Method and system for packaging and preparing a prosthetic heart valve and associated delivery system

• US 10,350,047 B2
• Filed: 08/29/2016
• Issued: 07/16/2019
• Est. Priority Date: 09/02/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rajpara, Vipul P., Patel, Darshin S., Bialas, Michael R., Lowry, Brian R., Hunton, Russ, Chang, Arvin T.
• Primary Examiner(s): Reynolds, Steven A.
• Application Number:
  US15/250,759
• Publication Number:
  US 20170056149A1
• Time in Patent Office: 1,051 Days
• Field of Search: 206364, 206363, 206438
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 2050/0082 Rib-and-groove connection
• CPC Class Codes: A61B 2050/0083 Snap connection
• CPC Class Codes: A61B 50/33 Trays
• 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 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: B65D 1/34 Trays or like shallow containers B65D81/3813 takes precedence
• CPC Class Codes: B65D 25/10 Devices to locate articles in containers for protecting articles from mechanical damage B65D81/02
• CPC Class Codes: B65D 77/26 Elements or devices for locating or protecting articles

Abstract

A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system includes a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

Claims

1. A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment, the packaging system comprising:

a tray for securing both a prosthetic valve and an elongated delivery system; and

a valve cover, wherein the prosthetic valve is maintained in a compressed state inside the valve cover and around a distal portion of the elongated delivery system and the valve cover is removable from the prosthetic valve and the delivery system, the tray including

a cavity comprising an open end, a floor, and a peripheral side wall defining a depth of the cavity, the cavity sized and shaped to house the valve cover and the prosthetic valve;

a mounting surface to removably couple the valve cover to the cavity floor;

an engaging surface peripherally of the cavity and elevated above the cavity floor; and

a ramp extending downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall;

wherein the engaging surface and the ramp are configured to secure at least a portion of the elongated delivery system externally of the cavity.

2. The packaging system of claim 1, wherein the prosthetic valve comprises a stent and a plurality of leaflets coupled to the stent, the plurality of leaflets comprising a biological tissue.

3. The packaging system of claim 1, wherein the engaging surface comprises a channel formed in the tray and shaped to accommodate the elongated delivery system and wherein the channel comprises tabs to resiliently engage the elongated delivery system within the channel.

4. The packaging system of claim 1, wherein the ramp is angled downwardly from the engaging surface to the floor of the cavity.

5. The packaging system of claim 4, wherein the ramp is provided at an angle of about 4 degrees to about 10 degrees relative to a horizontal plane bisecting the tray.

6. The packaging system of claim 1, further comprising a lock configured to be removably coupled to one or both of the valve cover and the distal portion of the elongated delivery system.

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

a lid removably coupled to the tray and partially enclosing the open end of the cavity.

8. The packaging system of claim 6, wherein the lock comprises a first end and a second end, wherein the first end is removably coupled to one or both of the valve cover and the distal portion of the elongated delivery system.

9. The packaging system of claim 8, wherein the second end is configured to protrude externally of the cavity through an aperture disposed on the lid, the second end being sized or shaped to prevent it from being passed through the aperture.

10. The packaging system of claim 8, wherein second end is fixed to or integrated with the lid.

11. The packaging system of claim 8, wherein removing the lid also removes the first end of the lock from the one or both of the valve cover and the elongated delivery system.

12. The packaging system of claim 1, wherein the valve cover comprises an internal cavity to house a nose piece, the prosthetic valve and part of the distal portion of the elongated delivery system.

14. The packaging system of claim 1, wherein the valve cover comprises wings extending laterally from opposing sides of the valve cover and wherein the wings are configured to couple the mounting surface disposed from the cavity floor.

15. The packaging system of claim 14, wherein the mounting surface is one of a pair of protrusions or a pair of recesses that are configured to mate with corresponding features of the wings, wherein the corresponding features of the wings are the other of the pair of protrusions or the pair of recesses and wherein the wings and the mounting surface are in resilient snap-fit engagement.

16. The packaging system of claim 1, wherein the cavity further comprises a fill line disposed from the cavity peripheral side wall between the floor and the open end.

17. The packaging system of claim 1, wherein a free segment of the elongated delivery system externally of the cavity is not in direct physical contact with the tray and wherein a space is provided around the free segment to permit a user'"'"'s hand to grasp the free segment and lift at least a portion of the elongated delivery system on both sides of the free segment out of engagement with the tray.

18. The packaging system of claim 1, wherein the proximal end of the elongated delivery device is engaged within a periphery of the tray and wherein the tray comprises a support surface for maintaining the proximal end of the elongated delivery system in position for coupling the proximal end with a handle when the proximal end is disengaged from and extends externally away from the periphery of the tray.

19. The packaging system of claim 1, wherein the mounting surface resiliently engages at least a portion of an external surface of the valve cover.

20. The packaging system of claim 1, wherein the valve cover comprises a flared open end, an opposing securing end, and a lock ring mounted slidably around the securing end between a locked position and an unlocked position.

21. The packaging system of claim 20, wherein in the locked position, the lock ring exerts a radially inward force around the securing end of the valve cover to secure the valve cover onto the delivery system and wherein in the unlocked position, the radially inward force exerted by the lock ring is released to permit removal of the delivery device from the valve cover.

22. The packaging system of claim 21, wherein the lock ring is housed within a spaced area of the mounting surface on the cavity floor to permit the lock ring to slide between the locked and the unlocked positions, wherein the mounting surface resiliently engages at least a portion of an external surface of the valve cover.

23. The packaging system of claim 7, wherein the lid completely encloses the upper surface of the tray.

24. The packaging system of claim 1, further comprising a handle attached to the delivery system and packaged within the tray.

25. The packaging system of claim 1, further comprising a reservoir in fluid communication with the cavity.

13. The packaging system of 12, further comprising a lock that is removably coupled to both the valve cover and the distal portion of the elongated delivery system, wherein a first end of the lock is positioned to maintain a separation between the nose piece and the prosthetic valve.

26. A method for preparing a prosthetic valve and its associated delivery system for implantation of the prosthetic valve in a patient, the method comprising:

(a) obtaining a tray, the tray comprising a prosthetic valve in a first compressed state inside a valve cover and coupled to an elongated delivery system, the valve cover being removable from the prosthetic valve and the delivery system, and the tray including

a cavity comprising an open end, a floor, and a peripheral side wall defining a depth of the cavity, the cavity sized and shaped to house the valve cover, the prosthetic valve and at least part of a distal portion of the elongated delivery system;

a mounting surface to substantially immobilize and maintain the valve cover and the prosthetic valve within the cavity;

an engaging surface peripherally of the cavity and elevated above the cavity floor; and

a ramp extending downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall;

wherein the engaging surface and the ramp are configured to secure at least a portion of the elongated delivery system externally of the cavity;

(b) at least partially filing the cavity with a first hydrating fluid to completely immerse the prosthetic valve;

(c) allowing the prosthetic valve to soak in the first hydrating fluid for a period of time;

(d) flushing the elongated delivery system by delivering a second hydrating fluid into a proximal end of the elongated delivery system and causing the second hydrating fluid to pass through a lumen extending through the elongated delivery system and out of the distal portion of the elongated delivery system; and

(e) causing the prosthetic valve to be loaded into a lumen of a delivery sheath associated with the elongated delivery system while the prosthetic valve is coupled to the cavity floor via the mounting surface;

wherein the loading is performed by causing the delivery sheath move axially over the prosthetic valve;

wherein the delivery sheath compresses and contains the prosthetic valve within a lumen of the delivery sheath in a second compressed state; and

wherein a diameter of the prosthetic valve in the first compressed state is larger than a diameter of the prosthetic valve in the second compressed state;

(f) removing the elongated delivery device with the prosthetic valve loaded into the lumen of the delivery sheath from the tray, including removing the distal portion of the delivery system from the valve cover and disengaging the prosthetic valve from the mounting surface; and

wherein (a) through (e) are performed while the prosthetic valve is substantially immobilized and maintained within the cavity.