ULTRASOUND ASSESSMENT OF LUMENS TO FACILITATE REPAIR OR REPLACEMENT

• US 20110251492A1
• Filed: 10/14/2010
• Published: 10/13/2011
• Est. Priority Date: 05/24/2006
• Status: Abandoned Application

• Current Assignee: Phoenix Biomedical Corporation
• Original Assignee: Phoenix Biomedical Corporation
• Inventors: Chen, Yenyu, Forster, David C.
• Application Number:
  US12/904,926
• Publication Number:
  US 20110251492A1
• Time in Patent Office: Days
• US Class Current: 600/470
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• 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
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Devices and methods for assessing the orientation and shape of vessel lumens and hollow portions of organs are described. The devices and methods are particularly adapted for determining the orientation and shape of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an expandable member fixed to a distal end of the catheter. Located within the expandable member is an ultrasonic imaging probe and an acoustic reflective material. The methods typically comprise deploying the balloon percutaneously to a target location, expanding the balloon, and determining the orientation and shape of a lumen, particularly a cardiac valve.

Claims

1. A device for assessing the shape and orientation of a lumen or hollow portion of an organ comprising:

a catheter shaft having a proximal end and a distal end;

an expandable member carried at or near the distal end of the catheter, the expandable member having an acoustic reflective material; and

an ultrasound imaging head contained within the expandable member, the ultrasound imaging head capable of emitting and receiving sound waves;

wherein, in operation, the sound waves emitted by the ultrasound imaging head are reflected by the acoustic reflective material so as locate the expandable member with respect to the lumen or hollow portion of the organ.

2. The device of claim 1 wherein the acoustic reflective material is on an inner surface of a wall of the expandable member.

3. The device of claim 1 wherein the acoustic reflective material is on an outer surface of a wall of the expandable member.

4. The device of claim 1 wherein the acoustic reflective material is within a wall of the expandable member.

5. The device of claim 1 wherein the acoustic reflective material is along substantially an entire length of the expandable member.

6. The device of claim 1 wherein a wall of the expandable member is acoustically reflective.

7. The device of claim 1 wherein there are a plurality of ultrasound imaging heads.

8. The device of claim 1 wherein the ultrasound imaging head is external to the expandable member.

9. The device of claim 1 wherein the lumen is a cardiac valve, atrial appendage, coronary lumen, peripheral lumen, abdominal lumen, biliary duct or fallopian tube.

10. The device of claim 1 wherein the sound waves emitted by the ultrasound imaging head are reflected by the acoustic reflective material so as to locate the expandable member with respect to the shape and orientation of the lumen.

11. The device of claim 1 wherein the expandable member is capable of performing a valvuloplasty procedure.

12. The device of claim 1 further comprising a medium for expanding the expandable member.

13. The device of claim 12 wherein the medium is selected from the group consisting of saline, acoustic gel, dielectric fluid, blood, gas and contrast medium.

14. The device of claim 12 wherein the medium is a liquid or a gas.

15. The device of claim 12 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is different than Z₂ and Z₃.

16. The device of claim 12 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is greater than Z₂ and Z₃.

17. The device of claim 12 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is less than Z₂ and Z₃.

18. The device of claim 1 wherein the expandable member is a balloon.

19. A device comprising:

a catheter shaft having a proximal end and a distal end;

an expandable member carried at or near the distal end of the catheter, the expandable member having an acoustic reflective material on or within the expandable member.

20. The device of claim 19 wherein the acoustic reflective material extends substantially an entire length of the expandable member.

21. The device of claim 19 wherein the acoustic reflective material is on an inner surface of a wall of the expandable member.

22. The device of claim 19 wherein the acoustic reflective material is on an outer surface of a wall of the expandable member.

23. The device of claim 19 wherein the acoustic reflective material is within a wall of the expandable member.

24. The device of claim 19 wherein the expandable member is a balloon.

25. A device comprising:

a catheter shaft having a proximal end and a distal end;

an expandable member carried at or near the distal end of the catheter, the expandable member having an acoustic reflective material on or within the expandable member, the acoustic reflective material enhancing the reflectivity of the expandable member.

26. The device of claim 25 wherein the acoustic reflective material reduces the reflectivity of the expandable member.

27. The device of claim 25 wherein the acoustic reflective material increases the reflectivity of the expandable member.

28. A device comprising:

a catheter shaft having a proximal end and a distal end;

an expandable member carried at or near the distal end of the catheter, the expandable member having a reflective material on or within the expandable member.

29. The device of claim 28 wherein the reflective material is an acoustically reflective material.

30. The device of claim 28 wherein the reflective material is an optically reflective material.

31. A method for assessing a lumen or hollow portion of an organ comprising:

deploying an expandable member having an acoustic reflective material and an ultrasound imaging head to the location of a lumen or hollow portion of an organ within the body of a patient, the expandable member being attached to a catheter at or near a distal end thereof;

expanding the expandable member to engage at least a portion of the lumen or hollow portion of an organ;

emitting sound waves by the ultrasound imaging head;

receiving sound waves reflected by the acoustic reflective material so as to locate the expandable member with respect to the lumen or hollow portion of an organ.

32. The method of claim 31 wherein the acoustic reflective material is on an inner surface of a wall of the expandable member.

33. The method of claim 31 wherein the acoustic reflective material is on outer inner surface of a wall of the expandable member.

34. The method of claim 31 wherein the acoustic reflective material is within a wall of the expandable member.

35. The method of claim 31 wherein a wall of the expandable member is acoustically reflective.

36. The method of claim 31 wherein there are a plurality of ultrasound imaging heads and emitting sound waves includes emitting sound waves by the plurality of ultrasound imaging heads.

37. The method of claim 31 wherein the ultrasound imaging head is external to the expandable member.

38. The method of claim 31 wherein the lumen is a cardiac valve, atrial appendage, coronary lumen, peripheral lumen, abdominal lumen, biliary duct or fallopian tube.

39. The method of claim 31 wherein receiving sound waves reflected by the acoustic reflective material so as to locate the expandable member with respect to the shape and orientation of the lumen.

40. The method of claim 31 further comprising a medium for expanding the expandable member.

41. The method of claim 40 wherein the medium is selected from the group consisting of saline, acoustic gel, dielectric fluid, blood, gas and contrast medium.

42. The method of claim 40 wherein the medium is a liquid or a gas.

43. The method of claim 40 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is different than Z₂ and Z₃.

44. The method of claim 40 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is greater than Z₂ and Z₃.

45. The method of claim 40 wherein the acoustic reflective material has an acoustic impedance Z₁, the medium has an acoustic impedance Z₂ and the expandable member has an acoustic impedance Z₃ such that Z₁ is less than Z₂ and Z₃.

46. The method of claim 31 wherein the expandable member is a balloon.

47. The method of claim 31 wherein after the step of expanding, further comprising further expanding the expandable member so as to expand the lumen or hollow portion of the organ valve outwardly.

48. The method of claim 47 wherein during the step of further expanding, further comprising performing a valvuloplasty procedure.

49. The method of claim 47 wherein during the step of further expanding, further comprising performing an assessment of the lumen or hollow portion of the organ.

50. The method of claim 47 wherein the steps of expanding and further expanding are done serially without withdrawing the expandable member from the lumen or hollow portion of the organ.