Devices, systems, and methods for improving cardiac function

Abstract

Devices, systems, and methods for improving cardiac function are disclosed, such as a system for altering blood flow direction in a coronary sinus shunted from a left atrium, the system comprising: a tool configured to pierce and cross a first implanted occluder disposed in the coronary sinus, the tool configured to form a limited passageway through the first implanted occluder; an expander configured for delivery into the limited passageway through the first implanted occluder and for expansion within the limited passageway to compress the first implanted occluder against a wall of the coronary sinus, thereby transforming the limited passageway into a dilated opening; a retainer, configured to permanently maintain the dilated opening by holding 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

DEVICES, SYSTEMS, AND METHODS FOR IMPROVING CARDIAC FUNCTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is based on and claims benefit of priority of Israel Patent Application No. IL310788, filed Feb. 12, 2024, the contents of which are incorporated herein by reference in their entireties.TECHNICAL FIELD

[0002] The present disclosure generally relates to the field of cardiac surgery, and particularly relates to devices, systems, and methods for improving cardiac function.BACKGROUND

[0003] The primary function of the heart (myocardium) is to pump oxygenated blood throughout the body. The heart includes four chambers: left and right atria and left and right ventricles, as well as a series of valves, and a network of veins and arteries. In a healthy myocardium, deoxygenated blood from the body enters the right atrium through 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 for oxygenation via the pulmonary valve and pulmonary arteries. Oxygenated blood then returns from the lungs towards the left atrium via the pulmonary veins where the oxygenated blood 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 arterial vessels.

[0004] While the superior and inferior vena cava are primarily responsible for directing deoxygenated blood from the body and into the right atrium, the coronary sinus is primarily responsible for directing venous (i.e., deoxygenated) blood from the vasculature of heart tissue into the right atrium. This large cardiac vein arises at the junction of the great cardiac vein and oblique vein of the left ventricle and is partially situated within 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), each drain into the coronary sinus. The oxygen saturation (PO2) within the coronary sinus generally falls in the range of 15-35 mmHg.

[0005] When vasculature within the heart is insufficiently oxygenated, e.g., as a result of coronary artery disease, atherosclerosis, and arteriosclerosis, complications including angina,heart attack, and heart failure may arise. Various surgical techniques may be used to mitigate these complications. Angioplasty, for example, (also known as Percutaneous Coronary Interventions, Balloon Angioplasty and Coronary Artery Balloon Dilation), involves the surgical widening of a clogged or otherwise narrowed artery. Here, the surgeon delivers a catheter balloon system to the site of obstruction and inflates the balloon to widen the obstruction and improve blood flow through the artery. A stent may be inserted to prevent the artery from contracting, thereby maintaining blood flow therethrough. The surgeon may also use a laser (laser angioplasty) or cutting tool (atherectomy) to vaporize or cut away any blockage.

[0006] Another method for correcting oxygen deficiency is coronary bypass surgery (also known as coronary artery bypass grafting or “CABG”). Here, an open-heart procedure is used to graft a healthy blood vessel onto the heart to reroute blood around the obstructed artery. The graft may be harvested from the patient or a donor and usually originates from one or more of the leg, arm, or chest, depending on the number of grafts needed. Complications and recovery time tend to be more extensive due to the invasiveness of the open-heart procedure, which usually requires the surgeon to stop the heart to complete the procedure and increases the risk of infection at both the chest incision and graft incision sites.

[0007] Y et another method for correcting oxygen deficiency involves perfusion of oxygenated blood throughout the heart using one or more surgically created holes 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 to the myocardium. The method may be beneficial when a patient is not responsive to or ineligible for coronary bypass surgery or percutaneous coronary intervention. Like TMR, percutaneous myocardial revascularization (PMR) also uses surgically created holes to enable direct myocardial perfusion; the procedure, however, tends to be less invasive.

[0008] Still, other methods contemplate the use of various stent devices or grafts to direct oxygenated blood from the left ventricle to a coronary artery or to provide a retrograde flow of oxygenated blood from the left ventricle to the myocardium via the coronary sinus. PCT Application No. PCT / IB2023 / 051918 (the disclosure of which is hereby incorporated herein by reference) discloses a method and device for creating a passage between a cavity in a heart chamber and a lumen in a vessel while extending the passage in a retrograde flow direction within the lumen by flow deflection. The device disclosed therefore, is designed to occlude blood flow through a coronary sinus, as well as shunt blood from a heart chamber towards the vessel. When a positive pressure gradient persists between the blood in the heart chamber andthe blood in the coronary sinus, for example, a retrograde flow of oxygenated blood towards the myocardium may ensue post-procedure. However, in some cases, a positive pressure gradient does not development immediately.

[0009] The devices, systems and methods described herein address at least some of the drawbacks of traditional revascularization techniques. Such devices, systems and methods may allow for a controlled transition of blood flow between a first and second direction within a vessel. The controlled transition may occur in varying inventive ways within the scope of this disclosure. For example, one or more temporary and permanent occluders may be used at varying times to change flow direction of newly sourced blood shunted from a left atrium, or an adjustable occluder may be employed to change flow direction, while minimally shifting the position of the shunt. In either instance, a medical practitioner might be able to confirm the existence of a positive pressure gradient prior to transitioning from an anterograde flow direction to a retrograde direction.SUMMARY

[0010] Embodiments consistent with the present disclosure provide devices, systems, and methods for improving cardiac function, including by selectively directing flow in a coronary sinus adjacent a left atrium and by altering blood flow direction in a coronary sinus shunted from a left atrium.

[0011] Some embodiments include a system for altering blood flow direction in a coronary sinus shunted from a left atrium. Embodiments may include a tool configured to pierce and cross a first implanted occluder disposed in the coronary sinus. The tool may be configured to form a limited passageway through the first implanted occluder when the first implanted occluder is located on an upstream side of a shunt bridging the coronary sinus and the left atrium and when, prior to piercing, the first implanted occluder and the shunt cooperate to enable flow of blood in an antegrade direction from the left atrium to a 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 for delivery into the limited passageway through the first implanted occluder and for expansion within the limited passageway to compress the first implanted occluder against a wall of the coronary sinus, thereby transforming the limited passageway into a dilated opening. Embodiments may also include a retainer, configured to permanently maintain the dilated opening by holding the compressed first implanted occluder against the wall of the coronary sinus. Embodiments may also include a second occluder configured for implantation on a downstream side of the shuntin the coronary sinus. The second occluder may be configured to cooperate with the shunt to cause retrograde flow from the left atrium in the coronary sinus and to restrict antegrade flow in the coronary sinus downstream of the second occluder.

[0012] Some embodiments include a method for improving cardiac function. Embodiments may include implanting a first occluder in a coronary sinus in a first occluder region proximate a left atrium to impose a first restriction on antegrade blood flow in the coronary sinus. Embodiments may also include implanting downstream of the first occluder region, a shunt bridging the coronary sinus and a left atrium, thereby establishing a first flow path relieving pressure in the left atrium by directing blood from the left atrium to the right atrium via the coronary sinus. Embodiments may also include maintaining the first flow path for an elapsed period of days, weeks, or months. Embodiments may also include, following the elapsed period, abating the first restriction. Embodiments may also include, following the elapsed period, after abating the first restriction, implanting a second occluder in the coronary sinus in a second occluder region downstream of the shunt, to impose a second restriction on antegrade blood flow in the coronary sinus and thereby establishing a second flow path of retrograde flow from the left atrium in the coronary sinus.

[0013] Some embodiments include a device for selectively directing flow in a coronary sinus from a left atrium. Embodiments include a shunt configured to bridge the left atrium and the coronary sinus. Embodiments may include an occluder selectively positionable between a first antegrade flow deflecting position and a second retrograde flow deflecting position. The occluder may be configured, in the first antegrade flow deflecting position, to direct flow in the coronary sinus from the left atrium in a first direction toward a right atrium. Additionally, the occluder may be configured, in the second retrograde flow deflecting position, to direct flow in the coronary sinus from the left atrium in a second direction away from the right atrium. Further, the occluder may be adjustable in situ to selectively change flow direction in the coronary sinus.

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

[0015] The foregoing summary is intended to provide an introductory flavor of a few aspects of innovations described more fully herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the present disclosure. The description taken with the drawings makes apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0017] FIG. 1A is a side view of a portion of an example intravascular medical system, consistent with some embodiments of the present disclosure.

[0018] FIG. IB is an isometric view of the system portion illustrated in FIG. 1A.

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

[0020] FIG. 2B is a front view of the system portion illustrated in FIG. 2A.

[0021] FIG. 3 A is a side view of a portion of the example intravascular medical system of FIG. 1 A, deployed between biological structures and having a tool crossing an occluder and with an expander in a non-expanded state, consistent with some embodiments of the present disclosure.

[0022] FIG. 3B is a front view of the system portion illustrated in FIG. 3A.

[0023] FIG. 4A is a side view of a portion of the example intravascular medical system of FIG. 3A, deployed between biological structures and with an expander in an expanded state, consistent with some embodiments of the present disclosure.

[0024] FIG. 4B is a front view of the system portion illustrated in FIG. 4A.

[0025] FIG. 5A is a side view of a portion of the example intravascular medical system of FIG. 1A, deployed between biological structures and with an occluder in an expanded state, consistent with some embodiments of the present disclosure.

[0026] FIG. 5B is a front view of the system portion illustrated in FIG. 5A, consistent with one embodiment where the expander remains in situ after expansion.

[0027] FIG. 5C is a front view of the system portion illustrated in FIG. 5 A, consistent with another embodiment where the expander is removed following expansion.

[0028] FIG. 6A is a side view of a portion of the example intravascular medical system of FIG. 1A, deployed between biological structures with a second occluder for shunting blood flow, consistent with some embodiments of the present disclosure.

[0029] FIG. 6B is a cross-sectional view of the system portion illustrated in FIG. 6A.

[0030] FIG. 6C is another cross-sectional view of the system portion illustrated in FIG. 6A.

[0031] FIGS. 7A, 7B, and 7C graphically depict steps of an example process of deploying an intravascular medical system between biological structures, consistent with some embodiments of the present disclosure.

[0032] FIG. 8 is a flowchart of an example process for improving cardiac function, consistent with some embodiments of the present disclosure.

[0033] FIG. 9A is a side view of an example of a transitionable intravascular medical system in a first configuration, consistent with some embodiments of the present disclosure.

[0034] FIG. 9B is a side view of the device illustrated in FIG. 9A in a second configuration, consistent with some embodiments of the present disclosure.

[0035] FIG. 10A is a side view of an example of another transitionable intravascular medical system deployed between biological structures in a first configuration, consistent with some embodiments of the present disclosure.

[0036] FIG. 10B is a side view of the device illustrated in FIG. 10A in a second configuration, consistent with some embodiments of the present disclosure.

[0037] FIG. 11A is a side view of an example of another transitionable intravascular medical system deployed between biological structures in a first configuration, consistent with some embodiments of the present disclosure.

[0038] FIG. 1 IB is a side view of the device illustrated in FIG. 11A in a second configuration, consistent with some embodiments of the present disclosure.

[0039] FIG. 11C is a side view of an example of another transitionable intravascular medical system deployed between biological structures in a first configuration, consistent with some embodiments of the present disclosure.

[0040] FIG. 1 ID is a side view of the device illustrated in FIG. 11C in a second configuration, consistent with some embodiments of the present disclosure.

[0041] FIG. HE is an exploded view of the exemplary transitionable intravascular medical system of FIGS. 11C and 1 ID.

[0042] FIG. 12 is a flowchart of an example process for shunting and selectively regulating anatomical fluid flow deployed between biological structures, consistent with some embodiments of the present disclosure.DETAILED DESCRIPTION

[0043] Exemplary embodiments are described with reference to the accompanying drawings. The figures are not necessarily drawn to scale. Elements represented by the same or likereference numerals are intended to represent the same or like parts unless otherwise disclosed or represented. While examples and features of disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Also, the words “comprising,” “having,” “containing,” “including,” and other similar forms are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items or meant to be limited to only the listed item or items. It should also be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Moreover, the relational terms herein such as “first” and “second” are used only to differentiate an entity or operation from another entity or operation, and do not require or imply any actual relationship or sequence between these entities or operations.

[0044] As used herein, unless specifically stated otherwise, the term “or” encompasses all possible combinations, except where infeasible. For example, if it is stated that a component can include A or B, then, unless specifically stated otherwise or infeasible, the component can include A or B, or A and B. As a second example, if it is stated that a component can include at least one of A, B, or C, then, unless specifically stated otherwise or infeasible, the component can 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 employs open-ended permissive language, indicating for example, that some embodiments “may” employ, involve, or include specific features. The use of the term “may” and other open-ended terminology is intended to indicate that although not every embodiment may employ the specific disclosed feature, at least one embodiment employs the specific disclosed feature.

[0046] In the following description, various working examples are provided for illustrative purposes. However, is to be understood the present 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 illustrated in the accompanying drawings. The examples are described below by referring to the drawings, wherein like reference numerals refer to like elements. When similar reference numerals are shown, corresponding description(s) are not repeated, and the interested reader is referred to the previously discussed figure(s) for a description of the like element(s).

[0047] Embodiments of the present disclosure relate to intravascular medical systems, including intravascular medical devices for shunting and selectively regulating anatomical fluid flow. As used herein, an intravascular medical system includes one or more components,devices, elements, or instruments configured to be placed within or to operate inside a blood vessel or another biological structure or organ within a human body for a medical purpose. Non-limiting examples of a system include system 100, described later herein with reference to the figures. It is to be understood that a system need not include all the components illustrated in any given figure. Rather, the term system, in the context of the non-limiting examples in the figures, includes any subset of components in any figure or combination of figures. Such components of a system may include either alone or in combination: shunts, stents, catheters, balloons, guidewires, or any other device, element, or combination configured to be placed within a blood vessel, organ, or other biological structure.

[0048] Consistent with some disclosed embodiments, a biological structure may include a hollow anatomic feature within the body of a patient. Non-limiting examples of a biological structure include a blood vessel, a capillary, an artery, a vein, a heart chamber (e.g., left atrium, left ventricle, right atrium, right ventricle), or any other anatomical organ. An intravascular medical device may be configured to be delivered from a first location (e.g., a location outside the body) to a treatment site in a blood vessel or other biological structure. Additionally, or alternatively, in some embodiments, an intravascular medical device may be configured to cause a temporary or permanent change or transformation at a treatment site in a blood vessel.

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

[0050] As a non-limiting example, a system for altering blood flow direction in the coronary sinus shunted from the left atrium includes a shunt for bridging a heart chamber (e.g., left atrium, left ventricle) and the coronary sinus and an occluder that together cooperate to enable retrograde oxygen-rich blood flow in the coronary sinus. Oxygenated blood flowing “backwards” in the coronary sinus may result in oxygenation of heart tissue that may otherwise receive insufficient oxygenated blood flow. An occluder positioned in the coronary sinus may aid in directing the retrograde flow, and may prevent, or at least partially impede, flow toward another biological structure, for example, the right atrium.

[0051] Consistent with some embodiments of the present disclosure, a system may include an occluder. As used herein, an occluder may refer to a device, component, or combination of devices and / or components configured to restrict fluid flowing through a structure, such as blood flowing through a biological structure. For example, an occluder may be configured to block or restrict a flow of fluid in a direction or to deflect a flow of fluid in a direction. By way of non-limiting example, an occluder may be configured to block or restrict a natural flow of fluid in a blood vessel. Additionally or alternatively, an occluder may be configured to deflect a flow of fluid in a blood vessel in a direction that may differ from a normal direction of flow. As used herein, deflecting flow may refer to causing a change of some or all flow 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. Thus, an occluder may include any component, device, or structure that deflects, diverts, occludes, blocks, obstructs, slows, or inhibits fluid flow.

[0052] As used herein, restricting may refer to limiting, reducing, or controlling a flow of fluid. For example, restricting fluid flowing through a structure may include decreasing the available passage area partially (e.g., partial occlusion) or fully (e.g., full occlusion). A partial occlusion may occur when an object or obstruction partially blocks a passage such that fluid flows at a reduced rate compared to a normal flow rate without the object or obstruction. A full occlusion may occur when an object or obstruction completely blocks a passage such that no fluid flows passes through.

[0053] As used herein, antegrade flow may refer to a flow in a normal or expected direction. For example, antegrade flow in a coronary sinus may include a flow of blood shunted from the left atrium into the coronary sinus and flowing in a vein-natural direction (e.g., away from the myocardium and towards the right atrium). As used herein, retrograde flow may refer to a flow in a direction opposite a normal or expected direction. For example, retrograde flow in a coronary sinus may include a flow of blood shunted from the left atrium into the coronary sinus and flowing in a direction opposing a vein-natural direction (e.g., towards the myocardium and away from the right atrium).

[0054] Consistent with some embodiments of the present disclosure, the system includes a shunt. As used herein, a shunt may refer to any structure capable of bridging two biological structures, such as a heart chamber and a blood vessel. For example, the shunt may be configured for deployment in a passageway between a first biological structure and a second adjacent biological structure. As used herein, deployment may pertain to the positioning orplacement of a device or component in the body. Furthermore, a passageway may refer to a channel or opening that allows a fluid, such as blood, to flow through. The passageway may be formed by a pre-incised hole. Furthermore, in some embodiments, the shunt may be configured to bridge a first cavity in the first biological structure and a second cavity in the second biological structure. The bridging of the first cavity in the first biological structure and the second cavity in the second biological structure may include providing a structure that allows fluid to flow between the first cavity and the second cavity. It is contemplated that the first biological structure and the second biological structure may be any biological organ or structure such as — but not limited to — blood vessels, anatomical cavities, and / or anatomical chambers. Furthermore, a shunt may redirect the flow of bodily fluids, as discussed further herein. One non-limiting example of a shunt includes shunt 120, described later herein. Other non-limiting examples of a shunt and at least some other portions of the tool described herein are described in PCT / IB2023 / 051918 (WO2023166447A1), entitled, “Devices, systems, and methods for revascularization of the myocardium,” as well as PCT / IB2023 / 061707 entitled “Devices, systems, and methods for intraluminal puncturing,” which are incorporated herein by reference.

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

[0056] A tool may be configured to pierce and cross an implanted occluder. Piercing refers to penetrating or breaking through a surface or material. Piercing may be accomplished, for example, with a sharp object or force. As used herein, crossing refers to moving from one side of a boundary, surface, plane, or dividing line to another side. For example, in some embodiments, crossing may occur through penetration of a thin surface of material, while in other embodiments crossing may occur by passing through a thicker piece of material, such as a plug or other seal. The tool may be configured to form a limited passageway through an implanted occluder. As used herein, a limited passageway may refer to a constricted or restricted passageway or narrow corridor, permitting a limited traversal. For example, a guidewire may cross a plug in a manner allowing the guidewire to pass through while limiting,preventing, or restricting fluid passage through the crossing. In another example, a catheter with a dimension less than the width of an occluder may cross the occluder, permitting limited flow passage therethrough. One non-limiting example of piercing and crossing an occluder to form a limited passageway is described later with reference to FIG. 3A.

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

[0058] For example, an implanted occluder may be located on a side of the shunt such that anatomical fluid flowing in an antegrade flow direction may contact the implanted occluder before reaching a position of the shunt. In another example, the implanted occluder may form a full occlusion such that anatomical fluid flowing in an antegrade flow direction may only contact the implanted occluder and may be prevented, by the implanted occluder, from contacting the shunt. Non-limiting examples of piercing and crossing on the upstream side of the shunt are discussed later herein, for example with reference to FIGS. 3A and 3B.

[0059] Further, in some embodiments, prior to piercing of the implanted occluder, the implanted occluder and the shunt may cooperate to enable flow of blood in an antegrade direction from a left atrium to a right atrium via a coronary sinus. As used herein, cooperate refers to two or more components, devices, elements, or instruments working together in a way that enables or enhances a function, goal, or outcome, even if they remain physically separate or operate independently. For example, the implanted occluder and the shunt may cooperate to enable flow of blood in an antegrade direction from a left atrium to or toward a right atrium via a coronary sinus by the shunt facilitating flow of blood from the left atrium to the coronary sinus, and the occluder blocking retrograde flow to encourage or deflect flow to the right atrium via the coronary sinus. A non-limiting example of this orientation is discussed later in connection with the structure of FIG. 2A.

[0060] Additionally, in some embodiments, prior to piercing an implanted occluder, the implanted occluder and the shunt may cooperate to restrict retrograde flow in a coronary sinus beyond the implanted occluder. As used herein, beyond refers to an area on another side of a component, device, element, or instrument. For example, when restricting retrograde flow in acoronary sinus beyond an implanted occluder, beyond may refer to an upstream area of the coronary sinus relative to the implanted occluder. By way of non-limiting example, the implanted occluder and the shunt may cooperate to restrict retrograde flow in the coronary sinus beyond the implanted occluder by the implanted occluder restricting (e.g., via partial occlusion, via full occlusion) flow of the blood from the left atrium to the myocardium via the coronary sinus in a retrograde flow direction in an upstream area of the coronary sinus. A nonlimiting example of a structure that restricts such retrograde blood flow is discussed later in connection with the structure of FIG. 2A.

[0061] Consistent with some embodiments of the present disclosure, the system may include an expander. As used herein an expander refers to a device or component configured to increase in size, volume, or capacity. For example, an expander may include any device that increases in dimension in response to mechanical force, inflation, or self-expansion. In some embodiments, an expander may include an inflatable balloon. As used herein, inflatable refers to a property or characteristic of a component, element, device, or instrument such that it may be filled with a medium (e.g., fluid, gas) to become larger and take 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, silicon, 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 be expanded using a gas (e.g., air) or a fluid (e.g., saline). By way of non-limiting example, an expander that includes an inflatable balloon is discussed later in greater detail with reference to FIG. 7B.

[0062] Additionally, or alternatively, in some embodiments, an expander may include a selfexpanding 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., coronary sinus). As used herein, selfexpanding may refer to a device, component, or material that is configured to automatically expand to an appropriate or intended size and shape after being deployed, 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 from an expandable material configured to expand when no longer compressed within a structure (e.g., catheter) or in response to a release mechanism. By way of non-limiting example, depending on implementation, stent 101 described later herein may be a self-expanding stent or a balloon expanding stent.

[0063] In some embodiments, the expander may be configured for delivery into a limited passageway through an implanted occluder. A limited passageway refers to an opening smaller in dimension than the vessel in which the occluder is implanted. For example, the expander may be configured to be delivered through an opening in the occluder by a catheter, a guidewire, a combination catheter-guidewire, directly (e.g., using a stent-mounted balloon), or any other suitable delivery means known to those skilled in the art. In another example, the expander may be configured for deliver into a limited passageway through an implanted occluder using the tool configured to pierce when the tool configured to pierce pierces and crosses an implanted occluder. By way of non-limiting example, as described later herein with reference to FIG. 3A, one example of a limited passageway includes limited passageway 132.

[0064] Furthermore, in some embodiments, the expander may be configured for expansion within a limited passageway to compress an implanted occluder against a wall of a coronary sinus, thereby transforming the limited passageway into a dilated opening. As used herein, a dilated opening refers to an opening or passageway that has been enlarged or widened. For example, a dilated opening may allow for a higher rate of flow than a limited passageway. As used herein, compressing may refer to reducing a size or a volume of an instrument, element, component, or device. For example, a compressed implanted occluder may have a smaller surface area with respect to the biological structure being occluded such that an amount of flow through or past the occluder is increased compared to a non-compressed implanted occluder. As used herein, transforming refers to changing or converting something from one state, form, condition, or configuration into another. For example, transforming a limited passageway into a dilated opening may include widening or enlarging the limited passageway (e.g., by compressing an implanted occluder) to form a dilated opening. By way of non-limiting example, an expander, in this example a stent, may compress an occluder against a wall of a coronary sinus, as discussed later in greater detail with reference to FIG. 3B.

[0065] Consistent with some embodiments of the present 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 maintain a dilated opening. As used herein, permanently may refer to something that is not temporary, lasts indefinitely, or at least remains in place over an intended or expected lifetime. For example, permanently maintaining may include keeping something in a substantially certain condition or state without any intention of changing, altering, or removing it over time. In one example, a retainer may be configured to permanently maintain a dilated opening by holding a compressed first implantedoccluder against a wall of a coronary sinus. The retainer may hold the compressed first implanted occluder against the wall of the coronary sinus such that the first implanted occluder and the wall of the coronary sinus are in direct or indirect contact (e.g., with one or more intermediate components, elements, devices, or instruments located in between) by exerting a pressure or force on the compressed first implanted occluder in a direction of the wall of the coronary sinus (e.g., radially outwards). A retainer may include a scaffold that holds the occluder in a dilated orientation. In some embodiments, a retainer may include a stent. In other embodiments, the retainer may be part of the design of the occluder such that once the occluder is dilated, it retains its dilation. This may occur for example, with an occluder that includes a material that once deformed, maintains its deformed shape. For example, an occluder structure may include a metal frame that once deformed to a dilated states, remains dilated. In one nonlimiting example, a stent such as stent 101 serves as the retainer, as described later in greater detail. If a stent is self-expanding, the stent may constitute both the expander and the retainer.

[0066] In some embodiments, an expander and a retainer may be combined in one of a balloon expandable stent or a self-expandable stent. As used herein, a balloon expandable stent may refer to a stent configured to be expanded with an inflation of a balloon. It is to be understood that the expander and the retainer can be separate structures or parts of a combined structure and that any recitations or exemplary descriptions of the expander or the retainer is intended to encompass the combined structure as well. Thus, in one non-limiting example, the balloon may serve as the expander and a balloon expandable stent may serve as a retainer. By way of one non-limiting example, such a combination is exemplified in FIG. 7B, as discussed later in greater detail.

[0067] Consistent with some embodiments of the present disclosure, the system may include a second occluder. In embodiments in which the system includes a first occluder and a second occluder, the first occluder and the second occluder may have similar or substantially identical structures, except that the first occluder may be configured to direct shunted blood flow in a first direction and the second occluder may be configured to direct shunted flow in a second direction different than the first direction. Additionally or alternatively, in some embodiments, each of the first occluder and the second occluder are configured to restrict an antegrade (natural flow) within the coronary sinus. Further, the first occluder and the second occluder may have different shapes, sizes, orientations, or forms. One non-limiting example of first and second occluders is described later in greater detail with reference to FIGS. 7A-C as described later in greater detail.

[0068] In some embodiments, the second occluder may be configured for implantation on a downstream side of a shunt in a coronary sinus. For example, the second occluder may be implanted (e.g., via a catheter, a guidewire, any combination of the foregoing, or any other suitable delivery means) in a coronary sinus in a location between the shunt and the right atrium. By way of non-limiting example, such an orientation is exemplified in FIG. 7C as described later in greater detail.

[0069] In some embodiments, the second occluder may be configured to cooperate with a shunt to cause retrograde flow from the left atrium in the coronary sinus. For example, the second occluder and the shunt may cooperate to enable blood flow in a retrograde direction from a left atrium to or toward a myocardium via a coronary sinus by the shunt facilitating flow of blood from the left atrium into the coronary sinus and the second occluding preventing antegrade flow, thereby causing retrograde blood flow in the coronary sinus toward the myocardium. This is exemplified by the non-limiting example in FIG. 7C, which is described later in greater detail.

[0070] Further, in some embodiments, the second occluder may be configured to cooperate with a shunt to restrict antegrade flow in the coronary sinus downstream of the second occluder. For example, the second occluder’s position in the coronary sinus may fully or partially block blood flow from the shunted left atrium in an antegrade direction in the coronary sinus. Nonlimiting examples of an occluder and shunt cooperating to restrict antegrade flow in the coronary sinus downstream of the second occluder described later with reference to FIG. 7C. Other non -limiting examples are provided in incorporated PCT / IB2023 / 051918 (WO2023166447A1).

[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 or components or devices that together are intended or configured to accomplish a task or a group of related tasks. The components of the kit may be packaged together, sold together, or sold separately with instructions of combined use. For example, in some embodiments, the tool, the expander, the retainer, and an occluder are provided as a kit. In another example, the tool, the expander, the retainer, and the second occluder are provided as a kit. Any combination of components described herein may be considered a kit.

[0072] FIGS. 1A and IB illustrate different views of a portion of an example intravascular medical system 100, consistent with some embodiments of the present disclosure. As used herein, a portion refers to one or more parts, devices, components, instruments, or elements of a whole or a set. For example, a portion of an example intravascular medical system mayinclude some components, devices, instruments, or elements of a kit. For example, the portion ofthe system illustrated in FIGS. 1A and IB, includes a stent 101, a shunt 120, and an occluder 130.

[0073] Stent 101 may include stent walls 102. Stent walls 102 may be formed of wire, wire mesh, struts, ribs, or other materials of scaffolding. Stent 101 may be configured for deployment in a passageway of a biological structure, such as a coronary sinus. Stent walls 102 may define a size and shape of stent 101 to enable stent 101 to engage the walls ofthe biological structure. Furthermore, stent 101 may include a primary orifice 103. Primary orifice 103 has an intermediate axial position along stent 101 and passes incoming blood from outside the stent (e.g., from outside the coronary sinus). Primary orifice 103 may be defined by a flange 104 transverse to a central axis of stent 101 and forming an opening in stent walls 102. Flange 104 of shunt 120 is located intermediate the downstream end 105 and the upstream end 106 of stent 101. As used herein, a flange may pertain to a projecting flat rim, collar, or rib structure on a component. A flange refers to a protruded ridge, lip, or rim, or edge that extends outward from a structure, in this instance the shunt. The flange may completely or partially circumscribe the outer periphery of the shunt, or it may include a series of flange portions or regions that work together for stabilization purposes. A flange region refers to all or part of a flange.

[0074] In some embodiments, stent 101 may include an opening 107 on a downstream end 105 of stent 101. Downstream end 105 may refer to the end of stent 101 further along the coronary sinus in an antegrade flow direction and may be nearer to a right atrium. Upstream end 106 may refer to the end of stent 101 closer to the myocardium and farther from a right atrium. In some embodiments, the opening on a downstream end of a stent may include a tubular opening. As used herein, tubular may pertain to a structure having an outer wall or walls that define an intermediate channel, regardless of the contour of the intermediate channel, or an opening that has a cylindrical or elongated shape or a circular or elliptical cross-section. By way of nonlimiting example, a tubular structure may include a not fully enclosed structure with a round side, which is exemplified in non-limiting example tubular flange 104. By way of another nonlimiting example, a tubular opening that may include a circular opening, which is exemplified in non-limiting example opening 107.

[0075] Further, as shown in FIGS. 1A and IB, a portion of intravascular medical system 100 may include a shunt 120. Shunt 120 may be configured to bridge two organs, such as a left atrium and a coronary sinus, via a central passageway 121. The bridging may facilitate or enable a flow from one biological structure, through central passageway 121, to anotherbiological structure. In some embodiments and as illustrated in FIG. 2A, shunt 120 is partially connected or integrally connected to stent 101, to extend from stent 101 into left atrium 170.

[0076] As further illustrated in FIGS. 1A and IB, a portion of intravascular medical system 100 may include an occluder 130. Occluder 130 may include an occluding surface 131. As used herein, an occluding surface may refer to a surface of an occluder that contacts and prevents fluid flow past, through, or beyond the occluding surface. For example, occluding surface 131 may be a surface of occluder 130 on an upstream end. In some embodiments, a first implanted occluder may be integrated with a stent. As used herein, integrating may refer to physically connecting or affixing two or more components, elements, or devices such that the two or more components function as a unified structure. For example, occluder 130 and stent 101 may be integrated into a unified structure configured to restrict a flow of fluid in a direction in a passageway as illustrated, for example, in FIG. 2A.

[0077] In some embodiments, an occluder may be biodegradable. By way of non-limiting example, occluder 130 may be configured to biodegrade over time after being implanted (e.g., when constructed of a biodegradable material). In some embodiments, an occluder may be configured to progressively restrict blood flow overtime. As used herein, progressive may refer to a process occurring in a gradual, step-by-step, or incremental manner over time. By way of non-limiting example, occluder 130 may be configured to gradually increase a restriction of upstream antegrade blood flow by expanding overtime.FIGS. 2A and 2B illustrate different views of a portion of the example medical system 100 of FIG. 1A, deployed between biological structures, consistent with some embodiments of the present disclosure. As illustrated, a portion of intravascular medical system 100 may be deployed between two cavities. For example, cavity 270 may be a left atrium and cavity 280 may be a coronary sinus. More generally, first cavity 270 and second cavity 280 may be any cavities of any dimension. In some embodiments, the first cavity 270 and the second cavity 280 may both be vessels, and in other embodiments, the first cavity and the second cavity may both be non-vessels. For example, both cavities may be blood vessels, both cavities can be part of major organs, or one cavity may be a blood vessel and another may be part of a major organ. In one embodiment of this disclosure the first cavity 270 is a left atrium and the second cavity 280 is a coronary sinus. Therefore, sometimes in this disclosure, the reference numerals 270 and 280 are referred to more generally as the first and second cavities, and other times those same reference numerals are used to refer to the example of the left atrium and the coronary sinus. It is to be understood that reference to this latter specific example is not intended to limit the disclosure of FIGS. 2A and 2B to the example of a shunted left atrium to a coronary sinus.Rather, FIGS. 2A and 2B are intended to broadly disclose any two cavities shunted together. It is to be understood that the above explanation similarly applies to FIGS. 3A and 3B, 4A and 4B, or any other figures of the present disclosure that depict cavities and the respective reference numerals labeling those cavities.

[0078] As shown in FIG. 2A, stent 101 and occluder 130 may be deployed, implanted, or located in cavity 280. Further, as shown in FIG. 2A, shunt 120 may be deployed, implanted, or located between cavity 270 and cavity 280 with a bridging central passageway 121 formed during an implantation process. In some embodiments, implanted occluder 130 and shunt 120 may cooperate to enable flow of blood in an antegrade direction from left atrium 270 to a right atrium via coronary sinus 280. For example, implanted occluder 130 and shunt 120 may cooperate to enable an antegrade flow of oxygenated blood from left atrium 270, through central passageway 121, to coronary sinus 280. Furthermore, in some embodiments, implanted occluder 130 and shunt 120 may cooperate to restrict retrograde flow in the coronary sinus beyond implanted occluder 130. For example, implanted occluder 130 shunt 120 may cooperate to occlude, either partially or fully, coronary sinus 280 such that oxygenated blood from left atrium 270 may be restricted from flowing from central passageway 121 to coronary sinus 280 in a retrograde flow direction (i.e., in a direction toward upstream end 106). Such a restriction may be a full or partial occlusion such that a degree of retrograde flow in the coronary sinus may exist upstream of implanted occluder 130. For example, blood entering coronary sinus 280 from may contact or interact with occluding surface 131 and may be redirected in a retrograde direction away from occluder 130.

[0079] In some embodiments, a first occluder and a shunt may be implanted in one or more cavities. For example, occluder 130 and shunt 301 may be implanted in or between left atrium 270 and coronary sinus 280 such that oxygenated blood may flow from left atrium 270 into coronary sinus 280 in an antegrade flow direction. In some embodiments, first occluder may be implanted before implanting a shunt. In other embodiments, first occluder may be implanted after implanting a shunt. Further, in some embodiments, a shunt may be implanted before implanting an occluder. For example, shunt 120 may be implanted before implanting occluder 130. Additionally, or alternatively, in some embodiments, a shunt may be implanted after implanting an occluder. For example, shunt 120 may be implanted after implanting occluder 130.

[0080] FIGS. 3 A and 3B illustrate different views of a portion of the intravascular medical system 100 of FIG. 1A, deployed between biological structures and having a tool crossing an occluder and with an expander in a non-expanded state. A non-expanded state may refer to astate in which a component, element, device, or instrument is compressed or contracted such that it has a reduced volume compared to an expanded state. By way of non-limiting example, when expander 350 is in a non-expanded state, it may not substantially inhibit the occluding function of occluder 130.

[0081] As shown in FIG. 3A, a portion of intravascular medical system 100 may include a tool 340. In some embodiments, a tool may be configured to pierce and cross a first implanted occluder disposed in the coronary sinus. For example, as shown in FIGS. 3A and 3B, tool 340 pierced and crossed occluder 130. Further, in some embodiments, a tool may be configured to form a limited passageway through a first implanted occluder located on an upstream side of a shunt bridging a coronary sinus and a left atrium. For example, after tool 340 pierces and crosses occluder 130, which is located on an upstream side of shunt 120 that bridges coronary sinus 280 and left atrium 270, occluder 130 may have a hole or opening constituting a limited passageway 132. In this example, the dimension of the limited passageway 132, substantially corresponds to the height or diameter of tool 340.

[0082] In some embodiments, a tool may include a wire configured to pierce a first implanted occluder. For example, a tool may include a wire with a sharpened tip, a needle tip, a beveled tip, a tapered tip, a trocar tip, a lancet tip, a stiffened core, a reinforced tip (e.g., diamond- coated, titanium-tipped), a serrated tip, a textured tip, or any other suitable tip for piercing a first implanted occluder. By way of non-limiting example, tool 340 may include a wire having a sharp tip configured to pierce occluder 130. Tool 340 may include a catheter configured to pierce a first implanted occluder 130. For example, tool 340 (or any other suitable tool) may include a catheter with a needle tip (e.g., including trocar or stylet-assisted), a beveled tip, a tapered tip, a reinforced tip, a stiffened tip (e.g., with stainless steel, a reinforced polymer), a serrated tip, a textured tip, an expandable or retractable piercing 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 piercing a first implanted occluder.

[0083] Further, as shown in FIG. 3 A, a portion of intravascular medical system 100 may include an expander 350, illustrated in FIGS. 3A and 3B in a non-expanded state, and illustrated in FIGS. 4A and 4B in an expanded state. In some embodiments, an expander may be configured for delivery via a limited passageway through a first implanted occluder 130 using tool 340. As tool 340 pierces occluder 130 and the expander is driven through the piercing, the limited passageway 132 may be formed.

[0084] In some embodiments, expander 350 may include an inflatable balloon, such as balloon 720 in FIG. 7B. By way of non-limiting example, the balloon may be inflatable via fluidinflation (e.g., with saline, contrast fluid, air, carbon dioxide, or the like), mechanical expansion (e.g., via a spring-loaded mechanism, self-expanding materials), osmotic inflation (e.g., via absorption of fluids), electrical activation, thermal expansion, or any other means of inflating a balloon.

[0085] In some embodiments, an expander 350 may include a self-expanding stent. By way of non-limiting example, the self-expanding stent may include a shape memory alloy (e.g., nitinol), a hydrogel or similar polymer configured to expand by absorbing fluid (e.g., water, bodily fluid), or a bioresorbable polymer configured to expand. Further by way of non-limiting example, the self-expanding stent may utilize a radial elastic recoil (e.g., using braided or woven metal wires that store elastic energy when compressed).

[0086] FIGS. 4A and 4B illustrate different views of portion of the example intravascular medical system 100 of FIG. 3 A, deployed between biological structures and with an expander 350 in an expanded state an expanded state may refer to a state in which component, device, instrument, or element is stretched or extended such that it has an increased volume compared to a non-expanded state. By way of non-limiting example, when expander 350 is in an expanded state, it may compress occluder against a wall of a coronary sinus, thereby transforming the limited passageway into a dilated opening. For example, as depicted in FIGS. 4A and 4B, expander 350 may be in a second, expanded state or configuration. Expander 350 expands from its position in the limited passageway through occluder 130 radially outwards towards the walls of coronary sinus 280 such that occluder 130 is compressed against the walls of coronary sinus 280 and the limited passageway is transformed into a dilated opening. For example, a compressed occluder 130 may have an occluding surface 131 compared to a noncompressed occluder 130, thereby allowing a greater amount of flow through coronary sinus 280. In one example, an expander may partially compress an occluder against the walls of a coronary sinus. For example, expander 350 may compress occluder 130 against the walls of coronary sinus 280 such that occluder 130 partially occludes flow of anatomical fluid through coronary sinus 280. In another example, an expander may completely or fully compress an occluder against the walls of a coronary sinus. For example, expander 350 may compress occluder 130 against the walls of coronary sinus 280 such that occluder 130 does not substantially occlude flow of anatomical fluid through coronary sinus 280 (e.g., having a similar flow as in a coronary sinus without any occluder).

[0087] In some embodiments, a portion of intravascular medical system 100 may include a retainer such as an additional stent positioned on the outer surface of expander 350 (e.g., on outer surface of expander balloon 350 in FIG. 4A) and configured to maintain (e.g.,permanently) the dilated opening by holding the compressed occluder 130 against a wall of coronary sinus 280 or stent 101. The retainer stent may be understood to be similar in composition, size, or shape to stent 101. By way of non-limiting example, the retainer stent may be self-expanding, balloon expandable, memory shape expandable, braided expandable, or may employ any other mechanism of expansion. Further by way of non-limiting example, the retainer stent may be made of nitinol, stainless steel, cobalt chrome, or any other suitable material known to those skilled in the art.

[0088] In some embodiments, an expander and a retainer may be combined in one of a balloon expandable stent or a self-expandable stent. For example, expander 350 may be implemented as or integrated into a single component or structure configured to perform the functions of both an expander and a retainer.

[0089] FIG. 5 A is a side view of a portion of the example intravascular medical system 100 of FIG. 1A, deployed between biological structures and with an occluder in an expanded state. For example, after piercing and crossing an occluder, tool 340 is removed, and the occluder 130 is compressed against a cavity wall, as best illustrated in FIGS. 5B and 5C.

[0090] FIG. 5B is a front view of the system portion illustrated in FIG. 5 A consistent with one embodiment where the expander remains in situ after expansion. In some embodiments, an expander, a retainer, or a combination expander and retainer may be configured to remain in situ after expansion. For example, as shown in FIG. 5B, expander 350 remains in situ in coronary sinus 280 after expansion to maintain occluder 130 in a compressed state and permit flow of fluid through dilated opening 532.

[0091] FIG. 5C is a front view of the system portion illustrated in FIG. 5A consistent with another embodiment where the expander is removed following expansion. In some embodiments, an expander, a retainer, or a combination expander and retainer may be configured to be removed following expansion. For example, as shown in FIG. 5C, expander 350 is removed. In some embodiments, an occluder may be configured to maintain a dilated opening without an expander, a retainer, or a combination expander and retainer. For example, occluder 130 may be configured to be self-maintaining after expansion such that occluder 130 is compressed against the walls of coronary sinus 280 and dilated opening 532 is maintained, permitting deoxygenated blood to flow from the myocardium through coronary sinus 280 in an antegrade direction or oxygenated blood to flow from left atrium 270 through coronary sinus 280 in a retrograde direction. In another example, an occluder may be configured to be selfcontracting such that, in response to being pierced and crossed, the occluder is compressed against the walls of a coronary sinus and a dilated opening is maintained. For example, occluder130 may comprise a tensioned, stressed, or taut surface or membrane configured to, after being pierced or punctured, move or contract radially outwards from the site of piercing or puncture. In such examples, occluder 130 may comprise a pre-stressed elastic or an auxetic material or elastomer. Alternatively, occluder 130 may be made of a material such that once pierced, the occluding function is abated without a need for removing occluder 130 or compressing it against a vessel wall.

[0092] As shown in FIGS. 6A, 6B, and 6C, a portion of intravascular medical system 100 may include a second occluder 633. In some embodiments, a second occluder may be configured for implantation on a downstream side of a shunt in a coronary sinus. For example, second occluder 633 may be configured to be implanted downstream of shunt 120. In some embodiments, a second occluder may be configured to cooperate with a shunt to cause retrograde flow from a left atrium in a coronary sinus. For example, second occluder 633 and shunt 120 may be configured to cooperate such that oxygenated blood may flow from left atrium 270, through central passageway 121, into coronary sinus 280, through dilated opening 532, and towards the myocardium in a retrograde flow direction. In this way, the myocardium may receive oxygenated blood shunted from the left atrium, which may improve cardiac function.

[0093] In some embodiments, a second occluder may have a bowed or bent frame, such as occluder 1031 in FIG. 10B. Alternatively, as illustrated in FIG. 6A, a scooped surface (deflector) 635 may be provided in addition to occluder 633. Scooped surface 635 may be omitted from the embodiment of FIG. 6A, depending on design choice. Additionally, or alternatively, scooped surface 635 may be integrally formed or connected to occluder 633. The scoop configuration may include additional flexibility at the edges or lip of second occluder 633 to accommodate a range of anatomy and patient-to-patient variance. As shown in FIG. 6A, the scoop surface 635 may generally be circular in shape in its cross-sectional profile. Furthermore, in some embodiments, a second occluder may form a crescent shape extending from a shunt. For example, scoop surface 635 may have a crescent shaped occluding surface extending from shunt 120.

[0094] In some embodiments, scoop surface 635 may have an arc-shaped concavity sized to cover most or all of an inner circumference of a vein, such as coronary sinus 280, such that it extends mostly or entirely across the entire cross-section in the vein. In some examples, this flow deflector may be sized to contact a perimeter of a cavity of the vein (e.g., coronary sinus) or span the cross section of the cavity of the vein (e.g., coronary sinus). For example, as shownin FIG. 6A, scoop surface 635 may span the cross-section of coronary sinus 280 and contact lower wall of coronary sinus 280.

[0095] FIGS. 7A, 7B, and 7C graphically depict steps of an example process of deploying an intravascular medical system 100 between biological structures, consistent with some embodiments of the present disclosure. FIG. 7A may correspond to a first step of deploying intravascular medical system 100, FIG. 7B may correspond to a second step following the first step, and FIG. 7C may correspond to a third step following the second step. However, it may be understood that the example process depicted in FIGS. 7A, 7B, and 7C is merely exemplary and steps may be added, omitted, or performed in another sequence to achieve a similar result.

[0096] As shown in FIG. 7A, a first implanted occluder 130 may be positioned in a cavity 280 and may restrict antegrade flow of fluid upstream of first implanted occluder 130. For example, first implanted occluder 130 may be positioned in a coronary sinus 280 and may restrict antegrade flow of deoxygenated blood from the myocardium towards the right atrium, which may or may not result in some retrograde flow of deoxygenated blood beyond (e.g., in an upstream direction) first implanted occluder 130 (e.g., natural antegrade flow striking occluder 130 and then moving in a retrograde direction).

[0097] Implanted shunt 120 may be positioned between cavity 270 and cavity 280 and may facilitate a flow of fluid from cavity 270 to cavity 280. For example, implanted shunt 120 may be positioned between left atrium 270 and coronary sinus 280 and may, in cooperation with first implanted occluder 130, facilitate a flow of oxygenated blood from left atrium 270, through central passageway 121, towards a right atrium within coronary sinus 280 in an antegrade direction.

[0098] In some embodiments, an occluder may be configured to restrict a natural flow of anatomical fluid. As used herein, a natural flow refers to an unimpeded, typical flow of a fluid through a particular pathway or channel. For example, a natural flow of anatomical fluid in a coronary sinus may include a flow of venous blood from the cardiac veins, through the coronary sinus, towards the right atrium. The direction of this natural flow is often referred to as antegrade flow. By way of non-limiting example, occluder 130 may restrict natural, antegrade flow of blood in coronary sinus 280 such that a natural, antegrade flow of blood in coronary sinus 280 may contact and / or be deflected by occluding surface 131 of occluder 130.

[0099] As shown in FIG. 7B, tool 340 may be inserted through first implanted occluder 130 to create a limited passageway. For example, tool 340 may traverse through vasculature of a patient to reach first implanted occluder 130 in coronary sinus 280. After piercing and crossing occluder 130, an expander, such as balloon 720 may be inflated to compress occluder 130against the wall of the coronary sinus. The dilated occluder 130 may be maintained in a dilated position as described earlier.

[0100] In some embodiments, a second occluder may be configured for implantation on a downstream side of a shunt in a coronary sinus. For example, tool 340 may carry (e.g., inside a catheter or around a wire of tool 340) second occluder 633 and second stent 711 to a same or nearby location with respect to shunt 120 and stent 101. For example, after tool 340 pierces and crosses implanted occluder 130, second occluder 633 may be positioned downstream of shunt 120 (e.g., near downstream end 105) and second stent 711 may be positioned in a similar location as stent 101.

[0101] In some embodiments, the second occluder 633 may be expandable such as via a selfexpanding material, including, e.g., shape memory alloy including nitinol, a hydrophilic polymer, or by utilizing a mechanical expansion, including, e.g., delivered as a compressed mesh or braid, via a spring-loaded mechanism, by an inflated balloon, by an actuator. By way of non-limiting example, second occluder 633 may be configured to expand via a trigger wire mechanism as a delivery mechanism that guided second occluder 633 (e.g., tool 340, a catheter, a guide wire) is pulled back or removed. Further, second occluder 633 may be delivered to an intended location in a compressed configuration (e.g., inside a catheter, around or adjacent a guide wire). While in a compressed configuration, second occluder 633 may have a diameter smaller than coronary sinus 280. While in an expanded configuration, second occluder 633 may have a diameter substantially equal to an inner diameter of coronary sinus 280 such that second occluder 633 restricts (e.g., partial occlusion, full occlusion) a flow of fluid in an antegrade flow direction from the myocardium towards the right atrium.

[0102] In some embodiments, a second occluder may be integrated with a stent. For example, an occluder and a stent may be connected to each other (e.g., physically, via an intermediate connecting element) or integrated into a single package. By way of non-limiting example, second occluder 633 may be integrated with second stent 711 in a single package for delivery through the vasculature of a patient to a desired location. Further, second occluder 633 and second stent 711 may be configured to cooperate to maintain a position of second occluder 633 and facilitate a flow of oxygenated blood from left atrium 270, through central passageway 121, towards the myocardium in coronary sinus 280 in a retrograde flow direction.

[0103] In some embodiments, a tool may be configured to remove first implanted occluder 130. For example, tool 340 may be configured to hook onto first implanted occluder 130 such that when tool 340 is removed, first implanted occluder 130 is also removed or repositioned.

[0104] As shown in FIG. 7C, second occluder 633 may be positioned downstream of shunt 120. In some embodiments, a second occluder is configured to cooperate with a shunt to cause retrograde flow from a left atrium in a coronary sinus. For example, second occluder 633 may be configured to cooperate with shunt 120 to cause a retrograde flow of oxygenated blood from left atrium 270 toward the myocardium through coronary sinus 280 in a retrograde flow direction. Further, in some embodiments, a second occluder may be configured to cooperate with a shunt to restrict antegrade flow in a coronary sinus downstream of the second occluder. For example, second occluder 633 may be configured to cooperate with shunt 120 to restrict (e.g., via partial occlusion, full occlusion) a flow of blood within coronary sinus 280 in an antegrade direction downstream of second occluder 633.

[0105] In some embodiments, a second occluder may be configured to restrict a natural flow of anatomical fluid. By way of non-limiting example, second occluder 633 may restrict natural, antegrade flow of blood in coronary sinus 280 such that a natural, antegrade flow of blood in coronary sinus 280 may contact and / or be deflected by second occluder 633. Further, the retrograde flow of oxygenated blood from left atrium 270, caused by the cooperation of shunt 120 and second occluder 633, may also restrict a natural, antegrade flow of blood in coronary sinus 280 by providing an opposing force (e.g., dynamic force with greater magnitude).

[0106] FIG. 8 illustrates a flowchart of a method 800 for improving cardiac function, consistent with some embodiments of the present disclosure. By way of example only, the method 800 may be accomplished using any of the example embodiments disclosed herein.

[0107] As shown in step 802, disclosed embodiments may involve implanting a first occluder in a coronary sinus in a first occluder region proximate a left atrium to impose a first restriction on antegrade blood flow in the coronary sinus. In some embodiments, a restriction on blood flow may include a partial occlusion or full occlusion. In some embodiments, the first occluder may be configured to progressively restrict blood flow over time. For example, the first occluder may initially form a partial occlusion in a coronary sinus and, over time, may gradually increase a restriction of blood flow in an antegrade flow direction until the first occluder forms a full occlusion in the coronary sinus. In one example, the first occluder may be self-expanding and gradually increase a restriction of blood flow over time.

[0108] As shown in step 804, disclosed embodiments may involve implanting downstream of the first occluder region, a shunt bridging the coronary sinus and the left atrium, thereby establishing a first flow path relieving pressure in the left atrium by directing blood from the left atrium to a right atrium via the coronary sinus. Bridging the coronary sinus and the left atrium may include facilitating a flow path between the coronary sinus and the left atrium,including, for example, after puncturing or piercing an opening in the coronary sinus and the left atrium. A flow path may refer to a route that a fluid may follow. For example, the shunt may establish a flow path between the left atrium and the coronary sinus through a central passageway of the shunt. Pressure may be relieved in the left atrium when or as blood flows from the left atrium, through the shunt, toward the right atrium via the coronary sinus.

[0109] In some embodiments, implanting the first occluder may occur before implanting the shunt. In some embodiments, implanting the first occluder may occur after implanting the shunt. In some embodiments, implanting the shunt may occur prior to implanting an occluder. For example, the shunt may be implanted prior to implanting a first occluder. In some embodiments, implanting the shunt may occur after implanting the first occluder. For example, the shunt may be implanted after implanting a first occluder. Whether or not the implanting of the first occluder is after or prior to the shunt, both occur prior to maintaining the first flow path for a period of days.

[0110] As shown in step 806, disclosed embodiments may involve maintaining the first flow path for a period of days. Maintaining a flow path may refer to keeping a flow path open such that fluid may flow from one place, through the flow path, to another place. For example, a shunt or stent may be configured to maintain a flow path between a left atrium and a coronary sinus. In some embodiments, the period of days may span weeks. In some embodiments, the period of days may span months. In some embodiments, the period of days may span years.

[0111] As shown in step 808, disclosed embodiments may involve, following the period of days, abating the first restriction. As used herein, abating may refer to reducing in intensity, amount, or degree. For example, abating a restriction may include reducing or lessening the restriction and allowing or permitting an increased amount of flow through or past the restriction. In some embodiments, abating the first restriction may involve piercing, removing, permitting biodegradation, or transitioning of the first occluder.

[0112] Removing of an occluder may refer to taking out the occluder from its location within a biological structure, including, for example, by a medical practitioner during a surgical operation. Removing an occluder may alternatively involve dilating the occluder so that it is effectively removed or prevented from materially blocking blood flow.

[0113] Permitting biodegradation of an occluder may refer to waiting for an occluder to naturally undergo a process by which the material the occluder comprises (e.g., organic material, biodegradable material) is broken down into simpler or smaller compounds.

[0114] Transitioning of an occluder may refer to changing an occluder from a first configuration for directing flow in a first direction of incoming shunted blood to a secondconfiguration for directing flow in a second direction different than the first direction of incoming shunted blood. In some embodiments, an occluder may partially or fully occlude a biological structure in both the first configuration and the second configuration. For example, an occluder in a first configuration for directing flow in a coronary sinus in a first, antegrade direction of incoming blood shunted from a left atrium may also, by at least partially occluding the coronary sinus, restrict a natural, antegrade flow of incoming blood from the myocardium. Further, an occluder in a second configuration for directing flow in a coronary sinus in a second, retrograde direction of incoming blood shunted from a left atrium may also, by at least partially occluding the coronary sinus, restrict a natural, antegrade flow of incoming blood from the myocardium.

[0115] By way of non-limiting example, an occluder may transition between a first configuration and a second configuration automatically or manually. An automatic transition may include an occluder transitioning between a first configuration and a second configuration in response to a stimulus (e.g., mechanical movement in response to received signal, after a predetermined amount of time). A manual transition may include an occluder transitioning between a first configuration and a second configuration via manual manipulation, including, for example, by a medical practitioner during a surgical operation.

[0116] In some embodiments, abating the first restriction may include forming a limited passageway in the first occluder. For example, forming a limited passageway in the first occluder may include piercing an occluder using a dedicated tool, a catheter, or a wire.

[0117] In some embodiments, abating the first restriction may include dilating the first occluder via the limited passageway. In some embodiments, dilating the first occluder may include passing a wire through the first occluder to form a limited passageway. For example, a wire may pierce and cross the first occluder to form a limited passageway. In some embodiments, dilating the first occluder may include passing a balloon through the limited passageway. For example, a non-inflated balloon may be inserted through the limited passageway. In some embodiments, dilating the first occluder may include inflating the balloon. For example, a balloon may be inflated (e.g., with gas, fluid) to dilate the limited passageway into a dilated opening.

[0118] In some embodiments, abating the first restriction may include permanently maintaining the diluted first occluder against a wall of the coronary sinus. In some embodiments, maintaining the dilated first occluder against the wall of the coronary sinus may include expanding a stent to hold the first occluder in a compressed state. For example, a stentmay be expanded to hold the first occluder in a compressed state and maintain the dilated opening.

[0119] In some embodiments, abating the first restriction may include removing the first occluder from the coronary sinus. In some embodiments, removing the first occluder occurs using a stent retriever. As used herein, a stent retriever may refer to a medical device or component that includes a self-expanding, mesh-like stent configured to be inserted into a blood vessel (e.g., via a guidewire), to be expanded to capture or trap an object (e.g., first occluder), and to be removed with the captured object.

[0120] In some embodiments, abating the first restriction may occur after confirming that a heart chamber pressure is greater than a venous pressure. For example, a healthcare medical practitioner may confirm that a left atrium pressure is greater than a coronary sinus pressure.

[0121] In some embodiments, a heart chamber pressure or a venous pressure may be derived from a direct measurement of a hemodynamic parameter. A direct measurement may refer to obtaining a parameter by using a sensor or device. A hemodynamic parameter may refer to a measurement that reflects blood flow, blood pressure, or function of the cardiovascular system. By way of non-limiting example, a hemodynamic parameter may include an arterial blood pressure, a central venous pressure, a pulmonary artery pressure, a cardiac output, a cardiac index, a stroke volume, a systemic vascular resistance, a pulmonary vascular resistance, a mixed venous oxygen saturation, or any other appropriate hemodynamic parameter. For example, a device or sensor may be inserted or implanted in a heart chamber or blood vessel to directly measure a heart chamber pressure or venous pressure, respectively. By way of nonlimiting example, a left atrium pressure may be directly measured via a pulmonary artery catheter (Swan-Ganz catheter) or similar means.

[0122] In some embodiments, a heart chamber pressure or a venous pressure may be derived from an indirect measurement of a hemodynamic parameter. An indirect measurement may 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 may be placed outside a body to measure one or more hemodynamic parameters for use in deriving or estimating a heart chamber pressure or a venous pressure. By way of non-limiting example, a doppler echocardiogram or similar means may be used to indirectly measure a left atrium pressure.

[0123] In some embodiments, a heart chamber pressure or venous pressure may be derived under a partial occlusion condition. Further, in some embodiments, a heart chamber pressure or venous pressure may be derived under a full occlusion condition. For example, a coronarysinus pressure may be obtained, either directly or indirectly, while an occluder partially or fully occludes a segment of the coronary sinus (e.g., a segment proximate the left atrium).

[0124] As shown in step 810, disclosed embodiments may include, after abating the first restriction, implanting a second occluder in the coronary sinus in a second occluder region downstream of the shunt, to impose a second restriction on antegrade blood flow in the coronary sinus and thereby establishing a second flow path of retrograde flow from the left atrium in the coronary sinus. For example, after abating the first restriction, a second occluder may be implanted downstream of a shunt between the left atrium and the coronary sinus to impose a restriction on antegrade blood flow in the coronary sinus. Further, the second occluder may, in cooperation with the shunt, establish a flow path of oxygenated blood from the left atrium toward the myocardium within the coronary sinus in a retrograde flow direction.

[0125] In some embodiments, a device for selectively directing flow in a coronary sinus adjacent a left atrium is disclosed. As used herein, selectively directing flow may refer to a control or manipulation of a movement of a fluid. For example, selectively directing flow in a coronary sinus may include controlling a flow direction of anatomical fluid in the coronary sinus, such as transitioning between a flow direction in a first direction and a flow direction in a second direction different than the first direction. Further, selectively directing flow may include being configured to transition between a first configuration for deflecting or restricting flow in a first direction and a second configuration for deflecting or restricting flow in a second direction different than the first direction.

[0126] In some embodiments, a device may include a shunt configured to bridge a left atrium and a coronary sinus. For example, the shunt may establish or maintain a flow path between the left atrium and the coronary sinus such that oxygenated blood may flow from the left atrium into the coronary sinus.

[0127] In some embodiments, the device may include an occluder selectively positionable between a first antegrade flow deflecting position and a second retrograde flow deflection position. Selectively positionable may refer to an object, device, or component configured to be moved, adjusted, or transitioned in different positions. For example, a selectively positionable occluder may include an occluder configured to transition between a first configuration and a second configuration (e.g., a transitionable occluder). In the first antegrade flow deflecting configuration, the occluder may be configured to direct flow in the coronary sinus from the left atrium in a first direction toward a right atrium. For example, when in the first antegrade flow deflecting configuration, the transitionable occluder may restrict (e.g., partially occlude, fully occlude) a retrograde flow in the coronary sinus from the left atriumtoward the myocardium. Further, when in the first antegrade flow deflecting configuration, the transitionable occluder may restrict (e.g., partially occlude, fully occlude) a natural, antegrade flow in the coronary sinus from the myocardium towards the right atrium.

[0128] In the second retrograde flow deflecting configuration, the occluder may be configured to direct flow in the coronary sinus from the left atrium in a second direction away from the right atrium. For example, when in the second retrograde flow deflecting configuration, the transitionable occluder may restrict (e.g., partial occlusion, full occlusion) an antegrade flow in the coronary sinus from the left atrium toward the right atrium. Further, when in the second retrograde flow deflecting configuration, the transitionable occluder may restrict (e.g., partially occlude, fully occlude) a natural, antegrade flow in the coronary sinus from the myocardium towards the right atrium.

[0129] In some embodiments, an intravascular medical device or kit for controlled change in the direction of shunted blood flow within a stent is provided. Similar to the other embodiments, the intravascular medical device or kit for controlled change in direction of shunted blood includes a stent defined by a stent wall with a primary orifice and a shunt. The stent extends between a proximal and distal end and is defined by a stent wall being sized and shaped to engage a blood vessel wall. The stent wall includes a primary orifice defined by a perimeter edge. The primary orifice is positioned between a proximal end and a distal end of the stent. The shunt defines a central passage. The shunt extends outwards from the perimeter edge towards a first cavity in an organ;

[0130] In some embodiments, the occluder or transitionable occluder may be adjustable in situ to selectively change flow direction in the coronary sinus. In situ may refer to a same, implanted, or original location. For example, the occluder may be adjustable between the first antegrade flow deflecting position and the second retrograde flow deflecting position while maintaining a same general location within a vessel, without removal required.

[0131] In some embodiments, the transitionable occluder may be adapted to engage the stent wall or an internal tubular frame positioned within the stent, and at least partially restrict blood flow through the stent. In some embodiments, the transitionable occluder is transitionable between a first configuration and a second configuration such that, in the first configuration, the transitionable occluder directs an extension of the central passage of the shunt towards a proximal end or opening of the stent; and in a second configuration, the occluder directs an extension of the central passage of the shunt in an opposing direction towards a distal end or opening of the stent. Said another way, in the first configuration, the occluder is configured to direct a first flow direction, and in the second configuration, the occluder is configured to directa second or opposing flow direction. In either of the first and second configurations, the extension of the central passage of the shunt is towards a single tubular opening of the stent. The shunt and stent are configured to be stationary during the transition between a first and second configuration. Transitionable occluder is adapted to transition between a first configuration and a second configuration such that, in the first configuration, a shunt proximate engagement of the transitionable occluder is distal to the primary orifice and in the second configuration, a shunt proximate engagement of the transitionable occluder is proximal to a primary orifice. A primary orifice may have a longest dimension in a range of 3 to 12 mm.

[0132] In the first configuration, the transitionable occluder may be transiently stable within the blood vessel while the second configuration may be stable within the blood vessel for more than half a year.

[0133] The transitionable occluder may be adapted to transition, for example by rotation or change in position in either direction - from the first to a second and from a second to a first configuration. Alternatively, the transitionable occluder may be adapted to transition, for example by axial rotation or change in longitudinal position, sequentially in a single direction. This transition may be by mechanical or automatic means.

[0134] In some embodiments, the transitionable occluder is adapted to transition via rotation around a longitudinal axis of the stent between a first and second configuration. In some embodiments, the transitionable occluder includes a coupling element adapted to couple or decouple from the shunt or the stent.

[0135] In some embodiments, the occluding surface in the first configuration is distinct from the occluding surface of the second configuration. In an alternative embodiment, the transitionable occluder is a single component in each of the first and the second configurations.

[0136] In some embodiments, the transitionable occluder is adapted to engage the stent with a planar engagement in both a first configuration and a second configuration. In some embodiments, the planar engagement is orthogonal to a longitudinal axis of the stent. In some embodiments, the occluding surface is curved or scooped.

[0137] In some embodiments, the transitionable occluder is adapted to transition between two longitudinal positions within the stent between the proximal and distal end.

[0138] In some embodiments, the transitionable occluder is a conformable sheet radially traversing the stent.

[0139] In some embodiments, the transitionable occluder is substantially impermeable to blood. In some embodiments, the transitionable occluder is adapted to decrease permeability to blood over time.

[0140] In some embodiments, the transitionable occluder, in its first or anterograde -flow configuration, includes a puncturable or removable surface.

[0141] In some embodiments, the intravascular medical device is adapted to be contracted in an over tube for percutaneous delivery via a coronary sinus and to expand after deployment from an over tube. In some embodiments, the over tube is adapted for delivery to a coronary sinus.

[0142] In some embodiments, the stent includes a coupling element adapted to couple or decouple from the occluder.

[0143] In some embodiments, the shunt further comprises a stabilizer configured to stabilize the shunt. In some embodiments, the shunt and the occluder are integrally formed. In an alternative embodiment, the shunt and the occluder are two parts. In some embodiments, the shunt includes a time-delayed opening or pressure-based valve. In some embodiments, the shunt is adapted to inhibit excessive tissue ingrowth within the central passage of the shunt.

[0144] In some embodiments, the shunt includes a coupling element adapted to couple or decouple from the occluder.

[0145] In some embodiments, the shunt defines a central passage extending from a coronary sinus to a left atrium to permit passage of blood from the left atrium via the shunt to the coronary sinus.

[0146] FIGS. 9A and 9B illustrate an example of a transitionable intravascular medical system 900 in different configurations, consistent with some embodiments of the present disclosure. In some embodiments, a transitionable intravascular medical system may include a stent, a shunt, and a transitionable occluder. For example, transitionable intravascular medical system 900 may include a stent 901 with stent walls 902 and primary orifice 903 defined by perimeter edges 904; a shunt 920 having a central passageway 921; and a transitionable occluder 930 with an occluding surface 931.

[0147] As shown in FIG. 9A, transitionable occluder 930 is in a first configuration. In the first configuration, transitionable occluder 930 may be configured to deflect or redirect blood flow shunted from left atrium 970 into coronary sinus 980 in an antegrade or downstream direction toward downstream end 905 (e.g., in a direction indicated by arrow A - antegrade flow direction).

[0148] Further, as shown in FIG. 9B, transitionable occluder 930 is in a second configuration. In the second configuration, transitionable occluder 930 may be configured to deflect or redirect blood flow shunted from left atrium 970 into coronary sinus 980 in a retrograde or upstream direction (e.g., in a direction indicated by arrow R - retrograde flow direction) towardupstream end 906. Transitionable occluder 930 may be adapted to transition between the first configuration and the second configuration. In some embodiments, a transition of an occluder between a first configuration and a second configuration may occur without substantially affecting a position of a shunt or a stent.

[0149] As shown in FIG. 9B, for reference purposes, shunt 120 may be divisible by central plane C defining an upstream side U and a downstream side D of shunt 120.

[0150] FIGS. 10A and 10B illustrate another example transitionable intravascular medical system 1000, deployed between biological structures, for shunting and selectively regulating anatomical fluid flow deployed between biological structures, consistent with some embodiments of the present disclosure. In one example, transitionable intravascular medical system 1000 may include a stent 1001 with stent walls 1002 and primary orifice 1003 defined by perimeter edges 1004; a shunt 1020 having a central passageway 1021; a transitionable occluder 1030 with an occluding surface 1031; and a coupling element 1035.

[0151] As shown in FIG. 10A, transitionable occluder 1030 is in a first configuration to deflect or redirect blood flow shunted from left atrium 1070 into coronary sinus 1080 in an antegrade or downstream direction. Further, as shown in FIG. 10B, transitionable occluder 1030 is in a second configuration to deflect or redirect blood flow shunted from left atrium 1070 into coronary sinus 1080 in a retrograde or upstream direction.

[0152] As shown in FIGS. 10A and 10B, a single transitionable occluder 1030 may have a substantially similar longitudinal position within stent 1001 in the first configuration and the second configuration. Further, transitionable occluder 1030 may be configured to adjust its shape and / or location of connection to stent 1001 from an upstream position to a downstream position relative to primary orifice 1003.

[0153] As shown in FIG. 10A, in a first stage, transitionable occluder 1030 is in a first or antegrade flow configuration to direct blood flow shunted from left atrium 1070, the blood typically having increased oxygenation and higher pressure, towards coronary sinus 1080 in an antegrade blood flow direction within the coronary sinus. Further, transitionable occluder 1030 may have a shunt-proximate engagement, which is upstream to primary orifice 1003 of stent 1001 or downstream to central passageway 1021 of shunt 1020.

[0154] Further, transitionable occluder 1030 may include occluding surface 1031, which may form part of the first or antegrade flow configuration as well as the second or retrograde flow configuration. For example, occluding surface 1031 may be a same element in both configurations and may be adapted to change its position and / or shape based on a configuration. The first or antegrade flow configuration in FIG. 10A includes occluding surface 1031 whichat least partially restricts (and may entirely restrict) deoxygenated blood flow coming from the myocardium in an anterograde flow direction. In some embodiments, after a period time, transitionable occluder 1030 may transition (or be transitioned) from the first configuration to the second configuration. By way of non-limiting example, the period of time may span days, weeks, or months.

[0155] As shown in FIG. 10B, in a second stage, transitionable occluder 1030 may have a shunt-proximate engagement which is downstream to primary orifice 1003 of stent 1001 or upstream to central passageway 1021 of shunt 1020. In this configuration, blood shunted from left atrium 1070, is directed to flow in a retrograde flow direction in coronary sinus 1080. To transition into the second stage, transitionable occluder 1030 may include a coupling element 1035 configured to couple or to decouple between transitionable occluder 1030 and shunt 1020 or stent 1001. By way of non-limiting example, coupling of transitionable occluder 1030 and shunt 1020 may be accomplished via sutures, adhesives, rivets, welds, solder, or other techniques known to those skilled in the art. The interconnection may be rotational such that the shunt may be rotated about an axis transverse to an axis of stent 1001 to thereby change a flow deflecting orientation (e.g., from an antegrade deflection to a retrograde deflection). Further by way of non-limiting example, indirect coupling may be accomplished via direct coupling of shunt 1020 and transitionable occluder 1030 to a common intermediate element. Coupling element 1035 may include a quick release mechanism, which may be mechanically implemented using, for example, a dedicated tool. Both the first and second configuration of transitionable occluder 1030 is stably engaged with stent 1001 such that transitionable occluder 1030 may perform its expected or intended function. Coupling element 1035 may be associated with or include a lock to ensure transitionable occluder 1030 maintains a desired or intended position over a period of time. Occluding surface 1031 may be curved or scooped to aid in deflecting flow. Transitionable occluder 1030 may include a curved occluding surface 1031 adapted to transition between a degree of curvature or direction of curve. Transitionable occluder 1030 may include a flexible biased frame which is biased towards decreasing the degree of curvature upon release of the coupling element.

[0156] FIGS. 11A and 11B illustrate an example of another transitionable intravascular medical system 1100 deployed between biological structures in a first configuration, consistent with some embodiments of the present disclosure. In one example, transitionable intravascular medical system 1100 may include a stent 1101 with stent walls 1102 and primary orifice 1103 defined by perimeter edges 1104; a shunt 1120 with a central passageway 1121; a transitionable occluder 1130 with an occluding surface 1131; and a rotatable element 1135.

[0157] As shown in FIG. 11A, transitionable occluder 1130 is in a first configuration. Further, as shown in FIG. 11B, transitionable occluder 1130 is in a second configuration. In some embodiments, transitionable occluder 1130 may have a substantially identical shape or size but a different position or orientation between the first configuration and in the second configuration. For example, in the second configuration, transitionable occluder 1130 may be rotated by 180 degrees about a longitudinal axis of stent 1101. In some embodiments, transitionable occluder 1130 may include a tubular frame having two holes on the surface at opposing locations and may rotate within stent 1101. Downstream end 1105 may further include a tool interface to control rotation of the device.

[0158] As shown in FIG. 11A, in a first stage, transitionable occluder 1130 is in a first or antegrade flow configuration to direct blood flow shunted from left atrium 1170 towards coronary sinus 1180 in an antegrade blood flow direction within coronary sinus 1180. Transitionable occluder 1130 may include a shunt-proximate engagement, which is upstream to primary orifice 1103 of stent 1101 or central passageway 1121. Transitionable occluder 1130 may include occluding surface 1131 which forms part of the first or antegrade flow configuration as well as the second or retrograde flow configuration. As shown in FIG. 11A, the first or antegrade flow configuration may include occluding surface 1131, which may be configured to, at least partially, restrict blood in an antegrade flow direction within coronary sinus 1180. For example, deoxygenated blood flow coming from the myocardium may be restricted from continuing in an antegrade flow direction. The determination of antegrade flow configuration is with respect to the blood entering coronary sinus 1180 by way of shunt 1120. In some embodiments, after a period time, transitionable occluder 1130 may transition from the first configuration to the second configuration. By way of non-limiting example, the period of time may span days, weeks, or months.

[0159] As shown in FIG. 1 IB, in a second stage, transitionable occluder 1130 is in a second or retrograde flow configuration. In the retrograde flow configuration, transitionable occluder 1130 may be positioned downstream with respect to primary orifice 1103 or central passageway 1121. In this configuration, blood shunted from left atrium 1170 may be directed to flow in a retrograde flow direction within coronary sinus 1180. In some embodiments, transitionable occluder 1130 may be configured to transition from the first configuration to the second configuration by way of rotation about a longitudinal axis of stent 1101. For example, transitionable occluder 1130 may include a rotatable element 1135 positioned on an outer surface of transitionable occluder 1130 and configured to enable sliding of transitionableoccluder 1130 along an inner circumference of stent 1101 to support rotation about a longitudinal axis of stent 1101.

[0160] A rotatable element may refer to a component, device, element, or instrument configured to rotate, itselfor another object, about an axis. For example, rotatable element 1135 may be configured to provides a means of rotating transitionable occluder 1130 by 180 degrees. By way of non-limiting example, the rotation may be by mechanical or manual means, for example, using a catheter tooling. Both the first configuration and the second configuration of transitionable occluder 1130 may be stably engaged with stent 1101 such that transitionable occluder 1130 may perform its intended or desired function. In some embodiments, rotatable element 1135 may be associated with a locking mechanism configured to maintain a position or orientation of transitionable occluder 1130. In some embodiments, the rotatable element 1435 may be mechanically driven with a tool. In some embodiments, occluding surface 1131 may be planar, curved or scooped.

[0161] FIGS. 11C, 11D and HE illustrate another example of a transitionable intravascular medical system 1400 deployed between biological structures, such as coronary sinus 1480 and left atrium 1470, consistent with some embodiments of the present disclosure. It may be understood that the reference numerals of FIGS. 11C, 1 ID, and 1 IE similar to the reference numerals of FIGS. 11A and 11B may indicate similar features or elements unless specified otherwise.

[0162] Transitionable intravascular medical system 1400 may include a stent 1401 having a shunt 1420 with a central passageway 1421 and a primary orifice 1403 defined by perimeter edges 1404 of the stent. Transitionable intravascular medical system 1400 may further include a transitionable occluder 1430 with an occluding surface 1431 and a rotatable element 1435. FIG. 11C illustrates a first configuration, consistent with some embodiments of the present disclosure, while FIG. 11D illustrates a second configuration, consistent with some embodiments of the present disclosure. FIG. HE illustrates an exploded view of the various parts of the transitionable intravascular medical system having a shunt-stent portion 1434 and a transitionable occluder 1430. Transitionable occluder 1430 is typically housed within the shunt-stent portion 1434. Transitionable occluder 1430 may be configured to enable ease of rotation about a longitudinal axis of stent 1401.

[0163] As shown in FIG. 11C, in a first configuration, transitionable occluder 1430 is in a first or antegrade flow configuration to direct blood flow shunted from left atrium 1470 towards coronary sinus 1480 in an antegrade blood flow direction within coronary sinus 1480.

[0164] The transitionable intravascular medical system 1400 includes a stent 1401 configured to provide structural support and house various components. Stent 1401 may be coated with a biocompatible material for vascular integration. Stent walls 1402 incorporate a lattice-like pattern of interconnected struts for flexibility and structural integrity. Stent 1401 features a primary orifice 1403 defined by a perimeter edge 1404 of stent 1401 and includes a central passageway 1421 for blood flow.

[0165] Shunt 1420 extends from an intermediate axial position along stent 1401 and bridges the left atrium 1470 and coronary sinus 1480.

[0166] Transitionable occluder 1430 may include occluding surface 1431 which forms part of the first or antegrade flow configuration as well as the second or retrograde flow configuration. The occluding surface 1431, has a shunt-proximate engagement, which is upstream to primary orifice 1403 or central passageway 1421 in the first configuration. In the first or antegrade flow configuration, occluding surface 1431 may be configured to, at least partially, direct blood in an antegrade flow direction within coronary sinus 1480 as well as restrict antegrade flow of deoxygenated blood coming from the myocardium. The determination of antegrade flow configuration of the occluding surface 1431 is with respect to the blood entering coronary sinus 1480 by way of shunt 1420.

[0167] The transitionable occluder 1430 may include an occluding sheet having occluding surface 1431 incorporated into the design, contacting an internal stent or tubular frame 1432 along the full internal perimeter and radially traversing the stent. This configuration promotes occlusion and helps control blood flow direction within the device. The transitionable occluder 1430 contacts the internal wall of the tubular frame 1432 over a length.

[0168] In some embodiments, occluding surface 1431 extends from tubular frame 1432. Transitionable occluder 1430 includes an occluding surface 1431 which may be planar, curved, or scooped.

[0169] In some embodiments, occluding surface 1431 may have the shape of a scoop surface and may be generally circular in shape in its cross-sectional profile. In some embodiments, occluding surface 1431 may form a crescent or scoop shape extending from a tubular frame 1432. In some embodiments, occluding surface 1431 may have an arc-shaped concavity sized to cover most or all of an inner circumference of a tubular frame 1432, such that it extends mostly or entirely across the entire cross-section of tubular frame 1432. In some examples, this occluding surface may be sized to contact a perimeter of tubular frame 1432 or alternatively, span the cross section of the tubular frame 1432.

[0170] Transitionable occluder 1430 occluder may engage the stent by way of a planar engagement in both a first configuration and a second configuration. The planar engagement may be orthogonal to a longitudinal axis of the stent.

[0171] The transitionable occluder 1430 may be selectively positionable between antegrade and retrograde flow positions. The transitionable occluder 1430 is rotatable within stent 1401 to achieve different configurations. Transitionable occluder 1430 may have identical shape and / or size in both configurations, differing only in orientation. In the second configuration, transitionable occluder 1430 may be rotated by 180 + / - 30 degrees about a longitudinal axis of stent 1401. 180-degree rotation ensures a complete reversal of the occluder's orientation, effectively switching between antegrade and retrograde flow configurations. Changing the antegrade flow to retrograde flow direction may be performed automatically. 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.

[0172] In some embodiments, after a period time, transitionable occluder 1430 may transition automatically or manually, from the first configuration to the second configuration. By way of non-limiting example, the period of time may span days, weeks, months, or years. The period of time may span days, weeks, or months.

[0173] As shown in FIG. 11D, in a second stage, transitionable occluder 1430 is in a second or retrograde flow configuration. In the retrograde flow configuration, transitionable occluder 1430 may be positioned downstream with respect to primary orifice 1403 or central passageway 1421. In this configuration, blood shunted from left atrium 1470 may be directed to flow in a retrograde flow direction within coronary sinus 1480. In this example, transitionable occluder 1430 may be configured to transition from the first configuration to the second configuration by way of rotation about a longitudinal axis of stent 1401.

[0174] As shown in FIG. 11D, transitionable occluder 1430 may be configured such that an occluding surface is positioned downstream of shunt 1420 such that it cooperates with a shunt to cause retrograde flow from a left atrium 1470 in a coronary sinus 1480. For example, in the second configuration, occluding surface 1431 may cooperate with shunt 1420 to cause a retrograde flow of oxygenated blood from left atrium 1470 toward the myocardium through coronary sinus 1480 in a retrograde flow direction.

[0175] Rotatable element 1435 provides a mechanism for easily adjusting the occluder's position, facilitating the transition between antegrade and retrograde flow configurations without the need for invasive procedures. Rotatable element 1435 provides a means fortransitioning of an occluder by rotation of the transitionable occluder 1430 relative to the longitudinal axis of the stent 1401. The ability to rotate the occluder provides a non-invasive means of altering flow direction, reducing the need for additional surgical interventions. Rotation about the longitudinal axis of the stent allows for precise and controlled adjustment of the occluder's position, facilitating the desired change in flow direction. In some embodiments, the rotatable element 1435 may be mechanically driven with a tool. In some embodiments, rotatable element 1435 may be associated with a locking mechanism configured to maintain a position or orientation of transitionable occluder 1430.

[0176] Rotatable element 1435 may include a tubular frame 1432 sized to fit within the stent 1401. The internal tubular frame in FIG. HE may include at least two holes on an external surface at opposing locations configured to align with the central passageway 1421 of the shunt 1420 in each configuration. This alignment allows for controlled blood flow through the device.

[0177] The contour of the transitionable occluder 1430 and the stent 1401 may each include a change in diameter 1436 to promote axial position within the stent 1401. Other means of maintaining longitudinal position of the internal tubular frame within the stent 1401 are also possible.

[0178] Stent 1401 and the transitionable occluder 1430 may be collectively configured for rotation of transitionable occluder 1430 relative to stent 1401. For example, the external surface of transitionable occluder 1430 may be compatible with frictionless rotation within the stent 1401. The rotational capability of the transitionable occluder 1430 within the stent 1401 enables in situ adjustment of the occluder's position, allowing for non-invasive modification of flow direction after elapse of a period of time. The rotational capabilities may be provided by low-friction coatings on the internal surface of the stent 1401 and / or external surface of the internal tubular frame 1432 or transitionable occluder 1430. Examples of low friction coatings may include polytetrafluoroethylene (PTFE) or other biocompatible lubricants to reduce friction during rotation. Alternatively, or additionally, micro-patterned surfaces on the internal tubular frame or transitionable occluder 1430 and stent may be designed to minimize contact area and reduce friction during rotation. Magnetic elements or shape memory alloy components may be integrated to initiate and control rotation when activated by temperature, magnets or electrical changes in the environment.

[0179] The system allows for in situ adjustment between antegrade and retrograde flow configurations, adapting to physiological needs overtime. Transition may be based on specific parameters, such as pressure differentials. The device can be implanted using minimally invasive techniques, positioning the shunt to bridge the coronary sinus and left atrium.

[0180] FIG. 12 illustrates a flowchart of a method 1200 for improving cardiac function, consistent with some embodiments of the present disclosure. By way of example only, the method 1200 may be accomplished using any of the example embodiments disclosed herein.

[0181] As shown in step 1202, disclosed embodiments may include implanting a shunt bridging a coronary sinus and a left atrium. For example, the implanted shunt may establish and maintain a flow path between the left atrium and the coronary sinus. In some embodiments, implanting the shunt may occur prior to implanting an occluder. For example, the shunt may be implanted prior to implanting an upstream occluder, a downstream occluder, or a transitionable occluder. In some embodiments, implanting the shunt may occur after implanting an occluder. For example, the shunt may be implanted after implanting an upstream occluder, a downstream occluder, or a transitionable occluder.

[0182] As shown in step 1204, disclosed embodiments may include directing antegrade blood flow in the coronary sinus from the left atrium toward the right atrium. In some embodiments, directing antegrade blood flow in the coronary sinus from the left atrium toward the right atrium may include progressively restricting blood flow over time. For example, an occluder may initially form a partial occlusion in a coronary sinus and, over time, may gradually increase a restriction of blood flow in an antegrade flow direction until the occluder forms a full occlusion in the coronary sinus.

[0183] As shown in step 1206, disclosed embodiments may include, after a period of elapsed time, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrium blood flow in the coronary sinus away from the right atrium. In some embodiments, the period of elapsed time may span weeks. In some embodiments, the period of elapsed time may span months. In some embodiments, the period of days may span years.

[0184] In some embodiments, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes abating a first restriction. In some embodiments, abating the first restriction may include forming a limited passageway in an implanted occluder. In some embodiments, abating the first restriction may include dilating the implanted occluder via the limited passageway. In some embodiments, dilating the implanted occluder may include passing a wire through the implanted occluder to form a limited passageway. In some embodiments, dilating the implanted occluder may include passing a balloon through the limited passageway. In some embodiments, dilating the implanted occluder may include inflating the balloon.

[0185] In some embodiments, abating the first restriction may include permanently maintaining the dilated implanted occluder against a wall of the coronary sinus. In some embodiments, maintaining the dilated implanted occluder against the wall of the coronary sinus may include expanding a stent to hold the dilated implanted occluder in a compressed state.

[0186] In some embodiments, abating the first restriction may include removing a first occluder from the coronary sinus. In some embodiments, removing the first occluder may occur using a stent retriever.

[0187] In some embodiments, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus occurs after confirming that a heart chamber pressure is greater than a venous pressure. In some embodiments, a heart chamber pressure or a venous pressure may be derived from a direct measurement of a hemodynamic parameter. In some embodiments, a heart chamber pressure or a venous pressure may be derived from an indirect measurement of a hemodynamic parameter.

[0188] In some embodiments, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves piercing, removing, permitting biodegradation, or transitioning of an implanted occluder.

[0189] In some embodiments, method 1200 may further comprise implanting an occluder before implanting the shunt. For example, an occluder located upstream the shunt, an occluder located downstream the shunt, or a transitionable occluder may be implanted before implanted the shunt. In some embodiments, method 1200 may further comprise implanting an occluder after implanting the shunt. For example, an occluder located upstream the shunt, an occluder located downstream the shunt, or a transitionable occluder may be implanted after implanted the shunt.

[0190] Also disclosed herein are the following clauses:Clause 1. A system for altering blood flow direction in a coronary sinus shunted from a left atrium, the system comprising: a tool configured to pierce and cross a first implanted occluder disposed in the coronary sinus, the tool configured to form a limited passageway through the first implanted occluder when the first implanted occluder is located on an upstream side of a shunt bridging the coronary sinus and the left atrium and when, prior to piercing, the first implanted occluder and the shunt cooperate to enable flow of blood in an antegrade direction from the left atrium to a right atrium via the coronary sinus, and to restrict retrograde flow in the coronary sinus beyond the first implanted occluder;an expander configured for delivery into the limited passageway through the first implanted occluder and for expansion within the limited passageway to compress the first implanted occluder against a wall of the coronary sinus, thereby transforming the limited passageway into a dilated opening; a retainer, configured to permanently maintain the dilated opening by holding 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, wherein the second occluder is configured to cooperate with the shunt to cause retrograde flow from the left atrium in the coronary sinus and to restrict antegrade flow in the coronary sinus downstream of the second occluder.Clause 2. The system of clause 1, wherein the tool includes a wire configured to pierce the first implanted occluder.Clause 3. The system of clause 1 or 2, wherein the tool includes a catheter configured to pierce the first implanted occluderClause 4. The system of any one of clauses 1-3, wherein the expander includes an inflatable balloon.Clause 5. The system of any one of clauses 1 -4, wherein the expander includes a self-expanding stent.Clause 6. The system of any one of clauses 1-5, wherein the retainer includes a stent.Clause 7. The system of clause 6, wherein the stent is balloon expandable.Clause 8. The system of any one of clauses 1-7, wherein the expander and the retainer are combined in one of a balloon expandable stent or a self-expandable stent.Clause 9. The system of any one of clauses 1-8, wherein the second occluder is expandable.Clause 10. The system of any one of clauses 1-9, wherein the second occluder is integrated with a stent.Clause 11. The system of any one of clauses 1-10, wherein the tool, the expander, the retainer, and the second occluder are provided as a kit.Clause 12. A method for improving cardiac function, the method comprising: implanting a first occluder in a coronary sinus in a first occluder region proximate a left atrium to impose a first restriction on antegrade blood flow in the coronary sinus; implanting downstream of the first occluder region, a shunt bridging the coronary sinus and a left atrium, thereby establishing a first flow path relieving pressure in the left atrium by directing blood from the left atrium to the right atrium via the coronary sinus; maintaining the first flow path for a period of days; andfollowing the period of days: abating the first restriction; and after abating the first restriction, implanting a second occluder in the coronary sinus in a second occluder region downstream of the shunt, to impose a second restriction on antegrade blood flow in the coronary sinus and thereby establishing a second flow path of retrograde flow from the left atrium in the coronary sinus.Clause 13. The method of clause 12, wherein the period of days spans weeks.Clause 14. The method of clause 12 or 13, wherein the period of days spans months.Clause 15. The method of any one of clauses 12-14, wherein abating the first restriction includes forming a limited passageway in the first occluder, dilating the first occluder via the limited passageway, and permanently maintaining the dilated first occluder against a wall of the coronary sinus.Clause 16. The method of clause 15, wherein dilating the first occluder includes passing a wire through the first occluder to form a limited passageway, passing a balloon through the limited passageway, and inflating the balloon.Clause 17. The method of clause 15 or 16, wherein maintaining the dilated first occluder against a wall of the coronary sinus includes expanding a stent to hold the first occluder in a compressed state.Clause 18. The method of any one of clauses 12-17, wherein abating the first restriction includes removing the first occluder from the coronary sinus.Clause 19. The method of clause 18, wherein removing the first occluder occurs using a stent retriever.Clause 20. The method of any one of clauses 12-19, wherein implanting the first occluder occurs before implanting the shunt.Clause 21. The method of any one of clauses 12-19, wherein implanting the first occluder occurs after implanting the shunt.Clause 22. The method of any one of clauses 12-21, wherein abating occurs after confirming that a heart chamber pressure is greater than a venous pressure.Clause 23. The method of any one of clauses 12-22, wherein the first occluder is configured to progressively restrict blood flow overtime.Clause 24. The method of any one of clauses 12-23, wherein abating the first restriction involves piercing, removing, permitting biodegradation, or transitioning of the first occluder.Clause 25. The method of any one of clauses 12-24, wherein implanting the shunt occurs prior to implanting the first occluder.Clause 26. The method of any one of clauses 12-24, wherein implanting the shunt occurs after implanting the first occluder.Clause 27. A method for improving cardiac function, the method comprising: implanting a shunt bridging a coronary sinus and a left atrium; directing antegrade blood flow in the coronary sinus from the left atrium toward a right atrium; and after a period of elapsed time, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrium blood flow in the coronary sinus away from the right atrium.Clause 28. The method of clause 27, wherein the period of elapsed time spans weeks.Clause 29. The method of clause 27 or 28, wherein the period of elapsed time spans months.Clause 30. The method of any one of clauses 27-29, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes abating a first restriction. Clause 31. The method of clause 30, wherein abating the first restriction includes forming a limited passageway in an implanted occluder, dilating the implanted occluder via the limited passageway, and permanently maintaining the dilated implanted occluder against a wall of the coronary sinus.Clause 32. The method of clause 31, wherein dilating the implanted occluder includes passing a wire through the implanted occluder to form a limited passageway, passing a balloon through the limited passageway, and inflating the balloon.Clause 33. The method of clause 31 or 32, wherein maintaining the dilated implanted occluder against the wall of the coronary sinus includes expanding a stent to hold the dilated implanted occluder in a compressed state.Clause 34. The method of any one of clauses 30-33, wherein abating the first restriction includes removing a first occluder from the coronary sinus.Clause 35. The method of clause 34, wherein removing the first occluder occurs using a stent retriever.Clause 36. The method of any one of clauses 27-35, further comprising: implanting an occluder before implanting the shunt.Clause 37. The method of any one of clauses 27-36, further comprising: implanting an occluder after implanting the shunt.Clause 38. The method of any one of clauses 27-37, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus occurs after confirming that a heart chamber pressure is greater than a venous pressure.Clause 39. The method of any one of clauses 27-38, wherein directing antegrade blood flow in the coronary sinus from the left atrium toward the right atrium includes progressively restricting blood flow over time.Clause 40. The method of any one of clauses 27-39, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves piercing, removing, permitting biodegradation, or transitioning of an implanted occluder.Clause 41. The method of any one of clauses 27-40, wherein implanting the shunt occurs prior to implanting an occluder.Clause 42. The method of any one of clauses 27-41, wherein implanting the shunt occurs after implanting an occluder.Clause 43. A device for selectively directing flow in a coronary sinus adjacent a left atrium, the device comprising: a shunt configured to bridge the left atrium and the coronary sinus; and an occluder selectively positionable between a first antegrade flow deflecting position and a second retrograde flow deflecting position, wherein in the first antegrade flow deflecting position, the occluder is configured to direct flow in the coronary sinus from the left atrium in a first direction toward a right atrium, and in the second retrograde flow deflecting position, the occluder is configured to direct flow in the coronary sinus from the left atrium in a second direction away from the right atrium, and wherein the occluder is adjustable in situ to selectively change flow direction in the coronary sinus.Clause 44. An intravascular medical device or kit for controlled change in the direction of shunted blood flow within a stent comprising: i) a stent extending between a proximal and distal end and defined by a stent wall being sized and shaped to engage a blood vessel wall, said stent wall comprising a primary orifice defined by a perimeter edge, said primary orifice positioned between a proximal end and a distal end of the stent; ii) a shunt defining a central passage, said shunt extending outwards from the perimeter edge towards a first cavity in an organ; and iii) an occluder adapted to engage the stent wall and at least partially restrict a blood flow therethrough, wherein the occluder has a first configuration and a second configuration such that, in the first configuration, the occluder directs an extension of the central passage of the shunt towards a proximal end of the stent; and in a second configuration, the occluderdirects an extension of the central passage of the shunt in an opposing direction towards a distal end of the stent.Clause 45. The intravascular medical device or kit of clause 44, wherein the occluder is adapted to transition between a first configuration and a second configuration.Clause 46. The intravascular medical device or kit of clause 44 or 45, wherein the occluder is adapted to engage the stent wall from within and having an occluding surface positioned between a proximal end and a distal end of the stent.Clause 47. The intravascular medical device or kit of clause 45 or 46, wherein the shunt and stent are configured to be stationary during the transition between a first and second configuration.Clause 48. The intravascular medical device or kit of any one of clauses 45-47, wherein the occluder is adapted to transition between a first configuration and a second configuration such that, in the first configuration, a shunt proximate engagement of the occluder is distal to the primary orifice and in the second configuration, a shunt proximate engagement of the occluder is proximal to the primary orifice.Clause 49. The intravascular medical device or kit of any one of clauses 44-48, wherein in the first configuration, the occluder is configured to direct a first flow direction, and in the second configuration, the occluder is configured to direct a second or opposing flow direction.Clause 50. The intravascular medical device or kit of any one of clauses 44-49, wherein said primary orifice has a longest dimension in a range of 3 to 12 mm.Clause 51. The intravascular medical device or kit of any one of clauses 44-50, wherein the first configuration is transiently stable within the blood vessel.Clause 52. The intravascular medical device or kit of clause 51, wherein the second configuration is stable within the blood vessel for more than half a year.Clause 53. The intravascular medical device or kit of any one of clauses 44-52, wherein the occluder is adapted to transition sequentially in a single direction.Clause 54. The intravascular medical device or kit of any one of clauses 45-53, wherein the occluder is adapted to transition from a first configuration to a second configuration and is further adapted to transition from the second configuration to the first configuration.Clause 55. The intravascular medical device or kit of any one of clauses 44-54, wherein the occluder is adapted to mechanically transition between a first configuration and a second configuration.Clause 56. The intravascular medical device or kit of any one of clauses 44-55, wherein the occluder is adapted to transition by an automatic transition.Clause 57. The intravascular medical device or kit of any one of clauses 44-56, wherein the occluder is adapted to transition via rotation around a longitudinal axis of the stent between a first and second configuration.Clause 58. The intravascular medical device or kit of any one of clauses 44-57, wherein the occluder includes a coupling element adapted to couple or decouple from the shunt or the stent. Clause 59. The intravascular medical device or kit of any one of clauses 44-58, wherein the occluding surface in the first configuration is distinct from the occluding surface of the second configuration.Clause 60. The intravascular medical device or kit of any one of clauses 44-59, wherein the occluder is a single component in each of the first and the second configurations.Clause 61. The intravascular medical device or kit of any one of clauses 44-60, wherein the occluder is adapted to engage the stent with a planar engagement in both a first configuration and a second configuration.Clause 62. The intravascular medical device or kit of clause 61, wherein the planar engagement is orthogonal to a longitudinal axis of the stent.Clause 63. The intravascular medical device or kit of any one of clauses 44-62, wherein the occluding surface is curved.Clause 64. The intravascular medical device or kit of clause 63, wherein the occluding surface is adapted to transition between a degree of curvature or direction of curve.Clause 65. The intravascular medical device or kit of any one of clauses 45-64, wherein the occluder is adapted to transition between two longitudinal positions within the stent between the proximal and distal end.Clause 66. The intravascular medical device or kit of any one of clauses 44-65, wherein the occluder is a conformable sheet radially traversing the stent.Clause 67. The intravascular medical device or kit of any one of clauses 44-66, wherein the occluder is substantially impermeable to blood.Clause 68. The intravascular medical device or kit of any one of clauses 44-67, wherein the occluder is adapted to decrease permeability to blood over time.Clause 69. The intravascular medical kit of any one of clauses 44-68, wherein the occluder in its first or anterograde-flow configuration includes a puncturable or removable surface.Clause 70. The intravascular medical device or kit of any one of clauses 44-69, further comprising an over tube adapted for delivery to a coronary sinus.Clause 71. The intravascular medical device of any one of clauses 44-70, wherein the intravascular medical device is adapted to be contracted in an over tube for percutaneousdelivery via a coronary sinus and to expand after deployment from an over tube. 29. The intravascular medical device or kit of any one of claims 1 to 28, wherein the stent includes a coupling element adapted to couple or decouple from the occluder.Clause 72. The intravascular medical device or kit of any one of clauses 44-71, wherein the shunt further comprises a stabilizer configured to stabilize the shunt. 31. The intravascular medical device or kit of any one of claims 1 to 30, wherein the shunt and the occluder are integrally formed.Clause 73. The intravascular medical device or kit of any one of clauses 44-72, wherein the shunt and the occluder are two parts.Clause 74. The intravascular medical device or kit of any one of clauses 44-73, wherein the shunt includes a coupling element adapted to couple or decouple from the occluder.Clause 75. The intravascular medical device or kit of any one of clauses 44-74, wherein the shunt includes a time-delayed opening or pressure-based valve.Clause 76. The intravascular medical device or kit of any one of clauses 44-75, wherein the shunt is adapted to inhibit excessive tissue ingrowth within the central passage of the shunt.Clause 77. The intravascular medical device or kit of any one of clauses 44-76, wherein the shunt defines a central passage extending from a coronary sinus to a left atrium to permit passage of blood from the left atrium via the shunt to the coronary sinus.Clause 78. A method of controlling a change in direction of shunted blood flow within a stent comprising: a) puncturing a hole through a target vein-heart chamber-juncture and inserting a shunt having a central passage therethrough; b) providing a stent comprising an occluder having a first or anterograde-flow configuration; and c) transitioning to a second or retrograde-flow configuration of an occluder after a predefined period of time or upon confirmation that a heart chamber pressure is greater than a vein pressure (Pressureheart chamber > Pressureblood vessel).Clause 79. The method of clause 78, wherein the vein-heart juncture is a coronary sinus-left atrium juncture.Clause 80. The method of clause 78 or 79, wherein an occluding surface in the second configuration gradually increases an extent of blood flow restriction overtime.Clause 81. The method of any one of clauses 78-80, wherein puncturing a hole through a target vein-heart-juncture is prior to transitioning between the first or anterograde-flow configuration and a retrograde-flow configuration of an occluder.Clause 82. The method of any one of clauses 78-81, wherein transitioning to a retrograde-flow configuration of an occluder is prior to puncturing a hole through a target vein-heart-juncture. Clause 83. The method of any one of clauses 78-82, wherein transitioning to a retrograde-flow configuration of an occluder is by replacing a punctured first occluding surface with a second occluding surface.Clause 84. The method of any one of clauses 78-83, wherein transitioning between the first or anterograde-flow configuration and a retrograde -flow configuration of an occluder is via a rotation of the stent around a central axis of the stent.Clause 85. The method of any one of clauses 78-84, wherein transitioning between the first or anterograde-flow configuration and a retrograde -flow configuration of an occluder is via a manual release of a coupling element between the stent and the occluder.Clause 86. The method of any one of clauses 78-85, wherein transitioning to a second configuration of an occluder is upon confirmation that the heart chamber pressure is greater than a coronary sinus or great cardiac vein pressure.Clause 87. The method of any one of clauses 78-86, wherein transitioning to a second configuration of an occluder is upon confirmation that a left atrium pressure is greater than a coronary sinus or great cardiac vein pressure.Clause 88. The method of any one of clauses 78-87, wherein the change in direction is from antegrade to retrograde within a blood vessel.Clause 89. The method of any one of clauses 85-88, wherein puncturing a hole through a target vein-heart-juncture is connecting between a heart chamber having a higher blood pressure than a blood pressure in the vein.Clause 90. The method of any one of clauses 85-89, wherein puncturing a hole through a target vein-heart-juncture connects a heart chamber with oxygenated blood and a vein with deoxygenated blood.

[0191] Disclosed embodiments may include any one of the following bullet-pointed features alone or in combination with one or more other bullet-pointed features, whether implemented as a system, device, and / or method.• a system for altering blood flow direction in a coronary sinus shunted from a left atrium• a tool configured to pierce and cross a first implanted occluder in a coronary sinus• a first implanted occluder and a shunt bridging a coronary sinus and a left atrium• a tool configured to form a limited passageway through a first implanted occluder when the first implanted occluder is located on an upstream side of a shunt bridging a coronary sinus and a left atrium• a first implanted occluder and a shunt cooperating to enable flow of blood in an antegrade direction from the left atrium to a right atrium via the coronary sinus• a first implanted occluder and a shunt cooperating to retrograde flow in the coronary sinus beyond the first implanted occluder• an expander• an expander configured for delivery into a limited passageway through a first implanted occluder• an expander configured for expansion within an initial passageway to compress a first implanted occluder against a wall of a coronary sinus, thereby transforming the limited passageway into a dilated opening• a retainer• a retainer configured to permanently maintain a dilated opening by holding a compressed first implanted occluder against a wall of a coronary sinus• a second occluder• a second occluder configured for implantation on a downstream side of a shunt in a coronary sinus• a second occluder configured to cooperate with a shunt to cause retrograde flow from a left atrium in a coronary sinus• a second occluder configured to cooperate with a shunt to restrict antegrade flow in a coronary sinus downstream of a second occluder• a tool including a wire configured to pierce a first implanted occluder• a tool including a catheter configured to pierce a first implanted occluder• an expander including an inflatable balloon• an expander including a self-expanding stent• a retainer including a stent o a stent is balloon expandable• an expander and a retainer combined in a balloon expandable stent• an expander and a retainer combined in a self-expandable stent• a second occluder is expandable• a second occluder integrated with a stent• a tool, an expander, a retainer, and a second occluder provided as a kit• a tool, a combined expander and retainer, and a second occluder provided as a kit• a method for improving cardiac function• implanting a first occluder in a coronary sinus in a first occluder region proximate a left atrium to impose a first restriction on antegrade blood flow in the coronary sinus and implanting downstream of a first occluder region, a shunt bridging a coronary sinus and a left atrium, thereby establishing a first flow path relieving pressure in the left atrium by directing blood from the left atrium to a right atrium via the coronary sinus• maintain a first flow path for a period of days• following a period of days, abating a first restriction• after abating a first restriction, implanting a second occluder in a coronary sinus in a second occluder region downstream of a shunt, to impose a second restriction on antegrade blood flow in the coronary sinus and thereby establishing a second flow path of retrograde flow from a left atrium in the coronary sinus• a period of days spanning weeks• a period of days spanning months• abating a first restriction including forming a limited passageway in a first occluder• abating a first restriction including dilating a first occluder via a limited passageway• abating a first restriction including permanently maintaining a dilated first occluder against a wall of a coronary sinus• dilating a first occluder including passing a wire through a first occluder to form a limited passageway• dilating a first occluder including passing a balloon through a limited passageway• dilating a first occluder including inflating a balloon• abating a first restriction including removing a first occluder from a coronary sinus• removing a first occluder occurring using a stent retriever• implanting a first occluder occurs before implanting a shunt and prior to an elapsed time spanning days• implanting a first occluder occurs after implanting a shunt and prior to an elapsed time spanning days• abating a first restriction occurring after confirming that a heart chamber pressure is greater than a venous pressure• a first occluder configured to progressively restrict blood flow over time• abating a first restriction involving piercing of a first occluder• abating a first restriction involving removing of a first occluder• abating a first restriction involving permitting biodegradation of a first occluder• abating a first restriction involving transitioning of a first occluder• implanting a shunt prior to implanting a first occluder and prior to an elapsed time spanning days• implanting a shunt after implanting a first occluder and prior to an elapsed time spanning days• implanting a shunt bridging a coronary sinus and a left atrium prior to an elapsed time spanning days• directing antegrade blood flow in a coronary sinus from a left atrium toward a right atrium• after a period of elapsed time, changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrium blood flow in the coronary sinus away from a right atrium.• a period of elapsed time spanning weeks• a period of elapsed time spanning months• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus including abating a first restriction• abating a first restriction including forming a limited passageway in an implanted occluder• abating a first restriction including dilating an implanted occluder via a limited passageway• abating a first restriction including permanently maintaining a dilated implanted occluder against a wall of a coronary sinus• dilating an implanted occluder including passing a wire through the implanted occluder to form a limited passageway• dilating an implanted occluder including passing a balloon through a limited passageway• dilating an implanted occluder including inflating a balloon• maintaining a dilated implanted occluder against a wall of a coronary sinus including expanding a stent to hold the dilated implanted occluder in a compressed state• abating a first restriction including removing a first occluder from a coronary sinus• removing the first occluder occurring using a stent retriever• implanting an occluder before implanting a shunt and prior to an elapsed time spanning days• implanting an occluder after implanting a shunt and prior to an elapsed time spanning days• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus occurring after confirming that a heart chamber pressure is greater than a venous pressure• directing antegrade blood flow in a coronary sinus from a left atrium toward a right atrium including progressively restricting blood flow over time• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus involves piercing of an implanted occluder• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus involves removing of an implanted occluder• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus involves permitting biodegradation of an implanted occluder• changing antegrade flow in a coronary sinus to retrograde flow in the coronary sinus involves transitioning of an implanted occluder• implanting a shunt occurring prior to implanting a first occluder and prior to a period of elapsed time• implanting a shunt occurring after implanting a first occluder and prior to a period of elapsed time• a device for selectively directing flow in a coronary sinus adjacent a left atrium• a shunt configured to bridge the left atrium and the coronary sinus and an occluder• an occluder selectively positionable between a first antegrade flow deflecting position and a second retrograde flow deflecting position• in a first antegrade flow deflecting position, an occluder configured to direct flow in a coronary sinus from a left atrium in a first direction toward a right atrium• in a second retrograde flow deflecting position, an occluder configured to direct flow in a coronary sinus from a left atrium in a second direction away from a right atrium• an occluder adjustable in situ to selectively change flow direction in a coronary sinus

[0192] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examplesbe considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.

Claims

CLAIMSWhat is claimed is:

1. A system for altering blood flow direction in a coronary sinus shunted from a left atrium, the system comprising: a tool configured to pierce and cross a first implanted occluder disposed in the coronary sinus, the tool configured to form a limited passageway through the first implanted occluder when the first implanted occluder is located on an upstream side of a shunt bridging the coronary sinus and the left atrium and when, prior to piercing, the first implanted occluder and the shunt cooperate to enable flow of blood in an antegrade direction from the left atrium to a right atrium via the coronary sinus, and to restrict retrograde flow in the coronary sinus beyond the first implanted occluder; an expander configured for delivery into the limited passageway through the first implanted occluder and for expansion within the limited passageway to compress the first implanted occluder against a wall of the coronary sinus, thereby transforming the limited passageway into a dilated opening; a retainer, configured to permanently maintain the dilated opening by holding 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, wherein the second occluder is configured to cooperate with the shunt to cause retrograde flow from the left atrium in the coronary sinus and to restrict antegrade flow in the coronary sinus downstream of the second occluder.

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

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

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

5. The system of any one of claims 1-4, wherein the expander includes a self-expanding stent.

6. The system of any one of claims 1-5, wherein the retainer includes a stent.

7. The system of claim 6, wherein the stent is balloon expandable.

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

9. The system of any one of claims 1-8, wherein the second occluder is expandable.

10. The system of any one of claims 1-9, wherein the second occluder is integrated with a stent.

11. The system of any one of claims 1-10, wherein the tool, the expander, the retainer, and the second occluder are provided as a kit.

12. A method for improving cardiac function, the method comprising: implanting a first occluder in a coronary sinus in a first occluder region proximate a left atrium to impose a first restriction on antegrade blood flow in the coronary sinus; implanting downstream of the first occluder region, a shunt bridging the coronary sinus and a left atrium, thereby establishing a first flow path relieving pressure in the left atrium by directing blood from the left atrium to a right atrium via the coronary sinus; maintaining the first flow path for a period of days; and following the period of days: abating the first restriction; and after abating the first restriction, implanting a second occluder in the coronary sinus in a second occluder region downstream of the shunt, to impose a second restriction on antegrade blood flow in the coronary sinus and thereby establishing a second flow path of retrograde flow from the left atrium in the coronary sinus.

13. The method of claim 12, wherein the period of days spans weeks.

14. The method of claim 12 or 13, wherein the period of days spans months.

15. The method of any one of claims 12-14, wherein abating the first restriction includes forming a limited passageway in the first occluder, dilating the first occluder via the limited passageway, and permanently maintaining the dilated first occluder against a wall of the coronary sinus.

16. The method of claim 15, wherein dilating the first occluder includes passing a wire through the first occluder to form a limited passageway, passing a balloon through the limited passageway, and inflating the balloon.

17. The method of claim 15 or 16, wherein maintaining the dilated first occluder against a wall of the coronary sinus includes expanding a stent to hold the first occluder in a compressed state.

18. The method of any one of claims 12-17, wherein abating the first restriction includes removing the first occluder from the coronary sinus.

19. The method of claim 18, wherein removing the first occluder occurs using a stent retriever.

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

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

22. The method of any one of claims 12-21, wherein abating occurs after confirming that a heart chamber pressure is greater than a venous pressure.

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

24. The method of any one of claims 12-23, wherein abating the first restriction involves piercing, removing, permitting biodegradation, or transitioning of the first occluder.

25. A method for improving cardiac function, the method comprising: implanting a shunt bridging a coronary sinus and a left atrium; directing antegrade blood flow in the coronary sinus from the left atrium toward a right atrium; and after a period of elapsed time, changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus, thereby directing left atrium blood flow in the coronary sinus away from the right atrium.

26. The method of claim 25, wherein the period of elapsed time spans weeks.

27. The method of claim 25 or 26, wherein the period of elapsed time spans months.

28. The method of any one of claims 25-27, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus includes abating a first restriction.

29. The method of claim 28, wherein abating the first restriction includes forming a limited passageway in an implanted occluder, dilating the implanted occluder via the limited passageway, and permanently maintaining the dilated implanted occluder against a wall of the coronary sinus.

30. The method of claim 29, wherein dilating the implanted occluder includes passing a wire through the implanted occluder to form a limited passageway, passing a balloon through the limited passageway, and inflating the balloon.

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

32. The method of any one of claims 28-32, wherein abating the first restriction includes removing a first occluder from the coronary sinus.

33. The method of claim 32, wherein removing the first occluder occurs using a stent retriever.

34. The method of any one of claims 25-33, further comprising: implanting an occluder before implanting the shunt.

35. The method of any one of claims 25-34, further comprising: implanting an occluder after implanting the shunt.

36. The method of any one of claims 25-35, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus occurs after confirming that a heart chamber pressure is greater than a venous pressure.

37. The method of any one of claims 25-36, wherein directing antegrade blood flow in the coronary sinus from the left atrium toward the right atrium includes progressively restricting blood flow over time.

38. The method of any one of claims 25-37, wherein changing the antegrade flow in the coronary sinus to retrograde flow in the coronary sinus involves piercing, removing, permitting biodegradation, or transitioning of an implanted occluder.

39. The method of any one of claims 25-38, wherein implanting the shunt occurs prior to implanting an occluder.

40. The method of any one of claims 25-39, wherein implanting the shunt occurs after implanting an occluder.

41. A device for selectively directing flow in a coronary sinus adjacent a left atrium, the device comprising: a shunt configured to bridge the left atrium and the coronary sinus; and an occluder selectively positionable between a first antegrade flow position and a second retrograde flow deflecting position, wherein in the first antegrade flow deflecting position, the occluder is configured to direct flow in the coronary sinus from the left atrium in a first direction toward a right atrium, and in the second retrograde flow deflecting position, the occluder is configured to direct flow in the coronary sinus from the left atrium in a second direction away from the right atrium, and wherein the occluder is adjustable in situ to selectively change flow direction in the coronary sinus.

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