Systems and methods for creating curvilinear lesions in body tissue

• US 6,146,379 A
• Filed: 12/10/1996
• Issued: 11/14/2000
• Est. Priority Date: 10/15/1993
• Status: Expired due to Term

• Current Assignee: EP Technology (Boston Scientific Corporation)
• Original Assignee: EP Technology (Boston Scientific Corporation)
• Inventors: Swanson, David K., Fleischman, Sidney D., McGee, David L.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/763,170
• Time in Patent Office: 1,435 Days
• Field of Search: 606/32-35, 606/37-42, 606/45-50, 607/100-102, 607/115, 607/116, 607/119, 607/122, 128/642, 600/372, 600/374
• US Class Current: 606/41
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Systems and methods ablate tissue within the body using a flexible guide element having an axis. A mechanism flexes the element along its axis. The flexible element carries a region for emitting energy. The region creates a lesion having a contour that follows the flexure of the element. The region creates a single continuous lesion that is curvilinear, long and thin. Manipulating such systems and methods creates diverse, specially shaped lesions in body tissue.

Claims

1. A device for ablating tissue within the body comprising

a source of tissue ablating energy,

an indifferent electrode adapted to be located on the exterior of the body,

a flexible guide element having an axis and a steerable tip, and

lesion creation means, associated with the steerable tip and coupled to the source, for creating at least two differently shaped continuous lesions, each having a curved contour and a length that is substantially greater than its width, by transmitting the tissue ablating energy through the tissue to the indifferent electrode.

2. A device according to claim 1

wherein the lesion created has a length to width ratio that is at least about 3:

1.

3. A device according to claim 1

wherein the lesion created has a width that is no greater than about 5 mm.

4. A device according to claim 1

wherein the lesion created has a length to width ratio that is in the range of about 10:

1 to 20;

1.

5. A device according to claim 4

wherein the lesion created has a width that is no greater than about 5 mm.

6. A device according to claim 1, where the lesion creation means comprises:

flexing means within the guide element for flexing the steerable tip along the axis, and

a region on the steerable tip coupled to the source for transmitting the tissue ablating energy.

7. A device according to claim 6

wherein the region comprises an array of energy transmitting areas spaced apart along the axis and the continuous lesion spans at least two energy transmitting areas.

8. A device according to claim 6

wherein the region comprises an array of energy transmitting areas spaced apart along the axis.

9. A device according to claim 8

wherein each area comprises a band of energy transmitting material wrapped about the axis.

10. A device according to claim 6

wherein the areas comprise energy transmitting material helically wrapped about and along the axis.

11. A device according to claim 6

wherein the region comprises at least one strip of energy transmitting material extending along the axis.

12. A device according to claim 11

wherein the strip comprises a metal.

13. A device according to claim 11

wherein the strip comprises a coating of energy transmitting material on the guide element.

14. A device according to claim 6

wherein the region comprises a metal attached to the steerable tip.

15. A device according to claim 6

wherein the region comprises a coating of energy transmitting material on the steerable tip.

16. A device according to claim 6

wherein the flexing means flexes the steerable tip between a generally straight configuration to a range of curvilinear configurations.

17. A device according to claim 16

wherein the flexing means flexes the steerable tip in a range of curvilinear configurations on opposite sides of the generally straight configuration.

18. A device for ablating tissue within the body comprising

a source of tissue ablating energy,

an indifferent electrode adapted to be located on the exterior of the body,

a flexible guide element having an axis, an elongate body defining a proximal end, a distal end, and a steerable tip extending from the distal end of the elongate body, the steerable tip defining a perimeter and a free end, the guide element being constructed such that, prior to flexing, the axis defines a substantially straight line from the free end of the steerable tip to the elongate body,

flexing means, at least a portion of which is located within the guide element and coupled to said steerable tip, for flexing the steerable tip along the axis such that the free end of the steerable tip and the elongate body define a curved line therebetween,

a control device located at the proximal end of the flexible guide element and secured to the flexing means such that steerable tip will assume a plurality of curved configurations in response to selective manipulation control device, and

a region on the steerable tip coupled to the source for transmitting the tissue ablating energy through the tissue to the indifferent electrode to create a straight lesion absent actuation of the flexing means and a lesion having a contour that follows the flexure of the steerable tip when the flexing means is actuated, at least a portion of the region extending substantially continuously around substantially the entire perimeter of the steerable tip.

19. A device according to claim 18

wherein the region extends along the axis.

20. A device according to claim 19

wherein the region comprises an array of energy transmitting areas spaced apart along the axis.

21. A device according to claim 20

wherein each area comprises a band of energy transmitting material wrapped about the axis.

22. A device according to claim 20

wherein the areas comprise energy emitting material helically wrapped about and along the axis on the outer-most surface of the device.

23. A device according to claim 18

wherein the region comprises at least one elongated strip of energy transmitting material extending along the axis.

24. A device according to claim 23

wherein the strip is formed of metal.

25. A device according to claim 23

wherein the strip comprises a coating of energy transmitting material on the guide element.

26. A device according to claim 18

wherein the region is formed of metal.

27. A device according to claim 18

wherein the region comprises a coating of energy transmitting material on the guide body.

28. A device according to claim 18

wherein the flexing means flexes the steerable tip between a generally straight configuration to a range of curvilinear configurations.

29. A device according to claim 28

wherein the flexing means flexes the steerable tip in a range of curvilinear configurations on opposite sides of the generally straight configuration.

30. A method for creating a complex lesion pattern in tissue within a body comprising the steps of:

providing a source of tissue ablating energy,

providing a flexible guide element having an axis, a steerable tip along the axis and a plurality of spaced regions on the steerable tip for transmitting energy to ablate tissue,

introducing the guide element into the body,

exposing the region to tissue,

flexing the steerable tip along its axis to a first desired curvilinear shape, thereby also flexing the regions,

simultaneously coupling the tissue ablating energy to the each of the regions of the flexed tip,

creating a continuous lesion pattern that forms a first part of the complex lesion pattern and spans the regions having a contour that corresponds to the first curvilinear shape of the steerable tip and a length that is substantially greater than its width,

flexing the steerable tip along its axis to a second desired curvilinear shape, thereby also flexing the regions, the second desired curvilinear shape being different than the first desired curvilinear shape;

simultaneously coupling the tissue ablating energy to the each of the regions of the flexed tip, and

creating a continuous lesion pattern that forms a second part of the complex lesion pattern and spans the regions having a contour that corresponds to the second curvilinear shape of the steerable tip and a length that is substantially greater than its width.

31. A method according to claim 30

wherein, in flexing the steerable tip, the steerable tip is flexed between a generally straight configuration through a range of curvilinear configurations.

32. A method according to claim 31

wherein, in flexing the steerable tip, the steerable tip is flexed in a range of curvilinear configurations on opposite sides of the generally straight configuration.

33. A method according to claim 30 further comprising the step of

placing an indifferent electrode on the exterior of the body,

wherein the step of creating a continuous lesion pattern that forms a first part of the complex lesion pattern comprises simultaneously transmitting energy from the plurality of spaced regions to the indifferent electrode on the exterior of the body.

34. A method according to claim 30

wherein the step of flexing the steerable tip along its axis to a first desired curvilinear shape comprises flexing the tip such that the regions for transmitting energy occupy a portion of the tip defining an arc of at least 90 degrees.

35. A device for ablating body tissue, comprising

a support element to contact a tissue area, the support element having an axis and a steerable tip,

at least two non-contiguous mutually longitudinally spaced energy emitting zones defining respective distal and proximal ends on a portion of the steerable tip, the mutual spacing between the zones being such that, when the portion of the tip is flexed and the zones simultaneously transmit energy through a contacted area to an indifferent electrode, a continuous curved lesion is formed in the contacted tissue area that spans between the at least two energy emitting zones,

a flexing device within the support element adapted to flex the portion of the steerable tip with the at least two energy emitting zones along the axis into at least two different curvatures, at least one of the curvatures defining an arc of at least 90 degrees extending from the distal end of one energy emitting zone to the proximal end of the another energy emitting zones, and

an ablation energy source, operably connected to the at least two energy emitting zones, adapted to simultaneously transmit ablation energy to each of the at least two energy emitting zones.

36. A device as claimed in claim 35, wherein the at least two non-contiguous longitudinally spaced energy emitting zones comprise at least three non-contiguous longitudinally spaced energy emitting zones and the energy source is adapted to simultaneously transmit energy to each of the at least three energy emitting zones.

37. A device as claimed in claim 35, wherein the support element defines an outer surface and each of the energy emitting zones extends continuously and completely around the outer surface the support element.

38. A device as claimed in claim 35, wherein the at least two non-contiguous longitudinally spaced energy emitting zones comprise at least two non-contiguous longitudinally spaced closely wound coil electrodes.

39. A device as claimed in claim 35, wherein the at least two non-contiguous longitudinally spaced energy emitting zones comprise at least two non-contiguous longitudinally spaced helical electrodes.