Endoprosthesis and method for treating non-thrombotic iliac vein lesions

Abstract

An endoprosthesis for preventing venous collapse may include an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, and a plurality of anchor legs extending axially away from a first end of the expandable frame. The plurality of anchor legs may be configured to transition between a delivery configuration and a deployed configuration. In the deployed configuration, the plurality of anchor legs may be configured to extend radially outward from the expandable frame in the radially expanded configuration. A system for preventing vein collapse may include a delivery catheter having a lumen, an endoprosthesis disposed within a distal portion of the lumen in a radially collapsed configuration, and at least one filament coupled with a plurality of anchor legs of the endoprosthesis and extending within the lumen of the delivery catheter.

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 402,206, filed on August 30, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices, and methods of manufacturing and / or using medical devices. More specifically, the present disclosure relates to improved designs and / or methods for endoprostheses or stents for treating non-thrombotic iliac vein lesions. Background Art

[0004] Stents, grafts, stent-grafts, and similar implantable medical devices (collectively referred to hereinafter as stents) are radially expandable or self-expandable endoprostheses that are intravascular or endoscopic implants capable of percutaneous or endoscopic transluminal implantation. Stents can be implanted into various body cavities or blood vessels, such as in the vascular system, urethra, bile duct, gastrointestinal tract, airway, etc. Stents can be used to open stenotic body cavities. Stents can be used to reinforce body blood vessels and prevent restenosis after angioplasty in the vascular system. They can be self-expandable, mechanically expandable, or hybrid-expandable. Generally, self-expandable stents are mounted on a delivery device consisting of two tubes. The stent is delivered by sliding the outer tube to expose and release the stent.

[0005] Stents are typically tubular members that, once deployed in the treatment location, can radially expand from a reduced-diameter configuration to an expanded configuration for delivery through a patient's body cavity. A stent can be formed from a tubular member, where a pattern is subsequently formed by etching or cutting material from the tubular member, or can be made from wires or filaments using techniques such as braiding, knitting, or weaving. Stents generally rely on radially outward forces to anchor the stent in place within the body cavity. Due to anatomical differences, venous stents may exhibit different characteristics and / or outcomes compared to arterial stents. Depending on the specific treatment scenario, certain stent characteristics may be opposing. There remains a need for new stent designs and / or configurations to better balance and / or combine various stent characteristics. Summary of the Invention

[0006] In one example, an endoprosthesis for preventing vein collapse can include: an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, the expandable frame having a first end and a second end opposite the first end; and a plurality of anchoring legs extending axially away from the first end of the expandable frame, the plurality of anchoring legs configured to transition between a delivery configuration and a deployed configuration. In the deployed configuration, the plurality of anchoring legs can be configured to extend radially outward from the expandable frame in the radially expanded configuration.

[0007] In addition to or as an alternative to any of the examples described herein, the expandable frame is self-biased toward a radially expanded configuration.

[0008] In addition to or as an alternative to any of the examples described herein, the plurality of anchoring legs are self-biased toward a deployed configuration.

[0009] In addition to or as an alternative to any of the examples described herein, the endoprosthesis may further include a plurality of anchoring barbs extending radially outward from the plurality of anchoring legs.

[0010] In addition to or as an alternative to any of the examples described herein, the plurality of anchoring legs include a plurality of paddles configured to engage the vein wall.

[0011] In addition to or as an alternative to any of the examples described herein, each of the plurality of paddles is disposed opposite the first end of the expandable frame.

[0012] In addition to or as an alternative to any of the examples described herein, each of the plurality of paddles includes at least one aperture formed therein.

[0013] In addition to or as an alternative to any of the examples described herein, each of the plurality of paddles includes at least one radiopaque marker.

[0014] In addition to or as an alternative to any of the examples described herein, when unconstrained, the radial extent defined by the plurality of paddles is at least 10% greater than the radial extent of the expandable frame.

[0015] In addition to or as an alternative to any of the examples described herein, when unconstrained, the radial extent defined by the plurality of paddles is at least 20% greater than the radial extent of the expandable frame.

[0016] In addition to or as an alternative to any of the examples described herein, a system for preventing vein collapse may include a delivery catheter having a lumen extending therethrough; an endoprosthesis disposed in the distal portion of the lumen in a radially collapsed configuration; and at least one filament coupled to the plurality of anchoring legs of the endoprosthesis and extending within the lumen of the delivery catheter; the endoprosthesis including: an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, the expandable frame having a first end and a second end opposite the first end; and the plurality of anchoring legs extending axially away from the first end of the expandable frame, the plurality of anchoring legs configured to transition between a delivery configuration and a deployed configuration; wherein, in the deployed configuration, the plurality of anchoring legs are configured to extend radially outward from the expandable frame in a radially expanded configuration.

[0017] In addition to or as an alternative to any of the examples described herein, the plurality of anchoring legs extend proximally from the expandable frame.

[0018] In addition to or as an alternative to any of the examples described herein, a plurality of anchoring legs include a plurality of paddles configured to engage the vein wall, and at least one filament is releasably coupled to the plurality of paddles.

[0019] In addition to or as an alternative to any of the examples described herein, the system may further include a plurality of anchoring barbs extending radially outward from the plurality of anchoring legs. At least one filament and the delivery catheter may cooperate to change the angle of the plurality of anchoring barbs relative to the central longitudinal axis of the expandable frame.

[0020] In addition to or as an alternative to any of the examples described herein, a method of preventing vein collapse may include: positioning a distal end of a delivery catheter adjacent a treatment location within a vein, the delivery catheter having a lumen extending therethrough; and deploying an implantable prosthesis at the treatment location. The implantable prosthesis may include: an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, the expandable frame having a first end and a second end opposite the first end; and a plurality of anchoring legs extending axially away from the first end of the expandable frame, the plurality of anchoring legs configured to transition between a delivery configuration and a deployed configuration. In the deployed configuration, the plurality of anchoring legs may be configured to extend radially outward from the expandable frame in the radially expanded configuration. After deploying the implantable prosthesis at the treatment location, the plurality of anchoring legs may extend upstream from the expandable frame within the vein.

[0021] In addition to or as an alternative to any of the examples described herein, prior to positioning the distal end of the delivery catheter adjacent the treatment location, the delivery catheter is advanced into the vein at a location upstream of the treatment location.

[0022] In addition to or as an alternative to any of the examples described herein, the expandable frame is sized and configured to prevent external compression of the vein at the treatment location while avoiding radial stretching of the vein at the treatment location.

[0023] In addition to or as an alternative to any of the examples described herein, the method may further include: recapturing the implantable prosthesis within the lumen of the delivery catheter and repositioning the implantable prosthesis at and / or adjacent the treatment location.

[0024] In addition to or as an alternative to any of the examples described herein, the expandable frame includes a plurality of closed cells.

[0025] In addition to or as an alternative to any of the examples described herein, the treatment location is a non-thrombotic iliac vein lesion.

[0026] The foregoing summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of the present disclosure. The following drawings and detailed description more particularly exemplify such embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] With reference to the accompanying drawings, the following specific embodiments may be considered to more fully understand the present disclosure, wherein:

[0028] Figure 1 is a schematic view of selected aspects of a patient's anatomy related to non-thrombotic iliac vein lesions;

[0029] Figure 2 is a cross-sectional view of a selected portion of the anatomy of a patient with non-thrombotic iliac vein lesions;

[0030] Figure 3 is a schematic view showing dilation that may be caused by non-thrombotic iliac vein lesions;

[0031] Figure 4 shows the Poisson effect that may occur when a stent is placed in a vein;

[0032] Figure 5 Schematically shows for a vessel with Figure 3 selected characteristics of an accepted treatment for non-thrombotic iliac vein lesions in a dilated blood vessel;

[0033] Figure 6 Schematically shows selected aspects of an endoprosthesis according to the present disclosure;

[0034] Figure 7 Schematically shows selected aspects of an endoprosthesis according to the present disclosure;

[0035] Figures 8 - 9 Schematically shows selected aspects of an alternative endoprosthesis according to the present disclosure;

[0036] Figure 10 Schematically shows selected aspects related to a system and method for preventing vein collapse;

[0037] Figure 11 Schematically shows selected aspects related to a system and method for preventing vein collapse;

[0038] Figure 12 Schematically shows selected aspects related to a system and method for preventing vein collapse; and

[0039] Figure 13 Schematically shows selected aspects of an endoprosthesis according to the present disclosure.

[0040] While aspects of the present disclosure may admit of various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. Detailed Description

[0041] The following description should be read with reference to the drawings, which are not necessarily drawn to scale, in which like reference numerals in the various views indicate like elements. The detailed description and the drawings are intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings illustrate exemplary aspects of the present disclosure.

[0042] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0043] It is assumed herein that all numerical values are modified by the term "about" whether or not explicitly indicated. The term "about" generally refers in a numerical context to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that round to the nearest significant figure. Unless otherwise indicated, it may be assumed that other uses of the term "about" (e.g., in contexts other than numerical) have their ordinary and customary definition as would be understood from the context of the specification and consistent therewith.

[0044] A numerical range expressed by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0045] Although some suitable dimensions, ranges, and / or values relating to various components, features, and / or specifications are disclosed, those skilled in the art will appreciate that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed, in light of the present disclosure.

[0046] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense of "and / or" unless the context clearly dictates otherwise. It should be noted that, for ease of understanding, some features of the present disclosure may be described in the singular, even though such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or discussed in detail below. However, it should be understood that, unless expressly stated to the contrary, the following discussion may equally apply to any and / or all components where multiple components exist.

[0047] Relative terms (such as "proximal", "distal", "advance", "retract", and their variants, etc.) can generally be considered in terms of the positioning, orientation, and / or operation of various elements relative to the user / operator / handler of the device, where "proximal" and "retract" indicate or refer to closer to or towards the user, while "distal" and "advance" indicate or refer to away from or further from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily designated for ease of understanding the present disclosure, and such cases will be apparent to those skilled in the art. Other relative terms (such as "upstream", "downstream", "inflow", and "outflow") refer to the direction of fluid flow within a lumen (such as a body cavity, blood vessel) or within a device. Other relative terms, such as "axial", "circumferential", "longitudinal direction", "lateral", "radial", etc. and / or their variants generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0048] The term "range" can be understood to represent the maximum measurement of the stated or determined dimension, unless the range or dimension being discussed is preceded by or identified as a "minimum value", which can be understood to represent the minimum measurement of the stated or determined dimension. For example, "outer range" can be understood to represent the outer dimension, "radial range" can be understood to represent the radial dimension, "longitudinal direction range" can be understood to represent the longitudinal direction dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal direction, lateral, radial, circumferential, etc.), and will be apparent to those skilled in the art based on the context of the individual usage. Generally, the "range" can be considered the maximum possible dimension measured according to the intended use, while the "minimum range" can be considered the minimum possible dimension measured according to the intended use. In some cases, the "range" can generally be measured orthogonally in a plane and / or cross-section, but it can be apparent from the specific context that it can be measured in different ways - for example but not limited to angular, radial, circumferential (e.g., along an arc), etc.

[0049] The terms "integral" and "unit" generally refer to one or more elements made or composed of a single structure or basic unit / component. The integral and / or unit elements do not include structures and / or features made by assembling or otherwise connecting multiple discrete structures or elements together.

[0050] It should be noted that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc. indicate that the embodiments may include certain features, structures, or characteristics, but each embodiment does not necessarily include the specific features, structures, or characteristics. Moreover, these phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, those skilled in the art will know that, unless otherwise explicitly stated, the particular feature, structure, or characteristic can be used in connection with other embodiments, whether or not explicitly described. That is, as understood by those of ordinary skill in the art, the various individual elements described below, even if not explicitly shown as a particular combination, are considered capable of being combined or arranged with each other to form other additional embodiments or to supplement and / or enrich the embodiments.

[0051] For clarity, throughout the specification and / or claims, certain identificatory numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish the various features described and / or claimed. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numerical nomenclature may be changed and deviated from. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted altogether, and / or different features may be referred to as the "first" element. The meaning and / or name in each case will be apparent to a skilled practitioner.

[0052] The drawings illustrate selected components and / or arrangements of an implant or stent. It should be noted that in any given figure, for simplicity, certain features of the implant or stent may not be shown, or may be shown schematically. Additional details regarding certain components of the implant or stent may be shown more specifically in other figures. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular, even though those features may be plural or may recur in the disclosed embodiments. Each instance of a feature may include and / or be covered by the singular disclosure, unless explicitly stated to the contrary. For example, a reference to "filament", "unit", "strut", or other feature may equally refer to all instances and amounts other than the feature described. Thus, it should be understood that, unless explicitly stated to the contrary, the following discussion may equally apply to any and / or all components within the implant or stent that have multiple parts. Further, for clarity, not all instances of certain elements or features may be shown in each figure.

[0053] Figure 1 shows the aorta 20 and the inferior vena cava 30 of patient 10. Near the pelvis of patient 10, the aorta 20 divides into the left common iliac artery 22 and the right common iliac artery 24, and the inferior vena cava 30 divides into the left common iliac vein 32 and the right common iliac vein 34. In some patients, when the right common iliac artery 24 overlaps the left common iliac vein 32, the right common iliac artery 24 may press the left common iliac vein 32 against the spine 12 of patient 10, as Figure 2 shown, resulting in non-thrombotic iliac vein lesions near the junction of the left common iliac vein 32, the right common iliac vein 34, and the inferior vena cava 30. In some cases, non-thrombotic iliac vein lesions may impede blood flow, leading to increased venous blood pressure, pain, leg swelling, and / or thrombosis. Additionally, in some patients, non-thrombotic iliac vein lesions may cause the formation of a dilation 36 in the left common iliac vein 32 immediately upstream of the non-thrombotic iliac vein lesion, as Figure 3 shown.

[0054] Some well-recognized treatment methods for non-thrombotic iliac vein lesions include placing a stent within the non-thrombotic iliac vein lesion, typically formed as a braided stent or a laser-cut stent, and extending upstream within the left common iliac vein 32 to secure the stent in place. Placing a stent in this position can be difficult. Commonly used braided stents have low compressibility at their ends but are flexible and provide several desirable characteristics for vein stent implantation. Unfortunately, crossing the opening of the right common iliac vein 34 into the inferior vena cava 30 such that the middle portion of the braided stent providing higher compression resistance and / or high outward radial force is located within the non-thrombotic iliac vein lesion may cause problems of its own (e.g., thrombosis, restricted blood flow, etc.).

[0055] It has been found that expandable stents, which are typically oversized and made of nitinol or other shape memory materials, due to chronic outward forces, stretch the blood vessel to dilate the vessel lumen and anchor the expandable stent, and may cause pain, discomfort, and / or vessel erosion. The chronic outward force is mainly determined by the amount of oversizing, and its value in veins lies mainly in anchoring the stent. An oversized stent within the vein 40, under the same chronic outward force, tends to stretch the vein 40 more than an artery, which may result in the Poisson effect that redistributes the radially applied force 42 (e.g., chronic outward force) to the longitudinal direction 44, as Figure 4 shown. As Figure 4As shown, upstream and downstream of the position where the vein 40 is radially stretched by a radially applied force 42 (e.g., a chronic outward force), the vein 40 narrows (e.g., at reference numeral 46), which may have a negative impact on the flow characteristics within the vein 40. The Poisson effect is more pronounced in veins than in arteries and poses challenges during vein stent implantation. To avoid the Poisson effect in veins, as well as reduce inflammation and pain, some physicians limit the stent size to be too large and / or may even set the ratio of the stent size to the blood vessel to 1:1 (e.g., place a 16-mm stent in a 16-mm blood vessel) in order to apply as little chronic outward force to the vein as possible. However, an undersized stent increases the risk of stent migration because the anchoring force is reduced.

[0056] Brief review Figure 3 , non-thrombotic iliac vein lesions can lead to the formation of a dilation 36 in the left common iliac vein 32 immediately upstream of the non-thrombotic iliac vein lesion. When treated with a stent of the smallest size or with a 1:1 or approximately 1:1 ratio to the vein lumen, the upstream end 52 of the stent 50 can be positioned within the dilation 36, as Figure 5 shown. The upstream end 52 of the stent 50 can be spaced apart from at least a portion of the wall of the dilation 36 and / or the left common iliac vein 32 such that the upstream end 52 of the stent 50 provides little (if any) anchoring force and / or resistance to migration. Thus, patients with a dilation 36 caused by a non-thrombotic iliac vein lesion may result in the stent 50 being more prone to migration because of the lack of anchoring force provided by the portion of the stent 50 disposed within the dilation 36. Accordingly, a recognized practice is to use a longer stent and / or use multiple overlapping stents to treat a longer vein to improve anti-migration. However, this may pose other risks because the lower position of the pelvic region where the stent is implanted in the patient may encounter curves in the vein anatomy, which may cause the stent to bend, the vein to deform, the patient to experience pain and / or discomfort due to the stent, and / or the stent to be subject to repetitive motion and potential fatigue.

[0057] The above discussion has given rise to an interest in an implantable prosthesis having high compressive resistance to treat non-thrombotic iliac vein lesions, low chronic outward force to minimize the Poisson effect, inflammation, and / or pain, and high anti-migration. The implantable prosthesis and / or method described herein may be an improvement over existing devices and methods for treating non-thrombotic iliac vein lesions.

[0058] Figures 6 - 7Schematically shown is an implantable prosthesis 100 for preventing venous collapse of a patient in a treatment position according to the present disclosure. The term "stent" may be used interchangeably with the term "implantable prosthesis" herein. The implantable prosthesis 100 may include an expandable frame 110 that defines an outer surface and / or has a generally cylindrical and / or tubular shape. The implantable prosthesis 100 and / or the expandable frame 110 may be defined by and / or may have a central longitudinal axis 102 that extends axially and / or longitudinally therethrough. The expandable frame 110 may extend from a first end 112 to a second end 114 that is opposite the first end 112. In some embodiments, the expandable frame 110 may include, comprise, and / or define a plurality of closed cells 116. The expandable frame 110 may include a lumen that extends longitudinally therethrough from the first end 112 to the second end 114. In some embodiments, the first end 112 may be a proximal end, while the second end 114 may be a distal end. In some alternative embodiments, the first end 112 may be a distal end, while the second end 114 may be a proximal end. The implantable prosthesis 100 and / or the expandable frame 110 may be configured to transition between a radially collapsed configuration and a radially expanded configuration. In some embodiments, the implantable prosthesis 100 and / or the expandable frame 110 may be self-biased toward the radially expanded configuration. In some embodiments, the implantable prosthesis 100 and / or the expandable frame 110 may be self-expandable, mechanically expandable, or balloon-expandable. Other configurations may also be contemplated.

[0059] In some embodiments, the expandable frame 110 may include one or more interwoven filaments that form a braided tubular stent, wherein the one or more interwoven filaments intersect and cross at a plurality of crossing locations and / or cross under each other. In some embodiments, the one or more interwoven filaments may include wires, threads, strands, etc. In some embodiments, the one or more interwoven filaments may extend in a helical direction while crossing each other along the length of the expandable frame 110. Other configurations may also be contemplated.

[0060] In some embodiments, the expandable frame 110 may be cut from a tube as a unitary structure. In some embodiments, the expandable frame 110 may be cut from a flat sheet, rolled to form a tubular structure and / or shape, and then welded together to form the expandable frame 110. Other configurations may also be contemplated. Some suitable but non-limiting materials for the implantable prosthesis 100, the expandable frame 110, and / or its components or elements are described below, such as metallic materials and / or polymeric materials.

[0061] In some embodiments, the expandable frame 110 may have a length measured from a first end 112 to a second end 114 of: about 20 millimeters to about 250 millimeters, about 25 millimeters to about 225 millimeters, about 30 millimeters to about 200 millimeters, about 35 millimeters to about 175 millimeters, about 40 millimeters to about 150 millimeters, or another suitable range. In some embodiments, the length of the expandable frame 110 may preferably be between about 20 millimeters and about 80 millimeters.

[0062] In some embodiments, the radial outer dimension or radial extent of the implant 100 and / or the expandable frame 110 may be: about 4 millimeters to about 30 millimeters, about 5 millimeters to about 25 millimeters, about 6 millimeters to about 20 millimeters, about 8 millimeters to about 18 millimeters, about 10 millimeters to about 16 millimeters, or another suitable range. In some embodiments, the radial outer dimension or radial extent of the implant 100 and / or the expandable frame 110 may be between about 10 millimeters and about 24 millimeters, and more preferably may be between about 12 millimeters and about 20 millimeters. Other configurations may also be considered.

[0063] In some embodiments, the implant 100 may optionally include a polymeric covering (not shown) that extends along and / or is fixed to the expandable frame 110. In some embodiments, the polymeric covering may cover, occlude the plurality of closure units 116 and / or prevent tissue ingrowth through the plurality of closure units 116. Some suitable but non-limiting polymeric covering materials, such as polymeric materials, will be discussed below.

[0064] In some embodiments, the implant 100 may include a plurality of anchoring legs 120 that extend axially away from the expandable frame 110. In some embodiments, the plurality of anchoring legs 120 may extend axially away from the first end 112 of the expandable frame 110. In some embodiments, the plurality of anchoring legs 120 may extend proximally from the expandable frame 110. In some embodiments, the plurality of anchoring legs 120 may extend proximally away from the first end 112 of the expandable frame 110. In some alternative embodiments, depending on the method used, the plurality of anchoring legs 120 may extend distally from the expandable frame 110. In some embodiments, the plurality of anchoring legs 120 may extend distally away from the first end 112 of the expandable frame 110.

[0065] In some embodiments, the plurality of anchoring legs 120 may be configured to transition between a delivery configuration and a deployed configuration. In some embodiments, in the delivery configuration, the plurality of anchoring legs 120 may be configured to extend radially inwardly toward the interior of the expandable frame 110. In some embodiments, in the deployed configuration, the plurality of anchoring legs 120 may be configured to extend radially outwardly toward the exterior of the expandable frame 110 in a radially expanded configuration and / or when the implant 100 is unconstrained. In at least some embodiments, the plurality of anchoring legs 120 may be self-biased toward the deployed configuration.

[0066] In some embodiments, each of the plurality of anchoring legs 120 may include a first segment 122 extending from the expandable frame 110. In some embodiments, each of the plurality of anchoring legs 120 may include only the first segment 122 extending from the expandable frame 110, as Figure 6 shown. It should be noted that, for illustrative purposes only, some instances of the first segment 122 shown in the figures may be incomplete and / or may not be directly attached to the expandable frame 110 because some portions of the implant 100 and / or the expandable frame 110 are not shown or are not shown in their entirety for clarity.

[0067] In some embodiments, each of the plurality of anchoring legs 120 may further include a second segment 124 extending away from the expandable frame 110 from the first segment 122, as Figure 7 shown. In some embodiments, the first segment 122 and the second segment 124 may be joined together along an intermediate portion of the plurality of anchoring legs 120.

[0068] In some embodiments, the implant 100 and / or the plurality of anchoring legs 120 may include a plurality of paddles 130 configured to engage the vein wall. In some embodiments, the plurality of paddles 130 may have a generally flat configuration. In some embodiments, the plurality of paddles 130 may have a circular shape. In some embodiments, the plurality of paddles 130 may preferably have an elongated shape. In some embodiments, the plurality of paddles 130 may have an elongated oval shape. Other configurations including combinations thereof may also be contemplated.

[0069] In some embodiments, the plurality of paddles 130 may be disposed opposite the first end 112 of the expandable frame 110, and / or at an end of the first segment 122 opposite the first end 112 of the expandable frame 110, such as Figure 6 shown. In some embodiments, the plurality of paddles 130 may be disposed at and / or along an intermediate portion of the plurality of anchoring legs 120. In some embodiments, at least one of the plurality of paddles 130 may be disposed at and / or along an intermediate portion of the plurality of anchoring legs 120, such asFigure 7 As shown. In some embodiments, each of the plurality of blades 130 may be disposed at and / or along an intermediate portion of the plurality of anchoring legs 120. In some embodiments, at least one of the plurality of blades 130 may be disposed at and / or along an intermediate portion of the plurality of anchoring legs 120. In some embodiments, each of the plurality of blades 130 may be disposed at and / or along an intermediate portion of the plurality of anchoring legs 120. In some embodiments, at least one of the plurality of blades 130 may be disposed at an end of the second segment 124 that is oppositely disposed to the first end 112 of the expandable frame 110 and / or oppositely disposed to the first segment 122. Other configurations including combinations thereof may also be contemplated.

[0070] In some alternative embodiments, the first segment 122 and the second segment 124 may be joined together at a joint. In some embodiments, the first segment 122 and the second segment 124 may be joined together at one of the plurality of blades 130. In some embodiments, one of the plurality of blades 130 may form a joint that joins the first segment 122 to the second segment 124. Other configurations including combinations thereof may also be contemplated.

[0071] In some embodiments, at least one of the plurality of blades 130 may include at least one hole 132 formed therein. In some embodiments, each of the plurality of blades 130 may include at least one hole 132 formed therein. In some embodiments, at least one of the plurality of blades 130 may include at least one radiopaque marker 134. In some embodiments, at least one of the plurality of blades 130 may include at least one radiopaque marker 134 fixedly attached thereto. In some embodiments, at least one of the plurality of blades 130 may include at least one radiopaque marker 134 embedded therein. Other configurations may also be contemplated. In some embodiments, each of the plurality of blades 130 may include at least one radiopaque marker 134. In some embodiments, each of the plurality of blades 130 may include at least one radiopaque marker 134 fixedly attached thereto. In some embodiments, each of the plurality of blades 130 may include at least one radiopaque marker 134 embedded therein. Other configurations including combinations thereof may also be contemplated.

[0072] In some embodiments, when the implant 100 and / or the plurality of anchoring legs 120 are unconstrained (e.g., when the expandable frame 110 is in a radially expanded configuration and the plurality of anchoring legs are in a deployed configuration), the radially extending extent 131 defined by the plurality of paddles 130 is at least 10% greater than the radially extending extent 111 of the expandable frame 110. In some embodiments, when the implant 100 and / or the plurality of anchoring legs 120 are unconstrained (e.g., when the expandable frame 110 is in a radially expanded configuration and the plurality of anchoring legs are in a deployed configuration), the radially extending extent 131 defined by the plurality of paddles 130 is at least 20% greater than the radially extending extent 111 of the expandable frame 110. In some embodiments, when the implant 100 and / or the plurality of anchoring legs 120 are unconstrained (e.g., when the expandable frame 110 is in a radially expanded configuration and the plurality of anchoring legs are in a deployed configuration), the radially extending extent 131 defined by the plurality of paddles 130 is at least 30% greater than the radially extending extent 111 of the expandable frame 110. Other configurations may also be contemplated.

[0073] In at least some embodiments, the size and configuration of the expandable frame 110 may prevent the vein at the treatment location from being externally compressed while avoiding radial stretching (and / or Poisson effect) of the vein at the treatment location. In some embodiments, the size of the radially extending extent 111 of the expandable frame 110 may be within 10% of the inner diameter of the vein lumen. In some embodiments, the size of the radially extending extent 111 of the expandable frame 110 may be within 5% of the inner diameter of the vein lumen. In some embodiments, the size of the radially extending extent 111 of the expandable frame 110 may be approximately equal to the inner diameter of the vein lumen. Other configurations may also be contemplated.

[0074] In some embodiments, the implant 100 may include a plurality of anchoring barbs 140 that extend radially outward from the plurality of anchoring legs 120. In some embodiments, in the deployed configuration, the plurality of anchoring barbs 140 may extend radially outward from the plurality of anchoring legs 120. In some embodiments, the plurality of anchoring barbs 140 may be configured to engage the vein wall. In some embodiments, the plurality of anchoring barbs 140 may be configured to penetrate the vein wall. Other configurations, including combinations thereof, may also be contemplated.

[0075] In some embodiments, at least one of the plurality of anchoring barbs 140 may be disposed at an end of the first segment 122 that is opposite to the first end 112 of the expandable frame 110. In some embodiments, each of the plurality of anchoring barbs 140 may be disposed at an end of the first segment 122 that is opposite to the first end 112 of the expandable frame 110. In some embodiments, at least one of the plurality of anchoring barbs 140 may be disposed at an end of the second segment 124 that is opposite to the first segment 122 and / or the first end 112 of the expandable frame 110. In some embodiments, at least one of the plurality of anchoring barbs 140 may be disposed at a joint located at and / or along an intermediate portion of the plurality of anchoring legs 120. In some embodiments, at least one of the plurality of anchoring barbs 140 may be fixed to and / or fixedly attached to the plurality of paddles 130. In some embodiments, each of the plurality of anchoring barbs 140 may be fixed to and / or fixedly attached to the plurality of paddles 130. Other configurations including combinations thereof are also conceivable.

[0076] In some embodiments, the plurality of anchoring legs 120 may be integrally formed with the expandable frame 110 as a single unitary structure and / or formed from a single unitary piece of material. In some alternative embodiments, the plurality of anchoring legs 120 may be separately formed from the expandable frame 110 and fixedly attached thereto. Figure 8 An alternative example of the implant 100 is shown, in which the plurality of anchoring legs 120 have been separately formed from the expandable frame 110 having a plurality of closed cells 116 and subsequently fixedly attached to the first end 112 of the expandable frame 110. In some embodiments, the thickness, width, and / or cross-sectional area of the plurality of anchoring legs 120 may be different from the thickness, width, and / or cross-sectional area of the respective struts or segments of the expandable frame 110. In some embodiments, the thickness, width, and / or cross-sectional area of the plurality of anchoring legs 120 may be less than the thickness, width, and / or cross-sectional area of the respective struts or segments of the expandable frame 110. In some embodiments, the thickness, width, and / or cross-sectional area of the plurality of anchoring legs 120 may be greater than the thickness, width, and / or cross-sectional area of the respective struts or segments of the expandable frame 110. Figure 9 Another alternative example of the implant 100 is shown, in which the positions of the plurality of anchoring barbs 140 are different and / or spaced apart from the plurality of paddles 130. Other configurations including combinations thereof are also contemplated.

[0077] In some embodiments, the plurality of paddles 130 may be integrally formed with the plurality of anchoring legs 120 as a single unitary structure and / or formed from a single unitary piece of material. In some embodiments, the plurality of paddles 130 may be separately formed from the plurality of anchoring legs 120 and fixedly attached thereto. Other configurations including combinations thereof are also conceivable.

[0078] In some embodiments, the plurality of anchoring barbs 140 may be integrally formed with the plurality of anchoring legs 120 and / or the plurality of vanes 130 as a single unitary structure and / or formed from a single unitary piece of material. In some embodiments, the plurality of anchoring barbs 140 may be separately formed and fixedly attached to the plurality of anchoring legs 120 and / or the plurality of vanes 130. Other configurations including combinations thereof may also be contemplated.

[0079] In some embodiments, the implant 100 may be bioabsorbable and / or may include bioabsorbable materials. In some embodiments, the implant 100 may include an adhesive material and / or a bioadhesive material. In some embodiments, the adhesive material and / or the bioadhesive material is designed to adhere to biological tissue. For example, the implant 100 may be configured to adhere to in-situ tissue. Other configurations may also be contemplated.

[0080] Figure 10 Selected aspects of a system 200 and method for preventing collapse of a vein (e.g., the left common iliac vein 32) are shown. The system 200 may include a delivery catheter 210 having a lumen extending therethrough. The system 200 may include an implant 100, where the implant 100 may be disposed within a distal portion of the lumen of the delivery catheter 210 in a radially collapsed configuration.

[0081] The method may include positioning a distal end of the delivery catheter 210 adjacent a treatment location (e.g., a non-thrombotic iliac vein lesion) within a vein (e.g., the left common iliac vein 32). The method may include deploying the implant 100 at the treatment location, as Figure 10 shown. In at least some embodiments, after deploying the implant 100 at the treatment location, the plurality of anchoring legs 120 extend upstream from the expandable frame 110 within the vein (e.g., the left common iliac vein 32).

[0082] In some embodiments, prior to positioning the distal end of the delivery catheter 210 adjacent the treatment location, the delivery catheter 210 may be advanced into the vein at a location upstream of the treatment location. For example, in some procedures, the entry location (e.g., a location upstream of the treatment location) may be the popliteal vein, the posterior tibial vein, or another suitable upstream entry location, depending on the location of the treatment site. In some alternative embodiments, prior to positioning the distal end of the delivery catheter 210 adjacent the treatment location, the delivery catheter 210 may be advanced into the vein at a location downstream of the treatment site. For example, in some procedures, the entry location (e.g., a location downstream of the treatment site) may be the jugular vein. In at least some embodiments, the treatment location may be a non-thrombotic iliac vein lesion.

[0083] In some embodiments, the system may include at least one filament 220 that may be coupled to multiple anchoring legs 120 of the implant 100 and may extend within the lumen of the delivery catheter 210. In at least some embodiments, at least one filament 220 may be coupled to multiple anchoring legs 120 of the implant 100 and may extend within the lumen of the delivery catheter 210 (e.g., Figures 11 - 12 ). In some embodiments, at least one filament 220 may be releasably coupled to multiple paddles 130 of the implant 100, as Figure 11 shown. In some embodiments, at least one filament 220 may engage and / or pass through at least one hole 132 formed in multiple paddles 130 of the implant 100.

[0084] In some embodiments, after deploying the implant 100 at the treatment location, at least one filament 220 may be separated and / or disconnected from the implant 100, multiple anchoring legs 120, and / or multiple paddles 130, as Figure 10 shown. After separating at least one filament 220 from the implant 100, multiple anchoring legs 120, and / or multiple paddles 130, the delivery catheter 210 and at least one filament 220 may be removed from the treatment location, vein, and / or patient.

[0085] In some embodiments, the method may include recapturing the implant 100 within the lumen of the delivery catheter 210 and repositioning the implant 100 at the treatment location and / or repositioning it adjacent to the treatment location. In some embodiments, at least one filament 220 may be configured to, at the treatment location, transform multiple anchoring legs 120 from a deployed configuration into and / or to a delivery configuration to facilitate recapturing the implant 100. For example, when recapturing the implant 100, at least one filament 220 may be configured to guide and / or pull multiple anchoring legs 120, the expandable frame 110, and / or the implant 100 into the lumen of the delivery catheter 210.

[0086] In some embodiments, the method may include recapturing the implant 100 within the lumen of the delivery catheter 210 and removing the implant 100 from the treatment location and / or the patient. For example, if deployment fails and / or the selected size of the implant 100 is incorrect, it may be necessary to remove the implant 100 from the treatment location and / or the patient and replace it with a new implant. In at least some embodiments, the method may include, after removing the implant 100 from the treatment location and / or the patient, repeating the positioning and deployment steps of the method to replace the implant 100 at the treatment location.

[0087] In some embodiments, at least one filament 220 and the delivery catheter 210 may be configured to cooperate with each other to change the angle of the plurality of anchoring barbs 140 relative to the central longitudinal axis 102 of the implant 100 and / or the expandable frame 110, as Figure 12 shown. In some embodiments, the delivery catheter 210 may be advanced distally along at least one filament 220 relative to the implant 100 and / or the plurality of paddles 130 such that the plurality of anchoring legs 120 and / or the plurality of paddles 130 are radially inwardly pulled towards the central longitudinal axis 102. In doing so, the free ends of the plurality of anchoring barbs 140 may be angled outwardly relative to the central longitudinal axis 102. In one example, where the plurality of anchoring barbs 140 are coupled to the distal ends of the plurality of paddles 130, at least one filament 220 and the delivery catheter 210 may cooperate to radially inwardly pull the proximal ends of the plurality of paddles 130 relative to the distal ends of the plurality of paddles 130 such that the plurality of paddles 130 are tilted and / or angled relative to the central longitudinal axis 102, thereby angling the free ends of the plurality of anchoring barbs 140 further outwardly relative to the central longitudinal axis 102.

[0088] In some embodiments, the system may include an elongate inner member disposed within the lumen of the delivery catheter 210. In some embodiments, the elongate inner member may be a tubular member having a lumen extending therethrough and / or within which. In some embodiments, the lumen of the elongate inner member may be a guidewire lumen. In some embodiments, the lumen of the elongate inner member may be used for flushing and / or aspiration. Other configurations may also be contemplated. In some alternative embodiments, the elongate inner member may be a solid shaft.

[0089] In some embodiments, the elongate inner member may be axially translatable relative to the delivery catheter 210. In some embodiments, the delivery catheter 210 may be translatable in the proximal direction relative to the elongate inner member. For example, the elongate inner member may be held in a fixed position while the delivery catheter 210 is withdrawn proximally. In some embodiments, the delivery catheter 210 and the elongate inner member may be configured to be advanced together and / or simultaneously to the treatment position. In at least some embodiments, during advancement to the treatment position, the delivery catheter 210 and the elongate inner member may be disposed and / or held in an axially fixed relationship relative to each other. Other configurations may also be contemplated.

[0090] In some embodiments, in a radially collapsed configuration, the implant 100 and / or the expandable frame 110 may be disposed within the lumen of the delivery catheter 210. In some embodiments, when the implant 100 is disposed within the lumen of the delivery catheter 210, the delivery catheter 210 may constrain the implant 100 and / or the expandable frame 110 in a radially collapsed configuration. In some embodiments, the implant 100 may be radially disposed between the delivery catheter 210 and the elongate inner member. In some embodiments, the implant 100 may be attached to the elongate inner member, crimped onto the elongate inner member, and / or otherwise held by the elongate inner member. Other configurations may also be contemplated.

[0091] Figure 13 An alternative configuration of the implant 100 is shown. In addition to those described herein, Figure 13 the implant 100 may be similar and / or identical to Figure 6 the implant 100.

[0092] In some embodiments, the implant 100 may include an expandable frame 110 that defines a tapered and / or generally conical outer surface and / or shape. In some embodiments, the expandable frame 110 may taper radially outwardly from a first end 112 to a second end 114. In some embodiments, the first end 112 may have a first radial extent, while the second end 114 may have a second radial extent, where the second radial extent is greater than the first radial extent. In some embodiments, the lumen that longitudinally extends through the expandable frame 110 from the first end 112 to the second end 114 may taper radially outwardly from the first end 112 to the second end 114.

[0093] In some embodiments, the expandable frame 110 may taper continuously from the first end 112 to the second end 114. In some embodiments, the expandable frame 110 may taper intermittently along the length of the expandable frame 110. For example, the expandable frame 110 may taper in steps or segments, where the intermediate steps or segments have a generally constant radial extent. Other configurations may also be contemplated.

[0094] Similar to other embodiments described herein, the radial extent of the plurality of paddles 130 may be greater than the first radial extent of the first end 112. The second radial extent and / or the relative dimensions of the second end 114 may depend on the length of the expandable frame 110 compared to the radial extent of the plurality of paddles 130. In some embodiments where the expandable frame 110 has a longer or extended length, the second radial extent may be approximately equal to the radial extent of the plurality of paddles 130, or the second radial extent may be greater than the radial extent of the plurality of paddles 130. In some embodiments, the second radial extent may be less than the radial extent of the plurality of paddles 130, similar to Figures 6 - 9and the endoprostheses shown in FIGS. 11-12.

[0095] Figure 13 The endoprosthesis 100 can be used for venous applications where the vein changes diameter and / or size along its length and / or at or along the treatment location. A second radial extension range and / or a second radial extension range can be selected and can be sufficient to accommodate the diameter change of the vein over a given length. Other applications and / or uses can also be considered.

[0096] The materials for the various components and their respective elements of the systems disclosed herein can include materials commonly associated with medical devices. For simplicity, the following discussion relates to the system. However, this is not intended to limit the systems, devices, and / or methods described herein, as the discussion can apply to other elements, components, assemblies, or devices disclosed herein, such as but not limited to endoprostheses, expandable frames, multiple anchoring legs, multiple paddles, multiple anchoring barbs, delivery catheters, at least one filament, polymer coatings, etc. and / or their elements or components.

[0097] In some embodiments, the system and / or its components can be made of metal, metal alloy, polymer (some examples are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc. or other suitable materials.

[0098] Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g. ), polyether block ester, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g. ), ether or ester-based copolymers (e.g. butene / poly(alkylene ether) phthalate and / or other polyester elastomers, e.g. ), polyamide (e.g. or ), elastic polyamide, block polyamide / ether, polyether block amide (PEBA, e.g. available under the trade name ), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (e.g. ) perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymer (e.g., Elast- or ) biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the system and / or its components may be mixed with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0099] Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nitinol alloys, such as wire elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, e.g., 625, UNS:N06022, e.g., UNS:N10276, e.g., other alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, e.g., 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, e.g., MP35- etc.), nickel-molybdenum alloys (e.g., UNS:N10665, e.g., ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; their combinations; or any other suitable materials.

[0100] In at least some embodiments, part or all of the system and / or its components may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopic screen or another imaging technique (such as ultrasound, etc.) during a medical procedure. This relatively bright image helps the system user to determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials filled with radiopaque fillers, etc. In addition, other radiopaque markers and / or coils may also be incorporated into the system design to achieve the same result.

[0101] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the system and / or its components or parts may be made of materials that do not significantly distort images and produce a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The system or parts thereof may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloy (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloy (e.g., UNS: R30035, such as MP35- etc.), nitinol, and so on.

[0102] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed on or within a structure. The fabric material may be composed of a biocompatible material (e.g., a polymeric material or a biomaterial) suitable for promoting in-growth within tissue. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (e.g., polyethylene, polypropylene, polyester, polyurethane), and / or mixtures or combinations thereof.

[0103] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from a fabric material. Some examples of suitable fabric materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyethylene, polymethyl acetate, polyamide, naphthalene dicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. In addition, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include those made of or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-based alloys. The yarn may also include carbon, glass, or ceramic fibers. Desirably, the yarn is made of a thermoplastic material, which includes, but is not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarn may be a multifilament, monofilament, or spun type. The type and denier of the yarn selected may be chosen in a manner that forms a biocompatible and implantable prosthesis, and more specifically, a vascular structure having the desired properties.

[0104] In some embodiments, the systems and / or other elements disclosed herein can comprise and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents can include antithrombotic agents (e.g., heparin, heparin derivatives, urokinase, and PPack (D-phenylalanyl-prolyl-arginine chloromethyl ketone)); antiproliferative agents (e.g., enoxaparin, angiotensin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (e.g., dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); anti-tumor / antiproliferative / antimitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine); anticoagulants (e.g., D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (e.g., growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translation initiators); vascular cell growth inhibitors (e.g., growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); immunosuppressive agents (e.g., drugs of the "olimus" family, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering drugs; vasodilators; and drugs that interfere with endogenous vasoactive mechanisms.

[0105] It should be understood that the present disclosure is illustrative in many respects. Changes can be made in the details, particularly in the shape, size, and arrangement of steps, without departing from the scope of the present disclosure. To the extent appropriate, this may include using any features of one exemplary embodiment in other embodiments. The scope of the present disclosure is, of course, defined by the language of the appended claims.

Claims

1. An implantable prosthesis for preventing vein collapse, comprising: an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, the expandable frame having a first end and a second end opposite the first end; and a plurality of anchoring legs extending axially away from the first end of the expandable frame, the plurality of anchoring legs configured to transition between a delivery configuration and a deployed configuration; wherein, in the deployed configuration, the plurality of anchoring legs are configured to extend radially outward from the expandable frame in the radially expanded configuration.

2. The implantable prosthesis according to claim 1, wherein the expandable frame is self-biased towards the radially expanded configuration.

3. The implantable prosthesis according to any one of claims 1-2, wherein the plurality of anchoring legs are self-biased towards the deployed configuration.

4. The implantable prosthesis according to any one of claims 1 to 3, further comprising a plurality of anchoring barbs extending radially outward from the plurality of anchoring legs.

5. The implantable prosthesis according to any one of claims 1 to 4, wherein the plurality of anchoring legs include a plurality of paddles configured to engage the vein wall.

6. The implantable prosthesis according to claim 5, wherein each of the plurality of paddles is arranged opposite the first end of the expandable frame.

7. The implantable prosthesis according to any one of claims 5 to 6, wherein each of the plurality of paddles includes at least one hole formed therein.

8. The implantable prosthesis according to any one of claims 5 to 7, wherein each of the plurality of paddles includes at least one radiopaque marker.

9. The implantable prosthesis according to any one of claims 5 to 8, wherein when unconstrained, the radial extent defined by the plurality of paddles is at least 10% greater than the radial extent of the expandable frame.

10. The implantable prosthesis according to claim 9, wherein when unconstrained, the radial extent defined by the plurality of paddles is at least 20% greater than the radial extent of the expandable frame.

11. A system for preventing vein collapse, comprising: a delivery catheter having a lumen extending therethrough; an implantable prosthesis according to any one of claims 1-3 and 5-10, wherein the implantable prosthesis is capable of being disposed within the distal portion of the lumen in a radially collapsed configuration; and at least one filament coupled to the plurality of anchoring legs of the implantable prosthesis and extending within the lumen of the delivery catheter.

12. The system according to claim 11, wherein the plurality of anchoring legs extend proximally from the expandable frame.

13. The system according to any one of claims 11 to 12, wherein the plurality of anchoring legs include a plurality of paddles configured to engage the vein wall, and the at least one filament is releasably coupled to the plurality of paddles.

14. The system according to claim 13, further comprising a plurality of anchoring barbs extending radially outward from the plurality of anchoring legs; wherein The at least one filament and the delivery catheter cooperate to vary the angle of the plurality of anchoring barbs relative to the central longitudinal axis of the expandable frame.

15. A method of preventing vein collapse, comprising: positioning a distal end of a delivery catheter adjacent a treatment location within a vein, the delivery catheter having a lumen extending therethrough; and deploying an implantable prosthesis at the treatment location, the implantable prosthesis comprising: an expandable frame configured to transition between a radially collapsed configuration and a radially expanded configuration, the expandable frame having a first end and a second end opposite the first end; and a plurality of anchoring legs extending axially away from the first end of the expandable frame, the plurality of anchoring legs configured to transition between a delivery configuration and a deployed configuration; wherein, in the deployed configuration, the plurality of anchoring legs are configured to extend radially outward from the expandable frame in the radially expanded configuration; wherein, after deploying the implantable prosthesis at the treatment location, the plurality of anchoring legs extend upstream within the vein from the expandable frame.

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