Claims
- 1. An occlusion device that is fully retrievable, the occlusion device comprising:
a center post; first and second fixation devices connected to the center post, the first and second fixation devices comprising a plurality of stranded wire support arms; first and second reinforced sheets attached to the first and second fixation devices, respectively; and end caps located at the tips of each arm.
- 2. The occlusion device of claim 1 wherein the reinforced sheets comprise layers of polyvinyl alcohol foam laminated together.
- 3. The occlusion device of claim 2 wherein the layers of polyvinyl alcohol foam further comprise:
a first layer; and a second layer laminated to the first layer to create a reinforced area on the sheet.
- 4. The occlusion device of claim 3 wherein the reinforced area is shaped to correspond to a shape of the first and second fixation devices.
- 5. The occlusion device of claim 4 wherein the reinforced sheets are attached to the fixation devices by sutures sewn at the reinforced area.
- 6. The occlusion device of claim 2 wherein the sheets have a thickness of between about 0.1 mm to about 2.0 mm.
- 7. The occlusion device of claim 1 wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.
- 8. The occlusion device of claim 7 wherein the arms of the first fixation device do not have equal lengths.
- 9. The occlusion device of claim 8 wherein the arms of the second fixation device do not have equal lengths.
- 10. The occlusion device that is fully retrievable through the same catheter used to deploy the occlusion device, the occlusion device comprising:
a support frame comprising stranded wire arms; and a sheet connected to the support frame; wherein the sheet has a tear strength high enough to prevent the sheet from tearing off the support frame when the occlusion device is withdrawn into the catheter.
- 11. The occlusion device of claim 10 wherein the sheet is formed of polyvinyl alcohol foam and wherein the tear strength of the sheet is provided by laminating two layers of polyvinyl alcohol foam together to form a two-ply area on the sheet.
- 12. The occlusion device of claim 11 wherein the two layers of polyvinyl alcohol foam comprise a first sheet and a second sheet, wherein the second sheet is shaped to correspond to a shape of the arms on the support frame.
- 13. The occlusion device of claim 11 wherein the tear strength of the sheet is provided by suturing the sheet to the support frame at the two ply area.
- 14. The occlusion device of claim 10 and further comprising atraumatic tips located at the ends of the stranded wire arms.
- 15. The occlusion device of claim 14 wherein the stranded wire arms are configured to allow the device to be withdrawn into the catheter by grasping any arm.
- 16. The occlusion device of claim 15 wherein the length of the arms is such that when withdrawn into a catheter, the atraumatic tips do not all meet at one location.
- 17. A method of retrieving an occlusion device having a center post, a fixation device attached to the center post, first and second fixation devices connected to the center post, the first and second fixation devices comprising a plurality of stranded wire support arms, and first and second reinforced sheets attached to the first and second fixation devices, respectively, after the occlusion device has been deployed through a catheter, the method comprising:
grasping the occlusion device; and withdrawing the occlusion device back into the same catheter used to deploy the device so that the occlusion device fully enters the catheter.
- 18. The method of claim 17 wherein grasping a part of the occlusion device comprises grasping the center post of the occlusion device and wherein withdrawing the occlusion device back into the same catheter used to deploy the device comprises withdrawing the center post into the catheter until the fixation devices and reinforced sheets collapse and are withdrawn inside the catheter.
- 19. The method of claim 17 wherein grasping a part of the device comprises grasping any of the plurality of stranded wire arms and withdrawing the grasped arm into the catheter until the fixation devices and reinforced sheets collapse and are withdrawn inside the catheter.
- 20. A method of laminating sheets for use in an occlusion device, the method comprising:
slicing sheets of polyvinyl alcohol foam to a thickness of between about 0.1 mm to about 2.0 mm; placing a first sheet on a second sheet; and applying heat and pressure to laminate the two sheets together.
- 21. The method of claim 20 wherein slicing the sheets of PVA foam further comprises slicing the sheets to a thickness of between about 0.3 mm to about 0.6 mm.
- 22. The method of claim 20 wherein applying heat and pressure to laminate the two sheets together comprises:
applying a temperature of between about 100 to 180 degrees Fahrenheit.
- 23. The method of claim 20 wherein applying heat and pressure comprises applying from about 0.25 to about 10 pounds of pressure for about 1 through 180 seconds.
- 24. The method of claim 19 and further comprising removing any wrinkles from the first or second sheet of foam when the two are placed together.
- 25. The method of claim 20 wherein slicing sheets of polyvinyl alcohol foam comprises slicing a block of polyvinyl alcohol foam.
- 26. The method of claim 25 and further comprising selecting a first sheet and a second sheet such that the first and second sheets were not adjacent sheets sliced from the polyvinyl alcohol foam block.
- 26. The method of claim 20 wherein a first sheet comprises a shape similar to the desired shape of the sheet used in the occlusion device and the second sheet comprises a shape similar to a configuration of arms of the occlusion device.
- 27. An improved occlusion device, the occlusion device comprising:
a center post; first and second fixation devices connected to the center post; first and second sheets attached to the first and second fixation devices, respectively, wherein the first and second sheets comprise multiple layers of polyvinyl alcohol foam laminated together to form a multi-ply area on the sheets.
- 28. The occlusion device of claim 27 wherein the layers of polyvinyl alcohol foam have a thickness from between about 0.1 millimeters to about 2.0 millimeters.
- 29. The occlusion device of claim 28 wherein the layers of polyvinyl alcohol foam have a thickness of between about 0.3 millimeters to about 0.6 millimeters.
- 30. The occlusion device of claim 27 wherein the layers of polyvinyl alcohol foam comprise first sheet and a second sheet, wherein the second sheet is shaped to correspond to a shape of the fixation device.
- 31. The occlusion device of claim 30 wherein the first and second sheet are sutured to the fixation device at the multi-ply area.
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is related to U.S. Patent application entitled Articulated Center Post, Serial Number ______, Occlusion Device Having Five or More Arms, Serial Number ______, Septal Stabilization Device, Serial Number and U.S. Patent application entitled Hoop Design for Occlusion Device, Serial Number ______, all filed on even date herewith.