Bioabsorbable polymeric implants and a method of using the same to create occlusions

• US 7,070,607 B2
• Filed: 02/16/2001
• Issued: 07/04/2006
• 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): Bennett, Henry
• Assistant Examiner(s): Ragonese, Andrea M.
• Application Number:
  US09/785,743
• Publication Number:
  US 20020040239A1
• Time in Patent Office: 1,964 Days
• Field of Search: 606/191, 606/194, 606/159, 606/198, 606/200, 606/153, 606/154, 604/159, 604/164, 623/1.1, 623/11.1, 623/1.38, 623/1.42, 623/1.45, 623/1.46, 623/1.48, 560/7, 562/1, 562/4, 563/0, 563/1, 563/2, 541/4, 542/5, 542/7, 128/845, 128/846, 128/847, 128/869, 128/870, 128/876, 602/33, 602/35
• US Class Current: 606/194
• 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• 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: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• 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

A new embolic agent, bioabsorbable polymeric material (BPM) is incorporated to a Guglielmi detachable coil (GDC) to improve long-term anatomic results in the endovascular treatment of intracranial aneurysms. The embolic agent, comprised at least in part of at least one biocompatible and bioabsorbable polymer and growth factors, is carried by hybrid bioactive coils and is used to accelerate histopathologic transformation of unorganized clot into fibrous connective tissue in experimental aneurysms. An endovascular cellular manipulation and inflammatory response are elicited from implantation in a vascular compartment or any intraluminal location. Thrombogenicity of the biocompatible and bioabsorbable polymer is controlled by the composition of the polymer. 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 bioabsorbable 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.

Claims

1. An endovascular apparatus for developing an inflammatory response in a body cavity with cellular manipulation comprising:

a separable implant comprised at least in part of at least one biocompatible and bioabsorbable polymeric material characterized by its ability to induce controlled inflammation to cause substantially complete occlusion of the body cavity by inducing the formation of scar tissue therein without excessive formation of scar tissue; and

an endovascular placement device associated with said separable implant adapted to dispose said implant into said body cavity,

where said biocompatible and bioabsorbable polymeric material comprises a mixture of polyglycolic/ poly-L-lactic acid copolymers with a 90/10 molar ratio of glycolic to L-lactic acid to control the degree of inflammatory response.

2. A method for creating an inflammatory response in a body cavity comprising:

causing substantially complete occlusion of the body cavity by inducing controlled formation of scar tissue therein by providing a separable implant comprised at least in part of at least one biocompatible and bioabsorbable polymeric material characterized by its ability to induce controlled inflammation without excessive formation of scar tissue; and

disposing said separable implant into said body cavity,

where causing substantially complete occlusion of flow of blood in the body cavity comprises providing an implant made from a mixture polyglycolic/poly-L-lactic acid copolymers with a 90/10 molar ratio of glycolic to L-lactic acid.