Aneurysm closure device assembly

• US 5,980,514 A
• Filed: 07/26/1996
• Issued: 11/09/1999
• Est. Priority Date: 07/26/1996
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Chee, Uriel Hiram, Eder, Joseph C., Bashiri, Mehran, Engelson, Erik T., Teoh, Clifford, Doan, Hong, Kupiecki, David, Gia, Son M.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US08/690,183
• Time in Patent Office: 1,201 Days
• Field of Search: 606/32-42, 606/45-50, 606/108, 606/191, 606/194, 604/104, 604/52, 579/533
• US Class Current: 606/32
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

This is an artificial occlusion kit for implanting and retaining an artificial occlusion device in a body space adjacent to and extending from a body lumen in a mammal. The includes at least one occlusion device and a retaining device for blocking the migration of the occlusion device out of the occlusion site. The retaining device is radially expandable at a retaining site adjacent the body space to be occluded to a diameter that is sufficient to engage the body lumen wall at the retaining site and form a barrier across the entrance zone of the body space to be occluded. The expanded retaining device also forms a lumen for flow through body lumen at the retaining site. At least one semi-penetrable space may also be provided in the retaining device, allowing introduction of occlusion devices into the body space to be occluded, but preventing subsequent migration of the occlusion devices out of the body space. This semi-penetrable space may also be distensible to allow for delivery of occlusion devices therethrough. An introducer wire or a tapered-tip delivery catheter may be used to distend the distensible space and deliver the occlusion devices. The retaining device structure may further include a radiopaque metal wire wound into a primary helix over an inner core member made of a superelastic alloy of nickel and titanium. An implantable medical device assembly is also provided, having the structure described for the retaining device of the novel artificial occlusion kit, and which is attached to an elongate pusher via a sacrificial link that is electrolytically dissolvable.

Claims

1. An artificial occlusion kit for implanting and retaining an artificial occlusion device in a body space to be occluded adjacent to and extending from a body lumen in a mammal, comprising:

at least one occlusion device adapted for filling at least a portion of the body space; and

a retaining device assembly having a retaining device adapted to be delivered and implanted at a retaining site in the body lumen adjacent to the body space, said retaining device having two opposite ends and forming a first shape with a first outer diameter, said retaining device being expandable to a second shape having a second outer diameter larger than said first outer diameter and sufficient to engage a body lumen wall at the retaining site such that a barrier is formed against migration of said at least one occlusion device out of the body space and into the body lumen, said second shape also forming a lumen along a longitudinal axis sufficient to allow flow of body fluids therethrough.

2. The artificial occlusion kit of claim 1, wherein said retaining device forms said first shape when radially constrained for percutaneous delivery to the retaining site, and forms said second shape upon release from said radial constraint at the retaining site.

3. The artificial occlusion kit of claim 2, further comprising

a delivery catheter having a proximal delivery catheter end with a proximal delivery port, an opposite distal delivery catheter end portion with a distal delivery port, and a delivery lumen extending between said delivery ports and having a delivery lumen inner diameter less than said second outer diameter,

wherein said retaining device is slideably disposable under radial constraint within said delivery lumen.

4. The artificial occlusion kit of claim 3, wherein said retaining device assembly further comprises a pusher that is coaxially slidable within said delivery lumen and has a distal pusher end portion and a proximal pusher end portion,

wherein said distal pusher end portion may be advanced through said delivery lumen in confronting engagement with a proximal end of said retaining device such that said retaining device may be pushed with the pusher out of the delivery lumen through the distal delivery port and into the body space.

5. The artificial occlusion kit of claim 2, wherein said retaining device assembly further comprises a pusher having a distal pusher end portion that is detachably secured to said retaining device and a proximal pusher end portion that is adapted to be axially manipulated by a user.

6. The artificial occlusion kit of claim 5, wherein said distal pusher end portion is electrolytically detachable from said retaining device via an electrolytically severable link.

7. The artificial occlusion kit of claim 6, further comprising:

a power source electrically coupled to said electrolytically severable link; and

an electrode electrically coupled to said power source;

wherein a circuit is formed when said electrode and electrolytically severable joint are both in contact with a patient.

8. The artificial occlusion kit of claim 5, wherein said distal pusher end portion is mechanically detachable from said retaining device.

9. The artificial occlusion kit of claim 2, wherein said retaining device form said first shape when radially constrained for a percutaneous delivery to a core wire extending between said retaining device'"'"'s opposite ends and constrained to said core wire by electrolytic links, and wherein said retaining device forms said second shape upon electrolytic release from said radial constraint.

10. The artificial occlusion kit of claim 9 wherein said retaining device assembly and said core wire are insulated from any fluid found in said body space and body lumen.

11. The artificial occlusion kit of claim 3, wherein said retaining device comprises at least one wire wound into a primary helix and having a secondary shape imparted thereto.

12. The artificial occlusion kit of claim 11, wherein said primary helix forms a primary helix lumen, said retaining device further comprising an elongate core member coaxially disposed within said primary helix lumen.

13. The artificial occlusion kit of claim 12, wherein said elongate core member is a metal.

14. The artificial occlusion kit of claim 1, wherein said second shape defines at least one semi-penetrable space between the body space to be occluded and the adjacent body lumen.

15. The artificial occlusion kit of claim 14, wherein said at least one occlusion device forms a first occlusion device shape that is advanceable through said semi-penetrable space, and is also expandable to a second occlusion device shape that is not advanceable through said semi-penetrable space.

16. The artificial occlusion kit of claim 14, wherein said second shape comprises a helix and said semi-penetrable space is the spacing between adjacent helical windings of said helix.

17. The artificial occlusion kit of claim 14, wherein said semi-penetrable space is distensible.

18. The artificial occlusion kit of claim 17, further comprising:

a delivery catheter having a proximal delivery catheter end with a proximal delivery port, an opposite distal delivery catheter end portion with a distal delivery port, and a delivery lumen extending between said delivery ports,

said distal delivery catheter end portion further having a tapered tip portion with a distal tip diameter smaller than said semi-penetrable space,

wherein said semi-penetrable spacing is distensible by advancing said tapered tip portion at least partially therethrough, and wherein said at least one occlusion device is advanceable within said delivery lumen.

19. The artificial occlusion kit of claim 17, wherein said at least one occlusion device comprises two opposite ends and forms an occlusion device lumen extending between two opposite occlusion device ports at said opposite ends, said kit further comprising:

an introducer wire being coaxially advanceable through said occlusion device lumen and through said opposite occlusion device ports, and having an introducer wire tip portion that is advanceable through and is adapted to distend said semi-penetrable spacing,

wherein said at least one occlusion device is advanceable through said semi-penetrable spacing when said introducer wire tip portion is advanced through and distending said semi-penetrable spacing, and wherein said at least one occlusion device is prevented from migrating from a body space to be occluded and through said semi-penetrable spacing when said semi-penetrable spacing is not distended.

20. The artificial occlusion kit of claim 1 wherein said at least one occlusion device approximates the shape of the body space into which it is placed.

21. The artificial occlusion kit of claim 1 wherein said retaining device assembly further comprises a distal end having a distal diameter smaller than said body lumen and said second outer diameter.