Method of forming medical devices; intravascular occlusion devices

• US 6,447,531 B1
• Filed: 07/10/2000
• Issued: 09/10/2002
• 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: Amplatz, Curtis
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/613,412
• Time in Patent Office: 792 Days
• Field of Search: 606/1, 606/127, 606/151, 606/159, 606/191-200, 623/111, 623/1.11, 623/1.48, 623/1.51, 623/1.53
• US Class Current: 606/200
• 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• 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 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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 2002/018 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• 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
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device

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 metal fabric formed of braided metal strands, the device having opposed ends and a collapsed configuration for delivery through a channel in a patient'"'"'s body and a generally dumbbell-shaped expanded configuration with two expanded diameter portions separated by a reduced diameter portion formed between the opposed ends, the strands at the opposed ends being clamped together by clamps, at least one of the clamps having a threaded surface for allowing releasable threaded attachment to a delivery device.

2. The medical device of claim 1 wherein each of the expanded diameter portions and the reduced diameter portion are all integrally formed from a single piece of said metal fabric.

3. The medical device of claim 1 and further including a thrombogenic agent.

4. The medical device of claim 3 wherein the thrombogenic agent comprises a coating of a thromboletic agent.

5. The medical device of claim 3 wherein the thrombogenic agent comprises a thrombogenic fabric.

6. The medical device of claim 5 wherein said thrombogenic fabric comprises silk or wool.

7. The medical device of claim 1 wherein the reduced diameter portion has an outer diameter which is no more than about one-third of an outer diameter of at least one of the expanded diameter portions.

8. The medical device of claim 7 wherein the outer diameter of the reduced diameter portion is no more than about one-quarter of the outer diameter of said at least one expanded diameter portion.

9. The medical device of claim 7 wherein the outer diameter of each of the enlarged diameter portions is about the same.

10. The medical device of claim 1 wherein the length of the reduced diameter portion comprises no more than about 50 percent of the overall length of the device.

11. The medical device of claim 10 wherein the length of the reduced diameter portion comprises between about 20 percent and about 50 percent of the overall length of the device.

12. The medical device of claim 1 further comprising a third expanded diameter portion and a second reduced diameter portion, the second reduced diameter portion being disposed between the third expanded diameter portion and one of the other two expanded diameter portions.

13. The medical device of claim 11 wherein each of the expanded diameter portions and reduced diameter portions are all integrally formed from a single piece of resilient metal fabric.