US 11,027,870 B2Granted

Prosthetic heart valve delivery systems and packaging

AssigneeEdwards Lifesciences Corporation

InventorsAbishek Gautam, Gregory A. Wright

Life of this patent

Estimating the term…

Loading patent…

Abstract

Packaging for dry prosthetic tissue heart valves and their delivery systems includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Dry tissue heart valves and their delivery systems are placed within a primary container such as a rigid tray that limits movement of the components therein. The primary container is placed within a secondary container, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. A collapsible delivery handle for a surgical heart valve may be provided which reduces the size of the packaging, and is useful for various types of prosthetic heart valves.

Claims24

Dependent claims

A method for packaging a bioprosthetic heart valve and its delivery system, the method comprising:

forming flexible leaflets from a bioprosthetic tissue, wherein the bioprosthetic tissue is treated with a polyhydric alcohol;
attaching the flexible leaflets to an expandable stent structure to form a bioprosthetic heart valve;
coupling the bioprosthetic heart valve to a delivery system, wherein the delivery system comprises a handle at one end and an expandable balloon at the other end, wherein the bioprosthetic heart valve is positioned around the expandable balloon;
packaging the bioprosthetic heart valve and the delivery system in a primary container after the coupling;
and
packaging the primary container comprising the bioprosthetic heart valve and the delivery system in a secondary container;
wherein the primary container is gas-permeable and comprises a tray having an opening and a lid attached to the try to cover the opening, the tray having a first cavity for the bioprosthetic heart valve and a second cavity for the delivery system, the first and second cavities being configured to retain and stabilize the bioprosthetic heart valve and the delivery system within the primary container and wherein the delivery system comprises passages to permit gas flow in and out of the delivery system;
wherein the secondary container is convertible from being gas-permeable to gas-impermeable;
and
wherein the primary container and the secondary container contain no liquid preservative solution.

7 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/357,998Filed 21 Nov 2016 · continuation
Priority: 16 Dec 2010
Published: US 2017/0073099 A116 Mar 2017
Granted: 8 Jun 2021
Term ends: Not estimatedThe source records don’t support an estimate.

Classification12 codes

B65B 55/18
Sterilising contents prior to, or during, packaging: by liquids or gases
A61F 2/0095
Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting…:…
A61F 2/2415
With soft flexible valve members, e.g. tissue valves shaped like natural valves: manufacturing methods
A61F 2/2418
With soft flexible valve members, e.g. tissue valves shaped like natural valves: scaffolds therefor, e.g. support stents

Family

Application61/423,785Us provisional application · filed 16 Dec 2010
Application13/324,124Parent of this continuation · filed 13 Dec 2011
US 9,498,317 B2Parent of this continuation · filed 22 Nov 2016
US 2017/0073099 A1Pre-grant publication · published 16 Mar 2017
US 2012/0158128 A1Published application
US 11,027,870 B2This patent

From the US filing history. Foreign family members aren’t listed.

Timeline

Citations

Open elsewhere

Building an agent or pulling many patents? Use the API or MCP server instead of scraping pages. Get an API key