Abstract: Catheter having a hypotube with a skive defined by a first angled cut, an axial cut, and a second angled cut. A midshaft member includes a guidewire lumen and an inflation lumen in fluid communication with an inflation lumen of the hypotube, the inflation lumen of the midshaft member configured to receive at least a portion of the hypotube. A distal tubular shaft member extends distally from the midshaft member. The distal tubular shaft member has a guidewire lumen and an inflation lumen defined therein, the guidewire lumen of the distal tubular shaft member in fluid communication with the guidewire lumen of the midshaft member. The inflation lumen of the distal tubular shaft member is in fluid communication with the inflation lumen of the midshaft member and a balloon is coupled to the distal tubular shaft member and in fluid communication with the inflation lumen.

Abstract: A method for manufacturing a shaping structure having a generally helical profile and configured to support electrodes for delivering electric energy into a cylindrical lumen of a patient. The method comprises providing a mandrel with a circular cylindrical shape and forming a first hole in the mandrel along the elongate axis, such that opposing ends of a bore of the first hole emerge at the proximal end and at the distal end; forming a second hole in the mandrel to extend from the curved surface to connect with the first hole; wrapping a metal wire around the mandrel; and inserting opposing ends of the metal wire into the second and the third hole respectively, and threading the opposing ends of the metal wire until they emerge from the opposing ends of the bore of the first hole; finally, heating the mandrel and the wire.

Abstract: A sheath used to protect a medical device has one or more strips formed over a portion thereof. The medical device is a scaffold crimped to a balloon and mounted to a catheter. The sheath is two-piece, including a protecting and constraining sheath part. The strips facilitate removal of the constraining sheath from the scaffold in manner that reduces instances of damage caused by improper removal of the sheath from the medical device.

Abstract: The invention is directed to an expandable stent for implantation in a body lumen, such as an artery, and a method for making it from a single length of tubing. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common axis and interconnected by one or more links. A Y-shaped member comprised of a link and a U-shaped member has relief dimples formed in the curved portion of a valley to reduce localized stress and thereby reduce fatigue failure that can lead to link structure failure.

Abstract: Embodiments are directed to radiopaque implantable structures (e.g., stents) formed of cobalt-based alloys that comprise cobalt, chromium and one or more platinum group metals, refractory metals, precious metals, or combinations thereof. Platinum group metals include platinum, palladium, ruthenium, rhodium, osmium, and iridium. Refractory metals include zirconium, niobium, rhodium, molybdenum, hafnium, tantalum, tungsten, rhenium, and precious metals include silver and gold. In one embodiment, the one or more included platinum group or refractory metals substitute at least partially for nickel, such that the alloy exhibits reduced nickel content, or is substantially nickel free. The stents exhibit improved radiopacity as compared to similar alloys including greater amounts of nickel.

Abstract: An apparatus and method for controlling inflation pressure, pressurization rate, and volumetric flow rate of a balloon during deployment of a stent or scaffold is disclosed.

Abstract: A teaching aid has visual indicia thereon simulating the circulatory system of an organism. The teaching aid includes (i) a template having visual indicia thereon simulating the circulatory system of an organism; and (ii) a plurality of connectors for connecting a medical device to the template. The template comprises (a) a base, and (b) visual indicia on the base, simulating the circulatory system of an organism.

Abstract: A system for delivering an implant including a handle, a trigger, and an actuation assembly. The actuation assembly can be configured to displace the outer tubular member in the proximal direction a distance (d) relative to the handle and to separately move the inner shaft member distally a distance (x) relative to the handle upon deployment of the trigger from a first position to a second position, and move the inner shaft member proximally a distance (y) relative to the handle with no displacement of the outer tubular member upon return of the trigger from the second position to the first position.

Abstract: A sheath used to protect a medical device has one or more strips formed over a portion thereof. The medical device is a scaffold crimped to a balloon and mounted to a catheter. The sheath is two-piece, including a protecting and constraining sheath part. The strips facilitate removal of the constraining sheath from the scaffold in manner that reduces instances of damage caused by improper removal of the sheath from the medical device.

Abstract: A device for connecting together two opposing leaflets of a valve in a patient's heart, comprising: a first clip having a generally U-shape, comprising a first prong and a second prong, and a first bridge connecting the first prong to the second prong; a second clip having a generally U-shape, comprising a third prong and a fourth prong, and a second bridge connecting the third prong to the fourth prong; a third clip having a generally U-shape, comprising a fifth prong and a sixth prong, and a third bridge connecting the fifth prong to the sixth prong, wherein the third prong has a first elongate axis and the fifth prong has a second elongate axis and the third prong and the fifth prong are positioned to extend adjacent to and parallel with the first prong, and are configured to rotate about the first elongate axis and the fifth elongate axis respectively.

Abstract: Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and a monolithic inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The monolithic inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through the balloon to form a tip.

Abstract: A vessel closure device that includes improved activation and alignment mechanisms that result in greater control and ease of use for the user.

Abstract: A system for repairing a tricuspid valve in a patient's heart comprising a post having a distal end and a proximal end, a capture element attached to the distal end of the post, the capture element including: a plurality of arms each having a first end and a second end, each arm attached at the first end to the post and extending both radially outwardly from the post and proximally, each arm defining an opening at the second end; a wire passing sequentially through the opening on each arm, whereby tensioning the wire draws the second end of each arm towards the post.

Abstract: Catheter including an inner tubular member, an outer tubular member movable relative to the inner tubular member, and a movable tubular structure coupled to the outer tubular member. A medical device disposed about a distal end portion of the inner tubular member. A proximal stopper is provided having a distal end and disposed proximal to a proximal end of the movable tubular structure. The distal end of the proximal stopper is spaced from the proximal end of the movable tubular structure at least a longitudinal length dimension of the medical device, wherein the outer tubular member and the movable tubular structure are movable in a proximal direction up to engagement of the proximal stopper to deploy the medical device from the inner tubular member.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through at least a portion of the balloon.

Abstract: Bioabsorbable polymeric stent patterns with linking struts between rings that are designed to fail upon deployment of the stent are disclosed.

Abstract: Catheter having an elongate tubular shaft including an inflation lumen and a guidewire lumen defined therein, the guidewire lumen extending along at least a distal length of an inner tubular member of the elongate tubular shaft. The catheter includes a distal tip member having a proximal end and a distal end, wherein the distal tip member is monolithic and the proximal end of the distal tip member is secured to a distal end of the inner tubular member. The catheter includes a balloon having a proximal portion and a distal portion, the proximal portion of the balloon sealingly coupled to the distal portion of the elongate tubular shaft. The distal portion of the balloon is sealingly coupled to the distal tip member and the balloon defines an inner chamber in communication with the inflation lumen, wherein the proximal end of the distal tip member is disposed within the inner chamber.

Abstract: A method for delivering a platform for reinforcing an annulus of a mitral valve: Passing a catheter having a sheath covering a tube formed from a metal into the left atrium, the tube including: an annular portion defining at least one opening, a plurality of upper elements attached to an upper perimeter of the annular portion and extending axially, and a plurality of lower elements attached to a lower perimeter of the annular portion. Inserting the tube into the annulus of the mitral valve; withdrawing the sheath, but leaving the sheath covering the annular portion and the upper elements; bending the lower elements until the lower elements extend radially so as to be positioned beneath the mitral valve; then withdrawing the sheath from covering the annular portion and the upper elements; bending the upper elements until the upper elements extend radially so as to be positioned above the mitral valve.

Abstract: Devices, systems and methods for repairing a valve in a patient's heart includes a two or more fixations devices, each fixation device being attachable to the free end of a target tissue, such as a valve leaflet, the fixation devices being coupled together by a coupling device capable of repositioning and coupling the fixation devices in order to re-position the free ends of the valve leaflets.