Ultrasoft embolism devices and process for using them

• US 6,458,119 B1
• Filed: 08/08/1997
• Issued: 10/01/2002
• Est. Priority Date: 11/18/1992
• Status: Expired due to Fees

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Berenstein, Alejandro, Sepetka, Ivan
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/909,004
• Time in Patent Office: 1,880 Days
• Field of Search: 606/1, 606/191-200, 606/151, 606/108, 606/127, 623/1.1, 623/1.15, 623/123
• US Class Current: 606/1
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/1209 detachable by electrical current or potential, e.g. electroactive polymer
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An exceptionally flexible, ultra-soft vasoocclusive or embolism forming device made of a material which may be a braid, coil, or chain which forms a long, thin thread-like device having little rigidity or column strength. The device is sufficiently flexible and small that it may be hydraulically delivered to a site within the vasculature of a human body using an injected drug or fluid flush through a catheter.

Claims

1. A flexible, vaso-occlusive device for forming an occlusion in a selected site of the vasculature, said device having a size and flexibility such that the device may be safely delivered to a selected site in the vasculature of the human body by hydraulic delivery, where the device deflects more than about 35°

under its own weight when one centimeter length of the device is supported horizontally at one end.

2. The device of claim 1 where the length of the device is between 2 mm and 120 cm.

3. The device of claim 1 having a preformed shape.

4. A flexible, vaso-occlusive device for forming an occlusion in a selected site of the vasculature, said device having a size and flexibility such that the device may be safely delivered to a selected site in the vasculature of the human body by hydraulic delivery, wherein the flexible vaso-occlusive device comprises a coil or a braid having an outside diameter less than about 0.010 inches, wherein the coil or braid is sufficiently flexible that a one centimeter length of the coil or braid supported horizontally at one end will deflect more than about 20°

under its own weight.

5. The device of claim 4 comprising silver, gold, palladium, platinum, tungsten, iridium, stainless steel, or alloys thereof.

6. The device of claim 5 comprising an alloy of platinum and tungsten.

7. The device of claim 5 where device comprises ribbon, said ribbon having a major axis of 0.001 to 0.002 inches and a minor axis of 0.0005 to 0.001 inches.

8. The device of claim 4 where the device is regularly wound.

9. The device of claim 4 where the device is not regularly wound.

10. The device of claim 4 where the outside diameter is between about 0.0014 inches and about 0.0095 inches.

11. The device of claim 10 where the outside diameter is between about 0.004 inches and about 0.0095 inches.

12. The device of claim 11 where the outside diameter is between about 0.004 inches and about 0.0075 inches.

13. The device of claim 4 where the device comprises a filament, said filament having a filament with a diameter of less than 0.0025 inches.

14. The device of claim 13 where the device comprises a filament, said filament having a diameter of between 0.00045 and less than 0.00225 inches.

15. The device of claim 14 where the device comprises a filament, said filament having a diameter of between 0.0005 and 0.002 inches.

16. The device of claim 15 where the device comprises a filament, said filament having a diameter of between 0.001 and 0.002 inches.

17. The device of claim 14 where the length of the device is between 30 cm and 120 cm.

18. A flexible, vaso-occlusive device of a size and flexibility safely deliverable to a selected site in the vasculature of the human body by hydraulic delivery where the device deflects more than about 35°

under its own weight when one centimeter length of the device is supported horizontally at one end.