WO2025019716A1

WO2025019716A1 - Implantable devices and methods for treating venous valve insufficiency

Info

Publication number: WO2025019716A1
Application number: PCT/US2024/038619
Authority: WO
Inventors: Teresa L. WOODSON; Dale L. Ehnes; David Hovda
Original assignee: Elevate Vascular Inc
Current assignee: Elevate Vascular Inc
Priority date: 2023-07-19
Filing date: 2024-07-18
Publication date: 2025-01-23
Anticipated expiration: 2026-01-19

Abstract

Methods, systems and devices for treating venous insufficiency may include an expandable frame that may include an inflow section comprising an inflow end with an inflow section and a narrowing section, a waist, and an outflow section comprising an outflow end downstream of the inflow section. The waist may have a smaller diameter than that of the inflow end and the outflow end and may have a smaller diameter than the target vessel. The outflow section may include an enlarging section, an outflow section, and a transition section configured to narrow toward the outflow end when the expandable tubular frame is positioned within the native vein. Systems may include multiple frames implanted serially, or a single frame with multiple serial waists.

Description

IMPLANTABLE DEVICES AND METHODS

FOR TREATING VENOUS VALVE INSUFFICIENCY

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63/514.517 filed July 19. 2023, the entire content of which is hereby incorporated by reference herein.

BACKGROUND

Field of the Invention

[0002] Embodiments of the present application are directed to methods, systems and devices for treating venous insufficiency.

Background

[0003] Veins in the human body are weak-walled blood vessels that carry blood under low pressures back to the heart from the extremities. To help move the blood toward the heart, most frequently against the force of gravity⁷, veins have one-way valves, which open in the direction of for ard-moving blood flow and close to prevent backflow of blood. When these valves become compromised, the veins cannot function properly. Venous disease, due to incompetent venous valves, is a prevalent clinical problem. In the U.S., 20 million patients demonstrate chronic venous insufficiency, with swelling, pain, and/or ulceration of the affected extremity . An additional 74 million patients exhibit the dilation and deformity⁷ of varicose veins.

SUMMARY

[0004] Devices, systems and methods are provided directed to an implantable device (or implant) for treating venous insufficiency. In some aspects, an implantable device may comprise an expandable frame having an inlet section, an outlet section and a reduced diameter section between the inlet section and the outlet section. The reduced diameter section may comprise a waist having a reduced diameter relative to the inlet section and the outlet section. The inlet and outlet sections may be oversized relative to the vein in which the device is implanted. The reduced diameter section or waist may be undersized relative to the vein in which the device is implanted. The outlet section may be configured after implantation to narrow in diameter towards a downstream end of the outlet section.

[0005] In use, an implantable device with a reduced diameter section may be located in a compromised vein. As blood flows from an inlet section through a reduced diameter or relatively narrow waist section, the velocity increases. This increased velocity may reduce venous regurgitation by providing increased forward flow velocity. The blood may exit the waist into a relatively larger diameter outlet section, where it is allowed to pool slightly before exiting the implant. The outlet section may comprise a transition where its diameter again narrows towards the downstream end of the implant to increase forward flow of blood out of the implant.

[0006] In some aspects, the implant may have an asymmetric hourglass shape, with an upstream end being smaller than a downstream end. Directional asymmetry of the device may provide less resistance to forward flow and more resistance to return flow due to the geometry effects. This could work partly like a fluidic diode where the diverging flow slows down and turns against the central flow lumen in retrograde flow.

[0007] In some aspects, a prosthetic implant for treating venous insufficiency is provided. The implant comprises an expandable tubular frame configured to be positioned within a native vein. The implant comprises an inflow section comprising an inflow end, a cylindrical inflow section, and a narrowing section downstream of the cylindrical inflow section. The implant further comprises an outflow section comprising an outflow end downstream of the inflow section, wherein the inflow section and the outflow section are separated by a waist having a smaller diameter than that of the inflow end and the outflow end. The outflow section comprises an enlarging section, a cylindrical outflow section downstream of the enlarging section, and a transition section configured to narrow toward the outflow end when the expandable tubular frame is positioned within the native vein.

[0008] In some aspects, the techniques described herein relate to a prosthetic implant for treating venous insufficiency, the implant including an expandable tubular frame configured to be positioned within a native vein, the implant including: an inflow section including an inflow end. a cylindrical inflow section, and a narrowing section downstream of the cylindrical inflow section; and an outflow section including an outflow end downstream of the inflow section, wherein the inflow section and the outflow section are separated by a waist having a smaller diameter than that of the inflow end and the outflow end, wherein the outflow section includes an enlarging section, a cylindrical outflow section downstream of the enlarging section, and a transition section configured to narrow toward the outflow end when the expandable tubular frame is positioned within the native vein.

[0009] In some aspects, the expandable tubular frame includes a unitary body. In some aspects, the outflow section is longer than the inflow section. In some aspects, the cylindrical inflow section and the cylindrical outflow section are configured to apply radial force to the native vein. In some aspects, the cylindrical inflow section has a smaller diameter than the cylindrical outflow section when in an expanded configuration. In some aspects, the waist is configured to be undersized relative to the native vein. In some aspects, at least the waist is covered by a coating. In some aspects, the transition section includes a plurality of distally extending petals that are configured to partially collapse when positioned within the native vein. In some aspects, the expandable tubular frame includes an unobstructed lumen through the inflow section, the waist and the outflow section.

[0010] In some aspects, the techniques described herein relate to a prosthetic implant for treating venous insufficiency, the implant including at least one expandable tubular frame configured to be positioned within a native vein. The implant comprises an inflow section including an inflow end, a cylindrical inflow section, and a narrowing section downstream of the cylindrical inflow section; a first waist section downstream of the inflow section; a second waist section downstream of the first waist section; and an outflow section including an outflow end downstream of the inflow section, wherein each waist includes a smaller diameter than that of the inflow end and the outflow end. wherein the outflow section includes an enlarging section.

[0011] In some aspects, the expandable tubular frame includes a unitary' body. In some aspects, the cylindrical inflow' section and the outflow section are configured to apply radial force to the native vein. In some aspects, the first waist and second waist are separated by a second inflow section. In some aspects, at least one waist is covered by a coating. In some aspects, the outflow section further includes a transition section configured to narrow^ toward the outflow' end when the expandable tubular frame is positioned within the native vein. In some aspects, the transition section further includes a plurality’ of distally extending petals that are configured to partially collapse when positioned within the native vein. In some aspects, the expandable tubular frame includes an unobstructed lumen through the inflow section, the first waist, the second waist, and the outflow^ section. In some aspects, the expandable tubular frame is a first tubular frame including the inflow' section and the first waist, and the implant further includes a second expandable tubular frame including the second waist and the outflow. In some aspects, at least a portion of the outflow section comprises a cylindrical shape. In some aspects, the techniques described herein relate to a method of treating venous insufficiency by implanting a device described herein into a native vein.

[0012] In the above aspect or in any aspects described herein, the implant may have one or more of the following features. The expandable tubular frame may comprise a unitary body. The outflow section may be longer than the inflow section. The cylindrical inflow section and the cylindrical outflow section may be configured to apply radial force to the native vein. The cylindrical inflow section may have a smaller diameter than the cylindrical outflow section when in an expanded configuration. The waist may be configured to be undersized relative to the native vein. At least the waist may be covered by a coating. The transition section may comprise a plurality of distally extending petals that are configured to partially collapse when positioned within the native vein. The expandable tubular frame may comprise an unobstructed lumen through the inflow section, the waist and the outflow section.

[0013] In other aspects, a method of treat venous insufficiency is provided. The method may comprise delivering the implant as described above or as described further herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIGS. 1 A-1C illustrate an implant for treating venous insufficiency.

[0015] FIG. 2 illustrates an implant with outflow petals to form a custom taper.

[0016] FIGS. 3A-3C illustrate implementations of implants with an outlet section having an increasing diameter.

[0017] FIG. 4 A illustrates a sectional view of an implementation of an implant in a vein

[0018] FIG. 4B illustrates the implant of FIG. 4A with shading to help identify the various section shapes and distinguish the vessel.

[0019] FIG. 4C illustrates a side profile of the anchoring frame of FIGS. 4A-4B within a vessel.

[0020] FIG. 5A illustrates a sectional view of another implementation of an implant in a vein

[0021] FIG. 5B illustrates the implant of FIG. 5A with shading.

[0022] FIGS. 5C and 5D illustrate a side profile of the anchoring frame of FIG. 5 A- 5B within a vein, where FIG. 5D includes shading.

[0023] FIG. 6 illustrates an implementation of an implant with a first anchoring frame deployed serially next to a second anchoring frame. [0024] FIG. 7A-7B illustrate a sectional view of an implementation of an implant with nested serial sections in a vein, where FIG. 7B includes shading.

[0025] FIG. 7C illustrates a side profile of the serial nested anchoring frame arrangement of FIGS. 7A-7B

[0026] FIGS. 8A-8B illustrate a sectional view of another implementation of an implant with nested serial sections in a vein, where FIG. 8B includes shading.

[0027] FIG 8C illustrates a side profile of the serial nested anchoring frame arrangement of FIGS. 8A-8B.

[0028] FIGS. 9A-9B illustrate an implementation of a lattice pattern consistent across the length.

[0029] FIGS. 10A-10B illustrate other implementations of a lattice pattern including one or more sections with a similar repeating pattern and one or more different sections with a more dense pattern.

DETAILED DESCRIPTION

[0030] As illustrated in FIGS. 1A-1C, an implant 100 for treating venous insufficiency may include a tubular expandable frame or anchoring body 110. In some implementations, the anchoring frame 110 may be a stent that extends from an upstream end 120 to a downstream end 130, and forms a lumen 140 between the ends 120, 130. As shown, the upstream end 120 may be cylindrical with a narrowing taper 122 to form an inlet section 124, which further narrow s to a waist 150 of the implant 100. In some implementations, the narrowing taper 122 in the inlet section 124 may comprise a linear taper to form a conical body. In some implementations, the narrowing taper 122 in the inlet section 124 may comprise a parabolic taper to form a parabolic conic section. The frame 110 may include a widening taper 126 downstream of the waist 150, which widens to an outlet section 128. The widening of the frame downstream of the waist 150 may be curved or linear or may for a parabolic conic section. The widening of the frame downstream of the w aist 150 may also occur over a shorter length of the frame 110 than the narrowing in the inlet section 124. Downstream of the widening portion 126, the outlet section 128 may comprise a cylindrical section before forming a transition section as discussed below. In some implementations, the anchoring frame 110 is shaped as a bowtie or hourglass with a narrow⁷ waist 150. In some implementations, the anchoring frame 110 is an asymmetric hourglass shape, as shown in the figures. One or more of the sections may be made of an expandable frame, for example an expandable wire frame or a laser-cut hypotube, similar to a stent. In some implementations, all of the sections may be formed from a single unitary body. In other implementations, one or more of the sections may be formed from separate bodies that are connected together.

[0031] As further illustrated in FIGS. IB and 1C, a portion of the frame 110 may be covered by a coating or graft material 160. In some embodiments part or all of the frame may be coated or covered with materials such as anti -clotting agents (e.g. heparin) to mitigate clot formation, and/or polymers (e.g. ePTFE) to direct the flow of blood. In some implementations, a covering 160, such as a membrane of ePTFE. may cover the inside and/or outside of the frame 110 to prevent blood from passing through open spaces in the frame 110, and to help direct blood through the waist 150.

[0032] In some implementations, the coating is a polymer membrane 160. In some implementations, such as the implant 180 shown in FIG. IB, a polymer membrane covering 160 is placed over a portion of the inlet section 124, the waist 150, and a portion of the outlet section 128. In some implementations, such as the implant 190 shown in FIG. 1C, a polymer membrane covering 160 covers more of the inlet section 124 than the outlet section 128. The inlet section 124 may be covered from the cylindrical upstream end 120, over the narrowing portion 122 of the inlet section 124. the w aist 150, and over part of the widening portion 126 of the outlet section 128. In some implementations, the frame 110 may be partially⁷ or completely covered, for example, 35%, 40%, 50%, 60%, 75%, 80%, 90%, 95%, 98%, 100%, or other fractions of the frame 110 may be covered. In some implementations, the cover 160 may include an inner cover inside the lumen 140 of the frame 110 and an outer cover over the external face of the frame 1 10. In some implementations, an inner cover and outer cover are sintered or otherwise laiminated together. In some implementations, an inner cover and outer cover are made of the same material. In some implementations, the frame 110 includes multiple covers, for example a heparin coating over the inside and outside of the entire device and one or more polymer covers over particular sections of the frame as discussed above.

[0033] The anchoring frame 110 is configured to collapse for delivery and to expand after delivery . After expanding, the upstream end 120 and outlet 128 are configured to apply radial force F outward against the inner wall 50 of the vein 10 after implantation. In some implementations, the upstream end 120 is oversized to expand the vein 10 and anchor the implant 100. The outlet section 128, including the transition discussed below, may also be oversized to expand the vein 10 and anchor the implant 100. The waist 150 may be undersized relative to the vein 10. The coating 160 may be positioned along part or all of the implant 100 that is undersized relative to the vein 10 to direct blood flow through the lumen 140 of the implant 100 and not through openings in the frame 110. [0034] In some implementations, the inlet 124 or upstream section may include a cylindrical section as shown in FIGS. 1 A-1C. For example, a cylindrical upstream end 120 may be configured to expand to an oversized diameter to anchor the implant 100 in the vein 10. Tapered sides may produce a conical inlet section 124 that reduces the diameter of the lumen 140 toward the waist 150. The inlet 124 may include straight or curved sides to produce an appropriate reducing shape to direct blood into the waist 150.

[0035] In some implementations, the outlet section 128 is oversized to expand the vein 10. The oversized outlet 128 may be useful in anchoring the downstream side of the implant 100, and also in creating a pool or volume of blood that may assist in reducing regurgitation. As shown in FIGS. IB and 1C, the downstream end 130 of the outlet section 128 may comprise a transition section 132 that is cylindrical with multiple long flexible petals 134 or crowns. Each petal 134 is configured to flex inward under radial force applied by the inner wall 50 of the vessel 10. As shown in FIG. 1A and FIG. 2, when implanted the petals 134 flex inward to form a custom taper between the oversized outlet section 128 and the native vessel diameter.

[0036] In some implementations, the outlet section 128 includes a cylindrical section, for example as shown in FIGS. IB and 1C. In some implementations, for example, as shown in FIGS. 1 A and 3A-3C, the outlet section 128 may provide an increasing diameter. For example, tapered sides may produce a conical outlet section 128 (as shown in FIG. 1 A), a bowlshaped outlet section 128’ (as shown in FIGS. 3A-3C), or other enlarging shape. As discussed above, the downstream end 130 of the anchoring frame 110 may include petals 134. The petals 134 can form a generally cylindrical shape before implantation, as shown in FIG. 3 A. In some implementations, the petals 134 may be pre-formed to taper to a smaller downstream diameter, as shown in FIG. 3B. The petals 134 may further flex inward when implanted as shown in FIG. 3C. The oversized outlet section 128 may expand the vein 10 while the transition section 132 provides a smooth interface back to the native vessel diameter.

[0037] In some implementations, such as the anchoring frames 400 shown in FIGS. 4A-C, the upstream end 420 includes a cylindrical section 420a that may be configured to anchor the implant 400 in the vein 10. The cylindrical section 420a abuts a tapered section 422 that feeds into the narrow waist 450, as described above. Downstream of the waist 450 is a wider outlet section 428 with a cylindrical shape, and then a tapered downstream end section 432, that may be similar to the transition section described above. FIG. 4A illustrates a sectional view of an implant 400 with these various sections in a vein 10 and FIG. 4B is the same view with shading to help identify the various section shapes and distinguish the vessel 10. FIG. 4C shows a side profile of the anchoring frame 400 shape within the vein 10.

[0038] In some implementations, such as the anchoring frames 500 shown in FIGS. 5A-D, the upstream end 520 includes a cylindrical section 520a that may be configured to anchor the implant 500 in the vein 10. The cylindrical section 520a abuts a tapered section 522 that feeds into the narrow waist 550, as described above. Downstream of the waist 550 is a wider outlet section 528 with tapered shape that may transition to a tapered downstream end section 532. The tapered outlet 528 and tapered transition section 532 may be similar to the transition section described above. In some implementations, the tapered outlet 528 and tapered transition section 532 may function as a long tapered transition section made of petals 534 as described above. FIG. 5A illustrates a sectional view of an implant 500 with these various sections in a vein 10 and FIG. 5B is the same view with shading to help identify the various section shapes and distinguish the vessel 10. FIGS. 5C and 5D show a side profile of the anchoring frame 500 shape within the vein 10, where FIG. 5D includes shading to help identify the various section shapes and distinguish the vessel 10.

[0039] In some implementations, the anchoring frame 110 may include a taper at the inlet section 124 and/or upstream end 120. In some implementations, the inlet section taper extends to the upstream end 120 of the anchoring frame 110. As noted above, in some implementations the anchoring frame 110 may be cylindrical as manufactured and configured to change shape after expansion in a vein 10 to accommodate the anatomy in vivo when deployed. In some implementations, an anchoring frame 110 may be manufactured with tapers in one or more sections, which may approximate the final deployed intended shape.

[0040] In some implementations, one or more anchoring frames 110 may be deployed together or sequentially to create a longer implanted system. For example, as shown in FIG. 6 , a first anchoring frame 600 may be deployed serially next to a second anchoring frame 600’ in a vein 10. In some implementations, the first 600 and second anchoring frames 600’ may be identical. In some implementations, the first 600 and second anchoring frames 600’ may have the same shape and arrangement of sections but may have different sizes selected to conform to changing vessel 10 anatomy. In some implementations, the first 600 and second anchoring frames 600’ may have a different arrangement of section shapes. For example, a first upstream implant 600 may include a cylindrical upstream end 620, a tapered inlet section 622. a waist 650, a cylindrical outlet section 628, and a tapered transition section 632 while a cooperating second downstream implant 600’ may include a tapered upstream end 620’ and tapered inlet section 622’, a waist 650’, and a tapered outlet section 628’ with tapered transition section 632’. Desired overall flow characteristics can be achieved with appropriate sections and implants arranged together.

[0041] In some impelementations, first and second anchoring frames, e.g., 600, 600’ may be implanted with a gap. In some implementations, first and second anchoring frames 600, 600’ may be implanted directly next to one another, with little to no gap between the downstream section of a first upstream implant 600 and the upstream section of the second or downstream implant 600’. In some implementations, additional anchoring frames, for example, a third, fourth, fifth, or more, may be implanted with or without varying gaps between the series of anchoring frames. In some implementations, two or more serial anchoring frames may be bridged together. In some implementations, a bridge section may include a frame, for example a wire frame or cut hypotube as discussed above. In some implementations, a bridge section may be optimized based on preferred hemodynamics. In some implementations, a bridge section may include flexible connecting bars in a cylindrical or tapered arrangement. In some implementations, a bridge section may be covered by a coating and/or membrane material as discussed above.

[0042] In some implementations, serial anchoring frames may be configured to be deployed in a nested arrangement, as illustrated in FIGS. 7A-7C and FIGS. 8A-8C. In some implementations, the outlet 728, 828 of an upstream anchoring frame 700, 800 may feed directly into, or be nested into, the next downstream section at a transition area 760, 860. FIG. 7A-7B and FIGS. 8A-8B each illustrate a sectional view of an implant with nested serial sections in a vein 10, where FIGS. 7B and 8B include shading to help identify the various section shapes and distinguish the vessel. FIGS. 7C and 8C each show a side profile of a serial nested anchoring frame arrangement. In some implementations, multiple devices may be partially nested or docked inside of each other during deployment to build the preferred flow conditions in vivo. In some implementations, a single device includes multiple zones and waists to create the desired hemodynamics.

[0043] In some implementations, a transition area may include a space of turbulence and/or pooling. Such a pooling space may be useful in limiting backflow and regurgitation through the vein. In some implementations, the transition area may be configured to avoid turbulence and/or pooling of blood. In some implementations, serial anchoring frames may be configured as a single large implant designed for delivery and expansion in the vein during a single process. In some implementations, additional serial anchoring frames may be deployed individually to create a final long implant. In some implementations a serial nested implant may include shorter or longer sections, and may include one or more cylindrical and/or tapered sections as discussed above. For example, FIGS. 7A-C illustrate an implementation 700 with a tapered upstream end 720 and tapered first inlet 722, multiple tapered waist sections 750, 750’, 750”, a downstream final tapered outlet section 728, and a cylindrical transition section 732. FIGS. 8A-C illustrate an implementation 800 with a cylindrical upstream end 820, a tapered first inlet 822, multiple tapered waist sections 850, 850’, 850”, a final tapered outlet section 828, and a cylindrical transition section 832.

[0044] In some implementations, one or more transition areas may be covered as a waist section as described above. In some implementations, an outer covering membrane may be used to smooth the outer side and/or an inner covering membrane may be used to adjust flow through the deployed implant. In some implementations, only the waist sections are covered with a covering membrane, which can minimize the chance of thrombosis by reducing the amount of foreign material in the vein. In some implementations, each waist is covered by a short covering membrane section, creating a series of covered waists/bands. In some implementations, one or more adjacent waists are covered with a single shared covering membrane, which may improve flow by reducing the number of transitions. A shared covering membrane may also be easier to reliably locate, and may reduce the risk of unwanted material becoming trapped in the lumen during manufacturing and/or installation.

[0045] In some implementations, the anchoring frame 110 is a wire lattice. In some implementations, a lattice may be made of wire, for example stainless steel, nitinol, or other shape memory metal. In some implementations, a flat wire lattice may be joined to form a generally tubular shape. In some implementations, the anchoring frame may be a laser cut tube. In some implementations, the lattice pattern 970 may be consistent across the length, as shown in FIGS. 9A-9B. An anchoring frame 110 with a consistent pattern 900 may tightly pack into a small compressed profile, allowing delivery through a small catheter. In some implementations, the anchoring frame 110 is a lattice 1070, 1070’ having different sections. For example, as shown in FIGS. 10A and 10B, a main body 110a of the anchoring frame 110 may include a similar repeating pattern 1070a for some or all sections, for example, the upstream end, inlet section, and outlet section, and a waist section 110b may be made with a more dense lattice pattern 1070b. In some implementations, dense patterns may provide extra flexibility in dense sections with an increased number of joints. In some implementations, dense patterns may provide increased rigidity with stronger shapes and an increased amount of material.

[0046] A tapered transition may be made with elongated shapes to help form the foldable petals 134 as discussed above. In some implementations, the lattice pattern is scalable or otherwise adjustable to create the desired zones and shapes discussed herein. In some implementations, the lattice pattern may be adjusted to accommodate the different size implants made to target different size vessels. For example, as shown in FIG. 10A, a small lattice 1070 may be used to target a vein with a small nominal diameter, and a larger size 1070’ as shown in FIG. 10B may be used for a larger vein. As shown, a lattice pattern may be based on a diamond shape. In some implementations, larger patterns 1070’ may include additional longitudinal sections 1072, additional radial sections 1074 and/or larger diamonds 1076. In some implementations, an anchoring frame 1 10 may be made of multiple sections connected together.

[0047] In some implementations, the anchoring frame 110 is selected or configured to create a waist of 60% of the nominal target vein area. In some implementations, the area at the waist 150 is designed to be 30-80% of the nominal vein area. In some implementations, the anchoring frame 110 is sized to fit in a vessel 10 with a nominal diameter of 6-1 mm, or a minimum vessel size of about 5.50 mm to a maximum of about 16.50 mm. In some implementations, the upstream end 120 and/or inlet 124 are selected to oversize the target vein 10 by about 15-30%, or by about 21-24%. In some implementations, the outlet section 128 is selected to oversize the target vein 10 by about 35-70%, or by about 41-62%. In some implementations, the outlet 128 external diameter is selected to be 115-130% larger than the inlet 120, 124 external diameter.

[0048] Further details of devices, systems and methods that may be incorporated with or applied to the implementations described above are described in U.S. Patent Nos. 10,231,838 and 10,912,647 and U.S. Publication No. 2021/0369459 Al, the entireties of each of which are hereby incorporated by reference. In any of the implementations incorporated by reference, a ball, tether, valve seat, and/or valve mechanism described therein may be considered optional. In these implementations and in the implementations described herein, the lumen defined by the frame or the implant may be unobstructed or substantially unobstructed from the inlet end, through the inlet section and the waist, and through the outlet section and outlet end.

[0049] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0050] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For example, the actual steps or order of steps taken in the disclosed processes may differ from those shown in the figure. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0051] Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the described embodiments, and may be defined by claims as presented herein or as presented in the future.

[0052] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term ‘“or” means one, some, or all of the elements in the list. Likewise the term ‘‘and/or” in reference to a list of two or more items, covers all of the following interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein.” “above.” "below." and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0053] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0054] Language of degree used herein, such as the terms “approximately,” “about.” “generally.” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of. within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0. 1 degree.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic implant for treating venous insufficiency, the implant comprising an expandable tubular frame configured to be positioned within a native vein, the implant comprising: an inflow section comprising an inflow end, a cylindrical inflow section, and a narrowing section downstream of the cylindrical inflow section; and an outflow section comprising an outflow end downstream of the inflow section, wherein the inflow section and the outflow section are separated by a waist having a smaller diameter than that of the inflow end and the outflow end, wherein the outflow section comprises an enlarging section, a cylindrical outflow section downstream of the enlarging section, and a transition section configured to narrow toward the outflow end when the expandable tubular frame is positioned within the native vein.

2. The implant of Claim 1, wherein the expandable tubular frame comprises a unitary body.

3. The implant of Claim 1, wherein the outflow section is longer than the inflow section.

4. The implant of Claim 1, wherein the cylindrical inflow section and the cylindrical outflow section are configured to apply radial force to the native vein.

5. The implant of Claim 4. wherein the cylindrical inflow section has a smaller diameter than the cylindrical outflow section when in an expanded configuration.

6. The implant of Claim 1, wherein the waist is configured to be undersized relative to the native vein.

7. The implant of Claim 1, wherein at least the waist is covered by a coating.

8. The implant of Claim 1, wherein the transition section comprises a plurality of distally extending petals that are configured to partially collapse when positioned within the native vein.

9. The implant of Claim 1, wherein the expandable tubular frame comprises an unobstructed lumen through the inflow section, the waist and the outflow section.

10. A prosthetic implant for treating venous insufficiency, the implant comprising: at least one expandable tubular frame configured to be positioned within a native vein, the implant comprising: an inflow section comprising an inflow end, a cylindrical inflow section, and a narrowing section downstream of the cylindrical inflow section; a first waist section downstream of the inflow section; a second waist section downstream of the first waist section; and an outflow section comprising an outflow end downstream of the inflow section, wherein each waist section comprises a smaller diameter than that of the inflow end and the outflow end, wherein the outflow section comprises an enlarging section.

11. The implant of Claim 10, wherein the expandable tubular frame comprises a unitary body.

12. The implant of Claim 10, wherein the cylindrical inflow section and the outflow section are configured to apply radial force to the native vein.

13. The implant of Claim 10, wherein the first waist section and second waist section are separated by a second inflow section.

14. The implant of Claim 10, wherein at least one waist section is covered by a coating.

15. The implant of Claim 10, wherein the outflow section further comprises a transition section configured to narrow toward the outflow end when the expandable tubular frame is positioned within the native vein.

16. The implant of Claim 15, wherein the transition section further comprises a plurality of distally extending petals that are configured to partially collapse when positioned within the native vein.

17. The implant of Claim 10, wherein the expandable tubular frame comprises an unobstructed lumen through the inflow section, the first waist section, the second waist section, and the outflow section.

18. The implant of Claim 10, wherein the expandable tubular frame is a first tubular frame comprising the inflow section and the first waist section, the implant further comprising a second expandable tubular frame comprising the second waist section and the outflow section.

19. The implant of Claim 10, wherein at least a portion of the outflow section comprises a cylindrical shape.

20. A method of treating venous insufficiency, comprising delivering the implant of any one of the preceding claims into a native vein.