Atrial fibrillation RF treatment device and method

• US 20020120263A1
• Filed: 12/17/2001
• Published: 08/29/2002
• Est. Priority Date: 12/15/2000
• Status: Active Grant

• Current Assignee: Tony R. Brown
• Original Assignee: Tony R. Brown
• Inventors: Wadhwani, Suresh, Nguyen, Hein, Laufer, Michael D., Brown, Tony R., Adame, Octavio V.
• Granted Patent: US 6,723,092 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/0225 using an instrument for clamping tissue, e.g. forceps
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• 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 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

An RF treatment device according to the present invention includes one or two radio frequency electrode holders each having multiple electrodes arranged to create a transmural lesion through tissue. The treatment device is placed with one holder placed on the endocardial surface of the heart wall with the electrodes protruding towards the epicardial surface of the heart and the other optional holder placed on the epicardial surface of the heart with the electrodes protruding towards the endocardial surface of the heart forming a bipolar arrangement of equally spaced electrodes. The embodiments of the present invention are described for use in creating a transmural lesion in heart tissue to treat atrial fibrillation by blocking the passage of abnormal electrical currents through the heart. However, the devices and methods may also be used to create continuous transmural lesions in heart tissue and other body organs and tissues to treat other conditions. Although the invention is primarily described with respect to the application of RF bi-polar energy, the devices may also be used to apply other types of energy, such as cryo, ultrasound, microwave, heat, or other electrical means of providing an interruption to the abnormal electrical circuits at given regions.

Claims

1. An RF treatment device for creating transmural lesions in tissue, the device comprising:

an electrode holder;

a plurality of tissue penetrating RF needle electrodes arranged in a single linear array to create a continuous transmural lesion, each of the RF needle electrodes having a length of at least 4 mm; and

an RF energy source connected to each of the RF needle electrodes with alternating electrodes connected to opposite polarities of the RF energy source.

2. The device of claim 1, wherein the linear array of RF needle electrodes forms a straight line.

3. The device of claim 1, wherein the linear array of RF needle electrodes forms a curved line.

4. The device of claim 1, wherein each of the RF needle electrodes has a length of about 5 mm to about 15 mm to completely transverse the tissue.

5. The device of claim 1, wherein each of the RF needle electrodes has a sharp tissue penetrating tip.

6. The device of claim 1, wherein the electrode holder is mounted on a catheter.

7. The device of claim 1, wherein the electrode holder is mounted on a non-catheter medical device.

8. The device of claim 1, further comprising an anvil movable with respect to the electrode holder to trap tissue between the electrode holder and the anvil.

9. The device of claim 8, further comprising a plurality of RF needle electrodes positioned on the anvil.

10. The device of claim 1, wherein the RF needle electrodes are retractable.

11. The device of claim 10, further comprising a cam element within the electrode holder for moving the RF needle electrodes from a retracted position to an extended position.

12. The device of claim 10, wherein the RF needle electrodes are rotatable within the electrode holder from a retracted position to an extended position.

13. The device of claim 10, wherein the needle holder is a tubular member and the RF needle electrodes are contained within the tubular member in a retracted position and are pushed out of a distal end of the tubular member to an extended position.

14. The device of claim 1, wherein the RF needle electrodes include holes for delivery of a sealant.

15. The device of claim 1, further comprising a temperature sensing member positioned between two of the RF needle electrodes.

16. The device of claim 16, wherein the temperature sensing member is mounted on a tissue penetrating needle.

17. The device of claim 1, further comprising diagnostic electrodes positioned on tissue penetrating needles arranged on opposite sides of the linear array of RF needle electrodes.

18. The device of claim 1, wherein the RF needle electrodes are parallel.

19. The device of claim 1, further comprising means for aiding penetration of the tissue with the RF needle electrodes.

20. The device of claim 19, wherein the means for aiding penetration is vibration, oscillation, or impact.

21. The device of claim 19, wherein the means for aiding penetration includes coatings or lubricants.

22. An RF treatment device for creating transmural lesions in heart tissue, the device comprising:

an electrode holder;

a plurality of tissue penetrating RF needle electrodes arranged in a single linear array to create a continuous transmural lesion, each of the RF needle electrodes having a length sufficient to create a transmural lesion through the entire thickness of the tissue of the heart wall; and

an RF energy source connected to each of the RF needle electrodes.

23. The device of claim 22, wherein the RF needle electrodes having a length of at least 4 mm.

24. The device of claim 22, wherein the linear array of RF needle electrodes forms a straight line.

25. The device of claim 22, wherein the linear array of RF needle electrodes forms a curved line.

26. The device of claim 22, wherein the RF needle electrodes are parallel.

28. The method of claim 27, wherein the heart tissue is penetrated from an endocardial surface of the heart.

29. The method of claim 27, wherein the heart tissue is penetrated from an epicardial surface of the heart.

30. The method of claim 27, wherein the heart tissue is penetrated with RF needle electrodes having a length sufficient to create a transmural lesion through the tissue of the heart wall.

31. The method of claim 27 , wherein the heart tissue is penetrated with RF needle electrodes having a length sufficient to penetrate at least ⅔

of the way through the heart wall.

32. The method of claim 27, further comprising a step of controlling the power delivered to the RF treatment device based on a temperature sensed within the heart tissue.

33. The method of claim 27, wherein the step of applying radio frequency energy forms a narrow transmural lesion with a width of about 1 mm to about 3 mm.

34. The method of claim 27, further comprising a step of applying a glue, sealant, hemostat or mechanical plug to prevent bleeding from the holes created by the RF needle electrodes.

35. The method of claim 27, further comprising retracting the RF needle electrodes from the heart tissue while applying radio frequency energy to assist in sealing the holes created by the RF needle electrodes.

36. The method of claim 27, further comprising controlling the application of radio frequency energy based on feedback from a temperature sensor and diagnostic electrodes.

39. The device of claim 38, wherein the electrodes are one of unipolar RF electrodes, bipolar RF electrodes, cryo-ablation electrodes, thermoelectric electrodes, heat pipe electrodes, and ultrasonic electrodes.

40. The device of claim 38, wherein the electrodes have a length of at least 4 mm to create the transmural lesion.

27. A method of treating atrial fibrillations comprising:

penetrating heart tissue to be treated with an RF treatment device comprising a plurality of tissue penetrating RF needle electrodes arranged in a single linear array; and

applying radio frequency energy to form a transmural lesion which provides a barrier across an entire thickness of the heart tissue to prevent the passage of abnormal electrical currents through the heart tissue.

37. A method of treating atrial fibrillations comprising:

positioning a first electrode of a radio frequency forceps on an endocardial surface of a heart at a location to be treated;

positioning a second electrode of the radio frequency forceps on an epicardial surface of the heart opposite the first electrode; and

applying radio frequency with the first and second electrodes to form a transmural lesion which provides a barrier to the passage of abnormal electrical currents through the heart tissue.

38. A medical device for creating transmural lesions in tissue, the device comprising:

an electrode holder;

a plurality of tissue penetrating needle electrodes arranged in a single linear array to create a continuous transmural lesion, each of the needle electrodes having a length sufficient to create a transmural lesion through the tissue of the heart wall; and

an energy source connected to each of the needle electrodes.