Abbott Cardiovascular Systems Inc.

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.

A stent made from a material comprising a polymer is disclosed. The stent has a pre-crimp diameter and a wall thickness such that a ratio of the pre-crimp diameter to the wall thickness is between 30 and 60. The stent has a pattern of interconnected elements. The interconnected elements including a plurality of rings connected by links, wherein each ring includes struts and crowns, and the struts are configured to fold at the crowns when the stent is crimped to the balloon.

A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Disclosed are methods of treating peripheral artery disease (particularly chronic limb threatening ischemia (CLTI)) with implantation of a polymeric scaffold into a vessel located below the knee. After implantation into a blood vessel of the patient below the knee, efficacy of the procedure is measured by performing duplex ultrasound (DUS) and/or angiography to measure binary restenosis at the site of the target lesion, where binary restenosis is defined as the presence of a hemodynamically significant restenosis of >50% identified through angiography, or peak systolic velocity ratio (PSVR) ≥2.0 as identified by DUS. The scaffold is made from a bioresorbable polymer. The scaffold has a pattern of interconnected elements. The interconnected elements include a plurality of rings connected by links, wherein each ring includes struts and crowns, and the struts are configured to fold at the crowns when the scaffold is crimped to a balloon.

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.

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.

A stent delivery catheter assembly for delivering and implanting a self-expanding stent in a body lumen includes a handle assembly for one handed use. The handle assembly has a mode selection for advancing, reversing and locking the stent delivery components. Rotation of a thumbwheel allows the physician to deploy and implant the self-expanding stent in the body lumen with control and precision by simultaneously pulling a sheath proximally and pushing a pusher member distally.

A shaping tool is used to form a bend in the distal end of a guidewire. The guidewire distal end is inserted through a channel and into a cavity of the shaping tool. Using hand pressure, a first member is moved axially relative to a second member of the shaping tool, thereby moving the cavity relative to the channel and imparting a bend in the distal end of the guidewire.

A mold is used to form a solder joint to join the distal end of the guidewire to a wire coil. The mold has a cavity that can have different configurations so that the solder joint can be any of bullet shaped, micro-J shaped, cone shaped, truncated cone shaped, or have a textured surface.

A method of removing needles operatively associated with suture through tissue surrounding an access tract, the method comprising advancing an elongate distal member along the access tract, locating an elongate proximal member in contact with tissue surrounding the puncture site, the elongate proximal member comprising a guide disposed within the elongate proximal member, a perimeter of the guide forming a plurality of needle receiving gaps that are circumferentially spaced about a needle deployment actuator with a portion of the guide disposed between adjacent needle receiving gaps extending outwardly towards a wall of the lumen of the elongate proximal member, the needle deployment actuator extending to the elongate distal member and being configured to initiate proximal movement of a needle toward an opening of the elongate proximal member, and actuating the needle deployment actuator to move the needle toward the opening of the elongate proximal member.