Implantable reservoir for improving compliance of blood vessel

Abstract

A vascular implant is provided for increasing the efficiency of blood flow through an aorta. The vascular implant includes a tubular shunt having a lumen for allowing blood to pass between an aorta and an inferior vena cava. An expandable reservoir is sized for placement in the inferior vena cava. The reservoir has a first region coupled to the tubular shunt and may include a second region formed with an exit port for allowing some blood to escape the reservoir into the inferior vena cava. The exit port reduces the possibility of stagnation in the reservoir. High pressure blood from the aorta temporarily passes through the tubular shunt and into the reservoir, such as during systole. When blood pressure reduces in the aorta, blood from the reservoir passes from the reservoir and through the shunt where it reenters the aorta, such as during diastole.

Description

Docket No.: ADV-23899WO01 IMPLANTABLE RESERVOIR FOR IMPROVING COMPLIANCE OF BLOOD VESSEL RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 669,105, filed July 9, 2024, the complete disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND

[0002] The present disclosure generally relates to the field of medical implant devices, including compliance-enhancing implant devices. Processes for fabricating membranes associated with such implant devices, as well as the material properties and / or characteristics thereof, can affect the efficacy of such implant devices in various respects. SUMMARY

[0003] Described herein are devices, methods, and systems relating to compliant, impermeable, and / or thrombus-resistant membranes for medical implant devices. Implant membranes of the present disclosure can be used for various types of implant devices, including compliance-enhancing tube / conduit (e.g., graft or other blood-flow conduit) or balloon type devices (e.g., vascular flow assist balloon devices).

[0004] In some implementations, aspects of the present disclosure relate to implant membranes including a textile scaffold component and a polymer coating and / or lamination component, wherein the polymer coating and / or lamination spans between fibers of the textile scaffold, thereby improving impermeability of the membrane. Either or both of the textile scaffold or the polymer coating and / or lamination can be elastic.

[0005] Textile and / or polymer components of membranes disclosed herein can be formed / applied over one or more mandrels, which may have a cylindrical shape (e.g., circular or elliptical cylinder) and may include one or more tapered portions, such as a tapered shoulder. When applying textile cloth / weaving over a mandrel with a tapered portion in fabricating a textile scaffold, certain implementations involve altering the textile’s weave structure, such as with respect to the number, angle, and / or material of the fibers, in a discrete or gradual / continuous manner in the area of the taper relative to a non-tapered (e.g., straight) area longitudinally adjacent to the tapered area, so as to maintain a consistent textile density in the straight and tapered portions, or establish a desired density for the tapered portion relative to the straight portion.Docket No.: ADV-23899WO01

[0006] Implant membranes as disclosed herein, such as membranes formed as blood- flow conduits or balloons, can advantageously provide compliance-enhancing characteristics for mimicking or improving compliance in a blood vessel associated with the implant device. In some implementations, implant membranes disclosed herein can provide compliance through elastic stretching and compressing of textile and / or polymer coating or lamination components of the membrane. Additionally or alternatively, compliance can be provided by implementing a non-circular stent or other mechanical component within or without a conduit or balloon membrane. For example, implant membranes of the present disclosure can include non- compliant textile scaffold or polymer coating or lamination components, wherein compliance- enhancing behavior of the implant membrane is provided through cyclical re-shaping of the conduit / balloon using a shape-set structure (e.g., frame) with a non-circular biased shape. Furthermore, membrane conduits / balloons disclosed herein can have certain radial reinforcement features associated with one or more segments thereof, which may comprise wire or stent reinforcement(s), for retaining conduit / balloon shape in areas otherwise at risk of collapsing or reshaping in an undesirable manner.

[0007] In some implementations, elastic tubular fabric scaffold components combined with polymer (e.g., polyurethane) layer(s) can provide a membrane that is fluid-tight (e.g., blood-tight), even after stretching. The textile scaffold can advantageously serve to maintain a seamless tubular shape and reduce crack penetration in the event of tearing. The polymer coating used can comprise water-based polymer, which can provide suitable biocompatibility features. In some implementations, an elastic or non-elastic textile may be fabricated (e.g., woven, braided, knitted) into a seamless tube and dipped or otherwise coated on one or more sides with a polymer coating or lamination, which may advantageously be elastic.

[0008] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0009] Any of the example methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and / or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascularDocket No.: ADV-23899WO01 system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic.

[0010] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.). BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0012] FIG.1 shows example cardiac and vascular anatomy.

[0013] FIGS.2A and 2B show side and axial cross-sectional views, respectively, of a compliant blood vessel experiencing compliant expansion and contraction over a cardiac cycle.

[0014] FIG.3 shows a vascular graft including an impermeable membrane according to some examples.

[0015] FIG.4 shows a vascular assist balloon implant including an impermeable membrane according to some examples.

[0016] FIG.5 shows a vascular bypass implant including an impermeable membrane according to some examples.

[0017] FIG.6 shows an arteriovenous shunt implant including an impermeable membrane according to some examples.

[0018] FIGS.7A and 7B show a cross-sectional view of a fluid chamber or conduit in circular and non-circular axial cross-sectional shapes, respectively.

[0019] FIGS.8A and 8B show perspective views of fluid containment devices comprising an impermeable membrane with a textile scaffold, with a non-circular re-shaping stent disposed within or without the membrane in accordance with some examples.

[0020] FIG.9 is a flow diagram illustrating a process for fabricating an impermeable membrane having a textile scaffold for an implant device in accordance with some examples.

[0021] FIGS.10A and 10B show a tubular membrane of an implant device in unassembled and assembled views, respectively, in accordance with some examples.Docket No.: ADV-23899WO01

[0022] FIG.11 is a flow diagram illustrating a process for fabricating an impermeable membrane having a textile scaffold in accordance with some examples.

[0023] FIG.12A shows a tubular elastic textile scaffold formed on a mandrel in accordance with some examples.

[0024] FIG.12B shows a tubular membrane of an implant device in accordance with some examples.

[0025] FIG.13A shows a compliance implant device implanted in vascular anatomy in a high-pressure stage of the cardiac cycle in accordance with some examples.

[0026] FIG.13B shows a cross-section of the compliance implant device of FIG.13A in accordance with some examples.

[0027] FIG.14A shows a compliance implant device implanted in vascular anatomy in a low-pressure stage of the cardiac cycle in accordance with some examples.

[0028] FIG.14B shows a cross-section of the compliance implant device of FIG.14A in accordance with some examples.

[0029] FIGS.15A and 15B illustrate a vascular implant for increasing the efficiency of blood flow through an arterial blood vessel (e.g., the aorta).

[0030] FIGS.16A, 16B, 16C, and 16D illustrate a coiled anchor cinching device and implantation procedure.

[0031] FIGS.17A, 17B, and 17C illustrate a spiraling anchor device configured to apply pressure against blood vessel walls to cinch the vessels and to seal the passageway between the blood vessels.

[0032] FIGS.18A and 18B illustrate examples of barbed anchoring devices.

[0033] FIGS.19A and 19B illustrate an expandable mesh shunt device.

[0034] FIGS.20A, 20B, 20C, 20D, 20E, and 20F illustrate different configurations for the exit port of a compliance device.

[0035] FIGS.21A and 21B illustrate effects on fluid ejection from exit port with different configurations of the opening. DETAILED DESCRIPTION

[0036] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0037] Although certain preferred examples are disclosed below, it should be understood that the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examplesDocket No.: ADV-23899WO01 described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0038] Certain reference numbers are re-used across different figures of the figure set of the present disclosure as a matter of convenience for devices, components, systems, features, and / or modules having features that may be similar in one or more respects. However, with respect to any of the examples disclosed herein, re-use of common reference numbers in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one having ordinary skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply similarity between referenced subject matter. Use of a particular reference number in the context of the description of a particular figure can be understood to relate to the identified device, component, aspect, feature, module, or system in that particular figure, and not necessarily to any devices, components, aspects, features, modules, or systems identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with common reference numbers can be interpreted to share characteristics or to be entirely independent of one another.

[0039] Where an alphanumeric reference identifier is used that comprises a numeric portion and an alphabetic portion (e.g., ‘10a,’ ‘10’ is the numeric portion and ‘a’ is the alphabetic portion), references in the written description to only the numeric portion (e.g., ‘10’) may refer to any feature identified in the figures using such numeric portion (e.g., ‘10a,’ ‘10b,’ ‘10c,’ etc.), even where such features are identified with reference identifiers that concatenate the numeric portion thereof with one or more alphabetic characters (e.g., ‘a,’ ‘b,’ ‘c,’ etc.). That is, a reference in the present written description to a feature ‘10’ may be understood to refer to either an identified feature ‘10a’ in a particular figure of the present disclosure or to an identifier ‘10’ or ‘10b’ in the same figure or another figure, as an example.Docket No.: ADV-23899WO01

[0040] Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to various examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s) / structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s) / structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position that is below or beside such other element / structure with respect to alternate orientations of the subject patient or element / structure, and vice-versa. It should be understood that spatially relative terms, including those listed above, may be understood relative to a respective illustrated orientation of a referenced figure. Vascular Anatomy and Compliance

[0041] Certain examples are disclosed herein in the context of vascular implant devices, and in particular, implant devices including fluid containment membranes having textile scaffolds. Such implant devices can be implanted / implantable in the aorta, for example. However, although certain principles disclosed herein may be particularly applicable to the anatomy of the aorta, it should be understood that fluid containment membranes in accordance with the present disclosure may be implanted at least in part in, or configured for implantation at least in part in, any suitable or desirable blood vessels or other anatomy, such as the inferior vena cava.

[0042] Anatomy of the heart and vascular system is described below to assist in the understanding of certain inventive concepts disclosed herein. FIG.1 illustrates an example representation of a heart 1 and associated vasculature having various features relevant to one or more examples of the present inventive disclosure. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood may be pumped toward the lungs and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.Docket No.: ADV-23899WO01 The pulmonary artery 11 includes a pulmonary trunk and left and right pulmonary arteries that branch off of the pulmonary trunk, as shown.

[0043] The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps / leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and, when functioning properly, closes during systole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3. A wall of muscle 17, referred to as the septum, separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0044] The vasculature of the human body, which may be referred to as the circulatory system, cardiovascular system, or vascular system, contains a complex network of blood vessels with various structures and functions and includes various veins (venous system) and arteries (arterial system). Generally, arteries, such as the aorta 16, carry blood away from the heart, whereas veins, such as the inferior vena cava 19 and the superior venae cava 18, carry blood back to the heart.

[0045] The aorta 16 is a compliant arterial blood vessel that buffers and conducts pulsatile left ventricular output and contributes the largest component of total compliance of the arterial tree. The aorta 16 includes the ascending aorta 12, which begins at the opening of the aortic valve 7 in the left ventricle of the heart. The ascending aorta 12 and pulmonary trunk 11 twist around each other, causing the aorta 12 to start out posterior to the pulmonary trunk 11, but end by twisting to its right and anterior side. Among the various segments of the aorta 16, the ascending aorta 12 is relatively more frequently affected by aneurysms and dissections, often requiring open heart surgery to be repaired. The transition from ascending aorta 12 to aortic arch 13 is at the pericardial reflection on the aorta. At the root of the ascending aorta 12, the lumen has three small pockets between the cusps of the aortic valve and the wall of the aorta, which are called the aortic sinuses or the sinuses of Valsalva. The left aortic sinus contains the origin of the left coronary artery, and the right aortic sinus likewise gives rise to the right coronary artery. Together, these two arteries supply the heart.

[0046] As mentioned above, the aorta 16 is coupled to the heart 1 via the aortic valve 7, which leads into the ascending aorta 12 and gives rise to the innominate artery 27, the left common carotid artery 28, and the left subclavian artery 26 along the aortic arch 13 beforeDocket No.: ADV-23899WO01 continuing as the descending thoracic aorta 14 and further to the abdominal aorta 15. References herein to the aorta may be understood to refer to the ascending aorta 12 (also referred to as the “ascending thoracic aorta”), aortic arch 13, descending or thoracic aorta 14 (also referred to as the “descending thoracic aorta”), abdominal aorta 15, or other arterial blood vessel or portion thereof.

[0047] Arteries, such as the aorta 16, may utilize blood vessel compliance (e.g., arterial compliance) to store and release energy through the stretching of blood vessel walls. The term “compliance” is used herein according to its broad and ordinary meaning, and may refer to the ability of an arterial blood vessel or prosthetic implant device to distend, expand, stretch, or otherwise deform in a manner as to increase in volume in response to increasing transmural pressure, and / or the tendency of a blood vessel (e.g., artery) or prosthetic implant device, or portion thereof, to recoil toward its original dimensions as transmural pressure decreases.

[0048] As referenced above, the systolic phase of the cardiac cycle is associated with the pumping phase of the left ventricle, while the diastolic phase of the cardiac cycle is associated with the resting or filling phase of the left ventricle. As shown in FIGS.2A and 2B, with proper arterial compliance, an increase in volume Δv will generally occur in an artery when the pressure in the artery is increased from diastole to systole. As blood is pumped into the aorta 16 through the aortic valve 7, the pressure in the aorta increases and the diameter of at least a portion thereof expands. A first portion of the blood entering the aorta 16 during systole may pass through the artery during the systolic phase, while a second portion (e.g., approximately half of the total blood volume) may be stored in the expanded volume Δv caused by compliant stretching of the blood vessel 16 from a non-expanded diameter dcto an expanded diameter de, thereby storing energy for contributing to perfusion during the diastolic phase. A compliant aorta may generally stretch with each heartbeat, such that the diameter of at least a portion of the aorta expands.

[0049] The tendency of the arteries to stretch in response to pressure as a result of arterial compliance may have a significant effect on perfusion and / or blood pressure in some patients. For example, arteries with relatively higher compliance may be conditioned to more easily deform than lower-compliance arteries under the same pressure conditions. Compliance (C) may be calculated using the following equation, where Δv is the change in volume (e.g., in mL) of the blood vessel, and Δp is the pulse pressure from systole to diastole (e.g., in mmHg):

[0050] ^ ^^^ ^^ (1)

[0051] In older individuals and patients suffering from heart failure and / or atherosclerosis, compliance of the aorta and other arteries can be diminished to some degree orDocket No.: ADV-23899WO01 lost. Such reduction in compliance can reduce the supply of blood to the organs of the body due to the decrease in blood flow during diastole. Among the risks associated with insufficient arterial compliance, a significant risk presented in such patients is a reduction in blood supply to the heart muscle itself. For example, during systole, generally little or no blood may flow in the coronary arteries and into the heart muscle due to the contraction of the heart which holds the heart at relatively high pressures. During diastole, the heart muscle generally relaxes and allows flow into the coronary arteries. Therefore, perfusion of the heart muscle relies on diastolic flow, and therefore on aortic / arterial compliance. Insufficient perfusion of the heart muscle can result in reduced cardiac output and / or elevated intra-cardiac pressures at rest or during stress. Systolic pressure in arteriosclerosis patients generally increases more than diastolic pressure, wherein less blood leaves the arterioles during diastole. Increases in peripheral resistance cause decreased peripheral run-off (i.e., reduced amount of blood leafing the arterioles), resulting in increases in arterial blood volume that can be detrimental to patient health. Vascular Prostheses Incorporating Compliant, Impermeable, and / or Thrombus-Resistant Materials

[0052] Examples of the present disclosure provide implants including fluid containment tubes or balloons that have membranes with textile scaffolding and polymer sealing layer(s) / coating(s). Any reference herein to a polymer coating can be understood to additionally or alternatively refer to a polymer (or other material) lamination, comprising one or more layers of laminate, or any other type of polymer sealant. In some implementations, fluid containment membranes with textile scaffolding and polymer coatings / laminations in accordance with the present disclosure are configured to change in volume in response to changing internal and / or external pressure conditions in a manner as to provide compliance characteristics. Example fluid containment devices of the present disclosure advantageously include textile scaffold structures coated or laminated on one or more sides thereof with fluid-impermeable layer(s)coating(s), such as polymer coating, wherein either or both of the textile or polymer layer components may be elastic to allow for stretching of the implant membrane.

[0053] Whereas certain implant components can include textile materials (e.g., graft textile tubes) that can seal over time through blood clotting, such solutions may not provide compliance and can therefore negatively impact fluid dynamics in the vasculature. The use of polymer membranes, in some instances, can be preferrable for providing implant wall impermeability compared to blood clot sealing. However, for certain implant components that include polymer materials that are at least partially elastic, there is generally an inverse relationship between elasticity and polymer tearing risk, and so the elasticity of the component may be intentionally limited to prevent undesirable tearing risk.Docket No.: ADV-23899WO01

[0054] Examples of the present disclosure advantageously provide impermeable composite implant fluid conduit / tube and / or balloon membranes configured to enhance / provide compliance for a target blood vessel. In some implementations, examples of the present disclosure include an elastic tubular fabric scaffold combined with one or more layers of elastic polymer sealant, such as a coating or lamination comprising polyurethane or other water-based polymer. The polymer sealant can provide blood impermeability even after stretching of the conduit / balloon. The use of a textile scaffold can serve to support a seamless tubular shape and reduce tear penetration in case of tearing of the textile scaffold and / or polymer sealant.

[0055] Various material compositions are disclosed herein for compliant, impermeable, and / or thrombus resistant membranes that can be used in a variety of different implant covering, conduit, and / or balloon applications (e.g., compliance-enhancing applications). For example, membranes having textile scaffolding and polymer sealant layer(s) / coating as disclosed herein can serve as a sealing skirt for a prosthetic heart valve (e.g., replacement aortic valve, mitral valve, tricuspid valve), a cover for a valve leaflet spacer and / or clip, a compliance- enhancing conduit or balloon, or any other implant application.

[0056] As a reference, certain graft and coronary replacement implants are made of non-elastic material and therefore reduce blood vessel compliance, resulting in increased pressures and afterloads. In some implementations, membranes of the present disclosure can be used with a tubular graft implant device, wherein such implant tubes can advantageously provide compliance in a manner as to enhance arterial compliance and / or reduce arterial compliance to a lesser degree compared to non-compliant solutions. That is, graft implant devices disclosed herein can include tubular conduit or stent structures configured to add back and / or increase compliance in the aorta or other arterial (or venous) blood vessel(s) to provide improved perfusion of the heart muscle and / or other organ(s) of the body. For example, graft implant devices of the present disclosure can include expandable and / or re-shapable tubes / conduits that, when implanted, are configured to increase in cross-sectional area / volume during high-pressure conditions, such as systole, and decrease in cross-sectional area / volume during low-pressure conditions, such as diastole, which serves to force blood through the target blood vessel segment by pushing the blood through the vessel as the tube volume reduces in connection with tube contraction induced by cyclical drops in blood pressure.

[0057] FIG.3 shows a compliance-enhancing graft implant device 30 anchored to a blood vessel segment 16 in accordance with some examples. The blood vessel segment 16 may represent a segment of a stiffened aorta or other blood vessel. Once the device 30 is implanted in the blood vessel 16, a portion of the blood vessel wall may be surgically excised to allow a compliant (e.g., elastically-expandable) tube 35 of the device 30 to expand to a diameter greaterDocket No.: ADV-23899WO01 than that of the relaxed blood vessel 16 to increase compliance of the blood vessel 16. Therefore, after resection, the graft 30 connects a first blood vessel portion 16a to a second blood vessel portion 16b of the target blood vessel 16. The device 30 can be used to manage blood flow in the target blood vessel.

[0058] The compliant tube 35 may comprise an elastic tubular conduit or other structure configured to change in cross-sectional area or volume between high- and low-pressure phases of the cardiac cycle to facilitate perfusion. The graft implant device 30 may include certain anchoring portions 31 on distal 31a and proximal 31b ends thereof. The tube 35 may be coupled to and / or integrated with the anchors 31 at the respective ends of the implant device 30. In some implementations, the anchors 31 comprise suture rings or stent frames. The anchors 31 may advantageously be implemented in a manner as to allow / provide for fluid sealing between the anchors 31 and the blood vessel 16. The conduit 35 may be exposed / free between the anchors 31 in the medial segment / portion oof the conduit 35, such that the conduit 35 can radially expand in such segment when not blocked / interfered with by another structure, such as the blood vessel wall or other structure of the implant 30. In some implementations, the anchors 31 do not include a separate suture ring or other anchoring structure, but rather the tube 35 may be sutured directly to the blood vessel wall.

[0059] The conduit 35 may be configured to radially expand, such that as blood within the channel 39 of the conduit 35 increases in pressure, such pressure increase may produce hoop stress in the walls of the balloon conduit 35, thereby producing elastic stretching of the conduit 35 to increase the volume of the conduit 35 and store elastic energy in the walls of the conduit 35. Such energy may be returned to the blood circulation as pressure levels in the channel 39 decrease, thereby permitting the stretched tube walls to contract to their relaxed / biased smaller-diameter shape, thereby reducing the volume of the channel 39 and pushing blood through the implant 30.

[0060] FIG.4 shows a vascular assist balloon implant 40 including an impermeable membrane 42 including textile scaffolding and elastic polymer coating according to some examples. The implant device 40 comprises a balloon 41 volume / form configured to become compressed and / or reshaped in response to increasing fluid pressure in a blood vessel or other chamber 16 in which the implant 40 is implanted. For example, the implant 40 may include a spheroid, cylindrical, or other-shaped balloon 41 form / volume configured such that pressure against / on an outer surface thereof causes the device to compress and / or reshape from a form having an expanded diameter to a compressed diameter, wherein subsiding pressure conditions allow for and / or cause the balloon 41 to re-expand to the expanded diameter. Such alternation between the expanded and compressed diameters can result in a change in volume occupied byDocket No.: ADV-23899WO01 the balloon component in correlation with changing pressure conditions, wherein such change in volume can reduce systemic pressure and / or flow during high-pressure conditions (e.g., systole) and increase fluid pressure and / or flow during lower-pressure conditions (e.g., diastole). Such effects on the systemic flow in the vessel 16 can increase compliant characteristics of the blood vessel 16 in the case where the compliance thereof has been compromised due to aging and / or other conditions. When compressed, the balloon 40 may store energy associated with the biasing of the shape thereof toward the expanded configuration shown, such that such energy may be returned to the blood circulation as pressure subsides, thereby increasing flow therein.

[0061] The balloon 41 is shown as an example axial compliance-enhancing implant device, wherein the balloon 41 is aligned with and / or overlaps a central axis of the blood vessel 16, such that blood flow through the portion of the blood vessel 16 shown passes through the blood vessel in the area around the spheroid form of the balloon 41. Although shown and described as an axial implant device, it should be understood that compressible devices similar to the balloon 41 may be implanted within a target blood vessel in a non-overlapping position with respect to the axis of the blood vessel 16. Any of the example compliance-enhancing implant balloon devices of the present disclosure may be similar in one or more respects to the implant device 40, with respect to shape, configuration, components, and / or other aspects / features thereof.

[0062] The balloon 41 may be anchored within the target blood vessel 16 in any suitable or desirable manner. For example, one or more stents or other anchors 44 may be deployed within the blood vessel 16, wherein such anchors hold the balloon 41 in the desired position within the blood vessel 16. In some implementations, a plurality of separate, serially- connected balloons may be used.

[0063] The balloon 41 can comprise compressible gas or other compressible medium / media in the internal space thereof, wherein compression of such media provides the change in volume and stored energy for introducing compliance to the blood vessel in which the device is implanted. Compressible gases used in compliance-enhancing balloon devices of the present disclosure can be any inert and / or biocompatible gas. In some implementations, carbon dioxide gas is used. In some implementations, compliance-enhancing balloon devices of the present disclosure can be vacuum-sealed, wherein the space within the balloon comprises a vacuum. Such compliance-enhancing balloon devices may include an inner or outer frame configured to hold the balloon shape, wherein a covering / sealing seals the space within the frame in a manner that holds a vacuum space / volume therein.

[0064] FIG.5 shows a vascular bypass implant 50 including a conduit 52 formed at least in part by an impermeable membrane 53 according to some examples. The conduit 52 canDocket No.: ADV-23899WO01 be a compliant bypass conduit configured to bypass flow from the aorta and / or other arterial blood vessel 16 into the inferior vena cava 19 and / or other venous blood vessel, such that aortic / arterial blood passes through a portion of the venous blood vessel(s). By bypassing arterial blood flow through a compliant fluid conduit disposed at least in part within a venous blood vessel, arterial compliance can be increased in a manner that presents a reduced risk of clotting / embolism formation compared to certain other compliance-restoration solutions. Furthermore, with the body of the fluid conduit 52 disposed within a venous blood vessel, as opposed to external to the vasculature, incidences of blood leakage and / or rupture of the container may be contained within the blood vessel(s), thereby reducing hazards associated with extravascular arterial blood leakage within the abdominal and / or chest cavity. The vascular bypass implant 50 can be implanted using a transcaval delivery / access, thereby allowing for delivery system components and / or other working instruments to be advanced through the venous system (e.g., inferior vena cava), rather than the arterial system, which can allow for relatively larger-profile devices / systems to be used and / or otherwise provide a relatively safer access and procedural implementation for implantation of the device(s).

[0065] In some implementations, the bypass implant 50 is implanted in a manner as to provide a blood flow bypass channel into which blood may flow from the artery (e.g., aorta) 16 into the conduit portion 52 disposed within the venous blood vessel 19 and back out into a downstream area of the artery 16. The bypass conduit 52 is advantageously compliant. For example, the membrane 53 may comprise an elastic textile scaffold and polymer coating composite, as described in detail herein, and / or may have a conduit re-shaping stent / structure disposed within or without the conduit 52, as described in detail herein. In some examples, the membrane 53 of the conduit 52 is configured to expand with respect to one or more dimensions during systole and store energy that is released when the bypass conduit 52 contracts or otherwise deforms during diastole in response to changes in pressure in the arterial blood vessel 16 and / or venous blood vessel 19. Port structures can be associated with the inlet and outlet ends of the conduit 52 that are configured to facilitate a seal between the openings of the arterial wall and the venous wall and the implant device 50. The port structures can be configured to maintain the opening(s) in the arterial and venous walls and may comprise certain wall anchor structure(s) (e.g., memory metal frames).

[0066] Although the vascular bypass implant 50 is illustrated as a tubular bypass structure, it should be understood that the implant 50 may have any suitable or desirable shape or form. For example, the implant 50 may have a pouch-type form that may not necessarily be tubular in shape. Furthermore, although the implant 50 is described as a bypass structure, in some examples, the implant may not provide bypass blood flow from an upstream port / openingDocket No.: ADV-23899WO01 in the arterial blood vessel to a downstream port / opening in the arterial system, but rather may circulate blood into the structure of the membrane 53 through a port / opening through the arterial wall, wherein blood is introduced back into the arterial system through the same port, such that substantially no segment of the arterial system is bypassed through the device.

[0067] FIG.6 shows an arteriovenous shunt implant 60 including a shunt balloon conduit 62 comprising a composite membrane 63 having a textile scaffold and a polymer membrane (e.g., coating or lamination) according to some examples. Like the example of FIG.5, the shunt implant 60 of FIG.6 provides an inlet port 64 in an arterial blood vessel (e.g., aorta), wherein blood may flow from the arterial blood vessel 16 into the conduit 62, which can be disposed at least in part within a venous blood vessel 19 (e.g., inferior vena cava). The port 64, as with other examples herein, may have associated therewith an anchoring stent or other anchoring / sealing structure. The port 64 can have a nitinol or other metal / material docking stent structure associated therewith.

[0068] The shunt conduit 62 may have a form and / or function of a balloon. The shunt conduit 62 can comprise an elastic membrane including elastic textile scaffolding and / or polymer coating, as described in detail herein. In some implementations, at least a portion of the length of the shunt conduit 62 has a re-shaping stent associated therewith, which can cyclically re-shape the shunt conduit 62 between more-circular and less-circular cross-sectional shapes to assist in providing compliant volume change as described herein.

[0069] In operation, during high-pressure conditions in the arterial system, blood may be forced into the conduit 62 through the port 64, thereby shunting arterial blood into the volume of the venous blood vessel 19 contained within the compliant conduit 62. The elasticity of the membrane 63 and / or the shape of a re-shaping stent around or within the conduit 62 can store energy during systole and push volume back into artery 16 during low-pressure conditions (e.g., diastole). During low-pressure conditions, blood may further be shunted into the venous blood flow through a nozzle 65 of the implant 60, which may be narrower than the diameter of the conduit 62 and / or the inlet passage of the port 64 in some examples. In examples in which the nozzle 65 is narrower than the body of the conduit 62, the conduit may taper down to the nozzle diameter over a tapered segment 66, as shown. The nozzle 65 may advantageously provide a relatively small orifice at the distal end of the conduit 62 that allows a relatively small volume of blood to exit the conduit 62 into the venous blood vessel 19 to prevent interior clotting. The membrane 63 associated with the conduit body portion 67, tapered portion 66, and / or nozzle portion 65 may comprise textile scaffolding and polymer coating as described in detail herein.

[0070] Although described as elastically-expandable conduits / balloons in some contexts herein, it should be understood that compliant conduits / balloons of the presentDocket No.: ADV-23899WO01 disclosure can comprise frames that are configured to reshape from more-circular axial cross- sectional shapes to less-circular axial cross-sectional shapes, which can provide for compliant volume change without necessarily requiring elastic expansion. For example, for a non- stretchable tube, generally, the greatest area / volume of the tube may be present / achieved when the tube forms a circular cross-sectional shape. Diverging from a circular cross-sectional shape can produce a cross-sectional area / volume for a tube that is less than the maximum, circular area. Therefore, transitioning a conduit / balloon from a more-circular shape to a less-circular shape can provide a reduction in area / volume of the tube, and therefore solutions that utilize compliant tubes that are configured to transition between more-circular and less-circular (e.g., oval) shapes between cardiac phases can provide compliance characteristics without the need for elasticity in the tube. Any conduit or balloon described herein as including an elastically stretchable / expandable membrane can be understood to possibly be implementable using a conduit / balloon that changes shape between more-circular and less-circular shapes as an alternative to, or in addition to, stretching / expanding of a perimeter thereof. For example, tubular frames may be implemented, wherein the frame has a non-circular (e.g., oval) biased cross- sectional shape, which may be implemented using shape-memory / superelasticity characteristics of the frame; increases in luminal pressure in the conduit / balloon that the frame is disposed on / in can overcome the non-circular shape bias of the frame to allow for the conduit / balloon to circularize and thereby produce an increase in volume of the conduit / tube.

[0071] FIGS.7A and 7B show a cross-sectional view of an implant 70 including a fluid chamber (e.g., balloon chamber) or conduit 72 with a re-shaping stent 79 disposed thereon, wherein the stent 79 and chamber / conduit 72 are shown in circular and non-circular axial cross- sectional shapes, respectively. The non-circular (e.g., oval- and / or peanut-shaped) stent 79 is configured to generate a differential cross-sectional area or volume of the fluid conduit / balloon 72 between high- and low-pressure phases of the cardiac cycle to cause the conduit / balloon 72 to behave in a compliant manner.

[0072] FIG.7A shows the example conduit / balloon 72 having a generally circular cross-sectional shape, such that the area Acthereof is maximized for the given perimeter / wall- length Pa. In the circular configuration, the diameter da is substantially constant at every angle about the axis of the vessel. The circular shape of the conduit / balloon 72 in FIG.7A may be set or permitted by the shape of the stent 79 disposed about the conduit / balloon 72.

[0073] Diverging from a circular cross-sectional shape can produce a cross-sectional area / volume for a conduit / balloon that is less than the maximum area Acshown in FIG.7A. For example, FIG.7B shows the conduit / balloon 72 having a shape that resembles an oval / ellipse (or other non-circular shape; e.g., peanut shape), which produces the cross-sectional area Aothat isDocket No.: ADV-23899WO01 less than the area Ac with the same wall / perimeter length Pa. The oval shape of the conduit / balloon 72 may have a major axis amhaving a dimension that is greater than a dimension of the minor axis an thereof. The oval shape of the conduit / balloon 72 may be set / forced by the stent 79, which may have a biased non-circular shape.

[0074] With further reference to FIGS.7A and 7B, due to the area Ao of the oval conduit / balloon being less than the area Ac of the circular configuration shown in FIG.7A, transitioning from the circular shape to the non-circular shape, can provide a reduction in area / volume of the conduit / balloon, and therefore use of the shape-biased stent 79 can provide compliance characteristics without the need for elasticity in the membrane material of the conduit / balloon.

[0075] The configurations of the implant device 70 of FIGS.7A and 7B are shown as an example demonstrating how compliance of a conduit / balloon structure of the present disclosure can be provided with or without elastically-expandable conduit / balloon membranes by covering / lining such membranes with frames that are configured to reshape from more-circular axial cross-sectional shapes to less-circular axial cross-sectional shapes, which can provide for compliant volume change without necessarily requiring elastic expansion. Transitioning a conduit / balloon from a more-circular shape to a less-circular shape can provide a reduction in area / volume of the conduit / balloon, and therefore solutions that utilize a compliant conduit / balloon that is configured to transition between more-circular and less-circular (e.g., oval) shapes between cardiac phases can provide compliance characteristics without the need for elasticity in the conduit / balloon membrane. Any conduit / balloon example described herein as including an elastically stretchable / expandable membrane can be understood to possibly be implementable using a conduit / balloon that changes shape between more-circular and less- circular shapes as an alternative to, or in addition to, stretching and expanding / increasing with respect to a perimeter thereof.

[0076] Compliance-enhancing frames having a non-circular biased cross-sectional shape, which may be implemented using shape-memory / superelasticity characteristics of the frame, can be implemented in any biased shape, such as an oval shape or a peanut shape, as described below. FIGS.8A and 8B show perspective views of fluid containment devices 70o, 70p comprising an impermeable membrane with a textile scaffold and polymer coating, with a non- circular re-shaping stent 79o, 79p disposed within or without the membrane of the conduit / balloon 72 in accordance with some examples. Although oval- and peanut-shaped stents / frames 79 are shown and described, it should be understood that the principles of the present disclosure may relate to frames having any non-circular shape in at least some configurations thereof (e.g., in a relaxed / biased configuration). Descriptions of frames in aDocket No.: ADV-23899WO01 relaxed or biased configuration should be understood to relate to a configuration that a stent naturally assumes in the absence of tension on the stent wall(s) from external forces (e.g., ambient fluid pressure, physical contact forces, etc.). For example, the biased / relaxed shape of the stent may be due to shape memory of the stent and / or frame thereof.

[0077] The frame 79o may be considered an oval stent with respect to the shape of the axial cross-section thereof. The term “oval” is used herein according to its broad and ordinary meaning and may be used substantially interchangeably with the term “ellipse” and / or “oblong,” which terms are likewise used according to their broad and ordinary meanings.

[0078] The shape of the frame 79p shown in FIG.8B deviates from the frame 79o shown in FIG.8B only in that the minor-axis (e.g., relatively flat and / or long) sidewalls of the frame 79pdeflect to a greater degree towards the center / axis of the frame in a relaxed state. The resulting shape may resemble that of an hourglass and / or peanut with respect to the axial cross- section. Furthermore, frame 79pmay have a minor axis dimension that is non-constant along the major axis dimension, which forms an externally-concave / internally-convex surface / form with respect to the minor axis sidewalls. For example, the minor axis sidewalls 78 may have a diameter dimension at a center thereof (with respect to the major axis dimension) that is less than the diameter / dimension at / towards the end portions of the minor-axis sidewalls 78. Non-circular stents of the present disclosure that have externally-concave / internally-convex minor-axis sidewalls as shown in FIG.8B are referred to herein as peanut-shaped stents; such peanut shape can be considered a variation of an oval, or oval-shaped, stent as described herein. The inwardly- deflected walls 78 can allow for a transition reshaping between peanut-shaped, to outwardly- bowed oval shape, and ultimately to a circular / more-circular shape.

[0079] Textile-based conduit / balloon structures that are impermeable to blood and also provide material compliance / elasticity in accordance with aspects of the present disclosure can be manufactured in various ways. For example, composite tubular textile structures can be fabricated using various yarns, fabric design patterns, and dimensions, and various fabrication methods like weaving, braiding, knitting and crocheting. Furthermore, various types of elastic coating / lamination polymers can be used to produce desired sealing and / or elasticity properties. In some examples, elastic tubular fabric can be combined with elastic coated polymer layer(s) to produce effective implant membrane physical characteristics (e.g., tensile strength). Textiles described herein may be fabricated by constructing or forming fibers into a fabric, cloth, or other textile. Such textiles can be constructed / formed by interlacing fibers using any suitable or desirable braiding, weaving, or knitting process. Any reference herein to a process or product associated with one of a group including braiding, weaving, or knitting can be interpreted to refer to any other of the listed processes of the group. That is, any description of weaving, braiding, orDocket No.: ADV-23899WO01 knitting herein can refer to particular aspects of the referenced process / product, or the term can be considered interchangeable with any of the other listed processes / products, depending on the desired implementation.

[0080] FIG.9 is a flow diagram illustrated a process 900 for fabricating an impermeable membrane having a textile scaffold and polymer coating / lamination in accordance with some examples. The description below of the process 900 of FIG.9 can be understood in some aspects with respect to the images of FIGS.10A and 10B, which show tubular membranes of a two-piece conduit assembly 80 of an implant device in accordance with some examples.

[0081] The process 900 can be implemented to produce custom textile shapes, such as tubular textile structures having relatively sharp tapering features. The process 900 can further be implemented to produce three-dimensional woven tubular structures that allow for reduced suture seams, providing improved implant integrity, durability, and less risk of leakage or embolism formation. The use of polymer sealant (e.g., thermoplastic polyurethane film) on textile scaffolds as described in detail herein can provide enhanced impermeability.

[0082] The process 900 can be implemented to produce a textile and polymer composite tube structure, which can serve as a balloon or blood flow conduit structure for an intravascular implant device. In some implementations, polymer-coated textile implants of the present disclosure can be constructed as two-piece (or three or more pieces) structures / assemblies, wherein the multiple woven pieces can be joined together to form an integrated implant structure / assembly.

[0083] Conduit / balloon implant composite membranes as described herein can include textile scaffolding components / features, which comprise fibers or fiber segments braided to form a three-dimensional tubular structure. The term “fiber” is used herein according to its broad and ordinary meaning and may refer to any elongated piece of material, which may be spun into yarns, twisted into cords, braided to form strings, or otherwise configured. The term “fiber” can refer to any type of filament, thread, strand (e.g., bunch or assembly of filaments), cord, wire (e.g., metallic form), yarn, string, rope, ribbon, floss, or the like. “Fibers” effectively captures the variety of materials and constructions (such as twisted, braided, or woven) that can make up a braided, woven, or knitted textile scaffold associated with an implant device. The term “fiber,” or any of the related terms recited above, can be understood to refer to a segment of a fiber or to an entire length of a fiber. That is, “fibers” may refer to different segments of a single strand or length of fiber. The terms “associated” and “associated with” are used herein according to their broad and ordinary meanings. For example, where 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 as indicating that the firstDocket No.: ADV-23899WO01 feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0084] At block 902, the process 900 involves fabricating / interlacing fibers (e.g., fiber segments) to form cylindrical barrel 87 and tapered 82, 86 portions of a body piece 81 of an implant conduit in a seamless, three-dimensional tubular form / shape. The implant conduit can be implemented as a sealed balloon or a passthrough fluid conduit, as described herein. The fibers can be elastic or inelastic. In the case of elastic fiber textile scaffolding, the textile scaffold can elastically stretch in response to increased luminal pressures within the conduit / balloon or contract in response to increased pressures without the conduit / balloon, thereby operating in a similar manner as a compliant blood vessel. In the case of non-elastic faber textile scaffold, compliance features can be implemented by way of re-shaping stents disposed one the outside or inside of the barrel portion 87. The textile scaffold can be fabricated (e.g., woven) with or without a mandrel.

[0085] The textile scaffold 801 (see FIG.10A) can be fabricated from fiber segments (e.g., fibers / segments 801a, 801b) into a tubular form. The textile scaffold 801 can advantageously be fabricated in a manner as to maintain similar fiber density in the barrel and tapered portions, thereby providing more uniform flexibility, thickness, and / or other characteristics throughout the conduit piece 81. The textile scaffold 801 can be fabricated by braiding, weaving and / or knitting methods. As described herein, description of textile segments with similar or matching fabric density may be understood to indicate that the fabric density between the referenced textile segments is within 10% with respect to loops / courses / ends / picks- per-inch. In order to maintain similar fabric density in differently-shaped textile segments, the weave configuration in each of the segments may be different to produce similar density in differently shaped planes.

[0086] With respect to examples of the process 900 implementing fabrication of textile scaffolds using weaving techniques, such textile scaffolds may advantageously be fabricated using a V-reeds weaving loom incorporating V-reeds reed structure. For example, part of the loom used to separate the warp threads and to guide the weft thread as it is inserted across the loom (i.e., the reed) can resemble a comb with relatively fine teeth, and can be placed in a beater that strikes or beats the weft into place. The implemented V-reed weaving loom can produce “V” shaped reeds, which can help in controlling and managing high-density weaving and efficiently handling the warp fibers, improving the textile quality by ensuring even spacing and tension across the warp. Such implementations can be particularly beneficial for fabricsDocket No.: ADV-23899WO01 requiring tight specifications and high precision, as contemplated for textile scaffolds in accordance with the present disclosure, such as the textile 801 of FIGS.10A and 10B.

[0087] The two-piece conduit structure 80 includes a body piece 81 and a nozzle piece 85. The body piece 81 can be a high-density tube. The textile scaffolding 801, as referenced above, can be non-compliant / non-elastic in terms of the material of the fibers thereof. Using non-elastic fibers for the textile scaffold 801 can be beneficial in some applications, as elasticity in the textile scaffold fibers can result in an elevated risk of rupture of the fibers compared to non-elastic fiber implementations. Furthermore, a textile scaffold comprising elastic fibers can have a lesser tendency / ability to seal under pressure compared to non-elastic-fiber textile scaffolds, which can provide a higher chance to be sealed in the blood and become blood- impermeable. In some implementations, the fibers of the textile scaffold 801 comprise non- elastic polyester, polyolefin, or polyamide yarn. The textile scaffold 801 can include a first set of warp (or weft) fibers 801a that helix in a first direction and a second set of warp (or weft) fibers 801b that helix or wrap in a second direction.

[0088] With respect to the straight and tapered forms of the conduit pieces 81 and 85 in FIG.10A, the differently-shaped parts / segments of the conduit structure 80 can have different textile configurations with respect to warp / weft filaments / yarns in order to produce more similar density characteristics in the differently-shaped portions. The conduit forms 81, 85 can advantageously be woven, such as by using a V-reed weaving loom, in three-dimensional conduit structures that do not include or require a vertical / longitudinal seam. That is, the tubular forms can be produced as continuous circumferential structures, rather than manipulations of a flat piece into a tubular structure that is sutured along a vertical / longitudinal seam.

[0089] The textile scaffold 801 can advantageously have relatively high density, which may improve fluid sealing. Use of a V-reed weaving loom can allow for three- dimensional textile printing, wherein fibers of the textile scaffold 801 can be controlled individually, allowing for variable braid parameters across the different segments of the conduit structure 80. By changing the weave geometry between the straight 87 and tapered 82, 86 portions of the body piece 81, uniform / matching textile density can be achieved in the different segments. This is contrary to other solutions in which a straight weave having a uniform weave configuration may be subsequently placed on a tapered mandrel (e.g., straight cylindrical mandrel with a tapered shoulder), which generally produces a greater density in the tapered portion compared to the straight cylinder portion due to having to shrink / restrict the fabric around the tapered shoulder.

[0090] At block 904, the process 900 involves reinforcing one or more target areas of the body piece 81 of the conduit structure 80. For example, one or more areas of the conduitDocket No.: ADV-23899WO01 piece 81 may be sufficiently narrow as to be prone to collapsing under pressure. Additionally or alternatively, one or more segments of the conduit piece 81, such as the proximal inlet tube / tail 83, may be intended to bend in an implanted state, wherein such bending can produce undesirable kinking in the absence of reinforcement.

[0091] FIGS.10A and 10B show reinforcement features 84 implemented in a reinforced segment of the proximal tube 83 of the conduit piece 81. The reinforcement features 84 can comprise wire or other fiber / filament strand(s) wrapped / wound around the circumference of the proximal inlet tube 83, which may lead into the barrel segment 87. The reinforcement features 84 can include filaments / wires wrapped circumferentially around the tubular structure, such as a helically-winding filament / wire, or a transversely-winding / wrapping (i.e., non- helically) filament / wire. For example, the reinforcement features 84 may comprise axially-offset circumferential bands of reinforcement fiber(s) (e.g., wire). Additionally or alternatively, reinforcement fiber(s) / wire(s) may be included that run longitudinally along the conduit structure rather than wrapping circumferentially.

[0092] In some implementations, the tubular scaffold 801 is woven initially, after which the reinforcement fiber(s) / wire(s) 84 can be applied, such as by winding the reinforcement strand / fiber around a circumference of the reinforced segment. Alternatively, the textile scaffold can be woven over the reinforcement fiber(s) / wire(s) 84. In some implementations, one or more fibers of the textile weave can be replaced with reinforcement fiber(s) / wire(s), or reinforcement fiber(s) / wire(s) may otherwise be introduced into the weave pattern using the weaving machine (e.g., V-reed loom). In any such implementation, the inclusion of reinforcement fiber(s) / wire(s) in the textile weave can be limited to selected localized regions. As an example, the woven textile 801 can comprise different fiber materials, some of which have higher tensile strength such that they can serve as reinforcement fiber(s) / wire(s). For example, reinforcement fiber(s) / wire(s) can be integrated with a polymer yarn weave in selected warp and / or weft positions.

[0093] Reinforcement fibers can be included exclusively in the transverse circumferential direction, for example. The reinforcement fiber(s) / wire(s) can increase the hoop strength and / or burst strength of the conduit structure. As shown in the assembled view of FIG. 10B, the reinforcement features 84 can operate in a manner like that of a bendable section of a flex straw, wherein the reinforcement fiber(s) / wire(s) form accordion-style pleats that facilitate controlled bending and kink prevention. Such features 84 can comprise rings with longitudinal gaps therebetween. The reinforcement fiber(s) / wire(s) 84 can comprise any suitable or desirable material, such as monofilament polyethylene terephthalate, nitinol wire, or the like. In some implementations, the reinforcement features 84 can comprise a shape-set stent, which may haveDocket No.: ADV-23899WO01 a desired shape (e.g., elbow shape) to hold the conduit in a desired shape / form without collapsing or kinking.

[0094] Generally, V-reed weaving of the conduit structure pieces 81, 85 can present certain limitations with regard to the amount of diameter change in the textile tube between the diameter d7 of the wider barrel portion 87 and the narrower end d4 of the tapered section(s). Therefore, the pieces 81, 85 can advantageously be fabricated with tubular textile scaffolds that have a minimum diameter that is no more than 50% less than the maximum diameter of the given piece. For example, with respect to the body piece 81, the reduced tapered diameter d4 and / or the diameter d11 of the proximal inlet tube 83 are at least half that of the barrel diameter d7. Further, with respect to the nozzle piece 85, the diameter of the distal tip d1 is advantageously at least half the dimension d4corresponding to the diameter of the expanded proximal tapered end of the nozzle piece 88. With respect to the assembled conduit structure 80, the narrow nozzle diameter d1can be more than 50% less than the maximum diameter d7of the body piece 81.

[0095] In order to produce a similar density in the tapered portions 82, 86 as in the straight barrel portion 87, the ends of the warp and / or weft fibers may be reduced in the tapered portions relative to the straight portion, such as from 40 to 20, by the weaving loom moving from one portion to the other. Such reduction (or increase in the case of moving from a tapered portion to the wider straight portion 87) can be implemented in a discrete manner, wherein a step drop is implemented at a transition point between the adjacent segments / portions, or reduction (or increase) can be implemented in a gradual manner moving through the tapered portion. Fiber reduction can be implemented by trimming the ends of the fibers fed by the weaving loom. With respect to reduction of weft fibers, one of a given set of increments of weft fibers may be omitted (or added) moving in the longitudinal direction of the conduit piece 81. In some implementations, weave density reduction or increase is performed by transitioning weft fibers to a warp direction to integrate with the warp fibers, or vice versa.

[0096] At block 906, the process 900 involves weaving a tapered convergent segment 88 and a straight port / nozzle segment 89 of the nozzle piece 85 in a seamless, three-dimensional form. For example, the conduit structure 80 can comprise a cylinder fabric tube with a distal narrow tip 89 on one end, a medial barrel 87, and a smaller proximal inlet tube 83, with tapered segments 88, 82, 86 transitioning between the different diameter segments. Similarly to the conduit piece 81, the nozzle piece 85 may be woven using a V-reed loom. The term “tapered” is used herein according to its broad and ordinary meaning, and may refer to a tubular segment having a gradually decreasing or increasing diameter along its length. As used herein, an expanding frustoconical flange is considered a tapered segment. The textile scaffold of the nozzle piece 85 may be woven on a mandrel with a flared shoulder corresponding to theDocket No.: ADV-23899WO01 seamless flared frustrum textile scaffold segment 85. In some implementations, the body piece 81 comprises a membrane comprising a textile scaffold and a polymer coating as described in detail herein, wherein the nozzle piece 85 has a different material construction, such as a rigid plastic form, or other construction.

[0097] The flared tapered segment 88 can have the shape of a conical frustrum that expands distally from a proximal end of the straight nozzle tube 89. In order to produce a similar density in the tapered portion 88 as in the straight portion 89, the ends of the warp and / or weft fibers may be reduced, or increased, depending on the direction of the weave. For example, as with the body piece 81, if the nozzle piece 85 is woven in the proximal direction, the number of warp and / or weft fibers may be increased at the transition between the straight nozzle 89 and the expanding flange 88 moving proximally (either as a discrete or gradual increase in fiber count). If the nozzle piece 85 is woven in the distal direction, the number of warp and / or weft fibers may be decreased moving through the tapered flange 88 and / or at the transition between the flange 88 and the straight nozzle 89 (either as a discrete or gradual decrease in fiber count).

[0098] In some implementations, both the conduit piece 81 and the nozzle piece 85 have a similar weave density, such as within 10% of one another with respect to the number of picks-per-inch (PPI), ends-per-inch (EPI), and or wall thickness. In some implementations, one or both of the pieces 81, 85 has an EPI greater than 300, such as about 400 and / or a PPI of greater than 200, such as about 225. In some implementations, one or more portions of the conduit implant 80 has a wall thickness of approximately 0.05 mm.

[0099] At block 908, the process 900 may involve reinforcing one or more target areas / segments of the nozzle piece 85. For example, the narrow neck / spout 89 can be reinforced with transverse or longitudinal reinforcement fiber(s) / wire(s), in accordance with any example described herein, to prevent collapsing thereof.

[0100] At block 910, the process 900 involves joining the body piece 81 and the nozzle piece 85 in some manner to form an integrated conduit assembly 80. For example, the pieces 81, 85 can be sutured together by one or more sutures 807. In some implementations, both pieces 81, 85 have relatively high density, such as about 400 EPI and / or 225 PPI weave density. The fibers of the woven textile scaffolds can be less than 40 μm, such as less than 20 μm, with respect to filament diameter. In attaching the nozzle piece 85 to the body piece 81, the proximal end / portion of the flange 88 of the nozzle piece 85 may be attached to the distal end / portion of the tapered segment 82 of the body piece 81, which may have similar diameters in some implementations.

[0101] With reference to FIG.10A, the nozzle neck / spout 89 may have a diameter d1 of about 1.5 mm and / or a length d2of about 15 mm (or 1.5 mm). The proximal flange 88 of theDocket No.: ADV-23899WO01 nozzle piece 85 may have a length d3 of about 5 mm, a distal diameter d1 of about 1.5 mm, and / or a proximal diameter d4of about 6 mm. The distal tapered segment 82 of the body piece 81 may have a length d5 of about 5 mm, a proximal diameter d7 of about 10.5 mm, and / or a distal diameter d4of about 6 mm. The barrel segment 87 of the body piece 81 may have a length d6of about 150 mm and / or a diameter d7 of about 10.5 mm. The proximal tapered segment 86 may have a length d8of about 5 mm, a distal diameter d7of about 10.5 mm, and / or a proximal diameter d11 of about 6 mm. The proximal tubular tail 83 may have a length of about 35 mm and / or a diameter d11 of about 6 mm. The reinforcement fiber(s) / wire(s) 84 may span a segment of the inlet tube 83 having a length d9 of about 14 mm, whereas a segment of the tube 83 uncovered / non-spanned by the reinforcement feature(s) 84 may have a proximal length d10 of about 20 mm. The particular dimensions recited above are example dimensions only, and aspects of the present disclosure can be implemented in conduit / balloon structures having any suitable or desirable shape or dimensions. The term “about,” when referring to a numerical value or range, should be understood by persons skilled in the art to encompass variations that may arise from ordinary methods of measuring or manufacturing the relevant material or component. Such variations are typically within ±10% of the stated value, unless explicitly noted otherwise. The term “about” is intended to accommodate minor discrepancies that are incidental to manufacturing processes and does not imply that the value or range must deviate from the specified parameters.

[0102] At block 912, the process 900 involves applying a sealant / sealing polymer membrane (e.g., polymer coating or lamination) 803 (see FIG.10B) to the joined conduit assembly 80 to provide a seal for the woven textile scaffold 801. Compositing the textile scaffold 801 with the polymer membrane 803 can form the assembly 80 into a non-permeable conduit / balloon, which may work together with a re-shaping outer stent in the barrel segment 87 in some implementations.

[0103] In some implementations, the membrane 803 comprises a water-based thermoplastic polyurethane (TPU) polymer, which can advantageously provide a reduced biocompatibility risk, as well as reduced hazard solvent usage in process / manufacturing in comparison with solvent-based TPU materials. Such coating can also be made into film and used in lamination. The membrane materials can provide beneficial elasticity, transparency, and / or resistance to abrasion. In producing the coating material 803, TPU particles may be dispersed in water. By using water as the dispersion medium, as opposed to non-water solvent, the coating 803 can be relatively safer and / or more environmentally friendly compared to solvent-based polymers that require organic solvents for their use and processing, which can be volatile and pose safety and environmental risks.Docket No.: ADV-23899WO01

[0104] The polymer membrane 803 can be used for mechanical and sealing purposes. For example, the membrane 803 can provide beneficial stretch and recovery tensile properties with a relatively low profile. For example, the unit elasticity of water-based TPU, as contemplated for polymer membranes disclosed herein, can be higher than that of certain other polymers, such as silicone. The membrane 803 can advantageously fill and seal gaps / holes between adjacent fibers of the textile scaffold 801 to increase safety and effectiveness of the implant 80. In some implementations, the membrane 803 comprises TPU dissolved in tetrahydrofuran (THF) or other organic solvent.

[0105] The assembled conduit structure 80 can advantageously provide a relatively stable structure. With respect to relevant implementations, due to the inelasticity of the fibers of the textile scaffold 801, the conduit structure 80 may not provide radial elasticity for expansion. Therefore, compliance characteristics may be added to the conduit structure 80 by including a frame or stent having a non-circular biased shape, as described in detail herein, to, for example, the barrel segment 87. At block 914, the process 900 involves disposing a non-circular stent / frame structure about the barrel 87 of the body piece / portion 81 of the conduit assembly 80. Although shown and described as a two-piece conduit structure, the conduit structure may be formed as a single unitary piece, or may comprise more than two pieces. In such implementations, the conduit structure may nevertheless be considered to include a barrel or body portion and a nozzle portion. As assembled, the tapered portion, including the distal tapered portion 82 of the body piece and the proximal tapered portion 88 of the nozzle piece, connects the barrel 87 to the nozzle spout 89.

[0106] FIG.10B shows the assembled conduit structure 80, with the proximal inlet tube / tail 83 including a bend 802, which may allow for the inlet of the conduit structure 80 (e.g., shunt implant) to cross over into an adjacent blood vessel or anatomical chamber (e.g., aorta) from the blood vessel or other anatomical chamber in which the barrel 87 and nozzle 85 are disposed (e.g., inferior vena cava). The reinforcement fiber(s) / wire(s) 84 can allow for the tail 83 to bend without kinking.

[0107] The shape of the conduit structure 80 can advantageously include tubular structures with tapered sections with variable diameter, as shown and described. Even with such variations in shape and dimension along the length of the conduit structure 80, the material characteristics of the composite can be maintained throughout the structural transitions along the length of the conduit structure by varying how the textile fibers are introduced / fed in the weaving loom. Such selective textile feeding can further be used to provide reinforcements and / or improve impermeability of the structure at certain segments along the length of the conduit structure 80.Docket No.: ADV-23899WO01

[0108] In some implementations, the membrane 803 is implemented with variable thickness and / or properties along the length of the conduit structure 80. Generally, the polymer membrane 803 may be impermeable, thereby improving the suitability of the implant 80 for chronic implantation. The presence of the membrane 803 can be particularly beneficial in the area of the curve / bend 802 to accommodate stretching of the inlet tube 83 while still maintaining impermeability. The combination of the textile scaffold 801 with the membrane 803 can provide desirable strength and flexibility for the implant 80. For example, the membrane 803 may not be sufficiently strong alone to sustain prolonged cycling in a patient’s vasculature, whereas the textile scaffold 801 alone may not be sufficiently dense / fluid-tight enough to provide an effective implant fluid conduit. However, the combined textile scaffold 801 and membrane 803 can provide both sufficient strength and sealing characteristics for chronic implantation.

[0109] To achieve the bend shape shown in FIG.10B, the textile scaffold in such area can be woven in a curved shape, wherein the fiber feeding of the textile loom can be configured to vary the warp and / or weft fiber densities to maintain uniform density around the curve, such as by including more fibers on an outside of the curve and / or fewer fibers on an inside of the curve. In some implementations, the curved shape of the bend 802 in the textile scaffold can be shape-set using a heat staking and / or annealing process. For example, the tubular textile scaffold may be woven in a shapeless (e.g., flat) manner and slid onto a mandrel and shape-set to the desired three-dimensional shape with heat-setting. The bend 802 may produce an orientation of the proximal inlet tube 83 that provides a vessel-to-vessel access port and / or anchor for blood vessel shunting and / or bypassing, as disclosed herein.

[0110] FIG.11 is a flow diagram illustrating a process 1100 for fabricating an impermeable composite membrane having a textile scaffold and a polymer membrane in accordance with some examples. FIGS.12A and 12B show a textile scaffold 90 and coated tubular membrane 95, respectively, of an implant device in accordance with some examples. The tubular membrane 95 is an elastic compliant composite conduit / balloon structure comprising elastic a seamless tubular fabricated textile scaffolding 90 and elastic polymer (e.g., thermoplastic polyurethane) dispersion coating or lamination 93, which serves as a sealant. The fabrication process / technology used in connection with FIGS.11, 12A and / or 12B may be weaving, knitting, crocheting, braiding, embroidery, or the like; braiding is shown and described below as example for illustration purposes.

[0111] The combination of elastic textile scaffolding 90 with the elastic membrane (e.g., coating and / or lamination) 93 produces a conduit structure that has desirable strength and elastic compliance for conduit / balloon-type implants as described herein. The textile scaffold 90Docket No.: ADV-23899WO01 is formed of elastic fibers 91 that serve as reinforcement to enhance the strength of the conduit structure 95.

[0112] At block 1102, the process 1100 involves providing elastic yarn / fiber segments for weaving the elastic textile scaffold 90 for a conduit device in accordance with aspects of the present disclosure. The textile scaffold 90 forms a base for a composite tube. The fibers (e.g., fiber segments) 91 of the textile scaffold 90 can comprise polyolefin-based stretch yarn, which may advantageously provide for more than 500% elongation stretch with strength to prevent rupture.

[0113] At block 1104, the process 1100 involves braiding (or weaving, knitting, etc.) the elastic fiber / yarn 91 into a tubular form on an outer surface of a cylindrical mandrel 901 having barrel 97 and tapered shoulder 92 portions for form a seamless braided tube / conduit. The fibers 91 braided onto the mandrel, or alternatively braided into a three-dimensional tubular form without the use of a mandrel. The geometry of the braided textile scaffold 90 advantageously provides elasticity and recovery. As shown, the textile scaffold 90 can be formed as an open braid, with open diamond-shaped (or other shape) cells 907 defined by adjacent ones of the fibers 91 separated by lateral gaps. The open construction of the textile scaffold 90 can promote stretching and may reduce fiber-to-fiber / lateral interference and reduce the collective volume / mass of the fibers 91, and therefore the stretching resistance of the scaffold 90. The application of axial and / or radial tension to the textile scaffold 90 can cause deformation of the diamond cells 907.

[0114] The use of the elastic fiber textile scaffold 90 as part of the composite conduit structure 95 can supplement the strength of the elastic polymer membrane / coating 93, which may have insufficient elasticity and / or strength for a given wall thickness, whereas the elastic textile scaffold 90 combined with the polymer membrane / coating 93 may provide sufficient strength and elasticity with a relatively small combined wall thickness. For example, the membrane / coating 93 may not be strong enough to resist tearing by itself, wherein the fibers 91 of the textile scaffold 90 act as rip-stop boundaries, providing a deterrent against tearing beyond a single cell. Furthermore, the presence of the textile scaffold 90 can serve to hold the polymer coating 93 in a manner as to promote thickness uniformity and coverage of the coating 93.

[0115] In some implementations, the textile scaffold 90 can be woven using a 24- carrier loom using half-load, with a first subset of the fiber ends (e.g., six) helixing in a clockwise direction and a second subset of the fiber ends (e.g., six) helixing in a counterclockwise direction. The density of the scaffold 90 may or may not be maintained between the straight 97 and tapered 92 segments. At least some of the fibers (e.g., a subset) used to weave the barrel portion 97 of the textile scaffold 90 may continue through at least a portionDocket No.: ADV-23899WO01 of the weave of the tapered portion 92 and / or spout portion 99 of the textile scaffold 90. In some implementations, the mandrel barrel 901 has a diameter of about 7 mm and the textile scaffold 90 has a wall thickness of about 0.05 mm.

[0116] The fibers 90 of the textile scaffold 90 can comprise any suitable or desirable type of elastic fiber, such as synthetic fiber (e.g., elastane or polyolefin-based fiber). In some implementations, the braid pattern of the textile scaffold 90 in the barrel portion 97 may form open cells, wherein adjacent ones of the fibers 91 helixing in the same direction are separated by a lateral gap / distance d12 that is more than twice the width of the individual fibers 91, such as three, four, five, or more times greater than the fiber width.

[0117] At block 1106, the process 1100 involves coating or laminating the mandrel 901 and / or textile scaffold 90 with an elastomeric polymer 93, thereby filling the open cells 907 of the woven scaffold 90 with the polymer 93. The coating / lamination 93 may be a water-based dispersion, as described herein. For example, the elastic polymer membrane / coating 93 may comprise water-based thermoplastic polyurethane.

[0118] The membrane 93 can be made by coating or lamination. For example, with respect to coating implementations, the membrane / coating 93 may be applied by dipping the mandrel 901, with the textile scaffold 90 formed thereon, in a polymer medium. Alternatively, the coating 93 may be brushed / painted onto the mandrel 901 and / or textile scaffold 90. The thickness of the coating application 93 may be selected to control the elasticity and strength of the conduit structure 95. The polymer coating 93 forms a film that covers the pores / cells 907 of the braided scaffold 90. Dipping the textile scaffold 90 in the polymer coating 93 can provide full coverage of the fibers 91 and cells 907, blocking any permeability of the conduit structure 95.

[0119] At block 1108, the process 1100 involves curing (e.g., heat curing) the polymeric coating 93. In some implementations, the coating 93, after application, may be air- dried and / or heated using an oven or other heating instrument to produce thermal curing to cause polymer chains of the coating 93 to crosslink for increased strength.

[0120] At block 1110, the process 1100 involves cutting the tubular structure composite of the textile scaffold 90 and the polymer coating 93 to a desired length and / or shape for use as a conduit structure of a blood flow management implant device in accordance with aspects of the present disclosure. The tailored conduit device 95 shown in FIG.12B includes a combination of elastic yarn / fiber 91 and elastic polymer 93 (e.g., thermoplastic polyurethane) coating layer, wherein the elastic yarn / fiber 91 serves to reduce cracking penetration of the polymer coating 93, which increase the durability of coating / film 93. The resulting composite conduit structure 95 provides relatively clean / smooth contours due to the coating 93 covering theDocket No.: ADV-23899WO01 outer (and / or inner) diameter of the textile scaffold 90, as well as due to the lack of longitudinal suture lines resulting from three-dimensional tubular fabric weaving, as described herein. The composite conduit structure 95 can comprise an elastic polyolefin braided tube coated by thermoplastic polyurethane water-based dispersion. Elastic yarns / fibers disclosed herein can comprise polyolefin, polyurethane, their co-polymer(s) or fiber blend.

[0121] FIG.13A depicts a pass-through compliance implant 138 in a systolic (high- pressure) condition after deployment between an aorta 16 and inferior vena cava (IVC) 19. The device 138 may have any feature described herein in connection with any of the various embodiments described above. For example, the compliance implant 138 may have the form and / or function of the device 80 described above with respect to FIGS.10A and 10B, at least in part. The device 138 can include an anchoring collar / dock / port 1364 (e.g., sealed stent-type anchor frame). The device 138 can further include a proximal inlet tube 133, which may be reinforced with bands or other reinforcements 134 designed to hold a patent channel through the tube 133 when bent. The device 138 can include a first tapered segment 136 that expands the diameter of the conduit implant device 138 to a wider barrel diameter of the barrel segment / portion 1387, which may have compliance characteristics as described in detail herein. The barrel 1387 may taper back down to a narrower distal nozzle outlet 139 via one or more tapered segments / portions 132. The nozzle 135 may be sutured to the barrel taper 132 in a two- piece implementation, as described above.

[0122] The proximal inlet tube 133 can be configured with a bend / turn that orients the barrel 1387 and inlet port 1364 at approximately 90° relative positioning, or other angle (e.g., the port 1364 may be angled towards an upstream or downstream direction of the aorta, and / or the barrel 1387 may be angled toward the opposite or adjacent wall portion of the inferior vena cava relative to the port 1364). In some implementations, the barrel 1387 may be positioned coaxial with the inferior vena cava flow axis.

[0123] The tubular conduit of the barrel portion 1387 may extend through a self- expanding, energy-storing oval stent frame 137, which may be positioned concentrically around the barrel 1387. The conduit membrane may be fabricated from a substantially non-compliant, tightly-woven textile and polymer coating 1301 as described in connection with FIGS.10A and10B, or from an elastically compliant, open-cell weave 1302 as described in connection with FIGS.11, 12A, and 12B, which is likewise over-coated with a hermetic polymer film. During ventricular systole, aortic pressure forces arterial blood through the inlet port 1364 and into the barrel / conduit 1387. The elevated intraluminal pressure circularizes the normally oval stent 137, elastically enlarging the cross-sectional area of the conduit (see FIG.13B) and thereby storing strain energy in the frame 137. FIG.13B shows a transverse cross-section taken through theDocket No.: ADV-23899WO01 barrel 1387 showing the inner wall 1388 of the barrel 1387 and the stent 137. Under systolic loading, the stent 137 may assume a substantially circular configuration, maximizing the internal area / volume of the conduit 1387. The figure shows pressurized arterial blood flowing into / within the conduit device 138, while venous blood surrounds the exterior of the conduit 138 in the IVC lumen.

[0124] FIG.14A illustrates the same compliance implant device 138 in a diastolic (low-pressure) condition. When aortic pressure subsides, inflow through the port 1364 diminishes and the resilient stent 137 relaxes toward its biased oval shape. The resulting reduction in conduit volume expels retained blood: a majority (e.g., ≈ 90 %) is driven retrograde through the port 1364 back into the aorta, while a smaller fraction is discharged distally through the nozzle tip 139 into the IVC stream. This cyclic storage-and-return behavior provides a compliance function that moderates instantaneous shunt flow while promoting net left-to-right (aorta-to-IVC) transfer over the cardiac cycle. FIG.14B is a cross-section similar to FIG.13B, but taken in the diastolic / low-pressure state. The stent frame 137 is shown in FIG.14B as having returned to an elliptical / oval profile, reducing the conduit’s internal area / volume. The diminished conduit volume forces blood residing in the barrel 1387 to exit through the respective openings identified above, thereby completing the compliance cycle.

[0125] FIGS.15A and 15B illustrate a vascular implant 1500 for increasing the efficiency of blood flow through an arterial blood vessel 16 (e.g., the aorta). The vascular implant 1500 is another example of a compliance implant similar to the shunt implant 60 of FIG.6 and the compliance implant 138 of FIGS.13A-14B. The vascular implant 1500 comprises an expandable reservoir 1562 coupled to a tubular shunt 1564. The expandable reservoir 1562 is deployed (e.g., via a catheter) in a first blood vessel 19 (e.g., a venous blood vessel such as the inferior vena cava) with the tubular shunt 1564 passing between a second blood vessel 16 (e.g., an arterial blood vessel such as the aorta) and the first blood vessel. As described in greater detail herein, the vascular implant 1500 enables high pressure blood from the aorta 16 to temporarily move into the expandable reservoir 1562. This can be done to effectively enhance compliance of the aorta 16 thereby simulating a young healthy aorta.

[0126] The expandable reservoir 1562 is similar to the shunt balloon conduit 62 described herein with reference to FIG.6 and to the barrel portion 1387 described herein with reference to FIGS.13A-14B. The expandable reservoir 1562 is made of a compliant material, examples of which are described herein. In some implementations, the expandable reservoir 1562 includes a support stent 1580 that is configured to enhance the elasticity of the expandable reservoir 1562 for volume change of the expandable reservoir 1562. The support stent 1580 can be associated with an exterior of the expandable reservoir 1562. As described herein, the supportDocket No.: ADV-23899WO01 stent 1580 can be shaped to store energy and can change shape in a targeted way. For example, the support stent 1580 can be oval-shaped in an expanded state and peanut-shaped in a contracted state. Examples of such stents are described herein, such as the re-shaping stent 79 described herein with reference to FIGS.8A and 8B. In some implementations, the support stent 1580 can be configured to have a change in area that is at least about 1.75 cm2. In some implementations, the support stent 1580 covers only a portion of the expandable reservoir 1562. That is, the support stent 1580 can be configured to extend so that it covers the entire length of the expandable reservoir 1562 or only a portion of the length of the expandable reservoir 1562.

[0127] The tubular shunt 1564 is similar to the inlet port 64 described herein with reference to FIG.6 and to the proximal inlet tube 133 described herein with reference to FIGS.13A-14B. The tubular shunt 1564 can include a tubular stent 1569 to provide structural support for the tubular shunt 1564 where it passes between the first vessel 19 and the second vessel 16.

[0128] The vascular implant 1500 also includes an anchoring device 1570. The anchoring device 1570 is configured to facilitate cinching the first blood vessel 19 and the second blood vessel 16. The anchoring device 1570 is also configured to provide a passage between the first blood vessel 19 and the second blood vessel 16. The anchoring device 1570 is configured to mate with or dock with the tubular shunt 1564 to provide a sealed passageway from the second blood vessel 16 into the expandable reservoir 1562. The anchoring device 1570 can also be configured to provide sealing functionality to inhibit or prevent blood from the second blood vessel 16 passing into the first blood vessel at the puncture site between the two blood vessels 16, 19.

[0129] The vascular implant 1500 also includes an exit port 1565 at a distal end of the expandable reservoir 1562. The exit port 1565 is similar to the nozzle 65 described herein with reference to FIG.6 and the nozzle 135 described herein with reference to FIGS.13A-14B. The exit port 1565 is configured to allow for blood to leave the expandable reservoir 1562. This inhibits or prevents stagnation in the expandable reservoir.

[0130] Thus, the vascular implant 1500 is configured to increase the efficiency of blood flow through the aorta by providing a compliant, expandable reservoir 1562 coupled to a tubular shunt 1564 that allows for blood to flow from the aorta into the expandable reservoir 1562. The tubular shunt 1564 forms a lumen between the first blood vessel 19 and the second blood vessel 16 to allow blood to pass therebetween. The expandable reservoir 1562 is sized for placement in the venous blood vessel 16 (e.g., the inferior vena cava). The expandable reservoir 1562 includes a first region coupled to the tubular shunt 1564 and a second region that is formed with the exit port 1565. The exit port 1565 is adapted to allow blood to escape the expandableDocket No.: ADV-23899WO01 reservoir 1562 into the venous blood vessel 19. The vascular implant 1500 is adapted such that blood from the arterial blood vessel (e.g., the aorta) is capable of passing through the tubular shunt 1564 into the expandable reservoir 1562 during systole and blood from the expandable reservoir 1562 is capable of passing through the tubular shunt 1564 back into the arterial blood vessel 16 during diastole.

[0131] FIG.15B illustrates an example of the anchoring device 1570 separate from the rest of the vascular implant 1500. The anchoring device 1570 is configured to enhance anchoring of the tubular shunt 1564 in the second blood vessel 16. The anchoring device 1570 includes fingers 1572 to press a flange 1573 against the wall of the second blood vessel 16. The anchoring device 1570 also includes distal arms 1571 that extend into the second blood vessel 16 to enhance the structure of the anchoring device 1570. The anchoring device 1570 also includes proximal arms 1575 that form a c-shape that extend along an inner wall of the first blood vessel 19. The proximal arms 1575 are backwardly-curved to facilitate sandwiching the walls of the blood vessels 16, 19 between the proximal arms 1575 and the flange 1573 (supported by the fingers 1572). The proximal arms 1575 can act as a proximal flange to complement the flange 1573 to securely cinch the walls of the two blood vessels together. The anchoring device 1570 forms a lumen using a stent-like structure between the proximal arms 1575 and the distal arms 1571 and fingers 1572.

[0132] The anchoring device 1570 can also include a sealing skirt 1574 that at least partially covers the tubular shunt 1564 when docked in the anchoring device 1570. In some implementations, the sealing skirt 1574 can be integral with the flange 1573. In some implementations, the sealing skirt 1574 can be made of a polyester material or other suitable sealing or compliant material. The sealing skirt 1574 can also be configured to provide a material such as a textile between the tubular stent and the stent-like elements of the anchoring device 1570 (e.g., the proximal arms 1575 and the stent-like structure between the proximal arms 1575 and the distal arms 1571 and fingers 1572). Thus, the sealing skirt 1574 can comprise a textile on the anchoring device barrel or lumen and can form the flange 1573, similar to a pledget in the second blood vessel 16.

[0133] In some implementations, the proximal arms 1575 and the flange 1573 can incorporate discs similar to double-disc occluders. Such discs can be made of a nitinol mesh and polyester material. The discs can be configured to securely appose the vessel walls and to provide a narrow waist between the discs to provide the passageway between the vessels. The discs can be self-expanding.

[0134] Thus, the anchoring device 1570 can act as a self-expandable cinching device for sealing between two adjacent blood vessels. The fingers 1572 are configured to expandDocket No.: ADV-23899WO01 radially around a central portion of the anchoring device 1570 to form a relatively planar flange on one side. The proximal arms 1575 are on a side of the anchoring device that is opposite the fingers 1572 and are configured to curve towards the flange 1573 and to tightly press there- against.

[0135] In some implementations, the self-expandable anchoring device 1570 and the vascular implant 1500 can be provided as two separate components. In such implementations, the implantation process includes deploying the anchoring device 1570 and then advancing the vascular implant 1500 and deploying the tubular stent 1569 within the central opening of the anchoring device 1570.

[0136] In certain implementations, the anchoring device 1570 can be integrated with the vascular implant 1500. In such implementations, the proximal arms 1575 and the distal arms 1571 and fingers 1572 can be affixed to, and disposed around, the tubular stent 1569 or the vascular implant 1500 such that a single-step deployment procedure can be employed.

[0137] Advantageously, the anchoring device is configured to cinch the two blood vessels together which inhibits or prevents pinching the tubular shunt 1564 and / or other portions of the vascular implant 1500 within the access hole between the blood vessels 16, 19. Other examples of methods and devices that can be used to anchor the vascular implant 1500 as well as to cinch the two blood vessels together are provided in FIGS.16A-19B.

[0138] FIGS.16A, 16B, 16C, and 16D illustrate a coiled anchor cinching device 1600 and implantation procedure. The coiled anchor cinching device 1600 is configured to act as an anchoring and cinching device, similar to the anchoring device 1570. The coiled anchor cinching device 1600 includes a first coiled anchor 1604 and a second coiled anchor 1602 configured to be deployed on an interior wall of an arterial vessel 16 and an interior wall of a venous vessel 19, respectively. The coiled anchor cinching device 1600 can be used with the vascular implant 1500 or other such devices to help to anchor the implant to targeted blood vessels as well as to cinch the targeted blood vessels together, similar to the anchoring device 1570, as described herein.

[0139] The coiled anchor cinching device 1600 can be implanted with a two-staged implantation procedure. FIG.16A illustrates that the coiled anchor cinching device 1600 is first delivered across the walls of both vessels 16, 19 using a delivery catheter 1610. FIG.16B illustrates that the coiled anchor cinching device 1600 is then released such that the first coiled anchor 1604 and the second coiled anchor 1602 are disposed on opposite sides of the blood vessels. The coiled anchors 1602, 1604 then tightly press the blood-vessel walls against each other. FIG.16C illustrates a front view of the second coiled anchor 1602 pressed against the interior wall of the arterial vessel 16, the coiled anchor providing space for the shunt of theDocket No.: ADV-23899WO01 vascular implant 1500 to pass through. FIG.16D illustrates that after the vessels 16, 19 have been cinched together, the second stage of the implantation procedure includes passing the tubular shunt 1564 through the coiled anchors 1602, 1604.

[0140] The coiled anchor cinching device 1600 can be formed from nitinol and the coiled anchors 1602, 1604 can be maintained in a straight configuration inside a lumen of the catheter 1610 during delivery. The coiled anchors 1602, 1604 can be pre-shaped to assume a spring-coiled configuration upon release from the catheter 1610. Releasing the coiled anchor cinching device 1600 causes the second coiled anchor to be released against the aortic wall and the first coiled anchor to be released against the venous wall. In some implementations, the guidewire for puncturing through the vessel walls and the coiled anchors 1602, 1604 can be delivered in a single multi-lumen catheter, each extending through a separate lumen. In various implementations, the same catheter can have several lumen through which both the coiled anchor cinching device 1600 and the vascular implant 1500 can be deployed.

[0141] In some implementations, the coil of one or both of the coiled anchors 1602, 1604 can span less than 360 degrees. In certain implementations, the coil of one or both of the coiled anchors 1602, 1604 can form a full circle or more than one coil can be provided.

[0142] FIGS.17A, 17B, and 17C illustrate a spiraling anchor device 1700 configured to apply pressure against blood vessel walls to cinch the vessels and to seal the passageway between the blood vessels. The spiraling anchor device 1700 is configured to act as an anchoring and cinching device, similar to the anchoring device 1570. The spiraling anchor device 1700 comprises a stent-like central structure 1702 with spiraling arms 1704 on a first end of the stent- like central structure 1702 and flanged fingers 1706 on a second end of the stent-like central structure 1702. The stent-like central structure 1702 of the spiraling anchor device 1700 is configured to extend axially around the tubular shunt 1564 of the vascular implant 1500 or other similar implant, as described herein.

[0143] The spiraling arms 1704 can be formed from a wire or a series of wires disposed around the circumference of the stent-like central structure 1702. The spiraling arms 1704 can be formed from a shape-memory material (e.g., nitinol) and can be pre-shaped to assume a coiled configuration.

[0144] Similarly, the flanged fingers 1706 can be formed from a wire or a series of wires disposed around the circumference of the stent-like central structure 1702. The flanged fingers 1706 can be formed from a shape-memory material (e.g., nitinol) and can be pre-shaped to assume a flat or flange configuration.

[0145] FIG.17B illustrates that when the spiraling anchor device 1700 is positioned across the walls of the first and second blood vessels 16, 19, the distal portion of the spiralingDocket No.: ADV-23899WO01 anchor device 1700 is exposed that includes the spiraling arms 1704. The proximal portion of the spiraling anchor device 1700 is then exposed that includes the flanged fingers 1706 that are pressed against a wall of the venous vessel 19. The spiraling anchor device 1700 can be covered by a sealing member 1708 (such as a fabric or textile) over the portion extending across the walls (e.g., the stent-like central structure 1702).

[0146] FIG.17C illustrates that, upon deployment, the spiraling arms 1704 can roll proximally towards the arterial wall 16 to press there-against. The spiraling arms 1704 are configured to provide a sufficient force to cinch the vessels and / or to provide sealing around the tubular stent 1569. Advantageously, the spiraling anchor device 1700 is configured to accommodate different sizes and thicknesses of vessel walls because the coiling spiraling arms 1704 are configured to roll to pull the arterial vessel 16 toward the flanged fingers 1706 pressed against the wall of the venous vessel 19.

[0147] FIGS.18A and 18B illustrate examples of barbed anchoring devices 1800a, 1800b, respectively. The barbed anchoring devices 1800a, 1800b are configured to act as anchoring and cinching devices, similar to the anchoring device 1570. FIG.18A illustrates a barbed anchoring device 1800a that includes a distal flange 1802 from which extends a cylindrical support structure 1806 that forms a lumen with a series of tapering barbs 1804 extending axially from the cylindrical support structure 1806. The barbed anchoring devices 1800a also includes a proximal flange 1808 configured to be passed over the cylindrical support structure 1806 so that the series of tapering barbs 1804 pass through a central opening of the proximal flange 1808 to secure the distal flange 1802 to the proximal flange 1808. The tubular shunt 1564 of the vascular implant 1500 is configured to pass through the lumen formed by the cylindrical support structure 1806.

[0148] The distal flange 1802 is configured to expand radially upon release from a delivery catheter. The distal flange 1802 is configured to be deployed next to the aortic wall so that the cylindrical support structure 1806 extends across the walls of the IVC and aorta. This places the tapering barbs 1804 next to the IVC wall. In this configuration, the proximal flange 1808 is deployed and advanced towards and over the tapering barbs 1804 in a ratchet-like mechanism. This causes the walls of the blood vessels 16, 19 to be tightly sandwiched between the distal flange 1802 and the proximal flange 1808.

[0149] FIG.18B illustrates that another embodiment of a barbed anchoring device 1800b does not include a proximal flange. In such embodiments, the tapering barbs 1804 are configured to apply sufficient force to press against the IVC wall without the need to use a separate proximal flange.Docket No.: ADV-23899WO01

[0150] FIGS.19A and 19B illustrate an expandable mesh shunt device 1900. The expandable mesh shunt device 1900 is configured to act as an anchoring and cinching device, similar to the anchoring device 1570. FIG.19A illustrates that the expandable mesh shunt device 1900 includes a woven basket structure 1906, such as in the form of a braid or a mesh, that can be disposed in a tubular configuration around the tubular shunt 1564 of the vascular implant 1500. The expandable mesh shunt device 1900 can be delivered in this configuration when delivered in a delivery catheter 1950 with an outer sheath that is passed through openings in the IVC and aortic walls. FIG.19B illustrates that upon retraction of the outer sheath, the distal portion 1906a and the proximal portion 1906b of the mesh 1906 are configured to radially expand so as to form radially-flanged configurations that tightly sandwich the IVC and aortic walls therebetween. In some implementations, the mesh 1906 can be lined or covered with a sealing member (such as a fabric) to form a sealed tunnel configuration.

[0151] In some implementations, the braid or mesh 1906 can be self-expandable, configured to assume the expanded configuration shown in FIG.19B upon removal from the delivery catheter 1950. In various implementations, pull wires 1908 can be attached to the braid or mesh 1906. Attachment of the pull wires 1908 can be accomplished by directly connecting the pull wires 1908 to the braid or mesh 1906. Attachment of the pull wires 1908 can be accomplished indirectly, by coupling the pull wires 1908 to one or more support stents 1902, 1904 which in turn, are coupled to the braid disposed therearound. In such implementations, expansion of the distal and proximal portions 1906a, 1906b of the braid or mesh 1906 can be actively actuated by proximally pulling on the pull wires 1908. In some implementations, the pull wires 1908 can be locked in place thereafter.

[0152] FIGS.20A, 20B, 20C, 20D, 20E, and 20F illustrate different configurations for the exit port of a compliance device, such as the nozzle 65 of FIG.6, the nozzle 135 of FIGS. 13A-14B, and / or the exit port 1565 of FIG.15A. FIGS.20A-20C illustrate different diameters of an exit port 2000a-2000c with straight walls 2002a-2002c at the opening 2004a-2004c of the exit port 2000a-2000c and FIGS.20D-20F illustrate different diameters of an exit port 2000d-2000f with flared walls 2002d-2002f at the opening 2004d-2004f of the exit port 2000d-2000f. Changing the size of the diameter changes the amount of blood ejected from the ballon (e.g., the expandable reservoir 1562 of the vascular implant 1500). In some implementations, the diameter of the opening can be at least about 0.5 mm and / or less than or equal to about 3 mm. The exit ports 2000a-2000f are configured to provide a shunting aspect to the vascular implant of which it is a part, to avoid stagnation of blood in the reservoir.

[0153] FIGS.21A and 21B illustrate effects on fluid ejection from exit port with different configurations of the opening. The exit ports 2100a, 2100b can be used as the exit portDocket No.: ADV-23899WO01 for vascular implants, such as the nozzle 65 of FIG.6, the nozzle 135 of FIGS.13A-14B, and / or the exit port 1565 of FIG.15A. FIG.21A illustrates fluid ejection 2105a for exit ports 2100a with straight walls 2102a at the opening 2104a of the exit port 2100a. FIG.21B illustrates fluid ejection 2105b for exit ports 2100b with flared walls 2102b at the opening 2104b of the exit port. Thus, the amount of fluid ejected can be controlled at least in part by changing a size of the opening and / or a shape of the walls around the opening. Furthermore, the amount, trajectory, and / or spread of the ejected fluid can be controlled at least in part by changing a size of the opening and / or a shape of the walls around the opening. Additional Description of Examples

[0154] Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.

[0155] Example 1. A vascular implant comprising a textile tube formed of a plurality of fiber segments interlaced together, and an elastic polymer membrane applied over an outer diameter of the textile tube.

[0156] Example 2. The vascular implant of any example herein, in particular example 1, wherein the textile tube and the elastic polymer membrane form a sealed balloon.

[0157] Example 3. The vascular implant of any example herein, in particular example 1, wherein the textile tube and the elastic polymer membrane form a passthrough fluid conduit.

[0158] Example 4. The vascular implant of any example herein, in particular example 1, wherein the textile tube is non-elastic.

[0159] Example 5. The vascular implant of any example herein, in particular example 4, wherein the textile tube comprises a barrel portion having a first diameter, and a nozzle portion having a second diameter that is less than the first diameter.

[0160] Example 6. The vascular implant of example 5, wherein the textile tube has a common fabric density in the barrel portion and the nozzle portion.

[0161] Example 7. The vascular implant of any example herein, in particular example 6, wherein the textile tube comprises a tapered portion connecting the barrel portion to the nozzle portion.

[0162] Example 8. The vascular implant of any example herein, in particular example 7, wherein the textile tube has a fabric density in the tapered portion that matches the common fabric density.Docket No.: ADV-23899WO01

[0163] Example 9. The vascular implant of any example herein, in particular example 6, wherein the textile tube has different fabric design patterns in the barrel portion and the nozzle portion, respectively.

[0164] Example 10. The vascular implant of any example herein, in particular example 5, further comprising a non-circular re-shaping stent associated with the barrel portion.

[0165] Example 11. The vascular implant of any example herein, in particular example 5, further comprising a proximal inlet tube portion that leads into the barrel portion.

[0166] Example 12. The vascular implant of any example herein, in particular example 11, wherein the proximal inlet tube portion comprises a reinforced segment.

[0167] Example 13. The vascular implant of any example herein, in particular example 12, wherein the reinforced segment comprises one or more strands of fiber wound around a circumference of the reinforced segment.

[0168] Example 14. The vascular implant of any example herein, in particular example 13, wherein the one or more strands of fiber comprise at least one of monofilament polyethylene terephthalate or nitinol wire.

[0169] Example 15. The vascular implant of any example herein, in particular example 12, wherein the proximal inlet tube portion is configured to bend, wherein the reinforced segment is configured to prevent kinking of the proximal inlet tube portion.

[0170] Example 16. The vascular implant of any example herein, in particular example 11, further comprising a vessel-to-vessel port anchor associated with a proximal end of the proximal inlet tube portion.

[0171] Example 17. The vascular implant of any example herein, in particular example 5, wherein at least a portion of the nozzle portion has reinforcement fiber associated therewith that is configured to prevent collapsing of the nozzle portion.

[0172] Example 18. The vascular implant of any example herein, in particular example 5, wherein the nozzle portion is part of a first piece, the barrel portion is part of a second piece, and a proximal portion of the first piece is attached to a distal portion of the second piece.

[0173] Example 19. The vascular implant of any example herein, in particular example 18, wherein the first piece has a first tapered portion that expands proximally from the nozzle portion, and the second piece has a second tapered portion that narrows distally from the barrel portion.

[0174] Example 20. The vascular implant of any example herein, in particular example 18, wherein the first piece is sutured to the second piece.Docket No.: ADV-23899WO01

[0175] Example 21. The vascular implant of any example herein, in particular example 18, wherein the first piece and the second piece both have a fabric density of more than 300 ends-per-inch and more than 200 picks-per-inch.

[0176] Example 22. The vascular implant of any example herein, in particular example 5, wherein the nozzle portion has a diameter less than 2 mm and the barrel portion has a diameter greater than 5 mm.

[0177] Example 23. The vascular implant of any example herein, in particular example 1, wherein the plurality of fiber segments comprise elastic yarn.

[0178] Example 24. The vascular implant of any example herein, in particular example 23, wherein the elastic yarn comprises one of polyolefin, polyurethane, or fiber blend, and the elastic polymer membrane comprises thermoplastic polyurethane.

[0179] Example 25. The vascular implant of any example herein, in particular example 23, wherein the elastic yarn has thickness of less than 0.1 mm.

[0180] Example 26. The vascular implant of any example herein, in particular example 23, wherein the elastic polymer membrane uses water as a dispersion medium.

[0181] Example 27. The vascular implant of any example herein, in particular example 23, wherein the textile tube includes open cells defined by lateral gaps between adjacent ones of the plurality of fiber segments.

[0182] Example 28. The vascular implant of any example herein, in particular example 27, wherein the lateral gaps have a dimension at least twice a width of the plurality of fiber segments.

[0183] Example 29. A method of forming a vascular implant, the method comprising interlacing a first plurality of fiber segments over an outer surface of a barrel portion of a mandrel into a three-dimensional, seamless barrel tube segment, the barrel tube segment having a first diameter and forming at least a portion of a flow conduit, interlacing a second plurality of fiber segments including at least a subset of the first plurality of fiber segments over an outer surface of a tapered shoulder portion of the mandrel to form a three-dimensional, seamless tapered frustrum segment having a distal second diameter that is less than the first diameter, wherein the tapered frustrum segment and the barrel tube segment form a first conduit piece and have a first common fabric density, and applying an elastic polymer membrane to the barrel tube segment and the tapered frustrum segment.

[0184] Example 30. The method of any example herein, in particular example 29, further comprising interlacing a third plurality of fiber segments over an outer surface of a nozzle mandrel portion into a three-dimensional, seamless nozzle tube segment, the nozzle tube segment having a third diameter that is less than the first diameter, and interlacing a fourthDocket No.: ADV-23899WO01 plurality of fiber segments including at least a subset of the third plurality of fiber segments over an outer surface of a flared shoulder portion of the nozzle mandrel portion to form a three- dimensional, seamless flared frustrum segment having a distal fourth diameter that is greater than the third diameter, wherein the flared frustrum segment and the nozzle tube segment form a second conduit piece and have a second common fabric density.

[0185] Example 31. The method of any example herein, in particular example 30, wherein the first common fabric density and the second common fabric density are the same.

[0186] Example 32. The method of any example herein, in particular example 30, further comprising attaching the first conduit piece to the second conduit piece by attaching the tapered frustrum segment to the flared frustrum segment.

[0187] Example 33. The method of any example herein, in particular example 29, further comprising reducing a number of ends of warp fibers in a fabric pattern moving from the barrel tube segment to the tapered frustrum segment to maintain the first common fabric density in the barrel tube segment and the tapered frustrum segment.

[0188] Example 34. The method of any example herein, in particular example 29, further comprising reducing a number of weft fibers in a fabric pattern moving from the barrel tube segment to the tapered frustrum segment to maintain the first common fabric density in the barrel tube segment and the tapered frustrum segment.

[0189] Example 35. The method of any example herein, in particular example 29, further comprising circumferentially wrapping one or more reinforcement fibers around a portion of the flow conduit.

[0190] Example 36. The method of any example herein, in particular example 35, wherein the one or more reinforcement fibers are integrated with a polymer yarn fabric that forms at least a portion of the flow conduit through a length segment of the flow conduit.

[0191] Example 37. The method of any example herein, in particular example 35, wherein the portion of the flow conduit includes a bend portion in the flow conduit.

[0192] Example 38. The method of any example herein, in particular example 37, further comprising heating the bend portion to shape-set the bend portion.

[0193] Example 39. The method of any example herein, in particular example 35, wherein the one or more reinforcement fibers form a plurality of axially-offset circumferential bands.

[0194] Example 40. A method of forming a vascular implant, the method comprising interlacing elastic yarn around a cylindrical mandrel to form a three-dimensional, seamless tubular scaffold, and combining the interlaced elastic yarn and the mandrel with an elastic polymer membrane that fills open cells in the tubular scaffold.Docket No.: ADV-23899WO01

[0195] Example 41. The method of any example herein, in particular example 40, wherein said combining involves dipping the mandrel in the elastic polymer membrane.

[0196] Example 42. A vascular implant for increasing efficiency of blood flow through an aorta, the vascular implant comprising a tubular shunt having a lumen for allowing blood to pass between an aorta and an inferior vena cava; and an expandable reservoir sized for placement in the inferior vena cava, the reservoir having a first region coupled to the tubular shunt, the reservoir having a second region formed with an exit port for allowing blood to escape the reservoir into the inferior vena cava; wherein blood from the aorta is capable of passing through the tubular shunt and into the reservoir during systole, and wherein blood from the reservoir is capable of passing through the shunt and back into the aorta during diastole.

[0197] Example 43. The vascular implant of any example herein, in particular example 42, further comprising an anchoring device configured to provide a lumen through which the tubular shunt extends.

[0198] Example 44. The vascular implant of any example herein, in particular example 43, wherein the anchoring device includes a plurality of distal arms, a plurality of fingers, a flange, and a plurality of proximal arms such that the plurality of fingers are configured to press the flange against a wall of the aorta, the plurality of proximal arms are configured to press against a wall of the inferior vena cava.

[0199] Example 45. The vascular implant of any example herein, in particular example 43, wherein the anchoring device includes a first coiled anchor configured to press against a wall of the aorta and a second coiled anchor configured to press against a wall of the inferior vena cava, the lumen running through a central axis of the first coiled anchor and the second coiled anchor.

[0200] Example 46. The vascular implant of any example herein, in particular example 43, wherein the anchoring device includes a stent-like structure, a plurality of spiraling arms extending from a distal end of the stent-like structure, and a plurality of flanged fingers extending from a proximal end of the stent-like structure, the plurality of spiraling arms configured to roll up to press a wall of the aorta towards a wall of the inferior vena cava, the plurality of flanged fingers configured to press against the wall of the inferior vena cava.

[0201] Example 47. The vascular implant of any example herein, in particular example 43, wherein the anchoring device includes a distal flange with a cylindrical support structure extending proximally therefrom, a series of tapering barbs extending axially from the cylindrical support, the cylindrical support forming the lumen, the distal flange configured to be pulled against a wall of the aorta to cause the barbs to pass through an opening in a wall of theDocket No.: ADV-23899WO01 inferior vena cava to approximate the aorta and the inferior vena cava via a ratchet-like mechanism.

[0202] Example 48. The vascular implant of any example herein, in particular example 47, wherein the anchoring device further includes a proximal flange configured to pass over the series of tapering barbs in a ratchet-like mechanism to cause the proximal flange to contact the wall of the inferior vena cava to thereby cinch the wall of the aorta to the wall of the inferior vena cava.

[0203] Example 49. The vascular implant of any example herein, in particular example 43, wherein the anchoring device includes an expandable mesh configured to radially expand on a proximal end and a distal end so that the proximal end contacts a wall of the aorta and the distal end contacts a wall of the inferior vena cava.

[0204] Example 50. The vascular implant of any example herein, in particular example 49, wherein the anchoring device further includes a support stent coupled to the expandable mesh and one or more pull wires coupled to the support stent such that pulling the one or more pull wires causes the radial expansion of the proximal end and the distal end.

[0205] Example 50. The vascular implant of any example herein, in particular example 42, further comprising an oval stent on a portion of the expandable reservoir.

[0206] Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

[0207] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specificallyDocket No.: ADV-23899WO01 stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

[0208] It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.

[0209] 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, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0210] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0211] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended toDocket No.: ADV-23899WO01 encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0212] Unless otherwise expressly stated, comparative and / or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”

Claims

Docket No.: ADV-23899WO01 WHAT IS CLAIMED IS:

1. A vascular implant for increasing efficiency of blood flow through an aorta, the vascular implant comprising: a tubular shunt having a lumen for allowing blood to pass between an aorta and an inferior vena cava; and an expandable reservoir sized for placement in the inferior vena cava, the reservoir having a first region coupled to the tubular shunt, the reservoir having a second region formed with an exit port for allowing blood to escape the reservoir into the inferior vena cava; wherein blood from the aorta is capable of passing through the tubular shunt and into the reservoir during systole, and wherein blood from the reservoir is capable of passing through the shunt and back into the aorta during diastole.

2. The vascular implant of claim 1, further comprising an anchoring device configured to provide a lumen through which the tubular shunt extends.

3. The vascular implant of claim 2, wherein the anchoring device includes a plurality of distal arms, a plurality of fingers, a flange, and a plurality of proximal arms such that the plurality of fingers are configured to press the flange against a wall of the aorta, the plurality of proximal arms are configured to press against a wall of the inferior vena cava.

4. The vascular implant of claim 2, wherein the anchoring device includes a first coiled anchor configured to press against a wall of the aorta and a second coiled anchor configured to press against a wall of the inferior vena cava, the lumen running through a central axis of the first coiled anchor and the second coiled anchor.

5. The vascular implant of claim 2, wherein the anchoring device includes a stent- like structure, a plurality of spiraling arms extending from a distal end of the stent-like structure, and a plurality of flanged fingers extending from a proximal end of the stent-like structure, the plurality of spiraling arms configured to roll up to press a wall of the aorta towards a wall of the inferior vena cava, the plurality of flanged fingers configured to press against the wall of the inferior vena cava.

6. The vascular implant of claim 2, wherein the anchoring device includes a distal flange with a cylindrical support structure extending proximally therefrom, a series of taperingDocket No.: ADV-23899WO01 barbs extending axially from the cylindrical support, the cylindrical support forming the lumen, the distal flange configured to be pulled against a wall of the aorta to cause the barbs to pass through an opening in a wall of the inferior vena cava to approximate the aorta and the inferior vena cava via a ratchet-like mechanism.

7. The vascular implant of claim 6, wherein the anchoring device further includes a proximal flange configured to pass over the series of tapering barbs in a ratchet-like mechanism to cause the proximal flange to contact the wall of the inferior vena cava to thereby cinch the wall of the aorta to the wall of the inferior vena cava.

8. The vascular implant of claim 2, wherein the anchoring device includes an expandable mesh configured to radially expand on a proximal end and a distal end so that the proximal end contacts a wall of the aorta and the distal end contacts a wall of the inferior vena cava.

9. The vascular implant of claim 8, wherein the anchoring device further includes a support stent coupled to the expandable mesh and one or more pull wires coupled to the support stent such that pulling the one or more pull wires causes the radial expansion of the proximal end and the distal end.

10. The vascular implant of claim 1 further comprising an oval stent on a portion of the expandable reservoir.

11. A vascular implant comprising: a textile tube formed of a plurality of fiber segments interlaced together, the textile tube including: a barrel portion having a first diameter, a nozzle portion having a second diameter that is less than the first diameter, and a first tapered portion connecting the barrel portion to the nozzle portion; and an elastic polymer membrane applied over an outer diameter of the textile tube.

12. The vascular implant of claim 11, wherein the textile tube and the elastic polymer membrane form a passthrough fluid conduit.

13. The vascular implant of claim 11, wherein the textile tube is non-elastic.Docket No.: ADV-23899WO01 14. The vascular implant of any of claims 11–13, wherein the textile tube further includes: a proximal inlet tube portion having a third diameter that is less than the first diameter and greater than the second diameter; and a second tapered portion connecting the proximal inlet tube portion to the barrel portion.

15. The vascular implant of claim 14, wherein: the proximal inlet tube portion is configured to bend; and the proximal inlet tube portion comprises a reinforced segment the reinforced segment designed to prevent kinking of the proximal inlet tube portion, the reinforced segment including one or more strands wound around a circumference of the reinforced segment.

16. The vascular implant of claim 15, wherein the one or more strands comprise at least one of monofilament polyethylene terephthalate or nitinol wire.

17. The vascular implant of claim 15, further comprising a vessel-to-vessel anchoring port anchor associated with a proximal end of the proximal inlet tube portion.

18. The vascular implant of any of claims 11–13, wherein the textile tube has a common fabric density in the barrel portion, the nozzle portion, and the first tapered portion.

19. The vascular implant of claim 18, wherein the textile tube has different fabric design patterns in the barrel portion, the nozzle portion, and the first tapered portion.

20. The vascular implant of any of claims 11–13, further comprising a non-circular re-shaping stent associated with the barrel portion.

21. The vascular implant of claim 11, wherein: the nozzle portion is part of a first piece having a proximal tapered portion that expands proximally from the nozzle portion; the barrel portion is part of a second piece having a distal tapered portion that narrows distally from the barrel portion; and a proximal portion of the first piece is attached to a distal portion of the second piece.Docket No.: ADV-23899WO01 22. The vascular implant of claim 11, wherein the plurality of fiber segments comprise elastic yarn.

23. The vascular implant of claim 22, wherein the elastic polymer membrane uses water as a dispersion medium.

24. The vascular implant of claim 22, wherein: the textile tube includes open cells defined by lateral gaps between adjacent ones of the plurality of fiber segments; and the lateral gaps have a dimension at least twice a width of the plurality of fiber segments.

25. A method of forming a vascular implant, the method comprising: interlacing a first plurality of fiber segments over an outer surface of a barrel portion of a mandrel into a three-dimensional, seamless barrel tube segment, the barrel tube segment having a first diameter and forming at least a portion of a flow conduit; interlacing a second plurality of fiber segments including at least a subset of the first plurality of fiber segments over an outer surface of a tapered shoulder portion of the mandrel to form a three-dimensional, seamless tapered frustrum segment having a distal second diameter that is less than the first diameter, wherein the tapered frustrum segment and the barrel tube segment form a first conduit piece and have a first common fabric density; and applying an elastic polymer membrane to the barrel tube segment and the tapered frustrum segment.

26. The method of claim 25, further comprising: interlacing a third plurality of fiber segments over an outer surface of a nozzle mandrel portion into a three-dimensional, seamless nozzle tube segment, the nozzle tube segment having a third diameter that is less than the first diameter; and interlacing a fourth plurality of fiber segments including at least a subset of the third plurality of fiber segments over an outer surface of a flared shoulder portion of the nozzle mandrel portion to form a three-dimensional, seamless flared frustrum segment having a distal fourth diameter that is greater than the third diameter, wherein the flared frustrum segment and the nozzle tube segment form a second conduit piece and have a second common fabric density.Docket No.: ADV-23899WO01 27. The method of claim 26, further comprising attaching the first conduit piece to the second conduit piece by attaching the tapered frustrum segment to the flared frustrum segment.

28. The method of claim 25, further comprising reducing a number of ends of warp fibers in a fabric pattern moving from the barrel tube segment to the tapered frustrum segment to maintain the first common fabric density in the barrel tube segment and the tapered frustrum segment.

29. The method of claim 25, further comprising reducing a number of weft fibers in a fabric pattern moving from the barrel tube segment to the tapered frustrum segment to maintain the first common fabric density in the barrel tube segment and the tapered frustrum segment.

30. A method of forming a vascular implant, the method comprising: interlacing elastic yarn around a cylindrical mandrel to form a three-dimensional, seamless tubular scaffold; and combining the interlaced elastic yarn and the mandrel with an elastic polymer membrane that fills open cells in the tubular scaffold by dipping the mandrel in the elastic polymer membrane.

31. A vascular implant comprising: a textile tube formed of a plurality of fiber segments interlaced together; and an elastic polymer membrane applied over an outer diameter of the textile tube.

Images