Embedded radiopaque marker in adaptive seal

Information

  • Patent Grant
  • 11439732
  • Patent Number
    11,439,732
  • Date Filed
    Tuesday, February 26, 2019
    5 years ago
  • Date Issued
    Tuesday, September 13, 2022
    a year ago
Abstract
A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.
Description
TECHNICAL FIELD

The present disclosure pertains to medical devices and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to configurations of a replacement heart valve implant.


BACKGROUND

A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, occlusive devices, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices.


SUMMARY

In a first aspect, a seal member for use with a replacement heart valve implant may comprise a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.


In addition or alternatively, and in a second aspect, the radiopaque element is at least partially embedded in the reinforcement strip.


In addition or alternatively, and in a third aspect, radiopaque element includes a polyurethane spray coating doped with radiopaque nanoparticles.


In addition or alternatively, and in a fourth aspect, the polyurethane spray coating is disposed on the reinforcement strip.


In addition or alternatively, and in a fifth aspect, the polyurethane spray coating is intermingled with the reinforcement strip.


In addition or alternatively, and in a sixth aspect, the radiopaque nanoparticles include one or more of the following: tungsten, platinum, tantalum, cobalt, chromium, nickel, titanium, gold, and palladium.


In addition or alternatively, and in a seventh aspect, the reinforcement strip is formed from an electrospun polyester matrix doped with radiopaque nanoparticles.


In addition or alternatively, and in an eighth aspect, the reinforcement strip is formed from a chopped radiopaque fiber-polyurethane matrix.


In addition or alternatively, and in a ninth aspect, a replacement heart valve implant may comprise a tubular metallic support structure defining a central longitudinal axis; a plurality of valve leaflets disposed within the tubular metallic support structure; and a seal member comprising a tubular polymeric seal element disposed on an outer surface of the tubular metallic support structure and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular metallic support structure. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.


In addition or alternatively, and in a tenth aspect, the reinforcement strip is fixedly attached to the inflow end of the tubular metallic support structure.


In addition or alternatively, and in an eleventh aspect, the tubular metallic support structure is configured to shift between a collapsed delivery configuration and an expanded deployed configuration.


In addition or alternatively, and in a twelfth aspect, an overall length of the tubular metallic support structure in the expanded deployed configuration is less than in the collapsed delivery configuration.


In addition or alternatively, and in a thirteenth aspect, the seal member is configured to engage and seal against an annulus of a native heart valve in the expanded deployed configuration.


In addition or alternatively, and in a fourteenth aspect, the reinforcement strip includes a scalloped downstream edge.


In addition or alternatively, and in a fifteenth aspect, the radiopaque element extends completely around the central longitudinal axis.


In addition or alternatively, and in a sixteenth aspect, a method of locating a replacement heart valve implant during an implantation procedure may comprise advancing the replacement heart valve implant through a vasculature toward a native heart valve in a delivery configuration, the replacement heart valve implant comprising an expandable tubular support structure defining a central longitudinal axis, a plurality of valve leaflets disposed within the tubular support structure, and a seal member comprising: a tubular polymeric seal element disposed on an outer surface of the tubular support structure and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular support structure. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis in a first plane. The method may further comprise imaging the replacement heart valve implant within the vasculature and the native heart valve concurrently as the replacement heart valve implant approaches the native heart valve, wherein the imaging identifies a reference plane extending through an annulus of the native heart valve generally perpendicular to a direction of fluid flow through the native heart valve; and expanding the tubular support structure within the native heart valve with the first plane positioned substantially parallel to the reference plane and offset less than 4 mm from the reference plane.


In addition or alternatively, and in a seventeenth aspect, the first plane is offset less than 2 mm from the reference plane.


In addition or alternatively, and in an eighteenth aspect, the first plane is positioned substantially coplanar with the reference plane.


In addition or alternatively, and in a nineteenth aspect, the radiopaque element includes radiopaque nanoparticles embedded in the reinforcement strip.


In addition or alternatively, and in a twentieth aspect, the reinforcement strip is fixedly attached to tubular support structure at the inflow end.


The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description which follows more particularly exemplify these embodiments.





BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:



FIG. 1 illustrates an example medical device system;



FIG. 2 illustrates an example replacement heart valve implant;



FIG. 3 a schematic view of a portion of a heart and certain connected vasculature; and



FIG. 4-6 illustrate aspects of deploying a replacement heart valve implant.





While aspects of the disclosure are amenable to various modifications and alternative forms, specifics 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 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 disclosure.


DETAILED DESCRIPTION

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. 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 disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.


For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.


All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of 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 are rounded to the nearest significant figure. Other uses of the term “about” (e.g., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.


The recitation of numerical ranges 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). Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.


As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For simplicity and clarity purposes, not all elements of the disclosed invention are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one, unless explicitly stated to the contrary. Additionally, not all instances of some elements or features may be shown in each figure for clarity.


Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as “upstream”, “downstream”, “inflow”, and “outflow” refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Still other relative terms, such as “axial”, “circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.


The term “extent” may be understood to mean a greatest measurement of a stated or identified dimension, unless specifically referred to as a minimum extent. For example, “outer extent” may be understood to mean a maximum outer dimension, “radial extent” may be understood to mean a maximum radial dimension, “longitudinal extent” may be understood to mean a maximum longitudinal dimension, etc. Each instance of an “extent” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an “extent” may be considered a greatest possible dimension measured according to the intended usage. However, where referred to as a “minimum extent”, the “extent” shall refer to a smallest possible dimension measured according to the intended usage. In some instances, an “extent” may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently—such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.


It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect the particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.


For the purpose of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and/or claims to name and/or differentiate between various described and/or claimed features. It is to be understood that the numerical nomenclature is not intended to be limiting and is exemplary only. In some embodiments, alterations of and deviations from previously-used numerical nomenclature may be made in the interest of brevity and clarity. 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 entirely, and/or a different feature may be referred to as the “first” element. The meaning and/or designation in each instance will be apparent to the skilled practitioner.


Diseases and/or medical conditions that impact the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the system. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed, for example, where a blocked coronary artery could be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.


Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve or the mitral valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with properly. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve, replacement mitral valve, etc.). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide other desirable features and/or benefits as described herein.


The figures illustrate selected components and/or arrangements of a medical device system 10, shown schematically in FIG. 1 for example. It should be noted that in any given figure, some features of the medical device system 10 may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the medical device system 10 may be illustrated in other figures in greater detail. A medical device system 10 may be used to deliver and/or deploy a variety of medical devices and/or implants to one or more locations within the anatomy. In at least some embodiments, the medical device system 10 may include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a replacement heart valve implant 16 (e.g. a replacement mitral valve, a replacement aortic valve, etc.) to an area of interest in the anatomy, such as a native heart valve. This, however, is not intended to be limiting as the medical device system 10 may also be used for other interventions including valve repair, valvuloplasty, and the like, or other similar interventions.



FIG. 1 illustrates the medical device system 10 including the replacement heart valve implant 16 configured to be disposed within the area of interest, such as a native heart valve (e.g., a mitral valve, an aortic valve, etc.), wherein the replacement heart valve implant 16 may be disposed within a lumen of the medical device system 10 in a delivery configuration for delivery to the area of interest. Upon delivery to the area of interest, the replacement heart valve implant 16 may be shifted to a deployed configuration. In some embodiments, the medical device system 10 may include an outer sheath 12 having a lumen extending from a proximal portion and/or proximal end of the outer sheath 12 to a distal end of the outer sheath 12. The replacement heart valve implant 16 may be disposed within the lumen of the outer sheath 12 proximate the distal end of the outer sheath 12 in the delivery configuration. In some embodiments, the medical device system 10 may include a handle 18 disposed proximate and/or at the proximal end of the outer sheath 12.


The medical device system 10 may include an inner sheath or catheter 14 disposed within the lumen of the outer sheath 12 and/or slidable with respect to the outer sheath 12 within the lumen of the outer sheath 12. In some embodiments, the handle 18 may be disposed proximate and/or at a proximal end of the inner sheath or catheter 14. In some embodiments, the inner sheath or catheter 14 may be a tubular structure having one or more lumens extending therethrough, the inner sheath or catheter 14 may be a solid shaft, or the inner sheath or catheter 14 may be a combination thereof. In some embodiments, the medical device system 10 may include an actuator element releasably connecting the replacement heart valve implant 16 to the handle 18. For example, the actuator element may extend from the handle 18 to the replacement heart valve implant 16, the replacement heart valve implant 16 being disposed at a distal end of the lumen of the outer sheath 12. The actuator element may extend distally from the inner sheath or catheter 14 to the replacement heart valve implant 16. In some embodiments, the actuator element may be slidably disposed within and/or may extend slidably through the inner sheath or catheter 14.


The handle 18 and/or the actuator element may be configured to manipulate the position of the outer sheath 12 relative to the inner sheath or catheter 14 and/or aid in the deployment of the replacement heart valve implant 16. For example, the inner sheath or catheter 14 and/or the actuator element may be used to move the replacement heart valve implant 16 with respect to the outer sheath 12 of the medical device system 10. In some embodiments, the inner sheath or catheter 14 and/or the actuator element may be advanced distally within the lumen of the outer sheath 12 to push the replacement heart valve implant 16 out the distal end of the outer sheath 12 and/or the medical device system 10 to deploy the replacement heart valve implant 16 within the area of interest (e.g., the native heart valve, etc.). Alternatively, the inner sheath or catheter 14 and/or the actuator element may be held in a fixed position relative to the replacement heart valve implant 16 and the outer sheath 12 may be withdrawn proximally relative to the inner sheath or catheter 14, the actuator element, and/or the replacement heart valve implant 16 to deploy the replacement heart valve implant 16 within the area of interest (e.g., the native heart valve, etc.).


In some embodiments, the medical device system 10 may include a nose cone disposed at a distal end of a guidewire extension tube, wherein the guidewire extension tube may extend distally from the inner sheath or catheter 14 and/or the outer sheath 12.


In at least some embodiments, the nose cone may be designed to have an atraumatic shape and/or may include a ridge or ledge that is configured to abut a distal end of the outer sheath 12 during delivery of the replacement heart valve implant 16. Some examples of suitable but non-limiting materials for the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the handle 18, the actuator element, the nose cone, etc. and/or components or elements thereof, are described below.


In use, the medical device system 10 may be advanced percutaneously through the vasculature to the area of interest. For example, the medical device system 10 may be advanced through the vasculature and across the aortic arch to a defective native heart valve (e.g., aortic valve, mitral valve, etc.). Alternative approaches to treat a defective native heart valve are also contemplated with the medical device system 10. During delivery, the replacement heart valve implant 16 may be generally disposed in an elongated and low profile “delivery” configuration within the lumen of the outer sheath 12. Once positioned at the area of interest, the outer sheath 12 may be retracted relative to the replacement heart valve implant 16 to expose the replacement heart valve implant 16. In at least some embodiments, the replacement heart valve implant 16 may be disposed in an “everted” configuration or a partially-everted configuration while disposed within the lumen of the outer sheath 12 and/or immediately upon exposure after retracting the outer sheath 12. In some embodiments, the replacement heart valve implant 16 may be everted in the “delivery” configuration. The “everted” configuration may involve at least a portion of the valve leaflets (discussed below) of the replacement heart valve implant 16 being disposed outside of the expandable anchor member (discussed below) of the replacement heart valve implant 16 during delivery, thereby permitting a smaller radial profile of the replacement heart valve implant 16 and the use of a smaller overall profile of the outer sheath 12 and/or the medical device system 10. In some embodiments, the “delivery” configuration and the “everted” configuration may be substantially similar and/or may be used interchangeably herein.


The replacement heart valve implant 16 may be actuated using the handle 18 and/or the actuator element in order to translate the replacement heart valve implant 16 into a radially expanded and larger profile “deployed” configuration suitable for implantation within the anatomy at the area of interest or the target location. When the replacement heart valve implant 16 is suitably deployed within the anatomy, the outer sheath 12 and/or the medical device system 10 can be removed from the vasculature, leaving the replacement heart valve implant 16 in place in a “released” configuration to function as, for example, a suitable replacement for the native heart valve. In at least some interventions, the replacement heart valve implant 16 may be deployed within the native heart valve (e.g., the native heart valve is left in place and not excised). Alternatively, the native heart valve may be removed and the replacement heart valve implant 16 may be deployed in its place as a replacement.


Disposed within a first lumen of the inner sheath or catheter 14 may be the actuator element, which may be used to actuate and/or translate (e.g., expand and/or elongate) the replacement heart valve implant 16 between the “delivery” configuration and the “deployed” configuration. In some embodiments, the actuator element may include or comprise a plurality of actuator elements, two actuator elements, three actuator elements, four actuator elements, or another suitable or desired number of actuator elements. In some embodiments, each actuator element may be disposed within a separate lumen of the inner sheath or catheter 14.


It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For example, a reference to “the actuator element” may be equally referred to all instances and quantities beyond one of “the at least one actuator element” or “the plurality of actuator elements”.



FIG. 2 illustrates some selected components of the medical device system 10 and/or the replacement heart valve implant 16, shown in the “deployed” configuration. The replacement heart valve implant 16 may include an expandable anchor member 17 that is reversibly actuatable between an elongated and/or radially-collapsed “delivery” configuration and an axially-shortened and/or radially-expanded “deployed” configuration. In some embodiments, the expandable anchor member 17 may be tubular and defines a lumen extending coaxially along a central longitudinal axis from a distal or inflow end of the expandable anchor member 17 and/or the replacement heart valve implant 16 to a proximal or outflow end of the expandable anchor member 17 and/or the replacement heart valve implant 16.


In some embodiments, the expandable anchor member 17 may comprise an expandable support structure and/or stent framework, which terms may be used interchangeably with “anchor member” herein. In some embodiments, the support structure and/or the expandable anchor member 17 may comprise a plurality of interconnected struts. In some embodiments, the support structure and/or the expandable anchor member 17 may comprise a self-expanding braided and/or woven mesh structure made up of one or more filaments disposed and/or interwoven circumferentially about the lumen of the support structure and/or the expandable anchor member 17 and/or the replacement heart valve implant 16. Non-self-expanding, mechanically-expandable, and/or assisted self-expanding expandable anchor members are also contemplated. In at least some embodiments, the support structure and/or the expandable anchor member 17 may be formed as a unitary structure (e.g., formed from a single filament or strand of wire, cut from a single tubular member, etc.). In some embodiments, the support structure and/or the expandable anchor member 17 may define a generally cylindrical outer surface in the deployed configuration. An overall length of the support structure and/or the expandable anchor member 17 in the axially-shortened and/or radially-expanded “deployed” configuration may be less than in the elongated and/or radially-collapsed “delivery” configuration. Other configurations are also possible—a cross-section defining a generally elliptical outer surface, for example. Some examples of suitable but non-limiting materials for the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17, and/or components or elements thereof, are described below.


Also shown in FIG. 2, but omitted from several other figures in the interest of clarity, the replacement heart valve implant 16 may include a plurality of valve leaflets 22 disposed within the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the plurality of valve leaflets 22 may be attached and/or secured to the support structure and/or the expandable anchor member 17 at a plurality of locations within the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the plurality of valve leaflets 22 may be attached and/or secured to the support structure and/or the expandable anchor member 17 using sutures, adhesives, or other suitable means.


In some embodiments, the plurality of valve leaflets 22 may include or comprise two leaflets, three leaflets, four leaflets, etc. as desired. For example, the plurality of valve leaflets 22 may comprise a first valve leaflet, a second valve leaflet, a third valve leaflet, etc., and may be referred to collectively as the plurality of valve leaflets 22. The plurality of valve leaflets 22 of the replacement heart valve implant 16 may be configured to move between an open configuration permitting antegrade fluid flow through the replacement heart valve implant 16 and/or the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17, and a closed configuration preventing retrograde fluid flow through the replacement heart valve implant 16 and/or the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. The plurality of valve leaflets 22 may each have a free edge, wherein the free edges of the plurality of valve leaflets 22 coapt within the replacement heart valve implant 16, the support structure and/or the expandable anchor member 17, and/or the lumen extending through the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 in the closed configuration. Some examples of suitable but non-limiting materials for the plurality of valve leaflets 22 (e.g., the first valve leaflet, the second valve leaflet, the third valve leaflet, etc.) may include bovine pericardial, polymeric materials, or other suitably flexible biocompatible materials.


The replacement heart valve implant 16 may include a replacement heart valve commissure assembly disposed within the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the replacement heart valve implant 16 may include more than one replacement heart valve commissure assembly. For example, each adjacent pair of valve leaflets 22 may form and/or define one replacement heart valve commissure assembly. Therefore, the number of replacement heart valve commissure assemblies may be directly related to the number of valve leaflets 22 (e.g., three valve leaflets form and/or define three replacement heart valve commissure assemblies, two valve leaflets form and/or define two replacement heart valve commissure assemblies, etc.).


In some embodiments, the replacement heart valve implant 16 and/or the replacement heart valve commissure assembly may include a locking mechanism 48 configured to lock the support structure and/or the expandable anchor member 17 in the “deployed” configuration. In some embodiments, the replacement heart valve implant 16 may include or comprise a plurality of locking mechanisms 48, two locking mechanisms 48, three locking mechanisms 48, etc. In some embodiments, each replacement heart valve commissure assembly may correspond to and/or include one corresponding locking mechanism 48. Each locking mechanism 48 may include a first locking portion or a post member 60 secured to the support structure and/or the expandable anchor member 17 and configured to engage with a second locking portion or a buckle member 50 secured to the support structure and/or the expandable anchor member 17.


In some embodiments, the actuator element may be configured to releasably engage the locking mechanism 48 and/or reversibly actuate the support structure and/or the expandable anchor member 17 and/or the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 between the “delivery” configuration and the “deployed” configuration and/or the “released” configuration while the actuator element is engaged with the locking mechanism 48. In some embodiments, one actuator element may correspond to, engage with, and/or actuate one locking mechanism 48. In some embodiments, one actuator element may correspond to, engage with, and/or actuate more than one locking mechanism 48. Other configurations are also contemplated.


In some embodiments, the actuator element may include a proximal end and a distal end. In use, the proximal end may be operatively connected to the handle 18, and/or manipulated or otherwise actuated by a user using the handle 18, to reversibly shift the replacement heart valve implant 16 between the “delivery” configuration and the “deployed” configuration. In some embodiments, the actuator element may be axially translatable relative to the first locking portion or post member 60 and/or the second locking portion or buckle member 50 of the replacement heart valve implant 16. In some embodiments, the actuator element may be releasably coupled to the first locking portion or post member 60. The handle 18 may be configured to actuate and/or translate the actuator element (e.g., each actuator element, etc.) relative to the outer sheath 12, the replacement heart valve implant 16, the corresponding locking mechanism(s) 48 (e.g., the plurality of locking mechanisms 48, etc.), and/or the first locking portion or post member 60 in the “delivery” and/or “deployed” configuration. In some embodiments, the actuator element may be generally round, oblong, ovoid, rectangular, polygonal (i.e., two-sided, three-sided, four-sided, five-sided, six-sided, etc.) and/or combinations thereof in shape. Other shapes, both regular and irregular, are also contemplated. In some embodiments, the actuator element may be formed from a single piece of wire, round stock, or other suitable material. In some embodiments, the actuator element may be formed by further processing the single piece of wire, round stock, or other suitable material, such as by machining, stamping, laser cutting, etc. Some suitable but non-limiting materials for the actuator element, for example metallic materials or polymeric materials, are described below.


In some embodiments, the replacement heart valve implant 16 may include a seal member 30 comprising a tubular polymeric seal element configured to be circumferentially disposed on and/or around at least a portion of an outer surface of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. The tubular polymeric seal element may define a central longitudinal axis of the seal member 30, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the seal member 30 and/or the tubular polymeric seal element may be fixedly attached and/or secured to the distal or inflow end of the replacement heart valve implant 16, the support structure and/or the expandable anchor member 17, and/or the seal member 30 and/or the tubular polymeric seal element may be fixedly attached and/or secured to the plurality of valve leaflets 22 proximate the distal or inflow end of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. The seal member 30 and/or the tubular polymeric seal element may be sufficiently flexible and/or pliable to engage, conform to, and/or seal against native valve leaflets and/or a native heart valve annulus in the axially-shortened and/or radially-expanded “deployed” configuration, thereby sealing an exterior of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 within and/or against the native heart valve annulus and/or the native valve leaflets and preventing leakage around the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17.


In some embodiments, the seal member 30 and/or the tubular polymeric seal element may include a plurality of layers of polymeric material. Some suitable polymeric materials may include, but are not necessarily limited to, polycarbonate, polyurethane, polyamide, polyether block amide, polyethylene, polyethylene terephthalate, polypropylene, polyvinylchloride, polytetrafluoroethylene, polysulfone, and copolymers, blends, mixtures or combinations thereof. Other suitable polymeric materials are also contemplated, some of which are discussed below.


In some embodiments, the seal member 30 and/or the tubular polymeric seal element may include a reinforcement strip 32 fixedly attached to the seal member 30 and/or the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, for example, at and/or adjacent the distal end and/or the inflow end of the support structure and/or the expandable anchor member 17, the seal member 30, and/or the tubular polymeric seal element. In at least some embodiments, the reinforcement strip 32 may extend circumferentially around the central longitudinal axis of the seal member 30, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the reinforcement strip 32 may include a scalloped downstream edge 36 to reduce bunching and/or bulk when in the delivery configuration.


In some embodiments, the reinforcement strip 32 may be integrally formed with, incorporated into, adhered to, and/or at least partially embedded within the seal member 30 and/or the tubular polymeric seal element. In some embodiments, the reinforcement strip 32 may be formed from a woven or nonwoven fabric strip, a textile, or other thin flexible material. The reinforcement strip 32 may include a radiopaque element 34 extending circumferentially around the central longitudinal axis of the seal member 30, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In some embodiments, the radiopaque element 34 may be at least partially embedded in the reinforcement strip 32. In some embodiments, the radiopaque element 34 may extend completely around the central longitudinal axis of the seal member 30, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17. In at least some embodiments, the radiopaque element 34 may be disposed at and/or adjacent the distal end and/or the inflow end of the support structure and/or the expandable anchor member 17, the seal member 30, and/or the tubular polymeric seal element. In some embodiments, the radiopaque element 34 may be disposed at a distalmost portion of the support structure and/or the expandable anchor member 17, the seal member 30, the tubular polymeric seal element, and/or the reinforcement strip 32.


In some embodiments, the radiopaque element 34 may include a polyurethane spray coating doped with radiopaque nanoparticles. In some embodiments, the polyurethane spray coating may be disposed on the reinforcement strip 32. In some embodiments, the polyurethane spray coating may be intermingled with the reinforcement strip 32 (e.g., as a matrix having and/or supporting a fiber reinforcement therein, etc.). In some embodiments, the radiopaque nanoparticles may include one or more of the following: tungsten, platinum, tantalum, cobalt, chromium, nickel, titanium, gold, and palladium. Other suitable radiopaque, biocompatible materials are also contemplated. In some embodiments, the reinforcement strip 32 and/or the radiopaque element 34 may be formed from an electrospun polyester matrix doped with radiopaque nanoparticles. In some embodiments, the reinforcement strip 32 and/or the radiopaque element 34 may be formed from a chopped radiopaque fiber-polyester matrix.


The reinforcement strip 32 may provide tear resistance in the vicinity of sutures, filaments, or other attachment elements associated with components or aspects of the replacement heart valve implant 16. In some embodiments, the seal member 30 and/or the reinforcement strip 32 may extend longitudinally beyond the distal end and/or the inflow end of the support structure and/or the expandable anchor member 17.


In some embodiments, a distal end of each one of the plurality of valve leaflets 22 may be secured directly to the reinforcement strip 32 and/or a distal end of the reinforcement strip 32. In some embodiments, the plurality of valve leaflets 22 may not be secured directly to the distal end of the support structure and/or the expandable anchor member 17. In some embodiments, the reinforcement strip 32 may include a plurality of perforations extending through the reinforcement strip 32 and/or the seal member 30. In some embodiments, the plurality of perforations may accommodate sutures passing therethrough (e.g., through the reinforcement strip 32 and/or the seal member 30) to secure elements or aspects of the replacement heart valve implant 16, such as (but not limited to) the plurality of valve leaflets 22, the support structure, and/or the expandable anchor member 17, for example.


In some embodiments, one or more whip sutures 40 may attach a distal end of the seal member 30 to a distal end of the plurality of valve leaflets 22 adjacent and/or at the distal or inflow end of the support structure and/or the expandable anchor member 17. In some embodiments, the one or more whip sutures 40 may attach the reinforcement strip 32 and/or a distal end of the reinforcement strip 32 to the distal end of the plurality of valve leaflets 22 adjacent and/or at a distal or inflow end of the support structure and/or the expandable anchor member 17. In some embodiments, the one or more whip sutures 40 may form one or more first helical spirals oriented in a first direction. In some embodiments, the one or more whip sutures 40 may include and/or form a plurality of windings.


In some embodiments, a plurality of proximal lashing sutures 46 may attach a proximal portion of the seal member 30 to a central portion and/or a distal portion of the support structure and/or the expandable anchor member 17. In some embodiments, at least one grommet 38 may be disposed along an outer surface of the seal member 30 and/or at least partially embedded within the seal member 30 at each of the plurality of proximal lashing sutures 46 to aid in attaching the seal member 30 to the support structure and/or the expandable anchor member 17. In some embodiments, the plurality of proximal lashing sutures 46 may extend through the at least one grommet 38. In some embodiments, the plurality of proximal lashing sutures 46 may attach the proximal portion of the seal member 30 to the central portion and/or the distal portion of the support structure and/or the expandable anchor member 17 proximal of the distal or inflow end of the support structure and/or the expandable anchor member 17.


During delivery, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 may be secured at the distal end of the inner sheath or catheter 14 by a plurality of fingers of a coupler coupled to a projecting portion at a proximal end of the second locking portion or buckle member 50 and/or a plurality of release pins securing together the actuator element and the first locking portion or post member 60. The plurality of release pins may releasably secure the actuator element to the first locking portion or post member 60, thereby limiting relative axial movement between the actuator element and the first locking portion or post member 60 and forms a configuration of these structures that can be utilized during delivery of the replacement heart valve implant 16.


After the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 is advanced within the anatomy and/or vasculature to the area of interest, the actuator element can be used to actuate the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 to the “deployed” configuration by proximally retracting the actuator element relative to the second locking portion or buckle member 50, the support structure, and/or the expandable anchor member 17, thereby pulling the first locking portion or post member 60 into engagement with the second locking portion or buckle member 50. Finally, the plurality of release pins can be removed using the handle 18, thereby uncoupling the actuator element from the first locking portion or post member 60, which allows the replacement heart valve implant 16 to be released from the medical device system 10 in the “released” configuration.


In some embodiments, the first locking portion or post member 60 and the second locking portion or buckle member 50 may be longitudinally movable relative to each other along an inner surface of the support structure and/or the expandable anchor member 17 in the “delivery” configuration and/or the “deployed” configuration. In some embodiments, the first locking portion or post member 60 may be non-releasably secured to a distal portion and/or proximate the distal or upstream end of the support structure and/or the expandable anchor member 17 along the inner surface of the support structure and/or the expandable anchor member 17. In some embodiments, the second locking portion or buckle member 50 may be fixedly secured to a proximal portion and/or proximate the proximal or downstream end of the support structure and/or the expandable anchor member 17 against the inner surface of the expandable anchor member 17. The second locking portion or buckle member 50 may be configured to slidably receive at least a portion of the first locking portion or post member 60 therein.


In some embodiments, the first locking portion or post member 60 may be disposed within the lumen of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 proximate the distal or inflow end of the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 when the support structure and/or the expandable anchor member 17 is in the elongated “delivery” configuration and/or the “everted” configuration. In some embodiments, at least a portion of the first locking portion or post member 60 may be disposed distal of the support structure and/or the expandable anchor member 17 when the support structure and/or the expandable anchor member 17 is in the elongated “delivery” configuration and/or the “everted” configuration. In some embodiments, the first locking portion or post member 60 may be configured to engage the second locking portion or buckle member 50 to lock the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 in the “deployed” configuration. Some suitable but non-limiting materials for the first locking portion or post member 60, for example metallic materials or polymeric materials, are described below.


The second locking portion or buckle member 50 may include a base portion, a body portion defining a longitudinal channel extending through the body portion, and a flap portion extending proximally and/or toward the proximal end of the base portion from the body portion of the second locking portion or buckle member 50. In at least some embodiments, the flap portion of the second locking portion or buckle member 50 may be configured to engage the first locking portion or post member 60 to lock the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 in the “deployed” configuration. Some suitable but non-limiting materials for the second locking portion or buckle member 50, for example metallic materials or polymeric materials, are described below.


After the replacement heart valve implant 16 is advanced within the anatomy and/or the vasculature to the area of interest, the outer sheath 12 may be translated and/or actuated proximally to expose the replacement heart valve implant 16. Then, the actuator element can be actuated (e.g., proximally retracted) to axially shorten and/or radially expand the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 from the “delivery” configuration toward the “deployed” configuration by proximally retracting and/or translating the actuator element to pull the first locking portion or post member 60 into engagement with the second locking portion or buckle member 50, using the handle 18 for example. After verifying satisfactory placement of the replacement heart valve implant 16, such as by an appropriate imaging technique, the actuator element may each be decoupled from the first locking portion or post member 60, which allows the distal portion of the actuator element to be pulled proximally out of the second locking portion or buckle member 50, thereby leaving the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 at the area of interest in a “released” configuration.



FIG. 3 illustrates a schematic view of a portion of a patient's heart 100 and certain connected vasculature, such as the aorta 120 connected to the heart 100 by the aortic arch 122, and the coronary arteries 130. Native valve leaflets 140 of a native heart valve 110 (e.g., an aortic valve, a mitral valve, etc.) may be seen schematically where the aorta 120 (disposed downstream of the native valve leaflets 140) meets and/or joins the heart 100 and in fluid communication with a left ventricle of the heart 100 (disposed upstream of the native valve leaflets 140). On a downstream side of the native valve leaflets 140 is an area described herein as a cusp, where the cusp is a space between the native valve leaflets 140 and a wall of the aorta 120 and/or the aortic arch 122 immediately downstream of and/or adjacent to the native heart valve 110 (e.g., the aortic valve, etc.). The native valve leaflets 140 meet or intersect at a commissure configured to reversibly and/or selectively permit antegrade fluid flow and prevent retrograde fluid flow through the native heart valve 110. As such, a tricuspid heart valve, such as a normal aortic valve, will include and/or define three commissures and three cusps. Similarly, a bicuspid heart valve will include and/or define two commissures and two cusps. For the purpose of understanding the placement of the replacement heart valve implant 16, a reference plane A-A may be identified extending through an annulus of the native heart valve 110 generally perpendicular to a direction of fluid flow through the native heart valve 110, as shown in FIG. 3.


A method of locating a replacement heart valve implant 16 during an implantation procedure may comprise advancing the replacement heart valve implant 16 through a vasculature (e.g., the aorta 120, the aortic arch 122, etc.) toward a native heart valve 110 (e.g., the aortic valve, etc.) in an elongated and/or radially-collapsed “delivery” configuration within the outer sheath 12. The replacement heart valve implant 16 may be constructed and/or arranged as described herein. In some embodiments, the medical device system 10, the outer sheath 12, and/or the replacement heart valve implant 16 may be advanced through the vasculature (e.g., the aorta 120, the aortic arch 122, etc.) within an optional introducer sheath 200, as illustrated in FIG. 4 for example.


The replacement heart valve implant 16 may be exposed and/or deployed from the outer sheath 12 at and/or adjacent to the native heart valve 110, as seen in FIGS. 4-6. In some embodiments, the replacement heart valve implant 16 may be exposed and/or deployed from the outer sheath 12 just downstream of the native heart valve 110 (e.g., FIG. 4), just upstream of the native heart valve 110 (e.g., FIG. 5), within the native heart valve 110 (e.g., FIG. 6), and/or combinations thereof. As described herein, the reinforcement strip 32 may include a radiopaque element 34 extending circumferentially around the central longitudinal axis of the seal member 30, the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 in a first plane B-B, shown in FIG. 4. The first plane B-B may be used to locate and/or position the replacement heart valve implant 16 relative to the annulus of the native heart valve 110.


For example, the method may include imaging the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 within the vasculature (e.g., the aorta 120, the aortic arch 122, etc.) and the native heart valve 110 concurrently as the replacement heart valve implant 16 approaches and/or is disposed within the native heart valve 110, using a suitable imaging technique (e.g., X-ray, fluoroscopy, etc.). The imaging may identify the reference plane A-A extending through the annulus of the native heart valve 110 generally perpendicular to the direction of fluid flow through the native heart valve 110. In some embodiments, an offset of the first plane B-B from the reference plane A-A may be measured to aid in locating and/or placing the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 relative to the annulus of the native heart valve 110, as seen in FIGS. 4 and 5. For example, reduced and/or limited intrusion of the replacement heart valve implant 16 into the left ventricle of the heart 100 may be desirable in some procedures and/or patients.


In some embodiments, the method may include, after initial imaging and/or during imaging, moving the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 to translate the first plane B-B upstream toward the reference plane A-A if the first plane B-B is initially offset too far downstream. In some embodiments, the method may include, after initial imaging and/or during imaging, moving the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 to translate the first plane B-B downstream toward the reference plane A-A if the first plane B-B is initially offset too far upstream.


The method may further include expanding the replacement heart valve implant 16, the support structure, and/or the expandable anchor member 17 within the native heart valve 110 with the first plane B-B positioned substantially parallel to the reference plane A-A and offset axially and/or in the direction of fluid flow less than 4 mm (millimeters) from the reference plane A-A. In some embodiments, the first plane B-B may be positioned substantially parallel to the reference plane A-A and offset axially and/or in the direction of fluid flow less than 2 mm (millimeters) from the reference plane A-A. In some embodiments, the first plane B-B may be positioned substantially coplanar with the reference plane A-A, as shown in FIG. 6 for example.


In some embodiments, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. and/or components thereof (such as, but not limited to, the actuator element, the support structure and/or expandable anchor member 17, the at least one grommet 38, the whip sutures 40, the proximal lashing sutures 46, the second locking portion or buckle member 50, the first locking portion or post member 60, etc.), may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, 444L, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.


As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear than the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.


In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.


In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.


In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.


In at least some embodiments, portions or all of the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc., and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. to achieve the same result.


In some embodiments, a degree of Magnetic Resonance Imaging (MM) compatibility is imparted into the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. For example, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc., and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc., or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.


In some embodiments, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.


In some embodiments, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. 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), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.


In some embodiments, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun-types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.


In some embodiments, the medical device system 10, the outer sheath 12, the inner sheath or catheter 14, the replacement heart valve implant 16, the handle 18, the seal member 30, the reinforcement strip 32, the radiopaque element 34, the introducer sheath 200, etc. may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.


It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims
  • 1. A method of locating a replacement heart valve implant during an implantation procedure, comprising: advancing the replacement heart valve implant through a vasculature toward a native heart valve in a delivery configuration, the replacement heart valve implant comprising: an expandable tubular support structure defining a central longitudinal axis, a plurality of valve leaflets disposed within the tubular support structure, and a seal member comprising: a tubular polymeric seal element disposed on an outer surface of the tubular support structure and a reinforcement strip fixedly attached to the tubular polymeric seal element at a distal end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular support structure;wherein the reinforcement strip includes a scalloped downstream edge and a radiopaque element extending circumferentially around the central longitudinal axis in a first plane;imaging the replacement heart valve implant within the vasculature and the native heart valve concurrently as the replacement heart valve implant approaches the native heart valve, wherein the imaging identifies a reference plane extending through an annulus of the native heart valve generally perpendicular to a direction of fluid flow through the native heart valve; andexpanding the tubular support structure within the native heart valve with the first plane positioned substantially parallel to the reference plane and offset less than 4 mm from the reference plane.
  • 2. The method of claim 1, wherein the first plane is offset less than 2 mm from the reference plane.
  • 3. The method of claim 1, wherein the first plane is positioned substantially coplanar with the reference plane.
  • 4. The method of claim 1, wherein the radiopaque element includes radiopaque nanoparticles embedded in the reinforcement strip.
  • 5. The method of claim 1, wherein the reinforcement strip is fixedly attached to the tubular support structure at the inflow end.
  • 6. A replacement heart valve implant, comprising: a tubular metallic support structure defining a central longitudinal axis;a plurality of valve leaflets disposed within the tubular metallic support structure;a seal member comprising a tubular polymeric seal element disposed on an outer surface of the tubular metallic support structure; anda reinforcement strip fixedly attached to the tubular polymeric seal element at a distal end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular metallic support structure, the reinforcement strip including a scalloped downstream edge.
  • 7. The replacement heart valve implant of claim 6, wherein the scalloped downstream edge extends completely around the circumference of the reinforcement strip.
  • 8. The replacement heart valve implant of claim 6, further comprising a plurality of proximal lashing sutures attaching a proximal portion of the seal member to the tubular metallic support structure.
  • 9. The replacement heart valve implant of claim 8, wherein the scalloped downstream edge of the reinforcement strip is disposed distal of the proximal lashing sutures.
  • 10. The replacement heart valve implant of claim 6, wherein the reinforcement strip includes a radiopaque element extending circumferentially around the central longitudinal axis.
  • 11. The replacement heart valve implant of claim 6, further comprising a radiopaque element disposed at a distalmost portion of the tubular metallic support structure.
  • 12. The replacement heart valve implant of claim 6, wherein the reinforcement strip is at least partially embedded within the seal member.
  • 13. The replacement heart valve implant of claim 6, wherein the seal member extends proximally and downstream of the scalloped downstream edge of the reinforcement strip.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 62/635,236, filed Feb. 26, 2018, the entirety of which is incorporated herein by reference.

US Referenced Citations (1023)
Number Name Date Kind
15192 Peale Jun 1856 A
2682057 Lord Jun 1954 A
2701559 Cooper Feb 1955 A
2832078 Williams Apr 1958 A
3029819 Starks Apr 1962 A
3099016 Lowell Jul 1963 A
3113586 Edmark Dec 1963 A
3130418 Head et al. Apr 1964 A
3143742 Cromie Aug 1964 A
3221006 Moore et al. Nov 1965 A
3334629 Cohn Aug 1967 A
3365728 Edwards et al. Jan 1968 A
3367364 Cruz et al. Feb 1968 A
3409013 Henry Nov 1968 A
3445916 Schulte May 1969 A
3503079 Smith Mar 1970 A
3540431 Mobin-Uddin Nov 1970 A
3546711 Boyros Dec 1970 A
3548417 Kischer et al. Dec 1970 A
3551913 Shiley et al. Jan 1971 A
3570014 Hancock Mar 1971 A
3587115 Shiley Jun 1971 A
3592184 Watkins et al. Jul 1971 A
3628535 Ostrowsky et al. Dec 1971 A
3642004 Osthagen et al. Feb 1972 A
3657744 Ersek Apr 1972 A
3671979 Moulopoulos Jun 1972 A
3714671 Goodenough et al. Feb 1973 A
3725961 Magovern et al. Apr 1973 A
3755823 Hancock Sep 1973 A
3795246 Sturgeon Mar 1974 A
3839741 Haller Oct 1974 A
3868956 Alfidi et al. Mar 1975 A
3874388 King et al. Apr 1975 A
3983581 Angell et al. Oct 1976 A
3997923 Possis Dec 1976 A
4035849 Angell et al. Jul 1977 A
4056854 Boretos et al. Nov 1977 A
4084268 Ionescu et al. Apr 1978 A
4106129 Carpentier et al. Aug 1978 A
4222126 Boretos et al. Sep 1980 A
4233690 Akins Nov 1980 A
4265694 Boretos et al. May 1981 A
4291420 Reul Sep 1981 A
4297749 Davis et al. Nov 1981 A
4323358 Lentz et al. Apr 1982 A
4326306 Poler Apr 1982 A
4339831 Johnson Jul 1982 A
4340977 Brownlee et al. Jul 1982 A
4343048 Ross et al. Aug 1982 A
4345340 Rosen Aug 1982 A
4373216 Klawitter Feb 1983 A
4388735 Ionescu et al. Jun 1983 A
4406022 Roy Sep 1983 A
4423809 Mazzocco Jan 1984 A
4425908 Simon Jan 1984 A
4470157 Love Sep 1984 A
4473423 Kolff Sep 1984 A
4484365 Murguet et al. Nov 1984 A
4484579 Meno et al. Nov 1984 A
4490859 Black et al. Jan 1985 A
4501030 Lane Feb 1985 A
4510628 Kolff Apr 1985 A
4531943 Tassel et al. Jul 1985 A
4535483 Klawitter et al. Aug 1985 A
4574803 Storz Mar 1986 A
4580568 Gianturco Apr 1986 A
4592340 Boyles Jun 1986 A
4602911 Ahmadi et al. Jul 1986 A
4605407 Black et al. Aug 1986 A
4610688 Silvestrini et al. Sep 1986 A
4612011 Kautzky Sep 1986 A
4617932 Kornberg Oct 1986 A
4643732 Pietsch et al. Feb 1987 A
4647283 Carpentier et al. Mar 1987 A
4648881 Carpentier et al. Mar 1987 A
4655218 Kulik et al. Apr 1987 A
4655771 Wallsten et al. Apr 1987 A
4662885 DiPisa May 1987 A
4665906 Jervis May 1987 A
4680031 Alonso Jul 1987 A
4692164 Dzemeshkevich et al. Sep 1987 A
4705516 Barone et al. Nov 1987 A
4710192 Liotta et al. Dec 1987 A
4733665 Palmaz et al. Mar 1988 A
4739759 Rexroth et al. Apr 1988 A
4755181 Igoe Jul 1988 A
4759758 Gabbay Jul 1988 A
4777951 Cribier et al. Oct 1988 A
4787899 Lazarus Nov 1988 A
4787901 Baykut Nov 1988 A
4796629 Grayzel Jan 1989 A
4819751 Shimada et al. Apr 1989 A
4829990 Thuroff et al. May 1989 A
4834755 Silvestrini et al. May 1989 A
4851001 Taheri Jul 1989 A
4856516 Hillstead Aug 1989 A
4865600 Carpentier et al. Sep 1989 A
4872874 Taheri Oct 1989 A
4873978 Ginsburg Oct 1989 A
4878495 Grayzel Nov 1989 A
4878906 Lindemann et al. Nov 1989 A
4883458 Shiber Nov 1989 A
4885005 Nashef et al. Dec 1989 A
4909252 Goldberger Mar 1990 A
4917102 Miller et al. Apr 1990 A
4922905 Strecker May 1990 A
4927426 Dretler May 1990 A
4954126 Wallsten Sep 1990 A
4966604 Reiss Oct 1990 A
4969890 Sugita et al. Nov 1990 A
4979939 Shiber Dec 1990 A
4986830 Owens et al. Jan 1991 A
4994077 Dobben Feb 1991 A
5002556 Ishida et al. Mar 1991 A
5002559 Tower Mar 1991 A
5007896 Shiber Apr 1991 A
5026366 Leckrone Jun 1991 A
5032128 Alonso Jul 1991 A
5037434 Lane Aug 1991 A
5047041 Samuels Sep 1991 A
5047050 Arpesani Sep 1991 A
5064435 Porter Nov 1991 A
5080668 Bolz et al. Jan 1992 A
5085635 Cragg Feb 1992 A
5089015 Ross Feb 1992 A
5122154 Rhodes Jun 1992 A
5132473 Furutaka et al. Jul 1992 A
5141494 Danforth et al. Aug 1992 A
5152771 Sabbaghian et al. Oct 1992 A
5159937 Tremulis Nov 1992 A
5161547 Tower Nov 1992 A
5163953 Vince Nov 1992 A
5167628 Boyles Dec 1992 A
5209741 Spaeth May 1993 A
5215541 Nashef et al. Jun 1993 A
5217481 Barbara Jun 1993 A
5217483 Tower Jun 1993 A
5238004 Sahatjian et al. Aug 1993 A
5258023 Reger Nov 1993 A
5258042 Mehta Nov 1993 A
5282847 Trescony et al. Feb 1994 A
5295958 Shturman Mar 1994 A
5326372 Mhatre et al. Jul 1994 A
5332402 Teitelbaum Jul 1994 A
5336258 Quintero et al. Aug 1994 A
5350398 Pavcnik et al. Sep 1994 A
5360444 Kusuhara Nov 1994 A
5370685 Stevens Dec 1994 A
5389106 Tower Feb 1995 A
5397351 Pavcnik et al. Mar 1995 A
5409019 Wilk Apr 1995 A
5411552 Andersen et al. May 1995 A
5425739 Jessen Jun 1995 A
5425762 Muller Jun 1995 A
5431676 Dubrul et al. Jul 1995 A
5443446 Shturman Aug 1995 A
5443449 Buelna Aug 1995 A
5443477 Marin et al. Aug 1995 A
5443495 Buscemi et al. Aug 1995 A
5443499 Schmitt Aug 1995 A
5469868 Reger Nov 1995 A
5476506 Lunn Dec 1995 A
5476510 Eberhardt et al. Dec 1995 A
5480423 Ravenscroft et al. Jan 1996 A
5480424 Cox Jan 1996 A
5489297 Duran Feb 1996 A
5500014 Quijano et al. Mar 1996 A
5507767 Maeda et al. Apr 1996 A
5522881 Lentz Jun 1996 A
5534007 Germain et al. Jul 1996 A
5545133 Burns et al. Aug 1996 A
5545209 Roberts et al. Aug 1996 A
5545211 An et al. Aug 1996 A
5545214 Stevens Aug 1996 A
5549665 Vesely et al. Aug 1996 A
5554185 Block et al. Sep 1996 A
5571175 Vanney et al. Nov 1996 A
5571215 Sterman et al. Nov 1996 A
5573520 Schwartz et al. Nov 1996 A
5575818 Pinchuk Nov 1996 A
5591185 Kilmer et al. Jan 1997 A
5591195 Taheri et al. Jan 1997 A
5607464 Trescony et al. Mar 1997 A
5609626 Quijano et al. Mar 1997 A
5628784 Strecker May 1997 A
5645559 Hachtman et al. Jul 1997 A
5653745 Trescony et al. Aug 1997 A
5662671 Barbut et al. Sep 1997 A
5667523 Bynon et al. Sep 1997 A
5674277 Freitag Oct 1997 A
5681345 Euteneuer Oct 1997 A
5693083 Baker et al. Dec 1997 A
5693088 Lazarus Dec 1997 A
5693310 Gries et al. Dec 1997 A
5695498 Tower Dec 1997 A
5709713 Evans et al. Jan 1998 A
5713951 Garrison et al. Feb 1998 A
5713953 Vallana et al. Feb 1998 A
5716370 Williamson et al. Feb 1998 A
5716417 Girard et al. Feb 1998 A
5720391 Dohm et al. Feb 1998 A
5725549 Lam Mar 1998 A
5728068 Leone et al. Mar 1998 A
5733325 Robinson et al. Mar 1998 A
5735842 Krueger et al. Apr 1998 A
5749890 Shaknovich May 1998 A
5755783 Stobie et al. May 1998 A
5756476 Epstein et al. May 1998 A
5769812 Stevens et al. Jun 1998 A
5769882 Fogarty et al. Jun 1998 A
5772609 Nguyen et al. Jun 1998 A
5776188 Shepherd et al. Jul 1998 A
5782904 White et al. Jul 1998 A
5800456 Maeda et al. Sep 1998 A
5800531 Cosgrove et al. Sep 1998 A
5807405 Vanney et al. Sep 1998 A
5817126 Imran Oct 1998 A
5824037 Fogarty et al. Oct 1998 A
5824041 Lenker et al. Oct 1998 A
5824043 Cottone Oct 1998 A
5824053 Khosravi et al. Oct 1998 A
5824055 Spiridigliozzi et al. Oct 1998 A
5824056 Rosenberg Oct 1998 A
5824064 Taheri Oct 1998 A
5840081 Andersen et al. Nov 1998 A
5843158 Lenker et al. Dec 1998 A
5843161 Solovay Dec 1998 A
5855597 Jayaraman Jan 1999 A
5855601 Bessler et al. Jan 1999 A
5855602 Angell Jan 1999 A
5860966 Tower Jan 1999 A
5860996 Urban et al. Jan 1999 A
5861024 Rashidi Jan 1999 A
5861028 Angell Jan 1999 A
5868783 Tower Feb 1999 A
5876419 Carpenter et al. Mar 1999 A
5876448 Thompson et al. Mar 1999 A
5885228 Rosenman et al. Mar 1999 A
5888201 Stinson et al. Mar 1999 A
5891191 Stinson Apr 1999 A
5895399 Barbut et al. Apr 1999 A
5906619 Olson et al. May 1999 A
5907893 Zadno-Azizi et al. Jun 1999 A
5910154 Tsugita et al. Jun 1999 A
5911734 Tsugita et al. Jun 1999 A
5925063 Khosravi Jul 1999 A
5944738 Amplatz et al. Aug 1999 A
5954766 Zadno-Azizi et al. Sep 1999 A
5957949 Leonhardt et al. Sep 1999 A
5968070 Bley et al. Oct 1999 A
5984957 Laptewicz et al. Nov 1999 A
5984959 Robertson et al. Nov 1999 A
5993469 McKenzie et al. Nov 1999 A
5997557 Barbut et al. Dec 1999 A
6010522 Barbut et al. Jan 2000 A
6015431 Thornton et al. Jan 2000 A
6022370 Tower Feb 2000 A
6027520 Tsugita et al. Feb 2000 A
6027525 Suh et al. Feb 2000 A
6042598 Tsugita et al. Mar 2000 A
6042607 Williamson et al. Mar 2000 A
6045576 Starr et al. Apr 2000 A
6051014 Jang Apr 2000 A
6059827 Fenton May 2000 A
6074418 Buchanan et al. Jun 2000 A
6093203 Uflacker Jul 2000 A
6096074 Pedros Aug 2000 A
6110198 Fogarty et al. Aug 2000 A
6123723 Konya et al. Sep 2000 A
6132473 Williams et al. Oct 2000 A
6139510 Palermo Oct 2000 A
6142987 Tsugita Nov 2000 A
6146366 Schachar Nov 2000 A
6162245 Jayaraman Dec 2000 A
6165200 Tsugita et al. Dec 2000 A
6165209 Patterson et al. Dec 2000 A
6168579 Tsugita Jan 2001 B1
6168614 Andersen et al. Jan 2001 B1
6171327 Daniel et al. Jan 2001 B1
6171335 Wheatley et al. Jan 2001 B1
6179859 Bates et al. Jan 2001 B1
6187016 Hedges et al. Feb 2001 B1
6197053 Cosgrove et al. Mar 2001 B1
6200336 Pavcnik et al. Mar 2001 B1
6206911 Milo Mar 2001 B1
6214036 Letendre et al. Apr 2001 B1
6221006 Dubrul et al. Apr 2001 B1
6221091 Khosravi Apr 2001 B1
6221096 Aiba et al. Apr 2001 B1
6221100 Strecker Apr 2001 B1
6231544 Tsugita et al. May 2001 B1
6231551 Barbut May 2001 B1
6241757 An et al. Jun 2001 B1
6245102 Jayaraman Jun 2001 B1
6251135 Stinson et al. Jun 2001 B1
6254636 Peredo Jul 2001 B1
6258114 Konya et al. Jul 2001 B1
6258115 Dubrul Jul 2001 B1
6258120 McKenzie et al. Jul 2001 B1
6258129 Dybdal et al. Jul 2001 B1
6267783 Letendre et al. Jul 2001 B1
6270513 Tsugita et al. Aug 2001 B1
6277555 Duran et al. Aug 2001 B1
6299637 Shaolian et al. Oct 2001 B1
6302906 Goicoechea et al. Oct 2001 B1
6306164 Kujawski Oct 2001 B1
6309417 Spence et al. Oct 2001 B1
6312465 Griffin et al. Nov 2001 B1
6319281 Patel Nov 2001 B1
6327772 Zadno-Azizi et al. Dec 2001 B1
6336934 Gilson et al. Jan 2002 B1
6336937 Vonesh et al. Jan 2002 B1
6338735 Stevens Jan 2002 B1
6346116 Brooks et al. Feb 2002 B1
6348063 Yassour et al. Feb 2002 B1
6352554 Paulis Mar 2002 B2
6352708 Duran et al. Mar 2002 B1
6361545 Macoviak et al. Mar 2002 B1
6363938 Saadat et al. Apr 2002 B2
6364895 Greenhalgh Apr 2002 B1
6371970 Khosravi et al. Apr 2002 B1
6371983 Lane Apr 2002 B1
6379383 Palmaz et al. Apr 2002 B1
6387122 Cragg May 2002 B1
6398807 Chouinard et al. Jun 2002 B1
6402736 Brown et al. Jun 2002 B1
6409750 Hyodoh et al. Jun 2002 B1
6416510 Altman et al. Jul 2002 B1
6425916 Garrison et al. Jul 2002 B1
6440164 DiMatteo et al. Aug 2002 B1
6454799 Schreck Sep 2002 B1
6458153 Bailey et al. Oct 2002 B1
6461382 Cao Oct 2002 B1
6468303 Amplatz et al. Oct 2002 B1
6468660 Ogle et al. Oct 2002 B2
6475239 Campbell et al. Nov 2002 B1
6482228 Norred Nov 2002 B1
6485501 Green Nov 2002 B1
6485502 Michael et al. Nov 2002 B2
6488704 Connelly et al. Dec 2002 B1
6494909 Greenhalgh Dec 2002 B2
6503272 Duerig et al. Jan 2003 B2
6508803 Horikawa et al. Jan 2003 B1
6508833 Pavcnik et al. Jan 2003 B2
6527800 McGuckin et al. Mar 2003 B1
6530949 Konya et al. Mar 2003 B2
6530952 Vesely Mar 2003 B2
6537297 Tsugita et al. Mar 2003 B2
6540768 Diaz et al. Apr 2003 B1
6540782 Snyders Apr 2003 B1
6558417 Peredo May 2003 B2
6562058 Seguin et al. May 2003 B2
6569196 Vesely May 2003 B1
6572643 Gharibadeh Jun 2003 B1
6585766 Huynh et al. Jul 2003 B1
6592546 Barbut et al. Jul 2003 B1
6592614 Lenker et al. Jul 2003 B2
6605112 Moll et al. Aug 2003 B1
6610077 Hancock et al. Aug 2003 B1
6616682 Joergensen et al. Sep 2003 B2
6622604 Chouinard et al. Sep 2003 B1
6623518 Thompson et al. Sep 2003 B2
6623521 Steinke et al. Sep 2003 B2
6626938 Butaric et al. Sep 2003 B1
6632243 Zadno-Azizi et al. Oct 2003 B1
6635068 Dubrul et al. Oct 2003 B1
6635079 Unsworth et al. Oct 2003 B2
6635080 Lauterjung et al. Oct 2003 B1
6652571 White et al. Nov 2003 B1
6652578 Bailey et al. Nov 2003 B2
6663588 DuBois et al. Dec 2003 B2
6663663 Kim et al. Dec 2003 B2
6663667 Dehdashtian et al. Dec 2003 B2
6669724 Park et al. Dec 2003 B2
6673089 Yassour et al. Jan 2004 B1
6673109 Cox Jan 2004 B2
6676668 Mercereau et al. Jan 2004 B2
6676692 Rabkin et al. Jan 2004 B2
6676698 McGuckin et al. Jan 2004 B2
6682543 Barbut et al. Jan 2004 B2
6682558 Tu et al. Jan 2004 B2
6682559 Myers et al. Jan 2004 B2
6685739 DiMatteo et al. Feb 2004 B2
6689144 Gerberding Feb 2004 B2
6689164 Seguin Feb 2004 B1
6692512 Jang Feb 2004 B2
6695864 Macoviak et al. Feb 2004 B2
6695865 Boyle et al. Feb 2004 B2
6702851 Chinn et al. Mar 2004 B1
6712842 Gifford et al. Mar 2004 B1
6712843 Elliott Mar 2004 B2
6714842 Ito Mar 2004 B1
6719789 Cox Apr 2004 B2
6723116 Taheri Apr 2004 B2
6729356 Baker et al. May 2004 B1
6730118 Spenser et al. May 2004 B2
6730377 Wang May 2004 B2
6733525 Yang et al. May 2004 B2
6736846 Cox May 2004 B2
6752828 Thornton Jun 2004 B2
6755854 Gillick et al. Jun 2004 B2
6758855 Fulton et al. Jul 2004 B2
6764503 Ishimaru Jul 2004 B1
6764509 Chinn et al. Jul 2004 B2
6767345 Germain et al. Jul 2004 B2
6769434 Liddicoat et al. Aug 2004 B2
6773454 Wholey et al. Aug 2004 B2
6773456 Gordon et al. Aug 2004 B1
6776791 Stallings et al. Aug 2004 B1
6786925 Schoon et al. Sep 2004 B1
6790229 Berreklouw Sep 2004 B1
6790230 Beyersdorf et al. Sep 2004 B2
6790237 Stinson Sep 2004 B2
6792979 Konya et al. Sep 2004 B2
6797002 Spence et al. Sep 2004 B2
6814746 Thompson et al. Nov 2004 B2
6814754 Greenhalgh Nov 2004 B2
6821297 Snyders Nov 2004 B2
6824041 Grieder et al. Nov 2004 B2
6830585 Artof et al. Dec 2004 B1
6837901 Rabkin et al. Jan 2005 B2
6840957 DiMatteo et al. Jan 2005 B2
6843802 Villalobos et al. Jan 2005 B1
6849085 Marton Feb 2005 B2
6863668 Gillespie et al. Mar 2005 B2
6863688 Ralph et al. Mar 2005 B2
6866650 Stevens et al. Mar 2005 B2
6866669 Buzzard et al. Mar 2005 B2
6872223 Roberts et al. Mar 2005 B2
6872226 Cali et al. Mar 2005 B2
6875231 Anduiza et al. Apr 2005 B2
6881220 Edwin et al. Apr 2005 B2
6883522 Spence et al. Apr 2005 B2
6887266 Williams et al. May 2005 B2
6890340 Duane May 2005 B2
6893459 Macoviak May 2005 B1
6893460 Spenser et al. May 2005 B2
6896690 Lambrecht et al. May 2005 B1
6905743 Chen et al. Jun 2005 B1
6908481 Cribier Jun 2005 B2
6911036 Douk et al. Jun 2005 B2
6911040 Johnson et al. Jun 2005 B2
6911043 Myers et al. Jun 2005 B2
6936058 Forde et al. Aug 2005 B2
6936067 Buchanan Aug 2005 B2
6939352 Buzzard et al. Sep 2005 B2
6951571 Srivastava Oct 2005 B1
6951573 Dilling Oct 2005 B1
6953332 Kurk et al. Oct 2005 B1
6964673 Tsugita et al. Nov 2005 B2
6969395 Eskuri Nov 2005 B2
6972025 WasDyke Dec 2005 B2
6974464 Quijano et al. Dec 2005 B2
6974474 Pavcnik et al. Dec 2005 B2
6974476 McGuckin et al. Dec 2005 B2
6979350 Moll et al. Dec 2005 B2
6984242 Campbell et al. Jan 2006 B2
6989027 Allen et al. Jan 2006 B2
7004176 Lau Feb 2006 B2
7011681 Vesely Mar 2006 B2
7018406 Seguin et al. Mar 2006 B2
7025791 Levine et al. Apr 2006 B2
7037331 Mitelberg et al. May 2006 B2
7041132 Quijano et al. May 2006 B2
7044966 Svanidze et al. May 2006 B2
7097658 Oktay Aug 2006 B2
7108715 Lawrence-Brown et al. Sep 2006 B2
7122020 Mogul Oct 2006 B2
7125418 Duran et al. Oct 2006 B2
7141063 White et al. Nov 2006 B2
7147663 Berg et al. Dec 2006 B1
7166097 Barbut Jan 2007 B2
7172625 Shu et al. Feb 2007 B2
7175652 Cook et al. Feb 2007 B2
7175653 Gaber Feb 2007 B2
7175654 Bonsignore et al. Feb 2007 B2
7175656 Khairkhahan Feb 2007 B2
7175659 Hill et al. Feb 2007 B2
7189258 Johnson et al. Mar 2007 B2
7191018 Gielen et al. Mar 2007 B2
7201772 Schwammenthal et al. Apr 2007 B2
7235093 Gregorich Jun 2007 B2
7252682 Seguin Aug 2007 B2
7258696 Rabkin et al. Aug 2007 B2
7261732 Justino Aug 2007 B2
7264632 Wright et al. Sep 2007 B2
7267686 DiMatteo et al. Sep 2007 B2
7276078 Spenser et al. Oct 2007 B2
7318278 Zhang et al. Jan 2008 B2
7322932 Xie et al. Jan 2008 B2
7326236 Andreas et al. Feb 2008 B2
7329279 Haug et al. Feb 2008 B2
7331993 White Feb 2008 B2
7374560 Ressemann et al. May 2008 B2
7381219 Salahieh et al. Jun 2008 B2
7381220 Macoviak et al. Jun 2008 B2
7399315 Iobbi Jul 2008 B2
7445631 Salahieh et al. Nov 2008 B2
7470285 Nugent et al. Dec 2008 B2
7491232 Bolduc et al. Feb 2009 B2
7510574 Lê et al. Mar 2009 B2
7524330 Berreklouw Apr 2009 B2
7524331 Birdsall et al. Apr 2009 B2
7530995 Quijano et al. May 2009 B2
7544206 Cohn Jun 2009 B2
7575594 Sieracki Aug 2009 B2
7622276 Cunanan et al. Nov 2009 B2
7628803 Pavcnik et al. Dec 2009 B2
7632298 Hijlkema et al. Dec 2009 B2
7641687 Chinn et al. Jan 2010 B2
7670370 Hill et al. Mar 2010 B2
7674282 Wu et al. Mar 2010 B2
7712606 Salahieh et al. May 2010 B2
7717955 Lane et al. May 2010 B2
7722638 Deyette et al. May 2010 B2
7722662 Steinke et al. May 2010 B2
7722666 Lafontaine May 2010 B2
7731742 Schlick et al. Jun 2010 B2
7736388 Goldfarb et al. Jun 2010 B2
7748389 Salahieh et al. Jul 2010 B2
7758625 Wu et al. Jul 2010 B2
7780725 Haug et al. Aug 2010 B2
7799065 Pappas Sep 2010 B2
7803185 Gabbay Sep 2010 B2
7819915 Stobie et al. Oct 2010 B2
7824442 Salahieh et al. Nov 2010 B2
7824443 Salahieh et al. Nov 2010 B2
7833262 McGuckin et al. Nov 2010 B2
7846204 Letac et al. Dec 2010 B2
7857845 Stacchino et al. Dec 2010 B2
7892281 Seguin et al. Feb 2011 B2
7892292 Stack et al. Feb 2011 B2
7918880 Austin Apr 2011 B2
7938851 Olson et al. May 2011 B2
7959666 Salahieh et al. Jun 2011 B2
7959672 Salahieh et al. Jun 2011 B2
7988724 Salahieh et al. Aug 2011 B2
7993394 Hariton et al. Aug 2011 B2
8012135 Dann et al. Sep 2011 B2
8029564 Johnson et al. Oct 2011 B2
8048153 Salahieh et al. Nov 2011 B2
8052749 Salahieh et al. Nov 2011 B2
8075611 Milwee et al. Dec 2011 B2
8136659 Salahieh et al. Mar 2012 B2
8157853 Laske et al. Apr 2012 B2
8163014 Lane et al. Apr 2012 B2
8172892 Chuter et al. May 2012 B2
8172896 McNamara et al. May 2012 B2
8182528 Salahieh et al. May 2012 B2
8192351 Fishler et al. Jun 2012 B2
8226710 Nguyen et al. Jul 2012 B2
8231670 Salahieh et al. Jul 2012 B2
8236049 Rowe et al. Aug 2012 B2
8246678 Salahieh et al. Aug 2012 B2
8252051 Chau et al. Aug 2012 B2
8252052 Salahieh et al. Aug 2012 B2
8287584 Salahieh et al. Oct 2012 B2
8308798 Pintor et al. Nov 2012 B2
8317858 Straubinger et al. Nov 2012 B2
8323335 Rowe et al. Dec 2012 B2
8328868 Paul et al. Dec 2012 B2
8343213 Salahieh et al. Jan 2013 B2
8376865 Forster et al. Feb 2013 B2
8377117 Keidar et al. Feb 2013 B2
8398708 Meiri et al. Mar 2013 B2
8403983 Quadri et al. Mar 2013 B2
8414644 Quadri et al. Apr 2013 B2
8579962 Salahieh et al. Nov 2013 B2
8603160 Salahieh et al. Dec 2013 B2
8617236 Paul et al. Dec 2013 B2
8623074 Ryan Jan 2014 B2
8623076 Salahieh et al. Jan 2014 B2
8623078 Salahieh et al. Jan 2014 B2
8668733 Haug et al. Mar 2014 B2
8696737 Gainor Apr 2014 B2
8696743 Holecek et al. Apr 2014 B2
8788020 Gregg et al. Jul 2014 B2
8828078 Salahieh et al. Sep 2014 B2
8840662 Salahieh et al. Sep 2014 B2
8840663 Salahieh et al. Sep 2014 B2
8858620 Salahieh et al. Oct 2014 B2
8894703 Salahieh et al. Nov 2014 B2
8951299 Paul et al. Feb 2015 B2
8992608 Haug et al. Mar 2015 B2
9005273 Salahieh et al. Apr 2015 B2
9011521 Haug et al. Apr 2015 B2
9089422 Ryan et al. Jul 2015 B2
9168129 Valdez et al. Oct 2015 B2
9168131 Yohanan et al. Oct 2015 B2
9675451 Garde et al. Jun 2017 B2
9763785 Styrc Sep 2017 B2
9895225 Rolando et al. Feb 2018 B2
9974649 Racchini et al. May 2018 B2
20010002445 Vesely May 2001 A1
20010007956 Letac et al. Jul 2001 A1
20010010017 Letac et al. Jul 2001 A1
20010021872 Bailey et al. Sep 2001 A1
20010025196 Chinn et al. Sep 2001 A1
20010027338 Greenberg Oct 2001 A1
20010032013 Marton Oct 2001 A1
20010039450 Pavcnik et al. Nov 2001 A1
20010041928 Pavcnik et al. Nov 2001 A1
20010041930 Globerman et al. Nov 2001 A1
20010044634 Michael et al. Nov 2001 A1
20010044652 Moore Nov 2001 A1
20010044656 Williamson et al. Nov 2001 A1
20020002396 Fulkerson Jan 2002 A1
20020010489 Grayzel et al. Jan 2002 A1
20020026233 Shaknovich Feb 2002 A1
20020029014 Jayaraman Mar 2002 A1
20020029981 Nigam Mar 2002 A1
20020032480 Spence et al. Mar 2002 A1
20020032481 Gabbay Mar 2002 A1
20020042651 Liddicoat et al. Apr 2002 A1
20020052651 Myers et al. May 2002 A1
20020055767 Forde et al. May 2002 A1
20020055769 Wang May 2002 A1
20020055774 Liddicoat May 2002 A1
20020058987 Butaric et al. May 2002 A1
20020058994 Hill et al. May 2002 A1
20020058995 Stevens May 2002 A1
20020077696 Zadno-Azizi et al. Jun 2002 A1
20020077698 Peredo Jun 2002 A1
20020082609 Green Jun 2002 A1
20020095173 Mazzocchi et al. Jul 2002 A1
20020095205 Edwin et al. Jul 2002 A1
20020095209 Zadno-Azizi et al. Jul 2002 A1
20020111674 Chouinard et al. Aug 2002 A1
20020120328 Pathak et al. Aug 2002 A1
20020123802 Snyders Sep 2002 A1
20020138138 Yang Sep 2002 A1
20020151970 Garrison et al. Oct 2002 A1
20020156522 Ivancev et al. Oct 2002 A1
20020161390 Mouw Oct 2002 A1
20020161392 Dubrul Oct 2002 A1
20020161394 Macoviak et al. Oct 2002 A1
20020165576 Boyle et al. Nov 2002 A1
20020177766 Mogul Nov 2002 A1
20020183781 Casey et al. Dec 2002 A1
20020188341 Elliott Dec 2002 A1
20020188344 Bolea et al. Dec 2002 A1
20020193871 Beyersdorf et al. Dec 2002 A1
20030014104 Cribier Jan 2003 A1
20030023303 Palmaz et al. Jan 2003 A1
20030028247 Cali Feb 2003 A1
20030036791 Philipp et al. Feb 2003 A1
20030040736 Stevens et al. Feb 2003 A1
20030040771 Hyodoh et al. Feb 2003 A1
20030040772 Hyodoh et al. Feb 2003 A1
20030040791 Oktay Feb 2003 A1
20030040792 Gabbay Feb 2003 A1
20030050694 Yang et al. Mar 2003 A1
20030055495 Pease et al. Mar 2003 A1
20030057156 Peterson et al. Mar 2003 A1
20030060844 Borillo et al. Mar 2003 A1
20030069492 Abrams et al. Apr 2003 A1
20030069646 Stinson Apr 2003 A1
20030070944 Nigam Apr 2003 A1
20030074058 Sherry Apr 2003 A1
20030093145 Lawrence-Brown et al. May 2003 A1
20030100918 Duane May 2003 A1
20030100919 Hopkins et al. May 2003 A1
20030109924 Cribier Jun 2003 A1
20030109930 Bluni et al. Jun 2003 A1
20030114912 Sequin et al. Jun 2003 A1
20030114913 Spenser et al. Jun 2003 A1
20030114924 Moe Jun 2003 A1
20030125795 Pavcnik et al. Jul 2003 A1
20030130729 Paniagua et al. Jul 2003 A1
20030135257 Taheri Jul 2003 A1
20030144732 Cosgrove et al. Jul 2003 A1
20030149475 Hyodoh et al. Aug 2003 A1
20030149476 Damm et al. Aug 2003 A1
20030149478 Figulla et al. Aug 2003 A1
20030153974 Spenser et al. Aug 2003 A1
20030165352 Ibrahim et al. Sep 2003 A1
20030171803 Shimon Sep 2003 A1
20030176884 Berrada et al. Sep 2003 A1
20030181850 Diamond et al. Sep 2003 A1
20030187495 Cully et al. Oct 2003 A1
20030191516 Weldon et al. Oct 2003 A1
20030195609 Berenstein et al. Oct 2003 A1
20030195620 Huynh et al. Oct 2003 A1
20030199759 Richard Oct 2003 A1
20030199913 Dubrul et al. Oct 2003 A1
20030199971 Tower et al. Oct 2003 A1
20030199972 Zadno-Azizi et al. Oct 2003 A1
20030204249 Letort Oct 2003 A1
20030208224 Broome Nov 2003 A1
20030212429 Keegan et al. Nov 2003 A1
20030212452 Zadno-Azizi et al. Nov 2003 A1
20030212454 Scott et al. Nov 2003 A1
20030216774 Larson Nov 2003 A1
20030225445 Derus et al. Dec 2003 A1
20030229390 Ashton et al. Dec 2003 A1
20030233117 Adams et al. Dec 2003 A1
20030236567 Elliot Dec 2003 A1
20040015232 Shu et al. Jan 2004 A1
20040019374 Hojeibane et al. Jan 2004 A1
20040030381 Shu Feb 2004 A1
20040033364 Spiridigliozzi et al. Feb 2004 A1
20040034411 Quijano et al. Feb 2004 A1
20040039436 Spenser et al. Feb 2004 A1
20040049224 Buehlmann et al. Mar 2004 A1
20040049226 Keegan et al. Mar 2004 A1
20040049262 Obermiller et al. Mar 2004 A1
20040049266 Anduiza et al. Mar 2004 A1
20040059409 Stenzel Mar 2004 A1
20040073198 Gilson et al. Apr 2004 A1
20040082904 Houde et al. Apr 2004 A1
20040082967 Broome et al. Apr 2004 A1
20040082989 Cook et al. Apr 2004 A1
20040087982 Eskuri May 2004 A1
20040088045 Cox May 2004 A1
20040093016 Root et al. May 2004 A1
20040093060 Seguin et al. May 2004 A1
20040097788 Mourlas et al. May 2004 A1
20040098022 Barone May 2004 A1
20040098098 McGuckin et al. May 2004 A1
20040098099 McCullagh et al. May 2004 A1
20040098112 DiMatteo et al. May 2004 A1
20040106990 Spence et al. Jun 2004 A1
20040107004 Levine et al. Jun 2004 A1
20040111096 Tu et al. Jun 2004 A1
20040116951 Rosengart Jun 2004 A1
20040116999 Ledergerber Jun 2004 A1
20040117004 Osborne et al. Jun 2004 A1
20040117009 Cali et al. Jun 2004 A1
20040122468 Yodfat et al. Jun 2004 A1
20040122516 Fogarty et al. Jun 2004 A1
20040127936 Salahieh et al. Jul 2004 A1
20040127979 Wilson et al. Jul 2004 A1
20040133274 Webler et al. Jul 2004 A1
20040138694 Tran et al. Jul 2004 A1
20040138742 Myers et al. Jul 2004 A1
20040138743 Myers et al. Jul 2004 A1
20040148018 Carpentier et al. Jul 2004 A1
20040148021 Cartledge et al. Jul 2004 A1
20040153094 Dunfee et al. Aug 2004 A1
20040158277 Lowe et al. Aug 2004 A1
20040167565 Beulke et al. Aug 2004 A1
20040167620 Ortiz et al. Aug 2004 A1
20040181140 Falwell et al. Sep 2004 A1
20040186558 Pavcnik et al. Sep 2004 A1
20040186563 Lobbi Sep 2004 A1
20040193261 Berreklouw Sep 2004 A1
20040197695 Aono Oct 2004 A1
20040199245 Lauterjung Oct 2004 A1
20040204755 Robin Oct 2004 A1
20040210304 Seguin et al. Oct 2004 A1
20040210306 Quijano et al. Oct 2004 A1
20040210307 Khairkhahan Oct 2004 A1
20040215331 Chew et al. Oct 2004 A1
20040215333 Duran et al. Oct 2004 A1
20040215339 Drasler et al. Oct 2004 A1
20040220655 Swanson et al. Nov 2004 A1
20040225321 Krolik et al. Nov 2004 A1
20040225353 McGuckin et al. Nov 2004 A1
20040225354 Allen et al. Nov 2004 A1
20040225355 Stevens Nov 2004 A1
20040243221 Fawzi et al. Dec 2004 A1
20040254636 Flagle et al. Dec 2004 A1
20040260390 Sarac et al. Dec 2004 A1
20050010287 Macoviak et al. Jan 2005 A1
20050021136 Xie et al. Jan 2005 A1
20050033398 Seguin Feb 2005 A1
20050033402 Cully et al. Feb 2005 A1
20050043711 Corcoran et al. Feb 2005 A1
20050043757 Arad et al. Feb 2005 A1
20050043790 Seguin Feb 2005 A1
20050049692 Numamoto et al. Mar 2005 A1
20050049696 Siess et al. Mar 2005 A1
20050055088 Liddicoat et al. Mar 2005 A1
20050060016 Wu et al. Mar 2005 A1
20050060029 Le et al. Mar 2005 A1
20050065594 DiMatteo et al. Mar 2005 A1
20050075584 Cali Apr 2005 A1
20050075662 Pedersen et al. Apr 2005 A1
20050075712 Biancucci et al. Apr 2005 A1
20050075717 Nguyen et al. Apr 2005 A1
20050075719 Bergheim Apr 2005 A1
20050075724 Svanidze et al. Apr 2005 A1
20050075730 Myers et al. Apr 2005 A1
20050075731 Artof et al. Apr 2005 A1
20050085841 Eversull et al. Apr 2005 A1
20050085842 Eversull et al. Apr 2005 A1
20050085843 Opolski et al. Apr 2005 A1
20050085890 Rasmussen et al. Apr 2005 A1
20050090846 Pedersen et al. Apr 2005 A1
20050090890 Wu et al. Apr 2005 A1
20050096692 Linder et al. May 2005 A1
20050096734 Majercak et al. May 2005 A1
20050096735 Hojeibane et al. May 2005 A1
20050096736 Osse et al. May 2005 A1
20050096738 Cali et al. May 2005 A1
20050100580 Osborne et al. May 2005 A1
20050107822 WasDyke May 2005 A1
20050113910 Paniagua et al. May 2005 A1
20050131438 Cohn Jun 2005 A1
20050137683 Hezi-Yamit et al. Jun 2005 A1
20050137686 Salahieh et al. Jun 2005 A1
20050137687 Salahieh et al. Jun 2005 A1
20050137688 Salahieh et al. Jun 2005 A1
20050137689 Salahieh et al. Jun 2005 A1
20050137690 Salahieh et al. Jun 2005 A1
20050137691 Salahieh et al. Jun 2005 A1
20050137692 Haug et al. Jun 2005 A1
20050137693 Haug et al. Jun 2005 A1
20050137694 Haug et al. Jun 2005 A1
20050137695 Salahieh et al. Jun 2005 A1
20050137696 Salahieh et al. Jun 2005 A1
20050137697 Salahieh et al. Jun 2005 A1
20050137698 Salahieh et al. Jun 2005 A1
20050137699 Salahieh et al. Jun 2005 A1
20050137701 Salahieh et al. Jun 2005 A1
20050137702 Haug et al. Jun 2005 A1
20050138689 Aukerman Jun 2005 A1
20050143807 Pavcnik et al. Jun 2005 A1
20050143809 Salahieh et al. Jun 2005 A1
20050149159 Andreas et al. Jul 2005 A1
20050165352 Henry et al. Jul 2005 A1
20050165477 Anduiza et al. Jul 2005 A1
20050165479 Drews et al. Jul 2005 A1
20050182486 Gabbay Aug 2005 A1
20050197694 Pai et al. Sep 2005 A1
20050197695 Stacchino et al. Sep 2005 A1
20050203549 Realyvasquez Sep 2005 A1
20050203614 Forster et al. Sep 2005 A1
20050203615 Forster et al. Sep 2005 A1
20050203616 Cribier Sep 2005 A1
20050203617 Forster et al. Sep 2005 A1
20050203618 Sharkawy et al. Sep 2005 A1
20050203818 Rotman et al. Sep 2005 A9
20050209580 Freyman Sep 2005 A1
20050228472 Case et al. Oct 2005 A1
20050228495 Macoviak Oct 2005 A1
20050234546 Nugent et al. Oct 2005 A1
20050240200 Bergheim Oct 2005 A1
20050240262 White Oct 2005 A1
20050251250 Verhoeven et al. Nov 2005 A1
20050251251 Cribier Nov 2005 A1
20050261759 Lambrecht et al. Nov 2005 A1
20050267560 Bates Dec 2005 A1
20050283231 Haug et al. Dec 2005 A1
20050283962 Boudjemline Dec 2005 A1
20060004439 Spenser et al. Jan 2006 A1
20060004442 Spenser et al. Jan 2006 A1
20060015168 Gunderson Jan 2006 A1
20060025854 Lashinski et al. Feb 2006 A1
20060025855 Lashinski et al. Feb 2006 A1
20060025857 Bergheim et al. Feb 2006 A1
20060058872 Salahieh et al. Mar 2006 A1
20060149360 Schwammenthal et al. Jul 2006 A1
20060155312 Levine et al. Jul 2006 A1
20060161249 Realyvasquez et al. Jul 2006 A1
20060173524 Salahieh et al. Aug 2006 A1
20060195183 Navia et al. Aug 2006 A1
20060195184 Lane et al. Aug 2006 A1
20060195185 Lane et al. Aug 2006 A1
20060253191 Salahieh et al. Nov 2006 A1
20060259134 Schwammenthal et al. Nov 2006 A1
20060259137 Artof et al. Nov 2006 A1
20060271166 Thill et al. Nov 2006 A1
20060271172 Tehrani Nov 2006 A1
20060287668 Fawzi et al. Dec 2006 A1
20060287717 Rowe et al. Dec 2006 A1
20070010876 Salahieh et al. Jan 2007 A1
20070010877 Salahieh et al. Jan 2007 A1
20070016286 Herrmann et al. Jan 2007 A1
20070018214 Ahn et al. Jan 2007 A1
20070027535 Purdy, Jr. et al. Feb 2007 A1
20070055340 Pryor Mar 2007 A1
20070061008 Salahieh et al. Mar 2007 A1
20070112355 Salahieh et al. May 2007 A1
20070118214 Salahieh et al. May 2007 A1
20070129795 Hill et al. Jun 2007 A1
20070162107 Haug et al. Jul 2007 A1
20070173918 Dreher et al. Jul 2007 A1
20070203503 Salahieh et al. Aug 2007 A1
20070244552 Salahieh et al. Oct 2007 A1
20070282436 Pinchuk Dec 2007 A1
20070288089 Gurskis et al. Dec 2007 A1
20080009940 Cribier Jan 2008 A1
20080033541 Gelbart et al. Feb 2008 A1
20080033543 Gurskis et al. Feb 2008 A1
20080071363 Tuval et al. Mar 2008 A1
20080082165 Wilson et al. Apr 2008 A1
20080125859 Salahieh et al. May 2008 A1
20080188928 Salahieh et al. Aug 2008 A1
20080208328 Antocci et al. Aug 2008 A1
20080208332 Lamphere et al. Aug 2008 A1
20080221672 Lamphere et al. Sep 2008 A1
20080234814 Salahieh et al. Sep 2008 A1
20080255661 Straubinger et al. Oct 2008 A1
20080269878 Iobbi Oct 2008 A1
20080275540 Wen Nov 2008 A1
20080288054 Pulnev et al. Nov 2008 A1
20090005863 Goetz et al. Jan 2009 A1
20090030512 Thielen et al. Jan 2009 A1
20090054969 Salahieh et al. Feb 2009 A1
20090076598 Salahieh et al. Mar 2009 A1
20090093877 Keidar et al. Apr 2009 A1
20090171456 Kveen et al. Jul 2009 A1
20090216312 Straubinger et al. Aug 2009 A1
20090222076 Figulla et al. Sep 2009 A1
20090240320 Tuval et al. Sep 2009 A1
20090264759 Byrd Oct 2009 A1
20090264997 Salahieh et al. Oct 2009 A1
20090299462 Fawzi et al. Dec 2009 A1
20100023120 Holecek et al. Jan 2010 A1
20100100176 Elizondo et al. Jan 2010 A1
20100036479 Hill et al. Feb 2010 A1
20100036484 Hariton et al. Feb 2010 A1
20100049313 Alon et al. Feb 2010 A1
20100082089 Quadri et al. Apr 2010 A1
20100082094 Quadri et al. Apr 2010 A1
20100094399 Dorn et al. Apr 2010 A1
20100121434 Paul et al. May 2010 A1
20100131054 Tuval et al. May 2010 A1
20100161045 Righini Jun 2010 A1
20100168844 Toomes et al. Jul 2010 A1
20100185275 Richter et al. Jul 2010 A1
20100191320 Straubinger et al. Jul 2010 A1
20100191326 Alkhatib Jul 2010 A1
20100191327 Lane et al. Jul 2010 A1
20100219092 Salahieh et al. Sep 2010 A1
20100249894 Oba et al. Sep 2010 A1
20100249908 Chau et al. Sep 2010 A1
20100249915 Zhang Sep 2010 A1
20100249916 Zhang Sep 2010 A1
20100249917 Zhang Sep 2010 A1
20100249918 Zhang Sep 2010 A1
20100256752 Forster et al. Oct 2010 A1
20100262231 Tuval et al. Oct 2010 A1
20100280495 Paul et al. Nov 2010 A1
20100298931 Quadri et al. Nov 2010 A1
20110000073 O'Fallon et al. Jan 2011 A1
20110098802 Braido et al. Apr 2011 A1
20110125258 Centola May 2011 A1
20110166648 Robin et al. Jul 2011 A1
20110172765 Nguyen et al. Jul 2011 A1
20110213460 Lashinski et al. Sep 2011 A1
20110218619 Benichou et al. Sep 2011 A1
20110224781 White Sep 2011 A1
20110230956 White Sep 2011 A1
20110245918 White Oct 2011 A1
20110257735 Salahieh et al. Oct 2011 A1
20110264196 Savage et al. Oct 2011 A1
20110276128 Cao et al. Nov 2011 A1
20110276129 Salahieh et al. Nov 2011 A1
20110288634 Tuval et al. Nov 2011 A1
20110295363 Girard et al. Dec 2011 A1
20110319991 Hariton et al. Dec 2011 A1
20120016469 Salahieh et al. Jan 2012 A1
20120016471 Salahieh et al. Jan 2012 A1
20120022629 Perera et al. Jan 2012 A1
20120022642 Haug et al. Jan 2012 A1
20120029627 Salahieh et al. Feb 2012 A1
20120041549 Salahieh et al. Feb 2012 A1
20120041550 Salahieh et al. Feb 2012 A1
20120046740 Paul et al. Feb 2012 A1
20120053683 Salahieh et al. Mar 2012 A1
20120059454 Millwee et al. Mar 2012 A1
20120078356 Fish et al. Mar 2012 A1
20120078357 Conklin Mar 2012 A1
20120089224 Haug et al. Apr 2012 A1
20120095549 Forster et al. Apr 2012 A1
20120101567 Jansen Apr 2012 A1
20120123529 Levi et al. May 2012 A1
20120132547 Salahieh et al. May 2012 A1
20120136432 Forster et al. May 2012 A1
20120143316 Seguin et al. Jun 2012 A1
20120179244 Schankereli et al. Jul 2012 A1
20120185039 Tuval et al. Jul 2012 A1
20120197379 Laske et al. Aug 2012 A1
20120226348 Lane et al. Sep 2012 A1
20120232459 Dann et al. Sep 2012 A1
20120245706 Alavi et al. Sep 2012 A1
20120259409 Nguyen et al. Oct 2012 A1
20120303113 Benichou et al. Nov 2012 A1
20120303116 Gorman et al. Nov 2012 A1
20120330409 Haug et al. Dec 2012 A1
20130013057 Salahieh et al. Jan 2013 A1
20130018457 Gregg et al. Jan 2013 A1
20130030520 Lee et al. Jan 2013 A1
20130079867 Hoffman et al. Mar 2013 A1
20130079869 Straubinger et al. Mar 2013 A1
20130090729 Gregg et al. Apr 2013 A1
20130096664 Goetz et al. Apr 2013 A1
20130116778 Gregg et al. May 2013 A1
20130123796 Sutton et al. May 2013 A1
20130138207 Quadri et al. May 2013 A1
20130158656 Sutton et al. Jun 2013 A1
20130184813 Quadri et al. Jul 2013 A1
20130190865 Anderson Jul 2013 A1
20130304199 Sutton et al. Nov 2013 A1
20140000112 Braido et al. Jan 2014 A1
20140005772 Edelman et al. Jan 2014 A1
20140018911 Zhou et al. Jan 2014 A1
20140094904 Salahieh et al. Apr 2014 A1
20140114405 Paul et al. Apr 2014 A1
20140114406 Salahieh et al. Apr 2014 A1
20140121766 Salahieh et al. May 2014 A1
20140135912 Salahieh et al. May 2014 A1
20140172077 Bruchman et al. Jun 2014 A1
20140243966 Garde et al. Aug 2014 A1
20140243967 Salahieh et al. Aug 2014 A1
20140277417 Schraut et al. Sep 2014 A1
20140277423 Alkhatib et al. Sep 2014 A1
20150005863 Para Jan 2015 A1
20150012085 Salahieh et al. Jan 2015 A1
20150073540 Salahieh et al. Mar 2015 A1
20150073541 Salahieh et al. Mar 2015 A1
20150127094 Salahieh et al. May 2015 A1
20150142104 Braido May 2015 A1
20150157455 Hoang et al. Jun 2015 A1
20150320552 Letac et al. Nov 2015 A1
20150320556 Levi et al. Nov 2015 A1
20160045307 Yohanan et al. Feb 2016 A1
20160199184 Ma et al. Jul 2016 A1
20170042672 Backus Feb 2017 A1
20170049566 Zeng et al. Feb 2017 A1
Foreign Referenced Citations (186)
Number Date Country
2002329324 Jul 2007 AU
2011202667 Sep 2012 AU
1338951 Mar 2002 CN
19532846 Mar 1997 DE
19546692 Jun 1997 DE
19857887 Jul 2000 DE
19907646 Aug 2000 DE
10049812 Apr 2002 DE
10049813 Apr 2002 DE
10049814 Apr 2002 DE
10049815 Apr 2002 DE
0103546 May 1988 EP
0144167 Nov 1989 EP
579523 Jan 1994 EP
0409929 Apr 1997 EP
0850607 Jul 1998 EP
0597967 Dec 1999 EP
1000590 May 2000 EP
1057459 Dec 2000 EP
1057460 Dec 2000 EP
1078610 Feb 2001 EP
1088529 Apr 2001 EP
0937439 Sep 2003 EP
1340473 Sep 2003 EP
1356793 Mar 2004 EP
1042045 May 2004 EP
0819013 Jun 2004 EP
1430853 Jun 2004 EP
1435879 Jul 2004 EP
1439800 Jul 2004 EP
1469797 Oct 2004 EP
1472996 Nov 2004 EP
1229864 Apr 2005 EP
1059894 Jul 2005 EP
1551274 Jul 2005 EP
1551336 Jul 2005 EP
1562515 Aug 2005 EP
1570809 Sep 2005 EP
1576937 Sep 2005 EP
1582178 Oct 2005 EP
1582179 Oct 2005 EP
1589902 Nov 2005 EP
1600121 Nov 2005 EP
1156757 Dec 2005 EP
1616531 Jan 2006 EP
1605871 Jul 2008 EP
2119417 Nov 2009 EP
2749254 Jun 2015 EP
2898858 Jul 2015 EP
2926766 Oct 2015 EP
2788217 Jul 2000 FR
2056023 Mar 1981 GB
2398245 Aug 2004 GB
2006333940 Dec 2006 JP
1271508 Nov 1986 SU
1371700 Feb 1988 SU
9117720 Nov 1991 WO
9217118 Oct 1992 WO
9301768 Feb 1993 WO
9315693 Aug 1993 WO
9504556 Feb 1995 WO
9529640 Nov 1995 WO
9614032 May 1996 WO
9624306 Aug 1996 WO
9640012 Dec 1996 WO
9721403 Jun 1997 WO
9748350 Dec 1997 WO
9829057 Jul 1998 WO
9836790 Aug 1998 WO
9850103 Nov 1998 WO
9855047 Dec 1998 WO
9857599 Dec 1998 WO
9933414 Jul 1999 WO
9940964 Aug 1999 WO
9944542 Sep 1999 WO
9947075 Sep 1999 WO
9951165 Oct 1999 WO
0009059 Feb 2000 WO
2000009059 Feb 2000 WO
0041652 Jul 2000 WO
0044308 Aug 2000 WO
0044311 Aug 2000 WO
0044313 Aug 2000 WO
0045874 Aug 2000 WO
0047139 Aug 2000 WO
0049970 Aug 2000 WO
0067661 Nov 2000 WO
0105331 Jan 2001 WO
0106958 Feb 2001 WO
0106959 Feb 2001 WO
0108596 Feb 2001 WO
0110320 Feb 2001 WO
0110343 Feb 2001 WO
0135870 May 2001 WO
0149213 Jul 2001 WO
0154625 Aug 2001 WO
0162189 Aug 2001 WO
2001054625 Aug 2001 WO
0164137 Sep 2001 WO
0176510 Oct 2001 WO
0197715 Dec 2001 WO
0236048 May 2002 WO
0241789 May 2002 WO
0243620 Jun 2002 WO
0247575 Jun 2002 WO
02056955 Jul 2002 WO
02069842 Sep 2002 WO
02100297 Dec 2002 WO
03003943 Jan 2003 WO
03003949 Jan 2003 WO
03011195 Feb 2003 WO
03015851 Feb 2003 WO
03028592 Apr 2003 WO
03030776 Apr 2003 WO
03032869 Apr 2003 WO
03037222 May 2003 WO
03037227 May 2003 WO
03047468 Jun 2003 WO
03047648 Jun 2003 WO
03088873 Oct 2003 WO
03094793 Nov 2003 WO
03094797 Nov 2003 WO
03096932 Nov 2003 WO
2004006803 Jan 2004 WO
2004006804 Jan 2004 WO
2004014256 Feb 2004 WO
2004019817 Mar 2004 WO
2004021922 Mar 2004 WO
2004023980 Mar 2004 WO
2004019811 Apr 2004 WO
2004026117 Apr 2004 WO
2004041126 May 2004 WO
2004043293 May 2004 WO
2004047681 Jun 2004 WO
2004058106 Aug 2004 WO
2004066876 Aug 2004 WO
2004082536 Sep 2004 WO
2004089250 Oct 2004 WO
2004089253 Oct 2004 WO
2004093728 Nov 2004 WO
2004105651 Dec 2004 WO
2005002466 Jan 2005 WO
2005004753 Jan 2005 WO
2005009285 Feb 2005 WO
2005011534 Feb 2005 WO
2005011535 Feb 2005 WO
2005023155 Mar 2005 WO
2005027790 Mar 2005 WO
2005046528 May 2005 WO
2005046529 May 2005 WO
2005048883 Jun 2005 WO
2005065585 Jul 2005 WO
2005084595 Sep 2005 WO
2005087140 Sep 2005 WO
2005096993 Oct 2005 WO
2006005015 Jan 2006 WO
2006009690 Jan 2006 WO
2006027499 Mar 2006 WO
2005062980 May 2006 WO
2006127412 Nov 2006 WO
2007028052 Mar 2007 WO
2007035471 Mar 2007 WO
2005102015 Apr 2007 WO
2006138391 Apr 2007 WO
2007044285 Apr 2007 WO
2007058847 May 2007 WO
2007092354 Aug 2007 WO
2007097983 Aug 2007 WO
2007053243 Sep 2007 WO
2007033093 Jan 2008 WO
2010042950 Apr 2010 WO
2010098857 Sep 2010 WO
2012116368 Aug 2012 WO
2012162228 Nov 2012 WO
2013009975 Jan 2013 WO
2013012801 Jan 2013 WO
2013028387 Feb 2013 WO
2013074671 May 2013 WO
2013096545 Jun 2013 WO
2014008207 Jan 2014 WO
2015152980 Oct 2015 WO
2016126511 Aug 2016 WO
2016126524 Aug 2016 WO
2016164209 Oct 2016 WO
2017027289 Feb 2017 WO
2017189671 Nov 2017 WO
Non-Patent Literature Citations (112)
Entry
US 8,062,356 B2, 11/2011, Salahieh et al. (withdrawn)
US 8,062,357 B2, 11/2011, Salahieh et al. (withdrawn)
US 8,075,614 B2, 12/2011, Salahieh et al. (withdrawn)
US 8,133,271 B2, 03/2012, Salahieh et al. (withdrawn)
US 8,211,170 B2, 07/2012, Paul et al. (withdrawn)
Cribier et al., “Percutaneous Transluminal Valvuloplasty of Acquired Aortic Stenosis in Elderly Patients: An Alternative to Valve Replacement?” The Lancet, 63-7 (Jan. 11, 1986).
Supplemental Search Report from EP Patent Office, EP Application No. 04813777.2, dated Aug. 19, 2011.
Laborde et al., “Percutaneous Implantation of the Corevalve Aortic Valve Prosthesis for Patients Presenting High Risk for Surgical Valve Replacement.” EuroIntervention: 472-474, Feb. 2006.
“A Matter of Size.” Triennial Review of the National Nanotechnology Initiative, The National Academies Press, Washington DC, v-13, http://www.nap.edu/catalog/11752/a-matter-of-size-triennial-review-of-the-national-nanotechnology, 2006.
“Heart Valve Materials—Bovine (cow).” Equine & Porcine Pericardium, Maverick Biosciences Pty. Lt, http://maverickbio.com/biological-medical-device-materials.php?htm. 2009.
“Pericardial Heart Valves.” Edwards Lifesciences, Cardiovascular Surgery FAQ, http://www.edwards.com/products/cardiovascularsurgeryfaq.htm, Nov. 14, 2010.
Allen et al., “What are the characteristics of the ideal endovascular graft for abdominal aortic aneurysm exclusion?” J. Endovasc. Surg., 4(2):195-202 (May 1997).
Andersen et al. “Transluminal catheter implantation of a new expandable artificial cardiac valve (the stent—valve) in the aorta and the beating heart of closed chest pigs (Abstract).” Eur. Heart J., 11 (Suppl.): 224a (1990).
Andersen et al., “Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.” Euro. Heart J., 13:704-708, May 1992.
Atwood et al., “Insertion of Heart Valves by Catheterization.” Project Supervised by Prof. S. Muftu of Northeastern University 2001-2002: 36-40, May 30, 2002.
Atwood et al., “Insertion of Heart Valves by Catheterization.” The Capstone Design Course Report. MIME 1501-1502. Technical Design Report. Northeastern University, pp. 1-93, Nov. 5, 2007.
Bailey, “Percutaneous Expandable Prosthetic Valves, Textbook of Interventional Cardiology.” vol. 2, 2d ed. Eric J. Topol, W.B. Saunders Co. (1994).
Blum et al., “Endoluminal Stent-Grafts for Intrarenal Abdominal Aortic Aneurysms.” New Engl. J. Med., 336:13-20 (1997).
Bodnar et al., “Replacement Cardiac Valves R Chapter 13: Extinct Cardiac Valve Prostheses.” Pergamon Publishing Corporation New York, 307-322, 1991.
Bonhoeffer et al., “Percutaneous Insertion of the Pulmonary Valve.” J. Am. Coll. Cardiol., 39:1664-9 (2002).
Bonhoeffer et al., “Transcatheter Implantation of a Bovine Valve in Pulmonary Position: A Lamb Study.” Circulation, 102: 813-16 (2000).
Bonhoeffer, et al., “Percutaneous replacement of pulmonary valve in a right ventricle to pulmonary-artery prosthetic conduit with valve dysfunction.” The Lancet, vol. 356, 1403-05 (Oct. 21, 2000).
Boudjemline et al., “Percutaneous Implantation of a Biological Valve in the Aorta to Treat Aortic Valve Insufficiency—A Sheep Study.” Med Sci. Monit., vol. 8, No. 4: BR113-116, Apr. 12, 2002.
Boudjemline et al., “Percutaneous Implantation of a Valve in the Descending Aorta in Lambs.” Euro. Heart J., 23: 1045-1049, Jul. 2002.
Boudjemline et al., “Percutaneous Pulmonary Valve Replacement in a Large Right Ventricular Outflow Tract: An Experimental Study.” Journal of the American College of Cardiology, vol. 43(6): 1082-1087, Mar. 17, 2004.
Boudjemline et al., “Percutaneous Valve Insertion: A New Approach?” J. of Thoracic and Cardio. Surg, 125(3): 741-743, Mar. 2003.
Boudjemline et al., “Steps Toward Percutaneous Aortic Valve Replacement.” Circulation, 105: 775-778, Feb. 12, 2002.
Couper, “Surgical Aspects of Prosthetic Valve Selection,” Overview of Cardiac Surgery for the Cardiologist, Springer-Verlag New York, Inc., 131-145 (1994).
Cribier et al., “Early Experience with Percutaneous Transcatheter Implantation of Heart Valve Prosthesis for the Treatment of End-Stage Inoperable Patients with Calcific Aortic Stenosis.” J. of Am. Coll. of Cardio, 43(4): 698-703, Feb. 18, 2004.
Cribier et al., “Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis First Human Case.” Percutaneous Valve Technologies, Inc., 16 pages, Apr. 16, 2002.
Cribier et al., “Percutaneous Transcatheter Implementation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis: First Human Case Description.” Circulation, 106: 3006-3008, Dec. 10, 2002.
Cribier et al., “Trans-Cathether Implantation of Balloon-Expandable Prosthetic Heart Valves: Early Results in an Animal Model.” Circulation [suppl. II] 104(17) II-552 (Oct. 23, 2001).
Cunanan et al., “Tissue Characterization and Calcification Potential of Commercial Bioprosthetic Heart Valves.” Ann. Thorac. Surg., S417-421, May 15, 2001.
Cunliffe et al., “Glutaraldehyde Inactivation of Exotic Animal Viruses in Swine Heart Tissue.” Applied and Environmental Microbiology, Greenport, New York, 37(5): 1044 1046, May 1979.
Dake et al., “Transluminal Placement of Endovascular Stent-Grafts for the Treatment of Descending Thoracic Aortic Aneurysms.” New Engl. J of Med., 331(26):1729-34 (1994).
Dalby et al., “Non-Surgical Aortic Valve Replacement” Br. J. Cardiol., 10:450-2 (2003).
Ohasmana, et al., “Factors Associated With Periprosthetic Leakage Following Primary Mitral Valve Replacement With Special Consideration of Suture Technique.” Annals of Thorac. Surg. 35(2), 170-8 (Feb. 1983).
Diethrich, AAA Stent Grafts: Current Developments, J. Invasive Cardiol. 13(5) (2001).
Dolmatch et al., Stent Grafts: Current Clinical Practice (2000)—EVT Endograft and Talent Endoprosthesis.
Dotter, “Transluminally-Placed Coilspring Endarterial Tube Grafts,” Investigative Radiology, pp. 329-332 (1969).
Emery et al., “Replacement of the Aortic Valve in Patients Under 50 Years of Age: Long-Term Follow-Up of the St. Jude Medical Prosthesis.” Ann. Thorac. Surg., 75:1815-9 (2003).
EP Search Report for EP Application No. 06824992.9, dated Aug. 10, 2011.
Examiner's First Report on AU Patent Application No. 2011202667, dated May 17, 2012.
Ferrari et al., “Percutaneous Transvascular Aortic Valve Replacement with Self-Expanding Stent-Valve Device.” Poster from the presentation given at SMIT 2000, 12th International Conference Sep. 5, 2000.
Greenberg, “Abdominal Aortic Endografting: Fixation and Sealing.” J. Am. Coll. Surg. 194:1:S79-S87 (2002).
Grossi, “Impact of Minimally Invasive Valvular Heart Surgery: A Case-Control Study.” Ann. Thorac. Surg., 71:807-10 (2001).
Helmus, “Mechanical and Bioprosthetic Heart Valves in Biomaterials for Artificial Organs.” Woodhead Publishing Limited: 114-162, 2011.
Hijazi, “Transcatheter Valve Replacement: A New Era of Percutaneous Cardiac Intervention Begins.” J. of Am. College of Cardio., 43(6): 1088-1089, Mar. 17, 2004.
Hourihan et al., “Transcatheter Umbrella Closure of Valvular and Paravalvular Leaks.” JACC, Boston, Massachusetts, 20(6): 1371-1377, Nov. 15, 1992.
Huber et al., “Do Valved Stents Compromise Coronary Flow?” European Journal of Cardio-thoracic Surgery, vol. 25: 754-759, Jan. 23, 2004.
Ing, “Stents: What's Available to the Pediatric Interventional Cardiologist?” Catheterization and Cardiovascular Interventions 57:274-386 (2002).
Ionescu, et al., “Prevalence and Clinical Significance of Incidental Paraprosthetic Valvar Regurgitation: A prospective study using transesophageal echocardiography.” Heart, 89:1316-21 (2003).
Kaiser, et al., “Surgery for Left Ventricle Outflow Obstruction: Aortic Valve Replacement and Myomectomy,” Overview of Cardiac Surgery for the Cardiologist. Springer-Verlag New York, Inc., 40-45 (1994).
Kato et al., “Traumatic Thoracic Aortic Aneurysm: Treatment with Endovascular Stent-Grafts.” Radiol., 205: 657-662 (1997).
Khonsari et al., “Cardiac Surgery: Safeguards and Pitfalls in Operative Technique.” 3d ed., 45-74 (2003).
International Search Report and Written Opinion dated May 21, 2019 for International Application No. PCT/US2019/019479.
Carpentier-Edwards PERIMOUNT Bioprosthesis (2003).
Knudsen et al., “Catheter-implanted prosthetic heart valves.” Int'l J. of Art. Organs, 16(5): 253-262, May 1993.
Kort et al., “Minimally Invasive Aortic Valve Replacement: Echocardiographic and Clinical Results ”Am Heart J., 142(3): 476-481, Sep. 2001.
Lawrence et al., “Percutaneous Endovascular Graft: Experimental Evaluation,” Radiology, 163(2): 357-60 (May 1987).
Levi et al., “Future of Interventional Cardiology in Pediactrics.” Current Opinion in Cardiol., 18:79-90 (2003).
Levy, “Mycobacterium chelonei Infection of Porcine Heart Valves.” The New England Journal of Medicine, Washington DC, 297(12), Sep. 22, 1977.
Love et al., The Autogenous Tissue Heart Valve: Current Status. Journal of Cardiac Surgery, 6(4): 499-507, Mar. 1991.
Lutter et al., “Percutaneous Aortic Valve Replacement: An Experimental Study. I. Studies on Implantation.” J. of Thoracic and Cardio. Surg., 123(4): 768-776, Apr. 2002.
Magovern et al., “Twenty-five-Year Review of the Magovern-Cromie Sutureless Aortic Valve.” Ann. Thorac. Surg., 48:533-4 (1989).
Maraj et al., Evaluation of Hemolysis in Patients with Prosthetic Heart Valves, Clin. Cardiol. 21, 387-392 (1998).
Mckay et al., “The Mansfield Scientific Aortic Valvuloplasty Registry: Overview of Acute Hemodynamic Results and Procedural Complications.” J. Am. Coll. Cardiol. 17(2): 485-91 (Feb. 1991).
Mirich et al., “Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study.” Radiology, 170 1033-1037 (1989).
Moazami et al., “Transluminal Aortic Valve Placement: A Feasibility Study With a Newly Designed Collapsiable Aortic Valve,” ASAIO J vol. 42:5, pp. M383-M385 (Sep. /Oct. 1996).
Moulopoulos et al., “Catheter-Mounted Aortic Valves.” Annals of Thoracic Surg., 11 (5): 423-430, May 1971.
Paniagua et al., “Heart Watch.” Texas Heart Institute. Edition: 8 pages, Spring, 2004.
Paniagua et al., “Percutaneous Heart Valve in the Chronic in Vitro Testing Model.” Circulation, 106: e51-e52, Sep. 17, 2002.
Parodi et al., “Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms.” Ann. Vase. Surg., 5 (6):491-9 (1991).
Pavcnik et al., “Percutaneous Bioprosthetic Venous Valve: A Long-term Study in Sheep.” J. of Vascular Surg., 35(3): 598-603, Mar. 2002.
Pavcnik et al., “Development and Initial Experimental Evaluation of a Prosthetic Aortic Valve for Transcatheter Placement.” Radiology 183:151-54 (1992).
Pavcnik, et al., “Aortic and venous valve for percutaneous insertion,” Min. Invas. Ther. & Allied Technol. 9(3/4) 287-292 (2000).
Phillips et al., “A Temporary Catheter-Tip Aortic Valve: Hemodynamic Effects on Experimental Acute Aortic Insufficiency.” Annals of Thoracic Surg., 21(2): 134-136, Feb. 1976.
Printz, et al., “Let the Blood Circulate.” Sulzer Tech. Rev. Apr. 1999.
U.S. Appl. No. 60/553,945 to White.
Raillat et al., “Treatment of Iliac Artery Stenosis with the Wallstent Endoprosthesis.” AJR 154(3):613-6 (Mar. 1990).
Remadi et al., “Preliminary results of 130 aortic valve replacements with a new mechanical bileaflet prosthesis: the Edwards MIRA valve” Interactive Cardiovasc. and Thorac. Surg. 2, 80-83 (2003).
Rosch et al., “Gianturco-Rosch Expandable Z-Stents in the Treatment of Superior Vena Cava Syndrome.” Cardiovasc. Intervent. Radiol. 15: 319-327 (1992).
Schurink et al,. “Stent Attachment Site-related Endoleakage after Stent Graft Treatment: An in vitro study of the effects of graft size, stent type, and atherosclerotic wall changes” J. Vase. Surg., 30(4):658-67 (Oct. 1999).
Seminars in Interventional Cardiology, ed. P.W. Surruys, vol. 5 (2000).
Sochman et al., “Percutaneous Transcatheter Aortic Disc Valve Prosthesis Implantation: A Feasibility Study.” Cardiovasc. Intervent. Radiol., 23: 384-388, Sep. 2000.
Southern Lights Biomaterials Homepage, http://www.slv.co.nz/, Jan. 7, 2011.
Stanley et al., “Evaluation of Patient Selection Guidelines for Endoluminal AAA Repair With the Zenith Stent Graft: The Australasian Experience.” J. Endovasc. Ther. 8:457-464 (2001).
Stassano, “Mid-term Results of the Valve-on-Valve Technique for Bioprosthetic Failure.” European Journal of Cardiothoracic Surgery: vol. 18, 453-457, Oct. 2000.
Steinhoff et al., “Tissue Engineering of Pulmonary Heart Valves on Allogenic Acellular Matrix Conduits.” Circulation, 102 [suppl. III]: III-50-III-55 (2000).
Stuart, “In Heart Valves, A Brave, New Non-Surgical World.” Start-Up. 9-17, Feb. 2004.
Supplemental Search Report from EP Patent Office, EP Application No. 04815634.3, dated Aug. 19, 2011.
Supplemental Search Report from EP Patent Office, EP Application No. 05758878.2, dated Oct. 24, 2011.
Textbook of Interventional Cardiology, 2d Ed., Chapter 75: Percutaneous Expandable Prosthetic Valves (1994).
Thompson et al., “Endoluminal stent grafting of the thoracic aorta: Initial experience with the Gore Excluder,” Journal of Vascular Surgery, 1163-70 (Jun. 2002).
Topol, “Percutaneous Expandable Prosthetic Valves.” Textbook of Interventional Cardiology, W.B. Saunders Company, 2: 1268-1276, 1994.
Vahanian et al., “Percutaneous Approaches to Valvular Disease.” Circulation, 109: 1572-1579, Apr. 6, 2004.
Van Herwerden et al., “Percutaneous Valve Implantation: Back to the Future?” Euro. Heart J., 23(18): 1415-1416, Sep. 2002.
VentureBeatProfiles, Claudio Argento, Jan. 7, 2010, http://venturebeatprofiles.com/person/profile/claudio-argento.
Vossoughi et al., Stent Graft Update (2000)—Kononov, Volodos, and Parodi and Palmaz Stents; Hemobahn Stent Graft.
White et al., “Endoleak as a Complication of Endoluminal Grafting of Abdominal Aortic Aneurysms: Classification, Incidence, Diagnosis, and Management.” J. Endovac. Surg., 4:152-168 (1997).
Yoshioka et al., “Self-Expanding Endovascular Graft: An Experimental Study in Dogs.” AJR 151: 673-76 (Oct. 1988).
USPTO Case IPR2017-01293, U.S. Pat. No. 8,992,608 B, Oct. 13, 2017.
Zhou et al., “Self-expandable Valved Stent of Large Size: Off-Bypass Implantation in Pulmonary Position.” Eur. J. Cardiothorac, 24: 212-216, Aug. 2003.
Gore Excluder Instructions for Use (2002).
USPTO Case IPR2016-_, U.S. Pat. No. 8,992,608 “Petition for Interpartes Review of U.S. Pat. No. 8,992,608” Oct. 12, 2016.
USPTO Case IPR 2017-0006, U.S. Pat. No. 8,992,608 B2, “Final Written Decision” dated Mar. 23, 2018.
Fluency Vascular Stent Graft Instructions for Use (2003).
Invite to Pay Additional Fees and, Where Applicable, Protest Fee, PCT/US2016/045335, dated Nov. 14, 2016.
International Search Report and Written Opinion dated Aug. 16, 2017 for International Application No. PCT/US2017/033160.
International Search Report and Written Opinion, PCT/US2016/045323, dated Feb. 2, 2017.
International Search Report and Written Opinion dated Jul. 11, 2017 for International Application No. PCT/US2017/029552.
Martin et al., “A radiopaque electrospun scaffold for engineering fibrous musculoskelatal tissues: scaffold characterization an in vivo applications” Acta Biomater, (26): 20 pages, Oct. 15, 2015.
Related Publications (1)
Number Date Country
20190262507 A1 Aug 2019 US
Provisional Applications (1)
Number Date Country
62635236 Feb 2018 US