In vivo biocompatible acoustic coupling media

• US 20010034486A1
• Filed: 03/12/2001
• Published: 10/25/2001
• Est. Priority Date: 10/09/1998
• Status: Active Grant

• Current Assignee: Lupercal LLC (IPValuation Partners, LLC)
• Original Assignee: John W. Rutter, Larry L. Smith, Margaret J. Larson
• Inventors: Smith, Larry L., Rutter, John W., Larson, Margaret J.
• Granted Patent: US 6,866,630 B2
• Time in Patent Office: Days
• US Class Current: 600/461
• 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), and aqueous solvent solutions. The inventive coupling media provides long term biocompatibility (bio-inert, bioerodable 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 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 a concentration amount of about 0.05 wt. % to about 65 wt. %, the balance water.

2. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyethylene oxide has a molecular weight of about 100,000 to about 8,000,000.

3. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyethylene oxide has a molecular weight of about 200,000 to about 2,000,000.

4. The ultrasound couplant and medical device lubricant of

claim 1

wherein said polyethylene oxide has a molecular weight of about 600,000.

5. The ultrasound couplant and medical device lubricant of

claim 4

comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 10 wt %.

6. The ultrasound couplant and medical device lubricant of

claim 4

comprising polyethylene oxide in a concentration amount of about 4 wt. %.

7. The ultrasound couplant and medical device lubricant of

claim 6

further comprising propylene glycol in an amount of 18 wt. %.

8. The ultrasound couplant and medical device lubricant of

claim 1

wherein said ultrasound couplant is biocompatible with body fluids and tissue.

9. The ultrasound couplant and medical device lubricant of

claim 1

being an in vivo biocompatible ultrasound couplant and medical device lubricant.

10. The ultrasound couplant and medical device lubricant of

claim 9

being biodegradable, bio-inert, or bio-erodable within a body.

11. The ultrasound couplant and medical device lubricant of

claim 1

being sterilizable by heat.

12. The ultrasound couplant and medical device lubricant of

claim 9

wherein said couplant is biodegradable within a body.

13. The ultrasound couplant and medical device lubricant of

claim 1

having a viscosity of about 4,000 centipoise.

14. The ultrasound couplant and medical device lubricant of

claim 1

wherein said water is sterile having low and acceptable levels of pyrogens.

15. The ultrasound couplant and medical device lubricant of

claim 1

being in the form of a fluid or gel.

16. The ultrasound couplant and medical device lubricant of

claim 1

being excretable from within the human body through natural pathways and processes.

17. The ultrasound couplant and medical device lubricant of

claim 1

further comprising polyalkylene glycol in the amount of 1 to 45 wt. %.

18. An ultrasound couplant and medical device lubricant comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt. %, polyalkylene glycol in the amount of 1 to 45 wt. %, and the balance water.

19. The ultrasound couplant and medical device lubricant of

claim 18

wherein said polyalkylene glycol comprises propylene glycol.

20. An in vivo biocompatible ultrasound couplant and medical device lubricant comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt. %, the balance water.

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

claim 20

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

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

claim 21

comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 35 wt. %.

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

claim 22

wherein said polyethylene oxide has a molecular weight of about 200,000 to about 2,000,000.

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

claim 23

comprising polyethylene oxide in a concentration amount of about 1% to about 20%.

25. An in vivo biocompatible ultrasound couplant and medical device lubricant comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt. %, polyalkylene glycol in the amount of 1 to 45 wt. %, and the balance water.

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

claim 25

wherein said polyalkylene glycol comprises propylene glycol.

27. A method of conducting ultrasound energy between an ultrasound transducer and a target to be imaged from within a body cavity, said method comprising:

providing said transducer with an active area for transmitting and receiving said ultrasound energy,

applying an ultrasound couplant to at least one of said target, said transducer, within a transducer cover fitted onto said transducer, and on the exterior of a transducer cover fitted onto said transducer, said couplant being in vivo biocompatible and comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt. %, the balance water, said couplant having acoustic properties generally equivalent to acoustic properties of said target,

placing said transducer into said body cavity aided by the lubricity of said couplant with said active area in contact with said couplant on said target,

transmitting and receiving said ultrasound energy respectively to and/or from said target through said ultrasound couplant,

whereby subsequent to said transmitting and receiving, said transducer is removed from said cavity and said couplant remains within the body cavity by design or by accident, where it is biodegradable, bio-inert or bioerodable with respect to said target and said body cavity.

28. The method of

claim 27

wherein said ultrasound couplant further comprises polyalkylene glycol in the amount of 1 to 45 wt. %.

29. The method of

claim 28

wherein said polyalkylene glycol comprises propylene glycol.

30. A method of conducting ultrasound energy between an ultrasound transducer and a target, said method comprising:

providing said transducer with an active area for transmitting and receiving said ultrasound energy,

arranging an ultrasound conducting sheath outwardly of said transducer active area,

providing an ultrasound couplant between said active area and said sheath, said couplant being in vivo biocompatible and comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt. %, and the balance water, said couplant having acoustic properties generally equivalent to acoustic properties of said target,

placing said couplant on said target if said target is located externally on a body,

placing the covered transducer on said target,

transmitting and receiving said ultrasound energy respectively to and/or from said target through said sheath and said ultrasound couplant.

31. The method of

claim 30

wherein said ultrasound couplant further comprises polyalkylene glycol in the amount of 1 to 45 wt. %.

32. The method of

claim 31

wherein said polyalkylene glycol comprises propylene glycol.

33. In an ultrasound guided needle puncture procedure wherein an ultrasound transducer is utilized to guide said needle through skin of a patient and into a target within the body of said patient, the improvement comprising:

applying an ultrasound couplant on said skin, said couplant being in vivo biocompatible and comprising polyethylene oxide in a concentration amount of about 0.05 wt. % to about 65 wt., the balance water,

carrying out said needle puncture procedure utilizing said ultrasound transducer to guide said needle to said target,

whereby couplant carried by said needle into said body during the procedure remains in said body where it is biodegradable, bio-inert or bioerodable with respect to said body.

34. The procedure of

claim 33

wherein said ultrasound couplant further comprises polyalkylene glycol in the amount of 1 to 45 wt. %.

35. The method of

claim 34

wherein said polyalkylene glycol comprises propylene glycol.