Prosthetic valve

Abstract

The present invention relates to a prosthetic heart valve configured to be implanted in patients presenting valve regurgitations and presenting at least one of the following parameters: a normal RV function to severe RV dysfunction, a FAC of from 10% to 60%, a FAC above 10%, a recommended treatable perimeter-derived diameter between 20mm and 80mm, and a recommended treatable perimeter-derived diameter above or equal 20mm.

Description

[0001] PROSTHETIC VALVE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 656,635 filed on June 6, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to a prosthetic valve and, more particularly, but not exclusively, to a prosthetic replacement for a tricuspid valve.

[0006] Additional background art includes U.S. Patent No. US 11045311B2 disclosing a prosthetic heart valve, for example a tricuspid valve, may include a flexible membrane and a frame. The frame may be attached to the periphery of the tricuspid orifice. The diaphragm may be attached to the frame around a part of the perimeter of the orifice. Optionally the frame may be flexible. For example, the frame may elastically flex between a substantially circular shape and / or an elliptical and / or crescent shape. Optionally there may not be a stiff cross piece crossing a central region of the orifice and connected on opposing sides of frame. In some embodiments, the diaphragm may take a dome shape during systole.

[0007] U.S. Patent No. US7347869B2 disclosing a stent-based valve. The valve includes a radially expandable structural frame including an anchor structure having a first and a second open end, a connecting member having a first and a second end, and a cantilever valve strut having a first and a second end. The first end of the connecting member is attached to the second end of the anchor structure. The first end of the cantilever valve strut is cooperatively associated with the second end of the connecting member. The prosthetic valve further includes a biocompatible membrane assembly having a substantially tubular configuration about the longitudinal axis, with a first open and a second closed end. The first end of the membrane assembly is attached to the structural frame along the second end of the cantilever valve strut.

[0008] U.S. Patent No. US9839511B2 disclosing a mitral valve replacement device adapted to be deployed at a mitral valve position in a human heart. The device has an atrial flange defining an atrial end of the device, a ventricular portion defining a ventricular end of the device, the ventricular portion having a height ranging between 2 mm to 15 mm, and an annulus support that is positioned between the atrial flange and the ventricular portion. The annulus support includes a ring of anchors extending radially therefrom, with an annular clipping space defined between the atrial flange and the ring of anchors. A plurality of leaflet holders positioned at the atrial end of the atrial flange, and a plurality of valve leaflets secured to the leaflet holders, and positioned inside the atrial flange at a location above the native annulus.

[0009] U.S. Patent No. US8246675B2 disclosing a kit for implanting in a duct, which includes a tubular endoprosthesis and a prosthetic valve is disclosed. The prosthetic valve includes a carrier frame that is radially deformable in elastic manner relative to a central axis of the tubular endoprosthesis between a deployed, implanted position, and a folded, implanting position. The carrier frame is urged elastically towards its deployed position. A flexible shutter is connected to the carrier frame. The shutter is deformable between an obstruction position in which it is extended transversely, and a release position in which it is contracted transversely under to allow a fluid to flow through the carrier frame. The carrier frame also includes an integrated centripetal compressing mechanism for centripetally compressing the carrier frame towards folded position.

[0010] U.S. Patent No. US8226710B2 disclosing a heart valve prosthesis is provided having a selfexpanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

[0011] U.S. Patent No. . US10213307B2 disclosing a transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

[0012] A publication by Itelman el al, The Association of Severe Tricuspid Regurgitation with Poor Survival Is Modified by Right Ventricular Pressure and Function: Insights from SHEBAHEART Big Data, Journal of the American Society of Echocardiography, Volume 35 Number 10, disclosing an association of severe tricuspid regurgitation (TR) and Right Ventricle function with excess mortality. SUMMARY OF THE INVENTION

[0013] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0014] Example 1. A prosthetic heart valve, comprising: a. a frame sized and shaped to fit in an orifice of a heart valve and defining a flow channel; b. a flexible diaphragm connected to said frame at two locations, each location opposite to the other; a portion of said flexible diaphragm in each of said two locations is held partially expanded along the length of the frame, and said flexible diaphragm divides said flow channel into two channels; wherein said flow channel comprises a diameter of from about 30mm to about 50mm.

[0015] Example 2. The prosthetic valve according to example 1, wherein said valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2.

[0016] Example 3. The prosthetic valve according to example 1 or example 2, wherein said valve comprises an effective orifice area (EOA) higher than 2cm2.

[0017] Example 4. The prosthetic valve according to any one of examples 1-3, wherein a size of said flexible diaphragm and said connection at two locations causes said flexible diaphragm to open and close gradually.

[0018] Example 5. The prosthetic valve according to any one of examples 1-4, wherein implantation of said prosthetic heart valve increases or maintains right ventricle (RV) function as measured using fractional area change (FAC).

[0019] Example 6. The prosthetic valve according to any one of examples 1-5, wherein implantation of said prosthetic heart valve does not exchange one disease with another, for example it does not reduce tricuspid regurgitation while at a same time reduces RV function.

[0020] Example 7. The prosthetic valve according to any one of examples 1-6, wherein said prosthetic heart valve is configured to be implanted in patients presenting a normal RV function.

[0021] Example 8. The prosthetic valve according to any one of examples 1-7, wherein said prosthetic heart valve is configured to be implanted in patients presenting a reduced RV function.

[0022] Example 9. The prosthetic valve according to any one of examples 1-8, wherein said prosthetic heart valve is configured to be implanted in patients presenting an abnormal RV function.

[0023] Example 10. The prosthetic valve according to any one of examples 1-9, wherein said prosthetic heart valve is configured to be implanted in patients presenting a FAC of from 10% to 60%. Example 11. The prosthetic valve according to any one of examples 1-10, wherein said prosthetic heart valve is configured to be implanted in patients presenting a FAC above 10%.

[0024] Example 12. The prosthetic valve according to any one of examples 1-11, wherein said prosthetic heart valve is configured to be implanted in patients presenting a recommended treatable perimeter- derived diameter between 20mm and 80mm.

[0025] Example 13. The prosthetic valve according to any one of examples 1-12, wherein said prosthetic heart valve is configured to be implanted in patients presenting a recommended treatable perimeter- derived diameter above or equal 20mm.

[0026] Example 14. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function to severe RV dysfunction.

[0027] Example 15. The method according to example 14, further comprising implanting a prosthetic valve according to example 1.

[0028] Example 16. The method according to example 14 or example 15, wherein said patient presents a normal RV function to severe RV dysfunction.

[0029] Example 17. The method according to any one of examples 14-16, wherein said patient presents a FAC of from 10% to 60%.

[0030] Example 18. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function severe RV dysfunction; c. identifying that said patient presents a recommended treatable perimeter-derived diameter between 20mm and 80mm.

[0031] Example 19. The method according to example 18, further comprising implanting a prosthetic valve according to example 1.

[0032] Example 20. The method according to example 18 or example 19, wherein said patient presents a normal RV function to severe RV dysfunction.

[0033] Example 21. The method according to any one of examples 18-20, wherein said patient presents a FAC of from 10% to 60%.

[0034] Example 22. The method according to any one of examples 18-21, wherein said patient presents a recommended treatable perimeter-derived diameter above or equal 20mm.

[0035] Example 23. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient requiring a prosthetic valve having an EOA higher than 2cm2. Example 24. The method according to example 23, further comprising implanting a prosthetic valve according to example 1.

[0036] Example 25. The method according to example 23 or example 24, wherein said prosthetic valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2. Example 26. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient presenting a low cardiac output of about 3.5 to 4.0 L / min.

[0037] Example 27. The method according to example 26, further comprising implanting a prosthetic valve according to example 1. Example 28. A method of improving RV function, comprising: a. a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function to severe RV dysfunction; and c. implanting a prosthetic valve according to example 1.

[0038] Example 29. The method according to example 28, wherein said patient presents normal RV function to severe RV dysfunction.

[0039] Example 30. The method according to example 28 or example 29, wherein said patient presents a FAC of from 10% to 60%.

[0040] Example 31. A method of treatment comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function to severe RV dysfunction; c. identifying that said patient presents a recommended treatable perimeter-derived diameter between 20mm and 80mm; and d. implanting a prosthetic valve according to example 1.

[0041] Example 32. The method according to example 31, wherein said patient presents normal RV function to severe RV dysfunction.

[0042] Example 33. The method according to example 31 or example 32, wherein said patient presents a FAC of from 10% to 60%.

[0043] Example 34. The method according to any one of examples 31-33, wherein said patient presents a recommended treatable perimeter-derived diameter above or equal 20mm.

[0044] Example 35. A method of treatment, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient requiring a prosthetic valve having an EOA higher than 2cm2; and c. implanting a prosthetic valve according to example 1. Example 36. The method according to example 35, wherein said prosthetic valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2.

[0045] Example 37. A method of improving cardiac output by more than 15%, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; and b. implanting a prosthetic valve according to example 1.

[0046] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0047] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0048] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0049] In the drawings:

[0050] Figures la- lb are a schematic side view and a schematic top view representation of an exemplary prosthetic valve, according to some embodiments of the invention;

[0051] Figures 2a-2b are schematic side view representations of exemplary sizes of prosthetic valves, according to some embodiments of the invention;

[0052] Figure 3 is a graph comparing the RV function in function of the Fractional Area Change (FAC) in patients that where implanted with a prosthetic valve according to the present invention and patients that where implanted with a prior art valve;

[0053] Figure 4 is a flowchart representing the changes in the status in patients treated with the prosthetic valve according to the present invention and in patients treated with a prior art valve;

[0054] Figure 5 is a flowchart representing the potential percentage of population which can be treated with the prosthetic valve of the present invention in comparison with prior art valves; Figure 6a is a flowchart comparing the continuous wave tricuspid valve diastolic mean gradient between the prosthetic valve of the present invention and the prior art valve;

[0055] Figures 6b-6c are flowcharts of a comparison of the cardiac output in patients after implantation of the prosthetic valve of the present invention and the prior art valve;

[0056] Figure 7 is a flowchart of an exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention;

[0057] Figure 8 is a flowchart of another exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention;

[0058] Figure 9 is a flowchart of another exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention; and

[0059] Figure 10 is a flowchart of an exemplary method of increasing a cardiac output in a patient, according to some embodiments of the invention.

[0060] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0061] The present invention, in some embodiments thereof, relates to a prosthetic valve and, more particularly, but not exclusively, to a prosthetic replacement for a tricuspid valve.

[0062] Overview

[0063] An aspect of some embodiments of the invention relates to improving right- ventricle (RV) function in patients suffering from regurgitation after prosthetic valve implantation. In some embodiments, Fractional Area Change (FAC) is used for evaluating the RV function. In some embodiments, the improvement is an improvement in FAC of from about 10% to about 60%.

[0064] An aspect of some embodiments of the invention relates to treating patients suffering from severe to torrential tricuspid regurgitation showing normal RV function or moderate RV dysfunction or severe RV dysfunction or a reduction in RV function. In some embodiments, treating the patients resolves the regurgitation and improves the RV function, especially when compared with prior art prosthetic valves.

[0065] An aspect of some embodiments of the invention relates to treating patients suffering from regurgitation showing either normal RV function or severe RV dysfunction or a reduction in RV function. In some embodiments, treating comprises treating patients exhibiting a FAC of from about 10% to about 60% or higher. In some embodiments, treating comprises treating patients exhibiting a FAC above 10%. An aspect of some embodiments of the invention relates to improving the cardiac output in a patient suffering from regurgitation. In some embodiments, implanting the device causes an improvement in the cardiac output of from about 20% to about 30%.

[0066] An aspect of some embodiments of the invention relates to methods of selection of patients for prosthetic valve implantation. In some embodiments, exemplary methods of patient selection comprise identifying a patient presenting, for example, a severe to torrential tricuspid regurgitation and identifying at least one or more of the following parameters: 1. a mild to severe reduction in RV function; 2. a recommended treatable perimeter-derived diameter between 55mm and 65mm (optionally between 20mm and 80mm; optionally above or equal 20mm); 3. a low cardiac output.

[0067] An aspect of some embodiments of the invention relates to providing a prosthetic valve adapted to be implanted in patients, the prosthetic valve having an Effective Orifice Area (EOA) higher than 2cm2, the implantation is done without incurring a secondary disease due to the implantation of a device.

[0068] An aspect of some embodiments of the invention relates to a prosthetic heart valve that presents one or more of the following advantages over prior art prosthetic heart valves:

[0069] 1. The valve can be used in patients presenting severe RV dysfunction;

[0070] 2. The valve increases the RV function (for example by 8%) after implantation;

[0071] 3. The valve does not reduce the RV function after implantation;

[0072] 4. The valve increases the cardiac output (for example by 27%) after implantation;

[0073] 5. The valve can be used in patients presenting annulus with large diameters (for example higher than 56mm);

[0074] 6. The valve does not increase the number of patients in need for a permanent pacemaker (for example, only about 5% of patients require a permanent pacemaker in comparison to 23% of patients in prior art valves);

[0075] 7. The valve does not cause thrombosis after implantation;

[0076] 8. The valve allows for re-sheath actions during valve implantation.

[0077] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Referring now to Figures la- lb, showing a schematic side view and a schematic top view representation of an exemplary prosthetic valve, according to some embodiments of the invention.

[0078] In some embodiments, an exemplary prosthetic valve 100, comprises a body or frame 102 (referred hereinafter as frame) configured to be positioned or attached to a native tissue in the patient. In some embodiments, the frame is attached to the tissue by means of one or more anchors 104 and or by means of a coaptive skirt 106. In some embodiments, the frame 102 defines an orifice 202 (not shown in Figures la- lb, but shown in Figures 2a-2b). In some embodiments, the orifice 202 comprises an Effective Orifice Area (EOA) higher than 2cm2, for example an EOA between about 3cm2and about 5cm2, optionally between about 2.5cm2and about 5.5cm2, optionally between about 2cm2and about 7cm2, for example an EOA of 3.84 cm2, 5.05 cm2.

[0079] In some embodiments, the prosthetic valve comprises a diaphragm 108 attached along part of the periphery of the frame 102 using one or more sutures 110. In some embodiments, the sutures are both in a longitudinal direction and in an axial direction. In some embodiments, the sutures are in diagonal in relation to a longitudinal / axial axis. In some embodiments, the diaphragm 108 is attached to the frame at two locations 112a / 112b thereby generating two channels that allow the passage of blood when the diaphragm 108 opens. In some embodiments, the diaphragm 108 is attached to the frame at more than two locations. In some embodiments, the flow channels are located on opposite sides of the diaphragm 108. Optionally, the sum of the cross-sectional areas of the peripheral flow channels (the channels generated by the connection of the diaphragm 108 with the frame 102) may range from 10 to 30% and / or 30 to 50% and / or from 50 to75% and / or from 75 to 100% of the cross section of the tricuspid annulus. For example, in some embodiments, the area flow channels in the open valve may be approximated by slightly (0 - 20%) less than the area of two segments of the circle formed by chords connected the ends of the attached portion of the periphery. For example, for an approximately circular frame of diameter 45 mm having an attachment length of 5 mm, the open area of the flow channels may be between 80 to 95% of the area of the orifice 202. For example, for an approximately circular frame of diameter 45 mm having an attachment length of 2.5 mm, the open area of the flow channels may be between 85 to 96% of the area of the orifice 202.

[0080] In some embodiments, flow from one side of the prosthetic valve 100 causes the diaphragm 108 to open (open configuration), by folding or collapsing the diaphragm, while flow from the other side of the prosthetic valve 100 causes the diaphragm 108 to close (close configuration), by unfolding or extending the diaphragm.

[0081] In some embodiments, the sutures 110 allow the diaphragm 108 to only partially fold, thereby allowing flow coming from the other side to unfold the diaphragm 108 when moving from the open configuration to the close configuration. In some embodiments, a potential advantage of avoiding total folding of the diaphragm is that it potentially avoids from the diaphragm to get stuck in a folded configuration, since the diaphragm will always have a small portion in an extended configuration that will allow from blood flow to enter the folded diaphragm and unfold it.

[0082] In some embodiments, the diaphragm 108 is attached to a periphery of the tricuspid annulus and / or frame 102. For example, attachment may be by means of the sutures 110. In some embodiments, the attachment optionally holds the diaphragm 108 at least partially expanded and / or open during diastole. In some embodiments, the attachment is along struts of the frame 102. In some embodiments, alternatively or additionally, the diaphragm 108 is sutured to the skirt. For example, the length of attachment and / or suture lines (suturing the diaphragm 108 to the frame and / or the skirt and / or the periphery of the orifice) may range between 0.1 to 1% and / or between 1% to 3% and / or between 3% to 5% and / or between 5% to 7% and / or between 7% to 10% and / or between 10% to 15% and / or between 15% to 30% and / or between 30% to 50% of the perimeter of the entire orifice for example the tricuspid annulus. Optionally, there may be one or more suture lines. For example, there may be 2 or 3 suture lines. In some embodiments, optionally, the diaphragm 108 is sutured not only along the perimeter of the frame but also in axial direction. In some embodiments, optionally, the diaphragm 108 is sutured not only along the perimeter of the frame but also in a diagonal direction in relation to the periphery. In some embodiments, the sutures follow the architecture of the frame. In some embodiments, the sutures hold a portion of the diaphragm 108 partially expanded and / or open during diastole.

[0083] In some embodiments, the prosthetic valve 100 includes a peripheral pericardium 114 (or skirt) attached to a portion of a frame 102. In some embodiments, the attachment of the peripheral pericardium 114 to the frame 102 is by means of sutures 116. In some embodiments, the skirt 114 covers the inner surface of the frame 102, for example an area ranging from 0 to 25% and / or from 25 to 50% and / or from 50 to 75% and / or from 75 to 100% of the inner walls of the frame 102. For example, the width of the skirt may range between 0.1 to 2 mm and / or between 2 to 4 mm and / or between 4 to 6 mm and / or between 6 to 10mm and / or between 10 to 15 mm. Optionally the skirt may be connected to another skirt may that covers the inner surface of the frame. For example, the skirt may cover an area ranging from 0 to 25% and / or from 25 to 50% and / or from 50 to 75% and / or from 75 to 100% of the inner walls of the frame and / or the orifice 202.

[0084] In some embodiments, the prosthetic valve 100 may be defined according to the location where it is implanted. For example, when the prosthetic valve 100 is used in a tricuspid valve, the prosthetic valve 100 can be defined as having a portion that is positioned in the ventricle, e.g. a ventricular oriented side, a portion which is engaged with the annulus, e.g., a middle portion, and a portion positioned in the atrium, e.g. atrial oriented side. In some embodiments, the anchors 104 are positioned in the ventricular side.

[0085] In some embodiments, the frame 102 is made of a resilient material and comprises a cantilever geometry. In some embodiments, optionally, the frame is a mesh. In some embodiments, the frame comprises a plurality of a resilient struts connected to each other via a plurality of contact points. In some embodiments, optionally, each strut is connected via said contact point intermittently, either to a strut positioned on its left side or to a strut positioned on its right side.

[0086] In some embodiments frame 102 may include one or more atrial extensions 118. In some embodiments, the extensions 118 optionally include anchors and / or stabilizers. In some embodiments, an atrial extension 208 may be bent to be approximately parallel (for example between +5 to -5 degrees and / or between +5 to +20 degrees and / or between -5 to -20 degrees) in relation to the frame 102 cross section. In some embodiments, optionally, the atrial extension 118 may be bent between 0 to -135 degrees and / or between 0 to +135 degrees and / or between +45 to +135 degrees and / or between -45 to -135 degrees in relation to the cross-section of the frame 102. In some embodiments, an atrial extension 118 extends outward between 0.5 to 2 mm and / or between 2 to 8 mm and / or between 8 to 12 mm and / or between 12 to 20mm. In some embodiments, a portion of the atrial extension may co-apt with the back wall of the heart tissue. For example, the coaptation may be with the inner wall of the atrium. In some embodiments, the atrial extension may be connected to the skirt 114 that covers the inner surface of the frame 102.

[0087] In some embodiments, the atrial extensions 118 are used to control the delivery of the exemplary prosthetic valve 100. In some embodiments, the exemplary prosthetic valve 100 is configured to allow re-sheathing during the delivery process to allow for re-positioning, if needed. In some embodiments, the re-sheathing is performed by controlling the positioning of the exemplary prosthetic valve 100 using the atrial extensions 118.

[0088] Exemplary dimensions of the exemplary prosthetic valve 100

[0089] Referring now to Figures 2a-2b, showing schematic side view representations of exemplary sizes of prosthetic valves, according to some embodiments of the invention.

[0090] In some embodiments, exemplary prosthetic valves are made in different sizes according to the needs. In some embodiments, when changing the sizes of the prosthetic valve, the whole device is amended accordingly. For example, a frame 102 of a first prosthetic valve defines an orifice 202 having a diameter of about 35mm, as shown for example in Figure 2a. When making the prosthetic valve bigger, the orifice 202’ defined by the frame 102 will increase as well, for example to a diameter of about 40mm, as shown for example in Figure 2b. In some embodiments, the exemplary device is configured to provide an outflow size of about 49mm, for example a size of from about 40mm to about 50mm, optionally from about 30mm to about 55mm, optionally from about 30mm to about 60mm. In some embodiments, a potential advantage of these sizes is that it potentially provides a low tricuspid valve gradient (TVG), which potentially indicates that the valve is functioning normally and there is minimal pressure difference across the valve.

[0091] It should be understood that the sizes mentioned in Figures 2a- 2b are exemplary sizes provided to allow a person having skills in the art to understand the invention and are not intended to limit the invention in any way.

[0092] In some embodiments, an exemplary prosthetic valve comprises an orifice 202 defined by the frame 102 having a diameter from about 30mm to about 50mm, optionally from about 20mm to about 60mm, optionally from about 10mm to about 80mm. In some embodiments, an exemplary prosthetic valve comprises an orifice 202 defined by the frame 102 having a diameter larger than 27mm. In some embodiments, an exemplary prosthetic valve comprises an axial length defined between anchors 104 from about 50mm to about 60mm, optionally from about 40mm to about 80mm, optionally from about 20mm to about 100mm. In some embodiments, an exemplary prosthetic valve comprises an axial length defined between the most distal points in the skirt 106 from about 60mm to about 70mm, optionally from about 50mm to about 80mm, optionally from about 30mm to about 120mm. In some embodiments, an exemplary prosthetic valve comprises a longitudinal length from about 20mm to about 25mm, optionally from about 18mm to about 30mm, optionally from about 10mm to about 40mm. In some embodiments, the prosthetic valve is configured to support an annulus having a diameter from about 50mm to bout 60mm, optionally from about 40mm to about 70mm, optionally from about 30mm to about 80mm. In some embodiments, contrary to prior art implants, the prosthetic heart valve described herein is configured to be implanted in hearts of patient presenting large annulus size. For example, an exemplary prosthetic heart valve can be implanted in patients presenting an annulus having a size of about 60mm.

[0093] In some embodiments, a region of the flow orifice is free from frame elements and / or rigid supports and / or rigid elements. For example, no metal cross piece and / or no self-supporting crosspiece. In some embodiments, the flow orifice is obstructed only by the diaphragm itself.

[0094] In general, the exemplary prosthetic valve is as described for example in US Patent

[0095] 11,045,311. Exemplary actuation of the exemplary prosthetic valve

[0096] In the following explanations, a tricuspid valve prosthesis will be used as reference for the explanations. It should be understood that the same principles apply to other types of valves, and that the following explanations are provided to allow a person having skills in the art to understand the invention and are not intended to be limiting in any way. In some embodiments, for example, for a tricuspid valve prosthesis, the diaphragm 108 is configured to close against the frame 102 during systole, impeding flow through the valve 100. In some embodiments, for example, for a tricuspid valve prosthesis, the diaphragm 108 is configured to be distanced from the frame 102 during diastole, opening one or more peripheral flow channels. In some embodiments, the valve 100 permits the annulus to flex while controlling flow through the two channels, the orifice and / or annulus. For example, the valve may permit one way flow.

[0097] In some embodiments, optionally, the valve allows mild and / or controlled regurgitation. For example, a valve that is connected to a chamber may allow regurgitation of a volume ranging between 1 to 10% of the volume of the chamber and / or between 10 to 15% and / or between 15 to 25% and / or between 25 to 40%. For example, in the case of a tricuspid prosthetic, the chamber may be the right ventricle. For example, limited regurgitation flow may be permitted from the right ventricle in the direction of the right atrium. For example, in the case of a tricuspid prosthetic, the regurgitated volume may range between 1 to 10 ml and / or between 10 to 15 ml and / or between 15 to 25 ml and / or between 25 to 40 ml. In some embodiments, regurgitated fluid may be returned to the original chamber. For example, for a tricuspid prosthetic some or all (for example ranging from 10 to 50% and / or from 50 to75 % and / or from 75 to 100%) of the fluid regurgitated from the ventricle during systole may be returned back to the ventricle during diastole. For example, regurgitated fluid may be returned to the ventricle at the beginning of diastole.

[0098] In some embodiments, the frame 102 of the valve 100 may take the form of a native annulus. For example, as the annulus flexes the frame 102 may flex and / or elastically deform. In some embodiments, the valve 100 closes and / or inhibits flow in one direction. For example, in the case of a tricuspid prosthetic valve, flow is blocked and / or inhibited from the right ventricle to the right atrium. Optionally a free edge of the diaphragm 108 is held pressed to the periphery of the orifice 202 (for example along an inner wall of the frame 102) by fluid pressure and / or close the valve 100. Optionally an attachment between the frame 102 and the diaphragm 108 prevents the diaphragm 108 from being pushed through the orifice 202.

[0099] In some embodiments, for example at the beginning of systole, flow into a portion of the diaphragm 108 that was expanded and / or open during diastole causes the diaphragm 108 to fill up with blood. In some embodiments, when the diaphragm 108 fills, a free edge of the diaphragm 108 is pushed against the periphery of the orifice 202 and / or frame 102, blocking back flow.

[0100] In some embodiments, due to the size and architecture of the diaphragm 108, the passage between an open configuration and a close configuration is not immediate. In some embodiments, the passage between an open configuration and a close configuration is gradual. In some embodiments, a potential advantage of providing a slower, gradual passage is that it potentially reduces the stress on the heart (see below). In some embodiments, providing a diaphragm that closes gradually enables to provide a reduced RV peak pressure gradient (max dP / dt - which refers to the maximum pressure change over time), which potentially provides and / or allows to preserve the RV function, due to the fact that it not exposes the RV to extreme changes in pressure that can further damage the heart.

[0101] Exemplary improvement of the Right Ventricle (RV) function

[0102] In some embodiments, a potential advantage of implanting a prosthetic device as disclosed herein is that, in addition to replacing the native valve, it potentially provides an improvement in the RV function, when compared with other devices having a same technical scope. Referring now to Figure 3, showing a graph comparing the RV function in function of the Fractional Area Change (FAC) in patients that were implanted with a prosthetic valve according to the present invention and patients that were implanted with a prior art valve. The Fractional Area Change (FAC) is obtained by tracing the right ventricular endocardial border at end diastole and end systole. The difference in the area at end diastole and end systole is divided by the area at end diastole. This is a reproducible measure of function that is not affected by pericardiotomy. It should be noted that a FAC above 35% is considered normal.

[0103] The graph shows that patients having a FAC below 35%, meaning presenting some level of RV dysfunction, were implanted with the prosthetic valve according to the present invention. After 30 days and even after 6 months, the FAC in those patients was well above 35% (around 40%).

[0104] Contrary to the above, other patients were implanted with a prior art implant. According to the specifications of that specific prior art implant, only patients having a FAC around 40% are eligible to receive the implant. As can be seen, after 30 days, the FAC was below 35% (around 25%), and it stayed at that level even after 6 months. It should be reminded again, that a FAC below 35% is considered abnormal and is an indication of RV dysfunction.

[0105] In summary, it can be seen that albeit the lower FAC base line in the patients that were implanted with a prosthetic valve according to the present invention in comparison with those than that of the prior art valve, there is a significant improvement in the RV function after 30 days and even after 6 months, when compared with the prior art valve.

[0106] Exemplary improvement in both RV function and tricuspid regurgitation

[0107] Referring now to Figure 4, showing a flowchart representing the changes in the status in patients treated with the prosthetic valve according to the present invention and in patients treated with a prior art valve.

[0108] The X axis in the flowchart in Figure 4 represents the state of tricuspid regurgitation in the patient. It is divided in two states to facilitate the explanations: “none to moderate” and “severe to torrential”.

[0109] The Y axis in the flowchart in Figure 4 represents the state of RV function / dysfunction in the patient. It is also divided in two states to facilitate the explanations: “normal function to mild dysfunction” and “moderate dysfunction to severe dysfunction”.

[0110] The flowchart shows that, according to the prior art guidelines, patients presenting severe to torrential regurgitation must present a normal RV function to mild RV dysfunction in order to qualify for implantation. After the implantation, the regurgitation is reduced to none or moderate, but at the same time, the same patients begin to present moderate to severe RV dysfunction. It is clear that the prior art valve replaces one disease (regurgitation) with another (RV dysfunction) - for example it does not reduce tricuspid regurgitation and in the same time reduces RV function. Without being bound to theory, the reason behind this phenomenon is that the prior art valve resolves the problem of regurgitation while applying a considerable stress to the RV. This happens because of the architecture of the diaphragm of the prior art valve that causes an immediate closure and opening of the valve. In a heart that has suffered of regurgitation, this change in function is dramatic, causing the heart to miss the opportunity to adapt to the new conditions, which then causes the development of the RV dysfunction.

[0111] The flowchart also shows that the prosthetic valve of the present invention can be implanted in patients presenting both pathologies: a severe to torrential regurgitation and mild to severe RV dysfunction. It can also be shown, that the results of the trials showed that implanting the prosthetic valve of the present invention solves the regurgitation in the patients while ameliorating the RV function in the patients. It is clear that the prosthetic valve of the present invention treats one condition (regurgitation) without replacing it with another (reduction in RV function), and additionally is capable of improving the state of patients, Without being bound to theory, the reason the prosthetic valve of the present invention is capable of providing this, is because of the architecture of the prosthetic valve, which allows a slower and / or gradual closure of the diaphragm that provides a less dramatic change in the status / pressure of the heart, which then allows thee heart to adapt to the new conditions, which then allows for an improvement in the RV function.

[0112] Exemplary treatment of patients presenting from normal RV function to severe RV dysfunction

[0113] Referring now to Figure 5, showing a flowchart representing the potential percentage of population which can be treated with the prosthetic valve of the present invention in comparison with prior art valves.

[0114] It should be noted that the flowchart is provided as an example and that the numbers provided are exemplary and are provided to allow a person having skills in the art to understand the invention.

[0115] The X axis in the flowchart in Figure 5 represents the recommended treatable perimeter- derived diameter range in systole. It is divided in three ranges: lower or equal than 55mm (which is about 75% of the population), between 55mm and 65mm (which is about 20%) of the population, and equal or above 65mm (which is about 5% of the population).

[0116] The Y axis in the flowchart in Figure 5 represents the state of RV function in the population. It is also divided in three groups: presenting normal RV function, having a FAC above 35% (about 53% of the population), presenting a mild to severe RV dysfunction, having a FAC from about 25% to about 35% (about 37% of the population), and presenting a very severe RV dysfunction, having a FAC below 25% (about 25% of the population).

[0117] The graph shows that while the prior art valve is capable of treating patients presenting a recommended treatable perimeter-derived diameter lower or equal than 55mm and presenting a normal RV function, having a FAC above 35%, the prosthetic valve of the present invention can be implanted, in addition to those cases as the prior art valve, also in patients presenting a recommended treatable perimeter-derived diameter between 55mm and 65mm and patients presenting a mild to severe RV dysfunction, having a FAC from about 25% to about 35%.

[0118] It can also be seen that the prosthetic valve of the present invention is adapted to address the needs of 85% of the patient population, while the prior art valve is also adapted to address the needs of about 40% of the patient population.

[0119] Exemplary Effective Orifice Area (EQ A) as parameter for implantation

[0120] In some embodiments, the exemplary prosthetic valve described herein is configured to provide an Effective Orifice Area (EOA) bigger than prior art prosthetic valves. For example, prior art prosthetic valves provide a EOA up to about 2cm2. In some embodiments, the prosthetic valve of the present invention provides a valve having a EOA bigger than 2cm2, for example an EOA between about 3cm2and about 5cm2, optionally between about 2.5cm2and about 5.5cm2, optionally between about 2cm2and about 7cm2, for example an EOA of 3.84 cm2, 5.05 cm2. In some embodiments, a potential advantage of providing a prosthetic valve having said EOA sizes is that it potentially reduces the chances of an increase in the in the tricuspid valve diastolic mean gradient, thereby potentially avoiding damages caused by an increase in the pressure that occurs in the prior art valve, as will be further shown below.

[0121] Exemplary improvement in cardiac output

[0122] Referring now to Figure 6a showing a flowchart comparing the continuous wave tricuspid valve diastolic mean gradient between the prosthetic valve of the present invention and the prior art valve.

[0123] It can be seen that both baselines are similar, while after 30 days, there is an increment in the pressure. In some embodiments, this is apparently caused by the small area of flow provided by the prior art valve. In some embodiments, the prosthetic valve of the present invention provides a big enough flow channel to potentially avoid an increase in the tricuspid valve diastolic mean gradient, thereby potentially avoiding damages caused by an increase in the pressure that occurs in the prior art valve.

[0124] Referring now to Figure 6b and 6c, showing flowcharts of a comparison of the cardiac output in patients after implantation of the prosthetic valve of the present invention and the prior art valve. It can be seen that after 30 days patients having the prosthetic valve of the present invention have an improvement in cardiac output of about 26% when compared to prior art valves.

[0125] Exemplary method of selection of patients

[0126] Referring now to Figure 7 showing a flowchart of an exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention.

[0127] In some embodiments, a method of selection of a patient for prosthetic valve implantation comprises one or more of the following actions:

[0128] 1. Identifying a patient presenting a severe to torrential tricuspid regurgitation 702.

[0129] 2. Identifying a patient presenting a mild to severe RV function 704. In some embodiments, the patient presents a moderate to severe RV dysfunction (presents a moderate reduction in RV function to a severe reduction in RV function). In some embodiments, the patient presents a FAC of from 25% to 35%. In some embodiments, the patient presents a FAC above 10%.

[0130] 3. Implanting a prosthetic valve according to the present invention 706. Referring now to Figure 8 showing a flowchart of an exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention.

[0131] In some embodiments, a method of selection of a patient for prosthetic valve implantation comprises one or more of the following actions:

[0132] 1. Identifying a patient presenting a severe to torrential tricuspid regurgitation 802.

[0133] 2. Identifying a patient presenting a mild to severe RV function 804. In some embodiments, the patient presents a moderate to severe RV dysfunction (presents a moderate reduction in RV function to a severe reduction in RV function). In some embodiments, the patient presents a FAC of from 25% to 35%. In some embodiments, the patient presents a FAC above 10%.

[0134] 3. Identifying a patient presenting a recommended treatable perimeter-derived diameter between 20mm and 80mm 806. In some embodiments, the patient presents a recommended treatable perimeter-derived diameter above of equal 20mm.

[0135] 4. Implanting a prosthetic valve according to the present invention 808.

[0136] Referring now to Figure 9 showing a flowchart of an exemplary method of selection of a patient for prosthetic valve implantation, according to some embodiments of the invention.

[0137] In some embodiments, a method of selection of a patient for prosthetic valve implantation comprises one or more of the following actions:

[0138] 1. Identifying a patient presenting a severe to torrential tricuspid regurgitation 902.

[0139] 2. Identifying a patient requiring a prosthetic heart valve having an EOA higher than 2cm2904. In some embodiments, the prosthetic heart has an EOA of up to 7cm2.

[0140] 3. Implanting a prosthetic valve according to the present invention 906.

[0141] Exemplary method of increasing cardiac output in a patient

[0142] Referring now to Figure 10 showing a flowchart of an exemplary method of increasing a cardiac output in a patient, according to some embodiments of the invention.

[0143] In some embodiments, a method of increasing a cardiac output in a patient comprises one or more of the following actions:

[0144] 1. Identifying a patient presenting a severe to torrential tricuspid regurgitation 1002.

[0145] 2. Identifying a patient presenting a low cardiac output, for example of about 3.5 to 4.0 L / min 1004.

[0146] 3. Implanting a prosthetic valve according to the present invention 1006.

[0147] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’. The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0148] The term “consisting of’ means “including and limited to”.

[0149] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0150] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0151] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0152] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0153] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0154] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0155] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0156] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0157] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0158] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic heart valve, comprising: a. a frame sized and shaped to fit in an orifice of a heart valve and defining a flow channel; b. a flexible diaphragm connected to said frame at two locations, each location opposite to the other; a portion of said flexible diaphragm in each of said two locations is held partially expanded along the length of the frame, and said flexible diaphragm divides said flow channel into two channels; wherein said flow channel comprises a diameter of from about 30mm to about 50mm.

2. The prosthetic valve according to claim 1 , wherein said valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2.

3. The prosthetic valve according to claim 1 or claim 2, wherein said valve comprises an effective orifice area (EOA) higher than 2cm2.

4. The prosthetic valve according to any one of claims 1-3, wherein a size of said flexible diaphragm and said connection at two locations causes said flexible diaphragm to open and close gradually.

5. The prosthetic valve according to any one of claims 1-4, wherein implantation of said prosthetic heart valve increases or maintains right ventricle (RV) function as measured using fractional area change (FAC).

6. The prosthetic valve according to any one of claims 1-5, wherein implantation of said prosthetic heart valve does not exchange one disease with another, for example it does not reduce tricuspid regurgitation while at a same time reduces RV function.

7. The prosthetic valve according to any one of claims 1-6, wherein said prosthetic heart valve is configured to be implanted in patients presenting a normal RV function.

8. The prosthetic valve according to any one of claims 1-7, wherein said prosthetic heart valve is configured to be implanted in patients presenting a reduced RV function.

9. The prosthetic valve according to any one of claims 1-8, wherein said prosthetic heart valve is configured to be implanted in patients presenting an abnormal RV function.

10. The prosthetic valve according to any one of claims 1-9, wherein said prosthetic heart valve is configured to be implanted in patients presenting a FAC of from 10% to 60%.

11. The prosthetic valve according to any one of claims 1-10, wherein said prosthetic heart valve is configured to be implanted in patients presenting a FAC above 10%.

12. The prosthetic valve according to any one of claims 1-11, wherein said prosthetic heart valve is configured to be implanted in patients presenting a recommended treatable perimeter- derived diameter between 20mm and 80mm.

13. The prosthetic valve according to any one of claims 1-12, wherein said prosthetic heart valve is configured to be implanted in patients presenting a recommended treatable perimeter- derived diameter above or equal 20mm.

14. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function to severe RV dysfunction.

15. The method according to claim 14, further comprising implanting a prosthetic valve according to claim 1.

16. The method according to claim 14 or claim 15, wherein said patient presents a normal RV function to severe RV dysfunction.

17. The method according to any one of claims 14-16, wherein said patient presents a FAC of from 10% to 60%.

18. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function severe RV dysfunction;c. identifying that said patient presents a recommended treatable perimeter-derived diameter between 20mm and 80mm.

19. The method according to claim 18, further comprising implanting a prosthetic valve according to claim 1.

20. The method according to claim 18 or claim 19, wherein said patient presents a normal RV function to severe RV dysfunction.

21. The method according to any one of claims 18-20, wherein said patient presents a FAC of from 10% to 60%.

22. The method according to any one of claims 18-21, wherein said patient presents a recommended treatable perimeter-derived diameter above or equal 20mm.

23. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient requiring a prosthetic valve having an EOA higher than 2cm2.

24. The method according to claim 23, further comprising implanting a prosthetic valve according to claim 1.

25. The method according to claim 23 or claim 24, wherein said prosthetic valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2.

26. A method of patient selection for a prosthetic valve implantation, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient presenting a low cardiac output of about 3.5 to 4.0 L / min.

27. The method according to claim 26, further comprising implanting a prosthetic valve according to claim 1.

28. A method of improving RV function, comprising: a. a. identifying a patient presenting a severe to torrential tricuspid regurgitation;b. identifying that said patient presents normal RV function to severe RV dysfunction; and c. implanting a prosthetic valve according to claim 1.

29. The method according to claim 28, wherein said patient presents normal RV function to severe RV dysfunction.

30. The method according to claim 28 or claim 29, wherein said patient presents a FAC of from 10% to 60%.

31. A method of treatment comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying that said patient presents normal RV function to severe RV dysfunction; c. identifying that said patient presents a recommended treatable perimeter-derived diameter between 20mm and 80mm; and d. implanting a prosthetic valve according to claim 1.

32. The method according to claim 31, wherein said patient presents normal RV function to severe RV dysfunction.

33. The method according to claim 31 or claim 32, wherein said patient presents a FAC of from 10% to 60%.

34. The method according to any one of claims 31-33, wherein said patient presents a recommended treatable perimeter-derived diameter above or equal 20mm.

35. A method of treatment, comprising: a. identifying a patient presenting a severe to torrential tricuspid regurgitation; b. identifying a patient requiring a prosthetic valve having an EOA higher than 2cm2; and c. implanting a prosthetic valve according to claim 1.

36. The method according to claim 35, wherein said prosthetic valve comprises an effective orifice area (EOA) between about 2cm2and about 7cm2.

37. A method of improving cardiac output by more than 15%, comprising:a. identifying a patient presenting a severe to torrential tricuspid regurgitation; and b. implanting a prosthetic valve according to claim 1.

Images