Methods for embolizing aneurysmal sites with a high viscosity embolizing composition

• US 7,374,568 B2
• Filed: 01/14/2003
• Issued: 05/20/2008
• Est. Priority Date: 01/14/2002
• Status: Expired due to Fees

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Whalen, Thomas J. II, Conner, Amanda, Slee, Earl
• Primary Examiner(s): Woodward; Michael P.
• Assistant Examiner(s): Silverman; Eric E.
• Application Number:
  US10/345,127
• Publication Number:
  US 20030223955A1
• Time in Patent Office: 1,953 Days
• Field of Search: None
• US Class Current: 606/194
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

Novel methods for embolizing blood vessels which are particularly suited for treating aneurysms are provided. The presently disclosed methods provide for the embolization of aneurysms wherein occlusion of the neck of the aneurysm during embolization by a flow arresting device such as balloon is not required. In one embodiment, the compositions employed in the methods of this invention comprise a biocompatible polymer, a biocompatible solvent and a biocompatible contrast agent wherein the viscosity of this composition is at least about 1000 centistokes at 40° C. and, preferably, at least about 2500 centistokes at 40° C.

Claims

1. A method for embolizing a vascular aneurysm comprising an aneurysmal sac, an opening, and fundus by delivering to said vascular aneurysm via a catheter having proximal and distal ends a composition comprising (1) a biocompatible polymer;

(2) a biocompatible water insoluble contrast agent; and

(3) a biocompatible solvent, said method includes;

(a) positioning the distal end of said catheter in said vascular aneurysm wherein the proximal end of said catheter is connected to a source of said composition and whereby said composition can be injected into the vascular aneurysm through said catheter wherein the distal end of the catheter is positioned through the opening into the aneurysmal sac to be embolized about 2/3 of the distance between the opening and the fundus; and

,

(b) injecting an amount of said composition into the vascular aneurysm; and

,

(c) waiting a sufficient period of time to permit blood flow to transport biocompatible solvent away from the vascular aneurysm;

wherein steps (b) and (c) may be repeated until the vascular aneurysm is substantially filled, and wherein said composition has a viscosity at about 40°

C. of greater than about 1000 centistokes,

wherein no flow arresting device is activated during steps (b) and (c), and further wherein

(d) after determining that the vascular aneurysm is substantially filled, activating a balloon capable of sealing the opening of the vascular aneurysm which is being embolized; and

,

(e) injecting a final amount of said composition into the vascular aneurysm such that the vascular aneurysm is completely filled with embolizing composition;

wherein the balloon is inflated in an arterial site to seal a neck of the vascular aneurysm that is about 100% to 130% of an inner diameter of a vascular vessel, and wherein no flow arresting device is activated during steps (b) and (c).

2. The method of claim 1, wherein the composition has a viscosity at 40°

C. of about 1000 to about 20,000 centistokes.

3. The method of claim 1, wherein the composition has a viscosity at 40°

C. of about 1000 to 4000 centistokes.

4. The method of claim 1, wherein the composition has a viscosity at 40°

C. of about 2000 to 3000 centistokes.

5. The method of claim 1, wherein the composition has a viscosity at 40°

C. selected from the group consisting of about 2300 centistokes, 2500 centistokes and 3200 centistokes.

6. The method of claim 1, wherein the composition has a viscosity such that a compact mass of embolizing precipitate is formed in the vascular aneurysm, in the form of a dense spheroid proximate to the distal end of the catheter.

7. The method of claim 1, wherein a pressure greater than the burst strength is not formed in any component of an apparatus through which the composition is delivered.

8. The method of claim 1, wherein the time waited in step (c) is sufficient to allow blood flow to transport biocompatible solvent away from the vascular aneurysm and is further sufficient to allow for precipitate formation.

9. The method of claim 1, wherein during the time of step (c), the extent to which the vascular aneurysm has been filled is determined.

10. The method of claim 1, further including a step, prior to step (b), injecting the biocompatible solvent into the catheter to fill a lumen of said catheter followed by injecting a first amount of said composition into said catheter whereby at least a portion of said biocompatible solvent is ejected from said catheter into the vascular aneurysm and washed downstream therefrom.

11. The method of claim 1, wherein injection in step (b) is continuous until the composition is observed to flow toward an undesired location and wherein the time in step (c) is sufficient to promote flow towards to another location unless the vascular aneurysm is substantially filled.