Focused ultrasound ablation devices having selectively actuatable ultrasound emitting elements and methods of using the same

• US 6,692,450 B1
• Filed: 01/19/2000
• Issued: 02/17/2004
• Est. Priority Date: 01/19/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Coleman, R. Glen
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): RUHL, DENNIS WILLIAM
• Application Number:
  US09/487,710
• Time in Patent Office: 1,490 Days
• Field of Search: 600/439, 600/471, 600/472, 601/2, 601/3, 601/4
• US Class Current: 601/3
• CPC Class Codes: A61H 23/0236 using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/027 with multiple foci created simultaneously
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A focused ultrasound ablation device includes an ultrasound emitting member having a plurality of individual ultrasound emitting elements arranged in an array. The ultrasound emitting elements are selectively, independently actuatable to emit ultrasound energy and focus the emitted ultrasound energy a predetermined distance from the ultrasound emitting member such that the ultrasound energy is focused within anatomical tissue adjacent which the ultrasound emitting member is positioned. The anatomical tissue is heated by the focused ultrasound energy to form a lesion in the tissue of desired size and/or surface configuration. A method of thermal ablation comprises the steps of selecting selected ones of a plurality of ultrasound emitting elements, arranged in an array on an ultrasound emitting member, for actuation to emit ultrasound energy in accordance with a desired size and/or surface configuration of a lesion to be formed in anatomical tissue, positioning the ultrasound emitting member adjacent the tissue, actuating the selected ones of the ultrasound emitting elements to emit ultrasound energy, focusing the ultrasound energy in the tissue with the selected ones of the ultrasound emitting elements, and heating the tissue with the focused ultrasound energy to form a lesion within the tissue having the desired size and/or surface configuration.

Claims

1. A focused ultrasound ablation device for creating a lesion in anatomical tissue of a patient comprising

an ultrasound emitting member including an active surface adapted for positioning adjacent anatomical tissue, said active surface carrying a plurality of individual ultrasound emitting elements arranged in an array along said active surface, said ultrasound emitting elements being actuatable to emit ultrasound energy and focus the emitted ultrasound energy at focusing zones, each focusing zone being separate and distinct to the ultrasound emitting element, and each focusing zone being spaced from one another and located the same fixed predetermined distance outwardly from said active surface whereby the ultrasound energy is focused within the anatomical tissue to form a lesion within the tissue, said ultrasound emitting elements in said array being selectively, independently actuatable to emit ultrasound energy therefrom and being selectively, independently non-actuatable to not emit ultrasound energy therefrom in response to selection by an operator of a particular size and surface configuration for the lesion to be formed within the tissue in accordance with the positions in said array of said ultrasound emitting elements selected to be actuated;

and

a handle coupled to said ultrasound emitting member

2. A focused ultrasound ablation device as recited in claim 1 wherein said ultrasound emitting elements are arranged along said active surface in rows and columns forming said array.

3. A focused ultrasound ablation device as recited in claim 2 wherein said ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

4. A focused ultrasound ablation device as recited in claim 3 wherein said piezoelectric elements are curved to effect focusing of the ultrasound energy said predetermined distance from said active surface.

5. A focused ultrasound ablation device as recited in claim 2 wherein said ultrasound emitting elements of said rows are vertically aligned with one another.

6. A focused ultrasound ablation device as recited in claim 2 wherein said ultrasound emitting elements of said rows are vertically offset from one another.

7. A focused ultrasound ablation device for creating a lesion in anatomical tissue of a patient comprising

an ultrasound emitting member comprising an active face adapted for positioning adjacent anatomical tissue, said active face carrying a planar array of ultrasound transducer elements, said ultrasound transducer elements each emitting ultrasound energy in response to an electrical signal supplied thereto, said ultrasound transducer elements having focusing configurations, respectively, by which ultrasound energy emitted therefrom is focused at focusing zones, respectively, located the same fixed predetermined distance from said active face such that the anatomical tissue is heated at the focusing zones, respectively, to form a lesion within the anatomical tissue, said ultrasound transducer elements in said array being selectively, independently actuatable to emit ultrasound energy and being selectively, independently non-actuatable to not emit ultrasound energy in response to selection by an operator of a particular size and surface configuration for the lesion to be formed within the tissue;

and

a handle coupled to said ultrasound emitting member.

8. A focused ultrasound ablation device as recited in claim 7 wherein said transducer elements are spaced from one another in said planar array.

9. A focused ultrasound ablation device as recited in claim 8 wherein said active face is adapted to be placed against an external surface of the tissue whereby said focusing zones are disposed in the tissue said predetermined distance from the external surface.

10. A focused ultrasound ablation device as recited in claim 8 wherein said transducer elements are arranged in a plurality of rows and columns forming said array.

11. A focused ultrasound ablation device as recited in claim 10 wherein each of said transducer elements includes a piezoelectric element.

12. A focused ultrasound ablation device as incited in claim 7 and further including an elongate handle shaft by which said handle is coupled to said ultrasound emitting member, said handle shaft having a distal end coupled to said ultrasound emitting member and having a proximal end coupled to said handle.

13. A method of thermal ablation of anatomical tissue using focused ultrasound comprising the steps of

selecting one or more of a plurality of individual ultrasound emitting elements, arranged in an array on an active face of an ultrasound emitting member, for actuation to emit ultrasound energy in accordance with a desired size and surface configuration of a lesion to be formed in anatomical tissue;

positioning the active face adjacent the anatomical tissue at a location aligned with a desired target area for the lesion within the tissue;

actuating the selected one or more ultrasound emitting elements to emit ultrasound energy;

focusing the ultrasound energy with the selected one or more of the ultrasound emitting elements so that the ultrasound energy is focused in the target area at one or more focusing zones corresponding to the selected one or more of the ultrasound emitting elements, each of the one or more focusing zones being disposed the same fixed predetermined distance from the active face; and

heating the tissue with the focused ultrasound energy to form a lesion at the target area having the desired size and surface configuration.

14. The method of thermal ablation as recited in claim 13 wherein the ultrasound emitting elements emit ultrasound energy in response to an electrical signal supplied thereto and said step of actuating includes electrically coupling the selected one or more of the ultrasound emitting elements with an electrical signal source.

15. The method of thermal ablation recited in claim 14 wherein said step of electrically coupling includes electrically coupling the selected one or more of the ultrasound emitting elements with a power supply producing the electrical signal.

16. The method of thermal ablation recited in claim 13 wherein said step of positioning includes positioning the active face of the ultrasound emitting member against an external surface of the tissue.

17. The method of thermal ablation recited in claim 16 wherein said step of focusing includes focusing the ultrasound energy so that each focusing zone is disposed a predetermined depth beneath the external surface of the tissue.

18. The method of thermal ablation recited in claim 13 wherein said step of selecting includes selecting a plurality of the plurality of ultrasound emitting elements to form a lesion of continuous planar surface area within the tissue.

19. The method of thermal ablation recited in claim 13 wherein said step of selecting includes selecting a plurality of the plurality of ultrasound emitting elements to form a lesion of discontinuous planar surface area in the tissue.

20. The method of thermal ablation recited in claim 19 wherein said step of selecting includes selecting a plurality of the plurality of ultrasound emitting elements to form a lesion comprising a plurality of planar, disconnected lesion segments in the tissue.

21. The method of thermal ablation recited in claim 20 wherein said step of selecting includes selecting a plurality of the plurality of ultrasound emitting elements to form a plurality of planar, disconnected lesion segments each surrounded by thermally undamaged portions of the tissue.

22. The method of thermal ablation as recited in claim 13 and further including, subsequent to said step of heating, the step of allowing at least part of the lesion to be naturally absorbed by the patients body.

23. The method of thermal ablation as recited in claim 13 and further including, subsequent to said step of heating, the step of allowing at least part of the lesion to remain as scar tissue in the patient'"'"'s body.

24. A method of thermal ablation of anatomical tissue comprising the steps of

positioning an active surface of an ultrasound emitting member adjacent anatomical tissue to be ablated;

actuating a plurality of ultrasound emitting elements disposed along the active surface to emit ultrasound energy;

emitting ultrasound energy into the anatomical tissue from the plurality of ultrasound emitting elements disposed along the active surface;

focusing the ultrasound energy at a plurality of focusing zones contained in a target area in the anatomical tissue, each focusing zone being separate and distinct to the ultrasound emitting element and each focusing zone being disposed the same predetermined distance from the ultrasound emitting elements;

heating the anatomical tissue at the focusing zones with the focused ultrasound energy to form an ablated tissue area at the target area containing a plurality of lesions at the focusing zones, respectively; and

removing the active surface from adjacent the anatomical tissue.

25. The method of thermal ablation of anatomical tissue as recited in claim 24 wherein said step of positioning includes positioning the active surface adjacent an external surface of the anatomical tissue and said step of focusing includes focusing the ultrasound energy in a target area disposed beneath the external surface.

26. The method of thermal ablation of anatomical tissue as recited in claim 25 wherein said step of positioning includes positioning the active surface in contact with the external surface.

27. The method of thermal ablation of anatomical tissue as recited in claim 25 wherein said step of heating includes heating the anatomical tissue at the focusing zones with the focused ultrasound energy so that the lesions begin at a beginning margin located below the external surface and end at an ending margin located further below the external surface than the beginning margin.

28. The method of thermal ablation of anatomical tissue as recited in claim 24 wherein said step of heating includes forming the ablated tissue area surrounded by unablated anatomical tissue.

29. The method of thermal ablation of anatomical tissue as recited in claim 28 wherein said step of heating includes forming the ablated tissue area so that the plurality of lesions do not contact one another.

30. A method of thermal ablation of anatomical tissue comprising the steps of

positioning an active surface of an ultrasound emitting member adjacent anatomical tissue to be ablated;

actuating a plurality of ultrasound emitting elements disposed in a plane along the active surface to emit ultrasound energy;

emitting ultrasound energy from the plurality of ultrasound emitting elements disposed in the plane along the active surface;

focusing the ultrasound energy in the anatomical tissue at a plurality of closely spaced focusing zones corresponding to the ultrasound emitting elements, each focusing zone is being separate and distinct to the ultrasound emitting elements, and each focusing zone being disposed in a plane located a fixed predetermined distance from the active surface;

ablating the anatomical tissue with the focused ultrasound energy to form an ablated tissue area containing a plurality of lesions at the focusing zones, respectively; and

removing the ultrasound emitting member from adjacent the anatomical tissue.

31. The method of thermal ablation of anatomical tissue as recited in claim 30 wherein said step of positioning includes positioning the active surface adjacent an external surface of the anatomical tissue.

32. The method of thermal ablation of anatomical tissue as recited in claim 31 wherein said step of positioning includes positioning the active surface in contact with the external surface.

33. The method of thermal ablation of anatomical tissue as recited in claim 30 wherein said step of ablating includes forming a planar ablated tissue area.

34. The method of thermal ablation of anatomical tissue as recited in claim 33 wherein said step of ablating includes forming the plurality of lesions to begin at a beginning margin located below the external surface and to end at an ending margin located further below the external surface than the beginning margin.

35. A method of thermal ablation of anatomical tissue comprising the steps of

positioning an active surface of an ultrasound emitting member adjacent anatomical tissue and in alignment with a target area in the anatomical tissue at which an ablated tissue area is to be created;

actuating selected ones of a plurality of ultrasound emitting elements disposed along the active surface to emit ultrasound energy;

emitting ultrasound energy from the selected ultrasound emitting elements into the anatomical tissue;

focusing the ultrasound energy in the anatomical tissue at a plurality of focusing zones corresponding to the selected ultrasound emitting elements, each focusing zone being separate and distinct to the ultrasound of emitting element, and each focusing zone being disposed the same predetermined distance from the ultrasound emitting elements; and

ablating the anatomical tissue with the focused ultrasound energy to form an ablated tissue area at the target area having a planar surface configuration containing a plurality of closely spaced lesions at which the anatomical tissue is ablated.

36. The method of thermal ablation of anatomical tissue as recited in claim 35 and further including, prior to said step of actuating, the step of selecting the ultrasound emitting elements to be actuated.

37. The method of thermal ablation of anatomical tissue as recited in claim 35 wherein said step of focusing includes focusing the ultrasound energy at a plurality of closely spaced focusing zones disposed below an external surface of the anatomical tissue.

38. A focused ultrasound ablation device for creating an ablated tissue area in anatomical tissue comprising

an ultrasound emitting member including an active surface adapted for positioning adjacent anatomical tissue and a plurality of individual ultrasound emitting elements arranged in a plane along said active surface, said ultrasound emitting elements being actuatable to emit ultrasound energy and focus the emitted ultrasound energy at a plurality of focusing zones, each focusing zone being separate and distinct to the ultrasound emitting element, and each focusing zone being disposed in a plane located a predetermined distance outwardly from said plane of said ultrasound emitting elements whereby the ultrasound energy is focused within the anatomical tissue to form a lesion within the anatomical tissue, said ultrasound emitting elements disposed along said active surface being selectively, independently actuatable to emit ultrasound energy and being selectively, independently non-actuatable to not emit ultrasound energy in response to selection by an operator of a particular size and surface configuration for the lesion;

and

a handle coupled to said ultrasound emitting member.

39. A focused ultrasound ablation device as recited in claim 38 wherein said ultrasound emitting elements are fixed in a planar array along said active surface.

40. A focused ultrasound ablation device for creating an ablated tissue area in anatomical tissue comprising

an ultrasound emitting member comprising an active face adapted for positioning adjacent anatomical tissue and carrying a plurality of spaced ultrasound emitting elements fixed in a planar array along said active face and capable of emitting ultrasound energy, said ultrasound emitting elements being selectively actuatable to focus the ultrasound energy emitted therefrom at a plurality of spaced focusing zones, each focusing zone being separate and distinct to the ultrasound emitting element, and each focusing zone being disposed in a plane located a fixed predetermined distance from said active face such that the anatomical tissue is heated at the focusing zones, respectively, to forms planar ablated tissue area in the anatomical tissue containing a plurality of lesions at the focusing zones, respectively, at which the anatomical tissue is ablated;

and

a handle coupled to said ultrasound emitting member.

41. A focused ultrasound ablation device as recited in claim 40 wherein said ultrasound emitting elements are selectively actuatable to emit ultrasound energy.

42. A focused ultrasound ablation device as recited in claim 40 wherein each of said ultrasound emitting elements includes a piezoelectric element.