Abstract: Aspects of the disclosure include sizing catheters and methods for determining the size and other physical parameters of an internal orifice or lumen. Embodiments include a sizing catheter assembly having a handle assembly and a catheter assembly including at least one catheter extending from the handle assembly. The catheter assembly also includes at least two sizers, which can be adjustably spaced from each other. Each of the sizers are configured to conform to respective portions of a lumen of a patient's anatomy. The sizing catheter is configured such that the sizers are configured to specify or determine first and second dimensions of the lumen and also distance between the sizers. The sizers can include valve leaflets or the sizing catheter can include a temporary valve. Additional aspects include software/methods of assessing and determining an appropriate implantable device that can include assessing the biomechanical interaction between the device and the anatomy.

Abstract: A balloon catheter includes a balloon coupled to a shaft. The shaft includes a proximal perfusion portion disposed proximal of the balloon and a distal perfusion portion disposed distal of the balloon. The proximal and distal perfusion portions each are formed by a respective plurality of wire members woven together to form a respective proximal and distal braided shafts. The plurality of wire members are woven together such that a plurality of perfusion openings are formed between the wire members. The plurality of perfusion openings extend from an outer surface of the respective proximal or distal braided shaft to a lumen of the respective proximal or distal braided shaft. A perfusion lumen extends between the proximal perfusion portion and the distal perfusion portion.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stem adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: A stent and a method for manufacturing a stent are provided. The stent includes a first ring having a plurality of peaks and a plurality of valleys, a second ring having a plurality of peaks and a plurality of valleys, and a connector that connects one of the peaks of the first ring to one of the valleys of the second ring. The connected peak of the first ring includes a deformed portion that extends towards the connected valley of the second ring. The method includes forming a first ring having a plurality of peaks and a plurality of valleys, forming a second ring having a plurality of peaks and a plurality of valleys, deforming a portion of at least one of the peaks of the first ring, and connecting the deformed portion of the peak of the first ring to one of the valleys of the second ring.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the stent which includes a plurality of self-expanding struts and an annular sealing membrane. Each strut has a first end coupled to a distal end of the stent and a second end not coupled to the stent. Each anti-paravalvular leakage component is moveable between a compressed configuration and a deployed configuration. In the compressed configuration, each strut extends distally away from the distal end of the stent. In the deployed configuration, each strut extends proximally away from the distal end of the stent. In an embodiment hereof, the deployed strut has a C-shape and is twisted such that the C-shape lies in a plane substantially along or tangential with the outer surface of the stent. In another embodiment hereof, the deployed strut is rolled-up and extends radially away from the outer surface of the stent.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the stent which includes a plurality of self-expanding struts and an annular sealing membrane. Each strut has a first end coupled to a distal end of the stent and a second end not coupled to the stent. Each anti-paravalvular leakage component is moveable between a compressed configuration and a deployed configuration. In the compressed configuration, each strut extends distally away from the distal end of the stent. In the deployed configuration, each strut extends proximally away from the distal end of the stent. In an embodiment hereof, the deployed strut has a C-shape and is twisted such that the C-shape lies in a plane substantially along or tangential with the outer surface of the stent. In another embodiment hereof, the deployed strut is rolled-up and extends radially away from the outer surface of the stent.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: A method for manufacturing a balloon catheter assembly includes forming a balloon from a polymer selected from the group consisting of polyamide, polyether block amide, and polyethylene terephthalate, forming a plurality of pores in the polymer, and mounting the balloon onto a catheter shaft. The shaft is configured to supply a fluid to the balloon to inflate the balloon, and the pores are configured to prevent the fluid from passing through the balloon.

Abstract: A prosthesis can include a collapsible, reexpandable frame comprising first, second, and third sets of struts that define first and second rows of expandable cells. In some embodiments, the struts of the first, second, and third set of struts can be tapered. In some embodiments, the frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A laminated stent encapsulated with a metal coating is provided. The metal coating may be a very thin metal coating. Portions of the metal coating may be removed such that the metal coating covers voids in the laminate, particularly in the area where the different layers of the laminated stent come together. The metal coating for the laminated stent may be provided by sputtering, such as vacuum deposition or ion beam sputtering, spraying, dipping, or other known methods.

Abstract: A catheter assembly and method includes a multi-lumen portion having a guide wire lumen and an inflation/deployment lumen. The guide wire lumen includes a distal guide wire lumen portion having a rapid exchange guide wire port, and a proximal guide wire lumen portion rotatable to selectively expose the rapid exchange guide wire port. The inflation/deployment lumen includes a rotatable seal which facilitates rotation of the proximal guide wire lumen portion.

Abstract: The stent with cathodic protection and stent delivery system includes a stent delivery system including a catheter; a balloon operably attached to the catheter; and a stent disposed on the balloon. The stent includes a stent body having a first stent layer of an anodic stent material disposed about a second stent layer of a cathodic stent material; and a battery having a first battery layer of an anodic battery material and a second battery layer of a cathodic battery material. The first stent layer is electrically coupled to the first battery layer and the second stent layer is electrically coupled to the second battery layer.

Abstract: A stent and method of forming a stent include a wire bent into a waveform spirally wrapped into a hollow cylindrical shape. The waveform includes a first end portion, a middle portion, and a second end portion. The middle portion of the waveform includes a first amplitude and a first period. The first end portion of the waveform includes a first plurality of amplitudes and a first plurality of periods, wherein the first plurality of amplitudes decrease from adjacent the middle portion to a first end of the wire and first plurality of frequencies increase from adjacent the middle portion to the first end of the wire. The waveform may also include a second end portion with a second plurality of amplitudes and a second plurality of periods, wherein the second plurality of amplitudes decrease from adjacent the middle portion to a second end of the wire and the second plurality of frequencies increase from adjacent the middle portion to the second end of the wire.

Abstract: A stent includes a central portion having a first waveform. The first waveform is wrapped around a longitudinal axis of the stent at a pitch to define a plurality of helical turns. The stent also includes an end segment connected to one end of the central portion. The end segment has a second waveform that includes a plurality of struts and a plurality of crowns. Each of the plurality of struts has a different length so that peaks of the crowns that define an end of the stent lie within a plane that is substantially perpendicular to the longitudinal axis. Cross-sectional areas of the struts having different lengths vary so that the struts move substantially uniformly during radial contraction and/or radial expansion of the stent.

Abstract: A method for manufacturing a balloon catheter assembly includes forming a balloon from a polymer selected from the group consisting of polyamide, polyether block amide, and polyethylene terephthalate, forming a plurality of pores in the polymer, and mounting the balloon onto a catheter shaft. The shaft is configured to supply a fluid to the balloon to inflate the balloon, and the pores are configured to prevent the fluid from passing through the balloon.