Venous valve devices, systems, and methods

Abstract

Embodiments of the present disclosure relate to devices, systems, and methods for treatment of the vasculature. In some embodiments, a venous valve may be treated by delivering an extravascular scaffold, creating one or more incisions in the vessel wall to form one or more new leaflets, and optionally delivering an internal support member.

Description

VENOUS VALVE DEVICES, SYSTEMS, AND METHODSINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 555782, filed February 20, 2024. This application is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Embodiments of the present disclosure relate to devices, systems, and methods for treatment of the vasculature.BACKGROUND

[0003] Venous disease, due to missing, diseased, damaged, or otherwise incompetent venous valves, is a prevalent clinical problem. Venous disease may result in chronic venous insufficiency, swelling, pain, and / or ulceration of the affected site. Venous disease may also result in dilation and / or deformity of varicose veins.

[0004] Accordingly, there is a need for devices, systems, and methods for treating incompetent venous valves.SUMMARY

[0005] Existing methods and devices for repair and replacement of existing venous valves may include creating an incision only partially through the vein wall to form a new valve flap. However, such methods and devices are not optimal due in part to the low blood flow rate found in native veins and the very thin wall structure of the venous wall and venous valve. There remains a need for minimally invasive approaches for repairing or replacing incompetent venous valves.

[0006] The present disclosure relates to an improved venous valve implant. The venous valve implant may include an extravascular scaffold configured to be delivered to and at least partially surround a native vein wall. The extravascular scaffold may include a frame and / or a membrane. The extravascular scaffold may be advanced intravascularly to the target vein using minimally invasive techniques. When implanted, the extravascular scaffold canform an inner wall of a modified venous valve. The modified venous valve may comprise the extravascular scaffold and at least one valve flap formed from a wall of the native vein. The extravascular scaffold may be configured such that the at least one flap formed from the wall of the native vein opens and closes within the extravascular scaffold in response to blood flowing through the modified venous valve.

[0007] The extravascular scaffold may be configured to be delivered via a transvascular approach. For example, the extravascular scaffold may be percutaneously introduced and transvascularly deployed around the vein.

[0008] The extravascular scaffold may be expandable, for example selfexpandable. The extravascular scaffold may comprise an annular shape or a sinus shape.

[0009] The extravascular scaffold may include one or more body portions, for example a first body portion configured to at least partially surround the vein wall and a second body portion configured to at least partially surround the vein wall. The first body portion may be configured to be coupled to the second body portion. In other configurations, the extravascular scaffold may include additional body portions or may be formed as a unitary body.

[0010] Additionally or alternatively to the extravascular scaffold, the venous valve implant may comprise an internal support structure configured to be positioned within the vein and adjacent to the at least one flap.

[0011] The present disclosure also relates to a method for percutaneously creating a modified venous valve. The method may comprise advancing a catheter to a target site within a vein, wherein the vein comprises a wall having an inner surface and an outer surface. The method may comprise extending a tissue piercing element through the inner surface of the vein wall and the outer surface of the vein wall to create one or more incisions through the vein wall. The method may comprise delivering an extravascular scaffold from within the vein to an extravascular space outside of the vein and positioning the extravascular scaffold at least partially around the vein. The method may comprise creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue. After forming the flap of vein wall tissue, the extravascular scaffold may form an inner wall of the modified venous valve and may allow blood to flow through the modified venous valve.

[0012] The method may comprise delivering a guidewire from within the vein and through the incision to a position outside of the vein. The method may comprise expanding a balloon carried on the guidewire to enlarge the extravascular space between the outer surface of the vein wall and a portion of tissue surrounding the vein wall.

[0013] Positioning the extravascular scaffold may comprise positioning a first body portion of the extravascular scaffold over an incision. For example, positioning the extravascular scaffold may comprise positioning a first body portion of the extravascular scaffold at least partially around the flap.

[0014] The method may comprise creating a second incision through the vein wall, wherein the second incision is diametrically opposed from the incision. The method may comprise positioning a second body portion of the extravascular scaffold at least partially around the vein, for example through the second puncture. The method may comprise creating a second transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the second transmural incision forming a second flap of the vein wall tissue.

[0015] The present disclosure also relates to an extravascular venous scaffold comprising an elongate body comprising a frame and a membrane. The membrane may be configured to contact an outer surface of a vein wall to form a hemostatic seal at least partially around the vein.

[0016] The elongate body may comprise a first diameter at a proximal end of the elongate body, a second diameter at a distal end of the elongate body, and a third diameter therebetween. The third diameter may be greater than the first diameter, and the third diameter may be greater than the second diameter.

[0017] The elongate body may comprise one or more body portions, for example a first body portion configured to at least partially surround the vein wall and a second body portion configured to at least partially surround the vein wall. The first body portion may be coupled to the second body portion to form an annular shape or a sinus shape.

[0018] The present disclosure also relates to a system for creating a modified venous valve at a native vein. The system may comprise an extravascular scaffold comprising a frame and a membrane. The system may further comprise a delivery catheter configured to deliver the extravascular scaffold via a transvascular approach. The system may further comprise a cutting tool configured to modify the native vein to form one or more valve flapsfrom a wall of the native vein. The extravascular scaffold may be configured to at least partially surround the one or more valve flaps to form an inner wall of the modified venous valve and allow blood to flow through the one or more valve flaps of the modified venous valve. The extravascular scaffold may include any of the features described herein.

[0019] The present disclosure also relates to a venous valve system for directing blood flow through a valve flap comprising native vein tissue of a mammal, wherein the valve flap may be formed by a transmural incision extending from an inner surface of a vein wall to an outer surface of the vein wall. The system may comprise an extravascular scaffold positionable at least partially outside of a vein such that an inner surface of the extravascular scaffold is in contact with an outer surface of the vein wall. The extravascular scaffold may be configured to form a seal around the vein at a longitudinal region of the vein where the valve flap is positioned. Additionally or alternatively to the extravascular scaffold, the system may comprise an internal support member positionable within the vein such that an outer surface of the internal support member is in contact with the inner surface of the vein wall. The internal support member may comprise a first anchor, a second anchor, and / or a support strut attached to and positioned between the first anchor and the second anchor.

[0020] The internal support member may be configured to support a portion of the valve flap. The internal support member may comprise a plurality of support struts configured to support a plurality of valve flaps.

[0021] The present disclosure also relates to an extravascular scaffold configured to be positioned relative to a vein wall. The extravascular scaffold may comprise a plurality of arm members. The extravascular scaffold may further comprise a plurality of overlapping members coupled to the plurality of arm members. The plurality of overlapping members may comprise a first overlapping member configured to contact an adjacent second overlapping member. The plurality of overlapping members may be configured to contact an outer vein wall and create a hemostatic seal. The plurality of arm members may be configured to protrude through a vein wall. The plurality of arm members may comprise a curved shape such that the plurality of overlapping members are configured to be compressed against an outer vein wall.

[0022] The present disclosure also relates to a method for transvascularly creating a modified venous valve. The method may comprise advancing a catheter to a target site within a vein, wherein the vein comprises a wall having an inner surface and an outer surface. Themethod may comprise extending a cutting element through the inner surface of the vein wall and the outer surface of the vein wall. The method may comprise delivering a tethering element configured to be coupled to the vein at a first position of the vein and at a second position of the vein. The method may comprise creating an incision at a third position of the vein, wherein the third position is at a longitudinal position between the first position and the second position, such that the vein is separated into a first portion and a second portion. The method may comprise delivering an extravascular scaffold from within the vein to an extravascular space outside of the vein to poistion the extravascular scaffold at least partially around the vein. The method may comprise creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue. After forming the flap of vein wall tissue, the extravascular scaffold may form an inner wall of the modified venous valve and may allow blood to flow through the modified venous valve.

[0023] The present disclosure also relates to a method for creating a modified venous valve. The method may comprise percutaneously advancing a separation element configured to an enlarge an extravascular space between an outer surface of a vein wall and a portion of tissue surrounding the vein wall. The method may comprise positioning an external membrane such that an inner surface of the external membrane surrounds a longitudinal portion of the outer surface of the vein wall. The method may comprise creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue, the transmural incision positioned within the longitudinal portion of the vein wall surrounded by the external membrane.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 A illustrates a cross-sectional view of a vessel, wherein a native valve is depicted in an open position. The native valve may be a native venous valve.

[0025] FIG. IB illustrates the native valve shown in FIG. 1A, the native valve depicted in a closed position.

[0026] FIG. 1C illustrates a cross-sectional view of a vessel, wherein an embodiment of a catheter system is depicted within the vessel.

[0027] FIG. ID illustrates a cross-sectional view of a vessel, wherein an incision is depicted.

[0028] FIG. IE illustrates a cross-sectional view of a vessel, wherein an embodiment of an extravascular scaffold is depicted in a crimped configuration.

[0029] FIG. IF illustrates a cross-sectional view of a vessel, wherein an embodiment of an extravascular scaffold is depicted being delivered.

[0030] FIG. 1G illustrates a cross-sectional view of a vessel, wherein an embodiment of an extravascular scaffold is depicted in a delivered configuration.

[0031] FIG. 1H illustrates a cross-sectional view of a vessel, where in an embodiment of a catheter system is depicted within the vessel and with the extravascular scaffold in the delivered configuration.

[0032] FIG. II illustrates a cross-sectional view of a vessel including an embodiment of a modified venous valve.

[0033] FIG. 1J illustrates a cross-sectional view of a vessel, wherein an embodiment of an internal support member is depicted in a crimped configuration.

[0034] FIG. IK illustrates a cross-sectional view of a vessel, wherein an embodiment of an internal support member is depicted in a delivered configuration.

[0035] FIG. 2A illustrates a perspective view of an embodiment of an internal support member.

[0036] FIG. 2B illustrates a side view of an embodiment of an internal support member.

[0037] FIG. 3A illustrates a top view of an embodiment of an internal support member.

[0038] FIG. 3B illustrates a side view of the embodiment of the internal support member shown in FIG. 3A.

[0039] FIG. 3C illustrates a top view of an embodiment of an internal support member.

[0040] FIG. 3D illustrates a side view of the embodiment of the internal support member shown in FIG. 3C.

[0041] FIG. 3E illustrates a top view of an embodiment of an internal support member.

[0042] FIG. 3F illustrates a side view of the embodiment of the internal support member shown in FIG. 3E.

[0043] FIG. 4 illustrates a cross-sectional view of a vessel including an embodiment of a modified venous valve.

[0044] FIG. 5A illustrates a cross-sectional view of a vessel, wherein an embodiment of a catheter system is depicted within the vessel.

[0045] FIG. 5B illustrates a cross-sectional view of a vessel, wherein an embodiment of an internal support member is depicted being delivered.

[0046] FIG. 5C illustrates a cross-sectional view of a vessel, wherein an embodiment of occlusion balloons is depicted within the vessel.

[0047] FIG. 5D illustrates a cross-sectional view of a vessel, wherein an incision is depicted.

[0048] FIG. 5E illustrates a cross-sectional view of a vessel, wherein an embodiment of an extravascular scaffold is depicted being delivered.

[0049] FIG. 5F illustrates a cross-sectional view of a vessel, wherein the extravascular scaffold is depicted in a delivered configuration.

[0050] FIG. 5G illustrates a cross-sectional view of a vessel, wherein the occlusion balloons are depicted being collapsed such that the catheter system may be retracted.

[0051] FIG. 5H illustrates a cross-sectional view of a vessel, wherein the internal support member and the extravascular scaffold are depicted in a delivered configuration.

[0052] FIG. 51 illustrates a perspective view of a vessel, an internal support member, and an extravascular scaffold.

[0053] FIG. 6A illustrates a cross-sectional view of a vessel, wherein a tether is depicted.

[0054] FIG. 6B illustrates a cross-sectional view of a vessel, wherein an embodiment of a catheter system is depicted within the vessel.

[0055] FIG. 6C illustrates a cross-sectional view of a modified vessel.

[0056] FIG. 7 illustrates a cross-sectional view of a vessel, wherein an embodiment of a catheter system is depicted within the vessel.

[0057] FIG. 8A illustrates an embodiment of an endoscopic system and method of treating a modified venous valve.

[0058] FIG. 8B illustrates an embodiment of an endoscopic system and method of treating a venous valve.DETAILED DESCRIPTION

[0059] Embodiments disclosed herein relate to devices, systems, and methods for treating valvular insufficiency. Some embodiments of devices disclosed herein relate to an extravascular scaffold configured to form an inner wall of a modified venous valve. Some embodiments disclosed herein relate to methods of creating a modified venous valve.

[0060] FIGS. 1A to IK provide a schematic illustration of a method of delivering an extravascular scaffold. FIG. 1A illustrates a vessel 100 having an inner wall 102, an outer wall 104, and a native valve 106. In some embodiments, the vessel 100 may be a saphenous vein or a femoral vein. The native valve 106 may be a native venous valve. The native valve 106 may include one or more leaflets, which alternatively may be referred to as flaps. The native valve 106 may include one leaflet, which may be referred to as a monocuspid valve. In other embodiments, the native valve 106 may include two leaflets, which may be referred to as a bicuspid valve. In other embodiments, the native valve 106 may include three leaflets, which may be referred to as a tricuspid valve. As depicted in Figure 1A, the native valve 106 may be configured to open to allow blood to flow in a first direction. The leaflets may be formed using a transmural incision, or an incision across the wall of the vein.

[0061] FIG. IB depicts a vessel 100 wherein a native valve 106 is in a closed position. The native valve 106 may be configured to close to substantially prevent blood from flowing in a second direction opposite to the first direction. If the native valve 106 does not sufficiently close to substantially prevent blood from flowing backwards, the native valve 106 may be referred to as incompetent.

[0062] FIGS. 1C-1K illustrate an embodiment of a system and method for treating an incompetent valve. The incompetent valve may be an incompetent venous valve. In some embodiments, the valve may be treated intravascularly.

[0063] FIG. 1C illustrates a catheter system 110 having an occlusion balloon 112 and / or a cutting tool 114. The cutting tool 114 may be any type of tool capable of cutting through the vessel wall, for example a sharp edge capable of cutting the vessel wall or an electrosurgical tool capable of forming an incision. In some embodiments, the catheter system110 may not include an occlusion balloon. The catheter system 110 may be advanced through the vessel 100 such that the cutting tool 114 is positioned at a site at or near the incompetent valve 106. As illustrated, the catheter system 110 is advanced to a location proximal of the incompetent valve 106, but in other methods, the catheter system 110 may be advanced past the incompetent valve 106.

[0064] The catheter system 110 may be delivered over a wire or through an access sheath. The occlusion balloon 112 and the cutting tool 114 may be carried by the same catheter shaft. But in other configurations, the cutting tool 114 may be carried on a separate shaft from the occlusion balloon. For example, the occlusion balloon 112 may be carried by an outer shaft, and the cutting tool may be carried on an inner shaft to be delivered through a lumen of the outer shaft. The cutting tool 114 may be released from a distal end of the outer shaft or through a side port proximal of the distal end of the outer shaft. The cutting tool 114 may be pre-bent or steerable such that the cutting tool 114 may be oriented to cut through the entire vessel wall. The cutting tool 114 may be rotatable relative to the occlusion balloon 112. The catheter system 110 and / or the extravascular scaffold 120 may be delivered to a vessel of a mammal. In some examples, the mammal may be a human, for example a patient. In some examples, the mammal may be a non-human animal. The catheter system 110 may be delivered to a target site percutaneously. For example, the catheter system 110 may be delivered to a vein to create a modified venous valve through the skin of a patient.

[0065] The occlusion balloon 112 may be configured to help stabilize the catheter system 110 relative to the vessel wall. For example, the occlusion balloon 112 may be configured to expand and provide a stabilization or opposition force as a cutting tool 114 cuts into the vessel wall.

[0066] As depicted in FIG. ID, the cutting tool 114 may be configured to create an incision 116 at least partially or entirely through the wall of the vessel 100. The cutting tool 114 may be selectively controlled to create an incision 116 extending 360 degrees or less around the circumference of the vessel 100. The cutting tool 114 may be selectively controlled to create an incision 116 around only a partial circumference of the vessel 100. The cutting tool 114 may be controlled to create an incision 116 extending 180 degrees or less around the circumference of the vessel 100, for example at least about 90 degrees and / or less than or equal to about 180 degrees around the vessel 100, such as between 90 degrees and 135 degrees orbetween 135 degrees and 180 degrees. In some embodiments, the cutting tool 114 may be controlled to create a puncture through the vessel wall, the puncture extending along less than or equal to 45 degrees of the vessel wall, less than or equal to 30 degrees around the vessel wall, or less than or equal to 15 degrees around the vessel wall. In some embodiments, the occlusion balloon 112 may be configured to stabilize the cutting tool 114 relative to the vessel 100 during operation of the cutting tool 114. Other stabilization elements are imaginable, for example temporary anchors such as barbs.

[0067] FIG. IE illustrates an embodiment of an extravascular scaffold 120 configured to be delivered transvascularly. In some examples, the vessel 100 can be a native vein. The transvascular approach to deliver the extravascular scaffold 120 to the native vein can include delivering the extravascular scaffold 120 across the wall of the native vein. A tissue puncturing element may be used to puncture an inner surface and / or an outer surface of a vein wall to create a puncture through the vein wall. In some examples, the tissue puncturing element can make two diametrically opposed punctures. The punctures may be directly across from each other along a diameter of the vessel. A guidewire may be delivered through the puncture from within the vein to the outside of the vein. As illustrated, the extravascular scaffold 120 is delivered after the catheter system 110 carrying the balloon 112 and / or cutting tool 114 has been removed. But in other configurations, the extravascular scaffold 120 may be delivered through the outer shaft carrying the balloon 112. The extravascular scaffold may be delivered over a guidewire or through the same access sheath used to deliver the catheter system 110. In some examples, the guidewire can carry the balloon 112. The balloon 112 can enlarge the extravascular space between the outer surface of the vein and the portion of tissue surrounding the vein wall.

[0068] In some examples, the extravascular scaffold 120 can be an elongate body. The extravascular scaffold 120 can have a first diameter at a proximal end of the elongate body and a second diameter at a distal end of the elongate body. The extravascular scaffold 120 may have a third diameter between the proximal end and the distal end that is greater than the first diameter and / or the second diameter. The extravascular scaffold 120 may include a frame. The frame may provide structural support for the extravascular scaffold. The frame may be selfexpanding and include, for example, a nitinol material. In some embodiments, the extravascular scaffold may include a membrane. The membrane may include a include a PTFEmaterial or other similar material configured to create a hemostatic seal with the vessel wall once delivered. The frame may be coated with or covered by the membrane material. For example, the membrane may be electrospun over the frame.

[0069] As depicted in FIG. IE, the extravascular scaffold 120 may be configured to be delivered in a crimped, or compressed, configuration. The extravascular scaffold 120 may be carried within a catheter and / or mounted on a tubular body for delivery.

[0070] FIG. IF illustrates the extravascular scaffold 120 being delivered. The extravascular scaffold 120 may be configured to be advanced through the incision 116 in the vessel wall to a space outside of the vessel wall. The extravascular scaffold 120 may be advanced from the delivery system to a location external of the vessel.

[0071] FIG. 1G illustrates a cross-section of the extravascular scaffold 120 in a delivered state. The extravascular scaffold 120 may include a proximal end 122 and a distal end 124. The proximal end 122 of the extravascular scaffold 120 may include features for securing the extravascular scaffold 120 relative to the vessel 100. The extravascular scaffold may include one or more securement features circumferentially spaced apart around the proximal end 122. For example, the proximal end 122 may include one or more securement features having a first prong configured to contact the inner wall 102 of the vessel 100 and a second prong configured to contact the outer wall 104 of the vessel 100. The first and second prongs may be configured to clamp, or clip, around the vessel wall to secure the extravascular scaffold 120 relative to the vessel 100. In other embodiments, the proximal end 122 may include other features, geometries, or structures configured to secure the extravascular scaffold 120 relative to the vessel 100.

[0072] The inner surface of at least the distal end 124 of the extravascular scaffold 120 may be configured to contact, or compress against, the outer wall 104 of the vessel 100. For example, the extravascular scaffold 120 may be shaped such that the distal end 124 is configured to compress against the outer wall 104 of the vessel 100 when the proximal end 122 is secured relative to the vessel 100. The extravascular scaffold 120 may include a bulbous shape, which may cause the distal end 124 to compress against the outer wall 104 of the vessel 100 when the proximal end 122 is secured relative to the vessel 100. As illustrated, a midsection of the extravascular scaffold 120, between the proximal end 122 and the distal end 124,may extend radially outward relative to the proximal end 122 and the distal end 124 to form a sinus.

[0073] In another embodiment, the distal end 124 of the extravascular scaffold 120 could include features for securing the extravascular scaffold 120 relative to the vessel 100, and the proximal end 122 could be configured to compress against the outer wall 104 of the vessel 100. In yet another embodiment, both the proximal end 122 and the distal end 124 of the extravascular scaffold 120 could include features for securing the extravascular scaffold 120 relative to the vessel 100. In another embodiment, both the proximal end 122 and the distal end 124 of the extravascular scaffold 120 could be configured to compress against the outer wall 104 of the vessel 100.

[0074] Once delivered, the extravascular scaffold 120 may be configured to form a hemostatic seal between the extravascular scaffold 120 and the vessel 100. The inner surface of the extravascular scaffold 120 may form a hemostatic seal with the outer wall 104 of the vessel 100. As discussed above, the extravascular scaffold 120 may include a membrane material. The membrane material may be configured to form a hemostatic seal when positioned in contact with a wall of the vessel 100.

[0075] One or more of the above devices, systems, and steps could be used to deliver the extravascular scaffold 120 in one or more components. In some embodiments, the extravascular scaffold 120 may include two or more separate scaffold portions to collectively form the extravascular scaffold. For example, the above methods could be performed to create a first incision 116 and to deliver a first extravascular scaffold 120. For example, a first incision 116 extending partially around the circumference of the vessel 100 could be created. A first incision 116 extending approximately 180 degrees or less around the circumference of the vessel 100 could be created. A first extravascular scaffold 120, or first body portion of the extravascular scaffold, could be delivered through the first incision 116 to partially surround the circumference of the vessel 100. A first extravascular scaffold 120 could be delivered through the first incision 116 to surround approximately 180 degrees around the circumference of the vessel 100.

[0076] In some embodiments, the above devices, systems, and steps could be used to create a second incision 116 and to deliver a second extravascular scaffold 120, or second body portion of the extravascular scaffold. For example, a second incision 116 extendingpartially around the circumference of the vessel 100 could be created. A second incision 1 16 extending approximately 180 degrees or less around the circumference of the vessel 100 could be created. A second extravascular scaffold 120 could be delivered through the second incision 116 to partially surround the circumference of the vessel 100. A second extravascular scaffold 120 could be delivered through the second incision 116 to surround approximately 180 degrees around the circumference of the vessel 100.

[0077] In some embodiments, the first extravascular scaffold 120 and the second extravascular scaffold 120 could be configured to collectively surround the circumference of the vessel 100. The first extravascular scaffold 120 and the second extravascular scaffold 120 could be configured to be coupled, attached, joined, or otherwise connected to each other. The first extravascular scaffold 120 and the second extravascular scaffold 120 could be configured to form a hemostatic seal around the circumference of the vessel 100.

[0078] FIG. 1H illustrates a catheter system 110 having an occlusion balloon 112 and / or a cutting tool 114. The catheter system 110 may be the same or different from the system described above with respect to FIG. 1C for creating the initial incision. The catheter system 110 may be advanced through the vessel 100 such that the cutting tool 114 is positioned within a longitudinal region of the vessel 100 that is surrounded by the extravascular scaffold 120. For example, the catheter system 110 may be advanced through the vessel 100 such that the cutting tool 114 is positioned distal to the proximal end 122 of the extravascular scaffold 120 and such that the cutting tool 114 is positioned proximal to the distal end 124 of the extravascular scaffold 120.

[0079] As depicted in FIGS. 1H and II, the cutting tool 114 may be controlled to create one or more incisions 130 through the wall of the vessel 100 to form one or more leaflets. The cutting tool 114 may be controlled to create one or more incisions 130 in a circumferential and / or transverse direction to shape the one or more leaflets. These incision(s) 130 may join the pre-existing incision 116 or be formed longitudinally displaced from the incision 116. The cutting tool 114 may be controlled to create an incision 130 extending at least partially or fully around the circumference of the vessel 100. The cutting tool 114 may then be controlled to create one or more longitudinal, or axial, incisions 130. In one embodiment, the cutting tool 114 may be controlled to create one longitudinal incision 130. In another embodiment, the cutting tool 114 may be controlled to create two longitudinal incisions 130. In yet anotherembodiment, the cutting tool 114 may be controlled to create three longitudinal incisions 130. In other embodiments, the cutting tool 114 may be controlled to create more than three longitudinal incisions 130. The first body portion and / or the second body portion of the extravascular scaffold 120 may at least partially surround the vessel, or vein, wall. The first body portion of the extravascular scaffold 120 may be coupled to the second body portion of the extravascular scaffold 120.

[0080] As shown in FIG. II, an incision 130 through the wall of the vessel 100 may result in a newly formed leaflet 132. The leaflet 132 may be positioned within the longitudinal region of the vessel 100 surrounded by the extravascular scaffold 120. The one or more leaflets 132 may be configured to function as a valve. The one or more leaflets 132 may be configured to open to allow blood to flow in a first direction, and the one or more leaflets 132 may be configured to close to substantially prevent blood from flowing in a second direction opposite to the first direction. Utilizing native vessel tissue to form the new leaflets 132 may advantageously reduce the risk of thrombosis and calcification.

[0081] The extravascular scaffold 120 may form a sinus area, which may include a bulbous shape. For example, the extravascular scaffold 120 may have middle portion with a diameter that is greater than a distal end 124 diameter and a proximal end 122 diameter. The bulbous shape of the sinus area may help to facilitate opening and closing of the newly formed leaflets 132. For example, blood may pool, or accumulate, in the bulbous area of the sinus, which may exert a pressure on the leaflets 132, thereby causing the leaflets 132 to cyclically close. In other embodiments, the extravascular scaffold 120 may include different shapes.

[0082] The inner surface of the extravascular scaffold 120 may form a hemostatic seal with the outer wall 104 of the vessel 100, which may thereby result in the inner surface of the extravascular scaffold 120 effectively functioning as an inner wall of the vessel 100.

[0083] In some embodiments, a particular region of the vessel 100 may be selected to facilitate formation and functioning of the new leaflets 132. For example, a region of the vessel 100 having a relatively thin wall may help facilitate opening and closing of the newly formed leaflets 132. Prior imaging may be performed on the vessel 100 to assist in selecting an optimal region of the vessel 100 for formation of new leaflets 132.

[0084] As depicted in FIG. 1 J, an internal support member 150 may be delivered to the region of the vessel 100 having the newly formed leaflets 132. One or more internal support members 150 may be delivered before or after creation of the leaflets.

[0085] The internal support member 150 may be delivered intravascularly. The internal support member 150 may be delivered in a crimped, or compressed, configuration. As illustrated, the internal support member 150 may be delivered after the catheter system 110 has been removed. But in other configurations, the internal support member 150 may be delivered through the catheter system 110. The internal support member 150 may be delivered over a guidewire or through the same access sheath used to deliver the catheter system 110.

[0086] As will be discussed in greater detail below with reference to FIGS. 2A-2B, the internal support member 150 may include a proximal portion, a distal portion, and one or more support structures, such as one or more axial struts.

[0087] As depicted in FIG. IK, the internal support member 150 may be delivered such that the internal support member 150 is configured to support the region of the vessel 100 having the newly formed leaflets 132. For example, the internal support member 150 may be delivered such that a proximal portion of the internal support member 150 is positioned proximal to the leaflets 132 and a distal portion of the internal support member 150 is positioned distal to the leaflets 132. The internal support member 150 may provide structural support for the walls of the vessel 100 at or near the region of the newly formed leaflets 132, which may help facilitate opening and closing of the leaflets 132. The internal support member 150 may be oriented such that any axial struts do not obstruct movement of the leaflets 132. For example, each axial strut may be positioned between adjacent leaflets 132.

[0088] FIGS. 2A-2B illustrate an embodiment of an internal support member 250. The internal support member 250 resembles or is identical to the internal support member 150 discussed above. Accordingly, numerals used to identify like features of are incremented by a factor of one hundred (100). This numbering convention generally applies to any element in the remainder of the figures. Any component or step disclosed in any embodiment in this specification can be used in other embodiments.

[0089] The internal support member may include a proximal portion 254, a distal portion 256, and support struts 252 extending therebetween. In some embodiments, the proximal portion 254 and the distal portion 256 may have a substantially cylindrical shape.The proximal portion 254 and the distal portion 256 may include a frame. The frame may be self-expanding and include, for example, a nitinol material or other similar material. In some embodiments, the support struts 252 may comprise a nitinol material or other similar material.

[0090] During delivery, the internal support member 250 may be rotationally controlled such that the support struts 252 may be delivered to be aligned relative to the newly formed leaflets 232. The support struts 252 may be configured to provide structural support to the vessel wall at the region of the vessel having the newly formed leaflets 232 without obstructing the leaflets 232. For example, when the leaflets 232 close to obstruct blood flow, the strut(s) 252 may be positioned in a region between or circumferentially offset from the closing leaflets 232 so the leaflets 232 may close around the strut(s) 252.

[0091] FIGS. 3A-3F illustrate various other combinations of an internal support member 350 and leaflet(s) 332. As depicted in FIGS. 3A-3F, the internal support member 350 may include one or more support struts 352, which may be referred to as rods, struts, or commissure supports. The number of support struts 352 may correspond to a number of newly formed leaflets 332. For example, FIG. 3A illustrates a modified valve having one newly formed leaflet 332. FIG. 3B illustrates an internal support member 350 having one support strut 352. As shown in FIG. 3A, the strut 352 is positioned along an uncut portion of the vessel wall or in a region circumferentially offset from the newly formed leaflet 332. FIG. 3C illustrates a modified valve having two newly formed leaflets 332. FIG. 3D illustrates an internal support member 350 having two internal support struts 352. As shown in FIG. 3C, each strut 352 is positioned along an uncut portion of the vessel wall or between adjacent leaflets 332. FIG. 3E illustrates a modified valve having three newly formed leaflets 332. FIG. 3F illustrates an internal support member 350 having three internal support struts 352. As shown in FIG. 3C, each strut 352 is positioned along an uncut portion of the vessel wall or between adjacent leaflets 332.

[0092] The support struts 352 may be formed from a nitinol material or other similar material. The support struts 352 may be connected to the proximal and distal ends 354, 356 of the internal support member 350. In another embodiment, the support struts 352 may be formed from a lattice structure. For example, the support struts 352 may be an extension of, or integral to, the proximal and distal ends 354, 356 of the internal support member 350.

[0093] FIG. 4 shows an embodiment of a modified vessel 400, which may include one or more features described above. For example, the vessel 400 may include an inner wall 402 and an outer wall 404. As depicted in FIG. 4, an external scaffold 420 may be delivered to the area of interest of the vessel 400. The external scaffold 420 may form a sinus space 440. One or more incisions through the vessel wall may result in newly formed leaflets 432. Additionally, one or more internal support members in the form of anchors 450 may be delivered to the area of interest. For example, an internal support anchor 450 may be delivered to an area proximal to the newly formed leaflets 432, and / or an internal support anchor 450 may be delivered to an area distal to the newly formed leaflets 432.

[0094] Internal support anchors 450 may include a frame. In some embodiments, the frame may include a substantially cylindrical shape. The frame may be self-expanding and include, for example, a nitinol material or other similar material. The internal support anchors 450 may be configured to provide structural support to the vessel wall at the region of the vessel 400 having the newly formed leaflets 432.

[0095] FIGS. 5A-5I illustrate other embodiments of devices, systems, and methods for creating a modified valve, which may be used in combination with any of the other methods and devices described above. As depicted in FIG. 5A, a catheter system 510 may be advanced to a desired region of the vessel 500. The catheter system 510 may include any of the features described above with respect to the catheter system 110. The catheter system 510 may include a proximal occlusion balloon 512 and / or a distal occlusion balloon 513. The proximal occlusion balloon 512 may be carried by an outer catheter 518. The distal occlusion balloon 513 may be pre-loaded within an inner catheter 519 and carried by a separate inner shaft. An extravascular scaffold 520 may be pre-loaded and configured in a constrained state, for example between inner catheter 519 and outer catheter 518. An internal support member 550 may be pre-loaded configured in a constrained state, for example within inner catheter 519. The extravascular scaffold 520 and the internal support member 550 may include features of any of the other extravascular scaffolds and internal support members, respectively, described herein.

[0096] As depicted in FIG. 5B, at least a portion of the internal support member 550 may be advanced and expanded to an expanded state. For example, the inner catheter 519 may be advanced from a distal end of the outer catheter 518 or pre-loaded with a distal portionof the inner catheter 519 extending from the distal end of the outer catheter 518. The inner catheter 519 may include a nose cone forming a distal end of the delivery system. A distal portion of the inner catheter 519 may be able to split and advance distally relative to a reminder of the inner catheter to allow at least a portion of the internal support member 550 to expand.

[0097] As depicted in FIG. 5C, the proximal and / or distal occlusion balloons 512, 513 may be expanded to contact the inner wall of the vessel 500. The occlusion balloons 512,513 may be configured to stabilize, or anchor, the catheter system 510 relative to the vessel 500. When expanded, the distal occlusion balloon 513 may be expanded within the internal support member 550 to stabilize a distal portion of the inner support member 550. The proximal occlusion balloon 513 may stabilize the outer catheter 518.

[0098] As depicted in FIG. 5D, the catheter system 510 may include a cutting tool514 carried by the same or different shaft as the balloons 512, 513. The cutting tool 514 may be rotatable relative to the occlusion balloons 512, 513. For example, occlusion balloons 512, 513 may be fixedly attached to an outer shaft, and the cutting tool may be fixedly attached to an inner shaft that is rotatable relative to the outer shaft. The cutting tool 514 may be operated to create an incision 516 extending at least partially or fully around the circumference of the vessel 500, which may result in a proximal region of the vessel 500 and a distal region of the vessel 500. The proximal region of the vessel 500 and the distal region of the vessel 500 may be prevented from fully separating due to the proximal occlusion balloon 512 and the distal occlusion balloon 513. The proximal occlusion balloon 512 may exert a force on the inner wall of the proximal region of the vessel 500, causing the proximal occlusion balloon 512 to be temporarily secured relative to the proximal region of the vessel 500. Similarly, the distal occlusion balloon 513 may exert a force on the inner wall of the distal region of the vessel 500, causing the distal occlusion balloon 513 to be temporarily secured relative to the distal region of the vessel 500. Accordingly, the proximal region of the vessel 500 may be secured relative to the distal region of the vessel 500.

[0099] As depicted in FIG. 5E, once the incision 516 is created, the extravascular scaffold 520 may be delivered. At least a distal portion of the extravascular scaffold 520 may be released from a distal end of the outer catheter 518. The extravascular scaffold 520 may be advanced or pushed through the incision 516 in the vessel wall using the inner catheter 519 orother pushable body. At least the distal portion of the extravascular scaffold 520 may surround an outer wall of the vessel.

[0100] As depicted in FIG. 5F, the extravascular scaffold 520 may include a proximal end 522 and a distal end 524. The proximal end 522 of the extravascular scaffold 520 may include features for securing the extravascular scaffold 520 relative to the vessel 500. As illustrated, the proximal end 522 expands within the vessel 500 and against an inner wall of the vessel. For example, the proximal end 522 may include one or more barbs, prongs, or other features configured to contact the inner wall of the vessel 500. The distal end 524 may include one or more barbs, prongs, or other features configured to contact the outer wall of the vessel 500. In other embodiments, the proximal end 522 and / or the distal end 524 may include other features, geometries, or structures configured to secure the extravascular scaffold 520 relative to the vessel 500.

[0101] As depicted in FIG. 5G, occlusion balloons 512, 513 may be collapsed such that the catheter system 510 may be retracted from within the vessel 500. A proximal portion of the internal support member 550 may be expanded to an expanded state within a proximal portion of the extravascular scaffold 520. The extravascular scaffold 520 can include arm members. The arm members can extend from within the vessel to the outside of the vessel. The arm members can be curved. The arm members can include engagement features configured to secure the arm members to the interior and / or exterior wall of the vessel. The arm members can protrude through the wall of the vessel 500. The arm members of the extravascular scaffold 520 can be coupled to the internal support member 550, or the overlapping members. The overlapping members may contact the inner and / or outer vein wall. When implanted, the extravascular scaffold 520 and the internal support member 550 may be substantially overlapping. The extravascular scaffold 520 may form a sinus.

[0102] As depicted in FIG. 5H, leaflets 532 may be formed by one or more incisions in the wall of the vessel 500. The leaflets 532 may be formed using any of the devices, systems, or methods described above with respect to formation of leaflets 132. For example, the cutting tool 514 may be controlled to create one or more incisions in a circumferential and / or transverse direction to shape the one or more leaflets 532. The leaflets 532 may be flaps formed from the wall of the vessel 500, for example a native vein. These incisions(s) may join the pre-existing incision 516 or be formed longitudinally displaced from the incisions 516. Thecutting tool 514 may be controlled to create an incision extending at least partially or fully around the circumference of the vessel 500. The cutting tool 514 may then be controlled to create one or more longitudinal, or axial, incisions. In one embodiment, the cutting tool 514 may be controlled to create one longitudinal incision. In another embodiment, the cutting tool 514 may be controlled to create two longitudinal incisions. In yet another embodiment, the cutting tool 514 may be controlled to create three longitudinal incisions. In other embodiments, the cutting tool 514 may be controlled to create more than three longitudinal incisions. The one or more incisions through the wall of the vessel 500 may result in one or more newly formed leaflets 532. The one or more leaflets 532 may be configured to open to allow blood to flow in a first direction, and the one or more leaflets 532 may be configured to close to substantially prevent blood from flowing in a second direction opposite to the first direction. The leaflets 532 may be configured to open and closed based on a parameter of blood flow in a vessel 500, for example the native vein. The leaflets 532 may be configured to open and close in response to blood flowing through the modified venous valve. The leaflets 532 may be configured to open in response to blood flow in the first direction being below a threshold. The leaflets 532 may be configured to close in response to blood flow in the second direction being above a threshold.

[0103] As depicted in FIG. 51, the internal support member 550 may include one or more support struts 552 configured to support the one or more valve flaps, or leaflets 532.

[0104] FIGS. 6A-6C illustrate other embodiments of devices, systems, and methods for creating a modified valve, which may be used in combination with any of the other methods and devices described above. As depicted in FIG. 6A, one or more tethers 660 may be positioned relative to the vessel 600. The tether 660 may include a proximal end 662 and a distal end 664. The proximal end 662 and distal end 664 of the tether 660 may include features for securing or anchoring the tether 660 relative to the vessel 600. For example, the proximal end 662 may include a first prong configured to contact the inner wall 602 of the vessel 600 and a second prong configured to contact the outer wall 604 of the vessel 600. The first and second prongs may be configured to clamp, or clip, around the vessel wall to secure the tether 660 relative to the vessel 600. In other embodiments, the proximal end 662 and distal end 664 may include other features, geometries, anchors, or structures configured to secure the tether 660 relative to the vessel 600.

[0105] The tether 660 may be delivered transvascularly. For example, tether 660 may be advanced through the vessel 600 and through a puncture or incision through the vessel wall created using any of the systems or methods described above. A cutting tool or guidewire may be used to create the puncture or incision through the vessel wall. On other embodiments, tether 660 may be delivered extravascularly.

[0106] FIG. 6A depicts an embodiment of a tether 660 positioned on the outside of the vessel 600. Alternatively, in other embodiments, the tether 660 may be delivered to be positioned within the vessel 600.

[0107] Tether 660 may be configured to be flexible and / or movable. For example, tether 660 may include a wire, suture, or other material configured to allow the tether 660 to be maneuverable.

[0108] As depicted in FIG. 6B, a catheter system having a cutting tool 614 may be advanced through the vessel 600 to a region of interest. For example, the catheter system may be advanced such that the cutting tool 614 is positioned distal to the proximal end 662 of the tether 660 and such that the cutting tool 614 is positioned proximal to the distal end 664 of the tether 660. In some embodiments, the catheter system may include an occlusion balloon. In other embodiments, the catheter system may not include an occlusion balloon.

[0109] As depicted in FIG. 6C, the cutting tool 614 may be controlled to create an incision 616 at least partially or entirely through the wall thickness of the vessel 600. The cutting tool 614 may be controlled to create an incision 616 extending at least partially or fully around the circumference of the vessel 600. The incision 616 may result in a proximal region of the vessel 600 and a distal region of the vessel. The proximal region of the vessel 600 and the distal region of the vessel 600 may be prevented from fully separating due to the one or more tethers 660. For example, the proximal end 662 of the tether 660 may be secured to the proximal region of the vessel 600, and the distal end 664 of the tether 660 may be secured to the distal region of the vessel 600, thereby securing the proximal region of the vessel 600 relative to the distal region of the vessel 600.

[0110] Once the incision 616 has been formed, an extravascular scaffold may be delivered through the incision 616 and positioned to surround a portion of the outer wall 604 of the vessel 600. The extravascular scaffold may be any of the above-described scaffolds. An extravascular scaffold may be delivered and positioned to circumferentially surround a portionof the vessel 600. One or more new leaflets may then be formed by creating one or more incisions through the wall of the vessel 600 using any of the devices, systems, and / or methods described above. Optionally, one or more internal supports may be provided as described above.[OlH] FIG. 7 illustrates other embodiments of a catheter system 710 that may be used with any of devices, systems, and methods for creating a modified valve. The catheter system 710 may include any of the features described above with respect to the catheter system 110. As depicted in FIG. 7, a catheter system 710 may be advanced through a vessel 700 to a region of interest. The catheter system may include a proximal occlusion balloon 712 and / or a distal occlusion balloon 713 and the catheter system 710 may include a cutting tool 714 carried by the same or different shaft as the balloons 712, 713. The cutting tool 714 may be rotatable relative to the occlusion balloons 712, 713. For example, occlusion balloons 712, 713 may be fixedly attached to an outer shaft, and the cutting tool may be fixedly attached to an inner shaft that is rotatable relative to the outer shaft.

[0112] The cutting tool 714 may be controlled to create one or more incisions 716 at least partially or fully through the wall thickness of the vessel 700. The cutting tool 714 may be controlled to create an incision 716 extending at least partially or fully around the circumference of the vessel 700, which may result in a proximal region of the vessel 700 and a distal region of the vessel 700. The proximal region of the vessel 700 and the distal region of the vessel 700 may be prevented from fully separating due to the proximal occlusion balloon 712 and the distal occlusion balloon 713. The proximal occlusion balloon 712 may exert a force on the inner wall of the proximal region of the vessel 700, causing the proximal occlusion balloon 712 to be temporarily secured relative to the proximal region of the vessel 700. Similarly, the distal occlusion balloon 713 may exert a force on the inner wall of the distal region of the vessel 700, causing the distal occlusion balloon 713 to be temporarily secured relative to the distal region of the vessel 700. Accordingly, the proximal region of the vessel 700 may be secured relative to the distal region of the vessel 700.

[0113] Once the incision 716 has been formed, any of the above-described extravascular scaffolds may be delivered through the incision 716 and positioned to surround a portion of the outer wall of the vessel 700. An extravascular scaffold may be delivered and positioned to circumferentially surround a portion of the vessel 700 as described above. Insome embodiments, the extravascular scaffold may be configured to be delivered using the catheter system 710. For example, the catheter system 710 may include one or more openings, or slots, configured to allow passage of an extravascular scaffold from the catheter system 710 and through the incision 716. One or more new leaflets may then be formed by creating one or more incisions through the wall of the vessel 700 using any of the devices, systems, and / or methods described above. In some embodiments, the leaflets may be formed by creating incisions using cuttingtool 714. This may advantageously allow placement of the extravascular scaffold and creation of the new leaflets to be achieved using a single catheter system 710. Optionally, one or more internal supports may be implanted as described above.

[0114] FIGS. 8A-8B depict other embodiments for delivering an extravascular scaffold that may be used with any of devices, systems, and methods for creating a modified valve described above. As depicted in FIGS. 8A-8B, a device may be used to at least partially separate a vessel 800 from its surrounding tissue. For example, a device may use carbon dioxide insufflation or other similar devices and / or methods to create a subcutaneous tunnel 870 or space surrounding a portion of the vessel 800, which may result in operative access to the outer wall of the vessel 800.

[0115] Once the vessel 800 has been at least partially separated from its surrounding tissue, a delivery device 810 may be configured to deliver an extravascular scaffold 820 to the vessel. The extravascular scaffold 820 may include any of the features of the extravascular scaffolds described above. For example, a delivery device 810 may be configured to crimp, connect, attach, or otherwise secure an extravascular scaffold 820 to the vessel 800. The extravascular scaffold 820 may include one or more features discussed above.

[0116] Once the extravascular scaffold 820 has been delivered, one or more new leaflets may then be formed by creating one or more incisions through the wall of the vessel 800 using any of the devices, systems, and / or methods described above.Other Variations

[0117] 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 methodsand 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 and / 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 and / 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.

[0118] The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for proper operation of the method that is being described, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0119] Conditional language used herein, such as, among others, “can,” “could”, “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or states. Thus, such conditional language is not generally intended to imply that features, elements and / or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or states 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. 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.

[0120] Conjunctive language, such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is to be understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, or a combination thereof. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0121] 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.

[0122] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations.

[0123] It should be noted that the terms “couple,” “coupling,” “coupled” or other variations of the word couple as used herein may indicate either an indirect connection or a direct connection. For example, if a first component is “coupled” to a second component, the first component may be either indirectly connected to the second component or directly connected to the second component. As used herein, the term “plurality” denotes two or more. For example, a plurality of components indicates two or more components.

[0124] 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 and / 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 specific disclosures of preferredembodiments herein, and may be defined by claims as presented herein or as presented in the future.

[0125] Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.

[0126] The previous description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

WHAT IS CLAIMED IS:

1. A venous valve implant, comprising: an extravascular scaffold configured to be delivered to and at least partially surround a native vein wall, the extravascular scaffold comprising a frame; wherein the extravascular scaffold is configured to form an inner wall of a modified venous valve, the modified venous valve comprising the extravascular scaffold and at least one valve flap formed from a wall of the native vein; wherein the extravascular scaffold is configured such that the at least one flap formed from the wall of the native vein opens and closes within the extravascular scaffold in response to blood flowing through the modified venous valve.

2. The venous valve implant of claim 1, wherein the extravascular scaffold further comprises a membrane.

3. The venous valve implant of claim 1, wherein the extravascular scaffold is configured to be delivered to the native vein via a transvascular approach.

4. The venous valve implant of claim 1, wherein the extravascular scaffold is expandable.

5. The venous valve implant of claim 1, wherein the extravascular scaffold comprises a sinus shape.

6. The venous valve implant of claim 1, wherein the extravascular scaffold comprises a first body portion configured to at least partially surround the vein wall and a second body portion configured to at least partially surround the vein wall.

7. The venous valve implant of claim 6, wherein the first body portion is configured to be coupled to the second body portion.

8. The venous valve implant of claim 1, further comprising an internal support structure configured to be positioned within the vein and adjacent to the at least one flap.

9. A method for percutaneously creating a modified venous valve, the method comprising: advancing a catheter to a target site within a vein, wherein the vein comprises a wall having an inner surface and an outer surface; extending a tissue puncturing element through the inner surface of the vein wall and the outer surface of the vein wall to create a puncture through the vein wall;delivering an extravascular scaffold from within the vein to an extravascular space outside of the vein; positioning the extravascular scaffold at least partially around the vein; and creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue; wherein after forming the flap of vein wall tissue, the extravascular scaffold forms an inner wall of the modified venous valve and allows blood to flow through the modified venous valve.

10. The method of claim 9, further comprising delivering a guidewire from within the vein and through the puncture to a position outside of the vein.

11. The method of claim 10, further comprising expanding a balloon carried on the guidewire to enlarge the extravascular space between the outer surface of the vein wall and a portion of tissue surrounding the vein wall.

12. The method of claim 9, wherein positioning the extravascular scaffold comprises positioning a first body portion of the extravascular scaffold over the puncture.

13. The method of claim 9, wherein positioning the extravascular scaffold comprises positioning a first body portion of the extravascular scaffold at least partially around the flap.

14. The method of claim 9, further comprising creating a second puncture through the vein wall, wherein the second puncture is diametrically opposed from the puncture.

15. The method of claim 14, further comprising positioning a second body portion of the extravascular scaffold at least partially around the vein.

16. The method of claim 14, further comprising creating a second transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the second transmural incision forming a second flap of the vein wall tissue.

17. An extravascular venous scaffold comprising: an elongate body comprising a frame and a membrane; wherein the membrane is configured to contact an outer surface of a vein wall to form a hemostatic seal at least partially around the vein.

18. The extravascular scaffold of claim 17, wherein the elongate body comprises a first diameter at a proximal end of the elongate body, a second diameter at a distal end of theelongate body, and a third diameter therebetween, wherein the third diameter is greater than the first diameter, and wherein the third diameter is greater than the second diameter.

19. The extravascular scaffold of claim 17, wherein the elongate body comprises a first body portion configured to at least partially surround the vein wall and a second body portion configured to at least partially surround the vein wall.

20. The extravascular scaffold of claim 19, wherein the first body portion is coupled to the second body portion to form a sinus shape.

21. A system for creating a modified venous valve at a native vein, comprising: an extravascular scaffold comprising a frame and a membrane; a delivery catheter configured to deliver the extravascular scaffold via a transvascular approach to the native vein; and a cutting tool configured to modify the native vein to form one or more valve flaps from a wall of the native vein; wherein the extravascular scaffold is configured to at least partially surround the one or more valve flaps to form an inner wall of the modified venous valve and allow blood to flow through the one or more valve flaps of the modified venous valve.

22. The system of claim 21, wherein the extravascular scaffold is expandable.

23. The system of claim 21, wherein the extravascular scaffold is configured to be delivered to and surround the native vein wall.

24. The system of claim 21, wherein the extravascular scaffold comprises a sinus shape.

25. The system of claim 21, wherein the membrane comprises a first body portion configured to surround a portion of the vein wall and a second body portion configured to surround another portion of the vein wall.

26. A venous valve system for directing blood flow through a valve flap comprising native vein tissue of a mammal, wherein the valve flap is formed by a transmural incision extending from an inner surface of a vein wall to an outer surface of the vein wall, the system comprising: an extravascular scaffold positionable at least partially outside of a vein such that an inner surface of the extravascular scaffold is in contact with an outer surface of the vein wall, wherein the extravascular scaffold is configured to form a seal around the vein at a longitudinal region of the vein where the valve flap is positioned; andan internal support member positionable within the vein such that an outer surface of the internal support member is in contact with the inner surface of the vein wall.

27. The system of claim 26, wherein the internal support member comprises a first anchor, a second anchor, and a support strut attached to and positioned between the first anchor and the second anchor.

28. The system of claim 26, wherein the internal support member is configured to support a portion of the valve flap.

29. The system of claim 26, wherein the internal support member comprises a plurality of support struts configured to support a plurality of valve flaps.

30. An extravascular scaffold configured to be positioned relative to a vein wall, the extravascular scaffold comprising: a plurality of arm members; and a plurality of overlapping members coupled to the plurality of arm members; wherein the plurality of overlapping members comprises a first overlapping member configured to contact an adjacent second overlapping member.

31. The extravascular scaffold of claim 30, wherein the plurality of overlapping members are configured to contact an outer vein wall.

32. The extravascular scaffold of claim 30, wherein the plurality of overlapping members are configured to create a hemostatic seal.

33. The extravascular scaffold of claim 30, wherein the plurality of arm members are configured to protrude through a vein wall.

34. The extravascular scaffold of claim 30, wherein the plurality of arm members comprise a curved shape such that the plurality of overlapping members are configured to be compressed against an outer vein wall.

35. A method for transvascularly creating a modified venous valve, the method comprising: advancing a catheter to a target site within a vein, wherein the vein comprises a wall having an inner surface and an outer surface; extending a cutting element through the inner surface of the vein wall and the outer surface of the vein wall;delivering a tethering element configured to be coupled to the vein at a first position of the vein and at a second position of the vein; creating a cut at a third position of the vein, wherein the third position is at a longitudinal position between the first position and the second position, such that the vein is separated into a first portion and a second portion; delivering an extravascular scaffold from within the vein to an extravascular space outside of the vein; positioning the extravascular scaffold at least partially around the vein; and creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue; wherein after forming the flap of vein wall tissue, the extravascular scaffold forms an inner wall of the modified venous valve and allows blood to flow through the modified venous valve.

36. A method for creating a modified venous valve, the method comprising: percutaneously advancing a separation element configured to an enlarge an extravascular space between an outer surface of a vein wall and a portion of tissue surrounding the vein wall; positioning an external membrane such that an inner surface of the external membrane surrounds a longitudinal portion of the outer surface of the vein wall; and creating a transmural incision from the inner surface of the vein wall to the outer surface of the vein wall, the transmural incision forming a flap of vein wall tissue, the transmural incision positioned within the longitudinal portion of the vein wall surrounded by the external membrane.

Images