Transcaval Venturi

Abstract

The present application discloses a device that can provide a fluid connection between fluid vessels (such as between the inferior vena cava and the abdominal aorta). The device may 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 to the first fluid vessel. The conduit structure may include a stenotic section, and the shunt structure is fixed to the stenotic section and is fluidically connected thereto.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 835,610, filed on April 18, 2019, entitled “Transcaval Venturi,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the field of medical devices and medical procedures. Background Art

[0004] Congestive heart failure (CHF) affects a large number of people. In some cases of CHF, there may be systemic fluid congestion, such as that caused by right-sided heart failure. This can lead to shortness of breath, fatigue, and ultimately hospitalization.

[0005] Shunts between blood vessels are used to provide blood flow between blood vessels and to treat various conditions. One aspect of such a shunt is that blood flows through it. However, too little blood flow may not provide the desired treatment results, while too much blood flow may produce other complications. Summary of the invention

[0006] The present disclosure describes systems, devices, and methods for providing fluid connections between blood vessels, such as may be required to treat congestive heart failure and other conditions.

[0007] In some embodiments, the present disclosure relates to a device for providing 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, the outer wall defining a conduit lumen extending between a conduit inlet and a conduit outlet, and the conduit structure including a contraction portion positioned between the conduit inlet and the conduit outlet. The contraction portion includes a contraction lumen diameter that is smaller than the diameter of at least one of the conduit inlet or the conduit outlet. The device also includes a shunt structure, the shunt structure being configured to be at least partially implanted in a second fluid vessel adjacent to the first fluid vessel and being configured to be attached to the contraction portion of the conduit structure. The shunt structure includes a shunt lumen, which is configured to be in fluid communication with the conduit lumen.

[0008] The shunt lumen may include a shunt lumen diameter that is no greater than the contraction lumen diameter. For example, the shunt lumen diameter may be 0.8 or less of the contraction lumen diameter. In some embodiments, the shunt structure may include a shunt anchor configured to be fixed to at least a portion of the second fluid vessel. The shunt anchor may 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 may be the abdominal aorta and the second fluid vessel may be the inferior vena cava.

[0009] The conduit structure may include a self-expanding stent frame configured to radially expand to engage a wall of a first fluid vessel. For example, the self-expanding stent frame may have a delivery configuration and an expansion configuration, the self-expanding stent frame being biased toward the expansion configuration. In some embodiments, the conduit structure and the diverter structure may both include a self-expanding structure. The conduit structure and the diverter structure may both include a memory material and be biased toward the expansion configuration. In some embodiments, the conduit structure may include a bifurcation between a contraction and a conduit outlet, and the conduit structure may include an outlet downstream of the bifurcation.

[0010] In some embodiments, the diameter of the conduit outlet can be the same as the diameter of the contraction lumen. In addition, in some embodiments, the diameter of the conduit outlet can be larger than the diameter of the contraction lumen. The contraction lumen diameter can be less than 0.8 of the conduit inlet diameter.

[0011] In some embodiments, the present disclosure relates to a system for providing 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, and the conduit structure includes a stenosis portion disposed between the first end and the second end. The diameter of the stenosis portion is smaller than at least one of the diameter of the first end or the diameter of the second end. The system also includes a shunt structure, which is attached to the stenosis portion of the conduit structure and is 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.

[0012] The system may further include a delivery catheter that removably receives the conduit structure and the shunt structure and is configured to maintain at least one of the conduit structure or the shunt structure in a compressed delivery configuration. The conduit structure may be self-expanding, and the delivery catheter may include a sheath configured to slidably receive the conduit structure. The delivery catheter may include a radially expandable balloon configured to deploy the conduit structure within the first fluid vessel. The delivery catheter may be configured to deploy the shunt structure between the first fluid vessel and the second fluid vessel.

[0013] The shunt structure can include a shunt anchor configured to secure at least a portion of the shunt structure to a wall of a second fluid vessel. For example, the shunt anchor can include a stent configured to be radially deployed within the second fluid vessel. The shunt anchor can include a disc-like form. 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, the diameter of the stenotic portion of the conduit structure is adjustable.

[0014] In some embodiments, the present disclosure relates to a method for providing a fluid connection between fluid vessels. The method includes advancing a delivery catheter to a target location, the delivery catheter including a conduit structure and a shunt structure attached to the conduit structure; advancing the delivery catheter into an anatomical structure between a first fluid vessel and a second fluid vessel adjacent to the first fluid vessel; deploying the conduit structure in the second fluid vessel, the conduit structure including a first segment, a second segment, and a lumen extending through the first segment and the second segment, the diameter of the second segment being smaller than the diameter of the first segment; and deploying the shunt structure in the anatomical structure between the first fluid vessel and the second fluid vessel, wherein the shunt structure extends into the first fluid vessel and is connected to the second segment of the conduit structure.

[0015] Advancing the delivery catheter to the target location may include advancing the delivery catheter within the first fluid vessel. In some embodiments, the method may further include creating a passage within the anatomical structure between the first fluid vessel and the second fluid vessel. Advancing the delivery catheter into the anatomical structure may include advancing the delivery catheter into the passage. Deploying a shunt structure in the anatomical structure between the first fluid vessel and the second fluid vessel may include sealing the passage so that fluid flow through the passage is blocked except for fluid flow through the shunt structure.

[0016] Deploying the shunt structure in the anatomical structure between the first fluid vessel and the second fluid vessel may occur after deploying the conduit structure in the second fluid vessel. In some embodiments, the shunt structure includes an anchor, and the method further includes deploying the anchor in the first fluid vessel. Deploying the anchor in the first fluid vessel may occur after deploying the shunt structure in the anatomical structure between the first fluid vessel and the second fluid vessel. The first fluid vessel may be the inferior vena cava and the second fluid vessel may be the aorta.

[0017] Advancing the delivery catheter to the target location may include advancing the delivery catheter through the femoral vein and through the inferior vena cava. In some embodiments, the method may also include securing the shunt structure to the delivery catheter before advancing the delivery catheter to the target location. In addition, in some embodiments, the method may also include adjusting the diameter of the second section of the conduit structure when the conduit structure is deployed in the second fluid vessel. Adjusting the diameter of the second section of the conduit structure may include using a tensioning wire extending through the conduit structure to reduce the diameter of the second section of the conduit structure.

[0018] Deploying the conduit structure within the second fluid vessel may include radially expanding the conduit structure, and deploying the diverter structure in the anatomical structure between the first fluid vessel and the second fluid vessel may include radially expanding the diverter structure. In some embodiments, the conduit structure and the diverter structure are both self-expanding. In addition, in some embodiments, the delivery catheter includes a sheath, deploying the conduit structure within the second fluid vessel includes slidingly retracting the sheath relative to the conduit structure, and deploying the diverter structure in the anatomical structure between the first fluid vessel and the second fluid vessel includes slidingly retracting the sheath relative to the diverter structure.

[0019] It should be understood that each element disclosed herein can be used with any and all elements disclosed herein, even though a particular combination of elements may not be explicitly shown in the drawings herein. In other words, based on the interpretation of a particular device, a person skilled in the art should have no difficulty combining the features of certain devices in two such devices. Therefore, it should be understood that many elements are interchangeable and that the present disclosure encompasses all permutations thereof.

[0020] Other objects, features and advantages of the present disclosure will become apparent through consideration of the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a side view of an example device deployed within a patient according to one or more embodiments;

[0022] Figure 2A-2D depicts a side view, a first end view, a bottom view, and a second end view of an example device according to one or more embodiments;

[0023] Figure 3 Schematic images of example stent portions are depicted according to one or more embodiments;

[0024] Figure 4-1 depicts a front view of an example device having a single funnel-shaped portion according to one or more embodiments;

[0025] Figure 4-2 Described in accordance with one or more embodiments is a method of deploying a Figure 4-1equipment;

[0026] Figure 5 depicts a front view of a partial cross-section of a kidney undergoing treatment according to one or more embodiments;

[0027] Figure 6 depicts a side view of an example device according to one or more embodiments;

[0028] Figure 7A-7C depicts a cross-sectional side view of a stent-like frame portion according to one or more embodiments;

[0029] Figure 8A-8C depicts an end view, a perspective view, and a side view, respectively, of an example stent-like frame portion according to one or more embodiments;

[0030] Fig. 9 depicts a side view of an example device according to one or more embodiments;

[0031] Fig.10 depicts a side view of an example device according to one or more embodiments;

[0032] Figures 11A-11D depicts a schematic side view of a partial cross-section of an example device with a delivery catheter according to one or more embodiments;

[0033] Figures 12A-12D depicts a front view of a patient's anatomy during delivery and deployment of an example device according to one or more embodiments;

[0034] Fig.13 An example process for implanting a device within one or more blood vessels of a patient is described according to one or more embodiments; and

[0035] Fig.14 An example device having an anchor implemented as a stent is described in accordance with one or more embodiments. DETAILED DESCRIPTION

[0036] Although certain embodiments and examples are disclosed below, the subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and uses and modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any particular embodiment described herein. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described in sequence as multiple discrete operations in a manner that helps to understand certain embodiments; however, the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems, and devices described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily implemented by any particular embodiment. Therefore, for example, various embodiments may be performed in a manner that realizes or optimizes an advantage or a group of advantages as taught herein, without having to realize other aspects or advantages that may also be taught or suggested herein.

[0037] The term "associated with" is used herein according to its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is directly or indirectly physically coupled, attached or connected to, integrated into, at least partially embedded in, or otherwise directly or indirectly physically related to the second feature, element, component, device, or member.

[0038] The systems, devices and methods of the present disclosure can be utilized in various surgical procedures as well as minimally invasive procedures, percutaneous procedures and other procedures. In some embodiments, the methods, systems and devices can be delivered and deployed into the patient's arterial system (e.g., through the femoral artery or brachial artery) via a catheter.

[0039] Figure 1 According to one or more embodiments, a device 10 is shown that is configured to be deployed or implanted in adjacent fluid vessels such as a vein 12 (e.g., the inferior vena cava) and an artery 14 (e.g., the abdominal aorta). For ease of illustration, Figure 1The vein 12 and artery 14 are depicted in a cross-sectional view, and the device 10 is depicted in a non-cross-sectional view. The device 10 may include a shunt structure 16, 24 (also referred to as a "shunt portion 16, 24") configured to be implanted or deployed within an anatomical structure between the vein 12 and the artery 14 or at least partially within the vein 12 or artery 14. When implanted or deployed, the shunt structure 16, 24 may extend between the vein 12 and the artery 14 or at least partially into the vein 12 or artery 14. The device 10 may also include a conduit structure 18 (also referred to as a "stent portion 18") configured to be implanted or deployed within a fluid vessel (such as the artery 14 or vein 12 in some cases). The conduit structure 18 may be connected to the shunt structure 16, 24.

[0040] 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 form having a lumen therein. In some embodiments, the lumen portion 16 has a cylindrical, rectangular or other form. The lumen portion 16 may have a shunt inlet end 20 configured to be positioned or implanted in a vein 12, and a shunt outlet end 22 configured to be positioned or implanted in an artery 14, thereby providing a fluid passage between these blood vessels. The shunt inlet end 20 may be secured to the anchor portion 24, which may be a stent or similar structure suitable for being secured in the vein 12. The anchor portion 24 may help maintain the shunt inlet end 20 in a desired position, for example, 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 disc-shaped or conical form and may be referred to as a "disc-shaped or conical structure 24". In some embodiments, anchor portion 24 can be implemented as a stent adapted for deployment within vein 12 in a manner similar to stent portion 18 depicted as deployed within artery 14. shunt outlet end 22 can be secured to stent portion 18 deployed within artery 14.

[0041] Figure 2A-2D. The device 10 is depicted in more detail in . The stent portion 18 has a stent wall 26 extending between an inlet end 28 and an outlet end 30, wherein a stent lumen 32 passes through the stent wall 26 between the inlet end 28 and the outlet end 30. The stent inlet portion 34 and the stent outlet portion 36 can be separated by a tapered middle portion 38 (also referred to as a "narrowing portion 38" or "constricted portion 38"), and the stent lumen 32 narrows at the tapered middle portion 38. The tapered middle portion 38 defines an orifice 39 having an inner diameter 40b that is narrower than the inlet diameter 40a. It can also be narrower than the outlet diameter 40c. The inlet diameter 40a can depend on the specific application, such as the characteristics of the blood vessel in which the stent portion is deployed. For example, for a stent portion suitable for deployment in the intrarenal abdominal aorta, the inlet diameter 40a can be 1.5 to 4 cm. The orifice inner diameter 40b can be 0.90 or less of the inlet diameter 40a, 0.80 or less of the inlet diameter 40a, 0.70 or less of the inlet diameter 40a, 0.60 or less of the inlet diameter 40a, 0.50 or less of the inlet diameter 40a, 0.40 or less of the inlet diameter 40a, or less. Other sizes are also within the scope of the present disclosure.

[0042] The size of the stent portion 18 can be designed 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 can be adapted to match the inner diameter of the desired blood vessel when in a deployment configuration so that the stent wall 26 engages the wall of the blood vessel. Stent length 42 and diameter 44 can depend on a specific application, including a blood vessel in which the stent portion is to be deployed. For example, in abdominal aorta applications, stent length 42 can be 40 to 80 mm, and diameter 44 can be 1.5 to 4 cm. Other sizes are also within the scope of the present disclosure.

[0043] The lumen portion 16 can have a shunt lumen 46 extending between the shunt inlet end 20 and the shunt outlet end 22. The shunt lumen diameter 48 can be constant along the shunt length 50, or can vary along the length 50, such as by becoming tapered. In some embodiments, the anchor portion 24 can be sized to securely position the anchor portion 24 within the vein 12, but not substantially block blood flow through the vein 12. For example, the anchor portion 24 can have a diameter 52 sufficient to securely position the anchor portion 24 in a desired location in the vein 12 (e.g., the diameter 52 can be within a particular range, above or below a threshold, etc.), or can have a thickness 54 that is small enough (e.g., within a particular range, above or below a threshold, etc.) so that the anchor portion 24 does not extend too far into the vein 12 (e.g., does not extend beyond a particular distance), thereby preventing the anchor portion 24 from substantially blocking blood flow within the vein 12. The shunt length 50 may be sufficient to span the distance between adjacent blood vessels in which the device 10 is deployed, with the shunt lumen diameter 48 being selected to accommodate sufficient blood flow therethrough as desired for a particular application.

[0044] In some embodiments, any element of the device 10 (e.g., the conduit structure 18, the lumen portion 16, or the anchor portion 24) can be formed of a flexible material or a mesh or a wireframe structure (such as a stent or a stent-like structure). In an example, the flexible material or mesh or wireframe structure can maintain a specific form unless sufficient force is applied. In some embodiments, the flexible material or mesh or wireframe structure can be formed of metal, plastic, silicone, or other materials. In addition, in some embodiments, the flexible material or mesh or wireframe structure can include a covering (also referred to as a "liner") that can be disposed on an outer portion or an inner portion of the frame structure. Although the conduit structure 18 is shown in many figures as being implemented as a stent, the conduit structure 18 can take other forms. For example, the conduit structure 18 can be implemented as a substantially cylindrical or rectangular structure or tube formed of metal, plastic, or other material.

[0045] although Figure 1 and other figures depict the wall of artery 14 along stent portion 18 as having a substantially uniform diameter, but in some cases, the wall may be formed to the stenotic region of stent portion 18. For example, in some embodiments, after deployment of device 10 or over time, the wall of artery 14 near the stenotic region of stent portion 18 (e.g., where lumen portion 16 connects to stent portion 18) may deform or collapse inwardly toward stent portion 18 to conform to the outer wall of the stenotic region of stent portion 18. In other embodiments, the wall of artery 14 near the stenotic region may maintain a relatively uniform diameter, such as Figure 1 shown.

[0046] In some embodiments, the present disclosure describes systems, devices, and methods based on the Venturi effect, in which a reduction in fluid pressure occurs when the fluid flows through a constriction region of a lumen. Using the Bernoulli equation in the case of incompressible, non-viscous flows (such as the flow of water and other liquids), the theoretical pressure drop at such a constriction can be given by the following formula:

[0047] Q=v 1 A 1 =v 2 A 2

[0048] Where v = fluid velocity at points 1 and 2; A = cross-sectional area at points 1 and 2; and p = density.

[0049] In some embodiments of the present disclosure, the corresponding Bernoulli equation can be derived by the following formula:

[0050]

[0051] v 1 A 1 =v 2 A 2

[0052]

[0053] In some embodiments, the pressure at the orifice where blood is drawn through the shunt can thus be calculated as:

[0054]

[0055] Of which blood

[0056] Using the known values ​​(mean or average) of abdominal aorta pressure, velocity and diameter, the change in intra-orifice blood pressure P2 can be calculated for the various parameters:

[0057]

[0058] Figure 3 An example operating principle of one or more devices of the present disclosure is shown. Blood flow from the inlet portion 34 to the outlet portion 36 passes through the narrow tapered portion 38. Due to the increased velocity of the blood flow through the narrow tapered portion 38, the inlet portion blood pressure 56 and the outlet portion blood pressure are higher than the narrow portion blood pressure 58. The blood pressure drop 59 helps to pull blood from the vein into the stent portion through the shunt and into the artery, which can increase arterial pressure while reducing venous pressure.

[0059] In some embodiments, a stent according to the present disclosure may be hourglass-shaped (e.g., Figure 1 and Figure 2A-2D ), or may be other shapes. Figure 4-1 As depicted, the device 60 can have a support portion 62 having a single funnel-shaped portion 68, wherein the support portion 62 has a relatively wide inlet end 64 and a narrower outlet end 66. The outlet end 66 can be at the distal end of the tapered or funnel portion 68, wherein a diverter portion 70 (also referred to as a "lumen portion 70") terminates within a narrow orifice portion 72 at the downstream end of the tapered or funnel portion 68.

[0060] like Figure 4-2 As shown, device 60 (and other devices discussed herein) can be positioned in or between the patient's inferior vena cava 80 and abdominal aorta 82. In some embodiments, device 60 can be positioned distally of renal arteries 84 and renal veins 86, or can be positioned proximal to aortic bifurcation 88. However, device 60 and any other device discussed herein can be positioned in other locations, such as other locations within 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 or separated by a certain distance from each other).

[0061] When deployed to draw blood from the inferior vena cava into the abdominal aorta (such as Figure 1 , Figure 4-1 and Figure 4-2 As depicted), the device disclosed herein can improve Figure 5 The function of the kidney 90 shown. For example, the device can increase blood pressure in the abdominal aorta, which may cause increased blood pressure in the renal artery 92. Such deployment of the device can also reduce blood pressure in the inferior vena cava, which may cause decreased blood pressure in the renal vein 94. The combination of increased renal artery pressure and decreased renal vein pressure can increase blood flow through the kidney 90, which can improve renal function.

[0062] The stent portion can be in various forms. For example, the graft-like stent portion 100 can be formed of a plurality of stent-like portions 102a, 102b that are fixed to the liner 104 in a graft-like configuration, such as Figure 6 The size of the stent-like portion 102a within the narrow portion 106 of the stent portion 100 can be designed to have a smaller diameter than the diameter of the stent-like portion 102b within the wider portion 108 of the stent portion 100. The independent stent-like portions 102a, 102b can be expanded independently of each other, such as via independent release from a constraining catheter sheath or independent expansion via catheter balloon expansion. The graft-like stent portion 100 can be funnel-shaped (similar to Figure 4-1 , Figure 4-2 and Figure 6 depicted), hourglass-shaped (similar to Figure 1 depicted) or in other forms.

[0063] In some embodiments, the stent portion may include an elongated torus-like form. For example, a region of abrupt narrowing of the diameter may be provided in the device without having a plurality of openings on either side of the opening. Figure 1 and Figure 2A-2D The relatively large tapered section shown. For illustration, the narrow diameter lumen region can extend the entire length of the device or substantially the entire length of the device, such as Figure 7A-7C In some embodiments, to create a stent portion, a metal mesh tube 110 may be provided having a tube lumen 112 and having opposite ends 116a, 116b ( Fig. 7A ) of the tube wall 114. The opposite ends 116a, 116b may be inverted into the tube lumen 112 ( Figure 7B ) until the opposite ends 116a, 116b meet each other ( Figure 7C The opposing ends 116a, 116b may be secured to one another, such as by sutures, silk connections, or other means. The resulting stent portion 120 ( Figure 8A-8C ) can have an outer wall portion 122 defining a stent outer diameter 124 and an inner wall portion 126 defining a stent inner lumen 128. Relative inlet and outlet ends 130a, 130b are at opposite ends of the stent inner lumen 128, respectively. The diameter 132 of the stent inner lumen 128 can be narrower than the outer wall portion 122, thereby defining a stent inner lumen 128 that is narrower (e.g., substantially narrower) than the lumen of the vessel in which the device is implanted. In some embodiments, the stent portion 120 can have an open mesh, but with a sufficiently thick mesh braid (e.g., satisfying a braid parameter, range, threshold, etc.) to cause a majority of the blood flow to be diverted into the orifice or inner lumen 128, resulting in an increased blood flow velocity and reduced blood pressure within the orifice or inner lumen 128. Furthermore, in some embodiments, the stent portion 120 can be combined with a liner covering the inner wall portion 126 to divert blood flow (e.g., substantially all, a specified amount, etc.) 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 components (such as those depicted elsewhere in this application), wherein the inlet end of the shunt is secured to the inner wall portion 126 to provide a fluid connection through the shunt and into the orifice or inner lumen 128 to form a device.

[0064] In some embodiments, the support portion 140 can have an aperture 142 having an adjustable aperture diameter 144, such as Fig. 9As shown. The orifice diameter 144 can be adjusted via a lasso suture 146 or other mechanism capable of tightening and loosening the orifice 142 to change the orifice diameter 144. This adjustment can be particularly applicable to a stent portion 140 having a frame formed by a self-expanding material (such as, nitinol, etc.). The orifice diameter adjustment can be performed by a surgeon or other user, who can check the patient's hemodynamic response before, during, or after the device is deployed (e.g., using echo flow assessment, etc.) to evaluate the desired modification of the orifice diameter 144 provided using a lasso suture 146 or other mechanism. Such a lasso suture or mechanism can be combined with various deployment procedures, such as any deployment method disclosed herein. In such procedures and methods, the adjustment of the orifice diameter 144 can occur before the device is advanced into the patient's body, during the initial deployment, immediately after the initial deployment, or at a later time, such as after the delivery catheter has been completely removed from the patient's body. In some embodiments, the lasso may remain secured to the device for later adjustment of the aperture diameter 144, with the proximal end of the lasso positioned, for example, just outside the patient's body so that it is accessible to the user.

[0065] Fig.10 An example stent portion 150 is depicted in which a stent frame section 152 surrounding an orifice 154 is expandable. For example, the stent frame section 152 can be formed of stainless steel, cobalt chromium, a plastically deformable material, or other materials. The orifice diameter 156 can be adjusted by a surgeon or other user by introducing a balloon catheter into the orifice 154 and expanding the balloon to expand the orifice diameter 156. This orifice diameter adjustment can be performed by a surgeon or other user during or after an examination of the patient's hemodynamic response (e.g., using echo flow assessment, etc.), which may occur before, during, or after device deployment to assess the desired modification to the orifice diameter 156 provided using a balloon or other expansion mechanism. This expansion of the orifice diameter 156 can occur when the device is initially deployed in the patient, or can be performed after the device is deployed.

[0066] In some embodiments, it may be desirable to expand the orifice of the stent portion after initial deployment. For example, in the case where the stent frame or other structure around the orifice is formed by a deformable material, a surgeon or other user can use a balloon catheter or other expansion mechanism to expand the orifice to a wider diameter, including a wider diameter, such as when the orifice is expanded to a fully open position, for example, until it is as wide as the blood vessel before treatment, etc. In the case where the stent frame or other structure around the orifice is formed by a self-expanding material, a surgeon or other user can loosen or cut sutures or other expansion control mechanisms to quickly expand the orifice to a desired wider diameter. This orifice widening can be provided instead of or before removing the device from the patient. In some embodiments, removing the device from the patient can include pulling the device into a removal catheter, or back into a delivery catheter, such as via the use of sutures or other mechanisms capable of engaging the device and pulling it back into the catheter.

[0067] Figures 11A-11D An example system 160 including a device 162 and a delivery catheter 164 is shown according to one or more embodiments. The delivery catheter 164 has a distal end 166 and a proximal end 168, wherein the device 162 is fixed to the catheter 164 adjacent to the distal end 166. The catheter 164 has an elongated body 170 and can include a retractable sheath 172 that surrounds and protects the device 162 or a portion thereof, and the retractable sheath 172 can also prevent undesired expansion of the device 162 or a portion thereof (such as the case where the device 162 or a portion thereof self-expands). The catheter 164 can include a balloon 174 or other expansion mechanism capable of mechanically expanding a portion of the device 162.

[0068] In some embodiments, a handle 176 may be provided at the proximal end 168 of the catheter 164. The handle 170 may include controls, such as controls for retracting a sheath or for expanding or deflation of a balloon or other expansion mechanism.

[0069] Device 162 may include a first portion 180 for deployment in a first vessel, a second portion 182 for deployment in a second vessel, or a lumen portion 184 connecting first portion 180 and second portion 182 and adapted to extend between the first vessel and the second vessel. In some embodiments, second portion 182 or lumen portion 184 may form a shunt structure or shunt portion. Device 162 may include any device discussed herein.

[0070] In some embodiments, system 160 can be advanced into a patient to deploy device 162 in first blood vessel 190 and second blood vessel 192. Fig. 11BAs depicted, catheter 164 can be advanced into first vessel 190 via second vessel 192, which can be accomplished as catheter 164 passes through a passage 194 created by a surgeon, interventionalist, or other user between first vessel 190 and second vessel 192. Catheter 164 can be advanced such that first portion 180 of device 162 is positioned within first vessel 190 (e.g., abdominal aorta), second portion 182 is positioned within second vessel 192 (e.g., inferior vena cava), or luminal portion 184 is positioned within passage 194.

[0071] like Fig. 11C As shown, first portion 180 can be expanded (e.g., by retraction of sheath 172, release of lasso, or activation of expansion mechanism (such as balloon 174)) in a position within first blood vessel 190. Second portion 182 can then be released to expand or otherwise deploy (e.g., by retraction of sheath 172, release of lasso, or activation of expansion mechanism (such as balloon 174)) within second blood vessel 192 (e.g., adjacent to a wall thereof), as shown. Fig.11D In some embodiments, the shunt 184 can also be transformed into a deployed configuration, such as via radial expansion (e.g., by retraction of the sheath 172, release of the lasso, or activation of an expansion mechanism (such as the balloon 174)), 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 can be removed from the patient. Although the first portion 180 is in Fig. 11C and Fig.11D 180 is shown as having a substantially uniform diameter, but the first portion 180 can have a narrow region (e.g., where the lumen portion 184 connects to the first portion 180), as discussed similarly in other portions of the present disclosure.

[0072] After the device 162 is deployed at the desired location, an orifice diameter adjustment may be made, such as with respect to Fig. 9 and Fig.10 In some embodiments, such adjustments can be made using catheter 164 (e.g., using catheter balloon 174). In some examples, catheter 164 may not be removed from the patient until the desired adjustment to the orifice diameter is made. In some examples, the adjustments can be made in conjunction with an examination of the patient's hemodynamic response by a surgeon or other user (e.g., using echogenic flow assessment, etc.).

[0073] Although examples are discussed in the context of providing blood from the inferior vena cava to the abdominal aorta, any of the devices and methods discussed herein can be used to provide blood or another fluid from the abdominal aorta to the inferior vena cava or between other fluid vessels. Figures 11A-11CIn some embodiments of the background of the present invention, the first portion 180 of the device 162 can be deployed or positioned in the inferior vena cava, and the second portion 182 of the device 162 can be deployed or positioned in the abdominal aorta. Here, blood from the abdominal aorta can pass through the device 162 into the inferior vena cava.

[0074] Figures 12A-12D An example method of deploying a device 200 to provide blood flow from a second vessel, such as the inferior vena cava 204, into a first vessel, such as the abdominal aorta 202, is described according to one or more embodiments. In some embodiments, a guidewire can be advanced between the inferior vena cava 204 and the abdominal aorta 202 (e.g., using a snare technique in some cases). For example, Fig. 12A As depicted, the snare 206 can be advanced into the abdominal aorta 202 via the femoral artery 208 (such as via an incision in the patient leading to the femoral artery 208) to a location between the femoral artery bifurcation 210 and the renal artery 212. The guidewire 214 can also be separately advanced into the inferior vena cava 204 via the femoral vein 216 (such as via an incision in the patient leading to the femoral vein 216) to a location between the femoral vein bifurcation 218 and the renal vein 220. In some embodiments, the advancement of the guidewire 214 can include or be preceded by the advancement of a catheter or other element suitable for creating a passage 222 (e.g., by puncture) between the inferior vena cava 204 and the abdominal aorta 202. The guidewire 214 can be advanced through the passage 222 or create the passage 222 into the abdominal aorta 202 and engage with the snare 206. In some embodiments, the snare 206 can be used as a landmark or target to assist in guiding the guidewire 214 into the abdominal aorta 202 (e.g., used in conjunction with imaging to identify a target location that spans from the inferior vena cava 204 into the abdominal aorta 202). Additionally or alternatively, the snare 206 can be used to pull the guidewire 214 into the abdominal aorta 202. In some embodiments, once within the abdominal aorta 202, the guidewire 214 can be further advanced upward along the abdominal aorta 202 (i.e., toward the patient's heart), such as Fig. 12B In other embodiments, the guidewire 214 can remain proximate to the initial entry point into the abdominal aorta 202.

[0075] The delivery catheter 226 can be advanced via the femoral vein 216 (including via a puncture in the patient's body leading to the femoral vein 216) and into the inferior vena cava 204, through the passage 222, and into the abdominal aorta 202, as shown. Fig. 12C Advancing the delivery catheter 226 may include advancing the delivery catheter along or over the guidewire 214. The delivery catheter 226 may be similar to Figures 11A-11D As described in .

[0076] The device 200 can then be delivered via a delivery catheter 226 (e.g., using catheter sheath withdrawal, balloon dilation, etc., such as via Figures 11A-11D The device and method of use depicted and described) is deployed at the desired location. After the device 200 is properly deployed, the delivery catheter 226 or guidewire 214 can be withdrawn from the patient's body. Fig.12D The device 200 is depicted after the catheter has been withdrawn.

[0077] Fig.13 An example process 300 for implanting a device into one or more blood vessels in a patient's body is shown according to one or more embodiments of the present disclosure. In some embodiments, process 300 can be performed to implant a device into a first fluid vessel (such as the inferior vena cava) or a second fluid vessel (such as the aorta). For ease of discussion, many of the embodiments discussed below may involve the aorta and the inferior vena cava and implanting specific structures in the aorta and the inferior vena cava. It should be understood that process 300 can be used to implant structures into other fluid vessels, and the structure can be implanted in the aorta and the inferior vena cava in a manner different from that described below.

[0078] At block 302, a shunt structure or a conduit structure may be secured to a delivery catheter. For example, the shunt structure or conduit structure may be attached to a delivery catheter in a collapsed or other state for delivery of the structure within a human anatomy. The shunt structure or conduit structure may be attached to a delivery catheter prior to advancing the delivery catheter within a human anatomy.

[0079] 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 within the inferior vena cava to a desired location within the inferior vena cava where the delivery catheter will span into the abdominal aorta (e.g., through a channel, as discussed below). In some embodiments, the delivery catheter is advanced over or along a guidewire located within the human anatomy.

[0080] At block 306, a passage can be created between the first fluid vessel and the second fluid vessel. In some embodiments, a guidewire is used to create a passage between the first fluid vessel and the second fluid vessel, such as before a delivery catheter is advanced to a target location. Therefore, in some cases, block 306 can be performed before block 304. Alternatively or additionally, in some embodiments, a delivery catheter is used to create a passage. The first fluid vessel can be adjacent to the second fluid vessel, such as directly adjacent, within a specific distance, etc.

[0081] At block 308, the 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 the passage, and into the abdominal aorta.

[0082] At box 310, the conduit structure can be deployed in a second fluid vessel. For example, the conduit structure can be implanted in the abdominal aorta. In some embodiments, the delivery catheter includes a sheath. The conduit structure can be deployed by slidingly retracting the sheath relative to the conduit structure or radially expanding the conduit structure. In some embodiments, the conduit structure includes 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 can be less than the diameter of the first section. In addition, in some examples, the conduit structure can be self-expanding.

[0083] At box 312, a shunt structure can be deployed in an anatomical structure between a first fluid vessel and a second fluid vessel. For example, the shunt structure can be implanted in a passage or at least partially implanted in the inferior vena cava, wherein the shunt structure is connected to the conduit structure. In some embodiments, the delivery catheter includes a sheath. The shunt structure can be deployed by slidingly retracting the sheath or radially expanding the shunt structure relative to the shunt structure. In some embodiments, the shunt structure is self-expanding. In addition, in some embodiments, the shunt structure is deployed after the conduit structure is deployed.

[0084] At block 314, an anchor may be deployed within the first fluid vessel. For example, a 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. In addition, in some embodiments, deploying the shunt structure or deploying the anchor may seal (or include sealing) the channel so that fluid flow through the channel is blocked except for fluid flow through the shunt structure.

[0085] At box 316, the diameter of the conduit structure can be adjusted. For example, the diameter of the second section (e.g., the stenosis) of the conduit structure or another section of the conduit structure can be reduced or increased. In some embodiments, a tensioner can be used to reduce the diameter of the second section of the conduit structure. The tensioner can extend through the conduit structure. Alternatively or additionally, in some embodiments, a balloon on the delivery catheter can be used to increase or reduce the diameter of the second section of the conduit structure. The diameter of the conduit structure can be adjusted when the conduit structure is deployed in the second fluid vessel.

[0086] Fig.14An example device 400 having an anchor implemented as a stent is shown according to one or more embodiments. The device 400 may include a conduit structure 402 configured to be implanted within a first fluid vessel, such as an aorta 404, or a shunt structure 406, 410 configured to be implanted within a second fluid vessel, such as a vein 408, or within an anatomical structure between the first fluid vessel and the second fluid vessel. In an example, the device 400 may be configured to draw fluid, such as blood, from the vein 408 into the aorta 404 through the shunt structure 406, 410.

[0087] The conduit structure 402 may have an inlet end 418 (eg, a first end) and an outlet end 416 (eg, a second end) through which the stent lumen passes. The conduit structure 402 may have a narrow portion or section, such as Fig.14 4. The middle portion of the conduit structure 402 is shown in FIG. 4. It should be understood that the narrow portion or section may be located at other locations along the conduit structure 402. The narrow portion or section may have a smaller diameter than the inlet end 418 or the outlet end 416.

[0088] The shunt structures 406, 410 may include a lumen portion 410 or an anchor portion 406. The lumen portion 410 may have an elongated form having 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 within the artery 404 or connected to a stenotic section of the conduit structure 402. The anchor portion 406 may be configured to hold the lumen portion 410 in place, such as Fig.14 In this example, the anchor portion 406 is implemented as a stent that is configured to expand radially during implantation to contact one or more walls of the vein 408, such as Fig.14 In an example, the stent can include similar materials and structures as the tubing structure 402 (when the tubing structure 402 is implemented as a stent), except that there is no stenosis section. For example, the anchor portion 406 can include a flexible material or a mesh or wireframe structure. The anchor portion 406 can include a lumen to allow fluid to flow through the anchor portion 406 or into the lumen portion 410. In some embodiments, the anchor portion 406 can have a smaller length than the tubing structure 402, such as Fig.14 Although in other embodiments, the anchor portion 406 can have the same or greater length as the tubing structure 402.

[0089] Fluid vessels may include any anatomical structure capable of carrying a fluid, such as an artery, vein, capillary, etc. Although certain embodiments are disclosed herein with respect to blood vessels (e.g., vessels of the aorta or venous system), it should be understood that any disclosed device may be at least partially implanted in any vessel, organ, or chamber of a patient's anatomy, including any chamber 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 both.

[0090] The stent framework for one or more of the devices discussed herein can be formed of various materials, depending on the specific application and desired structure. For example, nitinol, cobalt chromium, stainless steel and other metals can be used, as well as polymers or other materials. In some embodiments, the stent framework can be cut (e.g., laser cut) from a tube or flat form, made of a circular piece formed into an expandable shape (such as a zigzag), made of a wire braid or other wire form, including a mesh structure, etc. The liner can be made of various materials, such as a braided material, a thin mesh material, etc. Example liner materials include fabrics, polymers, ePTFA, sutures, electrospun materials, and tissues (e.g., pericardium). Any of these frameworks or liner materials and any combination thereof can be used in any device depicted and described herein.

[0091] Various treatment modalities, including advancing a catheter into position via a sheath, are within the scope of the present disclosure. In some embodiments, the transcatheter approach is performed via the femoral artery. For example, the implantation procedure can be similar to a transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI) procedure using a transcaval approach.

[0092] In some example procedures for deploying the device, the femoral artery access is obtained via an access sheath, and the size of the access sheath is designed to be used in a TAVR procedure. An incision can be created in the patient's body, thereby guiding an internal blood vessel, such as a femoral artery. The distal end of the access sheath can be advanced through the incision and the femoral artery and enter the desired position in the aorta, wherein the hub is positioned outside the patient's body adjacent to the incision or access site. The guidewire can be advanced from the femoral access site (for example, in the case of deploying an artificial aortic valve, through the aortic arch and into the patient's left ventricle). The steerable shaft of the imaging catheter or delivery catheter can be advanced on the guidewire (such as via standard on-wire technology) to advance the distal end of the device to the target location. For example, the device can have a guidewire lumen. Echo, fluoroscope or other visualization techniques and electrophysiology 3D mapping techniques can be used. Such as by deploying the device at the target location, treatment or implant deployment can occur. Once the correct deployment is confirmed, the catheter can be removed from the patient's body, the guidewire can be removed from the patient's body, the sheath can be removed from the patient's body, and (one or more) incisions are closed, such as via suture closure.

[0093] As noted above, the present disclosure relates to devices, systems, and methods for providing fluid connections between blood vessels, such as may be desired to treat congestive heart failure and other conditions.

[0094] 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 suitable for being deployed in a first blood vessel (such as an artery), and is shaped to create a local low pressure in the first blood vessel, thereby pulling fluid from the second blood vessel (e.g., vein) into the first blood vessel through the shunt. The result is a reduction in the load on the second vascular system (e.g., venous system). When implanted between the abdominal aorta and the inferior vena cava, renal function may be improved due to the increased pressure in the abdominal aorta and the renal arteries, and the reduced pressure in the inferior vena cava and the renal veins.

[0095] In some embodiments, a device for providing 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 contraction 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 contraction portion may have a contraction lumen diameter. The contraction 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 blood vessel, wherein the stent wall radially engages the vessel wall of the first blood vessel. A shunt device may include a shunt portion, the shunt portion having a shunt inlet and a shunt outlet at opposite ends of the shunt portion, wherein the shunt lumen extends from the shunt inlet to the shunt outlet. The shunt outlet may be fixed to the stent contraction portion, wherein the shunt lumen is in fluid communication with the stent lumen, and the shunt portion extends from the stent portion in a non-parallel direction so that the shunt inlet is positioned away from the stent portion. The shunt lumen diameter may be no greater than or less than the contraction lumen diameter. The shunt lumen diameter may be 0.80 or less of the contraction lumen diameter.

[0096] A shunt device according to the present disclosure may include a shunt anchor fixed to a shunt inlet, wherein the shunt anchor is adapted to be positioned against a wall of a second vessel, such as the inferior vena cava. The shunt anchor may be an auxiliary stent, wherein the auxiliary stent is adapted to be radially deployed within the second vessel and in contact with the wall of the second vessel.

[0097] The stent portion may be self-expanding or may have a self-expanding stent frame, such as a memory metal frame formed of nitinol. The self-expanding stent frame may have a delivery configuration and an expanded configuration, and the self-expanding stent frame may be biased toward the expanded configuration. Both the stent portion and the diverter portion may be self-expanding, or both may be formed of a memory material, or may be biased toward the expanded configuration.

[0098] The flow diverter device may be adapted for deployment in a bifurcated section of a blood vessel.The stent portion may include a bifurcation between the constriction portion and the stent outlet, wherein the stent portion has an auxiliary stent outlet downstream of the bifurcation.

[0099] The stent exit lumen diameter may be the same as the contraction lumen diameter or may be significantly larger than the contraction lumen diameter.

[0100] In some embodiments, a system for providing blood flow between blood vessels of a patient may include any shunt device 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 suitable for maintaining the device in a compressed delivery configuration, wherein the distal portion and the elongated central portion are suitable for percutaneous advancement into the patient. The delivery catheter distal portion may have a sheath such as a stent portion, a shunt portion, or a shunt anchor portion suitable for slidingly receiving a shunt device when the shunt device or a portion thereof is self-expanding. The delivery catheter distal portion may include a radially expandable balloon suitable for radially expanding one or more portions of the shunt device.

[0101] The distal portion of the catheter can be adapted to be percutaneously advanced to the aorta via the femoral vein and the inferior vena cava and through a channel created between the inferior vena cava and the aorta.

[0102] In some embodiments, the method may include providing a fluid connection between blood vessels, which may include providing a system having a delivery catheter (such as those disclosed herein) and a shunt device (such as those disclosed herein). The method may include creating a connecting channel between a first blood vessel and a second blood vessel; advancing a distal portion of a catheter having a shunt device fixed thereto to a desired treatment site, the advancement comprising advancing the catheter distally through the first blood vessel, and wherein the shunt device fixed thereto is advanced through the connecting channel and into the second blood vessel; deploying a stent portion in the second blood vessel; and deploying the shunt portion in the connecting channel, wherein the shunt outlet is in fluid communication with the second blood vessel. Deploying the shunt portion in the connecting channel may occur after deploying the stent portion in the first blood vessel. In the case where the shunt device has an anchor device fixed to the shunt outlet, the method may further include deploying the anchor device in the second blood vessel. Deploying the shunt portion in the connecting channel may occur after deploying the stent portion in the first blood vessel, and deploying the anchor device in the second blood vessel may occur after deploying the shunt portion in the connecting channel.

[0103] After deploying the shunt portion within the passage or after deploying the stent portion within the first vessel, the passage extending between the vessels can be sealed by the shunt device such that fluid flow through the passage is prevented except for fluid flow through the shunt lumen.

[0104] The first blood vessel may be the aorta, and the second blood vessel may be the inferior vena cava. Advancing the distal portion of the catheter having the shunt device secured thereto to the desired treatment site may include advancing the distal portion of the delivery catheter through the femoral vein and into the inferior vena cava.

[0105] In some embodiments, the method may include securing a shunt device to a distal portion of a catheter, which may occur during manufacture of the system or may be performed by a surgeon, interventionalist, or other user prior to use of the system to deploy the shunt device into a patient.

[0106] The system may have a tensioning wire extending through the stent portion and adapted to adjust the contraction lumen diameter. In such a system, a method of deployment may include, after deploying the stent portion within a first blood vessel, applying tension to the tensioning wire to reduce the contraction lumen diameter.

[0107] Where the stent portion or the shunt portion is expandable (eg, self-expanding), deploying the stent portion within the vessel may include radially expanding the stent portion, and deploying the shunt portion within the connecting passage may include radially expanding the shunt portion.

[0108] For a self-expanding shunt device, the catheter distal portion may have a sheath. Deploying the stent portion within the vessel may include slidingly retracting the sheath portion relative to the stent portion, and deploying the shunt portion within the connecting passage may include retracting the sheath portion relative to the shunt portion.

[0109] In some embodiments, any element of any embodiment disclosed herein and its corresponding elements may be used with any other embodiment disclosed herein and its corresponding elements.

[0110] All dimensions listed are by way of example, and devices according to the present disclosure may have dimensions outside of those specific values ​​and ranges.The size and shape of the device and its elements may depend on the specific application.

[0111] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by ordinary technicians in the field to which the present disclosure belongs. In order to facilitate the review of various embodiments of the present disclosure, the following term explanations are provided:

[0112] The singular terms "a", "an" and "the" include plural referents unless the context clearly indicates otherwise. The term "or" refers to a single element or a combination of two or more elements of the alternative elements, unless the context clearly indicates otherwise.

[0113] The term "comprising" means "including". For example, a device comprising or including A and B contains A and B, but may optionally contain C or other components in addition to A and B. In addition, a device comprising or including A or B may contain A or B or A and B, and optionally one or more other components, such as C.

[0114] The term "subject" refers to humans 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.

[0115] 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 the event of a conflict, the present specification (including claims) shall prevail. In addition, the materials, methods and examples are illustrative only and not restrictive.

[0116] The above description of the embodiments of the present disclosure is not intended to be exhaustive or limit the present disclosure to the precise form disclosed above. Although specific embodiments and examples are described above for illustrative purposes, as will be appreciated by those skilled in the relevant art, various equivalent modifications are possible within the scope of the present disclosure. For example, although flow or square frame are presented in a given order, alternative embodiments can perform routines with steps, or adopt systems with square frames in different orders, and some flow or square frames can be deleted, moved, added, subdivided, combined, or modified. Each of these flow or square frames can be implemented in a variety of different ways. In addition, although flow or square frame are sometimes shown as serial execution, these flow or square frames can be executed in parallel instead or can be executed at different times.

[0117] Certain terms of position are used herein with respect to various disclosed embodiments. Although certain spatially relative terms (e.g., "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," "top," "bottom," and the like) are used herein to describe the spatial relationship of one device or element or anatomical structure relative to another device or element or anatomical structure, it should be understood that these terms are used herein for ease of description to describe the positional relationship between elements or structures, as shown in the accompanying drawings. In addition to the orientations depicted in the accompanying drawings, spatially related terms are intended to cover different orientations of elements or structures in use or operation. For example, an element or structure described as "above" another element or structure may represent a position below or beside such other element or structure relative to an alternative orientation of a subject patient or element or structure, and vice versa.

[0118] Conditional language used herein, such as "may," "could," "might," "would," "for example," and similar language, unless otherwise specifically stated or otherwise understood in the context of use, is intended to be used in its ordinary sense, and is generally intended to convey that some embodiments include and other embodiments do not include certain features, elements, or steps. Thus, such conditional language is generally not intended to imply that features, elements, or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether such features, elements, and steps are included or to be performed in any particular embodiment.

[0119] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, ordinal terms (e.g., "first", "second", "third", etc.) used to modify elements (e.g., structures, components, operations, etc.) do not necessarily indicate the priority or order of an element relative to any other element, but the element can generally be distinguished from another element with a similar or identical name (but used for ordinal terms). In addition, as used herein, indefinite articles ("one" and "an") may indicate "one or more" rather than "one". In addition, operations "based on" conditions or events performed may also be performed based on one or more other conditions or events that are not explicitly listed. In some contexts, the description of an operation or event that occurs or is performed "based on" or "at least partially based on" the event or condition may be interpreted as being triggered or performed in response to the event or condition.

[0120] With respect to the various methods and processes disclosed herein, although certain orders of operations or steps are shown and described, it should be understood that the various steps and operations shown and described may be performed in any suitable or desired temporal order. In addition, any operations or steps shown or described may be omitted from any given method or process, and the methods and processes shown or described may include additional operations or steps that are not explicitly shown or described.

[0121] It should be understood that in the above description of the embodiments, in order to simplify the disclosure and assist in the understanding of one or more of the various inventive aspects, various features are sometimes combined in a single embodiment, figure or description thereof. However, this disclosure method should not be interpreted as reflecting the intention that any claim requires more features than those explicitly stated in the claim. In addition, any component, feature or step shown or described in a specific embodiment herein may be applied to any other embodiment or used with any other embodiment. In addition, for each embodiment, no component, feature, step or group of components, features or steps is necessary or indispensable. Therefore, the scope of the present disclosure and the scope of protection claimed should not be limited to the above-mentioned specific embodiments, but should only be determined by a reasonable reading of the following claims.

[0122] Unless the context clearly requires otherwise, throughout the specification and claims, the terms "comprising," "including," "having," "containing," "covering," "consisting of," and similar terms are to be interpreted in an open and inclusive sense rather than in a closed, exclusive or exhaustive sense; that is, in the sense of "including but not limited to."

[0123] The term "coupled" as generally used herein means that two or more elements may be physically, mechanically or electronically connected or otherwise associated, directly or indirectly (e.g., via one or more intermediate elements, components or devices). In addition, when "herein," "above," "below," and words of similar meaning are used in this application, the application as a whole, including any disclosure incorporated by reference, should be taken as a whole, rather than referring to a specific portion of the disclosure. Where the context permits, words used in the singular or plural in this disclosure may also include the plural or singular, respectively.

[0124] As may be used herein, the terms "substantially" and "approximately" provide industry-accepted tolerances for their corresponding terms or correlations between items. For some industries, the industry-accepted tolerance is less than 1%, while for other industries, the industry-accepted tolerance may be 10% or higher. Other examples of industry-accepted tolerances range from less than 1% to 50%. Industry-accepted tolerances may correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise times and fall times, thermal noise, dimensions, signal errors, packet loss, temperature, pressure, material composition, or performance indicators. Within the industry, the tolerance difference of the acceptable tolerance may be greater than or less than the percentage level (e.g., the dimensional tolerance is less than approximately + / - 1%). Some correlations between items may range from less than the percentage level to a difference of several percentages. Other correlations between items may vary from a difference of several percentages to the magnitude of the difference.

[0125] One or more embodiments may have been described above with the aid of method steps that illustrate the performance of specified functions and their relationships. For ease of description, the boundaries and order of these function building blocks or method steps have been arbitrarily defined herein. Alternative boundaries and orders may be defined as long as the specified functions and relationships are properly performed. Therefore, any such alternative boundaries or orders are within the scope and spirit of the claims. In addition, for ease of description, the boundaries of these function building blocks may be arbitrarily defined. Alternative boundaries may be defined as long as certain important functions are properly performed. Similarly, flowchart blocks may also be arbitrarily defined herein to illustrate certain important functions.

[0126] To the extent used, the flow chart block boundaries and order may be defined in other ways and still perform certain important functions. Therefore, such alternative definitions of functional building blocks and flow chart blocks and order are within the scope and spirit of the present disclosure. Those of ordinary skill in the art will also recognize that in some examples, the functional building blocks and other illustrative blocks, modules and components herein may be implemented as shown or by discrete components, application specific integrated circuits, processors executing appropriate software and the like, or any combination thereof.

[0127] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely examples of the subject matter and should not be taken as limiting the scope of the disclosure.

Claims

1. An apparatus for providing 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 smaller than a diameter of the conduit inlet and the conduit outlet; as well as a shunt structure configured to be at least partially implanted within 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 comprising a shunt lumen configured to be in fluid communication with the conduit lumen at the constricted portion, The shunt structure includes a shunt anchor and a lumen portion configured to expand within the second fluid vessel, the lumen portion having a shunt inlet end and a shunt outlet, the shunt inlet end being connected to the shunt anchor so that the shunt inlet end is in fluid communication with the second fluid vessel, and the shunt outlet is connected to the contraction portion of the pipeline structure so that the shunt outlet is in fluid communication with the pipeline lumen at the contraction portion.

2. The apparatus of claim 1, wherein the shunt lumen comprises a shunt lumen diameter that is no greater than a diameter of the constriction lumen.

3. The apparatus of claim 2, wherein the shunt lumen diameter is 0.8 or less of the constriction lumen diameter.

4. The apparatus of claim 1, 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.

5. The apparatus of any one of claims 1-4, wherein the first fluid vessel is the abdominal aorta and the second fluid vessel is the inferior vena cava.

6. The apparatus of any one of claims 1-4, wherein the conduit structure comprises a self-expanding stent frame configured to radially expand to engage a wall of the first fluid vessel.

7. The apparatus of claim 6, wherein the self-expanding stent frame has a delivery configuration and an expanded configuration, the self-expanding stent frame being biased toward the expanded configuration.

8. The apparatus of any one of claims 1-4 and 7, wherein the conduit structure and the diverter structure each comprise a self-expanding structure.

9. The apparatus of claim 7, wherein the conduit structure and the diverter structure each comprise a memory material and are biased toward an expanded configuration.

10. The apparatus according to any one of claims 1-4, 7 and 9, wherein the duct structure comprises a bifurcation between the constriction and the duct outlet, and the duct structure further comprises an outlet downstream of the bifurcation.

11. The apparatus of any one of claims 1-4, 7 and 9, wherein the diameter of the conduit outlet is greater than the constriction lumen diameter.

12. The apparatus of any one of claims 1-4, 7 and 9, wherein the constriction lumen diameter is less than 0.8 of the diameter of the conduit inlet.

13. A system for providing fluid flow between fluid vessels of a patient, the system 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 stenosis portion disposed between the first end and the second end, the stenosis portion having a diameter that is smaller than at least one of a diameter of the first end or a diameter of the second end; as well as a flow diverter structure attached to the narrowed portion of the conduit structure and configured to be at least partially disposed in a second fluid vessel adjacent to the first fluid vessel; wherein the conduit structure is configured to draw fluid from the second fluid vessel into the first fluid vessel through the diverter structure, and The shunt structure includes a shunt anchor configured to expand within the second fluid vessel and a lumen portion having a shunt inlet end connected to the shunt anchor and a shunt outlet connected to the stenotic portion of the tubing structure.

14. The system of claim 13, further comprising a delivery catheter to removably receive the conduit structure and the shunt structure, the delivery catheter being configured to retain at least one of the conduit structure or the shunt structure in a compressed delivery configuration.

15. The system of claim 14, wherein the tubing structure is self-expanding and the delivery catheter comprises a sheath configured to slidingly receive the tubing structure.

16. The system of claim 14, wherein the delivery catheter comprises a radially expandable balloon configured to deploy the conduit structure within the first fluid vessel.

17. The system of claim 14, wherein the delivery catheter is configured to deploy the flow diverter structure between the first fluid vessel and the second fluid vessel.

18. The system of claim 13, wherein the shunt anchor comprises a stent configured to be radially deployed within the second fluid vessel.

19. The system of claim 13, wherein the shunt anchor comprises a disc-like form.

20. The system of any one of claims 13-19, wherein the first fluid vessel is the aorta and the second fluid vessel is the inferior vena cava.

21. The system of any one of claims 13-19, wherein the diameter of the narrow portion of the conduit structure is adjustable.

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