Abiomed, Inc.

Christopher Nason Korkuch

Glen Robert Fantuzzi

Robert Fishman

Charles DeLorenzo

Caitlyn Hastie

John Modlish

Robert Swierczek

Michael Thomas Finnegan

Matthew D'Agostino

Andrew Gentile

Jonathan Barry

Anne Gabrielle McLoughlin

Brian Chouinard

Akshay Ashok

Alexander Ship

Clifford M Liu

Drew Calabrese

A blood pump assembly includes an introducer sheath with a proximal end and a distal end, a pump body which extends within the introducer sheath, and a catheter that interfaces with the pump body and extends proximally though the introducer sheath. In a rest state, the introducer sheath forms an oval cross-section sized to encompass the catheter and a medical device. In a constrained state when the pump body is within the introducer sheath, the cross-section of the introducer sheath is circular. The malleability of the introducer sheath allows larger medical devices to be passed through the introducer sheath, while still allowing other devices to be inserted through the introducer sheath after the pump has been guided through. A perimeter of oval cross-section of the introducer sheath is equal to the perimeter of the circular cross-section of the introducer sheath.

Malleable sheath body

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 expandable introducer sheath with an interlock dilator. The present technology provides an expandable sheath with a step feature inside its distal opening, and a dilator with an interlock that includes a catch surface configured to engage with the step feature and resist further relative movement so that the body of the dilator is prevented from exiting the distal end of the expandable sheath. This interlocking engagement may allow the dilator to be used to extend and maintain tension on the expandable sheath during insertion into a patient, and then to be retracted from the expandable sheath by pulling the dilator in the opposite direction. The present technology also provides a dilator hub with a spring mechanism configured to achieve and maintain a desired tension on the expandable sheath and to prevent overextension of the expandable sheath when the dilator is being inserted into the expandable sheath.

Expandable sheath with interlock dilator

A persistent perfusion sheath assembly can be used for the passage of an intravascular medical device while maintain a flow passage in the vessel. The sheath assembly passes through an arteriotomy and can include a first lumen configured for the passage of a medical device, a second lumen configured to allow a flow of fluid from a location in the blood vessel upstream of the arteriotomy to a location downstream of the arteriotomy. The sheath assembly can further include a stylet, a sleeve or an additional sheath configured to selectively open and close the flow of blood between upstream and downstream of the arteriotomy. The sheath assembly can further include a closure device distal of the arteriotomy, the closure device configured to control blood flow through the arteriotomy.

Persistent perfusion 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

An access sleeve can be attached to a medical device having first and second ends, the first end being positioned inside of a patient and the second end being positioned external to a patient. The access sleeve can include a tubular sleeve body having first and second open ends that define a first lumen extending along a longitudinal axis of the sleeve body. An opening in the sleeve body can connect the first lumen to an outer surface of the sleeve body. The access sleeve can be selectively attached to the medical device (e.g., catheter of a heart pump) and inserted into the access site when the medical device is positioned in the patient. The access sleeve can maintain vascular access to a patient's access site such as an arteriotomy and can be removed without disturbing the position of the medical device.

Guidewire access sleeve

Handle for a medical device

Hub for a medical device

An expandable medical sheath can include a sheath body having a lumen that extends between proximal and distal ends of the sheath. The sheath can have first and second members where the first member has a different elastic modulus than the second member such that one provides elasticity to the sheath and the other provides column strength. The first and second members can be coupled together in alternating sections to form the tubular sheath or the stiffer members can be embedded in the elastic member along all or a portion of the longitudinal length of the sheath. The sheath can automatically move to an expanded state to allow a larger diameter medical device to pass through the lumen, and once through the sheath can automatically return to its initial diameter.

Expandable introducer sheath for medical device

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.

Growing community of inventors

Beverly, MA, United States of America

Christopher Nason Korkuch