In vivo biocompatible acoustic coupling media

• US 20010039380A1
• Filed: 07/13/2001
• Published: 11/08/2001
• Est. Priority Date: 07/01/1999
• Status: Active Grant

• Current Assignee: Next Medical Products Company
• Original Assignee: Sonotech, Inc. (Illinois Tool Works Inc.)
• Inventors: Smith, Larry L., Rutter, John W., Larson, Margaret J.
• Granted Patent: US 6,776,757 B2
• Time in Patent Office: Days
• US Class Current: 600/437
• 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 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

A medical ultrasound coupling media and lubricant, in gel or liquid form, comprised of polyethylene oxide (PEO), at least one of polyalkylene glycols and polyhydric alcohols, and the balance water. The inventive coupling media provides long-term biocompatibility (bio-inert, bio-erodable or biodegraded and excreted) in vivo with human tissue and body fluids. The ultrasound coupling and lubricating media is formulated and manufactured in such manner and form that produces higher viscosity gels with decreased amounts of polymer and renders the acoustic media sterile, non-cross-linked, pseudoplastic, and containing acceptably low levels of pyrogens.

Claims

1. An ultrasound couplant and medical device lubricant comprising polyethylene oxide in an amount of about 0.05 wt. % to about 65 wt. %, at least one of polyalkylene glycols and polyhydric alcohols in the amount of about 1 wt. % to about 90 wt. %, and the balance water.

2. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyalkylene glycols include fats and esters thereof.

3. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyalkylene glycols comprise 2 or more carbon atoms.

4. The ultrasound coupl ant and medical device lubricant of

claim 3

wherein said polyalkylene glycols comprise 2 to 6 carbon atoms.

5. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyalkylene glycols comprise propylene glycol and/or glycerol.

6. The ultrasound couplant and medical device lubricant of

claim 5

comprising propylene glycol.

7. The ultrasound couplant and medical device lubricant of

claim 1

wherein said at least one of polyalkylene glycols and polyhydric alcohols is present in the amount of about 10 wt. % to about 70 wt. %.

8. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyhydric alcohols comprise sorbitol.

9. An in vivo biocompatible ultrasound couplant and medical device lubricant comprising polyethylene oxide in an amount of about 0.05 wt. % to about 65 wt. %, at least one of polyalkylene glycols comprising two or greater carbon atoms and polyhydric alcohols in the amount of about 1 wt. % to about 90 wt. %, and the balance water.

10. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 9

wherein said polyalkylene glycols comprise propylene glycol.

11. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 10

comprising propylene glycol in an amount of about 10 wt. % to about 70 wt. %.

12. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 9

wherein said polyethylene oxide has a molecular weight of about 100,000 to about 2,000,000.

13. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 12

wherein said polyethylene oxide has a molecular weight of about 100,000 to about 1,000,000.

14. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 9

comprising polyethylene oxide in an amount of about 1 wt. % to about 10 wt. %.

15. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 9

wherein the wt. % of said at least one of polyalkylene glycols and polyhydric alcohols is greater than the wt. % of said polyethylene oxide.

16. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 9

having a weight ratio of said at least one of polyalkylene glycols and polyhydric alcohols to said water of about 1.7:

1 or more.

17. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 13

comprising about 0.5 wt. % to about 25 wt. % polyethylene oxide having a molecular weight of about 600,000, propylene glycol in an amount of about 1 wt. % to about 90 wt. %, and the balance water.

18. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 17

comprising about 4.0 wt. % polyethylene oxide, about 61.0 wt. % propylene glycol, and the balance water.

19. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 13

comprising about 0.05 wt. % to about 15 wt. % polyethylene oxide having a molecular weight of about 900,000, propylene glycol in an amount of about 1 wt. % to about 90 wt. %, and the balance water.

20. The in vivo biocompatible ultrasound couplant and medical device lubricant of

claim 19

comprising about 3.25 wt. % polyethylene oxide, about 61.75 wt. % propylene glycol, and the balance water.