Device, system, and method for myocardial revascularization

Abstract

A device, system, and method for revascularization of the myocardium, such as an intravascular medical device, are disclosed for shunting and selectively controlling anatomical fluid flow. A tubular shunt is deployed in a passage between a first organ and a second adjacent organ and is configured to bridge a first cavity of the first organ and a second cavity of the second organ. A stabilizer is configured to stabilize the tubular shunt in the passage. A flow deflector extends from the tubular shunt and has a surface for deflecting flow into the second cavity.

Description

Technology Field

[0001] related Cross-reference regarding the application

[0002] This application is based on U.S. Provisional Patent Application No. 63 / 315,601 (filed March 2, 2022) and U.S. Provisional Patent Application No. 63 / 378,568 (filed October 6, 2022) and claims the benefit of priority thereof, the entire contents of which are incorporated herein by reference.

[0003] Technology field

[0004] The present invention generally relates to the field of cardiac surgery, and more specifically to a device, system, and method for revascularization of the heart. Background Technology

[0005] The primary function of the heart (myocardium) is to pump oxygenated blood throughout the body. The heart contains four chambers—the left and right atria and ventricles—as well as a series of valves and a network of veins and arteries. In a healthy myocardium, blood deoxygenated from the body enters the right atrium via the superior and inferior vena cava. This blood flows into the right ventricle through the tricuspid valve, where it is pumped to the lungs via the pulmonary valve and pulmonary artery to be oxygenated. The oxygenated blood then enters the left atrium from the lungs via the pulmonary vein, where it is pumped to the left ventricle through the mitral valve. The left ventricle pumps this oxygenated blood into the aorta through the aortic valve, from where it is distributed throughout the body via a complex network of arterial blood vessels.

[0006] The superior and inferior vena cava primarily serve to guide deoxygenated blood from the body into the right atrium, whereas the coronary sinus primarily serves to guide venous (i.e., deoxygenated) blood from the blood vessels of the heart tissue into the right atrium. This large cardiac vein originates at the junction of the great heart vein and the left ventricular oblique vein, and is located partially within the posterior interventricular groove between the left atrium and the left ventricle. Tributary veins, including the anterior interventricular vein (AIVV), great heart vein (GVC), and posterior interventricular vein (PIVV), each drain into the coronary sinus. Oxygen saturation (PO2) within the coronary sinus is generally in the range of 10 mmHg to 15 mmHg.

[0007] When oxygen supply to blood vessels within the heart is insufficient as a result of, for example, coronary artery disease, atherosclerosis, and arteriosclerosis, complications including angina, heart attack, and heart failure may occur. Various surgical techniques can be used to alleviate these complications. For example, angioplasty (also known as percutaneous coronary intervention, balloon angioplasty, and coronary balloon dilation) involves surgically widening blocked or narrowed arteries. In this procedure, a surgeon delivers a catheter-balloon system to the site of blockage and inflates the balloon to widen the blocked area and improve blood flow through the artery. A stent can be inserted to prevent the artery from constricting, thereby maintaining blood flow. Surgeons may also use a laser (laser angioplasty) or cutting instruments (arterectomy) to vaporize or cut away the blocked area.

[0008] Another method to correct oxygen deficiency is coronary bypass surgery (also known as coronary artery bypass grafting, or "CABG"). In this procedure, an open heart is used to transplant healthy blood vessels into the heart to recirculate blood around the blocked artery. The grafts can be taken from the patient or a donor, typically derived from one or more of the legs, arms, or chest, depending on the number of grafts required. Complications and recovery times tend to be longer due to the invasive nature of open heart surgery; typically, the surgeon must stop the heart to complete the procedure, and there is an increased risk of infection at both the chest incision site and the graft incision site.

[0009] Another method to correct oxygen deficiency involves perfusing 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. This method can be beneficial when a patient does not respond to or is not eligible for coronary artery bypass surgery or percutaneous coronary intervention. Like TMR, percutaneous myocardial revascularization (PMR) also enables direct myocardial perfusion using surgically created holes, but this procedure tends to be less invasive.

[0010] Another method involves using various stent devices or grafts to send oxygenated blood from the left ventricle to the coronary artery, or to provide retrograde flow of oxygenated blood from the left ventricle to the myocardium through the coronary sinus. The devices, systems, and methods described herein address at least some of the disadvantages of existing reperfusion techniques. These devices, systems, and methods can shorten patient recovery time and improve patient treatment outcomes. Prior art literature

[65535] US 2020 / 0261705 A1 (2020.08.20.)US 2021 / 0154012 A1 (2021.05.27.)US 2006 / 0122554 A1 (2006.06.08.)WO 2021 / 162888 A1 (2021.08.19.)WO 2020 / 215090 A1 (2020.10.22.)

[0011] An embodiment according to the present invention provides a device, system, and method for revascularization of the myocardium.

[0012] Some embodiments include an intravascular medical device for shunting and selectively controlling anatomical fluid flow. An embodiment may include a tubular shunt configured to extend into a passage between a first organ and a second adjacent organ and to bridge a first cavity of the first organ and a second cavity of the second organ. An embodiment may also include a stabilizer configured to stabilize the tubular shunt in the passage. An embodiment may also include a flow deflector having a surface extending from the tubular shunt and deflecting flow into the second cavity. The flow deflector may be configured to extend from a portion less than the entire circumferential edge of the tubular shunt.

[0013] Some embodiments comprise a device as an intravascular retrograde blood flow device, comprising: a catheter; an expanding shunt that is compressed into the catheter and bridges an opening between a first cavity and a second cavity; an expanding flow deflector that is compressed into the catheter and deflects flow into the second cavity; and a flexible hinge interconnecting the expanding shunt and the expanding flow deflector, wherein the flexible hinge is configured to be bent so as to allow for an axial positioning of the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector.

[0014] Some embodiments comprise a medical device for inducing retrograde blood flow, comprising: a tube for delivering to a coronary sinus from a first direction; and an expandable structure compressed into the tube. The expandable structure comprises a scaffold portion for maintaining an orifice between the coronary sinus and the heart chamber, and a flow deflector portion configured to induce retrograde blood flow in the coronary sinus. The flow deflector portion is configured such that, after the tube is withdrawn in the first direction, the flow deflector portion can be deployed in a second direction other than the first direction.

[0015] Some embodiments comprise a device as an intravascular retrograde blood flow device, comprising a tubular shunt portion configured to be deployed in a passage between an organ and an adjacent blood vessel to bridge the cavity of the organ and the interior of the blood vessel, a stabilizer configured to secure the tubular shunt portion in the passage, and a flow deflector portion connected to a proximal end of the tubular shunt portion. The flow deflector is configured to induce blood flow, and a tether interconnects the flow deflector portion and the tubular shunt portion in such a way that the flow deflector portion is positioned at a predetermined distance from the tubular shunt portion in the blood vessel. Brief explanation of the drawing

[0016] The accompanying drawings, which are included in and constitute part of this specification, illustrate the disclosed embodiments and serve to explain the disclosed embodiments together with the description portion. The details illustrated are provided by way of example and are provided for an exemplary discussion of the embodiments of the invention. The description taken together with the drawings clearly shows those skilled in the art the manner in which the embodiments of the invention can be practiced. FIG. 1A is a front view of an example of an intravascular medical device according to some embodiment of the present invention. FIG. 1B is a side view of the device of FIG. 1A. FIG. 1C is a bottom view of the device of FIG. 1A. FIG. 1D is a perspective view of the device of FIG. 1A. FIG. 2 is a side view of the device of FIG. 1A unfolded between biological organs according to some embodiment of the present invention. FIG. 3A is a front view of the device of FIG. 1A including a flexible cover according to some embodiment of the present invention. FIG. 3B is a side view of the covered device shown in FIG. 3A. FIG. 3C is a bottom view of the covered device shown in FIG. 3A. FIG. 3D is a perspective view of the covered device shown in FIG. 3A. FIG. 4 graphically illustrates an exemplary process of deploying an intravascular medical device between biological organs according to some embodiments of the present invention. FIG. 5 is a flowchart of a process for shunting and deflecting blood flow between biological organs according to some embodiments of the present invention. FIG. 6 illustrates an exemplary arrangement for deploying an intravascular medical device between biological organs of the heart according to some embodiments of the present invention. FIG. 7 is a side view of an exemplary extended frame having a drum-shaped flow deflector frame according to some embodiments of the present invention. FIG. 8A is a perspective view of the extended frame of FIG. 6.1 illustrating a drum-shaped cover having a drum-shaped flow deflector frame. FIG. 8B is a side view of another extended frame having a concave flow deflector cover according to some embodiments of the present invention. FIG. 8C is a side view of an alternative extended frame having an integrated shunt portion and a flow deflector portion according to some embodiments of the present invention. FIG. 8D is a side view of another alternative extended frame having an integrated shunt portion and a flow deflector portion according to some embodiments of the present invention. FIG. 9 is a flowchart of an exemplary method for inducing intravascular retrograde blood flow according to some embodiments of the present invention. FIG. 10 illustrates another view of an example of a flow deflection portion including a tool passage according to some embodiments of the present invention. FIG. 11 illustrates an additional view of the extended frame of FIG. 8B according to some embodiments of the present invention. FIG. 12 is a perspective view of an exemplary medical device for inducing retrograde blood flow according to some embodiments of the present invention. FIG. 13 is a schematic diagram of a medical device unfolded between a cardiac chamber and a generalized depiction of a coronary sinus to induce retrograde blood flow according to some embodiments of the present invention. FIG. 14A is a side view of the medical device disclosed in FIG. 13. FIG. 14B is a perspective view of the medical device of FIG. 13. FIG. 15 is a flowchart of an exemplary method for inducing retrograde blood flow according to some embodiments of the present invention. FIG. 16 is a cross-sectional view of a human heart having an exemplary intravascular retrograde blood flow device deployed in the heart according to some embodiments of the present invention. FIG. 17 is a schematic diagram of an exemplary intravascular retrograde blood flow device deployed between a heart chamber and a coronary sinus according to some embodiments of the present invention. FIG. 18 is a perspective view of another exemplary intravascular retrograde blood flow device according to some embodiments of the present invention. FIG. 19 is a side view of an additional exemplary embodiment of an intravascular retrograde blood flow device according to some embodiments of the present invention. FIG. 20 is a perspective view of an additional exemplary embodiment of an intravascular retrograde blood flow device according to some embodiments of the present invention. FIG. 21 is a flowchart of an exemplary method for inducing intravascular retrograde blood flow according to some embodiments of the present invention. Specific details for implementing the invention

[0017] Exemplary embodiments are described with reference to the accompanying drawings. The drawings are not necessarily drawn to scale. While examples and features of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Furthermore, the words “comprising,” “having,” “containing,” “comprising,” and other similar terms are intended to be open-ended terms in that they are equivalent in meaning and that the items or items following any of these words are not intended to be a complete list of such items or to be limited only to the listed items or items. It should also be noted that the singular and “the above” elements used in this specification and the appended claims include plural elements unless the context clearly indicates otherwise. Furthermore, relational terms such as “first” and “second” in this specification are used merely to distinguish an object or task from another object or task and do not require or imply any actual relationship or order between such objects or tasks.

[0018] As used herein, the term “or” includes all possible combinations except where not feasible, unless specifically stated otherwise. For example, if it is stated that a component may include A or B, the component may include A or B or A and B, except where specifically stated otherwise or not feasible. As a second example, if it is stated that a component may include at least one of A, B, or C, the component may include A, B, or C or A and B or A and C or B and C or A, B, and C, except where specifically stated otherwise or not feasible.

[0019] The present invention uses open language to indicate, for example, that some embodiments may use, relate to, or include a specific feature. The use of the term "may" and other open language is intended to indicate that not all embodiments use the specific disclosed feature, but at least one embodiment uses the specific disclosed feature.

[0020] Various working examples are provided in the following description for illustrative purposes. However, it should be understood that the present invention may be practiced without one or more of these details. We will now refer in detail to non-limiting examples of the present invention, which are illustrated in the accompanying drawings. Examples are described below with reference to the drawings, wherein the same reference numerals denote the same elements. Where similar reference numerals are shown, the corresponding description(s) are not repeated, and interested readers may refer to the previously discussed drawings for descriptions of the same elements(s).

[0021] Embodiments of the present invention relate to an intravascular medical device comprising an intravascular medical device for shunting and selectively regulating anatomical fluid flow. As used herein, an intravascular medical device may refer to any device or apparatus configured to be placed within or to operate within a blood vessel or other biological structure or organ in the human body for medical purposes. In the disclosed embodiments, the biological structure may include a hollow anatomical feature within the body of a patient. Non-limiting examples of biological structures include blood vessels, capillaries, arteries, veins, cardiac chambers (e.g., left atrium, left ventricle, right atrium, right ventricle), or any other anatomical organ. The intravascular medical device may be configured to be delivered from a first location (e.g., a location outside the body) to a treatment site within the blood vessel or other biological structure. Additionally or alternatively, in some embodiments, the intravascular medical device may be configured to induce a temporary or permanent change or deformation at the intravascular treatment site. Some non-limiting examples of the intravascular medical device according to the present invention may include a shunt, stent, catheter, or any other device configured to be placed within a blood vessel or other biological structure.

[0022] Embodiments of the present invention generally relate to medical devices, methods, and systems for shunting blood between two organs. In some embodiments, blood flow from the heart chamber is shunted to the coronary sinus to induce retrograde flow in the coronary sinus as a mechanism for treating heart disease.

[0023] As a non-limiting example, an intravascular medical device for inducing retrograde coronary sinus blood flow may include a tubular shunt to bridge the coronary sinus with a cardiac chamber, such as the left atrium or left ventricle, to induce oxygen-rich retrograde blood flow in the coronary sinus. Oxygenated blood flowing "backward" in the coronary sinus can result in oxygen supply to heart tissues, whereas otherwise, heart tissues may not receive sufficient blood flow. A flow deflector positioned in the coronary sinus can help induce retrograde blood flow and may prevent or at least partially obstruct flow to other biological structures, such as the right atrium.

[0024] An intravascular medical device according to an embodiment of the present invention may include a tubular shunt. As used herein, the tubular may relate to a structural part having a wall or outer wall that defines an intermediate channel regardless of the contour of the intermediate channel. As used herein, the shunt may represent any structural part capable of bridging two biological structures, such as a heart chamber and a blood vessel. For example, the tubular shunt may be configured to extend into a passage between a first organ and a second adjacent organ. As used herein, the extension may relate to the location or placement of the intravascular medical device within the body. Furthermore, the passage may represent a channel or opening through which a fluid, such as blood, can flow. The passage may be formed by a pre-cut opening. Furthermore, in some embodiments, the tubular shunt may be configured to extend into a first cavity of the first organ and a second cavity of the second organ. Extending into a first cavity of the first organ and a second cavity of the second organ may include providing a structural part capable of allowing fluid to flow between the first cavity and the second cavity. The first organ and the second organ are considered to be any biological organ, including but not limited to blood vessels, anatomical cavities and / or anatomical chambers. Furthermore, the shunt may divert the flow of body fluids, which is described in more detail herein.

[0025] FIGS. 1A through 1D illustrate various views of an example of an intravascular medical device (11) for shunting and selectively controlling anatomical fluid flow according to some embodiments of the present invention. As illustrated in FIGS. 1A through 1D, the intravascular medical device (11) may include a tubular shunt (110). The tubular shunt (110) may be tubular or annular in shape and may form a central opening (114) that defines a passage adapted to allow fluid flow from one end of the passage to the other end of the passage. Thus, the tubular shunt (110) may be configured to extend into a passage between an organ (e.g., left atrium) and an adjacent blood vessel (e.g., coronary sinus) to bridge the cavity of the organ with the interior or lumen of the blood vessel.

[0026] In some embodiments, the tubular shunt may comprise a tubular wall having at least one opening inside. The tubular wall may be formed of wire, wire mesh, strut, rib, or other material capable of scaffolding a passage. One or more openings in the wall may be gaps between strands of wire, wire mesh, strut, rib, or other material. For example, as illustrated in FIGS. 1A through 1D, the tubular shunt (110) may comprise a tubular wall having a series of openings (112). It is considered that the tubular wall may have any number of openings based on design considerations.

[0027] Furthermore, the tubular shunt (110) may include a central opening (114) and thus maintain an orifice through a pre-cut hole between the heart chamber (e.g., left atrium or left ventricle) and an adjacent organ (e.g., a blood vessel such as a vein including a coronary sinus). The pre-cut hole may have been formed as part of the implantation process or in a prior procedure before deploying the intravascular device to the desired deployment location. In some embodiments, the inner diameter of the central opening (114) in the expanded state may be less than 10 mm, less than 8 mm, less than 6 mm, or between 10 mm and 5 mm, or between 7 mm and 9 mm.

[0028] FIG. 2 shows a side view of an example of an intravascular medical device (11) deployed between two cavities. For example, the cavity (220) may be the left atrium and the cavity (210) may be the coronary vein.

[0029] FIG. 2 is intended to illustrate a generalized example of an adjacent organ in which an embodiment of the present invention may be developed. Although the larger first cavity (220) is depicted as being shunted by a blood vessel (210), it should be understood that the depiction in FIG. 2 is merely illustrative. In some embodiments, both the first cavity (220) and the second cavity (210) may be blood vessels, and in other embodiments, both the first cavity and the second cavity may be non-vascular. One embodiment used herein as an example is when the first cavity (220) is the left atrium and the second cavity (210) is the coronary sinus. Accordingly, in this specification, reference numbers (220 and 210) are sometimes referred to more generally as the first cavity and the second cavity, and in other cases, the same reference numbers are used to refer to the example of the left atrium and the coronary sinus. It should be understood that the reference to this particular latter example is not intended to limit the disclosure of FIG. 2 to an example where the left atrium is shunted to the coronary sinus. Rather, FIG. 2 is intended to broadly disclose any two cavities being shunted together.

[0030] As a non-limiting example, as illustrated in FIG. 2, a tubular shunt (110) may be deployed or positioned between the cavity (220) and the cavity (210) in a passage (270) formed during the implantation process. Furthermore, the tubular shunt (110) may bridge the internal lumen of the blood vessel, for example, between the cavity (220) and the cavity (210), as illustrated. In some embodiments, a pre-cut hole between the cavity (220) and the cavity (210) may form the passage (270).

[0031] The tubular shunt (11) may have flexibility and structural stability to prevent deviation or damage during intended use. In some embodiments, the tubular shunt (11) may include a number of struts and connectors, and the connectors may be located at equal distances from each other along the tubular circumference of the tubular shunt (11). As previously mentioned, the space between these struts and connectors may define an opening (112). The tubular shunt (11) may be configured so that a fluid (e.g., blood) can flow through the central opening (114) from a high-pressure area (e.g., the heart chamber) to a low-pressure area (e.g., a vein or coronary sinus). The pressure difference may exceed 1 mm Hg. In some embodiments, the shunt further includes a pressure valve configured to control or allow blood to pass through at a predetermined pressure.

[0032] The tubular shunt (11) may be sized to terminate at the boundary area between the central opening (114) or the passage (270). For example, one end of the tubular shunt (11) may terminate at the boundary area between the central opening (114) (or passage (270)) of the coronary sinus (210), for example, at the upper wall (250). The other end of the tubular shunt (11) may terminate at the boundary area between the central opening (114) (or passage (270)) of the left atrium (220), for example, at the inner wall (260).

[0033] In some embodiments, the tubular shunt (110) may include an orientation marker that facilitates rotational orientation around the central opening (114). The orientation marker may be configured to control the rotational orientation of the tubular shunt (110) around the central opening (114). In some embodiments, the control of the rotational orientation of the tubular shunt (110) may define the range of flow deflection in the second cavity (e.g., the tubular sinus (210)), which is described in more detail below in relation to the flow deflector (130). The orientation marker may include, for example, a tantalum marker or a specific structural design at a specific location.

[0034] The tubular shunt (110) may be configured to accommodate various anatomical parts and stabilize the flow deflector part (130) and the tubular shunt (110) by having an end that is axially spaced apart by a length of about 0.5 mm to 5 mm or 1 mm to 4 mm. As used herein, "axially spaced" may refer to the distance between the distal end and the proximal end along the longitudinal axis of the intravascular medical device. The tubular shunt (110) may be integrally connected or interconnected with one or more of the stabilizer (120) and the flow deflector (130), both of which are discussed in detail below.

[0035] In some embodiments, the intravascular medical device may include a stabilizer. As mentioned above, the stabilizer and the tubular shunt may be integrally connected, and the stabilizer may be configured to stabilize the tubular shunt in the passage. Stabilization of the tubular shunt may include fixing the tubular shunt in a specific position or rotational orientation, or otherwise preventing the tubular shunt from migrating, moving, or rotating.

[0036] As a non-limiting example, the stabilizer may include a first flange region connected to a tubular shunt. As used herein, the flange may relate to a protruding flat rim, collar, or rib structure of the component. The flange refers to a structure, in this case, a protruded ridge, lip, or rim or edge extending outward from the tubular shunt. The flange may completely or partially surround the outer periphery of the shunt or may include a series of flange parts or regions that work together for stabilization purposes. The flange region refers to all or part of the flange.

[0037] As illustrated as an example in FIGS. 1A through 1D, the first flange region (140) may include a substantially flared shape having a radius of curvature. The circumference of the flare may be larger than the circumference of the shunt to prevent the shunt from migrating. In some embodiments, the first flange region (140) may be located on the side of the tubular shunt (11) opposite the flow deflector, and an example of the flow deflector is illustrated as (130) in FIGS. 1A through 1D and is discussed in more detail below. Additionally or alternatively, in some embodiments, the first flange region (140) may be configured to be sealed (e.g., to provide a hermetic closure) against the inner wall (260) of the first cavity (e.g., left atrium (220)) when the intravascular medical device (11) is deployed or positioned so that blood passing between the first flange region (140) and the inner wall (260) of the first cavity is restricted (partially or completely). Furthermore, in some embodiments, the first flange region (140) may be asymmetric in terms of the radius of curvature at different locations or lengths of the flange.

[0038] As illustrated in FIGS. 1A through 1D and FIG. 2, when the first flange region (140) (illustrated in FIGS. 1A through 1D) extends into the second cavity (220) (illustrated in FIG. 2), the stabilizer (120) is positioned at the same height (or relatively the same height) as the inner wall (260) of the first cavity (220) so as to effectively provide an anchor for the intravascular medical device (11) upon implantation. Thus, the tubular shunt (110) can be stabilized in the passage (270). Although illustrated in FIG. 2 as having a shape at the same height, the stabilizer (120) may have an alternative shape, such as an S-shaped or C-shaped cross-sectional profile.

[0039] Additionally or alternatively, the tubular shunt may include a second flange region extending into a second cavity, and the second flange region may be configured to secure (e.g., secure or fasten) the tubular shunt within the passage so that the tubular shunt does not collapse, loosen, or migrate. As illustrated in FIGS. 1A through 1D, the tubular shunt (11) may include a second flange region (150). As illustrated in FIG. 2, the second flange region (150) may also have a flared shape so that the second flange region (150) extends into the second cavity (210). In some embodiments, the second flange region (150) may contact the upper wall (250) of the second cavity (210) near a pre-cut hole between the first cavity (220) and the second cavity (210).

[0040] As discussed above, the first flange region (140) may be at the same height as the inner wall (260) of the first cavity (220), and the second flange region (150) may be at the same height as the upper wall (250) of the second cavity (210). Thus, in some embodiments, the combination of the first flange region (140) and the second flange region (150) may stabilize the tubular shunt (110) in the axial and rotational positions between the left atrium (210) and the coronary sinus (210), thereby preventing the tubular shunt (110) from moving in the axial, rotational, or both directions.

[0041] Accordingly, the shunt-stabilizer combination may have an hourglass shape having a narrow waist in the middle section and a wider flange area (140 and 150) extending beyond the circumferential edge of the tubular shunt to the first cavity of the first organ and the second cavity of the second organ. In some embodiments, the flange area (150) may be omitted at the proximal end of the shunt, and stability at the proximal end is provided by a connected flow deflector as discussed below.

[0042] The disclosed embodiment may include a flow deflector having a surface extending from a tubular shunt and deflecting the flow into a second cavity. Flow deflection involves changing the direction of the flow. For example, a body fluid, such as blood, may be induced to change the 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. The second direction is considered to be perpendicular to the first direction, parallel to the first direction, or angled to the first direction. Accordingly, the flow deflector may include any structural part that deflects, redirects, blocks, obstructs, impedes, reduces, or inhibits the fluid flow.

[0043] In some embodiments, the flow deflector may be partially or integrally connected to the tubular shunt. Furthermore, the flow deflector may be configured to extend from less than the entire circumferential edge of the tubular shunt. For example, the flow deflector may extend from half of the circumferential edge of the tubular shunt. In some embodiments, the flow deflector may include an inner surface integrated with the tubular shunt so that there is no distinct transition between the tubular shunt and the flow deflector. (In other words, the structural part of the flow deflector and the shunt acts as a tether connecting the two components.) Additionally, or alternatively, in some embodiments, the flow deflector may include an outer surface integrated with the tubular shunt so that there is no distinct transition between the tubular shunt and the flow deflector.

[0044] As illustrated in FIGS. 1A through 1D, the intravascular medical device (11) may include a flow deflector (130). The flow deflector (130) may be located at the opposite end of the tubular shaft (110) from the stabilizer (120). The flow deflector (130) may be configured to be located in a vein, such as a coronary sinus (210), in the manner shown in FIG. 2. As a non-limiting example, the tubular shunt (110) and the flow deflector (130) may form a new junction connecting the first cavity (220) and the second cavity (210) after a pre-incised hole is created during the implantation process. The flow deflector (130) may be configured to deflect blood flowing in an initial direction, such as a natural flow (230), through the lumen of the second cavity (210) so that the blood is deflected in a reverse direction or reverse flow direction (240), as shown in FIG. 2. Blood flowing in the direction of natural flow (230) may be in a deoxygenated state, and blood flowing in the direction of reverse flow (240) may be in an oxygenated state.

[0045] As illustrated in FIG. 2, retrograde flow (240) or blood deflected in the retrograde direction can be achieved by at least partially blocking the natural flow (230) as well as by shunting the first cavity (220) and the second cavity (210) through the passage (270) using a tubular shunt (110). In a situation where the first cavity (220) is a source of oxygen-rich blood, for example, where the first cavity is on the left side of the heart (left atrium or left ventricle) and the second cavity (210) is the coronary sinus, retrograde flow can support heart tissue that has been deoxygenated as a result of heart disease.

[0046] As used herein, occlusion may refer to the blockage or diversion of fluid flowing through a structure, such as blood flowing through a biological organ. For example, occlusion of blood flowing in a first direction may include blockage of blood flowing in a first direction or diversion of blood flowing in a first direction. As another example, occlusion of a blood vessel may include blockage of fluid flow through a blood vessel or closure of a blood vessel. The flow deflector (130) may contribute to at least partial occlusion of the natural flow (230). Furthermore, if the pressure in the left atrium is higher than in the coronary sinus, it may contribute to retrograde flow (240).

[0047] Furthermore, in some embodiments, the flow deflector may include a non-tubular recess configured to deflect flow into a second cavity. As discussed above, the tubular may relate to a structural part having a wall or outer wall that defines the intermediate channel regardless of the contour of the intermediate channel. Accordingly, the non-tubular recess used herein may relate to a structural part having a wall that does not form an intermediate channel that leaves the non-tubular recess open. For example, as illustrated in FIGS. 1A through 1D, the flow deflector (130) may have a curved or bent frame. In some embodiments, the curved frame may have a scoop shape, wherein the scoop shape may be formed so that the flow deflector (130) has a radius of curvature. The scoop shape may include additional flexibility at the edge or rib of the flow deflector (130) to accommodate a range of anatomical differences between the parts and the patient. As illustrated in FIG. 1A, the trough of the flow deflector (130) may generally have a circular cross-sectional profile. Furthermore, in some embodiments, the flow deflector (130) may form a crescent shape extending from a tubular shunt, as illustrated in FIG. 1B.

[0048] In some embodiments, the flow deflector (130) may have a ladle or arc-shaped recess sized to cover most or all of the inner circumference of a vein, such as a coronary sinus (210), so as to extend over most or all of the entire cross-section of the vein. In some examples, the flow deflector may be sized to contact the circumference of the vein cavity (e.g., coronary sinus) or to span across the cross-section of the vein cavity (e.g., coronary sinus). For example, as shown in FIG. 2, the flow deflector (270) may contact the lower wall (280) of the coronary sinus (210) across the cross-section of the coronary sinus (210).

[0049] In some embodiments, the scoop shape may have a minimum radius when measured from the center of the tubular shunt (110), which may generally correspond to the cross-sectional height diameter of a second organ, such as a vein (e.g., a coronary sinus). In some embodiments, the radius of the scoop shape may be about 20% larger than the vein radius to create fixation and sealing. For example, a scoop radius of 5 mm may be used for a vein radius of 4 mm. A flow deflector according to some embodiments may include a second stabilizer for engaging with the wall of the coronary sinus. This second stabilizer may be in the form of a lip, a flange, or multiple prongs. In some cases, the second stabilizer may be configured to cooperate to maintain a fluid seal.

[0050] Additionally or alternatively, the flow deflector may include a tether configured to connect the flow deflector to the circumferential edge of the tubular shunt. The tether used herein may include a cloth, metal, wire, hinge, or other fastening component capable of connecting the flow deflector (130) to the circumferential edge of the tubular shunt (110). FIG. 16 illustrates an example of a tether (1624) interconnecting the flow deflector portion (1620) and the tubular shunt portion (1614). The disclosed embodiment may include at least one wavy flexible wire securing the tubular shunt to the flow deflector. The wavy flexible wire may be formed to have a shape or contour that allows the flexible wire to move smoothly up and down. The tether may be further configured to prevent the flow deflector (130) from migrating beyond a predetermined distance from the tubular shunt (110). This can contribute to flow deflectors that can adapt to various anatomical structures (for example, due to differences between individual anatomical structures and inter-individual differences).

[0051] Additionally or alternatively, the tubular shunt may be sized to terminate distally (e.g., end, stop, or interfacing) at the periphery edge of the passage adjacent to the first cavity, and the flow deflector may be sized to terminate (e.g., end, stop, or interfacing) at the wall of the second cavity opposite the passage. As illustrated in FIG. 2, the tubular shunt (110) may terminate at the periphery edge of the passage adjacent to the first cavity (220), for example, at the inner wall (260). In relation to FIG. 2, the tubular shunt (110) may terminate at the wall of the second cavity opposite the passage, for example, at the lower wall (280). Furthermore, the flow deflector (130) may include an edge or rib configured to engage with the wall of the second cavity (210), for example, the lower wall (280). The distal edge or rib may be flexible and configured to bend toward the lower wall (280) of the second cavity (210). Additionally, or alternatively, the distal edge or rib may be biased to the curvature of the second cavity (210) (e.g., coronary sinus).

[0052] In some embodiments, as discussed above, the flow deflector may be configured to enable reverse flow in the blood vessel. As a non-limiting example, as illustrated in FIG. 2, the intravascular medical device (11) may be positioned so that the flow deflector (130) induces reverse flow (240) in the second cavity (210) (e.g., coronary sinus). In some embodiments, the flow deflector may be configured to enable both the natural flow (230) and the reverse flow (240) within the blood vessel, for example, through partial occlusion of the natural flow (230), as further described below.

[0053] Additionally or alternatively, the flow deflector may include a penetrating tool passage. A flow deflector including a penetrating tool passage may allow various surgical tools to pass through the flow deflector, thereby enabling surgical operations including, but not limited to, corrective surgery, removal of an intravascular medical device, or monitoring or addressing conditions of the heart or blood vessels (e.g., pressure, plaque buildup). As an example, the flow deflector (130) may allow tools such as a cutting tool or a pushing tool, a guide wire, or a trigger wire to pass through the second cavity (210) to a location opposite the left atrium (220). For example, the cutting tool may be used to make an incision or opening in a biological organ or between two biological organs. The pushing tool may be used to deliver a second intravascular medical device to the same location as the first intravascular medical device or to a different location. Examples of tool passages include, but are not limited to, one-way valves, duckbill valves, stepped shutters, or two or more layered materials (wherein each individual layer has a slot positioned perpendicular to each other), plugs, or other temporary seals. Other approaches to tool passages are also conceived for use with the disclosed embodiments, for example, two partially overlapping layers configured to allow manipulation so that the two partially overlapping layers do not overlap with the location through which the tool passes.

[0054] In some embodiments, the tubular shunt and the flow deflector may be integrally connected in such a way that the rotational orientation of the tubular shunt in the passage defines the range of flow deflection in a second organ, wherein the second organ may be a blood vessel. The range of flow may include the quantification of properties of blood flow. For example, the range of flow may include, but is not limited to, the amount of blood flowing through the organ, the velocity of blood flowing through the organ, or the volume of blood flowing through the organ.

[0055] As illustrated in FIG. 2, the tubular shunt (110), stabilizer (120), and flow deflector (130) can be integrally connected to form an intravascular medical device (11). When the tubular shunt (110) rotates, the flow deflector (130) can also rotate in the same direction. The rotation of the flow deflector (130) can result in a rotational orientation that determines the extent of flow deflection or flow occlusion (e.g., blood flow rate, blood flow velocity, blood flow volume) in the coronary sinus (210).

[0056] The rotational orientation of the flow deflector (130) may form at least a partial blockage in the cross-sectional area of ​​the coronary sinus (210), thereby causing partial or complete blockage of blood flow in the coronary sinus (210) in the direction of natural flow (230). Blood flowing in natural flow (230) may be deflected, diverted, or recirculated toward the left atrium (220), causing a retrograde flow (240).

[0057] For example, in the first rotational orientation of the tubular shunt, the flow deflector may be configured to induce a first flow deflection over the width of the vessel. Furthermore, in the second rotational orientation of the tubular shunt, the flow deflector may be configured to induce a second flow deflection over a portion smaller than the width of the vessel. In some embodiments, the first flow deflection may be greater than the second flow deflection.

[0058] As a non-limiting example, the rotational orientation of the intravascular medical device (11) in the rotational orientation shown in FIG. 2 may result in complete occlusion (e.g., 100% deflection) of blood flowing in the direction of natural flow (230) through the coronary sinus (210). The flow deflector may be configured so that some blood can pass through even in a position of complete deflection. Thus, most or all of the blood flowing in the direction of natural flow (230) in the rotational orientation shown in FIG. 2 may be diverted to flow in the direction of reverse flow (240). Furthermore, the intravascular medical device (11) may be rotated around a central axis to achieve a second rotational orientation. In the second rotational orientation, depending on the degree of rotation, the intravascular medical device (11) may cause partial occlusion (e.g., 90%, 70%, 60%, 50%, or less) of the blood flowing in the natural flow (230) through the coronary sinus (210). Thus, in the second rotational orientation of the example, half of the blood flowing in the natural flow (230) direction may be diverted to flow in the reverse flow (240) direction, and the remaining half of the blood flowing in the natural flow (230) direction may continue to flow in the natural flow (230) direction. As described in this example, the flow divergence (or diversion of blood flow) caused by the rotational orientation of the intravascular medical device (11) shown in FIG. 2 may be greater than the flow divergence caused by the second rotational orientation of the intravascular medical device (11).

[0059] The intravascular medical device (11) can be positioned in any number of rotational orientations, and each rotational orientation is considered to result in a different degree of occlusion. Different degrees of occlusion may be required to address different heart diseases and / or impairment severity.

[0060] In some embodiments, the tubular shunt (110), stabilizer (120), and flow deflector (130) may be made of a biocompatible flexible material that forms a frame or scaffold (e.g., a wall with holes) that allows for a transition between a contracted form suitable for transdermal delivery within a delivery catheter and an expanded state, which is discussed in more detail below. The stiffness of the flexible material may be low enough not to interfere with the natural atrophy of the heart's atrial and ventricle. The flexible material may additionally have non-uniform flexibility to improve function within the heart. Furthermore, in some embodiments, the metal outer edge, such as the frame or scaffold of the tubular shunt (110), may be rounded to reduce trauma to the contacting tissue. Additionally, or alternatively, the flexibility of the outer edge engaging with the tissue may have a higher level of flexibility. The frame or scaffold portion of the tubular shunt may be interconnected with one or both of the stabilizer and the flow deflector.

[0061] Furthermore, the flexible material may include a material that is flexible enough to provide strength to resist deformation over time, have the ability to expand due to a reduction in pressure on the external circumference, and allow for a range of anatomical differences. Non-limiting examples of flexible materials may include superelastic alloys and / or shape memory materials, such as shape memory alloys (SMAs) like nickel-titanium alloys (known as Nitinol or NiTiCu (nickel-titanium copper), CuZn (copper-zinc), CuZnAl (copper-zinc-aluminum) and / or CuAlNi (copper-zinc-nickel)). Other suitable materials may include other biocompatible metals or stainless steels. The flexible material may be additionally coated and / or textured to increase biocompatibility, improve blood flow, and achieve optimal interlocking with tissue through the pre-incised opening.

[0062] FIGS. 3A through 3D illustrate an example of an intravascular medical device having a flexible cover (31). As illustrated in FIGS. 3A through 3D, a tubular shunt (110) may be covered by a tubular shaft cover (310), a stabilizer (120) may be covered by a stabilizer cover (320), and a flow deflector (130) may be covered by a flow deflector cover (330). The covers (310, 320, 330) may form a flexible cover alone or in any combination. When combined, the covers (310, 320, 330) may be integrated or continuous. The covers may be stitched, bonded, or otherwise attached to a base frame structure.

[0063] The flexible cover used herein may comprise a fabric cover or any flexible material capable of wrapping around components of an intravascular medical device. In some embodiments, the flexible cover may have greater flexibility than the flexible material discussed above in relation to the frame or scaffold. The flexible cover may be at least partially impermeable to fluids. In particular, the flexible cover may be at least partially impermeable to blood flow. In some embodiments, the flexible cover may be substantially impermeable to fluids. Being partially or substantially impermeable to fluids can help in the effective deflection of fluid flow, such as blood flow. For example, a flexible cover that is partially impermeable to blood flow may cause a portion of the blood flow through the flexible cover to be blocked and diverted by the flexible cover. As another example, a flexible cover that is substantially impermeable to blood flow may cause all blood flow through the flexible cover to be blocked and diverted by the flexible cover. In some embodiments, the flexible cover may be porous. As used herein, porous structures include empty spaces, through which some material or fluid may flow. The empty spaces may be of any size and are considered to be a combination of sizes within a single porous structure.

[0064] Additionally or alternatively, the flexible cover may promote endothelialization or epithelialization on the surface or within the porous (e.g., mesh or braid) flexible cover of the flow deflector. Non-limiting examples of compounds that may be implemented and may promote endothelialization or epithelialization include, but are not limited to, growth factors, e.g., transforming growth factor, fibroblast growth factor, epidermal growth factor, and other biological materials (e.g., tissues or tissue components). In some embodiments, the flexible cover is configured to inhibit coagulation on the surface or within the porous flexible cover of the flow deflector by including, for example, a molecule known to reduce coagulation, so that coagulation or thrombus formation in the vicinity may be minimized.

[0065] In some embodiments, the flow deflector (130) may include a flexible flow deflector cover (330), also called a flexible cover, and a scaffold portion. In some examples, the flow deflector cover (330) may be positioned on the flow deflector (130) so that the flow deflector (130) and the flow deflector cover (330) are configured to deflect blood flow from the heart chamber (220) in a retrograde manner within the coronary sinus (210) when expanded.

[0066] Furthermore, the flow deflection cover (330) may comprise a fabric, a mesh polymer coating, a synthetic material coating, or a combination thereof. In some embodiments, the flow deflection cover (330) may be configured to extend over at least 50% of the ladle shape of the flow deflector (130) to cover it. In other embodiments, the flexible flow deflection cover (330) may be configured to extend over at least 70% of the ladle shape of the flow deflector (130) to cover it. In yet another embodiment, the flexible flow deflection cover (330) may be configured to extend over at least 90% of the ladle shape of the flow deflector (130) to cover it. Furthermore, in some embodiments, the flexible flow deflection cover (330) may be configured to extend over at least 95% of the ladle shape of the flow deflector (130) to cover it. In some embodiments, the flow deflection cover (330) may comprise a fine mesh or fabric material.

[0067] The stabilizer may include a flexible cover and a plurality of arms configured to establish a fluid seal (e.g., complete or partial) between a first side of the flexible cover and a wall of a first cavity when deployed.

[0068] For example, a flexible cover (320) may be configured to seal the stabilizer (120) or flange against a wall, such as the inner wall (260) of a heart chamber, such as the left atrium (220), when the intravascular medical device is deployed. A fluid seal (e.g., a hermetic seal) may prevent blood from flowing between the stabilizer (120) and any adjacent structure. This may prevent the intravascular medical device (11) from migrating in either the axial or rotational direction, or both. Furthermore, by preventing blood from flowing between the stabilizer (120) and any adjacent structure, the fluid seal may avoid, limit, minimize, or prevent an increase in turbulent blood flow that could lead to weakening of the heart or blood vessel walls.

[0069] As illustrated in FIGS. 1A through 1D and FIGS. 3A through 3D, the stabilizer (120) may include a plurality of arms, and the arms may be made of a biocompatible flexible material capable of forming a frame or scaffold as previously discussed. In some embodiments, each arm may form a relatively triangular shape. However, the arms of the stabilizer (120) are considered to be of any shape suitable for helping to stabilize the tubular shunt (110). Additionally, or alternatively, a flexible cover may extend over the tubular shunt and the flow deflector.

[0070] Any number of covers (310, 320, 330) may be used to cover each part of the intravascular medical device (11), and the covers (310, 320, 330) are considered to be integrated or continuous. For example, in some embodiments, an intravascular medical device having a flexible cover (31) may include only one of a tubular shaft cover (310), a stabilizer cover (320), or a flow deflection cover (330). Any combination of covers may be included in an intravascular medical device having a flexible cover (31), and it is further considered that the covers may be integrated into a single flexible cover. Furthermore, the covers (310, 320, 330) may be mesh, fabric, polymer coating, or any other synthetic material configured to wrap around a part of the intravascular medical device (11) and restrict blood flow. In some embodiments, the covers (310, 320, 330) may include a fine mesh or fabric material. The covers (310, 320, 330) are considered to be made of different materials relative to each other.

[0071] In some embodiments, the flexible cover (or cover (310, 320, 330)) may be at least partially impermeable to a fluid (e.g., blood). Accordingly, non-limiting examples of materials that may comprise the flexible cover (or cover (310, 320, 330)) may include nylon, polyethylene, EPTFE, TPU, and PTFE.

[0072] In some embodiments, the tubular shunt, stabilizer, and flow deflector may be integrally connected and extended upon deployment via a delivery catheter. As used herein, "integrally connected" may relate to the joining of the components of the structure. For example, the tubular shunt, stabilizer, and flow deflector may be integrally connected due to being manufactured by the same process, such as etching, microelectric discharge machining, electroplating, die casting, laser cutting, and welding, or by being manufactured from the same material. As another example, the tubular shunt, stabilizer, and flow deflector may be integrally connected after being joined together, or connected to each other after manufacturing, such as by welding.

[0073] FIG. 4 illustrates an example of deploying an intravascular medical device (11) from a catheter (420) using a guide wire (430). An embodiment of the invention may include a sheath, such as a catheter (420), configured to include a tubular shunt and a flow deflector in a compressed form. As used herein, the sheath may relate to a structure or cover that encloses other structural parts or components. A sheath, such as a catheter (420), may enable the intravascular medical device (11) to navigate tortuous anatomical parts and prevent premature deployment within the body. As used herein with respect to an intravascular medical device, the compressed form may refer to the form of the intravascular medical device when stored in a sheath, such as a delivery catheter, for example. The intravascular medical device may be compressed to a second diameter (e.g., 2 mm to 7 mm or 2 mm to 5 mm) in the compressed form. In the compressed form, the length of the intravascular medical device may be 5 mm to 40 mm, 6 mm to 30 mm, 7 mm to 30 mm, 8 mm to 25 mm, or about 8 mm to 12 mm. Furthermore, the extended form as used herein in relation to the intravascular device may refer to the form of the intravascular medical device when unfolded into a passage or a pre-cut hole, slit, or perforation. The intravascular medical device may be extended to a first diameter in the extended form, wherein the first diameter is larger than the second diameter in the compressed form.

[0074] As illustrated in step (41a) of FIG. 4, the intravascular medical device (11) may be placed in a compressed form (410) within a catheter (420), wherein the intravascular medical device (11) may be compressed around or adjacent to a guide wire (430). Furthermore, in the compressed form, the flow deflector may be configured to be nested within a tubular shunt (e.g., at least partially placed or encircled). In another embodiment of the compressed form, the flow deflector may be configured to run parallel to and adjacent to the tubular shunt. The catheter (420) may be placed in the patient's body, and the catheter (420) may pass through the patient's blood vessels to reach a desired deployment location.

[0075] As illustrated in step (41b), the catheter (430) can be pulled back from the compressed form (410) to expand the intravascular medical device (11). As illustrated in step (41c), the stabilizer (120) of the intravascular medical device (11) can be expanded or unfolded as the catheter (420) continues to be pulled back. Step (41d) shows an example of a trigger wire mechanism (440, 450). The trigger wire mechanism (440, 450) can be used to selectively expand the flow deflection portion (130) after expansion of the stabilizer (120) (which may include a flange portion) and the tubular shunt (110). When ejected from the catheter (420), the trigger wire mechanism (440, 450) associated with the flow deflection portion (130) is pulled to release the flow deflection portion (130) so that it can be further expanded.

[0076] As illustrated in step (41e), the flow deflector (130) may include a catch portion to maintain the flow deflector (130) in at least a partially unextended form when ejected from the catheter (420). The flow deflector (130) may be configured to extend through the catheter (420) in a first direction, and the trigger wire mechanism (440, 450) may be configured so that when pulled from the first direction, the flow deflector (130) may extend in a second direction opposite to the first direction (illustrated in step (41f)). When ejected from the sheath (e.g., unfold, extend), the tubular shunt (110) may be configured to extend into a tubular shape, and the flow deflector (130) may be configured to extend into a curved (e.g., curved, rounded, arched) shape, as illustrated in step (41f).

[0077] FIG. 5 illustrates an exemplary method (51) for shunting and deflecting blood flow between biological organs. As illustrated in step (510), the disclosed embodiment may include perforating openings in a first organ and a second organ. The first organ may have a first cavity, and the second organ may have a second cavity. Perforation may be made using a sharp tip that pierces the walls of the first and second chambers before deploying the shunt through piercing. As a non-limiting example, the first organ may be a heart chamber and the second organ may be a blood vessel, and the flow deflector may be configured to generate at least partially retrograde blood flow in the blood vessel. As illustrated in step (520), the disclosed embodiment may include deploying a tubular shunt through the openings of the first cavity and the second cavity so that blood can pass from the first cavity to the second cavity. Furthermore, as illustrated in step (530), some embodiments may include deploying a flow deflector extending from a portion less than the entire circumferential edge of the tubular shunt within the second cavity. In some embodiments, as illustrated in step (540), the disclosed embodiment may further include using the flow deflector to deflect blood flow into the second cavity.

[0078] FIG. 6 illustrates, for example, an example of deploying an intravascular medical device (11) in a patient's body. As shown in FIG. 6, the intravascular medical device (11) may be placed or deployed between the left atrium (620) and the coronary sinus (610) of the heart (61).

[0079] Some disclosed embodiments may include a system and a method comprising an expanding shunt and an expanding flow deflector covered with a flexible material that at least partially restrict blood flow and deflect blood flow into the coronary sinus. Such a device may include a flexible hinge that can be bent to allow for axial positioning across the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector.

[0080] Some disclosed embodiments include an intravascular retrograde blood flow device. An intravascular retrograde blood flow device is a medical device configured to redirect or change the direction of natural blood flow in a blood vessel so that blood moves in a direction opposite to the natural direction of blood flow in the blood vessel. For example, blood flowing in a direction opposite to the natural blood flow in a vein or artery, including a coronary sinus, is considered retrograde blood flow. According to the disclosed embodiments, an intravascular retrograde blood flow device, such as the exemplary intravascular retrograde blood flow device (700) shown in FIG. 7, may be used in an interventional procedure to introduce oxygenated blood into a portion of the coronary sinus and reverse blood flow to revascularize coronary tissue that is deficient in oxygen-rich blood.

[0081] Some disclosed embodiments include a catheter. A catheter may refer to any tube configured to be inserted into a body cavity, duct, or blood vessel. A catheter may also refer to any slender structure capable of feeding, passing, advancing, pushing, pulling, or tossing into or along the lumen of a tubular structure. Thus, the catheter may have sufficient elasticity for axial tension to accommodate axial forces such as pushing and pulling. The catheter may be made of latex, silicone, Teflon, PVC, vinyl, red rubber, or any other suitable biocompatible material. The catheter may be sized to retain an expandable structure internally for intravascular delivery to a desired location, as further discussed herein.

[0082] Some disclosed embodiments include an expanding shunt configured to be compressed into a catheter and to bridge an opening between a first cavity of a first organ and a second cavity of a second organ. A shunt refers to any device, structure, or component configured to maintain an opening, whether temporary or permanent, between a first cavity of a first organ and a second cavity of a second organ to allow blood to flow so as to divert the flow of body fluids. For example, the shunt may include a central opening or passage around a tubular body to be deployed in a pre-incised opening to bridge the two organs and allow a biological fluid, such as blood, to move across the bridge. The expanding shunt portion may have a central opening or passage between a first organ (e.g., a heart chamber such as a left atrium or ventricle) and a second adjacent organ (e.g., a blood vessel such as a vein including a coronary sinus). An expandable shunt refers to a shunt that can be made larger or more extensive in a manner that is extendable, stretchable, elongable, flexible, malleable, flexible, elastic, conformable, moldable, or otherwise. An expandable shunt may be made of metal or polymer materials such as stainless steel or nitinol. An expandable shunt may be configured to have antibacterial, anticoagulant, and / or scar-preventing properties. An expandable shunt may be delivered to a cavity, blood vessel, opening, or passageway in a compressed state and then expand radially to its full size when placed in place or at a desired location. In some embodiments, an expandable shunt may be configured to monitor and regulate the blood flow velocity passing through it. One form of the expandable shunt (702) may include a mesh or strut-type structure having a series of struts or wire segments connected to form a tubular frame. The struts may be arranged in various patterns. For example, the expandable shunt (702) may consist of a series of connected curved struts arranged in a tubular form.The struts of the expandable shunt (702) are flexible, allowing the shunt to be adjusted to the curvature of the cavity, blood vessel, opening, or passage while maintaining its structure. Compressing the shunt into the catheter provides a minimally invasive approach to deliver and bridge the opening between the first cavity of the first organ and the second cavity of the second organ, thereby reducing the risk of complications associated with more invasive surgical procedures. In other words, the compressed expandable shunt can be delivered intravascularly into the cavity, blood vessel, opening, or passage, and then expanded to provide the necessary bridge, while minimizing the trauma and discomfort associated with conventional surgical techniques.

[0083] The cavity of the organ may refer to any hollow space within an organ or structural part of the body. In one example, the organ may be the left or right heart, and the cavity may be the associated left or right atrium. In another example, the organ may be the coronary sinus, and the cavity may be the lumen of the coronary sinus. The opening may refer to an aperture, fissure, incision, orifice, perforation, recess, slot, gap, slit, hole, or any other space that allows access to the cavity. The opening may be pre-existing or formed as part of a shunt procedure. For example, the opening may be an aperture formed between the left atrium and the coronary sinus. In some examples, the opening may be tubular as a result of a tubular incision or as a result of extending a non-tubular incision to accommodate a tubular shunt. The opening between the first cavity of the first organ and the second cavity of the second organ may be bridged by a shunt inserted into an aperture, cut, orifice, hole, or any other perforation formed between the first cavity and the second cavity. For example, an expanding shunt (702) may maintain the bridge between the first cavity and the second cavity by scaffolding the opening between the first cavity of the first organ and the second cavity of the second organ.

[0084] Some disclosed embodiments include an expandable flow deflector configured to be compressed into a catheter and to deflect flow into a second cavity. As discussed herein, the flow deflector includes a structure that deflects, redirects, occludes, blocks, obstructs, reduces, or inhibits fluid flow when deployed at a defined position. For example, the flow deflector (704) of the intravascular retrograde flow device (700) may be configured to deflect channeled blood from a cardiac chamber, such as the left atrium, through a shunt to the coronary sinus when expanded. Oxygen-rich channeled flow is deflected in a retrograde manner so that oxygen-deficient cardiac tissues can receive oxygenated blood. The flow deflector is expandable in that it has a first compressed orientation when in the catheter and takes on a second expanded form after being released from the catheter. In some cases, as described herein, the flow deflector expands only upon being released from the catheter, and in other cases, at least some expansion occurs after a subsequent trigger action. The flow deflector may be made of a metal or polymer material such as stainless steel or nitinol. An expandable flow deflector can be inserted into a cavity, vessel, opening, or passage in a compressed state and then expanded to its full size when placed in place or at a desired position. Like a shunt, the expandable flow deflector (704) can be made of a mesh-like or strut-like structure having a series of wire segments or struts connected to form a frame. The struts can be arranged in various patterns and are flexible, allowing the flow deflector to adjust to the curvature of the cavity, vessel, opening, or passage while maintaining its structure. The expandable flow deflector (704) can have struts arranged in the same way as the expandable shunt (702) or other patterns. The struts or wires of the expandable flow deflector (704) may also be interconnected with the struts or wires of the expandable shunt (702) as part of a single frame structure.Compression of the expandable flow deflector into the catheter provides a minimally invasive approach to deflecting flow into a second cavity, thereby reducing the risk of complications associated with more invasive approaches to implantation. In other words, the compressed expandable flow deflector can be easily inserted into a cavity, vessel, opening, or passageway, and then expands to provide the necessary flow deflection while minimizing the trauma and discomfort associated with conventional surgical techniques.

[0085] Some disclosed embodiments include a flexible hinge interconnecting an expanding shunt and an expanding flow deflector, wherein the flexible hinge is configured to be bent so as to allow for transverse axial positioning of the expanding shunt and the expanding flow deflector while maintaining interconnection between the expanding shunt and the expanding flow deflector when the expanding shunt is positioned along a first axis of the opening and the expanding flow deflector is positioned along a second axis transverse to the first axis within the second cavity. A flexible hinge refers to any structural part or joint that allows movement between two components or structural parts while maintaining a certain degree of flexibility. The flexible hinge interconnects the expanding shunt and the expanding flow deflector by extending between the two components and attaching to the two components. Generally, the flexible hinge interconnects the expanding shunt frame and the expanding flow deflector frame by extending between the two components and attaching to the two components. A flexible hinge may comprise two sides connected by an axis, joint, elbow, hook, pin, joint, junction, link, spring, rotation, or any other structural part that allows rotation or bending between the two sides. In one example, the flexible hinge is a bendable connection, such as a wire, that extends between an extending shunt and an extending flow deflector and is connected to the extending shunt and the extending flow deflector. A flexible hinge is desirable for allowing various movements while permitting bending and flexing without breakage. A flexible hinge may also be part of an endovascular retrograde blood flow device designed to bend, flex, or rotate so that the endovascular retrograde blood flow device can adapt to the natural curves and bends of blood vessels or other structures within the body. A flexible hinge may be made of a flexible biocompatible material, such as a wire, a flexible metal strut, silicone, a polymer, a fabric, or any combination thereof.The hinge may be configured to self-adjust to the anatomical part, or so that a surgeon can adjust the angle or position of the expanding flow deflector to ensure that the fluid is sent to the correct position. Similarly, the flexible hinge may allow the expanding shunt or expanding flow deflector to be deployed at an optimal angle or position for maximum fluid flow control. For example, the expanding flow deflector (704) and the expanding shunt (702) may be connected by a wire-shaped flexible hinge (706).

[0086] A flexible hinge (706) may be connected to any part of the expanding flow deflector (704) and the expanding shunt (702) to interconnect the two structures. The expanding flow deflector (704) may be configured to deflect blood, for example, by including an expanding frame that is at least partially covered by a flexible flow deflector cover. In some embodiments, the expanding flow deflector is partially connected to the circumferential edge of the expanding shunt via a flexible hinge. The circumferential edge of the expanding shunt refers to the outermost boundary or border of the expanding shunt. For example, the expanding shunt may have a generally tubular body ending at distal and proximal circumferential edges. In some embodiments, the expanding flow deflector is connected to the proximal circumferential edge of the expanding shunt via a flexible hinge. It may be preferable to connect the expanding flow deflector to the circumferential edge of the expanding shunt so as not to obstruct fluid flow within other areas of the intravascular retrograde blood flow device (e.g., the inner lumen of the expanding shunt). In the example illustrated in FIG. 7, the flexible hinge (706) contacts the expanding flow deflector (704) and the expanding shunt (702) at the proximal perimeter edge (720). In another example, the flexible hinge (706) may be connected to the expanding flow deflector (704) or the expanding shunt (702) at a different location on the expanding flow deflector (704) or the expanding shunt (702), for example, at a wall.

[0087] Bending of a flexible hinge can refer to any arching, bending, flexing, twisting, reversing, bending, or any other change in the direction, angle, or orientation of the flexible hinge. In one example, the hinge bends in a unidirectional or planar manner, much like paper bending. This can be useful for changing direction or navigating in narrow spaces within the body, such as blood vessels. In another example, the hinge bends at an angle, allowing an extendable shunt and an extendable flow deflector to be positioned at a specific angle or orientation. Angle bending may be desirable for insertion at a specific angle to access a particular area of ​​the body. In yet another example, the hinge rotates around an axis, which can be useful for navigating curved or meandering paths within the body. This type of bending can also be used to change the orientation of an intravascular retrograde blood flow device without the need to remove and reposition the device. In other examples, the hinge can implement a combination of these bending modes to provide greater flexibility and maneuverability. For example, a flexible hinge can be configured to bend at an angle and also twist around an axis to provide both directional control and the ability to navigate a winding path.

[0088] In some embodiments, the flexible hinge includes a tether. A tether refers to any device or structural part that interconnects the shunt and the flow deflector but limits or restricts the longitudinal distance between them. For example, a tether may include a wire, spring, flexible material, strut, braid, thread, coil, cord, rope, string, fabric material, or any other structural part for interconnecting the shunt and the flow deflector. FIG. 7 provides an example of a wire-shaped tether (706) connecting an expandable flow deflector (704) and an expandable shunt (702). The tether (706) may be configured to prevent and restrict the expansionable shunt or the expandable flow deflector from migrating within a cavity or passage. In some examples, the tether (706) may include a wire, such as a metal linkage, between the expandable shunt and the expandable flow deflector.

[0089] In some embodiments, the tether has a wave shape. A wave shape refers to a shape similar to rising and falling waves, zigzag, or any other pattern. As an example, the tether (706) of FIG. 7 has a wave shape. The wave shape of the tether (706) enables the tether to provide a secure and flexible connection between the extended flow deflector (704) and the extended shunt (702). The curved shape of the tether (706) provides natural flexibility that allows the tether to bend and adjust according to the movement of the heart chamber or blood vessel and / or the anatomical part of the patient during heart pumping while maintaining a secure connection. The wave shape of the tether (706) may also help reduce the risk of damage to the heart chamber, blood vessel, or surrounding tissue by more evenly distributing stress and pressure on the intravascular device (700).

[0090] FIG. 8 shows another example of a flexible hinge connecting an extendable shunt and an extendable flow deflector. In FIG. 8A, the flexible hinge (808) is a wavy wire connecting the perimeter edge of the extendable flow deflector (804) to the extendable shunt (802). Similarly, in FIG. 8B, the flexible hinge (818) is a wavy wire connecting the perimeter edge of the extendable flow deflector (814) to the extendable shunt (812). FIG. 11 illustrates an additional view of the extendable frame of FIG. 8B. However, the flexible hinge may also be part of the interconnection structure between the extendable shunt and the extendable flow deflector. For example, FIG. 8C shows an extendable shunt (822) connected to an extendable flow deflector (824) via a flexible hinge (828). In this example, the hinge (828) may be an extension of the extendable shunt (822) and the extendable flow deflector (824). Alternatively, the hinge (828) may be an interconnection between the extendable shunt (822) and the extendable flow deflector (824), provided that relative bending between the two components is allowed. The hinge (828) may also be an interconnection between the extendable flow deflector frame (824) and a cover (826) extending over the extendable shunt (822). FIG. 8D shows another example of the extendable flow deflector frame (834) and the extendable shunt (832) connected at a flexible hinge (838) formed by a fabric cover (836) attached to the extendable shunt (832) and the extendable flow deflector frame (834).

[0091] In some embodiments, one or more flexible hinges include two flexible hinges extending from both sides of the shunt circumference. In this context, the circumference relates to the circumference of the tubular shunt located proximal to the tube. It may be desirable to include two flexible hinges extending from both sides of the shunt circumference to add more structural stability to the connection between the expanding shunt and the expanding flow deflector when blood flow is particularly strong. Furthermore, including two flexible hinges on both sides can help distribute pressure more evenly. Moreover, the positioning of two opposing hinges located at the two ends of the proximal circumference diameter promotes minimal interference with retrograde blood flow and possible additional stabilization against the wall. In some examples, the flexible hinges may include three or more flexible hinges extending from the periphery edge of the expanding shunt. This may be desirable to add additional structural support to the connection between the expanding shunt and the expanding flow deflector. All hinges share the same or similar structure, or they may have different structures depending on the desired design.

[0092] The first axis of the opening generally refers to the direction of the passage extending between the two cavities. The passage, and thus the axis, may generally be straight or curved. In other words, in the context used herein, the axis does not need to be straight if it follows a curved passage rather than a straight passage. For example, the first axis (710) follows the passage extending between the two cavities that are crossed by an extending shunt (702). Since the first axis (710) follows the path of the passage with the extending shunt (702), it may be straight or curved as shown in FIG. 7. Similarly, the second axis of the second cavity generally refers to the path extending in the direction of the second cavity (e.g., the coronary sinus in some disclosed embodiments). The path passing through the second cavity may generally be straight or curved in the area of ​​interest, and thus the second axis may likewise generally be straight or curved. In some examples, the second axis may follow the contour of the wall of the second cavity. For example, the second axis (708) follows the longitudinal direction of the second cavity where the expanding flow deflector (704) expands. Since the second axis (708) follows the longitudinal direction of the second cavity where the expanding flow deflector (704) expands, it may be straight or curved as shown in FIG. 7. Additionally, the first axis (710) and the second axis (708) may be dynamic, meaning that each axis may change as the shape of the passage or the second cavity changes, including body movements such as the expansion and contraction of veins, arteries, or heart chambers.

[0093] The second axis may intersect the first axis, meaning that the first and second axes intersect each other (i.e., intersect because they are not parallel). The angle of intersection may be a function, at least in part, of the individual's anatomical parts and the orientation of the passages with respect to the first and second cavities. In some examples, the angle of incidence between the first and second axes intersecting at the intersection location may be 90 to 160 degrees, 100 to 120 degrees, 90 to 30 degrees, or even 20 to 160 degrees. In other words, the angle may be larger or smaller depending on the specific implementation and the relevant anatomical parts (it may even be an acute angle).

[0094] For example, referring to FIG. 7, the first axis (712) crosses the second axis (708). The intersection angle (712) is the position where the two axes cross each other. As illustrated, the angle (712) is orthogonal, but depending on the characteristics of the case, it may be obtuse or acute.

[0095] When the expansion shunt and the expansion flow deflector are positioned so that their axes intersect (regardless of the intersection angle), the two components are said to take an orientation that allows for an axial position across. For example, the interconnection between the expansion shunt (702) and the expansion flow deflector (704) is maintained when an axial position across is possible, which means that the expansion shunt (702) and the expansion flow deflector (704) remain connected, for example by a hinge (706), even if the axes of the two components intersect each other (again, regardless of the intersection angle (712)). The two components may remain connected in any of many ways, for example, through a tether, hinge, interconnect, scaffold, or other bendable, flexible, or rotatable connection. By doing so, this structure maintains the interconnection between the expansion shunt (702) and the expansion flow deflector (704).

[0096] In some embodiments, the expanding flow deflector comprises an expanding frame covered with a flexible flow deflector cover, wherein the expanding frame is fixed to the wall of the second cavity upon expansion, and this fixation is configured to help stabilize the expanding shunt in the opening. The expanding frame refers to a structural part or component of any shape that can be scaled. The expanding frame may comprise a series of interconnected struts or wires that can expand to a predetermined size and shape when deployed within the second cavity, such as a blood vessel. The exact shape of the expanding frame may vary depending on the specific design of the expanding flow deflector. In one example, the expanding frame comprises a central hub or anchor point from which a series of struts or wires extend radially outward. In some examples, the expanding frame comprises a series of tubular struts or wires. In other examples, the expanding frame comprises a tubular scaffold. In some examples, as the expanding frame expands, the struts or wires apply an outward force to the blood vessel wall, creating a stable supporting structure that helps anchor the flow deflector in place. In some examples, the expandable frame may be configured to expand to a predetermined diameter, length, or shape. In addition to providing a stable supporting structure, the expandable frame may also serve as a mechanism for adjusting the position of the expandable flow deflector within a blood vessel. For example, the expandable frame may include one or more struts or wires extending from the expandable frame to the expandable shunt, which act as flexible hinges interconnecting the expandable frame and the expandable shunt to allow for axial positioning across the expandable shunt and the expandable flow deflector.Non-limiting examples of expandable frame materials may include superelastic alloys and / or shape memory materials, such as shape memory alloys (SMAs) like nickel-titanium alloys (known as Nitinol or NiTiCu (nickel-titanium copper), CuZn (copper-zinc), CuZnAl (copper-zinc-aluminum) and / or CuAlNi (copper-zinc-nickel)). Other suitable materials may include other metals, stainless steel, or polymers. The expandable frame may be additionally coated or textured to enhance biocompatibility, improve blood flow, and achieve optimal interlocking with tissues.

[0097] FIG. 7 illustrates an exemplary extended form of an intravascular retrograde blood flow device (700). In the example of FIG. 7, the intravascular retrograde blood flow device (700) includes a frame of an extendable shunt (702) and a frame of an extendable flow deflector (704). The frames of the extendable shunt (702) and the extendable flow deflector (704) are connected via a flexible hinge consisting of a tether (706). The tether (706) is configured to be bent so that when the expansion shunt (702) is positioned along the first axis (710) of the opening and the frame of the expansion flow deflector (704) is deployed along the second axis (708) that crosses the first axis (710) within the second cavity, the flexible hinge (706) can be bent to allow the cross-axial positioning of the expansion shunt (702) and the frame of the expansion flow deflector (704) while maintaining the interconnection between the expansion shunt (702) and the frame of the expansion flow deflector (704). The second axis (708) crosses the first axis (710) at an angle (712). In this example, the angle (712) is greater than 90 degrees so that the expansion shunt (702) can adapt to the shape and angle of the opening between the first cavity and the second cavity. In this example, the tether (706) includes a wave shape that provides natural flexibility, allowing it to bend and adjust to movement during a retrograde blood flow procedure while maintaining a secure connection between the extendable shunt (702) and the extendable flow deflector (704).

[0098] A flexible flow-deflecting cover may extend over all or part of the frame. Such a cover may comprise any shield, housing, fabric, sheet, casing, coating, sheath, or other material. The cover may serve as a barrier to divert blood flow in a cavity, such as a blood vessel. The cover may have temporarily or permanently restricted permeability to fluids, particularly blood. In some examples, the cover is substantially impermeable to blood. A flexible flow-deflecting cover may provide a flexible and durable surface capable of diverting blood flow while minimizing the risk of vascular damage or irritation. In some embodiments, the flexible flow-deflecting cover may be configured to promote endothelialization (e.g., to promote growth factors, e.g., transforming growth factor, fibroblast growth factor, epidermal growth factor). In some embodiments, the flexible flow-deflecting cover may be configured to inhibit or limit endothelialization. In some embodiments, the flexible flow-deflecting cover may be configured to inhibit or limit endothelialization and / or thrombosis. Flexible flow deflection covers can be made of biocompatible materials such as silicone or polymer blends. In some examples, the flexible flow deflection cover comprises a series of flexible and overlapping panels or sheets that can bend and flex in response to changes in blood flow. In some examples, as blood passes through a blood vessel, the flexible panels of the flexible flow deflection cover can be adjusted and bent to divert blood flow from one direction to another, thereby achieving retrograde blood flow. Along with the frame, the flexible flow deflection cover can be configured to self-expand, meaning that the structure expands to an appropriate size and shape when deployed in a blood vessel using a catheter or similar delivery system. Alternatively, the structure can be designed to be manually adjusted and held in place using a series of clips or other mechanical fasteners.FIG. 8 shows examples of various configurations of flexible flow deflection covers, such as a cylindrical cover (806), a concave cover (816), or a ladle-shaped cover (826).

[0099] When the extension frame is secured to the wall of the second cavity upon extension, the extension frame is firmly fixed to the wall of the second cavity, providing stable support and preventing the intravascular retrograde blood flow device from moving or displaced during use. The extension frame can be secured to the wall of the second cavity, such as a blood vessel, in various ways. In one embodiment, the extension frame applies frictional force to the wall of the second cavity, allowing it to be stabilized through frictional fitting. The frame may include protrusions, protruding wires, protruding struts, or other contours that assist in securing through friction. In another example, a series of hooks or barbs located on the extension frame may be anchored to the wall of the blood vessel. These hooks or barbs may be configured to firmly grip the wall of the blood vessel without causing damage and may be adjusted or repositioned as needed to achieve the desired level of securing. In some embodiments, wires, struts, hooks, barbs, prongs, or other retaining elements may be configured to be adjusted or tightened as needed to achieve a desired level of fixation, and / or may be released if the intravascular retrograde blood flow device needs to be repositioned or removed. In some examples, the extension frame may be coated with a bioadhesive material that helps anchor the extension frame to the vessel wall. Stabilizing the extension shunt at the opening means ensuring that the extension shunt does not migrate out of the opening. Fixing the extension frame to the wall of the second cavity helps stabilize the extension shunt at the opening because the extension shunt is connected to the extension flow deflector fixed via a flexible hinge. Thus, when the extension frame is fixed to the wall of the second cavity, the extension shunt can be fixed at least partially in place at the opening because the connecting hinge prevents the extension shunt from migrating out of the opening. To stabilize the retrograde flow deflector device, the stabilization or fixing element of the shunt itself may cooperate with the stabilization / fixing element of the flow deflector.

[0100] In some embodiments, in an extended form, the extension frame includes a cylindrical portion, and a flow deflection cover extends across the circular base of the cylindrical portion in such a way that it forms a planar flow deflection surface. As used herein, the term "cylindrical" refers to a tubular shape of the generally associated passage shape, regardless of whether the shape is a perfect cylinder in geometric terms. Thus, the cylindrical portion may refer to an extension frame portion having a circular or oval cross-section along at least a portion of its length. In some examples, the cylindrical portion extends along the entire length of the extension frame. In other examples, the cylindrical portion extends along only a portion of the length of the extension frame. The cylindrical portion of the extension frame of an intravascular device can provide several advantages, including adaptability, anchoring, compression, and durability. The cylindrical portion of the extension frame can be configured to conform to the shape of the vessel wall and to be flexible, which allows the extension frame to adapt to changes in relevant vessel diameter, curvature, or irregularity, particularly in vivo. This allows the device to be more effective in diverting fluid flow, reducing the risk of complications, and promoting better clinical outcomes. As previously discussed, the cylindrical portion of the expandable frame may be equipped with projection elements that assist in anchoring to the blood vessel wall. These projections can reduce the risk of device migration or displacement and improve the long-term efficacy of the device. The cylindrical portion of the expandable frame may be configured to compress to a smaller diameter, allowing the device to be delivered via a catheter. This minimizes the size of the surgical access site and reduces the risk of complications associated with larger incisions. A planar flow deflection surface refers to a surface having a circular, oval, or other rounded shape to form a structure of a cavity (e.g., a blood vessel) where blood flow is deflected.In some embodiments, the planar flow deflection surface may be formed of a flexible material or fabric wrapped across at least one opening of the cylindrical frame. In other embodiments, the flexible material may cover a substantial portion of the inner surface of the cylindrical frame or the entire opening. Thus, at least one end of the planar flow deflection surface may be formed as a cover that extends over the cross-sectional end of the cylinder and is secured along at least a portion of the length of the cylinder. The planar surface and the cross-sectional position of this surface may be desirable for diverting flow because they can act as a plug by forming a seal closer to the vessel wall. In some embodiments, there may be no seal or a partial seal, allowing some blood to flow past the flow deflector while other blood is deflected. FIG. 8A shows an example of an extended frame comprising a cylindrical portion (804) and a flow deflection cover (806) extending over this cylindrical portion (804) in a manner that forms a planar flow deflection surface (806).

[0101] In some embodiments, in an extended form, the extended frame includes a deflector support, and a flow deflection cover extends over the deflector support in such a manner that it forms a concave flow deflection surface. The deflector support refers to any component or group of components configured to provide structural integrity to the flow deflection surface. The frame itself may have a concave curvature, and the frame may be configured simply to support the concave surface. The concave may be ladle-shaped, dish-shaped, cup-shaped, sunken, recessed, hollow, curved, rounded, sunken, or hollow. Such a concave surface may help to induce fluid flow. In other examples, the deflector support may have one or more of a semicircle, quadrant, sector, segment, arc, or chord shape. In other examples, the deflector support may have one or more of a circular, oval, elliptical, parabolic, or hyperbolic shape. In some embodiments, the concave flow deflector surface may be smooth and continuous and may have a gradually changing curvature that conforms to the shape of the blood vessel. In other embodiments, the flow deflector may not be concave, or the degree of concaveness may vary depending on design considerations. The surface may also include additional features, such as raised or textured areas, that create additional vortices or turbulence in the blood flow. FIG. 8B shows an example of an extended frame comprising a deflector support (814) having a flow deflector cover (816) that extends over the deflector support (814) in a manner that forms a concave flow deflector surface (816). The flow deflector cover (816) may also extend over other parts of the intravascular blood flow device, such as an extended shunt (812). The flow deflection cover (816) can also be formed to fit the edge of the extendable shunt (812), the deflection support (814), and the flexible hinge (818) connecting the extendable shunt (812) and the deflection support (814).

[0102] The ladle-shaped flow deflector surface may include a wide, shallow opening at one end, which tapers to a point where it gradually narrows at the other end. In some embodiments, the concave portion may include a curved or arched frame often made of metal or other supporting material. The frame may be configured to be curved, meaning it is intentionally bent or bent outward away from the center of the flow deflector. In some cases, the frame may be arched or have ribs, struts, or wires that cooperate to form the arch. The arch may be shallow or deep. A shallow curve may provide only a slight bending effect, whereas a deep arch may have a more pronounced curvature with a greater degree of bending. The curved shape of the frame can provide additional strength and stability by distributing the load and stress on the structural part more evenly. In some embodiments, the flow deflector forms a crescent shape extending from the shunt portion. In some embodiments, the trough of the ladle has a circular cross-sectional profile. The ladle shape can have a size capable of covering the entire cross-section of a vein or cavity, such as a coronary sinus.

[0103] FIG. 8C illustrates an example of an extendable frame comprising a concave portion (824) having a flow deflection cover (826) extending over the concave portion (824) in a manner that forms a ladle-shaped flow deflection surface (826). In this example, the flow deflection cover (816) may also extend over other parts of the intravascular blood flow device, such as an extendable shunt (822).

[0104] In some embodiments, in an extended form, the extended frame includes an extension extending from the extended frame beyond the intersection of the first axis and the wall of the second cavity, wherein the extension engages with the wall of the second cavity. The extension refers to a portion extending beyond the intersection point. The extension may include an appendage, arm, branch, expansion, elongation, stretching, wing, lip, or any other portion of the extended frame extending beyond the axis intersection point. It may be desirable to provide an extension extending from the extended frame beyond the intersection of the first axis and the wall of the second cavity to ensure that normal blood flow is diverted in a reverse direction in the second cavity away from the opening. FIG. 8B illustrates an example of an extension (824) extending beyond the intersection of the first axis (820) and the wall (821) of the second cavity.

[0105] In some embodiments, the extension extends in a direction opposite to the normal fluid flow direction. A direction opposite to the normal fluid flow direction refers to any direction that is opposite, transverse, reversed, or otherwise different from the normal fluid flow direction. It may be desirable to provide an extension that extends in a direction opposite to the normal fluid flow direction to guide the fluid in a reverse direction.

[0106] In some embodiments, the flexible flow deflection cover is substantially impermeable to blood. As used herein, the term “substantially impermeable to blood” refers to any material or device capable of preventing blood from passing through. Being substantially impermeable to blood allows the cover to deflect blood, as opposed to allowing blood to pass through. Impermeability can also reduce complications that may arise from absorbent materials in the bloodstream. In some embodiments disclosed herein, the flexible flow deflection cover may be used to prevent the normal flow of blood from the left atrium to the right atrium through the coronary sinus by blocking blood from passing through the cover that is substantially impermeable to blood.

[0107] In some embodiments, the flexible flow deflection cover includes a tool passage configured to minimize passing blood flow. The tool passage may refer to a channel or opening in the flexible flow deflection cover through which an instrument or tool can be inserted to manipulate an intravascular retrograde blood flow device or to perform a procedure within a blood vessel or body cavity. The tool passage may be configured to accommodate the size and shape of the instrument to be used, such as a guidewire and a balloon. The width of the tool passage may be sized to allow for easy insertion and removal of the instrument, but must not be wide enough to compromise the integrity of the flexible flow deflection cover or increase the risk of blood leakage in the normal direction. For example, to minimize normal flow, the tool passage may be configured to have a cover flap. Additionally, or alternatively, the tool passage may be a slit or multiple slits in the multilayer cover so as to allow individual cover layers to be mechanically manipulated to pass through, while providing a substantially impermeable blood barrier in a natural state. The tool passage may be located on the flat surface, concave part, or other surface of the flexible flow deflection cover, or may be located at the center or arranged at a non-central location. A coating or material may form part of the cover to resist the growth of bacteria and other microorganisms on or around the tool passage.

[0108] FIG. 10 illustrates various views of an example of a flow deflector (1002) comprising a tool passage (1004) according to some embodiments of the present invention. Examples of tool passages, such as the tool passage (1004), include a one-way valve, a ductile valve, a staggered shutter, or two or more layered materials (wherein each individual layer has a slot positioned 30 to 150 degrees or about 90 degrees relative to the other layer), a plug, or other suitable sealing material. An example illustrated in FIG. 10 illustrates a tool passage (1004) composed of two or more layered materials (wherein each individual layer has a slot positioned 90 degrees relative to the other layer). Other approaches to the tool passage, such as two partially overlapping layers configured to allow manipulation so as not to overlap with the position through which the tool passes, are also conceived for use with the disclosed embodiments. The cover may be a biocompatible, elastic, flexible, and substantially liquid-tight cover. Examples include, but are not limited to, biocompatible materials, mesh materials, cloth-like materials, fabrics, plastics or silicones, biological materials, collagen, or biological tissues. In some examples, the cover may be configured to trap, block, or catch materials with a length or diameter of about 5, 10, 15, 20, 25, 30, 35, 40, 90, and 100 micrometers or more. Optionally, the cover may be elastic or have a certain degree of elasticity. The cover may be bonded to the scaffold by, for example, one or more stitches, welds, adhesives, coatings, or soldering. In other examples, the flow deflector may include a flexible distal edge for removal from under the flow deflector so that the removal of the tool minimizes interference with the flow deflection. For example, the distal edge (1410) of the flow deflector (1404) of FIG. 14A and FIG. 14B is flexible and may include an open tool passage inside to minimize the disruption of flow deflection caused by the removal of the tool.

[0109] In some embodiments, the flexible flow deflection cover comprises at least one of a mesh, fabric, polymer coating, or synthetic material coating. A coating may refer to a layer of material applied to the surface of the flexible flow deflection frame or cover, or forming part of the surface, to deflect blood or provide additional structural support and protection. For example, the flow deflection frame may be coated with multiple layers of sprayed polymer to form a coating having blood-restricted permeability. A mesh coating may consist of a network of interlocked fibers or filaments forming an airtight, tough, and flexible web. A mesh coating may be made of biocompatible materials such as polyurethane, silicone, or polyethylene terephthalate (PET). These materials are flexible and highly durable, making them ideal for use in intravascular devices that must withstand movement within the body and the harshness of blood flow. A mesh coating may be applied to the surface of the flexible flow deflection cover using various techniques such as spraying, dip coating, sewing, welding, or electrospinning. Fabric coatings refer to cloths or fabrics configured to extend over or encircle the surface of a flexible flow-deflecting cover. Fabric coatings can be made of biocompatible materials such as nylon, polyester, or polyurethane that are flexible, durable, and safe for use in the body. Fabric coatings can be applied to the surface of the intravascular device using various techniques such as dip coating, spray coating, or lamination. In some examples, fabric coatings may include micropores or surface treatments to improve the adhesion of drugs or coatings. Fabric covers are also radiopaque, which can make it easier to visualize the position of the device during imaging procedures. Polymer coatings refer to a layer of polymer material applied to the surface of the flexible flow-deflecting cover.Polymer coatings can be applied using techniques such as spraying, dipping, or spin coating, and can be made of various polymers including silicone, polyurethane, or fluoropolymers. Synthetic material coatings refer to layers of artificial material applied to the surface of a flexible flow-deflecting cover. Various types of synthetic material coatings may be used in conjunction with the embodiments disclosed herein. Polyurethane coatings may be used to improve the lubricity of the flexible flow-deflecting cover. This polyurethane coating can provide a smooth surface that is flexible, durable, and can be easily inserted into the body. Polyurethane coatings may also be used to add drug delivery capabilities to the flexible flow-deflecting cover. Silicone coatings may be used to improve the biocompatibility of the flexible flow-deflecting cover. This silicone coating can provide a soft, hydrophobic, and non-stick surface. Silicone coatings may also be used to reduce friction during insertion. Hydrophilic coatings may be used to provide lubricity to the flexible flow-deflecting cover. Hydrophilic coatings are designed to attract water to reduce friction and allow for smooth insertion into the body. Hydrophilic coatings can be made from various materials, including polymers and ceramics. Polytetrafluoroethylene (PTFE) coatings can be used on flexible flow-deflecting covers to prevent blood clotting and promote healing. Polytetrafluoroethylene coatings are hydrophobic and provide a non-stick surface that reduces the risk of thrombosis. PTFE coatings can also be used to provide lubrication to the device. Bioabsorbable polymer coatings can be used on flexible flow-deflecting covers to promote healing and reduce the risk of restenosis. Bioabsorbable polymer coatings are designed to gradually dissolve in the body over time, allowing the flexible flow-deflecting cover to be absorbed without leaving any permanent residue.

[0110] Some embodiments may also include a first stabilizer extending from the distal end of the expanding shunt toward the hinge opposite, configured to engage with the inner wall of the first cavity to retain the expanding shunt in the opening. A stabilizer refers to any structural part or element that resists migration. For example, the stabilizer may be designed to engage with the inner wall of the cavity or opening to help secure the shunt in place. In some examples, the first stabilizer may include a flexible or semi-rigid ring in the expanding shunt. The ring may be made of various materials, such as silicone or polymer, and may be configured to fit the shape of the cavity in which the shunt is placed. Additionally or alternatively, the first stabilizer may include one or more flexible arms or protrusions that extend outward and engage with the inner wall of the cavity. These arms or protrusions may act as lips to help anchor the shunt in place, thereby preventing the shunt from moving or displaced due to changes in pressure or other factors. The extending walls of the shunt itself can act as a stabilizer by applying frictional force to the passage where the shunt is located. Once the shunt is correctly positioned, a locking mechanism can be used to secure the shunt in place. For example, the stabilizer may be a ring that locks to a given circumference when the ring extends along this circumference. As another example, the stabilizer may include an arm that seals against the inner wall of the cavity to lock the shunt in place. In this example, the arm may include a cover, such as an extension of a flexible flow deflection cover, to create a liquid seal against the inner wall of the cavity.

[0111] In some embodiments, the second stabilizer includes a flange region extending from the proximal end of the extending shunt into the second cavity, configured to engage with the inner wall of the second cavity to retain the extending shunt in the opening. The flange region refers to a protruding ridge, lip, or rim or edge extending outward from the base. The flange may completely or partially surround the outer periphery of the shunt or may include a series of flange portions that work together for stabilization purposes. The flange region may be formed of the same material as the shunt (e.g., extending metal) and may include a tissue-bonding cover. Alternatively, the flange region may be formed of other flexible or semi-rigid materials, such as silicone or polymer. The base of the flange region may be located on the inner wall of the second cavity, while the protruding rim or edge extends into the second cavity to secure the medical device in place.

[0112] In some embodiments, at least one of the first stabilizer and the second stabilizer comprises a plurality of branches of different lengths. The plurality of branches may refer to any slender or pointed extensions or protrusions extending from the body or base of the shunt or deflector. The branches may be made of the same material as the frame of the shunt or deflector and / or may comprise a flexible material such as silicone or polyurethane. In use, the branches may press against the inner wall of a heart chamber or blood vessel to stabilize the device while limiting tissue damage. The branches of the first or second stabilizer may help redistribute pressure and relieve unwanted vibration or movement, thereby providing smoother and more stable fixation of the intravascular retrograde blood flow device. The branches may differ in length, meaning that at least one branch is longer than the other. Disagreement in length may aid in stabilization. For example, a branch on one side of the stabilizer may be longer than a branch on the other side of the stabilizer, which may increase the need to stabilize one side. Alternatively, the lengths of the branches may alternate to distribute pressure more evenly. As another example, the branches may have an adjustable length that can be modified to fit the geometry of the cavity or blood vessel after being introduced into it.

[0113] In some embodiments, the first stabilizer comprises a plurality of outwardly extending branches, each branch having a distal end bent toward the inner wall of the first cavity. The plurality of outwardly extending branches refer to slender or pointed extensions or protrusions extending from the center lumen of the expanding shunt into the first cavity. Each branch has a distal end bent toward the inner wall of the first cavity such that the tip of the branch extends away from the cavity wall, thereby minimizing the risk of the wall being perforated.

[0114] For example, the extendable shunt (702) of FIG. 7 includes a first stabilizer (714) extending from the distal end (718) of the extendable shunt (702) opposite the hinge (706) to engage with the inner wall of the first cavity and maintain the extendable shunt (702) in the opening between the first cavity and the second cavity. In this example, the extendable shunt (702) includes a second stabilizer (716) including a flange area extending from the proximal end (720) of the extendable shunt (702) into the second cavity to engage with the inner wall of the second cavity and maintain the extendable shunt (702) in the opening between the first cavity and the second cavity.

[0115] As another example, the extendable shunt (812) of FIG. 8A includes a first stabilizer (803) extending from the distal end of the extendable shunt (802) toward the opposite side of the hinge (808) to engage with the inner wall of the first cavity and maintain the extendable shunt (802) in the opening between the first cavity and the second cavity. FIG. 8B shows another example of an extendable shunt (812) including a first stabilizer (813) comprising a plurality of outwardly curved branches extending from the distal end of the extendable shunt (812) toward the opposite side of the hinge (818) to engage with the inner wall of the first cavity and maintain the extendable shunt (812) in the opening between the first cavity and the second cavity. FIG. 8B shows another example of an extendable shunt (812) comprising a first stabilizer (813) including a plurality of outwardly curved branches extending from the distal end of the extendable shunt (812) toward the opposite side of the hinge (818) to engage with the inner wall of the first cavity and maintain the extendable shunt (812) in the opening between the first cavity and the second cavity. FIG. 8C shows another example of an extendable shunt (822) comprising a first stabilizer (823) including a plurality of outwardly directed branches extending from the distal end of the extendable shunt (822) toward the opposite side of the hinge (828) to engage with the inner wall of the first cavity and maintain the extendable shunt (822) in the opening between the first cavity and the second cavity. FIG. 8D shows another example of an extendable shunt (832) comprising a first stabilizer (833) having a plurality of curved outward protrusions having a flow deflection cover (836) extending from the distal end of the extendable shunt (832) toward the opposite side of the hinge (838) to engage with the inner wall of the first cavity and maintain the extendable shunt (832) in the opening between the first cavity and the second cavity. In some embodiments, the tubular shunt (802, 812, 822 or 832) may include an orientation marker that facilitates rotational orientation around the central opening with respect to the relevant position of the flow deflector (804, 814, 824 or 834).The orientation marker may be configured to control the rotational orientation of the tubular shunt (802, 812, 822, or 832) around the central opening. The orientation marker may include, for example, a tantalum marker or a specific structural design at a specific location.

[0116] In some embodiments, the expansion shunt comprises a tubular scaffold, wherein a flexible flow deflection cover extends over the tubular scaffold. The tubular scaffold refers to a structural part or matrix that holds the orifice. The tubular scaffold may be provided to reinforce or support the structural part that forms the framework and shape of the expansion shunt. Any biocompatible material, such as nitinol or stainless steel, which can be compressed or contracted to a smaller size for insertion into the body, may be used for the tubular scaffold. When the expansion shunt is positioned at the opening, the tubular scaffold may expand or inflate to its full size to create a passage through which blood or other body fluids can flow. The tubular scaffold may consist of a series of interconnected struts or wires that form a tubular shape. In some examples, the tubular scaffold may be covered with a thin membrane or implant material that helps seal the device and prevent blood from leaking around the edges. This cover can also provide additional support to openings or other tubular structures to help maintain their shape and prevent shrinkage or blockage.

[0117] It may be desirable for the flexible flow deflection cover to extend over the tubular scaffold to provide additional structural integrity to the connection between the extendable shunt and the extendable flow deflector. It may also be desirable for the flexible flow deflection cover to extend over the tubular scaffold to reinforce the tubular shape of the scaffold. In some examples, the flexible flow deflection cover may extend over the entire tubular scaffold. In other examples, the flexible flow deflection cover may extend over only a portion of the tubular scaffold.

[0118] In some embodiments, the flexible flow deflection cover is further configured to allow at least some non-retrograde blood flow in the second cavity. It may be desirable to allow at least some non-retrograde blood flow in the second cavity to ensure perfusion in the normal blood flow area while providing perfusion in the retrograde blood flow area. In some examples, the flow deflection cover may be configured to allow some non-retrograde blood flow in the second cavity by providing an opening in the flow deflection cover that can be opened or exposed as needed to generate the desired non-retrograde blood flow. In other examples, the flow deflection cover may be scoop-shaped or concave such that when the rotational orientation of the expanding shunt at the opening changes, the scoop-shaped or concave portion of the flow deflection cover blocks less than all blood flow in the normal blood flow direction, thereby enabling non-retrograde blood flow.

[0119] In some embodiments, the expanding flow deflector includes a lip that engages with the wall of the second cavity to help form a seal against the wall of the second cavity. Such a lip may refer to any projection that forms a seal against the wall of the second cavity. For example, the lip may include a ridge or curved edge projected from the edge or surface of the expanding flow deflector. In some examples, the lip may be located along the outer edge of the expanding flow deflector and may extend around the entire circumference of the expanding flow deflector. In other examples, the lip may extend only around the circumference of the expanding flow deflector. The lip is generally located at the distal end of the flow deflector or at the shunt end of the flow deflector. The lip may be desirable to help guide the blood flow in a desired reverse direction while preventing blood flow from leaking over the edge of the expanding flow deflector in the normal blood flow direction. The lip may be formed as an integral part of the expanding flow deflector or may be attached to the edge or surface of the deflector as a separate piece. Various materials, including polymers, metals, or biocompatible coatings, may be used for the lip. Additionally, or alternatively, the lip may be formed into a frame portion covered with fabric or other flexible materials. The lip of the expanding flow deflector can help reduce blood turbulence and recirculation within a second cavity, such as a blood vessel, which can help improve blood flow and reduce the risk of complications such as coagulation or embolism. The lip can also help protect the blood vessel wall from damage caused by turbulent blood flow.

[0120] In some embodiments, the expanding flow deflector comprises a frame configured to maintain an initially compressed form after ejection from the catheter, wherein the device further comprises a release mechanism to selectively expand the expanding flow deflector after the expansion of the expanding shunt. The compressed form refers to a smaller form of the frame prior to expansion at a target location, such as a second cavity. The compressed form is desirable for facilitating deployment through a blood vessel. Once the compressed frame is placed at a target location, such as a second cavity, the compressed frame may be expanded to its full size using various mechanisms, such as balloon expansion, self-expansion using an expanding material that expands when no longer compressed into a structure such as a catheter, and / or expansion using a release mechanism. As the frame expands from the compressed form, the expanding flow deflector may apply force to the wall of the blood vessel or cavity for structural support. The release mechanism refers to a structure or device configured to allow the expanding flow deflector to expand at least partially. In some examples, the release mechanism may include a trigger wire mechanism used to selectively expand the expanding flow deflector after the expansion of the expanding shunt. In this example, the trigger wire, flow deflector, and shunt can initially be crimped together as a crimped system over the guide wire. After the crimped system is inserted between the left atrium and the coronary sinus, the overtube of the guide wire can be pulled back to induce expansion of the crimped system. When ejected from the catheter, the trigger wire associated with the flow deflector can be pulled to release the flow deflector for further expansion. The trigger wire can be expanded through the opening of the flow deflector. Selective expansion of an expandable flow deflector refers to the controlled expansion of one or more components of the flow deflector. For example, the release mechanism may additionally include a controller configured to control the expansion timing of the flow deflector.

[0121] In some embodiments, the expanding frame is configured such that when the catheter is removed in a first direction to cause the expansion of the expansion flow deflector, the expansion frame expands in a second direction different from the first direction. Removing the catheter in a first direction to cause the expansion of the expansion flow deflector may mean sliding the catheter away from the expansion shunt and the expansion flow deflector, removing it, or otherwise separating it to cause the expansion of the expansion shunt and the expansion flow deflector. In one example, removing the catheter in a first direction may involve deploying the intravascular retrograde blood flow device into the opening between the left atrium and the coronary sinus, and then retracting the catheter in a direction away from the left atrium and toward the right atrium in the coronary sinus. In this example, the retraction of the catheter releases the expansion flow deflector so that the expansion frame expands in a direction away from the right atrium in the coronary sinus. By expanding in a direction away from the right atrium, the expanding frame causes the expanding flow deflector to divert the retrograde flow of blood that normally flows from the left atrium toward the right atrium in the coronary sinus away from the left atrium toward the right atrium. In one example, this can be achieved by providing a scoop-shaped flow deflector that expands by bending outward from the opening between the left atrium and the coronary sinus in the opposite direction to the direction in which the catheter is withdrawn from the coronary sinus, i.e., toward the right atrium.

[0122] The disclosed embodiment includes a method for inducing intravascular retrograde blood flow. The method may include the step of perforating an opening between a first cavity and a second cavity before advancing a catheter into the opening. The method may include the step of advancing a catheter into the opening between the first cavity and the second cavity. The method may include the step of releasing an expanding shunt compressed into the catheter from the opening, and releasing an expanding flow deflector from the catheter. The flow deflector may be connected to the expanding shunt by a flexible hinge, and the flexible hinge is configured to be bent so that when the expanding shunt is positioned along a first axis of the opening and the expanding flow deflector is positioned along a second axis crossing the first axis within the second cavity, the flexible hinge can be bent to allow for axial positioning of the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector. The method may include the step of securing the expanding flow deflector in the second cavity.

[0123] FIG. 9 illustrates a flowchart of a method (900) for inducing intravascular retrograde blood flow according to some embodiments of the present invention. The method (900) may include the step (902) of perforating an opening between a first cavity and a second cavity. The method (900) may include the step (904) of advancing a catheter into the opening between the first cavity and the second cavity. The method (900) may include the step (906) of releasing an expanded shunt compressed into the catheter from the catheter in the opening. The method (900) may include the step (908) of releasing an expanding flow deflector connected to an expanding shunt by a flexible hinge from a catheter, wherein the flexible hinge is configured to be bent so that when the expanding shunt is positioned along a first axis of the opening and the expanding flow deflector is positioned along a second axis crossing the first axis within a second cavity, the flexible hinge can be bent to allow for an axial positioning of the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector. The method (900) may include the step (910) of fixing the expanding flow deflector in the second cavity.

[0124] Some disclosed embodiments include a medical device for inducing retrograde blood flow. As used herein, a medical device may refer to any device or apparatus configured to diagnose and / or treat a patient. For example, some medical devices according to the present invention include a part that is placed within or operates inside a blood vessel or other biological structure or organ within the human body for medical purposes. Some medical devices according to the present invention include one or more delivery mechanisms (e.g., a catheter, a sheath, and / or a triggering mechanism). Biological structures to which the disclosed embodiments may be used include, for example, structures containing a cavity. Non-limiting examples of such biological structures include blood vessels, capillaries, arteries, veins, cardiac chambers (e.g., left atrium, left ventricle, right atrium, right ventricle), or any other anatomical organ. The medical device may be configured to be delivered from a first location (e.g., a location outside the body) to a treatment site of the blood vessel or other biological structure. Additionally or alternatively, in some embodiments, the medical device may be configured to induce a temporary or permanent change or deformation at the treatment site of the blood vessel. Some non-limiting examples of components of a medical device according to the present invention may include a shunt, stent, catheter, or any other device configured to be placed within a blood vessel or other biological structure. Retrograde blood flow may include blood flowing or moving in a direction opposite to the natural direction of blood flow in a blood vessel. For example, blood flowing in a direction opposite to the natural blood flow in a vein or artery, including a coronary sinus, is considered retrograde blood flow. Inducing retrograde blood flow may include guiding, circulating, regulating, influencing, or controlling retrograde blood flow opposite to the natural direction of blood flow. In some embodiments, inducing retrograde blood flow may include reversing or diverting the natural flow.

[0125] Some disclosed embodiments include a tube for delivery to a coronary sinus from a first direction. The tube may include any hollow elongated conduit, such as a catheter, sheath, hollow wire, pipe, probe, cannula, or other channel structure, which can be used to deliver fluid. For example, the tube may include a catheter in the form of a flexible tube configured to be inserted into a body cavity, such as a coronary sinus. As an example, FIG. 12 shows a catheter-shaped tube (1202) for insertion into a coronary sinus. The tube (1202) may include a hollow lumen configured to accommodate additional components of a medical device for inducing retrograde blood flow, as illustrated in FIG. 12. The first direction may refer to a point where an object such as a tube moves to or from. FIG. 13 shows an example of a first direction (1308) extending along the coronary sinus (1304) toward the right atrium and between the orifice (1318) coming from the right atrium. Delivering a tube from the first direction to the orifice of the coronary sinus may involve advancing, advancing, pushing, pulling, driving, forcing, displacing, or moving the tube from the first direction to the orifice of the coronary sinus in any other way. For example, delivering a tube (1306) to the coronary sinus (1304) may involve sliding the tube (1306) into the coronary sinus (1304) and through an orifice bridging the coronary sinus and the left atrium to the heart chamber or particularly the left atrium.

[0126] Some disclosed embodiments include an expandable structure that is compressed into a tube. An expandable structure may refer to any structure, device, or component that can be expanded or extended from a compressed form. Such devices may be extendable, elongable, extensible, expandable, or expandable. An example of an expandable structure is a wire or mesh structure, such as a stent, that can be expanded to a larger diameter. Another example of an expandable structure is a folded or compressed structure that can be extended or unfolded to become larger. As an example, FIG. 12 shows an expandable structure (1204), which is a compressed structure made of interconnected struts configured to expand to make the expandable structure (1204) larger. Being compressed into a tube may mean contracting, compressing, shrinking, restraining, crimping, narrowing, packing, pressurizing, reducing, folding, or tightening in other ways into a tube. Compression may occur by packing the expandable structure into a tube by folding at least one component of the expandable structure into, around, or along another component of the expandable structure. As an example, FIG. 12 shows the expandable structure (1204) being compressed into the tube (1202) by reducing the distance between the struts of the expandable structure (1204) to contract the expandable structure (1204) into the tube (1202). For example, the expandable structure may be formed of a shape memory alloy that returns to its original shape when released.

[0127] Some disclosed embodiments include a scaffold portion for maintaining an orifice between the coronary sinus and the heart chamber. The scaffold portion may include any frame, body, cage, enclosure, mount, contour, shell, setting, mesh, or other structural part configured to maintain the opening. For example, the scaffold portion may be a tubular mesh. As another example, the scaffold portion may be a frame of connected struts arranged in cylindrical tubes. As an example, FIG. 12 shows an example of a scaffold portion (1206) compressed into a tube (1202) made of a series of interconnected struts. The orifice may include an aperture, cavity, fissure, hole, mouth, exit, inlet, slit, spout, vent, aperture, perforation, cleft, cut, rupture, gap, perforation, slit, slot, space, or any other opening through which something can pass. As an example, the orifice may include an opening between two body cavities. FIG. 13 shows an example of an orifice (1318) between the heart chamber (1302) and the coronary sinus (1304). Maintaining an orifice between the coronary sinus and the heart chamber may include preserving, protecting, maintaining, supporting, sustaining, supporting, shielding, preserving, extending, or otherwise keeping the orifice between the coronary sinus and the heart chamber open. For example, maintaining may include inserting a scaffold portion into the opening to preserve the opening between the coronary sinus and the heart chamber. As an example, FIG. 13 illustrates a scaffold portion (1314) that maintains the opening (1318) between the heart chamber (1302) and the coronary sinus (1304) by extending into the opening (1318) so that the opening (1318) is open to blood flow between the heart chamber (1302) and the coronary sinus (1304).

[0128] Some disclosed embodiments include a flow deflector portion configured to induce retrograde blood flow in a coronary sinus, wherein the flow deflector portion is configured to be deployed in a second direction other than the first direction while the tube is withdrawn in a first direction. The flow deflector portion includes any structural part that deflects, redirects, occludes, blocks, obstructs, reduces, or inhibits fluid flow temporarily or for a predetermined period. In some embodiments, the flow deflector portion may partially block or obstruct blood flow in a vessel. The flow deflector portion may include a temporary or permanent, static, expandable, inflatable, or other adjustable plug, disc, patch, or other mechanism for achieving deflection as described above. For example, the flow deflector portion may be a rigid or semi-rigid surface configured to restrict or block blood flow in one direction of the coronary sinus. As another example, the flow deflector portion may be an adjustable plug configured to obstruct a variable amount of flow in one direction of the coronary sinus. As another example, the flow deflector may be an arc-shaped or flat surface sized to cross the coronary sinus in a direction perpendicular to the longitudinal axis of the coronary sinus. The surface is generally at least partially impermeable to blood so as to block blood flow in a first direction.

[0129] Some embodiments include a flow deflector portion configured such that the flow deflector portion can be deployed in a second direction rather than the first direction while the tube is being withdrawn in a first direction. In some embodiments, the flow deflector portion can be deployed in a second direction rather than the first direction without affecting the tube withdrawal. In some embodiments, the flow deflector is configured to have some flexibility at the distal edge of the flow deflector so as to be biased to the curvature of the coronary sinus. In some embodiments, the flow deflector has a tool passage. In some embodiments, a delay or controlled extension of the flow deflector enables this property.

[0130] FIG. 12 shows an example of a flow deflector portion (1208) compressed into a tube (1202). As illustrated in FIG. 12, the flow deflector portion (1208) may be a bendable flap extending from the distal end of a scaffold portion (1206) that folds into a scaffold portion (1206) when compressed into the tube (1202). FIG. 13 shows an example of a flow deflector portion (1310) in an extended form or not compressed into a tube (1306). As illustrated in FIG. 13, the flow deflector portion (1310) may form an obstruction within the coronary sinus (1304) to divert blood flow from the heart chamber (1302) from a first direction (1308) to a second direction (1312).

[0131] In some embodiments, the distal edge of the flow deflector portion is biased to the curvature of the coronary sinus. Being biased to the curvature of the coronary sinus means being extended, formed, bent, curved, twisted, or formed into other shapes to contact the curved wall of the coronary sinus. This biased distal edge of the flow deflector portion enables an improved fluid seal to prevent blood leakage in the normal blood flow direction and to guide diverted blood in the reverse direction. The biased distal edge may also have e to accommodate a tube drawn out in a first direction below the biased distal edge. In this case, sufficient elasticity is provided to ensure minimal damage to the fluid seal to prevent blood leakage in the normal blood flow direction when the tube is drawn out. For example, the distal edge of the flow deflector portion may be lip-shaped to be within the curved wall of the coronary sinus. FIG. 13 shows an example of a lip-shaped distal edge (1316) of a flow deflector (1310) biased to the curvature of the coronary sinus (1304). As illustrated as an example in FIG. 14A and FIG. 14B, the distal edge (1410) of the flow deflector (1404) may include a curve bent outward from the concave portion of the flow deflector (1404) to provide additional fixation to the coronary sinus.

[0132] The flow deflector portion may induce retrograde blood flow in the coronary sinus by deflecting, diverting, blocking, blocking, obstructing, reducing, or inhibiting blood flow in the normal direction. For example, the flow deflector portion (1310) may induce retrograde blood flow in the coronary sinus (1304) by blocking normal blood flow moving through the first direction (1308) from the heart chamber (1302) and causing blood flow in the coronary sinus (1304) in the opposite direction to the first direction (1308). In some embodiments, the flow deflector portion is configured to have a tube or a tool passage through which the tube can pass while blocking normal blood flow. The tube passage may include any shape or structure adapted to allow the tool to pass through after deployment without substantially compromising the liquid-tight seal or flow deflection. Examples of tool passages include, but are not limited to, one-way valves, duckbill valves, stepped shutters, or two or more layered materials (each individual layer having a slot positioned at an angle of about 90 degrees to the other layer), holes and plugs, or other suitable open seals. Other approaches to tool passages, such as two partially overlapping layers configured to allow manipulation so as not to overlap with the position through which the tool passes, are also conceived for use with the disclosed embodiments.

[0133] Pulling the tube out in the first direction may mean pulling, retracting, evacuating, sliding, contracting, or otherwise removing the tube in the first direction. When the expandable structure is positioned in the desired location, the tube may be pulled out in the first direction to limit the number of objects within the body. For example, FIG. 13 shows an example of pulling the tube (1306) through the coronary sinus (1304) to pull the tube (1306) out in the first direction (1308). Deploying the flow deflector portion in a second direction other than the first direction may mean causing the flow deflector portion to expand, open, extend, spread, fan, diffuse, form, or otherwise expand in a direction opposite to or different from the first direction. In some examples, deploying the flow deflector portion is achieved by pulling the tube out in the first direction. In other examples, deploying the flow deflector portion is achieved by further operating the flow deflector portion. As an example, FIG. 13 shows that after the tube (1306) is drawn out in the first direction (1308), the flow deflector portion (1310) can be extended in the second direction (1312) which is not the first direction (opposite to the first direction in the figure).

[0134] A second direction opposite to the first direction refers to a second direction facing in the opposite direction to the first direction. Therefore, in this context, opposite does not necessarily mean opposite in a mathematical sense. For example, if the second direction is upstream based on the natural flow of the blood vessels, the first direction may generally be downstream based on the natural flow of the blood vessels. It is desirable to induce retrograde blood flow in a second direction opposite to the first direction to enable perfusion to the heart or body parts opposite to normal blood flow. For example, inducing retrograde blood flow in a second direction opposite to the first direction may involve reversing blood flow from the left atrium to the right atrium, through the coronary sinus, toward the posterior collateral branch. As an example, FIG. 13 shows a flow deflector (1310) that induces retrograde blood flow in a second direction (1312) opposite to the first direction (1308).

[0135] In some embodiments, the flow deflector portion is configured to expand in a second direction by sweeping in the opposite direction to the first direction. Sweeping means moving or expanding in a curve. For example, the flow deflector portion may expand in a second direction by bending from a folded or compressed shape to a shape that unfolds or expands in the opposite direction to the first direction, such as flower petals expanding from a bud. As an example, FIG. 13 illustrates a flow deflector (1208) compressed into an expandable structural portion (1204) that can open outward from a folded shape and expand in a second direction.

[0136] In some embodiments, the flow deflector portion is arc-shaped, and the concave portion of the arc shape is configured to sweep in a second direction. The arc shape refers to a curved, arched, bent, crescent-shaped, rounded, or otherwise curved shape. For example, the flow deflector portion may be formed rounded, such as the circumference of a part of a circle. The concave portion of the arc shape refers to a cavity, recess, sunken portion, hollow portion, hollow portion, or other curved surface of the arc shape of the flow deflector portion. For example, the concave portion of the rounded flow deflector portion may be an internal curvature. An arc-shaped flow deflector portion with a concave portion is desirable for the smooth movement of blood within the coronary sinus. As an example, the flow deflector portion (1310) of FIG. 13 is a curved petal shape extending from the scaffold portion (1314), and the concave portion of the flow deflector portion (1310) sweeps in a second direction (1312). In another example, the flow deflector portion (1916) of FIG. 19 is a concave sail shape attached to a portion of the circumference of the scaffold portion (1912) and extending toward the distal edge of the flow deflector, wherein the concave portion of the flow deflector portion sweeps in a second direction (1924) opposite to the first direction (1926) in the coronary sinus. In another example, the flow deflector portion (816) is configured so that the tube is drawn out in the first direction (811) and the flow deflector portion (816) can be deployed in a second direction (810) other than the first direction (811). In another example, the flow deflector portion (816) is configured so that after the tube is drawn out in the first direction (811), the flow deflector portion (816) can be deployed in a second direction (810) other than the first direction (811).

[0137] In some embodiments, the flow deflector portion is configured to partially expand when discharged from the tube. Partial expansion of the flow deflector portion after discharge from the tube may include restricted, controlled, local, limited, or otherwise incomplete opening or expansion of the flow deflector portion. It may be desirable to keep the flow deflector portion in a partially expanded state to properly align or position the scaffold portion or the flow deflector portion before the flow deflector portion is fully expanded and comes into contact with the wall tissue of the coronary sinus.

[0138] In some embodiments, when the trigger wire is pulled after partial expansion, the flow deflector portion is further expanded. The trigger wire refers to a line, cable, thread, tube, coil, or other strand or slender structure or combination of structures that causes action resulting from the expansion of the flow deflector upon operation (causing further expansion of the flow deflector portion already partially expanded in this example). For example, the trigger wire may be a cable connecting two parts of an expandable structure configured to activate the movement of one of the two parts of the expandable structure. As an example, FIG. 12 illustrates a trigger wire connected to a flow deflector portion (1208) that causes the flow deflector portion (1208) to be further expanded when pulled after the flow deflector portion has been partially expanded by pulling the tube in a first direction. In some embodiments, activation may occur indirectly in that the trigger wire may be connected to another structure that causes the trigger wire to move upon movement.

[0139] In some embodiments, an inner tube is positioned within an expanding structure, wherein a trigger wire has one end connected to a flow deflector section and the other end connected to the inner tube. The inner tube refers to any wire, cylinder, duct, pipe, conduit, or cable within the expanding structure. The inner tube may be provided to provide additional structural stability to the compressed state of the expanding structure when positioned within the tube. The inner tube may also be provided as a simple mechanism for fully expanding the components of the expanding structure without inserting additional tools into the tube during expansion. As an example, FIG. 12 illustrates an inner tube (1212) positioned within an expanding structure (1204) having an inner wire (1210) with one end connected to a flow deflector section (1310) and the other end connected to an inner tube (1212).

[0140] In some embodiments, the trigger wire is configured to release the flow deflector portion to expand it to an expanded state when the inner tube is retracted from the expansion structure. Retraction of the inner tube refers to removing the inner tube, such as by pulling, sliding, or tucking the inner tube from the expansion structure. Retracting the inner tube from the expansion structure to release the flow deflector portion to an expanded state is desirable because it avoids causing expansion by inserting additional tools into the tube. For example, in FIG. 12, the trigger wire (1210) is configured to release the flow deflector portion (1208) to expand it to an expanded state when the inner tube (1212) is retracted from the expansion structure (1204).

[0141] In some embodiments, a mechanism is provided for delaying the deployment of a flow deflector portion until the tube is removed. The mechanism refers to any part or process used to influence a desired result, such as delaying the deployment of the flow deflector portion until the tube is removed. Delaying deployment refers to reducing, pausing, extending, or otherwise postponing the deployment of the flow deflector portion until the tube is removed. For example, the mechanism may be a catch portion, such as a clasp.

[0142] In some embodiments, a catch portion is provided to maintain the flow deflector portion in a partially unextended form when discharged from the tube, and a trigger wire is provided connected to the catch portion and extending through the tube in a first direction, wherein the trigger wire is configured to expand the flow deflector portion in a second direction when pulled from the first direction. The catch portion refers to a structural portion or component that joins two or more objects or surfaces while allowing the two or more objects or surfaces to be separated. For example, the catch portion may be a gripper configured to secure two portions of the expandable structural portion together and release the connection of the two portions automatically or by user action, such as pulling the gripper. The configuration of the catch portion and the trigger wire may be used to expand the flow deflector portion to release the flow deflector portion in a slow and controlled manner in a coronary sinus. FIG. 12 shows an example of a catch portion (1214) for maintaining the flow deflector portion (1208) in a partially unextended form when discharged from the tube (1202), and a trigger wire (1210) connected to the catch portion and extending through the tube (1202) in a first direction, wherein the trigger wire (1210) is configured such that the flow deflector portion (1208) expands in a second direction when pulled from the first direction. In this example, the catch portion (1214) is a curved strut of a scaffold portion (1206) that maintains the flow deflector portion (1208) in a compressed state within the tube before the wire (1210) is pulled from the first direction.

[0143] In some embodiments, a controller is configured to control the expansion timing of the flow deflector portion. A controller refers to any mechanical or electrical component that directs or regulates the expansion timing. Such a controller may be located on a handle for deployment outside the body so that a physician can selectively trigger the deployment of the flow deflector through rotation, twisting, pulling, pressing, or other actions that result in the deployment of the flow deflector portion. Thus, the controller may include one or more of a button, dial, switch, lever, rotatable or sliding sleeve, or any other structural component capable of converting the operator's physical action into the expansion of the flow deflector portion. Expansion timing refers to a time, duration, schedule, arrangement, plan, program, or other selection, judgment, or control regarding the point in time when the flow deflector portion is expanded. Thus, the physician may delay the full expansion of the flow deflector until an appropriate time. As another example, in some embodiments, expansion timing may include how quickly the flow deflector portion is expanded, the time at which the flow deflector portion is expanded, and / or a plan to partially expand the flow deflector portion and then fully expand it.

[0144] In some embodiments, the expansion structure further includes a stabilizer portion on the side of the scaffold portion opposite the flow deflector portion. The stabilizer portion refers to any structure or component configured to at least partially fix at least one part of the expansion structure in a specific position or rotational orientation, or otherwise prevent at least one part of the expansion structure from migrating, moving, or rotating. In some embodiments, the scaffold portion is generally annular or tubular, having a distal end opposite the flow deflector and a distal end near the flow deflector. The side of the scaffold portion opposite the flow deflector portion refers to a position that is opposite to the flow deflector portion, far from the flow deflector portion, opposite to the flow deflector portion, or across the flow deflector portion. It is desirable to provide a stabilizer portion on the side of the scaffold portion opposite the flow deflector portion to help fix the expansion structure on this side or to resist migration or movement caused by blood flow pressure. For example, FIGS. 14A and 14B show different views of an extended structure (1400) including a stabilizer portion (1406) on the side of the scaffold portion (1402) opposite the flow deflector portion (1404). In the example of FIGS. 14A and 14B, the stabilizer portion (1406) has a circumference that widens outward from the scaffold portion (1402) to secure the scaffold portion (1402) to the opening between the heart chamber and the coronary sinus.

[0145] In some embodiments, the stabilizer portion comprises a plurality of outwardly extending branches, and each branch has a distal end bent so that, upon expansion, the plurality of outwardly extending branches have at least a portion facing the inner wall of the heart chamber. The plurality of outwardly extending branches refer to extensions or protrusions extending from the central lumen of the scaffold portion to the heart chamber. In some embodiments, the series of branches extend in different directions. Depending on the number of branches, the branches may have at least a slender / tipped or pointed portion. Each branch may have a distal end bent toward the inner wall of the heart chamber, and the tips of the branches extend away from the cavity wall to minimize the risk of wall perforation. As an example, FIGS. 14A and FIGS. 14B illustrate a stabilizer portion (1406) comprising a plurality of outwardly extending branches (1408), each branch (1408) having a distal end bent so that, upon expansion, the plurality of outwardly extending branches face the inner wall of the heart chamber. Alternatively, some or all branches may have tips configured to face the wall.

[0146] In some embodiments, the scaffold portion and the flow deflector portion are configured to expand after the expansion of the stabilizer portion. The expansion of the stabilizer portion refers to any enlargement of the stabilizer portion, such as, for example, the transition of the stabilizer portion from a crimped or compressed shape to an uncrimped or uncompressed shape. The scaffold portion and the flow deflector portion may be expanded after the stabilizer portion has expanded so that the position of the expandable structure can be fixed using the stabilizer portion first before expanding the remaining components (w). This can reduce trauma that may occur if the entire expandable structure is repositioned in the event of inefficient initial deployment. For example, the tube is drawn out in a first direction by an amount at least corresponding to the length of the stabilizer portion, so that the stabilizer portion expands into the inner wall of the heart chamber and the expandable structure is fixed in place. Then, the tube may be drawn out further in the first direction so that these components can be expanded without repositioning the scaffold portion and the flow deflector portion into the opening or coronary sinus.

[0147] Some embodiments further include at least one extension on the side of the scaffold portion identical to the flow deflector portion to help stabilize by contacting the inner wall of the coronary sinus. An extension refers to an appendage, arm, branch, expansion, elongation, extension, wing, lip, or any other structural part. It may be desirable to provide such an extension for the purpose of stabilizing the device. For example, at least one extension may work in conjunction with a stabilizer at the distal end of the scaffold portion to hold the structural part in place. At least one extension may be provided as a lip structural part (e.g., a series of branches) that contacts the upper wall portion of the coronary sinus adjacent to the scaffold. Additionally or alternatively, at least one extension may include an extension extending from the flow deflector that forms part of the flow deflector frame that contacts the lower portion of the coronary sinus wall. For example, FIG. 14A illustrates a series of branches (1412) positioned on the periphery edge on the side of the scaffold portion (1402) identical to the flow deflector portion (1404). In some embodiments, one or more branches may be shorter in length than one or more other extensions. Generally, the extension along the circumference of the scaffold toward retrograde blood flow is shorter in length than the one located on the circumference of the scaffold toward the first direction (i.e., the tube withdrawal direction). These branches serving as extensions of the scaffold portion (1402) may be similar to the branches (1408) of the stabilizer portion (1406) in that all of the sets of branches come out from opposite sides of the scaffold portion (1402) and cooperate to stabilize the scaffold (1402) in the passage (1322) or to stabilize the position of the flow deflector within the coronary sinus as illustrated in FIG. 13. Additionally or alternatively, at least one extension may include a distal end (1922) of the flow deflector (1916) or a distal end (1410) of the flow deflector portion (1404) in a direction facing the second direction, provided that the extension is configured to engage with the wall of the coronary sinus.The distal end (1410) or distal end (1922) of the flow deflector may or may not be covered with material as described herein. In some embodiments, the distal end (1410) or distal end (1922) of the flow deflector may be identified as having a distinct structural part different from the flow deflector portion (1404 or 1916). In other embodiments, the distal end (1410) or distal end (1922) may not be distinguishable from the flow deflector portion (1404 or 1916), but even in this case, if the distal end (1410 or 1922) engages with the wall of the coronary sinus, it is still considered as the extension discussed herein that extends further than would be possible if the distal end simply touched the wall. In another embodiment, the distal end (1410) or the distal end (1922) may not be distinguishable from the flow deflector portion (1404 or 1916), but even in this case, when the distal end (1410) or the distal end (1922) engages with the wall of the coronary sinus, it is still considered as the extension discussed herein that can have a greater force than it would have if the distal end (1410) or the distal end (1922) simply touched the wall.

[0148] In some embodiments, the extension is located at the distal end of the flow deflector portion and is configured so that the extension can protrude in a second direction after the tube is drawn out in a first direction. In some embodiments, where the flow deflector has two or more distal ends as shown in (1916), the extension is located at the distal end of the flow deflector portion facing the second direction, for example, at the distal end (1922). At least one extension extends in the second direction to provide additional fixation of the flow deflector portion in the coronary sinus and may act as an additional stabilizing structure in the coronary sinus. Additionally, when the extension extends in the second direction, it may further help to induce flow in a reverse direction opposite to the first direction in which the tube is drawn out. As an example, FIG. 13 shows an extension (1320) that extends in a second direction (1312) after the tube (1306) is drawn out in a first direction (1308).

[0149] In some embodiments, at least one extension is located at the circumferential edge of the scaffold portion and is configured to fully expand before the flow deflector portion fully expands in the coronary sinus.

[0150] Fully expanded means expanding to a maximum size. It may be desirable for the extension to be fully expanded before the flow deflector portion is fully expanded in the coronary sinus so that the scaffold portion is stabilized before the flow deflector deployment. For example, the branch (1320) may be fully expanded after the tube (1306) is withdrawn, whereas the flow deflector portion (1310) may be partially released so as not to come into contact with the wall of the coronary sinus (1304). This configuration allows for the device fixation and repositioning of the flow deflector portion (1310) in the coronary sinus (1304) while limiting tissue damage to the wall of the coronary sinus (1304).

[0151] In some embodiments, a flexible fluid-impermeable cover is placed over an extendable structure. The flexible fluid-impermeable cover refers to a fabric cover or any flexible material configured to wrap around or be connected to a component of the extendable structure and to block the passage of fluid at least partially. In some embodiments, partial or substantial impermeability of the flexible cover to fluid may aid in the desired reverse blood flow direction. For example, a flexible cover that is partially impermeable to blood flow may cause a portion of the blood flow through the flexible cover to be blocked and diverted by the flexible cover. As another example, a flexible cover that is substantially impermeable to blood flow may cause all blood flow through the flexible cover to be blocked and diverted by the flexible cover. Some examples of flexible fluid-impermeable covers include latex, polyethylene, polyurethane, or other flexible or polymeric materials. The flexible fluid-impermeable cover may extend over part or all of the extendable structure. In some cases, the flexible fluid impermeable cover may extend only over the flow deflector portion. In other cases, the flexible fluid impermeable cover may extend over both the flow deflector portion and the scaffold portion. As an example, FIGS. 14A and 14B show a flexible fluid impermeable cover (1414) that extends over the scaffold portion (1402), the flow deflector portion (1404), and the stabilizer portion (1406) and reinforces the structure of these components together.

[0152] Some disclosed embodiments include a method for inducing retrograde blood flow. FIG. 15 illustrates a flowchart of an exemplary method (1500) for inducing retrograde blood flow. In step (1502), the method (1500) may include the step of perforating an orifice between the coronary sinus and the heart chamber. The step of perforating the orifice may include forming an opening between the coronary sinus and the heart chamber by penetrating, perforating, piercing, cutting, tearing, fragmenting, lancing, or other methods. For example, a surgeon may use a cutting device, such as a blade, to cut an opening between the coronary sinus and the heart chamber. As another example, a cutting device, such as a sharp edge, may be provided at the end of a tube comprising an expanding structure described herein, wherein the sharp edge may be used to penetrate the tissue between the coronary sinus and the heart chamber and to create an aperture inside. An example of the resulting aperture is shown in FIG. 13 as a hole (1318) between the coronary sinus (1304) and the heart chamber (1302).

[0153] In step (1504), the method (1500) may include the step of delivering a tube into a coronary sinus from a first direction, wherein the tube has an expanding retrograde blood flow device inside, and the retrograde blood flow device includes a scaffold portion and a flow deflector portion. The step of delivering the tube may include moving the tube into the coronary sinus from the first direction as described herein. For example, step (1504) may include sliding the tube (1306) into the coronary sinus (1304) as illustrated in FIG. 13. As illustrated in FIG. 12, an exemplary tube (1202) having an expanding retrograde blood flow device (1204) inside, including a scaffold portion (1206) and a flow deflector portion (1208), may be slid into the coronary sinus.

[0154] In step (1506), the method (1500) may include the step of partially ejecting the retrograde blood flow device from the tube so that the scaffold portion is deformed from a compressed state inside the tube to an expanded state outside the tube, so that the flow deflector portion is maintained in a partially expanded state outside the tube. Partial ejection and expansion may include restricting, controlling, localizing, limiting, or otherwise incompletely opening or expanding a portion of the retrograde blood flow device. It may be desirable to maintain the flow deflector portion in a partially expanded state to properly align or position the scaffold portion or the flow deflector portion before the flow deflector portion is fully expanded and comes into contact with the wall tissue of the coronary sinus. For example, step (1506) may include the step of pushing only the scaffold portion of the retrograde blood flow device out of the tube so that the scaffold portion is expanded from a crimped shape inside the tube to an uncrimped or expanded shape outside the tube, so that the flow deflector portion is maintained in a compressed or folded shape outside the tube.

[0155] In step (1508), the method (1500) may include the step of maintaining an orifice between the coronary sinus and the heart chamber using a scaffold portion. This maintaining step may include causing or enabling an orifice between the coronary sinus and the heart chamber as described herein. For example, FIG. 13 illustrates maintaining an opening (1318) between the heart chamber (1302) and the coronary sinus (1304) by extending a scaffold portion (1314) within the opening (1318) so that the opening (1318) remains open to blood flow between the heart chamber (1302) and the coronary sinus (1304).

[0156] In step (1510), the method (1500) may include the step of withdrawing the tube in a first direction. The step of withdrawing the tube may include removing the tube in the first direction as described herein. For example, FIG. 13 shows an example of withdrawing the tube (1306) in the first direction (1308) by pulling the tube (1306) through the coronary sinus (1304).

[0157] In step (1512), the method (1500) may include a step of further extending the flow deflector portion in a second direction rather than the first direction. The step of further extending the flow deflector portion may include further expanding the flow deflector portion. This additional expansion may be achieved in the same way as the portion expansion or in a different way from the portion expansion. As an example, the step of further extending the flow deflector portion may include pulling out the tube (1202) in the first direction and then pulling the trigger wire (1210) attached to the catch portion (1214) to extend the flow deflector portion (1208) so that the flow deflector sweeps in the second direction opposite to the first direction.

[0158] In step (1514), the method (1500) may include a step of inducing retrograde blood flow in the coronary sinus using a flow deflector part. The step of inducing retrograde blood flow may include forming, generating, inducing, causing, or otherwise inducing retrograde blood flow in the coronary sinus using a flow deflector part. The flow deflector may be used to induce retrograde by physically obstructing normal blood flow to block normal blood flow or by diverting blood flow to flow in a different direction, such as the direction of retrograde blood flow. For example, the method (1500) may include a step of blocking blood flow in the first direction (1308) between the heart chamber (1302) and the coronary sinus (1304) by using a flow deflector (1310) to block blood flow so that the blood flow is diverted into retrograde blood flow in the second direction (1312). As another example, the flow deflector portion (1310) may be curved to further induce retrograde blood flow in the coronary sinus (1304) by providing a curved surface or scoop shape that guides blood flow in the direction (1312).

[0159] The disclosed embodiments may include a device and a method for inducing intravascular retrograde blood flow. In some embodiments, the device and the method are configured to enable retrograde blood flow by maintaining a passage connecting two organs through a pressure gradient while simultaneously blocking natural blood flow in the second organ. The term “intravascular” refers to within a blood vessel. Such vessels may include veins, arteries, capillaries, or other biological ducts through which blood flows. Retrograde blood flow may involve blood flowing or moving in a direction opposite to the natural direction of blood flow within a blood vessel. For example, blood flowing in a direction opposite to natural blood flow in a vein or artery, including a coronary sinus, is considered retrograde blood flow. Some embodiments may include a tubular shunt portion. In some embodiments, the shunt is a device that diverts the flow of body fluids. The shunt portion includes a complete shunt or any shunt portion. For example, the shunt portion may divert blood flow between two adjacent organs. Adjacent organs may be any two biological structures located next to each other. Examples of organs may include blood vessels, anatomical cavities, and anatomical chambers. In some embodiments, the tubular shunt portion may include a tubular or annular passage forming a central opening adapted to allow fluid flow. For example, the tubular portion may enable fluid flow, including blood flow. In some embodiments, the shunt portion may be tubular in shape and may include side walls. A structural portion may be considered tubular within the meaning of the invention if there is a wall or outer wall defining the intermediate channel regardless of the contour of the intermediate channel. The wall may be unperforated or perforated. For example, a structural portion such as a series of wire struts or thin wires may generally form a tubular scaffold up to the extent that the outer structural portion borders the intermediate channel. Even if the channel is deformed, the structural portion is still considered tubular for the purposes of the invention.

[0160] In some embodiments, the tubular shunt portion may be configured to deploy into a passage between the trachea and an adjacent blood vessel. The shunt portion may be configured to deploy into the passage if it is configured in a manner (features and appropriate size and shape) such that it can be positioned in the passage. The passage may be pre-existing or may be surgically formed in connection with deployment. In some embodiments, the surgically formed portion may include a perforation device for forming a surgical opening prior to deployment. In some embodiments, the shunt portion may be configured to deploy in association with a delivery device configured to deploy the shunt portion into the passage. In some embodiments, the delivery device may be configured to maintain a modified shape or orientation of the shunt portion to enable delivery into the passage. For example, the shunt portion may be configured to expand after being compressed or contracted into the delivery device to enable transcutaneous delivery. The passage may include a channel, a surgically formed orifice, or other opening that allows fluid flow between the trachea and the blood vessel. Examples of the trachea may include blood vessels, anatomical cavities, and / or anatomical chambers including the heart chamber. Adjacent vessels may include veins, arteries, capillaries, arterioles, and venules located next to other organs or vessels. Vessels may include coronary sinuses. In one example, a passage may be formed between the coronary sinus and the left atrium or left ventricle. In another example, the device is configured to deploy specifically in the passage between the coronary sinus and the left atrium. A bridge may occur within a vessel or cavity, meaning the interior or inner side of the vessel or cavity. For example, the interior of a vessel may be a channel of the vessel through which blood flows. Bridging the cavity and the vessel may include a link, interfacing, or connection. Such a bridge may occur by forming a hole, cutout, channel, or gap, or may occur using an existing hole, cutout, channel, or gap.For example, bridging the cavity of an organ and the interior of a blood vessel may include connecting the cavity of the organ to the interior of the blood vessel, and in some embodiments may include allowing fluid flow or material transport between the organ and the blood vessel.

[0161] FIG. 16 illustrates an exemplary embodiment of a component of the heart. The heart (1600) may include various chambers, cavities, veins, arteries, and passages. For example, the heart (1600) may include a left atrium (1610), a right atrium (1612), a left ventricle (1616), a coronary sinus (1614), and a posterior interventricular vein (PIVV) (1620). A passage may include an opening in the heart (1600) that may be adjacent to a blood vessel such as the coronary sinus (1614). In some embodiments, a passage may include an opening in the heart (1600) that may be adjacent to the coronary sinus (1614) separated from the PIVV (1620) so that a flow deflector does not come into contact with the coronary sinus wall in the PIVV area. In some embodiments, the tubular shunt portion (1618) can bridge the passage between the left atrium (1610) and the coronary sinus (1614).

[0162] The disclosed embodiments may include a stabilizer configured to secure a tubular shunt portion to a passage. The stabilizer may include any structural part that anchors, supports, attaches, fastens, secures, and / or prevents movement or migration. In some embodiments, the stabilizer may include a flange or a projection. The stabilizer may be configured to secure a tubular shunt portion to a passage. For example, securing may include fastening, joining, anchoring, or retaining to prevent or resist movement. The stabilizer may secure the tubular shunt portion to a passage, e.g., a vein or other blood vessel, to resist the tubular shunt portion moving away from the passage. In some embodiments, the stabilizer may include a flange at the distal end of the tubular shunt portion. The flange may include a lip, rim, brim, projection, projection, or other extension. The flange at the distal end of the tubular shunt portion is the shunt region that is furthest from the direction of implantation when the device is implanted into a cavity from a blood vessel, or the end region of the device in the cavity. In some embodiments, the flange may be configured to engage with the inner wall of the organ cavity. Engaging with the inner wall may include having at least a portion in contact with the inner wall of the cavity (e.g., the inner wall of the heart chamber). In some embodiments, engaging may also include forming an anchoring, fastening, coupling, or other connection with the interior of the organ, such as the inner wall of the heart chamber. Alternatively or additionally, stabilization may occur through contact with or engaging with the wall of the passage. For example, the stabilizer may resist the migration of the shunt portion out of the passage by applying a restraining force to the surface of the inner wall of the atrium or, alternatively or additionally, to the wall of the passage. Thus, the stabilizer may be configured to ensure that the shunt portion and / or the flow deflector portion does not migrate despite the application of pressure.

[0163] FIG. 17 illustrates an exemplary embodiment of the deployment location of an intravascular retrograde blood flow device according to an embodiment of the present invention. The retrograde blood flow device (1700) may be deployed in a passage (1716) and may include a tubular shunt portion (1714), a stabilizer (1718), and a flow deflector portion (1720) as described herein. The retrograde blood flow device (1700) may be deployed between a cavity and a blood vessel, for example, between a cavity (1710) and a coronary sinus (1712). In some embodiments, the cavity (1710) may be a heart chamber. The tubular shunt portion (1714) may bridge the cavity (1710) with the interior (1728) of the coronary sinus (1712). A stabilizer (1718) including an associated flange (1719) can secure a tubular shunt portion (1714) in a passage (1716). The flange (1719) can engage with an inner wall (1726) of a cavity (1710). For example, the flange (1719) can apply stabilizing pressure to the inner wall (1726), or in some embodiments, penetrate the inner wall (1726), which may be an inner wall of a cavity such as a heart chamber. A series of stabilizers (1718) and associated flanges (1719) may be arranged at the distal end of the tubular shunt portion (1714) to cooperate in stabilizing the shunt portion (1714) in the passage (1716).

[0164] The disclosed embodiments may include a flow deflector portion connected to the proximal end of a tubular shunt portion. The flow deflector portion includes any structural part that deflects, redirects, blocks, obstructs, impedes, reduces, or inhibits fluid flow. In some embodiments, the flow deflector portion may partially block or impede blood flow in a blood vessel. The flow deflector portion may include any temporary or permanent, static, expandable, inflatable, or other adjustable plug, disc, patch, or other mechanism for achieving deflection as described above. In some embodiments, the flow deflector portion may be connected to the proximal end of a tubular shunt portion. The proximal end refers to the region opposite to the distal end of the tubular shunt portion as previously described. The region may be part of the tubular shunt portion or an extension of the tubular shunt portion. For example, in some embodiments, the flow deflector portion may be fully connected to the proximal end of the tubular shunt portion, whereas in other embodiments, the flow deflector portion may be partially connected to the proximal end of the tubular shunt portion or integrally connected to the proximal end. For example, the flow deflector portion may be partially connected to a circumferential edge opening at the proximal end of the tubular shunt portion, for example, to a metal frame of the tubular shunt portion. In some embodiments, the flow deflector portion may be configured to partially occlude the natural flow within the blood vessel.

[0165] In some embodiments, the flow deflector portion is a plug configured to substantially prevent blood flow from passing through a blood vessel. The plug may include a stopper, drum, clot, seal, or any other material that causes at least partial blockage. In cases where most of the blood cannot pass through, the plug may substantially prevent the blood from passing. Accordingly, some embodiments configured to substantially prevent passage may include blocking or occluding most of the fluid, such as blood, from moving, passing, or being delivered over the plug. For example, the plug may block and obstruct blood flowing through the plug in a blood vessel, such as a coronary sinus. In some embodiments, the plug includes a covered expandable frame. The expandable frame may include a casing, shell, scaffolding, perforated wall, or other supporting fixture that may increase in diameter, widen, stretch, or otherwise expand. For example, a series of struts may form the expandable frame. Such a frame or any other frame may be at least partially covered. The cover may comprise a flexible material, fabric, or other material that works in cooperation with the frame to substantially prevent fluid passage. For example, the cover may enclose, coat, wrap, or otherwise fit over at least a portion of the frame. In some embodiments, non-limiting examples of the flexible material may include a fabric cover or sheet, a polymer-based coating, or a high-density nitinol structure.

[0166] In some embodiments, an organ, blood vessel, or passage may have an associated natural flow. The natural flow may be determined by the function of the organ or blood vessel or by the direction in which the heart pumps. For example, a vein may direct venous (oxygen-free or oxygen-deficient) blood into the right atrium of the heart. As an example, the coronary sinus may direct venous blood from the blood vessels of the heart tissue into the right atrium, so that the coronary sinus may have a natural blood flow toward the right atrium of the heart. The disclosed embodiment may include a flow deflector portion configured to induce retrograde blood flow. Retrograde blood flow may include flow or movement in an organ, passage, or blood vessel in a direction reversed from the direction of natural flow, retrograde, reverse, or opposite. In some embodiments, the flow deflector portion may be configured to induce retrograde blood flow. Inducing retrograde blood flow may include guiding, circulating, regulating, influencing, or controlling retrograde blood flow opposite to the direction of natural blood flow. In some embodiments, inducing retrograde blood flow may involve reversing or diverting natural flow. For example, an intravascular medical device may include a shunt portion to bridge the heart chamber and the coronary sinus to induce oxygen-rich retrograde blood flow in the coronary sinus. A deflector portion may induce oxygenated retrograde blood to flow backward (opposite to the direction of natural blood flow) from the coronary sinus. As a result, heart tissue that might otherwise not receive sufficient blood flow can be oxygenated by the retrograde flow. In some embodiments, the flow deflector portion may be configured to allow both retrograde and natural flow in the vein. In some embodiments, the flow deflector portion may be perforated to allow natural blood flow. In some embodiments, the retrograde blood flow may additionally allow at least some non-retrograde (natural) blood flow in the vein or coronary sinus.

[0167] As an example, the retrograde blood flow device (1700) of FIG. 17 may include a flow deflector portion (1720). The flow deflector portion (1720) may be connected to a tubular shunt portion (1714). In some embodiments, the flow deflector portion (1720) may be a plug, and the plug may include a covered expandable frame (1730). The plug may block blood from the coronary sinus (1712) from passing through the flow deflector portion (1720), and the covered expandable frame may be expanded to fit the diameter of the coronary sinus (1712). In some embodiments, the flow deflector portion (1720) may induce retrograde blood flow (1722) in a vessel such as the coronary sinus (1712). The coronary sinus (1712) may have blood flowing in a natural direction, and retrograde blood flow (1722) may move in a direction opposite to the natural flow of the blood vessels. For example, the blood flow in the coronary sinus (1712) may have a natural flow opposite to the retrograde flow (1722) of blood leaving the cavity (1710) through the passage (1716). The flow deflector part (1720) may be configured to guide the blood leaving the cavity (1710) into the retrograde blood flow (1722) so that the retrograde blood flow (1722) moves from right to left (opposite to the natural flow in the blood vessels) in the coronary sinus (1712) as illustrated in FIG. 17.

[0168] The disclosed embodiment may include a tether interconnecting the flow deflector portion and the tubular shunt portion. The tether may include one or more of a string, strap, wire, link, tie, strut, or other means for associating the flow deflector portion with the tubular shunt portion. The tether may interconnect the flow deflector portion and the tubular shunt portion by connecting them to the flow deflector portion and the tubular shunt portion. The interconnection may be formed integrally, or may occur through joining or welding. In some embodiments, the tether may include at least one of cloth, metal, or wire. For example, the tether may be composed of cloth, metal, wire, or any combination of cloth, metal, and wire. The wire may be bent into a wavy shape, or the metal may be formed into a spring-like shape. In some embodiments, the tether may include a partial connection with a circumferential edge opening at the proximal end of the tubular shunt portion of the blood vessel. For example, the tether may at least partially interconnect the circumference of the tubular shunt portion with the circumference of the flow deflector portion of the vein. In some embodiments, the tether has a thickness smaller than the width of the vessel to allow blood flow between the tubular shunt portion and the flow deflector portion. The thickness of the tether may include the width, circumference, area, or diameter of the tether. A thickness smaller than the width of the vessel may include the width or diameter of the tether being smaller than the width or diameter of the vessel in which the tether is placed, e.g., the coronary sinus. Thus, blood flow between the tubular shunt portion and the flow deflector portion is allowed because the tether does not have a thickness that completely obstructs blood flow.

[0169] The disclosed embodiments may include allowing the flow deflector portion to be positioned at a predetermined distance from the tubular shunt portion in the vessel. This may occur at least partially as a result of the properties of the tether. For example, the length of the tether may determine the distance between the flow deflector portion and the tubular shunt portion. If the tether has a spring-like or wavy structure, the tether may be stretched, and the amount of stretching of the tether may determine the predetermined distance. The distance may also be a function of other properties of the tether, such as stiffness and elasticity. In some embodiments, the predetermined distance may be 2 mm to 40 mm. In this context, the predetermined distance is measured in a natural, curved, or wavy state. In some embodiments, the predetermined distance may be less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm. In some embodiments, a predetermined distance within the coronary sinus may be within the range of 2 mm to 30 mm, 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, or 2 mm to 6 mm. The predetermined distance may include a span, separation, or length along the coronary sinus between the center of the tubular shunt portion and the distal end of the deflector (e.g., the portion of the flow deflector closest to the passage). In some embodiments, the predetermined distance may be determined to reduce the risk associated with the shunt. For example, a predetermined distance of 2 mm to 40 mm may reduce the risk of blocking the inner surface of the coronary sinus or the shunt with other veins, and the predetermined distance may also provide proximity to the shunt to minimize the risk of blood coagulation.

[0170] In some embodiments, the tether is configured to exhibit a rigid state to prevent the flow deflector portion from migrating within the blood vessel. Exhibiting a rigid state may include exhibiting a rigid, hard, or inelastic characteristic or state. In some embodiments, preventing the flow deflector portion from migrating within the blood vessel may include hindering or impeding the flow deflector portion from moving, drifting, or displaced within the blood vessel. For example, a tether connected to the flow deflector portion and the tubular shunt portion may not stretch to prevent the flow deflector portion from moving within the blood vessel. The tether may prevent the flow deflector portion from migrating within a blood vessel, such as a coronary sinus, so as to prevent the flow deflector portion from moving beyond a predetermined distance from the tubular shunt portion. In some embodiments, the tether may reduce the risk of shunt blockage by preventing the flow deflector portion from migrating away from the tubular shunt portion when deployed in the blood vessel. In some embodiments, the tether may reduce the risk of blood clot buildup by preventing the flow deflector portion from migrating to the tubular shunt portion.

[0171] In some embodiments, the operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion in the blood vessel. The operable length may include a length, span, range, or distance suitable for a specific purpose. For example, the operable length of the tether may include a measurement from the proximal end to the distal end of the tether suitable for maintaining a desired distance between the flow deflector portion and the tubular shunt portion. The degree of bending of the tether may include a range, level, or amount of curvature, twist, arc, or angle of the tether. In some embodiments, the tether may be adjustable to selectively position in terms of flexibility to adapt to the anatomical part of the patient. In some embodiments, the operable length of the tether or the degree of bending of the tether may be adjustable to selectively position the flow deflector portion. In some embodiments, the operable length of the tether and the degree of bending of the tether may be adjustable to selectively position the flow deflector portion. For example, the operable length or degree of bending of the tether may be adjustable to position the flow deflector portion at a predetermined distance within a blood vessel, including the coronary sinus.

[0172] As illustrated in FIG. 17, the retrograde blood flow device (1700) may include a tether (1724). The tether (1724) may interconnect the flow deflector portion (1720) and the tubular shunt portion (1714). The tether (1724) may allow the flow deflector portion (1720) to be positioned at a predetermined distance from the tubular shunt portion (1714). For example, when blood flow exerts force on the flow deflector portion (1720) from the coronary sinus (1712), the tether (1724) will maintain the position of the flow deflector portion (1720) at a predetermined distance from the tubular shunt portion (1714). In some embodiments, as previously discussed, the predetermined distance from the tubular shunt portion (1714) to the flow deflector portion (1720) may be 2 millimeters to 40 millimeters. For example, the tether (1724) may exhibit a rigid state that prevents the flow deflector portion (1720) from moving within the coronary sinus (1712). In some embodiments, the operable length of the tether (1724) is adjustable. In some embodiments, the thickness of the tether (1724) is smaller than the width of the coronary sinus (1712) to allow blood flow between the tubular shunt portion (1714) and the flow deflector portion (1720). For example, the thickness or diameter of the tether (1724) may be smaller than the width of the vessel so as not to block blood flow in the passage (1716) or to block blood movement between the tubular shunt portion (1714) and the flow deflector portion (1720).

[0173] FIG. 20 illustrates an exemplary embodiment of a front view of an intravascular retrograde blood flow device according to an embodiment of the present invention. The retrograde blood flow device (2000) may include a tubular shunt portion (2010), a tether (2012), and a flow deflector portion (2014). In some embodiments, the flow deflector portion (2014) may be a plug configured to prevent blood flow in a blood vessel. The tether (2012) may be connected to the center of the flow deflector portion (2014) and may be connected to the circumferential edge of the tubular shunt portion (2010).

[0174] In some disclosed embodiments, the tether hinges the flow deflector portion to the tubular shunt portion. The size and shape of organs and blood vessels may vary from person to person, and retrograde blood flow devices may accommodate these different anatomical parts. For example, the coronary sinus may have a smaller or larger diameter, and the tether may hinge to form an angle between the flow deflector portion and the shunt portion. In some embodiments, the hinge may include one or more bendable components, such as wires, springs, wavy struts, or other joints or attachments, that can adapt to the orientation of one or more connected components. For example, the hinge may connect one or more objects to allow for a limited angle of movement within the blood vessel. In some embodiments, the tether may hinge the flow deflector portion and the tubular shunt portion so that the flow deflector portion or the tubular shunt portion may be oriented at an angle relative to each other or oriented to have a limited range of movement around the hinge relative to each other.

[0175] FIG. 18 illustrates an exemplary embodiment of a portion of an intravascular retrograde blood flow device according to an embodiment of the present invention, wherein the wire frame is interconnected by a common material piece. The material is shown in a dashed line in FIG. 18. In some embodiments, a tether (1812) (formed of an interconnecting material) connects the tubular shunt portion (1810) and the flow deflector portion (1814). In this example, the material (which may include a fabric) interconnects the components only partially. For example, the tether (1812) may be connected to a specific portion or part of a circumferential edge opening (1816) at the proximal edge of the tubular shunt portion (1810). In some embodiments, the tether (1812) may hinge a flow deflector portion (1814), having both a flow deflector frame and a cover, to a tubular shunt portion (1810) so that the flow deflector portion (1814) is oriented at an angle with respect to the tubular shunt portion (1810). (For example, an angle may exist between the axes of each component.)

[0176] The disclosed embodiment may include at least one additional tether interconnecting the flow deflector portion and the tubular shunt portion. For example, the retrograde blood flow device may have multiple tethers positioned at different distance intervals along the circumference of the shunt portion or the flow deflector portion. Different forms of the number of tethers and the distance between each tether along the circumference may provide specific advantages without impairing the function of the tethers. For example, two tethers may be positioned at both ends of the circumference of the tubular shunt portion or the flow deflector portion to increase strength and flexibility. In some embodiments, the tether (1724) (Fig. 17) interconnecting the tubular shunt portion (1714) and the flow deflector portion (1720) may include multiple tethers.

[0177] In some embodiments, the tether comprises a distal end connected to a tubular shunt portion and a proximal end connected to a flow deflector portion, and the distal end of the tether is connected to the periphery edge of the tubular shunt portion. The distal end may include a segment of the tether located opposite to or far from the point where the tubular shunt portion is attached to the passage. The proximal end may include a portion, segment, or periphery located on the same side as or close to the attachment point of the tubular shunt portion. In some embodiments, the distal end of the tether may be connected to the periphery edge of the flow deflector portion or to the periphery edge of the flow deflector stabilizer. The periphery edge may include an end, boundary, border, margin, circumference, or other periphery of the component. For example, the distal end of the tether may be connected to the periphery of the flow deflector portion. In some embodiments, the distal end of the tether may be connected to the edge of the flow deflector stabilizer. A flow deflector stabilizer may include a flow deflector having a stabilizing part for maintaining, anchoring, or fixing the flow deflector in a blood vessel.

[0178] FIG. 19 illustrates an exemplary embodiment of an intravascular retrograde blood flow device according to an embodiment of the present invention. The retrograde blood flow device (1900) may include a tubular shunt portion (1910), a tether (1914), and a flow deflector portion (1916). In some embodiments, the distal end of the tether (1914) may be connected to the circumferential edge (1920) of the tubular shunt portion (1910), and the distal end of the tether (1914) may be connected to the circumferential edge (1918) of the flow deflector portion (1916).

[0179] The disclosed embodiment may include a tubular shunt portion, a stabilizer, and a flow deflector portion, which are configured and sized to unfold through the coronary sinus. The component may be configured and sized so that it unfolds and can be delivered through the coronary sinus through its dimensions, shape, and structure. Thus, for example, the component may be configured to be compressed into a delivery mechanism (e.g., a tube or catheter) to be delivered to the coronary sinus. Furthermore, the diameter of the flow deflector, stabilizer, or tubular shunt portion may be smaller than the diameter of the coronary sinus when compressed so that the component can move within the coronary sinus for unfolding. In some embodiments, the tubular shunt portion may be configured to unfold in at least one of the left atrium or the left ventricle. For example, the tubular shunt portion may be sized to terminate at one end in the boundary region between the opening or passage and the vessel (e.g., the coronary sinus) and at the other end in the boundary region between the central opening or passage and the left atrium or left ventricle. In some embodiments, the flow deflector portion and the tether are configured to deploy into the coronary sinus to block blood flow from the left atrium to the right atrium. Blocking blood flow may include hindering, inhibiting, preventing, or reducing the movement, transport, or exercise of blood within an organ or blood vessel. In some embodiments, the blood flow blocked from the left atrium to the right atrium may include the flow deflector portion and the tether preventing blood from moving from the left atrium to the right atrium. For example, the flow deflector may prevent blood from flowing from the left atrium to the right atrium and enable retrograde blood flow in the coronary sinus.

[0180] For example, the coronary sinus shunt portion, stabilizer, and flow deflector portion may be configured to extend through the coronary sinus (1614) as referenced in FIG. 16. The coronary sinus shunt portion may be configured to extend from the left atrium (1610) or the left ventricle (1616). The flow deflector portion and the tether may be configured to extend from the coronary sinus (1614) to block blood flow from the left atrium (1610) to the right atrium (1612).

[0181] In some embodiments, the intravascular blood flow device is configured to be delivered via a catheter. Delivery via a catheter may include dispensing via a balloon catheter, overtube, Mullins catheter, pipe, or any other tube to be deployed in a vessel including a coronary sinus. Being configured to be delivered via a catheter may include the catheter receiving a compressed tubular shunt at a longitudinally distal position relative to a compressed flow deflector portion such that the shunt is configured to exit the catheter first. Components of the device, including the tubular shunt portion and the flow deflector portion, may be compressed into the catheter for delivery. In some embodiments, at least the tubular shunt portion is configured to expand after release from the catheter. Being configured to expand after release may include a component or material that increases in diameter, expands, or widens upon release or discharge. This may occur when the device is at least partially composed of a shape memory alloy such as nitinol. Expansion may occur at any point after the blood flow device is released from the catheter. For example, expansion may occur when the tubular shunt portion is discharged or otherwise exits the catheter. Additionally, or alternatively, expansion may occur when a trigger is activated after release. In either case, the tubular shunt portion may expand to increase its diameter. In some embodiments, the flow deflector portion is configured to expand after release from the catheter. For example, the flow deflector portion may expand after release from the catheter's constraints. Alternatively, a trigger mechanism may be included that allows part or all of the flow deflector portion to expand only after a trigger. In either case, the flow deflector portion may expand to increase its diameter. In some embodiments, the tubular shunt portion is configured to expand from the catheter before the flow deflector portion expands.The time prior to the expansion of the flow deflector portion may include any point in time prior to the release of the flow deflector portion. The disclosed embodiment may include causing the tubular shunt portion to expand before the flow deflector portion expands. Expanding the tubular shunt portion may include increasing the diameter of the tubular shunt portion as described herein. Expanding the flow deflector portion may include increasing the diameter of the flow deflector portion after release from the catheter. For example, the tubular shunt portion may first be released from the catheter and then expand within the blood vessel. Then, the flow deflector portion may be released from the catheter and then expand within the blood vessel. For example, the tubular shunt portion (1714) may be released from the catheter and then expand in the passage (1716). Next, the flow deflector portion (1720) may be released from the catheter and then expand in the coronary sinus (1712). In some embodiments, when expanded, the tubular shunt portion (1714) may have a circumference or diameter smaller than the diameter of the tubular sinus (1712). The expansion of the described component may occur as a result of relative movement between the component and the catheter, for example, when the component is pushed out of the catheter or when the catheter is withdrawn.

[0182] In some embodiments, the tubular shunt portion comprises a first frame structure, and the flow deflector portion comprises a second frame structure. The frame structure may comprise a casing, a shell, a series of interconnected struts, scaffolding, a perforation wall, or any other supporting fixture. In some embodiments, the frame structure may allow a transition between a contracted state, for example, when compressed into a catheter, and an expanded state, for example, while deployed within a blood vessel. The frame structure may be interconnected with the stabilizer portion, the tubular shunt portion, and the flow deflector portion. In some embodiments, the frame structure may be a biocompatible, flexible material. Relevant flexible materials will be recognized by those skilled in the art. Such materials may include materials that provide strength to resist deformation over time, have the ability to expand due to pressure reduction on the outer circumference, and may be flexible for differences in various anatomical parts. Non-limiting examples may include superelastic alloys and / or shape memory materials, such as nickel-titanium alloys (also known as Nitinol or NiTiCu (nickel-titanium-copper)) and / or shape memory alloys (SMA) such as CuAlNi (copper-zinc-nickel). Other suitable materials may include other metals or stainless steel. The first frame structure may include scaffolding forming the tubular shunt portion. The second frame structure may include separate scaffolding (or interconnected scaffolding) connected to the flow deflector portion. In some embodiments, the second frame structure is suitable for functioning as a fixing element for the flow deflector portion or the tubular shunt portion. For example, the second frame structure may fix, hold, or fasten the flow deflector portion within a vessel, or the second frame structure may also fix the tubular shunt portion in a cavity or passage. In some embodiments, the flow deflector portion may have a curved frame or surface.In some embodiments, the curved frame or surface has a ladle shape. The bow or ladle shape can facilitate the previously described backflow to eliminate stagnant or low-flow regions. In some embodiments, at least one of the first frame structure and the second frame structure is covered at least partially with a flexible material. Partially covered may include the frame structure being coated with the material, encircled, wrapped, or otherwise enclosed. In some embodiments, partially covered may include partially or incompletely encircling the frame structure. In some embodiments, the flexible material forms a bow or ladle-shaped surface to facilitate, for example, the previously described backflow to eliminate stagnant or low-flow regions. In some embodiments, non-limiting examples of the flexible material may include a fabric cover or sheet, a polymer-based coating, or a nitinol structure. The flexible material may have flexibility in addition to the flexibility of the frame scaffold. In some embodiments, the flexible material may be substantially impermeable to blood and blood flow. In some embodiments, the flexible material may be configured to become impermeable over time. For example, the flexible cover may be configured to allow blood coagulation to create an impermeable layer on the cover.

[0183] FIG. 19 illustrates an exemplary embodiment of an intravascular retrograde blood flow device according to an embodiment of the present invention. The retrograde blood flow device (1900) may include a tubular shunt portion (1910), a tether (1914), and a flow deflector portion (1916). A frame structure of the tubular shunt portion (1910) may be covered with a flexible material (1912). In some embodiments, the flexible material (1912) may be configured to divert blood. For example, the flexible material (1912) may be substantially impermeable to blood or blood flow, so that as a result some blood may not penetrate the flexible material and may be diverted around the flexible material.

[0184] In some embodiments, the tether may include a proximal end connected to the center of the first frame structure. The center of the first frame structure may be the midpoint of the first frame structure in the tubular shunt portion or another intermediate location. In some embodiments, the tether may include a distal end connected to the center of the second frame structure. The center of the second frame structure may include the midpoint of the second frame structure in the flow deflector portion or another intermediate location. For example, the tether (1724) (see FIG. 17) may be connected to the frame center of the tubular shunt portion (1714), and the tether (1724) may be connected to the frame center of the flow deflector portion (1720). As an additional example, the tubular shunt portion (1810) (see FIG. 18) may include the first frame structure, and the flow deflector portion (1814) may include the second frame structure. The tether (1812) can be connected to the center of the first frame of the tubular shunt section (1810), as well as to the center of the second frame of the flow deflector section (1814).

[0185] FIG. 21 illustrates a flowchart of an exemplary method for inducing intravascular retrograde blood flow. FIG. 21 includes steps (2110 to 2116). In step (2110), the method may include the step of deploying a stabilizer at the distal end of a tubular shunt portion into a tubular trachea. This may be achieved, for example, via a catheter as previously discussed. In step (2112), the method may include the step of deploying the tubular shunt portion into a passage between the trachea and an adjacent blood vessel to bridge the cavity of the trachea and the interior of the blood vessel. In step (2114), the method may include the step of positioning a flow deflector portion at the proximal end of the tubular shunt portion within the blood vessel at a predetermined distance from the tubular shunt portion using a tether interconnecting the flow deflector portion and the tubular shunt portion. Since a tether of a predetermined length interconnects the components, the distance between the components is positioned at a distance corresponding to the predetermined length by releasing the flow deflector portion from the catheter. In step (2116), the method may include a step of inducing retrograde blood flow using a flow deflector part. Thus, when blood begins to flow, the flow deflector part generates retrograde blood flow as previously discussed.

[0186] In addition, the following provisions are disclosed in this specification.

[0187] Clause 1.

[0188] As an intravascular medical device for shunting and selectively controlling anatomical fluid flow,

[0189] A tubular shunt deployed in a passage between a first institution and a second adjacent institution, configured to bridge the first cavity of the first institution and the second cavity of the second institution;

[0190] A stabilizer configured to stabilize a tubular shunt in a passage; and

[0191] A flow deflector having a surface for deflecting flow into a second cavity, extending from a tubular shunt and configured to extend from a portion less than the entire circumferential edge of the tubular shunt.

[0192] A device including

[0193] Clause 2.

[0194] In the previous clause, the tubular shunt, stabilizer, and flow deflector are integrally connected and expandable when deployed through a delivery catheter.

[0195] Clause 3.

[0196] In one of the preceding provisions, the second organ is a blood vessel, and the tubular shunt and the flow deflector are integrally connected in such a way that the rotational orientation of the tubular shunt in the passage defines the range of flow deflection of the blood vessel, a device.

[0197] Clause 4.

[0198] In any one of the preceding provisions, the second organ is a blood vessel, and in the first rotational orientation of the tubular shunt, the flow deflector is configured to cause a first flow deflector across the width of the blood vessel, and in the second rotational orientation of the tubular shunt, the flow deflector is configured to cause a second flow deflector across a portion smaller than the width of the blood vessel, and the first flow deflector is greater than the second flow deflector, device.

[0199] Clause 5.

[0200] In any of the preceding provisions, the second organ is a blood vessel, and the flow deflector is a device configured to enable both natural flow and retrograde flow in the blood vessel.

[0201] Clause 6.

[0202] In any one of the preceding provisions, the flow deflector is a device that additionally includes a tool passage.

[0203] Clause 7.

[0204] A device comprising, in any one of the preceding provisions, additionally comprising a sheath configured to include a tubular shunt and a flow deflector in a compressed form.

[0205] Clause 8.

[0206] A device in which, in any one of the preceding provisions, the tubular shunt is configured to expand into a tubular shape when discharged from the sheath, and the flow deflector is configured to expand into a curved shape.

[0207] Clause 9.

[0208] In any of the preceding provisions, a device configured such that the flow deflector in a compressed form is nested into a tubular shunt.

[0209] Clause 10.

[0210] A device, wherein in any one of the preceding provisions, the stabilizer comprises a first flange region connected to a tubular shunt, the first flange region is located on the tubular shunt side opposite the flow deflector, and the first flange region is configured to seal against the wall of a first cavity upon deployment.

[0211] Clause 11.

[0212] In any one of the preceding provisions, the device comprises a flexible cover and a plurality of arms configured to establish a fluid seal between a first side of the flexible cover and a wall of a first cavity when deployed.

[0213] Clause 12.

[0214] In any one of the preceding provisions, the flexible cover is at least partially impermeable to fluid, the device.

[0215] Clause 13.

[0216] In any one of the preceding provisions, the flexible cover extends over the tubular shunt and forms part of the flow deflector, the device.

[0217] Clause 14.

[0218] In any one of the preceding provisions, the device comprises a tubular shunt that includes a second flange area that extends into a second joint and is configured to secure the tubular shunt to a passage.

[0219] Clause 15.

[0220] In any one of the preceding provisions, the tubular shunt comprises a tubular wall having at least one opening inside, a device.

[0221] Clause 16.

[0222] A device in which, in any one of the preceding provisions, the tubular shunt is sized to terminate distally at the periphery edge of the passage adjacent to the first cavity, and the flow deflector is sized to terminate at the wall of the second cavity opposite the passage.

[0223] Clause 17.

[0224] In any one of the preceding provisions, the device is configured such that the stabilizer extends beyond the circumferential edge of the distal end of the tubular shunt into the first cavity of the first organ.

[0225] Clause 18.

[0226] In any one of the preceding provisions, the flow deflector comprises a non-tubular recess configured to deflect the flow to a second joint, a device.

[0227] Clause 19.

[0228] In any one of the preceding provisions, the device further comprises a tether configured to connect the flow deflector to the circumferential edge of a tubular shunt.

[0229] Clause 20.

[0230] A device comprising, in any one of the preceding provisions, at least one wavy flexible wire securing a tubular shunt to a flow deflector.

[0231] Clause 21.

[0232] As a method of shunting and diverting blood flow between biological organs,

[0233] A step of perforating an opening in a first organ having a first cavity and a second organ having a second cavity;

[0234] A step of deploying a tubular shunt through the openings of the first cavity and the second cavity so that blood can pass from the first cavity to the second cavity;

[0235] A step of deploying a flow deflector extending from a portion less than the entire perimeter edge of a tubular shunt into the second cavity; and

[0236] Step of deflecting blood flow into the second cavity using a flow deflector

[0237] A method including

[0238] Clause 22.

[0239] A method in which, in any one of the preceding provisions, the first organ is a heart chamber and the second organ is a blood vessel, and the flow deflector is configured to induce at least partial retrograde blood flow in the blood vessel.

[0240] Clause 23.

[0241] As an endovascular retrograde blood flow device,

[0242] catheter;

[0243] An expanding shunt configured to be compressed into a catheter and to bridge the opening between the first cavity of the first organ and the second cavity of the second organ;

[0244] An expandable flow deflector configured to be compressed into the catheter and to deflect flow into a second cavity; and

[0245] A flexible hinge interconnecting an expanding shunt and an expanding flow deflector, wherein the flexible hinge is configured to be bent so as to allow for axial positioning of the expanding shunt and the expanding flow deflector while maintaining interconnection between the expanding shunt and the expanding flow deflector when the expanding shunt is positioned along a first axis of an opening and the expanding flow deflector is positioned along a second axis traversing the first axis within a second cavity.

[0246] A device including

[0247] Clause 24.

[0248] In one of the preceding provisions, the expanding flow deflector comprises an expanding frame covered with a flexible flow deflector cover, the expanding frame is configured to be fixed to the wall of a second cavity when expanded, and the fixation helps to stabilize the expanding shunt at the opening, the device.

[0249] Clause 25.

[0250] A device in which, in any one of the preceding provisions, in an extended form, the extended frame comprises a cylindrical portion, and the flow deflection cover extends over the cylindrical portion in such a manner that it forms a drum-shaped planar flow deflection surface.

[0251] Clause 26.

[0252] A device in which, in any one of the preceding provisions, in an extended form, the extended frame includes a deflector support, and the flow deflection cover extends over the deflector support in such a way that it forms a concave flow deflection surface.

[0253] Clause 27.

[0254] A device in which, in any one of the preceding provisions, in an extended form, the extended frame includes a concave portion, and the flow deflection cover extends over the concave portion in such a manner that it forms a ladle-shaped flow deflection surface.

[0255] Clause 28.

[0256] In any one of the preceding provisions, the device, in an extended form, includes an extension extending from the extended frame beyond the intersection of the first axis and the second common wall, and the extension engages with the second common wall.

[0257] Clause 29.

[0258] A device in which, in any one of the preceding provisions, the extension extends in a direction opposite to the normal fluid flow direction.

[0259] Clause 30.

[0260] In any of the preceding provisions, the flexible flow deflection cover is substantially impermeable to blood, the device.

[0261] Clause 31.

[0262] In any of the preceding provisions, the flexible flow deflection cover comprises a tool passage configured to minimize blood flow passing through, a device.

[0263] Clause 32.

[0264] In any one of the preceding provisions, the flexible flow deflection cover comprises at least one of a mesh, a fabric, a polymer coating, or a synthetic material coating, a device.

[0265] Clause 33.

[0266] A device, wherein in any one of the preceding provisions, further comprises a first stabilizer extending from the distal end of the extending shunt toward the hinge opposite to engage with the inner wall of the first cavity to retain the extending shunt within the opening.

[0267] Clause 34.

[0268] A device further comprising, in any one of the preceding provisions, a second stabilizer including a flange area extending from the proximal end of the extending shunt into the second cavity to engage with the inner wall of the second cavity to maintain the extending shunt within the opening.

[0269] Clause 35.

[0270] A device in which, in any one of the preceding provisions, at least one of the first stabilizer and the second stabilizer comprises a plurality of branches of different lengths.

[0271] Clause 36.

[0272] A device in which, in any one of the preceding provisions, the first stabilizer comprises a plurality of outwardly extending branches, each branch having a distal end bent toward the inner wall of the first cavity.

[0273] Clause 37.

[0274] In any of the preceding provisions, the extendable shunt comprises a tubular scaffold, and the flexible flow deflection cover extends over the tubular scaffold, device.

[0275] Clause 38.

[0276] In any one of the preceding provisions, the flexible flow deflection cover is additionally configured to allow at least some non-retrograde blood flow in the second cavity, the device.

[0277] Clause 39.

[0278] In one of the preceding provisions, the device comprising an expandable flow deflector including a lip that engages with the wall of the second cavity to help form a seal against the wall of the second cavity.

[0279] Clause 40.

[0280] In any one of the preceding provisions, the expanding flow deflector comprises a frame configured to maintain an initially compressed form after being discharged from the catheter, and the device further comprises a release mechanism that enables selective expansion of the expanding flow deflector after expansion of the expanding shunt.

[0281] Clause 41.

[0282] In any of the preceding provisions, the device, wherein the expandable flow deflector is partially connected to the circumferential edge of the expandable shunt via a flexible hinge.

[0283] Clause 42.

[0284] In any one of the preceding provisions, the flexible hinge comprises a tether, a device.

[0285] Clause 43.

[0286] In any of the preceding provisions, the tether is a device having a wave shape.

[0287] Clause 44.

[0288] A device configured such that, in any one of the preceding provisions, the expanding frame expands in a second direction different from the first direction when the catheter is removed in a first direction to cause the release of the expanding flow deflector.

[0289] Clause 45.

[0290] A device comprising, in any one of the preceding provisions, one or more flexible hinges including two flexible hinges extending from both sides of a shunt circumference.

[0291] Clause 46.

[0292] As a method for inducing endovascular retrograde blood flow,

[0293] A step of drilling an opening between the first cavity and the second cavity;

[0294] A step of advancing a catheter into the opening between the first cavity and the second cavity;

[0295] A step of releasing a compressed, expandable shunt from an open catheter into the catheter;

[0296] A step of releasing an expanding flow deflector connected to an expanding shunt by a flexible hinge from a catheter, wherein the flexible hinge is configured to be bent so as to allow for axial positioning of the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector when the expanding shunt is positioned along a first axis of the opening and the expanding flow deflector is positioned along a second axis traversing the first axis within a second cavity; and

[0297] Step of fixing an extended flow deflector to the second joint

[0298] A method including

[0299] Clause 47.

[0300] As a medical device for inducing retrograde blood flow,

[0301] A tube for delivering to the coronary sinus from a first direction; and

[0302] It includes an expandable structural member compressed into a tube, and the expandable structural member,

[0303] A scaffold portion for maintaining an orifice between the coronary sinus and the heart chamber, and

[0304] A medical device comprising a flow deflector portion configured to induce retrograde blood flow in a coronary sinus, wherein the flow deflector portion is configured to be deployed in a second direction other than the first direction while the tube is withdrawn in a first direction.

[0305] Clause 48.

[0306] A device configured such that, in one of the preceding provisions, the flow deflector portion extends in a second direction by sweeping in the opposite direction to the first direction.

[0307] Clause 49.

[0308] A device, wherein in any one of the preceding provisions, the flow deflector portion is arc-shaped and the concave portion of the arc shape is configured to sweep in a second direction.

[0309] Clause 50.

[0310] A device configured such that, in any one of the preceding provisions, the flow deflector portion is partially expanded when discharged from the tube.

[0311] Clause 51.

[0312] A device comprising, in addition to one of the preceding provisions, a trigger wire configured to further expand the flow deflector portion when pulled after partial expansion.

[0313] Clause 52.

[0314] A device, in any one of the preceding provisions, further comprising an inner tube disposed within an expandable structural part, wherein a trigger wire has one end connected to a flow deflector part and the other end connected to the inner tube.

[0315] Clause 53.

[0316] A device configured such that, in any one of the preceding provisions, the trigger wire is released to expand the flow deflector portion to an expanded state when the inner tube is contracted from within the expansionary structure.

[0317] Clause 54.

[0318] A device in which, in any of the preceding provisions, the distal edge of the flow deflector portion is biased to match the curvature of the coronary sinus.

[0319] Clause 55.

[0320] A device, wherein in any one of the preceding provisions, it further comprises a catch portion for maintaining a flow deflector portion in a partially unexpanded form when discharged from a tube, and a trigger wire connected to the catch portion and extending through the tube in a first direction, wherein the trigger wire is configured such that the flow deflector portion expands in a second direction when pulled from the first direction.

[0321] Clause 56.

[0322] A device in which, in any one of the preceding provisions, the second direction is opposite to the first direction.

[0323] Clause 57.

[0324] A device that, in any one of the preceding provisions, further comprises a mechanism for delaying the development of the flow deflector portion until the tube is removed.

[0325] Clause 58.

[0326] A device comprising, in any one of the preceding provisions, an additional controller configured to control the extension timing of the flow deflector portion.

[0327] Clause 59.

[0328] A device in which, in any one of the preceding provisions, the extendable structural part additionally includes a stabilizer part on the scaffold part side opposite to the flow deflector part.

[0329] Clause 60.

[0330] A device in which, in any one of the preceding provisions, the stabilizing portion comprises a plurality of outwardly extending branches, each branch having a distal end that bends toward the inner wall of the heart chamber when extended, such that the plurality of outwardly extending branches are directed toward the inner wall of the heart chamber.

[0331] Clause 61.

[0332] A device configured such that, in any one of the preceding provisions, the scaffold portion and the flow deflector portion are extended after the extension of the stabilizer portion.

[0333] Clause 62.

[0334] A device comprising, in any one of the preceding provisions, at least one additional extension on the side of the scaffold portion identical to the flow deflector portion to help stabilize by contacting the inner wall of the coronary sinus.

[0335] Clause 63.

[0336] A device configured such that, in any one of the preceding provisions, the extension is located at the distal end of the flow deflector portion and the extension protrudes in a second direction after the tube is drawn out in a first direction.

[0337] Clause 64.

[0338] A device, wherein in any one of the preceding provisions, at least one extension is located at the circumferential edge of the scaffold portion and is configured to fully expand before the flow deflector portion fully expands in the coronary sinus.

[0339] Clause 65.

[0340] A device comprising, in any one of the preceding provisions, a flexible fluid-impermeable cover disposed over an expandable structural member.

[0341] Clause 66.

[0342] As a method of inducing retrograde blood flow,

[0343] Step of perforating an orifice between the coronary sinus and the heart chamber;

[0344] A step of delivering a tube from a first direction to a coronary sinus, wherein the tube has an expandable retrograde blood flow device inside, and the retrograde blood flow device includes a scaffold portion and a flow deflector portion;

[0345] A step of partially ejecting the retrograde blood flow device from the tube so that the scaffold portion is deformed from a compressed state inside the tube to an expanded state outside the tube, thereby maintaining the flow deflector portion in a partially expanded state outside the tube;

[0346] A step of maintaining an orifice between the coronary sinus and the heart chamber using a scaffold portion;

[0347] Step of withdrawing the tube in the first direction;

[0348] A step of additionally extending the flow deflector portion in a second direction rather than a first direction; and

[0349] Steps to induce retrograde flow in the coronary sinus using the flow deflector section

[0350] A method including

[0351] Clause 67. As an endovascular retrograde blood flow device,

[0352] A tubular shunt portion configured to extend into the passage between the trachea and an adjacent blood vessel to bridge the cavity of the trachea and the interior of the blood vessel;

[0353] A stabilizer configured to secure a tubular shunt portion to a passage;

[0354] A flow deflector portion connected to the proximal end of a tubular shunt portion, configured to induce retrograde blood flow; and

[0355] A tether interconnecting the flow deflector portion and the tubular shunt portion in a manner that allows the flow deflector portion to be located at a predetermined distance from the tubular shunt portion in the blood vessel.

[0356] A device including

[0357] Clause 68.

[0358] A device, wherein in one of the preceding provisions, the tubular shunt portion, the stabilizer portion, and the flow deflector portion are configured and sized to extend through the coronary sinus, the tubular shunt portion is configured to extend to at least one of the left atrium or left ventricle, and the flow deflector portion and the tether are configured to extend into the coronary sinus to block blood flow from the left atrium toward the right atrium.

[0359] Clause 69.

[0360] A device in which, in any one of the preceding provisions, the predetermined distance is 2 mm to 40 mm.

[0361] Clause 70.

[0362] In any one of the preceding provisions, the stabilizer comprises a flange at the distal end of the tubular shunt portion, and the flange is configured to engage with the inner wall of the cavity of the organ, a device.

[0363] Article 71.

[0364] In any one of the preceding provisions, the tether is a device comprising at least one of cloth, metal, or wire.

[0365] Clause 72.

[0366] In any of the preceding provisions, the tether is a device that hinges the flow deflector portion to the tubular shunt portion.

[0367] Article 73.

[0368] A device configured to be delivered through a catheter in any one of the preceding provisions, and configured to expand after release from the catheter, at least a tubular shunt portion.

[0369] Clause 74.

[0370] In any of the preceding provisions, the device, wherein the flow deflector portion is configured to expand after release from the catheter.

[0371] Clause 75.

[0372] A device configured such that, in any one of the preceding provisions, the tubular shunt portion is deployed from the catheter before the flow deflector portion is deployed, and the tubular shunt portion can be expanded before the flow deflector portion is expanded.

[0373] Clause 76.

[0374] In any of the preceding provisions, the flow deflector portion is a plug-in, device configured to substantially prevent the passage of blood flow in a blood vessel.

[0375] Article 77.

[0376] In any one of the preceding provisions, the plug is a device comprising a covered extendable frame.

[0377] Clause 78.

[0378] A device, wherein in any one of the preceding provisions, the operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion in the blood vessel.

[0379] Clause 79.

[0380] In any of the preceding provisions, the tether is a device configured to exhibit a rigid state to prevent the flow deflector portion from migrating within the blood vessel.

[0381] Clause 80.

[0382] A device comprising, in any one of the preceding provisions, at least one additional tether interconnecting the flow deflector portion and the tubular shunt portion.

[0383] Clause 81.

[0384] In any of the preceding provisions, the device comprises a tether having a distal end connected to a tubular shunt portion and a proximal end connected to a flow deflector portion, wherein the distal end of the tether is connected to the circumferential edge of the tubular shunt portion and the distal end of the tether is connected to the circumferential edge of the flow deflector portion or the circumferential edge of the flow deflector stabilizer.

[0385] Clause 82.

[0386] A device, wherein in any one of the preceding provisions, the tubular shunt portion comprises a first frame structure and the flow deflector portion comprises a second frame structure.

[0387] Clause 83.

[0388] A device in which, in any one of the preceding provisions, at least one of the first frame structure and the second frame structure is at least partially covered with a flexible material.

[0389] Clause 84.

[0390] In any one of the preceding provisions, the device comprises a tether including a proximal end connected to the center of a first frame structure and a distal end connected to the center of a second frame structure.

[0391] Clause 85.

[0392] In any of the preceding provisions, the device, having a thickness smaller than the width of the blood vessel, allows blood flow between the tubular shunt portion and the flow deflector portion.

[0393] Clause 86.

[0394] As a method for inducing endovascular retrograde blood flow,

[0395] A step of developing a tubular shunt portion in the passage between the trachea and an adjacent blood vessel to bridge the cavity of the trachea and the interior of the blood vessel;

[0396] Step of deploying a stabilizer located at the distal end of the tubular shunt portion into the trachea;

[0397] Step of deploying a flow deflector portion connected to the proximal end of the tubular shunt portion into the blood vessel;

[0398] A step of positioning a flow deflector portion at a predetermined distance from a tubular shunt portion within a blood vessel using a tether interconnecting the flow deflector portion and the tubular shunt portion; and

[0399] Step of inducing retrograde blood flow using a flow deflector part

[0400] A method including

[0401] The disclosed embodiments may include any of the following key features alone or in combination with one or more other key features, regardless of whether they are implemented as a system, device and / or method.

[0402] Intravascular medical devices

[0403] Shunts and selectively controls anatomical fluid flow

[0404] tubular shunt

[0405] The tubular shunt is configured to deploy into the passage between the first organ and the second adjacent organ.

[0406] o The second organ is a blood vessel.

[0407] The tubular shunt is configured to bridge the first joint of the first organ and the second joint of the second organ.

[0408] Stabilizer

[0409] The stabilizer is configured to stabilize the tubular shunt in the passage.

[0410] flow deflector

[0411] The flow deflector is extended from the tubular shunt.

[0412] The flow deflector has a surface for deflecting the flow into the second cavity.

[0413] The flow deflector is configured to extend from a portion less than the entire circumferential edge of the tubular shunt.

[0414] Tubular shunts, stabilizers, and flow deflectors are integrally connected.

[0415] Tubular shunts, stabilizers, and flow deflectors are expandable when deployed via a delivery catheter.

[0416]

[0417] Tubular shunts and flow deflectors are integrally connected

[0418] The tubular shunt and the flow deflector are integrally connected in such a way that the rotational orientation of the tubular shunt in the passage defines the range of the blood vessel flow deflection.

[0419] In the first rotational orientation of the tubular shunt, the flow deflector is configured to induce a first flow deflection across the width of the vessel.

[0420] In the second rotational orientation of the tubular shunt, the flow deflector is configured to induce a second flow deflection over a portion smaller than the width of the vessel.

[0421] o The first flow bias is greater than the second flow bias.

[0422] The flow deflector is configured to allow both natural and retrograde flow in blood vessels.

[0423] The flow deflector includes a penetrating tool passage.

[0424] The sheath is configured to include a tubular shunt and a flow deflector in a compressed form.

[0425] The tubular shunt is configured to expand into a tubular shape when discharged from the sheath.

[0426] The flow deflector is configured to expand in a curved shape when discharged from the sheath.

[0427] In the compressed form, the flow deflector is configured to nest into a tubular shunt.

[0428] The stabilizer includes a first flange area connected to a tubular shunt.

[0429] The first flange area is located on the tubular shunt side opposite the flow deflector.

[0430] The first flange area is configured to seal against the wall of the first cavity upon deployment.

[0431] The stabilizer includes a flexible cover.

[0432] The stabilizer includes multiple arms.

[0433] Multiple arms are configured to establish a fluid seal between the first side of the flexible cover and the wall of the first cavity when deployed.

[0434] The flexible cover is at least partially impermeable to fluids.

[0435] The flexible cover extends over the tubular shunt.

[0436] The flexible cover forms part of the flow deflector.

[0437] The tubular shunt includes a second flange area

[0438] The second flange area is extended into the second joint.

[0439] The second flange area is configured to secure a tubular shunt within the passage.

[0440] A tubular shunt includes a tubular wall having at least one opening inside.

[0441] The tubular shunt is sized to terminate distally at the perimeter edge of the passage adjacent to the first cavity.

[0442] The flow deflector is sized to terminate at the wall of the second cavity on the opposite side of the passage.

[0443] The stabilizer is configured to extend beyond the circumferential edge of the distal end of the tubular shunt.

[0444] The stabilizer is configured to be extended to the first joint of the first institution.

[0445] The flow deflector includes a non-tubular concave section.

[0446] The non-tubular depression is configured to deflect flow into the second cavity.

[0447] The flow deflector additionally includes tether.

[0448] The tether is configured to connect a flow deflector to the circumferential edge of the tubular shunt.

[0449] At least one wavy flexible wire

[0450] At least one wavy flexible wire secures the tubular shunt to the flow deflector.

[0451] Method of shunting and diverting blood flow between biological organs

[0452] Perforating an opening in a first organ having a first cavity and a second organ having a second cavity

[0453] A tubular shunt is developed through the openings of the first and second cavities to allow blood to pass from the first cavity to the second cavity.

[0454] Deploy a flow deflector extending from a portion less than the entire circumferential edge of the tubular shunt into the second cavity.

[0455] Deflect blood flow into the second cavity using a flow deflector.

[0456] If the first organ mentioned in this section is the heart chamber

[0457] If the second organ mentioned in this section is a blood vessel

[0458] A flow deflector is configured to induce at least partial retrograde blood flow in blood vessels.

[0459] Intravascular retrograde blood flow device

[0460] catheter

[0461] Extended shunt

[0462] Expandable shunt compressed into the catheter

[0463] An extension shunt is configured to bridge the opening between the first cavity of the first organ and the second cavity of the second organ.

[0464] The expandable flow deflector is compressed into the catheter.

[0465] The extended flow deflector is configured to deflect the flow in the second joint.

[0466] Gayageung Hinge

[0467] The flexible hinge interconnects the extendable shunt and the extendable flow deflector.

[0468] o Flexible hinges are configured to bend in the following cases

[0469] When an expanding shunt is positioned along the first axis of the opening and an expanding flow deflector is positioned along a second axis traversing the first axis within the second cavity, a flexible hinge can be bent to enable axial positioning of the expanding shunt and the expanding flow deflector while maintaining the interconnection between the expanding shunt and the expanding flow deflector.

[0470] The extended flow deflector includes an extended frame covered with a flexible flow deflection cover.

[0471] The expandable frame is configured to be fixed to the wall of the second cavity when expanded.

[0472] Fixation helps stabilize the expansion shunt at the opening.

[0473] In the extended form, the extended frame includes a cylindrical part.

[0474] The flow deflection cover extends over the cylindrical portion in a manner that forms a drum-shaped planar flow deflection surface.

[0475] In the extended form, the extended frame includes a deflection support.

[0476] The flow deflection cover extends over the deflectioner support in a manner that forms a concave flow deflection surface.

[0477] In the extended form, the extended frame includes a concave part.

[0478] The flow deflection cover extends over the concave portion in a manner that forms a ladle-shaped flow deflection surface.

[0479] In the extended form, the extended frame includes an extension extending from the extended frame beyond the intersection of the first axis and the second common wall.

[0480] The extension interlocks with the second common wall.

[0481] The extension extends in the opposite direction to the normal fluid flow direction.

[0482] Flexible flow-biased covers are practically impermeable to blood.

[0483] The flexible flow bias cover includes the tool channel

[0484] The tool passage is configured to minimize blood flow through it.

[0485] The flexible flow deflection cover comprises at least one of a mesh, fabric, polymer coating, or synthetic material coating.

[0486] The first stabilizer extends from the distal end of the extended shunt.

[0487] The first stabilizer is on the opposite side of the hinge.

[0488] The first stabilizer is designed to engage with the inner wall of the first cavity to maintain an expanding shunt in the opening.

[0489] 2nd Stabilizer

[0490] The second stabilizer has a flange area extending from the proximal end of the extended shunt to the second cavity.

[0491] The second stabilizer is designed to engage with the inner wall of the second cavity to maintain an expanding shunt in the opening.

[0492] At least one of the first stabilizer and the second stabilizer includes multiple branches of different lengths.

[0493] The first stabilizer includes a plurality of outwardly extending branches.

[0494] The branch has a distal end bent toward the inner wall of the first cavity.

[0495] The expandable shunt includes a tubular scaffold

[0496] The flexible flow-biased cover extends over the tubular scaffold.

[0497] The flexible flow-deflecting cover is configured to allow at least some non-retrograde blood flow in the second cavity.

[0498] The expanded flow deflector includes a lip for engaging with the wall of the second cavity to help form a seal against the wall of the second cavity.

[0499] Extended flow deflector includes frames

[0500] The frame is configured to maintain an initially compressed shape after being discharged from the catheter.

[0501] The release mechanism allows the expanded flow deflector to be selectively expanded after the expansion of the expanded shunt.

[0502] The extendable flow deflector is partially connected to the perimeter edge of the extendable shunt via a flexible hinge.

[0503] Flexible hinges include tethers

[0504] The tether has a wave shape.

[0505] The expansion frame is configured to expand in a second direction when the catheter is removed in a first direction to release the expansion flow deflector.

[0506] o The second direction is different from the first direction

[0507] One or more flexible hinges include two flexible hinges extending from both sides of the shunt column.

[0508] Method to induce endovascular retrograde blood flow

[0509] Drilling an opening between the first cavity and the second cavity

[0510] Advance the catheter into the opening between the first and second cavities.

[0511] Releases a compressed, expandable shunt from the catheter into the opening.

[0512] An expanding flow deflector connected to an expanding shunt by a flexible hinge is released from a catheter, wherein the flexible hinge is configured to be bent so as to allow for axial positioning of the expanding shunt and the expanding flow deflector while maintaining interconnection between the expanding shunt and the expanding flow deflector when the expanding shunt is positioned along a first axis of the opening and the expanding flow deflector is positioned along a second axis traversing the first axis within the second cavity.

[0513] Fixed an extended flow deflector in the second joint

[0514] Medical device for inducing retrograde blood flow

[0515] Tube for delivery to the coronary sinus from the first direction

[0516] Expanded structural part compressed into the tube

[0517] scaffold portion for maintaining the orifice between the coronary sinus and the heart chamber

[0518] A flow deflector part configured to induce retrograde blood flow in the coronary sinus.

[0519] A flow deflector part configured so that when the tube is drawn out in the first direction, the flow deflector part can be deployed in the second direction rather than the first direction.

[0520] The flow deflector portion is configured to extend in the second direction by sweeping in the opposite direction to the first direction.

[0521] The flow deflector part is arc-shaped.

[0522] The arc-shaped concave portion is configured to sweep in the second direction.

[0523] When discharged from the tube, the flow deflector portion is configured to partially expand.

[0524] The flow deflector portion is configured to expand further when the trigger wire is pulled after partial expansion.

[0525] The inner tube is placed within the expandable structural section.

[0526] One end of the trigger wire is connected to the flow deflector section.

[0527] The trigger wire has its other end connected to the inner tube.

[0528] The trigger wire is configured to release to expand the flow deflector portion to an expanded state when the inner tube contracts from within the expansion structure.

[0529] The distal edge of the flow deflector portion is biased to match the curvature of the coronary sinus.

[0530] When the catch portion is discharged from the tube, the flow deflector portion is maintained in a form that is at least partially unexpanded.

[0531] The trigger wire is connected to the catch and extends through the tube.

[0532] The trigger wire is configured so that the flow deflector portion expands in the second direction when pulled from the first direction.

[0533] o The second direction is opposite to the first direction.

[0534] The mechanism delays the development of the flow deflector section until the tube is removed.

[0535] The controller is configured to control the expansion timing of the flow deflector section.

[0536] The stabilizer section is located on the scaffold side opposite the flow deflector section.

[0537] The stabilizer portion includes multiple outwardly extending branches.

[0538] The branch has a distal end that bends toward the inner wall of the heart chamber upon expansion.

[0539] The scaffold section and the flow deflector section are configured to expand after the expansion of the stabilizer section.

[0540] At least one extension is located on the same scaffold side as the flow deflector portion to help stabilize by contacting the inner wall of the coronary sinus.

[0541] The extension is located at the distal end of the flow deflector section.

[0542] The extension is configured so that after the tube is drawn out in the first direction, the extension can protrude in the second direction.

[0543] At least one extension is located on the perimeter edge of the scaffold portion.

[0544] At least one extension is configured to fully expand before the flow deflector portion fully expands in the coronary sinus.

[0545] A flexible fluid-impermeable cover is placed over the expandable structural part.

[0546]

[0547] Perforating an orifice between the coronary sinus and the heart chamber

[0548] A tube is delivered from the first direction to the coronary sinus, where the tube has an internally expanded retrograde blood flow device.

[0549] The retrograde blood flow device includes a scaffold section and a flow deflector section.

[0550] Partially eject the retrograde blood flow device from the tube so that the scaffold portion changes from a compressed state inside the tube to an expanded state outside the tube, thereby maintaining the flow deflector portion in a partially expanded state outside the tube.

[0551] Using a scaffold portion to maintain an orifice between the coronary sinus and the ventricle

[0552] Extending the flow deflector part in the second direction rather than the first direction

[0553] Induce retrograde flow in the coronary sinus using the flow deflector section

[0554] Intravascular retrograde blood flow device

[0555] The tubular shunt portion is configured to extend into the passage between the trachea and an adjacent blood vessel to bridge the cavity of the trachea and the interior of the blood vessel.

[0556] The stabilizer is configured to secure the tubular shunt portion to the passage.

[0557] The flow deflector section is connected to the proximal end of the tubular shunt section.

[0558] The flow deflector section is configured to induce retrograde blood flow.

[0559] The tether interconnects the flow deflector section and the tubular shunt section.

[0560] The tether interconnects the flow deflector portion and the tubular shunt portion in a manner that allows the flow deflector portion to be located at a predetermined distance from the tubular shunt portion in the blood vessel.

[0561] The tubular shunt section, stabilizer, and flow deflector section are configured and sized to extend through the coronary sinus.

[0562] The tubular shunt portion is configured to extend from at least one of the left atrium or left ventricle.

[0563] The flow deflector portion and the tether are configured to deploy into the coronary sinus to block blood flow from the left atrium to the right atrium.

[0564] The predetermined distance between the shunt and the flow deflector is 2 mm to 40 mm.

[0565] The stabilizer includes a flange at the distal end of the tubular shunt portion.

[0566] The flange is configured to interlock with the inner wall of the organ's cavity.

[0567] The tether comprises at least one of cloth, metal, or wire.

[0568] The tether hinges the flow deflector section to the tubular shunt section.

[0569] Configured to be delivered via a catheter

[0570] The tubular shunt portion is configured to expand after release from the catheter.

[0571] The flow deflector portion is configured to expand after release from the catheter.

[0572] The tubular shunt portion is configured to deploy from the catheter before deploying the flow deflector portion.

[0573] The tubular shunt portion is configured to unfold from the catheter before expanding the flow deflector portion, so that the tubular shunt portion can be expanded.

[0574] The flow deflector part is a plug.

[0575] The plug is configured to substantially block the passage of blood flow in the blood vessel.

[0576] The plug includes a covered extension frame

[0577] The operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion in the vessel.

[0578] The tether is configured to exhibit a rigid state to prevent the flow deflector portion from migrating within the blood vessel.

[0579] At least one additional tether interconnects the flow deflector section and the tubular shunt section.

[0580] The tether includes a distal end connected to a tubular shunt portion.

[0581] The tether includes a proximal end connected to the flow deflector portion.

[0582] The distal end of the tether is connected to the circumferential edge of the tubular shunt portion.

[0583] The distal end of the tether is connected to the periphery edge of the flow deflector portion or the periphery edge of the flow deflector stabilizer.

[0584] The tubular shunt portion includes a first frame structure.

[0585] The flow deflector part includes the second frame structure part.

[0586] At least one of the first frame structure and the second frame structure is at least partially covered with a flexible material.

[0587] The tether includes a proximal end connected to the center of the first frame structure.

[0588] The tether includes a distal end connected to the center of the second frame structure.

[0589] The tether has a thickness smaller than the width of the blood vessel, allowing blood flow between the tubular shunt section and the flow deflector section.

[0590] Method to induce endovascular retrograde blood flow

[0591] A tubular shunt portion is deployed in the passage between the trachea and the adjacent blood vessel to bridge the tracheal cavity and the interior of the blood vessel.

[0592] Deploy the stabilizer located at the distal end of the tubular shunt into the trachea.

[0593] Deploy the flow deflector portion connected to the proximal end of the tubular shunt portion into the blood vessel.

[0594] Position the flow deflector portion at a predetermined distance from the tubular shunt portion within the blood vessel.

[0595] Uses a tether interconnecting the flow deflector section and the tubular shunt section

[0596] Induce retrograde blood flow using the flow deflector section

[0597] Other embodiments will become apparent from the practice of the embodiments disclosed herein and from considering this specification. This specification and the embodiments are to be considered merely as examples, and the true scope and spirit of the disclosed embodiments are intended to be indicated by the following claims.

Claims

Claim 1 A device comprising: a catheter as an intravascular retrograde blood flow device; an expanding shunt compressed into the catheter and configured to bridge an opening between a first cavity of a first organ and a second cavity of a second organ; an expanding flow deflector compressed into the catheter, configured to deflect flow into the second cavity in a first direction; and the expanding flow deflector configured to at least partially block flow into the second cavity in a second direction; and a flexible hinge interconnecting the expanding shunt and the expanding flow deflector, wherein the flexible hinge is configured to bend when the expanding shunt is positioned in the opening and the expanding flow deflector is positioned in the second cavity, such that the expanding flow deflector becomes movable relative to the expanding shunt. Claim 2 A device according to claim 1, wherein the expandable flow deflector comprises an expandable frame covered with a flexible flow deflector cover, the expandable frame is configured to be fixed to the wall of the second cavity when expanded, and the fixation helps to stabilize the expandable shunt at the opening. Claim 3 A device according to claim 2, wherein in an extended form, the extended frame comprises a cylindrical portion, and the flexible flow deflection cover extends over the cylindrical portion in such a manner that it forms a drum-shaped planar flow deflection surface. Claim 4 A device according to claim 2, wherein in an extended form, the extended frame includes a deflector support, and the flexible flow deflection cover extends over the deflector support in such a manner that it forms a concave flow deflection surface. Claim 5 A device according to claim 2, wherein in an extended form, the extended frame includes a concave portion, and the flexible flow deflection cover extends over the concave portion in such a manner that it forms a ladle-shaped flow deflection surface. Claim 6 A device according to claim 2, wherein in an extended form, the extended frame comprises an extension portion configured to extend from the extended frame beyond the intersection of the first axis of the opening between the first cavity of the first organ and the second cavity of the second organ and the wall of the second cavity, and the extension portion engages with the wall of the second cavity. Claim 7 A device according to claim 6, wherein the extension extends in a direction opposite to the normal fluid flow direction. Claim 8 The device of claim 2, wherein the flexible flow-deflecting cover is substantially impermeable to blood. Claim 9 The device according to claim 2, wherein the flexible flow deflection cover comprises a tool passage configured to minimize blood flow passing through it. Claim 10 The device according to claim 2, wherein the flexible flow deflection cover comprises at least one of a mesh, a fabric, a polymer coating, or a synthetic material coating. Claim 11 A device according to claim 1, further comprising a first stabilizer extending from the distal end of the extendable shunt toward the opposite side of the flexible hinge to engage with the inner wall of the first cavity and maintain the extendable shunt within the opening. Claim 12 A device according to claim 11, further comprising a second stabilizer including a flange region extending from a proximal end of the extending shunt into the second cavity to engage with the inner wall of the second cavity and maintain the extending shunt within the opening. Claim 13 A device according to claim 12, wherein at least one of the first stabilizer and the second stabilizer comprises a plurality of prongs of different lengths. Claim 14 A device according to claim 11, wherein the first stabilizer comprises a plurality of outwardly extending branches, each branch having a distal end bent toward the inner wall of the first cavity. Claim 15 A device according to claim 2, wherein the extendable shunt comprises a tubular scaffold, and the flexible flow deflection cover extends over the tubular scaffold. Claim 16 The device of claim 2, wherein the flexible flow deflection cover is further configured to allow at least some non-retrograde blood flow in the second cavity. Claim 17 A device according to claim 1, wherein the expanded flow deflector comprises a lip that engages with the wall of the second cavity to help form a seal against the wall of the second cavity. Claim 18 A device according to claim 1, wherein the expanding flow deflector comprises a frame configured to maintain an initially compressed form after being discharged from the catheter, and the device further comprises a release mechanism that enables selective expansion of the expanding flow deflector after expansion of the expanding shunt. Claim 19 A device according to claim 1, wherein the expanding flow deflector is partially connected to the circumferential edge of the expanding shunt through the flexible hinge. Claim 20 A device according to claim 1, wherein the flexible hinge comprises a tether. Claim 21 In claim 20, the device, wherein the tether has a wave shape. Claim 22 A device according to claim 2, wherein the expanding frame is configured such that when the catheter is removed in a first direction to cause the expansion flow deflector to be released, the expanding frame expands in a second direction different from the first direction. Claim 23 A device according to claim 2, wherein the flexible hinge comprises two flexible hinges extending from both sides of the circumference of the extendable shunt. 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