Abstract: A system for repairing a tricuspid valve and positioned at a distal end of a catheter having a proximal end and a distal end and a bore extending between the proximal end and the distal end. The system comprises an activation element extending along the bore, the activation element including a first push element and a first pull element; a second push element and a second pull element; a third push element and a third pull element; wherein the first push element, the second push element, and the third push element are independently slideable in relation to each other; a first lower jaw being pin connected to the first pull element; a second lower jaw being pin connected to the second pull element; a third lower jaw being pin connected to the third pull element.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

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: 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: This 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 is comprised of a U-shaped member and a link having a curved portion and a straight portion to improve the flexibility and thereby improve the fatigue performance of the Y-link junction.

Abstract: A method of pretinning a guidewire core made of shape memory alloy and having an elongate axis, comprising: placing a ball of solder in a pocket in a soldering block; melting the ball of solder; holding a guidewire core over the ball of solder; lowering the guidewire core into the ball of solder; removing the guidewire from the ball of solder.

Abstract: A medical device includes a balloon expanded scaffold crimped to a balloon catheter. The scaffold has a network of rings formed by struts connected at crowns and links connecting adjacent rings. The scaffold has a polymer coating and is crimped to the balloon. The scaffold is rotated, or allowed to rotate during crimping to improve results from crimping, such as reduced damage to the coating.

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: An apparatus for closing an opening in a body tissue. The apparatus includes a shaft, a plurality of arms, and an expander. The arms each extend between a proximal end and a distal end. The distal end of each arm is hingedly attached to or integrally formed with the shaft. The arms are laterally spaced apart from each other. The arms are movable between a retracted configuration, in which the arms are each aligned along the shaft, and a deployed configuration, in which the proximal end of each arm pivots respectively about the distal end of the arm so as to extend laterally away from the shaft. The expander is positioned within the shaft, and movement of the expander causes the arms to move between the retracted and deployed configurations. Methods of using the apparatus are also included.

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: Catheter including an inner tubular member, an outer tubular member movable relative to the inner tubular member, and an expandable member coupled to the distal end portion of the inner tubular member. The expandable member having an inner chamber and transitionable between a deflated configuration and an inflated configuration. A pressure chamber is defined by the proximal seal, the distal seal, the exterior surface of the inner tubular member and interior surface of the outer tubular member, with the pressure chamber in fluid communication with a fluid flow port, wherein fluid introduced through the fluid flow port and into the pressure chamber applies a force on the proximal seal to urge the outer tubular member in a proximal direction.

Abstract: The present invention involves laser machining polymer substrates to form a stent with laser parameters that minimize damage to the substrate in a surface region adjacent to the machined edge surface. The wavelength and pulse width are selected for this unique application and they can be controlled to minimize the surface modifications (such as voids, cracks which are induced by the laser-material interaction) which contribute to the variation in mechanical properties with distance from the edge surface, bulk mechanical properties, or a combination thereof.

Abstract: The present disclosure describes tissue gripping devices, systems, and methods for gripping mitral valve tissue during treatment of a mitral valve and while a tissue fixation device is implanted in the mitral valve. The tissue gripping device includes a flexible member and one or more tissue gripping members coupled to one or more arms of the flexible member. The flexible member is formed from a shape-memory material, such as nitinol, and the tissue gripping member(s) are formed from a material that is more rigid than the shape-memory material. The tissue gripping member(s) are attached to the flexible member by threading or looping suture lines around and/or through the tissue gripping member(s) and the flexible member and/or by applying a cover material to the tissue gripping device to hold the tissue gripping member(s) against the flexible member.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: An anchor assembly configured to locate and anchor body tissue surrounding an opening in the body tissue. The anchor assembly can include a plurality of anchor elements. Each anchor element can include an elongate portion and an anchor portion extending from the elongate portion. The elongate portion can be configured to be manipulated by a user. The anchor portion can have a contracted configuration capable of passing through the opening in the body tissue and can have an expanded configuration capable of anchoring the body tissue surrounding the opening. The anchor portion and the elongate portion can be integrally formed from a single wire.

Abstract: Bioabsorbable scaffolds having high crush recoverability, high fracture resistance, and reduced or no recoil due to self expanding properties at physiological conditions are disclosed. The scaffolds are made from a random copolymer of PLLA and a rubbery polymer such as polycaprolactone.

Abstract: A system for repairing a tricuspid valve and positioned at a distal end of a catheter having a proximal end and a distal end and a bore extending between the proximal end and the distal end. The system comprises an activation element extending along the bore, the activation element including a first push element and a first pull element; a second push element and a second pull element; a third push element and a third pull element; wherein the first push element, the second push element, and the third push element are independently slideable in relation to each other; a first lower jaw being pin connected to the first pull element; a second lower jaw being pin connected to the second pull element; a third lower jaw being pin connected to the third pull element.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: This 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 is comprised of a U-shaped member and a link having a curved portion and a straight portion to improve the flexibility and thereby improve the fatigue performance of the Y-link junction.

Abstract: A surgical device for suturing body lumen is described, as well as methods for suturing tissue employing the surgical device. The device can include a body having a shaft and a foot for insertion into an opening in a body lumen. The device can include tissue ports between configured to receive tissue surrounding the opening in the body lumen. The foot can include a suture secured to needle capture devices. The device can include needles that can be advanced through tissue and into the needle capture devices. The needle capture devices can then be withdrawn, thereby harvesting the suture, which can then be used to close the opening in the body lumen.