WO2025169124A1

WO2025169124A1 - Intra-aortic balloon assist devices, circulatory assist devices, and one-way valve devices for use with the same

Info

Publication number: WO2025169124A1
Application number: PCT/IB2025/051285
Authority: WO
Inventors: Constantinos ANAGNOSTOPOULOS
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-02-06
Filing date: 2025-02-06
Publication date: 2025-08-14
Anticipated expiration: 2026-08-06

Abstract

Circulatory assist devices for use to improve circulatory pressure and improved one-way valve devices for use to improve circulatory pressure and compartmentalize of circulatory flow in the aorta or other circulatory lumen with such circulatory assist devices. The valve device includes a radially expandable frame (120) having a first, smaller diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by manipulation by control mechanism. The frame (120) includes a plurality of distally extending resilient arms (124). Pairs of the plurality of distally extending resilient arms (124) are joined to inverted substantially V-shaped projections (126). The V-shaped projections (126) are bridged internally by a membrane (140) each forming a leaflet valve that collapses inwardly to form a seal against proximal-to-distal flow past the radially expandable frame (120) and that billowing outwardly to permit proximal flow past the radially expandable frame (120).

Description

INTRA-AORTIC BALLOON ASSIST DEVICES, CIRCUILATORY ASSIST DEVICES, AND

ONE-WAY VALVE DEVICES FOR USE WITH THE SAME

TECHNICAL FIELD

[0001] The present disclosure relates generally to Intra-Aortic Balloon (IAB) assist devices for assisting the pumping function of a failing heart and, more generally, to circulatory devices for producing circulatory compartmentalization and pressure differentials in a circulatory lumen. More specifically, the present disclosure relates to improved one-way valve devices for combination with such IAB assist devices or circulatory assist devices for improving circulatory compartmentalization and pressure differentials in such circulatory lumens.

SUMMARY

[0002] The present application discloses circulatory assist devices for use to improve circulatory pressure and create and augment circulatory flow in an aorta or other circulatory lumen, and improved one-way valve devices for use to improve circulatory pressure and compartmentalize of circulatory flow in the aorta or other circulatory lumen with such circulatory assist devices. The one-way valve device comprises an elongated operating wire or catheter having a distal end, joined to a radially expandable frame, and a proximal end, separated from the distal end by a length sufficient to extend from within the circulatory lumen to the outside of a patient's body. The radially expandable frame has a first, smaller diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by manipulation of an included control mechanism. The radially expandable frame includes a proximal, substantially cylindrical hub joined to a plurality of distally extending resilient arms. Pairs of the plurality of distally extending resilient arms are joined to inverted substantially V- shaped projections having a distally oriented vertex and a proximally oriented opening so as to provide a plurality of such projections. The V-shaped projections are bridged internally by a membrane extending from proximate the distally oriented vertex toward the proximally oriented opening, with the membranes forming leaflets which, collectively, form a multiple leaflet valve that collapses inwardly toward the longitudinal axis of the operating wire or catheter to form a seal against proximal-to-distal flow past the radially expandable frame and that billows outwardly away from the longitudinal axis of the operating wire or catheter to permit proximal flow past the radially expandable frame when the radially expandable frame is expanded within a circulatory lumen of the patient.

[0003] In some embodiments, the distally extending resilient arms may have substantially free distal ends joined only to opening-side ends of the inverted substantially V-shaped projections, and the control mechanism may comprise a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen. At least the distally extending resilient arms are biased towards a radially expanded position. In some constructions, both the distally extending resilient arms and the V-shaped projections themselves are biased towards a radially expanded position.

[0004] In some embodiments, the distally extending resilient arms may have distal ends joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter. The distally extending resilient arms may be biased towards a radially expanded position or towards a radially collapsed configuration. In some constructions with a bias towards the radially expanded position, the control mechanism may comprise a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen. In other constructions with a bias towards the radially expanded position, the control mechanism may comprise a control wire, or other tubular elongated structure, joined to the distal hub, directly or indirectly, and operable to oppose or allow the biased radial expansion of the distally extending resilient arms via relative movement of the proximal and distal hubs. In constructions with a bias towards the radially collapsed configuration, the control mechanism may comprise a control wire joined to the distal hub and operable to cause radial expansion of the distally extending resilient arms or to allow the biased collapse of the distally extending resilient arms via relative movement of the proximal and distal hubs. [0005] In some embodiments, the distally extending resilient arms may have distal ends indirectly joined to proximally extending resilient arms that are joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, with ones of the proximally extending resilient arms being joined to ones of the distally oriented vertexes of the inverted substantially V-shaped projections. At least the distally extending resilient arms and the proximally extending resilient arms may be biased towards a radially expanded position or towards a radially collapsed configuration. In some constructions with a bias towards the radially expanded position, the control mechanism may comprise a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms, proximally extending resilient arms, and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen. In other constructions with a bias towards the radially expanded position, the control mechanism may comprise a control wire joined to the distal hub and operable to oppose or allow the biased radial expansion of the distally extending resilient arms and the proximally extending resilient arms via relative movement of the proximal and distal hubs. In constructions with a bias towards the radially collapsed configuration, the control mechanism may comprise a control wire joined to the distal hub and operable to cause radial expansion of the distally extending resilient arms and the proximally extending resilient arms or allow the biased collapse of distally extending resilient arms and the proximally extending resilient arms via relative movement of the proximal and distal hubs.

In some embodiments the valve apparatus is used as a temporary or long term implant to alleviate symptoms of a valve deficiency such a heart valve regurgitation, valve stenosis and mixed valve disease, combining both stenosis and regurgitation. More than one, and any number of valve and stent segments can be combined together if more than one valve deficiencies need to be addressed, or it is desired to induce one way valve simultaneously at more than one anatomically connected sites. In such embodiments, although each one-way valve may deployed and/or operated independently from each other, the delivery may be accomplished by a system combining both, or all, valves. In such constructions the control mechanism may comprise a tubular segment upon which both valves are mounted, combined with a retractable sleeve tube, operable to withdraw and release said structures to radially expand.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The following detailed description references various aspects of an Intra-Aortic Balloon (IAB) assist device that includes an improved one-way valve device. It will be appreciated that the improved one-way valve device is operationally and commercially separable from the IAB assist device and may be used with other IAB assist devices or circulatory assist devices. Those of skill in the art will further appreciate that the features illustrated in the drawings may not be drawn to scale, that some of the drawings may not depict all of the components of a given device, mechanism, or component, and that one or more illustrated features may be used alone or in combination with other illustrated features in various other embodiments, constructions, and variants as described below. Those of skill in the art will still further appreciate that the features illustrated in the drawings are exemplary instances of features discussed in the detailed description and do not serve to limit the claims. In the drawings, like reference numerals refer to like features in the various views.

[0007] Figures 1A and IB are schematic representations of an exemplary embodiment of, and method of using, an IAB assist device and one-way valve device in an exemplary intra-aortic assist application.

[0008] Figure 2 is a schematic view of an exemplary embodiment of an improved one-way valve device.

[0009] Figure 3 is a schematic cut-away view of a first construction of an exemplary distal tip for one-way valve devices.

[0010] Figure 4 is a schematic cut-away view of a first construction of another exemplary distal tip for one-way valve devices.

[0011] Figure 5 is a pseudo-perspective view of a first embodiment of a radially expandable frame for the improved one-way valve device.

[0012] Figure 6 is a pseudo-perspective view of a second embodiment of a radially expandable frame for the improved one-way valve device. [0013] Figure 7A is a pseudo-perspective view of a third embodiment of a radially expandable frame for the improved one-way valve device in a radially expanded disposition.

[0014] Figure 7B is a pseudo-perspective view of the third embodiment of a radially expandable frame for the improved one-way valve device in a radially collapsed configuration.

[0015] Figure 8 A and 8B are a pseudo-perspective view of a fourth embodiment of a radially expandable frame for the improved one-way valve device.

[0016] Figure 9 is a pseudo-perspective view of another exemplary radially expandable frame for the improved one-way valve device.

[0017] Figure 10A is a schematic view of an exemplary membrane for assembly upon an exemplary plurality of V-shaped projections.

[0018] Figures 10B, lOCi, lOCii, 10D, 10E and 10F variously illustrate operation of the membranes of the V-shaped projections.

[0019] Figure 11 is a pseudo-perspective view of a variation of the radially expandable frame of Figure 9.

[0020] Figure 12 is a pseudo-perspective view of another variation of a radially expandable frame.

[0021] Figure 13 is a pseudo-perspective view of the first embodiment of a radially expandable frame illustrating features for the attachment of a membrane.

[0022] Figure 14 is a pseudo-perspective view of the first embodiment of a radially expandable frame illustrating an additional feature for the attachment of a membrane.

[0023] Figure 15 is a schematic view of an exemplary embodiment of an improved one-way valve device and push device.

[0024] Figures 16A and 16B are a schematic views of an exemplary embodiment of an improved one-way valve device and expandable mesh material.

[0025] Figures 17 A, 17Ai, 17B and 17C are pseudo-perspective and schematic views of three exemplary embodiments of an improved heart valve implantation system. [0026] Figures 18 A, 18Ai, 18B and 18C are schematic variations of another radially expandable frame incorporating V-Shape projections,

[0027] Figures 19A, 19B and 19C are pseudo-perspective views of variations of the radially expandable frame incorporating additional diamond shape stent segments

DESCRIPTION

[0028] Referring initially to Figures 1A and IB, an exemplary application involving a traditional femorally accessed IAB assist device placement is shown. The implanted portion is introduced percutaneously in the desired circulatory vessel or lumen 010 (as illustrated, the aorta) using the Seidinger technique. An access vessel or lumen 020 is punctured with a sharp hollow needle, with ultrasound guidance if necessary. A round-tipped guidewire is then advanced through the lumen of the needle and directed actinoscopically to the desired site within the desired vessel or lumen 010. An operating wire or a catheter 110, having a resiliently expandable frame 120 joined to it at its distal end, is passed over the guidewire and advanced into the vessels or lumens until its desired position is confirmed via fluoroscopy. Injection of radiocontrast may be used to visualize organs and the device's relative placement. The guidewire is withdrawn and the radially expandable frame 120 is deployed via an included control mechanism (not shown in Figures 1A and IB) described further below. Subsequently an elongated balloon catheter 1010, continuously accessible from its proximal end, and having one or more wrapped-around balloons 1020 positioned proximate its distal end in fluid communication with the balloon catheter for cyclic inflation and deflation, is passed over the operating wire or catheter and connected to an external balloon pump (not shown). The IAB assist device 1010, 1020 improves circulatory pressure and creates and augments circulatory flow in the aorta, and may operate either in counter pulsation mode, gated with a pulsatile CPB pump, or non-gated in internal pacing mode, combined with a continuous flow CPB pump, to provide pressure assist to the lower aorta, the renal arteries, and other peripheral arterial flows. Expandable frames 120 including one way valves, such as those described in PCT Patent Application Publication No. W02014/203078, the entirely of which is hereby incorporated by reference, may supplement or function in place of natural valves such as the aortic valve, or otherwise provide an artificial valve, to prevent the assist device from creating retrograde flow during inflation (upstream of the device), such as in the illustrated application, and/or creating retrograde flow during deflation (from downstream of the device), such as in other devices illustrated in the aforementioned publication, in order to optimize blood flow towards proximal or downstream circulatory lumens such as the renal arteries 030. It will be appreciated that the one-way valve devices and circulatory assist devices described herein may be used and configured for use in any venous, biliary, urinary, lymphatic, or cerebrospinal circulatory lumen. Furthermore, it will be appreciated that while one-way valve devices have been disclosed in the aforementioned publication, improvements to such devices remain possible.

[0029] Turning to Figure 2, a first embodiment of an improved one-way valve device 100 is shown. The one-way valve device 100 comprises an elongated operating wire or catheter 110 having a distal end 112, j oined to a radially expandable frame 120, and a proximal end (not shown), separated from the distal end by a length sufficient to extend from within the circulatory lumen to the outside of a patient's body. The radially expandable frame 120 has a first, smaller diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by manipulation of an included control mechanism 160 (illustrated as a sleeve tube 162). The radially expandable frame 120 includes a proximal, substantially cylindrical hub 122 joined to a plurality of distally extending resilient arms 124. Pairs of the plurality of distally extending resilient arms 124 are joined to inverted substantially V-shaped projections 126 each having a distally oriented vertex 127 and an open end 128, so as to provide a plurality of such projections. A small portion of the V-shape projections, adjacent to their vertices, are preferably shape set to be inverted inwardly, in order to avoid vascular trauma, and they may be combined with rounded endings. The V-shaped projections 126 are bridged, preferably internally, by a membrane 140 extending from proximate the distally oriented vertices 127 toward the open ends 128. Membrane 140 is partially segmented into multiple leaflets that cover the areas defined by the V-shaped projections 126, and the dimensions of the membrane 140 is preferably greater than the outer dimensions of the V-shaped projections 126, such that the membrane leaflets are movable with respect to the V-shaped projections. The leaflets of membrane 140 collectively form a multiple leaflet valve that collapses inwardly toward the longitudinal axis of the operating wire or catheter 110 to form a seal against proximal-to- distal flow past the radially expandable frame 120 and that billows outwardly away from the longitudinal axis of the operating wire or catheter to permit proximal flow past the radially expandable frame when the radially expandable frame is expanded within a circulatory lumen of the patient, thus serving as a one-way valve. The operating wire or catheter 110 may include a distal tip 150 and a proximal stop 152 bracketing the radially expandable frame 120 at the distal end 112. A sleeve tube 162 may extend over the proximal stop 152 up to the distal tip 150 and be reversibly retractable therefrom.

[0030] Figure 3 illustrates an exemplary distal tip construction 200 for the distal tip 150. The construction includes a hollow internal path 202, of uniform or variable diameter, to which a section of operating catheter 110 extending through the radially expandable frame 120 may be secured. The guidewire described in the context of the Seidinger technique may be passed proximally through the hollow internal path 202 and the section of operating catheter 110 past the proximal stop 152. In some constructions, the section of operating catheter 110 may be joined to a further section of operating guidewire 110 at the proximal stop 152, as described below, to form a hybrid operating wire or catheter 110, with the guidewire running proximally within the sleeve tube 162 or another catheter-like or tube-like structure (where sleeve tube 162 may be nested within such catheter-like or tube-like structures, or vice versa), or proximally outside the sleeve tube 162 and within another catheter-like or tube-like structure (with sleeve tube 162 nested within such catheter-like or tube-like structures, such as within a delivery catheter (not shown)). In other constructions, the operating catheter 110 may be continuously hollow from its distal end to a proximal end located outside of a patient's body, with the guidewire running proximally within the operating catheter 110 beyond the proximal stop 152 and to and beyond the proximal end of the operating catheter 110.

[0031] Figure 4 illustrates another exemplary distal tip construction 300 for the distal tip 150. The construction may include a nonlinear hollow internal path 302 including an axially aligned distal leg 304 open to an axially angled proximal leg 306. A linear blind path 308 may be provided at a proximal end of the construction 300 to which the operating wire or catheter 110 may be secured. The guidewire described in the context of the Seidinger technique may be passed proximally through the nonlinear hollow internal path 302, with the guidewire running proximally in parallel to the operating wire or catheter 110. For example, the guidewire may pass outside of the sleeve tube 162 and between the sleeve tube and a surrounding device catheter or other tubelike structure (not shown). For further example, the guidewire may pass outside of the sleeve tube 162 and between the sleeve tube and a separate delivery catheter (not shown). The non-linear hollow internal path 302 improves manufacturability for distal tips sized for use within circulatory lumens by eliminating a need to form two parallel internal paths (with one or both being through- paths) separated by a dividing wall of material.

[0032] The distal tip constructions 200 and 300 may have an atraumatic substantially ovoid shape (which includes rounded distal and proximal ends, and may include a cylindrical central section). The distal tip constructions 200 and 300 may have an outer diameter that is larger than an inner diameter of a distal end of the sleeve tube 162 so as to prevent the sleeve tube from being extended past the distal tip 152. The distal tip 150 is preferably constructed from a biocompatible radiopaque material.

[0033] A principal function of the proximal stop 152 may be to prevent an IAB device catheter from being advanced over the radially expandable frame 120 during introduction of an IAB device using the Sei dinger technique. However, in some constructions, the proximal stop 152 may join the proximal, substantially cylindrical hub 122 and the operating wire or catheter 110, and in some of the same or other constructions may join separate sections of operating catheter 110 extending through the radially expandable frame 120 and operating wire 110 extending proximally from the proximal stop. In the latter constructions, the section of operating catheter 110 may be lapped with the section of operating wire 110 within or upon the proximal stop 152 to form a hybrid operating structure. Such a hybrid operating structure may be advantageous because the section of operating catheter 110 may include a plurality of radially oriented apertures 114 (shown in Figure 2) fluidly communicating with the interior of the catheter, and allow for decontamination, flushing, and deairing of the radially expandable frame 120 and membrane structures via fluid communication between apertures, the interior of the section of operating catheter 110 extending through the radially expandable frame 120, and the interior of the sleeve tube 162, through which fluids may be introduced or withdrawn. In constructions in which the operating catheter 110 is continuously hollow from its distal end to a proximal end located outside of a patient's body, the distal end 112 of the operating catheter may include such a plurality of radially oriented apertures 114 (shown in Figure 2) fluidly communicating with the interior of the catheter, and allow for decontamination, flushing, and deairing of the radially expandable frame 120 and membrane structures via fluid communication between apertures, the interior of the operating catheter 110, and other structures located outside of the patient’s body through which fluids may be introduced or withdrawn. [0034] At least a portion of the proximal stop 152 may have an outer diameter that is larger than an inner diameter of the proximal, substantially cylindrical hub 122. However, it will be appreciated that the proximal hub 122 may also or instead be secured to the operating wire or catheter 110. The proximal stop 152 may be cylindrical, ovoid, spheroid, arctoid, or combinations thereof. The proximal stop 152 may be constructed from biocompatible metal(s), resin(s), polymer(s), or silicon material(s) or the like, and combinations thereof.

[0035] As shown in further detail in Figure 5, a first embodiment of a radially expandable frame 120’ ¹ for an improved one-way valve device includes a proximal, substantially cylindrical hub 122 joined to a plurality of distally extending resilient arms 124. The distally extending resilient arms 124 may have substantially free distal ends 125 joined only to opening-side ends of the inverted substantially V-shaped projections 126. As in the earlier presented description, the V- shaped projections 126 are bridged internally by a membrane 140 extending from proximate the distally oriented vertices 127 toward the open ends 128, and the membranes collectively form a multiple leaflet valve that collapses inwardly to form a seal against proximal-to-distal flow past the radially expandable frame and that billows outwardly to permit proximal flow past the radially expandable frame when the radially expandable frame is partially or fully expanded within a circulatory lumen of the patient. A control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a sleeve tube 162 that extends over the operating wire or catheter 110 and is extendable over the said distally extending resilient arms 124 and V-shaped projections 126 to gather the said structures together proximate the longitudinal axis of the operating wire or catheter (i.e., the longitudinal centerline of the operating wire or catheter or a projection thereof proximate the distal end 112). The sleeve tube 162 is retractable from over the said structures 124, 126 to release them for radial expansion towards the walls of the circulatory lumen. Reversible extension and retraction of the sleeve tube 162 may allow for control of the degree of expansion of the distally extending resilient arms 124 and thus, indirectly, the degree of expansion of the V-shaped projections 126. At least the distally extending resilient arms 124 are biased towards the radially expanded position. In some constructions, both the distally extending resilient arms 124 and the V-shaped projections themselves 126 are biased towards the radially expanded position. Further variations to this main construction are shown in Figure 19. [0036] As shown in Figure 6 (and in the more complete context of the exemplary embodiment of an improved one-way valve device of Figure 2), a second embodiment of a radially expandable frame 120’ ² for an improved one-way valve device includes a proximal, substantially cylindrical hub 122 joined to a plurality of distally extending resilient arms 124. The distally extending resilient arms 124 may have distal ends joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110. The proximal and distal hubs 122 and 132 and distally extending resilient arms 124 may be formed from a unitary, hollow cylindrical base shape in the manner of a Malecot multi-armed expandable frame. Medial portions of the distally extending resilient arms 124 are joined to opening-side ends of the inverted substantially V-shaped projections 126. As in the earlier presented description, the V-shaped projections 126 are bridged internally by a membrane 140 extending from proximate the distally oriented vertices 127 toward the open ends 128 of the V-shaped projections, and the membranes collectively form a multiple leaflet valve that collapses inwardly to form a seal against proximal -to-distal flow past the radially expandable frame and that billows outwardly to permit proximal flow past the radially expandable frame when the radially expandable frame is partially or fully expanded within a circulatory lumen of the patient. The distally extending resilient arms 124 may be biased towards a radially expanded position or towards a radially collapsed configuration. In some constructions with a bias towards the radially expanded position, a control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a sleeve tube 162 that extends over the operating wire or catheter 110 and is extendable over the said distally extending resilient arms 124 and the said V-shaped projections 126 to gather the said structures together proximate the longitudinal axis of the operating wire or catheter (i.e., the longitudinal centerline of the operating wire or catheter 110 proximate the distal end 112). The sleeve tube 162 is retractable from over the said structures 124, 126 to release them for radial expansion towards the walls of the circulatory lumen. Reversible extension and retraction of the sleeve tube 162 may allow for control of the degree of expansion of the distally extending resilient arms 124 and thus, indirectly, the degree of expansion of the V-shaped projections 126. In other constructions with a bias towards the radially expanded position, a control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a control wire 164 joined to the distal hub 132 and operable to oppose or allow the biased radial expansion of the distally extending resilient arms 124 via relative movement of the proximal and distal hubs 122, 132, i.e., sliding motion of the distal hub 132 along the operating wire or catheter 110. In constructions with a bias towards the radially collapsed configuration, the control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a control wire 164 joined to the distal hub 132 and operable to cause radial expansion of the distally extending resilient arms 124 or allow the biased collapse of the distally extending resilient arms via relative movement of the proximal and distal hubs 122, 132. It will be appreciated that to oppose biased radial expansion, the control wire 164 will be constructed to resist compression and buckling, whereas to allow biased collapse (and cause radial expansion in opposition thereto), the control wire 164 may be constructed as a tension element. It will be further appreciated that the sleeve tube 162 may work in combination with the control wire 164, at least prior to initial retraction, to maintain the radially expandable frame 120’² in a tight, radially collapsed configuration.

[0037] As shown in Figure 7A, a third embodiment of a radially expandable frame 120’³ for an improved one-way valve device includes a proximal, substantially cylindrical hub 122 joined to a plurality of distally extending resilient arms 124. The distally extending resilient arms 124 may have distal ends 125 indirectly joined to distally extending resilient arms 134 that are joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110. Specifically, end of each one of the distally extending resilient arms 124 may be affixed to a respective pair of V-shaped projections 126 where the opens ends 128 of the pair of V-shaped projections meet, and end of each one of the proximally extending resilient arms 134 may be joined to a respective vertex 127 of the substantially V-shaped projections 126. Accordingly, the proximally extending resilient arms 134 may be circumferentially offset from the distally extending resilient arms 124 with respect to an imaginary cylindrical surface oriented perpendicularly to the operating wire or catheter 110. As in the earlier presented description, the V-shaped projections 126 are bridged internally by a membrane 140 extending from proximate the distally oriented vertices 127 toward the open ends 128 of the V-shaped projections, and the leaflets of membrane 140 collectively form a multiple leaflet valve that collapses inwardly to form a seal against proximal-to-distal flow past the radially expandable frame and that billows outwardly to permit proximal flow past the radially expandable frame when the radially expandable frame is partially or fully expanded within a circulatory lumen of the patient. The distally extending resilient arms 124 and the proximally extending resilient arms 134 may be biased towards a radially expanded position or towards a radially collapsed configuration. In some constructions with a bias towards the radially expanded position, a control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a sleeve tube 162 that extends over the operating wire or catheter 110 and is extendable over the said distally extending resilient arms 124, the said proximally extending resilient arms 134, and the said V-shaped projections 126 to gather the said structures together proximate the longitudinal axis of the operating wire or catheter (i.e., the longitudinal centerline of the operating wire or catheter 110 proximate the distal end 112). As shown in Figure 7B, the sleeve tube 162 may, at least prior to initial retraction, maintain the radially expandable frame 120’ ³ in a tight, radially collapsed configuration during intraluminal delivery of the one-way valve device, and is retractable from over the said structures 124, 134, 126 to release them for radial expansion towards the walls of the circulatory lumen. Reversible extension and retraction of the sleeve tube 162 may allow for control of the degree of expansion of the distally extending resilient arms 124 and thus, indirectly, the degree of expansion of the V-shaped projections 126 and the proximally extending resilient arms 134. In other constructions with a bias towards the radially expanded position, a control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a control wire 164 joined to the distal hub 132 and operable to oppose or allow the biased radial expansion of the distally extending resilient arms 124 and the proximally extending resilient arms 134 via relative movement of the proximal and distal hubs 122, 132, i.e., sliding motion of the distal hub 132 along the operating wire or catheter 110. In constructions with a bias towards the radially collapsed position, the control mechanism 160 for controllable and reversible radial expansion of the radially expandable frame may comprise a control wire 164 joined to the distal hub 132 and operable to cause radial expansion of the distally extending resilient arms 124 and the proximally extending resilient arms 134 or allow the biased collapse of the distally extending resilient arms 124 and the proximally extending resilient arms 134 via relative movement of the proximal and distal hubs 122, 132. It will be appreciated that to oppose biased radial expansion, the control wire 164 will be constructed to resist compression and buckling, whereas to allow biased collapse (and cause radial expansion in opposition thereto), the control wire 164 may be constructed as a tension element. It will be further appreciated that the sleeve tube 162 may work in combination with the control wire 164, at least prior to initial retraction, to maintain the radially expandable frame 120’ ³ in a tight, radially collapsed configuration. The design features of Figure 7, may apply to either of the Figures 8, 9, 11, 12, 13, 14. More specifically in either frame structure, other than Fig. 7, each one of the proximally extending resilient arms may be joined to a respective vertex of the substantially V-shaped projections, instead of the distally extending resilient arms where the respective pair of V-shaped projections affix.

[0038] As shown in Figures 8 and 8B, a fourth embodiment of a radially expandable frame 120’ ⁴ for an improved one-way valve device includes a proximal, substantially cylindrical hub 122 joined to a plurality of distally extending resilient arms 124. The distally extending resilient arms 124 may have distal ends joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110. Medial portions of the distally extending resilient arms 124 are joined to opening-side ends of the inverted substantially V-shaped projections 126, however the construction may vary from that illustrated for the second embodiment of the radially expandable frame 120’ ² in that adjoining pairs of the distally extending resilient arms are joined to only a single one of the V-shaped projections. As illustrated, the embodiment provides a bicuspid one-way valve with dichotomized pairs of distally extending resilient arms 124 separated by gaps not bridged by such V-shaped projections (indicated as shaded regions), however it should be appreciated that tricuspid, quadrocuspid, and other higher order leaflet valves may be so constructed. As in the earlier presented description, the V-shaped projections 126 are bridged internally by a membrane 140 extending from proximate the distally oriented vertices 127 toward the open ends 128 of the V-shaped projections, and the membranes collectively form a multiple leaflet valve that collapses inwardly to form a seal against proximal -to-distal flow past the radially expandable frame and that billows outwardly to permit proximal flow past the radially expandable frame when the radially expandable frame is partially or fully expanded within a circulatory lumen of the patient. It will be noted that the shaded gaps may be bridged internally a membrane as well, however such membranes are not required for a one-way valve device. A secondary membrane 140 may also extend between the arms 124. The biasing of the distally extending resilient arms 124 and the control mechanism 160 may be those described in the context of the second embodiment of the radially expandable frame 120’², as well as the construction of the control wire 164 and the potential for the sleeve tube 162 to work in combination with the control wire 164.

[0039] Figure 9 illustrates an exemplary radially expandable frame for the improved one-way valve device that highlights a similarity of the second and fourth embodiments of the radially expandable frame 120’² and 120’⁴, which in turn illustrates an important aspect related to the description of the membrane(s) included above. The exemplary radially expandable frame includes a proximal, substantially cylindrical hub 122 joined to two distally extending resilient arms 124. The distally extending resilient arms 124 have distal ends joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110, and medial portions of the distally extending resilient arms 124 are each joined to an opening-side end of two inverted substantially V-shaped projections 126. Accordingly, the embodiment provides a bicuspid one-way valve with a single pair of distally extending resilient arms 124 rather than dichotomized pairs of distally extending resilient arms 124 separated by gaps. So long as the membrane(s) 140 span a substantial majority of the circumference of the circulatory lumen, i.e., the circumference of radially expandable frame in a partially or fully radially expanded position, the described and illustrated valves may form a seal against proximal-to-distal flow past the radially expandable frame without clinically significant leakage. Thus, the phrase “V-shaped projections 126 are bridged internally by a membrane 140” and variations thereof when appearing in the description and claims may refer to either a single membrane 140 bridging internally multiple V-shaped projections 126,as illustrated in the assembly shown in Figure 10 A, or multiple individual membranes 140 each bridging internally a single V-shaped projection 126, or a combination thereof, i.e., multiple individual membranes 140 each bridging internally at least one V-shaped projection 126. It will be appreciated that multiple individual membranes 140 each bridging internally at least one V-shaped projection 126 allow for a greater range of radial expansion of the radially expandable frame 120 in comparison to a single membrane, which may be drawn taut across the proximally oriented openings 128 of the V-shaped projections or otherwise across an enlarged span sufficient to interfere with the ability of the membrane/leaflet to properly collapse so as to form a seal if the frame is excessively expanded. It will be appreciated that each of the first, second, and third embodiments of the radially expandable frame 120’ 120’², and 120’⁴, and variations thereof, including variations having a greater or lesser number of distally extending resilient arms 124, proximally extending resilient arms 134, and/or inverted substantially V-shaped projections 126, may include either a single membrane 140 bridging internally multiple V-shaped projections 126, multiple membranes 140 each bridging internally a single V-shaped projection 126, or a combination of such, and such variations are expressly contemplated as individual and separate permutations of the disclosed radially expandable frame embodiments and constructions. The individual membranes 140 each bridging internally at least one V-shaped projection, may also bridge, adhere between them, at lesser or larger extent, to create functional flow stenosis, and create a pressure differential, a higher pressure on the inlet flow side of the valve.

[0040] Figures 10A, 10E and 10F illustrates an exemplary valve design that allow valve functionality at a plurality of different diameters. The optimal functionality of any bicuspid, tricuspid, quadricuspid valve is accomplished at a unique for each valve diameter (so called nominal diameter of the valve) where all the valve leaflets or membranes 140a, 140b, 140c (hereafter 140 unless specifically referenced) coapt in the center without any central leaks, and without any shrinkage. Reversibly expandable valves cannot expand above the nominal diameter without central leaks; and likewise they cannot shrink below the nominal diameter, because that will create shrinkage and abnormal function.

[0041] Figure 10b displays how a traditional tricuspid valve having three membranes 140a, 140b, 140c (hereafter 140 unless specifically referenced) can be formed by symmetric bulging of three equal portions of a cylinder.

[0042] Figures 10a, lOci and lOcii illustrate an exemplary membrane shape cut, which in smaller and membrane formation principles for an improved valve device having one or more membranes 140 that allow valve functionality at a variety of diameters, both the nominal and lesser to the nominal diameters. This is accomplished by modifying the current valve design from triangular to “bat shape”.

[0043] Figure lOd provides 3D and cranial preudoperspective views of a tricuspid valve having three membranes 140a, 140b, 140c (hereafter 140 unless specifically referenced) and shows how, at an expansion diameter of a transcatheter tricuspid valve, lesser to the nominal, the regular (in the current tricuspid transcatheter valves in the market) triangulated shape of a leaflet or membrane 140 creates side S shape projections of the leaflet at the coaptation surface while the leaflets are compressed side to side. Excess of material and inappropriate bulging of a shrunk valve makes it stenotic and dysfunctional and asynchronous, where some of the leaflet regions, during closure either coapt slower than others, or open slower than others, because they are compressed against other regions. As illustrated in Figure lOe the “bat shape” depicted allows the coaptation surface to bulge downwards creating downward reversible tissue indentations that absorb the tissue excess and prevent dysfunctional side to side bulges. The “bat shape” allows the excess of material to locate and concentrate, just below the “bat indentations” which upon fluid pressure, and under tension (during valve closure), may store an excess of volume (compared to the traditional shape); transform the leaflet shape to create a spherical surface, below the transverse of the coaptation point, which supports the neighbor leaflets and create a better side seal and support of the leaflets. The “bat shape” indentations/cuts can be anything between 0-20% lower in relation to the middle section height of the leaflet (coaptation point and highest point of the leaflet). The coaptation and middle point of the leaflet needs to be either on the line the connects the commissures, or 5-20% below to maintain functionality. If the coaptation point lowers the bat shape cuts indentations need to also lower to maintain functionality. The ratio between the width and height of the leaflet needs to ideally to be at a range between 1 : 1.25-1 : 1.6, with a preferred ratio of 1.4 in order to allow the perfect geometry of “spherical transformation” and prevent stenotic phenomena. The “bat indentations” ideally need to be symmetrical, and may be more than two on the same leaflet.

[0044] Another advantageous feature is that the “bat shape” also creates a difference in the regional mass of the leaflet, with more mass been concentrated at the central point of the leaflet and less mass at the sides of the leaflet. As illustrated in Figure lOf this is particular important during the opening of the leaflets or membranes 140a, 140b, 140c (hereafter 140 unless specifically referenced). As depicted in the pseudoperspective 3D views, 2D side and cranial (from above) views, in the “bat cut design pattern” (see bottom half) due to the sided smaller mass, there is smaller flow impedance at the lateral regions of the leaflet. When the inward flow opens the valve, will force the sides of the leaflets to collapse the towards the center. This side collapse appears to collapse and fold the leaflet first before opening it. That makes the leaflet to “open” much faster to any other valve design, by opening fast the sides of the leaflets, and collapsing the leaflet to the middle of it, rather than displacing, bulging out all the leaflet towards the perimeter of the outlet, as it happen with the current leaflet cut designs (illustrated in the upper half). The Authors have performed multiple testing which showed that this change of mass concentration, allows very fast leaflet opening unlike any other in the market.

[0045] The inclusion of multiple inverted substantially V-shaped projections 126 and membrane(s) 140 that internally bridge those V-shaped projections to form leaflets which, collectively, form a multiple leaflet valve, enable a deflection of the V-shaped projections, and thus the outer periphery of the one-way valve, in the event that a circulatory assist device generates an excessive pressure within the circulatory lumen. Specifically, above a preselected threshold pressure differential, the vertexes 127 of one or more of the V-shaped projections 126 may deflect away from the walls of the circulatory lumen toward the longitudinal axis of the operating wire or catheter, allowing for a thresholded and limited proximal-to-distal flow past the outer periphery of the radially expandable frame. That thresholded and limited proximal-to-distal flow will cease when the cause of the excessive pressure abates or is mitigated. The thresholded and limited “leakage” of the one-way valve device may serve to mitigate the effects of such excessive pressure upon the device and/or the circulatory lumen, reducing the risk that the membrane(s) 140 may rupture due to the pressure differential and/or accelerated fatigue, and reducing the risk that the compartmentalization of pressure enabled by the one-way valve will cause injury to the circulatory lumen or adjoining lumens. In embodiments which include proximally extending resilient arms 134 connected to the vertexes 127 of one or more of the V-shaped projections 126, the crosssections and span of the proximally extending resilient arms may be configured to allow reversible deflection or buckling above a preselected threshold pressure difference. In embodiments which lack proximally extending resilient arms, the cross-sections of the inverted substantially V-shaped members and/or configuration of the joints to the distally extending resilient arms 124 may be configured to make the sides of the V-shaped projections 126 prone to bending towards the longitudinal axis of the operating wire or catheter above a preselected threshold pressure difference. Consequently, the incorporation of a plurality of inverted substantially V-shaped projections as described herein may improve the durability and/or safety of intraluminal one-way valve devices, and combinations of IAB assist devices or circulatory assist devices with such oneway valve devices, in circulatory assist applications and the provision of patient care.

[0046] Figure 11 illustrates a variation of the fourth embodiment of the radially expandable frame 120’⁴. The exemplary radially expandable frame includes a proximal, substantially cylindrical hub 122 joined to two distally extending resilient arms 124. The distally extending resilient arms 124 have distal ends joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110, and medial portions of the distally extending resilient arms 124 are each joined to an opening-side end of two inverted substantially V-shaped projections 126. Accordingly, the variation provides a bicuspid oneway valve. However, the two inverted substantially V-shaped projections 126 may have different depths from their distally oriented vertex 127 to their open end 128, and thus include differently sized membranes 140 or portions of a single membrane 140. This asymmetric configuration of V-shaped projections 126 and membrane(s) 140 allows one valve leaflet to lay across the other leaflet proximate the opening 128 of the V-shaped projections 126, and, in preferred constructions, the membrane of the “deeper” V-shaped projection may be configured (e.g., via a more concavely shaped opening end edge) to accentuate this behavior. This improves the quality the seal, particularly when the radially expandable frame 120’⁴ is not expanded to is fully expanded extent. In contrast, trileaflet and higher order one-way valves require that the constituent leaflets coapt “perfectly” in order to form an optimal seal, and when such radially expandable frames cannot be expanded to their intended extents, bulging in any “surplus” portions of the constituent membrane(s) 140 may prevent proper coaptation and permit an undesirable degree of leakage. Furthermore, if such radially expandable frames are expanded beyond their intended extents, lack of coverage by the constituent membrane(s) 140 will leave a central opening that permits an undesirable degree of leakage, which leads to such valve being designed for a comparatively narrow range of expanded diameters without substantial over- or under-expansion. In contrast, asymmetric bicuspid valves may perform well both when expanded to their intended extents and to significantly lesser extents, allowing for a greater range of expanded diameters and a greater accommodation of potential overexpansion (due to, e.g., a greater than expected diameter across the walls of the circulatory lumen). It will be appreciated that the variation may be applied to the third embodiment of the radially expandable frame 120’³, as well as any other radially expandable frame 120 having a bicuspid configuration of V-shaped projections 126 and membrane(s) 140.

[0047] Figure 12 illustrates another variation of the fourth embodiment of the radially expandable frame 120’⁴. The exemplary radially expandable frame again includes a proximal, substantially cylindrical hub 122 joined to two distally extending resilient arms 124. The distally extending resilient arms 124 have distal ends joined to a distal, substantially cylindrical hub 132 slidably disposed around the operating wire or catheter 110, and medial portions of the distally extending resilient arms 124 are each joined to an opening-side end of two inverted substantially V-shaped projections 126. Accordingly, the variation provides a bicuspid oneway valve. However, the sides of the two inverted substantially V-shaped projections 126 may have different shapes between the distally oriented vertices 127 and the open ends 128 of the V-shaped projections, i.e., when placed in overlapping perspective have different coverages or widths leading to the open ends 128 of the V-shaped projections (Figure 12 showing one projection 126 (foreground) in solid lines and the other projection 126 (background) in dashed lines), and thus include differently shaped and sized membranes 140 or portions of a single membrane 140. The difference in configuration of the membrane(s) 140 likewise allows one valve leaflet to lay across the other leaflet proximate the opening 128 of the V-shaped projections 126. It will again be appreciated that the variation may be applied to the third embodiment of the radially expandable frame 120’³, as well as any other radially expandable frame 120 having a bicuspid configuration of V-shaped projections 126 and membrane(s) 140.

[0048] The distally extending resilient arms 124, proximally extending resilient arms 134, and inverted substantially V-shaped members 126 may be constructed from a resilient biocompatible metal(s), resin(s), polymer(s), or the like, including superelastic nitinol (nickel-titanium) and other alloys, other materials exhibiting shape memory, and combinations of any of the foregoing. Examples of biocompatible polymer materials include polypropylene, polyethylene, PVC, silicone, polyurethane, polystyrene, polyimide, polyamide, nylon, polytetrafluoroethylene (PTFE), and combinations thereof. It will be appreciated that the distally extending resilient arms 124, proximally extending resilient arms 134, and inverted substantially V-shaped members 126 do not necessarily need to be constructed from the same material(s). Referring back to Figure 10, the membrane 140 may be constructed from a polymeric film or a multilayered polymeric film laminate of one or more polymer materials. The membrane 140 may be a single membrane 140 bridging internally multiple V-shaped projections 126,or multiple individual membranes 140 each bridging internally a single V-shaped projection 126, or a combination thereof, i.e., multiple individual membranes 140 each bridging internally at least one V-shaped projection 126. For a predetermined, intended diameter of radial expansion, D, the height of an individual leaflet, H, is preferably in a range of 1.25:1 to 1.6: 1 (H.D), and more preferably in a range of 1.35: 1 to 1.45: 1 (77:D). [0049] Figure 13 illustrates a variation of the radially expandable frame 120’¹, and examples of several features for securement of a membrane 140 to an inverted substantially V-shaped projection 126, where such features may be used individually or in combination with any of the embodiments of the radially expandable frame 120 (and, specifically, the included V-shaped projections 126) shown or described herein. First, the sides 136 of the inverted substantially V- shaped projections 126 may be coated with a biocompatible polymer material. This may improve the attachment of a polymer membrane to the sides 136, particularly when the V-shaped projections 126 are constructed from super elastic alloys, and prevent substantial thinning of the membrane if thermobonding between the side and the membrane is used during manufacturing. Second, the sides 136 of the inverted substantially V-shaped projections 126 may include one or more dilated portions 137. This may improve the attachment of a membrane 140 to the sides 136 by resisting sliding movement of the membrane and/or any coating of the sides along the sides. Third, the sides 136 of the inverted substantially V-shaped projections 126 may include one or more narrowed portions 138. This may improve the attachment of a membrane 140 to the sides 136 by resisting sliding movement of the membrane and/or any coating of the sides along the sides at the ends of the narrowed portion(s). Fourth, the sides 136 of the inverted substantially V-shaped projections 126 may include one or more apertures 139. This may improve the attachment of a membrane 140 to the sides 136 by enabling a form of peg anchor to form between the membrane 140, any coating of the sides, or any adhesive material used and the walls of the apertures 139 in the sides. It will be appreciated that the features need not be combined as illustrated, e.g., have dilated portions 137 which include apertures 139 or have dilated portions 137 adjoining narrowed portions 138, and that the numbers and locations of the features need not exhibit symmetry between the sides 136 of any V-shaped projection 126 or among any of the V-shaped projections.

[0050] Figure 14 illustrates a further feature for securement of a membrane 140 to an inverted substantially V-shaped projection 126, where such feature may be used individually or in combination with any of the embodiments of the radially expandable frame 120 (and, specifically, the included V-shaped projections 126), and individually or in combination with any of the features described in the prior paragraph. V-shaped projections 126 may be split into mutually opposing, V-shaped halves 126’, 126” configured to sandwich a membrane 140 between the respective halves. The V-shaped halves 126’, 126” may be secured to each other by laser welding, adhesive bonding, crimping, thermobonding via the membrane 140 itself, or other direct or indirect mechanical connection. This may improve the attachment of a membrane 140 to the sides 136 by resisting sliding movement of the membrane along and/or across the sides of the V- shaped projections 126.

[0051] Figure 15 illustrates a variation of the one-way valve device 100. In many constructions, relative motion between the elongated operating wire or catheter 110 and sleeve tube 162 may be sufficient to deploy the radially expandable frame 120 and associated structures from within the sleeve tube 162 (or, analogously, any other catheter surrounding such frame) into the aorta or circulatory lumen. However, the structure or required sizing of the radially expandable frame 120, V-shaped projections 126, membrane 140, and the like may require comparatively tight packing of these structures within a sleeve tube 162. Accordingly, the one-way valve device 100 may further include a push device 166, slidably disposed relative to the operating wire or catheter 110, and positioned proximally from the radially expandable frame 120. In operation, the push device 166 may be abutted against the proximal end of the radially expandable frame 120, e.g., the proximal hub 122, to assist in overcoming friction between the radially expandable frame 120 and associated structures in the sleeve tube 162 (or, analogously, any other catheter surrounding such frame) upon deployment of the radially expandable frame 120 and associated structures into the aorta or circulatory lumen. As illustrated, the push device 166 may be a catheter or tube surrounding the operating wire or catheter 110. However, it will be appreciated that the push device 166 may be a rod or wire structure disposed in parallel with the operating wire or catheter 110 within the sleeve tube 162 (or, analogously, any other catheter surrounding such frame), or a combination of rod-like and tube-like portions (forming guide rings) which slides along the operating wire or catheter 110, and that the proximal hub 122 may include a flare for abutment by such structures.

[0052] Figures 16A and 16B illustrate another variation of the one-way valve device 100 and radially expandable frame 120. Packing of the radially expandable frame 120 and associated structures within the sleeve tube 162 may be improved by reducing the diameter of the proximal, substantially cylindrical hub 122, along with the operating catheter 110 and distal, substantially cylindrical hub 132 when present within the radially expandable frame, and so that the resilient arms 124 and V-shaped projections 126, along with any proximally extending arms 134 when present, may be packed in closer proximity to the longitudinal centerline. However, reducing the diameter of the cylindrical hub(s) 122, 132 and portion of any operating catheter 110 extending through the frame reduces the size of an IAB assist device that can be passed through those structures in order to provide a distally, rather than proximally, disposed IAB device with respect to the one-way valve device 100. Instead, in structures such as the radially expandable frames 120, 120’¹, 120’², 120’³, and 120’⁴ shown in Figures 5-9, and other the variations as described above, the proximal, substantially cylindrical hub 122 may be constructed from a radially expandable mesh 400, and the distal, substantially cylindrical hub 132 may, when present, be constructed from a radially expandable mesh 400 (See. Fig. 16B). The radially expandable mesh(es) may biased towards a radially expanded position so that upon deployment of the radially expandable frame 120 and associated structures from within the sleeve tube 162 (or, analogously, any other catheter surrounding such frame), the substantially cylindrical hub(s) 122, 132 expand and define a passageway (in lieu of any operating catheter which may be shown in the frames of the aforementioned figures) through the radially expandable frame 120 proximate its longitudinal centerline. Accordingly, a comparatively larger IAB device (such as the device shown in Figure 1 (1010, 1020) can be advanced through (as opposed to over) an operating catheter 110 to and through the distal hub 122, through the radially expandable frame 120, and through any proximal hub 132 to a distal position with respect to the one-way valve device 100. It will be appreciated that the illustrated radially expandable frame is similar to the frame 120’ ³ (shown in Figures 7A and 7B), but that the orientation of the V-shaped projections 126 is reversed, with ones of the distally extending resilient arms 124 joined to ones of proximally oriented vertexes 127 of substantially V-shaped projections 126 and ones of the proximally extending resilient arms 134 joined to ones of the sides of the substantially V-shaped projections 126 at a distally oriented opening 128. V-shaped projections 126 oriented as shown in Figures 7A and 7B, or as shown in Figure 16A, may be employed with variations of the one-way valve device 100 that are used with distally disposed or proximally disposed IAB devices, or in combination with other devices, or as independent devices, depending upon the direction of desired one-way flow.

[0053] Figure 16B, in particular, illustrates a side view of a an exemplary cylindrical mesh structure 400 including end structure 410 and interior structure 420. The end structure 410 may include longitudinally extending struts 412 interconnected by a transversely repeated array of arcuate sections 414 collectively forming an expandable end of a cylinder, i.e., a radially expandable end of a substantially cylindrical hub. The interior structure 420 may likewise include longitudinally extending struts 422 interconnected by a transversely repeated array of arcuate sections 424 collectively forming an expandable circumference of a cylinder, i.e., a radially expandable center of a substantially cylindrical hub. In variations of the interior structure 420, the longitudinally extending struts 422 may be interconnected by a transversely repeated array of longitudinally elongated loops, which it will be appreciated comprise mutually opposing transversely extending arcuate sections 424, such that opposing, oppositely directed arcuate sections are not required for an expandable mesh. In other variations, the longitudinally extending struts 412 may be interconnected by transversely repeated array of V-shapes, and the longitudinally extending struts 422 may be interconnected by a transversely repeated array of V- shapes or longitudinally elongated diamond (rhombus) shapes

[0054] As a general description it will become obvious that any two, or higher number of frames, of any valvular orientation, similar to the design features of Figure 7A, can be combined sequentially, and used either as temporary, or permanent implant. By the latter term “similar to Figure 7 A” are meant frames where the V-shaped projections 126 loops’ tip portions vertices 127 join to distally extending arms 134. The same terminology will be used further below. Regarding different frame designs, where the V-shaped projections loop portions do not connect to resilient arm, such as the ones depicted in Figure 2 and Figure 6, these can be also implanted, used or combined, noting that the valve orientation as a general rule can only be downstream, with the V loops pointing away from the entry point, such that the V loops will not traumatize the entry point upon withdrawal and removal from the circulation. Exceptions of this general rule apply to modified methods of withdrawal.

[0055] Figure 17A and 17Ai illustrates a device placement through the traditional jugular vein access, used as temporary implant, for the purpose of alleviating flow regurgitation, in the right (central venous) circulation. The device is used as temporary implant and combines two expandable frames 120a and 120b, substantially similar to Fig 7A, of opposing valvular orientation.

[0056] In an exemplary embodiment the frames 120a, 120b are used as temporary implants; they follow both the frame design features of Figure 7, and the construction features of the Figure 2 assembly. At first the access vessel 40 (internal jugular vein) is punctured with a sharp hollow needle, with ultrasound guidance if necessary. A round tipped guidewire is then advanced through the lumen of the needle and directed actinoscopically to the desired site within the desired vessel or lumen of Inferior Vena Cava (IVC). Injection of radiocontrast may be used to visualize organs and the device's relative placement. The distal frame 120b (in relation to the entry point) is inserted first as described above, having the V-shaped projections loops 127b orientation of Figure 2. Upon withdrawal of the sleeve tube the frame 120b deploys and the initial guidewire is removed. Upon deployment, the V-shaped projections loops 127b will be pointing away from the entry point, and there will be an elongated operating wire coming out of the patient’s body, through the jugular vein access point.

[0057] The operating wire of the distal frame 120b is next used to guide the insertion of the second proximal frame 120a, as it would occur if said operating wire, was a guide wire. The proximal frame 120a is inserted second and guided actinoscopically to its desired location. The proximal frame 120a is having the opposite valve orientation in comparison to the distal frame 120b, nevertheless they are both downstream and allow flow towards the heart. There will be a total number of two operating wires projecting through the access port, each one being the operating wire of respective each one of the frames. After operation both stents/frames can be removed sequentially in reverse sequence (first proximal, second distal) through the jugular vein.

[0058] Figure 17B illustrates a detail of another exemplary embodiment where a composite device 105 bearing two frames 120a, 120b, with design features, similar to the Figure 7A frame, is inserted together for similar to Fig 17A anatomical placement, through the traditional jugular vein access. The device 105 is used as temporary implant, for the same purpose of alleviating flow regurgitation, in the right (central venous) circulation. The device 105 is used as temporary implant and combines two expandable frames 102a, 120b, similar to Fig 7A design features, of opposing however valvular orientation. On the same lines, with the above Figure 17A insertion process, the access vessel (internal jugular vein) is punctured with a sharp hollow needle, and a round tipped guidewire is then advanced through the lumen of the needle and directed actinoscopically to the desired site within the desired vessel or lumen of Inferior Vena Cava (IVC). The composite device 105 comprises of either a catheter or wire portion bearing both frames, The frames 120a and 120b can be referred to as proximal and distal (in relation to the entry point). [0059] More specifically the composite device 150 comprises an elongated linear operating member comprising of a catheter 1050 (or a wire) having a distal end 1052, joined joinable to two radially expandable frames 120a, 120b, and a proximal end (not shown) separated from the distal end by a length sufficient to extend from within the IVC lumen to the outside of a patient's body. Both the radially expandable frames 120a, 120b have a first, smaller diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by manipulation of an included control mechanism (illustrated as a sleeve tube 1060). The radially expandable frames 120a, 120b share the design features of the frame depicted in Figure 7A, or any frame similar to Figure 7A. Each frame displays a proximal and distal cylindrical hub, in relation to the entry point. The proximal cylindrical hub 1054a, 1054b of each frame 120a, 120b is joined to the operating member 1050. The operating member 1050 may include a distal tip 1052 facilitating insertion, the latter tip sharing the design features of Figure 3, in an embodiment. The operating member 1050 may include two tips, herein referred as proximal tips 1054a, 1054b, one used for each proximal cylindrical hub, used to bridge the outer diameter of the catheter portion to the inner diameter of the proximal cylindrical hubs. The distal cylindrical hub of each frame 120a, 120b is free to slide along the catheter 1050 and collapse. The distance between the two frames, need to match the distance of the sites of their anatomical deployment; need to match and exceed the collapsed length of each frame, A sleeve tube 1060 may extend over the entire length of the frames 120a, 120b from outer of the body up to the distal tip and be reversibly retractable therefrom. The inner diameter of the sleeve tube need to match and exceed where necessary the outer diameter of the collapsed frame. The length of the operating linear member 1050 need to comfortably exceed the length of the sleeve tube 1060. The inner hollow part of the catheter tube 1050 provides the path of the guidewire 1062 and the catheter’s internal diameter need to match and/or exceed the outer diameter of the guidewire 1062.

[0060] As a first variation to this pattern, similar to Figure. 2 design features, part of the elongated linear operating member may be replaced (partially) by a durable and resilient wire extending proximally from out of the patient’s body to the proximal bridging element of the proximal frame. In such a case the Design features of the proximal tip may also match these of Figure. 4 where the short hollow part of the tip (308)1052 may accommodate the wire 1062, whereas the angulated hollow part may accommodate the catheter part extending between the proximal briding tip and the distal tip. The purpose of such a replacement would be to allow the use of bigger guidewire for better navigation, which would otherwise demand a bigger catheter portion (to thread through), and subsequently a bigger tip portion and a bigger frame cylindrical hub, therefore an overall bigger device profile diameter.

[0061] As a second variation to the pattern, illustrated in Figure 17C, the construction is modified, and simplified to allow long term implantation of the joined frames 120a, 120b. Part of the elongated linear operating member, and specifically the catheter part extending between the proximal tip of the proximal frame and the proximal tip of the distal frame may be replaced by a wire, resilient and durable enough to allow long term implantation. In said variation, the implanted part of the device only includes the frame portions 120a, 120b, a short linear connection 1070 between their respective proximal cylindrical hubs, and (optionally) their respective bridging elements, depicted here matching Fig.3 tip design features.

[0062] It will be appreciated, by those familiar with the art, that in any type of delivering a device there is the need for a hollow portion to allow safe passage of the guidewire through the valve portions. In order to allow deployment the connected frames are crimped in a double lumen sleeve tube 1080 is used, comprising of a central large diameter lumen 1082, able to accommodate the two frames 120a, 120b, and a second smaller diameter lumen, able to accommodate the guidewire. The Double lumen tube has a sufficient length, extending from the anatomical site to out of the patient body. The implanted part is crimped and loaded at the distal part of the double lumen tube. Once delivered to the deployment site it is pushed out of the sleeve tube through the use of a push tube.

[0063] It will be appreciated, by those familiar with the art, that in any type of delivering a device there is the need for a temporary placed catheter hollow portion combined during packing, to allow safe passage of the guidewire. In addition to the above there are a few exemplary variations available to address this need, which will not be shown here. In one, a removable catheter hollow portion is included during packaging and crimping of the valves in a sleeve tube. The removable catheter portion can be either placed on the side, parallel to crimped valve apparatus within the sleeve tube, or be part of a multi-lumen sleeve tube, or more advantageously may be threaded through channeled openings of the tip portions that bridge the cylindrical hubs of the stents. The combination of the two valve implant, with a removable hollow tube, accommodating the guidewire, allows is the device to be advanced over the guidewire and reach the desired site of implantation. In either case a push tube may be used to deploy the crimped apparatus, out of the sleeve tube, at the desired location. The outer diameter of the removable catheter portion is smaller to the inner diameter of the tip linear blind path, within which it resides during packing. The frame cylindrical hubs may either have a constant diameter, or been shape set to expand to allow safe removal of the temporary hollow portion.

[0064] Figures 18A and 18B and 18C variously illustrate another functional variation of Figure 6. It will be appreciated that the general structure is similar, but the functionality differs. A first embodiment, which acts as a one-way valve device, is shown in Fig 18A-1. The one-way valve device includes a frame 520 with a plurality of distally extending arms 524 that expand from a proximal hub 522 outward and reconverge at a distal hub 532. The frame 520 is either heat set or manually forced to expand to acquire a spherical, ovoid, ellipsoid, funnel, cylindrical shape, or other shape having a maximum diameter either matching or exceeding by a small amount (approximately 10-20%) the inner diameter of the surrounding body lumen. The V-shape projections 526 are shape set and differ from those depicted in Figure 6. In particular the V-shaped projections 526 either match substantially the frame’s shape, or they substantially match except for a small distal portion of the V-shape projections 526 that are shape set to a particular semiopen position. In the illustrated embodiment, vertices 527 of the V-shape projections 526 are disposed toward the proximal hub 522 of the frame 520. The V-shape projections 526 are pliable and resilient enough to achieve and tolerate repetitive patterned movements. That is, the V-shape projections 526 may freely move, based on blood flow, between an open position where the vertices 527 of the V-shape projections 526 are positioned away from the arms 524 of the frame (see Fig. 18A 2) and a closed position where the V-shape projections 526 are disposed against the arms 524 of the frame 520 (see, Fig. 18A 1) closing the valve device in a dome-shaped configuration. A small area of the V-shaped projections 526, adjacent to their vertices 527, may be shape set moderately inwardly to prevent vascular trauma after expansion.

[0065] The freely movable V-shaped projections 526 are covered by a membrane 540. As best shown in FIG. 18Ai, the V-shape projections 526 of the frame 520 are covered by substantially triangularly shaped, substantially flat membranous leaves 542 of the membrane. The leaves 542 as well as portions of frame 520 that support the V-shape projections 26 may be bridged by a body portion 544 (e.g., bridging portion) of the membrane 542, such that the leaves 542 and the bridging membrane 544 together form a composite, saw-shaped membrane 540. As depicted in Fig. 18Ai, the shape of the saw-shaped composite membrane 540 can be differently configured as illustrated by membranes 540a, 540b and 540cto suit particular applications in regard to intended flow specifications, etc. Leaves 542 of the composite membrane 540 simultaneously open when bodily fluid flows in a direction such that the fluid first impacts vertices 527 of the V-shaped projections 526, and conversely, leaves 542 simultaneously close when bodily fluid flows in an opposite direction, in which case the leaves collectively form a dome-shaped seal against the frame 520. The continuous membranous surface of the V-shaped projections 526 prevent an excessive inward movement of any one projection which could, if not prevented, cause the projection to overshoot the frame arms 524 and pass through to the inside of the frame 520. In another embodiment, such overshooting is prevented by providing the frame with membranous bridge portions, strips, or ribbons of polymeric material which extend between arms of the frame and that allow the flow of bodily fluid, and at the same time, prevent the V-shaped projections from falling below the frame surface and billowing inside the frame. The same or additional membranous connections between the arms of the frame and the V-shaped projections may be used to bias the V-shaped projections to move as intended when in an opened configuration and to thereby prevent undue overexpansion.

[0066] The cyclical opening and closing of the V-shaped projections induces a one-way valve function. When blood or other bodily fluid, as applicable to the deployment site, flows in a direction such that the fluid first impacts the interior surface of a membrane covering the V-shaped projections 526 , the V-shaped projections 526 move outwardly and allow the fluid to flow. When the flow velocity in this direction drops, the V-shaped projections 526 have a tendency to move back to their “on frame” memory shape position and act as a valve. When the flow is reversed, the V-shaped projections 526 will tend to close completely to a position on the frame 520 due to their memory shape, induced by both the flow reversal and their original shape set bias.

[0067] The substantially triangular and flat membrane portions can be either separate or combined in a composite membrane, forming anything from a saw-like to a continuous tubularlike or funnel-like outlet when fully expanded. The frame 520 can be covered partially with a skirt to form a tubular-type passage, or not be covered at all. The longer the tubular passage and the more the surface area covered by the skirt, the less the risk of paravalvular leak. [0068] In an attempt to minimize intravalvular flow regurgitation between membrane-covered V-shaped projections, the frame arms 524 that support the V-shaped projections 526 and create the dome described above may incorporate additional membranous segments, at the expense of forming a functional stenosis

[0069] Figure 18B is another functional variation of the a frame and V shape-projections structure. In this embodiment, the V-shape projections 526 are not directed towards a one-way valve mechanism, but are used solely to provide a reversibly expandable flow inlet or outlet and/or bridge an outer diameter difference between a valve (e.g., outer body of the frame 520) and the surrounding lumen. As shown the frame 520 incudes a plurality of distally extending arms 524 that expand from a proximal hub 522 outward and reconverge at a distal hub 532. The frame acquires, either through heat set, shape bias self-expansion or/and through manual force, and outer diameter that is lesser to the inner diameter of the surrounding lumen. The vertices 527 of the V- shape projections are disposed toward the distal hub 532. The V-shape projections are shape biased to expand and acquire a diameter larger to that of the outer diameter of the frame 524, thus bridging the gap between the outside of the frame and the inside of a larger diameter lumen. See also FIG. 18C 1 The V-shape projections may be shape biased to expand tangentially or not tangentially to the frame arms 524. The C-shape projections may acquire any degree of elastic or firm apposition to the surrounding lumen, depending on their shape bias, thickness and width. The whole structure may be combined of a membrane 540 that will collectively form upon expansion a funnel shape inlet, able to converge or diverge the flow as necessary. The membrane may include leaves 542 for attachment to the V-shaped projections as well as a body portion 544 for connection about the frame 520.

[0070] Figure 18C illustrates a structural variation where outwardly biased V-shape projections 526a that form an inlet on one end of the frame 520 are combined with V-shape projections 526b on the other end of the frame the form a one-way valve where both sets of V- shape projections support membranous material 540. This embodiment is effectively a combination of the embodiments of Figs. 18A and 18B. It becomes evident that the shape and dimensions of the membrane 540, will confer additional limitations and shape bias, if smaller to the expanded valve. The V loops may comprise of additional features, to allow stronger membrane to frame attachment, and mechanical stress release, including but not limited to fenestrations, dilatations and small circular segments as analyzed above elsewhere and depicted in Figures 13 and 14.

[0071] Figs. 18C 2 and 18 C 3 illustrate the overall operation of the device of Fig. 18C 1. As shown, the lower V-shape projections 526a hold the lower end of the membrane 540 open to funnel fluid (blood) into the interior of the frame 520. See Figs. 18C 2 and 18C 3. The lower V-shape projections 526a are static during use and continuously hold the lower end of the membrane 540 open. In contrast the upper V-shape projections 526b move tow and away from the arms of the frame 520 to close the upper end of the valve as shown in Fig 18C 2 and then open the valve as shown in Fig. 18C 3.

[0072] Figure 19 illustrates design features variations of Figure 5 where the radially expandable frame 620 may increase in length to incorporate more diamond shape segments, before or after the valve carrying V-shape projections. In Figure 19, the radially expandable frame 120’ ¹ of Fig. 5 is illustrated on the left hand side of the sheet. The embodiment of Fig. 5 includes a hub 122 joined to a plurality of distally extending arms 124that have free distal ends. Attached to each pair of adjacent distal ends are the open ends of the V-Shaped projections 126 that extend to terminal vertices 127. The illustrated embodiments of Figure 19 add additional structure (e.g., lower V-shaped projections) to adjected vertices 127 of the V-shaped projections 126. Collectively, two sets of connected V-shaped projections for a diamond shape stent segment 630. This is best illustrated in Fig. 19A where a lower V-shaped projection 627 attached to two vertices 127 of two upper V-shape projections 126. In Figure 19A this results in one set of three diamond shape stent segments below the V-shape projection 126 of Figure 5. However, more sets and different sizes of diamond shape stent segments may be incorporated, depending on the clinical application. Such stent frame constructions may be desired for a number of reasons. The extra length may be desired to increase the durability of the frame, and or the overall radial expansion and apposition strength to a surrounding lumen. The extra length of the expandable frame may incorporate a continuous membranous skirt in either its entire length, or any part of it, to form a durable, firmly positioned but also very importantly reversibly collapsible flow channel that is combined with a one way valve. By way of example, in certain pathologies and anatomical structures (e.g. Aortic Valve disease) where a temporary water tight valve function is desired, a diamond shape segment to increase length (Figure 19A), combined with a continuous membranous skirt, and a valve, may suitably provide a firm apposition and satisfactory valve function. The membranous skirt cover may be bound to some length, or the whole length of the longitudinal frame structure. The diamond shape structure may comprise of many small as opposed to few large diamond shape stent segments (Figure 19B 1) to achieve a more uniform force application. The diamond shape structure may be either asymmetric and one sided (Fig 19 B 1), or symmetric to achieve a variable force application. Fig 19B-2 is an exemplary embodiment where a construction of smaller diamond shape stent portions 630 has replaced just one of the large diamond shape stent structure of figure 19A. The same “extension” principle of the V- portions, can be applied to produce lengthy frames, where more diamond shape stents “rows” can be added to the desired extent. The same “replacement” principle of large diamond stent fragments with smaller ones can be applied as desired. The term “diamond” shape is only descriptive of an indefinite number of structural designs used in the market and the literature, to describe a repetitive pattern of small stent units, being part of a larger 3D cylindrical stent unit. Zig-zag, S-bridged, OCS-bridged, ring, honeycomb, inverted honeycomb, spiral units, are just some of the basic unit patterns of an indefinite number of variations that can be combined together to produce and “add on” segment to the V loop portions

[0073] The diamond shape lengthy frame structure may combine with a valve mechanism either distally (Figure 19C 1) or proximally, or in the middle, in relation to the extra frame length, depending what elements it is combining with. It becomes obvious that the Fig. 19 designs in combination with a continuous skirt 640 (Fig. 19C 2 and Fig. 19C 3) can deliver a composite reversibly collapsible, radially expandable hollow channel, combined with a valve, particularly important in the transcatheter heart valve implantation space. The skirt may be composed by any biocompatible material, preferably polymeric able to be produced in a membranous form, such as silicone, polyurethane, PTFE and the like (as mentioned in 0044). On the same lines the skirt substance and polymeric bonding method is like what has been described for the valve material above.

[0074] It will be appreciated that the embodiments, constructions, and variations described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the invention is considered to include both combinations and sub combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

[0075] Numerous specific details are set forth herein to provide a thorough understanding of the claimed subject matter. However, those skilled in the art will understand that the claimed subject matter may be practiced without these specific details. In other instances, devices, structures, processes, methods, and systems that would be known to those one of ordinary skill have not been described in detail so as not to obscure the claimed subject matter.

[0076] The use of “configured to” herein is meant as open and inclusive language that does not foreclose devices and structures adapted to or configured to perform or provide additional functions. As used in the description of the implementations and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the term “and/or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[0077] The foregoing description and summary of the invention are to be understood as being in every respect illustrative and exemplary, but not restrictive, and the scope of the invention disclosed herein is not to be determined only from the detailed description of illustrative implementations but according to the full breadth permitted by patent laws. It is to be understood that the implementations shown and described herein are only illustrative of the principles of the present invention and that various modification may be implemented by those skilled in the art without departing from the scope and spirit of the invention.

Claims

What is claimed is:

1. A one-way valve device for use to improve circulatory pressure and compartmentalize circulatory flow in an aorta or other circulatory lumen, the device comprising: an elongated operating wire or catheter having a distal end, joined to a radially expandable frame, and a proximal end, separated from the distal end by a length sufficient to extend from within the circulatory lumen to the outside of a patient's body; the radially expandable frame having a first, smaller diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by manipulation of an included control mechanism; the radially expandable frame including a proximal, substantially cylindrical hub joined to a plurality of distally extending resilient arms, wherein pairs of ones of the plurality of distally extending resilient arms are joined to inverted substantially V-shaped projections having a distally oriented vertex and a proximally oriented opening so as to provide a plurality of such projections; the V-shaped projections being bridged internally by a membrane extending from proximate the distally oriented vertex toward the proximally oriented opening, with the membranes forming leaflets which, collectively, form a multiple leaflet valve that collapses inwardly toward the longitudinal axis of the operating wire or catheter to form a seal against proximal-to-distal flow past the radially expandable frame and that billows outwardly away from the longitudinal axis of the operating wire or catheter to permit proximal flow past the radially expandable frame when the radially expandable frame is expanded within a circulatory lumen of the patient.

2. The one-way valve device of claim 1 , wherein the membrane comprises multiple individual membranes, each bridging internally at least one V-shaped projection.

3. The one-way valve device of claim 1, wherein: the distally extending resilient arms have substantially free distal ends joined only to opening-side ends of the inverted substantially V-shaped projections, and are biased towards a radially expanded position; and the control mechanism comprises a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen.

4. The one-way valve device of claim 3, wherein both the distally extending resilient arms and the V-shaped projections are biased towards a radially expanded position.

5. The one-way valve device of claim 1, wherein: the distally extending resilient arms have distal ends joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, and are biased towards a radially expanded position; and the control mechanism comprises a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen.

6. The one-way valve device of claim 1 , wherein: the distally extending resilient arms have distal ends joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, and are biased towards a radially expanded position; and the control mechanism comprises a control wire joined to the distal hub and operable to oppose or allow the biased radial expansion of the distally extending resilient arms via relative movement of the proximal and distal hubs.

7. The one-way valve device of claim 6, wherein the control mechanism includes a sleeve tube that extends over the operating wire or catheter and the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures.

8. The one-way valve device of claim 1, wherein: the distally extending resilient arms have distal ends joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, and are biased towards a radially collapsed configuration; and the control mechanism comprises a control wire joined to the distal hub and operable to cause radial expansion of the distally extending resilient arms or to allow the biased collapse of the distally extending resilient arms via relative movement of the proximal and distal hubs.

9. The one-way valve device of claim 8, wherein the control mechanism includes a sleeve tube that extends over the operating wire or catheter and the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures.

10. The one-way valve device of claim 1, wherein: the distally extending resilient arms have distal ends indirectly joined to proximally extending resilient arms that are joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, with ones of the proximally extending resilient arms being joined to ones of the distally oriented vertexes of the inverted substantially V-shaped projections; at least the distally extending resilient arms and the proximally extending resilient arms are biased towards a radially expanded position; and the control mechanism comprises a sleeve tube that extends over the operating wire or catheter and is extendable over the said distally extending resilient arms, proximally extending resilient arms, and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures for radial expansion towards the walls of the circulatory lumen.

11. The one-way valve device of claim 1 , wherein: the distally extending resilient arms have distal ends indirectly joined to proximally extending resilient arms that are joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, with ones of the proximally extending resilient arms being joined to ones of the distally oriented vertexes of the inverted substantially V-shaped projections; at least the distally extending resilient arms and the proximally extending resilient arms are biased towards a radially expanded position; and the control mechanism comprises a control wire joined to the distal hub and operable to oppose or allow the biased radial expansion of the distally extending resilient arms and the proximally extending resilient arms via relative movement of the proximal and distal hubs.

12. The one-way valve device of claim 10, wherein the control mechanism includes a sleeve tube that extends over the operating wire or catheter and the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures.

13. The one-way valve device of claim 1, wherein: the distally extending resilient arms have distal ends indirectly joined to proximally extending resilient arms that are joined to a distal, substantially cylindrical hub slidably disposed around the operating wire or catheter, with ones of the proximally extending resilient arms being joined to ones of the distally oriented vertexes of the inverted substantially V-shaped projections; at least the distally extending resilient arms and the proximally extending resilient arms are biased towards a radially collapsed configuration; and the control mechanism comprises a control wire joined to the distal hub and operable to cause radial expansion of the distally extending resilient arms and the proximally extending resilient arms or allow the biased collapse of distally extending resilient arms and the proximally extending resilient arms via relative movement of the proximal and distal hubs.

14. The one-way valve device of claim 13, wherein the control mechanism includes a sleeve tube that extends over the operating wire or catheter and the said distally extending resilient arms and inverted substantially V-shaped projections to gather the said structures together proximate the longitudinal axis of the operating wire or catheter, and that is retractable from over the said structures to release the said structures.

15. The one-way valve device of claim 1, in combination with an elongated balloon catheter, continuously accessible from its proximal end, and having one or more wrapped-around balloons positioned proximate its distal end and in fluid communication with the balloon catheter, positionable over the operating wire or catheter of the one-way valve device and connectable to an external balloon pump.