Methods for embolizing vascular sites with an embolizing composition

• US 6,645,167 B1
• Filed: 05/19/2000
• Issued: 11/11/2003
• Est. Priority Date: 05/21/1999
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Roth, Noah Michael, Tran, Chinh Ngoc, Hayman, Douglas Ray, Greff, Richard J., Whalen, Thomas J. II, Moret, Jacques
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): MAIORINO, ROZ
• Application Number:
  US09/574,500
• Time in Patent Office: 1,271 Days
• Field of Search: 112/241, 424/423, 424/484, 424/422, 424/499, 424/264, 424/507, 424/28, 424/9.41, 604/891.1, 604/96.01, 604/264, 604/49, 604/504, 604/28, 514/772.4, 514/529, 128/898, 606/191, 606/159, 606/170
• US Class Current: 604/28
• CPC Class Codes: A61K 49/0419 Microparticles, microbeads, microcapsules, microspheres, i.e. having a size or diameter higher or equal to 1 micrometer
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 24/08 Polysaccharides A61L24/043 takes precedence
• 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: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 5/31586 performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
• CPC Class Codes: C08J 3/091 characterised by the chemical constitution of the organic liquid
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

Disclosed are novel methods for embolizing blood vessels comprising delivering, via a catheter, an embolic composition comprising a biocompatible polymer, a biocompatible water insoluble contrast agent, and a biocompatible solvent. In one embodiment, the method is conducted during a single surgical procedure whereby a flow-arresting device is positioned and activated at the vascular site to be embolized, the embolic composition is injected, and the flow-arresting device is deactivated. In another embodiment, the method is conducted during a single surgical procedure whereby two embolic compositions, situated adjacent to one another, are injected at the vascular site to be embolized.

Claims

1. A method for embolizing a vascular site, comprising delivering, via a catheter, to said vascular site a composition comprising:

(1) a biocompatible polymer;

(2) a biocompatible water insoluble contrast agent; and

(3) a biocompatible solvent,

wherein said method comprises the following protocols, conducted during a single surgical procedure;

(a) positioning the distal end of said delivery catheter in said vascular site, wherein said delivery catheter is connected to a source of said composition and whereby said composition can be injected into the vascular site through said delivery catheter;

(b) positioning a flow-arresting device at said vascular site to be embolized;

(c) activating the flow-arresting device at said vascular site to be embolized such that the activated device substantially arrests blood flow through said vascular site;

(d) injecting said composition into said vascular site;

(e) partially deactivating said flow-arresting device until is has a diameter of from about 10% to about 90% of said inner diameter of said vascular site to permit sufficient blood flow through said vascular site to be embolized, such that removal of said biocompatible solvent is facilitated and oxygenated blood is delivered to the tissue distal to said flow-arresting device; and

(f) repeating protocols (c)-(e) at least once, and as necessary, to effect embolization of said vascular site.

2. The method according to claim 1, wherein protocol (c) comprises inflating said flow-arresting device so that said inflated flow-arresting device has a diameter that is greater than the inner diameter of said vascular site.

3. The method according to claim 2, wherein said flow-arresting device is inflated to a diameter that is about 100% to 130% of the inner diameter of said vascular site.

4. The method according to claim 1, wherein in protocol (e), the flow-arresting device is deactivated until its diameter is about 20 to about 25% of the diameter of said vascular site, allowing at least some of said biocompatible solvent to be removed from said vascular site, by entrapment in the body fluid.

5. A method for embolizing a vascular site, comprising delivering, via a catheter, into said vascular site a first embolic composition and then a second embolic composition, wherein each embolic composition comprises:

(1) a biocompatible polymer,

(2) a biocompatible water insoluble contrast agent, and

(3) a biocompatible solvent,

said method comprises the following protocols, conducted during a single surgical procedure;

(a) positioning the distal end of said delivery catheter in said vascular site, wherein said delivery catheter defines a channel that contains said first embolic composition and said second embolic composition, wherein said first embolic composition is situated adjacent to said first embolic composition, and whereby each embolic composition can be injected into said vascular site through said delivery catheter, and wherein said first embolic composition has a higher concentration of biocompatible polymer or viscosity than said second embolic composition;

(b) injecting said first embolic composition in said vascular site, whereby substantially no axial mixing of said first and said second embolic compositions occurs in said channel; and

, thereafter;

(c) injecting said second embolic composition into said vascular site.

6. The method according to claim 5, wherein protocol (b) comprises applying a first force into said channel to inject said first embolic composition into said vascular site, and wherein protocol (c) comprises applying a second force into said channel to inject said second embolic composition into said vascular site, wherein said first force is greater than said second force.

7. The method according to claim 5, wherein following protocol (b), said first embolic composition forms a nidus in said vascular site, and, following protocol (c), said second embolic composition forms a precipitate than emanates from said nidus, wherein said precipitate embolizes said vascular site.