Methods for treating aneurysms

• US 6,569,190 B2
• Filed: 03/20/2001
• Issued: 05/27/2003
• Est. Priority Date: 10/11/2000
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Wallace, George, Hewitt, Todd J., Olson, Ed L., Pecor, Mark A., Gilmartin, Kevin P., Hayman, Douglas Ray, Greff, Richard J., Whalen, Thomas J. II, Slee, Earl H.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/811,423
• Publication Number:
  US 20020168331A1
• Time in Patent Office: 798 Days
• Field of Search: 606/53-49, 606/200, 623/1.15, 623/1.1, 604/53
• US Class Current: 623/1.1
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

This invention is directed to methods for treating aneurysms wherein the aneurysmal sac is filled with a non-particulate agent or plurality of such agents and/or with a fluid composition which solidifies in situ. Filling of the aneurysmal sac employs sufficient amount of the non-particulate agent or plurality of such agents and/or the fluid composition to inhibit blood flow into the aneurysm sac. In addition, the methods of this invention also provide for non-endogenous isolation of the parent artery proximal and distal to the aneurysmal sac from systemic blood flow of the treated mammal. The combination of these features provides for treatment of the aneurysmal sac while, at the same time, inhibiting aneurysm formation and/or regrowth in the diseased portions of the arterial wall proximal and distal to the treated aneurysm.

Claims

1. A method for treating an aneurysm in a mammalian patient which method comprises:

(a) identifying the vascular site of an aneurysm in a mammalian patient wherein said aneurysm comprises an aneursymal sac formed from the vascular wall of a parent artery and further wherein said aneurysmal sac participates in the systemic blood flow of said patient;

(b) inhibiting systemic blood flow into said aneurysmal sac by filling at least a portion of said sac with a fluid composition and/or a non-particulate agent or plurality of said agents; and

(c) non-endogenously isolating the parent artery proximal and distal to said aneurysm from systemic blood flow by placement of a porous stent adjacent the aneurysmal sac wherein said stent extends in both the proximal and distal directions of the parent artery followed by addition of a sufficient amount of the fluid composition to the aneursymal sac to overfill said sac such that said excess amount of fluid composition encapsulates at least a portion of the porous stent both proximally and distally to the aneurysmal sac.

2. The method of claim 1, wherein the non-particulate agent or plurality of non-particulate agents comprise metallic coils.

3. The method of claim 2, wherein the metallic coils are platinum coils.

4. The method of claim 1, wherein the fluid composition comprises either a biocompatible polymer or a biocompatible prepolymer.

5. The method of claim 4 wherein the fluid composition comprises a biocompatible polymer, a biocompatible contrast agent, and a biocompatible solvent which solubilizes the biocompatible polymer wherein sufficient amounts of the polymer are employed in the composition such that, upon delivery to the aneurysm, a polymer precipitate forms which fills at least a portion of the aneurysmal sac thereby inhibiting blood flow therein.

6. The method of claim 5 wherein the viscosity of the polymer composition is at least about 150 cSt at 40°

C.

7. The method of claim 6 wherein the polymer composition comprises a biocompatible polymer at a concentration of from about 2 to 50 weight percent;

a biocompatible contrast agent at a concentration of from about 10 to about 40 weight percent; and

a biocompatible solvent from about 10 to 88 weight percent wherein the weight percents of the biocompatible polymer, contrast agent and biocompatible solvent are based on the total weight of the complete composition.

8. The method of claim 1, where the fluid composition comprises a biocompatible prepolymer, a biocompatible contrast agent, and optionally a biocompatible solvent wherein sufficient amounts of the prepolymer are employed in the composition such that, upon delivery to the aneurysm, a polymer precipitate forms which fills at least a portion of the aneurysmal sac thereby inhibiting blood flow therein.

9. The method of claim 5 wherein the biocompatible solvent is dimethylsulfoxide (DMSO), ethanol, ethyl lactate or acetone.

10. The method of claim 8 wherein the biocompatible solvent is dimethylsulfoxide (DMSO), ethanol, ethyl lactate or acetone.