Metallic coils enlaced with biological or biodegradable or synthetic polymers or fibers for embolization of a body cavity

• US 20060036281A1
• Filed: 05/23/2005
• Published: 02/16/2006
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: McCarthy, Thomas, Patterson, William R., Henkes, Hans, Wilder, Tom, Slee, Earl, Strauss, Brian, Monstadt, Herman
• Granted Patent: US 7,896,899 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 17/12113 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61L 2300/606 Coatings
• 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 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

The invention provides for vaso-occlusive coils comprising fibers.

Claims

1-135. -135. (canceled)

136. A vaso-occlusive device for occluding blood flow in a patient, the device comprising:

a) a coil, comprising a lumen and a first and a second end, and sized for insertion to a point of use in a vascular network of the patient;

b) a stretch resistant member having a first end fixedly attached to the first end of the coil and a second end fixedly attached to the second end of the coil; and

c) a plurality of fibers where each of the fibers is wrapped around the stretch resistant member at least two times.

140. The device of claim 136, wherein the stretch resistant member is comprised of a metal wire.

142. The device of claim 140, wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten and tantalum or an alloy of two or more of these metals or a superelastic metal.

147. The device of claim 136, wherein the stretch resistant member is comprised of a polymer.

148. The device of claim 147, wherein the polymer is one of non-biodegradable and biodegradable.

150. The device of claim 136, wherein the stretch resistant member is further comprised of a bioactive coating.

151. The device of claim 150, wherein the bioactive coating is chosen from a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.

152. The device of claim 150, wherein the bioactive coating comprises a polymer.

155. The device of claim 136, wherein the coil is comprised of metal wire.

159. The device of claim 155, wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten, tantalum, an alloy of two or more of these metals, or a superelastic metal.

166. The device of claim 136, wherein the coil is comprised of a primary helix which is itself wound into a secondary shape.

168. The device of claim 166, wherein the secondary shape is a helix.

178. The device of claim 136, wherein the fibers are comprised of one of a bioactive and a non-bioactive material.

180. The device of claim 136, wherein the fibers are comprised of a copolymer of glycolic acid and lactic acid.

181. The device of claim 136, wherein the fibers further comprise a bioactive coating.

182. The device of claim 181, wherein the bioactive coating is one of a lubricious hydrophilic coating and a hydrophobic coating.

185. The device of claim 181, wherein the bioactive coating comprises a copolymer.

186. The device of claim 185, wherein the copolymer is comprised of lactic acid and glycolic acid.

187. The device of claim 136, wherein the fibers are comprised of non- biodegradable polymer.

188. The device of claim 187, wherein the non-biodegradable polymer is chosen from a polyethylene, a polyacrylic, a polypropylene, a polyvinylchloride, a polyamide, a polyurethane, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyvinylacetate, a cellulose acetate, a polystyrene, a polytetrafluoroethylene, a polyester, silk, nylon, polyethylene terephthalate, or cotton.

191. The device of claim 136, wherein the fibers are comprised of biodegradable polymer.

192. The device of claim 191, wherein the biodegradable polymer is chosen from polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate, polyorthoester, polylactic acid, poly (p-dioxanone), poly (valetolactone), poly (tartronic acid), poly (β

-malonic acid), poly (propylene fumarate), a tyrosine based polycarbonate, and a copolymer of polyethylene oxide and polybutylene terephthalate.

193. The device of claim 186, wherein a ratio of glycolic acid to lactic acid is chosen to be one of:

99;

1, 1;

99, 95;

5. 5;

95, 50;

50, 90;

10, and 10;

90.

199. The device of claim 181, wherein the coating material is chosen from a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.

200. The device of claim 181, wherein the bioactive coating is applied to the coil and the stretch resistant member.

201. The device of claim 181, wherein the bioactive coating is applied to the fiber as a single layer.

202. The device of claim 200, wherein the bioactive coating is applied to the coil and the stretch resistant member as a single layer.

203. The device of claim 181, wherein the bioactive coating is dispersed throughout the fiber.

204. The device of claim 181, wherein the bioactive coating promotes cell attachment and is thrombogenic.

205. The device of claim 181, wherein the bioactive coating material is chosen from collagen, fibrinogen, vitronectin, vascular endothelial growth factor, and a peptide comprising the sequence arginine-glycine-aspartic acid (RGD).

219. The device of claim 136, wherein each of the fibers comprises first and second ends and each of the first and second fiber ends extends freely from the coil.

137. The device of 136, wherein the stretch resistant member axially traverses the lumen of the coil.

138. (canceled)

139. (canceled)

141. (canceled)

143-146. -146. (canceled)

149. (canceled)

153. (canceled)

154. (canceled)

156-158. -158. (canceled)

160-165. -165. (canceled)

167. (canceled)

169-177. -177. (canceled)

179. (canceled)

183. (canceled)

184. (canceled)

189. (canceled)

190. (canceled)

194-198. -198. (canceled)

206. A method of treating an aneurysm in a patient comprising introducing a vaso-occlusive device into the patient thereby treating the aneurysm, wherein the vaso-occlusive device comprises:

a) a coil sized for insertion to a point of use in a vascular network of the patient, where the coil comprises a first and a second end and is comprised of a first surface area;

b) a stretch resistant member having a first end and a second end fixedly attached, respectively, to the first and second ends of the coil; and

c) a plurality of fibers, each fiber having first and second ends and where each of the enlaced fibers is wrapped around the stretch resistant member at least two times, wherein each of the first and second fiber ends extends freely from the coil.

208. The method of claim 206, wherein the coil is a helix.

207. (canceled)

209-211. -211. (canceled)

212. A method of making a vaso-occlusive device comprising the steps of:

a) obtaining a helically coiled wire core comprising a lumen, a first and second end and a fiber gripping spacing between adjacent windings when not under tension;

b) extending the wire core into an extended condition;

c) inserting a stretch resistant member into the lumen of the helically coiled wire and fixedly attaching a first end of the stretch resistant member to at least one end of the helically coiled wire;

d) wrapping a plurality of fibers around the stretch resistant member at least two times; and

e) relaxing the coil thereby causing the adjacent windings of the coil to grip the fibers.

213. The method of claim 212, further comprising:

fixedly attaching a second end of the stretch resistant member to a second end of the helically coiled wire.

214. The method of claim 212, wherein the wrapping is through multiple windings of the coil.

218. The method of claim 212, wherein each of the fibers comprises first and second ends, the method further comprising:

arranging the first and second ends of each of the fibers to extend freely from the coil.

215-217. -217. (canceled)