Packaging systems for percutaneously deliverable bioprosthetic valves
First Claim
1. A packaging system for a medical device, the system comprising:
- a delivery catheter having an outer tubular component and an inner component slidably disposed within the outer tubular component;
a shipping container sealingly attached to a distal end of the outer tubular component of the delivery catheter and filled with a storage solution, wherein the inner component of the delivery catheter extends within the shipping container;
a prosthetic tissue valve in an expanded configuration disposed in the storage solution within the shipping container and positioned to surround the inner component of the delivery catheter that extends within the shipping container, the prosthetic valve including a stent-like frame with a band that longitudinally-extends from a proximal end of the stent-like frame, wherein the band includes an eyelet or a broadened paddle-like area at a proximal end thereof; and
an attachment assembly for releasably attaching the prosthetic tissue valve to the delivery catheter, wherein the attachment assembly includes a c-shaped locking collar for attaching a proximal end of the prosthetic tissue valve to the inner component, the locking collar having first projections surrounding a distal end thereof that define a plurality of slots therebetween, wherein at least one slot is sized to receive the band of the stent-like frame therethrough with the slot being narrower than the eyelet or broadened paddle-like area of the band proximal end and wherein the locking collar includes second projections protruding from a first longitudinal end surface thereof that align with and have an interference fit within corresponding holes in a second longitudinal end surface thereof, wherein the second projections fit within the holes to attach the locking collar to the inner component.
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Accused Products
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.
67 Citations
12 Claims
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1. A packaging system for a medical device, the system comprising:
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a delivery catheter having an outer tubular component and an inner component slidably disposed within the outer tubular component; a shipping container sealingly attached to a distal end of the outer tubular component of the delivery catheter and filled with a storage solution, wherein the inner component of the delivery catheter extends within the shipping container; a prosthetic tissue valve in an expanded configuration disposed in the storage solution within the shipping container and positioned to surround the inner component of the delivery catheter that extends within the shipping container, the prosthetic valve including a stent-like frame with a band that longitudinally-extends from a proximal end of the stent-like frame, wherein the band includes an eyelet or a broadened paddle-like area at a proximal end thereof; and an attachment assembly for releasably attaching the prosthetic tissue valve to the delivery catheter, wherein the attachment assembly includes a c-shaped locking collar for attaching a proximal end of the prosthetic tissue valve to the inner component, the locking collar having first projections surrounding a distal end thereof that define a plurality of slots therebetween, wherein at least one slot is sized to receive the band of the stent-like frame therethrough with the slot being narrower than the eyelet or broadened paddle-like area of the band proximal end and wherein the locking collar includes second projections protruding from a first longitudinal end surface thereof that align with and have an interference fit within corresponding holes in a second longitudinal end surface thereof, wherein the second projections fit within the holes to attach the locking collar to the inner component. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification