Medical acoustic imaging

• US 5,454,373 A
• Filed: 07/20/1994
• Issued: 10/03/1995
• Est. Priority Date: 07/20/1994
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Vincent, Jean C., Crowley, Robert J., Koger, James D., Nicholas, Peter M.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/278,079
• Time in Patent Office: 440 Days
• Field of Search: 128/662.03, 128/660.02, 128/662.05, 128/662.06, 128/663.01, 128/660.09, 128/660.10, 128/772
• US Class Current: 600/463
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe

Abstract

An ultrasound imaging device has a stationary, elongated flexible tubular body, a rotatable drive shaft extending through the body, and a nose member located distally of the tubular body. The nose member is mounted on the distal end of the drive shaft to rotate therewith, and an acoustic imaging instrument is incorporated in the nose member for producing acoustic images of adjacent tissue as the drive shaft turns. The nose member is covered with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material sufficient to shield and space the nose member from the adjacent tissue. The lubricous coating of hydrophilic material covers an area of the surface of the ultrasound imaging device through which the acoustic imaging instrument causes acoustic signals to pass. The coating has sufficient thickness to avoid puncturing of a wall of a blood vessel by the nose member while the nose member rotates within the blood vessel sufficiently close to the wall for puncturing otherwise to occur.

Claims

1. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and a rotatable nose member located distally of said tubular body, said rotatable nose member being mounted on the distal end of said drive shaft to rotate therewith, and an acoustic imaging instrument incorporated in said rotatable nose member for producing acoustic images of adjacent tissue as said drive shaft turns, said nose member having a rotatable outer surface directly covered with a bio-compatible, lubricous coating of hydrophilic material sufficient to shield and space said outer surface of said nose member from said adjacent tissue as said outer surface rotates with respect to said elongated flexible tubular body, said coating having sufficient thickness to avoid puncturing of a wall of a blood vessel by said nose member while said nose member rotates within said blood vessel sufficiently close to said wall to enable puncturing if said coating were absent.

2. The ultrasound imaging device of claim 1, wherein said lubricous coating comprises an organic solvent and an isocyanate compound.

3. The ultrasound imaging device of claim 2, wherein said isocyanate compound comprises MDI.

4. The ultrasound imaging device of claim 1, wherein said lubricous coating comprises an organic solvent and a water-soluble compound.

5. The ultrasound imaging device of claim 1, wherein said acoustic imaging instrument lies substantially at the surface of said nose member for substantially direct exposure to tissue to be imaged.

6. The ultrasound imaging device of claim 1 wherein said coating covering said rotatable nose member also covers said tubular body over a substantial portion of its length.

7. The ultrasound imaging device of claim 1 wherein said elongated flexible tubular body is a catheter body, said ultrasonic imaging device configured as an intravascular catheter.

8. The ultrasound imaging device of claim 1 wherein said elongated flexible tubular body is sized for use as a guidewire, said ultrasonic imaging device configured as an intravascular guidewire.

9. The ultrasound imaging device of claim 1 wherein said coating of hydrophilic material directly covering said rotatable outer surface of said rotatable nose member erodes from said outer surface during rapid rotation of said nose member.

10. The ultrasound imaging device of claim 1 wherein said coating comprises a medication.

11. The ultrasound imaging device of claim 1 wherein said coating is formed from a solution of said hydrophilic material, and is caused to adhere to said rotatable nose member by dipping said nose member in a bath comprising said solution of said hydrophilic material a sufficient number of times to result in said coating having said sufficient thickness to avoid puncturing said wall of said blood vessel.

12. The ultrasound imaging device of claim 1 wherein said acoustic imaging instrument comprises a transducer.

13. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and a nose member located distally of said tubular body, said nose member being mounted on the distal end of said drive shaft to rotate therewith, and an acoustic imaging instrument incorporated in said nose member for producing acoustic images of adjacent tissue as said drive shaft turns, said nose member covered with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material sufficient to shield and space said nose member from said adjacent tissue, said coating having sufficient thickness to avoid puncturing of a wall of a blood vessel by said nose member while said nose member rotates within said blood vessel sufficiently close to said wall to enable puncturing if said coating were absent, wherein said lubricous coating comprises a primer coat and at least one top coat.

14. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and a nose member located distally of said tubular body, said nose member being mounted on the distal end of said drive shaft to rotate therewith, and an acoustic imaging instrument incorporated in said nose member for producing acoustic images of adjacent tissue as said drive shaft turns, said nose member covered with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material sufficient to shield and space of said nose member from said adjacent tissue, said coating having sufficient thickness to avoid puncturing of a wall of a blood vessel by said nose member while said nose member rotates within said blood vessel sufficiently close to said wall to enable puncturing if said coating were absent, wherein said lubricous coating comprises an organic solvent and a water-soluble compound comprising dimethyl formamide.

15. The ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and a nose member located distally of said tubular body, said nose member being mounted on the distal end of said drive shaft to rotate therewith, and an acoustic imaging instrument incorporated in said nose member for producing acoustic images of adjacent tissue as said drive shaft turns, said nose member covered with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material sufficient to shield and space said nose member from said adjacent tissue, said coating having sufficient thickness to avoid puncturing of a wall of a blood vessel by said nose member while said nose member rotates within said blood vessel sufficiently close to said wall to enable puncturing if said coating were absent, wherein said lubricous coating comprises an organic solvent and a water-soluble compound comprising butanol.

16. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and a nose member located distally of said tubular body, said nose member being mounted on the distal end of said drive shaft to rotate therewith, and an acoustic imaging instrument incorporated in said nose member for producing acoustic images of adjacent tissue as said drive shaft turns, said nose member covered with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material sufficient to shield and space said nose member from said adjacent tissue, said coating having sufficient thickness to avoid puncturing of a wall of a blood vessel by said nose member While said nose member rotates within said blood vessel sufficiently close to said wall to enable puncturing if said coating were absent and wherein said ultrasound imaging device further comprise a lumen for injection of fluid to create a protective boundary layer surrounding said coating during rotation of said nose member.

17. The ultrasound imaging device of claim 16 further comprising means for providing a drug in said fluid.

18. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and an acoustic imaging instrument mounted on said rotatable drive shaft to rotate therewith and to produce acoustic images of adjacent tissue as said drive shaft turns, said ultrasound imaging device being covered over at least a portion of its surface with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material, said lubricous coating of hydrophic material covering an area of said surface of said ultrasound imaging device through which said acoustic imaging instrument causes acoustic signals to pass, wherein said lubricous coating comprises a primer coat and at least one top coat.

19. The ultrasound imaging device of claim 18, wherein said lubricous coating comprises an organic solvent and an isocyanate compound.

20. The ultrasound imaging device of claim 19, wherein said isocyanate compound comprises MDI.

21. The ultrasound imaging device of claim 18, wherein said lubricous coating comprises an organic solvent and a water-soluble compound.

22. The ultrasound imaging device of claim 18, wherein said acoustic imaging instrument lies substantially at the surface of said ultrasound imaging device for substantially direct exposure to tissue to be imaged.

23. The ultrasound imaging device of claim 18 wherein said coating covers said tubular body over at least substantially all of its length.

24. The ultrasound imaging device of claim 18 wherein said elongated flexible tubular body is a catheter body, said ultrasonic imaging device configured as an intravascular catheter.

25. The ultrasound imaging device of claim 18 wherein said elongated flexible tubular body is sized for use as a guidewire, said ultrasonic imaging device configured as an intravascular guidewire.

26. The ultrasound imaging device of claim 18 wherein said coating of hydrophilic material is ablative during rapid rotation of at least a portion of said ultrasound imaging device.

27. The ultrasound imaging device of claim 18 wherein said coating comprises a medication.

28. The ultrasound imaging device of claim 18 wherein said coating is formed by dipping said ultrasound imaging device in a bath comprising a solution of said hydrophilic material.

29. The ultrasound imaging device of claim 18 wherein said acoustic imaging instrument comprises a transducer.

30. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and an acoustic imaging instrument mounted on said rotatable drive shaft to rotate therewith and to produce acoustic images of adjacent tissue as said drive shaft turns, said ultrasound imaging device being covered over at least a portion of its surface with a bio-compatible acoustically transparent, lubricous coating of hydrophilic material, said lubricous coating of hydrophic material covering an area of said surface of said ultrasound imaging device through which said acoustic imaging instrument causes acoustic signals to pass wherein said lubricous coating comprises an organic solvent and a water-soluble compound comprising dimethyl formamide.

31. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and an acoustic imaging instrument mounted on said rotatable drive shaft to rotate therewith and to produce acoustic images of adjacent tissue as said drive shaft turns, said ultrasound imaging device being covered over at least a portion of its surface with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material, said lubricous coating of hydrophic material covering an area of said surface of said ultrasound imaging device through which said acoustic imaging instrument causes acoustic signals to pass wherein said lubricous coating comprises an organic solvent and a water-soluble compound comprising butanol.

32. An ultrasound imaging device comprising a stationary, elongated flexible tubular body, a rotatable drive shaft extending through said body, and an acoustic imaging instrument mounted on said rotatable drive shaft to rotate therewith and to produce acoustic images of adjacent tissue as said drive shaft turns, said ultrasound imaging device being covered over at least a portion of its surface with a bio-compatible, acoustically transparent, lubricous coating of hydrophilic material, said lubricous coating of hydrophic material covering an area of said surface of said ultrasound imaging device through which said acoustic imaging instrument causes acoustic signals to pass and further comprising a lumen for injection of fluid to create a protective boundary layer surrounding said coating during rotation of at least a portion of said ultrasound imaging device.

33. The ultrasound imaging device of claim 32 further comprising means for providing a drug in said fluid.