Lung shunt

Abstract

The shunt system includes a shunt configured to maintain a blood flow pathway between a first blood vessel and a second blood vessel, and a deformable device configured to elastically deform in response to blood flow through the shunt.

Description

Technical Field

[0001] Related Applications This application was filed on March 24, 2023, claims priority to U.S. Provisional Application No. 63 / 492,185, entitled "PULMONARY SHUNT SYSTEMS", the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The present invention generally relates to the field of medical devices and procedures. Pulmonary hypertension is a rapidly progressive vascular disease associated with high short-term mortality. The main cause of disease progression is an increase in pulmonary artery pressure due to decreased vascular compliance.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Some embodiments of the present disclosure relate to a shunt system including a shunt configured to maintain a blood flow path between a first blood vessel and a second blood vessel, and a deformable device configured to elastically deform in response to blood flow through the shunt.

Means for Solving the Problems

[0004] For the purpose of summarizing the present disclosure, certain aspects, advantages, and novel features are described herein. It should be understood that not necessarily all such advantages can be achieved according to any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or a group of advantages as taught by the present disclosure without necessarily achieving other advantages that may be taught or suggested by the present disclosure.

[0005] The methods and structures disclosed herein for treating patients also encompass similar methods and structures performed on or placed on simulated patients, which are useful, for example, training, demonstration, treatment and / or device development, and similar purposes. Simulated patients may be physical, virtual, or a combination of physical and virtual. The simulation may include a simulation of all or part of a patient, e.g., the whole body, a part of the body (e.g., the chest), a system (e.g., the cardiovascular system), an organ (e.g., the heart), or any combination thereof. Physical elements may be natural, synthetic, or any combination of natural and synthetic, including human or animal carcasses or parts thereof. Virtual elements may be entirely in silico or overlaid on one or more of the physical components. Virtual elements may be presented on any combination of screens, headsets, holographics, projections, loudspeakers, headphones, pressure transducers, temperature transducers, or using any combination of appropriate technologies.

[0006] Various embodiments are shown in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the invention. In addition, various configurations of different disclosed embodiments can be combined to form additional embodiments which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate agreement between reference elements. However, it should be understood that the use of similar reference numerals in relation to multiple drawings does not necessarily imply similarity between the respective embodiments relating thereto. Furthermore, it should be understood that the configurations in each drawing are not necessarily drawn to scale, and their illustrated sizes are presented for illustrative purposes only to illustrate aspects of the invention. In general, some of the illustrated configurations may be relatively smaller than those illustrated in some embodiments or configurations. [Brief explanation of the drawing]

[0007] [Figure 1]Figure 1 shows an illustrative diagram of the heart, including indicators representing blood flow through the heart. [Figure 2A] Figure 2A shows an optional delivery method for delivering one or more implants described in this disclosure. [Figure 2B] Figure 2B shows an optional delivery method for delivering one or more implants described in this disclosure. [Figure 3A] Figure 3A shows the delivery of shunts and / or fluid transfer / movement devices to the SVC and / or RPA. [Figure 3B] Figure 3B illustrates the delivery of stents and / or similar devices to the SVC and / or RPA. [Figure 4A] Figure 4A shows the default and / or first state of the shunt system before blood transfer from the RPA to the SVC. [Figure 4B] Figure 4B shows a second state of the shunt system where the blood pressure in the RPA increases by enough (e.g., during systole) to push excess blood out of the RPA, through the shunt, and / or into the SVC. [Figure 4C] Figure 4C shows the third state of the shunt system, in which blood pressure in the RPA decreases from the increased amount of the second state, as pulling and / or suction are generated to draw blood in the SVC through the shunt and / or back into the RPA. [Figure 5] Figure 5 provides a side view of another exemplary shunt system for diverting blood between a first blood vessel and / or chamber (e.g., RPA) and a second blood vessel and / or chamber (e.g., SVC), according to one or more embodiments. [Figure 6] Figure 6 shows an example of a compliance system for shunting, moving, and / or exchanging fluid (e.g., blood and / or saline) between a first blood vessel and / or chamber (e.g., RPA) and a second blood vessel and / or chamber (e.g., SVC), according to one or more embodiments. [Figure 7]Figure 7 shows an example of a compliance system for the shunting, movement, and / or exchange of fluid (e.g., blood and / or saline) between a first blood vessel and / or chamber (e.g., RPA) and a second blood vessel and / or chamber (e.g., SVC), according to one or more embodiments. [Figure 8] Figure 8 provides a flowchart illustrating an exemplary process for the delivery of one or more shunt implants and / or shunt systems described herein. [Modes for carrying out the invention]

[0008] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0009] While specific preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred order, and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a plurality of distinct operations in a manner that may be useful for understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other embodiments or advantages that may similarly be taught or suggested herein.

[0010] The following includes a general description of human cardiac anatomy, relating to the features and embodiments of the specific inventions disclosed herein and included to provide context for the specific aspects of this disclosure.

[0011] In humans and other vertebrates, the heart generally comprises a muscular organ with four pumping chambers, and its flow is at least partially controlled by various heart valves: the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to open and close in response to pressure gradients present at different stages of the cardiac cycle (e.g., relaxation and contraction), thereby at least partially controlling the flow of blood to each corresponding region of the heart and / or to blood vessels (e.g., lungs, aorta, etc.).

[0012] Figure 1 shows an exemplary diagram of heart 1, including indicators representing blood flow through heart 1. Heart 1 contains four chambers, namely the left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. A muscular wall called the septum separates the left atria 2 and right 5, as well as the left ventricles 3 and right 4.

[0013] The heart 1 further includes four valves to assist in the circulation of blood within it, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may generally have three coronary or valve leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The valves of the heart 1 further include a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 18 and may be configured to open during systole so that blood can be pumped toward the lungs and close during diastole to prevent blood from flowing backward from the pulmonary artery into the heart. The pulmonary valve 9 may generally have three coronary / valve leaflets, each of which may have a crescent shape. The heart 1 further includes a mitral valve 6, which may generally have two coronary / valve leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 may generally be configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3, and to close during diastole to favorably prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to flow out of the left ventricle 3 into the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0014] A heart valve may generally consist of a relatively dense fibrous ring, referred to in this disclosure as the annulus, and several leaflets or coronary cusps attached to the annulus. Generally, the size of the leaflets or coronary cusps may be such that, when the heart contracts, the increase in blood pressure occurring within the corresponding chamber causes the leaflets to open at least partially, thereby allowing flow from the chamber. When the pressure within the chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant, pushing back towards the leaflets. As a result, the leaflets / coronary cusps juxtapose with each other, thereby closing the flow path.

[0015] One of several access routes may be used to manipulate the guidewire and catheter within and around the heart 1 in order to deploy the medical implant of the present invention (e.g., a shunt). For example, access to the superior vena cava (SVC) 15 and right atrium (RA) 5 may be provided via either the subclavian or jugular vein. In another embodiment, the access route may originate from the femoral vein and be introduced into the heart 1 through the inferior vena cava (IVC) 14. Other access routes may also be used, each typically utilizing a percutaneous incision through which the guidewire and catheter are inserted into the vascular system, usually through a sealed introducer, from which the physician controls the distal end of the device from outside the body.

[0016] The pulmonary artery 18 branches into the right pulmonary artery (RPA) 13 and the left pulmonary artery (LPA) 11. Some embodiments of the present disclosure may involve delivering one or more implants (e.g., shunts) to the intersection 19 and / or the intersection between the RPA 13 and the SVC 15. For example, the RPA 13 may extend generally perpendicular to the SVC 15 and / or traverse behind / in front of the SVC 15. In some cases, the RPA 13 may be in contact with the SVC 15, and in other cases, there may be a separation between the RPA 13 and the SVC 15.

[0017] Some embodiments described in the present disclosure include the percutaneous delivery of a shunt and / or compliance system to connect RPA13 to SVC15. Considering that RPA13 and SVC15 are anatomically adjacent, the two intersection 19 regions provide an ideal location for establishing a shunt. Further, since RPA13 has a higher pressure than SVC15, especially in a pulmonary hypertension state, the one-way movement of blood flow is consistently deflected from RPA13 into SVC15. The net result of this shunt is to decompress and reduce the pressure in the main pulmonary artery 18, including the mean systolic pressure and the peak systolic pressure. This reduces the afterload on the right ventricle 4, reduces the amount of work required to eject blood, thereby reducing the compensatory response of the right ventricle 4 to pulmonary hypertension and maintaining ventricular-vascular coupling. The movement (e.g., shunting, moving, and / or exchanging) of fluid (e.g., blood and / or saline) in some embodiments of the present disclosure may occur at all pressures, or the shunt and / or compliance system may be pre-loaded to dynamically move the fluid at an offset pressure. In some cases, the shunt and / or compliance system may or may not significantly reduce the pressure (e.g., in the pulmonary artery 18). The system may be configured to enable the right ventricle 4 to eject a greater amount of blood during contraction. The right ventricle 4 may experience the same peak pressure, but is able to eject more blood because the compliance chamber allows for a greater blood flow.

[0018] Pulmonary hypertension is a rapidly worsening vascular disease associated with a high short-term mortality rate. The primary cause of disease progression is increased pulmonary artery pressure due to decreased vascular compliance. This decreased compliance is caused by several key factors, namely, increased pressure or remodeling of the microcirculation or arteriosclerosis due to systemic inflammation, respectively. Sustained and progressive increases in pulmonary artery pressure lead to dissociation of the right ventricle-vascular junction, thereby preventing the right ventricle from compensating for the increased afterload, which is typically achieved by increased stroke volume and contractility. Once this dissociation occurs, the right ventricle begins to expand with increased filling pressure, which can lead to tricuspid regurgitation and peripheral venous congestion. The combination of decreased antegrade flow and increased posterior pressure transfer results in decreased transpulmonary perfusion, loss of gas exchange, hypoxemia, impaired LV filling, peripheral organ venous congestion, and ultimately heart failure. This invention aims to reduce pulmonary artery pressure (both mean and systolic) associated with increased afterload and work by the right ventricle. By reducing pulmonary artery pressure, embodiments of the present disclosure can preserve right ventricular function, reduce progressive remodeling that occurs, and / or prevent symptoms associated with peripheral venous congestion and insufficient transpulmonary perfusion. Some embodiments may be applicable across multiple types of pulmonary hypertension conditions.

[0019] Multiple examples of the present disclosure relate to various percutaneous shunt methods and / or shunt devices that can be delivered percutaneously to connect different blood flow paths. The disclosure of the present disclosure focuses on the connection and / or shunt between the RPA13 and the SVC15, which is for illustrative purposes, and the embodiments described in the present disclosure can be applied to other regions of the anatomical structure. Since the RPA13 and the SVC15 are anatomically adjacent, the intersection of the RPA13 and the SVC15 can provide an effective location for establishing one or more shunts. Further, since the RPA has a higher pressure than the SVC15, especially in a pulmonary hypertension state, the one-way movement of blood flow is consistently deflected from the RPA13 into the SVC15. The pressure of the RPA13 decreases during diastole, and the pressure of the SVC15 and / or the shunt and / or compliance system described herein can push the conserved blood into the lungs. The net result of this shunt is to reduce and lower the pressure of the main pulmonary artery 18, including the mean systolic pressure and the peak systolic pressure. This reduces the afterload on the right ventricle 4, reduces the amount of work required to eject blood, thereby reducing the compensatory response of the right ventricle 4 to pulmonary hypertension, and maintaining ventricular-vascular coupling. The various shunt methods described in the present disclosure may be performed at any pressure, and / or the various shunt devices described herein may be pre-loaded to shunt dynamically at an offset pressure.

[0020] This disclosure provides methods and devices for shunting blood within the human body, including various medical implants. The term “implant” is used herein in its plain and ordinary sense and may refer to any medical implant, frame, valve, shunt, stent, anchor, and / or similar device for use in treating various conditions of the human body. Implants may be delivered via catheters (i.e., transcatheter) for various medical procedures and may generally have a robust and / or flexible structure. The term “catheter” is used herein in its broad and ordinary sense and may include any tube, sheath, maneuverable sheath, maneuverable catheter, and / or any other type of elongated tubular delivery device having a lumen configured to slidably receive an instrument for purposes such as positioning within the atrium or coronary sinus, including, for example, delivery catheters and / or cannulas.

[0021] Figures 2A and 2B illustrate an arbitrary delivery method for delivering one or more implants described herein. Some of the transcatheter processes described herein can utilize a single catheter 206 or multiple catheters 206. For example, Figure 2A shows an embodiment in which one or more implants can be delivered to the SVC 15 and / or RPA 13 using a first catheter 206a. The first catheter 206a can be delivered to the SVC 15 and / or RPA 13 via any suitable delivery route. For example, the first catheter 206a may be delivered to the right ventricle 4 through the pulmonary valve 9 via the RPA 13 and PA 18, to the right atrium 5 through the tricuspid valve 8, and from the right atrium 5 to the SVC 15. As an additional or alternative configuration, the first catheter 206a may be delivered to the right atrium 5 via the SVC 15, to the right ventricle 4 through the tricuspid valve 8, to the PA 18 through the pulmonary valve 9, and finally to the RPA 13. Regardless of the delivery route used, one or more implants may be delivered in or near the cross region 19 via RPA13 and / or SVC15.

[0022] Figure 2B shows another example in which two catheters, a first catheter 206a and a second catheter 206b, are delivered and / or used simultaneously. The first catheter 206a may be delivered via the SVC 15 and / or into the right atrium 5. The second catheter 206b may be delivered via the RPA 13 and PA 18, through the pulmonary valve 9 to the right ventricle 4, through the tricuspid valve 8 to the right atrium 5, and from the right atrium 5 out of the IVC 14. As an additional or alternative configuration, catheter 206 may be delivered via the IVC 14 to the right atrium 5, through the tricuspid valve 8 to the right ventricle 4, through the pulmonary valve 9 to the PA 18, and finally to the RPA 13. Regardless of which delivery route is used, one or more implants may be delivered in or near the crossing region 19 at the RPA 13 and / or SVC 15.

[0023] One or more catheters 206 may be delivered via transcervical, brachial, subclavian, and / or transfemoral approaches. Within each access point, one or two catheters 206 may be used for delivery. If two catheters 206 are used, the first catheter 206a may be a stent snare catheter and / or the second catheter 206b may be a puncture delivery catheter, or vice versa. In the case of a single catheter system, puncture may be performed and / or one or more implants may be delivered in the SVC 15 to the RPA 13, in one direction or in the other, using the same catheter 206. In some cases, it may be easier to deliver the catheter 206 through the RPA 13 than through the SVC 15 and / or IVC 14.

[0024] The crossing region 19 between RPA13 and SVC15 may provide an appropriate and / or desirable shunt location, at least partially due to the proximity and / or contact between RPA13 and SVC15. In some cases, diverting from RPA13 to SVC15 may be advantageous, particularly in patients with pulmonary hypertension. For example, patients experiencing pulmonary hypertension may experience increased pressure that can support the benefits of an intervascular shunt. In some cases, the amount of disease in the pulmonary circulation may be independent of the left atrium. For example, even if left atrial pressure increases, pulmonary artery pressure may increase without being proportional to left atrial pressure. As another example, pulmonary artery pressure may increase even if left atrial pressure stabilizes. Therefore, an intervascular shunt in patients with pulmonary hypertension may provide an incremental improvement compared to, for example, directly draining pressure from the pulmonary circulation. By draining pressure, right ventricular function can be improved. Once right ventricle begins to deteriorate, survival can rapidly decline. A localized or otherwise altered pressure reduction can significantly reduce the amount of work the right ventricle needs to do to continue pumping blood to the left side of the heart.

[0025] The right side of the heart (e.g., the right ventricle) may not be able to support relatively high loads. In contrast, the left side of the heart may be better suited to supporting large fluctuations in blood volume to itself. Therefore, it may be beneficial to reduce pressure from the right side of the heart and instead moderately increase and / or reorient the pressure to the left side.

[0026] The direction of flow between RPA13 and SVC15 can be determined naturally. For example, the patient's condition (e.g., pulmonary hypertension) may cause the pressure in RPA13 to increase, thus directing the flow from RPA13 to SVC15.

[0027] In some cases, it may be advantageous to insert one or more delivery systems from the RPA13 into the right ventricle 4 to allow for longer-distance routing. This may be particularly advantageous in an RPA13 / SVC15 shunt due to the vertical orientation of the RPA13 and SVC15. One or more delivery systems may be maintained in the right ventricle 4 to provide traceability and support for other delivery systems.

[0028] Examples of specific delivery methods are illustrated in Figures 2A and 2B, but other delivery methods may be used for the exemplary devices described herein. For example, a single catheter 206 may be delivered via SVC15 and / or IVC14. In another embodiment, a first catheter 206a and / or a second catheter 206b may be delivered to SVC15 via RPA13, enabling one or more shunt devices to be delivered from SVC15 to RPA13. Additionally or alternatively, a first catheter 206a and / or a second catheter 206b may be delivered to RPA13 via SVC15, enabling one or more shunt devices to be delivered from RPA13 to SVC15. Lung shunt system

[0029] The embodiments described herein provide devices (e.g., medical implants) and / or methods (e.g., delivery methods) configured to reduce right ventricular afterload in patients having a combination of pre- and post-capillary pulmonary hypertension (CpcPH) due to left heart failure. Some embodiments may be advantageously configured to reduce progression to right ventricular failure. When a patient experiences increased afterload (e.g., right ventricular afterload), the heart (e.g., right ventricle) may be required to overcome the high pressure needed to pump blood to the lungs. Embodiments described herein can reduce health complications in patients by advantageously reducing tissue wall stress (e.g., right ventricular wall) and / or reducing dilation (e.g., right ventricle).

[0030] The pulmonary and systemic circulations generally transport roughly equal volumes of blood. The pulmonary circulation operates at much lower pressures than the systemic circulation. Pulmonary artery pressure is generally low because of the lower resistance and the greater fit of the pulmonary vascular system. The pulmonary arteries, with their two main branches, account for only 15–20% of total pulmonary artery compliance, with the remainder distributed throughout the entire pulmonary artery system.

[0031] Figures 3A and 3B illustrate the delivery of one or more implants and / or systems to exemplary heart 1 for improved compliance, according to one or more embodiments. Some embodiments of this disclosure may describe the placement of one or more implants in SVC15 and / or RPA13, but this is for illustrative purposes only, and exemplary implants may be configured for delivery and / or placement in other vascular and / or cardiac chambers.

[0032] Figure 3A shows the delivery of the shunt 302 and / or fluid transfer and / or exchange device to the SVC15 and / or RPA13. In some embodiments, the shunt 302 may be configured to be delivered via a catheter. A puncture may be generated in the SVC15 and / or RPA13 to accommodate the shunt 302. In some embodiments, the shunt 302 may be configured to extend at least partially into the SVC15 and / or RPA13 and / or across any gap between the SVC15 and RPA13. The shunt 302 may be configured to form a bridge between the SVC15 and RPA13 and / or at least partially pull the SVC15 toward the RPA13 and / or the RPA13 toward the SVC15. The term “shunt” is used in this disclosure in its express and ordinary sense and may refer to any device and / or mechanism configured to allow the movement of fluid (e.g., blood and / or saline) from a first vessel and / or chamber to a second vessel and / or chamber, and / or from the second vessel and / or chamber back to the first vessel and / or chamber. In some embodiments, the fluid passing through the shunt 302 (e.g., from RPA13 to SVC15) may be configured to return through the shunt 302 (e.g., from SVC15 to RPA13). For example, the shunt 302 may include a bladder and / or inflatable body located in the SVC15 and / or configured to be filled with fluid from the RPA13. The shunt 302 may be configured to push the fluid back from the bladder and / or inflatable body and / or into the RPA13.

[0033] Although shunt 302 is described as bridging SVC15 and RPA13, shunt 302 and / or additional shunts may be used as additional or alternative configurations in other anatomical locations, such as as shunts between RPA13 and other venous vessels and / or chambers (e.g., the right atrium).

[0034] In some embodiments, the shunt 302 may be at least partially liquid-tight and / or configured to provide a channel for blood flow between the SVC 15 and the RPA 13. For example, when the blood pressure of the RPA 13 increases (e.g., during systole), blood may be pushed from the RPA 13 through the shunt 302 and / or into the SVC 15. When the blood pressure of the RPA 13 decreases (e.g., during diastole), the blood pushed from the RPA 13 into the SVC 15 may be pushed back into the RPA 13 through the shunt 302 and / or aspirated back.

[0035] Shunt 302 may have any suitable form and / or structure. In some embodiments, shunt 302 may include laser-cut hypotube and / or other devices. Shunt 302 may have at least a partially cylindrical shape and / or have a lumen configured to allow blood flow through the outer frame of shunt 302. In some embodiments, shunt 302 may include a flared end (e.g., a flange) configured to facilitate fixation of shunt 302 to the walls of SVC15 and / or RPA13.

[0036] Shunt 302 may be delivered to a point on SVC15 adjacent to and / or near RPA13, and / or to a point on RPA13 adjacent to and / or near SVC15. For example, a puncture may be performed, and / or shunt 302 may be delivered to the overlap point between SVC15 and RPA13.

[0037] In some embodiments, the shunt 302 may be configured to form a connection and / or bridge between two or more blood vessels and / or chambers. The shunt 302 may be configured to be at least partially located between two or more tissue walls and / or within at least one tissue wall. The shunt 302 may be configured to generate and / or maintain blood flow pathways between and / or through tissue walls. The shunt 302 may be coupled to one or more anchoring mechanisms (e.g., flanges), which may include distal anchoring mechanisms and / or proximal anchoring mechanisms. The shunt 302 may form a generally tubular shape, which may have a set / pre-formed size and / or a variable size.

[0038] The shunt 302 and / or anchor mechanism may be at least partially constructed from any suitable material(s), which may include expandable stainless steel, cobalt-chromium, textile, and / or nitinol. In some embodiments, the shunt 302 and / or anchor mechanism may be expanded via coaxial displacement of the delivery system (e.g., catheter). The shunt effective orifice area (EOA) and / or diameter of the shunt 302 may be configured to support any desired amount of shunting. For example, the shunt 302 may be configured to achieve a minimum reduction in pulmonary artery pressure while maintaining the transpulmonary pressure gradient necessary to facilitate pulmonary perfusion and blood delivery to the left atrium. The length of the shunt EOA and / or shunt 302 may be configured, but are not limited, to maintain pressure reduction across a variety of clinical conditions, including peripheral venous hypertension and exercise.

[0039] Figure 3B illustrates the delivery of the stent 304 and / or similar devices to the SVC15 and / or RPA13. In some embodiments, the stent 304 may be delivered via a catheter. The stent 304 may comprise one or more self-expanding and / or balloon-expandable materials and / or be configured to spontaneously expand outward in the absence of substantial inward forces. In some examples, the stent 304 may be at least partially composed of one or more shape memory alloys, which may comprise nitinol and / or similar materials. The material of the stent 304 may be shaped in a generally open form. For example, the stent 304 may have a lumen that is completely open in the default form of the stent 304. The stent 304 may have walls and / or sides formed from sheets and / or lines of material that can be configured to bend inward in response to outward pressure (e.g., blood pressure).

[0040] The stent 304 may include an intermediate section 313 positioned between the first end 312 and / or the second end 314. The first end 312 and / or the second end 314 may be configured to be firmly fixed to the surrounding tissue and / or to be resistant to deformation. The intermediate section 313 may be configured to be loosely fixed and / or detached from the surrounding tissue, allowing the intermediate section 313 to bend inward in response to external pressure. In some embodiments, the stent 304 may be configured to be delivered adjacent to the shunt 302 and / or adjacent to the puncture site between the SVC 15 and the RPA 13. For example, the intermediate section 313 may be configured to extend across an opening and / or channel formed between the SVC 15 and the RPA 13.

[0041] In some embodiments, stent 304 may be configured for delivery to SVC15, as shown in Figure 3B. However, stent 304 may also be configured for delivery to RRPA13 and / or other blood vessels and / or cardiac chambers.

[0042] The stent 304 may have a substantially cylindrical shape and / or other suitable shape. In some embodiments, the stent 304 may comprise a frame made of one or more shape memory alloys and / or generally rigid materials. The stent 304 may further comprise a cover and / or skirt that at least partially encloses the outer and / or inner surfaces of the frame. The cover may be at least partially liquid-tight and / or configured to capture and / or retain blood that is forced into contact with the cover. In some embodiments, the cover may be configured to extend along the intermediate section 313, the first end 312 and / or the second end 314 of the stent 304.

[0043] Blood passing through the shunt 302 (e.g., from the RPA 13) may push against the cover and / or bend inward around the intermediate section 313 of the stent 304. The first end 312 and / or the second end 314 may be configured to maintain their default shape and / or not bend inward in response to changes in blood pressure. Thus, blood may be held around the intermediate section 413 until the blood is pushed through the shunt 302 (e.g., to the RPA 13) and / or pulled back. In some embodiments, the cover may not be completely liquid-tight and / or may be configured to allow some blood flow through the cover to favorably prevent coagulation and / or thrombus formation due to blood stagnation. Furthermore, the first end 312 and / or the second end 314 may be configured to form a partial seal and / or to allow a controlled amount of blood to leak beyond the stent 304 and / or into the SVC 15.

[0044] SVC15 is a relatively large vessel. Significant levels of compliance can be obtained in the pulmonary artery system by diverting blood to SVC15 from systole to diastole.

[0045] In some embodiments, the shunt 302 and / or stent 304 may be at least partially composed of a braided material, which may include stainless steel, nitinol, and / or other metals, polymers, and / or fibrous materials including flexible and / or braided fibers. The fibrous material may be configured to include shape memory fibers. The shunt 302 and / or stent 304 may be configured to fold to a smaller diameter for delivery while maintaining the flexibility of the shunt 302 and / or stent 304. In some embodiments, the shunt 302 and / or stent 304 may be covered by a tubular sheath (not shown) configured to surround at least a portion of the shunt 302 and / or stent 304, and / or the shunt 302 and / or stent 304 may include a solid tubular material. The sheath may be configured to prevent the implant from expanding from its folded configuration. In some embodiments, additional and / or alternative devices and / or methods may be used to prevent expansion of the shunt 302 and / or stent 304.

[0046] The shunt 302 may be positioned at least partially between the first end 312 and the second end 314. The shunt 302 may form a channel and / or lumen through which blood can flow.

[0047] In some embodiments, the shunt 302 may include one or more flare barbs on the surface facing the lumen of a flange configured to stabilize the shunt 302 by fixing it to a tissue wall. The distal flange and / or proximal flange may include one or more such flare barbs.

[0048] The shunt 302 may be at least partially composed of exposed and / or enclosed metal and / or other material. In some embodiments, the shunt 302 may be exposed in the case of adjacent anatomical structures (e.g., adjacent RPA13 and SVC15), and / or the shunt 302 may be at least partially covered in the case of non-adjacent anatomical structures. For example, a shunt 302 that is at least partially covered may be configured to prevent blood from infiltrating the pleural cavity and / or other anatomical areas.

[0049] In some embodiments, the delivery process for delivering the shunt 302 and / or stent 304 may involve delivery through multiple vessels. For example, the internal jugular vein and the right femoral vein are used for dual access. The shunt 302 and / or stent 304 may be positioned at the end of a transcatheter delivery system that can cross the right atrium and right ventricle and enter the right pulmonary artery. This delivery catheter may or may not have an end-hole or side-hole catheter for injecting contrast agent to confirm its position. In some embodiments, the catheter has one or more articulation points at the distal end of the catheter, allowing manipulation and angulation using a needle at the distal end for puncture. In some embodiments, a loop or snare marker may be provided within the SVC 15 to allow targeted puncture and / or capture of the distal end or wire as needed. The shunt 302 may be configured to extend across the RPA-SVC to be installed, creating a shunt between the RPA 13 and the SVC 15.

[0050] In another embodiment, a coiled wire, snare, or wire marker may be used to traverse the right atrium 5, right ventricle 4, and RPA 13 with imaging guidance. The imaging guidance may be in the form of a catheter having contrast angiography at the end or side hole, a radiopaque tip, a marker band, or an immunogenic tip, or a combination of the above. The marker can mark the RPA 13 site. The delivery catheter is then utilized at SVC 15 from either the femoral vein or internal jugular vein having one or more articular points at the distal end of the delivery catheter to better facilitate targeted puncture of SVC-RPA. With the aid of imaging guidance, SVC 15 and RPA 13 may be punctured by subsequent placement of the device and creation of a shunt.

[0051] In some embodiments, the shunt 302 is positioned at the RPA / SVC junction to effectively reduce the patient's systolic and / or mean pulmonary artery pressure while minimizing the impact on right ventricular function. The RPA 13 and SVC 15 are described herein for illustrative purposes, but the devices may be variable orifice devices.

[0052] Shunt 302 may include a valve shunt composed of various metal alloys and / or plastics. In some embodiments, shunt 302 may include commissure posts configured to support the attachment of tissue valve leaflets. Shunt 302 can be pre-loaded to a specific force level, while the valve leaflet assembly can be pre-formed so that the tissue valve leaflets can close spontaneously under zero pressure gradient and / or small defined pressure gradient.

[0053] The valve leaflets may be hydraulically loaded to deform the shunt 302 so that they can open to form an open opening that allows blood flow. The valve leaflets may be configured to close when the pressure gradient falls below a set pressure or zero.

[0054] Figures 4A to 4C illustrate exemplary shunt systems for diverting blood between a first vessel and / or chamber (e.g., RPA13) and a second vessel and / or chamber (e.g., SVC15) according to one or more embodiments. Figures 4A to 4C provide a cross-sectional side view of SVC15 and a cross-sectional top view of RPA13. In some cases, SVC15 and RPA13 may extend generally orthogonal and / or perpendicular to each other and / or have a single intersection.

[0055] In some embodiments, the system may include a shunt 402 configured to form and / or maintain a flow channel between the RPA13 and SVC15 and / or between other blood vessels and / or chambers. In response to changes in blood pressure, blood may flow through the shunt 402 (e.g., out of the RPA13) and / or into contact with the stent 404 (e.g., into the SVC15) and / or into contact with other implants positioned at least partially within the SVC15. Figure 4A shows the default and / or first state of the shunt system before the movement of blood from the RPA13 to the SVC15. Figure 4B shows a second state of the shunt system where the blood pressure in the RPA13 increases by enough (e.g., during systole) to push excess blood out of the RPA13, through the shunt 402 and / or into the SVC15. In some cases, the blood pressure through the shunt 402 is high enough for blood to move into the stent 404 and / or the intermediate section 413 of the stent 404. Figure 4C shows a third state of the shunt system, illustrating how the blood pressure in the RPA 13 decreases from the increased amount in the second state as the stent 404 recovers to the shape and / or form shown in Figure 4A, allowing blood in the SVC 15 to return through the shunt 402 and / or into the RPA 13. For example, the stent 404 (e.g., at least the middle section 413 of the stent 404) may be at least partially elastic and / or configured to elastically recover to its original shape and / or default shape. The decrease in pressure in the RPA 13 may allow the spring-like material of the stent 404 to push blood back into the RPA 13 and / or towards the lungs.

[0056] In some embodiments, the stent 404 may be at least partially self-expanding and / or at least partially covered. The stent 404 and / or one or more components of the stent 404 may be radially sealed to prevent blood leakage. For example, blood entering the SVC 15 through the shunt 402 may be sealed between the first end 412 and the second end 414 of the stent 404. The first end 412 and / or the second end 414 may be configured to expand to a diameter and / or width equal to and / or greater than the diameter and / or width of the SVC 15. Thus, the first end 412 and / or the second end 414 may expand to contact the wall of the SVC 15. In some embodiments, the first end 412 and / or the second end 414 may be configured to improve sealing and / or fixation of the first end 412 and / or the second end 414 for tissue growth at the first end 412 and / or the second end 414. For example, the first end 412 and / or the second end 414 may include a coating configured to promote internal tissue growth around the first end 412 and / or the second end 414. In another embodiment, the first end 412 and / or the second end 414 may include one or more barbs and / or needles configured to penetrate the surrounding tissue and promote internal tissue growth around the first end 412 and / or the second end 414.

[0057] During systole, the pressure in RPA13 rises above the pressure in SVC15, which may cause stent 404 to be at least partially compressed. Compression of stent 404 can add compliance to the pulmonary artery and / or reduce the afterload of the right ventricle. During diastole, the pressure in RPA13 decreases. As a result, the spring force of stent 404 (e.g., the shaping components of stent 404) can cause stent 404 to expand radially and / or shunt blood back into RPA13 and into the lungs.

[0058] In some embodiments, the stent 404 may be at least partially covered. For example, at least the inner and / or outer surfaces of the intermediate section 413 of the stent 404 may be provided with a frame that is at least partially surrounded by a cover. The cover can be made from a variety of suitable materials, including one or more polymers, elastomers, and / or textiles.

[0059] The cover does not have to be completely liquid-tight and / or may be at least partially permeable. In some embodiments, the cover may be configured to allow controlled leakage of blood through the cover and / or into the SVC15. Leakage of blood through the cover may prevent thrombus and / or shunt volume from RPA13 to SVC15. The cover may be configured to be at least partially liquid-tight and / or to prevent a sufficient amount of leakage in response to trapped blood adjacent to the stent 404 so that the stent 404 can be at least partially compressed.

[0060] The first end 412 and / or the second end 414 may be configured to include one or more covered and / or coated self-expanding materials. For example, the first end 412 and / or the second end 414 may have a self-expanding and / or balloon-expandable implant that is at least partially covered with one or more textiles and / or other suitable materials.

[0061] The configuration may involve forming a puncture in the SVC15 and / or RPA13 to accommodate the shunt 402. In some embodiments, the shunt 402 may be configured to extend at least partially within the SVC15 and / or RPA13 and / or across any gap between the SVC15 and RPA13. The shunt 402 may be configured to form a bridge between the SVC15 and RPA13 and / or at least partially pull the SVC15 toward the RPA13 and / or the RPA13 toward the SVC15.

[0062] Although shunt 402 is described as bridging SVC15 and RPA13, shunt 402 and / or additional shunts may be used as additional or alternative configurations in other anatomical locations, such as as shunts between RPA13 and other venous vessels and / or chambers (e.g., the right atrium).

[0063] In some embodiments, the shunt 402 may be at least partially liquid-tight and / or configured to provide a channel for blood flow between the SVC 15 and the RPA 13. For example, when the blood pressure of the RPA 13 increases (e.g., during systole), blood may be pushed from the RPA 13 through the shunt 402 and / or into the SVC 15. When the blood pressure of the RPA 13 decreases (e.g., during diastole), the blood pushed from the RPA 13 into the SVC 15 may be pushed back into the RPA 13 through the shunt 402 and / or aspirated back.

[0064] Shunt 402 may have any suitable form and / or structure. In some embodiments, shunt 402 may include laser-cut hypotube and / or other devices. Shunt 402 may have at least a partially cylindrical shape and / or have a lumen configured to allow blood flow through the outer frame of shunt 402. In some embodiments, shunt 402 may include a flared end 415 (e.g., a flange) configured to facilitate fixation of shunt 402 to the walls of SVC15 and / or RPA13.

[0065] Shunt 402 may be delivered to a point on SVC15 adjacent to and / or near RPA13, and / or to a point on RPA13 adjacent to and / or near SVC15. For example, a puncture may be performed, and / or shunt 402 may be delivered to the overlap point between SVC15 and RPA13.

[0066] In some embodiments, the stent 404 may be delivered via a catheter. The stent 404 may comprise one or more self-expanding and / or balloon-expandable materials and / or be configured to spontaneously expand outward in the absence of substantial inward forces. In some embodiments, the stent 404 may be at least partially composed of one or more shape memory alloys, which may comprise nitinol and / or similar materials. The material of the stent 404 may be shaped in a generally open form. For example, the stent 404 may have a lumen that is completely open in the default form of the stent 404. The stent 404 may comprise walls and / or sides formed from sheets and / or lines of material that can be configured to bend inward in response to outward pressure (e.g., blood pressure).

[0067] The stent 404 may include an intermediate section 413 positioned between a first end 412 and / or a second end 414. The first end 412 and / or the second end 414 may be configured to be firmly fixed to the surrounding tissue and / or to be resistant to deformation. The intermediate section 413 may be configured to be loosely fixed and / or detached from the surrounding tissue, allowing the intermediate section 413 to bend inward in response to external pressure. In some embodiments, the stent 404 may be configured to be delivered adjacent to the shunt 402 and / or adjacent to the puncture site between the SVC 15 and the RPA 13. For example, the intermediate section 413 may be configured to extend across an opening and / or channel formed between the SVC 15 and the RPA 13.

[0068] In some embodiments, stent 404 may be configured for delivery to SVC15. However, stent 404 may also be configured for delivery to RPA13 and / or other blood vessels and / or cardiac chambers.

[0069] The stent 404 may have a substantially cylindrical shape and / or other suitable shape. In some embodiments, the stent 404 may comprise a frame made of one or more shape memory alloys and / or generally rigid materials. The stent 404 may further comprise a cover and / or skirt that at least partially encloses the outer and / or inner surfaces of the frame. The cover may be at least partially liquid-tight and / or configured to capture and / or retain blood that is forced into contact with the cover. In some embodiments, the cover may be configured to extend along the intermediate section 413, the first end 412 and / or the second end 414 of the stent 404.

[0070] Blood passing through the shunt 402 (e.g., from the RPA 13) may push against the cover and / or bend inward around the intermediate section 413 of the stent 404. The first end 412 and / or the second end 414 may be configured to retain their default shape and / or not bend inward in response to changes in blood pressure. Thus, blood may be held around the intermediate section 413 until the blood is pushed through the shunt 402 (e.g., to the RPA 13) and / or pulled back. In some embodiments, the cover may not be completely liquid-tight and / or may be configured to allow some blood flow through the cover to favorably prevent coagulation and / or thrombus formation due to blood stagnation.

[0071] The stent 404 (e.g., a deformable device, a deformable balloon, a deformable stent, an expandable balloon, an expandable stent, etc.) may be configured to elastically deform in response to an increase in blood flow and / or blood pressure. For example, the stent 404 may be configured to extend and / or deform from a substantially cylindrical shape to an hourglass and / or inwardly curved shape. The stent 404 may be configured to elastically and / or spontaneously return to a substantially cylindrical shape in response to a decrease in blood flow and / or blood pressure.

[0072] The system may be configured to provide a liquid-tight seal and / or prevent flow between the RPA13 and SVC15 outside the stent 404 and / or shunt 402. The stent 404 and / or shunt 402 may include an anchor frame and / or a liquid-tight and / or fluid-preventing cover. The frame(s) may be attached to the cover by stitching, suturing, and / or other means. The seal formed by the system can facilitate the filling and / or compression of the stent 404 and / or expandable device and / or minimize undesirable changes in blood flow caused by excessive blood flow between the RPA13 and SVC15. The stent 404 and / or shunt 402 may be configured to extend coplanar and / or closely along and / or around the original tissue wall to minimize the gap between the system and the original tissue.

[0073] The stent 404 may be at least partially elastic and / or have an elastic configuration. In some embodiments, the stent 404 may be configured to store energy when the stent 404 is deformed from its default state to a compressed and / or expanded state. For example, when the stent 404 is deformed, the stent 404 may spontaneously store potential energy to spontaneously extend back to its default form when the deformation force is removed. The stent 404 may extend at least partially within the SVC 15 and / or the energy stored in the stent 404 may be stored at least partially within the SVC 15.

[0074] The deformation of stent 404 may be configured to reduce and / or reduce blood flow through SVC15. For example, blood flow from RPA13 into and / or to stent 404 may spread stent 404 into and / or throughout SVC15, thereby obstructing blood flow through SVC15 at least partially. In some embodiments, stent 404 may be configured to diametrically bifurcate SVC15. Thus, an increase in blood pressure in RPA13 may reduce blood flow in SVC15 through the use of the system.

[0075] Figure 5 provides a side view of another exemplary shunt system for diverting blood between a first vessel and / or chamber (e.g., RPA13) and a second vessel and / or chamber (e.g., SVC15), according to one or more embodiments. The system may include a shunt 502 configured to direct blood flow from the RPA13 toward an intermediate section 513 of a stent 504 located in the SVC15. The intermediate section 513 may be located between the first end 512 and / or the second end 514 of the stent 504. In some embodiments, the intermediate section 513 may be configured to compress at least partially in response to an increase in blood pressure flowing from the RPA13 to the SVC15. However, one or more portions of the intermediate section 513 may be configured not to compress in response to an increase in blood pressure. For example, the intermediate section 513 may be configured to compress at the first side 507 adjacent to the shunt 502 and / or RPA 13, and / or the other sides of the intermediate section 513 may be configured to maintain their default shape in response to increased pressure. For example, the first side 507 may have a thinner and / or more flexible structure than the other sides and / or parts of the intermediate section 513. Similarly, the first end 512 and / or the second end 514 may not be configured to compress and / or move in response to increased blood pressure. For example, the first end 512 and / or the second end 514 may contain a thicker and / or different material than the first side 507 of the intermediate section 513.

[0076] In some embodiments, the shunt 502 may include a flared end 515 (e.g., a flange) configured to facilitate the attachment of the shunt 502 to the wall of the SVC15 and / or RPA13.

[0077] Figure 6 shows an example of a compliance system 601 for shunting, moving, and / or exchanging fluid (e.g., blood and / or saline) between a first vessel and / or chamber (e.g., RPA13) and a second vessel and / or chamber (e.g., SVC15), according to one or more embodiments. The shunt system 601 may comprise a shunt 602 and / or shunt portion, and / or an expandable and / or deformable device 604 and / or expandable portion. In some embodiments, the expandable device 604 may comprise a fitted bladder and / or tube configured to be positioned in the SVC15 and / or right atrium. The expandable device 604 may be configured to add compliance to the pulmonary artery and / or reduce the afterload of the right ventricle. In some embodiments, the expandable device 604 may be configured to expand, compress, and / or deform in response to blood pressure. In some embodiments, the shunt 602 may be configured to temporarily transfer and / or exchange fluid (e.g., blood and / or saline solution) between a first blood vessel and / or chamber and a second blood vessel and / or chamber.

[0078] The expandable device 604 may be attached to the shunt 602 and / or extend from the shunt 602. However, the expandable device and the shunt 602 may be separate devices and / or disconnected in some embodiments. The expandable device 604 may be configured to receive blood flow from the RPA 13 via the shunt 602 and / or expand in response to blood flow. Additionally or alternatively, the device 604 may be configured to receive saline and / or other fluids contained within the shunt 602. For example, the shunt 602 may be configured to include a liquid-tight container containing saline and / or other fluids configured to move between a first portion of the shunt 602 located in the RPA 13 and / or a second portion of the shunt 602 (e.g., the device 604) located in the SVC 15. As the expandable device 604 expands, it may be configured to extend further into the SVC 15 and / or occupy an increased portion of the SVC 15. The shunt 602 may include a bladder and / or an inflatable and / or expandable device, which is at least partially located within the RPA 13 and / or configured to exchange fluid (e.g., saline solution) with an expandable device 604 (e.g., a bladder).

[0079] In some embodiments, the expandable device 604 may be at least partially composed of one or more expandable and / or stretchable materials to allow the size and / or shape of the expandable device 604 to change in response to blood flow. The expandable device 604 may be configured to fold and / or compress in the absence of blood flow to the expandable device 604. In response to blood flow to the expandable device 604, the expandable device 604 may be configured to be taught and / or stretch. The device 604 may be at least partially elastic and / or configured to be elastic enough to generate a rebound in response to expansion and / or to push fluid out of the device 604.

[0080] In some embodiments, the system may include a shunt 602 configured to form and / or maintain a flow channel between the RPA13 and SVC15 and / or between other blood vessels and / or chambers. In response to changes in blood pressure, the system may be configured to allow blood to flow through the shunt 602 (e.g., out of the RPA13) and / or into an expandable device 604 (e.g., inside the SVC15) and / or into other implants positioned at least partially inside the SVC15.

[0081] In some embodiments, the expandable device 604 may be configured to expand at least partially and / or be at least partially covered. For example, the expandable device 604 may comprise a frame at least partially composed of one or more shape memory alloys (e.g., Nitinol), and / or the frame may be at least partially surrounded by one or more covers. The cover(s) may be made from a variety of suitable materials, including one or more polymers, elastomers, and / or textiles.

[0082] During systole, the pressure in the RPA13 rises above the pressure in the SVC15, which may cause the expandable device 604 to inflate at least partially. The inflation of the expandable device 604 can add compliance to the pulmonary artery and / or reduce the right ventricular afterload. During diastole, the pressure in the RPA13 decreases. As a result, the spring force of the expandable device 604 (e.g., the shaping components of the expandable device 604) may cause the expandable device 604 to compress and / or shunt blood back into the RPA13 and lungs.

[0083] The cover does not have to be completely liquid-tight. In some embodiments, the cover may be configured to allow controlled leakage of blood through the cover and / or into the SVC15. Leakage of blood through the cover may prevent thrombus and / or shunt volume from RPA13 to SVC15. The cover may be configured to be at least partially liquid-tight and / or to prevent a sufficient amount of leakage so that the expandable device 604 can be at least partially compressed in response to trapped blood adjacent to the expandable device 604.

[0084] The configuration may involve forming a puncture in the SVC15 and / or RPA13 to accommodate the shunt 602. In some embodiments, the shunt 602 may be configured to extend at least partially within the SVC15 and / or RPA13 and / or across any gap between the SVC15 and RPA13. The shunt 602 may be configured to form a bridge between the SVC15 and RPA13 and / or at least partially pull the SVC15 toward the RPA13 and / or the RPA13 toward the SVC15.

[0085] Although shunt 602 is described as bridging SVC15 and RPA13, shunt 602 and / or additional shunts may be used as additional or alternative configurations in other anatomical locations, such as as shunts between RPA13 and other venous vessels and / or chambers (e.g., the right atrium).

[0086] In some embodiments, the shunt 602 may be at least partially liquid-tight and / or configured to provide a channel for blood flow between the SVC15 and the RPA13. For example, when the blood pressure of the RPA13 increases (e.g., during systole), blood may be pushed from the RPA13 through the shunt 602 and / or into the SVC15. When the blood pressure of the RPA13 decreases (e.g., during diastole), the blood pushed from the RPA13 into the SVC15 may be pushed back into the RPA13 through the shunt 602 and / or aspirated back.

[0087] Shunt 602 may have any suitable form and / or structure. In some embodiments, shunt 602 may include laser-cut hypotube and / or other devices. Shunt 602 may have at least a partially cylindrical shape and / or have a lumen configured to allow blood flow through the outer frame of shunt 602. In some embodiments, shunt 602 may include a flared end 615 (e.g., a flange) configured to facilitate fixation of shunt 602 to the walls of SVC15 and / or RPA13.

[0088] Shunt 602 may be delivered to a point on SVC15 adjacent to and / or near RPA13, and / or to a point on RPA13 adjacent to and / or near SVC15. For example, a puncture may be performed, and / or shunt 602 may be delivered to the overlapping point between SVC15 and RPA13.

[0089] In some embodiments, the expandable device 604 may be delivered via a catheter. The expandable device 604 may comprise one or more self-expanding and / or balloon-expandable materials and / or may be configured to expand spontaneously outward in the absence of substantial inward forces. In some embodiments, the expandable device 604 may comprise at least partially one or more shape memory alloys, which may comprise nitinol and / or similar materials.

[0090] In some embodiments, the expandable device 604 may be configured for delivery to the SVC15. However, the expandable device 604 may also be configured for delivery to the RPA13 and / or other blood vessels and / or cardiac chambers.

[0091] In some embodiments, the expandable device 604 may comprise a frame made of one or more shape memory alloys and / or generally rigid materials. The expandable device 604 may further comprise a cover and / or skirt that at least partially encloses the outer and / or inner surfaces of the frame. The cover may be at least partially liquid-tight and / or configured to capture and / or retain blood that is pressed into contact with the cover.

[0092] Blood passing through the shunt 602 (e.g., from the RPA 13) may press against the cover and / or stretch the expandable device 604 outward. In some embodiments, the cover may not be completely liquid-tight and / or may be configured to allow some blood flow through the cover to advantageously prevent coagulation and / or thrombus formation due to blood stagnation.

[0093] The system may be configured to provide a liquid-tight seal and / or prevent flow between the RPA13 and SVC15 outside the expandable device 604 and / or shunt 602. The expandable device 604 and / or shunt 602 may include an anchor frame and / or a liquid-tight and / or fluid-proof cover. The frame(s) may be attached to the cover by stitching, suturing, and / or other means. The seal formed by the system can facilitate filling and / or compression of the expandable device 604 and / or the expandable device and / or minimize undesirable changes in blood flow caused by excessive blood flow between the RPA13 and SVC15. The expandable device 604 and / or shunt 602 may be configured to extend coplanar and / or closely along and / or around the original tissue wall to minimize the gap between the system and the original tissue.

[0094] The expandable device 604 may be at least partially elastic and / or have an elastic configuration. In some embodiments, the expandable device 604 may be configured to store energy when the expandable device 604 is deformed from its default state to a compressed and / or expanded state. For example, when the expandable device 604 is deformed, it may spontaneously store potential energy to spontaneously extend back to its default form when the deformation force is removed. The expandable device 604 may extend at least partially within the SVC 15 and / or the energy stored in the expandable device 604 may be at least partially stored within the SVC 15.

[0095] The deformation of the expandable device 604 may be configured to reduce and / or reduce blood flow through the SVC 15. For example, blood flow from the RPA 13 into and / or to the expandable device 604 may extend the expandable device 604 into and / or throughout the SVC 15, thereby obstructing blood flow through the SVC 15 at least partially. In some embodiments, the expandable device 604 may be configured to diametrically bifurcate the SVC 15. Thus, an increase in blood pressure in the RPA 13 may reduce blood flow in the SVC 15 through the use of the system.

[0096] Figure 7 shows an example of a compliance system 701 for the diversion, movement, and / or exchange of fluid (e.g., blood and / or saline) between a first vessel and / or chamber (e.g., RPA13) and a second vessel and / or chamber (e.g., SVC15), according to one or more embodiments. The shunt system 701 may comprise a shunt 702 and / or shunt portion, and / or an expandable device 704 and / or expandable portion. In some embodiments, the expandable device 704 may comprise a fitted bladder and / or tube configured to be positioned within the SVC15 and / or right atrium 5. The expandable device 704 may be configured to add compliance to the pulmonary artery and / or reduce the afterload of the right ventricle.

[0097] The expandable device 704 may be attached to the shunt 702 and / or extend from the shunt 702. However, the expandable device and the shunt 702 may be separate devices and / or disconnected in some embodiments. The expandable device 704 may be configured to receive blood flow from the RPA 13 via the shunt 702 and / or expand in response to blood flow. As the expandable device 704 expands, it may be configured to extend further into the SVC 15 and / or out of the SVC 15 and / or descend into the right atrium 5. In some embodiments, the expandable device 704 may be configured to extend deeper and / or further in a first direction (e.g., downward and / or toward the right atrium 5) than in a second direction (e.g., upward and / or away from the right atrium 5). For example, the expandable device 704 may be shaped to facilitate expansion in a desired direction and / or may be configured to move in response to gravity and / or blood flow.

[0098] Expanding the expandable device 704 into the right atrium 5 is advantageous in that it allows for greater expandability of the expandable device 704. For example, the right atrium 5 may provide a larger volume and / or space for the expandable device 704 to fill. In this way, limitations from the SVC 15 and / or other anatomical features may be minimized. Furthermore, expanding the expandable device 704 out of the SVC 15 and / or into the right atrium 5 may minimize blockage and / or obstruction of the SVC 15 by the expandable device 704.

[0099] In some embodiments, the expandable device 704 may be at least partially composed of one or more expandable and / or stretchable materials to allow the size and / or shape of the expandable device 704 to change in response to blood flow. The expandable device 704 may be configured to fold and / or compress in the absence of blood flow to the expandable device 704. In response to blood flow to the expandable device 704, the expandable device 704 may be configured to be taught and / or stretched.

[0100] In some embodiments, the system may include a shunt 702 configured to form and / or maintain a flow channel between the RPA13 and SVC15 and / or between other blood vessels and / or chambers. In response to changes in blood pressure, the system may be configured to allow blood to flow through the shunt 702 (e.g., out of the RPA13) and / or into an expandable device 704 (e.g., inside the SVC15) and / or into other implants positioned at least partially inside the SVC15.

[0101] In some embodiments, the expandable device 704 may be configured to be at least partially self-expanding and / or at least partially covered. For example, the expandable device 704 may comprise a frame at least partially composed of one or more shape memory alloys (e.g., Nitinol), and / or the frame may be at least partially surrounded by one or more covers. The cover(s) may be made from a variety of suitable materials, including one or more polymers, elastomers, and / or textiles.

[0102] During systole, the pressure in the RPA13 rises above the pressure in the SVC15, which may cause the expandable device 704 to expand at least partially. The expansion of the expandable device 704 can add compliance to the pulmonary artery and / or reduce the afterload of the right ventricle. During diastole, the pressure in the RPA13 decreases. As a result, the spring force of the expandable device 704 (e.g., the shaping components of the expandable device 704) may cause the expandable device 704 to compress and / or shunt blood back into the RPA13 and into the lungs. The expandable device 704 may be at least partially elastic and / or configured to store potential energy in response to deformation (e.g., caused by increased blood pressure and / or flow in and around the expandable device 704). Thus, the device 704 may be configured to convert increased blood flow in the RPA13 into stored energy and / or increase compliance in the SVC15 and / or other vessels.

[0103] The cover does not have to be completely liquid-tight. In some embodiments, the cover may be configured to allow controlled leakage of blood through the cover and / or into the SVC15. Leakage of blood through the cover may prevent thrombus and / or shunt volume from RPA13 to SVC15. The cover may be configured to be at least partially liquid-tight and / or to prevent a sufficient amount of leakage so that the expandable device 704 can be at least partially compressed in response to trapped blood adjacent to the expandable device 704.

[0104] The configuration may involve forming a puncture in the SVC15 and / or RPA13 to accommodate the shunt 702. In some embodiments, the shunt 702 may be configured to extend at least partially within the SVC15 and / or RPA13 and / or across any gap between the SVC15 and RPA13. The shunt 702 may be configured to form a bridge between the SVC15 and RPA13 and / or at least partially pull the SVC15 toward the RPA13 and / or the RPA13 toward the SVC15.

[0105] Although shunt 702 is described as bridging SVC15 and RPA13, shunt 702 and / or additional shunts may be used as additional or alternative configurations in other anatomical locations, such as as shunts between RPA13 and other venous vessels and / or chambers (e.g., right atrium 5).

[0106] In some embodiments, the shunt 702 may be at least partially liquid-tight and / or configured to provide a channel for blood flow between the SVC15 and the RPA13. For example, when the blood pressure of the RPA13 increases (e.g., during systole), blood may be pushed from the RPA13 through the shunt 702 and / or into the SVC15. When the blood pressure of the RPA13 decreases (e.g., during diastole), the blood pushed from the RPA13 into the SVC15 may be pushed back into the RPA13 through the shunt 702 and / or aspirated back.

[0107] Shunt 702 may have any suitable form and / or structure. In some embodiments, shunt 702 may include laser-cut hypotube and / or other devices. Shunt 702 may have at least a partially cylindrical shape and / or have a lumen configured to allow blood flow through the outer frame of shunt 702. In some embodiments, shunt 702 may include a flared end 715 (e.g., a flange) configured to facilitate fixation of shunt 702 to the walls of SVC15 and / or RPA13.

[0108] Shunt 702 may be delivered to a point on SVC15 adjacent to and / or near RPA13, and / or to a point on RPA13 adjacent to and / or near SVC15. For example, a puncture may be performed, and / or shunt 702 may be delivered to the overlap point between SVC15 and RPA13.

[0109] In some embodiments, the expandable device 704 may be delivered via a catheter. The expandable device 704 may comprise one or more self-expanding and / or balloon-expandable materials and / or may be configured to expand spontaneously outward in the absence of substantial inward forces. In some embodiments, the expandable device 704 may comprise at least partially one or more shape memory alloys, which may comprise nitinol and / or similar materials.

[0110] The expandable device 704 (e.g., deformable device, deformable balloon, deformable stent, expandable balloon, expandable stent, etc.) may be configured to elastically deform in response to an increase in blood flow and / or blood pressure (e.g., within the RPA13). For example, the expandable device 704 may be configured to expand and / or deform from a smaller and / or contracted form to an expanded and / or spherical and / or elliptical form. The expandable device 704 may be configured to elastically and / or spontaneously return to a smaller and / or contracted form in response to a decrease in blood flow and / or blood pressure (e.g., within the RPA13).

[0111] In some embodiments, the expandable device 704 may be configured for delivery to the SVC15. However, the expandable device 704 may also be configured for delivery to the RPA13 and / or other blood vessels and / or cardiac chambers.

[0112] In some embodiments, the expandable device 704 may comprise a frame made of one or more shape memory alloys and / or generally rigid materials. The expandable device 704 may further comprise a cover and / or skirt that at least partially encloses the outer and / or inner surfaces of the frame. The cover may be at least partially liquid-tight and / or configured to capture and / or retain blood that is pressed into contact with the cover.

[0113] Blood passing through the shunt 702 (e.g., from the RPA 13) may press against the cover and / or stretch the expandable device 704 outward. In some embodiments, the cover may not be completely liquid-tight and / or may be configured to allow some blood flow through the cover to advantageously prevent coagulation and / or thrombus formation due to blood stagnation.

[0114] Figure 8 provides a flowchart illustrating an exemplary process 800 for the delivery of one or more shunt implants and / or shunt systems described herein. The steps of process 800 may be performed in any suitable order, and / or steps may be added and / or omitted as needed.

[0115] In step 802, process 800 includes creating openings in the SVC and / or RPA. In some embodiments, a first opening in the SVC may be created at a point in the wall of the SVC that intersects and / or overlaps with the RPA. Similarly, a second opening in the RPA may be created at a point in the wall of the RPA that intersects and / or overlaps with the SVC. The SVC and / or RPA may be accessed by any suitable means, and / or openings may be created in a single step or in multiple steps.

[0116] In step 804, process 800 includes inserting the shunt through the created opening(s) and / or extending the shunt between the SVC and the RPA. In some embodiments, the shunt may be configured to be located at least partially within the SVC and / or at least partially within the RPA. The shunt may extend across the gap between the SVC and the RPA. In some embodiments, the shunt may have flared ends and / or various anchoring mechanisms to facilitate securing the shunt in place.

[0117] In step 806, process 800 includes the delivery of an expandable device and / or implant adjacent to the shunt. In some embodiments, the expandable device may be delivered to the SVC. In another configuration, the expandable device may be delivered to the RPA.

[0118] The expandable device may comprise a self-expandable and / or balloon-expandable stent and / or similar device, and / or an inflatable and / or expandable balloon and / or similar device. The expandable device may have a cylindrical, spherical, elliptical, and / or other suitable shape. The expandable device may be configured to inflate and / or compress by the blood flow passing through the shunt. In some embodiments, the expandable device may be configured to generally prevent blood flow from the RPA from leaking beyond the expandable device. For example, the expandable device may be configured to hold the majority of the blood passing through the shunt within the expandable device (e.g., as an inflatable balloon). In another embodiment, the expandable device may be configured to hold the majority of the blood passing through the shunt around an intermediate section of the expandable device, and / or the expandable device may have ends configured to substantially prevent blood flow above or below the expandable device. In some embodiments, the expandable device may be at least partially porous and / or configured to allow at least partial blood leakage through the expandable device.

[0119] In step 808, process 800 includes securing the expandable device adjacent to the shunt and / or adjacent to the opening created by the SVC and / or RPA. In some embodiments, the expandable device may be configured to be attached to the shunt. For example, the expandable device and / or the shunt may have one or more hooks configured to mate with corresponding hooks and / or components of the expandable device and / or the shunt. However, the expandable device may be configured to be secured independently adjacent to the shunt. In some embodiments, the expandable device may include one or more anchoring elements, which may include hooks, needles, pins, and / or sealing materials. The expandable device may be configured to expand in contact with the surrounding tissue wall to securely fix the expandable device in place.

[0120] The expandable device may be fixed to one and / or both sides of the shunt. For example, the shunt may be configured to supply blood flow toward an intermediate section of the expandable device, and / or the expandable device may have a first end and / or second end on either side and / or both sides of the intermediate section, configured to substantially capture and / or contain blood in or near the intermediate section and / or between the first and second ends. The delivery system (e.g., a catheter) may be removed from the body while the shunt and / or expandable device remain fixed.

[0121] Additional explanation of the examples A list of examples is provided below, each of which may include any aspect of any other example disclosed herein. Furthermore, any aspect of any example described above may be implemented in any of the numbered examples provided below. Various exemplary medical sheaths and / or delivery methods are described herein. Some of the examples described herein may be used in combination and / or independently.

[0122] Example 1: A shunt system comprising a shunt configured to maintain a blood flow pathway between a first blood vessel and a second blood vessel, and a deformable device configured to elastically deform in response to blood flow through the shunt.

[0123] Example 2: The shunt system according to any embodiment of this specification, in particular Example 1, wherein the shunt is removed from the deformable device.

[0124] Example 3: Any embodiment of this specification, in particular the shunt system according to Example 1, wherein the shunt is configured to be attached to the deformable device.

[0125] Example 4: Any embodiment of this specification, particularly the shunt system according to Example 1, wherein the deformable device includes a stent.

[0126] Example 5: The shunt system according to any embodiment of this specification, particularly Example 4, wherein the stent is at least partially surrounded by a cover.

[0127] Example 6: The shunt system according to any embodiment of this specification, in particular Example 5, wherein the cover is substantially liquid-tight.

[0128] Example 7: The shunt system according to any embodiment of this specification, in particular Example 6, wherein the cover is configured to allow some blood flow through the cover.

[0129] Example 8: A shunt system according to any embodiment of the Specified, particularly Example 4, wherein the stent has a cylindrical shape.

[0130] Example 9: A shunt system according to any embodiment of this specification, particularly the shunt system according to Example 4, wherein the stent comprises an intermediate section positioned between a first end and a second end.

[0131] Example 10: The shunt system according to any embodiment of this specification, in particular Example 9, wherein the intermediate section is configured to bend inward in response to an increase in blood pressure passing through the shunt.

[0132] Example 11: The shunt system according to any embodiment of this specification, in particular Example 10, wherein the intermediate section is configured to return to a default configuration in response to a decrease in blood pressure passing through the shunt.

[0133] Example 12: The shunt system according to any embodiment of this specification, in particular Example 9, wherein the first end is at least partially surrounded by a sealing material.

[0134] Example 13: A shunt system according to any embodiment of this specification, particularly the shunt system according to Example 12, wherein the sealing material is configured to promote tissue growth.

[0135] Example 14: A shunt system according to any embodiment of this specification, particularly the shunt system according to Example 9, wherein the first end is configured not to deform in response to blood flow through the shunt.

[0136] Example 15: A shunt system according to any embodiment of this specification, particularly the shunt system according to Example 9, wherein the second end is configured not to deform in response to blood flow through the shunt.

[0137] Example 16: A shunt system according to any embodiment of this specification, particularly the shunt system according to Example 9, wherein the intermediate section is configured to be elastically deformable on a first side surface and not elastically deformable on a second side surface opposite to the first side surface.

[0138] Example 17: The shunt system according to any embodiment of this specification, in particular Example 1, wherein the deformable device is configured to expand with blood flow through the shunt.

[0139] Example 18: Any embodiment of the Specified, particularly the shunt system according to Example 1, wherein the deformable device is elliptical.

[0140] Example 19: A method comprising: percutaneously delivering a shunt to a first vessel near the intersection between a first vessel and a second vessel; passing the shunt at least partially through the vessel wall of the first vessel until the shunt enters the second vessel; and percutaneously delivering a deformable device into the first vessel near the intersection between the first vessel and the second vessel, wherein the deformable device is configured to elastically deform in response to blood flow through the shunt.

[0141] Example 20: The method according to any embodiment of this specification, in particular Example 19, wherein the shunt is removed from the deformable device.

[0142] Example 21: Any embodiment of this specification, in particular the method of Example 19, wherein the shunt is configured to be attached to a deformable device.

[0143] Example 22: Any embodiment of this specification, particularly the method of Example 19, wherein the deformable device includes a stent.

[0144] Example 23: The method according to any embodiment of this specification, particularly the method of Example 22, wherein the stent is at least partially surrounded by a cover.

[0145] Example 24: The method according to any embodiment of this specification, particularly the method according to Example 23, wherein the cover is substantially liquid-tight.

[0146] Example 25: The method according to any embodiment of this specification, in particular Example 24, wherein the cover is configured to allow some blood flow through the cover.

[0147] Example 26: Any embodiment of this specification, particularly the method of Example 22, wherein the stent includes an intermediate section positioned between a first end and a second end.

[0148] Example 27: Any embodiment of this specification, in particular the method of Example 26, wherein the intermediate section is configured to bend inward in response to an increase in blood pressure passing through the shunt.

[0149] Example 28: Any embodiment of this specification, particularly the method of Example 26, wherein the intermediate section is configured to be elastically deformable on a first side surface and not elastically deformable on a second side surface opposite to the first side surface.

[0150] Example 29: Any embodiment of this specification, in particular the method of Example 19, wherein the deformable device is configured to expand with blood flow through the shunt.

[0151] Example 30: Any embodiment of this specification, in particular the method described in Example 19, wherein the deformable device is elliptical.

[0152] Depending on the embodiment, any particular action, event, or function of any of the processes or algorithms described herein may be performed in a different order, added, merged, or completely omitted. Therefore, in a particular embodiment, not all described actions or events are necessary for the practice of the process.

[0153] In particular, conditional language used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” is intended in its ordinary sense unless otherwise stated or understood differently in the context in which it is used, and is generally intended to convey that a particular embodiment includes a particular configuration, element, and / or step, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that the configuration, element, and / or step is required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these configurations, elements, and / or steps are included or performed in any particular embodiment. Terms such as “comprising,” “including,” and “having” are synonymous and are used in their ordinary sense, comprehensively and non-restrictively, without precluding additional elements, functions, actions, etc. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense), for example, when used to connect a list of elements, so that the term "or" can mean one, some, or all of the elements in the list. Connecting phrases such as "at least one of X, Y, and Z" are understood in context to be used to generally convey that an item, term, element, etc., may be any of X, Y, or Z, unless otherwise specified. Thus, such connecting phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0154] In the above descriptions of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various embodiments of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more functionality than is expressly described in that claim. Furthermore, any component, configuration, or step illustrated and / or described in a particular embodiment of this specification can be applied to or used in conjunction with any other embodiment. Moreover, there is no component, configuration, step, or group of components, configurations, or steps that is required or essential to each embodiment. Accordingly, the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, and should be determined solely by a fair reading of the following claims.

[0155] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, as used herein, sequential terms used to modify elements such as structures, components, and actions (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of the element relative to any other element, but rather generally distinguish the element from other elements having similar or identical names (other than the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a condition or event may also be performed on the basis of one or more other conditions or events not explicitly stated.

[0156] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as those commonly understood by those skilled in the art in the field to which the exemplary examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and it is understood that they should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0157] While specific preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred order, and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a plurality of distinct operations in a manner that may be useful for understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other embodiments or advantages that may similarly be taught or suggested herein.

[0158] The spatially relative terms “outside,” “inside,” “top,” “bottom,” “downward,” “upward,” “vertical,” and “horizontal,” and similar terms, may be used herein to facilitate explanation and to describe the relationship between one element or component and another, as illustrated in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of a device in use or operation, in addition to the orientation depicted in the drawings. For example, if a device shown in a drawing is turned over, a device positioned “below” or “directly below” another device may be positioned “above” another device. Thus, the exemplary term “downward” may include both the lower and upper positions. Devices may also be oriented in other directions, and therefore, the spatially relative terms may have different interpretations depending on the orientation.

[0159] Unless otherwise explicitly stated, comparative terms and / or quantitative terms such as “less,” “more,” “greater,” and “same kind” are intended to encompass equivalent concepts. For example, “less” may mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

[0160] The delivery systems described herein may be used to position a catheter tip and / or catheter in various regions of the human heart. For example, the catheter tip and / or catheter may be configured to pass from the right atrium into the coronary sinus. However, the description may refer to, or generally apply to, positioning the catheter tip and / or catheter from a first body chamber or lumen to a second body chamber or lumen, where it will be understood that the catheter tip and / or catheter may be bent when positioned from the first body chamber or lumen into the second body chamber or lumen. The body chamber or lumen may refer to any one of numerous fluid channels, blood vessels, and / or organ chambers (e.g., ventricles). Furthermore, the references herein to “catheter,” “tube,” “sheath,” “maneuverable sheath,” and / or “maneuverable catheter” may generally refer to or apply to any type of elongated tubular delivery device, including, for example, a delivery catheter and / or cannula, which includes a lumen configured to slidably receive an instrument, such as for positioning within the atrium or coronary sinus. It will be understood that other types of medical implant devices and / or procedures can be delivered to the coronary sinus using the delivery systems described herein, for example, including ablation procedures, drug delivery and / or placement of coronary sinus leads.

Claims

1. It is a shunt system, A shunt configured to maintain a blood flow pathway between a first blood vessel and a second blood vessel, A shunt system comprising a deformable device configured to deform elastically in response to blood flow through the shunt.

2. The shunt system according to claim 1, wherein the shunt is removed from the deformable device.

3. The shunt system according to claim 1 or 2, wherein the shunt is configured to be attached to the deformable device.

4. The shunt system according to claim 1 or 2, wherein the deformable device comprises a stent at least partially enclosed by a cover.

5. The shunt system according to claim 4, wherein the stent comprises an intermediate section positioned between a first end and a second end.

6. The shunt system according to claim 5, wherein the intermediate section is configured to bend inward in response to an increase in blood pressure passing through the shunt.

7. The shunt system according to claim 5, wherein the first end is at least partially surrounded by a sealing material.

8. The shunt system according to claim 5, wherein the first end is configured not to deform in response to blood flow through the shunt.

9. The shunt system according to claim 1 or 2, wherein the deformable device is configured to expand with blood flow through the shunt.

10. The shunt system according to claim 1 or claim 2, wherein the deformable device is elliptical.

11. It is a method, The shunt is delivered percutaneously to the first blood vessel near the intersection between the first and second blood vessels, The shunt is passed at least partially through the wall of the first blood vessel until it enters the second blood vessel, A method comprising delivering a deformable device percutaneously into the first vessel near the intersection between the first vessel and the second vessel, wherein the deformable device is configured to be elastically deformable in response to blood flow through the shunt.

12. The method according to claim 11, wherein the shunt is removed from the deformable device.

13. The method according to claim 11 or 12, wherein the shunt is configured to be attached to the deformable device.

14. The method according to claim 11 or 12, wherein the deformable device comprises a stent.

15. The method according to claim 14, wherein the stent is at least partially surrounded by a cover.

16. The method according to claim 14, wherein the stent comprises an intermediate section positioned between a first end and a second end.

17. The method according to claim 16, wherein the intermediate section is configured to bend inward in response to an increase in blood pressure passing through the shunt.

18. The method according to claim 16, wherein the intermediate section is configured to be elastically deformable on a first side surface and not elastically deformable on a second side surface opposite to the first side surface.

19. The method according to claim 11 or 12, wherein the deformable device is configured to expand with blood flow through the shunt.

20. The method according to claim 11 or claim 12, wherein the deformable device is elliptical.

Images