One-way valve implant

Abstract

The invention relates to a one-way valve implant. The valve implants and vascular closure devices herein are configured to be positioned in a heart and block regurgitated blood from the heart into a blood vessel supplying blood to the heart. The valve implant may have a cap, a membrane, a valve, a resilient frame, and / or other features. Some valve implants may have anchors positioned in a blood vessel, such as in a pulmonary vein, and may anchor the implant to a heart wall. Various embodiments of the cap and / or membrane act as valves that contract and expand to alternately permit and occlude blood flow. The valve implant may cover one or more blood vessels, such as one, two, three or four pulmonary veins, and may also be configured and implanted to occlude an appendage of the heart, such as the left atrial appendage.

Description

[0001] This application is a divisional application. The application date of the original application is December 4, 2019, the application number is 201980088980.6, and the name of the invention is “One-way valve implant”, which is incorporated herein by reference in its entirety.

[0002] Related Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 776,100, filed on December 6, 2018, entitled “ONE-WAY VALVE IMPLANT,” which is incorporated herein by reference in its entirety. Technical Field

[0004] The present application relates generally to one-way valve implants. Background Art

[0005] If any heart valve does not function properly, heart function will be seriously impaired. Heart valves may lose the ability to close normally, such as due to dilation of the annulus around the valve, ventricular dilatation, or relaxation of the valve leaflets, leading to valve leaflet prolapse. The valve leaflets may also shrink due to diseases such as rheumatic diseases, leaving gaps in the valve between the valve leaflets. The inability of the heart valve to close properly can lead to backward leakage through the valve and / or blood vessels (i.e., from the outflow side to the inflow side), commonly known as regurgitation. Heart valve regurgitation may seriously impair heart function because more blood must be pumped through the regurgitated valve to maintain adequate circulation. Heart valve regurgitation reduces the efficiency of the heart, reduces blood circulation, and increases the stress on the heart. In the early stages, heart valve regurgitation can cause fatigue or shortness of breath. If left unchecked, the problem may lead to congestive heart failure, arrhythmia, or death.

[0006] Heart valve disease, which can include valvular regurgitation, is usually treated by replacing or repairing the diseased valve. However, when the anatomy of the mitral valve is dysfunctional but not diseased, indirect treatment approaches may be considered advantageous.

[0007] Functional mitral regurgitation (MR) is a common clinical entity that can occur when the mitral valve structure is normal, and the regurgitation is due to failure of mitral valve leaflet coaptation without coexisting structural changes in the valve itself. Functional MR differs from primary MR in that, in primary MR, there are impaired or structurally disrupted components of the mitral valve that affect both mitral valve structure and function, which can be caused by a variety of diseases.

[0008] Figure 1 and 2sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves). In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 5 and 6 , which extend inwardly across respective orifices that meet or "join" in the flow stream to form a one-way, fluid-occlusive surface.

[0009] Figure 3 and 4 is an illustration of a human heart H including a pulmonary vein 301 and a pulmonary vein ostium 302 located in the wall surface of the left atrium LA. Figure 3 The approximate anatomical location of the pulmonary veins PV is illustrated. The pulmonary veins can be grouped into two pairs of pulmonary veins, each pair providing blood flow from one lung to the left atrium. This pairing and the anatomical distance between each pulmonary vein can be used to determine which exemplary embodiment is suitable for implantation. Figure 4 A simplified schematic cross-sectional view of a heart is shown having four pulmonary veins draining into the left atrium LA.

[0010] For the purpose of illustration, the native valve repair system of the present application is mainly described with respect to the mitral valve MV. Therefore, the anatomical structure of the left atrium LA and the left ventricle LV will be explained in more detail. However, it should be understood that the device described herein may also be applicable to repair other parts of the body, native valves and / or blood vessels, for example, the device can be used to repair the tricuspid valve TV, for example, by preventing backflow into one or more of the inferior vena cava IVC, the superior vena cava SVC and / or the coronary sinus CS.

[0011] The left atrium LA receives oxygenated blood from the lungs. During diastole or the relaxation of the heart, e.g. Figure 1 As shown, blood collected in the left atrium LA enters the mitral valve MV through the expansion of the left ventricle LV. During systole or contraction of the heart, as shown Figure 2 As shown, the left ventricle LV contracts, forcing blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back into the left atrium LA.

[0012] refer to Figure 1-6, the mitral valve MV is shown having two leaflets: an anterior leaflet 502 and a posterior leaflet 504. The mitral valve MV also includes an annulus 506, which is a fibrous ring of tissue of variable density surrounding the leaflets 502, 504. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Instead, the papillary muscles support the mitral valve MV against the high pressures required for blood to circulate throughout the body. The papillary muscles and chordae tendineae are referred to as the subvalvular apparatus, and their function is to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0013] Various disease lesions can impair the normal function of one or more native valves of the heart H. These disease lesions include degenerative lesions (e.g., Barlow's disease, fibroelastic defects), inflammatory lesions (e.g., rheumatic heart disease), and infectious lesions (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the geometry of the native valve, which can lead to native valve dysfunction. However, most patients who undergo valve surgery (such as mitral valve MV surgery) suffer from degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 502, 504) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0014] A native valve can malfunction in a number of different ways. One possible malfunction is valvular stenosis, which occurs when the native valve does not open fully, resulting in blood flow obstruction. Typically, valvular stenosis is caused by a buildup of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the valve's ability to open fully to allow forward blood flow.

[0015] Another possible dysfunction is valvular regurgitation, which occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle to the left atrium). There are three mechanisms that can lead to native valve regurgitation or dysfunction, including Carpentier's Type I, Type II, and Type III dysfunction. Carpentier's Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to distract from each other and fail to form a tight seal (i.e., fail to coapt properly). Type I mechanism dysfunction is leaflet perforation, such as in endocarditis. Carpentier's Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III dysfunction involves restriction of the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally restricted below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease (Ma) or ventricular dilatation (IIIb).

[0016] refer to Figure 5 , when the healthy mitral valve MV is in the closed position, the anterior leaflet 502 and the posterior leaflet 504 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 6 Regurgitation occurs when the anterior leaflet 502 and / or posterior leaflet 504 of the mitral valve MV are displaced into the left atrium LA and / or do not coapt with the other leaflet during systole. This failure to coapt results in a gap 608 between the anterior leaflet 502 and the posterior leaflet 504, which allows blood to flow from the left ventricle LV back into the left atrium LA during systole. As described above, there are several different ways that leaflets (e.g., leaflets 502, 504 of the mitral valve MV) may malfunction, which may result in regurgitation.

[0017] Regurgitation is a common problem affecting the mitral valve MV and the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for the circulation of blood flow throughout the body, dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the substantially higher pressures on the left side of the heart, dysfunction of the mitral valve MV or aortic valve AV can be even more problematic.

[0018] Heart valve diseases, such as valvular regurgitation, are usually treated by replacing or repairing the diseased valve. Summary of the invention

[0019] This summary of the invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, unless the claim explicitly states the feature, any feature included in the example of the summary of the invention is not necessary for the claim. In addition, the features, components, steps, concepts, etc. described in the examples of the summary of the invention and other places in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0020] In one exemplary embodiment, the implants, devices, and systems described herein are used to repair or improve the function of a defective mitral valve MV.

[0021] An exemplary apparatus, implant or device for closing and / or covering a pulmonary vein opening in the left atrium of a heart has at least one pulmonary vein closure device or cover having a flexible frame and a valve. The pulmonary vein closure device has two configurations: an open configuration that allows blood to flow from the pulmonary vein into the left atrium and a closed configuration that blocks blood from flowing from the left atrium into the pulmonary vein.

[0022] In some embodiments, the apparatus or device may also have a second elastic frame and a bridge connecting the frames, wherein one or more membranes are attached to and span each elastic frame. The one or more membranes may be part of an embodiment having an opening and a leaflet or flap attached to the membrane over the opening. The membrane may also be part of an embodiment wherein each membrane has an opening and the membranes gather to close the opening. Various embodiments may also have a strain reducing ring on each elastic frame.

[0023] In some embodiments, the elastic frame may have struts and a membrane covering the struts to define an internal volume. The membrane may collapse inwardly to define an open configuration, and the membrane may define a closed configuration when expanded. In some embodiments, the open configuration provides a flow channel between the membrane and the left atrium wall. In the closed configuration, the membrane may be configured to abut the pulmonary vein orifice to block fluid flow.

[0024] In various embodiments, the valve can be a check valve and the resilient frame can have one or more friction enhancing elements and / or coverings on at least a portion of the frame.

[0025] In various embodiments, the frame can anchor the valve in the left atrium. In various embodiments, the device may include at least one anchor (e.g., a first anchor) or one or more anchors. A cover or film can be connected to the elastic frame so that the cover or film forms a seal between the anchor and the frame. In some embodiments, there can be a second anchor. The second anchor can be integrated with the frame and / or connected to the frame via a film, and can be connected to the first anchor via a connecting portion of the film and / or frame. The anchor and the valve can be integrated with the frame and / or connected to the frame via the same film. In some embodiments, the pulmonary vein cover also has a third and fourth anchor connected to the film. One, some or all of the anchors can be configured as a stent, such as a cylindrical stent portion, etc.

[0026] A method for implanting an apparatus, device, or system in a heart (e.g., any of the apparatus, devices, and / or systems described above or elsewhere herein) can have, and in some embodiments does have, one or more of the following steps: inserting a guide catheter into the left atrium of the heart; advancing a delivery tube having at least one compression pulmonary vein cover or closure device into the left atrium; and expanding the pulmonary vein cover or closure device in the left atrium. Additional method steps may include removing a pull wire or suture from the pulmonary vein cover or closure device. The method may include implanting a pulmonary vein cover or closure device having an integrated valve and anchor, and / or it may include implanting the anchor and valve separately. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Further features and advantages of the present invention will become apparent from the description of the embodiments using the accompanying drawings.

[0028] In the figure:

[0029] Figure 1 A cross-sectional view of a human heart during diastole is shown.

[0030] Figure 2 A cross-sectional view of a human heart during systole is shown.

[0031] Figure 3 A cross-sectional view of a human heart with four pulmonary vein ostia is illustrated.

[0032] Figure 4 Another cross-sectional view of a human heart with four pulmonary vein ostia is illustrated.

[0033] Figure 5 Shown is a healthy mitral valve, viewed from the atrial side of the mitral valve, with the leaflets closed.

[0034] Figure 6 The figure shows a dysfunctional mitral valve, with gaps visible between the leaflets, as viewed from the atrial side of the mitral valve.

[0035] Figure 7 A schematic diagram of a portion of a human heart with an exemplary check valve located in an ostium of a pulmonary vein is illustrated.

[0036] Figure 8 A schematic diagram of a portion of a human heart with an exemplary closed position check valve located in an ostium of a pulmonary vein is illustrated.

[0037] Fig. 9 A schematic diagram of a portion of a human heart with an exemplary open position check valve in a pulmonary vein ostium is illustrated.

[0038] Fig. 10A A schematic diagram of a portion of a human heart with an exemplary membrane in a closed position is illustrated.

[0039] Fig. 10B A schematic diagram of a portion of a human heart with an exemplary valve implant or device in an open position is illustrated.

[0040] Fig.11A A schematic diagram of a portion of a human heart is illustrated with two exemplary valve implants or devices in a closed position.

[0041] Fig. 11B A schematic diagram of a portion of a human heart is illustrated with two exemplary valve implants or devices in an open position.

[0042] Fig. 12A An exemplary valve implant or device is illustrated in an open position.

[0043] Fig. 12B An exemplary valve implant or device is illustrated in a closed position.

[0044] Fig.13A A schematic diagram of a portion of a human heart with an exemplary annular support is illustrated, wherein a valve, such as a check valve, is in an open position.

[0045] Fig. 13B yes Fig.13A A plan view of an exemplary embodiment of a support and valve is shown in FIG.

[0046] Fig. 13C illustrates a schematic diagram of a portion of a human heart with an exemplary support, and Fig.13A The valve is in the closed position.

[0047] Fig.14 A schematic diagram of a portion of a human heart is illustrated with a valve integrated with an exemplary docking device positioned in the left atrium of the human heart.

[0048] Fig.15 A valve and an exemplary docking device are illustrated.

[0049] Fig.16A A schematic diagram of a portion of a human heart with an exemplary support (which may be ring-shaped and / or disc-shaped, for example) is illustrated, with multiple valves such as a check valve in an open configuration.

[0050] Fig. 16B yes Fig.16A A plan view of an exemplary support and valve.

[0051] Fig. 16C A schematic diagram of a portion of a human heart with an exemplary support is illustrated, wherein: Fig.16A The multiple valves are in a closed configuration.

[0052] Fig.16D Exemplary embodiments of exemplary hemispherical support components of valve implants or systems are illustrated.

[0053] Fig.16E A diagram showing a multi-valve or check valve Fig.16D Schematic diagram of a portion of an exemplary hemispherical support member.

[0054] Fig.16F is along Fig.16E A view taken along line 16F-16F in FIG.

[0055] Fig.17AIllustrated is a schematic diagram of a portion of a human heart with an exemplary valve implant or device having a central opening in an open configuration.

[0056] Fig. 17B is along Fig.17A A view taken along line 17B-17B in FIG.

[0057] Fig. 17C The diagram shows a closed configuration. Fig.17A Schematic diagram of a portion of a human heart with a valve implant or device.

[0058] Fig.17D is along Fig. 17C A view taken along line 17D-17D in FIG.

[0059] Fig.17E The diagram shows Fig.16D An exemplary hemispherical support assembly Fig.17A Schematic diagram of a portion of a human heart of an exemplary valve implant or device.

[0060] Fig.18A An exemplary valve implant or device is illustrated in an open configuration.

[0061] Fig.18B An exemplary valve implant or device is illustrated in a closed configuration (ie, a configuration that closes a blood vessel opening).

[0062] Fig.19A An exemplary valve implant or device configured as a pulmonary vein valve implant or device is illustrated shown in an open configuration relative to a pulmonary vein ostium.

[0063] Fig.19B The pulmonary vein ostium is shown in a closed configuration relative to the pulmonary vein ostium (ie, a configuration that closes the pulmonary vein ostium or opening). Fig.19A An exemplary valve implant or device.

[0064] Fig. 20A An exemplary valve implant or device is illustrated in an open configuration.

[0065] Fig. 20B The diagram shows a closed configuration (ie, a configuration that closes the blood vessel opening). Fig. 20A An exemplary valve implant or device.

[0066] Fig.21A A cross-sectional view of an exemplary valve implant or device in an open configuration positioned between heart chamber walls is illustrated.

[0067] Fig.21B is along Fig.21AA view taken along line 21B-21B in FIG.

[0068] Fig. 21C is a cross-sectional view of an exemplary valve implant or device in a closed position positioned between heart chamber walls.

[0069] Fig.21D is along Fig. 21C A view taken along line 21D-21D in FIG.

[0070] Fig. 22 A schematic diagram of an exemplary delivery device or system positioned in the left atrium that may be used to deliver at least a portion of a valve implant or device is illustrated.

[0071] Fig.23 A schematic diagram of any exemplary valve implant or device deployed in the left atrium is illustrated.

[0072] Fig.23A A side view of an exemplary support frame is illustrated.

[0073] Fig. 23B Picture shows Fig. 23B A top plan view of the supporting frame.

[0074] Fig.23C Illustration attached to Fig.23A and 23B An exemplary embodiment of a film of a frame.

[0075] Fig.23D Illustration attached to Fig.23A and 23B An exemplary embodiment of a film with an opening in a frame.

[0076] Fig.23E The left atrium of a human heart is shown in a closed configuration taken along section line 23E-23E. Fig.23D Schematic diagram of the device.

[0077] Fig.23F The left atrium of the heart is shown in an open configuration taken from section line 23E-23E. Fig.23D Schematic diagram of the device.

[0078] Fig.24 A side view of an exemplary anchor or anchor frame is illustrated.

[0079] Fig.25 Picture shows Fig.24 The bending of the anchor or anchor frame shown in FIG.

[0080] Fig.26 Picture shows Fig.24Expansion and contraction of the anchor frame portion and the flexible portion of the anchor or anchor frame.

[0081] Fig. 27 An exemplary anchor or anchoring framework is illustrated deployed in a blood vessel.

[0082] Fig.28 An exemplary valve implant, device or system is illustrated having an anchor or anchor frame mounted in a blood vessel and a dock or dock frame mounted in the left atrium.

[0083] Fig.29 Picture shows Fig.28 Schematic diagram of deployment of two valve implants or devices of an exemplary embodiment illustrated in FIG.

[0084] Fig.30 An exemplary valve implant or device is illustrated having a docking portion or docking section and an anchor or anchoring member for anchoring within a blood vessel orifice.

[0085] Fig.31 Picture shows Fig.30 Schematic diagram of deployment of four valve implants or devices of an exemplary embodiment illustrated in FIG.

[0086] Fig.32 A valve implant or device is illustrated having four anchors or anchoring frames for fitting in four vessels, such as four pulmonary veins, and an exemplary docking portion / docking section (or optionally, an integrated valve / valve section).

[0087] Fig.33 Picture shows Fig.32 A schematic diagram of deployment of a pulmonary vein implant device according to an exemplary embodiment is illustrated in FIG.

[0088] Fig.34 An exemplary pulmonary vein implant device having two valve segments is illustrated.

[0089] Fig.35 The diagram shows the Fig.34 Exemplary valve panels or membranes in the illustrated embodiments.

[0090] Fig.36 Picture shows Fig.34 An exemplary valve leaflet, membrane or flap of the embodiment illustrated in FIG.

[0091] Figures 37A-37C is based on Fig.34 The schematic diagram shows an exemplary framework of an implant in three different orientations, bottom, side and perspective views.

[0092] Fig.38An exemplary valve implant or device is shown having a wireframe and two valves or valve portions or segments that may be incorporated into a Figure 34-37C The features shown in FIG. 1 are the same or similar features.

[0093] Fig.39 An exemplary valve implant or device is illustrated having a wire frame and a single-piece thin film valve or valve portion.

[0094] Fig.40 The diagram shows a valve implant or device such as Fig.39 An exemplary film of an exemplary implant / device is illustrated in FIG.

[0095] Fig.41 A schematic diagram of an exemplary valve implant or device implanted in the left atrium is illustrated.

[0096] Figures 42A-42I Diagram of the Figure 34-41 Exemplary steps of a valve implant according to the embodiment illustrated in FIG.

[0097] Figures 43A-43D Diagram of the Figure 34-41 Exemplary steps of a valve implant according to the embodiment illustrated in FIG.

[0098] Fig.44 An exemplary valve implant or device is illustrated having a wire frame and two valves or valve portions or segments.

[0099] Fig.45 Picture shows Fig.44 Another view of the valve implant.

[0100] Fig.46 Illustration of the closed configuration in the left atrium Fig.44 Schematic diagram of the valve implant.

[0101] Fig.47 Illustration of the open configuration in the left atrium Fig.44 Schematic diagram of the valve implant.

[0102] Fig.48 A schematic diagram of an exemplary valve implant or device in a closed configuration in the left atrium is illustrated.

[0103] Fig.49 A schematic diagram of an exemplary valve implant in an open configuration in the left atrium is illustrated.

[0104] Fig.50 The diagram shows Figure 44-49 A deployed valve implant of the embodiment illustrated in FIG.

[0105] Fig.51 A schematic diagram of an exemplary stent cover for a valve implant or device is illustrated.

[0106] Fig.52 A schematic diagram of an exemplary docking ring skirt cover for a valve implant or device is illustrated.

[0107] Fig.53 A schematic diagram of an exemplary stent cover having tapered edges for a valve implant or device is illustrated.

[0108] Fig.54 A schematic diagram of an exemplary docking ring skirt having a tapered edge for a valve implant or device is illustrated.

[0109] Fig.55 The diagram shows Fig.54 The diagram in the figure is used for assembly according to Fig.23 Another view of a schematic diagram of an exemplary stent cover in a first position of an exemplary embodiment of a soft-covered valve implant.

[0110] Fig.56A The diagram shows the assembly according to Fig.23 Schematic diagram of an exemplary stent cover in a second position with the side of an exemplary embodiment of a soft covered valve implant method being bent.

[0111] Fig.56B The diagram shows the Fig.56A Schematic side view of the bracket cover in the second position shown in FIG.

[0112] Fig.56C The diagram shows the Fig.56A Schematic front view of the bracket cover in the second position shown in FIG.

[0113] Fig.57 A schematic perspective view of the bracket cover in a third position is illustrated, wherein the first side is partially bent.

[0114] Fig.58 A schematic perspective view of the bracket cover in a fourth position when the first side forms a substantially cylindrical shape is illustrated.

[0115] Fig.59 A perspective view of a schematic diagram of a bracket cover in a fifth position is illustrated when the second side portion is bent.

[0116] Fig.60A A schematic diagram of the bracket cover is shown in a sixth position, wherein both sides now have a substantially cylindrical shape.

[0117] Fig.60BPicture shows Fig.60A Another schematic diagram of the bracket cover shown in FIG.

[0118] Fig.61 A schematic diagram of an exemplary docking ring skirt is illustrated in a first, flat position.

[0119] Fig.62 A schematic diagram of an exemplary docking ring skirt in a second position wrapped around a stent cover is illustrated.

[0120] Fig.63A A schematic diagram of an exemplary soft covering applied to a valve implant according to an exemplary embodiment is illustrated.

[0121] Fig.63B A schematic diagram of an exemplary soft covering applied to a valve implant and underlying frame is illustrated.

[0122] Fig.64 The diagram shows Figure 51-63B Schematic diagram of an exemplary embodiment of a valve implant implanted in the left atrium. DETAILED DESCRIPTION

[0123] Disclosed herein are various exemplary embodiments of implant devices, apparatuses, and systems that can be docked in chambers of the heart or atria and / or nearby blood vessels (e.g., the left atrium of the heart and / or the pulmonary veins), methods of implanting devices, and methods of covering implants with soft materials. The devices, apparatuses, systems, etc. disclosed herein can provide indirect treatment of valvular regurgitation such as mitral regurgitation. The disclosed devices, apparatuses, systems, etc. can be used to prevent blood from flowing back through blood vessels in the wrong direction. Various devices, apparatuses, systems, etc. can be expanded from a compressed state (e.g., sufficient to be delivered to the heart via a delivery catheter via a blood vessel or via the femoral artery) to an expanded or deployed state.

[0124] For example, when the heart has a mitral valve with regurgitation, the device, apparatus, system, etc. herein can be used to prevent the blood in the left atrium from flowing back into the pulmonary vein. For example, when the heart is in systole, implants, devices, apparatus, systems, etc. can be used to block the blood from flowing into the pulmonary vein by blocking the pulmonary vein orifice, because this may occur in the case of mitral valve prolapse or other mitral valve or other heart defects. The implants, devices, apparatus, systems, etc. herein can have a valve or valve portion and an elastic frame. The frame can provide a position or docking / landing area for the valve to be inserted, or have a valve or valve member integrated with the frame. Implanting such a valve in the left atrium and / or pulmonary vein can prevent high pressure below or downstream of the valve position, reducing the consequences of regurgitation, for example, blood flows from the left atrium into the pulmonary vein, which may cause pulmonary edema.

[0125] refer to Figure 7-9, illustrating an exemplary valve implant system or a schematic diagram of a valve implant system. Figure 7 Four separate implants 701 are schematically illustrated, one in each pulmonary vein 301, wherein each valve implant comprises a one-way valve or valve member 702. The valve may be a non-return valve having a number of different forms. Any valve configured for use within the heart may be used. Figure 8 The valve implant 701 is shown in a closed position. This position may occur when the heart is in systole to prevent backflow through the blood vessels or pulmonary veins. Backflow blood flow in the left atrium caused by a defective mitral valve can be prevented by positioning the one-way valve in a direction where blood cannot flow from the left atrium back into the pulmonary veins. Arrow 801 indicates the direction of the blood, and line 802 indicates that the valve is closed to blood flowing in the direction of the arrow. Fig. 9 In FIG. 7 , valve 702 is in an open configuration, freely allowing blood in the pulmonary veins to flow into the left atrium LA. Fig. 9 Arrow 901 in indicates the direction of blood flow through the valve and into the left atrium, which may occur, for example, when the heart is in diastole or the pressure in the left atrium is relatively low. Figure 7-9 The schematic diagrams presented in represent any exemplary embodiments of a single pulmonary vein check valve or valve system described herein. In this type of system, one or more valves can be used (e.g., one valve in one vein, two valves in two veins, three valves in three veins, four valves in four veins, etc.).

[0126] Valvular regurgitation, such as blood flowing from the ventricles into the atria and back into the veins supplying the atria, can be prevented by placing a one-way valve implant (such as a ventral ventricular valve) comprising a thin membrane in or over a vein supplying the atria (such as the four pulmonary veins in the left atrium). Figures 10A-11B As shown in the schematic implementation example, Figures 10A-11B An "umbrella" shaped, "umbrella" or dome-shaped implant) is shown for indirect treatment.

[0127] refer to Fig. 10A and 10B , shows an exemplary closure device, valve or valve implant 1002 having a dome, umbrella or hemispherical shape. The valve implant 1002 is depicted as a one-way pulmonary vein valve implant that is configured to act on all four pulmonary vein orifices 302 simultaneously. Fig. 10AThe valve implant is depicted when the heart is in systole and the pressure in the heart chamber or left atrium is elevated, with the valve 1002 in a closed configuration (i.e., a configuration in which blood is blocked from flowing back into the blood vessels or pulmonary veins). In the closed position, the membrane of the valve 1002 seals the openings of all blood vessels (e.g., all four depicted pulmonary veins) so that any blood in the atrium cannot flow back up and through the blood vessels or pulmonary veins. Arrow 1001 indicates the direction in which the blood is attempting to flow. Blood in a heart with a normal mitral valve will flow from the left ventricle and out of the heart through the aortic valve and into the aortic arch. However, in the event that the mitral valve is damaged, some blood will flow back into the left atrium. The pulmonary vein valve or valve implant 1002 blocks retrograde flow of blood in the left atrium into the pulmonary veins.

[0128] Fig. 10B The valve or valve implant 1002 is illustrated in an open configuration. For example, when the heart is in diastole, oxygenated blood from the lungs can enter the left atrium through the pulmonary veins. The membrane of the valve 1002 is in a relaxed configuration in which it is spaced from the pulmonary veins so that blood can flow around them, or between the membrane and the atrial wall into the atrium. In this configuration, the blood vessels or pulmonary vein orifices are not blocked. Arrows 1003 indicate the direction of blood flow from the veins into the atrium. Such a valve or valve implant improves cardiac output (which can reduce the risk of pulmonary edema) by enhancing forward flow and blocking regurgitation or the reverse flow of blood back into the veins and other organs (such as the lungs).

[0129] The valve or implant can be of different sizes and located at different locations or heights within the atrium. In some exemplary embodiments, the implant includes a membrane that can be positioned against the top of the left atrium to block blood flow into a vessel such as the pulmonary vein. In some exemplary embodiments, components of the implant device can extend all the way down to the native mitral valve without obstructing blood flow. The size of the implant in the exemplary embodiments can be configured to fit the anatomy of the atrium and / or the veins that supply blood to the atrium, such as the left atrium and / or the pulmonary veins. For example, the implant described below Fig.34 The exemplary embodiment shown in can have a film having a size ranging from about 3 cm to about 5 cm.

[0130] refer to Fig.11A and 11B , illustrates an exemplary closure device / system or valve implant / system 1002. In this embodiment, the system is provided with Fig. 10A and 10B works in a similar way and can be used with Fig. 10A and 10B1002 (which may be completely separate, unconnected implants, or in some embodiments may be linked or attached in some manner). The membrane of each valve implant occludes a different blood vessel, for example, each valve implant may occlude a set of two pulmonary vein orifices when in a closed configuration. In some embodiments, one membrane covers or is configured to cover the pulmonary vein orifices from the left lung, while the other membrane covers or is configured to cover the pulmonary vein orifices from the right lung. Fig.11A is a schematic diagram when the membrane of each of the two valves or valve implants 1002 is in a closed configuration. Fig. 11B The two membranes are shown in an open configuration. Fig. 11B The open configuration provides a flow path from the blood vessels or pulmonary veins to the heart or left atrium.

[0131] The embodiments described herein can also be implanted in a suitable position to cover the opening of an appendage or aneurysm such as the left atrial appendage opening. The exemplary embodiments described herein can be deployed by a transapical approach or by a transvascular approach, such as a transseptal approach, for example, through the lateral venous fossa and into the final position in the left atrium.

[0132] refer to Fig. 12A and 12B , illustrating a valve implant (which may be similar to Figures 10A-11B Schematic diagram of an exemplary embodiment of a valve implant), such as a dome or “umbrella” type one-way valve or valve implant. Fig. 12A Diagram showing the open position and Fig. 12B The closed position is shown. Fig. 12A In the exemplary embodiment of the valve portion or sealing member 1003 (e.g., membrane, etc.) of the valve implant 1002 has a curved and / or domed shape so that it curves away from the blood vessel 301. The stem 1201 is optional, and the valve implant can be secured to the heart or atrium of the heart by other means, such as a friction fit, or having anchors or barbs attached to the heart or atrium wall. Fig. 12B The closed configuration of the valve implant 1002 is illustrated, wherein a blood vessel 301, such as a pulmonary vein, is blocked. In the closed configuration, blood cannot flow into the heart through the blood vessel orifice or flow back from the heart into the orifice or blood vessel.

[0133] refer to Figures 13A to 13C , illustrating an embodiment of a valve implant or device. Fig.13A In the example shown, the device has an anchor or support 1301 in which a valve or check valve 702 is positioned. The anchor or support is partially located in the left atrium. Fig.13AIn the embodiment, valve 702 is in an open position so that blood can flow through valve 702, such as from a vein (e.g., pulmonary vein, IVC, SVC, etc.) into the heart or an atrium (e.g., a portion of an atrium) of the heart, and from there through a natural valve (e.g., mitral valve, etc.) into a ventricle (e.g., left ventricle, etc.) of the heart. Fig. 13B is along Fig.13A A cross-sectional view of the anchor or support portion 1301 and the valve 702 located in the atrium, taken along line 13B-13B in FIG.

[0134] exist Fig. 13C , the valve or check valve 702 is in a closed position. Pressure exerted by regurgitant blood (such as from the left ventricle through the mitral valve) causes the valve 702 to close and prevents blood from flowing in a retrograde manner into a blood vessel, such as the pulmonary vein. The valve 702 and anchor or support 1301 are exemplary and may take the form of embodiments described in more detail elsewhere herein.

[0135] The various vascular closure devices and valve implants herein may be attached to the desired location in the heart by friction fit and / or utilizing friction enhancing elements 1302 such as frame hooks, barbs, clips, adhesives, bonding, etc. These may also include anchors, anchoring portions, and / or include portions or areas that assist or promote tissue ingrowth to better secure them in the desired location / positioning over time.

[0136] Fig.14 and 15 An exemplary valve implant, assembly or system is schematically illustrated. In this example, a separate anchor, support or docking station 1401 has a docking portion or landing area 1402 for a separate valve 702. In this example, the docking station 1401 is first deployed in the atrium and then the valve 702 is deployed in the docking portion, docking portion or landing area of ​​the docking station 1401. In one embodiment of a similar assembly / system, the valve 702 may already be assembled with and attached to the anchor or support 1401. The docking station valve, for example, in Fig.14 1401 and the valve 702. The assembly or system having the docking station 1401 and the valve 702 controls blood flow through the valve without directly blocking the orifice of a blood vessel such as a pulmonary vein. An enlarged schematic diagram of the docking station and the valve is shown in FIG. Fig.15 The docking station 1401 can be configured to maintain its position in the left atrium in a variety of ways, including, for example, by a friction fit and / or utilizing friction enhancing elements 1302, such as frame hooks, barbs, clips, adhesives, bonding, and the like.

[0137] The valve 702, or any valve described herein as docked in another anchor, support, docking portion, or docking station, can be a variety of types of valves (e.g., collapsible and expandable transcatheter prosthetic heart valves such as the Edwards Lifesciences SAPIEN 3 or CENTERA valves, etc.).

[0138] about Figures 16A-16C , illustrates a schematic diagram of an exemplary valve implant or system having an anchor, docking station or support having multiple valves. Figures 13A-13C As in the embodiment shown, blood flowing from a blood vessel such as the pulmonary vein into the upper portion of the heart (e.g., the left atrium or the right atrium) can flow through the open valve or check valve 702 and into the lower portion of the heart or atrium, and from there into another chamber of the heart, such as the left ventricle or the right ventricle, when the check valve 702 is in the open position. When the heart is in diastole, the valve 702 can be in the open position so that the open check valve allows blood to flow from the blood vessel 301 (indicated by arrow 1601) through the atrium to and through the mitral valve or tricuspid valve. Fig. 16B is a cross-sectional view taken along line 16B-16B showing the anchor or support 1301 and valve 702 positioned in the atrium.

[0139] Fig. 16C The valve 702 is shown in the closed position. Fig.16A and 16B Schematic diagram of an anchor of . The closed position occurs when the heart is in systole. For example, when the left ventricle contracts in a heart with a defective mitral valve, blood flow (indicated by arrow 1602) re-entering the left atrium pushes on the valves 702 so that they are in a closed position and blood cannot flow back into the upper portion of the left atrium.

[0140] Fig.16D An exemplary hemispherical dome-shaped or umbrella-shaped support portion 1603 is illustrated, which can be an integral part of the docking station / anchor 1301 or a separate component coupled or otherwise attached to the docking station / anchor 1301. The dome or support portion 1603 can have a stent-like structure and can have struts similar to those commonly used in stents. The dome / support 1603 can optionally have an opening at the top 1604 and can be open at the bottom 1605. In the illustrated embodiment, the dome / support 1603 is uncovered so that blood can flow through the openings of all cells of the stent-like structure. In another embodiment, portions of the dome 1603 (e.g., such as those portions that do not cover the pulmonary veins) can be covered with a material or film, such as a fabric, a cover, or a tissue, such as pericardial tissue.

[0141] Fig.16E and16F A schematic diagram of an exemplary dome or dome-shaped support 1603 is illustrated, wherein: Fig.16A -C multiple valves deployed in the atrium. In this embodiment, the dome / support 1603 occupies the upper portion of the atrium to hold the valve 702 in place in the atrium. Fig.16F is along Fig.16E 16F-16F of FIG. 7A and 7B showing a cross-sectional view of the dome-shaped support 1603 and valve 702 taken along line 16F-16F in FIG. 7B (looking upward from below the anchor 1301). Fig.16E and 16F The illustrated embodiment may include a support portion 1301 or another structure to block blood flow around the valve 702. Thus, Fig.16E and 16F The device shown is Figures 16A-16C The devices shown operate in essentially the same manner.

[0142] Fig.17A -D illustrates a schematic diagram of an exemplary closure device / system or valve implant / system providing unidirectional flow. Fig.17A 1701. In the embodiment, the implant is in an open configuration. In the open configuration, the implant allows blood to flow through the implant, as indicated by the unidirectional arrow 1701. In this embodiment, the implant may have a dome, umbrella or hemisphere, or a shape similar to a dome, umbrella or hemisphere. The implant may be tented against the left atrium wall. Also in this embodiment, the implant has a valve portion, which is depicted as a film 1002 in these figures. The implant may have one or more valve portions or films covering some or all of the implant, and may have an outflow opening 1702 in the center of one or more implant films. Fig. 17B is along Fig.17A of Fig.17A 17B-17B in FIG. 17B and illustrates the relative position of the pulmonary vein PV relative to the outflow opening 1702 of the membrane. The valve portion or membrane 1002 of the implant moves up and down in the atrium depending on whether the heart is in systole or diastole. In diastole, the membrane may be in Fig.17A The open configuration of the apparatus and blood can flow through the centrally located outflow opening 1702.

[0143] During systole, the valve portion or membrane may be in Fig. 17C and 17D The closure configuration shown in is to prevent or inhibit retrograde flow of blood. Fig. 17C , the membrane is shown in contact with the upper surface of the left atrium, for example, so that the pulmonary vein orifice 302 is completely blocked by the membrane 1002. In this configuration, blood cannot flow back from the left atrium to the pulmonary vein by any pressure of the reverse blood. Arrow 1703 indicates that the membrane 1002 is pushed against the left atrium wall. Fig.17D is along Fig. 17C 17D-17D of the view of the pulmonary vein, and particularly illustrates the closure of the pulmonary vein orifice. In the closed configuration, no blood can flow into the pulmonary vein through the opening 1702 of the membrane.

[0144] Fig.17E The diagram shows Fig. 17C Schematic diagram of an implant similar to the embodiment shown, but with the addition of a hemispherical dome / support 1603 that can have a stent-like configuration. The dome / support can be Fig.16D The dome / support 1603 is the same or similar to the dome / support shown in FIG. 1604 or another similar configuration. The dome / support 1603 properly positions the membrane 1002 in the left atrium. Thus, Fig.17E The device shown is Figures 17A-17D The devices shown operate in essentially the same manner.

[0145] Fig.18A and 18B An exemplary closure device / system or valve implant / system is illustrated having a frame 1801 and one or more valve portions of a membrane 1002 (or multiple membranes) configured to be attached to the frame. Frame 1801 (and other frames described elsewhere) may include nitinol, steel, plastic, elastomeric material, and / or other flexible materials that can expand from a compressed condition (e.g., sufficient to be delivered to the heart via a delivery catheter transvascularly or transfemorally) to an expanded or deployed condition. The frame has a membrane 1002 attached thereto. The membrane may be made of pericardium, ePTFE, PET, and / or another biocompatible material. The membrane may be treated and / or coated with chemicals, drugs, etc. to prevent or inhibit calcification and / or tissue ingrowth into the membrane. The membrane may be secured to frame 1801 by suturing, electrospinning, or other lamination processes. Fig.18A 18, implant 1800 is in an open configuration, and blood can flow through gaps formed between the outside of membrane 1002 and the heart wall or atrium wall, wherein each opening for blood flow is defined by a gap between struts 1806 of frame 1801. Blood can also flow through central opening 1702. However, the central opening is optional.

[0146] exist Fig.18B , a closed configuration is illustrated. In the closed configuration, the membrane expands outward to form a convex surface to abut against the atrial wall and occlude a blood vessel orifice, such as a pulmonary vein orifice.

[0147] Fig.19A and 19B The diagram shows Figures 18A-18BThe exemplary closure device / system or valve implant / system shown in FIG. 1 has a pulmonary vein 301 added to the illustration. In the open configuration, each segment of the membrane 1002 is in a recessed position so that the ostium of the pulmonary vein is not blocked by the membrane. There is a gap 1804 between each pulmonary vein ostium 302 and the membrane 1002. However, in the open configuration, each segment of the membrane 1002 is in a recessed position so that the ostium of the pulmonary vein is not blocked by the membrane. Fig.19B In the occluding flow configuration, the membrane blocks the orifice of the pulmonary vein and there is no gap between the orifice and the membrane. The membrane blocking the pulmonary vein prevents blood from flowing into the pulmonary vein.

[0148] Fig. 20A , 20B 21A and 21B illustrate similar Fig.18A and 18B The exemplary closure member or valve implant or system shown, but without the central opening, covers the center 2001 instead. Fig.21A and 21B An open configuration of a one-way valve implant is illustrated. Fig. 21C and 21D The closed configuration of the same embodiment is shown. The valve portion or membrane 1002 and frame 1801 allow only one-way blood flow when implanted in an atrium, such as the left atrium. Fig.21B , blood flowing in from a blood vessel or pulmonary vein (indicated by arrow 2101) can pass through the implant gap, exposing the flow path between the membrane and the atrium for blood to flow through. Fig.21B is from Fig.21A 0 is a view taken along line AA in FIG. 1 and illustrates the gap between the membrane and the atrial wall when the valve device is open, such as when the heart is in diastole.

[0149] exist Fig.21D In the systole phase, the implant is in a closed configuration and there is no blood flow, even if there is valve regurgitation. A closed configuration occurs when the membrane is close to the atrial wall to block blood flow back into the vessel, for example, when it is close to the left atrial wall to block blood flow to the pulmonary veins. Fig.21D The diagram shows Fig. 21C The implant is observed in line CC.

[0150] The various systems and implants disclosed herein can be delivered via the fossa ovalis (FO) in a transvascular and / or transseptal approach. The right atrium is approached transvascularly or transfemorally. If deployed in the right atrium, the system or implant can be deployed upon reaching the right atrium. If deployed in the left atrium, a transseptal puncture is performed, such as via the FO. In one embodiment, a guidewire 2201 is inserted into the heart H and, as shown, the ... Fig. 22 As shown positioned in the LAA, or in one of the pulmonary veins. The implantable system or implant can be advanced over a guidewire into the left atrium. Fig. 22A guidewire 2201 is illustrated in a heart H positioned from the fossa ovalis through the left atrium to the left atrial appendage (LAA), with the distal end 2202 of the guidewire in the LAA. Fig.23 A schematic diagram of a closure device or valve implant 1800 is illustrated with a resilient structural frame 2300 being deployed. The implantable system has been advanced over a guidewire and into the left atrium. The positioning of the guidewire helps stabilize and locate the position of the system, as the FO and LAA are identifiable landmarks in the cardiac anatomy. The implant is then deployed in place. A balloon may be used to expand the implant until it attaches to the left atrium wall and / or the implant may be self-expanding and / or mechanically expandable for deployment.

[0151] Fig.23A and 23B Picture shows Fig.23 An optional view of the elastic structural frame 2300. Fig.23A A side perspective view of the frame 2300 is shown, and Fig. 23B A top plan view of a frame 2300 is illustrated. The frame 2300 may have two ends 2301 where the frames 2302 come together and / or connect together. The ends 2301 may be circular or cylindrical or any other shape that allows the frame 2300 to be attached to a deployment tool. An opening 2303 may be provided to allow one or more valve portions and / or membranes to be attached to the struts. The valve portion or one or more membranes may span the opening, as will be described in more detail below, or cover selected portions of the frame and / or opening.

[0152] Fig.23C and 23D An exemplary embodiment of a film 2304 attached to a frame 2300 is shown. Fig.23D In the embodiment of the present invention, two membranes 2304 are attached to the frame 2300 and can be attached to the struts 2302. Each membrane can cover a portion of the exterior of the dome-shaped frame such that there is a gap 2305 between the membranes. When the implant 1800 is in the open configuration, the gap 2305 allows blood to flow from the upper part of the atrium to the lower part of the atrium. The membrane can be configured to cover one, some, or all blood vessels (e.g., pulmonary veins PV) to prevent blood flow when in the closed configuration.

[0153] exist Fig.23D 2304 is attached to the struts 2302 of the frame 2300. The membrane can be a single membrane attached to the frame as shown (or can be multiple membranes), and can have at least one opening 2306 to allow blood to flow from one side of the membrane to the other side of the membrane when the device 1800 is located in the heart, such as in the left atrium, and in an open position. When implanted, the membrane is aligned so that the solid portion of the membrane covers one or more of the blood vessels or pulmonary veins PV. Thus, the membrane prevents blood flow in the closed position.

[0154] Fig.23E and 23F is along Fig.23C and 23D These cross-sectional views illustrate Fig.23C and 23D The operation of each device. Fig.23E , implant 1800 is in a closed configuration. Arrow 2308 indicates that reverse blood flow that would otherwise flow back into the blood vessels or pulmonary veins is blocked by membrane 2304. Blood flow is blocked because in the closed configuration, the pressure of the reverse blood flow pushes the membrane against the heart wall or left atrium wall 2307. Fig.23F 2, implant 1800 is in an open configuration and blood flow enters the left atrium from the blood vessels or pulmonary veins as indicated by arrow 2309. In the open configuration, struts 2302 position the membrane against the heart wall or left atrium wall 2307. Pressure from the incoming blood flow causes portions of membrane 2304 to be pushed inward, which in turn causes blood to flow through gaps in the membrane ( Fig.23C Reference character 2305) or opening ( Fig.23D Reference character 2306 in the figure creates space 2310 for blood to enter above the membrane before entering a heart chamber, such as the lower portion of the left atrium or the right atrium.

[0155] The system or implant 1800 can have the configuration of any embodiment described herein; implant 1800 is intended as a general depiction of any embodiment disclosed herein. The implant can be delivered transseptally, transapically, transatrially, by transaortic techniques, or other delivery methods.

[0156] The system or implant 1800 can also be designed to close an aneurysm or appendage in the heart, such as the left atrial appendage LAA. For example, in an embodiment where the LAA is to be closed from the left atrium, the film portion of the implant surrounding the LAA can be designed to remain closed and serve as a LAA closure. For example, struts can be placed around the LAA, or the film in this area can have a harder material than elsewhere in the implant so that the device permanently seals the LAA.

[0157] Various features of the exemplary embodiments described herein include various frame shapes, such as a sphere, hemisphere, dome, ring, disk, or other shapes that conform to the LAA. The devices are illustrated as circular; however, in actual practice, the contour of the device can match the shape of the atrial wall. The frame can be made of nitinol, stainless steel, MP35, and / or other metals.

[0158] refer to Figure 24-27 , in one exemplary embodiment, Figure 28-33The anchor or anchor frame 2801 of the illustrated embodiment includes springs or spring / flexible segments 2401 to allow the anchor 2801 to bend. The frame 2801 is elastic. The spring / flexible segments 2401 allow the stent segment to be anchored to the wall of the vessel while enabling the docking station to bend as needed. Fig.24 In the example shown, the frame or stent segments 2402 are attached to each other by a plurality of springs or spring / flexible segments 2401. Any anchor or anchor frame shown and described herein may optionally have any combination of spring / flexible segments 2402 and frame or stent segments 2401. The spring / flexible segments 2402 may take a variety of different forms. Examples of spring / flexible segments 2402 include, but are not limited to, spring wires, springs constructed by selectively removing material to compress the spring, torsion springs, and / or extension springs.

[0159] refer to Fig.25 , the spring / flexible section 2402 allows the anchor or anchor frame 2801 to bend more easily. The frame 2801 can be bent in a variety of different ways. Fig.25 In the example shown, the spring on one side 2501 is stretched, while the spring on the other side 2502 is compressed to bend in the direction shown. Since multiple springs / flexible sections 2401 are provided in the frame 2801, the frame can be easily bent in different directions along the length of the frame 2801.

[0160] Fig.26 The illustration shows that the frame or stent segment 2402 is expandable (indicated by arrow 2601) and compressible (indicated by arrow 2602). By having individual stent segments 2402 connected by spring / flexible segments 2401, the frame can more easily conform to vessels or pulmonary veins having different sizes. The combination of stent segments 2402 and spring segments 2401 allows the anchoring frame to conform to vessels having varying cross-sectional sizes of the vessel, cross-sectional shapes of the vessel, and flow shapes or paths of the vessel.

[0161] Fig. 27 An exemplary embodiment of an anchor or anchor bracket 2801 is shown, which includes two frame or bracket segments 2402 connected by a spring segment 2401. Fig. 27In the example shown, anchoring stent 2801 is deployed in a blood vessel (referred to as pulmonary vein 301 for illustration), which is curved and has a variable cross-sectional size. The first framework or stent segment 2402a expands to a first size to conform to the size of the pulmonary vein at the position where the first framework or stent segment is deployed. The second framework or stent segment 2402b expands to a second, larger size to conform to the size of the pulmonary vein at the position where the second framework or stent segment is deployed. Anchoring stent 2801 without valve can be positioned in the pulmonary vein. The pulmonary vein is bent from the position of the first stent or framework segment 2402a to the position of the second stent or framework segment 2402b. Spring element 2401 allows the framework to bend and conform to the curvature of the pulmonary vein.

[0162] Fig.28 Another embodiment of a closure device or valve implant / system is illustrated having a docking portion 1401 with a valve 702. As with other exemplary embodiments described herein, the valve may be integral to the docking portion, or may be a separate component that is inserted in a separate step after the docking portion is inserted. Fig.28 The docking portion 1401 in the embodiment may have an anchor or anchoring portion 2801, which is only a part of the entire device and may have a Figure 24-27 The implant 2800 has two anchors or anchor portions 2801 (which may be pulmonary vein anchors) and a docking portion 1401 (which may be an atrial docking portion) for holding a one-way valve. The anchors 2801 may be stents and may be made of superelastic laser cut tubing or braided nitinol tubing and may have alternating struts. The anchors 2801 may be covered with a suture cloth or a polymer coating that is polymer impregnated or applied by electrospinning. The covering applies sealing properties to the device. The diameter of each anchor / anchoring portion applies a smaller outward force so it can match a larger range of diameters while applying a constant force. The material properties allow the material to adapt to different anatomical structures so that after implantation there can be a seal between the two anchors 2801, for example, in a blood vessel or pulmonary vein, regardless of the exact anatomical spacing between the two blood vessels or pulmonary veins. The docking portion or atrial docking portion 1401 may be made of superelastic laser cut tubing, such as Figure 24-27 The tube may be made of braided nitinol. In embodiments where the valve is implanted alone, the docking portion 1401 may have a higher force than the anchor or anchor portion to allow the valve 702 to dock.

[0163] Fig.28Also illustrated is a connector 2803 between the docking portion 1401 and the anchor / anchoring frame 2801. The connector can be made in a variety of ways, for example, it can be made of a variety of one or more materials, such as cloth or a dense nitinol braid, or the connector can be any biocompatible material that is soft and inhibits blood flow, and / or can form a seal between the anchors. In an exemplary embodiment, the rigid component can hold the nitinol frame, and a covering or soft material can be used to seal the rigid component. In an exemplary embodiment, the material 2803, the stent 2801, and the anchor 1401 are all sealed together so that blood flow from the blood vessels or pulmonary veins is directed downward and leaves through the valve 702. The connector 2803 holds the anchor in place relative to the docking portion and maintains the proper positioning of the components of the implant relative to each other. The complete implant unit 2800 can be covered with a soft material to seal the device and prevent inappropriate blood flow.

[0164] Fig.29 An exemplary position of the heart is shown. Fig.28 Implant. By using two implants, each with two pulmonary vein anchors, one or two pairs of pulmonary veins can be selected for protection. One pair of pulmonary veins enters the left atrium from the left lung and the other pair of pulmonary veins enters the left atrium from the right lung. By using one implant device 2800, one pair of pulmonary veins can be protected from inappropriate blood flow. The pulmonary veins protected from inappropriate blood flow can be those that connect the right lung or the left lung to the left atrium. By using two implant devices 2800, all four pulmonary veins can be protected from inappropriate blood flow.

[0165] During the first stage of implantation, one or two anchoring units may be implanted. Then in the second stage of implantation, valve 702 may be implanted in each atrial docking portion or docking anchor. Implant 2800 may be implanted transseptally or transapically. The cover material (e.g., cloth, cloth-like material, polymer, etc.) in combination with the stent-like frame of the anchor is configured to allow the elements of the device to be compacted and positioned in a delivery catheter for transcatheter delivery through the vasculature and into the right atrium or left atrium of the heart.

[0166] Fig.30 and 31 The diagram is similar to Fig.28 and 29Schematic diagram of an exemplary closure device or valve implant docking portion. There is an anchor or anchoring stent 2801 connected to the docking portion 1401. In one embodiment, the anchor / anchoring stent 2801 can be configured to be implanted in a pulmonary vein while the docking portion 1401 remains in the left atrium. One or more implants 3000 can be implanted, such as one, two, three, four, etc. identical units separated from each other; for example, one unit 3000 can be implanted in each pulmonary vein. By using implant 3000, any combination of one to four blood vessels or pulmonary veins can be protected from inappropriate blood flow. The materials and structure of the components can be the same as the dual pulmonary vein anchor embodiment. However, there is no need for a piece of material or anything to connect any pulmonary vein anchors 2801 together. In various embodiments, material 2803 connects the anchor 2801 to the docking portion 1401, which provides a fluid seal around the valve.

[0167] Fig.32 and 33 A schematic diagram of an exemplary closure device or valve implant / system 3200 is illustrated. Implant 3200 has four vascular anchors or anchoring portions 2801 for a one-way valve and a docking portion 1401. All four vascular anchors 2801 are shown connected to the same valve implant / system. The connector or sack 2803 can be nitinol or other biocompatible material and can be covered with cloth to provide a seal to block unwanted blood flow. The connector or sack 2803 in this embodiment can have an opening at the top near the blood vessel or pulmonary vein orifice to direct blood flow through the connector or sack and through the valve. Figure 28-31 As in the embodiment described in the previous section, the valve 702 in the docking portion 1401 is a one-way valve. The anchor and stent of this embodiment are similar to Figure 28-31 The valve may be integrated with the docking portion or implanted as part of a two-stage procedure, wherein the first stage includes implanting the anchoring component and the second stage includes implanting the valve. In all embodiments where the valve is already connected to the anchor, the valve may be connected to the anchor by suturing.

[0168] refer to Figure 34-41 , discloses an exemplary closure device or valve implant / system. In this embodiment, two one-way portions 1002, each including a one-way valve portion 702 and each configured to cover a plurality of blood vessels, such as two pulmonary vein ostia each. Fig.34 A schematic diagram of this embodiment is illustrated and how it may be positioned, for example, in the left atrium LA of the heart.

[0169] Figures 37A-37CThe flexible wireframe 3700 of various configurations is shown. The frame may be made of Nitinol. The frame 3700 has a connecting bridge 3701 between two frame bases 3702. The frame bases may be large curved portions, loop portions, expansion portions, etc. The frame bases may have a variety of shapes in two and three dimensions, including circular, oval, elliptical, other shapes, substantially or approximately one or another of these shapes, etc., and may also have strain reducing elements 3703. The strain reducing elements may be annular and may face inward (not shown) or they may face outward, such as Fig.37A As shown in . The connecting bridge 3701 can be a tube, a spring, a wire and / or other structures.

[0170] Fig.35 and 36 Exemplary one-way valve portions or components of a two-layer membrane valve are illustrated. Fig.35 The first membrane or valve plate 3501 is shown attached to a frame base 3702. The first layer has an outer periphery with optional notches 3502 to help properly fit and connect the membrane to the base. The first layer also has openings 3503. Fig.36 A second membrane, leaflet or flap 3601 is shown covering the opening 3503 of the first layer 3501. These two membranes form the one-way valve or valve portion of the wireframe implant.

[0171] exist Fig.38 middle, Fig.35 , 36 All elements of 37A-37C are assembled together to form a closure device or valve implant / system. In one embodiment, the valve implant or system is configured as a pulmonary vein valve implant for use with all four pulmonary veins. Each membrane can cover a portion of the left atrium wall having two pulmonary vein orifices. In one embodiment, the valve implant or system is configured to cover a portion of the right atrium wall to cover the inferior vena cava IVC and the superior vena cava SVC orifices. On each side of the implant, blood entering the heart (e.g., entering the left atrium, etc.) from a blood vessel (e.g., from the pulmonary veins, etc.) can flow freely into the heart or left atrium through opening 3503. However, the membrane, leaflet or flap 3601 is positioned so that blood cannot flow back from the heart (e.g., left atrium, right atrium, etc.) into the blood vessel (e.g., pulmonary veins, IVC, SVC, etc.). Any blood in the left atrium due to a defective mitral valve, or any blood in the right atrium due to a defective tricuspid valve will cause the flap 3601 to be pushed back against the atrial wall and block the opening of the blood vessel. The flap 3601 may be attached to the first layer of film 3501 by sutures, adhesives, or other known techniques.

[0172] Fig.39An exemplary embodiment of a linear valve implant or system formed using a membrane is illustrated.Each membrane or valve plate 3501 can be made from a single piece of material attached to one or both of the frame bases 3702 to form a one-way valve or valve portion that is activated by flow. Fig.40 Picture shows Fig.39 The film 3501 also has an opening 3503 and may have a notched periphery with optional notches 3502. The film may be attached to the frame such that the material of the film gathers to open the opening 3503. Blood entering the heart (e.g., left atrium, right atrium, etc.) from a blood vessel (e.g., pulmonary vein, etc.) may flow into the heart (e.g., left atrium, right atrium, etc.) through the opening 3503. However, the gathered material is pushed and flattened by any backflowing blood to expand and close the opening 3503 to prevent or inhibit blood from flowing back into the blood vessel. Fig.41 The diagram shows a device implanted in a suitable location, such as in the left atrium of the heart. Fig.39 3701 , the frame base 3702, the bridge tube 3701 , the single layer membrane 3501 and the opening 3503 in the membrane are visible. Two membranes 3503 can cover all four pulmonary veins.

[0173] exist Figures 42A-42I , an exemplary deployment of a linear, membrane valve implant, or closure device is illustrated. Deployment can be performed transvascularly or transseptally, including through a flexible, active introducer sheath, from the right atrium to the left atrium through the fossa ovalis. Deployment can be performed in a living animal or in a non-living cadaver, cadaver heart, simulator, anthropomorphic ghost, etc. Reference Fig.42A and 42B , for example, advancing the tube toward the left atrial appendage. Fig.42C and 42D , the implant is deployed by pulling back the tube and advancing the internal pusher. Figures 42E-42H Once the distal membrane valve is deployed, the catheter is retracted to deploy the remainder of the implant. Fig.42I , the final stage of deployment is the release of the internal pull wire or suture 4203. The device is fully retractable throughout deployment by pulling back the pull wire and / or suture 4203 in the proximal direction.

[0174] Fig.42A The introducer sheath 4201 is shown in a flexed position. Fig.42B A delivery catheter or tube 4202 is shown emerging from an introducer sheath 4201. When deployed in the heart, the introducer sheath and delivery catheter may be pointed in the direction of the left atrial appendage. Fig.42C In, the implant 3200 is advanced out of the delivery catheter / tube. Fig.42DIn the embodiment, the implant is sufficiently advanced so that the first membrane 3201 is deployed. The first membrane portion of the implant can be positioned above one or more vascular openings (e.g., pulmonary vein openings, etc.) on one side of the atrium. Fig.42E The illustration shows the deployed first membrane 3201 and bridge 3701, both now outside of the delivery catheter / tube 4202. Fig.42F The second film 3201 is shown being advanced from a delivery catheter / tube 4202. Figure 42G In the second film, the second film is almost completely deployed from the delivery catheter / tube, while in Figure 42H In the implant, the second membrane is deployed. At this point in the deployment process, it is desirable to place the second membrane of the implant over another one or more vascular ostia, such as over the second two pulmonary veins. Fig.42I The implant is shown deployed from a catheter / tube 4202 and an internal pull wire or suture 4203 extending from the tube. The internal pull wire or suture 4203 can be passed through the strain reduction ring 3703. Once the implant is properly positioned, as a final step in deployment, the pull wire is removed from the implant. The pull wire can be removed by cutting the pull wire at the proximal end and pulling it out. The film of the implant can be a two-piece film or a one-piece film embodiment, such as Fig.38 and 39 As shown in .

[0175] Figures 43A-43D Picture shows Fig.38 An exemplary implant or system or Fig.39 An exemplary implant or system of is deployed in the left atrium (although deployment may be applicable to other locations, such as the right atrium). When the implant is deployed to the final position, all desired blood vessels or pulmonary vein orifices are covered, and the left atrial appendage is optionally blocked. Fig.43A The guide catheter 4201 and delivery catheter / tube 4202 are shown in the left atrium LA after passing through the fossa ovalis FO. The balloon catheter and guide catheter are pointed in the direction of the left atrial appendage LAA. Fig.43B In the embodiment, when a film 3201 is pushed out of the delivery catheter / tube, the deployment of the film 3201 in the implant has begun. Optionally, the delivery catheter or sheath can be retracted while holding the implant in place. Fig.43C The deployment of the first membrane and bridge tube 3701 is illustrated in a position covering two blood vessels or pulmonary vein ostium 302 and the LAA. In an exemplary embodiment, the LAA is curved by a portion of the membrane. Fig.43D The fully deployed implant is illustrated, wherein the second film 3201 is also deployed and covers the remaining two blood vessels or pulmonary vein orifices 302. The components used and the method of implanting the implant allow the implant to be retracted and repositioned. In the installed position, the implant or device allows blood to flow out of all blood vessels (e.g., out of all four pulmonary veins), but prevents blood from flowing back into the blood vessels or pulmonary veins.

[0176] Fig.44 Another exemplary embodiment of a wire-type valve implant or system 4400 formed using a wire frame 4401, a connecting material 4402, and a valve portion including a flap 4403 is illustrated. The connecting material 4402 is connected around the periphery of the wire frame 4401. In the example shown, two flaps are connected to the connecting material. In an exemplary embodiment, the flap 4403 is omitted and the connecting material 4402 covers the Fig.44 In one exemplary embodiment, flap 4403 can be attached to the entire overlapping area between connecting material 4402 and flap 4403 (see Fig.47 , wherein the flap flexes outwardly due to the connection around the overlap area). In another exemplary embodiment, only the ends of the flap 4403 are attached to the connecting material 4402 (see Fig.49 , where the flap is turned outward due to connections only at the ends of the flap).

[0177] The connecting material 4402 and / or the film or flap 4403 can be made of fabric and / or tissue such as pericardial tissue. The film or flap (and other valve parts described elsewhere herein) can be treated and / or coated with chemicals, drugs, etc. to prevent or inhibit calcification and / or tissue ingrowth into the film. The frame 4401 can be nitinol and can have an end 4404 of a strain reduction shape (which can have the shape shown or another strain reduction shape, similar to, for example, the strain reduction portion 3703). The flap 4403 can be connected to the film 4402 by sutures, adhesives, etc. The frame 4401 can have an hourglass shape when in an expanded configuration, which also bends to conform to the circumference of the left atrium in the pulmonary vein region. The exemplary frame 4401 shown has a connecting material 4402 attached to the frame (always around the frame). In the narrower "bridge" or "waist" region 4406 of the frame, the opening 4405 remains uncovered by the flap 4403. Attached to the connecting material 4402 on each side of the frame 4401 is a flap 4403. The flap can be attached to the connecting material 4402 around most of the flap so that at least the remaining portion of the flap can be flexed open to allow blood flow when in the open configuration. Alternatively, the flap can be attached to the connecting material 4402 around only a small portion of the flap 4403 so that the remaining portion can be flipped or turned open to allow blood flow when in the open position. Fig.45 Picture shows Fig.44 Another view of an embodiment of the invention.

[0178] Fig.46 and 47 Schematically illustrates that when the flap 4403 is attached to the entire overlapping area between the connecting material 4402 and the flap 4403, Fig.44 and45 The implant or device of the illustrated embodiment, for example, in the left atrium in an open position and a closed position, respectively. Regurgitant blood flow, indicated by arrows 4600, causes the flap 4403 to be pushed back against the atrial wall and block blood flow back into the blood vessels or pulmonary veins PV. When implanted in the illustrated embodiment, the central bridge 4406 spans at least a portion of the atrium.

[0179] Fig.47 Figure 1 shows the Fig.46 The implant is shown in Figure 47. Arrows 4700 indicate the direction of blood flow from the blood vessels or pulmonary veins PV, applying pressure to the flap 4403 to flex the flap to an open or bulging position. The blood passes between the flap and the atrial wall into the space in the upper left atrium. From there, the blood flows through an opening 4405 in the central bridge area of ​​the implant and toward the mitral valve. Optionally, one or both flaps can also be configured to open at the other end of the flap so the blood flows down the heart wall.

[0180] Fig.48 and 49 Schematically illustrates when only the end of the flap 4403 is attached to the connecting material 4402. Fig.44 and 45 The implant / device of the illustrated embodiment is shown, for example, in the left atrium in an open position and a closed position, respectively. Fig.48 In FIG. 4 , the implant is in a closed configuration. Arrows 4800 indicate that the reverse blood flow exerts pressure on the flaps 4403 and pushes them upward against the atrial wall and the vascular or pulmonary vein openings. Fig.49 4900. The implant is in an open configuration. Blood flows out of the vessels or pulmonary veins PV and pushes the flap outward. Blood flows through the flap and into the atrium. Blood can flow from the pulmonary veins into the portion of the left atrium below the implant, as shown by arrow 4900.

[0181] Figure 44-49 The deployment of the exemplary embodiment may be with Figures 42A-42I The deployment illustrated and described in FIG. Fig.50 The implant framework 4401 is shown almost completely deployed from the catheter 4201, with the end 4404 (not visible) still within the delivery catheter 4201. Fig.50 to show that although the framework 4401 is somewhat different, the deployment is the same as Figures 42A-42I The embodiment shown is essentially the same except that the bridge portion of the frame is Figure 44-50 The embodiment shown is expanded.

[0182] Exemplary valve implants or systems herein (e.g., Fig.28 and 29 The implant 2800 shown in Fig.30The implant 3000 shown in Fig.32 The implant 3200 shown in FIG. 3200 , etc.) can be covered by a soft cover, which can be a soft material, according to one or more of the following methods. Two pieces of soft material can be used to cover part or all of the valve implant or system. Fig.51 A first piece is shown, which is a stent cover 5100 (e.g., a pulmonary artery stent cover, etc.). The stent cover can be a single piece of material that has a generally H-shaped footprint when in a flat position. The H-shaped footprint can be divided into different areas. There can be a first stent coverage area 5101 and a second stent coverage area 5102. The crossbar of the "H" can be a connection area 5103. Fig.52 A second piece for covering the implant 2800 is shown, which is a soft docking skirt cover 5200. The soft material may be fabric, foam, and / or tissue, such as pericardial tissue.

[0183] Fig.53 It is depicted that the bracket cover 53 may have a tapered edge 5301, while Fig.54 Depicted is a tapered edge 5301 on the docking skirt soft cover 5200. When the soft cover piece has been assembled on the valve implant 2800, the tapered edge can help create a smooth surface along the edge of the material.

[0184] When in the flat position, the stent cover 5100 can have a size sufficient to cover the anchor or anchoring portion 2801 and the connector 2803 of the valve implant 2800. For example, in the flat position, the stent cover 5100 can have an overall width W0 of between 20 and 40 mm, such as between 25 and 35 mm, such as about 32.92 mm, and an overall length L0 of between 30 and 70 mm, such as between 40 and 60 mm, such as about 53.50 mm. The connection region 5103 can have an exemplary length L3 of between 3 and 9 mm, such as between 4 and 8 mm, such as about 6.00 mm, which is defined by the portion of the crossbar cut from the monolith to form the "H". In the flat position, the width W1 of the connection region can be between 3 and 20 mm, such as between 6 and 17 mm, such as about 13.50 mm, in an exemplary embodiment, wherein the connection region is centrally located along the width of the monolith 5100. These exemplary dimensions give each stent coverage area a width dimension between 20 and 40 mm, such as between 25 and 35 mm, such as about 32.92 mm. The first and second stent coverage areas do not have to have equal areas. For example, the length L1 of the first stent coverage area can be between 15 and 35 mm, such as between 20 and 30 mm, such as 23.00 mm, and the length L2 of the second stent coverage area 5102 can be between 15 and 35 mm, such as between 20 and 30 mm, such as 24.50 mm. When in a flat position, the docking ring skirt soft cover 5200 can have a size sufficient to cover the anchoring connector 2803 and the docking station 1401 of the valve implant 2800. The docking ring skirt soft cover 5200 may have an exemplary width of 51.77 mm and an exemplary length of 27.50 mm. These measurements of the soft cover and the docking skirt soft cover are approximate and can be changed depending on the size of the implant.

[0185] Figure 55-62 Depicted are exemplary steps taken to cover and / or manufacture valve implants such as valve implants 2800, 3000, and / or 3200 with soft covers 5200 and 5300. In various embodiments, soft covers 5200 and 5300 are wrapped around valve implants, wherein valve implant 2800 is referenced and depicted herein as a representative example. For simplicity, the drawings depicting schematic diagrams of the steps taken are of the soft covers only to show how they are bent, rolled, and otherwise shaped into place. In practice, the cover can be placed on an implant such as implant 2800. Fig.55 The support cover 5100 is depicted in a flat position. Fig.56ADepicted is a stent cover positioned such that its first stent coverage region 5101 and second stent coverage region 5102 are each bent at an angle from the soft cover connection region 5103. The curved portions 5601, 5602 are flexible, and although they can be positioned at a 90 degree angle, they are flexible due to the soft material and can bend or change angles as needed to accommodate the structure of the implant 2800 and the anatomy of a vascular opening, such as a pulmonary vein opening of the left atrium wall. Fig.56B Another view of a stent cover is depicted with its side regions curved. Fig.56C Another view of a pulmonary artery stent cap depicting a bend in its lateral region. Fig.56A -C, the inner and outer surfaces of each bracket covering area can also be identified. The first soft cover connection area 5101 and the second soft cover connection area 5102 have inner surfaces 5603 and 5604, respectively. The first soft cover connection area 5101 also has an outer surface 5605 and the second soft cover connection area also has an outer surface 5606.

[0186] In another exemplary embodiment of a cover implant, a first stent-covering region may be bent and crimped around a first stent, such as a first pulmonary vein stent, and then a second stent-covering region may be bent and crimped around a second stent, such as a second pulmonary vein stent.

[0187] Fig.57 A schematic diagram of a soft cover is depicted as the first stent covering region 5101 begins to wrap around a stent (not shown). The stent may be a first anchor or anchor frame 2801 . Fig.58 The first stent-covered region 5101 is depicted as being wrapped into a generally cylindrical shape, and may be wrapped to completely cover the outer surface of the anchor / anchor frame 2801. The inner surface 5603 may be in close contact with the anchor / anchor frame 2801, and the outer surface 5601 may be in close contact with a blood vessel or pulmonary vein when the device is implanted.

[0188] Fig.59 The stent cover is depicted with the second stent cover portion 5102 in a position to begin wrapping around a stent such as the second anchor / anchor frame 2801 . Fig.60A The second stent covering region 5102 is depicted as being wrapped into a generally cylindrical shape, and may be wrapped to completely cover the outer surface of the anchor frame 2801. The inner surface 5604 may be in close contact with the anchor / anchor frame 2801, and the outer surface 5602 may be in close contact with the blood vessel or pulmonary vein when the device is implanted. Fig.60B Depicted from Fig.60A An alternative view of cover 5100 is shown in FIG.

[0189] Fig.61A second soft cover is depicted, which may be a docking skirt soft cover 5200. When in a flat position, the docking skirt soft cover 5200 may be of sufficient size to wrap around the stent cover 5100 when it is positioned over a valve implant, such as the valve implant 2800. For example, in a flat position, the docking skirt soft cover 5200 may have an overall width W2 of between 30 and 70 mm, such as between 40 and 60 mm, such as about 51.77 mm, and an overall length L4 of between 20 and 40 mm, such as between 25 and 35 mm, such as about 27.5 mm.

[0190] refer to Fig.62 , the docking skirt soft cover is wrapped around the stent cover 5100 and the docking station 1401 of the implant 2800. The docking skirt soft cover 5200 is fixed in place. The docking skirt soft cover 5200 can be fixed on the cover portions 5101, 5102 and the connecting portion 5103 to prevent leakage between the cover 5200 and the cover 5100. That is, the portion 5103 blocks the flow from the cover 5200 between the portions 5101 and 5102 of the cover 5100.

[0191] Fig.63A Another schematic diagram of a soft covering as an outer cover / covering is depicted wrapped around an implant 2800. In this figure, an anchor member / anchor frame 2801 is included for reference. Fig.63B Another schematic diagram of an exemplary embodiment is depicted in which the soft coverings 5100 and 5200 are translucent and the framework of the implant 2800 can be seen through some of the single layer of soft covering material.

[0192] Fig.64 A schematic diagram of a pulmonary vein valve implant 2800 is depicted wrapped in soft covers 5100 and 5200 (shown as outer covers) and where it can be implanted in the heart. A first stent-covered area 5101 covering a first anchor / anchor frame 2801 is implanted in a pulmonary vein, and a second stent-covered area 5102 wrapped around a second anchor / anchor frame 2801 is implanted in another pulmonary vein. The docking skirt soft cover 5200 wrapped around the docking station 1401 is located in the left atrium. As described in the exemplary embodiments described herein, the valve can be fixed within the docking portion or docking station 1401.

[0193] For the purpose of this description, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure is only directed to all novel and non-obvious features and aspects of each disclosed embodiment, both individually and in various combinations and sub-combinations with each other. The methods, devices and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or solutions to problems.

[0194] Although the operations of some disclosed embodiments are described in a specific sequential order for convenience of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a specific order. For example, in some cases, the operations described in sequence can be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary depending on the specific implementation and can be easily discerned by a person of ordinary skill in the art. In addition, any and all methods related to the use of the devices, implants, systems, etc. described herein can be performed on living animals or non-living corpses, corpse hearts, simulators, anthropomorphic phantoms, etc.

[0195] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the present disclosure. Accordingly, the scope of the present disclosure is limited only by the appended claims.

Claims

1. An apparatus for closing a pulmonary vein opening in the left atrium of a heart, comprising: at least one pulmonary vein closure device comprising: Flexible framework, and valve; wherein the at least one pulmonary vein closure device has an open configuration and a closed configuration, wherein, when deployed in the left atrium, the open configuration allows blood to flow from the pulmonary veins into the left atrium, and wherein the closed configuration blocks blood flow from the left atrium into the pulmonary vein.

2. The apparatus of claim 1, comprising a second elastic frame, and a bridge connecting the first elastic frame and the second elastic frame; in, A membrane is attached to and spans each elastic frame.

3. An apparatus according to any of the preceding claims, wherein each valve comprises an opening in the membrane and a leaflet attached to the membrane.

4. The apparatus of claim 2, wherein each membrane is configured to gather upon itself to open the valve.

5. The apparatus of any one of claims 2 to 4, wherein each resilient frame has a strain relief ring extending laterally away from the resilient frame.

6. The apparatus of any one of claims 2 to 4, wherein each resilient frame has a strain relief ring extending in an inward direction.

7. An apparatus according to any one of claims 2 to 6, wherein each frame is made of one or more of shape memory material, steel or MP35.

8. An apparatus according to any one of claims 2 to 7, wherein the bridge is a spring or a tube.

9. The device of any one of claims 2 to 8, wherein the membrane is made of one or more of pericardium, ePTFE or PET.

10. The device of claim 3, wherein the leaflets are made of one or more of pericardium, ePTFE, or PET.

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