Medtronic Vascular, Inc.

Medtronic, Inc.

David Clarke

Paul Devereux

Robert H Murray

Stephen Nash

Mark Casley

Sameer Upadhyaya

Paul Cassidy

Ak Masud

Raymond Ryan

Patrick Edward Macaulay

Kshitija P Garde

Benjamin Wong

Wei Wang

Laura McKinley

Tracey Tien

Yogesh Darekar

Joshua Dudney

Ya Guo

Karl Olney

Stephen Montgomery

Luke Lehmann

Joshua Hillas

Padraigh Jennings

Karina Doyle

Gerry Kearns

Constantino Fiuza

John Gallagher

Jeffrey Barnell

Patrick MacAulay

Christopher Faherty

Kate Molan

Aspects of the disclosure relate to 'wet' transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Assemblies for sterilizing a wet stored prosthetic heart valve

A 'dry' packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Packaging for dry tissue prosthetic heart valve

A flexible, sterilizable pouch includes a first gas-impermeable web, a second gas-permeable web, and the third gas-impermeable web. The webs are arranged and sealed to form a cavity portion of the pouch and a header portion of the pouch. The header portion of the pouch is gas-permeable through the second gas-permeable web. The cavity portion of the pouch is configured to hold a medical device for sterilization and is configured to be sealed from the header portion after sterilization, thereby making the cavity portion gas-impermeable. The header is also configured to be removed from the pouch, leaving the cavity portion.

Sterilizable pouches for medical devices

A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Delivery catheter system with micro and macro movement control

In some examples, a package includes a package body enclosing a medical supply. The package body defines a window. The package includes a breathable membrane adjacent the package body and extending across the window. The package includes a moisture oxygen scavenger adjacent the package body and extending across the breathable membrane. The package includes an adhesive layer configured to hold the moisture oxygen scavenger adjacent the breathable membrane. In some examples, a technique includes sterilizing a package precursor including the package body and the breathable membrane, and after the sterilizing, adhering the moisture oxygen scavenger to the package body to form the package.

Techniques and packages for packaging medical supplies

Assemblies and methods of sterilizing a wet stored prosthetic heart valve

A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

Pouches with multi-layer walls for improved durability and protection of medical devices

A delivery system package includes a tray, a delivery system, and a slip card between the tray and the delivery system. To remove the delivery system, a pull tab of the slip card is moved to raise the slip card including the delivery system from the tray. At the same time, this moves the slip card over a lid sealing flange of the tray, considered a non-sterile surface in accordance one embodiment. Accordingly, the slip card extends over the lid sealing flange preventing contact between the delivery system and the lid sealing flange. In addition, the slip card effectively forms a ramp for sterile removal of the delivery system from the tray.

Slip card for long sealed trays and method

Pouches with multi-layer walls for improved durability and protection medical devices

Packaging and preparation tray for a delivery system

A package includes a box having an interior volume and a first pocket disposed at a first corner of the box. The first pocket includes a lip configured for a finger of a user to be inserted therein for removal of the package from a storage unit.

Package for a medical device

Growing community of inventors

Galway, Ireland

David Clarke