Systems and methods for visualizing tissue during diagnostic or therapeutic procedures

• US 5,904,651 A
• Filed: 10/28/1996
• Issued: 05/18/1999
• Est. Priority Date: 10/28/1996
• Status: Expired due to Term

• Current Assignee: EP Technology (Boston Scientific Corporation)
• Original Assignee: EP Technology (Boston Scientific Corporation)
• Inventors: McGee, David, Panescu, Dorin, Swanson, David K., TenHoff, Harm, Whayne, James G.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US08/739,504
• Time in Patent Office: 932 Days
• Field of Search: 128/653.1, 128/660.01, 128/660.03, 128/657, 128/656, 128/662.03, 128/662.06, 128/642, 607/4, 607/122, 607/99, 606/41, 606/15, 600/407, 600/437, 600/439, 600/434, 600/433, 600/459, 600/462, 600/373, 600/478, 600/342, 600/160, 600/182
• US Class Current: 600/407
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 6/541 involving acquisition triggered by a physiological signal
• 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 8/54 Control of the diagnostic device
• CPC Class Codes: A61B 8/543 involving acquisition triggered by a physiological signal

Abstract

A catheter tube carries an imaging element for visualizing tissue. The catheter tube also carries a support structure, which extends beyond the imaging element for contacting surrounding tissue away from the imaging element. The support element stabilizes the imaging element, while the imaging element visualizes tissue in the interior body region. The support structure also carries a diagnostic or therapeutic component to contact surrounding tissue.

Claims

1. A probe, comprising:

a catheter tube having a distal region,

an imaging element comprising a fiber optic assembly on the distal region for visualizing tissue,

a support structure on the distal region, the support structure expandable beyond the imaging element for contacting surrounding tissue away from the imaging element to allow for visualization tissue, and

a diagnostic or therapeutic element on the support structure to contact surrounding tissue.

2. A probe according to claim 1 and further including a steering element coupled to the imaging element to move the imaging element.

3. A probe according to claim 1 and further including a steering element coupled to the imaging element to move the imaging element without moving the support structure.

4. A probe according to claim 1

wherein the fiber-optic assembly comprises an optical fiber channel and a transparent balloon for shielding the optical fiber channel from blood contact.

6. A probe according to claim 1 wherein the diagnostic or therapeutic element comprises an electrode element capable of transmitting energy to tissue.

7. A probe according to claim 1 wherein the diagnostic or therapeutic element comprises an electrode element capable of sensing electrical signals in tissue.

8. A probe according to claim 1 and further including an electrode element carried by the imaging element.

9. A probe according to claim 1

wherein the support structure has an axis, and

further including a steering element to move the imaging element along the axis.

10. A probe according to claim 1

wherein the support structure has an axis, and

further including a steering element to move the imaging element transverse to the axis.

11. A probe according to claim 1

wherein the support structure has an axis, and

further including a steering element to rotate the imaging element about the axis.

12. A probe according to claim 1

and further including a steering element including an actuator coupled to the imaging element to move the imaging element in response to control commands.

13. A probe according to claim 1

wherein the support structure comprises at least two spaced apart support members.

14. A probe according to claim 13

wherein the support members are made from metal material.

15. A probe according to claim 14

wherein the metal material includes nickel titanium.

16. A probe according to claim 14

wherein the metal material includes stainless steel.

17. A probe according to claim 13

wherein the support members are made from plastic material.

18. A probe according to claim 13

wherein the support members comprise elongated spline elements assembled in a circumferentially spaced relationship.

19. A probe according to claim 13

wherein the support structure is adapted to assume a collapsed geometry in response to external force, the support structure being urged by the support members toward a normally expanded geometry in the absence of the force.

20. A probe according to claim 19

and further including a sheath slidable relative to the support structure in a first direction to apply external force to urge the support elements into the collapsed geometry and in a second direction to release the external force, thereby allowing the support structure to assume an expanded geometry.

21. A probe according to claim 1

wherein the support element forms a three-dimensional structure.

22. A probe according to claim 21

wherein the three-dimensional structure includes an open interior area peripherally surrounding the imaging element.

23. A probe according to claim 21

wherein the three-dimensional structure keeps tissue from contacting the imaging element.

24. A probe according to claim 21

wherein the three-dimensional structure comprises an expandable body.

25. A probe according to claim 24

wherein the expandable body expands to an expanded geometry in response to fluid pressure.

26. A probe according to claim 24

wherein the expandable body collapses in the absence of fluid pressure.

27. A probe according to claim 24,

wherein the expandable body is adapted to normally assume an expanded geometry.

55. A probe according to claim 1, wherein the fiber optic assembly comprises

a lens optically coupled to an optic fiber path extending proximally from the distal region, and

a mirror surface optically coupled to the lens for transmitting and receiving optical energy.

5. A probe comprising

a catheter tube having a distal region,

an imaging element on the distal region for visualizing tissue, and

a support structure on the distal region extending beyond the imaging element for contacting surrounding tissue away from the imaging element, and

a diagnostic or therapeutic element on the support structure to contact surrounding tissue,

wherein the imaging element includes a phased array ultrasound transducer assembly.

28. A probe comprising

a catheter tube having a distal region,

an imaging element on the distal region for visualizing tissue, and

a support structure on the distal region extending beyond the imaging element for contacting surrounding tissue away from the imaging element, and

a diagnostic or therapeutic element on the support structure to contact surrounding tissue,

wherein the support structure forms a three-dimensional structure, wherein the three-dimensional structure comprises an expandable body, and

wherein the expandable body is porous.

29. A system for ablating heart tissue, comprising;

a catheter tube having a distal region,

an imaging element on the distal region for visualizing surrounding endocardial tissue,

a support body carried by the distal region of the catheter tube, the support structure expandable beyond the imaging element adapted to contact endocardial tissue away from the imaging element to allow for visualization of tissue, and

a plurality of energy transmitting electrodes carried in a spaced apart relationship on the support body for use with a source of ablation energy, the spaced apart relationship being set to create, when the electrodes simultaneously transmit ablating energy from the source, an additive heating effect between the electrodes that forms a continuous lesion pattern in surrounding myocardial tissue that extends between the electrodes.

30. A system according to claim 29,

and further including an indifferent patch electrode for contacting tissue spaced from the support body.

31. A system according to claim 29,

wherein each electrode has a diameter, and

wherein the set spaced apart relationship lies within a range of distances equal to or less than about 3 times the smallest of the diameters of the electrodes.

32. A system according to claim 29,

wherein each electrode has a length,

wherein the set spaced apart relationship lies within a range of distances equal to or less than about 2 times the longest of the lengths of the electrodes.

33. A system according to claim 32,

wherein the range of distances is essentially equal to the longest of the lengths of the electrodes.

34. A system according to claim 29,

wherein the electrodes comprise metallic material attached about the support element.

36. A system according to claim 29

wherein the electrodes comprise a coating on the support element.

37. A system according to claim 29,

and further including an element coupled to the imaging element for processing the visualizing signal to display the tissue image.

38. A system according to claim 29

and further including a steering device coupled to the imaging element to move the imaging element.

39. A system according to claim 29,

wherein the imaging element comprises an ultrasound transducer.

40. A system according to claim 29,

wherein the imaging element comprises a fiber optic assembly.

41. A system according to claim 33

wherein the support body includes an axis,

and further including a steering element to move the imaging element in a first direction along the axis and in a second direction rotating about the axis.

42. A system according to claim 41,

wherein the steering element moves the imaging element in a third direction normal to the axis.

43. A system according to claim 41,

and further including an actuator coupled to the steering element to move the imaging element in response to control commands.

57. A probe according to claim 33, wherein the support body comprises a three-dimensional structure.

35. A system for ablating heart tissue, comprising;

a catheter tub having a distal region,

an imaging element on the distal region for visualizing surrounding endocardial tissue,

a support element carried by the distal region of the catheter tube beyond the imaging element to contact endocardial tissue away from the imaging element, and

a plurality of energy transmitting electrodes carried in a spaced apart relationship on the support element for use with a source of ablation energy, the spaced apart relationship of the electrodes being set to create, when the electrodes simultaneously transmit ablating energy from the source, an additive heating effect between the electrodes that forms a continuous lesion pattern in surrounding myocardial tissue that extends between the electrodes,

wherein the electrodes comprise wire helically wrapped about the support element.

44. A method for treating atrial fibrillation, comprising the steps of:

introducing into an atrium a catheter tube carrying an optical imaging element and including a support structure spaced from the imaging element that contacts tissue in the atrium away from the imaging element, the support structure carrying a plurality of spaced apart energy transmitting electrodes for contact with tissue,

simultaneously transmitting ablating energy from a source through each electrode to generate an additive heating effect between electrodes that forms a continuous lesion pattern in tissue contacted by the electrodes, and

operating the imaging element to visualize tissue surrounding the support structure.

45. A method according to claim 44 and further including the step of displaying an image of tissue visualized during the operating step.

46. A method according to claim 44 and further including the step of moving the imaging element.

47. A method according to claim 44 and further including the step of moving the imaging element without moving the support structure.

48. A method according to claim 46 or 47

wherein the operating step acquires image slices during the moving step.

49. A method according to claim 44

wherein the operating step includes reflecting light from the tissue contacting the support body.

50. A method according to claim 44

and further including the step of using the image to orient the support body within the atrium.

51. A method according to claim 44

and further including the step of using the image to view the continuous lesion pattern.

52. A method according to claim 44

and further including the step of using the image to assess contact between the electrode elements and endocardium.

53. A method according to claim 44

and further including the step of using the image to identify thrombus.

54. A method according to claim 44

and further including the step of using the image to characterize tissue morphology.

56. A probe, comprising:

a catheter tube having a distal region,

an imaging element comprising a fiber optic assembly on the distal region for visualizing surrounding endocardial tissue,

a support body called by the distal region of the catheter tube beyond the imagine element to contact endocardial tissue away from the imaging element, and

a diagnostic or therapeutic, element on the support structure to contact surrounding tissue,

wherein the optic fiber assembly comprises a lens optically coupled to an optic fiber path extending proximally from the distal region, a mirror surface optically coupled to the lens for transmitting and receiving optical energy, and an optical coherence domain reflectometer system optically coupled to the optic fiber path.

58. A system for treating heart tissue, comprising:

a catheter tube having a distal region,

a fiber optic assembly on the distal region for visualizing surrounding endocardial tissue, a support body on the distal region of the catheter, the support body expandable radially beyond the fiber optic assembly to contact surrounding myocardial tissue when disposed in a patient'"'"'s cardiovascular region, thereby allowing for tissue visualization, and

at least one of the group consisting of a pacing electrode on the support body for use with a source of pacing energy to pace surrounding myocardial tissue, a sensing electrode on the support body for sensing electrical events in surrounding myocardial tissue, or an ablation electrode on the support body for use with a source of ablation energy to form a lesion pattern in surrounding myocardial tissue.

59. A system for treating heart tissue, comprising:

a catheter tube having a distal region and adapted to be inserted into a heart chamber,

an expandable body on the dial region defining a hollow interior and adapted to expand when fluid is introduced into the hollow interior,

an optical imaging element within the hollow interior for visualizing surrounding endocardial tissue beyond the expandable body, and

an ablation element on the distal region for use with a source of ablation energy to form a lesion pattern in surrounding myocardial tissue.

60. A system according to claim 59, wherein the expandable body comprises an inflatable balloon adapted to provide a fluid-tight seal between the hollow interior and surrounding myocardial tissue.

61. A system according to claim 59, wherein the ablation element is deployable within the hollow interior for establishing an electrically conductive path with surrounding myocardial tissue when the hollow interior is filled with electrically conductive fluid.

62. A system according to claim 59, further comprising a multiple spline structure on the distal region expandable beyond the expandable body.

63. A system according to claim 62, wherein the multiple spline structure includes an array of electrodes thereon.