Filamentous embolic device with expansible elements

• US 6,238,403 B1
• Filed: 10/04/1999
• Issued: 05/29/2001
• Est. Priority Date: 10/04/1999
• Status: Expired due to Term

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Rosenbluth, Robert F., Cox, Brian J., Greene, George R. Jr.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/410,970
• Time in Patent Office: 603 Days
• Field of Search: 606/108, 606/191, 606/194, 606/195, 606/200
• US Class Current: 606/108
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

An embolization device includes a plurality of highly-expansible embolizing elements disposed at spaced intervals along a filamentous carrier. In a preferred embodiment, the carrier is a suitable length of very thin, highly flexible filament of nickel/titanium alloy. The embolizing elements are separated from each other on the carrier by radiopaque spacers in the form of highly flexible microcoils made of platinum or platinum/tungsten alloy. In a preferred embodiment, the embolizing elements are made of a hydrophilic, macroporous, polymeric, hydrogel foam material. The device is particularly suited for embolizing a vascular site such as an aneurysm. The embolization bodies have an initial configuration in the form of small, substantially cylindrical “micropellets” of small enough outside diameter to fit within a microcatheter. The bodies are hydrophilically expansible into an expanded configuration in which they substantially conform to and fill the vascular site while connected to the carrier. A method for embolizing a vascular site using this device includes the steps of: (a) passing a microcatheter intravascularly so that its distal end is in a vascular site; (b) providing a vascular embolization device comprising a plurality of highly expansible embolizing elements carried on a filamentous carrier and separated from each other on the carrier by microcoil spacers; (c) passing the embolization device through the microcatheter so that it emerges from the distal end of the microcatheter into the vascular site; and (d) expanding the embolizing elements in situ substantially to fill the vascular site.

Claims

1. A device for embolizing a vascular site, comprising:

an elongate, filamentous carrier formed of a flexible material having an elastic memory and initially configured with a portion forming a looped structure whereby the carrier assumes a three-dimensional shape; and

a plurality of expansible embolizing elements non-releaseably carried on the carrier at spaced intervals along the length of the carrier within the portion forming the looped structure.

2. The device of claim 1, wherein the embolizing elements are formed of a hydrophilic hydrogel foam material.

3. The device of claim 2, wherein the foam material includes a water-swellable foam matrix formed as a macroporous solid comprising a foam stabilizing agent and a polymer or copolymer of a free radical polymerizable hydrophilic olefin monomer cross-linked with up to about 10% by weight of a multiolefin-functional cross-lining agent.

4. The device of claim 1, wherein the embolizing elements are formed of a material selected from the group consisting of polyvinyl alcohol foam, collagen foam, and poly (2-hydroxyethyl methacrylate).

5. The device of claim 1, wherein the embolizing elements are an initial diameter of not more than about 0.5 mm and are expansible to a diameter of at least about 3.0 mm.

6. The device of claim 1, wherein each of the embolizing elements has a predetermined initial volume and is expansible to an expanded volume that is at least 25 times its initial volume.

7. The device of claim 1, further comprising microcoil spacers located on the carrier between the expansible embolizing elements.

8. The device of claim 1, wherein the carrier includes a thin, flexible metal wire formed into a multi-looped configuration.

9. The device of claim 8, wherein the wire is made of an alloy of nickel and titanium that exhibits good elastic memory properties.

10. The device of claim 1, wherein the carrier includes a thin filament of polymer formed into a multi-looped configuration.

11. A method for embolizing a vascular site, comprising the steps of:

(a) passing a microcatheter intravascularly so that its distal end is in a vascular site;

(b) providing a vascular embolization device comprising a plurality of highly expansile embolizing elements carried on a flexible filamentous carrier initially configured with a portion forming a looped structure whereby the carrier assumes a three-dimensional shape, the embolizing elements being located at spaced intervals along the length of the carrier within the portion forming the looped structure;

(c) passing the embolization device through the microcatheter so that it emerges from the distal end of the microcatheter into the vascular site; and

(d) expanding the embolizing elements in situ substantially to fill the vascular site with the embolizing elements and the carrier, while retaining the embolizing elements on the carrier.

12. The method of claim 11, wherein the step of providing a vascular embolization device includes the steps of:

(b)(1) determining at least the approximate volume of the vascular site; and

(b)(2) selecting a vascular embolization device sized substantially to fill the entire volume of the vascular site after the expanding step.

13. The method of claim 12, wherein the step of determining at least the approximate volume of the vascular site includes the step of visualizing the vascular site prior to or during the step of passing the microcatheter intravascularly.

14. The method of claim 11, wherein the expanding step includes the step of passing saline solution through the microcatheter and into the vascular site.

15. The method of claim 11, wherein the step of passing the embolization device through the microcatheter includes the step of injecting a biocompatible, substantially non-aqueous fluid through the microcatheter to prevent the hydration of the expansible embolizing elements within the microcatheter.

16. The method of claim 15, wherein the substantially non-aqueous fluid is polyethylene glycol.

17. A device for embolizing a vascular site, comprising:

an elongate, filamentous carrier formed of a flexible material having an elastic memory and initially configured in a multi-loop configuration; and

a plurality of expansible embolizing elements located at spaced intervals along the length of the carrier.

18. The device of claim 17, wherein the embolizing elements have a predetermined initial volume and are expansible to an expanded volume that is at least about 25 times their initial volume.

19. The device of claim 17, wherein the carrier has an intermediate portion on which the expansible embolizing elements are located, a proximal portion, and a distal portion.

20. The device of claim 19, wherein the intermediate portion is formed into at least one loop of approximately a first diameter, the proximal portion is formed into at least one loop of approximately the first diameter, and the distal portion is formed into at least one loop of approximately a second diameter that is greater than the first diameter.

21. The device of claim 19, further comprising an expansible linkage element on the proximal portion.

22. The device of claim 21, wherein the linkage elements are formed of the same material as are the embolizing elements.

23. The device of claim 17, wherein the embolizing elements are formed of a hydrophilic hydrogel foam material.

24. The device of claim 23, wherein the foam material includes a water-swellable foam matrix formed as a macroporous solid comprising a foam stabilizing agent and a polymer or copolymer of a free radical polymerizable hydrophilic olefin monomer cross-linked with up to about 10% by weight of a multiolefin-functional cross-linking agent.

25. The device of claim 17, wherein the embolizing elements are formed of a material selected from the group consisting of polyvinyl alcohol foam, collagen foam, and poly (2-hydroxyethyl methacrylate).

26. The device of claim 17, wherein the embolizing elements have an initial diameter of not more than about 0.5 mm and are expansible to a diameter of at least about 3.0 mm.