Percutaneous catheter directed occlusion devices

• US 5,846,261 A
• Filed: 09/08/1997
• Issued: 12/08/1998
• 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: Amplatz, Kurt, Kotula, Frank
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/925,935
• Time in Patent Office: 456 Days
• Field of Search: 606/213, 606/215, 606/216, 606/217, 606/151, 606/153, 606/191-198, 606/199, 606/200, 604/167, 604/281, 600/32, 128/899
• 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 2017/00575 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 2017/00867 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 2002/016 made from wire-like elements
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: B21F 45/008 : of medical instruments, e.g. stents, corneal rings medical science A61

Abstract

A collapsible medical device and associated methods for occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from a heat treatable metal fabric. The metal fabric is formed from a plurality of metal strands and is heat treated within a mold in order to substantially set a desired shape of the device. The medical device includes a fastener for attaching to the end of a guide wire or delivery catheter, wherein the shape of the medical device is formed such that the fastener is attached to the metal fabric within a recess formed in the shape of the medical device. A medical device having a preselected shape is delivered through a catheter or the like for deployment in a desired channel or opening in a patient'"'"'s body. The medical device may be shaped, for example, to occlude an ASD, PDA, or a VSD.

Claims

1. A collapsible medical device, comprising a metal fabric having an expanded preset configuration and including a recess in each of a proximal end and a distal end of the preset configuration, said proximal and distal end each having means for securing each end attached to the metal fabric and contained within the recess, wherein said medical device is shaped to create an occlusion of an abnormal opening, whereby said expanded preset configuration is 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 such that the medical device tends to return to said expanded preset configuration when unconstrained.

2. The medical device as recited in claim 1, wherein the expanded preset configuration comprises two expanded diameter portions and a reduced diameter portion disposed between the two expanded diameter portions, said reduced diameter portion having a length dimension which approximates a thickness of the abnormal opening.

3. The medical device as recited in claim 2, wherein an inner surface of at least one of the expanded diameter portions is concave.

4. The medical device as recited in claim 2, wherein an inner surface of a first expanded diameter portions is concave and a length of the reduced diameter portion is dimensioned such that a perimeter edge of the first expanded diameter portion overlaps a perimeter edge of a second diameter portion.

5. The medical device as recited in claim 2, wherein a center of at least one of the expanded diameter portions is offset relative to the center of the reduced diameter portion.

6. The medical device as recited in claim 1, wherein the reduced diameter portion has a length approximating a thickness of a patient'"'"'s atrial septum.

7. The medical device as recited in claim 1, wherein the reduced diameter portion has a length approximating a thickness of a patient'"'"'s ventricular septum.

8. The medical device as recited in claim 1, wherein said expanded preset configuration is in a shape of a bell.

9. The medical device as recited in claim 1, wherein said expanded preset configuration is in a shape of a dumbbell.

10. A collapsible medical device, comprising a metal fabric having an expanded preset configuration in a shape of a bell and including a recess in each of a proximal end and a distal end, said proximal and distal end each having means for securing each end attached to the metal fabric and contained within the recess, wherein said medical device is shaped to create an occlusion in a patent ductus arteriosus, whereby said expanded preset configuration is 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 such that the medical device tends to return to said expanded preset configuration when unconstrained.

11. A collapsible medical device, comprising a metal fabric having an expanded preset configuration including two expanded diameter portions and a reduced diameter portion disposed between the two expanded diameter portions, each expanded diameter portion having a recess extending inward from an outer surface of the expanded diameter portion, such that means for securing an outer edge of said metal fabric is attached thereto and contained within each recess, said medical device is shaped to create an occlusion of an abnormal opening and said reduced diameter portion has a length dimension which approximates a thickness of the abnormal opening, whereby said expanded preset configuration is 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 such that the medical device tends to return to said expanded preset configuration when unconstrained.

12. The medical device as recited in claim 11, wherein the reduced diameter portion has a length approximating a thickness of a patient'"'"'s atrial septum.

13. The medical device as recited in claim 11, wherein the reduced diameter portion has a length approximating a thickness of a patient'"'"'s ventricular septum.

14. The medical device as recited in claim 11, wherein an inner surface of at least one of the expanded diameter portions is concave.

15. The medical device as recited in claim 11, wherein an inner surface of a first expanded diameter portions is concave and a length of the reduced diameter portion is dimensioned such that a perimeter edge of the first expanded diameter portion overlaps a perimeter edge of a second diameter portion.

16. The medical device as recited in claim 11, wherein a center of at least one of the expanded diameter portions is offset relative to the center of the reduced diameter portion.

17. The medical device as recited in claim 11, wherein said means for securing includes an internal threading for attachment to a delivery device.

18. A collapsible medical device, comprising a metal fabric having an expanded preset configuration and having a proximal end and a distal end of the preset configuration, said proximal and distal end each having means for securing each end attached to the metal fabric, wherein the expanded preset configuration comprises two expanded diameter portions and a reduced diameter portion disposed between the two expanded diameter portions, said reduced diameter portion having a tapered cross-section extending between the two expanded diameter portions, whereby said expanded preset configuration is 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 such that the medical device tends to return to said expanded preset configuration when unconstrained.