Delivery/recovery system for septal occluder

• US 8,945,158 B2
• Filed: 09/30/2013
• Issued: 02/03/2015
• Est. Priority Date: 03/03/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Devellian, Carol A., Widomski, David R., Chanduszko, Andrzej J.
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US14/042,134
• Publication Number:
  US 20140088640A1
• Time in Patent Office: 491 Days
• Field of Search: 604104-109, 604/164.1, 604/164.11, 604/192, 604540-544, 606/157, 606/213, 623/23.72
• US Class Current: 606/157
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor

Abstract

A delivery/recovery system to allow an operator to deploy and recover a medical implant, such as an occluder for closing a patent foramen ovale (PFO). In one embodiment, the system includes a delivery mandrel for preventing the occluder from moving in the proximal direction, a delivery wire for securing the occluder to the delivery mandrel and preventing unwanted movement in the distal direction, and a sheath for enveloping the delivery wire, mandrel and occluder. By moving the sheath relative to the occluder in a series of steps, the occluder opens first on a distal side and then on a proximal side, in a manner that holds the occluder in place.

Claims

1. A delivery system for delivering a medical device to a living body, the device adapted to be elongated along an axial direction when in a sheath in a delivery position, the device including one or more expanding portions that expand in a radial direction perpendicular to the axial direction when delivered to form a deployed configuration, the device further including means for holding the device in the deployed position when the device is in the living body, the system comprising:

means for limiting movement by the device in the proximal direction;

means for limiting movement by the holding means in the proximal direction;

means for limiting movement by the device in a distal direction; and

means for enveloping the three limiting means;

the three limiting means and the enveloping means being movable relative to each other and to the device in a series of steps for allowing the expanded portions of the device to expand, and for the holding means to hold the device in its expanded configuration when in the deployed configuration.

2. The delivery system of claim 1, in combination with the device.

3. The delivery system of claim 2, wherein the device is a septal occluder.

4. The delivery system of claim 3, wherein the septal occluder includes one of a polymer, nitinol, or stainless steel.

5. The delivery system of claim 4, wherein the occluder is at least partly made of a bioresorbable polymer.

6. The delivery system of claim 3, wherein the occluder includes a fabric for promoting tissue growth.

7. The delivery system of claim 3, wherein the septal occluder has a center joint for passing through a PFO tunnel, and wherein, when delivered, the expanded components include a first portion on a distal (left atrial) side of the PFO and a second portion on a proximal (right atrial) side of the PFO.

8. The delivery system of claim 7, wherein at least one of the expanded portions of the septal occluder includes one of loops, open ended struts, or struts that double back from the center joint to an end of the occluder.

9. The delivery system of claim 3, wherein the septal occluder includes loops that are in a plane substantially parallel to the tunnel for contacting the septum along the lengths of the loops.

10. The delivery system of claim 1, wherein the holding means comprises a catheter.

11. The delivery system of claim 10, wherein the limiting means comprises a catch mechanism for holding the device in the deployed position when in the living body.

12. The delivery system of claim 11, wherein the limiting means further comprises a mandrel.

13. The delivery system of claim 12, wherein the delivery system further includes springs for biasing the catheter and mandrel, wherein controlling the positions of the springs allows for delivery and withdrawal of the delivery system.

14. The delivery system of claim 12, wherein the mandrel extends along an axial direction and through the catheter and at least a portion of the device and for contacting the catch mechanism at a proximal end of the catch mechanism for limiting movement by the catch mechanism in the proximal direction.

15. The delivery system of claim 12, further comprising a wire extending along the axial direction and through the catheter, the mandrel, and the device, the wire including a distal end that extends beyond a distal end of the device and that is adapted for limiting movement by the device in the distal direction, the wire being removable while the mandrel is still in contact with the catch mechanism.

16. The delivery system of claim 1, wherein the enveloping means comprises a sheath.