Delivery/recovery system for septal occluder

• US 20050267523A1
• Filed: 03/02/2005
• Published: 12/01/2005
• 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.
• Granted Patent: US 7,871,419 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 for contacting the device at a proximal end of the device for limiting movement by the device in the proximal direction;

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

a 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.

2. The system of claim 1, wherein the catheter includes claws that can be controlled to grasp the device when a partially deployed and for withdrawing the device back into the sheath for repositioning and/or removal from the body.

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

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

5. The system of claim 1, wherein the device is a PFO occluder that has a center joint for passing through a PFO tunnel, and wherein 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.

6. The system of claim 5, 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.

7. The system of claim 6, 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.

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

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

10. The system of claim 5, wherein the occluder includes a fabric for promoting tissue growth.

11. The system of claim 5, wherein the catch mechanism includes a first distal stop and a second proximal stop connected together.

12. The system of claim 11, 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.

13. The system of claim 11, 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.

14. The system of claim 11, wherein at least one of the stops is spherical or hemi-spherical.

15. The system of claim 11, wherein the stops are connected together with a rod.

16. The system of claim 11, wherein the stops are connected together with one or more strings.

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

18. The system of claim 2, wherein the delivery system that comes into contact with the device consists essentially of the catheter, mandrel, wire, sheath, and claws.

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

22. A method for operating the delivery system of claim 1 with a septal occluder 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 the distal end of the device, and a second stop at a proximal end of the device, 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 proximal 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;

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

23. The method of claim 22, further comprising removing the sheath, mandrel, catheter, and wire from the body and leaving the device in the body.

26. The method of claim 22, 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.

27. The method of claim 22, 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.

28. The method of claim 23, 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.

29. The method of claim 22, 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.

20. 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 wire, the mandrel, the catheter, and the device;

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.

21. The system of claim 20, in combination with the device.

24. The method of 22, further including, while the device is not completely deployed, 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.

25. The method of claim 24, 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.