Aneurysm closure device assembly

• US 6,344,041 B1
• Filed: 10/26/2001
• Issued: 02/05/2002
• Est. Priority Date: 07/26/1996
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Clifford Teoh, David Kupiecki, Erik T. Engelson, Hong Doan, Joseph C. Eder, Mehran Bashiri, Son M. Gia, Uriel Hiram Chee
• Inventors: Chee, Uriel Hiram, Eder, Joseph C., Bashiri, Mehran, Teoh, Clifford, Doan, Hong, Kupiecki, David, Gia, Son M., Engelson, Erik T.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): RUDDY, DAVID M
• Application Number:
  US09/699,267
• Time in Patent Office: 102 Days
• Field of Search: 606/32-42, 606/45-50, 606/108, 606/191, 606/196, 606/194, 606/198, 606/200, 606/95.05
• 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 implantable medical device assembly for engaging a body space wall in a mammalian body, comprising:

an elongate implantable member having two opposite ends, and wherein said member forms

a first shape having a longitudinal axis and a first outer diameter on a radial aspect of said longitudinal axis when radially artificially constrained for percutaneous delivery into a body space having a body space wall, and

a second shape about said longitudinal axis upon release from said radial constraint, said second shape having a second outer diameter larger than said first outer diameter and sufficient to engage the body space wall, and forming a lumen along said longitudinal axis with a lumen diameter sufficient to allow fluid flow through said implantable member wherein said second shape has at least one region having a reduced diameter.

2. The implantable medical device assembly of claim 1, further comprising

a delivery catheter having a proximal end with a proximal delivery port, an opposite distal end 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 elongate implantable member is slideably disposable under radial constraint within said delivery lumen.

11. The implantable medical device assembly of claim 1 wherein said elongate implantable member having two opposite ends further comprises a distal end having a distal diameter smaller than said body lumen and said second outer diameter.

3. An implantable medical device assembly for engaging a body space wall in a mammalian body, comprising:

an elongate implantable member having two opposite ends, and wherein said member forms

a first shape having a longitudinal axis and a first outer diameter on a radial aspect of said longitudinal axis when radially artificially constrained for percutaneous delivery into a body space having a body space wall, and

a second shape about said longitudinal axis upon release from said radial constraint, said second shape having a second outer diameter larger than said first outer diameter and sufficient to engage the body space wall, and forming a lumen along said longitudinal axis with a lumen diameter sufficient to allow fluid flow through said implantable member; and

a power source electrically coupled to an electrolytically severable joint located at one of said opposite ends; and

an electrode electrically coupled to said power source;

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

4. The implantable medical device assembly of claim 3, wherein said power source comprises a direct current source.

5. The implantable medical device assembly of claim 4, wherein said power source comprises an alternating current source.

6. The implantable medical device assembly of claim 5, wherein said power source produces a signal comprising an alternating current signal superimposed over a direct current signal, said assembly further comprising a sensing circuit for monitoring changes in said alternating current signal indicative of progression of electrolytic detachment of said implantable member from an elongate pusher at said electrolytically severable joint.

7. An implantable medical device assembly for engaging a body space wall in a mammalian body, comprising:

an elongate implantable member having two opposite ends, and wherein said member forms

a first shape having a longitudinal axis and a first outer diameter on a radial aspect of said longitudinal axis when radially artificially constrained for percutaneous delivery into a body space having a body space wall, and

a second shape about said longitudinal axis upon release from said radial constraint, said second shape having a second outer diameter larger than said first outer diameter and sufficient to engage the body space wall, and forming a lumen along said longitudinal axis with a lumen diameter sufficient to allow fluid flow through said implantable member wherein said implantable member comprises at least one wire wound into a primary helix and having a secondary geometry imparted thereto and wherein said primary helix forms a primary helix lumen, said implantable member further comprising an elongate core member coaxially disposed within said primary helix lumen.

8. The implantable medical device assembly of claim 7, wherein said elongate core member is a metal.

9. The implantable medical device assembly of claim 8, wherein said metal is a super-elastic alloy.

10. The implantable medical device assembly of claim 9, wherein said super-elastic alloy comprises nickel and titanium.