Closure prosthesis for transcatheter placement

• US 5,643,317 A
• Filed: 05/27/1994
• Issued: 07/01/1997
• Est. Priority Date: 11/25/1992
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: William Cook Europe ApS (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Wallace, Sidney, Wright, Kenneth C.
• Primary Examiner(s): DAWSON, GLENN K
• Application Number:
  US08/244,580
• Time in Patent Office: 1,131 Days
• Field of Search: 606/1, 606/151, 606/190, 606/198, 606/213, 606/215, 604/11, 604/13, 604/15, 604/16, 128/20, 128/830-839
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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

Abstract

A closure prosthesis and transcatheter delivery system includes a closure prosthesis for sealing across all opening of a fluid passageway within a living body. The closure prosthesis is a flexible disk including a flexible ring and diaphragm having a plurality of hollow flexible wire segments attached thereto. Delivery of the closure prosthesis is accomplished using a hollow sheath and a pusher catheter slidable within the sheath, wherein filaments are looped through the wire segments to releasably connect the disk to the pusher catheter. The disk is resiliently compressed within the sheath and, upon release therefrom, the disk resiliently expands into a larger, unrestrained shape. Tension applied to the filaments resiliently bends the wire segments so that they may be drawn through the opening of the defect. Upon releasing the filaments from the disk, the wire segments resiliently expand to trap the disk in place to seal across the opening.

Claims

1. A flexible closure prosthesis and transcatheter delivery system, wherein said closure prosthesis is adapted to seal across an opening of a fluid passageway within a living body, comprising:

a flexible sealing element;

a flexible restraining element attached to said sealing element, said sealing element and said restraining element defining an integral closure prosthesis prior to delivery across the opening;

a hollow sheath;

a pusher catheter slidable within said sheath;

filament means for resiliently bending said closure prosthesis, said filament means releasably connecting said closure prosthesis to said pusher catheter;

said closure prosthesis being resiliently compressible into a first insertion form constrained within said sheath for delivery adjacent the opening, said closure prosthesis resiliently expanding after release from said sheath into a first operational form large than said first insertion form;

said closure prosthesis being resiliently compressible into a second insertion form constrained by said filament means for placement across the opening, said closure prosthesis resiliently expanding after release from said filament means into a second operational form larger than said second insertion form, wherein said sealing element seals across the opening and said restraining element restrains said closure prosthesis in place across the opening;

said flexible sealing element comprising a flexible ring having an opening therethrough and a flexible diaphragm attached to said ring and covering said opening; and

said flexible restraining element comprising a plurality of hollow flexible wire segments attached to said diaphragm.

2. The flexible closure prosthesis and transcatheter delivery system of claim 1 wherein said flexible ring further comprises a plurality of flexible elements attached across said ring.

3. The flexible closure prosthesis and transcatheter delivery system of claim 2 wherein:

said flexible ring is constructed from a length of coiled wire resiliently bent into a ring and attached at its ends and includes two to three loops of flexible safety wire inside said coiled wire;

said flexible elements are constructed of elastic filaments tied across said coiled wire;

said flexible diaphragm is constructed from a double wall nylon mesh attached to said flexible ring and containing a flexible foam core therein;

said hollow flexible wire segments are discrete lengths of coiled wire, each wire being attached along a portion of its length to said diaphragm.

4. The flexible closure prosthesis and transcatheter delivery system of claim 1 wherein:

said flexible ring is constructed from a length of coiled wire resiliently bent into a ring and attached at its ends and includes two to three loops of flexible safety wire inside said coiled wire;

said flexible diaphragm is constructed from a double wall nylon mesh attached to said flexible ring and containing a flexible foam core therein;

said hollow flexible wire segments are discrete lengths of coiled wire, each wire being attached along a portion of its length to said diaphragm.

5. The flexible closure prosthesis and transcatheter delivery system of claim 1 wherein said filament means comprises:

a pull ring, said pull ring being larger in diameter than said pusher catheter to prevent passage therethrough;

a plurality of filaments corresponding to said plurality of hollow flexible wire segments, at least one of said filaments routed through one of said wire segments and each of said filaments connected at one end to said pusher catheter and at another end to said pull ring; and

wherein pulling of said pull ring causes said filaments to resiliently compress said wire segments.

6. The flexible closure prosthesis and transcatheter delivery system of claim 5 wherein said filaments are monofilaments constructed of nylon.

7. The flexible closure prosthesis and transcatheter delivery system of claim 1 wherein:

said pusher catheter is a double lumen catheter having an inner lumen and an outer lumen;

said pusher catheter has a proximal end and an opposite distal end; and

said filament means comprise a plurality of filaments coupled to said pusher catheter, said plurality of filaments routed through one of said inner lumen and said outer lumen as said plurality of filaments extend from said proximal end of said pusher catheter to said flexible restraining element and continuing through the outer of said inner lumen and said outer lumen to said proximal end of said pusher catheter to couple said closure prosthesis to said pusher catheter.

8. The flexible closure prosthesis and transcatheter delivery system of claim 1 wherein said filament means comprises:

a pull ring, said pull ring being larger in diameter than said pusher catheter to prevent passage therethrough;

a plurality of filaments corresponding to said plurality of said hollow wire segments, at least one of said filaments routed through one of said wire segments and each of said filaments connected at one end to said pusher catheter and at another end to said pull ring; and

wherein pulling of said pull ring causes said filaments to resiliently compress said wire segments.

9. The flexible closure prosthesis and transcatheter delivery system of claim 8 wherein:

said pusher catheter is a double lumen catheter having an inner lumen and an outer lumen; and

said filaments attach at an end of said pusher catheter opposite said closure prosthesis and are routed through said outer lumen to said closure prosthesis, through said hollow wire segments, and through said inner lumen to attach to said pull ring.

10. A method for delivering a closure prosthesis for sealing across an opening of a fluid passageway within a living body, comprising the steps of:

connecting a closure prosthesis to a pusher catheter, said closure prosthesis including a flexible sealing element and a flexible restraining element attached thereto;

inserting said closure prosthesis and said pusher catheter into a sheath adjacent the opening, said closure prosthesis resiliently compressing into a first insertion form constrained within said sheath;

releasing said closure prosthesis from said sheath adjacent the opening, said closure prosthesis resiliently expanding into a first operational form larger than said first insertion form adjacent the opening;

resiliently compressing said closure prosthesis into a second insertion form, said restraining element being resiliently compressed to permit passage thereof through the opening;

releasing said closure prosthesis from said pusher catheter, said closure prosthesis expanding into a second operational form larger than said second insertion form, wherein said sealing element seals across the opening and said restraining element restrains said closure prosthesis in place across the opening.

11. A closure prosthesis and transcatheter delivery system for sealing an opening in a fluid passageway within a living body, comprising:

a resiliently flexible sealing element;

at least one flexible restraining element fixedly attached and extendable along one side of said sealing element, said restraining element and said sealing element defining an integral closure element;

said integral closure element compressable into a reduced insertion form suitable for insertion through the fluid passageway and the opening but tending to resiliently assume a relatively thin shape with a surface area sufficiently large to cover the opening;

said fixedly attached restraining element deformable into a reduced insertion form suitable for insertion through the fluid passageway and the opening but tending to resiliently assume a configuration extending adjacent said one side of said sealing element such that said integral closure element pinches an edge of the opening between a portion of said restraining element and said sealing element;

a hollow sheath sized to fit through the opening and having a proximal end;

a pusher catheter slidable within said sheath; and

at least one filament slidably connected to said at least one restraining element and having ends extending proximally from said proximal end of said sheath.

12. The closure prosthesis and transcatheter delivery system of claim 11 wherein said at least one flexible restraining element is at least one hollow cylinder;

and

said at least one filament is threaded through said hollow cylinder.

13. The closure prosthesis and transcatheter delivery system of claim 11 wherein said sealing element is disk shaped.

14. The closure prosthesis and transcatheter delivery system of claim 11 wherein said sealing element has a center portion;

and

said at least one flexible restraining element is attached to said center portion of said sealing element.

15. The closure prosthesis and transcatheter delivery system of claim 11 wherein each of said at least one flexible restraining element is configured to be longer than the diameter of the opening.

16. The closure prosthesis and transcatheter delivery system of claim 11 wherein said sealing element comprises a resiliently flexible ring and a flexible diaphragm attached across said ring.

17. The closure prosthesis and transcatheter delivery system of claim 11 wherein said sealing element tends to resiliently assume a planar configuration.

18. The closure prosthesis and transcatheter delivery system of claim 11 wherein said pusher catheter has two lumens;

and

each end of said at least on filament is threaded through a different one of said two lumens.

19. A flexible closure prosthesis and transcatheter delivery system, wherein said closure prosthesis is adapted to seal across an opening of a fluid passageway within a living body, comprising:

a flexible sealing element;

a flexible restraining element attached to said sealing element, said sealing element and said restraining element defining an integral closure prosthesis prior to delivery across the opening;

a hollow sheath;

a pusher catheter slidable within said sheath;

filament means coupling said closure prosthesis and said pusher catheter for bending said flexible restraining element;

said closure prosthesis deformable into a first insertion form constrainable within said sheath for delivery adjacent the opening, said closure prosthesis being resiliently expandable upon release from said sheath into a first operational form that is larger than said first insertion form; and

said flexible restraining element deformable into a second insertion form constrained by said filament means, said flexible restraining element resiliently expanding upon release of the constraint of said filament means into a second operational form that is larger than said second insertion form, wherein said sealing element seals across the opening and said restraining element restrains said closure prosthesis across the opening.