Aperture occlusion device

• US 5,108,420 A
• Filed: 02/01/1991
• Issued: 04/28/1992
• Est. Priority Date: 02/01/1991
• Status: Expired due to Term

• Current Assignee: Lloyd A. Marks
• Original Assignee: Temple University
• Inventors: Marks, Lloyd A.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/649,593
• Time in Patent Office: 452 Days
• Field of Search: 606/78, 606/151, 606/157, 606/158, 606/215, 606/108, 606/213, 128/898, 128/628, 128/686, 128/843, 128/831
• 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 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 2017/00623 Introducing or retrieving devices therefor
• 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

Abstract

A device consisting of a wire for occluding an aperture within a body surface, such as atrial and ventricular septal defects (and the method of using such a device). The wire comprises two configurations, an elongated configuration for passage into said body through a catheter and through the aperture, and a preprogrammed configuration including occlusion-forming wire segments, one on each side of said aperture. The wire also includes means (preferably a temperature-induced shape change) for changing the wire from the elongated configuration to the preprogrammed configuration in the body.

Claims

1. A device adapted to occlude an aperture within a body surface, and adapted to be passed into said body, through a catheter and through said aperture, said device comprising a wire having two configurations, an elongated configuration for passage through said catheter and through said aperture, and a preprogrammed configuration which includes occlusion-forming wire segments one on each side of said aperture urged toward one another and means for causing said wire to change from said elongated configuration to said preprogrammed configuration inside said body, said means being a temperature responsive material of construction of said wire, by which said wire is activated at body temperature, to assume said preprogrammed configuration.

2. A device of claim 1 wherein said wire is combined with a catheter means for introducing said wire into said body, said catheter means also includes means for holding said wire, while it is in said catheter, at a temperature at which said wire does not tend to assume said preprogrammed configuration.

3. A device of claim 1 wherein said occlusion-forming segments each comprise helical coils urged toward one another.

4. A device of claim 1 wherein said wire further includes two foldable membranes, one associated with said first occlusion-forming wire segment and the other associated with said second occlusion-forming wire segment, said membranes in folded configuration being transportable through a catheter along with said wire, said wire adapted upon converting from said elongated configuration to said preprogrammed configuration to unfold said membranes and to form a frame supporting said membranes as essentially planar members, one disposed on each side of said aperture, and urged toward one another, wherein said means for causing a change in configuration is a thermally responsive material of construction.

5. A device according to claim 4 wherein said wire is secured to said membranes of said occlusion-forming wire segments.

6. A device according to claim 1, wherein said wire consists of nitinol.

7. A device according to claim 1, wherein said wire is biocompatible.

8. A device according to claim 1, wherein said wire is coated to enhance biocompatibility.

9. A device adapted to occlude an aperture within a body surface, and adapted to be passed into said body, through a catheter and through said aperture, said device comprising a wire having two configurations, an elongated configuration for passage through said catheter and through said aperture, and a preprogrammed configuration which includes occlusion-forming wire segments one on each side of said aperture, and means for causing said wire to change from said elongated configuration to said preprogrammed configuration inside said body, wherein said occlusion forming segments each comprise helical coils urged toward one another.

10. A device according to claim 9, wherein said wire consists of spring steel.

11. A method for occluding an aperture within a body surface by positioning the end of a catheter at the distal side of the aperture, deploying a wire of temperature responsive material of construction in an elongated configuration through said catheter to the distal side of said aperture with the aid of a means for holding said wire, permitting the wire exposed thereby to assume a preprogrammed configuration, including an occlusion-forming wire segment on the distal side of said aperture, and urged toward said aperture, withdrawing the end of said catheter through said aperture and deploying an additional length of said wire in an elongated configuration to be exposed on the proximal side of said aperture, whereupon said continued deployment, said wire is permitted to assume a preprogrammed configuration, including an opposing occlusion-forming wire segment urged toward said aperture on the proximal side of the aperture, and disengaging the wire from the means for holding said wire.

12. A method as recited in claim 11, wherein said defect is a atrial septal defect.

13. A method as recited in claim 11, wherein said defect is a ventricular septal defect.

14. A method as recited in claim 11, wherein said defect is a patent ductus arteriosus.