Abiomed, Inc.

John Modlish

Glen Robert Fantuzzi

Christopher Nason Korkuch

Caitlyn Hastie

Robert Fishman

Akshay Ashok

Matthew D'Agostino

Clifford M Liu

Drew Calabrese

There is provided an introducer system for percutaneously delivering a first and a second medical device to a patient. The system may comprise an introducer sheath having a longitudinal axis and a lumen formed therein. The system may also comprise a bifurcated hub coupled to a proximal end of the sheath. The hub may comprise a first arm having a first lumen and a first hemostasis valve for the passage of the first medical device. The hub may also comprise a second arm coupled to the first arm and having a second lumen and a second hemostasis valve for the passage of the second medical device. Further, the hub may comprise a connection port such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath for the passage of at least one of the first and second medical devices through the introducer sheath for delivery to the patient.

Bifurcated hub

Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

Variable size repositioning sheath

An introducer sheath assembly for percutaneously delivering a medical device that maintains hemostasis in a patient. The assembly has a hub, a hub cap and a hemostasis valve. The introducer sheath assembly has a longitudinal axis and a lumen formed therein. The hemostasis valve has a frame portion and a valve portion, the valve portion having a plurality of slits that are offset through the thickness of the valve portion therein and an extension of the frame portion formed from an incompressible material. The extension of the frame portion is received by a valve seat feature in the hub, when the valve is received by the hub. The valve seat feature also receives a seating portion of the hub cap as the hub and hub cap are advanced into engagement, the seating portion of the hub cap advanced into the valve seat feature subjecting the incompressible extension of the frame portion to a compressive force.

Hemostasis valve for sheath assembly

Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump, the peel-away sheath assembly including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly. The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. A first layer material and a third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner notches, outer notches, or both inner notches and outer notches. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

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Danvers, MA, United States of America

John Modlish