Vena Cava Venturi

Abstract

A device can establish fluid communication between fluid vessels, such as between the inferior vena cava and the abdominal aorta. The device can include a conduit structure for deployment in a first fluid vessel or a shunt structure for deployment in a passage between the first fluid vessel and a second fluid vessel adjacent the first fluid vessel. The conduit structure can include a narrow section, with the shunt structure secured to and in fluid communication with the narrow section.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 835,610, entitled "Transcaval Venturi," filed April 18, 2019, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE This disclosure relates to the field of medical devices and procedures. [Background technology]

[0003] Congestive heart failure (CHF) is a common disease. In some cases of congestive heart failure, such as right heart failure, systemic congestion can occur, which can lead to shortness of breath, fatigue, and ultimately hospitalization.

[0004] Shunts between blood vessels are used to establish blood flow between blood vessels and are used to treat a variety of conditions. One aspect of such shunts is to allow blood to flow through the shunt. However, too low a blood flow may not produce the desired therapeutic outcome, and too high a blood flow may cause other complications. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure describes systems, devices, and methods for establishing fluid communication between blood vessels, such as may be desired to treat congestive heart failure and other conditions. [Means for solving the problem]

[0006] In some implementations, the present disclosure relates to a device for establishing fluid flow between fluid vessels of a patient. The device includes a conduit structure configured to be implanted in a first fluid vessel, the conduit structure including an outer wall defining a conduit lumen extending between a conduit inlet and a conduit outlet, the conduit structure including a constriction positioned between the conduit inlet and the conduit outlet. The constriction includes a constricted lumen diameter that is less than a diameter of at least one of the conduit inlet or the conduit outlet. The device also includes a shunt structure configured to be implanted at least partially in a second fluid vessel adjacent to the first fluid vessel and configured to be attached to the constricted portion of the conduit structure. The shunt structure includes a shunt lumen configured to be in fluid communication with the conduit lumen.

[0007] The shunt lumen can have a shunt lumen diameter that is equal to or less than the stenotic lumen diameter. For example, the shunt lumen diameter can be equal to or less than 0.8 times the stenotic lumen diameter. In some embodiments, the shunt structure can include a shunt anchor configured to be secured to at least a portion of the second fluid vessel. The shunt anchor can include a stent adapted to be radially deployed within the second fluid vessel and placed in contact with a wall of the second fluid vessel. The first fluid vessel can be the abdominal aorta and the second fluid vessel can be the inferior vena cava.

[0008] The conduit structure can include a self-expanding stent frame configured to radially expand to engage a wall of the first fluid vessel. For example, the self-expanding stent frame can have a delivery configuration and an expanded configuration, and the self-expanding stent frame is biased to the expanded configuration. In some embodiments, the conduit structure and the shunt structure can each include a self-expanding structure. The conduit structure and the shunt structure can each include a shape memory material and are biased to the expanded configuration. In some embodiments, the conduit structure can include a bifurcation between the stenosis and the conduit outlet, and the conduit structure can include an outlet downstream of the bifurcation.

[0009] In some embodiments, the diameter of the conduit outlet can be the same as the constricted lumen diameter. Additionally, in some embodiments, the diameter of the conduit outlet can be greater than the constricted lumen diameter. The constricted lumen diameter can be less than 0.8 times the diameter of the conduit inlet.

[0010] In some implementations, the present disclosure relates to a system for establishing fluid flow between fluid vessels of a patient. The system includes a conduit structure configured to be implanted in a first fluid vessel, the conduit structure including a conduit lumen extending between a first end of the conduit structure and a second end of the conduit structure, the conduit structure including a narrow portion disposed between the first end and the second end. A diameter of the narrow portion is less than at least one of a diameter of the first end or a diameter of the second end. The system also includes a shunt structure attached to the narrow portion of the conduit structure and configured to be at least partially disposed in a second fluid vessel adjacent to the first fluid vessel. The conduit structure is configured to draw fluid from the second fluid vessel into the first fluid vessel through the shunt structure.

[0011] The system may further include a delivery catheter for removably receiving the conduit structure and the shunt structure, the delivery catheter configured to hold at least one of the conduit structure or the shunt structure in a compressed delivery configuration. The conduit structure is self-expanding, and the delivery catheter may include a sheath configured to slidingly receive the conduit structure. The delivery catheter may include a radially expandable balloon configured to deploy the conduit structure in the first fluid vessel. The delivery catheter may be configured to deploy the shunt structure between the first and second fluid vessels.

[0012] The shunt structure can include a shunt anchor configured to secure at least a portion of the shunt structure against a wall of the second fluid vessel. For example, the shunt anchor can include a stent configured to be radially deployed in the second fluid vessel. The shunt anchor can include a disk-shaped configuration. In some embodiments, the first fluid vessel can be the aorta and the second fluid vessel can be the inferior vena cava. Additionally, in some embodiments, a diameter of the narrow portion of the conduit structure can be adjustable.

[0013] In some implementations, the present disclosure relates to a method of establishing fluid communication between fluid vessels, the method including: advancing a delivery catheter to a target location, the delivery catheter comprising a conduit structure and a shunt structure mounted on the conduit structure, advancing the delivery catheter into an anatomical structure between a first fluid vessel and a second fluid vessel adjacent the first fluid vessel, deploying the conduit structure in the second fluid vessel, the conduit structure comprising a first section, a second section, and a lumen extending through the first and second sections, the second section having a diameter smaller than the diameter of the first section, and deploying the shunt structure in the anatomical structure between the first and second fluid vessels with the shunt structure extending into the first fluid vessel and coupled to the second section of the conduit structure.

[0014] Advancing the delivery catheter to the target location can include advancing the delivery catheter within the first fluid vessel. In some embodiments, the method can further include forming a passageway in the anatomical structure between the first and second fluid vessels. Advancing the delivery catheter within the anatomical structure can include advancing the delivery catheter within the passageway. Deploying the shunt structure within the anatomical structure between the first and second fluid vessels can include sealing the passageway such that fluid flow is prevented from passing through the passageway, except for fluid flow through the shunt structure.

[0015] Deploying the shunt structure in the anatomical structure between the first and second fluid vessels can be performed after deploying the conduit structure in the second fluid vessel. In some embodiments, the shunt structure comprises an anchor and the method further includes deploying the anchor in the first fluid vessel. Deploying the anchor in the first fluid vessel can be performed after deploying the shunt structure in the anatomical structure between the first and second fluid vessels. The first fluid vessel can be the inferior vena cava and the second fluid vessel can be the aorta.

[0016] Advancing the delivery catheter to the target location may include advancing the delivery catheter through the femoral vein and the inferior vena cava. In some embodiments, the method may further include securing the shunt structure relative to the delivery catheter prior to advancing the delivery catheter to the target location. Additionally, in some embodiments, the method may further include adjusting a diameter of the second section of the conduit structure during the step of deploying the conduit structure in the second fluid vessel. Adjusting a diameter of the second section of the conduit structure may include using a tensioning line extending through the conduit structure to reduce a diameter of the second section of the conduit structure.

[0017] Deploying the conduit structure in the second fluid vessel can include radially expanding the conduit structure, and deploying the shunt structure in the anatomical structure between the first and second fluid vessels can include radially expanding the shunt structure. In some embodiments, each of the conduit structure and the shunt structure is self-expanding. Further, in some embodiments, the delivery catheter includes a sheath, and deploying the conduit structure in the second fluid vessel can include slidably retracting the sheath relative to the conduit structure, and deploying the shunt structure in the anatomical structure between the first and second fluid vessels can include slidably retracting the sheath relative to the shunt structure.

[0018] It should be understood that each element disclosed herein can be used with any element disclosed herein, even if the specific combination of elements may not be specified in the drawings in this specification. In other words, based on the description of a particular device, a person skilled in the art should have little difficulty in combining the features of two particular such devices. Therefore, it should be understood that many of these elements are interchangeable, and the present disclosure encompasses any permutation thereof.

[0019] Other objects, features and advantages of the present disclosure will become apparent from consideration of the following detailed description. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 illustrates a side view of an example device deployed within a patient in accordance with one or more embodiments. [Figure 2A] FIG. 2 is a side view of an example device according to one or more embodiments. [Figure 2B] FIG. 2 is a first end view of an example device according to one or more embodiments. [Figure 2C] FIG. 2 illustrates a bottom view of an example device according to one or more embodiments. [Figure 2D] FIG. 2 is a second end view of an example device according to one or more embodiments. [Diagram 3] 1 is a schematic diagram of an example stent portion according to one or more embodiments. [Figure 4-1] FIG. 2 is a front view of an example device having a single funnel-shaped portion according to one or more embodiments. [Figure 4-2] FIG. 4-1 illustrates the device of FIG. 4-1 deployed within a patient according to one or more embodiments. [Diagram 5] FIG. 1 illustrates a frontal partial cross-sectional view of a kidney with treatment according to one or more embodiments. [Figure 6] FIG. 2 is a side view of an example device according to one or more embodiments. [Figure 7A] FIG. 2 is a side cross-sectional view of a stent-like frame portion according to one or more embodiments. [Figure 7B] FIG. 2 is a side cross-sectional view of a stent-like frame portion according to one or more embodiments. [Figure 7C] FIG. 2 is a side cross-sectional view of a stent-like frame portion according to one or more embodiments. [Figure 8A] FIG. 2 illustrates an end view of an example stent-like frame portion according to one or more embodiments. [Figure 8B] FIG. 2 illustrates a perspective view of an example stent-like frame portion according to one or more embodiments. [Figure 8C] FIG. 2 illustrates a side view of an example stent-like frame portion according to one or more embodiments. [Figure 9] FIG. 2 is a side view of an example device according to one or more embodiments. [Figure 10] FIG. 2 is a side view of an example device according to one or more embodiments. [Figure 11A] FIG. 2 is a schematic partial cross-sectional side view of an example device with a delivery catheter according to one or more embodiments. [Figure 11B]FIG. 2 is a schematic partial cross-sectional side view of an example device with a delivery catheter according to one or more embodiments. [Figure 11C] FIG. 2 is a schematic partial cross-sectional side view of an example device with a delivery catheter according to one or more embodiments. [Figure 11D] FIG. 2 is a schematic partial cross-sectional side view of an example device with a delivery catheter according to one or more embodiments. [Figure 12A] FIG. 1 illustrates a front view of a patient's anatomy during delivery and deployment of an example device according to one or more embodiments. [Figure 12B] FIG. 1 illustrates a front view of a patient's anatomy during delivery and deployment of an example device according to one or more embodiments. [Figure 12C] FIG. 1 illustrates a front view of a patient's anatomy during delivery and deployment of an example device according to one or more embodiments. [Figure 12D] FIG. 1 illustrates a front view of a patient's anatomy during delivery and deployment of an example device according to one or more embodiments. [Figure 13] 1 illustrates an example process for implanting a device in one or more blood vessels of a patient according to one or more embodiments. [Figure 14] FIG. 1 illustrates an example device with an anchor implemented as a stent in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Although specific embodiments and examples are disclosed below, the subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and uses, as well as to modifications and equivalents thereof. Thus, the scope of claims that may be based on this specification is not limited by any of the specific embodiments described herein. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order, and are not necessarily limited to any particular disclosed order. Although various operations may be described in sequence as multiple separate operations, which may help to facilitate understanding of a particular embodiment, the order of description should not be interpreted to suggest that the operations are order-dependent. Furthermore, the structures, systems, and devices described herein may be embodied as integral or separate components. For purposes of comparison of various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily realized by any particular embodiment. Thus, for example, various embodiments may be implemented to achieve or optimize one advantage or set of advantages as taught herein, but not necessarily achieve other aspects or advantages as may be taught or suggested herein.

[0022] The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, when a first feature, first element, first component, first device, or first member is described as being "associated with" a second feature, second element, second component, second device, or second member, such description should be understood to suggest that the first feature, first element, first component, first device, or first member is physically coupled to, attached or connected to, integrated with, at least partially embedded in, or otherwise physically associated with, the second feature, second element, second component, second device, or second member, whether directly or indirectly.

[0023] The disclosed systems, devices, and methods can be used in a variety of surgical and minimally invasive, percutaneous, and other procedures. In some embodiments, the methods, systems, and devices can be delivered and deployed via a catheter into a patient's arterial system (e.g., through the femoral or brachial artery).

[0024] FIG. 1 illustrates a device 10 configured for delivery or implantation in adjacent fluid vessels, such as a vein 12 (e.g., the inferior vena cava) and an artery 14 (e.g., the abdominal aorta), according to one or more embodiments. For ease of illustration, FIG. 1 illustrates the vein 12 and artery 14 in cross-section and the device 10 in a non-cross-section. The device 10 may include a shunt structure 16, 24 (also referred to as a "shunt portion 16, 24") that is configured to be implanted or deployed in an anatomical structure between the vein 12 and the artery 14, or at least partially within the vein 12 or the artery. When implanted or deployed, the shunt structure 16, 24 may extend between the vein 12 and the artery 14, or at least partially within the vein 12 or the artery 14. In some examples, the device 10 may also include a conduit structure 18 (also referred to as a “stent portion 18”) that is configured to be implanted or deployed within a fluid vessel, such as an artery 14 or a vein 12. The conduit structure 18 may be coupled to a shunt structure 16, 24.

[0025] The shunt portions 16, 24 may include a lumen portion 16 or an anchor portion 24 (also referred to as an "anchor 24" or "shunt anchor 24"). The lumen portion 16 may have an elongated shape with a lumen therein. In some embodiments, the lumen portion 16 has a cylindrical, rectangular, or other shape. The lumen portion 16 may have a shunt inlet end 20 configured to be positioned or implanted in the vein 12 and a shunt outlet end 22 configured to be positioned or implanted in the artery 14, thus forming a fluid passageway between the blood vessels. The shunt inlet end 20 may be secured to the anchor portion 24, which may be a stent or similar structure adapted to be secured within the vein 12. The anchor portion 24 may help hold the shunt inlet end 20 in a desired position, such as to prevent the shunt inlet end 20 from sliding into or out of the vein 12. In some embodiments, the anchor portion 24 may have a disk-like or tapered shape and may also be referred to as a "disk-like or tapered structure 24." In some embodiments, the anchor portion 24 may be implemented as a stent adapted to be deployed in the vein 12 in a manner similar to the stent portion 18 shown as being deployed in the artery 14. The shunt outlet end 22 may be secured to the stent portion 18, which is deployed in the artery 14.

[0026] 2A-2D, the device 10 is shown in more detail. The stent section 18 has a stent wall 26 extending between an inlet end 28 and an outlet end 30, and a stent lumen 32 extends through the stent wall 26 between the inlet end 28 and the outlet end 30. The stent inlet section 34 and the stent outlet section 36 may be separated by a tapered intermediate section 38 (also referred to as a "narrowed section 38" or "stenosed section 38"), in which the stent lumen 32 is narrow. The tapered intermediate section 38 defines an orifice 39 having an inner diameter 40b that is smaller than an inlet diameter 40a. The inner diameter 40b may also be smaller than an outer diameter 40c. The inlet diameter 40a may be determined depending on the particular application, such as the characteristics of the vessel in which the stent section is to be deployed. For example, for a stent portion adapted to be deployed in the infrarenal abdominal aorta, the inlet diameter 40a may be 1.5-4 cm. The orifice inner diameter 40b may be 0.90 or less than the inlet diameter 40a, 0.80 or less than the inlet diameter 40a, 0.70 or less than the inlet diameter 40a, 0.60 or less than the inlet diameter 40a, 0.50 or less than the inlet diameter 40a, 0.40 or less than the inlet diameter 40a, or less than or equal to the inlet diameter 40a. Other diameters are also within the scope of this disclosure.

[0027] The stent portion 18 may be sized to be deployed in a desired fluid vessel, such as the abdominal aorta. The stent portion 18 has a stent length 42 and a stent outer diameter 44. The stent outer diameter 44 may be adapted to match the inner diameter of a desired vessel such that the stent wall 26 engages the vessel wall when in a deployed configuration. The stent length 42 and stent outer diameter 44 may be determined by the particular application, including the vessel in which the stent portion is to be deployed. For example, in an abdominal aorta application, the stent length 42 may be 40-80 mm and the diameter 44 may be 1.5-4 cm. Other dimensions are also within the scope of the present disclosure.

[0028] The lumen portion 16 may have a shunt lumen 46 extending between the shunt inlet end 20 and the shunt outlet end 22. The shunt lumen diameter 48 may be constant along the shunt length 50 or may vary along the length 50, such as by tapering. In some embodiments, the anchor portion 24 may be sized to fixedly seat the anchor portion 24 within the vein 12, but not substantially block blood flow through the vein 12. For example, the anchor portion 24 may have a diameter 52 sufficient to fixedly seat the anchor portion 24 at a desired location within the vein 12 (e.g., the diameter 52 may be within a certain range, above a certain threshold, or below a certain threshold), or may have a thickness 54 that is sufficiently small (e.g., within a certain range, below a certain threshold, or above a certain threshold) such that the anchor portion 24 does not extend excessively into the vein 12 (e.g., does not extend beyond a certain distance), thereby preventing the anchor portion 24 from substantially blocking blood flow within the vein 12. The shunt length 50 may be sufficient to traverse the distance between adjacent blood vessels in which the device 10 is deployed, and the shunt lumen diameter 48 is selected to allow sufficient blood flow therethrough as desired for a particular application.

[0029] In some embodiments, any of the elements of the device 10, such as the conduit structure 18, the lumen portion 16, or the anchor portion 24, may be formed from a flexible material or a flexible mesh or wire frame structure, such as a stent or stent-like structure. For example, the flexible material or the flexible mesh or wire frame structure may maintain a certain shape unless a sufficient force is applied. In some embodiments, the flexible material or the flexible mesh or wire frame structure may be formed from metal, plastic, silicone, or other materials. Furthermore, in some embodiments, the flexible material or the flexible mesh or wire frame structure may include a covering (also called a "lining"), which may be disposed on an exterior or interior portion of the frame structure. Although the conduit structure 18 is illustrated as being implemented as a stent in many of the figures, it may have other shapes. For example, the conduit structure 18 may be implemented as a substantially cylindrical or substantially rectangular structure or tube formed from metal, plastic, or other material.

[0030] 1 and other figures illustrate the walls of artery 14 along stented portion 18 as having a substantially uniform diameter, these walls may in some instances conform to the narrowed region of stented portion 18. For example, in some embodiments, the walls of artery 14 near the narrowed region of stented portion 18 (e.g., where lumen portion 16 connects to stented portion 18) may conform to the outer wall of the narrowed region of stented portion 18 by deforming or contracting toward stented portion 18 after deployment of device 10 or over time. In other embodiments, the walls of artery 14 near the narrowed region may remain with a relatively uniform diameter as illustrated in FIG.

[0031] In some embodiments, the present disclosure describes systems, devices, and methods based on the Venturi effect, where a drop in fluid pressure occurs as the fluid flows through a constricted region of a lumen. Using Bernoulli's principle in the case of incompressible, non-viscous flows (such as water and other liquid flows), the theoretical pressure drop across such a constriction can be calculated as follows:

[0032]

number

[0033] where v=fluid velocity at points 1 and 2, A=cross-sectional area at points 1 and 2, and ρ=density.

[0034] In some embodiments of the present disclosure, this corresponding Bernoulli principle can be expanded by:

[0035]

number

[0036] Thus, in some embodiments, the pressure at the orifice to draw blood through the shunt can be calculated as follows:

[0037]

number

[0038] Here, the blood is as follows:

[0039]

number

[0040] By utilizing known values ​​(average values) of abdominal aortic pressure, abdominal aortic flow velocity, and abdominal aortic diameter, the change in blood pressure P2 within the orifice can be calculated with respect to the various parameters.

[0041] [Table 1]

[0042] An example of the principle of operation of one or more devices of the present disclosure is shown in Figure 3. Blood flow from the inlet section 34 to the outlet section 36 passes through a narrow tapered section 38. The increased velocity of blood flow through this narrow tapered section 38 causes the inlet section blood pressure 56 and the outlet section blood pressure to be higher than the narrow section blood pressure 58. The pressure drop 59 helps draw blood from the vein, through the shunt and into the stented section in the artery, which may cause the venous pressure to drop while the arterial pressure increases.

[0043] In some embodiments, stents according to the present disclosure may have an hourglass shape, such as those in Figures 1 and 2A-2D, or may have other shapes. For example, as shown in Figure 4-1, a device 60 may have a stent portion 62 having a single funnel-shaped portion 68 with a relatively wide inlet end 64 and a narrower outlet end 66. The outlet end 66 may be located at the distal end of the tapered or funnel portion 68, and a shunt portion 70 (also referred to as "lumen portion 70") terminates in a narrow orifice portion 72 located at the downstream end of the tapered or funnel portion 68.

[0044] As shown in FIG. 4-2, device 60 (and other devices discussed herein) may be positioned in or between the patient's inferior vena cava 80 and abdominal aorta 82. In some embodiments, device 60 may be positioned distal to the renal artery 84 and renal vein 86, or proximal to the aortic bifurcation 88. However, device 60 and any other devices discussed herein may be positioned in other locations, such as other locations in the aorta, vena cava, or other anatomical structures. In some embodiments, the device is positioned in or between other fluid vessels, such as other blood vessels that may be located adjacent to one another or spaced apart at a distance.

[0045] When deployed to draw blood from the inferior vena cava into the abdominal aorta, for example as shown in Figures 1 and 4, the device of the present disclosure can improve the function of the kidney 90, as shown in Figure 5. For example, the device can increase blood pressure in the abdominal aorta, which can increase blood pressure in the renal artery 92. Deployment of such a device can also decrease blood pressure in the inferior vena cava, which can decrease blood pressure in the renal vein 94. The combination of decreasing renal vein pressure and increasing renal artery pressure increases blood flow through the kidney 90, which can improve renal function.

[0046] The stent portion may be in various forms. For example, a graft-like stent portion 100 may be formed from multiple stent-like portions 102a, 102b secured to a liner 104 in a graft-like configuration as shown in FIG. 6. The stent-like portions 102a in the narrow portion 106 of the stent portion 100 may be sized to have a smaller diameter than the stent-like portions 102b in the wider portion 108 of the stent portion 100. Each stent-like portion 102a, 102b may be expandable independently of one another, such as by being individually released from the restraint of a catheter sheath or by being individually expanded by catheter balloon expansion. The graft-like stent portion 100 may be funnel-shaped (similar to that shown in FIGS. 4-1, 4-2, and 6), hourglass-shaped (similar to that shown in FIG. 1), or other shapes.

[0047] In some embodiments, the stent portion can have an elongated torus-like shape. For example, a region of abruptly narrowed diameter can be provided in the device without a relatively large tapered section on each side of the orifice as shown in Figures 1 and 2A-2D. For illustration, a region of narrow diameter lumen can extend the entire length of the device or substantially the entire length of the device, such as that shown in the side cross-sectional views of Figures 7A-7C. In some embodiments, to form the stent portion, a metal mesh tube 110 (Figure 7A) can be provided having a tube lumen 112 and a tube wall 114 having opposite ends 116a, 116b. The ends 116a, 116b can be folded back into the tube lumen 112 (Figure 7B) until the ends 116a, 116b contact each other (Figure 7C). The ends 116a, 116b can be secured to each other, such as by sutures, wire connections, or the like. The resulting stent section 120 (FIGS. 8A-8C) may have an outer wall portion 122 that defines a stent outer diameter 124 and an inner wall portion 126 that defines a stent inner lumen 128. Opposite inlet and outlet ends 130a, 130b are at each end of the stent inner lumen 128. The stent inner lumen 128 may have a narrower diameter 132 than the outer wall portion 122, thus defining a stent inner lumen 128 that is narrower (e.g., substantially narrower) than the lumen of a blood vessel in which the device is implanted. In some embodiments, the stent section 120 may have an open mesh, but with a mesh mesh (for example) dense enough to direct a majority of the blood flow into the orifice or inner lumen 128, thereby increasing blood flow velocity and decreasing blood pressure in the orifice or inner lumen 128. Additionally, in some embodiments, the stent portion 120, in combination with a lining covering the inner wall portion 126, may allow blood flow (e.g., substantially all, a certain amount, etc.) to pass through the orifice or inner lumen 128, resulting in increased blood flow velocity and reduced blood pressure within the orifice or inner lumen 128.Such a stent portion 120 can be combined with a shunt portion and other elements, such as those illustrated elsewhere herein, where the inlet end of the shunt is secured to the inner wall portion 126 to establish fluid communication through the shunt into an orifice or inner lumen 128 to form a device.

[0048] In some embodiments, the stent portion 140 may have an orifice 142 with an adjustable orifice diameter 144 as shown in FIG. 9. The orifice diameter 144 may be adjustable via lasso sutures 146 or other mechanisms that may change the orifice diameter 144 by tightening and loosening the orifice 142. Such adjustments may be particularly applicable to stent portions 140 having frames formed from self-expanding materials such as Nitinol. Adjustments to the orifice diameter may be performed by a surgeon or other user who may consider the patient's hemodynamic response before, during, or after deployment of the device (e.g., using echo flow assessment, etc.) to assess the desired modifications to be made to the orifice diameter 144 using the lasso sutures 146 or other mechanisms. Such lasso sutures or mechanisms may be combined with various deployment procedures, such as any of the deployment methods disclosed herein. In such procedures and methods, adjustment of orifice diameter 144 may be performed prior to advancing the device within the patient, during initial deployment, immediately after initial deployment, or at some later time, such as after the delivery catheter has been completely removed from the patient. In some embodiments, the lasso may remain fixed relative to the device for subsequent adjustment of orifice diameter 144, such that the proximal end of the lasso is positioned, such as near the exterior of the patient's body, thereby allowing access by the user.

[0049] FIG. 10 illustrates an example stent portion 150 in which a stent frame section 152 around an orifice 154 is expandable. For example, the stent frame section 152 may be formed from stainless steel, cobalt chrome, a plastically deformable material, or other substances. The orifice diameter 156 may be adjusted by the surgeon or other user by introducing a balloon catheter into the orifice 154 and expanding the balloon to enlarge the orifice diameter 156. Such orifice diameter adjustment may be performed by the surgeon or other user during or after consideration of the patient's hemodynamic response (e.g., using echo flow assessment, etc.) that may occur before, during, or after device deployment to assess any desired modifications to be made to the orifice diameter 156 using the balloon or other expansion mechanism. Such expansion of the orifice diameter 156 may be performed at the time the device is initially deployed in the patient or may be performed after device deployment.

[0050] In some embodiments, it may be desirable to expand the orifice of the stent portion after initial deployment. For example, if the stent frame or other structure around the orifice is made of a deformable material, the surgeon or other user can expand the orifice to a wider diameter, including a much wider diameter when the orifice is expanded to a fully open position, for example, until the orifice is as wide as the vessel before treatment, by using a balloon catheter or other expansion mechanism. If the stent frame or other structure around the orifice is made of a self-expanding material, the surgeon or other user can quickly expand the orifice to a desired wider diameter by loosening or cutting the sutures or other expansion control mechanism. Such orifice widening may be performed instead of or before removing the device from the patient. In some embodiments, removal of the device from the patient may include retracting the device into a removal catheter, such as by using a suture or other mechanism that can engage the device and retract it back into the catheter, or retracting the device into the delivery catheter.

[0051] 11A-11D show an example system 160 including a device 162 and a delivery catheter 164 according to one or more embodiments. The delivery catheter 164 has a distal end 166 and a proximal end 168, and the device 162 is secured to the catheter 164 near the distal end 166. The catheter 164 has an elongate body 170 and may include a retractable sheath 172 that surrounds and protects the device 162 or portions thereof. The retractable sheath 172 may further prevent undesired expansion of the device 162 or portions thereof (such as when the device 162 or portions thereof are self-expanding). The catheter 164 may include a balloon 174 or other expansion mechanism that may mechanically expand portions of the device 162.

[0052] In some embodiments, a handle 176 may be provided at the proximal end 168 of the catheter 164. The handle 176 may include controls for retracting a sheath or for expanding or contracting a balloon or other expansion mechanism.

[0053] Device 162 may comprise a first portion 180 for deployment in a first blood vessel, a second portion 182 for deployment in a second blood vessel, or a lumen portion 184 connecting first portion 180 and second portion 182 and adapted to extend between the first and second blood vessels. In some embodiments, second portion 182 or lumen portion 184 may form a shunt structure or portion. Device 162 may consist of any of the devices discussed herein.

[0054] In some embodiments, the system 160 may be advanced into the patient to deploy the device 162 in the first blood vessel 190 and the second blood vessel 192. As shown in FIG. 11B, the catheter 164 may be advanced into the first blood vessel 190 via the second blood vessel 192, which may be accomplished by the catheter 164 passing through a passageway 194 formed by a surgeon, interventionist, or other user between the first blood vessel 190 and the second blood vessel 192. The catheter 164 may be advanced such that the device 162 is positioned with the first portion 180 located in the first blood vessel 190 (such as the abdominal aorta), the second portion 182 located in the second blood vessel 192 (such as the inferior vena cava), or the lumen portion 184 positioned in the passageway 194.

[0055] As shown in FIG. 11C, the first portion 180 may be expanded in place within the first blood vessel 190 (e.g., by retracting the sheath 172, loosening the lasso, or activating an expansion mechanism such as the balloon 174, etc.). The second portion 182 may then be released or otherwise deployed to expand within (e.g., adjacent the wall of) the second blood vessel 192 (e.g., by retracting the sheath 172, loosening the lasso, or activating an expansion mechanism such as the balloon 174, etc.), as shown in FIG. 11D. In some embodiments, the shunt 184 may be transitioned to a deployed configuration, such as by radial expansion (e.g., by retracting the sheath 172, loosening the lasso, or activating an expansion mechanism such as the balloon 174, etc.), which may occur after deployment or expansion of the first portion 180 or before deployment or expansion of the second portion 182. With the device 162 properly deployed, the catheter 164 may be removed from the patient. In Figures 11C and 11D, first portion 180 is shown as having a substantially uniform diameter, however, as discussed elsewhere in this disclosure, first portion 180 may have a narrowed region (e.g., at the location where lumen portion 184 is connected to first portion 180).

[0056] After the device 162 is deployed at the desired location, adjustments may be made to the orifice diameter, for example, as discussed and illustrated in connection with Figures 9 and 10. In some embodiments, such adjustments may be made using the catheter 164 (e.g., using the catheter balloon 174). In some examples, the catheter 164 may not be removed from the patient until the desired adjustments have been made to the orifice diameter. In some examples, adjustments may be made in combination with consideration of the patient's hemodynamic response by the surgeon or other user (e.g., using echo flow assessment, etc.).

[0057] Although examples are discussed in the context of supplying blood from the inferior vena cava into the abdominal aorta, any of the devices and methods discussed herein may be used to supply blood or other fluids from the abdominal aorta into the inferior vena cava or between other fluid vessels. For example, in some embodiments in the context of Figures 11A-11C, a first portion 180 of device 162 may be deployed or positioned in the inferior vena cava and a second portion 182 of device 162 may be deployed or positioned in the abdominal aorta. In this case, blood from the abdominal aorta may be passed through device 162 and into the inferior vena cava.

[0058] 12A-12D illustrate an example method of deploying device 200 to effect blood flow from a second vessel, such as inferior vena cava 204, into a first vessel, such as abdominal aorta 202, according to one or more embodiments. In some embodiments, a guidewire may be advanced between inferior vena cava 204 and abdominal aorta 202 (e.g., utilizing a snaring technique in some cases). For example, as shown in FIG. 12A, snare 206 may be advanced via femoral artery 208 (e.g., via a patient's incision leading to femoral artery 208) into abdominal aorta 202 to a location between femoral artery bifurcation 210 and renal arteries 212. Also, guidewire 214 may be separately advanced via femoral vein 216 (e.g., via a patient's incision leading to femoral vein 216) into inferior vena cava 204 to a location between femoral vein bifurcation 218 and renal vein 220. In some embodiments, advancement of the guidewire 214 may include or be advanced by advancement of a catheter or other element adapted to form (e.g., by puncture) a passageway 222 between the inferior vena cava 204 and the abdominal aorta 202. The guidewire 214 may be advanced through or forming the passageway 222 into the abdominal aorta 202 and engage the snare 206. In some embodiments, the snare 206 may be used as a marker or target to help guide the guidewire 214 into the abdominal aorta 202 (e.g., used in conjunction with imaging to identify a target location for spanning from the inferior vena cava 204 into the abdominal aorta 202). Additionally or alternatively, the snare 206 may be used to retract the guidewire 214 into the abdominal aorta 202. In some embodiments, once the guidewire 214 is retracted into the abdominal aorta 202, it may be advanced further up the abdominal aorta 202 (i.e., toward the patient's heart) as shown in FIG. 12B. While in other embodiments, the guidewire 214 may remain within proximity of the initial entry point into the abdominal aorta 202.

[0059] As shown in Figure 12C, a delivery catheter 226 may be advanced via the femoral vein 216 (including via a patient puncture leading to the femoral vein 216) into the inferior vena cava 204, through passageway 222, and into the abdominal aorta 202. Advancement of the delivery catheter 226 may include advancing the delivery catheter along or over the guidewire 214. The delivery catheter 226 may be similar to the delivery catheter shown in Figures 11A-11D.

[0060] Device 200 may then be deployed via delivery catheter 226 at the desired location (such as by using the devices and methods shown and described in connection with FIGS. 11A-11D, by withdrawing the catheter sheath, expanding a balloon, etc.). After device 200 is properly deployed, delivery catheter 226 or guidewire 214 may be withdrawn from the patient. In FIG. 12D, device 200 is illustrated after withdrawal of the catheter.

[0061] 13 illustrates an example process 300 for implanting a device in one or more vessels of a patient, according to one or more embodiments of the present disclosure. In some embodiments, the process 300 may be performed to implant a device in a first fluid vessel, such as the inferior vena cava, or in a second fluid vessel, such as the aorta. For ease of explanation, many of the embodiments discussed below may relate to the aorta and inferior vena cava, and implantation of certain structures in the aorta and inferior vena cava. It should be understood that the process 300 may be utilized for implantation of structures in other fluid vessels, and that these structures may be implanted in the aorta and inferior vena cava in a manner different from that described below.

[0062] At block 302, the shunt or conduit structure may be secured to a delivery catheter. For example, the shunt or conduit structure may be mounted to the delivery catheter in a contracted or other state for delivery of the structure into the human anatomy. The shunt or conduit structure may be mounted to the delivery catheter prior to advancing the delivery catheter into the human anatomy.

[0063] At block 304, the delivery catheter may be advanced to the target location. For example, the delivery catheter may be advanced through the femoral vein and to a desired location within the inferior vena cava where the delivery catheter will span into the abdominal aorta (e.g., via a passageway as discussed below). In some embodiments, the delivery catheter is advanced over or along a guidewire located within the human anatomy.

[0064] At block 306, a passageway may be formed between the first and second fluid vessels. In some embodiments, a guidewire is used to form a passageway between the first and second fluid vessels, such as before a delivery catheter is advanced to the target location. Thus, in some cases, block 306 may be performed before block 304. Alternatively or additionally, in some embodiments, a delivery catheter is used to form the passageway. The first fluid vessel may be adjacent to the second fluid vessel, e.g., immediately adjacent, within a certain distance, etc.

[0065] At block 308, a delivery catheter may be advanced into the anatomical structure between the first fluid vessel and the second fluid vessel. For example, the delivery catheter may be advanced from the inferior vena cava through a passageway and into the abdominal aorta.

[0066] At block 310, the conduit structure may be deployed in the second fluid vessel. For example, the conduit structure may be implanted in the abdominal aorta. In some embodiments, the delivery catheter comprises a sheath. The conduit structure may be deployed by slidably retracting the sheath over the conduit structure or by radially expanding the conduit structure. In some embodiments, the conduit structure comprises a first section, a second section, and a lumen extending through the first section and the second section. In some examples, the diameter of the second section may be smaller than the diameter of the first section. Additionally, in some examples, the conduit structure may be self-expanding.

[0067] At block 312, the shunt structure may be deployed within the anatomical structure between the first and second fluid vessels. For example, the shunt structure may be implanted within the passageway or at least partially within the inferior vena cava while coupled to the conduit structure. In some embodiments, the delivery catheter comprises a sheath. The shunt structure may be deployed by slidingly retracting the sheath relative to the shunt structure or by radially expanding the shunt structure. In some embodiments, the shunt structure is self-expanding. Additionally, in some embodiments, the shunt structure is deployed after the conduit structure is deployed.

[0068] At block 314, an anchor may be deployed in the first fluid vessel. For example, the shunt structure may include an anchor that may be deployed in the inferior vena cava. In some embodiments, the anchor is deployed after the shunt structure is deployed. Additionally, in some embodiments, deploying the shunt structure or deploying the anchor may seal (or may include sealing) the passageway to prevent fluid flow through the passageway except through the shunt structure.

[0069] At block 316, the diameter of the conduit structure may be adjusted. For example, the diameter of the second section (e.g., narrow portion) of the conduit structure or other sections of the conduit structure may be reduced or enlarged. In some embodiments, a tensioning line may be used to reduce the diameter of the second section of the conduit structure. The tensioning line may extend through the conduit structure. Alternatively or additionally, in some embodiments, a balloon on the delivery catheter may be used to increase or decrease the diameter of the second section of the conduit structure. The diameter of the conduit structure may be adjusted when deploying the conduit structure in the second fluid vessel.

[0070] 14 illustrates an example device 400 in which an anchor is implemented as a stent, according to one or more embodiments. The device 400 may include a conduit structure 402 configured to be implanted in a first fluid vessel, such as the aorta 404, or a shunt structure 406, 410 configured to be implanted in a second fluid vessel, such as a vein 408, or in an anatomical structure between the first and second fluid vessels. In some examples, the device 400 is configured to draw a fluid, such as blood, from the vein 408 into the aorta 404 via the shunt structure 406, 410.

[0071] The conduit structure 402 may have an inlet end 418 (e.g., a first end) and an outlet end 416 (e.g., a second end) through which the stent lumen extends. The conduit structure 402 may have a narrowed portion or section, shown in FIG. 14 at an intermediate portion of the conduit structure 402. It should be understood that the narrowed portion or section may be located at other locations along the conduit structure 402. The narrowed portion or section may have a smaller diameter than the inlet end 418 or the outlet end 416.

[0072] The shunt structure 406, 410 may comprise a lumen portion 410 or an anchor portion 406. The lumen portion 410 may have an elongated shape with a lumen therein. The lumen portion 410 may have a shunt inlet end 412 (e.g., a first end) configured to be positioned or implanted in the vein 408 and a shunt outlet end 414 (e.g., a second end) configured to be positioned or implanted in the aorta 404 or coupled to a narrow section of the conduit structure 402. The anchor portion 406 may be configured to hold the lumen portion 410 in an appropriate position, such as the position shown in FIG. 14. In this example, the anchor portion 406 is implemented as a stent configured to radially expand during implantation to contact one or more walls of the vein 408 as shown in FIG. 14. In some examples, the stent may comprise similar materials and structures as the conduit structure 402 (when the conduit structure 402 is implemented as a stent), except that it does not have a narrow section. For example, anchor portion 406 may comprise a flexible material or a flexible mesh or wire frame structure. Anchor portion 406 may comprise a lumen to allow fluid to flow through anchor portion 406 or into lumen portion 410. In some embodiments, anchor portion 406 may be shorter in length than conduit structure 402, as shown in FIG. 14, while in other embodiments, anchor portion 406 may be the same length or longer than conduit structure 402.

[0073] Fluid vessels may include any anatomical structure capable of carrying a fluid, such as arteries, veins, capillaries, etc. Although certain embodiments are disclosed herein in relation to blood vessels (such as those of the aortic or venous systems), it should be understood that any of the disclosed devices may be implanted at least partially within any vessel, organ, or cavity of a patient's anatomical structure, including any cavity or vessel associated with the heart or cardiac circulatory system. As used herein, the term "fluid" may refer to a gas, a liquid, or a combination of the two.

[0074] A stent frame for use in one or more of the devices discussed herein can be made from a variety of materials depending on the particular application and structure desired. For example, Nitinol, CoCr, stainless steel, and other metals may be used, as well as polymers or other materials can be used. In some embodiments, the stent frame can be made from a round cut (e.g., laser cut) from a tube or flat shape, formed into an expandable shape (e.g., a zigzag shape), or made from a wire braid or other wire shape, including mesh-like structures, etc. The lining can be made from a variety of materials, such as woven materials, thin mesh-like materials, etc. Examples of liner materials include fibers, polymers, ePTFA, sutures, electrospun materials, and tissues (e.g., pericardium). Any of these frame or liner materials, and any combination thereof, can be used in any of the devices shown and described herein.

[0075] Various approaches to treatment are within the scope of the present disclosure, including advancing a catheter into position through a sheath. In some embodiments, a transcatheter approach is performed through the femoral artery. For example, the implantation procedure can be similar to a transcatheter aortic valve replacement (TAVR) procedure or a transcatheter aortic valve implantation (TAVI) procedure using transcaval access.

[0076] In some examples of procedures for deploying a device, femoral artery access is achieved through an access sheath sized for use in a TAVR procedure. An incision can be made in the patient leading to a body vessel such as the femoral artery. The distal end of the access sheath can be advanced through the incision and the femoral artery to a desired location in the aorta, and the hub can be positioned near the exterior of the patient near the incision or access site. A guidewire can be advanced from the femoral access site (and through the aortic arch into the patient's left ventricle, for example, in the case of deploying a prosthetic aortic valve). A steerable shaft of an imaging or delivery catheter can be advanced over the guidewire, such as by standard over-the-wire techniques, to advance the distal end of the device to the target location. For example, the device can have a guidewire lumen. Echo, fluoroscopy, or other visualization techniques can be used in addition to electrophysiological 3D mapping techniques. Therapeutic or implant deployment can be performed, such as by deploying the device at the target location. Once proper deployment is confirmed, the catheter may be removed from the patient, the guidewire may be removed from the patient, the sheath may be removed from the patient, and the incision may be closed with sutures or the like.

[0077] As noted above, the present disclosure is directed to devices, systems, and methods for establishing fluid communication between blood vessels such as may be desired to treat congestive heart failure or other conditions.

[0078] In some embodiments, the device has a first vascular portion, a second vascular portion, and a shunt portion connecting the first vascular portion and the second vascular portion. The first vascular portion is adapted to be deployed in a first vessel, such as an artery, and is configured to draw fluid from a second vessel (e.g., a vein) through the shunt into the first vessel by generating a localized low pressure in the first vessel. As a result, the load on the second vascular system (e.g., a venous system) is reduced. When the device is implanted between the abdominal aorta and the inferior vena cava, the pressure in the abdominal aorta and renal artery is increased and the pressure in the inferior vena cava and renal vein is decreased, thereby improving renal function.

[0079] In some embodiments, a device for establishing blood flow between blood vessels of a patient may include a stent portion having a stent outer wall defining a stent lumen extending between a stent inlet and a stent outlet. The stent portion may have a stent stenosed portion positioned between the inlet and the outlet. The stent inlet may have a stent inlet lumen diameter, the stent outlet may have a stent outlet lumen diameter, and the stent stenosed portion may have a stenosed lumen diameter. The stent lumen diameter may be less than 0.80 of the stent inlet diameter or the stent outlet diameter. The stent portion may be adapted to be positioned in a first vessel with the stent wall radially engaging a vessel wall of the first vessel. A shunt device may include a shunt portion having a shunt inlet and a shunt outlet at opposite ends of the shunt portion, and the shunt lumen may extend from the shunt inlet to the shunt outlet. The shunt outlet may be fixed relative to the stent stenotic segment, the shunt lumen may be in fluid communication with the stent lumen, and the shunt segment may extend in a non-parallel direction from the stent segment such that the shunt inlet is positioned away from the stent segment. The shunt lumen diameter may be equal to or less than the stenotic lumen diameter. The shunt lumen diameter may be equal to or less than 0.80 of the stenotic lumen diameter.

[0080] A shunt device according to the present disclosure may include a shunt anchor secured relative to the shunt inlet, the shunt anchor adapted to be positioned against a wall of a second vessel, such as the inferior vena cava, and the shunt anchor may be a second stent adapted to be radially deployed within and in contact with the wall of the second vessel.

[0081] The stent portion may be self-expanding or may have a self-expanding stent frame, such as a shape memory metal frame formed, for example, from Nitinol. The self-expanding stent frame may have a delivery configuration and an expanded configuration, and the self-expanding stent frame may be biased into the expanded configuration. The stent portion and the shunt portion may both be self-expanding, both be formed from a shape memory material, or both be biased into the expanded configuration.

[0082] The shunt device may be adapted to be deployed within a bifurcated section of a blood vessel. The stent portion may include a bifurcation between the stenosis and the stent outlet, and the stent portion may have a secondary stent outlet downstream of the bifurcation.

[0083] The stent exit lumen diameter may be the same as the stenotic lumen diameter or may be substantially larger than the stenotic lumen diameter.

[0084] In some embodiments, a system for establishing blood flow between blood vessels of a patient may include any of the shunt devices discussed herein in combination with a delivery catheter. The delivery catheter may include a distal portion, an elongated central portion, and a proximal portion. The distal portion may be adapted to hold the device in a compressed delivery configuration, and the distal portion and the elongated central portion may be adapted to be percutaneously advanced into the patient. The delivery catheter distal portion may have a sheath adapted to slidingly receive a stent portion, a shunt portion, or a shunt anchor of the shunt device, such as when the shunt device or portions thereof are self-expanding. The delivery catheter distal portion may include a radially expandable balloon adapted to radially expand one or more portions of the shunt device.

[0085] The catheter distal portion may be adapted to be percutaneously advanced through the femoral vein and the inferior vena cava and through the passageway formed between the inferior vena cava and the aorta to the aorta.

[0086] In some embodiments, the methods may include establishing fluid communication between blood vessels. The methods may include providing a system having a delivery catheter, such as those disclosed herein, and a shunt device, such as those disclosed herein. The methods may include forming a connecting passage between a first blood vessel and a second blood vessel, advancing a catheter distal portion having a shunt device secured thereto to a desired treatment site, including advancing the catheter distal portion having a shunt device secured thereto through the first blood vessel and the connecting passage into the second blood vessel, deploying a stent portion in the second blood vessel, and deploying the shunt portion in the connecting passage with the shunt outlet in fluid communication with the second blood vessel. Deploying the shunt portion in the connecting passage may be performed after deploying the stent portion in the first blood vessel. If the shunt device has an anchor device secured to the shunt outlet, the method may include deploying the anchor device in the second blood vessel. Deploying the shunt portion in the connecting passage may be performed after deploying the stent portion in the first vessel, and deploying the anchor device in the second vessel may be performed after deploying the shunt portion in the connecting passage.

[0087] After deployment of the shunt portion in the passageway or after deployment of the stent portion in the first blood vessel, the passageway extending between the blood vessels may be sealed by the shunt device to prevent fluid flow therethrough, except through the shunt lumen.

[0088] The first blood vessel may be the aorta and the second blood vessel may be the inferior vena cava. Advancing the catheter distal portion having the shunt device secured thereto to the desired treatment site may include advancing the delivery catheter distal portion through the femoral vein and into the inferior vena cava.

[0089] In some embodiments, the method may include securing the shunt device to the catheter distal portion, which may be performed during system manufacturing or by a surgeon, interventionalist, or other user immediately prior to using the system in deploying the shunt device within a patient.

[0090] The system may include a tensioning line extending through the stent portion and adapted to adjust the stenotic lumen diameter, and in such a system, a method of deployment may include, after deploying the stent portion in the first vessel, applying tension to the tensioning line to reduce the stenotic lumen diameter.

[0091] If the stent portion or shunt portion is expandable (e.g., self-expanding), deploying the stent portion within the blood vessel may include radially expanding the stent portion, and deploying the shunt portion within the connecting passage may include radially expanding the shunt portion.

[0092] In the case of a self-expanding shunt device, the distal catheter portion may include a sheath, and deploying the stent portion within the blood vessel may include slidably retracting the sheath portion relative to the stent portion, and deploying the shunt portion within the connecting passageway may include retracting the sheath portion relative to the shunt portion.

[0093] In some embodiments, any element of any embodiment disclosed herein, and individual elements thereof, can be used with any other embodiment disclosed herein, and individual elements thereof.

[0094] All dimensions listed are exemplary and devices according to the present disclosure may have dimensions outside those specific values ​​and ranges. The size and shape of the device and its elements may depend on the particular application.

[0095] Unless otherwise noted, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. Hereinafter, explanations of terms are provided to facilitate identification of various embodiments of the present disclosure.

[0096] The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a single element within a listed alternative or combination of two or more elements, unless the context clearly dictates otherwise.

[0097] The term "comprises" means "has." For example, a device that includes or comprises A and B may include A and B, but may optionally include C or other components excluding A and B. Furthermore, a device that includes or comprises A or B may include A or B, or may include A and B, and may optionally include one or more other components, such as C.

[0098] The term "subject" refers to both human and other animal subjects. In certain embodiments, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In one example, the subject is a human patient.

[0099] Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. In case of conflict, the present specification, including the terminology, will control. Furthermore, these materials, methods, and examples are illustrative only and are not intended to be limiting.

[0100] The above description of the embodiments of the present disclosure is not intended to be exhaustive or to limit the present disclosure to the precise form disclosed above. Although specific embodiments and examples have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present disclosure. For example, although processes or blocks are shown in a given order, alternative embodiments may perform routines having multiple steps in a different order, or use systems having multiple blocks in a different order, and some processes or blocks may be deleted, moved, added, divided, combined, or modified. Each of these processes or blocks may be performed in a variety of different ways. Also, although processes or blocks may sometimes be shown as being performed sequentially, these processes or blocks may be performed in parallel or at different times.

[0101] Certain location terms are used herein in connection with various disclosed embodiments. Although several spatially relative terms, such as "outer", "inner", "upper", "lower", "lower", "upper", "vertical", "horizontal", "top", "bottom" and similar terms, are used herein to describe the spatial relationship of one device or element or anatomical structure to another, it is understood that these terms are used for ease of description to describe the positional relationship between elements or structures as shown in the drawings. The spatially relative terms are intended to encompass different orientations of the elements or structures in use or operation in addition to the orientation shown in the drawings. For example, an element or structure described as being "above" another element or structure may represent a position below or to the side of such other element or structure relative to the subject patient or alternative orientations of the element or structure, and vice versa.

[0102] Conditional words used herein, such as "may," "could," "could," "could," and "for example," among others, are intended in their ordinary sense unless otherwise expressly stated or understood within the context in which they are used, and are generally intended to convey that certain embodiments include certain features, elements, or steps, but not others. Thus, such conditional words are not generally intended to suggest that features, elements, or steps are necessarily required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and steps are included in or will be implemented in any particular embodiment, whether or not informed or affirmatively suggested by the author.

[0103] It should be understood that certain ordinal terms (e.g., "first" or "second") may be used for ease of reference, but do not necessarily imply physical characteristics or order. Thus, an ordinal term (e.g., "first," "second," "third," etc.) used to modify an element, such as a structure, component, operation, etc., does not necessarily imply a superiority or ranking of that element over any other element, but rather may generally distinguish that element from other elements having similar or equivalent names (in the absence of the use of that ordinal number). Furthermore, as used herein, the indefinite article "a" or "an" may imply "one or more" rather than "one." Furthermore, an action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events that are not specified. In some contexts, a statement that an action or event occurs or is performed "based on" or "based at least in part on" a stated event or condition can be interpreted as being triggered or performed in response to the stated event or condition.

[0104] With reference to the various methods and processes disclosed herein, a particular order of operations or steps is illustrated and described, but it should be understood that the various steps and operations illustrated and described may be performed in any suitable or desired temporal order. Further, any illustrated or described operation or step may be omitted from any given method or process, and the illustrated or described methods and processes may include additional operations or steps not explicitly shown in the drawings or description.

[0105] In the description of the above embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description to simplify the disclosure and aid in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated or described in a particular embodiment herein may be applicable to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is essential or essential to each embodiment. Therefore, it is intended that the scope of the disclosure as claimed herein and in the appended claims should not be limited by the specific embodiments described above, but should be determined solely by a fair interpretation of the appended claims.

[0106] Unless the context clearly requires otherwise, throughout this description and claims, terms such as "comprises," "comprising," "has," "having," "including," and "including" are to be construed in an open and non-exclusive sense, i.e., "including but not limited to," as opposed to a closed, exclusive, or inclusive sense.

[0107] As used herein, the term "coupled" refers to two or more elements that may be physically, mechanically, or electrically coupled / connected or otherwise associated, whether directly or indirectly (such as through one or more intermediate elements, components, or devices). Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole, including any disclosure incorporated by reference, and not to any particular portions of this disclosure. Where the context permits, words using singular or plural numbers in this disclosure may include the plural or singular numbers, respectively.

[0108] As used herein, the terms "substantially" and "about" provide an industry-accepted range for its corresponding term or relativity between items. In some industries, the industry-accepted range is less than 1 percent, while in other industries, the industry-accepted range may be 10 percent or more. Other examples of industry-accepted ranges range from less than 1 percent to 50 percent. Industry-accepted ranges correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, packet drops, temperature, pressure, material composition, or performance metrics. Within an industry, the allowable variation of an accepted range may be higher or lower than the percentage level (e.g., dimensional tolerances of less than about ±1%). Some relationships between items may range from less than the percentage level to several percent. Other relativities between items may range from several percent error to significant error.

[0109] One or more embodiments have been described above using method steps that show certain functional capabilities and their relationships. The boundaries and orders of these functional building blocks or method steps have been arbitrarily defined herein for convenience of description. Other boundaries and orders can be defined so long as these specific functions and relationships are properly implemented. Thus, any such other boundaries or orders are within the scope and spirit of the claims. Furthermore, the boundaries of these functional building blocks may be arbitrarily defined for convenience of description. Other boundaries can be defined so long as certain important functions are properly implemented. Similarly, flow chart blocks may be arbitrarily defined herein to show certain important functionality.

[0110] Depending on the scope of use, the block boundaries and order of the flow diagram can be defined differently and still achieve certain important functionality. Thus, all such different definitions of the functional building blocks and the flow diagram blocks and flow diagram order are also within the scope and spirit of the present disclosure. Additionally, one of ordinary skill in the art will appreciate that the functional building blocks and other illustrated blocks, modules, and components herein may be implemented in some instances as illustrated, or by separate components, application specific integrated circuits, processors executing appropriate software, or the like, or any combination thereof.

[0111] In view of the numerous possible embodiments to which the principles of the present disclosure may be applied, it should be understood that the illustrated embodiments are merely examples of the subject matter and should not be construed as limiting the scope of the present disclosure. [Explanation of symbols]

[0112] 10 Devices 12 Veins 14 arteries 16 Shunt structure, shunt portion, lumen portion 18. Conduit structure, stent portion 20 Shunt inlet end 22 Shunt outlet end 24 Shunt structure, shunt portion, anchor, anchor portion, shunt anchor, disk-shaped structure, tapered structure 26 Stent wall 28 Inlet end 30 Outlet end 32 Stent lumen 34 Stent entrance 36 Stent exit section 38 Tapered intermediate section, narrow section, constricted section, narrow tapered section 39 Orifice 40a inlet diameter 40b Inner diameter 40c outer diameter 42 Stent length 44 Stent outer diameter 46 Chanteloumen 48 Shunt lumen diameter 50 Shunt Length 52 diameter 54 Thickness 56 Inlet Segment Blood Pressure 58 Narrow Part Blood Pressure 59 Lowering blood pressure 60 Devices 62 Stent section 64 Inlet end 66 Outlet end 68 Single funnel-shaped section, tapered section, funnel section 70 Shunt section, lumen section 72 Narrow orifice section 80 Inferior vena cava 82 Abdominal aorta 84 Renal artery 86 Renal vein 88 Aortic bifurcation 90 Kidneys 92 Renal artery 94 Renal vein 100 Graft-like stent portion 102a stent-like portion 102b stent-like portion 104 Raina 106 Narrow part 108 Wider part 110 Metal Mesh Tube 112 tube lumens 114 Tube wall 116a End 116b End 120 Stent section 122 Outer wall section 124 Stent outer diameter 126 Inner wall section 128 Stent inner lumen 130a Inlet end 130b Outlet end 132 Narrow Diameter 140 Stent section 142 Orifice 144 Orifice diameter 146 Lasso suture 150 Stent section 152 Stent Frame Section 154 Orifice 156 Orifice diameter 160 Systems 162 devices 164 Delivery Catheter 166 Distal end 168 Proximal end 170 Elongated body 172 Retractable Sheath 174 Balloon 176 Handle 180 First Part 182 Second Part 184 Lumen part, shunt 190 First Blood Vessel 192 Second Blood Vessel 194 Aisle 200 devices 202 Abdominal aorta 204 Inferior vena cava 206 Snare 208 Femoral artery 210 Femoral artery bifurcation 212 Renal artery 214 Guidewire 216 Femoral vein 218 Femoral vein bifurcation 220 Renal vein 222 Passage 226 Delivery Catheter 400 devices 402 Conduit structure 404 Aorta 406 Shunt structure, anchor part 408 Veins 410 Shunt structure, lumen portion 412 Shunt inlet end 414 Shunt outlet end 416 Outlet end 418 Inlet end

Claims

1. 1. A device for establishing fluid flow between fluid vessels of a patient, comprising: a conduit structure configured to be implanted within a first fluid vessel, the conduit structure comprising an outer wall defining a conduit lumen extending between a conduit inlet and a conduit outlet, the conduit structure comprising a constricted portion positioned between the conduit inlet and the conduit outlet, the constricted portion comprising a constricted lumen diameter that is less than a diameter of at least one of the conduit inlet or the conduit outlet; a shunt structure configured to be implanted at least partially within a second fluid vessel adjacent to the first fluid vessel and configured to be attached to the stenosed portion of the conduit structure, the shunt structure comprising a shunt lumen configured to be in fluid communication with the conduit lumen; Equipped with the shunt structure includes a lumen portion defining the shunt lumen; the lumen portion is disposed external to the first fluid vessel and the second fluid vessel; A device, wherein one end of the lumen portion is located within the first fluid vessel and is configured to be attached to the narrowed portion of the conduit structure, and the other end of the lumen portion is located within the second fluid vessel.

2. The device of claim 1 , wherein the shunt lumen comprises a shunt lumen diameter that is less than or equal to the stenotic lumen diameter.

3. The device of claim 2 , wherein the shunt lumen diameter is less than or equal to 0.8 times the stenotic lumen diameter.

4. The device of claim 1 , wherein the shunt structure comprises a shunt anchor configured to be secured to at least a portion of the second fluid vessel.

5. 5. The device of claim 4, wherein the shunt anchor comprises a stent adapted to be radially deployed within the second fluid vessel and placed in contact with a wall of the second fluid vessel.

6. 6. The device of claim 1, wherein the first fluid vessel is the abdominal aorta and the second fluid vessel is the inferior vena cava.

7. 7. The device of claim 1, wherein the conduit structure comprises a self-expanding stent frame configured to radially expand to engage a wall of the first fluid vessel.

8. The device of claim 7 , wherein the self-expanding stent frame has a delivery configuration and an expanded configuration, the self-expanding stent frame being biased into the expanded configuration.

9. The device of claim 1 , wherein each of the conduit structure and the shunt structure comprises a self-expanding structure.

10. The device of claim 1 , wherein each of the conduit structure and the shunt structure comprises a shape memory material and is biased into an expanded configuration.

11. 11. The device of claim 1, wherein the conduit structure comprises a bifurcation between the constriction and the conduit outlet, the conduit structure further comprising an outlet downstream of the bifurcation.

12. 12. The device of claim 1, wherein the diameter of the conduit outlet is the same as the constricted lumen diameter.

13. The device of claim 1 , wherein the diameter of the conduit outlet is greater than the narrowed lumen diameter.

14. 14. The device of claim 1, wherein the narrowed lumen diameter is less than 0.8 times the diameter of the conduit inlet.

15. 1. A system for establishing fluid flow between fluid vessels of a patient, comprising: a conduit structure configured to be implanted within a first fluid vessel, the conduit structure comprising a conduit lumen extending between a first end of the conduit structure and a second end of the conduit structure, the conduit structure comprising a narrowed portion disposed between the first end and the second end, the narrowed portion having a diameter less than at least one of a diameter of the first end or a diameter of the second end; a shunt structure attached to the narrowed portion of the conduit structure and configured to be at least partially disposed within a second fluid vessel adjacent to the first fluid vessel; Equipped with the conduit structure is configured to draw fluid from the second fluid vessel into the first fluid vessel through the shunt structure; the shunt structure includes a lumen portion defining a shunt lumen configured to be in fluid communication with the conduit lumen; the lumen portion is disposed external to the first fluid vessel and the second fluid vessel; a first end of the lumen portion located within the first fluid vessel and configured to be attached to the narrowed portion of the conduit structure, and a second end of the lumen portion located within the second fluid vessel.

16. 16. The system of claim 15, further comprising a delivery catheter for removably receiving the conduit structure and the shunt structure, the delivery catheter configured to hold at least one of the conduit structure or the shunt structure in a compressed delivery configuration.

17. 17. The system of claim 16, wherein the conduit structure is self-expanding and the delivery catheter comprises a sheath configured to slidingly receive the conduit structure.

18. 17. The system of claim 16, wherein the delivery catheter comprises a radially expandable balloon configured to deploy the conduit structure within the first fluid vessel.

19. The system of claim 16 , wherein the delivery catheter is configured to deploy the shunt structure between the first fluid vessel and the second fluid vessel.

20. 20. The system of any one of claims 15 to 19, wherein the shunt structure comprises a shunt anchor configured to secure at least a portion of the shunt structure against a wall of the second fluid vessel.

21. 21. The system of claim 20, wherein the shunt anchor comprises a stent configured to be radially deployed in the second fluid vessel.

22. The system of claim 20 , wherein the shunt anchor comprises a disk-shaped configuration.

23. 23. The system of any one of claims 15 to 22, wherein the first fluid vessel is the aorta and the second fluid vessel is the inferior vena cava.

24. 24. The system of any one of claims 15 to 23, wherein the diameter of the narrow portion of the conduit structure is adjustable.

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