Devices, systems, and methods for improving cardiac function

Abstract

Disclosed are devices, systems, and methods for improving heart function, such as systems for changing the direction of blood flow in the coronary sinus shunted from the left atrium, the system comprising: a tool configured to pierce through and pass a first implanted occluder disposed in the coronary sinus, the tool configured to form a restrictive passageway through the first implanted occluder; an expander configured for delivery through the first implanted occluder into the restrictive passageway and for expanding within the restrictive passageway to compress the first implanted occluder against a wall of the coronary sinus, thereby transforming the restrictive passageway into an expanded opening; a retainer configured to permanently retain the expanded opening by retaining the compressed first implanted occluder against the wall of the coronary sinus; and a second occluder configured for implantation on a downstream side of the shunt in the coronary sinus.

Description

[0001] Cross-references to related applications This application is based on and claims priority to Israeli Patent Application No. IL310788, filed on February 12, 2024, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] This disclosure generally relates to the field of cardiac surgery, and more specifically to devices, systems and methods for improving cardiac function.

[0003] background The primary function of the heart (myocardium) is to pump oxygenated blood throughout the body. The heart comprises four chambers: the left and right atria and the left and right ventricles, along with a series of valves and a network of veins and arteries. In a healthy heart muscle, deoxygenated blood from the body enters the right atrium via the superior and inferior vena cava. This blood is forced through the tricuspid valve and into the right ventricle, where it is then pumped to the lungs via the pulmonary valve and pulmonary artery for oxygenation. The oxygenated blood then returns from the lungs to the left atrium via the pulmonary veins, and is then pumped into the left ventricle through the mitral valve. The left ventricle pumps this oxygenated blood through the aortic valve and into the aorta, where it is then distributed throughout the body via a complex network of arteries.

[0004] While the superior and inferior vena cava are primarily responsible for guiding deoxygenated blood from the body into the right atrium, the coronary sinus is primarily responsible for guiding venous (i.e., deoxygenated) blood from the vascular system of the heart tissue into the right atrium. This great cardiac vein appears at the junction of the great cardiac vein and oblique veins of the left ventricle, and is partially located in the posterior atrioventricular groove between the left atrium and left ventricle. Tributary veins, including the anterior interventricular vein (AIVV), great cardiac vein (GVC), and posterior interventricular vein (PIVV), drain into the coronary sinus. Oxygen saturation (PO2) within the coronary sinus typically falls within the range of 15 mmHg–35 mmHg.

[0005] When the blood vessels within the heart are under-oxygenated due to conditions such as coronary artery disease, atherosclerosis, and arteriosclerosis, complications including angina, heart attacks, and heart failure can occur. Various surgical techniques can be used to alleviate these complications. For example, angioplasty (also known as percutaneous coronary intervention, balloon angioplasty, and coronary balloon dilation) involves surgically widening an artery that is blocked or otherwise narrowed. Here, the surgeon delivers a catheter-balloon system to the site of the blockage and inflates the balloon to widen the blockage and improve blood flow through the artery. A stent can be inserted to prevent artery constriction, thus maintaining blood flow through the artery. Surgeons can also use lasers (laser angioplasty) or cutting tools (atherosclerosis) to vaporize or remove any blockage.

[0006] Another method used to correct oxygen deficiency is coronary artery bypass surgery (also known as coronary artery bypass grafting or "CABG"). Here, an open-chest procedure is used to transplant a healthy blood vessel to the heart to alter the blood flow path around a blocked artery. Grafts can be obtained from the patient or a donor and are typically sourced from one or more of the leg, arm, or chest, depending on the number of grafts needed. Due to the invasive nature of open-chest surgery, complications tend to be more frequent and recovery times are often longer. Open-chest surgery usually requires the surgeon to stop the heart to complete the procedure and increases the risk of infection at both the chest incision site and the graft incision site.

[0007] Another approach to correcting oxygen deficiency involves perfusing oxygenated blood throughout the heart using one or more surgically created openings in the left ventricle. In transmyocardial revascularization (TMR), one or more lasers are used to create multiple channels through the left ventricle to improve direct perfusion of the myocardium. This approach can be beneficial when the patient is unresponsive to or unsuitable for coronary artery bypass surgery or percutaneous coronary intervention. Like TMR, percutaneous myocardial revascularization (PMR) also uses surgically created openings to achieve direct myocardial perfusion; however, this procedure tends to be less invasive.

[0008] Furthermore, other methods envision using various stent devices or grafts to guide oxygenated blood from the left ventricle to the coronary arteries or to provide retrograde flow of oxygenated blood from the left ventricle to the myocardium via the coronary sinus. PCT application PCT / IB2023 / 051918 (the disclosure of which is incorporated herein by reference) discloses a method and apparatus for creating a channel between a lumen in a heart chamber and a lumen in a blood vessel, while simultaneously extending the channel in the direction of retrograde flow within the lumen by flow deflection. Thus, the disclosed apparatus is designed to obstruct blood flow through the coronary sinus and to shunt blood from the heart chamber towards the blood vessel. For example, retrograde flow of oxygenated blood towards the myocardium may occur post-procedure when a positive pressure gradient persists between the blood in the heart chamber and the blood in the coronary sinus. However, in some cases, a positive pressure gradient does not form immediately.

[0009] The devices, systems, and methods described herein address at least some of the drawbacks of conventional revascularization techniques. Such devices, systems, and methods allow for a controlled transition of blood flow within the vessel between a first and a second direction. This controlled transition can occur in various inventive ways within the scope of this disclosure. For example, one or more temporary and permanent occluders can be used at different times to alter the flow direction of newly sourced blood shunted from the left atrium, or an adjustable occluder can be employed to change the flow direction while minimizing changes in the shunt's position. In either case, a medical practitioner may be able to confirm the presence of a positive pressure gradient before the flow direction transitions from anterograde to retrograde.

[0010] Overview Embodiments consistent with this disclosure provide apparatus, systems, and methods for improving cardiac function, including by selectively directing flow in the coronary sinus adjacent to the left atrium and by altering the direction of blood flow in the coronary sinus shunt from the left atrium.

[0011] Some embodiments include a system for altering the direction of blood flow in a coronary sinus shunt from the left atrium. Embodiments may include a tool configured to puncture and pass through a first implanted occluder disposed in the coronary sinus. This tool may be configured to form a restricted passageway through the first implanted occluder when the first implanted occluder is located upstream of a shunt bridging the coronary sinus and the left atrium, and when, prior to puncture, the first implanted occluder and the shunt cooperate to allow blood to flow anterogradely from the left atrium to the right atrium via the coronary sinus and to restrict retrograde flow in the coronary sinus beyond the first implanted occluder. Embodiments may also include an expander configured to be delivered through the first implanted occluder into the restricted passageway and expand within the restricted passageway to compress the first implanted occluder against the wall of the coronary sinus, thereby transforming the restricted passageway into a dilated opening. Embodiments may also include a retainer configured to permanently maintain the dilated opening by retaining the compressed first implanted occluder against the wall of the coronary sinus. The embodiment may also include a second occluder configured for implantation downstream of a shunt in the coronary sinus. The second occluder may be configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus and constrain antegrade flow in the coronary sinus downstream of the second occluder.

[0012] Some embodiments include methods for improving cardiac function. Embodiments may include implanting a first occluder in the coronary sinus in a first occluder region proximal to the left atrium to impose a first constraint on antegrade blood flow in the coronary sinus. Embodiments may also include implanting a shunt bridging the coronary sinus and left atrium downstream of the first occluder region to establish a first flow path that relieves pressure in the left atrium by directing blood from the left atrium through the coronary sinus to the right atrium. Embodiments may also include maintaining the first flow path for a period of several days, weeks, or months. Embodiments may also include weakening the first constraint after the period. Embodiments may further include, after the period and after weakening the first constraint, implanting a second occluder in the coronary sinus in a second occluder region downstream of the shunt to impose a second constraint on antegrade blood flow in the coronary sinus, thereby establishing a second flow path in the coronary sinus for retrograde flow from the left atrium.

[0013] Some embodiments include means for selectively guiding flow from the left atrium in the coronary sinus. Embodiments include a shunt configured to bridge the left atrium and the coronary sinus. Embodiments may include an occluder selectively positioned between a first anterograde flow deflection position and a second retrograde flow deflection position. The occluder may be configured at the first anterograde flow deflection position to guide flow in the coronary sinus from the left atrium toward the right atrium in a first direction. Additionally, the occluder may be configured at the second retrograde flow deflection position to guide flow in the coronary sinus from the left atrium away from the right atrium in a second direction. Furthermore, the occluder may be adjustable in situ to selectively change the direction of flow in the coronary sinus.

[0014] Some embodiments include methods for improving cardiac function. Embodiments may include implanting a shunt bridging the coronary sinus and left atrium. Embodiments may also include directing anterograde blood flow in the coronary sinus from the left atrium toward the right atrium. Embodiments may further include, after a period of time, changing the anterograde flow in the coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrial blood flow away from the right atrium.

[0015] The foregoing overview is intended to provide an introductory style for several aspects of the innovation described in this article more comprehensively. Brief description of the attached diagram The accompanying drawings, which are included in and constitute a part of this disclosure, illustrate the disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The details shown are as examples and for the purpose of an illustrative discussion of embodiments of this disclosure. The description taken in conjunction with the drawings makes it apparent to those skilled in the art how embodiments of this disclosure can be practiced.

[0017] Figure 1A This is a side view of a portion of an example intravascular medical system consistent with some embodiments of this disclosure.

[0018] Figure 1B yes Figure 1A An isometric view of the system portion shown.

[0019] Figure 2A This is consistent with some embodiments of the present disclosure, deployed between biological structures. Figure 1A A side view of a portion of an example intravascular medical system.

[0020] Figure 2B yes Figure 2A The front view of the system section shown.

[0021] Figure 3A It is consistent with some embodiments of this disclosure. Figure 1AA side view of a portion of an example endovascular medical system deployed between biological structures and having a tool for passing through an occluder, wherein the expander is in a non-expanded state.

[0022] Figure 3B yes Figure 3A The front view of the system section shown.

[0023] Figure 4A It is consistent with some embodiments of this disclosure. Figure 3A A side view of a portion of an example intravascular medical system deployed between biological structures, wherein the extender is in an extended state.

[0024] Figure 4B yes Figure 4A The front view of the system section shown.

[0025] Figure 5A It is consistent with some embodiments of this disclosure. Figure 1A A side view of a portion of an example endovascular medical system deployed between biological structures, with the occluder in an extended state.

[0026] Figure 5B yes Figure 5A The front view of the system portion shown is consistent with an embodiment where the extender remains in place after expansion.

[0027] Figure 5C yes Figure 5A The front view of the system portion shown is consistent with another embodiment where the extender is removed after expansion.

[0028] Figure 6A It is consistent with some embodiments of this disclosure. Figure 1A A side view of a portion of an example endovascular medical system deployed between biological structures, having a second occluder for shunting blood flow.

[0029] Figure 6B yes Figure 6A A cross-sectional view of the system portion shown.

[0030] Figure 6C yes Figure 6A Another cross-sectional view of the system portion shown.

[0031] Figure 7A , Figure 7B and Figure 7C The steps of an example process for deploying an intravascular medical system between biological structures are illustrated graphically, consistent with some embodiments of this disclosure.

[0032] Figure 8 This is a flowchart of an example process for improving cardiac function, consistent with some embodiments of this disclosure.

[0033] Figure 9A This is a side view of an example of a convertible intravascular medical system in a first configuration consistent with some embodiments of this disclosure.

[0034] Figure 9B It is consistent with some embodiments of this disclosure and is in a second configuration. Figure 9A Side view of the device shown.

[0035] Figure 10A This is a side view of an example of another convertible intravascular medical system deployed in a first configuration between biological structures, consistent with some embodiments of this disclosure.

[0036] Figure 10B It is consistent with some embodiments of this disclosure and is in a second configuration. Figure 10A Side view of the device shown.

[0037] Figure 11A This is a side view of an example of another convertible intravascular medical system deployed in a first configuration between biological structures, consistent with some embodiments of this disclosure.

[0038] Figure 11B It is consistent with some embodiments of this disclosure and is in a second configuration. Figure 11A Side view of the device shown.

[0039] Figure 11C This is a side view of an example of another convertible intravascular medical system deployed in a first configuration between biological structures, consistent with some embodiments of this disclosure.

[0040] Figure 11D It is consistent with some embodiments of this disclosure and is in a second configuration. Figure 11C Side view of the device shown.

[0041] Figure 11E yes Figure 11C and Figure 11D An exemplary exploded view of a transformable intravascular medical system.

[0042] Figure 12 This is a flowchart of an example process for diverting and selectively modulating anatomical fluid flows deployed between biological structures, consistent with some embodiments of this disclosure.

[0043] Detailed description Exemplary embodiments are described with reference to the accompanying drawings. The drawings are not necessarily drawn to scale. Unless otherwise disclosed or indicated, elements indicated by the same or similar reference numerals are intended to represent the same or similar parts. While examples and features of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Furthermore, the terms “comprising,” “having,” “containing,” “including,” and other similar forms are intended to be synonymous and open-ended, as one or more items following any of these terms do not imply an exhaustive list of such one or more items, nor do they imply limitation to the listed one or more items. It should also be noted that, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the,” as used herein and in the appended claims, include the plural references. Moreover, relational terms throughout this document, such as “first” and “second,” are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any actual relationship or order between these entities or operations.

[0044] As used herein, unless otherwise specified, the term "or" covers all possible combinations unless impractical. For example, if a descriptive component may include A or B, then unless explicitly stated otherwise or impractical, the component may include A or B, or A and B. As a second example, if a descriptive component may include at least one of A, B, or C, then unless explicitly stated otherwise or impractical, the component may include A, B, or C, or A and B, or A and C, or B and C, or A, B, and C.

[0045] This disclosure uses open-source language to indicate, for example, that certain embodiments "may" employ, involve, or include certain features. The use of the term "may" and other open-source terms is intended to indicate that while not every embodiment may employ a particular disclosed feature, at least one embodiment employs a particular disclosed feature.

[0046] In the following description, various examples of work are provided for illustrative purposes. However, it should be understood that this disclosure may be practiced without one or more of these details. Reference will now be made in detail to non-limiting examples of this disclosure, examples of which are shown in the accompanying drawings. These examples are described below with reference to the accompanying drawings, wherein similar reference numerals denote similar elements. When similar reference numerals are shown, corresponding descriptions are not repeated, and interested readers will refer to the previously discussed drawings to describe similar elements.

[0047] Embodiments of this disclosure relate to endovascular medical systems, including endovascular medical devices for shunt and selectively modulating anatomical fluid flow. As used herein, an endovascular medical system includes one or more components, devices, elements, or instruments configured for placement or manipulation within a blood vessel or other biological structure or organ in the human body for medical purposes. A non-limiting example of a system includes system 100, described later herein with reference to the accompanying drawings. It should be understood that a system need not include all the components shown in any given drawing. Rather, in the context of the non-limiting examples in the drawings, the term system includes any subset of the components in any drawing or combination of drawings. Such components of a system may, individually or in combination, include: shunts, stents, catheters, balloons, guidewires, or any other devices, elements, or combinations configured for placement within a blood vessel, organ, or other biological structure.

[0048] Consistent with some disclosed embodiments, biological structures may include hollow anatomical features within a patient's body. Non-limiting examples of biological structures include blood vessels, capillaries, arteries, veins, cardiac chambers (e.g., left atrium, left ventricle, right atrium, right ventricle), or any other anatomical organ. An endovascular medical device may be configured for delivery from a first location (e.g., an external location) to a treatment site within a blood vessel or other biological structure. Additionally or alternatively, in some embodiments, an endovascular medical device may be configured to cause a temporary or permanent alteration or transformation at the treatment site within a blood vessel.

[0049] Embodiments of this disclosure generally relate to medical devices, methods, and systems for shunting blood between two biological structures. For example, some disclosed embodiments may relate to systems for shunting blood flow from a cardiac chamber (e.g., the left atrium) to the coronary sinus and altering the direction of blood flow in the coronary sinus. In embodiments, blood flow from the left atrium is shunted to the coronary sinus, thereby causing antegrade flow in the coronary sinus. Furthermore, in some embodiments, after a period of time, blood flow from the left atrium may then be shunted to the coronary sinus, thereby causing retrograde flow in the coronary sinus as a mechanism for treating heart disease.

[0050] As a non-limiting example, systems for altering the direction of blood flow in the coronary sinus shunt from the left atrium include shunts for bridging cardiac chambers (e.g., left atrium, left ventricle) and the coronary sinus, as well as occluders that work together to allow retrograde oxygenated blood flow in the coronary sinus. The oxygenated blood flowing "backward" in the coronary sinus can induce oxygenation of cardiac tissue that would otherwise receive insufficient oxygenated blood flow. An occluder positioned in the coronary sinus can help guide the retrograde flow and can prevent or at least partially impede flow toward another biological structure (e.g., the right atrium).

[0051] Consistent with some embodiments of this disclosure, the system may include an occluder. As used herein, an occluder can refer to a device, component, or combination of devices and / or components configured to restrict the flow of fluid through a structure (e.g., blood flowing through a biological structure). For example, an occluder may be configured to block or restrict the flow of fluid in one direction or to deflect the flow of fluid in one direction. As a non-limiting example, an occluder may be configured to block or restrict the natural flow of fluid in a blood vessel. Alternatively or additionally, an occluder may be configured to deflect the flow of fluid in a blood vessel to a direction that may differ from the normal flow direction. As used herein, deflecting the flow may mean causing some or all of the flow to change from a first direction to a second direction. In some embodiments, the second direction may be opposite to the first direction. In other embodiments, the second direction may be perpendicular to the first direction. It is contemplated that the second direction may be perpendicular to, parallel to, or angled relative to the first direction. Therefore, an occluder may include any component, device, or structure that deflects, redirects, blocks, impedes, slows, or inhibits the flow of fluid.

[0052] As used herein, constraint can refer to limiting, reducing, or controlling the flow of fluid. For example, constraining the flow of fluid through a structure can include partially (e.g., partially blocking) or completely (e.g., completely blocking) reducing the available channel area. Partial blockage may occur when an object or blockage partially obstructs the channel, causing the fluid to flow at a reduced rate compared to the normal flow rate without the object or blockage. Complete blockage may occur when an object or blockage completely obstructs the channel, causing no fluid flow.

[0053] As used herein, anterograde flow can refer to flow in the normal or desired direction. For example, anterograde flow in the coronary sinus can include blood flow shunt from the left atrium into the coronary sinus and flowing in the natural direction of the veins (e.g., away from the myocardium and towards the right atrium). As used herein, retrograde flow can refer to flow in the opposite direction to the normal or desired direction. For example, retrograde flow in the coronary sinus can include blood flow shunt from the left atrium into the coronary sinus and flowing in the opposite direction to the natural direction of the veins (e.g., towards the myocardium and away from the right atrium).

[0054] Consistent with some embodiments of this disclosure, the system includes a shunt. As used herein, a shunt can refer to any structure capable of bridging two biological structures, such as a heart chamber and a blood vessel. For example, a shunt can be configured for deployment in a pathway between a first biological structure and a second adjacent biological structure. Deployment, as used herein, can involve the positioning or placement of a device or component within the body. Furthermore, a pathway can refer to a channel or opening through which fluid (e.g., blood) flows. The pathway can be formed by a pre-cut orifice. Additionally, in some embodiments, the shunt can be configured to bridge a first cavity in a first biological structure and a second cavity in a second biological structure. Bridging the first cavity in the first biological structure and the second cavity in the second biological structure can include providing a structure that allows fluid to flow between the first and second cavities. It is contemplated that the first and second biological structures can be any biological organ or structure, such as, but not limited to, blood vessels, anatomical cavities, and / or anatomical chambers. Furthermore, the shunt can redirect the flow of bodily fluids, as discussed further herein. A non-limiting example of a shunt includes shunt 120, described later herein. Other non-limiting examples of at least some other parts of the shunts and tools described herein are described in PCT / IB2023 / 051918 (WO2023166447A1) entitled “Devices, systems, and methods for revascularization of the myocardium” and PCT / IB2023 / 061707 entitled “Devices, systems, and methods for intraluminal puncturing”, both of which are incorporated herein by reference.

[0055] Consistent with some embodiments of this disclosure, the system may include a tool configured to puncture and pass through an implanted occluder disposed in the coronary sinus. As used herein, a tool configured to puncture may include any structure or instrument designed with a sharp, pointed, thin, or otherwise adapted end that allows it to penetrate or puncture material typically by applying pressure and / or rotational force. Non-limiting examples of tools configured to puncture include guidewires, needles, spikes, spears, punches, catheters, screws, and awls. Another non-limiting example of a tool consistent with some embodiments of this disclosure includes tool 340, which is shown in the accompanying drawings and described in more detail later.

[0056] The tool can be configured to pierce and pass through the implanted occluder. Piercing refers to penetrating or breaking through a surface or material. Piercing can be accomplished, for example, with a sharp object or force. As used herein, passing means moving from one side of a boundary, surface, plane, or dividing line to the other. For example, in some embodiments, passing can occur by penetrating a thin material surface, while in other embodiments, passing can occur by passing through a thicker material element (e.g., a plug or other seal). The tool can be configured to form a restrictive passage through the implanted occluder. As used herein, a restrictive passage can refer to a constricted or constrained passage or narrow channel that allows restricted traversal. For example, a guidewire can pass through a plug in a manner that allows the guidewire to pass through while restricting, preventing, or constraining fluid through the point of pass. In another example, a catheter smaller than the width of the occluder can pass through the occluder, allowing restricted flow through it. See later. Figure 3A A non-limiting example describing puncture and penetration of an occluder to create a restricted pathway.

[0057] In some embodiments, the implanted occluder punctured and penetrated by a tool may be located upstream of a shunt bridging the coronary sinus and the left atrium. As used herein, upstream refers to the direction opposite to the normal antegrade flow in the coronary sinus (i.e., retrograde flow). As used herein, downstream refers to the direction of the normal antegrade flow in the coronary sinus. As used herein, bridging means linking or connecting a first region and a second region such that fluid can flow between the first region and the second region. For example, a shunt may bridge the coronary sinus and the left atrium, allowing oxygenated blood to flow from the left atrium to the coronary sinus (e.g., through the shunt, adjacent to the shunt, or around the shunt).

[0058] For example, the implanted occluder can be located on one side of the shunt, such that anatomical fluid flowing in the anterograde flow direction can contact the implanted occluder before reaching the location of the shunt. In another example, the implanted occluder can form a complete blockage, such that anatomical fluid flowing in the anterograde flow direction can only contact the implanted occluder and can be prevented from contacting the shunt by the implanted occluder. Non-limiting examples of puncture and penetration on the upstream side of the shunt will be referenced later in this document, for example. Figure 3A and Figure 3B discuss.

[0059] Furthermore, in some embodiments, prior to puncture of the implanted occluder, the implanted occluder and shunt can cooperate to allow blood to flow in an anterograde direction from the left atrium via the coronary sinus to the right atrium. As used herein, cooperation means that two or more components, devices, elements, or instruments work together in a manner that achieves or enhances a function, goal, or outcome, even if they remain physically separate or operate independently. For example, the implanted occluder and shunt can cooperate to allow blood to flow in an anterograde direction from the left atrium via the coronary sinus to the right atrium or toward the right atrium, which is achieved by the shunt facilitating blood flow from the left atrium to the coronary sinus and the occluder blocking retrograde flow to promote or deflect the flow to the right atrium via the coronary sinus. (To be continued...) Figure 2A The structure discusses non-restrictive examples of this orientation.

[0060] Additionally, in some embodiments, prior to puncture of the implanted occluder, the implanted occluder and shunt can cooperate to restrain retrograde flow in the coronary sinus beyond the implanted occluder. As used herein, "beyond" refers to the region on the other side of a component, device, element, or instrument. For example, when restraining retrograde flow in the coronary sinus beyond the implanted occluder, "beyond" can refer to the region of the coronary sinus upstream of the implanted occluder. As a non-limiting example, the implanted occluder and shunt can cooperate to restrain retrograde flow in the coronary sinus beyond the implanted occluder, which is achieved by the implanted occluder restraining (e.g., via partial occlusion, via complete occlusion) blood from the left atrium in the upstream region of the coronary sinus in a retrograde flow direction through the coronary sinus to the myocardium. (To be continued later) Figure 2A The structural discussion provides non-restrictive examples of structures that constrain such retrograde blood flow.

[0061] Consistent with some embodiments of this disclosure, the system may include an expander. As used herein, an expander refers to a device or component configured to increase size, volume, or capacity. For example, an expander may include any device that increases in size in response to mechanical force, inflation, or self-expansion. In some embodiments, an expander may include an inflatable balloon. As used herein, inflatable means a property or characteristic of a component, element, device, or instrument that allows it to be filled with a medium (e.g., a fluid, a gas) to become larger and take on a desired shape. For example, an inflatable component may include a component of a flexible or expandable material (e.g., polyurethane, polyethylene terephthalate (PET), nylon, silicone, latex, or any other suitable material, including biocompatible materials). As used herein, a balloon refers to a flexible inflatable component, element, device, or instrument configured to expand using a gas (e.g., air) or a fluid (e.g., saline). Reference will be made later as a non-limiting example. Figure 7B A more detailed discussion will be given of expanders, including inflatable balloons.

[0062] Alternatively or additionally, in some embodiments, the expander may include a self-expanding stent. As used herein, a stent may refer to a splint or tube configured to keep a passageway of a biological structure open. For example, a stent may be configured for deployment in a passageway of a blood vessel (e.g., a coronary sinus). As used herein, self-expanding may refer to a device, component, or material configured to automatically expand to an appropriate or intended size and shape after deployment, including without the need for external inflation or force. For example, a self-expanding stent may include a stent configured to expand upon deployment due to its construction of an expandable material configured to expand when no longer compressed within a structure (e.g., a catheter) or in response to a release mechanism. As a non-limiting example, according to an embodiment, the stent 101 described later herein may be a self-expanding stent or a balloon-expandable stent.

[0063] In some embodiments, the expander may be configured for delivery through an implanted occluder into a restricted pathway. A restricted pathway is an opening in a vessel smaller than in which the occluder is implanted. For example, the expander may be configured to deliver through an opening in the occluder via a catheter, guidewire, catheter-guidewire assembly, directly (e.g., using a stent-mounted balloon), or any other suitable delivery device known to those skilled in the art. In another example, the expander may be configured for delivery through the implanted occluder using a tool configured to puncture, once the tool has punctured and passed through the occluder. As a non-limiting example, see references later herein. Figure 3A An example of a restricted pathway includes restricted pathway 132.

[0064] Furthermore, in some embodiments, the expander can be configured to expand within a restrictive pathway to compress the implanted occluder against the wall of the coronary sinus, thereby transforming the restrictive pathway into an expanded opening. As used herein, an expanded opening refers to an opening or pathway that has been enlarged or widened. For example, an expanded opening may allow a higher flow rate than a restrictive pathway. As used herein, compression may refer to reducing the size or volume of an instrument, element, component, or device. For example, a compressed implanted occluder may have a smaller surface area relative to the obstructed biological structure, resulting in an increased flow through or through the occluder compared to an uncompressed implanted occluder. As used herein, transformation refers to changing or converting something from one state, form, condition, or configuration to another. For example, transforming a restrictive pathway into an expanded opening may include widening or enlarging the restrictive pathway (e.g., by compressing the implanted occluder) to form an expanded opening. As a non-limiting example, the expander (in this example, a stent) may compress the occluder against the wall of the coronary sinus, as referred to later. Figure 3BTo be discussed in more detail.

[0065] Consistent with some embodiments of this disclosure, the system may include a retainer. As used herein, a retainer refers to a device, component, or structure configured to hold something in place, prevent movement, or maintain a desired position. For example, in some embodiments, a retainer may be configured to permanently retain an enlarged opening. As used herein, "permanently" can mean something that is not temporary, continues indefinitely, or remains in place at least for its intended or desired lifespan. For example, permanent retention may include holding something in essentially a certain condition or state without any intention to change, alter, or remove it over time. In one example, a retainer may be configured to permanently retain an enlarged opening by holding a compressed first implanted occluder against the wall of the coronary sinus. The retainer may hold a compressed first implanted occluder against the wall of the coronary sinus such that by applying pressure or force to the compressed first implanted occluder in the direction of the wall of the coronary sinus (e.g., radially outward), the first implanted occluder and the wall of the coronary sinus are in direct or indirect contact (e.g., having one or more intermediate components, elements, devices, or instruments located therebetween). The retainer may include a scaffold that holds the occluder in an expansion orientation. In some embodiments, the retainer may include a support. In other embodiments, the retainer may be part of the design of the occluder such that the retainer retains the expansion of the occluder once the occluder expands. For example, this can occur with an occluder comprising a material that retains its deformed shape once deformed. For example, the occluder structure may include a metal frame that retains its expansion once deformed to an expanded state. In a non-limiting example, a support such as support 101 serves as the retainer, as described in more detail later. If the support is self-expanding, the support may constitute both an expander and a retainer.

[0066] In some embodiments, the expander and retainer may be combined in one of a balloon-expandable stent or a self-expanding stent. As used herein, a balloon-expandable stent may refer to a stent configured to expand upon balloon inflation. It should be understood that the expander and retainer may be separate structures or parts of a combined structure, and any description or exemplary representation of the expander or retainer is intended to cover the combined structure. Thus, in a non-limiting example, the balloon may be used as the expander, and the balloon-expandable stent may be used as the retainer. As a non-limiting example, such a combination in Figure 7B Examples are shown below, as will be discussed in more detail later.

[0067] Consistent with some embodiments of this disclosure, the system may include a second occluder. In embodiments where the system includes a first occluder and a second occluder, the first and second occluders may have similar or substantially identical structures, except that the first occluder may be configured to guide shunt blood flow in a first direction and the second occluder may be configured to guide shunt blood flow in a second direction different from the first direction. Additionally or alternatively, in some embodiments, each of the first and second occluders is configured to constrain antegrade (natural flow) within the coronary sinus. Furthermore, the first and second occluders may have different shapes, sizes, orientations, or forms. See below for further details. Figures 7A-7C A non-limiting example of the first and second occluders is described in more detail later.

[0068] In some embodiments, the second occluder can be configured for implantation downstream of the shunt in the coronary sinus. For example, the second occluder can be implanted in the coronary sinus at a location between the shunt and the right atrium (e.g., via a catheter, guidewire, any combination of the foregoing, or any other suitable delivery device). As a non-limiting example, such an orientation is... Figure 7C Examples are shown below, as described in more detail later.

[0069] In some embodiments, the second occluder can be configured to cooperate with a shunt to induce retrograde flow from the left atrium in the coronary sinus. For example, the second occluder and the shunt can cooperate to allow blood to flow retrogradely through the coronary sinus from the left atrium to or toward the myocardium, achieved by the shunt facilitating blood flow from the left atrium into the coronary sinus and the second occluder blocking antegrade flow, thereby causing retrograde blood flow in the coronary sinus toward the myocardium. This is achieved by… Figure 7C The non-restrictive examples in the text will be described in more detail later.

[0070] Furthermore, in some embodiments, the second occluder can be configured to cooperate with the shunt to constrain antegrade flow in the coronary sinus downstream of the second occluder. For example, the location of the second occluder in the coronary sinus can completely or partially block antegrade blood flow from the shunt left atrium in the coronary sinus. Non-limiting examples of the occluder and shunt cooperating to constrain antegrade flow in the coronary sinus downstream of the second occluder will be referenced later. Figure 7C The description is provided. Other non-limiting examples are provided in PCT / IB2023 / 051918 (WO2023166447A1), which is incorporated herein by reference.

[0071] In some embodiments, one or more elements or components of the system may be provided as a kit. As used herein, a kit may refer to a collection of components or devices designed or configured together to perform a task or a set of related tasks. The components of a kit may be packaged together and sold together, or sold separately with instructions for use in combination. For example, in some embodiments, tools, extenders, retainers, and occluders are provided as a kit. In another example, tools, extenders, retainers, and a second occluder are provided as a kit. Any combination of the components described herein may be considered a kit.

[0072] Figure 1A and Figure 1B Different views of a portion of an example endovascular medical system 100 consistent with some embodiments of this disclosure are shown. As used herein, a portion refers to one or more parts, devices, components, instruments, or elements of a whole or suite. For example, a portion of the example endovascular medical system may include some components, devices, instruments, or elements of a suite. Figure 1A and Figure 1B The system shown includes a support 101, a diverter 120, and a plug 130.

[0073] The stent 101 may include a stent wall 102. The stent wall 102 may be formed of filaments, mesh, struts, ribs, or other support frame materials. The stent 101 may be configured for deployment in the passage of a biological structure, such as the coronary sinus. The stent wall 102 may define the size and shape of the stent 101 to allow the stent 101 to engage with the wall of the biological structure. Furthermore, the stent 101 may include a main orifice 103. The main orifice 103 has a central axial location along the stent 101 and allows inflow of blood from outside the stent (e.g., from outside the coronary sinus). The main orifice 103 may be defined by a flange 104 transverse to the central axis of the stent 101 and forming an opening in the stent wall 102. The flange 104 of the shunt 120 is located between the downstream end 105 and the upstream end 106 of the stent 101. As used herein, the flange may involve a projecting flat edge, collar, or rib structure on a component. A flange is a protruding ridge, lip, edge, or margin extending outward from a structure (in this case, a splitter). A flange may completely or partially surround the outer perimeter of the splitter, or it may comprise a series of flange portions or regions that work together for stabilization purposes. A flange region refers to all or part of the flange.

[0074] In some embodiments, the stent 101 may include an opening 107 at a downstream end 105 of the stent 101. The downstream end 105 may refer to an end of the stent 101 further along the coronary sinus in the anterograde flow direction and closer to the right atrium. The upstream end 106 may refer to an end of the stent 101 closer to the myocardium and further away from the right atrium. In some embodiments, the opening at the downstream end of the stent may include a tubular opening. As used herein, tubular may refer to a structure having one or more outer walls defining an intermediate channel, regardless of the profile of the intermediate channel, or defining an opening having a cylindrical or elongated shape or a circular or elliptical cross-section. As a non-limiting example, the tubular structure may include a partially closed structure with a circular side, illustrated in the non-limiting example tubular flange 104. As another non-limiting example, the tubular opening may include a circular opening, illustrated in the non-limiting example opening 107.

[0075] In addition, such as Figure 1A and Figure 1B As shown, a portion of the endovascular medical system 100 may include a shunt 120. The shunt 120 may be configured to bridge two organs, such as the left atrium and the coronary sinus, via a central pathway 121. This bridging may facilitate or enable flow from one biological structure to another through the central pathway 121. In some embodiments and as shown... Figure 2A As shown, the shunt 120 is partially or integrally connected to the stent 101 to extend from the stent 101 into the left atrium 170.

[0076] like Figure 1A and Figure 1B As further shown, a portion of the endovascular medical system 100 may include an occluder 130. The occluder 130 may include an occlusion surface 131. As used herein, an occlusion surface may refer to the surface of the occluder that contacts and prevents fluid flow through, across, or beyond the occlusion surface. For example, the occlusion surface 131 may be the surface of the occluder 130 at its upstream end. In some embodiments, the first implanted occluder may be integrated with a stent. As used herein, integration may refer to physically connecting or attaching two or more components, elements, or devices such that the two or more components function as a unified structure. For example, the occluder 130 and the stent 101 may be integrated into a unified structure configured to restrict fluid flow in one direction within the pathway, for example, as... Figure 2A As shown.

[0077] In some embodiments, the occluder may be biodegradable. As a non-limiting example, the occluder 130 may be configured to biodegrade over time after implantation (e.g., when constructed of a biodegradable material). In some embodiments, the occluder may be configured to progressively restrict blood flow over time. As used herein, progressive can refer to a process that occurs gradually, stepwise, or incrementally over time. As a non-limiting example, the occluder 130 may be configured to progressively increase the restriction on upstream antegrade blood flow by extending it over time.

[0078] Figure 2A and Figure 2B This illustrates deployments consistent with some embodiments of the present disclosure between biological structures. Figure 1A The following are different views of a portion of an example medical system 100. As shown, a portion of the endovascular medical system 100 may be deployed between two cavities. For example, cavity 270 may be the left atrium, and cavity 280 may be the coronary sinus. More generally, the first cavity 270 and the second cavity 280 may be any cavity of any size. In some embodiments, both the first cavity 270 and the second cavity 280 may be containers, and in other embodiments, both the first cavity and the second cavity may be non-containers. For example, both cavities may be blood vessels, both cavities may be part of a major organ, or one cavity may be a blood vessel and the other cavity may be part of a major organ. In one embodiment of this disclosure, the first cavity 270 is the left atrium, and the second cavity 280 is the coronary sinus. Therefore, sometimes in this disclosure, reference numerals 270 and 280 are more generally referred to as the first cavity and the second cavity, and at other times those same reference numerals are used to refer to examples of the left atrium and the coronary sinus. It should be understood that reference to such specific examples thereafter is not intended to... Figure 2A and Figure 2B The publicly available information is limited to examples of shunts from the left atrium to the coronary sinus. Instead, Figure 2A and Figure 2B The aim is to broadly disclose any two cavities that are diverged together. It should be understood that the above interpretation similarly applies to... Figure 3A and Figure 3B , Figure 4A and Figure 4B Or any other drawing that depicts the cavities and labels those cavities with corresponding reference numerals.

[0079] like Figure 2A As shown, the stent 101 and occluder 130 can be deployed, implanted, or positioned within the cavity 280. Additionally, as... Figure 2AAs shown, the shunt 120 can be deployed, implanted, or positioned between cavities 270 and 280, wherein a bridging central pathway 121 is formed during implantation. In some embodiments, the implanted occluder 130 and shunt 120 can cooperate to allow blood to flow anterogradely from the left atrium 270 through the coronary sinus 280 to the right atrium. For example, the implanted occluder 130 and shunt 120 can cooperate to allow oxygenated blood to flow anterogradely from the left atrium 270 through the central pathway 121 to the coronary sinus 280. Furthermore, in some embodiments, the implanted occluder 130 and shunt 120 can cooperate to restrain retrograde flow in the coronary sinus beyond the implanted occluder 130. For example, the implanted occluder 130 and shunt 120 can cooperate to partially or completely block the coronary sinus 280, such that oxygenated blood from the left atrium 270 can be restricted to flow from the central pathway 121 into the coronary sinus 280 in a retrograde direction (i.e., toward the upstream end 106). Such restriction can be complete or partial, allowing a degree of retrograde flow in the coronary sinus to exist upstream of the implanted occluder 130. For example, blood entering the coronary sinus 280 can contact or interact with the occlusion surface 131 and can be redirected retrogradely away from the occluder 130.

[0080] In some embodiments, the first occluder and shunt can be implanted in one or more cavities. For example, the occluder 130 and shunt 301 can be implanted in or between the left atrium 270 and the coronary sinus 280, allowing oxygenated blood to flow from the left atrium 270 into the coronary sinus 280 in an anterograde flow direction. In some embodiments, the first occluder can be implanted before the shunt. In other embodiments, the first occluder can be implanted after the shunt. Furthermore, in some embodiments, the shunt can be implanted before the occluder. For example, the shunt 120 can be implanted before the occluder 130. Additionally or alternatively, in some embodiments, the shunt can be implanted after the occluder. For example, the shunt 120 can be implanted after the occluder 130.

[0081] Figure 3A and Figure 3B It shows Figure 1A The image shows a different view of a portion of an endovascular medical system 100 deployed between biological structures and having a tool for passing through an occluder, wherein the expander is in a non-expanded state. A non-expanded state can refer to a state in which a component, element, device, or instrument is compressed or contracted such that it has a reduced volume compared to its expanded state. As a non-limiting example, when the expander 350 is in the non-expanded state, the expander 350 may substantially not inhibit the occlusion function of the occluder 130.

[0082] like Figure 3AAs shown, a portion of the endovascular medical system 100 may include a tool 340. In some embodiments, the tool may be configured to puncture and pass through a first implanted occluder disposed in the coronary sinus. For example, as... Figure 3A and Figure 3B As shown, tool 340 pierces and passes through occluder 130. Furthermore, in some embodiments, the tool can be configured to form a restrictive pathway through a first implanted occluder located upstream of a shunt bridging the coronary sinus and left atrium. For example, after tool 340 pierces and passes through occluder 130 located upstream of shunt 120 bridging coronary sinus 280 and left atrium 270, occluder 130 may have a hole or opening forming restrictive pathway 132. In this example, the dimensions of restrictive pathway 132 substantially correspond to the height or diameter of tool 340.

[0083] In some embodiments, the tool may include a wire configured to puncture the first implanted occluder. For example, the tool may include a wire having a sharp end, a needle end, a beveled end, a tapered end, a cannula end, a lancet end, a hardened core, a reinforcing end (e.g., diamond-coated, titanium-tipped), a serrated end, a textured end, or any other suitable end for puncturing the first implanted occluder. As a non-limiting example, tool 340 may include a wire with a sharp end configured to puncture occluder 130. Tool 340 may include a catheter configured to puncture the first implanted occluder 130. For example, tool 340 (or any other suitable tool) may include a catheter having a needle tip (e.g., including cannula or core needle assisted), a beveled tip, a tapered tip, a reinforced tip, a hardened tip (e.g., having stainless steel, reinforced polymer), a serrated tip, a textured tip, an expandable or retractable puncture mechanism (e.g., a retractable needle via a spring or similar mechanism), a laser tip, an electrocautery-assisted tip, or any other suitable tip for puncturing the first implanted occluder.

[0084] In addition, such as Figure 3A As shown, a portion of the endovascular medical system 100 may include an extender 350, the extender 350 in Figure 3A and Figure 3B It is shown as being in a non-expanded state, and in Figure 4A and Figure 4B The expander is shown in an expanded state. In some embodiments, the expander can be configured for delivery via a restrictive passage through the first implanted occluder 130 using a tool 340. When the tool 340 punctures the occluder 130 and the expander is driven through the puncture, a restrictive passage 132 can be formed.

[0085] In some embodiments, the expander 350 may include an inflatable balloon, such as Figure 7B The balloon 720 in the example. As a non-limiting example, the balloon may be inflatable via fluid inflation (e.g., with saline, contrast fluid, air, carbon dioxide, etc.), mechanical expansion (e.g., via a spring-loaded mechanism, a self-expanding material), osmotic inflation (e.g., via an absorbent fluid), electrical activation, thermal expansion, or any other means of inflating the balloon.

[0086] In some embodiments, the expander 350 may include a self-expanding scaffold. As a non-limiting example, the self-expanding scaffold may include a shape memory alloy (e.g., nitinol), a hydrogel or similar polymer configured to expand by absorbing fluids (e.g., water, body fluids), or a bioabsorbable polymer configured to expand. Furthermore, as a non-limiting example, the self-expanding scaffold may utilize radial elastic recoil (e.g., using braided or woven wires that store elastic energy upon compression).

[0087] Figure 4A and Figure 4B It shows Figure 3A A different view of a portion of an example endovascular medical system 100 deployed between biological structures, wherein an expander 350 is in an expanded state. An expanded state can refer to a state in which a component, device, instrument, or element is stretched or extended such that it has an increased volume compared to its non-expanded state. As a non-limiting example, when the expander 350 is in the expanded state, the expander 350 can compress an occluder against the wall of the coronary sinus, thereby transforming a restricted passage into a dilated opening. For example, as... Figure 4A and Figure 4B As shown, the expander 350 can be in a second expanded state or configuration. The expander 350 expands radially outward toward the wall of the coronary sinus 280 from its position within the restrictive passage of the occluder 130, such that the occluder 130 is compressed against the wall of the coronary sinus 280, and the restrictive passage is transformed into an expanded opening. For example, compared to an uncompressed occluder 130, the compressed occluder 130 may have an obstructive surface 131, thereby allowing a greater flow through the coronary sinus 280. In one example, the expander may partially compress the occluder against the wall of the coronary sinus. For example, the expander 350 may compress the occluder 130 against the wall of the coronary sinus 280, such that the occluder 130 partially obstructs the flow of anatomical fluid through the coronary sinus 280. In another example, the expander may completely or entirely compress the occluder against the wall of the coronary sinus. For example, the expander 350 can abut against the wall of the coronary sinus 280 and compress the occluder 130 such that the occluder 130 does not substantially obstruct the flow of anatomical fluid through the coronary sinus 280 (e.g., having a flow similar to that in a coronary sinus without any occluder).

[0088] In some embodiments, a portion of the endovascular medical system 100 may include a retainer, the retainer being positioned, for example, on the outer surface of the expander 350 (e.g., on...). Figure 4A An additional stent (on the outer surface of the expander balloon 350) is provided and configured to retain (e.g., permanently) the dilated opening by holding the compressed occluder 130 against the wall of the coronary sinus 280 or the stent 101. The retainer stent can be understood to be similar to the stent 101 in composition, size, or shape. As a non-limiting example, the retainer stent may be self-expanding, balloon-expandable, shape-memory expandable, braided expandable, or may employ any other expansion mechanism. Further as a non-limiting example, the retainer stent may be made of nitinol, stainless steel, cobalt-chromium, or any other suitable material known to those skilled in the art.

[0089] In some embodiments, the expander and retainer may be combined in one of a balloon expandable stent or a self-expanding stent. For example, the expander 350 may be implemented as a single component or structure or integrated into a single component or structure configured to perform the functions of both the expander and the retainer.

[0090] Figure 5A yes Figure 1A A side view of a portion of an example endovascular medical system 100, which is deployed between biological structures and in which an occluder is in an expanded state. For example, after puncture and penetration of the occluder, tool 340 is removed, and the occluder 130 is compressed against the lumen wall, as... Figure 5B and Figure 5C The best result is shown in the middle.

[0091] Figure 5B yes Figure 5A The front view of the system portion shown corresponds to an embodiment where the extender remains in place after expansion. In some embodiments, the extender, retainer, or a combination of extender and retainer can be configured to remain in place after expansion. For example, as... Figure 5B As shown, the expander 350 remains in place in the coronary sinus 280 after expansion to keep the occluder 130 in a compressed state and allow fluid flow through the expanded opening 532.

[0092] Figure 5C yes Figure 5A The front view of the system portion shown corresponds to another embodiment where the extender is removed after expansion. In some embodiments, the extender, retainer, or a combination of extender and retainer can be configured to be removed after expansion. For example, as... Figure 5CAs shown, the expander 350 is removed. In some embodiments, the occluder may be configured to maintain the expanded opening in the absence of an expander, retainer, or a combination of expander and retainer. For example, the occluder 130 may be configured to self-maintain after expansion, such that the occluder 130 is compressed against the wall of the coronary sinus 280 and maintains the expanded opening 532, thereby allowing deoxygenated blood to flow from the myocardium in an anterograde direction through the coronary sinus 280 or oxygenated blood to flow from the left atrium 270 in a retrograde direction through the coronary sinus 280. In another example, the occluder may be configured to self-contract, such that in response to puncture and penetration, the occluder is compressed against the wall of the coronary sinus and maintains the expanded opening. For example, the occluder 130 may include a tensioned, compressed, or stretched surface or membrane configured to move radially outward from the site of puncture or penetration after puncture or penetration. In such an example, the occluder 130 may include a pre-compressed elastic or tensile material or elastomer. Alternatively, the occluder 130 may be made of a material such that once the material is punctured, the occlusion function is reduced without requiring the removal of the occluder 130 or compression of the occluder 130 against the blood vessel wall.

[0093] like Figure 6A , Figure 6B and Figure 6C As shown, a portion of the endovascular medical system 100 may include a second occluder 633. In some embodiments, the second occluder may be configured for implantation downstream of a shunt in the coronary sinus. For example, the second occluder 633 may be configured for implantation downstream of the shunt 120. In some embodiments, the second occluder may be configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus. For example, the second occluder 633 and the shunt 120 may be configured to cooperate such that oxygenated blood may flow from the left atrium 270 into the coronary sinus 280 through a central pathway 121, through a dilated opening 532, and toward the myocardium in a retrograde flow direction. In this way, the myocardium can receive oxygenated blood shunt from the left atrium, which can improve cardiac function.

[0094] In some embodiments, the second occluder may have an arcuate or curved frame, for example... Figure 10B The occluder 1031 in the middle. Alternatively, such as Figure 6A As shown, in addition to the plug 633, a shovel-shaped surface (deflector) 635 can also be provided. Depending on the design selection, it can be derived from... Figure 6AIn this embodiment, the shovel-shaped surface 635 is omitted. Alternatively, the shovel-shaped surface 635 may be integrally formed or attached to the occluder 633. The shovel configuration may include additional flexibility at the edge or lip of the second occluder 633 to accommodate a range of anatomical structures and patient-to-patient differences. Figure 6A As shown, the shovel-shaped surface 635 may be generally circular in its cross-sectional profile. Furthermore, in some embodiments, the second plug may form a crescent shape extending from the diverter. For example, the shovel-shaped surface 635 may have a crescent-shaped blocking surface extending from the diverter 120.

[0095] In some embodiments, the shovel-shaped surface 635 may have an arcuate concave surface sized to cover most or all of the inner circumference of a vein (e.g., coronary sinus 280), such that the arcuate concave surface extends substantially or entirely through the entire cross-section of the vein. In some examples, the flow deflector may be sized to contact the perimeter of the lumen of a vein (e.g., coronary sinus) or to cross the cross-section of the lumen of a vein (e.g., coronary sinus). For example, as Figure 6A As shown, the shovel-shaped surface 635 can span the cross-section of the coronary sinus 280 and contact the inferior wall of the coronary sinus 280.

[0096] Figure 7A , Figure 7B and Figure 7C The steps of an example process for deploying an intravascular medical system 100 between biological structures are illustrated graphically, consistent with some embodiments of this disclosure. Figure 7A This corresponds to the first step of deploying the intravascular medical system 100. Figure 7B This can correspond to the second step after the first step, and Figure 7C This could correspond to the third step following the second step. However, it is understandable that... Figure 7A , Figure 7B and Figure 7C The example process described is merely illustrative, and steps may be added, omitted, or performed in a different order to achieve a similar result.

[0097] like Figure 7A As shown, the first implanted occluder 130 can be positioned within the cavity 280 and can constrain the anterograde flow of fluid upstream of the first implanted occluder 130. For example, the first implanted occluder 130 can be positioned within the coronary sinus 280 and can constrain the anterograde flow of deoxygenated blood from the myocardium toward the right atrium, which may or may not cause some retrograde flow of deoxygenated blood beyond (e.g., in the upstream direction) of the first implanted occluder 130 (e.g., natural anterograde flow impacts the occluder 130 and then moves in the retrograde direction).

[0098] The implanted shunt 120 can be positioned between chambers 270 and 280 and can facilitate fluid flow from chamber 270 to chamber 280. For example, the implanted shunt 120 can be positioned between the left atrium 270 and the coronary sinus 280 and can cooperate with the first implanted occluder 130 to facilitate the anterograde flow of oxygenated blood from the left atrium 270 through the central pathway 121 toward the right atrium within the coronary sinus 280.

[0099] In some embodiments, the occluder may be configured to restrict the natural flow of anatomical fluid. As used herein, natural flow refers to the unobstructed, typical flow of fluid through a particular path or channel. For example, the natural flow of anatomical fluid in the coronary sinus may include the flow of venous blood from the cardiac veins through the coronary sinus toward the right atrium. The direction of this natural flow is generally referred to as antegrade flow. As a non-limiting example, the occluder 130 may restrict the natural antegrade blood flow in the coronary sinus 280 such that the natural antegrade blood flow in the coronary sinus 280 may contact and / or be deflected by the occlusion surface 131 of the occluder 130.

[0100] like Figure 7B As shown, tool 340 can be inserted through the first implanted occluder 130 to create a restricted pathway. For example, tool 340 can pass through the patient's vascular system to reach the first implanted occluder 130 in the coronary sinus 280. After puncture and passage through the occluder 130, an expander such as balloon 720 can be inflated to compress the occluder 130 against the wall of the coronary sinus. The expanded occluder 130 can be held in the expanded position as previously described.

[0101] In some embodiments, the second occluder may be configured for implantation downstream of a shunt in the coronary sinus. For example, tool 340 may carry (e.g., within a catheter or around the wire of tool 340) the second occluder 633 and the second stent 711 to the same or near location relative to shunt 120 and stent 101. For example, after tool 340 punctures and passes through implanted occluder 130, the second occluder 633 may be positioned downstream of shunt 120 (e.g., near the downstream end 105), and the second stent 711 may be positioned in a similar location to stent 101.

[0102] In some embodiments, the second occluder 633 may be expandable, for example via a self-expanding material (including, for example, shape memory alloys (including nitinol), hydrophilic polymers), or by utilizing mechanical expansion (including, for example, delivery as a compression mesh or braid), via a spring-loaded mechanism, by an inflatable balloon, or by an actuator. As a non-limiting example, the second occluder 633 may be configured to expand via a trigger wire mechanism when the delivery mechanism guiding the second occluder 633 (e.g., tool 340, catheter, guidewire) is pulled back or removed. Furthermore, the second occluder 633 may be delivered in a compression configuration to a desired location (e.g., within a catheter, around a guidewire, or adjacent to a guidewire). When in a compression configuration, the second occluder 633 may have a diameter smaller than that of the coronary sinus 280. When in the extended configuration, the second occluder 633 may have a diameter substantially equal to the inner diameter of the coronary sinus 280, such that the second occluder 633 restricts (e.g., partially or completely occludes) the flow of fluid from the myocardium toward the right atrium in the anterograde flow direction.

[0103] In some embodiments, the second occluder may be integrated with a stent. For example, the occluder and stent may be connected to each other (e.g., physically, via an intermediate connecting element) or integrated into a single package. As a non-limiting example, the second occluder 633 may be integrated with the second stent 711 in a single package for delivery to the desired location via the patient's vascular system. Furthermore, the second occluder 633 and the second stent 711 may be configured to cooperate to maintain the position of the second occluder 633 and facilitate the flow of oxygenated blood in the retrograde direction from the left atrium 270 through the central pathway 121 toward the myocardium in the coronary sinus 280.

[0104] In some embodiments, the tool can be configured to remove the first implanted occluder 130. For example, the tool 340 can be configured to hook onto the first implanted occluder 130 such that when the tool 340 is removed, the first implanted occluder 130 is also removed or repositioned.

[0105] like Figure 7C As shown, the second occluder 633 can be positioned downstream of the shunt 120. In some embodiments, the second occluder is configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus. For example, the second occluder 633 can be configured to cooperate with the shunt 120 to induce retrograde flow of oxygenated blood from the left atrium 270 through the coronary sinus 280 toward the myocardium in the retrograde flow direction. Furthermore, in some embodiments, the second occluder can be configured to cooperate with the shunt to restrict antegrade flow in the coronary sinus downstream of the second occluder. For example, the second occluder 633 can be configured to cooperate with the shunt 120 to restrict (e.g., via partial or complete occlusion) the antegrade flow of blood within the coronary sinus 280 downstream of the second occluder 633.

[0106] In some embodiments, the second occluder may be configured to restrict the natural flow of anatomical fluid. As a non-limiting example, the second occluder 633 may restrict the natural antegrade blood flow in the coronary sinus 280 such that the natural antegrade blood flow in the coronary sinus 280 can contact and / or be deflected by the second occluder 633. Furthermore, the retrograde flow of oxygenated blood from the left atrium 270 caused by the cooperation of the shunt 120 and the second occluder 633 may also restrict the natural antegrade flow of blood in the coronary sinus 280 by providing an opposing force (e.g., a dynamic force with a larger magnitude).

[0107] Figure 8 A flowchart of a method 800 for improving cardiac function, consistent with some embodiments of this disclosure, is shown. Method 800 can be performed using any of the example embodiments disclosed herein, by way of example only.

[0108] As shown in step 802, the disclosed embodiments may involve implanting a first occluder in the coronary sinus within the region of the first occluder proximal to the left atrium to impose a first constraint on antegrade blood flow in the coronary sinus. In some embodiments, the constraint on blood flow may include partial or complete occlusion. In some embodiments, the first occluder may be configured to progressively constrain blood flow over time. For example, the first occluder may initially create a partial occlusion in the coronary sinus, and the constraint on blood flow in the antegrade direction may be progressively increased over time until the first occluder creates a complete occlusion in the coronary sinus. In one example, the first occluder may be self-expanding and progressively increase the constraint on blood flow over time.

[0109] As shown in step 804, the disclosed embodiments may involve implanting a shunt bridging the coronary sinus and left atrium downstream of the first occluder region to establish a first flow path that relieves pressure in the left atrium by guiding blood from the left atrium through the coronary sinus to the right atrium. Bridging the coronary sinus and left atrium may include facilitating a flow path between the coronary sinus and left atrium, including, for example, after puncturing or perforating openings in the coronary sinus and left atrium. The flow path may refer to the route that fluid can follow. For example, the shunt may establish a flow path between the left atrium and coronary sinus through the central passage of the shunt. Pressure in the left atrium may be relieved as blood flows from the left atrium through the shunt via the coronary sinus toward the right atrium, or as blood flows from the left atrium through the shunt via the coronary sinus toward the right atrium.

[0110] In some embodiments, the implantation of the first occluder may occur before the implantation of the shunt. In some embodiments, the implantation of the first occluder may occur after the implantation of the shunt. In some embodiments, the implantation of the shunt may occur before the implantation of the occluder. For example, the shunt may be implanted before the implantation of the first occluder. In some embodiments, the implantation of the shunt may occur after the implantation of the first occluder. For example, the shunt may be implanted after the implantation of the first occluder. Regardless of whether the implantation of the first occluder occurs before or after the shunt, both occur before the period of several days in which the first flow path is maintained.

[0111] As shown in step 806, the disclosed embodiments may involve maintaining a first flow path for a period of several days. Maintaining a flow path may mean keeping the flow path open so that fluid can flow from one place to another through the flow path. For example, a shunt or stent may be configured to maintain a flow path between the left atrium and the coronary sinus. In some embodiments, the period of several days may span several weeks. In some embodiments, the period of several days may span several months. In some embodiments, the period of several days may span several years.

[0112] As shown in step 808, the disclosed embodiments may involve weakening the first constraint after a period of several days. As used herein, weakening can refer to a reduction in intensity, amount, or degree. For example, weakening the constraint may include reducing or mitigating the constraint and allowing or permitting an increase in the amount of flow through or across the constraint. In some embodiments, weakening the first constraint may involve puncturing, removing, allowing biodegradation, or transforming the first occluder.

[0113] Device removal can refer to the removal of the occluder from its location within a biological structure, including removal by a medical practitioner, for example, during surgery. Device removal may alternatively involve dilating the occluder so that it is effectively removed or prevents the occluder from substantially obstructing blood flow.

[0114] Allowing the occluder to biodegrade can refer to waiting for the occluder to naturally undergo the process of the materials contained in the occluder (e.g., organic materials, biodegradable materials) breaking down into simpler or smaller compounds.

[0115] The conversion of the occluder can refer to changing the occluder from a first configuration to a second configuration, whereby the first configuration guides the flow of incoming shunt blood in a first direction, and the second configuration guides the flow of incoming shunt blood in a second direction different from the first direction. In some embodiments, the occluder can partially or completely block biological structures in both the first and second configurations. For example, an occluder in the first configuration for guiding flow in the coronary sinus in a first anterograde direction of incoming blood shunt from the left atrium can also restrict the natural anterograde flow of incoming blood from the myocardium by at least partially blocking the coronary sinus. Furthermore, an occluder in the second configuration for guiding flow in the coronary sinus in a second retrograde direction of incoming blood shunt from the left atrium can also restrict the natural anterograde flow of incoming blood from the myocardium by at least partially blocking the coronary sinus.

[0116] As a non-limiting example, the occluder can be switched automatically or manually between a first configuration and a second configuration. Automatic switching may include the occluder switching between the first and second configurations in response to a stimulus (e.g., mechanical movement in response to a received signal after a predetermined amount of time). Manual switching may include the occluder switching between the first and second configurations via manual manipulation, including, for example, manual manipulation by a medical practitioner during surgical procedures.

[0117] In some embodiments, reducing the first constraint may include creating a restrictive pathway in the first occluder. For example, creating a restrictive pathway in the first occluder may include puncturing the occluder using a specialized tool, catheter, or wire.

[0118] In some embodiments, reducing the first constraint may include expanding the first occluder via a restrictive passage. In some embodiments, expanding the first occluder may include passing a wire through the first occluder to form a restrictive passage. For example, the wire may pierce and pass through the first occluder to form a restrictive passage. In some embodiments, expanding the first occluder may include passing a balloon through the restrictive passage. For example, an uninflated balloon may be inserted through the restrictive passage. In some embodiments, expanding the first occluder may include inflating the balloon. For example, the balloon may be inflated (e.g., with gas, fluid) to expand the restrictive passage into an expanded opening.

[0119] In some embodiments, reducing the first constraint may include permanently retaining the dilated first occluder against the wall of the coronary sinus. In some embodiments, retaining the dilated first occluder against the wall of the coronary sinus may include extending a stent to hold the first occluder in a compressed state. For example, the stent may extend to hold the first occluder in a compressed state and maintain the dilated opening.

[0120] In some embodiments, reducing the first constraint may include removing the first occluder from the coronary sinus. In some embodiments, the first occluder is removed using a stent retrieval device. As used herein, a stent retrieval device may refer to a medical device or component comprising a self-expanding mesh stent configured to be inserted into a blood vessel (e.g., via a guidewire), expand to capture or trap an object (e.g., the first occluder), and be removed together with the captured object.

[0121] In some embodiments, the first constraint may be weakened after it has been confirmed that the pressure in the heart chambers is greater than the pressure in the veins. For example, a healthcare practitioner may confirm that the pressure in the left atrium is greater than the pressure in the coronary sinus.

[0122] In some embodiments, cardiac chamber pressure or venous pressure can be derived from direct measurement of hemodynamic parameters. Direct measurement can refer to obtaining parameters using sensors or devices. Hemodynamic parameters can refer to measurements reflecting blood flow, blood pressure, or the function of the cardiovascular system. As a non-limiting example, hemodynamic parameters may include arterial blood pressure, central venous pressure, pulmonary artery pressure, cardiac output, cardiac index, stroke volume, systemic vascular resistance, pulmonary vascular resistance, mixed venous oxygen saturation, or any other suitable hemodynamic parameter. For example, devices or sensors can be inserted into or implanted in cardiac chambers or blood vessels to directly measure cardiac chamber pressure or venous pressure, respectively. As a non-limiting example, left atrial pressure can be directly measured via a pulmonary artery catheter (Swan-Ganz catheter) or a similar device.

[0123] In some embodiments, cardiac chamber pressure or venous pressure can be derived through indirect measurement of hemodynamic parameters. Indirect measurement can refer to deriving a parameter from one or more other variables or estimating a parameter using one or more mathematical relationships. For example, a device or sensor can be placed externally to measure one or more hemodynamic parameters for deriving or estimating cardiac chamber pressure or venous pressure. As a non-limiting example, Doppler echocardiography or a similar device can be used to indirectly measure left atrial pressure.

[0124] In some embodiments, ventricular or venous pressure can be extracted under partial occlusion. Furthermore, in some embodiments, ventricular or venous pressure can be extracted under complete occlusion. For example, coronary sinus pressure can be obtained directly or indirectly while the occluder partially or completely blocks a segment of the coronary sinus (e.g., a segment proximal to the left atrium).

[0125] As shown in step 810, the disclosed embodiments may include, after reducing the first constraint, implanting a second occluder in the coronary sinus in the region of the second occluder downstream of the shunt to impose a second constraint on antegrade blood flow in the coronary sinus, thereby establishing a second flow path in the coronary sinus for retrograde flow from the left atrium. For example, after reducing the first constraint, a second occluder may be implanted downstream of the shunt between the left atrium and the coronary sinus to impose constraint on antegrade blood flow in the coronary sinus. Furthermore, the second occluder may cooperate with the shunt to establish a flow path for oxygenated blood from the left atrium toward the myocardium within the coronary sinus in a retrograde flow direction.

[0126] In some embodiments, a means for selectively guiding flow in the coronary sinus adjacent to the left atrium is disclosed. As used herein, selectively guiding flow can refer to controlling or manipulating the movement of fluid. For example, selectively guiding flow in the coronary sinus can include controlling the direction of flow of anatomical fluid in the coronary sinus, such as switching between a flow direction in a first direction and a flow direction in a second direction different from the first direction. Furthermore, selectively guiding flow can include switching between a first configuration configured to deflect or constrain flow in the first direction and a second configuration configured to deflect or constrain flow in the second direction different from the first direction.

[0127] In some embodiments, the device may include a shunt configured to bridge the left atrium and the coronary sinus. For example, the shunt may establish or maintain a flow path between the left atrium and the coronary sinus, allowing oxygenated blood to flow from the left atrium into the coronary sinus.

[0128] In some embodiments, the device may include an occluder selectively positioned between a first anterograde flow deflection position and a second retrograde flow deflection position. Selective positioning can refer to an object, device, or component configured to move, adjust, or change positions. For example, a selectively positioned occluder may include an occluder configured to change between a first configuration and a second configuration (e.g., a variable occluder). In the first anterograde flow deflection configuration, the occluder may be configured to direct flow in the coronary sinus from the left atrium toward the right atrium in a first direction. For example, when in the first anterograde flow deflection configuration, the variable occluder may restrain (e.g., partially or completely block) retrograde flow in the coronary sinus from the left atrium toward the myocardium. Furthermore, when in the first anterograde flow deflection configuration, the variable occluder may restrain (e.g., partially or completely block) the natural anterograde flow in the coronary sinus from the myocardium toward the right atrium.

[0129] In the second retrograde flow deflection configuration, the occluder can be configured to guide flow in the coronary sinus away from the right atrium in a second direction from the left atrium. For example, in the second retrograde flow deflection configuration, the variable occluder can restrain (e.g., partially or completely block) the antegrade flow in the coronary sinus from the left atrium to the right atrium. Furthermore, in the second retrograde flow deflection configuration, the variable occluder can restrain (e.g., partially or completely block) the natural antegrade flow in the coronary sinus from the myocardium to the right atrium.

[0130] In some embodiments, an endovascular medical device or kit is provided for controlled reversal of the direction of shunt blood flow within a stent. Similar to other embodiments, the endovascular medical device or kit for controlled reversal of the direction of shunt blood flow includes a stent defined by a stent wall having a main orifice and a shunt. The stent extends between a proximal end and a distal end and is defined by a stent wall that is sized and shaped to engage a vessel wall. The stent wall includes a main orifice defined by a peripheral edge. The main orifice is located between the proximal and distal ends of the stent. A shunt defines a central passage. The shunt extends outward from the peripheral edge toward a first lumen in the organ.

[0131] In some embodiments, the occluder or variable occluder may be adjustable in situ to selectively alter the flow direction in the coronary sinus. In situ can refer to the same, implanted, or original location. For example, the occluder may be adjustable between a first anterograde flow deflection position and a second retrograde flow deflection position while maintaining the same approximate location within the vessel without requiring removal.

[0132] In some embodiments, the variable occluder may be adapted to engage the stent wall or an internal tubular frame positioned within the stent and to at least partially restrict blood flow through the stent. In some embodiments, the variable occluder is convertible between a first configuration and a second configuration, such that in the first configuration, the variable occluder guides an extension of the central channel of the shunt toward the proximal end or opening of the stent; and in the second configuration, the occluder guides an extension of the central channel of the shunt toward the distal end or opening of the stent in the opposite direction. In other words, in the first configuration, the occluder is configured to guide a first flow direction, and in the second configuration, the occluder is configured to guide a second or opposite flow direction. In either the first or second configuration, an extension of the central channel of the shunt faces a single tubular opening of the stent. The shunt and stent are configured to remain fixed during the conversion between the first and second configurations. The variable plug is adapted to switch between a first configuration and a second configuration, such that in the first configuration, the proximal junction of the variable plug is distal to the main orifice, and in the second configuration, the proximal junction of the variable plug is proximal to the main orifice. The main orifice may have a maximum dimension ranging from 3 mm to 12 mm.

[0133] In the first configuration, the variable occluder can be temporarily stabilized in the blood vessel, while in the second configuration it can be stabilized in the blood vessel for more than six months.

[0134] The variable occluder can be adapted to be changed in either direction—from a first configuration to a second configuration and from a second configuration to a first configuration—for example, by rotation or repositioning. Alternatively, the variable occluder can be adapted to be changed sequentially in a single direction, for example, by axial rotation or repositioning. This change can be performed by mechanical or automatic means.

[0135] In some embodiments, the variable occluder is adapted to switch between a first configuration and a second configuration by rotating about the longitudinal axis of the support. In some embodiments, the variable occluder includes a coupling element adapted to be coupled to or disconnected from a shunt or support.

[0136] In some embodiments, the blocking surface in the first configuration is different from the blocking surface in the second configuration. In alternative embodiments, the convertible plug is a single component in each of the first and second configurations.

[0137] In some embodiments, the variable occluder is adapted to engage the stent in a planar engagement manner in both a first and a second configuration. In some embodiments, the planar engagement is orthogonal to the longitudinal axis of the stent. In some embodiments, the occlusion surface is curved or shovel-shaped.

[0138] In some embodiments, the variable occluder is adapted to change between two longitudinal positions within the stent, between the proximal and distal ends.

[0139] In some embodiments, the convertible occluder is a conformal sheet that radially traverses the support.

[0140] In some embodiments, the variable occluder is substantially impermeable to blood. In some embodiments, the variable occluder is adapted to reduce blood permeability over time.

[0141] In some embodiments, the variable occluder includes a puncture- or removable surface in its first or antegrade flow configuration.

[0142] In some embodiments, the endovascular medical device is adapted to retract within an overtube for percutaneous delivery via the coronary sinus and to expand after deployment from the overtube. In some embodiments, the overtube is adapted for delivery to the coronary sinus.

[0143] In some embodiments, the support includes a connecting element adapted to be connected to or disconnected from the occluder.

[0144] In some embodiments, the shunt further includes a stabilizer configured to stabilize the shunt. In some embodiments, the shunt and the plug are integrally formed. In alternative embodiments, the shunt and the plug are two parts. In some embodiments, the shunt includes a time-delayed opening or a pressure-based valve. In some embodiments, the shunt is adapted to inhibit excessive inward growth of tissue within the central channel of the shunt.

[0145] In some embodiments, the shunt includes a coupling element adapted to be connected to or disconnected from the plug.

[0146] In some embodiments, the shunt defines a central channel extending from the coronary sinus to the left atrium to allow blood to flow from the left atrium through the shunt to the coronary sinus.

[0147] Figure 9A and Figure 9B Examples of a convertible endovascular medical system 900 in a different configuration consistent with some embodiments of the present disclosure are shown. In some embodiments, the convertible endovascular medical system may include a stent, a shunt, and a convertible occluder. For example, the convertible endovascular medical system 900 may include a stent 901 having a stent wall 902 and a main orifice 903 defined by a peripheral edge 904; a shunt 920 having a central access 921; and a convertible occluder 930 having an occlusion surface 931.

[0148] like Figure 9AAs shown, the variable occluder 930 is in a first configuration. In the first configuration, the variable occluder 930 can be configured to deflect or redirect blood flow shunt from the left atrium 970 to the coronary sinus 980 in an anterograde or downstream direction toward the downstream end 905 (e.g., in the direction indicated by arrow A (anterograde flow direction)).

[0149] In addition, such as Figure 9B As shown, the variable occluder 930 is in a second configuration. In the second configuration, the variable occluder 930 can be configured to deflect or redirect blood flow shunt from the left atrium 970 to the coronary sinus 980 in a retrograde or upstream direction (e.g., in the direction indicated by arrow R (retrograde flow direction)) toward the upstream end 906. The variable occluder 930 can be adapted to switch between a first configuration and a second configuration. In some embodiments, the switching of the occluder between the first and second configurations can occur without substantially affecting the position of the shunt or stent.

[0150] like Figure 9B As shown, for reference purposes, the splitter 120 may be divided by a central plane C, which defines the upstream side U and the downstream side D of the splitter 120.

[0151] Figure 10A and Figure 10B Another example of a scalable endovascular medical system 1000 consistent with some embodiments of the present disclosure is shown, which is deployed between biological structures for shunt and selectively modulating anatomical fluid flow deployed between the biological structures. In one example, the scalable endovascular medical system 1000 may include a stent 1001 having a stent wall 1002 and a main orifice 1003 defined by a peripheral edge 1004; a shunt 1020 having a central access 1021; a scalable occluder 1030 having an occlusion surface 1031; and a coupling element 1035.

[0152] like Figure 10A As shown, the convertible occluder 1030 is in a first configuration to deflect or redirect blood flow shunt from the left atrium 1070 to the coronary sinus 1080 in an anterograde or downstream direction. Furthermore, as... Figure 10B As shown, the variable occluder 1030 is in a second configuration to deflect or redirect blood flow shunt from the left atrium 1070 to the coronary sinus 1080 in a retrograde or upstream direction.

[0153] like Figure 10A and Figure 10BAs shown, in both the first and second configurations, a single variable occluder 1030 can have substantially similar longitudinal positions within the support 1001. Furthermore, the variable occluder 1030 can be configured to adjust its shape and / or its connection position with the support 1001 from an upstream position relative to the main orifice 1003 to a downstream position.

[0154] like Figure 10A As shown, in the first stage, the variable occluder 1030 is in a first or anterograde flow configuration to guide blood flow shunt from the left atrium 1070 (blood typically with increased oxygenation and higher pressure) toward the coronary sinus 1080 along the anterograde flow direction within the coronary sinus. Furthermore, the variable occluder 1030 may have a proximal shunt junction upstream of the main orifice 1003 of the stent 1001 or downstream of the central access 1021 of the shunt 1020.

[0155] Furthermore, the variable plug 1030 may include a blocking surface 1031, which may form part of a first or co-current flow configuration and a second or countercurrent flow configuration. For example, the blocking surface 1031 may be the same element in both configurations and may be adapted to change its position and / or shape based on the configuration. Figure 10A The first or anterograde flow configuration includes an obstruction surface 1031 that at least partially (and may completely) constrain deoxygenated blood flow from the myocardium in the anterograde flow direction. In some embodiments, after a period of time, the convertible occluder 1030 may be converted from the first configuration to a second configuration. As a non-limiting example, this period of time may span several days, weeks, or months.

[0156] like Figure 10BAs shown, in the second stage, the convertible occluder 1030 may have a proximal shunt junction downstream of the main orifice 1003 of the stent 1001 or upstream of the central passage 1021 of the shunt 1020. In this configuration, blood shunt from the left atrium 1070 is directed to flow in a retrograde direction within the coronary sinus 1080. To switch to the second stage, the convertible occluder 1030 may include a coupling element 1035 configured to connect or disconnect the convertible occluder 1030 from the shunt 1020 or the stent 1001. As a non-limiting example, the connection between the convertible occluder 1030 and the shunt 1020 may be achieved via sutures, adhesives, rivets, welds, brazing, or other techniques known to those skilled in the art. The interconnection can be rotatable, allowing the diverter to rotate about an axis transverse to the axis of the support 1001, thereby altering the flow deflection orientation (e.g., from antegrade to retrograde deflection). Further, as a non-limiting example, indirect interconnection can be achieved via a direct connection of the diverter 1020 and the variable plug 1030 to a common intermediate element. The connecting element 1035 may include a quick-release mechanism, which can be mechanically implemented using, for example, a special tool. Both the first and second configurations of the variable plug 1030 are stably engaged with the support 1001, allowing the variable plug 1030 to perform its desired or intended function. The connecting element 1035 may be associated with or include a lock to ensure that the variable plug 1030 maintains the desired or intended position for a period of time. The blocking surface 1031 may be curved or shovel-shaped to aid in deflecting flow. The variable plug 1030 may include a curved blocking surface 1031 adapted to change between curvature or curvature direction. The convertible plug 1030 may include a flexible bias frame that is biased toward reduced curvature when the coupling element is released.

[0157] Figure 11A and Figure 11B An example of another convertible endovascular medical system 1100 deployed in a first configuration between biological structures, consistent with some embodiments of this disclosure, is shown. In one example, the convertible endovascular medical system 1100 may include: a stent 1101 having a stent wall 1102 and a main aperture 1103 defined by a peripheral edge 1104; a shunt 1120 having a central access 1121; a convertible occluder 1130 having an obstruction surface 1131; and a rotatable element 1135.

[0158] like Figure 11A As shown, the convertible plug 1130 is in the first configuration. Furthermore, as... Figure 11BAs shown, the variable occluder 1130 is in a second configuration. In some embodiments, the variable occluder 1130 may have substantially the same shape or size, but with different positions or orientations between the first and second configurations. For example, in the second configuration, the variable occluder 1130 can rotate 180 degrees about the longitudinal axis of the support 1101. In some embodiments, the variable occluder 1130 may include a tubular frame having two holes at opposite positions on its surface and being rotatable within the support 1101. The downstream end 1105 may also include a tool interface for controlling the rotation of the device.

[0159] like Figure 11A As shown, in the first stage, the variable occluder 1130 is in a first or anterograde flow configuration to guide blood flow shunt from the left atrium 1170 toward the coronary sinus 1180 along the anterograde flow direction within the coronary sinus 1180. The variable occluder 1130 may include a proximal shunt junction located upstream of the main orifice 1103 or central access 1121 of the stent 1101. The variable occluder 1130 may include an occlusion surface 1131 forming part of both the first or anterograde flow configuration and a second or retrograde flow configuration. Figure 11A As shown, a first or anterograde flow configuration may include an occlusion surface 1131, which may be configured to at least partially confine blood flowing in the anterograde direction within the coronary sinus 1180. For example, deoxygenated blood flow from the myocardium may be confined to continue in the anterograde direction. The anterograde flow configuration is determined relative to blood entering the coronary sinus 1180 via the shunt 1120. In some embodiments, the convertible occluder 1130 may be converted from a first configuration to a second configuration after a period of time. As a non-limiting example, this period of time may span several days, weeks, or months.

[0160] like Figure 11B As shown, in the second stage, the variable occluder 1130 is in a second or retrograde flow configuration. In the retrograde flow configuration, the variable occluder 1130 may be positioned downstream relative to the main orifice 1103 or the central access 1121. In this configuration, blood shunt from the left atrium 1170 may be directed to flow in a retrograde direction within the coronary sinus 1180. In some embodiments, the variable occluder 1130 may be configured to change from a first configuration to a second configuration by rotation about the longitudinal axis of the stent 1101. For example, the variable occluder 1130 may include a rotatable element 1135 located on the outer surface of the variable occluder 1130 and configured to allow the variable occluder 1130 to slide along the inner circumference of the stent 1101 to support rotation about the longitudinal axis of the stent 1101.

[0161] A rotatable element can refer to a component, device, element, or instrument configured to rotate itself or another object about an axis. For example, rotatable element 1135 can be configured to provide a way to rotate the reversible occluder 1130 180 degrees. As a non-limiting example, rotation can be performed mechanically or manually, for example, using a catheter tool. Both the first and second configurations of the reversible occluder 1130 can be stably engaged with the support 1101, allowing the reversible occluder 1130 to perform its intended or desired function. In some embodiments, rotatable element 1135 can be associated with a locking mechanism configured to hold the position or orientation of the reversible occluder 1130. In some embodiments, rotatable element 1435 can be mechanically driven with a tool. In some embodiments, the occlusion surface 1131 can be planar, curved, or shovel-shaped.

[0162] Figure 11C , Figure 11D and Figure 11E Another example of a convertible endovascular medical system 1400, consistent with some embodiments of this disclosure, is shown, deployed between biological structures such as between the coronary sinus 1480 and the left atrium 1470. It will be understood that, unless otherwise stated, Figure 11C , Figure 11D and Figure 11E and Figure 11A and Figure 11B Similar reference numerals in the accompanying drawings can indicate similar features or elements.

[0163] The variable endovascular medical system 1400 may include a stent 1401 having a shunt 1420 with a central access 1421 and a main orifice 1403 defined by a peripheral edge 1404 of the stent. The variable endovascular medical system 1400 may also include a variable occluder 1430 having an occlusion surface 1431 and a rotatable element 1435. Figure 11C A first configuration consistent with some embodiments of this disclosure is shown, while Figure 11D A second configuration consistent with some embodiments of this disclosure is shown. Figure 11E An exploded view of the various parts of a variable endovascular medical system having a shunt stent portion 1434 and a variable occluder 1430 is shown. The variable occluder 1430 is typically housed within the shunt stent portion 1434. The variable occluder 1430 can be configured to be easily rotated about the longitudinal axis of the stent 1401.

[0164] like Figure 11CAs shown, in the first configuration, the convertible occluder 1430 is in a first or anterograde flow configuration to guide blood flow shunted from the left atrium 1470 toward the coronary sinus 1480 along the anterograde flow direction within the coronary sinus 1480.

[0165] The versatile endovascular medical system 1400 includes a stent 1401 configured to provide structural support and accommodate various components. The stent 1401 may be coated with a biocompatible material for vascular integration. The stent wall 1402 comprises a lattice pattern of interconnected struts for flexibility and structural integrity. The stent 1401 is characterized by a main aperture 1403 defined by a peripheral edge 1404 of the stent 1401 and includes a central pathway 1421 for blood flow.

[0166] Shunt 1420 extends along stent 1401 from the intermediate axial position and bridges the left atrium 1470 and coronary sinus 1480.

[0167] The convertible occluder 1430 may include an occlusion surface 1431 forming part of a first or anterograde flow configuration and a second or retrograde flow configuration. The occlusion surface 1431 has a shunt proximal engagement, which, in the first configuration, is located upstream of the main orifice 1403 or central access 1421. In the first or anterograde flow configuration, the occlusion surface 1431 may be configured to at least partially guide blood in the anterograde flow direction within the coronary sinus 1480 and constrain the anterograde flow of deoxygenated blood from the myocardium. The determination of the anterograde flow configuration of the occlusion surface 1431 is relative to the blood entering the coronary sinus 1480 through the shunt 1420.

[0168] The variable occluder 1430 may include an occlusion piece with an occlusion surface 1431 incorporated into the design, contacting the internal stent or tubular frame 1432 along its entire internal perimeter and radially traversing the stent. This configuration facilitates occlusion and helps control the direction of blood flow within the device. The variable occluder 1430 contacts the inner wall of the tubular frame 1432 along a certain length.

[0169] In some embodiments, the blocking surface 1431 extends from the tubular frame 1432. The convertible occluder 1430 includes the blocking surface 1431, which may be planar, curved, or shovel-shaped.

[0170] In some embodiments, the blocking surface 1431 may have a shovel-shaped shape and may be generally circular in its cross-sectional profile direction. In some embodiments, the blocking surface 1431 may be formed in a crescent or shovel shape extending from the tubular frame 1432. In some embodiments, the blocking surface 1431 may have an arcuate concave surface sized to cover most or all of the inner circumference of the tubular frame 1432, such that the arcuate concave surface extends substantially or entirely through the entire cross-section of the tubular frame 1432. In some examples, the blocking surface may be sized to contact the perimeter of the tubular frame 1432, or alternatively, to span the cross-section of the tubular frame 1432.

[0171] The 1430 occluder can engage the support via a planar joint in both a first and a second configuration. The planar joint can be orthogonal to the longitudinal axis of the support.

[0172] The variable occluder 1430 can be selectively positioned between an anterograde flow position and a retrograde flow position. The variable occluder 1430 can rotate within the stent 1401 to achieve different configurations. The variable occluder 1430 can have the same shape and / or size in both configurations, differing only in orientation. In the second configuration, the variable occluder 1430 can rotate 180 + / - 30 degrees about the longitudinal axis of the stent 1401. This 180-degree rotation ensures a complete reversal of the occluder's orientation, effectively switching between anterograde and retrograde flow configurations. The change from anterograde to retrograde flow direction can be performed automatically. This automatic flow direction change reduces the need for manual intervention, potentially improving patient outcomes by ensuring timely adjustments based on predetermined criteria or physiological feedback.

[0173] In some embodiments, after a period of time, the convertible occluder 1430 can automatically or manually switch from a first configuration to a second configuration. As a non-limiting example, this period of time can span several days, weeks, months, or years.

[0174] like Figure 11D As shown, in the second stage, the variable occluder 1430 is in a second or retrograde flow configuration. In the retrograde flow configuration, the variable occluder 1430 can be positioned downstream relative to the main orifice 1403 or the central access 1421. In this configuration, blood shunt from the left atrium 1470 can be directed to flow in a retrograde direction within the coronary sinus 1480. In this example, the variable occluder 1430 can be configured to change from a first configuration to a second configuration by rotating about the longitudinal axis of the stent 1401.

[0175] like Figure 11DAs shown, the variable occluder 1430 can be configured such that the occlusion surface is positioned downstream of the shunt 1420, such that the occlusion surface cooperates with the shunt to induce retrograde flow from the left atrium 1470 in the coronary sinus 1480. For example, in a second configuration, the occlusion surface 1431 can cooperate with the shunt 1420 to induce retrograde flow of oxygenated blood from the left atrium 1470 through the coronary sinus 1480 toward the myocardium in a retrograde flow direction.

[0176] The rotatable element 1435 provides a mechanism for easily adjusting the position of the occluder, facilitating transitions between antegrade and retrograde flow configurations without the need for invasive surgery. The rotatable element 1435 provides a means for changing the occluder by rotating the reversible occluder 1430 relative to the longitudinal axis of the stent 1401. The ability to rotate the occluder provides a non-invasive way to change the flow direction, thereby reducing the need for additional surgical intervention. Rotation about the longitudinal axis of the stent allows for precise and controlled adjustment of the occluder's position, facilitating desired changes in flow direction. In some embodiments, the rotatable element 1435 can be mechanically driven with a tool. In some embodiments, the rotatable element 1435 may be associated with a locking mechanism configured to retain the position or orientation of the reversible occluder 1430.

[0177] The rotatable element 1435 may include a tubular frame 1432, which is sized to fit within the support 1401. Figure 11E The internal tubular frame may include at least two holes at opposite positions on the outer surface, these holes being configured to align with the central passage 1421 of the shunt 1420 in each configuration. This alignment allows controlled blood flow through the device.

[0178] The contours of the variable occluder 1430 and the support 1401 may each include variations in diameter 1436 to facilitate axial positioning within the support 1401. Other methods of maintaining the longitudinal position of the internal tubular frame within the support 1401 are also possible.

[0179] The stent 1401 and the variable occluder 1430 can be jointly configured to allow the variable occluder 1430 to rotate relative to the stent 1401. For example, the outer surface of the variable occluder 1430 can be compatible with frictionless rotation within the stent 1401. The rotational capability of the variable occluder 1430 within the stent 1401 enables in-situ adjustment of the occluder's position, thereby allowing non-invasive changes in flow direction after a period of time. Rotational capability can be provided by a low-friction coating on the inner surface of the stent 1401 and / or the inner tubular frame 1432 or the outer surface of the variable occluder 1430. Examples of low-friction coatings may include polytetrafluoroethylene (PTFE) or other biocompatible lubricants to reduce friction during rotation. Alternatively or additionally, micropatterned surfaces on the inner tubular frame or the variable occluder 1430 and the stent can be designed to minimize contact area and reduce friction during rotation. Magnetic elements or shape memory alloy components can be integrated to initiate and control rotation when activated by changes in temperature, magnetism, or electricity in the environment.

[0180] The system allows for in-situ adjustment between anterograde and retrograde flow configurations, adapting to physiological needs over time. Switching can be based on specific parameters, such as pressure gradient. The device can be implanted using minimally invasive techniques, positioning the shunt to bridge the coronary sinus and left atrium.

[0181] Figure 12 A flowchart of a method 1200 for improving cardiac function, consistent with some embodiments of this disclosure, is shown. Method 1200 can be performed using any of the example embodiments disclosed herein, by way of example only.

[0182] As shown in step 1202, the disclosed embodiments may include implanting a shunt that bridges the coronary sinus and left atrium. For example, the implanted shunt can establish and maintain a flow path between the left atrium and the coronary sinus. In some embodiments, shunt implantation may occur before occlusion device implantation. For example, the shunt may be implanted before implantation of an upstream occlusion device, a downstream occlusion device, or a variable occlusion device. In some embodiments, shunt implantation may occur after occlusion device implantation. For example, the shunt may be implanted after implantation of an upstream occlusion device, a downstream occlusion device, or a variable occlusion device.

[0183] As shown in step 1204, the disclosed embodiments may include guiding anterograde blood flow in the coronary sinus from the left atrium to the right atrium. In some embodiments, guiding anterograde blood flow in the coronary sinus from the left atrium to the right atrium may include progressively restricting the blood flow over time. For example, the occluder may initially create a partial blockage in the coronary sinus, and the restriction on the blood flow in the anterograde direction may be gradually increased over time until the occluder creates a complete blockage in the coronary sinus.

[0184] As shown in step 1206, the disclosed embodiments may include, after a period of time, changing the anterograde flow in the coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrial blood flow away from the right atrium. In some embodiments, the period of time may span several weeks. In some embodiments, the period of time may span several months. In some embodiments, the period of several days may span several years.

[0185] In some embodiments, changing antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes reducing a first constraint. In some embodiments, reducing the first constraint may include forming a restrictive pathway in the implanted occluder. In some embodiments, reducing the first constraint may include expanding the implanted occluder via the restrictive pathway. In some embodiments, expanding the implanted occluder may include passing a wire through the implanted occluder to form a restrictive pathway. In some embodiments, expanding the implanted occluder may include passing a balloon through the restrictive pathway. In some embodiments, expanding the implanted occluder may include inflating a balloon.

[0186] In some embodiments, reducing the first constraint may include permanently retaining the expanded implanted occluder against the wall of the coronary sinus. In some embodiments, retaining the expanded implanted occluder against the wall of the coronary sinus may include extending a stent to hold the expanded implanted occluder in a compressed state.

[0187] In some embodiments, reducing the first constraint may include removing the first occluder from the coronary sinus. In some embodiments, removal of the first occluder may be performed using a stent retrieval device.

[0188] In some embodiments, the change from antegrade flow in the coronary sinus to retrograde flow in the coronary sinus occurs after it has been confirmed that the intracardiac chamber pressure is greater than the venous pressure. In some embodiments, the intracardiac chamber pressure or venous pressure can be derived from direct measurement of hemodynamic parameters. In some embodiments, the intracardiac chamber pressure or venous pressure can be derived from indirect measurement of hemodynamic parameters.

[0189] In some embodiments, changing antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves puncturing, removing, allowing biodegradation, or transforming the implanted occluder.

[0190] In some embodiments, method 1200 may further include implanting an occluder before implanting the shunt. For example, an occluder located upstream of the shunt, a occluder located downstream of the shunt, or a variable occluder may be implanted before implanting the shunt. In some embodiments, method 1200 may further include implanting an occluder after implanting the shunt. For example, an occluder located upstream of the shunt, a occluder located downstream of the shunt, or a variable occluder may be implanted after implanting the shunt.

[0191] This article also discloses the following terms: Clause 1. A system for altering the direction of blood flow in a coronary sinus shunt from the left atrium, the system comprising: A tool configured to puncture and pass through a first implanted occluder disposed in the coronary sinus, the tool being configured to form a restricted pathway through the first implanted occluder when the first implanted occluder is located upstream of a shunt bridging the coronary sinus and the left atrium, and when the first implanted occluder and the shunt cooperate prior to puncture to allow blood to flow anterogradely from the left atrium to the right atrium via the coronary sinus and to constrain retrograde flow in the coronary sinus beyond the first implanted occluder; An expander configured to be delivered through the first implanted occluder into the restrictive pathway and expand within the restrictive pathway to compress the first implanted occluder against the wall of the coronary sinus, thereby transforming the restrictive pathway into an dilated opening; A retainer configured to permanently retain the dilated opening by holding a compressed first implanted occluder against the wall of the coronary sinus; and A second occluder is configured for implantation downstream of the shunt in the coronary sinus, wherein the second occluder is configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus and constrain antegrade flow in the coronary sinus downstream of the second occluder.

[0192] Clause 2. The system according to Clause 1, wherein the tool includes a wire configured to puncture the first implanted occluder.

[0193] Clause 3. The system according to Clause 1 or 2, wherein the tool includes a catheter configured to puncture the first implanted occluder.

[0194] Clause 4. The system according to any one of Clauses 1-3, wherein the expander comprises an inflatable balloon.

[0195] Clause 5. The system according to any one of Clauses 1-4, wherein the extender includes a self-expanding bracket.

[0196] Clause 6. The system according to any one of Clauses 1-5, wherein the retainer comprises a support.

[0197] Clause 7. The system according to Clause 6, wherein the stent is balloon-expandable.

[0198] Clause 8. The system according to any one of Clauses 1-7, wherein the expander and the retainer are combined in one of a balloon expandable stent or a self-expanding stent.

[0199] Clause 9. The system according to any one of Clauses 1-8, wherein the second occluder is scalable.

[0200] Clause 10. The system according to any one of Clauses 1-9, wherein the second occluder is integrated with the support.

[0201] Clause 11. The system according to any one of Clauses 1-10, wherein the tool, the extender, the retainer and the second occluder are provided as a kit.

[0202] Clause 12. A method for improving cardiac function, said method comprising: A first occluder is implanted in the coronary sinus in the region of the first occluder proximal to the left atrium to apply a first constraint to the antegrade blood flow in the coronary sinus; A shunt bridging the coronary sinus and left atrium is implanted downstream of the first occluder region to establish a first flow path that relieves pressure in the left atrium by guiding blood from the left atrium through the coronary sinus to the right atrium.

[0203] Maintain the first flow path for a period of several days; and Following the aforementioned period of several days: - Reduce the first constraint; and - After reducing the first constraint, a second occluder is implanted in the coronary sinus in the second occluder region downstream of the shunt to impose a second constraint on antegrade blood flow in the coronary sinus, thereby establishing a second flow path in the coronary sinus for retrograde flow from the left atrium.

[0204] Clause 13. The method described in Clause 12, wherein the period of several days spans several weeks.

[0205] Clause 14. The method described in Clause 12 or 13, wherein the period of said several days spans several months.

[0206] Clause 15. The method according to any one of Clauses 12-14, wherein reducing the first constraint comprises forming a restrictive pathway in the first occluder, expanding the first occluder via the restrictive pathway, and permanently maintaining the expanded first occluder against the wall of the coronary sinus.

[0207] Clause 16. The method according to Clause 15, wherein expanding the first occluder includes passing a wire through the first occluder to form a restrictive passage, passing a balloon through the restrictive passage, and inflating the balloon.

[0208] Clause 17. The method according to Clause 15 or 16, wherein holding the dilated first occluder against the wall of the coronary sinus includes an extended stent to hold the first occluder in a compressed state.

[0209] Clause 18. The method according to any one of Clauses 12-17, wherein reducing the first constraint comprises removing the first occluder from the coronary sinus.

[0210] Clause 19. The method of Clause 18, wherein a stent retrieval device is used to remove the first occluder.

[0211] Clause 20. The method according to any one of Clauses 12-19, wherein the implantation of the first occluder occurs before the implantation of the shunt.

[0212] Clause 21. The method according to any one of Clauses 12-19, wherein the implantation of the first occluder occurs after the implantation of the shunt.

[0213] Clause 22. The method according to any one of Clauses 12-21, wherein attenuation occurs after confirming that the pressure in the cardiac chambers is greater than the pressure in the veins.

[0214] Clause 23. The method according to any one of Clauses 12-22, wherein the first occluder is configured to progressively restrict blood flow over time.

[0215] Clause 24. The method according to any one of Clauses 12-23, wherein weakening the first constraint includes puncturing, removing, allowing biodegradation, or transforming the first occluder.

[0216] Clause 25. The method according to any one of Clauses 12-24, wherein the implantation of the shunt occurs before the implantation of the first occluder.

[0217] Clause 26. The method according to any one of Clauses 12-24, wherein the implantation of the shunt occurs after the implantation of the first occluder.

[0218] Clause 27. A method for improving cardiac function, said method comprising: A shunt was implanted to bridge the coronary sinus and left atrium; Guide the antegrade blood flow in the coronary sinus from the left atrium toward the right atrium; and After a certain period of time, the anterograde flow in the coronary sinus is changed to retrograde flow in the coronary sinus, thereby guiding the left atrial blood flow in the coronary sinus away from the right atrium.

[0219] Clause 28. The method described in Clause 27, wherein the elapsed time period spans several weeks.

[0220] Clause 29. The method described in accordance with Clause 27 or 28, wherein the time period spans several months.

[0221] Clause 30. The method according to any one of Clauses 27-29, wherein changing the anterograde flow in the coronary sinus to retrograde flow in the coronary sinus includes weakening the first constraint.

[0222] Clause 31. The method according to Clause 30, wherein reducing the first constraint includes forming a restrictive pathway in the implanted occluder, dilating the implanted occluder via the restrictive pathway, and permanently maintaining the dilated implanted occluder against the wall of the coronary sinus.

[0223] Clause 32. The method according to Clause 31, wherein expanding the implanted occluder includes passing a wire through the implanted occluder to form a restrictive pathway, passing a balloon through the restrictive pathway, and inflating the balloon.

[0224] Clause 33. The method according to Clause 31 or 32, wherein holding the dilated implanted occluder against the wall of the coronary sinus includes an expansion stent to hold the dilated implanted occluder in a compressed state.

[0225] Clause 34. The method according to any one of Clauses 30-33, wherein reducing the first constraint comprises removing the first occluder from the coronary sinus.

[0226] Clause 35. The method according to Clause 34, wherein a stent retrieval device is used to remove the first occluder.

[0227] Clause 36. The method according to any one of Clauses 27-35 further includes: An occluder is implanted before the shunt is implanted.

[0228] Clause 37. The method according to any one of Clauses 27-36 further includes: An occluder is implanted after the shunt is implanted.

[0229] Clause 38. The method according to any one of Clauses 27-37, wherein changing the anterograde flow in the coronary sinus to retrograde flow in the coronary sinus occurs after confirming that the cardiac chamber pressure is greater than the venous pressure.

[0230] Clause 39. The method according to any one of Clauses 27-38, wherein guiding antegrade blood flow in the coronary sinus from the left atrium toward the right atrium comprises progressively constraining the blood flow over time.

[0231] Clause 40. The method according to any one of Clauses 27-39, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes puncture, removal, allowing biodegradation, or conversion of the implanted occluder.

[0232] Clause 41. The method according to any one of Clauses 27-40, wherein the implantation of the shunt occurs before the implantation of the occluder.

[0233] Clause 42. The method according to any one of Clauses 27-41, wherein the implantation of the shunt occurs after the implantation of the occluder.

[0234] Clause 43. A device for selectively guiding flow in the coronary sinus adjacent to the left atrium, the device comprising: A shunt, configured to bridge the left atrium and the coronary sinus; and An occluder is selectively positioned between a first anterograde flow deflection position and a second retrograde flow deflection position, wherein, at the first anterograde flow deflection position, the occluder is configured to guide flow in the coronary sinus from the left atrium toward the right atrium in a first direction, and at the second retrograde flow deflection position, the occluder is configured to guide flow in the coronary sinus from the left atrium away from the right atrium in a second direction, and wherein the occluder is adjustable in situ to selectively change the flow direction in the coronary sinus.

[0235] Clause 44. An endovascular medical device or kit for controlled alteration of the direction of shunt blood flow within a stent, comprising: i) A stent extending between a proximal end and a distal end and defined by a stent wall sized and shaped to engage a vessel wall, the stent wall including a main orifice defined by a peripheral edge, the main orifice being located between the proximal end and the distal end of the stent; ii) A shunt defining a central passage, the shunt extending outward from the peripheral edge toward a first cavity within the organ; and iii) An occluder adapted to engage the stent wall and at least partially restrict blood flow through the stent wall, wherein the occluder has a first configuration and a second configuration, such that in the first configuration, the occluder guides an extension of the central channel of the shunt toward the proximal end of the stent; and in the second configuration, the occluder guides an extension of the central channel of the shunt toward the distal end of the stent in the opposite direction.

[0236] Clause 45. An intravascular medical device or kit as described in Clause 44, wherein the occluder is adapted to switch between a first configuration and a second configuration.

[0237] Clause 46. An intravascular medical device or kit as described in Clause 44 or 45, wherein the occluder is adapted to engage the stent wall from the inside and has an occlusive surface positioned between the proximal and distal ends of the stent.

[0238] Clause 47. An intravascular medical device or kit as described in Clause 45 or 46, wherein the shunt and stent are configured to be fixed during transitions between a first configuration and a second configuration.

[0239] Clause 48. An intravascular medical device or kit according to any one of Clauses 45-47, wherein the occluder is adapted to switch between a first configuration and a second configuration such that, in the first configuration, the proximal shunt junction of the occluder is located distal to the main orifice, and in the second configuration, the proximal shunt junction of the occluder is located proximal to the main orifice.

[0240] Clause 49. An intravascular medical device or kit according to any one of Clauses 44-48, wherein, in a first configuration, the occluder is configured to guide a first flow direction, and in a second configuration, the occluder is configured to guide a second or opposite flow direction.

[0241] Clause 50. An intravascular medical device or kit according to any one of Clauses 44-49, wherein the main orifice has a maximum dimension in the range of 3 mm to 12 mm.

[0242] Clause 51. An intravascular medical device or kit according to any one of Clauses 44-50, wherein the first configuration is temporarily stable within the blood vessel.

[0243] Clause 52. An intravascular medical device or kit as described in Clause 51, wherein the second configuration is stable in the blood vessel for more than six months.

[0244] Clause 53. An intravascular medical device or kit according to any one of Clauses 44-52, wherein the occluder is adapted to be sequentially rotated in a single direction.

[0245] Clause 54. An intravascular medical device or kit according to any one of Clauses 45-53, wherein the occluder is adapted to be converted from a first configuration to a second configuration, and is also adapted to be converted from a second configuration to a first configuration.

[0246] Clause 55. An intravascular medical device or kit according to any one of Clauses 44-54, wherein the occluder is adapted to mechanically switch between a first configuration and a second configuration.

[0247] Clause 56. An intravascular medical device or kit according to any one of Clauses 44-55, wherein the occluder is adapted to be switched by automatic switching.

[0248] Clause 57. An intravascular medical device or kit according to any one of Clauses 44-56, wherein the occluder is adapted to change between a first configuration and a second configuration by rotation about the longitudinal axis of the stent.

[0249] Clause 58. An intravascular medical device or kit according to any one of Clauses 44-57, wherein the occluder includes a connecting element adapted to be connected to or disconnected from a shunt or stent.

[0250] Clause 59. An intravascular medical device or kit according to any one of Clauses 44-58, wherein the occlusion surface in a first configuration is different from the occlusion surface in a second configuration.

[0251] Clause 60. An intravascular medical device or kit according to any one of Clauses 44-59, wherein the occluder is a single component in each of the first and second configurations.

[0252] Clause 61. An intravascular medical device or kit according to any one of Clauses 44-60, wherein the occluder is adapted to engage a stent in a planar engagement manner in both a first configuration and a second configuration.

[0253] Clause 62. An intravascular medical device or kit as described in Clause 61, wherein the planar engagement is orthogonal to the longitudinal axis of the stent.

[0254] Clause 63. An intravascular medical device or kit according to any one of Clauses 44-62, wherein the occlusive surface is curved.

[0255] Clause 64. An intravascular medical device or kit as described in Clause 63, wherein the occlusive surface is adapted to change between curvature or direction of curvature.

[0256] Clause 65. An intravascular medical device or kit according to any one of Clauses 45-64, wherein the occluder is adapted to change between two longitudinal positions within the stent between the proximal and distal ends.

[0257] Clause 66. An intravascular medical device or kit according to any one of Clauses 44-65, wherein the occluder is a conformal sheet that radially traverses the stent.

[0258] Clause 67. An intravascular medical device or kit according to any one of Clauses 44-66, wherein the occluder is substantially impermeable to blood.

[0259] Clause 68. An intravascular medical device or kit according to any one of Clauses 44-67, wherein the occluder is adapted to reduce blood permeability over time.

[0260] Clause 69. An intravascular medical kit according to any one of Clauses 44-68, wherein the occluder in its first or anterograde flow configuration includes a puncturable or removable surface.

[0261] Clause 70. An intravascular medical device or kit according to any one of Clauses 44-69 further includes an outer cannula suitable for delivery to the coronary sinus.

[0262] Clause 71. An endovascular medical device according to any one of Clauses 44-70, wherein the endovascular medical device is adapted to contract within an outer cannula for percutaneous delivery via the coronary sinus and to expand after deployment from the outer cannula. 29. An endovascular medical device or kit according to any one of claims 1 to 28, wherein the stent includes a connecting element adapted to engage or disengage from an occluder.

[0263] Clause 72. An intravascular medical device or kit according to any one of Clauses 44-71, wherein the shunt further comprises a stabilizer configured to stabilize the shunt. 31. An intravascular medical device or kit according to any one of claims 1 to 30, wherein the shunt and the occluder are integrally formed.

[0264] Clause 73. An intravascular medical device or kit according to any one of Clauses 44-72, wherein the shunt and the occluder are two parts.

[0265] Clause 74. An intravascular medical device or kit according to any one of Clauses 44-73, wherein the shunt includes a coupling element adapted to be coupled to or disconnected from the occluder.

[0266] Clause 75. An intravascular medical device or kit according to any one of Clauses 44-74, wherein the shunt includes a time-delayed opening or a pressure-based valve.

[0267] Clause 76. An intravascular medical device or kit according to any one of Clauses 44-75, wherein the shunt is adapted to inhibit excessive inward tissue growth within the central channel of the shunt.

[0268] Clause 77. An intravascular medical device or kit according to any one of Clauses 44-76, wherein the shunt defines a central passage extending from the coronary sinus to the left atrium to allow blood to flow from the left atrium through the shunt to the coronary sinus.

[0269] Clause 78. A method for controlling changes in the direction of shunt blood flow within a stent, comprising: a) Pass through the target vein-heart chamber-junction puncture hole and insert a shunt device having a central channel passing through it; b) Provide a support, the support including an occluder having a first or antegrade flow configuration; and c) After a predefined time period or when it is confirmed that the cardiac chamber pressure is greater than the venous pressure (cardiac chamber pressure > vascular pressure), switch to the second or retrograde flow configuration of the occluder.

[0270] Clause 79. The method described in Clause 78, wherein the venous-cardiac junction is the coronary sinus-left atrium junction.

[0271] Clause 80. The method according to Clause 78 or 79, wherein the occlusion surface in the second configuration gradually increases the degree of blood flow constraint over time.

[0272] Clause 81. The method according to any one of Clauses 78-80, wherein the puncture site of the target vein-heart junction is passed through prior to the transition between the first or antegrade flow configuration and the retrograde flow configuration of the occluder.

[0273] Clause 82. The method according to any one of Clauses 78-81, wherein the occluder is switched to a retrograde flow configuration prior to passing through the puncture site of the target venous-cardiac junction.

[0274] Clause 83. The method according to any one of Clauses 78-82, wherein the transition to the reverse flow configuration of the occluder is accomplished by replacing the punctured first occluder surface with a second occluder surface.

[0275] Clause 84. The method according to any one of Clauses 78-83, wherein the transition between the first or antegrade flow configuration and the anti-antegrade flow configuration of the occluder is accomplished by rotation of the support about the central axis of the support.

[0276] Clause 85. The method according to any one of Clauses 78-84, wherein the transition between the first or antegrade flow configuration and the anti-antegrade flow configuration of the occluder is accomplished via a manually released connecting element between the support and the occluder.

[0277] Clause 86. The method according to any one of Clauses 78-85, wherein, upon confirmation that the pressure in the cardiac chambers is greater than the pressure in the coronary sinus or great cardiac vein, the device is switched to a second configuration.

[0278] Clause 87. The method according to any one of Clauses 78-86, wherein, upon confirmation that the left atrial pressure is greater than the coronary sinus or great cardiac vein pressure, the device is switched to a second configuration.

[0279] Clause 88. The method according to any one of Clauses 78-87, wherein the change of direction is from antegrade to retrograde within the blood vessel.

[0280] Clause 89. The method according to any one of Clauses 85-88, wherein the puncture hole through the target vein-heart junction is a connection between heart chambers having a blood pressure higher than that in the vein.

[0281] Clause 90. The method according to any one of Clauses 85-89, wherein a puncture hole is made through a target venous-cardiac junction to connect the cardiac chamber to oxygenated blood and to the vein to deoxygenated blood.

[0282] The disclosed embodiments may include any of the following key features individually or in combination with one or more other key features, whether implemented as a system, apparatus and / or method.

[0283] - A system used to change the direction of blood flow in the coronary sinus, which shunt from the left atrium. - A tool configured to puncture and pass through the first implanted occluder in the coronary sinus. - First implanted occluder and shunt bridging the coronary sinus and left atrium - A tool configured to create a restricted pathway through the first implanted occluder when the first implanted occluder is located upstream of a shunt bridging the coronary sinus and left atrium. - A first implanted occluder and shunt, which work together to allow blood to flow anterogradely from the left atrium to the right atrium via the coronary sinus. - A first implanted occluder and shunt, which cooperate to allow retrograde flow in the coronary sinus to flow beyond the first implanted occluder. - Expander - An extender configured for delivery into the restricted pathway via a first implanted occluder. - An expander configured to expand within the initial pathway to compress the wall of the first implanted occluder against the coronary sinus, thereby transforming the restricted pathway into an expanded opening. - Holder - A retainer configured to permanently maintain the dilated opening by holding the compressed first implanted occluder against the wall of the coronary sinus. - Second occluder - A second occluder, configured for implantation downstream of the shunt in the coronary sinus. - A second occluder, configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus. - A second occluder, configured to cooperate with the shunt to constrain antegrade flow in the coronary sinus downstream of the second occluder. - Tools including wires, the wires being configured to puncture the first implanted occluder. - Tools including a catheter, the catheter being configured to puncture the first implanted occluder. - Includes expander for inflatable balloons - Extender including self-expanding bracket - Including the retainer of the bracket -- The stent is balloon-expandable. - Expander and retainer combined in a balloon expandable stent - Expander and retainer combined in a self-expanding bracket - The second occluder is expandable. - Second occluder integrated with the stent - Tools, expanders, retainers, and second plugs provided as part of the kit - The kit includes tools, a combination of expanders and retainers, and a second plug. - Methods for improving heart function - A first occluder is implanted in the coronary sinus within the first occluder region proximal to the left atrium to impose a first constraint on antegrade blood flow in the coronary sinus. A shunt bridging the coronary sinus and left atrium is implanted downstream of the first occluder region to establish a first flow path that relieves pressure in the left atrium by guiding blood from the left atrium through the coronary sinus to the right atrium. - Maintain the first flow path for several days - After a period of several days, weaken the first constraint. - After reducing the first constraint, a second occluder is implanted in the coronary sinus in the second occluder region downstream of the shunt to apply a second constraint to the antegrade blood flow in the coronary sinus, thereby establishing a second flow path in the coronary sinus for retrograde flow from the left atrium. - A period of several days, spanning several weeks - A period of several days, spanning several months - Reduce the first constraint, including creating a restrictive pathway in the first occluder. - Reduce the first constraint, including expanding the first occluder via the restrictive pathway. - Reduce the first constraint, including permanently maintaining the dilated first occluder against the wall of the coronary sinus. - Expanding the first occluder includes passing a wire through the first occluder to create a restrictive pathway. - Expanding the first occluder, including allowing the balloon to pass through the restrictive pathway. - Expand the first occluder, including inflating the balloon. - Reduce the first constraint, including removing the first occluder from the coronary sinus. - Use a stent retrieval device to remove the first occluder. - The first occluder was implanted before the shunt was implanted and before several days had elapsed. - The first occluder was implanted after the shunt was implanted and before several days had elapsed. - The first constraint is weakened, which occurs after it is confirmed that the intracardiac chamber pressure is greater than the venous pressure. - The first occluder is configured to progressively restrict blood flow over time. - Weakening the first constraint involves puncturing the first occluder. - Reducing the first constraint involves removing the first occluder. - Reducing the first constraint involves allowing the first obstruction to biodegrade. - Weakening the first constraint involves a change in the first occluder. - The shunt was implanted before the first occluder was inserted and before a period of several days had elapsed. - The shunt was implanted after the first occluder was inserted and before a period of several days had elapsed. - A shunt bridging the coronary sinus and left atrium was implanted several days before the expected timeframe. - Directing the antegrade blood flow in the coronary sinus from the left atrium to the right atrium. - After a certain period of time, the anterograde flow in the coronary sinus is changed to retrograde flow in the coronary sinus, thereby guiding the blood flow in the left atrium away from the right atrium.

[0284] - Over a period of time, spanning several weeks - Over a period of time, spanning several months - To change the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus, including weakening the first constraint. - Reduce the first constraint, including creating a restrictive pathway in the implanted occluder. - Reduce the first constraint, including expanding the implanted occluder via a restrictive pathway. - Reduce the first constraint, including permanently maintaining the expanded implanted occluder against the wall of the coronary sinus. - Expanding the implanted occluder includes passing a wire through the implanted occluder to create a restrictive pathway. - Expanding the implanted occluder, including guiding the balloon through the restrictive pathway. - Expanding the implanted occluder, including inflating the balloon. - To maintain the expanded implanted occluder against the wall of the coronary sinus, an expansion stent is included to hold the expanded implanted occluder in a compressed state. - Reduce the first constraint, including removing the first occluder from the coronary sinus. - Use a stent retrieval device to remove the first occluder. - The occluder was implanted before the shunt was implanted and before a period of several days had elapsed. - The occluder was implanted after the shunt was inserted and before a period of several days had elapsed. - This changes the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus, which occurs after it is confirmed that the pressure in the heart chambers is greater than the pressure in the veins. - Guiding antegrade blood flow in the coronary sinus from the left atrium to the right atrium, including gradually restricting the blood flow over time. - Changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves puncture and implantation of an occluder. - Changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves removing the implanted occluder. - Changing antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves allowing the implanted occluder to biodegrade. - Changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves the transformation of the implanted occluder. - The shunt was implanted before the first occluder was implanted and before the elapsed time period. - After the first occluder is implanted and before the elapsed time period, the shunt is implanted. - A device for selectively directing flow in the coronary sinus adjacent to the left atrium. - Shunt and occluder, the shunt is configured to bridge the left atrium and coronary sinus. - A plug that can be selectively positioned between a first forward flow deflection position and a second reverse flow deflection position. - At the first anterograde flow deflection position, the occluder is configured to guide flow in the coronary sinus from the left atrium toward the right atrium in a first direction. - At the second retrograde flow deflection position, the occluder is configured to guide the flow in the coronary sinus away from the right atrium in a second direction from the left atrium. - An occluder that can be adjusted in situ to selectively alter the flow direction in the coronary sinus. Other embodiments will be apparent from consideration of the description and practice of the embodiments disclosed herein. It is intended that the description and examples be considered as illustrative only, and that the true scope and spirit of the disclosed embodiments are indicated by the appended claims.

Claims

1. A system for altering the direction of blood flow in a coronary sinus shunt from the left atrium, the system comprising: A tool configured to puncture and pass through a first implanted occluder disposed in the coronary sinus, the tool being configured to form a restricted pathway through the first implanted occluder when the first implanted occluder is located upstream of a shunt bridging the coronary sinus and the left atrium, and when the first implanted occluder and the shunt cooperate prior to puncture to allow blood to flow anterogradely from the left atrium to the right atrium via the coronary sinus and to constrain retrograde flow in the coronary sinus beyond the first implanted occluder; An expander configured to be delivered through the first implanted occluder into the restrictive pathway and expand within the restrictive pathway to compress the first implanted occluder against the wall of the coronary sinus, thereby transforming the restrictive pathway into an dilated opening; A retainer configured to permanently retain the dilated opening by holding a compressed first implanted occluder against the wall of the coronary sinus; and A second occluder is configured for implantation downstream of the shunt in the coronary sinus, wherein the second occluder is configured to cooperate with the shunt to induce retrograde flow from the left atrium in the coronary sinus and constrain antegrade flow in the coronary sinus downstream of the second occluder.

2. The system according to claim 1, wherein, The tool includes a wire configured to puncture the first implanted occluder.

3. The system according to claim 1 or 2, wherein, The tool includes a catheter configured to puncture the first implanted occluder.

4. The system according to any one of claims 1-3, wherein, The expander includes an inflatable balloon.

5. The system according to any one of claims 1-4, wherein, The extender includes a self-expanding bracket.

6. The system according to any one of claims 1-5, wherein, The retainer includes a support.

7. The system according to claim 6, wherein, The stent is balloon-expandable.

8. The system according to any one of claims 1-7, wherein, The expander and the retainer are combined in one of a balloon expandable stent or a self-expanding stent.

9. The system according to any one of claims 1-8, wherein, The second occluder is scalable.

10. The system according to any one of claims 1-9, wherein, The second occluder is integrated with the support.

11. The system according to any one of claims 1-10, wherein, The tool, the extender, the retainer, and the second plug are provided as a kit.

12. A method for improving cardiac function, the method comprising: A first occluder is implanted in the coronary sinus in the region of the first occluder proximal to the left atrium to apply a first constraint to the antegrade blood flow in the coronary sinus; A shunt bridging the coronary sinus and left atrium is implanted downstream of the first occluder region to establish a first flow path that relieves pressure in the left atrium by guiding blood from the left atrium through the coronary sinus to the right atrium. The first flow path will be maintained for a period of several days; and Following the aforementioned period of several days: - Reduce the first constraint; and - After reducing the first constraint, a second occluder is implanted in the coronary sinus in the second occluder region downstream of the shunt to impose a second constraint on antegrade blood flow in the coronary sinus, thereby establishing a second flow path in the coronary sinus for retrograde flow from the left atrium.

13. The method according to claim 12, wherein, The aforementioned period of several days spans several weeks.

14. The method according to claim 12 or 13, wherein, The period of several days spans several months.

15. The method according to any one of claims 12-14, wherein, Reducing the first constraint includes forming a restrictive pathway in the first occluder, expanding the first occluder via the restrictive pathway, and permanently maintaining the expanded first occluder against the wall of the coronary sinus.

16. The method according to claim 15, wherein, Expanding the first occluder includes passing a wire through the first occluder to form a restrictive passage, passing a balloon through the restrictive passage, and inflating the balloon.

17. The method according to claim 15 or 16, wherein, The first occluder, which is dilated, is held against the wall of the coronary sinus and includes an extended stent to keep the first occluder in a compressed state.

18. The method according to any one of claims 12-17, wherein, Reducing the first constraint includes removing the first occluder from the coronary sinus.

19. The method according to claim 18, wherein, Use a stent retrieval device to remove the first occluder.

20. The method according to any one of claims 12-19, wherein, The implantation of the first occluder occurs before the implantation of the shunt.

21. The method according to any one of claims 12-20, wherein, The implantation of the first occluder occurs after the implantation of the shunt.

22. The method according to any one of claims 12-21, wherein, The pressure decreases after it is confirmed that the pressure in the heart chambers is greater than the pressure in the veins.

23. The method according to any one of claims 12-22, wherein, The first occluder is configured to progressively restrict blood flow over time.

24. The method according to any one of claims 12-23, wherein, Reducing the first constraint includes puncturing, removing, allowing biodegradation, or transforming the first occluder.

25. A method for improving cardiac function, the method comprising: A shunt was implanted to bridge the coronary sinus and left atrium; The antegrade blood flow in the coronary sinus is directed from the left atrium toward the right atrium; and After a certain period of time, the anterograde flow in the coronary sinus is changed to retrograde flow in the coronary sinus, thereby guiding the left atrial blood flow in the coronary sinus away from the right atrium.

26. The method of claim 25, wherein, The time period mentioned spans several weeks.

27. The method according to claim 25 or 26, wherein, The time period mentioned spans several months.

28. The method according to any one of claims 25-27, wherein, Changing the anterograde flow in the coronary sinus to retrograde flow in the coronary sinus includes weakening the first constraint.

29. The method according to claim 28, wherein, Reducing the first constraint includes forming a restrictive pathway in the implanted occluder, expanding the implanted occluder via the restrictive pathway, and permanently maintaining the expanded implanted occluder against the wall of the coronary sinus.

30. The method according to claim 29, wherein, Expanding the implanted occluder includes passing a wire through the implanted occluder to form a restrictive pathway, passing a balloon through the restrictive pathway, and inflating the balloon.

31. The method according to claim 29 or 30, wherein, The expansion of the implanted occluder against the wall of the coronary sinus includes an expansion stent to hold the expansion of the implanted occluder in a compressed state.

32. The method according to any one of claims 28-32, wherein, Reducing the first constraint includes removing the first occluder from the coronary sinus.

33. The method according to claim 32, wherein, Use a stent retrieval device to remove the first occluder.

34. The method according to any one of claims 25-33, further comprising: An occluder is implanted before the shunt is implanted.

35. The method according to any one of claims 25-34, further comprising: An occluder is implanted after the shunt is implanted.

36. The method according to any one of claims 25-35, wherein, The change from antegrade flow in the coronary sinus to retrograde flow in the coronary sinus occurs after it is confirmed that the pressure in the cardiac chambers is greater than the pressure in the veins.

37. The method according to any one of claims 25-36, wherein, Guiding antegrade blood flow in the coronary sinus from the left atrium toward the right atrium includes gradually constraining the blood flow over time.

38. The method according to any one of claims 25-37, wherein, Changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes puncture, removal, allowing biodegradation, or conversion of the implanted occluder.

39. The method according to any one of claims 25-38, wherein, The shunt is implanted before the occluder is implanted.

40. The method according to any one of claims 25-39, wherein, The shunt is implanted after the occluder is implanted.

41. A device for selectively guiding flow in the coronary sinus adjacent to the left atrium, the device comprising: A shunt, configured to bridge the left atrium and the coronary sinus; and An occluder is selectively positioned between a first anterograde flow position and a second retrograde flow deflection position, wherein, at the first anterograde flow deflection position, the occluder is configured to guide flow in the coronary sinus from the left atrium toward the right atrium in a first direction, and at the second retrograde flow deflection position, the occluder is configured to guide flow in the coronary sinus from the left atrium away from the right atrium in a second direction, and wherein the occluder is adjustable in situ to selectively change the flow direction in the coronary sinus.

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