Packaging systems for percutaneously deliverable bioprosthetic valves

• US 9,066,785 B2
• Filed: 04/06/2009
• Issued: 06/30/2015
• Est. Priority Date: 04/06/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Tran, Don, Ryan, Timothy, Allen, Jeffrey, Denton, Melissa, Podbelski, Adam
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US12/418,684
• Publication Number:
  US 20100256749A1
• Time in Patent Office: 2,276 Days
• Field of Search: 206/438, 623/1.11, 623/2.1, 623/2.11, 606/108, 606/194, 606/200
• US Class Current: 1/1
• 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 and loading system for a medical device, the system comprising:

a shipping container having a removable cap for selectively covering a mouth of the shipping container, wherein the removable cap has a holding tube attached thereto such that the holding tube of the removable cap extends into the shipping container when the removable cap is secured to the shipping container;

a prosthetic tissue valve disposed within the shipping container, the prosthetic tissue valve having a stent-like frame with at least two bands longitudinally extending therefrom; and

an attachment assembly fully disposed within the shipping container, the attachment assembly being releasably secured to the at least two bands of the prosthetic tissue valve to be removed from the shipping container with the prosthetic tissue valve, the attachment assembly being configured to secure the prosthetic tissue valve to a delivery catheter after the prosthetic tissue valve is removed from the shipping container, wherein when the removable cap is secured to the shipping container the holding tube of the removable cap is positioned to extend through within the attachment assembly and at least a portion of the prosthetic tissue valve to prevent movement of the prosthetic tissue valve within the shipping container; and

a storage solution contained within the shipping container to preserve the prosthetic tissue valve.

2. The system of claim 1, wherein the shipping container is a jar-like vessel to which the cap is threadably secured.

3. The system of claim 1, further comprising:

an inflow port for introducing a rinsing solution into the shipping container; and

an outflow port for draining the storage and rinsing solutions from the shipping container.

4. The system of claim 3, wherein an open end of the holding tube is accessible from an outside surface of the cap and forms the inflow port and one or more apertures in the shipping container form outflow ports.

5. The system of claim 1, wherein the attachment assembly includes a locking collar and a holding sleeve surrounding the locking collar between which a portion of the at least two bands of the prosthetic tissue valve are radially secured.

6. The system of claim 5, further comprising:

a delivery catheter having an elongate inner component slidably disposed therethrough, wherein when the attachment assembly and prosthetic tissue valve are removed from the shipping container the locking collar is sized to close around the inner component to releasably attach the prosthetic tissue valve to the delivery catheter.

7. The system of claim 6, wherein the delivery catheter includes an outer tubular component within which the inner component is slidably disposed such that relative longitudinal movement between the inner component and the outer tubular component collapses and loads the attached prosthetic tissue valve and draws the locking collar within the outer tubular component.

8. The system of claim 6, wherein the locking collar is held between proximal and distal stoppers of the delivery catheter to maintain a longitudinal position of the prosthetic tissue valve relative to the inner component.

9. A system for loading a prosthetic valve within a delivery catheter, the system comprising:

a delivery catheter having an inner component;

a prosthetic valve having a stent-like frame, wherein at least one longitudinal band extends from the stent-like frame; and

an attachment assembly independent of the delivery catheter, the attachment assembly including a collar component surrounded by a holding sleeve, wherein the longitudinal band of the stent-like frame is radially secured between the collar component and the holding sleeve such that the prosthetic valve is releasably secured to the attachment assembly prior to being attached to and loaded within the delivery catheter,

wherein the collar component is configured to lock onto the inner component of the delivery catheter for attaching the prosthetic valve thereto,

wherein the collar component includes cog-like projections radially extending from an outer surface thereof with a slot defined between adjacent projections in which the longitudinal band of the stent-like frame is radially secured by the holding sleeve, and

wherein the collar component has a c-shaped configuration that is sized to close around the inner component of the delivery catheter to position the prosthetic valve for loading within the delivery catheter.

10. The system of claim 9, wherein the slot is sized to have an interference fit with the longitudinal band.

11. The system of claim 9, wherein the longitudinal band includes a wide proximal end that is disposed proximal of the slot and the slot is sized to be narrower than the proximal end.

12. The system of claim 9, wherein a post on a first longitudinal end surface of the c-shaped collar component fits within a hole in a corresponding second longitudinal end surface of the c-shaped collar component to lock the collar component in a closed configuration.

13. A method of using the system according to claim 9 comprising:

closing the collar component around the inner component of the delivery catheter to releasably secure the prosthetic valve to the delivery catheter; and

manipulating an outer tubular component of the delivery catheter over the prosthetic valve thereby loading the prosthetic valve within the delivery catheter.

14. The method of claim 13, further comprising:

removing the holding sleeve from the collar component prior to loading the prosthetic valve within the delivery catheter.

15. The system of claim 9, wherein the collar component has an outer diameter that is sized to be slidably received within the delivery catheter when the prosthetic valve is loaded within the delivery catheter.

16. A system for loading a prosthetic valve within a delivery catheter, the system comprising:

a delivery catheter having an inner component;

a prosthetic valve having a stent-like frame, wherein at least one longitudinal band extends from the stent-like frame; and

an attachment assembly independent of the delivery catheter, the attachment assembly including a collar component surrounded by a holding sleeve, wherein the longitudinal band of the stent-like frame is radially secured between the collar component and the holding sleeve such that the prosthetic valve is releasably secured to the attachment assembly prior to being attached to and loaded within the delivery catheter,

wherein the collar component is configured to lock onto the inner component of the delivery catheter for attaching the prosthetic valve thereto,

wherein the collar component includes coq-like protections radially extending from an outer surface thereof with a slot defined between adjacent projections in which the longitudinal band of the stent-like frame is radially secured by the holding sleeve, and

wherein the collar component includes first and second half-ring segments that lock together to close around the inner component of the delivery catheter to position the prosthetic valve for loading within the delivery catheter.

17. A method of using the system according to claim 16 comprising:

closing the collar component around the inner component of the delivery catheter to releasably secure the prosthetic valve to the delivery catheter; and

manipulating an outer tubular component of the delivery catheter over the prosthetic valve thereby loading the prosthetic valve within the delivery catheter.

18. The method of claim 17, further comprising:

removing the holding sleeve from the collar component prior to loading the prosthetic valve within the delivery catheter.