Devices, systems and methods for myocardial revascularization

Abstract

Disclosed are devices, systems and methods for myocardial revascularization, including endovascular medical devices for shunting and selectively regulating anatomical fluid flow. A tubular shunt is configured to be placed in a passage between a first organ and an adjacent second organ and 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 in the second cavity.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is based on and claims the benefit of priority to 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, the entire contents of which are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally to the field of cardiac surgery, and more particularly to devices, systems, and methods for cardiac revascularization. [Background technology]

[0003] The primary function of the heart (myocardium) is to pump oxygenated blood (blood rich in oxygen) 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 healthy myocardium, deoxygenated blood from the body enters the right atrium through the superior and inferior vena cava. This blood is pumped through the tricuspid valve into the right ventricle and then pumped to the lungs for oxygenation via the pulmonary valve and pulmonary artery. The oxygenated blood then returns from the lungs via the pulmonary veins to the left atrium, where it is pumped through the mitral valve into the left ventricle. The left ventricle pumps this oxygenated blood through the aortic valve into the aorta, where it is distributed throughout the body via a complex network of arterial blood vessels.

[0004] While the superior and inferior venae cavae are primarily responsible for conducting deoxygenated blood from the body to the right atrium, the coronary sinus is primarily responsible for conducting venous (i.e., deoxygenated) blood from the cardiac vasculature to the right atrium. This great cardiac vein arises at the junction of the great cardiac vein and the oblique vein of the left ventricle and is partially located within the posterior atrioventricular groove between the left atrium and left ventricle. Three branches of the coronary sinus, including the anterior ventricle vein (AIVV), great cardiac vein (GVC), and posterior ventricle vein (PIVV), each drain blood into the coronary sinus. Oxygen saturation (PO2) within the coronary sinus is generally in the range of 10–15 mmHg.

[0005] For example, if the vascular system in the heart is not adequately oxygenated as a result of coronary artery disease, atherosclerosis, and arteriosclerosis, complications including angina, heart attack, and heart failure can occur. Various surgical techniques can be used to mitigate these complications. For example, angioplasty (also known as percutaneous coronary intervention, balloon angioplasty, and coronary balloon dilation) involves surgical widening of a clogged or otherwise narrowed artery. Here, a surgeon delivers a catheter balloon system to the site of the blockage and inflates the balloon to open the blockage and improve blood flow through the artery. A stent can be inserted to prevent the artery from constricting, thereby maintaining blood flow through it. Surgeons can also use a laser (laser angioplasty) or a cutting tool (atherectomy) to vaporize or ablate any blockages.

[0006] Another method of correcting oxygen deficiency is coronary artery bypass surgery (also known as coronary artery bypass grafting, "CABG"). Here, open-heart surgery is used to transplant healthy blood vessels into the heart to divert blood around the blocked arteries. The grafts can be harvested from the patient or a donor, usually from one or more of the legs, arms, or chest, depending on the number of grafts needed. Due to the invasive nature of open-heart surgery, complications and recovery times tend to be longer, which usually requires the surgeon to stop the heart to complete the procedure, increasing the risk of infection at both the chest incision site and the graft incision site.

[0007] Yet another method for improving oxygen deficiency involves perfusing oxygenated blood throughout the heart using one or more surgically created holes in the left ventricle. Transmyocardial revascularization (TMR) involves using one or more lasers to create multiple channels through the left ventricle to improve direct perfusion to the myocardium. This method can be beneficial when patients do not respond to or are ineligible for coronary artery bypass surgery or percutaneous coronary intervention. Similar to TMR, percutaneous myocardial revascularization (PMR) also uses surgically created holes to allow direct myocardial perfusion, but this procedure tends to be less invasive.

[0008] Still other methods contemplate the use of various stent devices or grafts to direct oxygenated blood from the left ventricle into the coronary arteries or to allow the return flow of oxygenated blood from the left ventricle to the myocardium via the coronary sinus. The devices, systems, and methods described herein address at least some of the problems with conventional revascularization techniques. Such devices, systems, and methods can shorten patient recovery times and improve patient outcomes. Summary of the Invention [Problem to be solved by the invention]

[0009] Embodiments according to the present disclosure provide devices, systems and methods for myocardial revascularization. [Means for solving the problem]

[0010] Some embodiments include an intravascular medical device for shunting and selectively regulating the flow of an anatomical fluid. The embodiments may include a tubular shunt configured to be positioned within a passageway between a first organ and an adjacent second organ and to bridge a first cavity of the first organ with a second cavity of the second organ. The embodiments may also include a stabilizer configured to stabilize the tubular shunt within the passageway. The embodiments may also include a flow deflector extending from the tubular shunt and having a surface for deflecting flow within the second cavity. The flow deflector may be configured to extend from less than the entire circumference of the tubular shunt.

[0011] Some embodiments include an intravascular retrograde blood flow device comprising: a catheter; an expandable shunt compressed within the catheter to bridge an opening between a first cavity and a second cavity; an expandable flow deflector compressed within the catheter to deflect flow in the second cavity; and a flexible hinge interconnecting the expandable shunt and the expandable flow deflector, the flexible hinge being configured to bend when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned within the second cavity along a second axis transverse to the first axis, such that the flexible hinge is bendable and allows transverse axial positioning of the expandable shunt and the expandable flow deflector while maintaining the interconnection between the expandable shunt and the expandable flow deflector.

[0012] Some embodiments include a medical device for directing retrograde blood flow, the medical device comprising: a tube for delivery to the coronary sinus from a first direction; and an expandable structure compressed within the tube. The expandable structure includes a scaffold portion for maintaining an orifice between the coronary sinus and a heart chamber; and a flow deflector portion configured to induce retrograde blood flow into the coronary sinus. The flow deflector portion is configured to allow deployment in a second direction other than the first direction after the tube is withdrawn in the first direction.

[0013] Some embodiments include an intravascular retrograde blood flow device comprising a tubular shunt portion configured to be positioned within a passage between an organ and an adjacent blood vessel to bridge an intravascular cavity and the interior of the blood vessel, a stabilizer configured to secure the tubular shunt portion within the passage, and a flow deflector portion connected to a proximal end of the tubular shunt portion, the flow deflector configured to direct blood flow, and a tether interconnecting the flow deflector portion and the tubular shunt portion to enable the flow deflector portion to be positioned a predetermined distance from the tubular shunt portion within the blood vessel.

[0014] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The details shown are by way of example and for illustrative purposes of embodiments of the present disclosure. The description, taken in conjunction with the drawings, will make apparent to those skilled in the art how embodiments of the present disclosure may be practiced. [Brief explanation of the drawings]

[0015] [Figure 1A] FIG. 1 is a front view of an example of an intravascular medical device according to some embodiments of the present disclosure.

[0016] [Figure 1B] FIG. 1B is a side view of the device of FIG. 1A.

[0017] [Figure 1C] FIG. 1B is a bottom view of the device of FIG. 1A.

[0018] [Figure 1D] FIG. 1B is an isometric view of the device of FIG. 1A.

[0019] [Figure 2] FIG. 1B is a side view of the device of FIG. 1A placed between biological organs, according to some embodiments of the present disclosure.

[0020] [Figure 3A] FIG. 1B is a front view of the device of FIG. 1A including a flexible covering, according to some embodiments of the present disclosure.

[0021] [Figure 3B] FIG. 3B is a side view of the coated device shown in FIG. 3A.

[0022] [Figure 3C] FIG. 3B is a bottom view of the coated device shown in FIG. 3A.

[0023] [Figure 3D] FIG. 3B is an isometric view of the coated device shown in FIG. 3A.

[0024] [Figure 4] 1A-1C are visual illustrations of an exemplary method of placing an intravascular medical device between biological organs, according to some embodiments of the present disclosure.

[0025] [Figure 5] 1 is a flowchart of a method for diverting and diverting blood flow between biological organs, according to some embodiments of the present disclosure.

[0026] [Figure 6] 1A-1C illustrate exemplary placement of an intravascular medical device between biological organs within the heart, according to some embodiments of the present disclosure.

[0027] [Figure 7] FIG. 1B is a side view of an exemplary expandable frame having a drum-shaped flow deflector frame, according to some embodiments of the present disclosure.

[0028] [Figure 8A] FIG. 7 is a perspective view of the expandable frame of FIG. 6, showing a drum-shaped enclosure with a drum-shaped flow deflector frame.

[0029] [Figure 8B] FIG. 10 is a side view of another expandable frame having a concave flow deflector cover, according to some embodiments of the present disclosure.

[0030] [Figure 8C] FIG. 10 is a side view of an alternative expandable frame with integrated shunt and flow deflector portions, according to some embodiments of the present disclosure.

[0031] [Figure 8D] FIG. 10 is a side view of another alternative expandable frame with integrated shunt and flow deflector portions, according to some embodiments of the present disclosure.

[0032] [Figure 9] 1 is a flowchart of an exemplary method for directing intravascular retrograde blood flow, according to some embodiments of the present disclosure.

[0033] [Figure 10] 10A-10C are different views of an example of a flow deflection portion including a tool passage, according to some embodiments of the present disclosure.

[0034] [Figure 11] 8C is an additional view of the expandable frame of FIG. 8B according to some embodiments of the present disclosure.

[0035] [Figure 12]FIG. 1 is a perspective view of an exemplary medical device for directing retrograde blood flow, according to some embodiments of the present disclosure.

[0036] [Figure 13] 1 is a schematic illustration of a medical device deployed to direct retrograde blood flow between a generalized heart chamber and the coronary sinus, according to some embodiments of the present disclosure. FIG.

[0037] [Figure 14A] FIG. 14 is a side view of the medical device disclosed in FIG. 13.

[0038] [Figure 14B] FIG. 14 is a perspective view of the medical device of FIG.

[0039] [Figure 15] 1 is a flowchart of an exemplary method for directing retrograde blood flow, according to some embodiments of the present disclosure.

[0040] [Figure 16] 1 is a cross-sectional view of a human heart with an exemplary intravascular retrograde blood flow device placed therein, according to some embodiments of the present disclosure.

[0041] [Figure 17] 1 is a schematic diagram of an exemplary intravascular retrograde blood flow device placed between a heart chamber and a coronary sinus, according to some embodiments of the present disclosure. FIG.

[0042] [Figure 18] FIG. 1 is a perspective view of another exemplary intravascular retrograde blood flow device, according to some embodiments of the present disclosure.

[0043] [Figure 19] FIG. 10 is a side view of a further exemplary embodiment of an intravascular retrograde blood flow device, according to some embodiments of the present disclosure.

[0044] [Figure 20]FIG. 10 is a perspective side view of a further exemplary embodiment of an intravascular retrograde blood flow device, according to some embodiments of the present disclosure.

[0045] [Figure 21] 1 is a flowchart of an exemplary method for directing intravascular retrograde blood flow, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0046] Exemplary embodiments are described with reference to the accompanying drawings, which 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. Additionally, the terms "comprising," "having," "containing," "including," and other similar terms are intended to be equivalent in meaning and open-ended in that the one or more items following any one of these terms are not intended to be an exhaustive listing of such one or more items, nor are they intended to be limited to only the listed one or more items. Note that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, relative terms such as "first" and "second" used herein are used only to distinguish one entity or operation from another and do not require or imply an actual relationship or order between those entities or operations.

[0047] As used herein, unless otherwise stated, the term "or" includes all possible combinations unless impracticable. For example, if it is stated that a component can include A or B, the component can include "A or B" or "A and B" unless otherwise stated or impracticable. As a second example, if it is stated that a component can include at least one of A, B, or C, the component can include "A, B, or C," "A and B," "A and C," or "A, B, and C" unless otherwise stated or impracticable.

[0048] This disclosure uses open-ended permissive language indicating, for example, that some embodiments "may use," "may involve," or "may include" a particular feature. Use of the phrase "may" and other open-ended phrases is intended to indicate that not all embodiments can use a particular disclosed feature, but that at least one embodiment does use a particular disclosed feature.

[0049] In the following description, for illustrative purposes, examples of various implementations are presented; however, it should be understood that the present disclosure may be practiced without one or more of these details. Reference will now be made in detail to non-limiting examples of the present disclosure, examples of which are illustrated in the accompanying drawings. The examples are described below by reference to the drawings, in which like reference numerals refer to like elements. Where like reference numerals are shown, corresponding descriptions will not be repeated. The interested reader is referred to the foregoing figures for descriptions of like elements.

[0050] Embodiments of the present disclosure relate to intravascular medical devices, including intravascular medical devices for shunting and selectively regulating anatomical fluid flow. As used herein, an intravascular medical device may refer to any device or instrument configured to be placed within or operate within a blood vessel or another biological structure or organ within the human body for medical purposes. In disclosed embodiments, the biological structure may include a hollow anatomical feature within a patient's body. Non-limiting examples of biological structures include blood vessels, capillaries, arteries, veins, heart chambers (e.g., left atrium, left ventricle, right atrium, right ventricle), or any other anatomical organ. An intravascular medical device may be configured to be delivered to a treatment site from a first location (e.g., a location outside the body) within a blood vessel or other biological structure. Additionally or alternatively, in some embodiments, an intravascular medical device may be configured to effect a temporary or permanent change or deformation at the treatment site within the blood vessel. Some non-limiting examples of intravascular medical devices according to the present disclosure may include a shunt, a stent, a catheter, or any other device configured to be placed within a blood vessel or other biological structure.

[0051] FIELD OF THE DISCLOSURE Embodiments of the present disclosure generally relate to medical devices, methods, and systems for shunting blood between two organs. In some embodiments, blood flow from a heart chamber may be shunted into the coronary sinus, thereby creating backflow in the coronary sinus as a mechanism for treating heart disease.

[0052] As a non-limiting example, an intravascular medical device for creating retrograde coronary sinus blood flow may include a tubular shunt bridging a heart chamber, such as the left atrium or left ventricle, with the coronary sinus to create retrograde, oxygen-rich blood flow through the coronary sinus. Oxygenated blood flowing "backward" through the coronary sinus may result in oxygenation of cardiac tissue that may otherwise receive inadequate blood flow. A flow deflector placed within the coronary sinus may help direct the retrograde flow and may block or at least partially obstruct flow to another biological structure, such as the right atrium.

[0053] Intravascular medical devices according to embodiments of the present disclosure may include tubular shunts. As used herein, tubular may refer to a structure having one or more outer walls defining an intermediate channel, regardless of the contours of the intermediate channel. As used herein, shunt may refer to any structure capable of bridging two biological structures, such as a heart chamber and a blood vessel. For example, a tubular shunt may be configured for placement in a passageway between a first organ and an adjacent second organ. As used herein, placement may relate to the positioning or placement of an intravascular medical device within the body. Furthermore, a passageway may refer to a channel or opening that allows a fluid, such as blood, to flow. The passageway may be formed by a pre-drilled hole. Furthermore, in some embodiments, a tubular shunt may be configured to bridge a first cavity of a first organ and a second cavity of a second organ. Bridging the first cavity of a first organ and the second cavity of a second organ may include providing a structure that allows fluid to flow between the first and second cavities. It is contemplated that the first organ and the second organ may be any biological organ, such as, but not limited to, a blood vessel, an anatomical cavity, and / or an anatomical chamber. Additionally, a shunt may redirect the flow of bodily fluids, as further described herein.

[0054] 1A-1D show various views of an example of an intravascular medical device 11 for shunting and selectively regulating anatomical fluid flow, according to some embodiments of the present disclosure. As shown in FIGS. 1A-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 defining a passageway configured to allow fluid flow from one end to the other. Thus, the tubular shunt 110 may be configured to be placed in a passageway between an organ (e.g., the left atrium) and an adjacent blood vessel (e.g., the coronary sinus) to bridge a cavity within the organ with the interior or lumen of the blood vessel.

[0055] In some embodiments, a tubular shunt may include a tubular wall having at least one opening. The tubular wall may be formed of wire, wire mesh, struts, ribs, or other material capable of providing scaffolding for a passageway. One or more openings in the wall may be gaps between strands of wire, wire mesh, struts, ribs, or other material. For example, as shown in FIGS. 1A-1D, a tubular shunt 110 may include a tubular wall having a series of openings 112. It is contemplated that the tubular wall may have any number of openings based on design considerations.

[0056] Additionally, the tubular shunt 110 may include a central opening 114, thereby maintaining an orifice between a heart chamber (e.g., the left atrium or left ventricle) and an adjacent organ (e.g., a blood vessel, such as a vein, including the coronary sinus), for example, via a pre-drilled hole between the heart chamber and an adjacent organ. The pre-drilled hole may be formed as part of the implantation process prior to placing the intravascular device at the desired location, or may have been formed in a previous procedure. 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 and 9 mm.

[0057] 2 is a side view illustrating an example of an intravascular medical device 11 positioned between two cavities. For example, cavity 220 can be the left atrium and cavity 210 can be the coronary sinus.

[0058] FIG. 2 is intended to represent a general example of adjacent organs in which embodiments of the present disclosure may be placed. While shown as a larger first cavity 220 shunted to a blood vessel 210, it should be understood that the depiction in FIG. 2 is merely exemplary. In some embodiments, the first cavity 220 and the second cavity 210 may both be blood vessels, while in other embodiments, the first cavity and the second cavity 210 may both be non-vascular. As an example, one embodiment used in this disclosure is one in which the first cavity 220 is the left atrium and the second cavity 210 is the coronary sinus. Accordingly, in this disclosure, reference numerals 220 and 210 may be more generally referred to as the first and second cavities, and these same reference numerals may be used to refer to examples of the left atrium and coronary sinus. It should be understood that reference to this latter example is not intended to limit the disclosure of FIG. 2 to examples of a left atrium shunted to the coronary sinus. Rather, FIG. 2 is intended to broadly disclose any two cavities shunted together.

[0059] 2, tubular shunt 110 may be placed or positioned between cavity 220 and cavity 210 with passageway 270 formed during the implantation process. Additionally, tubular shunt 110 may, for example, bridge cavity 220 and cavity 210, in the illustrated case the interior lumen of a blood vessel. In some embodiments, a pre-cut hole between cavity 220 and cavity 210 may form passageway 270.

[0060] The tubular shunt 11 may have flexibility and structural stability to prevent dislodgement or damage during its intended use. In some embodiments, the tubular shunt 11 may include multiple struts and connectors, which may be spaced equal distances from one another along the tubular circumference of the tubular shunt 11. As previously described, the spaces between the struts and connectors may define openings 112. The tubular shunt 11 may be configured to allow fluid (e.g., blood) to flow from an area of ​​higher pressure (e.g., a heart chamber) to an area of ​​lower pressure (e.g., a vein or coronary sinus) through a central opening 114. The pressure difference may exceed 1 mmHg. In some embodiments, the shunt further includes a pressure valve configured to restrict or allow blood to pass at a predetermined pressure.

[0061] The tubular shunt 11 can be sized to terminate at a boundary region between the central opening 114 or passageways 270. For example, one end of the tubular shunt 11 may terminate at a boundary region between the central opening 114 (or passageways 270) of the coronary sinus 210, such as at the superior wall 250. The other end of the tubular shunt 11 may terminate at a boundary region between the central opening 114 (or passageways 270) of the left atrium 220, such as at the inner wall 260.

[0062] In some embodiments, the tubular shunt 110 may include an orientation marker to facilitate rotational orientation about the central opening 114. The orientation marker may be configured to allow control of the rotational orientation of the tubular shunt 110 about the central opening 114. In some embodiments, control of the rotational orientation of the tubular shunt 110 can define the degree of flow deflection within the second cavity (e.g., the coronary sinus 210), which is described in more detail below with respect to the flow deflector 130. The orientation marker may include, for example, a tantalum marker or a specific structural design at a specific location.

[0063] The tubular shunt 110 can be configured to accommodate various anatomical structures and stabilize the flow deflector portion 130 and the tubular shunt 110 by having ends axially spaced apart from one another by approximately 0.5-5 mm in length or 1-4 mm in length. As used herein, axially spaced apart can refer to the distance between the distal and proximal ends along the longitudinal axis of the intravascular medical device. The tubular shunt 110 can be integrally connected or interconnected with one or more of the stabilizer 120 and the flow deflector 130, both of which are described in detail below.

[0064] In some embodiments, the intravascular medical device can include a stabilizer. As described above, the stabilizer and the tubular shunt can be integrally connected, and the stabilizer can be configured to stabilize the tubular shunt within the passageway. Stabilizing the tubular shunt can include fixing the tubular shunt in a particular position or rotational orientation, or preventing the tubular shunt from migrating, moving, or rotating.

[0065] As a non-limiting example, the stabilizer may include a first flange region connected to the tubular shunt. As used herein, a flange may refer to a protruding flat rim, collar, or rib structure on a component. A flange refers to a protruding ridge, lip, or rim, or edge that extends outward from a structure, in this example, the tubular shunt. The flange may completely or partially surround the outer periphery of the shunt, or may include a series of flange portions or flange regions that cooperate to provide stabilization. A flange region refers to all or a portion of the flange.

[0066] As shown by way of example in FIGS. 1A-1D , the first flange region 140 may include a substantially flared shape having a radius of curvature. The perimeter of the flare may be larger than the perimeter of the shunt to prevent shunt migration. In some embodiments, the first flange region 140 may be disposed on a side of the tubular shunt 11 opposite a flow deflector, an example of which is shown as 130 in FIGS. 1A-1D and described in further detail below. Additionally or alternatively, in some embodiments, the first flange region 140 may be configured to seal (e.g., form a tight closure) against an inner wall 260 of the first cavity (e.g., left atrium 220) upon placement or deployment of the intravascular medical device 11 such that blood flow between the first flange region 140 and the inner wall 260 of the first cavity (e.g., left atrium 220) is restricted (partially or completely). Additionally, in some embodiments, the first flange region 140 may be asymmetric with respect to the radius of curvature at various locations or along the length of the flange.

[0067] 1A-1D and 2, when first flange region 140 (shown in FIGS. 1A-1D ) extends into second cavity 220 (shown in FIG. 2 ), stabilizer 120 may sit flush (or relatively flush) with inner wall 260 of first cavity 220, effectively providing an anchor for intravascular medical device 11 when implanted. Thus, tubular shunt 110 may be stabilized within passageway 270. Although shown in FIG. 2 as assuming a flush configuration, stabilizer 120 may assume alternative configurations, such as an S-shaped or C-shaped cross-sectional profile.

[0068] Additionally or alternatively, the tubular shunt may include a second flange region extending into the second cavity, which may be configured to secure (e.g., anchor or fasten) the tubular shunt within the passageway to prevent the tubular shunt from bending, loosening, or moving. As shown in FIGS. 1A-1D, the tubular shunt 11 may include a second flange region 150. As shown in FIG. 2, the second flange region 150 may also have a flared shape such that the second flange region 150 extends into the second cavity 210. In some embodiments, the second flange region 150 may abut the upper wall 250 of the second cavity 210 near the pre-cut hole between the first cavity 220 and the second cavity 210.

[0069] As described above, the first flange region 140 may seat flush with the inner wall 260 of the first cavity 220, and the second flange region 150 may seat flush with 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 can stabilize the tubular shunt 110 in its axial and rotational position between the left atrium 210 and the coronary sinus 210 and prevent axial, rotational, or both movement of the tubular shunt 110.

[0070] Thus, the shunt and stabilizer combination may have an hourglass shape with a narrower body at its midsection and wider flange regions 140 and 150 that extend beyond the periphery of the tubular shunt into the first cavity of the first organ and the second cavity of the second organ. In some embodiments, flange region 150 may be omitted at the proximal end of the shunt, and stability at the proximal end may be provided by an attached flow deflector, as described below.

[0071] Disclosed embodiments may include a flow deflector extending from the tubular shunt and having a surface for deflecting flow within the second cavity. Flow deflection involves changing the direction of flow. For example, a bodily fluid, such as blood, may be redirected from a first direction to a second direction. In some embodiments, the second direction may be opposite the first direction. In other embodiments, the second direction may be perpendicular to the first direction. It is contemplated that the second direction may be perpendicular, parallel, or oblique to the first direction. Thus, a flow deflector may include any structure that deflects, diverts, occludes, blocks, obstructs, slows, or prevents fluid flow.

[0072] 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 circumference of the tubular shunt. For example, the flow deflector may extend from half the circumference of the tubular shunt. In some embodiments, the flow deflector may include an inner surface that is integral with the tubular shunt, such that there is no clear transition between the tubular shunt and the flow deflector. (In other words, the structure 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 that is integral with the tubular shunt, such that there is no clear transition between the tubular shunt and the flow deflector.

[0073] As shown in FIGS. 1A-1D , the intravascular medical device 11 may include a flow deflector 130. The flow deflector 130 may be positioned at the opposite end of the tubular shunt 110 from the stabilizer 120. The flow deflector 130 may be configured for placement within a vein, such as the coronary sinus 210, in a manner as 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-cut hole is formed during the implantation process. The flow deflector 130 may be configured to deflect blood flowing in an initial direction, such as natural flow 230, through the lumen of the second cavity 210 such that the blood is deflected in a retrograde or reverse flow 240 direction, as shown in FIG. 2 . Blood flowing in the natural flow 230 direction may be deoxygenated, and blood flowing in the reverse flow 240 direction may be oxygenated.

[0074] 2, reverse flow 240, or blood deflected in a retrograde direction, may be achieved by shunting the first cavity 220 and the second cavity 210 via a passageway 270 using the tubular shunt 110 and through at least partial occlusion of the natural flow 230. In situations where the first cavity 220 is a source of oxygen-rich blood, such as when the first cavity 220 is on the left side of the heart (left atrium or left ventricle) and the second cavity 210 is the coronary sinus, reverse flow may support heart tissue deprived of oxygen as a result of heart disease.

[0075] As used herein, occlusion may refer to the blocking or redirection 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 blocking blood flowing in the first direction or redirecting blood flowing in the first direction. As another example, occlusion of a blood vessel may include blocking fluid flow through the vessel or closing the vessel. The flow deflector 130 may contribute to at least partial occlusion of natural flow 230. Additionally, higher pressure in the left atrium than in the coronary sinus may contribute to backflow 240.

[0076] Additionally, in some embodiments, the flow deflector may include a non-tubular recess configured to deflect flow within the second cavity. As noted above, tubular may refer to a structure having one or more outer walls defining an intermediate channel, regardless of the contours of the intermediate channel. Thus, as used herein, a non-tubular recess may refer to a structure that does not form a completely enclosed intermediate channel and may have walls that leave the non-tubular recess open. For example, as shown in FIGS. 1A-1D, the flow deflector 130 may have a curved or bent frame. In some embodiments, the bent frame may have a scoop-like configuration, in which case the scoop-like configuration may be shaped so that the flow deflector 130 has a radius of curvature. The scoop-like configuration may provide increased flexibility to the edges or lips of the flow deflector 130 to accommodate a range of anatomical and inter-patient variations. As shown in FIG. 1A, the scoop-like groove of the flow deflector 130 may generally be circular in cross-sectional shape. Additionally, in some embodiments, the flow deflector 130 may form a crescent shape extending from the tubular shunt, as shown in FIG. 1B.

[0077] In some embodiments, the flow deflector 130 may have a scoop-like or arc-like recess sized to cover most or all of the inner circumference of a vein, such as the coronary sinus 210, such that the flow deflector extends almost or completely across the entire cross-section within the vein. In some examples, the flow deflector may be sized to abut the periphery of the venous cavity (e.g., the coronary sinus) or to span the cross-section of the venous cavity (e.g., the coronary sinus). For example, as shown in FIG. 2, the flow deflector 270 may span the cross-section of the coronary sinus 210 and abut the inferior wall 280 of the coronary sinus 210.

[0078] In some embodiments, the scoop shape has a minimum radius measured from the center of the tubular shunt 110, which may correspond approximately to the cross-sectional height diameter of a second organ, such as a vein (e.g., the coronary sinus). In some embodiments, the scoop shape radius may be approximately 20% larger than the vein radius to securely form a seal. For example, for a vein radius of 4 mm, a scoop radius of 5 mm may apply. According to some embodiments, the flow deflector may include a second stabilizer for engaging 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 stabilizers may be configured to cooperate to maintain a fluid seal.

[0079] Additionally or alternatively, the flow deflector may include a tether configured to connect the flow deflector to the periphery of the tubular shunt. As used herein, a tether may include fabric, metal, wire, a hinge, or other fastening component that may connect the flow deflector 130 to the periphery of the tubular shunt 110. FIG. 16 shows an example of a tether 1624 interconnecting the flow deflector portion 1620 and the tubular shunt portion 1614. Disclosed embodiments may include at least one wavy flexible wire connecting the tubular shunt to the flow deflector. The wavy flexible wire may be shaped such that the flexible wire has a form or profile that smoothly rises and falls. The tether may be further configured to prevent the flow deflector 130 from moving beyond a predetermined distance from the tubular shunt 110. This can contribute to a flow deflector that can be adaptable to various anatomies (eg, due to variations between and among individual anatomies).

[0080] Additionally or alternatively, the tubular shunt may be sized to terminate distally (e.g., terminate, stop, interconnect) at a periphery of the passageway proximate the first cavity, and the flow deflector may be sized to terminate against (e.g., terminate, stop, interconnect) a wall of a second cavity on the opposite side of the passageway. As shown in FIG. 2, the tubular shunt 110 may terminate at a periphery of the passageway proximate the first cavity 220, e.g., the inner wall 260. With reference to FIG. 2, the tubular shunt 110 may terminate against a wall of the second cavity on the opposite side of the passageway, e.g., the lower wall 280. Furthermore, the flow deflector 130 may include an edge or lip configured to engage a wall, such as the lower wall 280 of the second cavity 210. The distal edge or lip may be flexible and configured to flex relative to the lower wall 280 of the second cavity 210. Additionally or alternatively, the distal edge or lip may be biased to conform to the curvature of the second cavity 210 (eg, the coronary sinus).

[0081] In some embodiments, as described above, the flow deflector may be configured to allow retrograde flow within the vessel. As a non-limiting example, as shown in FIG. 2 , the intravascular medical device 11 may be positioned such that the flow deflector 130 induces retrograde flow 240 into the second cavity 210 (e.g., the coronary sinus). In some embodiments, the flow deflector may be configured to allow both natural flow 230 and retrograde flow 240 within the vessel, for example, by partially occluding the natural flow 230, as described in more detail below.

[0082] Additionally or alternatively, the flow deflector may include a tool passage therethrough. A flow deflector including a tool passage allows various surgical tools to pass through the flow deflector, enabling surgical procedures such as, but not limited to, revision surgery, removal of an intravascular medical device, or monitoring or resolving a cardiac or intravascular condition (e.g., pressure, plaque buildup). As an example, the flow deflector 130 may allow a tool, such as a cutting tool or pushing tool, a guidewire, or a trigger wire to be passed through the second cavity 210 to a location on the opposite side of the left atrium 220. Continuing the example, a cutting tool may be used to form an incision or hole in one biological organ or between two biological organs. A 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, staggered shutters, or two or more layers of laminated material with each individual layer having a slot, plug, or other temporary seal positioned perpendicular to one another. Other approaches to tool passages, such as two overlapping layers configured to allow non-overlapping manipulation as tool passage locations, are also contemplated for use with the disclosed embodiments.

[0083] In some embodiments, the tubular shunt and flow deflector may be integrally connected such that a rotational orientation of the tubular shunt within the passageway defines a degree of flow deflection in the second organ, where the second organ may be a blood vessel. The degree of flow may include a quantification of a characteristic of blood flow. For example, the degree 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.

[0084] 2, the tubular shunt 110, stabilizer 120, and flow deflector 130 may be integrally connected to form the intravascular medical device 11. As the tubular shunt 110 rotates, the flow deflector 130 may rotate in the same direction. The rotation of the flow deflector 130 may result in a rotational orientation that defines the degree of flow deflection or flow occlusion (e.g., amount of blood flow, velocity of blood flow, volume of blood flow) in the coronary sinus 210.

[0085] The rotational orientation of the flow deflector 130 can create at least a partial blockage in the cross section of the coronary sinus 210, partially or completely blocking blood flow within the coronary sinus 210 in the direction of natural flow 230. Blood flowing in natural flow 230 may be deflected, redirected, or rerouted into the left atrium 220, and backflow 240 may occur.

[0086] For example, in a first rotational orientation of the tubular shunt, the flow deflector may be configured to span the width of the blood vessel to cause a first flow deflection. Further, in a second rotational orientation of the tubular shunt, the flow deflector may be configured to span less than the width of the blood vessel to cause a second flow deflection. In some embodiments, the first flow deflection may be greater than the second flow deflection.

[0087] 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 a complete blockage (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 to allow some blood to pass even in the fully deflected position. Thus, in the rotational orientation shown in FIG. 2, most or all of the blood flowing in the direction of natural flow 230 may be redirected to flow in the direction of reverse flow 240. Additionally, the intravascular medical device 11 may be rotated about its 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 a partial blockage (e.g., a 90%, 70%, 60%, 50% or less deflection) of blood flowing in the natural flow 230 through the coronary sinus 210. Thus, in the example second rotational orientation, half of the blood flowing in the direction of natural flow 230 may be redirected to flow in the direction of counterflow 240, and the other half of the blood flowing in the direction of natural flow 230 may continue to flow in the direction of natural flow 230. As illustrated in this example, the flow deflection (or blood flow redirection) caused by the rotational orientation of intravascular medical device 11 as shown in FIG. 2 may be greater than the flow deflection caused by the second rotational orientation of intravascular medical device 11.

[0088] It is contemplated that the intravascular medical device 11 can be placed in any number of rotational orientations, each of which can provide a different degree of occlusion. Different degrees of occlusion may be desired to address different degrees of disease and / or impairment of the heart.

[0089] In some embodiments, the tubular shunt 110, stabilizer 120, and flow deflector 130 may be made from a biocompatible, flexible material that forms a frame or scaffold (e.g., walls with holes) that allows for transition between a collapsed configuration suitable for percutaneous delivery within a delivery catheter and an expanded state, as described in further detail below. The stiffness of the flexible material may be low enough so as not to interfere with the natural contractions of the atrial chambers of the heart. The flexible material may also have non-uniform flexibility to enhance its function within the heart. Furthermore, in some embodiments, the metal outer edges, such as those of 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 tissue-engaging outer edges may be more flexible. The frame or scaffold portion of the tubular shunt may be interconnected with one or both of the stabilizer and the flow deflector.

[0090] Additionally, flexible materials may include materials that provide strength to resist deformation over time, have the ability to expand with a reduced circumferential pressure, and may be flexible to accommodate a range of anatomical variations. Non-limiting examples of flexible materials may include superelastic alloys and / or shape memory materials, such as shape memory alloys (SMAs) such as Nitinol or nickel-titanium alloys, also known as NiTiCu (nickel-titanium copper), CuZn (copper zinc), CuZnAI (copper zinc aluminum), and / or CuAINi (copper zinc nickel). Other suitable materials may include other biocompatible metals or stainless steel. Flexible materials may be further coated and / or textured to improve blood flow and enhance biocompatibility for optimal engagement with tissue within the pre-cut hole.

[0091] 3A-3D illustrate an example of an intravascular medical device having a flexible covering 31. As shown in FIGS. 3A-3D, the tubular shunt 110 may be covered by a tubular shunt cover 310, the stabilizer 120 may be covered by a stabilizer cover 320, and the flow deflector 130 may be covered by a flow deflection cover 330. The covers 310, 320, and 330, alone or in any combination, may form the flexible covering. In combination, the covers 310, 320, and 330 may be integral or continuous. The covering may be stitched, glued, or otherwise secured to an underlying framework.

[0092] As used herein, a flexible covering may include a fabric cover or any flexible material that can be wrapped around a component of an intravascular medical device. In some embodiments, the flexible covering may have greater flexibility than the flexible materials described above with respect to the frame or scaffold. The flexible covering may be at least partially impermeable to fluids. In particular, the flexible covering may be at least partially impermeable to blood flow. In some embodiments, the flexible covering may be substantially impermeable to fluids. The partial or substantial impermeability of the flexible covering to fluids may facilitate effective deflection of fluid flow, such as blood flow. For example, a flexible covering that is partially impermeable to blood flow may allow the flexible covering to block and redirect a portion of the blood flow passing through the flexible covering. As another example, a flexible covering that is substantially impermeable to blood flow may allow the flexible covering to block and redirect all of the blood flow passing through the flexible covering. In some embodiments, the flexible covering may be porous. As used herein, a porous structure may include voids such that any material or fluid flowing therethrough can flow through the porous structure. It is contemplated that the voids may be of any size or combination of sizes within a single porous structure.

[0093] Additionally or alternatively, the flexible covering can promote endothelialization or epithelialization on the surface of the flow deflector or within the porous (e.g., mesh or braid) flexible covering. Non-limiting examples of compounds that can be implemented to promote endothelialization or epithelialization include, but are not limited to, growth factors such as transforming growth factors, fibroblast growth factors, epidermal growth factors, and other biological materials (e.g., tissue or tissue components). In some embodiments, the flexible covering can be configured to inhibit clotting on the surface of the flow deflector or within the porous flexible covering, such as by including molecules known to reduce clotting, so that the formation of thrombi or emboli is minimized in the vicinity.

[0094] In some embodiments, the flow deflector 130 can include a scaffold portion and a flexible flow deflecting cover 330, also referred to as a pliable covering. In some examples, the flow deflector 130 can be disposed on the flow deflector 130 such that the flow deflector 130 and the flow deflecting cover 330 are configured to deflect blood flow from the heart chamber 220 in a retrograde manner within the coronary sinus 210 upon expansion.

[0095] Additionally, 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 and cover at least 50% of the scoop shape of the flow deflector 130. In other embodiments, the flexible flow deflection cover 330 may be configured to extend and cover at least 70% of the scoop shape of the flow deflector 130. In yet other embodiments, the flexible flow deflection cover 330 may be configured to extend and cover at least 90% of the scoop portion of the flow deflector 130. Furthermore, in some embodiments, the flexible flow deflection cover 330 may be configured to extend and cover at least 95% of the scoop shape of the flow deflector 130. In some embodiments, the flow deflection cover 330 may comprise a fine mesh or woven material.

[0096] The stabilizer may include a flexible covering and a plurality of arms configured to establish a fluid seal (e.g., complete or partial) between a first side of the flexible covering and a wall of the first cavity when deployed.

[0097] As an example, flexible covering 320 may be configured to seal stabilizer 120 or a flange against a wall, such as interior wall 260 of a heart chamber, such as left atrium 220, during placement of the intravascular medical device. The fluid seal (e.g., hermetic seal) may prevent blood from flowing between stabilizer 120 and any adjacent structures, thereby preventing axial or rotational movement of intravascular medical device 11 or both. Additionally, the fluid seal may prevent blood from flowing between stabilizer 120 and any adjacent structures to avoid, limit, minimize, or prevent increased turbulence that may result in weakening of the heart or vessel wall.

[0098] As shown in Figures 1A-1D and 3A-3D, the stabilizer 120 may include multiple arms, which may be made from a biocompatible, flexible material that can form a frame or scaffold, as previously described. In some embodiments, each arm may form a relatively triangular shape. However, it is contemplated that the arms of the stabilizer 120 may be any shape suitable for assisting in stabilizing the tubular shunt 110. Additionally or alternatively, a flexible covering may extend to cover the tubular shunt and flow deflector.

[0099] It is contemplated that any number of covers 310, 320, 330 can be used to cover each portion of the intravascular medical device 11, and that the covers 310, 320, 330 may be integrated or continuous. For example, in some embodiments, an intravascular medical device with a flexible covering 31 may include only one of the tubular shunt cover 310, the stabilizer cover 320, or the flow deflector cover 330. It is further contemplated that any combination of covers may be included in an intravascular medical device with a flexible covering 31, and that the covers may be integrated into a single flexible covering. Furthermore, the covers 310, 320, 330 may be a mesh, fabric, polymer coating, or any other synthetic material wrapped around a portion of the intravascular medical device 11 and configured to restrict blood flow. In some embodiments, the covers 310, 320, 330 may include a fine mesh or woven material. It is contemplated that the covers 310, 320, 330 may be different materials from each other.

[0100] In some embodiments, the flexible coverings or covers 310, 320, 330 may be at least partially impermeable to fluids (e.g., blood). Accordingly, non-limiting examples of materials from which the flexible coverings or covers 310, 320, 330 may be constructed include nylon, polyethylene, EPTFE, TPU, and PTFE.

[0101] In some embodiments, the tubular shunt, stabilizer, and flow deflector may be integrally connected and expandable during deployment through a delivery catheter. As used herein, "integrally connected" may refer to components of an integrated structure. For example, the tubular shunt, stabilizer, and flow deflector may be integrally connected by fabrication from the same material or by the same process, such as etching, micro-electrical discharge machining, electroforming, die casting, and laser cutting and welding. As another example, the tubular shunt, stabilizer, and flow deflector may be integrally connected after assembly, or may be connected to one another post-fabrication, such as by welding.

[0102] FIG. 4 illustrates an example of deployment of an intravascular medical device 11 from a catheter 420 using a guidewire 430. Embodiments of the present disclosure may include a sheath, such as a catheter 420, configured to house a tubular shunt and a flow deflector in a compressed configuration. As used herein, a sheath may refer to a structure or covering that can surround another structure or component. A sheath, such as a catheter 420, may enable the intravascular medical device 11 to navigate through tortuous anatomical structures and avoid premature deployment within the body. As used herein, with respect to an intravascular medical device, a compressed configuration may refer to the shape of the intravascular medical device when housed within a sheath, such as a delivery catheter. The intravascular medical device may be compressed to a second diameter (e.g., 2-7 mm or 2-5 mm) in the compressed configuration. The length of the intravascular medical device in the compressed configuration may be 5-40 mm, 6-30 mm, 7-30 mm, 8-25 mm, or approximately 8-12 mm. Additionally, as used herein with respect to an intravascular device, an expanded configuration may refer to the shape of the intravascular medical device when placed within a passageway or a pre-cut hole, slit, or perforation. The intravascular medical device may be expanded to a first diameter in the expanded configuration, the first diameter being larger than a second diameter in the compressed configuration.

[0103] 4, the intravascular medical device 11 may be positioned within a catheter 420 in a compressed configuration 410, where the intravascular medical device 11 may be compressed around or adjacent to a guidewire 430. Additionally, in the compressed configuration, the flow deflector may be configured to nest within (e.g., at least partially disposed or surrounded by) the tubular shunt. In other embodiments of the compressed configuration, the flow deflector may be configured to extend parallel to and adjacent to the tubular shunt. The catheter 420 may be positioned within the patient, and the catheter 420 may be advanced through the patient's vasculature to reach a desired location for placement.

[0104] As shown in step 41b, the catheter 430 can be pulled back, expanding the intravascular medical device 11 from its compressed configuration 410. As shown in step 41c, the stabilizer 120 of the intravascular medical device 11 can expand or unfold as the catheter 420 continues to be pulled back. Step 41d shows examples of trigger wire mechanisms 440, 450. The trigger wire mechanisms 440, 450 can be used to selectively expand the flow deflector portion 130 following expansion of the stabilizer 120 (which may include a flange portion) and the tubular shunt 110. Upon removal from the catheter 420, the trigger wire mechanisms 440, 450 associated with the flow deflector 130 can be pulled and released to further expand the flow deflector 130.

[0105] As shown in step 41e, the flow deflector 130 may include a catch to maintain the flow deflector 130 in at least a partially unexpanded configuration when removed from the catheter 420. The flow deflector 130 may be configured to extend in a first direction through the catheter 420, and the trigger wire mechanism 440, 450 may be configured such that, when pulled from the first direction, the flow deflector 130 may expand toward a second direction opposite the first direction (as shown in step 41f). As shown in step 41f, upon removal from the sheath (e.g., upon deployment and expansion), the tubular shunt 110 may be configured to expand into a tubular shape, and the flow deflector 130 may be configured to expand into a curved configuration (e.g., a curved, rounded, or arched configuration).

[0106] FIG. 5 illustrates an exemplary method 51 for shunting and diverting blood flow between biological organs. As shown in step 510, the disclosed embodiments may involve drilling 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. The drilling may be performed using a sharp tip to puncture the walls of the first and second chambers before placing a shunt through the puncture. By way of 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 induce at least partial retrograde blood flow within the blood vessel. As shown in step 520, the disclosed embodiments may include placing a tubular shunt within the first and second cavities through the openings to allow blood to pass from the first cavity to the second cavity. Additionally, some embodiments may include placing a flow deflector extending from less than the entire circumference of the tubular shunt within the second cavity, as shown in step 530. In some embodiments, as shown in step 540, the disclosed embodiments may further include using the flow deflector to deflect blood flow within the second cavity.

[0107] 6 illustrates an exemplary placement of an intravascular medical device 11 within a patient's body. As shown in FIG. 6, the intravascular medical device 11 may be positioned or placed between the left atrium 620 and the coronary sinus 610 of the heart 61.

[0108] Some disclosed embodiments may include systems and methods including an expandable shunt and an expandable flow deflector coated with a flexible material that at least partially restricts blood flow and deflects blood flow within the coronary sinus. Such devices may include flexible hinges that are bendable to allow transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining an interconnection between the expandable shunt and the expandable flow deflector.

[0109] 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 flow direction in the blood vessel. For example, blood flowing in a direction opposite to the natural flow of blood in a vein or artery, including the coronary sinus, is considered retrograde blood flow. In accordance with disclosed embodiments, an intravascular retrograde blood flow device, such as the exemplary intravascular retrograde blood flow device 700 shown in FIG. 7, can be used in interventional procedures in which oxygenated blood is introduced into a portion of the coronary sinus and blood flow is reversed to revascularize coronary tissue deprived of oxygen-rich blood.

[0110] 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 elongated structure that can be fed, threaded, advanced, pushed, pulled, or meandered along or within the lumen of a tubular structure. Thus, the catheter may have sufficient elasticity in 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 therein for intravascular delivery to a desired location, as further described herein.

[0111] Some disclosed embodiments include an expandable shunt configured to be compressed within a catheter and 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 temporarily or permanently maintain an opening between a first cavity of a first organ and a second cavity of a second organ, allowing blood to flow through the opening to redirect bodily fluid flow. For example, a shunt may include a central opening or passageway around a tubular body, allowing placement within a pre-drilled hole to bridge the two organs and allow biological fluids, such as blood, to flow across the bridge. The expandable shunt portion may have a central opening or passageway between a first organ (e.g., a heart chamber such as the left atrium or left ventricle) and an adjacent second organ (e.g., a blood vessel, such as a vein, including the coronary sinus). An expandable shunt refers to a shunt that is expandable, extensible, stretchable, flexible, malleable, soft, elastic, resilient, moldable, or otherwise capable of being made larger or more expandable. The expandable shunt may be made of a metal, such as stainless steel or nitinol, or a polymeric material. The expandable shunt may be configured to have antibacterial, anticoagulant, and / or anti-scarring properties. The expandable shunt may be delivered to a cavity, vessel, opening, or passageway in a compressed state and then radially expanded to its full size once in place or at a desired location. In some embodiments, the expandable shunt may be configured to monitor and adjust the rate of blood flow therethrough. One form of the expandable shunt 702 may include a mesh-like or strut 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 be composed of a series of connected curved struts arranged in a tubular configuration. The struts of the expandable shunt 702 may be flexible, allowing the shunt to conform to the curvature of the cavity, vessel, opening, or passageway while maintaining its structure.Compression of the shunt within a catheter allows for a minimally invasive approach to delivery and bridging of the opening between a first cavity of a first organ and a second cavity of a second organ, reducing the risk of complications associated with more invasive surgical procedures. That is, a compressed, expandable shunt can be delivered intravascularly to a cavity, vessel, opening, or passageway and then expanded to provide the necessary bridging while minimizing the trauma and discomfort associated with conventional surgical techniques.

[0112] An organ cavity may refer to any hollow space within an organ or bodily structure. In one example, the organ may be the left or right atrium, and the cavity may be the associated left or right atrial cavity. As another example, the organ may be the coronary sinus, and the cavity may be the lumen of the coronary sinus. An opening may also refer to an aperture, crevices, cuts, orifices, perforations, recesses, slots, gaps, slits, holes, or any other space that allows access to the cavity. The opening may be pre-existing or may be formed as part of a shunt procedure. For example, the opening may be an opening formed between the left atrium and the coronary sinus. In some examples, the opening may be tubular, either as a result of a tubular incision or as a result of stretching 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 opening, incision, orifice, hole, or any other perforation formed between the first and second cavities. For example, the expandable shunt 702 may scaffold the opening between the first cavity of the first organ and the second cavity of the second organ and maintain a bridge between the first and second cavities.

[0113] Some disclosed embodiments include an expandable flow deflector configured to be compressed within the catheter and deflect flow within the second cavity. As described herein, the flow deflector includes a structure that, when deployed, deflects, redirects, blocks, obstructs, slows, or prevents fluid flow. For example, the flow deflector 704 of the intravascular retrograde blood flow device 700 can be configured, upon expansion, to deflect blood channeled from a heart chamber, such as the left atrium, through a shunt into the coronary sinus. The oxygen-rich channeled flow is deflected in a retrograde manner, allowing otherwise oxygen-deprived cardiac tissue to receive oxygenated blood. The flow deflector is expandable in that it assumes a first compressed orientation while within the catheter and a second expanded configuration after release from the catheter. In some instances, as described herein, removal from the catheter alone allows the flow deflector to expand, while in other instances, at least a portion of the expansion occurs after a subsequent triggering action. The flow deflector may be made of a metal or polymer material, such as stainless steel or nitinol. The expandable flow deflector is inserted into a cavity, vessel, opening, or passageway in a compressed state and can expand to its full size once in place or at the desired location. Similar to a shunt, the expandable flow deflector 704 may be made of a mesh or strut structure having a series of wire segments or struts connected to form a frame. The struts may be arranged in various patterns and may be flexible, allowing the flow deflector to conform to the curvature of the cavity, vessel, opening, or passageway while maintaining its structure. The expandable flow deflector 704 may have struts arranged in the same manner as the expandable shunt 702 or in 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 within the catheter allows for a minimally invasive approach to deflecting flow within the second cavity, reducing the risk of complications associated with more invasive approaches to implantation.That is, the compressed expandable flow deflector can be easily inserted into a cavity, vessel, opening or passageway and then expanded to provide the necessary flow deflection while minimizing the trauma and discomfort associated with conventional surgical techniques.

[0114] Some disclosed embodiments include a flexible hinge interconnecting the expandable shunt and the expandable flow deflector, configured such that when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned along a second axis transverse to the first axis within the second cavity, the flexible hinge bends to allow transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining interconnection between them. A flexible hinge refers to any structure or joint that allows movement between two components or two structures while maintaining a degree of flexibility. The flexible hinge extends between and is attached to the expandable shunt and the expandable flow deflector, thereby interconnecting these two components. Typically, the flexible hinge extends between and is attached to the expandable shunt frame and the expandable flow deflector frame, thereby interconnecting these two components. A flexible hinge has two sides, which may be connected by a shaft, joint, elbow, hook, pin, coupling, joint, link, spring, swivel, or any other structure that allows rotation or bending between the two sides. In one example, a flexible hinge is a bendable connection, such as a wire, that extends between and connects an expandable shunt and an expandable flow deflector. A flexible hinge is desirable because it allows a range of motion while allowing bending and flexing without breaking. A flexible hinge may also be part of an intravascular retrograde blood flow device designed to flex, flex, or rotate, allowing the intravascular retrograde blood flow device to conform to the natural curvature and bending of blood vessels or other structures in the body. A flexible hinge may be made of a flexible biocompatible material, such as a wire, flexible metal struts, silicone, polymer, fabric, or any combination of the foregoing. The hinge can be configured to self-adjust to the anatomy or to allow the surgeon to adjust the angle or position of the expandable flow deflector to ensure fluid is directed to the correct location.Similarly, the flexible hinge can allow the expandable shunt or expandable flow deflector to be positioned at an optimal angle or position for maximum fluid flow control. For example, the expandable flow deflector 704 and the expandable shunt 702 may be connected by a flexible hinge 706 in the form of a wire.

[0115] The flexible hinge 706 can be connected to any portion of the expandable flow deflector 704 and the expandable shunt 702 to interconnect the two structures. The expandable flow deflector 704 is configured to deflect blood, for example, by including an expandable frame at least partially covered by a flexible flow deflecting cover. In some embodiments, the expandable flow deflector is partially connected to the periphery of the expandable shunt via a flexible hinge. The periphery of the expandable shunt refers to the outermost boundary or border of the expandable shunt. For example, the expandable shunt may have a generally tubular body terminating in a distal periphery and a proximal periphery. In some embodiments, the expandable flow deflector is connected to the proximal periphery of the expandable shunt via a flexible hinge. It may be desirable to connect the expandable flow deflector to the periphery of the expandable shunt to prevent interference with fluid flow in other regions of the intravascular retrograde blood flow device, such as the lumen of the expandable shunt. 7, the flexible hinge 706 abuts the expandable flow deflector 704 and the expandable shunt 702 at the proximal periphery 720. In other examples, the flexible hinge 706 may be connected to the expandable flow deflector 704 or the expandable shunt 702 at another location, such as at the wall of the expandable flow deflector 704 or the expandable shunt 702.

[0116] Bending of a flexible hinge may refer to any arching, bowing, curving, twisting, turning, bowing, or any other change in direction, angle, or orientation of the flexible hinge. In one example, the hinge bends in one direction or within a plane, like a piece of paper bending. This may be useful for redirecting or guiding within a tight space within the body, such as a blood vessel. In another example, the hinge bends at an angle, allowing the expandable shunt and expandable flow deflector to be positioned at a specific angle or orientation. An angled bend may be desirable for insertion at a specific angle to access a specific area of ​​the body. In another example, the hinge rotates about an axis, which may be useful for guiding a curved or winding path within the body. This type of bending may also be used to change the direction of an intravascular retrograde blood flow device without having to remove and reposition the device. In another example, the hinge may implement a combination of these bending modes to provide greater flexibility and maneuverability. For example, the flexible hinge may be configured to bend at an angle and twist about an axis to provide both directional control and the ability to steer a winding path.

[0117] In some embodiments, the flexible hinge comprises a tether. A tether refers to any device or structure that interconnects the shunt and flow deflector but limits or restricts the longitudinal distance between them. For example, the tether may comprise a wire, spring, flexible material, strut, braid, thread, coil, cord, rope, string, fabric material, or any other structure for interconnecting the shunt and flow deflector. FIG. 7 shows an example of a tether in the form of a wire 706 connecting the expandable flow deflector 704 and the expandable shunt 702. The tether 706 may be configured to secure and restrict movement of the expandable shunt or expandable flow deflector within a cavity or passageway. In some examples, the tether 706 may comprise a wire, such as a metallic linkage, between the expandable shunt and the expandable flow deflector.

[0118] In some embodiments, the tether has a wavy shape. A wavy shape refers to a shape that resembles a wave, zigzag, or other undulating pattern. As an example, tether 706 in FIG. 7 has a wavy shape. The wavy shape of tether 706 allows for a secure yet flexible connection between the expandable flow deflector 704 and the expandable shunt 702. The curved shape of tether 706 provides natural flexibility, allowing it to flex and adjust to the movement of the patient's anatomy and / or heart chamber or vessel during pumping by the heart while maintaining a secure connection. The wavy shape of tether 706 may also help reduce the risk of damage to the heart chamber, vessel, or surrounding tissue by more evenly distributing stress and pressure on the intravascular device 700.

[0119] FIG. 8 illustrates another example of a flexible hinge connecting an expandable shunt and an expandable flow deflector. In FIG. 8A, the flexible hinge 808 is a wavy wire connecting the periphery of the expandable flow deflector 804 to the expandable shunt 802. Similarly, in FIG. 8B, the flexible hinge 818 is a wavy wire connecting the periphery of the expandable flow deflector 814 to the expandable shunt 812. FIG. 11 is an additional illustration of the expandable frame of FIG. 8B. However, the flexible hinge may also be part of the interconnection structure between the expandable shunt and the expandable flow deflector. For example, FIG. 8C illustrates an expandable shunt 822 connected to an expandable flow deflector 824 via a flexible hinge 828. In this example, the hinge 828 may be an extension of the expandable shunt 822 and the expandable flow deflector 824. Alternatively, the hinge 828 may be the interconnection between the expandable shunt 822 and the expandable flow deflector 824, so long as relative flexing between the two components is permitted. The hinge 828 may also be the interconnection between a cover 826 that extends over the expandable shunt 822 and the expandable flow deflector frame 824. Figure 8D shows another example of an expandable shunt 832 and an expandable flow deflector frame 834 connected at a flexible hinge 838 formed by a fabric cover 836 attached to the expandable flow deflector frame 834 and the expandable shunt 832.

[0120] In some embodiments, the one or more flexible hinges include two flexible hinges extending from opposite sides of the shunt's circumference. Circumference in this context refers to the circumference of the tubular shunt located proximal to the tube. When blood flow is particularly strong, it may be desirable to include two flexible hinges extending from opposite sides of the shunt's circumference to add more structural stability to the connection between the expandable shunt and the expandable flow deflector. Furthermore, including two flexible hinges on opposite sides can help distribute pressure more evenly. Furthermore, the placement of two opposing hinges located at two ends of the diameter of the proximal circumference minimizes interference with retrograde blood flow and promotes possible additional stabilization against the wall. In some instances, the flexible hinges may include three or more flexible hinges extending from the periphery of the expandable shunt. This may be desirable to add additional structural support to the connection between the expandable shunt and the expandable flow deflector. The hinges may all share the same or similar structure, or may have different structures, depending on the desired design.

[0121] The first axis of the opening generally points in the direction of the passageway extending between the two cavities. The passageway, and therefore the axis, may be approximately straight or curved. In other words, in the context used herein, an axis need not be straight if it follows a curved rather than straight passageway. For example, the first axis 710 extends along the passageway extending between the two cavities bridged by the expandable shunt 702. The first axis 710 may be straight, as shown in FIG. 7, or curved, since it follows the path of the passageway in which the expandable shunt 702 sits. Similarly, the second axis within the second cavity generally points in the direction of the second cavity (e.g., in some disclosed embodiments, the coronary sinus). The path through the second cavity may be approximately straight or curved within the region of interest, and therefore the second axis may likewise be approximately 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 extends along the length of the second cavity through which the expandable flow deflector 704 expands. The second axis 708 may be straight, as shown in FIG. 7, or curved, since it follows the length of the second cavity through which the expandable flow deflector 704 expands. Additionally, the first axis 710 and the second axis 708 may be dynamic, meaning that each axis may change as the shape of the passageway or second cavity changes, including bodily movements such as the expansion and contraction of veins, arteries, or heart chambers.

[0122] The second axis may be transverse to the first axis, meaning that the first and second axes intersect each other (i.e., they are non-parallel, so that they intersect each other). The angle of intersection may depend, at least in part, on the individual's anatomy and the orientation of the passageway relative to the first and second cavities. In some instances, the angle of incidence between the transverse first and second axes at the intersection may be 90-160 degrees, 100-120 degrees, 90-30 degrees, or even 20-160 degrees. Again, the angle may be larger or smaller (even acute), depending on the specific implementation and anatomy at issue.

[0123] 7, for example, a first axis 712 is transverse to a second axis 708. The intersection angle 712 is where the two axes intersect with one another. As shown, the angle 712 is perpendicular, but it could equally be an obtuse or even acute angle, depending on the specifics of the case.

[0124] When the expandable shunt and the expandable flow deflector are positioned so that their axes intersect (regardless of the intersection angle), the two components are said to be oriented with a transaxial orientation. By way of example, the interconnection between the expandable shunt 702 and the expandable flow deflector 704 is maintained when there is a transaxial orientation, meaning that the expandable shunt 702 and the expandable flow deflector 704 remain connected, such as by a hinge 706, even when the two components have axes that intersect with one another (again, regardless of the intersection angle 712). The two components may remain connected in any one of a number of ways, such as via a tether, hinge, interconnect, scaffold, or other bendable, flexible, or rotatable connection between them. Such a structure thereby maintains the interconnection between the expandable shunt 702 and the expandable flow deflector 704.

[0125] In some embodiments, the expandable flow deflector includes an expandable frame covered by a flexible flow deflecting cover, configured to anchor against the wall of the second cavity upon expansion, thereby helping to stabilize the expandable shunt within the opening. An expandable frame refers to any shaped structure or component whose size is adjustable. The expandable frame may include a series of interconnected struts or wires that can expand to a predetermined size and shape when placed within the second cavity, such as a blood vessel. The exact configuration of the expandable frame may vary depending on the specific design of the expandable flow deflector. In one example, the expandable frame includes a central hub or anchor point from which a series of struts or wires extend radially outward. In some examples, the expandable frame includes a tubular series of struts or wires. In other examples, the expandable frame includes a tubular scaffold. In some examples, as the expandable frame expands, the struts or wires exert an outward force against the vessel wall, creating a stable support 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 support structure, the expandable frame may also serve as a mechanism for adjusting the position of the expandable flow deflector within the vessel. For example, the expandable frame may include one or more struts or wires extending from the expandable frame to the expandable shunt, acting as a flexible hinge interconnecting the expandable frame and the expandable shunt to enable transaxial positioning of the expandable shunt and the expandable flow deflector. Non-limiting examples of materials for the expandable frame may include superelastic alloys and / or shape memory materials (e.g., shape memory alloys (SMAs) such as Nitinol or nickel-titanium alloys also known as NiTiCu (nickel titanium copper), CuZn (copper zinc), CuZnAI (copper zinc aluminum), and / or CuAINi (copper zinc nickel), etc.). Other suitable materials may include other metals, stainless steel, or polymers.The expandable frame may be further coated and / or textured to enhance biocompatibility for improved blood flow and optimal engagement with tissue.

[0126] Figure 7 illustrates an exemplary expanded configuration of an endovascular retrograde blood flow device 700. In the example of Figure 7, the endovascular retrograde blood flow device 700 includes a frame of an expandable shunt 702 and a frame of an expandable flow deflector 704. The frames of the expandable shunt 702 and the expandable flow deflector 704 are connected via a flexible hinge comprising a tether 706. The tether 706 is configured to bend such that when the expandable shunt 702 is positioned along a first axis 710 of the opening and the frame of the expandable flow deflector 704 is positioned along a second axis 708 transverse to the first axis 710 within the second cavity, the flexible hinge 706 is bendable to allow transaxial positioning of the frames of the expandable shunt 702 and the expandable flow deflector 704 while maintaining the interconnection between the frames of the expandable shunt 702 and the expandable flow deflector 704. The second axis 708 intersects the first axis 710 at an angle 712. In this example, the angle 712 is greater than 90 degrees to allow the expandable shunt 702 to conform to the angle and shape of the opening between the first and second cavities. The tether 706 in this example includes a wavy shape that provides natural flexibility, allowing it to flex and adjust for movement during the retrograde blood flow procedure while maintaining a secure connection between the expandable shunt 702 and the expandable flow deflector 704.

[0127] The flexible flow deflecting cover may extend over all or a portion of the frame. Such a cover may include any shield, housing, fabric, sheet, casing, coating, sheath, or other material. The cover may function as a barrier to redirect blood flow within a cavity, such as a blood vessel. The cover may have temporary or permanent limited permeability to fluids, specifically blood. In some examples, the cover is substantially impermeable to blood. The flexible flow deflecting cover may provide a flexible and durable surface that can redirect blood flow while minimizing the risk of vascular injury or irritation. In some embodiments, the flexible flow deflecting cover may be configured to promote endothelialization (e.g., promote growth factors such as transforming growth factor, fibroblast growth factor, epidermal growth factor, etc.). 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. The flexible flow deflection cover may be made of a biocompatible material, such as silicone or a polymer blend. In some examples, the flexible flow deflection cover includes a series of overlapping flexible panels or sheets that can bend and flex in response to changes in blood flow. In some examples, as blood flows through a blood vessel, the flexible panels of the flexible flow deflection cover can adjust and flex to direct blood flow away from one direction and toward another, allowing for retrograde blood flow. The flexible flow deflection cover may be configured to self-expand with the frame, meaning that upon placement within a blood vessel using a catheter or similar delivery system, the structure expands to the appropriate size and shape. Alternatively, the structure may be designed to be manually adjusted and secured in place using a series of clips or other mechanical fasteners. Figure 8 shows examples of various configurations of the flexible flow deflection cover, such as a cylindrical cover 806, a concave cover 816, or a scoop-shaped cover 826.

[0128] By securing the expandable frame against the wall of the second cavity upon expansion, it can remain securely in place against the wall of the second cavity, providing stable support and preventing migration or dislodgement of the intravascular retrograde blood flow device during use. The expandable frame can be secured against the wall of the second cavity, such as a blood vessel, in various ways. In one embodiment, the expandable frame exerts a frictional force against the wall of the second cavity, allowing for stabilization through a frictional fit. The frame may include prongs, protruding wires, protruding struts, or other features that aid in frictional retention. In another example, a series of hooks or barbs disposed on the expandable frame may be anchored against the vessel wall. These hooks or barbs may be configured to firmly grip the vessel wall without causing damage and may be adjusted or repositioned as needed to achieve the desired level of fixation. In some embodiments, the wires, struts, hooks, barbs, prongs, or other retention 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 instances, the expandable frame may be coated with a bioadhesive material to aid in anchoring to the vessel wall. Stabilizing the expandable shunt within the opening refers to ensuring that the expandable shunt does not migrate from the opening. Because the expandable shunt is connected to the fixed expandable flow deflector via a flexible hinge, fixation of the expandable frame to the wall of the second cavity helps stabilize the expandable shunt within the opening. Thus, once the expandable frame is fixed to the wall of the second cavity, the expandable shunt may be at least partially fixed in place within the opening, as the connecting hinge prevents the expandable shunt from migrating away from the opening. The stabilizing or fixation elements of the shunt itself may cooperate with the stabilizing / fixation elements of the flow deflector to stabilize the retrograde flow deflection device.

[0129] In some embodiments, in the expanded configuration, the expandable frame includes a cylindrical portion, and the flow deflecting cover extends across the circular base of the cylindrical portion to form a flat flow deflection surface. As used herein, the term cylindrical generally refers to the tubular shape of the associated passageway, regardless of whether the shape is a perfect cylinder. Thus, a cylindrical portion may refer to a portion of the expandable frame having a circular or elliptical cross-section along at least a portion of its length. In some instances, the cylindrical portion extends along the entire length of the expandable frame. In other instances, the cylindrical portion extends along only a portion of the length of the expandable frame. The cylindrical portion of an expandable frame in an intravascular device may provide several advantages, including conformability, anchoring, compression, and durability. The cylindrical portion of the expandable frame is flexible and can be configured to conform to the shape of the vessel wall, allowing it to accommodate variations in vessel diameter, curvature, or other irregularities particularly relevant in vivo. This may make the device more effective at redirecting fluid flow, reducing the risk of complications and promoting better clinical outcomes. As previously mentioned, the cylindrical portion of the expandable frame may include protruding elements that aid in anchoring to the vessel wall. These protrusions can reduce the risk of device migration or dislodgement and improve the long-term effectiveness of the device. The cylindrical portion of the expandable frame may be configured to be compressed to a smaller diameter, allowing the device to be delivered through a catheter. This minimizes the size of the surgical access site and reduces the risk of complications associated with larger incisions. A flat flow deflection surface refers to a surface having a circular, oval, or other rounded shape for forming a structure within a cavity (e.g., a blood vessel) where blood flow is redirected. In some embodiments, the flat flow deflection surface may be formed from a flexible material or fabric that covers at least the opening across the cylindrical frame. In other embodiments, the flexible material may cover the entire opening or a significant portion of the inner surface of the cylindrical frame.Thus, at least one end of the flat flow deflection surface may be formed as a cover that spans the cross-sectional end of the cylinder and is secured along at least a portion of the length of the cylinder. The flat surface and cross-sectional positioning of the surface may be desirable for redirecting flow because it can form a seal closer to the vessel wall, acting as a plug. 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 expandable frame that includes a cylindrical portion 804 and a flow deflection cover 806 that extends over the cylindrical portion 804 to form a flat flow deflection surface 806.

[0130] In some embodiments, in the expanded configuration, the expandable frame includes a deflector support, and the flow deflection cover extends over the deflector support to form 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 or may simply be configured to support a concave surface. The concave portion may be scoop-shaped, dish-shaped, cup-shaped, dented, dimpled, dipped, hollow, incurvate, round, sunken, or swooped. Such a concave surface can help direct fluid flow. In other examples, the deflector support may have one or more of a semicircular, quarter-circular, sector-shaped, arc-shaped, arc-shaped, or chordal 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, with a gradually varying curvature that conforms to the shape of the blood vessel. In other embodiments, the flow deflector may not be concave, or may have varying degrees of concavity depending on design considerations. The surface may also include additional features, such as ridges or textured areas, that create additional turbulence or vortices in the blood flow. FIG. 8B shows an example of an expandable frame including a deflector support 814 with a flow deflection cover 816 that extends over the deflector support 814 in a manner that forms a concave flow deflection surface 816. The flow deflection cover 816 may also extend over other portions of an intravascular blood flow device, such as an expandable shunt 812. The flow deflection cover 816 may also be shaped to fit over the edges of the expandable shunt 812, the edges of the deflector support 814, and the edges of the flexible hinge 818 connecting the expandable shunt 812 and the deflector support 814.

[0131] The scoop-shaped flow deflection surface may include a wide, shallow opening at one end that gradually tapers to a narrower point at the other end. In some embodiments, the recess may include a curved or arched frame, often made of metal or other supporting material. The frame may be configured to be curved, meaning that the frame is intentionally curved or bent outward 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 an arch. The arch may be shallow or extreme. A shallow curve may provide only a slight bowing effect, while a deep arch may have a more pronounced curvature with a greater degree of bowing. The curved shape of the frame may provide additional strength and stability by distributing loads and stresses in the structure more evenly. In some embodiments, the flow deflector forms a crescent shape extending from the shunt portion. In some embodiments, the trough portion of the scoop is circular in cross-sectional shape. The scoop shape may be sized to cover the complete cross-section of a cavity or vein, such as the coronary sinus.

[0132] 8C shows an example of an expandable frame including a recess 824, with a flow deflection cover 826 extending over the recess 824 in a manner that forms a scoop-shaped flow deflection surface 826. In this example, the flow deflection cover 816 may also extend over other portions of an intravascular blood flow device, such as an expandable shunt 822.

[0133] In some embodiments, in the expanded configuration, the expandable frame includes an extension extending from the expandable frame beyond the intersection of the first axis and the wall of the second cavity, where the extension engages the wall of the second cavity. The extension refers to a portion extending beyond the intersection. The extension may include an appendage, arm, branch, extension, extension, protrusion, wing, lip, or any other portion of the expandable frame that extends beyond the axis intersection. It may be desirable to provide an extension extending from the expandable frame beyond the intersection of the first axis and the wall of the second cavity to ensure that normal blood flow is redirected in a retrograde direction within the second cavity, away from the opening. FIG. 8B shows an example of an extension 824 extending beyond the intersection of the first axis 820 and the wall 821 of the second cavity.

[0134] In some embodiments, the extension extends in a direction opposite to the normal direction of fluid flow. Opposite to the normal direction of fluid flow refers to a direction opposite, transverse, reverse, or any direction that is otherwise different from the normal direction of fluid flow. It may be desirable to provide an extension that extends in a direction opposite to the normal direction of fluid flow to direct fluid in a counter-flow direction.

[0135] In some embodiments, the flexible flow deflecting cover is substantially impermeable to blood. As used herein, the phrase "substantially impermeable to blood" refers to any material or device that can prevent the passage of blood. Being substantially impermeable to blood allows the cover to deflect blood as opposed to allowing the passage of blood. Impermeability may also reduce complications that can arise from absorbent materials in the bloodstream. In some embodiments disclosed herein, the flexible flow deflecting cover can be used to prevent the normal flow of blood from the left atrium to the right atrium via the coronary sinus by blocking the passage of blood through the substantially blood impermeable cover.

[0136] In some embodiments, the flexible flow deflecting cover includes a tool passage configured to minimize blood flow therethrough. A tool passage may refer to a channel or opening in the flexible flow deflecting cover through which an instrument or tool can be inserted and used to manipulate an intravascular retrograde blood flow device or 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 or balloon. The width of the tool passage may be sized to allow easy insertion and removal of the instrument, but not so wide as to compromise the integrity of the flexible flow deflecting cover or increase the risk of blood leakage in the normal direction. For example, to minimize normal flow, the tool passage may be configured with a covering flap. Additionally or alternatively, the tool passage may be a slit or slits in a multi-layer cover, whereby individual cover layers may be mechanically manipulated to allow passage but provide a substantially impermeable blood barrier in their natural state. The tool passages may be aligned, centered, or positioned at non-central locations on the flat, concave, or other surface of the flexible flow deflecting cover. A coating or material may form part of the covering to resist bacterial growth and other microorganisms on or around the tool passages.

[0137] FIG. 10 shows different views of an example of a flow deflector 1002 including a tool passageway 1004, according to some embodiments of the present disclosure. Examples of tool passageways, such as the tool passageway 1004, include one-way valves, duckbill valves, alternating shutters, or two or more layers of laminated material with slots, plugs, or other suitable seals, each individual layer positioned at 30-150 degrees or approximately 90 degrees from the other layer. The example shown in FIG. 10 illustrates a tool passageway 1004 constructed of two or more layers of layered material, with each layer having a slot positioned at 90 degrees from the other layer. Other approaches to the tool passageway, such as two partially overlapping layers configured to allow manipulation without overlapping as a tool passageway, are also contemplated for use with the disclosed embodiments. The cover may be biocompatible, resilient, flexible, and substantially liquid-tight. Examples include, but are not limited to, a biocompatible material, a mesh-like material, a cloth-like material, fabric, plastic or silicone, a biomaterial, collagen, or biological tissue. In some examples, the cover may be configured to trap, block, or catch material of at least about 5, 10, 15, 20, 25, 30, 35, 40, 90, and 100 micrometers in length or diameter. Optionally, the cover may be elastic or have some degree of elasticity. The cover may be coupled to the scaffold by, for example, one or more stitches, welding, adhesives, coatings, or soldering. In other examples, the flow deflector may include a flexible distal edge for removal under the flow deflector such that tool removal minimizes flow deflection. For example, the distal edge 1410 of the flow deflector 1404 in FIGS. 14A and 14B is flexible and includes an open tool passage to allow tool removal with minimal flow deflection.

[0138] In some embodiments, the flexible flow deflection cover comprises at least one of a mesh, a fabric, a polymer coating, or a synthetic material coating. A coating may refer to a layer of material applied to or forming part of the surface of a flexible flow deflection frame or cover to deflect blood or provide additional structural support and protection. For example, a flow deflection frame may be coated with multiple layers of sprayed polymer to form a coating with blood-restricting permeability. A mesh coating may be composed of a network of interlocking fibers or filaments that form a dense, strong, and flexible web. A mesh coating may be made of a biocompatible material such as polyurethane, silicone, or polyethylene terephthalate (PET). These materials are flexible and durable, making them ideal for use in intravascular devices that must be able to withstand the rigors of blood flow and movement within the body. A mesh coating may be applied to the surface of a flexible flow deflection cover using a variety of techniques, such as spraying, dip coating, sewing, welding, or electrospinning. A fabric coating may refer to a fabric or woven material configured to extend over or encase the surface of a flexible flow deflection cover. The fabric coating may be made of a biocompatible material, such as nylon, polyester, or polyurethane, that is flexible, durable, and safe for use in the body. The fabric coating may be applied to the surface of the intravascular device using various techniques, such as dip coating, spray coating, or lamination. In some examples, the fabric coating may include micropores or a surface treatment to improve adhesion of the drug or coating. The fabric cover may also be radiopaque, making it easier to visualize the device's location during imaging procedures. A polymer coating may refer to a layer of polymer material applied to the surface of a flexible flow deflection cover. The polymer coating may be applied using techniques such as spraying, dip, or spin coating, and may be made from a variety of different polymers, including silicone, polyurethane, or fluoropolymers.A synthetic material coating may refer to a layer of artificial material applied to the surface of a flexible flow deflection cover. Various types of synthetic material coatings can be used in the embodiments disclosed herein. Polyurethane coatings can be used to improve the lubricity of flexible flow deflection covers. They are flexible and durable, and can provide a smooth surface for easy insertion into the body. Polyurethane coatings can also be used to add drug delivery capabilities to flexible flow deflection covers. Silicone coatings can be used to improve the biocompatibility of flexible flow deflection covers. They are soft, hydrophobic, and can provide a non-stick surface. Silicone coatings can also be used to reduce friction during insertion. Hydrophilic coatings can be used to provide lubricity to flexible flow deflection covers. They are designed to attract water, reducing friction and facilitating smooth insertion into the body. Hydrophilic coatings can be made from a variety of materials, including polymers and ceramics. Polytetrafluoroethylene (PTFE) coatings can be used on flexible flow deflection covers to prevent blood clotting and promote healing. They are hydrophobic, providing a non-stick surface that reduces the risk of thrombosis. PTFE coatings can also be used to provide lubricity to the device. Bioabsorbable polymer coatings can be used on flexible flow deflector covers to promote healing and reduce the risk of restenosis. They are designed to gradually dissolve in the body over time, allowing the flexible flow deflector covers to be absorbed without leaving any permanent residue.

[0139] Some embodiments may also include a first stabilizer extending from the distal end of the expandable shunt opposite the hinge and configured to engage the inner wall of the first cavity to maintain the expandable shunt within the opening. A stabilizer refers to any structure or element that resists movement. For example, the stabilizer may be designed to engage the inner wall of a cavity or opening to help secure the shunt in place. In some examples, the first stabilizer may include a flexible or semi-rigid ring on the expandable shunt. The ring may be made of various materials, such as silicone or polymer, and may be configured to conform to 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 the inner wall of the cavity. These arms or protrusions may act as lips that can help anchor the shunt in place and prevent the shunt from moving or shifting due to changes in pressure or other factors. The expandable walls of the shunt itself may act as a stabilizer by exerting a frictional force against the passageway in which it is placed. A locking mechanism may be used to secure the shunt in place once it is properly placed. For example, the stabilizer may be a ring that locks into a given circumference when expanded to that circumference. As another example, the stabilizer may include arms that seal against the interior wall of the cavity to lock the shunt in place. In this example, the arms may include a cover, such as an extension of a flexible flow deflector cover, to form a liquid seal against the interior wall of the cavity.

[0140] In some embodiments, the second stabilizer includes a flange region extending from the proximal end of the expandable shunt into the second cavity, configured to engage the inner wall of the second cavity to maintain the expandable shunt within 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 cooperate for stabilization purposes. The flange region may be formed from the same material as the shunt (e.g., an expandable metal) or may include a tissue-engaging cover. Alternatively, the flange region may be formed from another flexible or semi-rigid material, such as silicone or a polymer. The base of the flange region may be positioned against the inner wall of the second cavity, with the protruding rim or edge extending into the second cavity to hold the medical device in place.

[0141] In some embodiments, at least one of the first stabilizer and the second stabilizer includes multiple prongs having unequal lengths. Multiple prongs may refer to any elongated or pointed extensions or protrusions extending from the body or base of the shunt or deflector. The prongs may be made of the same material as the frame of the shunt or deflector and / or may include a flexible material such as silicone or polyurethane. During use, the prongs can press against the inner wall of the heart chamber or blood vessel to stabilize the device while limiting tissue damage. The prongs of the first or second stabilizer can help redistribute pressure and reduce unwanted vibration or movement, resulting in smoother and more stable fixation of the intravascular retrograde blood flow device. The prongs may have unequal lengths, meaning that at least one of the prongs is longer than another prong. The unequal lengths can aid in stabilization. For example, the prongs on one side of the stabilizer may be longer than the prongs on the other side of the stabilizer to account for greater stabilization needs on one side, or the prong lengths may be alternated to distribute pressure more evenly. As another example, the prongs may have an adjustable length that can be changed once introduced into a cavity or vessel to conform to the geometry of the cavity or vessel.

[0142] In some embodiments, the first stabilizer includes a plurality of outwardly extending prongs, each having a curved distal end facing the inner wall of the first cavity. The plurality of outwardly extending prongs refers to elongated or pointed extensions or protrusions that extend into the first cavity, away from the central lumen of the expandable shunt. Each prong may have a curved distal end facing the inner wall of the first cavity such that the tip of the prong extends away from the wall of the cavity to minimize the risk of wall perforation.

[0143] 7 includes a first stabilizer 714 extending from a distal end 718 of the expandable shunt 702 opposite the hinge 706 to engage the inner wall of the first cavity to maintain the expandable shunt 702 within the opening between the first and second cavities. The expandable shunt 702 in this example includes a second stabilizer 716 comprising a flange region extending from a proximal end 720 of the expandable shunt 702 into the second cavity to engage the inner wall of the second cavity to maintain the expandable shunt 702 within the opening between the first and second cavities.

[0144] As another example, the expandable shunt 812 of Figure 8A includes a first stabilizer 803 extending from a distal end of the expandable shunt 802 opposite the hinge 808 to engage the inner wall of the first cavity to maintain the expandable shunt 802 within the opening between the first and second cavities. Figure 8B shows another example of an expandable shunt 812 that includes a first stabilizer 813 having multiple outwardly curved prongs extending from a distal end of the expandable shunt 812 opposite the hinge 818 to engage the inner wall of the first cavity to maintain the expandable shunt 812 within the opening between the first and second cavities. Figure 8B shows another example of an expandable shunt 812 that includes a first stabilizer 813 having multiple outwardly curved prongs extending from a distal end of the expandable shunt 812 opposite a hinge 818 to engage the inner wall of the first cavity to maintain the expandable shunt 812 within the opening between the first and second cavities. Figure 8C shows another example of an expandable shunt 822 that includes a first stabilizer 823 having multiple outwardly curved prongs extending from a distal end of the expandable shunt 822 opposite a hinge 828 to engage the inner wall of the first cavity to maintain the expandable shunt 822 within the opening between the first and second cavities. 8D shows another example of an expandable shunt 832 including a first stabilizer 833 including multiple curved outward protrusions having a flow deflecting cover 836 extending over the protrusions extending from the distal end of the expandable shunt 832 opposite the hinge 838 to engage the inner wall of the first cavity to maintain the expandable shunt 832 within the opening between the first and second cavities. In some embodiments, the tubular shunt 802, 812, 822, or 832 may include an orientation marker to facilitate rotational orientation about the central opening for the associated placement of the flow deflector 804, 814, 824, or 834. The orientation marker may be configured to allow control of the rotational orientation of the tubular shunt 802, 812, 822, or 832 about the central opening. The orientation marker may include, for example, a tantalum marker or a specific structural design at a specific location.

[0145] In some embodiments, the expandable shunt includes a tubular scaffold, and the flexible flow deflecting cover extends over the tubular scaffold. The tubular scaffold refers to the structure or matrix that maintains the orifice. The tubular scaffold may be provided to reinforce or support the structure that forms the shape and framework of the expandable shunt. Any biocompatible material, such as nitinol or stainless steel, that can be compressed or reduced to a smaller size for insertion into the body may be used for the tubular scaffold. Once the expandable shunt is in place within the opening, the tubular scaffold can be expanded or inflated to its full size to form a flow path for blood or other fluids to flow. The tubular scaffold may be composed of a series of interconnected struts or wires that form a tubular shape. In some examples, the tubular scaffold may be coated with a thin film or graft material that helps seal the device and prevent blood from leaking around the edges. The covering can also provide additional support to the opening or other tubular structure, helping to maintain its shape and prevent collapse or blockage.

[0146] 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 expandable shunt and the expandable 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.

[0147] In some embodiments, the flexible flow deflecting cover is further configured to allow at least some non-retrograde blood flow within the second cavity. It may be desirable to allow at least some non-retrograde blood flow within the second cavity to ensure perfusion in areas of normal blood flow while also allowing perfusion in areas of retrograde blood flow. In some examples, the flow deflecting cover may be configured to allow some non-retrograde blood flow within the second cavity by providing an opening in the flow deflecting cover that can be opened or exposed as needed to create the desired non-retrograde blood flow. In other examples, the flow deflecting cover may be scoop-shaped or concave, such that by changing the rotational orientation of the expandable shunt within the opening, the scoop or concave portion of the flow deflecting cover can block less than all of the blood flow in the normal blood flow direction, thereby allowing non-retrograde blood flow.

[0148] In some embodiments, the expandable 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 protrusion that forms a seal against the wall of the second cavity. For example, the lip may include a raised or curved edge that protrudes from the edge or surface of the expandable flow deflector. In some examples, the lip may be disposed along the outer edge of the expandable flow deflector or may extend around the entire circumference of the expandable flow deflector. In other examples, the lip may extend around only a portion of the circumference of the expandable flow deflector. The lip is typically disposed at the distal end of the flow deflector or the shunt end of the flow deflector. The lip helps direct blood flow toward the desired retrograde direction while sometimes being desirable to prevent leakage beyond the edge of the expandable flow deflector into the normal direction of blood flow. The lip may be formed as an integral part of the expandable flow deflector or may be attached to the edge or surface of the deflector as a separate part. The lip can be made of a variety of materials, including polymers, metals, or biocompatible coatings. Additionally or alternatively, the lip can be formed from a frame portion coated with fabric or other flexible material. The lip of the expandable flow deflector can help reduce turbulence and recirculation of blood within a second cavity, such as a blood vessel, which can improve blood flow and help reduce the risk of complications such as clotting or embolism. The lip can also help protect the wall of the blood vessel from damage caused by turbulent blood flow.

[0149] In some embodiments, the expandable flow deflector includes a frame configured to initially maintain a compressed configuration after removal from the catheter, in which case the device further includes a release mechanism for enabling selective expansion of the expandable flow deflector after expansion of the expandable shunt. The compressed configuration refers to the smaller configuration of the frame prior to expansion at the target location, such as the second cavity. The compressed configuration is desirable for ease of placement through the vasculature. Once the compressed frame is in place at the target location, such as the second cavity, it can be expanded to its full size using various mechanisms, such as balloon inflation, self-expansion using an expandable material that expands when no longer compressed within a structure such as a catheter, and / or expansion via a release mechanism. Expansion of the frame from the compressed configuration allows the expandable flow deflector to exert a force against the vessel or cavity wall for structural support. A release mechanism refers to a structure or device configured to at least partially expand the expandable flow deflector. In some examples, the release mechanism may include a trigger wire mechanism used for selective expansion of the expandable flow deflector following expansion of the expandable shunt. In such an example, the trigger wire, flow deflector, and shunt may be initially crimped together as a crimped system onto a guidewire. After the crimped system is inserted between the left atrium and the coronary sinus, the guidewire overtube may be pulled back to cause expansion of the crimped system. Upon removal from the catheter, a trigger wire associated with the flow deflector may be pulled and released to further expand the flow deflector. The trigger wire may extend through an opening in the flow deflector. Selective expansion of an expandable flow deflector refers to controlled expansion of one or more components of the flow deflector. For example, the release mechanism may further include a controller configured to enable control of the timing of the expansion of the flow deflector.

[0150] In some embodiments, the expandable frame is configured such that when the catheter is removed in a first direction to cause release of the expandable flow deflector, the expandable frame is configured to expand in a second direction different from the first direction. Removing the catheter in a first direction to release the expandable flow deflector may refer to sliding, removing, or otherwise separating the catheter from the expandable shunt and the expandable flow deflector to expand the expandable shunt and the expandable flow deflector. In one example, removing the catheter in a first direction may include, after positioning the endovascular retrograde blood flow device at an opening between the left atrium and the coronary sinus, retracting the catheter within the coronary sinus in a direction away from the left atrium and toward the right atrium. In this example, retracting the catheter releases the expandable flow deflector such that the expandable frame expands within the coronary sinus in a direction away from the right atrium. The expandable frame expands away from the right atrium, so that the expandable flow deflector directs the retrograde flow of blood that normally flows in the coronary sinus from the left atrium to the right atrium, away from the right atrium, in the coronary sinus. 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 direction of the coronary sinus opposite the direction the catheter is withdrawn, i.e., toward the right atrium.

[0151] Disclosed embodiments include a method for directing retrograde blood flow within a blood vessel. The method may include drilling an opening between a first cavity and a second cavity before advancing a catheter into the opening. The method may include advancing the catheter into the opening between the first cavity and the second cavity. The method may include expelling an expandable shunt compressed within the catheter from the catheter within the opening and expelling an expandable flow deflector from the catheter. The flow deflector may be connected to the expandable shunt by a flexible hinge configured to flex to enable transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned within the second cavity along a second axis transverse to the first axis. The method may include anchoring the expandable flow deflector within the second cavity.

[0152] 9 shows a flowchart of a method 900 for directing intravascular retrograde blood flow according to some embodiments of the present disclosure. Method 900 may include step 902 of drilling an opening between a first cavity and a second cavity. Method 900 may include step 904 of advancing a catheter into the opening between the first cavity and the second cavity. Method 900 may include step 906 of delivering an expandable shunt compressed within the catheter from the catheter within the opening. The method 900 may include step 908 of delivering an expandable flow deflector connected to the expandable shunt from the catheter by a flexible hinge configured to bend such that when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned within the second cavity along a second axis transverse to the first axis, the flexible hinge being bendable to allow transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining interconnection between the expandable shunt and the expandable flow deflector. The method 900 may include step 910 of securing the expandable flow deflector within the second cavity.

[0153] Some disclosed embodiments include medical devices for directing retrograde blood flow. As used herein, medical device may refer to any device or instrument configured to diagnose and / or treat a patient. For example, some medical devices according to the present disclosure include a portion that is placed within or operates within a blood vessel or another biological structure or organ within the human body for medical purposes. Some medical devices according to the present disclosure include one or more delivery mechanisms (e.g., a catheter, a sheath, and / or a trigger mechanism). Biological structures in which the disclosed embodiments may be used include, for example, those containing cavities. 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 to a treatment site from a first location within the blood vessel or other biological structure (e.g., a location outside the body). Additionally or alternatively, in some embodiments, the medical device may be configured to cause a temporary or permanent change or deformation at the treatment site within the blood vessel. Some non-limiting examples of medical device components according to the present disclosure may include shunts, stents, catheters, or any other devices configured to be placed within a blood vessel or other biological structure. Retrograde blood flow may include the flow or movement of blood in a direction opposite to the natural flow direction within a blood vessel. For example, blood flowing in a direction opposite to the natural flow of blood within an artery or vein, including the coronary sinus, is considered retrograde blood flow. Directing retrograde blood flow may include guiding, routing, regulating, influencing, or controlling retrograde blood flow relative to the natural blood flow direction. In some embodiments, directing retrograde blood flow may include reversing or redirecting the natural flow.

[0154] Some disclosed embodiments include a tube for delivery into the 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 that can be used to carry fluids. 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 the coronary sinus. As an example, FIG. 12 illustrates a tube 1202 in the form of a catheter for insertion into the coronary sinus. The tube 1202 may include a hollow lumen configured to accommodate additional components of a medical device for directing retrograde blood flow, as shown in FIG. 12. The first direction may refer to a point to which or from which an object, such as a tube, can be moved. FIG. 13 illustrates an example of a first direction 1308 extending along the coronary sinus 1304 toward and from the right atrium to an orifice 1318. Delivering the tube from a first direction into the orifice of the coronary sinus can include advancing, progressing, pushing, pulling, driving, pushing, shifting, or otherwise moving the tube from a first direction into the orifice of the coronary sinus. For example, delivering the tube 1306 into the coronary sinus 1304 can include sliding the tube 1306 into the coronary sinus and into a chamber of the heart, specifically the left atrium, through an orifice bridging the coronary sinus 1304 and the left atrium.

[0155] Some disclosed embodiments include an expandable structure compressed within a tube. An expandable structure may refer to any structure, device, or component that can expand or expand from a compressed configuration. Such a device may be stretchable, extensible, stretchable, expandable, or inflatable. One 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 collapsed or compressed structure that can expand or unfold to a larger size. As an example, FIG. 12 shows an expandable structure 1204, which is a compressed structure made from interconnected struts configured to expand the expandable structure 1204 to a larger size. Compressed within a tube may refer to being reduced, squeezed, contracted, pinched, crimped, constricted, packed, pressed, reduced in volume, folded, or otherwise made smaller within the tube. Compression can be achieved by folding at least one component of the expandable structure into, around, or along another component of the expandable structure to pack the expandable structure inside the tube. 12 shows the expandable structure 1204 being compressed within the tube 1202 by decreasing the distance between the struts of the expandable structure 1204 to contract the expandable structure 1204 within the tube 1202. For example, the expandable structure may be formed from a shape memory alloy that returns to its original shape when released from constriction.

[0156] Some disclosed embodiments include a scaffold portion for maintaining an orifice between the coronary sinus and a heart chamber. The scaffold portion may include any frame, body, cage, housing, mount, outline, shell, underframe, mesh, or other structure configured to maintain an 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 as a cylindrical tube. As an example, FIG. 12 shows an example of a scaffold portion 1206 made of a series of interconnected struts compressed within a tube 1202. The orifice may include an opening, cavity, crevice, hole, mouth, outlet, inlet, slit, spout, vent, aperture, perforation, cleft, incision, fissure, gap, perforation, slit, slot, space, or any other opening through which something may pass. As an example, the orifice may include an opening between two body cavities. FIG. 13 shows an example of an orifice 1318 between a heart chamber 1302 and a coronary sinus 1304. Maintaining the orifice between the coronary sinus and a heart chamber can include maintaining, preserving, protecting, retaining, sustaining, upholding, guarding, preserving, prolonging, or otherwise leaving open or allowing the orifice between the coronary sinus and a heart chamber. For example, maintaining can include preserving an opening between the coronary sinus and a heart chamber by placing a scaffold portion in the opening. As an example, FIG. 13 shows a scaffold portion 1314 maintaining an opening 1318 between the heart chamber 1302 and the coronary sinus 1304 by being expanded within the opening 1318 such that the opening 1318 remains open to blood flow between the heart chamber 1302 and the coronary sinus 1304.

[0157] Some disclosed embodiments include a flow deflector portion configured to induce retrograde blood flow into the coronary sinus, where the flow deflector portion is configured to allow the tube to be withdrawn in a first direction while the flow deflector portion is deployed in a second direction other than the first direction. The flow deflector portion includes any structure that temporarily or for a period of time deflects, redirects, blocks, obstructs, slows, or prevents fluid flow. In some embodiments, the flow deflector portion can partially block or partially impede blood flow within a blood vessel. The flow deflector portion may include any temporary or permanent, static, expandable, inflatable, or otherwise adjustable plug, disk, 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 unidirectional blood flow through the coronary sinus. As another example, the flow deflector portion may be an adjustable plug configured to impede a variable amount of unidirectional flow through the coronary sinus. As another example, the flow deflector may be an arcuate or flat surface sized to traverse the coronary sinus in a direction perpendicular to the longitudinal axis of the coronary sinus, the surface typically being at least partially impermeable to blood to occlude blood flow in a first direction.

[0158] Some embodiments include a flow deflector portion configured to allow the tube to be pulled in a first direction while the flow deflector portion is deployed in a second direction other than the first direction. In some embodiments, the flow deflector portion is capable of being deployed in a second direction other than the first direction without affecting tube withdrawal. In some embodiments, the flow deflector is configured with some flexibility at its distal edge so that it is biased to conform to the curvature of the coronary sinus. In some embodiments, a tool passage exists within the flow deflector. In some embodiments, delayed or controlled expansion of the flow deflector enables this feature.

[0159] Figure 12 illustrates an example of a flow deflector portion 1208 compressed within the tube 1202. As shown in Figure 12, the flow deflector portion 1208 may be a bendable flap extending from a distal end of the scaffold portion 1206 that folds into the scaffold portion 1206 when compressed within the tube 1202. Figure 13 illustrates an example of a flow deflector portion 1310 in an expanded or uncompressed configuration within the tube 1306. As shown in Figure 13, the flow deflector portion 1310 may form an occlusion within the coronary sinus 1304 to redirect blood flow from the heart chamber 1302 away from the first direction 1308 or toward the second direction 1312.

[0160] In some embodiments, the distal edge of the flow deflector portion is biased to conform to the curvature of the coronary sinus. Biased to conform to the curvature of the coronary sinus refers to being stretched, molded, curved, bent, kinked, or otherwise shaped to contact the curved wall of the coronary sinus. Such a biased distal edge of the flow deflector portion can enable both an improved fluid seal to prevent leakage of blood in the normal direction of blood flow and guidance of diverted blood in the retrograde direction. The biased distal edge may also have an e to accommodate a tube being withdrawn in a first direction under the biased distal edge. In this case, the degree of elasticity is sufficient so that there is minimal compromise of the fluid seal to prevent leakage of blood in the normal direction of blood flow upon withdrawal of the tube; for example, the distal edge of the flow deflector portion may be lip-shaped to seat within the curved wall of the coronary sinus. 13 shows an example of a lip-shaped distal edge 1316 of a flow deflector 1310 that is biased to conform to the curvature of the coronary sinus 1304. As shown by way of example in FIGS. 14A and 14B, the distal edge 1410 of the flow deflector 1404 includes a curvature that bends outward from the recess of the flow deflector 1404 to allow for further anchoring within the coronary sinus.

[0161] The flow deflector portion may induce retrograde blood flow into the coronary sinus by deflecting, diverting, blocking, occluding, slowing, or preventing blood flow in the normal direction. For example, the flow deflector portion 1310 may induce retrograde blood flow into the coronary sinus 1304 by blocking the normal flow of blood from the heart chamber 1302 in the first direction 1308, thereby causing blood to flow into the coronary sinus 1304 away from the first direction 1308. In some embodiments, the flow deflector portion comprises a tube or a tool passageway through which a tube can pass while also blocking the normal flow of blood. The tube passageway may include any shape or structure adapted to allow a tool to pass through after placement without compromising the substantially fluid-tight seal or flow deflection. Examples of tool passageways include, but are not limited to, one-way valves, duckbill valves, alternating shutters, or two or more layers of laminated material with slots, holes, and plugs or another suitable openable seal, each individual layer positioned approximately 90 degrees from the other layers. Other approaches to tool passage, such as two overlapping layers configured to allow non-overlapping operation as tool passage locations, are also contemplated for use with the disclosed embodiments.

[0162] Withdrawing the tube in a first direction may refer to pulling, retreating, ejecting, sliding, retracting, or otherwise removing the tube in a first direction. Once the expandable structure is positioned at a desired location, the tube may be withdrawn in a first direction to limit the number of objects in the body. For example, FIG. 13 illustrates an example of withdrawing the tube 1306 in a first direction 1308 by pulling the tube 1306 through the coronary sinus 1304. Deploying the flow deflector portion in a second direction other than the first direction may refer to expanding, opening, stretching, unfolding, fanning out, spreading out, shaping, or otherwise expanding the flow deflector portion in a direction opposite or different from the first direction. In some examples, deploying the flow deflector portion is achieved by withdrawing the tube in a first direction. In other examples, deploying the flow deflector portion is achieved by further actuation of the flow deflector portion. As an example, Figure 13 shows that after the tube 1306 is withdrawn in a first direction 1308, the flow deflector portion 1310 can be deployed in a second direction 1312 other than the first direction (in this depicted example, a direction opposite to the first direction).

[0163] A second direction opposite to the first direction refers to a second direction pointing away from the first direction. Thus, opposite in this context does not necessarily refer to mathematical opposite. For example, if the second direction is upstream based on the natural flow in the blood vessel, the first direction may be generally downstream based on the natural flow in the blood vessel. It may be desirable to direct retrograde blood flow in a second direction opposite to the first direction to enable perfusion in a region of the heart or body opposite to normal blood flow. For example, directing retrograde blood flow in a second direction opposite to the first direction may include reversing blood flow from the left atrium to the right atrium via the coronary sinus toward the posterolateral branch. As an example, FIG. 13 illustrates a flow deflector 1310 directing retrograde blood flow in a second direction 1312 opposite to the first direction 1308.

[0164] In some embodiments, the flow deflector portion is configured to expand in a second direction by sweeping away from a first direction. Sweeping away refers to moving or expanding in a curved manner. For example, the flow deflector portion may expand in the second direction by curving from a folded or compressed shape away from the first direction to an unfolded or expanded shape, like petals unfolding from a bud. As an example, FIG. 13 shows a compressed flow deflector 1208 within an expandable structure 1204 that can expand in a second direction by blooming outward from its folded shape.

[0165] In some embodiments, the flow deflector portion is arc-shaped, and the arc-shaped recess is configured to be pulled apart in the second direction. An arc-shaped recess refers to a curved, arched, curved, crescent-shaped, rounded, or otherwise curved shape. For example, the flow deflector portion may be rounded like the circumference of a portion of a circle. An arc-shaped recess refers to an arc-shaped cavity, recess, indentation, hollow portion, pit, or other curved surface of the flow deflector portion. For example, the recess of a rounded flow deflector portion may be inwardly curved. An arc-shaped flow deflector portion with a recess is desirable for smooth blood movement within the coronary sinus. As an example, the flow deflector portion 1310 of FIG. 13 is shaped as a curved petal extending from the scaffold portion 1314, in which case the recess of the flow deflector portion 1310 is pulled apart in the second direction 1312. 19 is attached to a portion of the circumference of the scaffold portion 1912 and is shaped as a concave sail extending toward the distal edge of the flow deflector, where the concave portion of the flow deflector portion is pulled away in a second direction 1924, away from the first direction 1926, within the coronary sinus. In another example, the flow deflector portion 816 is configured to allow the tube to be withdrawn in the first direction 811, thereby allowing the flow deflector portion 816 to be deployed in a second direction 810 other than the first direction 811. In another example, the flow deflector portion 816 is configured to allow the tube to be withdrawn in the first direction 811, after which the flow deflector portion 816 can be deployed in a second direction 810 other than the first direction 811.

[0166] In some embodiments, the flow deflector portion is configured to partially expand upon removal from the tube. The partial expansion of the flow deflector portion after removal from the tube can involve limited, controlled, localized, restricted, or otherwise incomplete opening or widening of the flow deflector portion. It may be desirable to maintain the flow deflector portion in a partially expanded state to properly align or position the scaffold portion or flow deflector portion before the flow deflector portion is fully expanded so that it contacts the wall tissue of the coronary sinus.

[0167] In some embodiments, when the trigger wire is pulled following partial expansion, the flow deflector portion further expands. A trigger wire refers to a line, cable, thread, tube, coil, or other strand or elongated structure or combination of structures that, when actuated, causes the resulting action of expanding the flow deflector (in this example, causing further expansion of the already partially expanded flow deflector portion). For example, the trigger wire may be a cable connecting two portions of the expandable structure, the cable configured to actuate movement of one of the portions. As an example, FIG. 12 shows a trigger wire connected to a flow deflector portion 1208 that, when pulled following partial expansion caused by withdrawal of the tube in a first direction, further expands the flow deflector portion 1208. In some embodiments, actuation can occur indirectly, in that the trigger wire can be connected to another structure that, when actuated, moves the trigger wire.

[0168] In some embodiments, an inner tube is disposed within the expandable structure, and a trigger wire is connected at one end to the flow deflector portion and at the other end to the inner tube. The term "inner tube" refers to any wire, cylinder, duct, pipe, conduit, or cable located within the expandable structure. The inner tube may be provided to provide additional structural stability to the compressed state of the expandable structure when seated within the tube. The inner tube may also be provided as a simple mechanism for fully expanding components of the expandable structure without inserting an additional tool within the tube during expansion. As an example, FIG. 12 shows an inner tube 1212 disposed within the expandable structure 1204, with the inner wire 1210 connected at one end to the flow deflector portion 1310 and at the other end to the inner tube 1212.

[0169] In some embodiments, the trigger wire is configured to release the flow deflector portion 1208 to the expanded state for expansion when the inner tube is retracted from within the expandable structure. Retraction of the inner tube refers to any removal of the inner tube, such as pulling, sliding, or tugging the inner tube from within the expandable structure. Releasing the flow deflector portion to the expanded state by retracting the inner tube from within the expandable structure is desirable because it avoids inserting an additional tool into the tube to cause expansion. For example, in FIG. 12 , the trigger wire 1210 is configured to release the flow deflector portion 1208 to the expanded state for expansion when the inner tube 1212 is retracted from within the expandable structure 1204.

[0170] In some embodiments, a mechanism is provided to delay deployment of the flow deflector portion until the tube is removed. The mechanism refers to any part or process used to affect a desired outcome, such as delaying deployment of the flow deflector portion until the tube is removed. Delaying deployment refers to slowing, pausing, extending, or otherwise postponing deployment of the flow deflector portion until the tube is removed. For example, the mechanism may be a catch, such as a fastener.

[0171] In some embodiments, the device includes a catch for maintaining the flow deflector portion in an at least partially unexpanded configuration upon removal from the tube, and a trigger wire connected to the catch and extending through the tube in a first direction, where the trigger wire is configured to expand the flow deflector portion in a second direction when pulled from the first direction. A catch refers to a structure or component that joins two or more objects or surfaces while allowing them to be separated. For example, the catch may be a fastener that holds two portions of an expandable structure together and is configured to release the connection between the two portions automatically or through a user action, such as pulling the fastener. The catch and trigger wire configuration can be used to expand the flow deflector portion, causing a slow, controlled release of the flow deflector portion within the coronary sinus. 12 shows an example of a catch 1214 that maintains the flow deflector portion 1208 in an at least partially unexpanded configuration upon removal from the tube 1202, and a trigger wire 1210 connected to the catch and extending in a first direction through the tube 1202, the trigger wire 1210 configured to expand the flow deflector portion 1208 in a second direction when pulled from the first direction. In this example, the catch 1214 is a curved strut in the scaffold portion 1206 that holds the flow deflector portion 1208 in a compressed state within the tube before the wire 1210 is pulled from the first direction.

[0172] In some embodiments, the controller is configured to control the timing of the expansion of the flow deflector portion. The term "controller" refers to any mechanical or electrical component that directs or adjusts the timing of expansion. Such a controller may be located on a handle for extracorporeal deployment, allowing a physician to selectively trigger deployment of the flow deflector portion by rotating, twisting, pulling, pushing, or other movements that deploy the flow deflector portion. Thus, the controller may include one or more of a button, dial, switch, lever, rotatable or slidable sleeve, or any other structure capable of translating physical movement by an operator into expansion of the flow deflector portion. The timing of expansion refers to the time, duration, schedule, placement, plan, program, or other selection, determination, or control of when the flow deflector portion expands. Thus, a physician may delay full expansion of the flow deflector until an appropriate time. As another example, in some embodiments, the timing of expansion may include how quickly the flow deflector portion expands, the time for expanding the flow deflector portion, and / or a plan for partially and then fully expanding the flow deflector portion.

[0173] In some embodiments, the expandable structure further includes a stabilizer portion on the scaffold portion opposite the flow deflector portion. A stabilizer portion refers to any structure or component configured to at least partially fix at least a portion of the expandable structure in a particular position or rotational orientation, or to prevent at least a portion of the expandable structure from shifting, moving, or rotating. In some embodiments, the scaffold portion is generally annular or tubular with a distal end opposite the flow deflector and a distal end proximate the flow deflector. A side of the scaffold portion opposite the flow deflector portion refers to a location diametrically opposite, away from, opposite, or otherwise across the flow deflector portion. It may be desirable to provide a stabilizer portion on the scaffold portion opposite the flow deflector portion to help fix the expandable structure therein and / or to resist shifting or movement caused by blood flow pressure. 14A and 14B show different views of an expandable structure 1400 that includes a stabilizer portion 1406 on an opposite side of the scaffold portion 1402 from the flow deflector portion 1404. In the example of FIGS. 14A and 14B, the stabilizer portion 1406 has a perimeter that flares outward from the scaffold portion 1402 to secure the scaffold portion 1402 in an opening between a heart chamber and the coronary sinus.

[0174] In some embodiments, the stabilizer portion includes multiple outwardly extending prongs, each having a curved distal end such that, upon expansion, the multiple outwardly extending prongs have at least one portion facing toward the interior wall of the heart chamber. Multiple outwardly extending prongs refer to extensions or protrusions that extend from a central lumen of the scaffold portion into the heart chamber. In some embodiments, a series of prongs extend in different directions. Depending on the number of prongs, the prongs may have at least a thin and / or pointed portion. Each prong may have a curved distal end facing toward the interior wall of the heart chamber, with the tip of the prong extending away from the chamber wall to minimize the risk of perforating the chamber wall. As an example, FIGS. 14A and 14B show a stabilizer portion 1406 including multiple outwardly extending prongs 1408, each prong 1408 having a curved distal end such that, upon expansion, the multiple outwardly extending prongs face toward the interior wall of the heart chamber. Alternatively, some or all of the prongs may have tips configured to face the wall.

[0175] In some embodiments, the scaffold portion and the flow deflector portion are configured to expand after the stabilizer portion is expanded. Expansion of the stabilizer portion refers to any widening of the stabilizer portion, such as the stabilizer portion transitioning from a crimped or compressed shape to an uncrimped or compressed shape. The scaffold portion and the flow deflector portion can expand after the stabilizer portion is expanded, and the stabilizer portion can be used first to secure the position of the expandable structure before expanding the remaining components. This can reduce trauma that can be caused by having to reposition the complete expandable structure if it is initially ineffectively positioned. For example, a tube can be withdrawn in a first direction by an amount corresponding to at least the length of the stabilizer portion to expand the stabilizer portion against the interior wall of the heart chamber, thereby securing the expandable structure in place. The tube can then be withdrawn further in the first direction to expand the scaffold portion and the flow deflector portion without having to reposition these components within the opening or coronary sinus.

[0176] Some embodiments further include at least one extension on the same side of the scaffold portion as the flow deflector portion to contact the inner wall of the coronary sinus and aid in stabilization. Extension refers to any appendage, arm, branch, extension, extension, protrusion, wing, lip, or any other structure. Providing such an extension may be desirable for device stabilization purposes. For example, the at least one extension may cooperate with a stabilizer at the distal end of the scaffold portion to secure the structure in place. The at least one extension may be provided as a lip structure (e.g., a series of prongs) that contacts the upper wall portion of the coronary sinus adjacent the scaffold. Additionally or alternatively, the at least one extension may include an extension extending from a flow deflector that forms part of the flow deflector frame that contacts the lower portion of the coronary sinus wall. For example, FIG. 14A shows a series of prongs 1412 peripherally disposed on the same side of the scaffold portion 1402 as the flow deflector portion 1404. In some embodiments, one or more prongs may be short relative to another one or more extensions. Typically, extensions along the circumference of the scaffold toward retrograde blood flow are short relative to those disposed along the circumference of the scaffold toward a first direction (i.e., the direction of tube withdrawal). These prongs serving as extensions of the scaffold portion 1402 may be similar to the prongs 1408 of the stabilizer portion 1406 in that both sets of prongs emerge from opposite sides of the scaffold portion 1402 and cooperate to stabilize the scaffold portion 1402 within the passageway 1322 or cooperate to stabilize the flow deflector position within the coronary sinus as shown in FIG. 13 . Additionally or alternatively, at least one extension may include the distal end 1410 of the flow deflector portion 1404 or the distal end 1922 of the flow deflector 1916 toward a second direction, as long as it is configured to engage the wall of the coronary sinus. The distal end 1410 or the distal end 1922 of the flow deflector may or may not be coated with a material described herein.In some embodiments, the flow deflector distal end 1410 or distal end 1922 may be identifiable as having a unique structure distinct from the flow deflector portion 1404 or 1916. In other embodiments, the distal end 1410 or distal end 1922 may be indistinguishable from the flow deflector portion 1404 or 1916, but in such instances, when the distal end 1410 or 1922 engages the wall of the coronary sinus, it is still considered an extension as defined herein, extending further than if the distal end simply touched the wall. In still other embodiments, the distal end 1410 or distal end 1922 may be indistinguishable from the flow deflector portion 1404 or 1916, but in such instances, it is still considered an extension as defined herein when the distal end 1410 or distal end 1922 engages the wall of the coronary sinus with a force greater than if the distal end 1410 or distal end 1922 were simply touching the wall.

[0177] In some embodiments, the extensions are disposed at the distal end of the flow deflector portion and are configured to allow the extensions to protrude in a second direction after the tube is withdrawn in a first direction. In some embodiments, when the flow deflector has multiple distal ends, as shown at 1916, the extensions are disposed at the distal end of the flow deflector portion facing the second direction, for example, at distal end 1922. At least one extension may extend in the second direction to provide additional fixation of the flow deflector portion within the coronary sinus and to act as an additional stabilizing structure within the coronary sinus. Furthermore, extension extensions in the second direction may further help direct retrograde flow away from the first direction in which the tube is withdrawn. As an example, FIG. 13 shows extension 1320 extending in a second direction 1312 after tube 1306 is withdrawn in a first direction 1308.

[0178] In some embodiments, the at least one extension is disposed on a periphery of the scaffold portion and is configured to fully expand before the flow deflector portion is fully expanded within the coronary sinus.

[0179] Fully expanded may refer to expanding to a maximum size. It may be desirable for the expansion section to fully expand before the flow deflector portion is fully expanded within the coronary sinus so that the scaffold portion is stabilized prior to deployment of the flow deflector. For example, the prongs 1320 may be fully expanded after the tube 1306 is withdrawn, while the flow deflector portion 1310 may be only partially released so that it does not contact the wall of the coronary sinus 1304. This configuration allows for device fixation and repositioning of the flow deflector portion 1310 within the coronary sinus 1304 while limiting tissue damage at the wall of the coronary sinus 1304.

[0180] In some embodiments, a flexible, fluid-impermeable covering is disposed over the expandable structure. A flexible, fluid-impermeable covering may be wrapped around or connected to a component of the expandable structure and may refer to a fabric covering or any flexible material at least partially configured to block the passage of fluid. In some embodiments, the partial or substantial fluid impermeability of the flexible covering may provide conductivity for a desired direction of retrograde blood flow. For example, a flexible covering that is partially impermeable to blood flow may allow the flexible covering to block and redirect a portion of the blood flow through the flexible covering. As another example, a flexible covering that is substantially impermeable to blood flow may allow all of the blood flow through the flexible covering to be blocked and redirected by the flexible covering. Some examples of flexible, fluid-impermeable coverings include latex, polyethylene, polyurethane, or other flexible or polymeric materials. The flexible, fluid-impermeable covering may extend to cover any or all portions of the expandable structure. In some cases, the flexible, fluid-impermeable covering may extend only over the flow deflector portion. In other examples, the flexible, fluid-impermeable covering may extend over both the flow deflector portion and the scaffold portion. As an example, Figures 14A and 14B show a flexible, fluid-impermeable covering 1414 extending over the scaffold portion 1402, the flow deflector portion 1404, and the stabilizer portion 1406 to reinforce the structure of these components together.

[0181]

[0182] Some disclosed embodiments include methods for directing retrograde blood flow. FIG. 15 shows a flowchart of an exemplary method 1500 for directing retrograde blood flow. In step 1502, the method 1500 may include drilling an orifice between the coronary sinus and a heart chamber. Drilling the orifice may include piercing, puncturing, punching, cutting, tearing, piercing, lancing, or otherwise creating an opening between the coronary sinus and the heart chamber. For example, a surgeon may use a cutting device such as a blade to cut and create a hole between the coronary sinus and the heart chamber. As another example, a cutting device such as a sharp edge may be provided on the end of a tube containing the expandable structure described herein, and the sharp edge may be used to pierce the tissue between the coronary sinus and the heart chamber and create an opening therein. An example of the resulting opening is shown in FIG. 13 as hole 1318 between the coronary sinus 1304 and the heart chamber 1302.

[0183] At step 1504, method 1500 may include delivering a tube into the coronary sinus from a first direction, the tube having an expandable retrograde blood flow device therein, the retrograde blood flow device including a scaffold portion and a flow deflector portion. 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 a tube 1306 into the coronary sinus 1304, as shown in FIG. 13. As shown in FIG. 12, an exemplary tube 1202 having an expandable retrograde blood flow device 1204 therein, including a scaffold portion 1206 and a flow deflector portion 1208, may be slid into the coronary sinus.

[0184] In step 1506, method 1500 may include partially removing the retrograde blood flow device from the tube, transforming the scaffold portion from a compressed state within the tube to an expanded state outside the tube, while maintaining the flow deflector portion in a partially expanded state outside the tube. The partial removal and expansion may involve enlarging a restricted, controlled, localized, limited, or otherwise incomplete opening or 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 flow deflector portion before the flow deflector portion is fully expanded so that it contacts the coronary sinus wall tissue. For example, step 1506 may include pushing only the scaffold portion of the retrograde blood flow device out of the tube, expanding the scaffold portion from a crimped shape within the tube to an uncrimped or expanded shape outside the tube, while maintaining the flow deflector portion in a compressed or folded shape outside the tube.

[0185] At step 1508, method 1500 may include maintaining an orifice between the coronary sinus and the heart chamber using the scaffold portion. Such maintenance may include continuing or enabling the orifice between the coronary sinus and the heart chamber, as described herein. For example, FIG. 13 illustrates maintaining the opening 1318 between the heart chamber 1302 and the coronary sinus 1304 by expanding the scaffold portion 1314 within the opening 1318 such that the opening 1318 remains open to blood flow between the heart chamber 1302 and the coronary sinus 1304.

[0186] At step 1510, the method 1500 may include withdrawing the tube in a first direction. Withdrawing the tube may include removing the tube in the first direction, as described herein. For example, FIG. 13 illustrates an example of withdrawing the tube 1306 in a first direction 1308 by pulling the tube 1306 through the coronary sinus 1304.

[0187] In step 1512, method 1500 may include further expanding the flow deflector portion in a second direction other than the first direction. Further expanding the flow deflector portion may include making the flow deflector portion larger. This further expansion may be achieved in the same manner as partial expansion or in a manner different from partial expansion. As an example, further expanding the flow deflector portion may include expanding the flow deflector portion 1208 by withdrawing the tube 1202 in the first direction and then pulling the trigger wire 1210 attached to the catch 1214 to pull the flow deflector away in a second direction opposite the first direction.

[0188] At step 1514, the method 1500 may include creating retrograde flow in the coronary sinus using the flow deflector portion. Creating retrograde flow may include using the flow deflector portion to form, generate, direct, create, or otherwise induce retrograde flow in the coronary sinus. The flow deflector may be used to create retrograde flow by blocking or redirecting normal blood flow by physically occluding the normal blood flow, thereby allowing blood flow in another direction, such as the retrograde direction of blood flow. For example, the method 1500 may include blocking blood flow in a first direction 1308 between the heart chamber 1302 and the coronary sinus 1304 by blocking that flow using the flow deflector 1310, thereby redirecting the blood flow in a retrograde direction 1312. As another example, flow deflector portion 1310 may be curved to further direct retrograde flow within coronary sinus 1304 by providing curved surfaces or scoops that direct blood flow in direction 1312.

[0189] Disclosed embodiments may include devices and methods for inducing intravascular retrograde blood flow. In some embodiments, the devices and methods are configured to allow retrograde blood flow by maintaining a flow path connecting two organs with a pressure gradient between them while simultaneously blocking natural blood flow within the second organ. The term "intravascular" refers to within a vessel. Such vessels may include veins, arteries, capillaries, or other biological tubes into which blood enters. Retrograde blood flow may include the flow or movement of blood in a direction opposite to the natural flow direction within a vessel. For example, blood flowing in a direction opposite to the natural flow of blood within an artery or vein, including the coronary sinus, is considered retrograde blood flow. Some embodiments may include a tubular shunt portion. In some embodiments, a shunt is a device that redirects the flow of bodily fluids. The shunt portion may include a complete shunt or any portion of a shunt. For example, the shunt portion may redirect blood flow between two adjacent organs. The adjacent organs may be any two biological structures located adjacent to each other. Examples of organs may include blood vessels, anatomical cavities, and anatomical chambers. In some embodiments, a tubular shunt portion may include a tubular or annular passageway forming a central opening adapted to allow fluid flow. For example, the tubular portion may allow fluid flow, including blood flow. In some embodiments, the shunt portion may be tubular and may include sidewalls. A structure may be considered tubular within the meaning of the present disclosure if it has one or more outer walls defining an intermediate channel, regardless of the contours of the intermediate channel. The walls may be non-porous or perforated. For example, a series of wire struts or thin wire-like structures may constitute a generally tube-shaped scaffold to the extent that the outer structures delimit the intermediate channel. Even if the channel is deformed, the structure is still considered tubular for purposes of the present disclosure.

[0190] In some embodiments, the tubular shunt portion may be configured for placement in a passage between an organ and an adjacent blood vessel. A shunt portion may be configured for placement in a passage if it is configured (having features, being of an appropriate size and shape) in a manner that allows it to be placed within the passage. The passage may be pre-existing or may be surgically formed in connection with placement. In some embodiments, surgical formation may include a drilling device for forming a surgical hole prior to placement. In some embodiments, the shunt portion may be configured for placement via association with a delivery device configured to place the shunt portion within the passage. In some embodiments, the delivery device may be configured to maintain the altered shape or orientation of the shunt portion to enable delivery into the passage. For example, the shunt portion may be configured to be compressed or reduced within the delivery device to enable percutaneous delivery, after which the shunt portion may be expanded. A passage may include a channel, a surgically or naturally formed orifice, or other opening that allows fluid flow between an organ and a blood vessel. Examples of organs may include blood vessels, anatomical cavities, and / or anatomical cavities, including cardiac chambers. Adjacent blood vessels may include veins, arteries, capillaries, arterioles, and venules located adjacent to another organ or blood vessel. The blood vessel may include the coronary sinus. In one example, a passageway may be formed between the coronary sinus and the left atrium or left ventricle. In another example, the device is configured to be specifically placed in the passageway between the coronary sinus and the left atrium. Bridging may occur within a blood vessel or cavity, meaning the inside or interior portion of a blood vessel or cavity. For example, the interior of a blood vessel may be a vascular channel through which blood flows. Bridging a cavity and a blood vessel may include linking, interconnecting, or connecting. Such bridging may be achieved by forming a hole, notch, channel, or gap, or may be achieved using an existing hole, notch, channel, or gap. For example, bridging a cavity within an organ with the interior of a blood vessel may include connecting the cavity within the organ to the interior of the blood vessel and, in some embodiments, allowing fluid flow or material transport between the organ and the blood vessel.

[0191] 16 illustrates an exemplary embodiment of cardiac components. The heart 1600 may include various chambers, cavities, veins, arteries, and passageways. 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. The passageways may include openings in the heart 1600 that may be adjacent to a blood vessel, such as the coronary sinus 1614. In some embodiments, the passageways may include openings in the heart 1600 that may be adjacent to the coronary sinus 1614 at a distance from the PIVV 1620 such that the flow deflector does not contact the coronary sinus wall in the region of the PIVV. In some embodiments, a tubular shunt portion 1618 may bridge the passageway between the left atrium 1610 and the coronary sinus 1614.

[0192] Disclosed embodiments may include a stabilizer configured to secure the tubular shunt segment within a passageway. The stabilizer may include any structure that anchors, supports, attaches, fastens, secures, and / or prevents movement or migration. In some embodiments, the stabilizer may include a flange or protrusion. The stabilizer may be configured to secure the tubular shunt segment within a passageway. For example, securing may include fastening, joining, anchoring, or retaining to prevent or resist movement. The stabilizer may secure the tubular shunt segment within a passageway, such as a vein or other blood vessel, to resist movement of the tubular shunt segment away from the passageway. In some embodiments, the stabilizer may include a flange at the distal end of the tubular shunt segment. The flange may include a lip, rim, collar, protrusion, projection, or other extension. The flange at the distal end of the tubular shunt segment is the region of the shunt farthest from the direction of implantation when the device is implanted into the cavity from the blood vessel, or is the end region of the device within the cavity. In some embodiments, the flange may be configured to engage an interior wall of a cavity within the organ. Engaging with an interior wall may include having at least a portion abutting the interior wall of the cavity (e.g., the interior wall of a heart chamber). In some embodiments, engagement may also include anchoring, fastening, joining, or otherwise forming a connection with the interior of an organ, such as the interior wall of a heart chamber. Alternatively or additionally, stabilization may occur by contacting or engaging with a wall of the passageway. For example, the stabilizer may exert a restraining force on the surface of the interior atrial wall, or alternatively or additionally, on the wall of the passageway, resisting movement of the shunt portion from the passageway. Thus, the stabilizer may be configured to ensure that the shunt portion and / or flow deflector portion do not move when pressure is applied.

[0193] 17 illustrates an exemplary embodiment of a placement location for an intravascular retrograde blood flow device in accordance with an embodiment of the present disclosure. The retrograde blood flow device 1700 can be placed in a passageway 1716 and can include a tubular shunt portion 1714, a stabilizer 1718, and a flow deflector portion 1720, as described herein. The retrograde blood flow device 1700 can be placed between a cavity and a blood vessel, such as between a cavity 1710 and a coronary sinus 1712. In some embodiments, the cavity 1710 can be a heart chamber. The tubular shunt portion 1714 can bridge the cavity 1710 and an interior 1728 of the coronary sinus 1712. The stabilizer 1718, including an associated flange 1719, can secure the tubular shunt portion 1714 within the passageway 1716. The flange 1719 can engage an inner wall 1726 of the cavity 1710. For example, the flange 1719 may apply a stabilizing pressure to the interior wall 1726, or in some embodiments, may penetrate the interior wall 1726, which may be the interior wall of a cavity such as a chamber of the heart. A series of stabilizers 1718 and associated flanges 1719 may be disposed at the distal end of the tubular shunt portion 1714 to cooperate to stabilize the shunt portion 1714 within the passageway 1716.

[0194] The disclosed embodiments may include a flow deflector portion connected to the proximal end of the tubular shunt portion. The flow deflector portion includes any structure that deflects, redirects, blocks, obstructs, slows, or prevents fluid flow. In some embodiments, the flow deflector portion can partially block or partially impede blood flow within a blood vessel. The flow deflector portion may include any temporary or permanent, static, expandable, inflatable, or otherwise adjustable plug, disk, 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 the tubular shunt portion. The proximal end, as described above, refers to the region opposite the distal end of the tubular shunt portion. 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 completely connected to the proximal end of the tubular shunt portion, while in other embodiments, the flow deflector portion may be partially or integrally connected to the proximal end of the tubular shunt portion. For example, the flow deflector portion may be partially connected to a peripheral opening at the proximal end of the tubular shunt portion, such as a metal frame of the tubular shunt portion. In some embodiments, the flow deflector portion may be configured to only partially occlude natural flow within a blood vessel.

[0195] In some embodiments, the flow deflector portion is a plug configured to substantially prevent the passage of blood through a blood vessel. The plug may include a stopper, a drum, a clot, a seal, or any other mass that causes at least a partial blockage. A plug may substantially prevent the passage of blood if a majority of blood is prevented from passing through. Thus, some embodiments configured to substantially prevent passage may include blocking or closing a majority of a volume of fluid, such as blood, from moving, passing, or flowing past the plug. For example, the plug may block and occlude blood flow past the plug in a blood vessel, such as the coronary sinus. In some embodiments, the plug includes a covered expandable frame. The expandable frame may include a casing, shell, scaffold, a wall with holes, or other support fixture that can increase in diameter, expand, stretch, or otherwise expand. For example, a series of struts may form an expandable frame. Such a frame, or any other frame, may be at least partially covered. The cover may include a flexible material, fabric, or other material that cooperates with the frame to substantially prevent the passage of fluid. For example, the cover may be attached so as to surround, coat, encase, or otherwise cover at least a portion of the frame. In some embodiments, non-limiting examples of flexible materials may include a fabric cover or sheet, a polymer-based coating, or a high-density nitinol structure.

[0196] In some embodiments, an organ, vessel, or passageway may have an associated natural flow. The natural flow may be determined by the function of the organ or vessel or by the direction the heart pumps. For example, a vein may conduct venous blood (deoxygenated or oxygen-deficient) to the right atrium of the heart. As an example, the coronary sinus may conduct venous blood from the vasculature of cardiac tissue to the right atrium, and the coronary sinus may have a natural flow of blood toward the right atrium of the heart. Disclosed embodiments may include a flow deflector portion configured to direct retrograde blood flow. Retrograde blood flow may include flow or movement in a direction that is opposite, backward, retrograde, or contrary to the direction of natural flow within an organ, passageway, or vessel. In some embodiments, the flow deflector portion may be configured to direct retrograde blood flow. Directing retrograde blood flow may include directing, routing, regulating, influencing, or controlling retrograde blood flow relative to the natural blood flow direction. In some embodiments, directing retrograde blood flow may include reversing or redirecting natural blood flow. For example, an intravascular medical device may include a shunt portion to bridge a heart chamber and the coronary sinus to create oxygen-rich retrograde blood flow in the coronary sinus. The deflector portion allows retrograde oxygenated blood to flow backward (against the direction of natural flow) within the coronary sinus. As a result, cardiac tissue that may otherwise receive insufficient blood flow may be oxygenated by the retrograde flow. In some embodiments, the flow deflector portion may be configured to allow both retrograde and natural flow within the vein. In some embodiments, the flow deflector portion may be perforated to allow natural flow of blood. In some embodiments, the retrograde blood flow may further allow at least some non-retrograde (natural) blood flow in the vein or coronary sinus.

[0197] 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 the tubular shunt portion 1714. In some embodiments, the flow deflector portion 1720 may be a plug, which may include a covered expandable frame 1730. The plug may block blood in the coronary sinus 1712 from passing through the flow deflector portion 1720, and the covered expandable frame may expand to fit the diameter of the coronary sinus 1712. In some embodiments, the flow deflector portion 1720 may direct retrograde blood flow 1722 in a blood vessel, such as the coronary sinus 1712. The coronary sinus 1712 may have blood flowing in a natural direction, and the retrograde blood flow 1722 may travel against the natural flow in the blood vessel. For example, blood flow within coronary sinus 1712 may be a natural flow that opposes retrograde blood flow 1722 exiting cavity 1710 via passageway 1716. Flow deflector portion 1720 may be configured to direct blood exiting cavity 1710 toward retrograde blood flow 1722 such that retrograde blood flow 1722 flows from right to left within coronary sinus 1712 (opposite the natural flow within the blood vessel) as shown in FIG.

[0198] The disclosed embodiments may include a tether interconnecting the flow deflector portion and the tubular shunt portion. The tether may include one or more of a lead, 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 via a connection thereto. The interconnection may be integrally formed or may be achieved by bonding or welding. In some embodiments, the tether may include at least one of fabric, metal, or wire. For example, the tether may be composed of fabric, metal, wire, or any combination of fabric, metal, and wire. The wire may be bent in a wave-like shape, or the metal may be formed in a spring-like shape. In some embodiments, the tether may include a partial connection to a peripheral opening at the proximal end of the tubular shunt portion within the blood vessel. For example, the tether may at least partially interconnect the periphery of the tubular shunt portion around the flow deflector portion within the vein. In some embodiments, the tether has a thickness that is less than the width of the blood vessel, thereby allowing blood flow between the tubular shunt portion and the flow deflector portion. The thickness of the tether may include the width, circumference, extent, or diameter of the tether. A thickness that is less than the width of the blood vessel may include the width or diameter of the tether being less than the width or diameter of the blood vessel in which the tether is placed, such as the coronary sinus. Thus, blood flow is permitted between the tubular shunt portion and the flow deflector portion due to the fact that the tether does not have a thickness that completely occludes blood flow.

[0199] Disclosed embodiments may include enabling the flow deflector portion to be positioned a predetermined distance from the tubular shunt portion within the blood vessel. This may occur, at least in part, as a result of the characteristics 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 stretch of the tether may define the predetermined distance. The distance may also depend on other characteristics of the tether, such as stiffness and elasticity. In some embodiments, the predetermined distance may be between 2 mm and 40 mm. In this regard, the predetermined distance is measured in its natural, bent, 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, the predetermined distance within the coronary sinus may be within a range of 2 to 30 mm, 2 to 20 mm, 2 to 10 mm, 2 to 8 mm, or 2 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 passageway). In some embodiments, the predetermined distance may be determined to reduce risks associated with the shunt. For example, a predetermined distance of 2 mm to 40 mm can reduce the risk of blocking the shunt or the inner surface of the coronary sinus with another vein, and the predetermined distance can also minimize the risk of thrombus formation in the vicinity of the shunt.

[0200] In some embodiments, the tether is configured to exhibit a rigid state to prevent the flow deflector portion from migrating within the vessel. Exhibiting a rigid state may include exhibiting a stiff, firm, or inelastic property or state. In some embodiments, preventing the flow deflector portion from migrating within the vessel may include preventing or slowing the flow deflector portion from migrating, drifting, or shifting within the vessel. For example, a tether connected to the flow deflector portion and the tubular shunt portion may be inelastic, such that the flow deflector portion cannot move within the vessel. The tether can prevent the flow deflector portion from migrating within the vessel, such as the coronary sinus, such that the flow deflector portion can be prevented from migrating beyond a predetermined distance from the tubular shunt portion. In some embodiments, the tether can prevent the flow deflector portion from moving away from the tubular shunt portion when deployed within the vessel, reducing the risk of shunt occlusion. In some embodiments, the tether can prevent the flow deflector portion from migrating toward the tubular shunt portion, thereby reducing the risk of thrombus accumulation.

[0201] In some embodiments, the operable length or degree of curvature of the tether can be adjusted to selectively position the flow deflector portion within the blood vessel. The operable length can include a length, span, range, or distance suitable for a particular purpose. For example, the operable length of the tether can 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 curvature of the tether can include a range, level, or magnitude of the curvature, twist, arc, or angle of the tether. In some embodiments, the tether can be adjustable for selective positioning in that the tether is flexible to conform to the patient's anatomy. In some embodiments, the operable length of the tether or the degree of curvature of the tether can be adjustable to selectively position the flow deflector portion. In some embodiments, the operable length of the tether and the degree of curvature of the tether can 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 the blood vessel, including the coronary sinus.

[0202] The retrograde blood flow device 1700 may include a tether 1724, as shown in FIG. 17 . 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 a predetermined distance from the tubular shunt portion 1714. For example, when blood flow exerts a force on the flow deflector portion 1720 within the coronary sinus 1712, the tether 1724 maintains the position of the flow deflector portion 1720 at the predetermined distance from the tubular shunt portion 1714. In some embodiments, as described above, the predetermined distance from the tubular shunt portion 1714 to the flow deflector portion 1720 may be between 2 mm and 40 mm. For example, the tether 1724 may exhibit a rigid state that may prevent 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 less 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 less than the width of the blood vessel so as not to impede blood from flowing through the passageway 1716 or to not impede blood from moving between the tubular shunt portion 1714 and the flow deflector portion 1720.

[0203] 20 is a front view illustrating an exemplary embodiment of an intravascular retrograde blood flow device in accordance with embodiments of the present disclosure. The retrograde blood flow device 2000 can include a tubular shunt portion 2010, a tether 2012, and a flow deflector portion 2014. In some embodiments, the flow deflector portion 2014 can be a plug configured to block the flow of blood within a blood vessel. The tether 2012 can be connected to the center of the flow deflector portion 2014 or to the periphery of the tubular shunt portion 2010.

[0204] In some disclosed embodiments, a tether hingeably connects the flow deflector portion to the tubular shunt portion. The sizes and shapes of organs and blood vessels vary from person to person, and the retrograde blood flow device can accommodate these different anatomical structures. For example, the coronary sinus can have a smaller or larger diameter, and the tether can hinge to provide an angle between the flow deflector portion and the shunt portion. In some embodiments, the hinge can include a bendable structure, such as one or more wires, springs, wavy struts, or other joints or fittings that allow for adaptability in the orientation of one or more connected components. For example, the hinge can connect one or more objects to allow for a limited angle of movement within the vessel. In some embodiments, the tether can hingeably connect the flow deflector portion and the tubular shunt portion so that the flow deflector portion or the tubular shunt portion can be oriented at an angle to each other or have a limited range of movement around the hinge relative to each other.

[0205] FIG. 18 shows an exemplary embodiment of portions of an intravascular retrograde blood flow device according to an embodiment of the present disclosure, in which wire frames are interconnected by a common piece of material. The material is shown in FIG. 18 with dashed lines. In some embodiments, a tether 1812 (formed of the interconnecting material) joins the tubular shunt portion 1810 and the flow deflector portion 1814. In this example, the material (which may include fabric) only partially interconnects the components. For example, the tether 1812 may be connected to a specific portion or part of the peripheral opening 1816 on the proximal edge of the tubular shunt portion 1810. In some embodiments, the tether 1812 may hingedly connect the flow deflector portion 1814, including both the flow deflector frame and cover, to the tubular shunt portion 1810, allowing the flow deflector portion 1814 to be oriented at an angle relative to the tubular shunt portion 1810. (For example, an angle may be provided between the axes of each component.)

[0206] The disclosed embodiments may include at least one additional tether interconnecting the flow deflector portion and the tubular shunt portion. For example, a retrograde blood flow device may have multiple tethers spaced at different intervals along the circumference of the shunt or flow deflector portion. Various configurations of the number of tethers and the distance between each tether along the circumference may provide certain advantages without compromising the functionality of the tether. For example, two tethers may be located at opposite ends of the circumference of the tubular shunt or flow deflector portion, which may 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.

[0207] In some embodiments, the tether includes a distal end connected to the tubular shunt portion and a proximal end connected to the flow deflector portion, the distal end of the tether being connected to the periphery of the tubular shunt portion. The distal end may include a segment of the tether opposite or spaced apart from the attachment point of the tubular shunt portion to the passageway. The proximal end may include a portion, segment, or periphery on the same side as the attachment point of the tubular shunt portion or proximal to the attachment point of the tubular shunt portion. In some embodiments, the distal end of the tether may be connected to the periphery of the flow deflector portion or the periphery of the flow deflector stabilizer. A periphery may include an end, boundary, border, margin, perimeter, or other periphery of a 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. The flow deflector stabilizer may include a flow deflector having a stabilizing portion for holding, securing, or anchoring the flow deflector within a blood vessel.

[0208] 19 illustrates an exemplary embodiment of an intravascular retrograde blood flow device in accordance with embodiments of the present disclosure. The retrograde blood flow device 1900 can 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 can be connected to a periphery 1920 of the tubular shunt portion 1910, and the distal end of the tether 1914 can be connected to a periphery 1918 of the flow deflector portion 1916.

[0209] Disclosed embodiments may include tubular shunt portions, stabilizers, and flow deflector portions sized and configured for placement through the coronary sinus. The components may be sized and configured for placement such that their dimensions, shapes, and structures allow for delivery through the coronary sinus. Thus, for example, the components may be configured to be compressed within a delivery mechanism (e.g., a tube or catheter) for delivery to the coronary sinus. Furthermore, the diameter of the flow deflector, stabilizer, or tubular shunt portion, when compressed, is smaller than the diameter of the coronary sinus, allowing the components to be moved within the coronary sinus for placement. In some embodiments, the tubular shunt portion may be configured for placement in at least one of the left atrium or left ventricle. For example, the tubular shunt portion may be sized to terminate at one end in the region of the boundary between an opening or passageway and a blood vessel (such as the coronary sinus) and at the other end in the region of the boundary between a central opening or passageway and the left atrium or left ventricle. In some embodiments, the flow deflector portion and tether are configured for placement in the coronary sinus to block blood flow in a direction from the left atrium to the right atrium. Blocking blood flow can include impeding, inhibiting, preventing, or slowing the movement, transport, or motion of blood within an organ or vessel. In some embodiments, the blocked blood flow in a direction from the left atrium to the right atrium can include the flow deflector portion and tether, preventing blood from moving from the left atrium to the right atrium. For example, the flow deflector can block blood flow from the left atrium to the right atrium and allow retrograde blood flow in the coronary sinus.

[0210] For example, the tubular shunt portion, stabilizer, and flow deflector portion may be configured for placement through the coronary sinus 1614, as shown in FIG. 16. The tubular shunt portion may be configured for placement in the left atrium 1610 or the left ventricle 1616. The flow deflector portion and tether may be configured for placement in the coronary sinus 1614 to block blood flow from the left atrium 1610 toward the right atrium 1612.

[0211] In some embodiments, the intravascular blood flow device is configured for delivery via a catheter. Delivery via a catheter may include delivery via a balloon catheter, an overtube, a Mullins catheter, a pipe, or any other tube for placement within a blood vessel, including the coronary sinus. Being configured for delivery via a catheter may include a catheter containing a compressed tubular shunt in a position longitudinally distal to the compressed flow deflector portion such that the shunt is configured to exit the catheter first. Device components, including the tubular shunt portion and the flow deflector portion, may be compressed within 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 components or materials that increase in diameter, widen, or widen upon release or removal. This may occur if the device is at least partially constructed of a shape memory alloy, such as Nitinol. Expansion may occur any time after the blood flow device is released from the catheter. For example, expansion may occur when the tubular shunt portion is removed or otherwise exits the catheter. Additionally or alternatively, a trigger may be actuated after release to allow expansion. In either case, the tubular shunt portion may expand to a larger 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 being released from the restraints of the catheter. Alternatively, a trigger mechanism may be included that allows expansion of some or all of the flow deflector portion only after a trigger action. In either case, the flow deflector portion may expand to a larger diameter. In some embodiments, the tubular shunt portion is configured to be deployed from the catheter prior to deployment of the flow deflector portion. Prior to deployment of the flow deflector portion may include any time prior to release of the flow deflector portion. Disclosed embodiments may include allowing the tubular shunt portion to expand prior to expansion of the flow deflector portion.Enabling expansion of the tubular shunt portion may include increasing the diameter of the tubular shunt portion, as described herein. Expansion of 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 can first be released from the catheter and then expand within the blood vessel. The flow deflector portion can then be released from the catheter and expand within the blood vessel. For example, the tubular shunt portion 1714 can be released from the catheter and expand within the passageway 1716. Next, the flow deflector portion 1720 can be released from the catheter and expand within the coronary sinus 1712. In some embodiments, when expanded, the tubular shunt portion 1714 can have a circumference or diameter that is smaller than the diameter of the coronary sinus 1712. The described expansion of the components may occur as a result of relative movement between the component and the catheter, such as when the component is pushed out of the catheter or when the catheter is withdrawn.

[0212] In some embodiments, the tubular shunt portion includes a first framework and the flow deflector portion includes a second framework. The framework may include a casing, a shell, a series of interconnected structures, a scaffold, a perforated wall, or any other support fixture. In some embodiments, the framework may allow for transition between a collapsed state, such as when compressed within a catheter, and an expanded state, such as during deployment within a blood vessel. The framework may interconnect the stabilizer portion, the tubular shunt portion, and the flow deflector portion. In some embodiments, the framework may be a biocompatible, flexible material. Relevant flexible materials may be recognized by those skilled in the art. Such materials may include materials that are strong enough to resist deformation over time, capable of expanding with a decrease in circumferential pressure, and flexible enough to accommodate a range of anatomical variations. Non-limiting examples 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 (SMAs), such as CuAINi (copper zinc nickel). Other suitable materials may include other metals or stainless steel. The first framework may include a scaffold forming the tubular shunt portion. The second framework may include a separate scaffold (or interconnected scaffolds) connected to the flow deflector portion. In some embodiments, the second framework is adapted to serve as a fixation element for the flow deflector portion or the tubular shunt portion. For example, the second framework may fix, hold, or fasten the flow deflector portion within a vessel, or the second framework may fix the tubular shunt portion within a cavity or passageway. In some embodiments, the flow deflector portion may have a curved frame or surface. In some embodiments, the curved frame or surface has a scoop configuration. The curved or scooped portions can encourage such retrograde flow and eliminate areas of stagnation or low flow. In some embodiments, at least one of the first framework and the second framework is at least partially coated with a flexible material.Partially covered may include a framework that is covered, surrounded, enveloped, or otherwise surrounded by or with a material. In some embodiments, partially covered may include partial or incomplete coverage of the framework. In some embodiments, the flexible material forms a curved or scooped surface that can encourage retrograde flow and eliminate areas of stagnation or low flow, for example, as described above. In some embodiments, non-limiting examples of flexible materials may include a fabric cover or sheet, a polymer-based coating, or a Nitinol structure. In addition to the flexibility of the frame scaffold, the flexible material may also be flexible. 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 clotting, which may form an impermeable layer on the cover.

[0213] 19 illustrates an exemplary embodiment of an intravascular retrograde blood flow device in accordance with embodiments of the present disclosure. The retrograde blood flow device 1900 may include a tubular shunt portion 1910, a tether 1914, and a flow deflector portion 1916. The framework of the tubular shunt portion 1910 may be covered by a flexible material 1912. In some embodiments, the flexible material 1912 may be configured to redirect blood. For example, the flexible material 1912 may be substantially impermeable to blood or blood flow, such that some blood may not penetrate the flexible material and may be redirected around the flexible material.

[0214] In some embodiments, the tether can include a proximal end connected to a center of the first frame structure. The center of the first frame structure can be a midpoint or other intermediate location of the first frame structure on the tubular shunt portion. In some embodiments, the tether can include a distal end connected to a center of the second frame structure. The center of the second frame structure can include a midpoint or other intermediate location of the second frame structure on the flow deflector portion. For example, the tether 1724 (as seen in FIG. 17 ) can be connected to a center on the frame of the tubular shunt portion 1714, and the tether 1724 can also be connected to a center on the frame of the flow deflector portion 1720. As a further example, the tubular shunt portion 1810 (as seen in FIG. 18 ) can include a first frame structure, and the flow deflector portion 1814 can include a second frame structure. The tether 1812 may be connected to the center of a first frame on the tubular shunt portion 1810 and to the center of a second frame on the flow deflector portion 1814 .

[0215] FIG. 21 shows a flowchart of an exemplary method for directing retrograde blood flow within a blood vessel. FIG. 21 includes steps 2110 through 2116. In step 2110, the method may include placing a stabilizer on the distal end of a tubular shunt segment within the organ. This may be accomplished, for example, via a catheter, as described above. In step 2112, the method may include placing the tubular shunt segment within a passageway between the organ and an adjacent blood vessel to bridge a cavity within the organ and the interior of the blood vessel. In step 2114, the method may include positioning a flow deflector segment on the proximal end of the tubular shunt segment within the blood vessel at a predetermined distance from the tubular shunt segment using a tether interconnecting the flow deflector segment and the tubular shunt segment. Because a tether of a predetermined length interconnects the components, by releasing the flow deflector segment from the catheter, the distance between the components corresponds to the predetermined length. In step 2116, the method may include directing retrograde blood flow using the flow deflector segment. Thus, when blood begins to flow, the flow deflector portion causes backflow as previously described.

[0216] The following provisions are also disclosed herein: Clause 1. An intravascular medical device for shunting and selectively regulating anatomical fluid flow, comprising: a tubular shunt disposed within the passageway between the first organ and an adjacent second organ and configured to bridge a first cavity of the first organ and a second cavity of the second organ; a stabilizer configured to stabilize the tubular shunt within the passageway; a flow deflector extending from the tubular shunt and having a surface for deflecting flow within the second cavity; wherein the flow deflector is configured to extend from less than the entire circumference of the tubular shunt. Clause 2. An intravascular medical device as described in clause 1, wherein the tubular shunt, stabilizer and flow deflector are integrally connected and expandable when placed through a delivery catheter. Clause 3. An intravascular medical device as described in clause 1 or 2, wherein the second organ is a blood vessel and the tubular shunt and flow deflector are integrally connected in such a manner that the rotational orientation of the tubular shunt within the passage determines the degree of flow deflection within the blood vessel. Clause 4. An intravascular medical device described in any of clauses 1 to 3, wherein the second organ is a blood vessel, and in a first rotational orientation of the tubular shunt, the flow deflector is configured to span the width of the blood vessel to cause a first flow deflection, and in a second rotational orientation of the tubular shunt, the flow deflector is configured to span less than the width of the blood vessel to cause a second flow deflection, the first flow deflection being greater than the second flow deflection. Clause 5. An intravascular medical device described in any of clauses 1 to 4, wherein the second organ is a blood vessel and the flow deflector is configured to allow both natural flow and reverse flow within the vessel. Clause 6. The intravascular medical device of any of clauses 1-5, wherein the flow deflector further comprises a tool passageway therethrough. Clause 7. The intravascular medical device of any of clauses 1-6, further comprising a sheath configured to house the tubular shunt and the flow deflector in a compressed configuration. Clause 8. An intravascular medical device described in any of clauses 1 to 7, wherein upon removal from the sheath, the tubular shunt is configured to expand into a tubular shape and the flow deflector is configured to expand into a curved configuration. Clause 9. The intravascular medical device of any of clauses 1-8, wherein in the compressed configuration, the flow deflector is configured to nest within the tubular shunt. Clause 10. An intravascular medical device described in any of clauses 1 to 9, wherein the stabilizer includes a first flange region connected to the tubular shunt, the first flange region being positioned on the side of the tubular shunt opposite the flow deflector, and the first flange region being configured to seal against the wall of the first cavity when deployed. Clause 11. An intravascular medical device described in any of clauses 1 to 10, wherein the stabilizer includes a flexible covering and a plurality of arms configured to establish a fluid seal between a first side of the flexible covering and a wall of the first cavity when deployed. Clause 12. The intravascular medical device of any of clauses 1-11, wherein the flexible covering is at least partially impermeable to fluids. Clause 13. An intravascular medical device according to any one of clauses 1 to 12, wherein the flexible covering extends over the tubular shunt and forms part of the flow deflector. Clause 14. An intravascular medical device described in any of clauses 1 to 13, wherein the tubular shunt includes a second flange region extending into the second cavity, the second flange region configured to secure the tubular shunt within the passage. Clause 15. An intravascular medical device according to any one of clauses 1 to 14, wherein the tubular shunt comprises a tubular wall having at least one opening. Clause 16. An intravascular medical device described in any of clauses 1 to 15, wherein the tubular shunt is sized to terminate distally at the periphery of the passageway adjacent to the first cavity, and the flow deflector is sized to terminate against the wall of the second cavity on the opposite side of the passageway. Clause 17. An intravascular medical device described in any of clauses 1 to 16, wherein the stabilizer is configured to extend beyond the periphery of the distal end of the tubular shunt into the first cavity of the first organ. Clause 18. An intravascular medical device described in any of clauses 1 to 17, wherein the flow deflector includes a non-tubular recess configured to deflect flow within the second cavity. Clause 19. The intravascular medical device of any of clauses 1-18, wherein the flow deflector further comprises a tether configured to connect the flow deflector to a periphery of the tubular shunt. Clause 20. An intravascular medical device according to any one of clauses 1 to 19, further comprising at least one wavy flexible wire connecting the tubular shunt to the flow deflector. Clause 21. A method for shunting and diverting blood flow between biological organs, comprising: drilling an opening in a first organ having a first cavity and a second organ having a second cavity; placing a tubular shunt through the openings of the first cavity and the second cavity to allow blood to pass from the first cavity to the second cavity; placing a flow deflector extending from less than the entire circumference of the tubular shunt within the second cavity; deflecting the blood flow in the second cavity using a flow deflector; A method comprising: Clause 22. The method of clause 21, wherein the first organ is a cardiac chamber and the second organ is a blood vessel, and the flow deflector is configured to cause at least partial retrograde blood flow within the blood vessel. Clause 23. An intravascular retrograde blood flow device, comprising: A catheter, an expandable shunt configured to be compressed within the catheter and to bridge the opening between a first cavity of the first organ and a second cavity of the second organ; an expandable flow deflector configured to be compressed within the catheter and to deflect flow within the second cavity; a flexible hinge interconnecting the expandable shunt and the expandable flow deflector, the flexible hinge being configured to flex to allow transaxial alignment of the expandable shunt and the expandable flow deflector while maintaining the interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned within the second cavity along a second axis transverse to the first axis; An intravascular retrograde blood flow device comprising: Clause 24. An intravascular retrograde blood flow device as described in Clause 23, wherein the expandable flow deflector includes an expandable frame covered by a flexible flow deflecting cover, the expandable frame configured to fixate against the wall of the second cavity upon expansion, such that fixation helps stabilize the expandable shunt within the opening. Clause 25. An intravascular retrograde blood flow device as described in clause 23 or 24, wherein in the expanded configuration, the expandable frame includes a cylindrical portion and the flow deflection cover extends over the cylindrical portion to form a drum-shaped flat flow deflection surface. Clause 26. An intravascular retrograde blood flow device as described in any of clauses 23 to 25, wherein in the expanded configuration, the expandable frame includes a deflector support, and the flow deflection cover extends over the deflector support to form a concave flow deflection surface. Clause 27. An intravascular retrograde blood flow device as described in any of clauses 23 to 26, wherein in the expanded configuration, the expandable frame includes a recess and the flow deflection cover extends over the recess to form a scoop-shaped flow deflection surface. Clause 28. An intravascular retrograde blood flow device as described in any of clauses 23 to 27, wherein in the expanded configuration, the expandable frame includes an extension extending from the expandable frame beyond the intersection of the first axis and the wall of the second cavity, the extension engaging the wall of the second cavity. Clause 29. An intravascular retrograde blood flow device according to any one of clauses 23 to 28, wherein the extension extends in a direction opposite to the normal direction of fluid flow. Clause 30. An intravascular retrograde blood flow device according to any one of clauses 23 to 29, wherein the flexible flow deflecting cover is substantially impermeable to blood. Clause 31. An intravascular retrograde blood flow device as described in any of clauses 23 to 30, wherein the flexible flow deflection cover includes a tool passage configured to minimize blood flow through the flexible flow deflection cover. Clause 32. An intravascular retrograde blood flow device according to any one of clauses 23 to 31, wherein the flexible flow deflecting cover comprises at least one of a mesh, a fabric, a polymer coating, or a synthetic material coating. Clause 33. An intravascular retrograde blood flow device as described in any of clauses 23 to 32, further comprising a first stabilizer extending from the distal end of the expandable shunt opposite the flexible hinge for engaging the inner wall of the first cavity to maintain the expandable shunt within the opening. Clause 34. An intravascular retrograde blood flow device as described in any of clauses 23 to 33, further comprising a second stabilizer having a flange region extending from the proximal end of the expandable shunt into the second cavity for engaging the inner wall of the second cavity to maintain the expandable shunt within the opening. Clause 35. An intravascular retrograde blood flow device according to any one of clauses 23 to 34, wherein at least one of the first stabilizer and the second stabilizer comprises a plurality of prongs having unequal lengths. Clause 36. An intravascular retrograde blood flow device described in any of clauses 23 to 35, wherein the first stabilizer includes a plurality of outwardly extending prongs, each of the prongs having a distal end curved in a direction facing the inner wall of the first cavity. Clause 37. An intravascular retrograde blood flow device according to any one of clauses 23 to 36, wherein the expandable shunt comprises a tubular scaffold and the flexible flow deflecting cover extends over the tubular scaffold. Clause 38. An intravascular retrograde blood flow device described in any of clauses 23 to 37, wherein the flexible flow deflecting cover is further configured to allow at least some non-retrograde blood flow within the second cavity. Clause 39. An intravascular retrograde blood flow device as described in any of clauses 23 to 38, wherein the expandable flow deflector includes a lip for engaging a wall of the second cavity to assist in forming a seal against the wall of the second cavity. Clause 40. An intravascular retrograde blood flow device as described in any of clauses 23 to 39, wherein the expandable flow deflector includes a frame configured to initially maintain a compressed configuration after removal from the catheter, and the intravascular retrograde blood flow device further includes a release mechanism for allowing selective expansion of the expandable flow deflector after expansion of the expandable shunt. Clause 41. An intravascular retrograde blood flow device according to any one of clauses 23 to 40, wherein the expandable flow deflector is partially connected to the periphery of the expandable shunt via a flexible hinge. Clause 42. An intravascular retrograde blood flow device according to any one of clauses 23 to 41, wherein the flexible hinge comprises a tether. Clause 43. An intravascular retrograde blood flow device according to any one of clauses 23 to 42, wherein the connecting portion has a wavy shape. Clause 44. An intravascular retrograde blood flow device according to any of clauses 23 to 43, wherein the expandable frame is configured such that when the catheter is removed in a first direction to cause release of the expandable flow deflector, the expandable frame expands in a second direction different from the first direction. Clause 45. An intravascular retrograde blood flow device as described in any of clauses 23 to 44, wherein the one or more flexible hinges include two flexible hinges extending from opposite sides of the circumference of the shunt. Article 46. A method for directing intravascular retrograde blood flow, comprising: drilling an opening between the first cavity and the second cavity; advancing a catheter into an opening between the first cavity and the second cavity; delivering an expandable shunt compressed within the catheter through the catheter within the opening; delivering an expandable flow deflector connected to the expandable shunt from the catheter by a flexible hinge configured to flex to allow transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned along a second axis transverse to the first axis within the second cavity; securing an expandable flow deflector within the second cavity; A method comprising: Article 47. A medical device for directing retrograde blood flow, comprising: a tube for delivery into the coronary sinus from a first direction; an expandable structure compressed within a tube, 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 configured to allow the tube to be withdrawn in a first direction while the flow deflector portion is deployed in a second direction other than the first direction; an extensible structure including: A medical device comprising: Clause 48. The medical device of clause 47, wherein the flow deflector portion is configured to expand in a second direction away from the first direction. Clause 49. A medical device according to clause 47 or 48, wherein the flow deflector portion is arcuate and the arcuate recesses are configured to be pulled apart in the second direction. Clause 50. A medical device according to any one of clauses 47 to 49, wherein the flow deflector portion is configured to partially expand upon removal from the tube. Clause 51. A medical device according to any of clauses 47 to 50, further comprising a trigger wire configured to cause further expansion of the flow deflector portion when pulled following partial expansion. Clause 52. A medical device described in any of clauses 47 to 51, further comprising an inner tube disposed within the expandable structure, the trigger wire being connected at one end to the flow deflector portion and at the other end to the inner tube. Clause 53. A medical device as described in any of clauses 47 to 52, wherein the trigger wire is configured to release the flow deflector portion to an expanded state for expansion when the inner tube is retracted from within the expandable structure. Clause 54. A medical device according to any one of clauses 47 to 53, wherein the distal edge of the flow deflector portion is biased to conform to the curvature of the coronary sinus. Clause 55. A medical device as described in any of clauses 47 to 54, further comprising a catch for maintaining the flow deflector portion in an at least partially unextended configuration upon removal from the tube, and a trigger wire connected to the catch and extending in a first direction through the tube, the trigger wire configured to cause the flow deflector portion to expand in a second direction when pulled from the first direction. Clause 56. A medical device described in any of clauses 47 to 55, wherein the second direction is opposite to the first direction. Clause 57. A medical device according to any one of clauses 47 to 56, further comprising a mechanism for delaying deployment of the flow deflector portion until the tube is removed. Clause 58. A medical device according to any of clauses 47 to 57, further comprising a controller configured to control the timing of expansion of the flow deflector portion. Clause 59. A medical device described in any of clauses 47 to 58, wherein the expandable structure further comprises a stabilizer portion on a side of the scaffold portion opposite the flow deflector portion. Clause 60. A medical device described in any of clauses 47 to 59, wherein the stabilizer portion includes a plurality of outwardly extending prongs, each of the prongs having a distal end that is curved so that, upon expansion, the outwardly extending prongs face toward the inner wall of the heart chamber. Clause 61. A medical device described in any of clauses 47 to 60, wherein the scaffold portion and the flow deflector portion are configured to expand following expansion of the stabilizer portion. Clause 62. A medical device as described in any of clauses 47 to 61, further comprising at least one extension on the same side of the scaffold portion as the flow deflector portion to contact the inner wall of the coronary sinus and assist in stabilization. Clause 63. A medical device described in any of clauses 47 to 62, wherein the extension is positioned at the distal end of the flow deflector portion and is configured to allow the extension to protrude in a second direction after the tube is withdrawn in a first direction. Clause 64. A medical device described in any of clauses 47 to 63, wherein at least one extension portion is disposed on the periphery of the scaffold portion and configured to fully expand before the flow deflector portion is fully expanded within the coronary sinus. Clause 65. A medical device according to any one of clauses 47 to 64, further comprising a flexible, fluid-impermeable cover positioned over the expandable structure. Article 66. A method for directing retrograde blood flow, comprising: drilling an orifice between the coronary sinus and the heart chamber; delivering a tube from a first direction into the coronary sinus, the tube having an expandable retrograde blood flow device therein, the retrograde blood flow device including a scaffold portion and a flow deflector portion; partially removing the retrograde blood flow device from the tube to change the scaffold portion from a compressed state within the tube to an expanded state outside the tube and maintain the flow deflector portion in a partially expanded state outside the tube; maintaining an orifice between the coronary sinus and the heart chamber using a scaffold portion; withdrawing the tube in a first direction; further expanding the flow deflector portion in a second direction other than the first direction; generating retrograde flow in the coronary sinus using the flow deflector portion; A method comprising: Article 67. An intravascular retrograde blood flow device, comprising: a tubular shunt portion configured for placement within a passageway between an organ and an adjacent blood vessel to bridge a cavity within the organ and the interior of the blood vessel; a stabilizer configured to secure the tubular shunt portion within the passageway; a flow deflector portion connected to a proximal end of the tubular shunt portion, the flow deflector portion configured to direct retrograde blood flow; a tether interconnecting the flow deflector portion and the tubular shunt portion so as to enable the flow deflector portion to be positioned within the blood vessel at a predetermined distance from the tubular shunt portion; An intravascular retrograde blood flow device comprising: Clause 68. An intravascular retrograde blood flow device as described in Clause 67, wherein the tubular shunt portion, stabilizer and flow deflector portion are sized and configured for placement through the coronary sinus, the tubular shunt portion is configured for placement in at least one of the left atrium or left ventricle, and the flow deflector portion and tether are configured for placement in the coronary sinus to block blood flow in a direction from the left atrium to the right atrium. Clause 69. An intravascular retrograde blood flow device according to clause 67 or 68, wherein the predetermined distance is between 2 mm and 40 mm. Clause 70. An intravascular retrograde blood flow device described in any of clauses 67 to 69, wherein the stabilizer includes a flange at the distal end of the tubular shunt portion, the flange configured to engage with the inner wall of the organ cavity. Clause 71. An intravascular retrograde blood flow device described in any of clauses 67 to 70, wherein the connecting portion comprises at least one of fabric, metal or wire. Clause 72. An intravascular retrograde blood flow device according to any one of clauses 67 to 71, wherein the tether hingeably connects the flow deflector portion to the tubular shunt portion. Clause 73. An intravascular retrograde blood flow device according to any of clauses 67 to 72, configured for delivery through a catheter, wherein at least the tubular shunt portion is configured to expand after release from the catheter. Clause 74. An intravascular retrograde blood flow device according to any one of clauses 67 to 73, wherein the flow deflector portion is configured to expand after release from the catheter. Clause 75. An intravascular retrograde blood flow device as described in any of clauses 67 to 74, wherein the tubular shunt portion is configured to be deployed from the catheter prior to deployment of the flow deflector portion, thereby allowing the tubular shunt portion to expand prior to expansion of the flow deflector portion. Clause 76. An intravascular retrograde blood flow device according to any one of clauses 67 to 75, wherein the flow deflector portion is a plug configured to substantially block blood flow within the blood vessel. Clause 77. An intravascular retrograde blood flow device according to any one of clauses 67 to 76, wherein the plug comprises a covered expandable frame. Clause 78. An intravascular retrograde blood flow device as described in any of clauses 67 to 77, wherein the operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion within the blood vessel. Clause 79. An intravascular retrograde blood flow device according to any one of clauses 67 to 78, wherein the tether is configured to assume a rigid state to prevent the flow deflector portion from moving within the blood vessel. Clause 80. An intravascular retrograde blood flow device according to any of clauses 67 to 79, further comprising at least one additional tether interconnecting the flow deflector portion and the tubular shunt portion. Clause 81. An intravascular retrograde blood flow device as described in any of clauses 67 to 80, wherein the tether portion includes a distal end connected to the tubular shunt portion and a proximal end connected to the flow deflector portion, and the distal end of the tether portion is connected to the periphery of the tubular shunt portion, and the distal end of the tether portion is connected to the periphery of the flow deflector portion or the periphery of the flow deflector stabilizer. Clause 82. An intravascular retrograde blood flow device according to any one of clauses 67 to 81, wherein the tubular shunt portion comprises a first frame structure and the flow deflector portion comprises a second frame structure. Clause 83. An intravascular retrograde blood flow device according to any one of clauses 67 to 82, wherein at least one of the first frame structure and the second frame structure is at least partially covered with a flexible material. Clause 84. An intravascular retrograde blood flow device described in any of clauses 67 to 83, wherein the connecting portion includes a proximal end connected to the center of the first framework structure and a distal end connected to the center of the second framework structure. Clause 85. An intravascular retrograde blood flow device according to any of clauses 67 to 84, wherein the tether has a thickness less than the width of the blood vessel, thereby allowing blood flow between the tubular shunt portion and the flow deflector portion. Article 86. A method for directing intravascular retrograde blood flow, comprising: placing a tubular shunt portion within the passageway between the organ and an adjacent blood vessel to bridge a cavity within the organ and the interior of the blood vessel; placing a stabilizer at the distal end of the tubular shunt portion within the organ; placing a flow deflector portion connected to a proximal end of the tubular shunt portion within the blood vessel; positioning the flow deflector 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; directing retrograde blood flow using a flow deflector portion; Including, a method.

[0217] The disclosed embodiments, whether implemented as a system, device, and / or method, may include any one of the following dotted features, either alone or in combination with one or more other dotted features. Intravascular medical devices Shunt and selectively regulate anatomical fluid flow Tubular shunt a tubular shunt configured to be placed within a passageway between a first organ and an adjacent second organ; ○The second organ is the blood vessels a tubular shunt configured to bridge a first cavity in a first organ and a second cavity in a second organ; Stabilizer A stabilizer configured to stabilize a tubular shunt within a passageway Flow deflector Flow deflector extending from the tubular shunt a flow deflector having a surface for deflecting the flow within the second cavity; a flow deflector configured to extend from less than the entire periphery of the tubular shunt; Integral connected tubular shunts, stabilizers and flow deflectors Flow deflectors that are expandable when placed through tubular shunts, stabilizers, and delivery catheters · Integral connected tubular shunt and flow deflector A tubular shunt and a flow deflector integrally connected thereto such that the rotational orientation of the tubular shunt within the passageway determines the degree of flow deflection within the vessel. In a first rotational orientation of the tubular shunt, the flow deflector is configured to span a width of the blood vessel to create a first flow deflection. In a second rotational orientation of the tubular shunt, the flow deflector is configured to span less than the width of the blood vessel to create a second flow deflection. ○ The deflection of the first flow is greater than the deflection of the second flow A flow deflector configured to allow both natural and reverse flow within the vessel Flow deflector including tool passage A sheath configured to receive the tubular shunt and the flow deflector in a compressed configuration. The tubular shunt is configured to expand into a tubular shape when removed from the sheath. When removed from the sheath, the flow deflector is configured to expand into a curved configuration. In the compressed configuration, the flow deflector is configured to nest within the tubular shunt. The stabilizer includes a first flange region connected to the tubular shunt. A first flange area located on the side of the tubular shunt opposite the flow deflector a first flange region configured to seal against a wall of the first cavity upon deployment; - Stabilizer with flexible covering - Stabilizer with multiple arms a plurality of arms configured to establish a fluid seal between the first side of the flexible cover and a wall of the first cavity upon deployment; A flexible covering that is at least partially impermeable to fluids The flexible sheath extends over the tubular shunt. The flexible covering forms part of the flow deflector The tubular shunt includes a second flange region The second flange region extends into the second cavity. a second flange region configured to secure the tubular shunt within the passageway; The tubular shunt includes a tubular wall having at least one opening. The tubular shunt is sized to terminate distally at a periphery of the passageway proximate the first cavity. The flow deflector is sized to terminate against the wall of the second cavity on the opposite side of the passageway. The stabilizer is configured to extend beyond the periphery of the distal end of the tubular shunt. The stabilizer is configured to extend into a first cavity of a first organ. Flow deflector includes non-tubular recess a non-tubular recess configured to deflect flow within the second cavity; The flow deflector also includes a connecting section. a tether configured to connect the flow deflector to a periphery of the tubular shunt; At least one wavy flexible wire At least one wavy flexible wire connecting the tubular shunt to the flow deflector Methods for shunting and diverting blood flow between vital organs Drilling an opening in a first organ having a first cavity and a second organ having a second cavity. placing a tubular shunt through the openings in the first cavity and the second cavity to allow blood to pass from the first cavity to the second cavity; Placing a flow deflector extending from less than the entire periphery of the tubular shunt within the second cavity. Using a flow deflector to deflect blood flow in the second cavity If the first organ referred to in this section is a cardiac chamber - When the second organ is a blood vessel The flow deflector is configured to induce at least partial retrograde blood flow within the blood vessel. Intravascular retrograde blood flow device ·catheter Expandable shunt Expandable shunt compressed within the catheter an expandable shunt configured to bridge an opening between a first cavity of a first organ and a second cavity of a second organ; Expandable flow deflector compressed within the catheter an expandable flow deflector configured to deflect the flow within the second cavity; Flexible hinge A flexible hinge interconnecting the expandable shunt and the expandable flow deflector. The flexible hinge is configured to bend When the expandable shunt is positioned along a first axis in the opening and the expandable flow deflector is positioned along a second axis transverse to the first axis within the second cavity, the flexible hinge is bendable to permit transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining interconnection between the expandable shunt and the expandable flow deflector. The expandable flow deflector includes an expandable frame covered by a flexible flow deflecting cover. The expandable frame is configured to secure to a wall of the second cavity when expanded. Fixation aid to stabilize the expandable shunt within the opening In the expanded configuration, the expandable frame includes a cylindrical portion The flow deflection cover extends over the cylindrical portion to form a drum-shaped flat flow deflection surface. In the extended configuration, the extendable frame includes a deflector support The flow deflection cover extends over the deflector support to form a concave flow deflection surface. In the expanded configuration, the expandable frame includes a recess The flow deflection cover extends over the recess in a manner that forms a scoop-shaped flow deflection surface. In the expanded configuration, the expandable frame includes an extension extending from the expandable frame beyond the intersection of the first axis and the wall of the second cavity. The extension engages the wall of the second cavity. The extension extends in the opposite direction to the normal direction of fluid flow The flexible flow deflecting cover is substantially impermeable to blood Flexible flow deflector cover includes tool passage Tool passageways configured to minimize blood flow therethrough The flexible flow deflecting cover includes at least one of a mesh, a fabric, a polymer coating, or a synthetic material coating. A first stabilizer extending from the distal end of the expandable shunt. First stabilizer facing the hinge a first stabilizer that engages an interior wall of the first cavity to maintain the expandable shunt within the opening; Second stabilizer a second stabilizer having a flange region extending from the proximal end of the expandable shunt into the second cavity; a second stabilizer that engages the interior wall of the second cavity to maintain the expandable shunt within the opening; At least one of the first stabilizer and the second stabilizer includes a plurality of prongs having unequal lengths. The first stabilizer includes a plurality of outwardly extending prongs. prongs having distal ends curved in a direction facing the inner wall of the first cavity; Expandable shunts include tubular scaffolds A flexible flow deflecting cover extends over the tubular scaffold a flexible flow deflecting cover configured to allow at least some non-retrograde blood flow within the second cavity; The expandable flow deflector includes a lip for engaging a wall of the second cavity to assist in forming a seal against the wall of the second cavity. Expandable flow deflector includes frame A frame configured to initially maintain a compressed configuration after removal from the catheter. A release mechanism to allow selective expansion of the expandable flow deflector after expansion of the expandable shunt. The expandable flow deflector is partially connected to the periphery of the expandable shunt via a flexible hinge Flexible hinge includes a joint The joint has a wavy shape. The expandable frame is configured such that when the catheter is removed in a first direction to cause release of the expandable flow deflector, the expandable frame expands in a second direction. ○ A second direction different from the first direction The one or more flexible hinges include two flexible hinges extending from opposite sides of the periphery of the shunt. A method for directing intravascular retrograde blood flow Drilling an opening between the first cavity and the second cavity. advancing a catheter into the opening between the first cavity and the second cavity; Delivering a compressed expandable shunt through a catheter in the opening. delivering, from the catheter, an expandable flow deflector connected to the expandable shunt by a flexible hinge, the flexible hinge bendable to permit transaxial positioning of the expandable shunt and the expandable flow deflector while maintaining an interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned along a second axis transverse to the first axis within the second cavity; Fixing the expandable flow deflector within the second cavity. Medical devices for directing retrograde blood flow Tube for delivery into the coronary sinus from the first direction Expandable structure compressed within a tube A scaffold to maintain the orifice between the coronary sinus and the heart chambers A flow deflector portion configured to induce retrograde blood flow into the coronary sinus a flow deflector portion configured such that when the tube is withdrawn in a first direction, the flow deflector portion can be deployed in a second direction other than the first direction; The flow deflector portion is configured to expand in a second direction away from the first direction. The flow deflector part is arc-shaped The arc-shaped concave surface is configured to be pulled apart in a second direction. The flow deflector portion is configured to partially expand when removed from the tube. a trigger wire configured to further expand the flow deflector portion when pulled following partial expansion; Inner tube placed within an expandable structure The trigger wire is connected to the flow deflector at one end. The trigger wire is connected to the inner tube at the other end The trigger wire is configured to release the flow deflector portion for expansion to the expanded state when the inner tube is retracted from within the expandable structure. The distal edge of the flow deflector is biased to conform to the curvature of the coronary sinus A catch for maintaining the flow deflector portion in an at least partially unextended configuration upon removal from the tube. A trigger wire connected to the catch and running through the tube The trigger wire is configured to expand the flow deflector portion in a second direction when pulled in a first direction. The second direction is opposite to the first direction A mechanism to delay placement of the flow deflector until the tube is removed a controller configured to control the timing of the expansion of the flow deflector portion; The stabilizer part on the opposite side of the scaffold part from the flow deflector part The stabilizer portion includes a plurality of outwardly extending prongs. Prongs with curved distal ends that face toward the inner wall of the heart chamber during expansion The scaffold portion and the flow deflector portion are configured to expand following expansion of the stabilizer portion. At least one extension on the same side of the scaffold section as the flow deflector section to contact the interior wall of the coronary sinus to aid in stabilization. The extension is disposed at the distal end of the flow deflector portion. an extension configured to allow the tube to protrude in a second direction after being withdrawn in a first direction; At least one extension is disposed on the periphery of the scaffold portion. The at least one extension portion is configured to fully expand before the flow deflector portion fully expands within the coronary sinus. A flexible, fluid-impermeable cover placed over the expandable structure Drilling an orifice between the coronary sinus and the heart chambers delivering a tube from a first direction into the coronary sinus, the tube having an expandable retrograde blood flow device therein; A retrograde blood flow device including a scaffold portion and a flow deflector portion. Partially removing the retrograde blood flow device from the tube, causing the scaffold portion to transition from a compressed state within the tube to an expanded state outside the tube, with the flow def portion remaining in a partially expanded state outside the tube. Use of the scaffold to maintain the orifice between the coronary sinus and the heart chambers Expanding the flow deflector portion in a second direction other than the first direction. - Using the flow deflector to induce backflow into the coronary sinus Intravascular retrograde blood flow device a tubular shunt portion configured to be placed in a passageway between an organ and an adjacent blood vessel to bridge a cavity in the organ with the interior of the blood vessel; a stabilizer configured to secure the tubular shunt segment within the passageway; A flow deflector portion connected to the proximal end of the tubular shunt portion. A flow deflector portion configured to direct reverse blood flow. A junction that interconnects the flow deflector portion and the tubular shunt portion. a tether interconnecting the flow deflector portion and the tubular shunt portion to enable the flow deflector portion to be positioned within the blood vessel at a predetermined distance from the tubular shunt portion; The tubular shunt portion, stabilizer, and flow deflector portion are sized and configured for placement through the coronary sinus. a tubular shunt portion configured for placement in at least one of the left atrium or the left ventricle; a flow deflector portion and a tether configured for placement in the coronary sinus to block blood flow from the left atrium toward the right atrium; The predetermined distance between the shunt and the flow deflector is 2mm~40mm The stabilizer includes a flange at the distal end of the tubular shunt section a flange configured to engage an interior wall of a cavity within the organ; The connecting portion includes at least one of fabric, metal, or wire. The tether connects the flow deflector section to the tubular shunt section in a hinged manner. configured for delivery through a catheter The tubular shunt portion is configured to expand after release from the catheter. The flow deflector portion is configured to expand after removal from the catheter. The tubular shunt portion is configured to be deployed from the catheter prior to deployment of the flow deflector portion. The tubular shunt portion is configured to be deployed from the catheter, thereby allowing the tubular shunt portion to expand before the expansion of the flow deflector portion. The flow deflector part is a plug A plug configured to substantially block blood flow through a blood vessel. The plug includes a coated expandable frame The operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion within the vessel. The tether is configured to assume a rigid state to prevent the flow deflector portion from migrating within the vessel. At least one additional tether interconnecting the flow deflector portion and the tubular shunt portion. The tether portion includes a distal end connected to the tubular shunt portion. The tether portion includes a proximal end connected to the flow deflector portion. The distal end of the tether connected to the periphery of the tubular shunt segment The distal end of a tether connected to the periphery of a flow deflector portion or the periphery of a flow deflector stabilizer The tubular shunt portion includes a first frame structure. The flow deflector section includes a second frame structure At least one of the first frame structure and the second frame structure is at least partially covered with a flexible material. The tether includes a proximal end connected to a center of the first framework. The tether includes a distal end connected to a center of the second framework. The tether has a thickness less than the width of the blood vessel, thereby permitting blood flow between the tubular shunt portion and the flow deflector portion. A method for directing intravascular retrograde blood flow Placing a tubular shunt segment in the passageway between an organ and an adjacent blood vessel to bridge the cavity within the organ with the interior of the blood vessel. Placement of a stabilizer at the distal end of the tubular shunt segment within the organ Placing a flow deflector portion connected to the proximal end of the tubular shunt portion in the blood vessel. Positioning the flow deflector portion within the blood vessel at a predetermined distance from the tubular shunt portion. Use of a tether interconnecting the flow deflector portion and the tubular shunt portion. - Directing retrograde blood flow using flow deflectors

[0218] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosed embodiments being indicated by the following claims.

Claims

1. 1. An intravascular medical device for shunting and selectively regulating anatomical fluid flow, comprising: a tubular shunt disposed in a passageway between a first organ and an adjacent second organ and configured to bridge a first cavity of the first organ and a second cavity of the second organ; a stabilizer configured to stabilize the tubular shunt within the passage; a flow deflector extending from the tubular shunt and having a surface for deflecting flow within the second cavity; wherein the flow deflector is configured to extend from less than an entire circumference of the tubular shunt.

2. The intravascular medical device of claim 1 , wherein the tubular shunt, the stabilizer and the flow deflector are integrally connected and expandable when deployed through a delivery catheter.

3. The intravascular medical device of claim 1 , wherein the second organ is a blood vessel, and the tubular shunt and the flow deflector are integrally connected in such a manner that a rotational orientation of the tubular shunt within the passage determines the degree of flow deflection within the blood vessel.

4. 2. The intravascular medical device of claim 1, wherein the second organ is a blood vessel, and in a first rotational orientation of the tubular shunt, the flow deflector is configured to span a width of the blood vessel to cause a first flow deflection, and in a second rotational orientation of the tubular shunt, the flow deflector is configured to span less than a width of the blood vessel to cause a second flow deflection, the first flow deflection being greater than the second flow deflection.

5. The intravascular medical device of claim 1 , wherein the second organ is a blood vessel and the flow deflector is configured to allow both natural flow and reverse flow within the blood vessel.

6. The intravascular medical device of claim 1 , wherein the flow deflector further comprises a tool passage therethrough.

7. The intravascular medical device of claim 1 , further comprising a sheath configured to house the tubular shunt and the flow deflector in a compressed configuration.

8. The intravascular medical device of claim 7 , wherein upon removal from the sheath, the tubular shunt is configured to expand into a tubular shape and the flow deflector is configured to expand into a curved configuration.

9. The intravascular medical device of claim 7 , wherein in the compressed configuration, the flow deflector is configured to nest within the tubular shunt.

10. 2. The intravascular medical device of claim 1, wherein the stabilizer includes a first flange region connected to the tubular shunt, the first flange region being positioned on a side of the tubular shunt opposite the flow deflector, and the first flange region being configured to seal against a wall of the first cavity when deployed.

11. The intravascular medical device of claim 10 , wherein the stabilizer includes 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 the first cavity upon deployment.

12. The intravascular medical device of claim 11 , wherein the flexible covering is at least partially impermeable to fluids.

13. The intravascular medical device of claim 11 , wherein the flexible covering extends over the tubular shunt and forms a portion of the flow deflector.

14. The intravascular medical device of claim 10 , wherein the tubular shunt includes a second flange region extending into the second cavity and configured to secure the tubular shunt within the passageway.

15. The intravascular medical device of claim 1 , wherein the tubular shunt comprises a tubular wall having at least one opening.

16. The intravascular medical device of claim 1 , wherein the tubular shunt is sized to terminate distally at a periphery of the passage proximate the first cavity and the flow deflector is sized to terminate against a wall of the second cavity on the opposite side of the passage.

17. The intravascular medical device of claim 1 , wherein the stabilizer is configured to extend beyond a periphery of the distal end of the tubular shunt into the first cavity of the first organ.

18. The intravascular medical device of claim 1 , wherein the flow deflector includes a non-tubular recess configured to deflect flow within the second cavity.

19. The intravascular medical device of claim 1 , wherein the flow deflector further comprises a tether configured to connect the flow deflector to the periphery of the tubular shunt.

20. The intravascular medical device of claim 1 , further comprising at least one undulating flexible wire connecting the tubular shunt to the flow deflector.

21. 1. A method for shunting and diverting blood flow between biological organs, comprising: drilling an opening in a first organ having a first cavity and in a second organ having a second cavity; placing a tubular shunt through the openings in the first and second cavities to allow blood to pass from the first cavity to the second cavity; placing a flow deflector extending from less than the entire circumference of the tubular shunt within the second cavity; deflecting blood flow in the second cavity with the flow deflector; A method comprising:

22. 22. The method of claim 21, wherein the first organ is a heart chamber and the second organ is a blood vessel, and the flow deflector is configured to cause at least partial retrograde blood flow in the blood vessel.

23. 1. An intravascular retrograde blood flow device, comprising: A catheter; an expandable shunt compressed within 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 expandable flow deflector configured to be compressed within the catheter and to deflect flow within the second cavity; a flexible hinge interconnecting the expandable shunt and the expandable flow deflector, the flexible hinge being configured to bend to permit transaxial alignment of the expandable shunt and the expandable flow deflector while maintaining an interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned within the second cavity along a second axis transverse to the first axis; An intravascular retrograde blood flow device comprising:

24. 24. The intravascular retrograde blood flow device of claim 23, wherein the expandable flow deflector includes an expandable frame covered by a flexible flow deflecting covering, the expandable frame configured to be fixed against a wall of the second cavity upon expansion, such that the fixation helps stabilize the expandable shunt within the opening.

25. 25. The intravascular retrograde blood flow device of claim 24, wherein in an expanded configuration, the expandable frame includes a cylindrical portion and the flow deflecting cover extends over the cylindrical portion to form a drum-shaped flat flow deflecting surface.

26. 25. The intravascular retrograde blood flow device of claim 24, wherein in an expanded configuration, the expandable frame includes a deflector support, and the flow deflection covering extends over the deflector support in a manner that forms a concave flow deflection surface.

27. 25. The intravascular retrograde blood flow device of claim 24, wherein in an expanded configuration, the expandable frame includes a recess, and the flow deflecting cover extends over the recess in a manner that forms a scoop-shaped flow deflecting surface.

28. 25. The intravascular retrograde blood flow device of claim 24, wherein in an expanded configuration, the expandable frame includes an extension extending from the expandable frame beyond an intersection of the first axis and a wall of the second cavity, the extension engaging the wall of the second cavity.

29. 30. The intravascular retrograde blood flow device of claim 28, wherein the extension extends in a direction opposite to the normal direction of fluid flow.

30. 25. The intravascular retrograde blood flow device of claim 24, wherein the flexible flow deflecting covering is substantially impermeable to blood.

31. 25. The intravascular retrograde blood flow device of claim 24, wherein the flexible flow deflecting covering includes a tool channel configured to minimize blood flow through the flexible flow deflecting covering.

32. 25. The intravascular retrograde blood flow device of claim 24, wherein the flexible flow deflecting covering comprises at least one of a mesh, a fabric, a polymeric coating, or a synthetic material coating.

33. 24. The intravascular retrograde blood flow device of claim 23, further comprising a first stabilizer extending from a distal end of the expandable shunt opposite the hinge for engaging an inner wall of the first cavity to maintain the expandable shunt within the opening.

34. 34. The intravascular retrograde blood flow device of claim 33, further comprising a second stabilizer comprising a flange region extending from a proximal end of the expandable shunt into the second cavity for engaging an inner wall of the second cavity to maintain the expandable shunt within the opening.

35. 35. The intravascular retrograde blood flow device of claim 34, wherein at least one of the first stabilizer and the second stabilizer comprises a plurality of prongs having unequal lengths.

36. 34. The intravascular retrograde blood flow device of claim 33, wherein the first stabilizer includes a plurality of outwardly extending prongs, each of the prongs having a distal end curved in a direction facing an inner wall of the first cavity.

37. 24. The intravascular retrograde blood flow device of claim 23, wherein the expandable shunt comprises a tubular scaffold, and the flexible flow deflecting covering extends over the tubular scaffold.

38. 25. The intravascular retrograde blood flow device of claim 24, wherein the flexible flow deflecting covering is further configured to allow at least some non-retrograde blood flow within the second cavity.

39. 24. The intravascular retrograde blood flow device of claim 23, wherein the expandable flow deflector includes a lip for engaging a wall of the second cavity to assist in forming a seal against the wall of the second cavity.

40. 24. The intravascular retrograde blood flow device of claim 23, wherein the expandable flow deflector includes a frame configured to initially maintain a compressed configuration after removal from the catheter, and the intravascular retrograde blood flow device further includes a release mechanism for allowing selective expansion of the expandable flow deflector after expansion of the expandable shunt.

41. 24. The intravascular retrograde blood flow device of claim 23, wherein the expandable flow deflector is partially connected to a periphery of the expandable shunt via the flexible hinge.

42. 24. The intravascular retrograde blood flow device of claim 23, wherein the flexible hinge includes a tether.

43. 43. The intravascular retrograde blood flow device of claim 42, wherein the tether has a wavy shape.

44. 25. The intravascular retrograde blood flow device of claim 24, wherein the expandable frame is configured such that when the catheter is removed in a first direction to cause release of the expandable flow deflector, the expandable frame expands in a second direction different from the first direction.

45. 25. The intravascular retrograde blood flow device of claim 24, wherein the one or more flexible hinges include two flexible hinges extending from opposite sides of the circumference of the shunt.

46. 1. A method for directing retrograde blood flow in a blood vessel, comprising: drilling an opening between the first cavity and the second cavity; advancing a catheter into the opening between the first cavity and the second cavity; delivering an expandable shunt compressed within the catheter through the opening; delivering an expandable flow deflector connected to the expandable shunt from the catheter by a flexible hinge configured to bend to permit transaxial alignment of the expandable shunt and the expandable flow deflector while maintaining an interconnection between the expandable shunt and the expandable flow deflector when the expandable shunt is positioned along a first axis of the opening and the expandable flow deflector is positioned along a second axis transverse to the first axis within the second cavity; securing the expandable flow deflector within the second cavity; A method comprising:

47. 1. A medical device for directing retrograde blood flow, comprising: a tube for delivery to the coronary sinus from a first direction; an expandable structure compressed within the tube, 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 configured to be deployed in a second direction other than the first direction while the tube is withdrawn in the first direction; and an extensible structure including: A medical device comprising:

48. 48. The medical device of claim 47, wherein the flow deflector portion is configured to expand in the second direction away from the first direction.

49. 48. The medical device of claim 47, wherein the flow deflector portion is arcuate and the arcuate recesses are configured to be separated in the second direction.

50. 48. The medical device of claim 47, wherein the flow deflector portion is configured to partially expand upon removal from the tube.

51. 51. The medical device of claim 50, further comprising a trigger wire configured to further expand the flow deflector portion when pulled following partial expansion.

52. 51. The medical device of claim 50, further comprising an inner tube disposed within the expandable structure, the trigger wire being connected at one end to the flow deflector portion and at the other end to the inner tube.

53. 53. The medical device of claim 52, wherein the trigger wire is configured to release the flow deflector portion to an expanded state for expansion when the inner tube is retracted from within the expandable structure.

54. 48. The medical device of claim 47, wherein a distal edge of the flow deflector portion is biased to conform to the curvature of the coronary sinus.

55. 48. The medical device of claim 47, further comprising a catch for maintaining the flow deflector portion in an at least partially unexpanded configuration upon removal from the tube, and a trigger wire connected to the catch and extending through the tube in the first direction, the trigger wire configured to expand the flow deflector portion in the second direction when pulled from the first direction.

56. 48. The medical device of claim 47, wherein the second direction is opposite to the first direction.

57. 48. The medical device of claim 47, further comprising a mechanism for delaying deployment of the flow deflector portion until the tube is removed.

58. 48. The medical device of claim 47, further comprising a controller configured to control a timing of expansion of the flow deflector portion.

59. 48. The medical device of claim 47, wherein the expandable structure further comprises a stabilizer portion on a side of the scaffold portion opposite the flow deflector portion.

60. 60. The medical device of claim 59, wherein the stabilizer portion includes a plurality of outwardly extending prongs, each of the prongs having a distal end that is curved such that when expanded, the outwardly extending prongs face toward an inner wall of the heart chamber.

61. 60. The medical device of claim 59, wherein the scaffold portion and the flow deflector portion are configured to expand subsequent to expansion of the stabilizer portion.

62. 48. The medical device of claim 47, further comprising at least one extension on the same side of the scaffold portion as the flow deflector portion to contact an inner wall of the coronary sinus to aid in stabilization.

63. 63. The medical device of claim 62, wherein the extension is disposed at a distal end of the flow deflector portion and configured to allow the extension to protrude in the second direction after the tube is withdrawn in the first direction.

64. 64. The medical device of claim 63, wherein the at least one extension is disposed on a periphery of the scaffold portion and configured to fully expand before the flow deflector portion is fully expanded within the coronary sinus.

65. 48. The medical device of claim 47, further comprising a flexible, fluid-impermeable cover disposed over the expandable structure.

66. 1. A method for directing retrograde blood flow, comprising: drilling an orifice between the coronary sinus and a heart chamber; delivering a tube into the coronary sinus from a first direction, the tube having an expandable retrograde blood flow device therein, the retrograde blood flow device including a scaffold portion and a flow deflector portion; partially removing the retrograde blood flow device from the tube to change the scaffold portion from a compressed state within the tube to an expanded state outside the tube and to maintain the flow deflector portion in a partially expanded state outside the tube; maintaining the orifice between the coronary sinus and the heart chamber using the scaffold portion; withdrawing the tube in the first direction; further expanding the flow deflector portion in a second direction other than the first direction; creating a backflow in the coronary sinus using the flow deflector portion; A method comprising:

67. 1. An intravascular retrograde blood flow device, comprising: a tubular shunt portion configured for placement in a passage between an organ and an adjacent blood vessel to bridge a cavity in the organ and the interior of the blood vessel; a stabilizer configured to secure the tubular shunt portion within the passageway; a flow deflector portion connected to a proximal end of the tubular shunt portion, the flow deflector portion configured to direct retrograde blood flow; a tether interconnecting the flow deflector portion and the tubular shunt portion to enable the flow deflector portion to be positioned within the blood vessel at a predetermined distance from the tubular shunt portion; An intravascular retrograde blood flow device comprising:

68. 68. The intravascular retrograde blood flow device of claim 67, wherein the tubular shunt portion, the stabilizer, and the flow deflector portion are sized and configured for placement via the coronary sinus, the tubular shunt portion configured for placement in at least one of the left atrium or left ventricle, and the flow deflector portion and the tether configured for placement in the coronary sinus to block blood flow in a direction from the left atrium toward the right atrium.

69. 68. The intravascular retrograde blood flow device of claim 67, wherein the predetermined distance is between 2 mm and 40 mm.

70. 68. The intravascular retrograde blood flow device of claim 67, wherein the stabilizer includes a flange at a distal end of the tubular shunt portion, the flange configured to engage an inner wall of the cavity of the organ.

71. 68. The intravascular retrograde blood flow device of claim 67, wherein the tether comprises at least one of a fabric, a metal, or a wire.

72. 68. The intravascular retrograde blood flow device of claim 67, wherein the tether hingeably connects the flow deflector portion to the tubular shunt portion.

73. 68. The intravascular retrograde blood flow device of claim 67, configured for delivery through a catheter, and wherein at least the tubular shunt portion is configured to expand after release from the catheter.

74. 74. The intravascular retrograde blood flow device of claim 73, wherein the flow deflector portion is configured to expand after release from the catheter.

75. 74. The intravascular retrograde blood flow device of claim 73, wherein the tubular shunt portion is configured to be deployed from the catheter prior to deployment of the flow deflector portion, thereby allowing the tubular shunt portion to expand prior to expansion of the flow deflector portion.

76. 68. The intravascular retrograde blood flow device of claim 67, wherein the flow deflector portion is a plug configured to substantially prevent blood flow through the blood vessel.

77. 77. The intravascular retrograde blood flow device of claim 76, wherein the plug comprises a covered expandable frame.

78. 68. The intravascular retrograde blood flow device of claim 67, wherein the operable length or degree of bending of the tether is adjustable to selectively position the flow deflector portion within the blood vessel.

79. 68. The intravascular retrograde blood flow device of claim 67, wherein the tether is configured to assume a rigid state to prevent the flow deflector portion from moving within the blood vessel.

80. 68. The intravascular retrograde blood flow device of claim 67, further comprising at least one additional tether interconnecting said flow deflector portion and said tubular shunt portion.

81. 68. The intravascular retrograde blood flow device of claim 67, wherein the tether includes a distal end connected to the tubular shunt portion and a proximal end connected to the flow deflector portion, the distal end of the tether being connected to a periphery of the tubular shunt portion, and the distal end of the tether being connected to a periphery of the flow deflector portion or a periphery of a flow deflector stabilizer.

82. 68. The intravascular retrograde blood flow device of claim 67, wherein the tubular shunt portion comprises a first framework and the flow deflector portion comprises a second framework.

83. 83. The intravascular retrograde blood flow device of claim 82, wherein at least one of the first framework and the second framework is at least partially covered with a flexible material.

84. 83. The intravascular retrograde blood flow device of claim 82, wherein the tether includes a proximal end connected to a center of the first framework and a distal end connected to a center of the second framework.

85. 68. The intravascular retrograde blood flow device of claim 67, wherein the tether has a thickness less than a width of the blood vessel, thereby allowing blood flow between the tubular shunt portion and the flow deflector portion.

86. 1. A method for directing retrograde blood flow in a blood vessel, comprising: placing a tubular shunt portion within a passage between an organ and an adjacent blood vessel to bridge a cavity within the organ and an interior of the blood vessel; placing a stabilizer at a distal end of the tubular shunt portion within the organ; placing a flow deflector portion connected to a proximal end of the tubular shunt portion within the blood vessel; positioning the flow deflector 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; directing retrograde blood flow using the flow deflector portion; Includes, a method.

Images