Transcatheter occluding implant

• US 6,245,090 B1
• Filed: 11/09/1998
• Issued: 06/12/2001
• Est. Priority Date: 11/07/1997
• Status: Expired due to Fees

• Current Assignee: Cellogy Limited, Cellology Limited
• Original Assignee: Salviac Ltd. (Abbott Laboratories)
• Inventors: Brady, Eamon, Gilson, Paul
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/188,473
• Time in Patent Office: 946 Days
• Field of Search: 606/213, 606/215, 606/151, 606/216-217, 606/153, 606/191, 606/198, 606/78, 604/167, 604/281, 600/32, 623/11, 623/1, 623/7, 623/8, 623/12, 623/16
• 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 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices

Abstract

A transcatheter occluding implant (50) is used to seal off a vessel lumen such as for arterial and venous embolization, cutting off of supply to tumors, male and female sterilization. There is illustrated a plug member of an open foam plastics material having good hysteresis properties in the form of a shaft 51 carrying annular supports. The implant (50) can be compressed into a very small size and then will expand to contact the internal bore of the vessel to form a force fit within the vessel lumen for secure anchoring of the implant. The open cell foam construction encourages tissue growth and thus further contributes to the stabilization of the implant.

Claims

1. A transcatheter occluding implant for occluding a vessel lumen, comprising:

a plug member having a porous outer surface, a compressed configuration allowing for transcatheter delivery to a vessel lumen to be occluded, and an expanded, occluding configuration;

the plug member further including a lumen anchoring portion having a transverse dimension in the expanded configuration which is greater than a transverse dimension of at least a portion of an internal bore of the lumen in which it is to be deployed, the lumen anchoring portion providing a force fit within the lumen to secure the plug therein;

the plug member being formed at least partially of a resilient foam plastics material, the resilient foam plastics material;

assisting in causing the lumen anchoring portion to bear against the internal bore of the lumen when in the expanded configuration, providing support for retaining the anchoring portion in position in the lumen, and having a void content of greater than 70%.

2. A transcatheter occluding implant of claim 1 in which the outer surface of the plug member forms a part of the anchoring portion and provides a closed path around the plug member for total occlusion of the vessel on initial insertion and expansion.

3. A transcatheter occluding implant of claim 1, in which the outer surface of the plug member adjacent the interior of the lumen is of an open cell structure forming a plurality of tissue receiving orifices.

4. A transcatheter occluding implant of claim 1, in which substantially all the plug member is of a foam plastics material.

5. A transcatheter occluding implant of claim 1, in which the foam plastics material is an open foam cell material with good hysteresis properties.

6. A transcatheter occluding implant of claim 1, in which the foam plastics material is manufactured from a polymeric material having good hysteresis properties and in which the rate of expansion and compressibility of the foam material is chosen to be greater than that to which the bore of the lumen is subjected.

7. A transcatheter occluding implant of claim 1, in which the foam material has a pore size of less than 250 microns.

8. A transcatheter occluding implant of claim 1, in which the foam material has a pore size of less than 100 microns.

9. A transcatheter occluding implant of claim 1, in which the foam material has a pore size within the range of 30 to 50 microns.

10. A transcatheter occluding implant of claim 1, in which the foam material has a void content greater than 90%.

11. A transcatheter occluding implant of claim 1, in which the foam material has a void content greater than 94%.

12. A transcatheter occluding implant of claim 1, in which the surface area of the plug member in contact with the internal bore of the lumen on initial insertion exceeds the minimum area necessary to anchor the occluding implant within the lumen.

13. A transcatheter occluding implant of claim 1, in which the plug member is substantially cylindrical in shape.

14. A transcatheter occluding implant of claim 1, in which the plug member has a circumferentially arranged open slot.

15. A transcatheter occluding implant of claim 1, in which the plug member has a longitudinally arranged open slot.

16. A transcatheter occluding implant of claim 1 in which the plug member is substantially cylindrical in shape and in which the cylindrical plug member is bent around itself to form shapes of differing geometries.

17. A transcatheter occluding implant of claim 1 in which the plug member is in the form of a shaft carrying a plurality of spaced-apart annular supports.

18. A transcatheter occluding implant of claim 1, in which the plug member is in the form of a central shaft carrying two end portions of gradually increasing cross section and in which each end face of the plug member is of a dished configuration.

19. A transcatheter occluding implant of claim 1 in which the plug member comprises a central shaft having at its distal end an enlarged head formed from a plurality of radially arranged flights tapering towards its extremity and a tail portion at its proximal end comprising a plurality of longitudinally spaced-apart flights projecting radially from the shaft and a circular annular support mounted on the shaft intermediate the tail and head portions.

20. A transcatheter occluding implant of claim 1, in which the implant is an aneurysm implant having a substantially spherical plug member.

21. A transcatheter occluding implant for occluding a vessel lumen, comprising:

a plug member having a porous outer surface, a compressed configuration allowing for transcatheter delivery to a vessel lumen to be occluded, and an expanded, occluding configuration;

the plug member further including a lumen anchoring portion having a transverse dimension in the expanded configuration which is greater than a transverse dimension of at least a portion of an internal bore of the lumen in which it is to be deployed, the lumen anchoring portion providing a force fit within the lumen to secure the plug therein; and

an attachment mechanism formed in the plug member for allowing repositioning and removal of the plug member with respect to the vessel lumen;

the plug member being formed at least partially of a resilient foam plastics material, the resilient foam plastics material;

assisting in causing the lumen anchoring portion to bear against the internal bore of the lumen when in the expanded configuration, providing support for retaining the anchoring portion in position in the lumen, and having a void content of greater than 70%.

22. A transcatheter occluding implant of claim 21, wherein the attachment mechanism includes an opening extending along a longitudinal axis of the plug member.

23. A transcatheter occluding implant of claim 21, in which the outer surface of the plug member adjacent the interior of the lumen is of an open cell structure forming a plurality of tissue receiving orifices.

24. A transcatheter occluding implant of claim 21, in which substantially all the plug member is of a foam plastics material.

25. A transcatheter occluding implant of claim 21, in which the foam material has a pore size of less than 250 microns.

26. A transcatheter occluding implant of claim 21, in which the foam material has a pore size of less than 100 microns.

27. A transcatheter occluding implant of claim 21, in which the foam material has a pore size within the range of 30 to 50 microns.

28. A transcatheter occluding implant of claim 21, in which the foam material has a void content of greater than 70%.

29. A transcatheter occluding implant of claim 21, in which the foam material has a void content greater than 90%.

30. A transcatheter occluding implant of claim 21, in which the foam material has a void content greater than 94%.

31. A transcatheter occluding implant of claim 21, in which the surface area of the plug member in contact with the internal bore of the lumen on initial insertion exceeds the minimum area necessary to anchor the occluding implant within the lumen.

32. A transcatheter occluding implant of claim 21, in which the plug member is substantially cylindrical in shape.

33. A transcatheter occluding implant of claim 21, in which the plug member has a circumferentially arranged open slot.

34. A transcatheter occluding implant of claim 21, in which the plug member has a longitudinally arranged open slot.

35. A transcatheter occluding implant of claim 21, in which the plug member is substantially cylindrical in shape and in which the cylindrical plug member is bent around itself to form shapes of differing geometries.

36. A transcatheter occluding implant of claim 21, in which the plug member is in the form of a shaft carrying a plurality of spaced-apart annular supports.

37. A transcatheter occluding implant of claim 21, in which the plug member is in the form of a central shaft carrying two end portions of gradually increasing cross section and in which each end face of the plug member is of a dished configuration.

38. A transcatheter occluding implant of claim 21, in which the plug member comprises a central shaft having at its distal end an enlarged head formed from a plurality of radially arranged flights tapering towards its extremity and a tail portion at its proximal end comprising a plurality of longitudinally spaced-apart flights projecting radially from the shaft and a circular annular support mounted on the shaft intermediate the tail and head portions.

39. A transcatheter occluding implant of claim 21, in which the implant is an aneurysm implant having a substantially spherical plug member.