Packaging and preparation tray for a delivery system

• US 9,486,604 B2
• Filed: 05/11/2012
• Issued: 11/08/2016
• Est. Priority Date: 05/12/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Murray, Robert, Upadhyaya, Sameer, Casley, Mark, Macaulay, Patrick, Masud, Ak, Cassidy, Paul, Clarke, David
• Primary Examiner(s): Pickett, J. Gregory
• Assistant Examiner(s): PAGAN, JENINE MARIE
• Application Number:
  US13/469,676
• Publication Number:
  US 20120305441A1
• Time in Patent Office: 1,642 Days
• Field of Search: 206/364, 206/205, 206/207, 206/210, 206/213.1, 206/370, 206/363, 206/365, 206/558, 206/557, 206/563, 206/562, 206/561, 220/23.2, 220/23.4, 220/23.83, 220/520
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30

Abstract

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.

Claims

1. A packaging and preparation tray having a delivery system for percutaneous delivery of an expandable prosthetic heart valve wherein the delivery system includes an elongate catheter that extends from a proximal end to a distal end with a deployment portion at a distal end of the delivery system and a control handle portion at a proximal end of the delivery system, the packaging and preparation tray comprising:

a first main tray and a second main tray that are each formed to provide supporting features based upon the shape and dimensions of the delivery system, are elongate in shape and are articulated together at a hinge so that the first and second main trays are configured to be arranged in a first configuration with the first and second trays positioned end-to-end and connected together by the hinge and a second configuration with the first and second trays positioned substantially side-by-side and connected together by the hinge, the first main tray including a first tray support shaped to correspond with and support a proximal portion of the delivery system so as to keep the control handle portion of the delivery system in place as packaged, and the second main tray including a second tray support shaped to correspond with and support a distal portion of the delivery system so as to keep the deployment portion of the delivery system in place as packaged,

whereby, in the first configuration, the first main tray and the second main tray are configured to support a delivery system such that the elongate catheter of the delivery system extends linearly from the first main tray to the second main tray, and in the second configuration, the first main tray and the second main tray are configured to support the delivery system such that the elongate catheter of the delivery system extends from the first main tray and is turned back in a U-shaped manner into the second main tray such that the deployment portion of the delivery system is positioned to the side of the control handle portion of the delivery system.

2. The packaging and preparation tray of claim 1, further comprising at least one securing tray for each of the first and second main trays, wherein each securing tray is configured to be secured over a portion of the respective first or second main tray for holding a portion of the delivery system in place relative to the respective first tray support or second tray support.

3. The packaging and preparation tray of claim 1, wherein the second main tray further includes a bath area that is formed into the second main tray.

4. The packaging and preparation tray of claim 3, further comprising at least one securing tray configured to be secured over the bath area of the second main tray and for holding a portion of the delivery system in place relative to the second tray support.

5. The packaging and preparation tray of claim 3, wherein the second configuration corresponds to a preparation configuration whereby the delivery system as supported by the first and second main trays can be prepared for use with the bath area located adjacent to the first tray support for the proximal portion of the delivery system.

6. The packaging and preparation tray of claim 1, wherein the first and second main trays are each formed to be generally rectangular in shape and are sized similar to one another.

7. The packaging and preparation tray of claim 6, wherein the hinge is provided at a corner of the first main tray, and the second main tray includes a hinge pintle that extends from the second main tray to fit within a bearing surface of the hinge.

8. The packaging and preparation tray of claim 7, wherein the second main tray includes a thin portion provided adjacent to the hinge pintle that is slidable beneath the first main tray when the packaging and preparation tray is configured in the second configuration.

9. The packaging and preparation tray of claim 1, wherein the first and second main trays are configured to each support approximately half of a length of a delivery system.