Delivery/recovery system for septal occluder

• US 7,871,419 B2
• Filed: 03/02/2005
• Issued: 01/18/2011
• Est. Priority Date: 03/03/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Widomski, David, Chanduszko, Andrzej J., Devellian, Carol A.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US11/070,027
• Publication Number:
  US 20050267523A1
• Time in Patent Office: 2,148 Days
• Field of Search: 623/23.72, 606/213, 606/157, 604104-109, 604/164.1, 604/164.11, 604/192, 604540-544
• 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 method for operating a delivery system for delivering a septal occluder 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, wherein

the delivery system comprising:

a mandrel extending along the axial direction and through at least a portion of the device while the device is in the delivery position, wherein the mandrel contacts the catch mechanism at a proximal end of the catch mechanism, and limits movement by the catch mechanism in the proximal direction;

a wire extending along the axial direction and through 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, and the device; and

wherein the sheath, 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; and

the septal occulder device comprising a center joint for passing through a defect, a distal expandable component for expanding on a distal side of the defect, a proximal expandable portion for expanding on a proximal side of the defect, and a catch mechanism that includes a first stop at a distal end of the catch mechanism, and a second stop at a proximal end of the catch mechanism;

the method comprising;

providing the sheath into the distal side of the defect and withdrawing the sheath while limiting the device from moving in the proximal direction to allow the distal expandable component to expand on the distal side of the defect;

moving the center joint relative to the catch mechanism to cause the second stop to pass through the center joint;

further withdrawing the sheath while limiting the device from moving in the proximal direction to allow the proximal expandable component to expand on the proximal side of the defect; and

moving the proximal end of the device relative to the catch mechanism to cause the second stop to pass through the proximal end.

2. The method of claim 1, further comprising removing the sheath, mandrel, and wire from the body and leaving the device in the body.

3. The method of claim 2, wherein the wire has a bent end for limiting proximal movement by the catch mechanism, wherein removing the wire includes moving one of the mandrel and the wire relative to the other to straighten the bent portion.

6. The method of claim 1, wherein the catch mechanism further includes a third stop between the distal and proximal stops, the method including moving the center joint relative to the third stop to cause the center joint and the distal end to be clamped between the first and third stops.

7. The method of claim 1, wherein the method includes delivering a PFO occluder that has on each side of the defect one of loops, open ended struts, or struts that double back from the center joint to an end of the occluder.

8. The method of claim 1, wherein delivery system further includes springs for biasing the catheter and mandrel, the providing and withdrawing steps are performed by controlling positions of the springs.

4. The method of 1, further including grasping the device at the proximal end and pulling to cause the proximal expanded component to return to the delivered configuration while limiting movement of the catch mechanism in the proximal direction.

5. The method of claim 4, further comprising moving the proximal end of the catch mechanism in a distal direction relative the center joint to cause the proximal end to pass through the center joint and to allow the distal expandable component to return to its delivered position.

9. 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, the catheter 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 a 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; and

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

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.

10. A method for operating the delivery system of claim 9 with a septal occluder device that has a center joint for passing through a defect, a distal expandable component for expanding on a distal side of the defect, a proximal expandable portion for expanding on a proximal side of the defect, and a catch mechanism that includes a first stop at a distal end of the catch mechanism, and a second stop at a proximal end of the catch mechanism, the method comprising:

providing the sheath into the distal side of the defect and withdrawing the sheath while limiting the device from moving in the proximal direction to allow the distal expandable component to expand on the distal side of the defect;

moving the center joint relative to the catch mechanism to cause the second stop to pass through the center joint;

further withdrawing the sheath while limiting the device from moving in the proximal direction to allow the proximal expandable component to expand on the proximal side of the defect; and

moving the proximal end of the device relative to the catch mechanism to cause the second stop to pass through the proximal end.

11. The method of claim 10, wherein the catch mechanism further includes a third stop between the distal and proximal stops, the method including moving the center joint relative to the third stop to cause the center joint and the distal end to be clamped between the first and third stops.

12. The method of claim 10, wherein the method includes delivering a PFO occluder that has on each side of the defect one of loops, open ended struts, or struts that double back from the center joint to an end of the occluder.

13. The method of claim 10, wherein the wire has a bent end for limiting proximal movement by the catch mechanism, wherein removing the wire includes moving one of the mandrel and the wire relative to the other to straighten the bent portion.

14. A method for delivering an occluder to a defect, the method comprising:

providing a sheath containing an occluder through a defect and into a distal side of the defect;

withdrawing the sheath in a proximal direction while limiting the occluder from moving in the proximal direction to extend a distal expandable component of the occluder from a distal end of the sheath to allow the distal expandable component to expand on the distal side of the defect;

moving a center joint of the occluder and a catch mechanism of the occluder relative to each other to cause a proximal stop disposed on a proximal end of the catch mechanism to pass through the center joint of the occluder;

further withdrawing the sheath while limiting the occluder from moving in the proximal direction to extend a proximal expandable component of the occluder from the distal end of the sheath to allow the proximal expandable component to expand on a proximal side of the defect; and

moving a proximal end of the occluder and the catch mechanism relative to each other to cause the proximal stop to pass through the proximal end of the occluder.

15. The method of claim 14, further comprising providing the occluder, the occluder having the center joint for passing through the defect, the distal expandable component for expanding on the distal side of the defect, the proximal expandable portion for expanding on the proximal side of the defect, and the catch mechanism, the catch mechanism including a distal stop at the distal end of the catch mechanism, and the proximal stop at the proximal end of the catch mechanism.