, where the tubular vena cava member comprises an expandable stent body.Example 11 : The device of any of examples 1-10, where the at least one blocking member comprises at least one flap or cover pivoted to a portion of said vena cava member.Example 12: The device of any of examples 1-11, where the at least one blocking member is normally open with respect to the at least one fenestration.Example 13: The device of any of examples 1-12, where the at least one blocking member is normally open with respect to said at least one fenestration by means of at least one stent strut between the hinge and the fenestration.Example 14: The device of any of example 1-13, where the at least one fenestration faces in a direction of an orifice of a superior vena cava of the patient.Example 15: The device of any of examples 1-13, where the at least one fenestration faces in a direction of an orifice of an inferior vena cava of the patient.Example 16: The device of any of examples 1-15, where the at least one blocking member comprises a plurality of blocking members wherein the at least one fenestration comprises a plurality of fenestrations, wherein a respective blocking member corresponds to a respective fenestration.Example 17: The device of example 16, where one or more of the blocking members face in a firstdirection and one or more of the blocking members face in one or more different directions from the first direction.Example 18: The device of any of example 1-17, where the at least one blocking member comprises a plurality of blocking members and the at least one fenestration comprises a plurality of fenestrations equal to the number of the plurality of blocking members, a respective blocking member corresponding to a respective fenestration, and wherein the plurality of blocking members and plurality of fenestrations are circumferentially spaced around at least a portion of the circumference of the tubular vena cava member.Example 19: The device of any of examples 1-18, where the tubular vena cava member includes one or more barbs.Example 20: The device of any of examples 1-19, where the at least one blocking member includes reinforcing structure.Example 21: The device of any of examples 1-20, where the tubular vena cava member includes diverging stent graft ends.Example 22: The device of example 21, where one or both of the diverging stent graft ends are at least partially covered by graft material.Example 23: The device of any of examples 1-22, where a first end of the at least one the blocking member is secured to a first end of the at least one fenestration.Example 24: The device of example 23, where securing of the first end of the at least one blocking member and the first end of the at least one fenestration via a plurality of sutures.Example 25: The device of example 24, where the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration.Example 26: The device of example 24, where the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to the surface of the tubular vena cava member and / or the surface of the tubular vena cava member.Example 27: The device of example 24, where the plurality of sutures are configured or installed to correspond to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to the surface of the tubular vena cava member and / or the surface of the tubular vena cava member.Example 28: The device of any of examples 1-27, where a / the stent of the tubular vena cava member does not comprise nitinol.Example 29: The device of any of example 1-28, where the graft material is configured to inhibit tissue growth along different areas of the device.Example 30: The device of any of example 1-29, where the tubular vena cava member does not provide support in and around the right atrium, such that the device accommodates angulation.Example 31: The device of any of examples 1-30, further comprising a skirt in either or both of portions of the device arranged in the I VC and SVC.Example 32: A method of connection between a blocking member and a fenestration of a prosthetic heart valve includes providing a stent structure and a graft material forming a prosthetic heart valve that is generally tubular, the prosthetic heart valve having at least one fenestration, and suturing with one more sutures at least a portion of at least one edge of a blocking member to at least one of the stent structure and graft material of the prosthetic heart valve at a predetermined location of the at least one fenestration spaced a predetermined distance from the edge of the at least one fenestration, where a tension of the one or more sutures, a total number of sutures, and / or a number of sutures per a distance of connection (e.g., per mm), is configured to pull the blocking member open in a controlled manner, the one or more sutures form a hinge between the at least one blocking member and the at least one fenestration at the predetermined distance which defines an angle between the at least one blocking member and the at least one fenestration and increasing the predetermined distance increases a normally open angle relative to a circular cross section of the generally tubular device, and / or at least one strut of the stent structure is positioned between the hinge and fenestration.Example 33: The method of example 32, where the number of sutures is between 1-20, 5-20, 10- 20, 15-20, 1-15, 5-15, 5-10, 1-10, 2-10, 3-10, 4-10, 5-10, 6-10, 7-10, 8-10, 9-10 and ranges therebetween.Example 34: The method of examples 32 or 33, where the number of sutures per distance is between 1 suture per 5 mm, 1 suture per 4 mm, 1 suture per 3 mm, 1 suture per 2 mm, 1 suture per 1 mm, 1 suture per 0.5 mm, 1 suture per 0.25 mm, and ranges therebetween.Example 35: The method of any of examples 32-34, where the hinge distance is between: l-20mm, l-15mm, l-12mm, l-10mm, l-9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1-1.5mm, 2-20mm, 2-15mm, 2- 12mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm, 2- 4mm, 2-3mm, 2-2.5mm, 3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm, 3-6mm, 3-5mm, 3-4mm, 3-3.5mm, 4-20mm, 4-15mm, 4-12mm, 4-10mm, 4-9mm, 4-8mm, 4-7mm, 4- 6mm, 4-5mm, 4-4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm, 5-7mm, 5-6mm, 5-5.5mm, 6-20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm, 6-6.5mm, 7-20mm, 7- 15mm, 7-12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-20mm, 8-15mm, 8-12mm, 8-10mm, 8- 9mm, 8-8.5mm, 9-20mm, 9-15mm, 9-12mm, 9-10mm, 9-9.5mm, and ranges therebetween.Example 36: The method of any of examples 32-35, where the angle is less than 20 degrees from the end of the fenestration.Example 37: The method of any of examples 32-35, where the angle is between 5-45 degrees, 5- 40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15-35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges there-between.General Considerations

[0089] 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 or illustrated 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 specificapplication 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).

[0090] Also, as noted, various inventive concepts may be embodied as one or more methods. The acts performed as part of a 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.

[0091] 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. For example, this disclosure incorporates by reference herein the entirety of the disclosure of U.S. patent no. 10,799,342.

[0092] 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, orproduced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to) for a particular embodiment(s). Additionally, “any and all” of certain recited items including a part(s), a structure(s), a function(s) / functionality, a clarification(s) or a step(s) (and the like) corresponds to certain embodiments only including one of such item (and in some embodiments, only such item), certain embodiments including two or more of such items (and in some embodiments, only two or more of such items), certain embodiments including substantially all of the items (and in some embodiments, only substantial number of the items), and certain embodiments including all of such items (and in some embodiment, only all of such embodiments).

[0093] 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.

[0094] 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.

[0095] 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.”

[0096] “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0097] 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.

[0098] 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.

Claims

Claims:

1. A tricuspid valve insufficiency device comprising: a tubular vena cava member implantable in a vena cava of a patient, at least one fenestration formed in a side wall of the tubular vena cava member; at least one blocking member arranged to block and unblock the at least one fenestration; and a graft material arranged to cover at least a portion of the tubular vena cava member. wherein: the at least one blocking member is normally open with respect to said at least one fenestration by means of suture or connector, and optionally, via tension thereof, the suture or connector corresponding to a hinge, and the at least one blocking member is normally open with respect to said at least one fenestration by means of predetermined distance from the hinge forming a hinge distance from the fenestration.

2. A tricuspid valve insufficiency treatment device comprising: a tubular vena cava member implantable in a vena cava of a patient, the tubular vena cava member comprising a stent structure and a graft material covering at least a portion thereof; at least one fenestration formed in a side wall of the tubular vena cava member; at least one blocking member arranged to block and unblock the at least one fenestration and having an end affixed to the tubular vena cava member proximate a first end of the fenestration forming a hinge, wherein the at least one fenestration and blocking member form a valve; wherein: the blocking member is configured to be normally open relative to the fenestration,the at least one blocking member is normally open with respect to said at least one fenestration by means of suture or connector, and optionally, tension thereof, and the at least one blocking member is normally open with respect to at least one fenestration by means of predetermined hinge distance from the fenestration.

3. The device of any of claims 1 -2, wherein the hinge distance is between: 1 -20mm, 1 -15mm,1-12mm, 1-10mm, l-9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1- 1.5mm, 2-20mm, 2-15mm, 2- 12mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm,2-4mm, 2-3mm, 2-2.5mm, 3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm,3-6mm, 3-5mm, 3-4mm, 3-3.5mm, 4-20mm, 4-15mm, 4-12mm, 4-10mm, 4-9mm, 4-8mm,4-7mm, 4-6mm, 4-5mm, 4-4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm,5-7mm, 5-6mm, 5-5.5mm, 6-20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm,6-6.5mm, 7-20mm, 7-15mm, 7-12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-20mm, 8- 15mm, 8-12mm, 8-10mm, 8-9mm, 8-8.5mm, 9-20mm, 9-15mm, 9-12mm, 9-10mm, 9- 9.5mm, and ranges therebetween.

4. The device of claim 1, wherein an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is less than 20 degrees from the end of the fenestration.

5. The device of claim 1, wherein an angle formed by the at least one blocking member is normally open with respect to said at least one fenestration is between 5-45 degrees, 5-40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15- 40 degrees, 15-35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges therebetween.

6. The device of claim 1, wherein the graft material is configured to cover or at leastsubstantially cover a first portion of the tubular member configured to be positioned upon implantation adjacent the superior vena cava (SVC).

7. The device of claim 1, wherein the graft material is configured to fully cover a second portion of the tubular member configured to be positioned upon implantation adjacent to the right atrium (RA).

8. The device of claim 1, wherein the graft material is configured to cover at least part of a third portion of the tubular member configured to be positioned adjacent the inferior vena cava (I VC) in immediate proximity to the RA.

9. The device of claim 8, wherein the part of the third portion comprises a distance or length along the tubular vena cava member, the distance of length is selected from the group consisting of between: l-20mm; 1-15mm; 1-1 Omm; l-5mm; 2-20mm; 2- 15mm; 2- 10mm; 2-5mm; 3-20mm; 3-15mm; 3-1 Omm; 3-5mm; 4-20mm; 4-15mm; 4-1 Omm; 4-5mm; 5- 20mm; 5-15mm; 5-10mm; 6-20mm; 6-15mm; 6-10mm; 7-20mm; 7-15mm; 7-10mm; 8- 20mm; 8-15mm; 8- 10mm; 9-20mm; 9- 15mm; 9- 10mm; 10-20mm; 10- 15mm; 11 -20mm; ll-15mm; 12-20mm; 12-15mm; 13-20mm; 13-15mm; 14-20mm; 14-15mm; 15-20mm; 16-20mm; 17-20mm; 18-20mm; 19-20mm, and ranges therebetween.

10. The device of claim 1, wherein the tubular vena cava member comprises an expandable stent body.

11. The device of claim 1 , wherein the at least one blocking member comprises at least one flap or cover pivoted to a portion of said vena cava member.

12. The device of claim 1, wherein the at least one blocking member is normally open withrespect to said at least one fenestration.

13. The device of claim 1, wherein the at least one blocking member is normally open with respect to said at least one fenestration by means of at least one stent strut between the hinge and the fenestration.

14. The device of claim 1 , wherein said at least one fenestration faces in a direction of an orifice of a superior vena cava of the patient.

15. The device of claim 1 , wherein said at least one fenestration faces in a direction of an orifice of an inferior vena cava of the patient.

16. The device of claim 1, wherein the at least one blocking member comprises a plurality of blocking members wherein the at least one fenestration comprises a plurality of fenestrations, wherein a respective blocking member corresponds to a respective fenestration.

17. The device of claim 16, wherein one or more of the blocking members face in a first direction and one or more of the blocking members face in one or more different directions from the first direction.

18. The device of claim 1, wherein the at least one blocking member comprises a plurality of blocking members and the at least one fenestration comprises a plurality of fenestrations equal to the number of the plurality of blocking members, a respective blocking member corresponding to a respective fenestration, and wherein the plurality of blocking members and plurality of fenestrations are circumferentially spaced around at least a portion of a circumference of the tubular vena cava member.

19. The device of claim 1, wherein the tubular vena cava member includes one or more barbs.

20. The device of claim 1, wherein the at least one blocking member includes reinforcing structure.

21. The device of claim 1 , wherein the tubular vena cava member includes diverging stent graft ends.

22. The device of claim 21, wherein one or both of the diverging stent graft ends are at least partially covered by graft material.

23. The device of claim 1 , wherein a first end of the at least one the blocking member is secured to a first end of the at least one fenestration.

24. The device of claim 23, wherein securing of the first end of the at least one blocking member and the first end of the at least one fenestration via a plurality of sutures.

25. The device of claim 24, wherein the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration.

26. The device of claim 24, wherein the plurality of sutures comprise a first number of stitches corresponding to a number which corresponds to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to a surface of the tubular vena cava member and / or the surface of the tubular vena cava member.

27. The device of claim 24, wherein the plurality of sutures are configured or installed to correspond to a force necessary to open the at least one blocking member relative to the at least one fenestration such that the at least one blocking member opens up to a predetermined angle relative to the surface of the tubular vena cava member and / or the surface of the tubular vena cava member.

28. The device of claim 1, wherein a / the stent of the tubular vena cava member does not comprise nitinol.

29. The device of claim 1, wherein the graft material is configured to inhibit tissue growth along different areas of the device.

30. The device of claim 1, wherein the tubular vena cava member does not provide support in and around the right atrium, such that the device accommodates angulation.

31. The device of claim 1, further comprising a skirt in either or both of portions of the device arranged in the I VC and SVC.

32. A method of a connection between a blocking member and a fenestration of a prosthetic heart valve comprising: providing a stent structure and a graft material forming a prosthetic heart valve that is generally tubular, the prosthetic heart valve having at least one fenestration; and suturing with one more sutures at least a portion of at least one edge of a blocking member to at least one of the stent structure and graft material of the prosthetic heart valve at a predetermined location of the at least one fenestration spaced a predetermined distance from the edge of the at least one fenestration, wherein:a tension of the one or more sutures, a total number of sutures, and / or a number of sutures per a distance of connection (e.g., per mm), is configured to pull the blocking member open in a controlled manner, the one or more sutures form a hinge between the at least one blocking member and the at least one fenestration at the predetermined distance, which corresponds to a hinge distance, which defines an angle between the at least one blocking member and the at least one fenestration and increasing the predetermined distance increases a normally open angle relative to a circular cross section of the generally tubular device, and / or at least one strut of the stent structure is positioned between the hinge and fenestration.

33. The method of claim 32, wherein the number of sutures is between 1-20, 5-20, 10-20, 15- 20, 1-15, 5-15, 5-10, 1-10, 2-10, 3-10, 4-10, 5-10, 6-10, 7-10, 8-10, 9-10 and ranges there between.

34. The method of claim 32, wherein the number of sutures per distance is between 1 suture per 5 mm, 1 suture per 4 mm, 1 suture per 3 mm, 1 suture per 2 mm, 1 suture per 1 mm, 1 suture per 0.5 mm, 1 suture per 0.25 mm, and ranges therebetween.

35. The method of claim 32, wherein the hinge distance is between: l-20mm, 1-15mm, 1- 12mm, 1-10mm, l-9mm, l-8mm, l-7mm, l-6mm, l-5mm, l-4mm, l-3mm, l-2mm, 1- 1.5mm, 2-20mm, 2-15mm, 2- 12mm, 2- 10mm, 2-9mm, 2-8mm, 2-7mm, 2-6mm, 2-5mm,2-4mm, 2-3mm, 2-2.5mm, 3-20mm, 3-15mm, 3-12mm, 3-10mm, 3-9mm, 3-8mm, 3-7mm,3-6mm, 3-5mm, 3-4mm, 3-3.5mm, 4-20mm, 4-15mm, 4-12mm, 4-10mm, 4-9mm, 4-8mm,4-7mm, 4-6mm, 4-5mm, 4-4.5mm, 5-20mm, 5-15mm, 5-12mm, 5-10mm, 5-9mm, 5-8mm,5-7mm, 5-6mm, 5-5.5mm, 6-20mm, 6-15mm, 6-12mm, 6-10mm, 6-9mm, 6-8mm, 6-7mm,6-6.5mm, 7-20mm, 7-15mm, 7-12mm, 7-10mm, 7-9mm, 7-8mm, 7-7.5mm, 8-20mm, 8- 15mm, 8-12mm, 8-10mm, 8-9mm, 8-8.5mm, 9-20mm, 9-15mm, 9-12mm, 9-10mm, 9- 9.5mm, and ranges therebetween.

36. The method of claim 32, wherein the angle is less than 20 degrees from the end of the fenestration.

37. The method of claim 32, wherein the angle is between 5-45 degrees, 5-40 degrees, 5-35 degrees, 5-30 degrees, 5-25 degrees, 5-20 degrees, 10-45 degrees, 10-40 degrees, 10-35 degrees, 10-30 degrees, 10-25 degrees, 10-20 degrees, 15-45 degrees, 15-40 degrees, 15- 35 degrees, 15-30 degrees, 15-25 degrees, 15-20 degrees, and ranges there-between.

38. A method, device, or system according to any of embodiments disclosed herein.

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