US-20260124030-A1 - ASSEMBLIES FOR STERILIZING A WET STORED PROSTHETIC HEART VALVE

US20260124030A1US 20260124030 A1US20260124030 A1US 20260124030A1US-20260124030-A1

Abstract

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.

Inventors

David Clarke
Karina Doyle
Paul Devereux
Gerry Kearns
Padraigh Jennings
Constantino Fiuza
Stephen Montgomery

Assignees

MEDTRONIC VASCULAR, INC.

Dates

Publication Date: 20260507
Application Date: 20251231

Claims (10)

1 . An assembly comprising: a storage container comprising: a first portion configured to receive a distal end of a spindle, and configured to receive an implant carried by the spindle; and a second portion comprising an open end configured to establish a fluid-tight connection with an open end of the first portion, and the second portion comprising an aperture configured to receive the spindle carrying the implant; and a seal configured to provide a fluid-tight interface between the second portion and the spindle carrying the implant, wherein the fluid-tight connection of the open end of the second portion with the open end of the first portion and the fluid-tight interface between the second portion and the spindle is configured to provide a fluid-tight sterile storage area for an implant carried by the spindle within the fluid-tight sterile storage area.
2 . The assembly of claim 1 , further comprising a lid connected to the second portion, wherein the lid is configured to compress the seal to provide the fluid-tight interface between the second portion and the spindle.
3 . The assembly of claim 2 , wherein the lid is threadedly connected to the second portion, and configured to be threadedly tightened to compress the seal to provide the fluid tight interface between the second portion and the spindle.
4 . The assembly of claim 1 , wherein the open end of the second portion is configured to be threadedly connected to the open end of the first portion, wherein a threaded connection between the open end of the second portion and the open end of the first portion is configured to be tightened to provide the fluid-tight connection.
5 . A method of sterilizing an implant with the assembly of claim 1 comprising: mounting the seal on the second portion of the storage container; inserting a spindle through the aperture of the second portion with the seal circumscribing the spindle; mounting an implant on the spindle; filling a reservoir of the first portion of the storge container with sterilization fluid; inserting the distal tip of the spindle and implant mount on the spindle into the reservoir to suspend the implant within he sterilization fluid; and providing a fluid-tight connection between the open end of the second portion and the open end of the first portion.
6 . The method of claim 5 , wherein, after inserting the spindle through the aperture of the second portion, further comprising compressing the seal to provide the fluid-tight interface between the second portion and the spindle carrying the implant.
7 . The method of claim 5 , wherein, after inserting the spindle through the aperture of the second portion, further comprising: connecting a lid to the second portion with the spindle extending through an aperture of the lid; and tightening the lid to compress the seal to provide a fluid-tight interface between the second portion and the spindle carrying the implant.
8 . A method of sterilizing an implant comprising: filling a reservoir of a first portion of a storage container with a volume of sterilization fluid; mounting an annular seal on a second portion of a storage container; inserting a spindle through an aperture of the second portion of the storage container and an aperture of the annular seal; mounting an implant on the spindle; submerging a distal portion of the spindle and mounted implant in the volume of sterilization fluid; and providing a fluid-tight connection between the open end of the second portion and the open end of the first portion.
9 . The method of claim 8 , further comprising compressing the seal to provide a fluid-tight interface between the second portion and the spindle carrying the implant.
10 . The method of claim 8 , further comprising: connecting a lid to the second portion with the spindle extending through an aperture of the lid; and tightening the lid to compress the seal to provide a fluid-tight interface between the second portion and the spindle carrying the implant.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 19/018,672, filed Jan. 13, 2025, which is a continuation of U.S. application Ser. No. 18/410,239, filed Jan. 11, 2024, now U.S. Pat. No. 12,245,928, which is a continuation of U.S. application Ser. No. 17/354,596, filed Jun. 22, 2021, now U.S. Pat. No. 11,903,808, which is a divisional of U.S. application Ser. No. 15/968,867, filed May 2, 2018, now U.S. Pat. No. 11,284,984, which claims the benefit of U.S. Provisional Application No. 62/595,618, filed Dec. 7, 2017, and U.S. Provisional Application No. 62/500,046, filed May 2, 2017, the entire contents of each application which are incorporated herein by reference. BACKGROUND Disclosed embodiments relate to packaging for a “wet” tissue prosthetic heart valve or other implant with at least a portion of a delivery device. Methods of assembling packaged transcatheter prosthetic heart valves or implants with the portion of the delivery device and sterilizing the same are also disclosed. A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient. Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of the valve prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable valve prosthesis is compressed about or within a catheter of a delivery device, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart where the valve prosthesis is then deployed. Known valve prostheses include a stent frame supporting a valve structure. The valve structure can assume a variety of forms, and can be formed, for example, from tissue made from one or more biocompatible synthetic materials, synthetic polymers, autograft tissue, homograft tissue, xenograft tissue, or one or more other suitable materials. In some embodiments, the valve structure can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. The valve structure can be formed from heart valve tissue, pericardium, and/or other suitable tissue. In some embodiments, the valve structure can include or form one or more leaflets. For example, the valve structure can be in the form of a tri-leaflet bovine pericardium valve, a bi-leaflet valve, or another suitable valve. A valve prosthesis is often packaged in a container filled with solution, such as glutaraldehyde, for sterilizing and preserving the valve prosthesis prior to attachment to a delivery device for delivery to a patient. Such a method is generally referred to as a “wet” stored valve. Sometimes, the valve prosthesis is preloaded on a distal portion of the delivery device, which are both packaged in the container. Some known packaging configurations include both wet and dry compartments; wherein the valve prosthesis is stored in a wet compartment loaded onto the delivery device component and the remainder of the delivery device component is secured in a dry compartment. The disclosed embodiments address problems and limitations with the related art. SUMMARY It has been found that adequate sterilization of “wet” stored or packaged prosthetic heart valves or other implants, preloaded onto at least a first portion of an elongated delivery device, can be problematic as there are difficulties in sterilizing the device proximate one or more seals retaining sterilization fluid within a container containing the prosthetic heart valve. Disclosed assemblies provide “wet” packaging for a prosthetic heart valve with the first portion of a delivery device as well as methods of sterilizing a packaged prost