Percutaneous catheter directed intravascular occlusion devices

• US 5,725,552 A
• Filed: 05/14/1996
• Issued: 03/10/1998
• Est. Priority Date: 07/08/1994
• Status: Expired due to Term

• Current Assignee: AGA Medical Corporation (Abbott Laboratories Incorporated)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories Incorporated)
• Inventors: Kotula, Frank, Amplatz, Kurt, Amplatz, Curtis
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/647,712
• Time in Patent Office: 665 Days
• Field of Search: 606/191-200, 606/213, 606/151, 606/1
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: B21F 45/00 : Wire-working in the manufacture of other particular articles of pins, needles, nails, hairpins B21G; of chains B21L ; for semiconductor devices H01L24/42
• CPC Class Codes: B21F 45/008 : of medical instruments, e.g. stents, corneal rings medical science A61

Abstract

The present invention provides a method of forming a medical device and medical devices which can be formed in accordance with the method. In one embodiment, the method includes the steps of a) providing a metal fabric formed of a plurality of strands formed of a metal which can be heat treated to substantially set a desired shape; b) deforming the metal fabric to generally conform to a surface of a molding element; c) heat treating the metal fabric in contact with the surface of the molding element to substantially set the shape of the fabric in its deformed state; and d) removing the metal fabric from contact with the molding element. The resulting metal fabric will define a medical device which can be collapsed for passage through a catheter or the like for deployment in a channel of a patient'"'"'s body. Medical devices made in accordance with this method can have varying structures.

Claims

1. A collapsible medical device, comprising a plurality of metal strands woven into a tubular woven metal fabric having a proximal end and a distal end, each end having a means for securing each end attached to said tubular woven metal fabric, thereby gathering said strands and inhibiting unraveling of the strands, said tubular woven metal fabric having an expanded preset configuration shaped to create an occlusion of an abnormal opening in a body organ, said expanded preset configuration being in a shape of a bell and deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.

2. The medical device as recited in claim 1, wherein said means for securing each end has a threaded bore for rotational attachment to a delivery device.

3. The medical device as recited in claim 2, further including an occluding fiber retained within a hollow central portion formed by said tubular woven fabric.

4. The medical device as recited in claim 1, wherein the metal fabric is manufactured from an alloy selected from the group consisting of stainless steel, nickel-titanium, and cobalt-chromium-nickel.

5. The medical device as recited in claim 4, further including an occluding fiber retained within a hollow central portion formed by said tubular woven fabric.

6. The medical device as recited in claim 1, further including an occluding fiber retained within a hollow central portion formed by said tubular woven fabric.

7. A collapsible medical device, comprising:

a tubular woven metal fabric including a plurality of braided strands and having a proximal end and a distal end, each end having a clamp attached to said metal fabric to thereby gather said strands together and inhibit unraveling of the strands, said metal fabric having a collapsed configuration for delivery through a channel in a patient'"'"'s body and a generally dumbbell shaped expanded preset configuration for substantially creating an occlusion of an abnormal opening in a body organ, the metal fabric in its expanded configuration having two expanded diameter portions and a reduced diameter portion disposed between the two expanded diameter portions, each expanded diameter portion having an inner and outer wall, wherein the inner wall of at least one of the expanded diameter portions is generally concave.

8. The medical device as recited in claim 7, further including an occluding fiber retained within a hollow central portion formed by said generally dumbbell shaped expanded configuration.

9. A collapsible medical device, comprising a tubular woven metal fabric including a plurality of braided strands and having a proximal end and a distal end, each end having a clamp attached to said tubular woven metal fabric to thereby gather said strands together and inhibit the strands from unraveling, said tubular woven metal fabric having an expanded preset configuration shaped to create an occlusion of an abnormal opening in a body organ, said expanded preset configuration being deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, wherein the expanded preset configuration comprises two expanded diameter portions and a reduced diameter portion, said reduced diameter portion having a length approximating a thickness of a patient'"'"'s atrial septum, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.

10. The medical device as recited in claim 9, wherein said clamp has a threaded bore adapted for rotationally receiving a delivery device.

11. The medical device as recited in claim 9, further including an occluding fiber contained within a hollow center portion formed by said tubular woven metal fabric.

12. The medical device as recited in claim 9, wherein the metal fabric is manufactured from an alloy selected from the group consisting of stainless steel, nickel-titanium, and cobalt-chromium-nickel.