Abiomed, Inc.

Robert Fishman

Christopher Nason Korkuch

Glen Robert Fantuzzi

Caitlyn Hastie

Robert Swierczek

Michael Thomas Finnegan

Charles DeLorenzo

Matthew D'Agostino

Andrew Gentile

Jonathan Barry

Anne Gabrielle McLoughlin

John Modlish

Emmanuel N Ilongo

Mithun Rajaram

Akshay Ashok

Vladimir Gilman

Alexander Ship

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

An expandable sheath for use in an intravascular blood pump. The sheath has a sheath frame surrounded by one or more sleeves. The frame may have at least one of a braid, a wound wire, and a laser-cut material. The sheath frame may be a metal that is at least one of Nitinol and stainless steel. The sleeves may be made of one or more plastics. The expandable sheath is manufactured by surrounding the sheath frame with the sleeves and heating the sleeves and the frame around a mandrel. The frame and sleeves are heated in multiple steps, along multiple areas of the sheath, and to different temperatures and for different time periods. The temperatures at which the sheath is heated, and the time periods over which the sheath is heated, are selected such that after heating, the materials of the plastic sleeves penetrate the sheath frame to various depths.

Nitinol braid processing procedure

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 for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal and the distal ends, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Expandable introducer sheath for medical device

Systems and methods for packaging an optical sensor assembly. An optical sensor assembly for use in a blood pump assembly comprises a visor affixed to a pump housing of the blood pump assembly. A support jacket is in contact with an inner surface of the visor, and defines a cavity in which an optical sensor is disposed. Silicone gel is introduced into the cavity, where it cures. Silicone gel within the cavity protects the optical sensor, and the support jacket prevents the overflowing of the gel and contamination of the visor.

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Danvers, MA, United States of America

Robert Fishman