Biodegradable polymer coils for intraluminal implants

• US 6,423,085 B1
• Filed: 09/27/1999
• Issued: 07/23/2002
• Est. Priority Date: 01/27/1998
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Murayama, Yuichi, Vinuela, Fernando
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/406,306
• Time in Patent Office: 1,030 Days
• Field of Search: 606/200, 606/153, 606/154, 623/1.11, 623/1.38, 623/1.42, 623/1.45, 623/1.46, 623/1.48
• 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• 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
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

An endovascular cellular manipulation and inflammatory response are elicited from implantation in a vascular compartment or any intraluminal location of a separable coil comprised at least in part of at least one biocompatible and absorbable polymer or protein and growth factors. Typically a catheter associated with the separable coil is used to dispose the coil into a selected body lumen. The biocompatible and absorbable polymer or protein is thrombogenic. The coil further is comprised at least in part of a growth factor or more particularly a vascular endothelial growth factor, a basic fibroblast growth factor or other growth factors. The biocompatible and absorbable polymer is in the illustrated embodiment at least one polymer selected from the group consisting of polyglycolic acid, poly˜glycolic acid poly-L-lactic acid copolymers, polycaprolactive, polyhydroxybutyrate/hydroxyvalerate copolymers, poly-L-lactide. Polydioxanone, polycarbonates, and polyanhydrides. The biocompatible and absorbable protein is at least one protein selected from the group consisting of collagen, fibrinogen, fibronectin, vitronectin, laminin, and gelatin. In one embodiment the coil is composed of the biocompatible and absorbable polymer or protein with a radio-opaque material is disposed thereon. Alternatively, the coil is composed of a radio-opaque material, and the biocompatible and absorbable polymer or protein is disposed thereon. This apparatus may be positioned within intracranial aneurysms or any aneurysm in the body as well as within other body cavities.

Claims

1. An endovascular apparatus of biodegradable and biocompatible polymers for developing a controlled inflammatory response with cellular manipulation in a selected aneurysm comprising:

a separable coil comprised at least in part of at least one biocompatible and biodegradable polymer, which produces or enhances said inflammatory response with cellular manipulation to effect wound healing of said aneurysm, wherein said coil is adapted for disposition into said selected aneurysm; and

an endovascular placement device associated with said separable coil.

2. The apparatus of claim 1 wherein said coil is composed of said biocompatible and biodegradable polymer, and wherein a radio-opaque material is disposed thereon.

3. The apparatus of claim 1 wherein said coil composed of a radio-opaque material, and wherein said biocompatible and biodegradable polymer is disposed thereon.

4. The apparatus of claim 1 wherein said biocompatible and biodegradable polymer promotes a controlled inflammatory response and controlled vascular healing.

5. The apparatus of claim 1 wherein said aneurysm is located within brain tissue and has a mass effect, and wherein said biocompatible and biodegradable polymer reduces said mass effect.

6. The apparatus of claim 1 wherein said biocompatible and biodegradable polymer comprises a synthetic biodegradable polymer or copolymer.

7. The apparatus of claim 6 wherein said synthetic biocompatible and biodegradable polymer is comprised of at least one synthetic polymer selected from the group consisting of polyglycolic acid, poly˜

glycolic acid/poly-L-lactic acid copolymers, polycaprolactive, polyhydroxybutyrate/hydroxyvalerate copolymers, poly-L-lactide, polydioxanone, polycarbonates, and polyanhydrides.

8. A method for producing an endovascular inflammatory response with cellular manipulation in an aneurysm comprising:

providing a separable coil comprised at least in part of at least one biocompatible and biodegradable polymer, which bioactively produces or enhances said inflammatory response with cellular manipulation to effect wound healing of said aneurysm; and

disposing said separable coil into said aneurysm.

9. The method of claim 8 wherein providing said separable coil comprised with said biocompatible and biodegradable polymer comprises providing said coil with at least one synthetic polymer selected from the group consisting of polyglycolic acid, poly˜

lycolic acid/poly-L-lactic acid copolymers, polycaprolactive, polyhydroxybutyrate/hydroxyvalerate copolymers, poly-L-lactide, polydioxanone, polycarbonates, and polyanhydrides.

10. The method of claim 8 wherein providing said coil provides a coil composed of said biocompatible and biodegradable polymer with a radio-opaque material is disposed thereon.

11. The method of claim 8 wherein providing said coil provides a coil composed of a radio-paque material with said biocompatible and biodegradable polymer is disposed thereon.

12. The method of claim 8 wherein said aneurysm is located within brain tissue and has a mass effect, and wherein providing a separable coil comprised at least in part of at least one biocompatible and biodegradable polymer or protein comprises reducing said mass effect.

13. The method of claim 8 wherein providing a separable coil comprised at least in part of at least one biocompatible and biodegradable polymer or protein comprises providing a synthetic biodegradable polymer or copolymer.