Delivery/recovery system for septal occluder

• US 8,568,431 B2
• Filed: 01/16/2011
• Issued: 10/29/2013
• 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, Chanduszko, Andrzej J.
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US13/007,660
• Publication Number:
  US 20110112633A1
• Time in Patent Office: 1,017 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 in a delivery sheath to a living body, the device adapted to be elongated along an axial direction when in the 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 a catch mechanism for holding the device in the deployed position when in the living body, the system comprising:

a catheter extending along the axial direction including claws, the claws being disposed at a distal end of the catheter and including grasping elements biased away from a central axis of the catheter, the grasping elements capable of movement toward the central axis of the catheter for grasping the device when partially deployed and for withdrawing the device back into the sheath for repositioning and/or removal from the body;

a mandrel extending along the 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;

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;

a sheath for enveloping the wire, the mandrel, the catheter, and the device; and

the sheath, catheter, mandrel, and wire 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 catch mechanism to hold the device in its expanded configuration.

2. The system of claim 1, further comprising a handle for assisting an operator with manipulations to deliver and recover a device.

3. The system of claim 2, wherein the handle includes springs for biasing the mandrel and sheath, with knobs for holding these components in desired positions.

4. The system of claim 1, in combination with the medical device, wherein the device is a PFO occluder that 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.

5. The system of claim 4, wherein at least one of the expanded portions includes one of loops, open ended struts, or struts that double back from the center joint to an end of the occluder.

6. The system of claim 5, wherein the occluder includes loops that are in a plane substantially parallel to the tunnel for contacting the septum along the lengths of the loops.

7. The system of claim 6, wherein the occluder includes one of a polymer, nitinol, or stainless steel.

8. The system of claim 7, wherein the occluder is at least partly made of a bioresorbable polymer.

9. The system of claim 4, wherein the occluder includes a fabric for promoting tissue growth.

10. The system of claim 4, wherein the catch mechanism includes a first distal stop and a second proximal stop connected together.

11. The system of claim 10, wherein the catch mechanism further includes a third stop between the first distal stop and the second proximal stop, the third stop for contacting a proximal end of the center joint, the first and third stops together allowing a distal expanded portion in the left atrium to be held in a deployed configuration without requiring that a proximal expanded portion in the right atrium also be held open.

12. The system of claim 10, wherein the catch mechanism has two and only two stops, the first and second stops together allowing a distal expanded portion in the left atrium to be held in a deployed configuration without requiring that a proximal expanded portion in the right atrium also be held open.

13. The system of claim 10, wherein at least one of the stops is spherical or hemi-spherical.

14. The system of claim 10, wherein the stops are connected together with a rod.

15. The system of claim 10, wherein the stops are connected together with one or more strings.

16. The system of claim 1, wherein the wire includes a bendable distal end for limiting distal direction movement by the device.

17. The system of claim 1, wherein the catheter, mandrel, wire, and sheath are coaxially disposed along the axial direction.

18. A delivery system for delivering a medical device to a living body, the device adapted to be elongated along an axial direction when in the 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 means for limiting movement by the device in the proximal direction, the means for limiting movement by the holding means in the proximal direction, the means for limiting movement by the device in a distal direction, and the device;

the means for limiting movement by the device in the proximal direction, the means for limiting movement by the holding means in the proximal direction, the means for limiting movement by the device in a distal direction, 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.