Therapeutic ultrasonic catheter for delivering a uniform energy dose

• US 6,296,619 B1
• Filed: 12/30/1998
• Issued: 10/02/2001
• Est. Priority Date: 12/30/1998
• Status: Expired due to Fees

• Current Assignee: PharmaSonics, Inc.
• Original Assignee: PharmaSonics, Inc.
• Inventors: Cowan, Mark W., Brisken, Axel F., McKenzie, John R., Corl, Paul D., Nassi, Menahem, Zuk, Robert F.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/223,225
• Time in Patent Office: 1,007 Days
• Field of Search: 601/2, 600/437, 600/447, 600/459, 600/462, 600/466, 600/467, 600/470, 600/472, 604/20-22, 604/96.01, 604/101-1-1
• US Class Current: 604/22
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A method of treating a target region in a body lumen, said method comprising: directing a uniform dose of ultrasonic energy from an interior of the lumen radially outward over a treatment length of the lumen, wherein the dosage of ultrasonic energy received at any one point along the length varies by no more than plus or minus 6 decibels from that received at any other point along the length.

Claims

1. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of cylindrically-shaped ultrasound transducers each having a central axis disposed parallel with the central axis of the catheter, said transducers being axially spaced apart along the central axis of the catheter, wherein each of the plurality of ultrasound transducers is adapted to deliver a therapeutic dose of ultrasound energy; and

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen.

2. The device of claim 1, wherein, the plurality of ultrasound transducers are each fabricated from a material selected from the group consisting of a single crystal piezoelectric material, a polycrystalline piezoelectric material, an electrostrictive material, and a magnetostrictive material.

13. The device of claims 1, 3, 6, 9, or 10, further comprising,

a distal balloon mounted to the catheter and having an inflation lumen extending through the catheter; and

a proximal balloon mounted to the catheter and having an inflation lumen extending through the catheter; and

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

14. The ultrasound delivery system of claim 13, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

15. The ultrasound delivery system of claims 1, 3, 6, 9 ,or 10, further comprising,

a balloon having distal and proximal shoulders, the balloon mounts to the catheter and having an inflation lumen extending through the catheter.

16. The ultrasound delivery system of claim 15, further comprising,

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

17. The ultrasound delivery system of claim 15, wherein, the balloon is porous.

18. The ultrasound delivery system of claim 15, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

19. The ultrasound delivery system of claim 13, further comprising, an infusion chamber disposed between the distal and proximal shoulders of the balloon, the infusion chamber surrounding the region of the balloon between the distal and proximal shoulders of the balloon.

20. The ultrasound delivery system of claims 1, 3, 6, 9, or 10, further comprising,

a porous compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

21. The ultrasound delivery system of claims 1, 3, 6, 9, or 10, further comprising,

a porous non-compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

22. The ultrasound delivery system of claims 13, further comprising,

a sheath internal to the balloon or balloons, wherein the ultrasound transducers can be translated or rotated independent of the balloon or balloons.

3. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of cylindrically shaped axially spaced apart transducers each having a central axis disposed parallel with the central axis of the catheter, said transducers being disposed along the central axis, wherein each of the transducers is adapted to deliver a therapeutic dose of ultrasound energy; and

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter.

4. The device of claim 3, further comprising,

a translation system for moving the plurality of spaced apart ultrasound transducers at a controlled velocity in a direction parallel to the central axis of the catheter.

5. The device of claim 3, wherein, the plurality of ultrasound transducers are each fabricated from a material selected from the group consisting of a single crystal piezoelectric material, a polycrystalline piezoelectric material, an electrostrictive material, and a magnetostrictive material.

6. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

an ultrasound transducer attached to the catheter, wherein said transducer is adapted to deliver a therapeutic dose of ultrasound energy;

a translation system for moving the ultrasound transducer at a controlled velocity in a direction parallel to the central axis of the catheter; and

a rotation system for rotating the ultrasound transducer at a controlled angular velocity about the central axis of the catheter.

7. The device of claim 6, wherein the ultrasound transducer comprises,

a rectangular bar shaped transducer having at least two surfaces disposed parallel to the central axis acoustically insulated to block ultrasound emissions therefrom such that ultrasound energy is only emitted from at least one unblocked surface disposed parallel to the central axis of the catheter.

8. The device of claim 6, wherein, the transducer is fabricated from a material selected from the group consisting of a single crystal piezoelectric material, a polycrystalline piezoelectric material, an electrostrictive material, and a magnetostrictive material.

9. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis, wherein the plurality of ultrasound transducers are positioned at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen and

a translation system adapted to step translate the respective transducers a distance equal to one half the center-to-center spacing between adjacent transducers.

10. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy while simultaneously imaging the target region, comprising:

a catheter having a central axis;

at least one therapeutic ultrasound transducer disposed on the catheter;

an imaging ultrasound transducer disposed on the catheter;

a rotation system for rotating the at least one therapeutic ultrasound transducer and at least one imaging ultrasound transducer at a controlled angular velocity about the central axis of the catheter; and

a translation system for axially moving the at least one therapeutic ultrasound transducer and the at least one imaging ultrasound transducer at a controlled velocity through the lumen.

11. The device of claim 10, wherein, the at least one therapeutic ultrasound transducer comprises a plurality of cylindrically shaped transducers spaced apart along the central axis of the catheter.

12. The device of claim 10, wherein, the at least one therapeutic ultrasound transducer comprises a plurality of rectangular bar transducers spaced apart along the central axis of the catheter.

23. The device of claim 11, wherein, the cylindrically shaped transducers have opposite electroded surfaces.

24. The device of claim 23, wherein,

the opposite electroded surfaces are flat ends of each transducer disposed perpendicular to the central axis of the catheter.

25. The device of claim 23, wherein,

the opposite electroded surfaces of each transducer are an outer curved surface and an inner curved surface defined by a longitudinally extending bore passing through the transducer.

26. The device of claim 23, further comprising,

a guidewire received through a longitudinally extending bore passing through each of the plurality of transducers.

27. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis; and

a plurality of ultrasound transducers axially spaced apart along the central axis of the catheter wherein each of the ultrasound transducers are spaced apart by a distance not exceeding their lengths and

a translation system adapted to step translate the respective transducers a distance equal to one half the center-to-center spacing between adjacent transducers.

28. The device of claim 27, herein, the plurality of ultrasound transducers comprise,

cylindrical shaped transducers, each having a central axis disposed parallel with a central axis of the lumen.

29. The device of claim 27, wherein the plurality of ultrasound transducers comprise,

rectangular bar shaped transducers having at least two surfaces of each transducer disposed parallel to the central axis acoustically insulated to block ultrasound emissions therefrom such that ultrasound energy is only emitted from at least one unblocked surface disposed parallel to the central axis of the catheter.

30. The device of claim 29, wherein,

successive transducers are disposed at an angle to one another about the central axis of the catheter such that the transducers emit ultrasound energy in different radial directions, the different radial directions all being normal to the central axis of the catheter.

31. The device of claim wherein,

the plurality of ultrasound transducers are each fabricated from a material selected from the group consisting of a single crystal piezoelectric material, a polycrystalline piezoelectric material, an electrostrictive material, and a magnetostrictive material.

32. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of rectangular bar shaped ultrasound transducers axially spaced apart along the central axis of the catheter, each transducer having at least two surfaces of each transducer disposed parallel to the central axis acoustically insulated to block ultrasound emissions therefrom such that ultrasound energy is only emitted from at least one unblocked surface disposed parallel to the central axis of the catheter, and wherein successive transducers are disposed at an angle to one another about the central axis of the catheter such that the transducers emit ultrasound energy in different radial directions, the different radial directions all being normal to the central axis of the catheter; and

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen.

33. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen; and

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter.

34. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of ultrasound transducers axially spaced apart along the central axis of the catheter;

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen;

a distal balloon mounted to the catheter and having an inflation lumen extending through the catheter;

a proximal balloon mounted to the catheter and having an inflation lumen extending through the catheter; and

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

35. The ultrasound delivery system of claim 34, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

43. The device of claim 34, further comprising:

a sheath internal to the balloon or balloons, wherein the ultrasound transducers can be translated or rotated independent of the balloon or balloons.

36. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of ultrasound transducers axially spaced apart along the central axis of the catheter;

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen; and

a balloon having distal and proximal shoulders, the balloon mounted to the catheter and having an inflation lumen extending through the catheter.

37. The device of claim 36, farther comprising:

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

38. The device of claim 36, wherein the balloon is porous.

39. The device of claim 36, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

40. The device of claim, further comprising,

an infusion chamber disposed between the distal and proximal shoulders of the balloon, the infusion chamber surrounding the region of the balloon between the distal and proximal shoulders of the balloon.

41. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of ultrasound transducers axially spaced apart along the central axis of the catheter;

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen; and

a porous compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

42. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of ultrasound transducers axially spaced apart along the central axis of the catheter;

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen; and

a porous non-compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

44. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of cylindrical shaped ultrasound transducers axially spaced apart along the central axis of the catheter, each having a central axis disposed parallel with a central axis of the lumen, and each having opposite electroded surfaces; and

a translation system for moving the plurality of ultrasound transducers at a controlled velocity through the body lumen.

45. The device of claim 44, wherein,

the opposite electroded surfaces are flat ends of each transducer disposed perpendicular to the central axis of the catheter.

46. The device of claim 44, wherein,

the opposite electroded surfaces of each transducer are an outer curved surface and an inner curved surface defined by a longitudinally extending bore passing through the transducer.

47. The device of claim 44, a further comprising,

a guidewire received through a longitudinally extending bore passing through each of the plurality of transducers.

48. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis;

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter;

a distal balloon mounted to the catheter and having an inflation lumen extending through the catheter;

a proximal balloon mounted to the catheter and having an inflation lumen extending through the catheter; and

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

49. The device of claim 48, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

54. The device of claim 48, further comprising,

an infusion chamber disposed between the distal and proximal shoulders of the balloon, the infusion chamber surrounding the region of the balloon between the distal and proximal shoulders of the balloon.

55. The device of claim 48, further comprising,

a sheath internal to the balloon or balloons, wherein the ultrasound transducers can be translated or rotated independent of the balloon or balloons.

50. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis;

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter; and

a balloon having distal and proximal shoulders, the balloon mounted to the catheter and having an inflation lumen extending through the catheter.

51. The device of claim 50, further comprising,

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

52. The device of claim 50, wherein the balloon is porous.

53. The device of claim 50, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

56. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis;

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter; and

a porous compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

57. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis;

a rotation system for rotating the plurality of spaced apart ultrasound transducers at a controlled angular velocity around the central axis of the catheter; and

a porous non-compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

58. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy while simultaneously imaging the target region, comprising:

a catheter having a central axis;

a plurality of cylindrically shaped transducers spaced apart along the central axis of the catheter, the transducers having opposite electroded surfaces;

an imaging ultrasound transducer disposed on the catheter;

a rotation system for rotating the at least one therapeutic ultrasound transducer and at least one imaging ultrasound transducer at a controlled angular velocity about the central axis of the catheter; and

a translation system for axially moving the at least one therapeutic ultrasound transducer and the at least one imaging ultrasound transducer at a controlled velocity through the lumen.

59. The device of claim 58, wherein,

the opposite electroded surfaces are flat ends of each transducer disposed perpendicular to the central axis of the catheter.

60. The device of claim 58, wherein,

the opposite electroded surfaces of each transducer are an outer curved surface and an inner curved surface defined by a longitudinally extending bore passing through the transducer.

61. The device of claim 58, further comprising,

a guidewire received through a longitudinally extending bore passing through each of the plurality of transducers.

62. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis, wherein the plurality of ultrasound transducers are positioned at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen;

a distal balloon mounted to the catheter and having an inflation lumen extending through the catheter;

a proximal balloon mounted to the catheter and having an inflation lumen extending through the catheter; and

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

63. The device of claim 62, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

68. The device of claim 62, further comprising,

an infusion chamber disposed between the distal and proximal shoulders of the balloon, the infusion chamber surrounding the region of the balloon between the distal and proximal shoulders of the balloon.

71. The device of claim 62, further comprising,

a sheath internal to the balloon or balloons, wherein the ultrasound transducers can be translated or rotated independent of the balloon or balloons.

64. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis, wherein the plurality of ultrasound transducers are positioned at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen;

a balloon having distal and proximal shoulders, the balloon mounted to the catheter and having an inflation lumen extending through the catheter.

65. The device of claim 64, further comprising

an infusion port in the catheter, the infusion port having a fluid delivery lumen extending through the catheter.

66. The device of claim 64, wherein,

the balloon is porous.

67. The device of claim 64, further comprising,

a flushing port in the catheter, the flushing port having a fluid delivery lumen extending through the catheter.

69. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis, wherein the plurality of ultrasound transducers are positioned at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen; and

a porous compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.

70. A device for treating a target region in a body lumen with a uniform dose of therapeutic ultrasound energy, comprising:

a catheter having a central axis;

a plurality of spaced apart transducers disposed along the central axis, wherein the plurality of ultrasound transducers are positioned at a separation distance less than or equal to the diameter of the catheter to generate a uniform emission along the length of a body lumen; and

a porous non-compliant balloon mounted to the catheter and having a fluid delivery lumen extending through the catheter.