Packaging Systems for Percutaneously Deliverable Bioprosthetic Valves

• US 20100252470A1
• Filed: 04/06/2009
• Published: 10/07/2010
• Est. Priority Date: 04/06/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Allen, Jeffrey, Podbelski, Adam, Denton, Melissa, Ryan, Timothy, Tran, Don
• Granted Patent: US 7,967,138 B2
• Time in Patent Office: Days
• US Class Current: 206/370
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Abstract

A packaging system is disclosed for shipping a prosthetic tissue valve in a storage solution and preparing and loading of the bioprosthetic valve onto a catheter-based delivery system. The packaging system includes a fluid tight container filled with the storage solution attached to a delivery catheter, wherein the container surrounds the prosthetic tissue valve that is in a pre-loaded position on the delivery catheter during shipment and storage. The prosthetic tissue valve may include an attachment mechanism that attaches to the delivery catheter to properly position the tissue valve for loading within the delivery catheter. In another embodiment where the prosthetic tissue valve is not attached to the delivery catheter during shipment, the attachment mechanism may interact with the prosthetic tissue valve shipping container to prevent the bioprosthetic valve from moving during shipment.

Claims

1. A packaging system for a medical device, the system comprising:

a delivery catheter;

a shipping container sealingly attached to the delivery catheter and filled with a storage solution, wherein a component of the delivery catheter extends within the shipping container; and

a prosthetic tissue valve in an expanded configuration disposed in the storage solution within the shipping container and positioned to surround the component of the delivery catheter that extends within the shipping container.

2. The packaging system of claim 1, further comprising:

an attachment assembly for releasably attaching the prosthetic tissue valve to the delivery catheter.

3. The packaging system of claim 2, wherein the delivery catheter further comprises:

an outer tubular component having a distal end to which the shipping container is sealing attached; and

an inner component slidably disposed within the outer tubular component, wherein the component of the delivery catheter that extends within the shipping container is the inner component and the prosthetic tissue valve is secured to the inner component by the attachment assembly.

4. The packaging system of claim 3, wherein upon removal of the storage solution from the shipping container relative longitudinal movement between the inner component and the outer tubular component collapses and loads the prosthetic tissue valve within the outer tubular component.

5. The packaging system of claim 4, wherein upon removal of the shipping container the delivery catheter with the prosthetic tissue valve loaded therein are ready for delivery to a treatment site within the vasculature.

6. The packaging system of claim 1, wherein the shipping container is a bladder of a polymeric material.

7. The packaging system of claim 1, wherein the shipping container includes an inflow port for introducing a rinsing solution into an interior of the shipping container and an outflow port for draining the storage and rinsing solutions from the shipping container.

8. The packaging system of claim 1, wherein an outer surface of the prosthetic tissue valve touches an inner surface of the shipping container to thereby maintain a longitudinal position of the prosthetic tissue valve relative to the delivery catheter.

9. The packaging system of claim 8, wherein the delivery catheter further comprises:

an outer sheath having a distal end to which the shipping container is sealing attached; and

a balloon catheter slidably disposed within the outer sheath and having a dilatation balloon disposed along a distal portion thereof, wherein the component of the delivery catheter that extends within the shipping container includes the dilatation balloon of the balloon catheter such that the prosthetic tissue valve is positioned around the dilatation balloon.

10. The packaging system of claim 9, wherein upon removal of the storage solution from the shipping container longitudinally compressing the shipping container collapses the prosthetic tissue valve onto the dilatation balloon.

11. The packaging system of claim 10, wherein the shipping container forms accordion-like folds when longitudinally compressed and compression rings between the folds contact and collapse the prosthetic tissue valve.

12. The packaging system of claim 9, wherein upon removal of the shipping container the outer sheath is slidable over the prosthetic tissue valve and balloon catheter for delivery to a treatment site within the vasculature.