Systems, methods, and devices for treating tricuspid valve insufficiency

Abstract

Embodiments of the present disclosure relate to devices and methods for treating tricuspid valve insufficiency. For example, in some embodiments, provided tricuspid valve insufficiency treatment devices include a tubular member configured for implantation within a vena cava of a patient, where the tubular member is formed with a sidewall. The device further comprises at least two (2) valves arranged circumferentially along the side wall, wherein each valve comprises an opening formed in the side wall, and a blocking member arranged to block and dredge a respective one of the plurality of openings. Each occlusion member comprises a flap or closure pivotally attached at or near a portion of a respective opening and arranged to occlude the opening during ventricular contraction and dredge the opening during ventricular diastole such that the opening is dredged in a direction opposite the attachment direction of the flap or closure. At least two valves are arranged along a first circumference at a first location between the ends of the tubular member.

Description

[0001] This application is a divisional application of the invention patent application entitled “Systems, methods and devices for treating tricuspid insufficiency”, with an international application date of June 7, 2019, an international application number of PCT / IL2019 / 050658, and a national application number of 201980046618.2.

[0002] Related Applications This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 682,948, filed on June 8, 2018, the entire contents of which are incorporated herein by reference. Embodiments of the present disclosure are also related to PCT Application No. PCT / IB2017 / 050534, entitled “Treatment of Tricuspid Insufficiency,” filed on February 1, 2017, and U.S. Provisional Patent Application No. 62 / 292,422, filed on February 8, 2016, the entire contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to medical systems, devices, apparatus and methods for implantation in the heart thereof, and particularly (but not exclusively) to stent-based devices for treating incompetent or regurgitant tricuspid (atrioventricular) valves. Background Art

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

[0005] A dysfunctional tricuspid valve causing tricuspid regurgitation (TR) may occur in the setting of tricuspid annular dilatation and right ventricular enlargement. TR is usually secondary to left heart failure due to myocardial or valvular causes, right ventricular volume or pressure overload, and chamber dilatation. TR causes right atrial overload, which is transmitted to the superior vena cava (SVC) and / or inferior vena cava (IVC) and their tributaries. Ultimately, this leads to hepatic congestion, ascites, anasarca, peripheral edema, and other clinical symptoms of congestive heart failure. If left untreated, severe tricuspid regurgitation often leads to heart failure and death.

[0006] Clinically available treatments for TR are open heart surgery or drug therapy. However, open heart surgery for tricuspid valve replacement / repair is rarely performed, mainly due to its high mortality and morbidity rates. On the other hand, drug therapy may not solve the problem and allow the disease to progress, causing the patient's quality of life and heart function to decline.

[0007] The vast majority of TR patients are currently considered inoperable due to the high surgical risks of tricuspid valve replacement / repair, which results in a large number of patients with severe TR who remain untreated. Summary of the invention

[0008] Therefore, in some embodiments, a tricuspid insufficiency treatment device is provided, which includes a tubular member configured for implantation in a patient's vena cava, wherein the tubular member is formed with a side wall. The device also includes at least two (2) valves arranged circumferentially along the side wall, wherein each valve includes an opening formed in the side wall, and a blocking member arranged to block and clear a corresponding opening among a plurality of openings. Each blocking member includes a flap or cover that is pivotally attached at or near a portion of the corresponding opening and is arranged to block and clear the opening during ventricular contraction and ventricular relaxation, respectively, so that the opening is cleared in a direction opposite to the attachment direction of the flap or cover. At least two valves are arranged at a first position between the ends of the tubular member along a first circumference.

[0009] Such an embodiment may further include at least one (in some embodiments, multiple, and in some embodiments, substantially all) of the following additional structures, features, steps, functions, and / or instructions, thereby generating other embodiments (in addition, each item in the following list and the combination of the items listed below may be an independent embodiment): A third valve may be disposed on a second circumference spaced closer to one of the ends of the tubular member than one of the two (2) valves disposed on the first circumference.

[0010] The at least two (2) valves may be configured as only three (3) valves; The tubular member and the blocking member of the valve may be configured to form a closed cylindrical shape when each blocking member blocks a corresponding opening; a covering that may be configured as at least a portion of the tubular member; The cover may be configured to not cover the opening; The cover may be configured to additionally cover each blocking member; Each of the first and second valves may be hinged or otherwise attached to the tubular member on opposite sides such that each obstruction member opens away from the other obstruction member; A third valve of the plurality of valves may be hinged or otherwise attached such that the stop member opens away from the first and second stop members.

[0011] The tubular member may include an expandable stent having a plurality of cells, wherein each of the plurality of valves corresponds to a particular stent cell; Each opening and / or each cell receiving a corresponding opening comprises a rhombus shape; The stent may comprise a coronary stent wherein: The coronary stent includes at least one of a first inferior vena cava (IVC) portion, a second superior vena cava (SVC) portion, and a third central portion disposed between the IVC portion and the SVC portion; Each occlusion member may include a shape memory reinforcement wire therein or thereon, wherein the reinforcement wire may be disposed at or about at least a portion of a perimeter of the occlusion member, wherein the reinforcement wire may be disposed at or about substantially the entire perimeter of the occlusion member; A single side of the occluding member may be attached to the tubular member via, for example, suturing; a skirt, wherein the skirt may be disposed over and / or otherwise attached to a portion of the tubular member and may be configured to prevent backflow from the right atrium (RA) to the inferior vena cava (IVC) to redundantly obtain graft coverage of the IVC member and / or to prevent obstruction of one or more hepatic veins; The skirt may include at least one of a fabric and a reinforcement material; The skirt may include a fabric and a reinforcement material, wherein the reinforcement material may include a shape memory wire; The wire may be arranged along at least a portion of the periphery of the skirt; The wire may be arranged along most of the length of the skirt perimeter; a covering that may be attached to the tubular member and / or the stent via a plurality of sutures; and The tubular member may include a longitudinal axis, wherein at least one of the plurality of valves and / or the device as a whole may be configured such that substantially all blood flowing therefrom flows in a non-perpendicular direction relative to at least the longitudinal axis and the vena cava.

[0012] Thus, in some embodiments, a tricuspid insufficiency treatment device or apparatus (which may also be referred to as an apparatus or system) is provided and includes a tubular member configured for implantation in a patient's vena cava, wherein the tubular member includes a stent and is formed with a sidewall, and the stent includes a plurality of openings and is expandable (in some embodiments, self-expandable). The device also includes at least three (3) valves arranged circumferentially along the sidewall, wherein each valve includes an opening (which may also be referred to as a fenestration or orifice) formed in the sidewall, and a blocking member arranged to block and unblock a corresponding opening of the plurality of openings. Each blocking member includes a reinforcing wire arranged therein and / or thereon, and includes a flap or cover that is pivotally attached at or near a portion of the corresponding opening and is arranged to block the opening during ventricular contraction and unblock the opening during ventricular diastole, such that the opening is unblocked in a direction opposite to the attachment direction of the flap or cover. The device also includes a first and a second valve of at least three (3) valves arranged along a first circumference at a first position between the ends of the tubular member, and a third valve of the three (3) valves arranged on a second circumference that is spaced closer to one of the ends of the tubular member than one of the two (2) valves arranged on the first circumference. The first valve and the second valve are both hinged to the tubular member on opposite sides so that each occlusion member opens away from the other occlusion member. In some embodiments, the stent includes a plurality of cells, and each of the plurality of valves corresponds to a particular cell. The device also includes: a covering attached to the tubular member via a plurality of sutures and configured to cover at least a portion of the sidewall and the stent (except for the opening); and / or a skirt including a reinforcing wire therein and / or thereon. The skirt is arranged on and attached to a portion of the tubular member and is configured to prevent backflow from the right atrium (RA) into the inferior vena cava (IVC) to redundantly obtain graft coverage of the IVC member and / or prevent occlusion of one or more hepatic veins.

[0013] Such an embodiment may further include at least one (in some embodiments, multiple, and in some embodiments, substantially all) of the following additional structures, features, steps, functions, and / or instructions, thereby generating other embodiments (in addition, each item in the following list and the combination of the items listed below may be an independent embodiment): The cover may be configured to additionally cover each blocking member; The tubular member and the blocking member of the valve may be configured to form a closed cylindrical shape when the blocking member blocks the opening; Each opening and / or each cell accommodating a corresponding opening may have a rhombus shape; The stent may include a coronary stent; The coronary stent may include a first inferior vena cava (IVC) portion, a second superior vena cava (SVC) portion, and a third central portion disposed between the IVC portion and the SVC portion; The reinforcement wire may include a shape memory reinforcement wire; The reinforcing wire may be arranged at or near at least a portion of the periphery of the blocking member; The reinforcing wire may be arranged at or about substantially the entire periphery of the blocking member; A single side of each blocking member may be attached to the tubular member; The blocking member may be attached by suturing; The reinforcing wires of the skirt may include shape memory wires; The wire may be arranged along at least a portion of the periphery of the skirt; The wire can be run along most of the length of the skirt perimeter; The covering may be attached to the tubular member and / or the stent by a plurality of sutures; and The tubular member may include a longitudinal axis, wherein at least one of the plurality of valves or the device as a whole may be configured such that substantially all blood flowing therefrom flows in a non-perpendicular direction relative to at least the longitudinal axis and the vena cava.

[0014] In some embodiments, a tricuspid insufficiency treatment device is provided, the device comprising a tubular member configured for implantation in a vena cava of a patient and formed with a side wall. The device further comprises at least three (3) valves arranged circumferentially along the side wall, wherein each valve comprises: an opening formed in the side wall; and a blocking member comprising a flap or cover pivotally attached at or near a portion of the corresponding opening and arranged to block the opening during ventricular systole and unblock the opening during ventricular diastole, so that the opening is unblocked in a direction opposite to the attachment direction of the flap or cover. A first valve and a second valve of the at least three (3) valves are arranged at a first position between the ends of the tubular member along a first circumference, and a third valve of the three (3) valves is arranged on a second circumference, the second circumference being spaced closer to one of the ends of the tubular member than one of the two (2) valves arranged on the first circumference.

[0015] Such an embodiment may further include at least one (in some embodiments, multiple, and in some embodiments, substantially all) of the following additional structures, features, steps, functions, and / or instructions, thereby generating other embodiments (in addition, each item in the following list and the combination of the items listed below may be an independent embodiment): The at least three (3) valves may include only three (3) valves; The tubular member and the blocking member of the valve may form a closed cylindrical shape when each blocking member blocks a corresponding opening; may include a covering configured as at least a portion of the tubular member; The covering does not have to cover the opening; and The cover may be configured to additionally cover each blocking member; The first and second valves may both be hinged or otherwise attached to the tubular member on opposite sides such that each obstruction member opens away from the other obstruction member; A third valve of the plurality of valves may be hinged or otherwise attached such that the blocking member may be opened away from the first blocking member and the second blocking member; The tubular member may include an expandable stent having a plurality of cells, wherein each of the plurality of valves may correspond to a particular stent cell; Each opening and / or each cell accommodating a corresponding opening may be rhombus-shaped; If a stent is included, the stent may include a coronary stent, wherein the coronary stent may include or otherwise include any one or more of: a first inferior vena cava (IVC) portion, a second superior vena cava (SVC) portion, and a third central portion disposed between the IVC portion and the SVC portion; Each occluding member may include a shape memory reinforcement wire therein or thereon.

[0016] The reinforcing wire may be arranged at or near at least a portion of the periphery of the blocking member; The reinforcing wire may be arranged at or about substantially the entire periphery of the blocking member; A single side of the blocking member may be attached to the tubular member; Each occluding member may be attached by suture; A skirt may be included, wherein the skirt may be disposed over and attached to a portion of the tubular member and may be further configured to prevent backflow from the right atrium (RA) into the inferior vena cava (IVC) to redundantly obtain coverage of the IVC member and / or prevent obstruction of one or more hepatic veins; The skirt may include at least one of a fabric and a reinforcement material, wherein the reinforcement material may include a shape memory wire, and the wire may be arranged along at least a portion of the periphery of the skirt, or the wire may be arranged along a majority of the length of the periphery of the skirt; If a covering is included, the covering may be attached to the tubular member and / or the stent by a plurality of sutures; and The tubular member may include a longitudinal axis, and in some embodiments, at least one of the plurality of valves, or the device as a whole, may be configured such that substantially all blood flowing therefrom flows in a non-perpendicular direction relative to at least the longitudinal axis and the vena cava.

[0017] Some embodiments of the present disclosure relate to methods of treating tricuspid insufficiency. Specifically, in some embodiments, a method for treating tricuspid insufficiency is provided, the method comprising providing a device according to any device disclosed herein, and positioning the device in or near the right atrium of a patient such that a portion is disposed in or near the superior vena cava and an opposing portion is disposed in or near the inferior vena cava. In some embodiments, the device is positioned through the vasculature of the patient.

[0018] It should be understood that all combinations of the foregoing concepts and other concepts discussed in more detail below (assuming such concepts are not mutually inconsistent) are considered part of the inventive subject matter disclosed herein. In particular, all combinations of subject matter appearing anywhere in this disclosure are considered part of the inventive subject matter disclosed herein. It should also be understood that terms explicitly adopted herein that may also appear in any disclosure incorporated by reference should be given the meaning most consistent with the specific concepts disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Those skilled in the art will appreciate that the drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily drawn to scale. In some cases, various aspects of the inventive subject matter disclosed herein may be exaggerated or enlarged in the drawings to facilitate understanding of different features. In the drawings, the same reference numerals generally refer to the same features (e.g., functionally similar and / or structurally similar components).

[0020] Figure 1A and 1B The diastolic phase is Figure 1A ) and ventricular systole ( Figure 1B ) in which the tricuspid valve does not close properly during ventricular contraction ( Figure 1B ), resulting in tricuspid regurgitation.

[0021] Figure 2A -F is a simplified schematic diagram of a tricuspid insufficiency treatment device having one or more valves according to some embodiments, including a diagram showing a slightly open position of a rhombus / diamond-shaped valve according to some embodiments ( Figures 2A-2F ), a circular / elliptical valve according to some embodiments ( Figure 2B -C), according to some embodiments, a pair of (at least) oval circular valves ( Figure 2D ) and a large circular valve device according to some embodiments ( Figure 2E ).

[0022] Figure 3A and 3B According to some embodiments, Figure 4A ) and systolic period ( Figure 4B ) Simplified perspective view of a tricuspid valve insufficiency treatment device implanted in the vasculature.

[0023] FIG. 4A to FIG. 4C is a simplified illustration of a tricuspid insufficiency treatment device showing a side view during diastole ( Figure 4A ), perspective view during diastole ( Figure 4B ) and cross section AA ( Figure 4C ).

[0024] Figure 5 is a simplified illustration of a percutaneous venous route for implanting an embodiment of a device of the present disclosure, showing implantation via a lower or upper extremity, in accordance with some embodiments.

[0025] Fig. 6A and 6B is a graph showing physiological improvements relative to post-implantation studies. Specific embodiments Figure 1A-1B Simplified illustrations of the heart during diastole and ventricular systole are provided, respectively, wherein, according to some embodiments, during ventricular systole, the tricuspid valve 4 does not close properly, so that tricuspid regurgitation exists. The superior vena cava 1 returns blood from the upper part of the body and opens to the upper and rear part of the right atrium 2 through a valveless orifice pointing forward and downward. The inferior vena cava 3 is usually larger than the superior vena cava, returns blood from the lower part of the body, and opens to the lowest part of the atrium 2 near the atrial septum. Its orifice points backward and upward and is protected by the valve of the inferior vena cava (called the Eustachian valve). The tricuspid valve 4 is located between the right atrium 2 and the right ventricle 5.

[0027] The coronary sinus 6 opens into the right atrium 2 and is located between the orifice of the inferior vena cava and the atrioventricular opening. It returns blood from the heart substance and is protected by a semicircular valve, which is the valve of the coronary sinus (also called the valve of Thebesius). The mitral valve 7 is between the left ventricle 8 and the left atrium 9.

[0028] Ventricular contraction causes an increase in pressure in the right ventricle 5 and the left ventricle 8. The pressure in the ventricles rises to a level higher than that in the atria 2 and 9, thereby closing the tricuspid valve 4 and the mitral valve 7. Figure 1B The tricuspid valve 4 is shown not closing properly, so that tricuspid regurgitation will occur.

[0029] Figure 2A-F shows an exemplary schematic diagram of a tricuspid insufficiency treatment device according to some embodiments. Each includes a tubular member / structure 10 configured for implantation into the vena cava (which may also be referred to as a vena cava member 12 or a tubular member 12; it should be understood that in some embodiments, the body of the device 10 may not be tubular), which may include one or more valves, each valve including, for example, a blocking member 16 and an opening 14 (such terms are used interchangeably). The blocking member may be a flap (which may also be referred to as a cover) configured to open an opening in the side wall of the device 10 / tubular member 12 and close the opening (e.g., at least to the fluid passing therethrough), respectively. The blocking member / opening valve combination is configured to allow blood (blood received from the vena cava by the end of the device) to flow out of the opening during ventricular diastole when the device is implanted into the vena cava.

[0030] As described above, the treatment device 10 includes a tubular member 12 that is implantable in the superior vena cava (SVC) and / or the inferior vena cava (IVC). The side wall of the tubular member 12 may be formed with an opening 14 (e.g., a right atrial opening), and further include a blocking member 16 that is arranged to block and clear the opening 14. It should also be noted that, for example, the blocking member 16 may be a flap valve, wherein the blocking member 16 is a flap or cover that is pivoted to a portion of the tubular member 12 to block / clear the opening. In some embodiments, the blocking member is arranged or fixed at or near the opening, which is preferably (in some embodiments) on a portion of the periphery of the blocking member. Such fixation may be performed by sutures (e.g., see Figure 2D , 2F ). The blocking member may open outwardly away from the sidewall of the tubular member, or in other embodiments, may open laterally or in other directions.

[0031] The blocking member 16 may be normally open (e.g. Figure 2A ) or normally closed relative to the corresponding opening 14. The mechanism of the normally open or closed blocking member can further help control the degree of backflow or stenosis, respectively. For example, the normally open blocking member requires a certain measurable and controlled closing force. Therefore, the normally open blocking member can produce a measurable and controlled level of backflow. Conversely, the normally closed blocking member can produce a measurable and controlled level of stenosis.

[0032] According to some embodiments, the device can be implanted so that the opening 14 is aligned with the orifice of the SVC or the orifice of the IVC (a direction facing the orifice of the SVC or the orifice of the IVC), or the opening 14 can face other directions, such as facing the side (forward / backward). Thus, the blocking member 16 can have its open portion (opening 14) directed to the upper part, lower part, front part or back part of the right atrium.

[0033] exist Figure 2AIn the present invention, a plurality of (in some embodiments, two, in some embodiments, two or more, in some embodiments, three, in some embodiments, three or more) openings 14 and corresponding blocking members 16 are provided. For example, the blocking member 16 may be configured (e.g., in size and shape) such that when the tricuspid insufficiency treatment device 10 is in the closed position, the blocking member 16 may fit within the corresponding opening 14 and block the opening.

[0034] In some embodiments (see, e.g., Figure 2B -C), a single opening can be associated with one or more (in some embodiments) blocking members, each of which is configured to cover a portion of the single opening. In such an embodiment, the tricuspid insufficiency treatment device 10 in the closed position corresponds to a plurality of blocking members, which are configured to cooperate with each other so that the combined blocking members block or cover at least a majority of the single opening (e.g., including the entirety of the single opening). In other words, one or more blocking members can be configured integrally with each other to integrally block one (or more) openings. For example, Figure 2A -F and Figure 3A -B can be configured to block a single opening 14 (e.g., three blocking members 16), or such blocking members can be configured to block multiple openings. In the illustration, each opening can be shaped, for example, as a parallelogram / rhombus / diamond, and in some embodiments, the three blocking members swing open to form a large opening (in some embodiments) or to open three separate openings (in some embodiments). In embodiments with a single opening or one opening, the blocking members cooperate with each other to block the entire opening as a unit (e.g., Figure 2C , 2E ). Thus, it should be noted that in some embodiments, the opening can be associated with any number of occluding members, and in some embodiments, the occluding members can include any variety of shapes, particularly shapes that are suitable for closing the opening during systole when the tricuspid insufficiency treatment device 10 is implanted in the vasculature.

[0035] Treatment devices according to some embodiments (eg, having multiple flap / blocking member valves) significantly improve the chances of effective and safe blood flow relative to tissue ingrowth, thrombosis, or other causes of device deterioration.

[0036] In some embodiments, the tubular member 10 may be / include a stent 15, which may be self-expanding (e.g., shape memory alloys, polymers, etc.) or balloon expandable (e.g., steel alloys, polymers, etc.). The blocking member 16 may be made of the same material as the tubular member (e.g., a covered stent), or of other graft materials (e.g., pericardium, porcine valve material, PE material). For example, the opening 14 may be an opening formed when the side wall of the tricuspid insufficiency treatment device 10 is cut in a semicircular manner without removing any portion of the cut side wall. In such an embodiment, the flap valve formed as a result of the incision (and remains attached or connected to the tricuspid insufficiency treatment device 10 via a portion of the side wall itself) may be used as the blocking member 16 of the opening 14.

[0037] In some embodiments, the stent includes a plurality of open-cells that are covered by a material (forming the tubular member and / or its sidewalls). At least one cell can be configured to function as an opening, and a covering (or other suitable material) is hinged or otherwise attached along at least a portion of its periphery to function as an occluding member to cover the at least one cell (e.g., see the cutout embodiment above) and allow blood to flow out of the at least one cell during various points in the cardiac cycle.

[0038] In some embodiments, the stent may be covered by fabric or other material (e.g., pericardium) 18, and in such embodiments, the occluding member 16 may be a fabric valve (and / or also pericardium). Figure 2C As shown, the obstruction member 16 can be a flat valve 22 that is configured to open during systole when the tricuspid insufficiency treatment device 20 is implanted in the vascular system. In some embodiments, the obstruction element 22 can be a single element that covers the entire opening 14, or it can be composed of multiple elements that fit together during systole to completely or at least substantially completely cover the opening. Again, according to some embodiments (e.g., Figure 2C ), the blocking member can cover one or more openings (e.g., one or more cells in the stent) and be centrally attached, for example, at 17 (for example), within the center of the opening. Thus, a portion (in some embodiments, a majority (or all) of the periphery of the blocking member can be opened at multiple angles to allow blood to flow therefrom.

[0039] In some embodiments, the blocking member may not have or include a reinforcing structure 16a such as a wire, rod, tube, suture or mesh. The covering (including the material used for the blocking member) may be immersed, sprayed or covered with anticoagulants, antiplatelet agents, tissue promoters or inhibitors, antibiotics, statins, anti-inflammatory agents and other materials or drugs. The stent structure may include, but is not limited to, stent rings, independent or interconnected braided or laser-cut meshes, braided or laser-cut tubular structures and / or struts (and / or the like). According to some embodiments, the insufficiency device can be fixed in situ, for example, by radial forces of expandable members, barbs, divergent tubular member ends, stents or other members deployed in the tributaries, or other suitable means. Any subsequent tissue growth on the device may also contribute to fixation.

[0040] The obstruction member may be connected to the vena cava / tubular member by any suitable means (including, for example, integrally therewith, see paragraph), such as, but not limited to, sutures, adhesives, polymer embedding, welding, ultrasonic welding, unified graft and obstruction member materials, etc. In some embodiments, when the device 10 is implanted in the vascular system, the obstruction member may be connected or attached to the tricuspid insufficiency treatment device (or its sidewall) in a manner that allows seamless opening and closing of the tricuspid insufficiency treatment device during diastole and systole, respectively. For example, the obstruction member may be connected to the sidewall of the device 10 via any one or more types of connections or joints. For example, the connection, joint or attachment between the obstruction member 16 and the sidewall may be in the form of a hinge (via a ring or similar element), a pivot, etc. In some embodiments, the joint may be a weakened joint between the obstruction member and the sidewall, serving as an axis around which the obstruction member can swing during diastole.

[0041] The tubular member can be generally cylindrical, as already stated, it can be referred to as tubular (the two terms are used interchangeably throughout the text), but can alternatively be non-cylindrical. The term "cylindrical" used throughout the specification and claims includes not only circular cross-sections, but also elliptical cross-sections and other curved cross-sections. According to some embodiments, the diameter of the tubular member can be the same over its axial length. Alternatively, according to some embodiments, the diameter of the tubular member can vary over its axial length. According to some embodiments, the blocking member can have a triangle with rounded corners as shown. Alternatively, it can have an elliptical, rectangular, circular or other shape, such as a diamond (according to some embodiments).

[0042] Figure 3A -B is a simplified illustration of the tricuspid insufficiency treatment device 10 implanted in the vasculature (eg, vena cava) during diastole and systole, respectively, according to some embodiments. Figure 3ADiastole is shown, wherein the pressure in the right ventricle drops (eg, in some embodiments, to about 0 mm Hg), and the blood pressure in the vena cava causes the obstruction member 16 to open and allow flow through the opening 14 . Figure 3B systole is shown, where the pressure in the right ventricle increases. In some embodiments, the device 10 is used because the tricuspid valve is inadequate and cannot completely prevent blood from flowing back from the right ventricle to the right atrium (i.e., because it cannot close completely). Thus, for the device according to some embodiments, systolic pressure causes the obstruction member to close and prevent flow through the right atrial opening (see Figure 3B ). This greatly reduces the blood return from the right ventricle and atrium to the venous system. In some embodiments, such as Figure 3B As shown, when the blocking member 16 blocks the opening 14, the tubular member and the blocking member together comprise a closed cylindrical outer shape, which is advantageous for inserting and removing the device into and from a delivery catheter.

[0043] Figures 4A-4C Some embodiments of tricuspid insufficiency devices of the present disclosure are shown. As shown, the device 10 includes: a tubular member 12, which may include a stent 15 and a covering 18 that may include a plurality of cells 15a; and a plurality of valves, which include a blocking member 16 for blocking and unblocking the opening 14. In some embodiments, the opening for one or more valves may correspond to only a portion of the area of ​​the cell 15a of the stent (e.g., as shown). As shown, the ends of the stent may be slightly curved to avoid interaction with the inner surface of the vena cava.

[0044] in addition: The covering 18 may cover substantially the entire stent, or may cover a portion thereof. Thus, for example, in some embodiments, a portion of the stent at one or more ends (as shown, both ends) may be left without a covering; and / or Radiopaque markers 28 may be provided on the device (see Figure 4A -B) for axial and rotational positioning within the body lumen. Typically, radiopaque markers may be in the shape of the letters "L", "E", or "C" to mark the rotational position of the device, and these or other markers may be placed at various axial locations on the device so that the implant operator can understand and control the axial position of the device.

[0045] in addition, Figure 4A The device shown in -C may also include a skirt 24, which may include reinforcing wires 26 therein and / or thereon (e.g., in some embodiments, which may be arranged in a wavy / sinusoidal form). The skirt may be arranged on and attached to a portion of the tubular member and is configured to prevent backflow from the right atrium (RA) to the inferior vena cava (IVC) and / or prevent obstruction of one or more hepatic veins.

[0046] The device can be delivered percutaneously or by surgical means. Figure 5 As shown in the exemplary embodiment of , the device can be delivered percutaneously through the IVC via a transcatheter femoral / iliac approach, or through the SVC via a transcatheter jugular / radial / subclavian approach.

[0047] Fig. 6A - B is a graph showing physiological improvements relative to post-implantation studies.

[0048] Of particular note, in some embodiments of the present disclosure, the direction of blood flow entering and / or exiting need not be in a specific (e.g., single) direction. For example, in some embodiments, blood does not need to flow into the device in one direction and then flow out in another direction, such as perpendicularly relative to the blood flowing into the device. In some embodiments, a relatively small angle between the blood entry and exit directions provides greater efficacy for the patient.

[0049] Specifically, rapid changes in flow direction, primarily due to the geometry of the blood vessel (or device through which blood flows), can lead to turbulence and flow separation. Turbulence is a non-efficient form of fluid flow characterized by rapid changes in pressure and velocity. In a physiological setting, turbulence prevents blood from moving in a natural course and can result in a reduction in the flow of blood across a given cross-sectional area. While a reduction in blood supply rate can be overcome by an increase in blood pressure / velocity, since turbulence is directly affected by fluid velocity, an increase in blood velocity will result in more turbulence, and so on.

[0050] Furthermore, because flow separation (when fluid pulls away from the wall resulting in an area with reduced flow velocity associated therewith) is a common phenomenon in vascular bifurcations, aneurysms, stenoses, and other blood flow disturbances, areas of slow blood flow often develop recirculation patterns where blood is trapped within the area (i.e., trapped within the recirculation zone because the blood cannot overcome the fluid pressure of the flow to reenter the main flow). Typically, this occurs when the angle between the main fluid flow direction and the wall is large.

[0051] Thus, in some embodiments of the present disclosure, a valve comprising one or more flaps / covering / blocking members and one or more openings is configured to open in a manner that allows blood to flow out of the tubular member (i.e., the device) in a flow direction that is relatively close to the direction of natural flow within the vena cava. This results in reduced or, in most cases, eliminated turbulence and flow separation compared to devices that forcibly redirect blood flow.

[0052] It is also worth noting that the duration of the tricuspid valve opening during diastole is typically a fraction of a second. For this reason, the amount of blood that should pass through the tricuspid valve into the right ventricle during each diastole is typically more than 50 ml. In addition, the pressure gradient across the tricuspid valve during diastole (which is the driving force for blood flow) is only a few mmHg, typically less than 10 mmHg. Therefore, the tricuspid valve naturally allows a relatively large inflow rate at a smaller duration and driving force. Therefore, the tricuspid valve (and the mitral valve that experiences similar conditions) are typically characterized by a large inflow cross-sectional area. Therefore, some embodiments obey this principle and provide a high flow valve that constitutes a relatively large opening area.

[0053] To this end, it is also particularly noteworthy that in some embodiments, the tricuspid insufficiency device and the valve structure included allow for changes in pressure gradients (which can change significantly in a fraction of a second). Therefore, such embodiments allow large amounts of blood (e.g., 50 ml or more) to flow through it, while prior art devices cannot. This is because in the remaining fraction of a second that the valve is open, it must be quickly closed to stop backflow through it, which occurs in some embodiments of the present disclosure (because the inflow of blood through such embodiments is driven by a pressure gradient of only a few mmHg). It is impossible (for example) to flow through a "slit valve" in such a short time.

[0054] Thus, in some embodiments, the disclosed device provides a high flow valve (e.g., not provided by a slit valve) that allows a relatively large amount of blood to flow therethrough in a short period of time driven by a small pressure gradient (e.g., less than about 10 mmHg). According to some embodiments, this is achieved by configuring a device including one or more valves that form a relatively large (e.g., greater than 2 square centimeters) opening (open) area.

[0055] Although various inventive embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily conceive of a variety of other means and / or structures for performing functions and / or obtaining results and / or one or more advantages described herein, and each such variation and / or modification is considered to fall within the scope of the inventive embodiments described herein. More generally, it will be readily understood by those skilled in the art that all structures, parameters, dimensions, materials, functions, and configurations described herein are only examples, and the actual structures, parameters, dimensions, materials, functions, and configurations will depend on one or more specific applications using the teachings of the present invention. A person skilled in the art will recognize or be able to determine many equivalents to the specific inventive embodiments described herein using only routine experiments. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and within the scope of the claims supported by the present disclosure and their equivalents, embodiments of the present invention may be practiced in a manner different from that specifically described and claimed. The inventive embodiments of the present disclosure are also directed to each individual feature, system, article, structure, material, kit, function, step, and method described herein. In addition, any combination of two or more such features, systems, articles, structures, materials, kits, functions, steps, and methods, if not mutually contradictory, is included within the scope of the invention disclosed herein. Some embodiments may be distinguished from the prior art by specifically lacking one or more features / elements / functions (ie, claims directed to such embodiments may include negative limitations).

[0056] Moreover, as noted, various inventive concepts are embodied as one or more methods for which examples have been provided. The actions performed as part of the method may be ordered in any suitable manner. Thus, even though shown as sequential actions in illustrative embodiments, embodiments may be constructed in which the actions are performed in an order different from that shown, and may also include performing some actions simultaneously.

[0057] Any and all references to publications or other documents (including but not limited to patents, patent applications, articles, web pages, books, etc.) cited anywhere in this application are hereby incorporated by reference in their entirety. Furthermore, 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.

[0058] Unless expressly indicated to the contrary, the indefinite articles "a" and "an" used in the specification and claims should be understood to mean "at least one". The phrase "and / or" used in the specification and claims should be understood to mean "one or two" of the elements so connected, i.e., elements that are presented in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" elements so connected. In addition to the elements explicitly identified by the "and / or" clause, other elements may be optionally present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, in one embodiment, "A and / or B", when used in conjunction with an open language such as "comprising", may refer only to A (optionally including elements other than B), in another embodiment, only to B (optionally including elements other than A), in yet another embodiment, to both A and B (optionally including other elements), and so on.

[0059] As used herein in the specification and claims, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating the items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one of a plurality of or a plurality of element lists, but also including more than one, and (optionally) other unlisted items. Only the opposite terms are clearly indicated, otherwise such as "only one" or "just one", or when used in the claims, "consisting of..." will refer to only including one element in a plurality of elements or element lists. In general, when an exclusive alternative is limited by an exclusive term such as "any one of...", "one of...", "only one of them" or "just one of them" (e.g., "one or not the other of the two"), the term "or" used herein should only be interpreted as indicating the exclusive alternative. "Substantially consisting of..." should have the common meaning used in the field of patent law when used in the claims.

[0060] As used herein in the specification and claims, when referring to a list of one or more elements, the phrase "at least one" should be understood to refer to at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows that elements other than the elements specifically identified in the list of elements referred to by the phrase "at least one" may optionally appear, whether related to or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B"), in one embodiment, may refer to optionally including more than one A (i.e., at least one A), but not having B (and optionally including elements other than B); in another embodiment, may refer to optionally including more than one B (i.e., at least one B), but not having A (and optionally including elements other than A); and in yet another embodiment, may refer to optionally including more than one A and optionally including more than one B (i.e., at least one A and at least one B) (and optionally including other elements); and so on.

[0061] In the claims and the above description, all transitional phrases such as "including", "comprising", "carrying", "having", "containing", "involving", "maintaining", "consisting of", etc. should be understood as open-ended, i.e., meaning including but not limited to. As provided in Section 2111.03 of the Manual of Patent Examining Procedures of the United States Patent Office, only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively.

Claims

1. A tricuspid valve insufficiency treatment device, comprising: a tubular member configured for implantation within the vena cava of a patient, the tubular member being formed with a side wall; as well as At least two (2) valves arranged circumferentially along the side wall, each valve comprising: an opening formed in the side wall, and a blocking member arranged to block and clear corresponding openings among the plurality of openings, in: each blocking member comprises a flap or cover pivotally attached at or near a portion of a respective opening and arranged to block the opening during ventricular systole and to unblock the opening during ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover, and The at least two valves are arranged along a first circumference at a first position between the ends of the tubular member.

2. The device of claim 1 further comprising a third valve disposed on a second circumference spaced closer to one of the ends of the tubular member than the at least two (2) valves disposed on the first circumference.

3. The device according to claim 1 or 2, wherein the at least two (2) valves comprise only three (3) valves.

4. The device according to any one of claims 1 to 3, wherein the tubular member and the blocking member of the valve form a closed cylindrical shape when each blocking member blocks a corresponding opening.

5. The device of any one of claims 1-4, further comprising a covering configured to cover at least a portion of the tubular member. The device of claim 5 , wherein the cover does not cover the opening.

7. The device according to claim 1 or 5, wherein the cover is configured to additionally cover each blocking member.

8. The device according to any one of claims 1 to 7, wherein the first and second valves are each hinged to the tubular member on opposite sides such that each blocking member opens away from the other blocking member.

9. The device according to any one of claims 2 to 8, wherein a third valve of the plurality of valves is hinged so that the stop member opens away from the first and second stop members.

10. The device of any one of claims 1 to 9, wherein the tubular member comprises an expandable stent having a plurality of cells, wherein each of the plurality of valves corresponds to a specific cell of the stent.

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