Balloon expandable endoprosthesis

Abstract
An improved medical device reduces the loss of longitudinal length during expansion of a stent-graft from a compressed state to an expanded state. For example, the stent-graft is placed over a cover that provides resistance to expansion of the balloon during inflation, which reduces longitudinal compressing forces exerted on the stent-graft.
Description
FIELD

The present disclosure generally relates to endoprosthesis for treating vasculature, and more particularly, to balloon expandable endoprosthesis.


BACKGROUND

Endoprosthesis are valuable tools for improving and saving lives. In many instances, an endoprosthesis is inserted into a vasculature in an “undeployed” state and must be expanded into a “deployed” state. To transition the endoprosthesis between these two states, a balloon may be located within the endoprosthesis in its undeployed state and inflated, with the expansion of the balloon pushing the endoprosthesis into its deployed state. However, in many instances the balloon extends beyond the longitudinal length of the endoprosthesis. As a result, those portions of the balloon unconstrained by the endoprosthesis expand rapidly in comparison to those portions of the balloon within the endoprosthesis, causing the balloon to exert a longitudinal force on the endoprosthesis that causes the endoprosthesis to diminish in longitudinal length. Aspects of the present disclosure reduce that effect in order to create an improved endoprosthesis, among other features and benefits discussed below in more detail.


SUMMARY OF THE DISCLOSURE

In one embodiment, a medical device, comprises a stent-graft defining a first free end, a second free end, and an intermediate portion between the first and second free ends, the stent-graft having an undeployed state with an undeployed diameter and an undeployed longitudinal length between the first free end and the second free end and a deployed state with a deployed diameter and a deployed longitudinal length between the first free end and the second free end. The stent-graft includes a stent portion and a graft portion. The medical device further comprises a catheter assembly onto which the stent-graft is assembled in the undeployed state. The catheter assembly includes a balloon and a cover concentrically surrounding the balloon. The intermediate portion of the stent-graft imparts a resistance to expansion of the balloon at the intermediate portion of the stent-graft and the cover also imparts a resistance to expansion of the balloon to reduce a difference in an expansion rate of the balloon at the free ends of the stent-graft relative to an expansion rate of the balloon at the intermediate portion of the stent-graft so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.


In one variation, the deployed length of the stent-graft is at least 85% of the undeployed length of the stent-graft.


In one variation, the cover includes reinforcing portions configured to resist inflation of corresponding shoulder portions of the balloon so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.


In one variation, the stent portion of the stent graft includes a plurality of ring stent elements that are separate components connected by the graft portion of the stent-graft.


In one variation, the graft portion is configured to store longitudinal length of the stent-graft when the stent-graft is in the undeployed state.


In one variation, the graft portion of the stent-graft is formed of ePTFE.


In another embodiment, a medical device comprises a stent-graft defining a first free end, a second free end, and an intermediate portion between the first and second free ends, the stent-graft having an undeployed state with undeployed longitudinal length between the first free end and the second free end and a deployed state with a deployed longitudinal length between the first free end and the second free end. The stent-graft includes a stent portion, and a graft portion. The catheter assembly, onto which the stent-graft is assembled in the undeployed state, includes a balloon and a cover concentrically surrounding the balloon, the intermediate portion of the stent-graft imparting a resistance to expansion of the balloon at the intermediate portion of the stent-graft and the cover also imparting a resistance to expansion of the balloon such that the deployed length of the stent-graft is at least 85% of the undeployed length of the stent-graft.


In one variation, the graft portion of the stent-graft is formed of ePTFE.


In one embodiment, a medical device comprises a stent-graft including: an inner ePTFE graft element, an outer ePTFE graft element, and a multiplicity of ringed stent elements positioned between the inner ePTFE graft element and the outer ePTFE graft element, the stent-graft having an undeployed state with a undeployed diameter and a deployed state with a deployed diameter greater than the undeployed diameter; and a catheter assembly including a balloon concentrically surrounded by a cover, the cover including reinforcing portions configured to resist inflation of corresponding shoulder portions of the balloon so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.


In one variation, the reinforcing portions of the cover maintain an expansion profile of the balloon that diminishes an amount of radial expansion of the shoulder portions of the balloon relative to a middle portion of the balloon as the balloon is inflated.


In one variation, the multiplicity of ringed stent elements are configured to store longitudinal length when the stent-graft is in the undeployed state.


In one variation, the stent-graft has an undeployed length in the undeployed state and a deployed length in the deployed state, wherein the deployed length is between 85% and 99% of the undeployed length.


In one variation, the deployed diameter is about 10 mm, and wherein the stent-graft is sufficiently flexible to withstand a bend radius of less than about 8 mm without kinking when in the deployed state.


In one variation, the deployed diameter is about 10 mm, and wherein the stent-graft has a radial strength of between about 11 psi and about 12 psi when in the deployed state.


In one variation, at least one ringed stent element is spaced apart between about 0.5 mm and about 2.0 mm from an adjacent ringed stent element when the stent-graft is in the deployed state.


In one variation, the at least one ringed stent element is spaced apart between about 0.0 mm and about 0.2 mm from the adjacent ringed stent element when the stent-graft is in the undeployed state.


In one variation, the multiplicity of ringed stent elements comprise interconnected wire frames.


In one variation, an internal angle of one of the interconnected wire frames is about 90 degrees when the stent-graft is in the deployed state.


In one variation, the multiplicity of ringed stent elements comprise a single row of interconnected diamond shaped wire frames.


In one variation, the multiplicity of ringed stent elements comprise stainless steel.


In one variation, an apex of a first ringed stent element is out of phase with an adjacent apex of a second ringed stent element along a longitudinal axis.


In another embodiment, a medical device comprises a stent-graft having an undeployed state with an undeployed diameter and an undeployed length, and a deployed state with a deployed diameter and a deployed length, the stent-graft including: an inner graft element; an outer graft element; and a plurality of ringed stent elements positioned between and attached to the inner graft element and the outer graft element; and a catheter assembly including: a balloon having a cone-shaped end; a cover concentrically surrounding the balloon, the cover having a middle portion and a reinforcing portion concentrically surrounding the cone-shaped end of the balloon, the reinforcing portion of the cover having a higher density than a density of the middle portion of the cover in order to maintain an expansion profile that reduces longitudinal compression of the graft-stent.


In one variation, a spacing of at least some of the plurality of ringed stent elements when the stent-graft is in its undeployed state stores longitudinal length that is recovered by the stent-graft in its deployed state.


In one variation, the deployed length exhibits less than 1% foreshortening compared to the undeployed length.


In one variation, the stent-graft is compacted onto the cover so as to resist movement of the stent-graft relative to the balloon prior to deployment.


In one variation, the reinforcing portion of the cover has a radial strength that is greater than a radial strength of the middle portion.


In one variation, the outer graft element includes an outer surface comprising ePTFE in contact with an inner surface of the cover, and wherein the inner surface of the cover comprises ePTFE.


In one variation, the balloon comprises nylon.


In one variation, a luminal surface of the inner graft element comprises an antithrombogenic coating.


In one variation, the reinforcing portion of the cover restricts expansion of the cone-shaped end of the balloon during inflation of the balloon.


In one variation, the reinforcing portion of the cover includes an axially compressed portion of the cover.


In one variation, the reinforcing portion of the cover includes a pleated portion of the cover.


In one variation, pleatings in the pleated portion of the cover correspond to pleatings in a pleated portion of the balloon.


In another embodiment, a method of making an stent-graft comprises: placing a plurality of ringed stent elements along a longitudinal axis and between an inner graft element and outer graft element; compressing the plurality of ringed stent elements, the inner graft element, and the outer graft element into a compressed configuration; and moving at least two of the plurality of ringed stent elements closer together to store longitudinal length so that when the stent-graft expands into a deployed configuration, the stored longitudinal length is recovered.


In another embodiment, a method of making a deployment system comprises assembling a stent graft to a deployment device, the stent-graft having a first free end, a second free end, an intermediate portion between the first and second free ends, and a first diameter in an undeployed state and the deployment device having a balloon and a cover surrounding the balloon, the stent-graft assembled to the deployment device such that the stent-graft surrounds the cover and the balloon, the intermediate portion of the stent-graft imparting a resistance to expansion of the balloon and the cover also imparting a resistance to expansion of the balloon to reduce a difference in an expansion rate of the balloon at the intermediate portion of the stent-graft relative to an expansion rate of the balloon at the first and second free ends of the stent-graft so as to reduce longitudinal compression of the stent-graft upon expansion of the balloon to transition the stent-graft from the undeployed state to the deployed state.


In one variation, moving the at least two of the plurality of ringed stent elements closer together comprises moving the at least two of the plurality of ringed stent elements from a separation distance of between about 0.5 mm and about 2.0 mm to a separation distance of between about 0.0 mm and about 0.2 mm.


In one variation, the method further includes placing a cover over a balloon, the cover having at least one reinforcing portion overlaying a shoulder of the balloon, the at least one reinforcing portion providing increased resistance to inflation relative to a middle portion of the cover; and placing the stent-graft over the middle portion of the cover, such that the reinforcing portion of the cover reduces longitudinal compressing forces exerted on the stent-graft during inflation of the balloon.


In one variation, the stent-graft exhibits greater than 99% longitudinal efficiency when the stent-graft expands from the compressed configuration into a deployed configuration.


In another embodiment, a method for treating a patient includes: inserting a stent-graft into a vessel of the patient, the stent-graft having a first length and a first diameter, the stent-graft surrounding a middle portion of a cover that concentrically surrounds a balloon, the cover and the balloon each having a length that is greater than the first length of the stent-graft such that at least one shoulder of the balloon and a corresponding portion of the cover are outside of the stent-graft, the corresponding portion of the cover being reinforced to provide greater resistance to inflation of the shoulder of the balloon than a middle portion of the cover provides to a middle portion of the balloon; and applying a pressure to the balloon to expand the stent-graft to a second diameter that is greater than the first diameter and to expand the stent-graft to a second length, the reinforced portion of the cover restricting inflation of the shoulder of the balloon to limit longitudinal compressing forces on the stent-graft.


In one variation, the second length of the stent-graft is at least 85% of the first length of the stent-graft.


In one variation, the reinforcing portion of the cover includes scrunched portions of the cover.


In one variation, the reinforcing portion of the cover includes pleated portions of the cover.


In one variation, pleatings in the pleated portions of the cover correspond to pleatings in pleated portions of the balloon.


In another embodiment, a method for treating a patient includes: inserting a stent-graft into a vessel of the patient, the stent-graft having a first length and a first diameter, the stent-graft surrounding a cover that surrounds a balloon, the stent-graft including a plurality of stent elements that are positioned to store longitudinal length; and applying a pressure to the balloon to expand the stent-graft to a second diameter that is greater than the first diameter and a second length, wherein expanding the stent-graft recovers the stored longitudinal length.


In one variation, the second length of the stent-graft is between 85% and 99% of the first length of the stent-graft.


In one variation, the second length of the stent-graft is at least 85% of the first length of the stent-graft.


In one variation, the second length of the stent-graft is at least 99% of the first length of the stent-graft.


In another embodiment, a method for treating a patient includes: inserting a stent-graft into a vessel of the patient, the stent-graft having a first free end, a second free end, an intermediate portion between the first and second free ends, and a first diameter, the stent-graft surrounding a cover that surrounds a balloon, the stent-graft including a plurality of stent elements; and applying a pressure to the balloon to expand the stent-graft from an undeployed state to a deployed state having a second diameter that is greater than the first diameter, the intermediate portion of the stent-graft resisting expansion of the balloon and the cover also resisting expansion of the balloon to reduce a difference in an expansion rate of the balloon at the intermediate portion of the stent-graft relative to an expansion rate of the balloon at the first and second free ends of the stent-graft so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from the undeployed state to the deployed state.


In one variation, the second length of the stent-graft is between 85% and 99% of the first length of the stent-graft.


In one variation, the stent-graft defines a first length in the undeployed state and a second length in the deployed state that is at least 85% of first length.


In one variation, the stent-graft defines a first length in the undeployed state and a second length in the deployed state that is at least 99% of first length.





BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein:



FIGS. 1A and 1B illustrate side views of an endoprosthesis in accordance with embodiments of the present disclosure;



FIGS. 2A and 2B illustrate a side view and a partial cross section of an endoprosthesis delivery system in accordance with embodiments of the present disclosure;



FIG. 3 illustrates a perspective view of a medical device delivery system in accordance with embodiments of the present disclosure;



FIGS. 4A and 4B illustrate a cross sectional view of an undeployed balloon and cover and a cross sectional view of a deployed balloon, cover, and endoprosthesis, respectively, in accordance with embodiments of the present disclosure; and



FIGS. 5A-5F illustrate side views of an endoprosthesis delivery system in accordance with embodiments of the present disclosure in various stages of deployment.





DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. Stated differently, other methods and apparatuses can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. Finally, although the present disclosure may be described in connection with various principles and beliefs, the present disclosure should not be bound by theory.


The terms “endoprosthetic device,” “endoprosthesis,” “vascular device,” and the like can refer, throughout the specification and in the claims, to any medical device capable of being implanted and/or deployed within a body lumen. In various embodiments, an endoprosthesis can comprise a stent, a stent-graft, a graft, a filter, an occluder, a balloon, a lead, and energy transmission device, a deployable patch, an indwelling catheter, and the like.


In addition, throughout this specification and claims, the delivery systems described herein can, in general, include an endoprosthesis constrained by a “covering member” or “sheath.” The covering member or sheath can, in various embodiments, comprise a sheet of material that is fitted about an endoprosthesis. As used throughout the specification and in the claims, the term “elongate member” can refer to a shaft-like structure such as a catheter, guidewire, introducer sheath, or the like. In various embodiments, an endoprosthesis can be mounted or loaded on a catheter, also referred to herein as an inner shaft, and, in a constrained diameter, fit within an introducer sheath, also referred to herein as an outer shaft.


Further, the term “distal” refers to a relative location that is farther from a location in the body at which the medical device was introduced. Similarly, the term “distally” refers to a direction away from a location in the body at which the medical device was introduced.


The term “proximal” refers to a relative location that is closer to the location in the body at which the medical device was introduced. Similarly, the term “proximally” refers to a direction towards a location in the body at which the medical device was introduced.


With continuing regard to the terms proximal and distal, this disclosure should not be narrowly construed with respect to these terms. Rather, the devices and methods described herein may be altered and/or adjusted relative to the anatomy of a patient.


As used herein, the term “constrain” may mean (i) to limit expansion, occurring either through self-expansion or expansion assisted by a device, of the diameter of an expandable implant, or (ii) to cover or surround, but not otherwise restrain, an expandable implant (e.g., for storage or biocompatibility reasons and/or to provide protection to the expandable implant and/or the vasculature).


As used herein, the term “vessel” refers to any luminal or tubular structure within the body to which these constructs can be utilized. This includes, but is not limited to, vascular blood vessels, vascular defects such as arteriovenous malformations, aneurysm, or others, vessels of the lymphatic system, esophagus, intestinal anatomy, sinuous cavity, urogenital system, or other such systems or anatomical features. Embodiments of the present invention are also suitable for the treatment of a malignant disease (e.g., cancer) within or associated with a vessel.


With initial reference to FIGS. 1A and 1B, an endoprosthesis 100 is illustrated. Endoprosthesis 100 may comprise, for example, an expandable stent-graft. In various embodiments, endoprosthesis 100 comprises a balloon expandable stent-graft. Although endoprosthesis 100 will be herein described as a balloon expandable stent-graft, endoprosthesis 100 may comprise other implantable, expandable medical devices, including a self-expandable stent-graft.


In various embodiments, stent-graft 100 comprises a stent member 102. For example, stent member 102 can comprise one or more ringed stent elements 104. As will be discussed in greater detail, ringed stent elements 104 can be positioned adjacent to one another along a longitudinal axis 192 of stent-graft 100. In various embodiments, ringed stent elements 104 are evenly spaced from each other (i.e., uniformly distributed along the longitudinal axis). In other embodiments, one or more ringed stent elements 104 can be spaced apart from one another at different spacing along longitudinal axis 192 (i.e., non-uniformly distributed along the longitudinal axis). Any arrangement of ringed stent elements 104 is within the scope of the present disclosure.


Ringed stent elements 104 can comprise, for example, interconnected wire frames 106 arranged in a circular pattern. For example, ringed stent elements 104 can comprise a single row of interconnected wire frames 106. One or more points 118 of a wire frame 106 can be in contact with and connected to points 118 of adjacent wire frames 106. In various embodiments, ringed stent elements 104 can comprise a multiplicity of individual wire frames 106 formed independently of one another and connected to each other at one or more points 118. In other embodiments, wire frames 106 are formed together as a single interconnected stent element 104.


In various embodiments, ringed stent elements 104 can vary from each other in stiffness. For example, one or more ringed stent elements 104 having an increased stiffness can be located at a distal and/or proximal end of stent-graft 100. Further, one or more ringed stent elements 104 having reduced stiffness can be located away from a distal and/or proximal end of stent-graft 100. Any combination of ringed stent elements 104, including multiple elements comprising different stiffness from each other, is within the scope of the present disclosure.


Wire frames 106 can comprise a polygon, such as, for example, a parallelogram. In various embodiments, wire frames 106 comprise a diamond shape. In other embodiments, wire frames 106 can comprise a square or rectangular shape. Any shape of wire frames 106, including shapes that are not polygonal (such as ovoid or rounded shapes) or shapes that include undulations or bends, are within the scope of the present disclosure.


In various embodiments, wire frames 106 comprise a metal material. For example, wire frames 106 can comprise a steel, such as stainless steel or other alloy. In other embodiments, wire frames 106 can comprise a shape memory alloy, such as, for example, Nitinol. In yet other embodiments, wire frames 106 comprise a non-metallic material, such as a polymeric material. Further, the material of wire frames 106 can be permanent (i.e., non-bioabsorbable) or bioabsorbable. Any material of wire frames 106 having sufficient strength is within the scope of the present disclosure.


For example, ringed stent elements 104 can, for example, be cut from a single metallic tube. In various embodiments, ringed stent elements 104 are laser cut from a stainless steel tube. However, any manner of forming ringed stent elements 104 and/or wire frames 106 is within the scope of the present disclosure.


Endoprosthesis 100 can further comprise a graft member 114. Graft member 114 may, for example, provide a lumen through which blood may flow from one end to another. Further, as will be discussed in greater detail, graft member 114 can comprise a number of layers or elements secured together to form a single graft member 114.


Graft member 114 can comprise, for example, an inner graft element 108. In various embodiments, stent member 102 is positioned concentrically around inner graft element 108. For example, inner graft element 108 can comprise a layer of polymeric material having a luminal surface 110 that is in contact with blood flow within a vessel. Stent member 102 can surround, be in contact with, and provide support to inner graft element 108.


In various embodiments, inner graft element 108 comprises a polymeric membrane capable of providing a bypass route to avoid vessel damage or abnormalities, such as aneurysms. Inner graft element 108 can comprise, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for a graft member material can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Any graft member that is capable of providing a lumen for fluid flow within the body of a patient is within the scope of the present disclosure.


Inner graft element 108 can comprise, for example, one or more layers of a polymeric material. In various embodiments, inner graft element 108 comprises a polymeric material continuously wrapped over a substrate or mandrel to form a generally tubular member. For example, inner graft element 108 can be constructed with circumferential-, helical-, or axial-orientations of the polymeric material. “Orientations,” as used herein, generally refers to a directional property of a component or material (e.g., the polymetric material) often with reference to the longitudinal axis 192. Orientations may also be used to refer to directional properties of certain features, such as, for example, orientations of the strength of the material.


In the embodiments discussed above, the polymeric material can be wrapped generally perpendicular to the longitudinal axis of the mandrel or substrate, i.e., circumferentially wrapped. In other embodiments, the material can be wrapped at an angle between greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the mandrel or substrate, i.e., helically wrapped. In yet other embodiments, the polymeric material can be wrapped generally parallel to the longitudinal axis of the mandrel or substrate, i.e., axially (or longitudinally) wrapped.


In various embodiments, inner graft element 108 may comprise a coating on luminal surface 110. For example, a therapeutic agent such as antithrombogenic coating may be applied to luminal surface 110. In various embodiments, a heparin coating is applied to luminal surface 110.


Graft member 114 can further comprise, for example, an outer graft element 112. In various embodiments, outer graft element 112 concentrically surrounds at least a portion of stent member 102. For example, outer graft element 112 can concentrically surround stent member 102 and inner graft element 108, essentially sandwiching ringed stent elements 104 of stent member 102 between the two graft elements 108 and 112.


Similarly to inner graft element 108, outer graft element 112 can comprise, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Outer graft element 112 can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Further, outer graft element 112 can comprise one or more layers of polymeric material, and may be a tube or a wrapped element as described in connection with inner graft element 108. In various embodiments, inner graft element 108 and outer graft element 112 comprise the same polymeric material. In other embodiments, inner graft element 108 and outer graft element 112 comprise different polymeric materials.


In such embodiments, inner graft element 108 and outer graft element 112 can orient and maintain the position of each of a multiplicity of ringed stent element 104. For example, each ringed stent element 104 of stent member 102 can be positioned at a desired location along inner graft element 108 and then surrounded by outer graft element 112. In various embodiments, after ringed stent elements 104 are properly positioned along inner graft element 108, inner graft element 108 and outer graft element 112 are bonded together. For example, heat can be applied to bond inner graft element 108 and outer graft element 112 together, thereby maintaining the position of ringed stent elements 104 with respect to graft member 114.


In various embodiments, ringed stent elements 104 are spaced apart at a desired distance from each other. For example, each of ringed stent element 104 can be positioned at between about 0 mm (i.e., one ringed stent element 104 abutting another) and about 4 mm apart from each other. In various embodiments, each of ringed stent element 104 can be between about 1.0 mm and about 2.0 mm apart from each other, and in particular embodiments are between about 1.1 mm and 1.5 mm from each other. Although described with reference to specific embodiments, ringed stent elements 104 of stent member 102 can be spaced any distance apart, including multiple different spacings within the same stent member 102.


Further, in embodiments in which stent member 102 comprises spaced apart ringed stent element 104, stent-graft 100 can comprise one or more intra-ring graft segments 120. For example, intra-ring graft segments 120 can comprise the portion of inner graft element 108 and outer graft element 112 located between adjacent ringed stent element 104. As will be discussed further, the properties of intra-ring graft segments 120, including the length of segments 120, can be manipulated to provide desired properties to stent-graft 100.


In various embodiments, a first ringed stent element 106a comprises a first apex 120a and a second ringed stent element 106b comprises a second apex 120b. First apex 120a and second apex 120b can be adjacent to each other. For example, first ringed stent element 106a and second ringed stent element 106b can be oriented with respect to each other such that first apex 120a and second apex 120b are in a common plane 190 orthogonal to a longitudinal axis 192. Stated another way, first apex 120a and second apex 120b are in phase with each other. In other embodiments, first apex 120a and second apex 120b are not in a common plane orthogonal to longitudinal axis 192 (i.e., apices 120a and 120b are out of phase, or are otherwise not coplanar with each other). Although described with reference to specific embodiments, any orientation of ringed stent elements 104, including multiple different orientations with the same medical device (i.e., stent-graft) is within the scope of the present disclosure.


Stent-graft 100 can be delivered to and deployed within a treatment area of a patient. For example, with initial reference to FIGS. 2A and 2B, stent-graft 100 can be prepared and mounted to a catheter assembly 260 comprising a catheter tube 262 with a continuous lumen 264. A cover 266 can coaxially surround a balloon 268, which is coupled to catheter tube 262 and continuous lumen 264 at or near the distal end of catheter tube 262. Attachment of cover 266 to catheter tube 262 can be accomplished in various ways, including adhering the proximal and distal ends of cover 266 to catheter tube 262 using an adhesive, such as, for example, a cyanoacrylate adhesive. Further, polymeric tape and/or film may be used to secure the proximal and distal ends of cover 266 to catheter tube 262.


Balloon 268 can comprise, for example a generally tubular shaped balloon capable of inflating within the vasculature of a patient upon pressurization. For example, a biocompatible fluid, such as, for example, water or saline, can be introduced into catheter tube 262, pass through continuous lumen 264 and through an inflation port (not shown) in catheter tube 262 located at the interior of balloon 268, and pressurize balloon 268. As pressure to balloon 268 is increased, the diameter of balloon 268 is also increased.


Balloon 268 can comprise, for example, a non-compliant, generally inelastic balloon. In such embodiments, balloon 268 can comprise a material that is configured to allow balloon 268 to expand to a chosen diameter upon sufficient pressurization and remain at or near the chosen diameter under further pressurization until a burst pressure is reached, such as, for example, nylon, polyethylene, polyethylene terephthalate (PET), polycaprolactam, polyesters, polyethers, polyamides, polyurethanes, polyimides, ABS copolymers, polyester/poly-ether block copolymers, ionomer resins, liquid crystal polymers and rigid rod polymers.


In various embodiments, balloon 268 can comprise a compliant, relatively elastic balloon. In such embodiments, balloon 268 can comprise a material that is configured to allow balloon 268 to continuously increase in diameter as pressure to balloon 268 is increased, such as, for example polyurethanes, latex and elastomeric organosilicone polymers, such as, polysiloxanes. When a distension limit is reached, balloon 268 can rupture.


In yet other embodiments, balloon 268 comprises a semi-compliant balloon. In such embodiments, balloon 268 behaves in a combination of compliant and non-compliant attributes. Although described in connection with compliant and non-compliant embodiments, any material or configuration that allows balloon 268 to inflate in a predictable manner within the body of a patient, including in a combination of compliant and non-compliant behavior, is within the scope of the present disclosure.


With reference to FIG. 3, in various embodiments, balloon 268 can comprise a plurality of pleats 370. Pleats 370 can comprise, for example, folds or inflection points in the material of balloon 268 extending generally along at least a portion of longitudinal axis 192. In such embodiments, balloon 268 comprises a generally tubular shape having one or more pleats 370.


In various embodiments, balloon 268 can be coaxially surrounded by cover 266. Cover 266 can comprise an inner surface that can substantially conform to an outer surface of balloon 268, such that both balloon 268 and cover 266 comprise substantially the same shape, including when balloon 268 is deflated. However, in other embodiments, cover 266 can comprise a different shape or configuration from balloon 268.


In various embodiments, cover 266 can comprise a plurality of pleats 372. Similarly to balloon 268, pleats 372 can comprise, for example, folds or inflection points in the material of cover 266 extending generally along at least a portion of the longitudinal axis. In such embodiments, cover 266 comprises a generally tubular shape having two or more pleats 372. In various embodiments, cover 266 comprises the same number of pleats 372 as balloon 268. In various embodiments, along at least a section of or the entire working length of balloon cover 266, the inner surface of balloon cover 266 interfaces with the outer surface of balloon 268 in both the pleated, collapsed configuration and the un-pleated, inflated configuration. In other words, and as shown in FIG. 3, the pleated portions of the cover 266 substantially correspond in their configurations to the corresponding pleated portions of the balloon 268, and the non-pleated portions of the cover 266 substantially correspond in their configurations to the corresponding non-pleated portions of the balloon 268.


Pleats 370 and 372 can be formed in cover 266 and balloon 268 simultaneously. For example, balloon 268 can be coaxially surrounded by cover 266, and pleats 370 and 372 can then be formed in both balloon 268 and cover 266, respectively.


In other embodiments, pleats 372 can be formed in cover 266 after pleats 370 are formed in balloon 268. For example, a pre-pleated balloon 268 can be coaxially surrounded by cover 266. In such embodiments, both cover 266 and pre-pleated balloon 268 can be inflated together to a working pressure, after which cover 266 and balloon 268 are subjected to a mechanical pleat forming process that can form, for example, the same number and configuration of pleats in cover 266 as in pre-pleated balloon 268. While forming pleats 372 in cover 266, both cover 266 and balloon 268 can be deflated and compacted for delivery into the body of a patient. Although described in specific embodiments, any manner of forming pleats in cover 266 is within the scope of the present disclosure.


In yet other embodiments, balloon 268 can comprise a plurality of pleats 370 and cover 266 can comprise no pleats 372. In such embodiments, pleats 370 can be formed in balloon 268, followed by cover 266 being placed coaxially around the outer surface of balloon 268. Although described in connection with specific examples (i.e., balloon 268 and cover 266 both comprising pleats, or only balloon 268 or cover 266 comprising pleats), any configuration in which balloon 268 and/or cover 266 comprises a plurality of pleats is within the scope of the present disclosure.


Cover 266 can comprise, for example, a polymer such as, for example, expanded fluoropolymers, such as, expanded polytetrafluoroethylene (ePTFE), modified (e.g., densified) ePTFE, and expanded copolymers of PTFE. In various embodiments, the polymer can comprise a node and fibril microstructure. In various embodiments, the polymer can be highly fibrillated (i.e., a non-woven web of fused fibrils). Although described in connection with specific polymers, any material or configuration that allows cover 266 to inflate in a predictable manner within the body of a patient is within the scope of the present disclosure.


In various embodiments, cover 266 can comprise multiple layers of a polymeric material. For example, cover 266 can comprise a polymeric material continuously wrapped over a substrate or mandrel to form a generally tubular member. In various embodiments, cover 266 can be constructed with circumferential-, helical-, or axial-orientations of the polymeric material. In such embodiments, the polymeric material can be wrapped generally perpendicular to the longitudinal axis of the mandrel or substrate, i.e., circumferentially wrapped. In other embodiments, the material can be wrapped at an angle between greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the mandrel or substrate, i.e., helically wrapped. In yet other embodiments, the polymeric material can be wrapped generally parallel to the longitudinal axis of the mandrel or substrate, i.e., axially (or longitudinally) wrapped.


With reference to FIG. 2B, cover 266 can, for example, have a length 282 that is greater than a length 280 of balloon 268. In various embodiments, cover 266 is placed around balloon 268 such that a first cover end 270 and a second cover end 272 extend beyond a first balloon end 274 and second balloon end 276. In such embodiments, a segment 284 of the material of cover 266 positioned at first cover end 270 or second cover end 272 can be compressed along longitudinal axis 192 (i.e., axially compressed). For example, with reference to FIGS. 4A and 4B, segment 284 of the material of cover 266 can be axially compressed (e.g., scrunched) at first cover end 270 and a segment 286 can be axially compressed at second cover end 272.


As shown in FIGS. 4A and 4B, segment 284 and/or segment 286 are aligned with a first balloon shoulder 290 and/or a second balloon shoulder 292. In other embodiments, the segments 284 and/or 286 are aligned with different portions of the balloon 268. In FIGS. 4A and 4B, the first balloon shoulder 290 and/or second balloon shoulder 292 are cone-shaped shoulders. Although described with reference to a specific embodiment, any shape of balloon shoulder is within the scope of the present disclosure.


Segment 284 can, for example, be positioned such that it at surrounds at least a portion of first balloon shoulder 290, and segment 284 can be positioned such that it at surrounds at least a portion of second balloon shoulder 292. Providing additional axially compressed (e.g., scrunched) material around balloon shoulders (such as balloon shoulders 290 and 292) can increase the thickness and/or density of cover 266 in the general area of the balloon shoulders. Furthermore, having additional axially compressed material of the cover 266 over the balloon shoulders allows for radial expansion of balloon 268 while limiting axial compression to the balloon during inflation. For example, without having those compressed portions, the shoulders of the balloon will inflate before the body of the balloon and cause axial compression of the balloon and endoprosthesis. But with the axially compressed material, the shoulders of the balloon can expand in a manner that causes less axial compression of the endoprosthesis (e.g., due to the changed angle between the expanded portion of the balloon and the unexpanded or less expanded portion of the balloon) until the pressure within the balloon as a whole is sufficient to more fully expand the cover and the endoprosthesis surrounding the body of the balloon. Further, increased thickness and/or density in the general region of balloon shoulders 290 and 292 can provide additional radial strength to the balloon shoulders to achieve a similar effect.


As previously described above, the balloon 268 can be inflated by providing pressurized fluid into balloon 268. FIGS. 5A-5F illustrate one example of the cover 266 restricting expansion of balloon 268 to one desired inflation profile as the balloon 268 is inflated. The intermediate portion 200 of the stent-graft 100 imparts a resistance to expansion of the balloon 268 at the intermediate portion 20 of the stent-graft 100, as well as at, or proximate to, the free ends 196, 198. The cover 266 also imparts a resistance to expansion of the balloon to reduce a difference in an expansion rate of the balloon 268 at the free ends 196, 198 of the stent-graft 100 relative to an expansion rate of the balloon 268 at the intermediate portion 200 of the stent-graft 100 so as to reduce longitudinal compression of the stent-graft 100 as the balloon 268 expands the stent-graft 100 from its undeployed state (FIG. 5A) to its deployed state (FIG. 5F). In some embodiments, the cover 266 acts to equalize the expansion rate of the balloon 268 at the intermediate portion 200 of the stent with the expansion rate of the balloon at, or proximate to the free ends 196, 198 (e.g., proximate or at the shoulders).


For example, in some embodiments axially compressed segments 284 and/or 286 are configured to provide additional resistance to the expansion of balloon shoulders 290 and 292, causing a middle portion 294 of balloon 268 to inflate more readily than it would without such segments 284 and 286, which limits the expansion of the balloon shoulders to more closely match the expansion of the middle portion 294 of the balloon 268. Axially compressed segments 284 and/or 286 can also substantially impede inflation of balloon shoulder 290 and/or 292. In various embodiments, this has the effect of controlling the extent of balloon inflation in these regions which, in turn, controls the expansion profile of balloon 268 and/or stent-graft 100.


In various embodiments, the expansion of balloon 268 can be controlled by covered segments 284 and/or 286 in a manner that may reduce undesirable expansion characteristics of stent-graft 100. For example, covered segments 284 and/or 286 may reduce the degree of foreshortening of stent-graft 100 during expansion. In particular, segments 284 and/or 286 may be configured to force the balloon to into a specific inflation profile in which axial forces resulting from inflating balloon shoulders are significantly reduced, for example, due to the diminished angle between the shoulder portions of the balloon and the middle portion of the balloon or the stent-graft. Further, covered segments 284 and/or 286 may reduce or prevent stacking (e.g., reduction of spacing between ringed stent elements 106 during expansion) of stent-graft 100.


With reference to FIGS. 2A and 2B, after balloon 268 is surrounded by cover 266, stent-graft 100 can be loaded on to balloon 268 and cover 266. For example, stent-graft 100 can be positioned to concentrically surround a portion of balloon 268 and cover 266. In various embodiments, once stent-graft 100 is properly positioned around balloon 268 and cover 266, stent-graft 100 is radially compressed to an undeployed diameter 242. For example, stent-graft 100 can be compacted to undeployed diameter 242 to reduce the profile of stent-graft 100 during implantation within a treatment area. Further, stent-graft 100 can be compacted onto balloon 268 and cover 266 so as to resist movement of the stent-graft on balloon 268 prior to deployment.


In various embodiments, upon compaction, stent-graft 100 can imbed itself into cover 266. For example, by imbedding itself into cover 266, stent-graft 100 may exhibit improved stent retention. Such improved stent retention may, for example, assist in maintaining proper positioning of stent-graft 100 relative to cover 266 and/or balloon 268 during deployment to the treatment area of a patient.


Another way to limit any reduction in the length of the endoprosthesis (e.g., as measured between one free end 196 and the opposite free end 198) between its compressed and expanded configurations is by altering the position and/or orientation of the ringed stent elements 104 of a stent member 102. In particular, in some embodiments the position and/or orientation of one or more ringed stent elements 104 of stent member 102 can be altered prior to compaction of stent-graft 100. For example, the distance between two or more adjacent ringed stent element 104 may be reduced prior to compaction of stent-graft 100. For more particular examples, one or more ringed stent elements 104 can be moved so that they are each less than about 1 mm apart from each other or even so that they are in contact with one another (i.e., spaced 0 mm apart from each other).


In other embodiments, the position and/or orientation of ringed stent elements 104 may be altered after compaction of the stent-graft 100. For example, and with reference to FIG. 2A, stent-graft 100 has a length that can be changed by reducing the longitudinal spacing of two or more ringed stent element 104. Reducing the longitudinal spacing between adjacent ringed stent element 104 can, for example, create stored longitudinal length that is recovered when the stent element 104 is expanded into its deployed state. For example, stored longitudinal length may be defined as the length or segment of graft material of intra-ring graft segments 120 axially compressed between adjacent ringed stent elements 104 which is retrieved (i.e., axially expanded) upon expansion and deployment of stent-graft 100. The “undeployed length” of the stent-graft 100 generally refers to the stent-graft 100 in the compressed state prior to delivery and the “deployed length” of the stent-graft 100 generally refers to the stent-graft 100 in the expanded state. In some embodiments, changing the spacing of the ringed stent elements 104 creates a new length that may be referred to as the undeployed length (e.g., length 240 in FIG. 2A).


Stated another way, reducing the spacing between adjacent stent elements 104 can axially compress or scrunch intra-ring graft segments 120. By creating stored length by axial compression, the outside diameter of the stent-graft 100 is not increased. By not increasing the diameter of the device while creating stored length, the transverse-cross section of the device remains minimal and thus does not adversely affect delivery of the stent-graft through the vasculature. At the same time, recovery of the stored length increases the ability of the stent-graft to reduce or offset any loss of length, e.g., due to axial compression forces from inflating the balloon.


Upon delivery of stent-graft 100 to the treatment area of a patient, stent-graft 100 can be deployed. In various embodiments, stent-graft 100 is deployed by inflating balloon 268 to a desired diameter, thereby increasing the diameter of stent-graft 100 from an undeployed diameter 242 to a deployed diameter 146. This process further increases the length of the stent-graft from the undeployed length 240 to a deployed length 148. After balloon 268 is sufficiently inflated, so that deployed diameter 146 is achieved, balloon 268 can be deflated, allowing for removal of catheter assembly 260 from the body of the patient.


Deployed length 148 can, for example, be less than undeployed length 240. For example, deployed length 148 can be about 60% to about 95% of undeployed length 240, and further, about 80% to about 90% of undeployed length 240. Testing has shown that certain embodiments have achieved deployed lengths 148 greater than 99% the undeployed length, thus demonstrating a foreshortening length of less than 1%. The ability of a stent-graft to achieve a high percentage of its undeployed length is also referred to herein as longitudinal efficiency.


Expanding stent-graft 100 from the undeployed configuration to the deployed configuration can also, for example, increase an internal angle of one or more wire frames 106 of ringed stent elements 104. For example, when stent-graft 100 is in the deployed configuration, internal angle 188 of wire frames 106 of ringed stent elements 104 can be between about 70 and 110 degrees, and further, between about 80 and 100 degrees.


EXAMPLE 1
Bend Radius

Various stent-grafts in accordance with the present disclosure were tested to evaluate their flexibility in the deployed configuration. Specifically, the stent-grafts were tested to determine the bend radius that the stent-graft can accommodate without kinking and can recover its original size and shape after testing. Kinking occurs at the point at which the stent-graft exhibits a diameter reduction of greater than 50%, or where it cannot recover its original size and shape after testing.


The stent-grafts were tested according to ISO25539-2 (2009), section D.5.3.6, method A with the following exceptions: 1) testing was not performed in a tube of the minimum nominal indicated vessel diameters or at maximum indicated vessel diameter, and 2) overlapped condition testing was not performed. The stent-grafts comprise stainless steel ringed stent elements spaced apart at approximately 0.5 mm to 1.5 mm from each other. The stents were approximately 59 mm long. The inner and outer graft elements comprised ePTFE, and the stent-grafts were mounted on a nylon balloon surrounded by an ePTFE cover having scrunched proximal and distal ends. The results of the bend radius testing are summarized below in Table 1.










TABLE 1








Bend Radius (mm)









Nominal Diameter (mm)
5
10












Mean
4
7


Maximum
4
8


Minimum
4
6


Sample Size
10
10









EXAMPLE 2
Radial Strength

Various stent-grafts in accordance with the present disclosure were tested to evaluate their radial strength in the deployed configuration. Specifically, the stent-grafts were tested to determine the radial compressive pressure at which the stent-grafts would become irrecoverably deformed.


The stent-grafts were tested according to ISO25539-2:2009, section D.5.3.4 with the following exceptions: 1) pressure was reported in pounds per square inch, and 2) testing was conducted until a 50% reduction in the nominal device diameter was achieved.


The stent-grafts comprise stainless steel ringed stent elements spaced apart at approximately 0.5 mm to 1.5 mm from each other. The stents were approximately 59 mm long. The inner and outer graft elements comprised ePTFE, and the stent-grafts were mounted on a nylon balloon surrounded by an ePTFE cover having scrunched proximal and distal ends. The results of the radial strength testing are summarized below in Table 2.










TABLE 2








Radial Strength (psi)









Nominal Diameter (mm)
5
10












Mean
18.3
11.9


Maximum
20.9
12.6


Minimum
14.4
11.2


Sample Size
8
8









While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.


Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size, and arrangement of parts including combinations within the principles of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.

Claims
  • 1. A method of making a stent-graft, the method comprising: placing a plurality of ringed stent elements along a longitudinal axis and between an inner graft element and outer graft element;compressing the plurality of ringed stent elements, the inner graft element, and the outer graft element into a compressed configuration; andmoving at least two of the plurality of ringed stent elements closer together to store longitudinal length so that when the stent-graft expands into a deployed configuration, the stored longitudinal length is recovered.
  • 2. The method of claim 1, wherein moving the at least two of the plurality of ringed stent elements closer together comprises moving the at least two of the plurality of ringed stent elements from a separation distance of between about 0.5 mm and about 2.0 mm to a separation distance of between about 0.0 mm and about 0.2 mm.
  • 3. The method of claim 1, wherein moving the at least two of the plurality of ringed stent elements closer together comprises moving the at least two of the plurality of ringed stent elements to reduce between about 60% and about 100% of a separation distance.
  • 4. The method of claim 1, further comprising: placing a cover over a balloon, the cover having at least one reinforcing portion; andplacing the stent-graft over the cover such that the reinforcing portion of the cover reduces longitudinal compressing forces exerted on the stent-graft during inflation of the balloon.
  • 5. The method of claim 4, wherein the reinforcing portion of the cover has a radial strength that is greater than a radial strength of a middle portion of the cover.
  • 6. The method of claim 4, wherein the reinforcing portion of the cover includes a pleated portion of the cover.
  • 7. The method of claim 1, wherein the stent-graft exhibits greater than 99% longitudinal efficiency when the stent-graft expands from the compressed configuration into a deployed configuration.
  • 8. The method of claim 1, wherein the inner graft element and the outer graft element of the stent-graft are formed of ePTFE.
  • 9. The method of claim 1, wherein placing the plurality of ringed stent elements along a longitudinal axis includes evenly spacing apart the plurality of ringed stent elements from each other along the longitudinal axis.
  • 10. The method of claim 1, wherein placing the plurality of ringed stent elements along a longitudinal axis includes spacing apart one or more of the plurality of ringed stent elements from each other at different distance along the longitudinal axis.
  • 11. The method of claim 1, wherein the plurality of ringed stent elements comprise interconnected wire frames.
  • 12. The method of claim 1, wherein each of the plurality of ringed stent elements comprises a single row of interconnected diamond shaped wire frames.
  • 13. The method of claim 1, wherein an apex of a first ringed stent element is out of phase with an adjacent apex of a second ringed stent element along the longitudinal axis.
  • 14. The method of claim 1, wherein one or more of the plurality of ringed stent elements located away from a distal end or a proximal end of the stent-graft has decreased stiffness with respect to one or more of the plurality of ringed stent elements located proximate to the distal end or the proximal end.
  • 15. A method of making a stent-graft, the method comprising: placing a plurality of ringed stent elements along a longitudinal axis and between an inner graft element and outer graft element;compressing the plurality of ringed stent elements, the inner graft element, and the outer graft element into a compressed configuration;moving at least two of the plurality of ringed stent elements closer together to store longitudinal length so that when the stent-graft expands into a deployed configuration, the stored longitudinal length is recovered; andplacing the plurality of ringed stent elements over a balloon to reduce longitudinal compressing forces exerted on the stent-graft during inflation of the balloon.
  • 16. The method of claim 15, further comprising: placing a cover over the balloon, the cover having at least one reinforcing portion; andcompressing a segment of the cover at least partially over each shoulder portion of the balloon along the longitudinal axis to form a plurality of axially compressed segments over at least a portion of the shoulder portions of the balloon.
  • 17. The method of claim 15, wherein the axially compressed segments entirely surround both of the shoulder portions of the balloon.
  • 18. The method of claim 15, wherein the axially compressed segments are configured to maintain a longitudinal spacing between the ringed stent elements during the inflation of the balloon.
  • 19. The method of claim 15, wherein the cover is formed of ePTFE.
  • 20. A method of making a stent-graft, the method comprising: compressing a plurality of ringed stent elements, an inner graft element, and an outer graft element into a compressed configuration, wherein the plurality of ringed stent elements extend along a longitudinal axis between the inner graft element and the outer graft element;moving at least two of the plurality of ringed stent elements closer together to store longitudinal length so that when the stent-graft expands into a deployed configuration, the stored longitudinal length is recovered; andplacing the stent-graft over a balloon to reduce longitudinal compressing forces exerted on the stent-graft during inflation of the balloon, wherein the stent-graft includes a first free end of the stent-graft that is disposed proximate to a first shoulder portion of the balloon, a second free end of the stent-graft that is disposed proximate to a second shoulder portion of the balloon, and an intermediate portion between the first and second free ends such that the intermediate portion of the stent-graft imparts a resistance to expansion of the balloon at the intermediate portion of the stent-graft and proximate to the first and second free ends of the stent-graft.
  • 21. The method of claim 20, further comprising: placing a cover over the balloon, the cover having a first reinforcing portion configured to impart a resistance to expansion of the balloon at the first shoulder portion and a second reinforcing portion configured to impart the resistance expansion of the balloon at the second shoulder portion; andplacing the stent-graft over the cover such that the reinforcing portion of the cover reduces longitudinal compressing forces exerted on the stent-graft during inflation of the balloon.
  • 22. A method of making a medical device, the method comprising: compressing a plurality of support components, an inner layer component, and an outer layer component into a compressed configuration to form a restricting member, wherein the plurality of support components extend along a longitudinal axis between the inner layer component and the outer layer component;moving at least two of the plurality of support components closer together to store longitudinal length so that when the medical device expands into a deployed configuration, the stored longitudinal length is recovered;placing a cover component over an expandable member, the cover component having a first reinforcing portion configured to impart a resistance to expansion of the expandable member at a first shoulder portion and a second reinforcing portion configured to impart the resistance expansion of the expandable member at a second shoulder portion; andplacing the restricting member over the cover component such that the reinforcing portion of the cover component reduces longitudinal compressing forces exerted on the restricting member during inflation of the expandable member.
CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 15/531,252, filed May 26, 2017, which is a 371 National Phase Applications of PCT/US2015/062799, filed Nov. 25, 2015, which is a continuation of U.S. patent application Ser. No. 14/950,165, filed Nov. 24, 2015, now U.S. Pat. No. 10,299,948, issued May 28, 2019, which claims the benefit of U.S. Provisional Application 62/085,066, filed Nov. 26, 2014, all of which are incorporated herein by reference in their entireties for all purposes.

US Referenced Citations (309)
Number Name Date Kind
4503569 Dotter Mar 1985 A
4655771 Wallsten Apr 1987 A
4739762 Palmaz Apr 1988 A
4776337 Palmaz Oct 1988 A
4884573 Wijay et al. Dec 1989 A
5019090 Pinchuk May 1991 A
5037427 Harada et al. Aug 1991 A
5061275 Wallsten et al. Oct 1991 A
5102417 Palmaz Apr 1992 A
5104404 Wolff Apr 1992 A
5122154 Rhodes Jun 1992 A
5123917 Lee Jun 1992 A
5201757 Heyn et al. Apr 1993 A
5236447 Kubo et al. Aug 1993 A
5282824 Gianturco Feb 1994 A
5300500 Lee et al. Apr 1994 A
5314472 Fontaine May 1994 A
5330500 Song Jul 1994 A
5360443 Barone et al. Nov 1994 A
5405377 Cragg Apr 1995 A
5443495 Buscemi et al. Aug 1995 A
5443496 Schwartz et al. Aug 1995 A
5443499 Schmitt Aug 1995 A
5449373 Pinchasik et al. Sep 1995 A
5507767 Maeda et al. Apr 1996 A
5507771 Gianturco Apr 1996 A
5549663 Cottone, Jr. Aug 1996 A
5575816 Rudnick et al. Nov 1996 A
5591195 Taheri et al. Jan 1997 A
5613979 Trotta et al. Mar 1997 A
5662703 Yurek et al. Sep 1997 A
5665115 Cragg Sep 1997 A
5674241 Bley et al. Oct 1997 A
5683448 Cragg Nov 1997 A
5693086 Goicoechea et al. Dec 1997 A
5708044 Branca Jan 1998 A
5725570 Heath Mar 1998 A
5728150 McDonald et al. Mar 1998 A
5735892 Myers et al. Apr 1998 A
5749852 Schwab et al. May 1998 A
5755774 Pinchuk May 1998 A
5756553 Iguchi et al. May 1998 A
5769884 Solovay Jun 1998 A
5769887 Brown et al. Jun 1998 A
5800456 Maeda et al. Sep 1998 A
5800515 Nadal et al. Sep 1998 A
5800521 Orth Sep 1998 A
5814063 Freitag Sep 1998 A
5824043 Cottone, Jr. Oct 1998 A
5824059 Wijay Oct 1998 A
5843092 Heller Dec 1998 A
5843161 Solovay Dec 1998 A
5873906 Lau et al. Feb 1999 A
5876432 Lau et al. Mar 1999 A
5879369 Ishida Mar 1999 A
5891193 Robinson et al. Apr 1999 A
5899934 Amundson et al. May 1999 A
5906639 Rudnick et al. May 1999 A
5919225 Lau et al. Jul 1999 A
5922020 Klein et al. Jul 1999 A
5968091 Pinchuk et al. Oct 1999 A
5984957 Laptewicz et al. Nov 1999 A
6001125 Golds et al. Dec 1999 A
6004348 Banas et al. Dec 1999 A
6007545 Venturelli Dec 1999 A
6013854 Moriuchi Jan 2000 A
6015432 Rakos et al. Jan 2000 A
6016846 Knittel et al. Jan 2000 A
6022359 Frantzen Feb 2000 A
6022374 Imran Feb 2000 A
6048360 Khosravi et al. Apr 2000 A
6071307 Rhee et al. Jun 2000 A
6077296 Shokoohi et al. Jun 2000 A
6107004 Donadio, III Aug 2000 A
6123712 Di et al. Sep 2000 A
6139573 Sogard et al. Oct 2000 A
6139575 Shu et al. Oct 2000 A
6143022 Shull et al. Nov 2000 A
6146417 Ischinger Nov 2000 A
6159219 Ren Dec 2000 A
6159239 Greenhalgh Dec 2000 A
6165210 Lau et al. Dec 2000 A
6171334 Cox Jan 2001 B1
6174328 Cragg Jan 2001 B1
6217609 Haverkost Apr 2001 B1
6231597 Deem et al. May 2001 B1
6264687 Tomonto Jul 2001 B1
6283990 Kanesaka Sep 2001 B1
6283992 Hankh et al. Sep 2001 B1
6287333 Appling et al. Sep 2001 B1
6290722 Wang Sep 2001 B1
6312458 Golds Nov 2001 B1
6315791 Gingras et al. Nov 2001 B1
6315792 Armstrong et al. Nov 2001 B1
6331188 Lau et al. Dec 2001 B1
6331190 Shokoohi et al. Dec 2001 B1
6334868 Ham Jan 2002 B1
6336937 Vonesh et al. Jan 2002 B1
6340366 Wijay Jan 2002 B2
6344054 Parodi Feb 2002 B1
6350277 Kocur Feb 2002 B1
6355055 Waksman et al. Mar 2002 B1
6357104 Myers Mar 2002 B1
6361637 Martin et al. Mar 2002 B2
6364903 Tseng et al. Apr 2002 B2
6387122 Cragg May 2002 B1
6398803 Layne et al. Jun 2002 B1
6409754 Smith et al. Jun 2002 B1
6419685 Di et al. Jul 2002 B2
6432133 Lau et al. Aug 2002 B1
6436132 Patel et al. Aug 2002 B1
6451050 Rudakov et al. Sep 2002 B1
6461380 Cox Oct 2002 B1
6488701 Nolting et al. Dec 2002 B1
6488705 Schmitt et al. Dec 2002 B2
6497722 Von et al. Dec 2002 B1
6500203 Thompson et al. Dec 2002 B1
6503556 Harish et al. Jan 2003 B2
6506202 Dutta et al. Jan 2003 B1
6511496 Huter et al. Jan 2003 B1
6520986 Martin et al. Feb 2003 B2
6527739 Bigus et al. Mar 2003 B1
6537311 Cox et al. Mar 2003 B1
6540773 Dong Apr 2003 B2
6540776 Sanders et al. Apr 2003 B2
6541589 Baillie Apr 2003 B1
6551350 Thornton et al. Apr 2003 B1
6551352 Clerc et al. Apr 2003 B2
6554848 Boylan et al. Apr 2003 B2
6558414 Layne May 2003 B2
6558415 Thompson May 2003 B2
6565599 Hong et al. May 2003 B1
6585755 Jackson et al. Jul 2003 B2
6589275 Ivancev et al. Jul 2003 B1
6589276 Pinchasik et al. Jul 2003 B2
6602284 Cox et al. Aug 2003 B2
6605056 Eidenschink et al. Aug 2003 B2
6607551 Sullivan et al. Aug 2003 B1
6616689 Ainsworth et al. Sep 2003 B1
6620128 Simhambhatla Sep 2003 B1
6620193 Lau et al. Sep 2003 B1
6626939 Burnside et al. Sep 2003 B1
6629992 Bigus et al. Oct 2003 B2
6645239 Park et al. Nov 2003 B1
6652574 Jayaraman Nov 2003 B1
6652579 Cox et al. Nov 2003 B1
6669719 Wallace et al. Dec 2003 B2
6673103 Golds et al. Jan 2004 B1
6689162 Thompson Feb 2004 B1
6709454 Cox et al. Mar 2004 B1
6712357 Tranquilla Mar 2004 B1
6713357 Wang et al. Mar 2004 B1
6730117 Tseng et al. May 2004 B1
6740114 Burgermeister May 2004 B2
6749584 Briggs Jun 2004 B2
6770087 Layne et al. Aug 2004 B2
6770089 Hong et al. Aug 2004 B1
6776771 Van et al. Aug 2004 B2
6805705 Hong et al. Oct 2004 B2
6849086 Cragg Feb 2005 B2
6866805 Hong et al. Mar 2005 B2
6872433 Seward et al. Mar 2005 B2
6881216 Di et al. Apr 2005 B2
6881221 Golds Apr 2005 B2
6887266 Williams et al. May 2005 B2
6893457 Dong May 2005 B2
6923827 Campbell et al. Aug 2005 B2
6945991 Brodeur et al. Sep 2005 B1
6960186 Fukaya et al. Nov 2005 B1
7105018 Yip et al. Sep 2006 B1
7105021 Edens et al. Sep 2006 B2
7108716 Burnside et al. Sep 2006 B2
7112293 Dubson et al. Sep 2006 B2
7115220 Dubson et al. Oct 2006 B2
7118592 Dang et al. Oct 2006 B1
7141062 Pinchasik et al. Nov 2006 B1
7144422 Rao Dec 2006 B1
7163533 Hobbs et al. Jan 2007 B2
7163553 Limon Jan 2007 B2
7186263 Golds et al. Mar 2007 B2
7273495 Limon Sep 2007 B2
7288111 Holloway et al. Oct 2007 B1
7314480 Eidenschink et al. Jan 2008 B2
7323008 Kantor et al. Jan 2008 B2
7329276 Smith et al. Feb 2008 B2
7384411 Condado Jun 2008 B1
7455687 Saunders et al. Nov 2008 B2
7510571 Spiridigliozzi et al. Mar 2009 B2
7540879 Lualdi Jun 2009 B2
7578831 Von et al. Aug 2009 B2
7686841 Eidenschink et al. Mar 2010 B2
7691461 Prabhu Apr 2010 B1
7704274 Boyle et al. Apr 2010 B2
7727271 Kujawski et al. Jun 2010 B2
7967836 Warnack et al. Jun 2011 B2
8066667 Hayman et al. Nov 2011 B2
8221484 Wesselmann Jul 2012 B2
8257432 Kaplan et al. Sep 2012 B2
8444686 Holman et al. May 2013 B2
8585640 Alpini et al. Nov 2013 B2
8597566 Eskaros et al. Dec 2013 B2
8672990 Holman et al. Mar 2014 B2
8858863 Venturelli Oct 2014 B2
8926688 Burkart et al. Jan 2015 B2
8979886 Campbell et al. Mar 2015 B2
9149612 Chuter Oct 2015 B2
9370643 Hedberg et al. Jun 2016 B2
9370647 Campbell et al. Jun 2016 B2
9622888 Armstrong et al. Apr 2017 B2
9669194 Campbell et al. Jun 2017 B2
9682219 Venturelli Jun 2017 B2
9770352 Kanjickal et al. Sep 2017 B2
9901715 Cully et al. Feb 2018 B2
9943428 Burkart et al. Apr 2018 B2
10299948 Bohn et al. May 2019 B2
10456281 Armstrong et al. Oct 2019 B2
10543116 Bohn Jan 2020 B2
20010020181 Layne Sep 2001 A1
20010025130 Tomonto Sep 2001 A1
20020007102 Salmon et al. Jan 2002 A1
20020049408 Van et al. Apr 2002 A1
20020077690 Wang Jun 2002 A1
20020111668 Smith Aug 2002 A1
20020151964 Smith et al. Oct 2002 A1
20020165601 Clerc Nov 2002 A1
20030060756 Hayman et al. Mar 2003 A1
20030208260 Lau et al. Nov 2003 A1
20030236563 Fifer Dec 2003 A1
20040019373 Casey et al. Jan 2004 A1
20040024442 Sowinski et al. Feb 2004 A1
20040024448 Chang et al. Feb 2004 A1
20040030377 Dubson et al. Feb 2004 A1
20040033364 Spiridigliozzi et al. Feb 2004 A1
20040096532 Dubson et al. May 2004 A1
20040096533 Dubson et al. May 2004 A1
20040106980 Solovay et al. Jun 2004 A1
20040143272 Cully et al. Jul 2004 A1
20040167635 Yachia et al. Aug 2004 A1
20040172127 Kantor Sep 2004 A1
20040236402 Layne et al. Nov 2004 A1
20050004647 Bassoe Jan 2005 A1
20050010281 Yodfat et al. Jan 2005 A1
20050125071 Nahleili Jun 2005 A1
20050137675 Dubson et al. Jun 2005 A1
20050154449 Elmaleh Jul 2005 A1
20050182474 Jones et al. Aug 2005 A1
20050186243 Hunter et al. Aug 2005 A1
20050209672 George et al. Sep 2005 A1
20050228480 Douglas et al. Oct 2005 A1
20060009835 Osborne et al. Jan 2006 A1
20060036308 Goshgarian Feb 2006 A1
20060036311 Nakayama et al. Feb 2006 A1
20060085065 Krause et al. Apr 2006 A1
20060122691 Richter Jun 2006 A1
20060184237 Weber et al. Aug 2006 A1
20060190072 Das Aug 2006 A1
20060259133 Sowinski et al. Nov 2006 A1
20060266474 Burnside et al. Nov 2006 A1
20060271091 Campbell et al. Nov 2006 A1
20060271157 Edens et al. Nov 2006 A1
20060271165 Yip et al. Nov 2006 A1
20060287709 Rao Dec 2006 A1
20060293743 Andersen et al. Dec 2006 A1
20070055365 Greenberg et al. Mar 2007 A1
20070073383 Yip et al. Mar 2007 A1
20070129791 Balaji Jun 2007 A1
20070208412 Elmaleh Sep 2007 A1
20070250146 Cully et al. Oct 2007 A1
20080161901 Heuser et al. Jul 2008 A1
20080319388 Slattery et al. Dec 2008 A1
20090054967 Das Feb 2009 A1
20090069878 Weber et al. Mar 2009 A1
20090138070 Holzer et al. May 2009 A1
20090182413 Burkart et al. Jul 2009 A1
20090283206 Eskaros et al. Nov 2009 A1
20100069839 Holman et al. Mar 2010 A1
20100222870 Kaplan et al. Sep 2010 A1
20100228333 Drasler et al. Sep 2010 A1
20110087191 Scheuermann Apr 2011 A1
20120071912 Campbell et al. Mar 2012 A1
20120109283 Burkart et al. May 2012 A1
20120253380 Venturelli Oct 2012 A1
20120330232 Hedberg et al. Dec 2012 A1
20130018406 Campbell et al. Jan 2013 A1
20130184807 Kovach et al. Jul 2013 A1
20130253466 Campbell et al. Sep 2013 A1
20140066896 Tilson et al. Mar 2014 A1
20140066897 Campbell et al. Mar 2014 A1
20140066898 Cully et al. Mar 2014 A1
20140135891 Poehlmann et al. May 2014 A1
20140142684 Zukowski May 2014 A1
20140172066 Goepfrich et al. Jun 2014 A1
20140276406 Campbell et al. Sep 2014 A1
20140277346 Kanjickal et al. Sep 2014 A1
20140277374 Kovach Sep 2014 A1
20140378896 Venturelli Dec 2014 A1
20150133988 Chuter May 2015 A1
20160143759 Bohn et al. May 2016 A1
20160243340 Campbell et al. Aug 2016 A1
20170172776 Kanjickal et al. Jun 2017 A1
20170340464 Kovach et al. Nov 2017 A1
20170340465 Kanjickal et al. Nov 2017 A1
20180049898 Armstrong et al. Feb 2018 A1
20180193177 Burkart et al. Jul 2018 A1
20180296377 Bohn et al. Oct 2018 A1
20190298556 Bohn Oct 2019 A1
20190388252 Armstrong et al. Dec 2019 A1
20200253763 Kovach et al. Aug 2020 A1
20210236314 Bohn et al. Aug 2021 A1
Foreign Referenced Citations (56)
Number Date Country
101636130 Jan 2010 CN
101822868 Sep 2010 CN
102940543 Feb 2013 CN
103561686 Feb 2014 CN
103702709 Apr 2014 CN
103930157 Jul 2014 CN
103930158 Jul 2014 CN
0745395 Dec 1996 EP
0951877 Oct 1999 EP
1110561 Jun 2001 EP
1550477 Jul 2005 EP
1927327 Jun 2008 EP
09-099087 Apr 1997 JP
11-299901 Nov 1999 JP
2002-501404 Jan 2002 JP
2005-535414 Nov 2005 JP
2010-500107 Jan 2010 JP
2014-520632 Aug 2014 JP
2014-530045 Nov 2014 JP
2015-534883 Dec 2015 JP
9517223 Jun 1995 WO
9526695 Oct 1995 WO
9621404 Jul 1996 WO
9831305 Jul 1998 WO
9917680 Apr 1999 WO
9934855 Jul 1999 WO
0042949 Jul 2000 WO
0043051 Jul 2000 WO
0045741 Aug 2000 WO
0049971 Aug 2000 WO
0121101 Mar 2001 WO
0222024 Mar 2002 WO
0313337 Feb 2003 WO
0307795 Apr 2003 WO
0357075 Jul 2003 WO
0357077 Jul 2003 WO
2004016199 Feb 2004 WO
2004093941 Nov 2004 WO
2005096997 Oct 2005 WO
2006029617 Mar 2006 WO
2006081568 Aug 2006 WO
2006124824 Nov 2006 WO
2008019022 Feb 2008 WO
2009009635 Jan 2009 WO
2009066330 May 2009 WO
2010037141 Apr 2010 WO
2013009740 Jan 2013 WO
2013040522 Mar 2013 WO
2013096854 Aug 2013 WO
2013162685 Oct 2013 WO
2014078558 May 2014 WO
2014152684 Sep 2014 WO
2014158516 Oct 2014 WO
2015073114 May 2015 WO
2016086202 Jun 2016 WO
2018039444 Mar 2018 WO
Non-Patent Literature Citations (14)
Entry
European Search Report and Search Opinion Received for EP Application No. 19167993.5, dated Jul. 31, 2019, 7 pages.
European Search Report issued in EP Application No. 00311543.3, completed Oct. 31, 2002, 6 pages.
International Preliminary Reporton Patentability issued in PCT/US2015/062799, dated Jun. 8, 2017, 10 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US09/00144, dated Jul. 22, 2010, 10 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US16/39565, dated Dec. 6, 2018, 15 pages.
International Search Report and Written Opinion from PCT/US2009/000144, dated May 6, 2009, 14 pages.
International Search Report and Written Opinion issued in PCT/US2009/000144, dated Jun. 5, 2009, 14 pages.
International Search Report and Written Opinion issued in PCT/US2015/062799, dated Jul. 27, 2016, 17 pages.
International Search Report and Written Opinion issued in PCT/US2016/039565, dated Oct. 10, 2016, 20 pages.
International Search Report issued in PCT/US0001715, dated Oct. 27, 2000, 7 pages.
Nakayama Y, Nishi S, Ueda H, et al. Fabrication of micropored elastomeric film covered stents and acute-phase performances. Development of Covered Stents 2002; 52-61.
Nishi S, Nakayama Y, Ueda H, et al. Newly developed stent graft with micropored and heparin impregnated SPU film Long-term follow-up study in vivo. 2001 (Suppl 1) 161-166.
Wilson EP, White RA, Kopchok GE, et al. Deployment and Healing of an ePTFE Encapsulated Stent Endograft in the Canine Aorta. Annals of Vascular Surgery 1997; v11, n4:354-358.
Wilson, Eric et al., “Deployment and Healing of an ePTFE Encapsulated Stent Endograft in the Canine Aorta,” Annals of Vascular Surgery, (1997), vol. 11, No. 4, pp. 354-358.
Related Publications (1)
Number Date Country
20190298556 A1 Oct 2019 US
Provisional Applications (1)
Number Date Country
62085066 Nov 2014 US
Continuations (2)
Number Date Country
Parent 15531252 US
Child 16444725 US
Parent 14950165 Nov 2015 US
Child 15531252 US