Methods for embolizing vascular sites with an emboilizing composition comprising dimethylsulfoxide

• US 5,830,178 A
• Filed: 10/11/1996
• Issued: 11/03/1998
• Est. Priority Date: 10/11/1996
• Status: Expired due to Term

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Jones, Michael L., Greff, Richard J.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/730,701
• Time in Patent Office: 753 Days
• Field of Search: 604/49, 604/30, 604/65-67, 604/118, 604/246
• US Class Current: 604/507
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices

Abstract

Disclosed are novel methods for embolizing blood vessels which are particularly suited for treating vascular lesions via catheter delivery of an embolic composition comprising a biocompatible polymer and an embolic solvent.

Claims

1. A method for intra-vascular delivery to a mammal of an embolic composition while inhibiting vasospasms in the mammal which method comprises:

(a) selecting an embolic composition comprising a biocompatible, water insoluble polymer and an embolic solvent; and

(b) intra-vascularly injecting the composition selected in (a) above into the mammal at a flow rate such that the concentration of the embolic solvent in a given blood volume is maintained at a level insufficient to initiate vasospasms.

2. The method according to claim 1 wherein said embolic solvent is dimethylsulfoxide.

3. The method according to claim 1 wherein the embolic composition further comprises a contrast agent.

4. The method according to claim 3 wherein the contrast agent is a water insoluble contrast agent.

5. The method according to claim 4 wherein said water insoluble contrast agent is selected from the group consisting of tantalum, tantalum oxide, tungsten and barium sulfate.

6. The method according to claim 4 wherein said water insoluble contrast agent is tantalum.

7. The method according to claim 1 wherein said biocompatible polymer is selected from the group consisting of cellulose acetates, ethylene vinyl alcohol copolymers, hydrogels, polyacrylonitrile, polyvinylacetate, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid, and mixtures thereof.

8. The method according to claim 6 wherein said biocompatible polymer is an ethylene and vinyl alcohol copolymer.

9. The method according to claim 4 wherein said water insoluble contrast agent has an average particle size of about 10 microns or less.

10. A method for the catheter delivery of an embolic composition comprising a biocompatible polymer, a water insoluble biocompatible contrast agent, and an embolic solvent to an intra-vascular injection site of a mammal which method comprises:

(a) select a microcatheter comprising a luer hub and a delivery means;

(b) insert the delivery means of the microcatheter selected in (a) above into a to-be-embolized vascular site of a mammal and confirming placement in vivo with a water soluble contrast agent;

(c) connect a syringe to the microcatheter luer hub and flushing any remaining water soluble contrast agent from the microcathether hub and delivery means with a solution comprising water;

(d) add at least 0.50 cc of the embolic solvent to a second syringe;

(e) attach the second syringe prepared in (d) above to the microcatheter luer hub and then inject no more than about 0.3 cc of the embolic solvent into vascular site to flush out the aqueous contrast agent;

(f) remove the second syringe from the luer hub and then overfill/wash the luer hub of the microcatheter with the balance of the embolic solvent;

(g) connect a syringe comprising an embolic composition to the microcatheter hub while ensuring that air does not enter into the hub during connection wherein the embolic composition comprises an embolic solvent, a biocompatible polymer dissolved in the solvent, and a water insoluble biocompatible contrast agent dispersed therein;

(h) create a sharp interfacial boundary between the embolic solvent and the embolic composition;

(i) inject over about a 1 minute period sufficient amount of the solution to displace the DMSO in the microcatheter; and

(j) inject the embolic composition into the vascular site at a flow rate such that the concentration of the embolic solvent in a given blood volume is maintained at a level which inhibits vasospasms.

11. The method according to claim 10 wherein said embolic solvent is dimethylsulfoxide.

12. The method according to claim 10 wherein said water insoluble contrast agent is selected from the group consisting of tantalum, tantalum oxide, tungsten and barium sulfate.

13. The method according to claim 12 wherein said water insoluble contrast agent is tantalum.

14. The method according to claim 10 wherein said biocompatible polymer is selected from the group consisting of cellulose acetates, ethylene vinyl alcohol copolymers, hydrogels, polyacrylonitrile, polyvinylacetate, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid, and mixtures thereof.

15. The method according to claim 14 wherein said biocompatible polymer is an ethylene and vinyl alcohol copolymer.

16. The method according to claim 10 wherein said water insoluble contrast agent has an average particle size of about 10 microns or less.

17. The method according to claim 10 wherein the luer hub comprises multiple injection ports thereby permitting the attachment of multiple syringes simultaneously to the luer hub.