Apparatus and methods for coronary sinus access

• US 20040097788A1
• Filed: 05/29/2003
• Published: 05/20/2004
• Est. Priority Date: 05/30/2002
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC), Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Mourlas, Nicholas J., Miller, David John, Leeflang, Stephen Arie, Nayak, Asha Shrinivas, Eversull, Christian Scott
• Granted Patent: US 6,979,290 B2
• Time in Patent Office: Days
• US Class Current: 600/116
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

An apparatus for locating morphological features within a body cavity includes a catheter including proximal and distal ends, a transparent balloon carried on the distal end, and an optical imaging assembly carried on the distal end for imaging through the balloon. The balloon includes a channel extending therethrough to a lumen extending through the catheter. A guidewire or other localization member is received in the lumen that is extendabe through the channel. During use, the catheter is inserted into a right atrium of a heart, and the balloon is expanded and placed against the wall of the heart to locate the coronary sinus. Sufficient force is applied to clear blood between the surface and the wall and clear the field of view of the imaging assembly. The catheter is manipulated to locate the coronary sinus, whereupon the localization member is advanced into the coronary sinus.

Claims

1. An apparatus for locating morphological features within a body cavity, comprising:

a flexible tubular member comprising a proximal end, a distal end having a size for introduction into a body cavity, and defining a longitudinal axis extending between the proximal and distal ends;

an optical imaging assembly carried by the distal end of the tubular member for imaging beyond the distal end;

a substantially transparent displacement member carried by the distal end of the tubular member and at least partially surrounding the optical imaging assembly; and

a localization member slidably received in a cannulation lumen of the tubular member, the localization member being movable beyond the distal end of the tubular member for temporarily localizing the distal end of the tubular member at a morphologic feature within a body cavity.

2. The apparatus of claim 1, wherein the displacement member comprises an expandable member.

3. The apparatus of claim 2, wherein the expandable member comprises a channel communicating with the cannulation lumen, the localization member being extendable from a retracted position proximal to the surface through the channel to a deployed position beyond the surface for localizing the distal end of the tubular member.

4. The apparatus of claim 2, wherein the expandable member comprises a compliant balloon.

5. The apparatus of claim 2, wherein the expandable member comprises a noncompliant balloon.

6. The apparatus of claim 1, wherein the localization member terminates in a distal-tip configured for engaging a morphological feature.

7. The apparatus of claim 6, wherein the distal tip is selected from a tapered distal tip, a forked distal tip, and a steerable distal tip.

8. The apparatus of claim 1, wherein the displacement member comprises an expandable member comprising an interior communicating with the cannulation lumen, and therein the localization member comprises a distal tip that is advanceable into the interior of the expandable member to puncture through the expandable member.

9. The apparatus of claim 1, further comprising a capture device coupled to the proximal end of the tubular member and coupled to the optical imaging assembly for acquiring images obtained using the optical imaging assembly.

10. The apparatus of claim 9, wherein the capture device comprises at least one of a display, a processor for processing the acquired images, and memory for storing the acquired images.

11. The apparatus of claim 1, wherein the displacement member comprises an expandable membrane, and wherein the localization member is coupled to a distal end of the membrane.

12. The apparatus of claim 11, wherein the localization member is movable between a retracted position wherein the distal end of the membrane at least partially everts into an interior of the membrane, and an extended position wherein the distal end of the membrane extends distally to create a nipple.

13. The apparatus of claim 11, wherein the localization member is movable for changing a shape of the membrane when the membrane is expanded to an enlarged condition.

14. The apparatus of claim 1, further comprising an occlusion member carried on the distal end of the tubular member proximal to the displacement member.

15. The apparatus of claim 14, wherein the tubular member comprises a perfusion lumen extending to an outlet port between the occlusion member and the displacement member for delivering fluid from the proximal end of the tubular member to a location distal to the occlusion member.

16. The apparatus of claim 1, wherein the distal end of the tubular member is steerable.

17. An apparatus for accessing a coronary sinus ostium extending from a right atrium of a heart, comprising:

a flexible tubular member comprising a proximal end, a distal end having a size for introduction into a right atrium, and a cannulation lumen extending between the proximal and distal ends, thereby defining a longitudinal axis;

a localization member slidably received in the cannulation lumen, the localization member being movable beyond the distal end of the tubular member for temporarily localizing the distal end of the tubular member at a morphologic feature within a body cavity; and

one or more oxygen sensors arrayed on the distal end of the tubular member for localizing a position of a coronary sinus ostium.

18. The apparatus of claim 17, wherein the one or more oxygen sensors are carried on ends of a plurality of filaments extending from the distal end of the tubular member.

19. The apparatus of claim 18, wherein the filaments are biased to extend away from one another, thereby arranging the oxygen sensors in an annular array.

20. The apparatus of claim 17, wherein the one or more oxygen sensors are carried on an expandable member on the distal end of the tubular member.

21. An apparatus for imaging within a body lumen, comprising:

a flexible tubular member comprising proximal and distal ends defining a longitudinal axis therebetween;

a substantially transparent expandable member on the distal end of the tubular member, the expandable member being expandable from a contracted condition to an enlarged condition when fluid is introduced through the tubular member into an interior of the expandable member; and

an optical imaging element disposed within the interior of the expandable member, the imaging element extending from the distal end of the tubular member in a direction at least partially transversely relative to the longitudinal axis.

22. The apparatus of claim 21, wherein the optical imaging element comprises a plurality of optical fibers.

23. The apparatus of claim 22, wherein the optical imaging element further comprises a lens coupled to the plurality of optical fibers for imaging through a distal end of the expandable member.

24. The apparatus of claim 23, wherein the distal end of the expandable member is substantially flat.

25. The apparatus of claim 23, wherein the distal end of the expandable member is contoured to match a surface relief of a target anatomical feature to be imaged.

26. The apparatus of claim 22, further comprising a light source carried by the distal end of the tubular member for delivering light from the interior through the expandable member.

27. The apparatus of claim 21, further comprising a channel extending through the expandable member that communicates with a lumen extending between the proximal and distal ends of the tubular member.

28. The apparatus of claim 27, further comprising a source of fluid coupled to the proximal end of the tubular member, the source of fluid communicating with the lumen for delivering fluid through the channel to a location beyond the expandable member.

29. The apparatus of claim 27, further comprising an elongate member insertable through the lumen such that a distal end of the elongate member may be extended through the channel to a location beyond the expandable member.

30. The apparatus of claim 27, wherein the lumen and channel extend substantially concentrically along a central longitudinal axis of the tubular member.

31. The apparatus of claim 27, wherein the lumen extends along a periphery of the tubular member, and wherein the channel extends along a wall of the expandable member.

32. The apparatus of claim 21, wherein the expandable member comprises a balloon.

33. The apparatus of claim 32, wherein the balloon comprises compliant material.

34. The apparatus of claim 21, wherein the tubular member comprises one or more lumens extending between the proximal and distal end for at least one of perfusing, infusing, and aspirating fluids.

35. The apparatus of claim 21, further comprising a steering member extending along at least a distal portion of the tubular member for bending the distal end transversely relative to the longitudinal axis.

36. An apparatus for accessing a body lumen communicating with a body cavity, comprising:

a flexible tubular member comprising a proximal end, a distal end having a size for introduction into a body cavity, and defining a longitudinal axis extending between the proximal and distal ends;

an inner member slidably coupled to the tubular member;

a substantially transparent expandable member comprising a proximal end attached to the distal end of the tubular member and a distal end attached to a distal end of the inner member, the expandable member being expandable from a contracted condition to an enlarged condition when fluid is introduced through the tubular member into an interior of the expandable member, the inner member being slidable from a retracted position wherein the distal end of the expandable member at least partially everts into the interior of the expandable member and an extended position wherein the expandable member defines a stabilizing element insertable into a body lumen extending from a body cavity for stabilizing the tubular member relative to the body lumen; and

an optical imaging element carried by the distal end of the tubular member for imaging through the expandable member.

37. The apparatus of claim 36, wherein a distal portion of the expandable member tapers when the inner member is directed to the extended position.

38. The apparatus of claim 36, further comprising a steering member extending along at least a distal portion of the tubular member for bending the distal end transversely relative to the longitudinal axis.

39. The apparatus of claim 36, wherein the expandable member comprises a balloon.

40. The apparatus of claim 37, wherein the balloon comprises compliant material.

41. A method for cannulating a body lumen communicating with a body cavity of a patient, the method comprising:

inserting a distal end of a tubular member into the body cavity, the tubular member comprising a substantially transparent expandable member thereon in a contracted condition;

expanding the expandable member within the body cavity;

placing a surface of the expanded expandable member in contact with a wall of the body cavity in order to image the wall through the expandable member;

manipulating the tubular member to move the expandable member along the wall, while imaging the wall through the expandable member, until the body lumen is identified; and

advancing an instrument from the tubular member into the body lumen.

42. The method of claim 41, wherein the body cavity comprises a right atrium of a patient'"'"'s heart, and wherein the body lumen comprises a coronary sinus ostium.

43. The method of claim 42, wherein the tubular member is advanced from a peripheral vein through a vena cava to insert the distal end into the right atrium.

44. The method of claim 41, wherein the instrument comprises at least one of a guide wire, a cannula, and a catheter.

45. The method of claim 41, wherein the instrument is advanced into the body lumen through a channel extending through the expandable member that communicates with the lumen.

46. The method of claim 45, wherein the channel is disposed concentrically with a central axis of the tubular member, and wherein the tubular member is manipulated to align the channel with the body lumen.

47. The method of claim 41, wherein the surface of the expanded expandable member is placed in contact with the wall of the body cavity with sufficient force to at least partially clear fluid from between the surface and the wall to enhance imaging the wall.

48. The method of claim 41, further comprising delivering a fluid between the surface and the wall to at least partially clear bodily fluid from between the surface and the wall to enhance imaging the wall.

49. The method of claim 41, further comprising expanding an occlusion member on the tubular member to substantially seal the body lumen from the body cavity.

50. The method of claim 49, further comprising infusing fluid into the body lumen.

51. The method of claim 50, wherein the fluid comprises contrast, and wherein the method further comprises obtaining a venogram of a location distal to the occlusion member.

52. The method of claim 49, further comprising aspirating fluid from the body lumen.