Method for ablating heart tissue to treat a cardiac arrhythmia
Devices and methods provide for ablation of cardiac tissue for treating cardiac arrhythmias such as atrial fibrillation. Although the devices and methods are often be used to ablate epicardial tissue in the vicinity of at least one pulmonary vein, various embodiments may be used to ablate other cardiac tissues in other locations on a heart. Devices generally include at least one tissue contacting member for contacting epicardial tissue and securing the ablation device to the epicardial tissue, and at least one ablation member for ablating the tissue. Various embodiments include features, such as suction apertures, which enable the device to attach to the epicardial surface with sufficient strength to allow the tissue to be stabilized via the device. For example, some embodiments may be used to stabilize a beating heart to enable a beating heart ablation procedure. Many of the devices may be introduced into a patient via minimally invasive introducer devices and the like. Although devices and methods of the invention may be used to ablate epicardial tissue to treat atrial fibrillation, they may also be used in veterinary or research contexts, to treat various heart conditions other than atrial fibrillation and/or to ablate cardiac tissue other than the epicardium.
1. A method for ablating heart tissue on a heart of a patient to treat a cardiac arrhythmia, the method comprising:
providing an introducer having a distal end and a proximal end and also comprising a tube with a pre-bent shape and comprising an obturator positioned within the introducer;
advancing the introducer through a first incision into the transverse sinus cavity of a patient;
removing the obturator from the introducer, allowing the introducer to conform to the pre-bent shape partially encircling the pulmonary veins;
coupling a distal end of an ablation device to the proximal end of the introducer;
inserting an instrument to grasp the distal end of the introducer and to move the distal end of the introducer until the ablation device is in position at least partially encircling the pulmonary veins;
contacting heart tissue with at least one tissue contacting member of the ablation device;
applying sufficient suction force through the tissue contacting member to secure the contacting member to the tissue;
applying ablation energy to at least a portion of the heart tissue in contact with the ablation device.
2. The method as in claim 1 , further comprising the step of removing the ablation device and the introducer.
3. The method as in claim 1 , wherein the step of moving the introducer comprises pulling the distal end of the introducer outside the body of the patient.
4. The method as in claim 3 wherein the ablation device includes at least two plugs, with each plug providing power to a subset of a plurality of electrodes on the ablation device.
5. The method as in claim 1 , wherein the instrument is introduced through the same incision as the introducer.
6. The method as in claim 4 , further comprising the steps of: connecting a first plug of the ablation device to an energy source, applying ablation energy to the tissue, unplugging the first plug from the energy source, plugging a second plug of the ablation device in to the energy source, and applying ablation energy to the tissue.
7. The method as in claim 1 , wherein the instrument is introduced through a second incision.
8. The method as in claim 1 , wherein the introducer comprises indicator markings.
9. The method as in claim 1 , wherein the ablation device comprises indicator markings.
10. The method as in claim 1 , wherein the introducer is configured to provide torsional rigidity to facilitate steerability.
11. The method as in claim 1 , wherein the introducer is a visible color selected to visually distinguish the introducer from natural anatomical colors.
12. The method as in claim 1 , further comprising the step of separately creating Maze-like ablation lesions.
13. The method as in claim 1 , further comprising visualizing the heart tissue with an imaging device coupled with the ablation device.
14. The method as in claim 13 , further comprising: positioning an insufflation device between the heart tissue and a layer of pericardial tissue; and introducing an insufflation medium into the insufflation device to create a space between the heart tissue and the pericardial tissue.
15. The method as in claim 14 , further comprising positioning an imaging device within the space to view the heart tissue.
16. The method as in claim 15 , wherein applying ablation energy comprises applying energy through at least one ablation member selected from the group consisting of a radio frequency device, a cryogenic device, an ultrasound device, a laser device, a thermoelectric chip device, a chemical agent delivery device, a biological agent delivery device, a light-activated agent device, a thermal device, a microwave device, and an ablating drug delivery device.
17. The method as in claim 1 , wherein applying sufficient suction force secures the ablation device to the heart tissue in a location so as to maintain a margin of safety away from the pulmonary veins.
18. The method as in claim 1 , further comprising stabilizing the heart using the ablation device.
19. The method as in claim 18 , wherein stabilizing the heart comprises securing the ablation device to the heart tissue with sufficient force to maintain the tissue in a position to perform an ablation procedure while the heart is beating.
20. The method as in claim 1 , further comprising sensing an extent of ablation of the heart tissue, using at least one sensor coupled with the tissue contacting member so as to contact the heart tissue.
21. The method as in claim 1 , further comprising sensing desired contact of the ablation device with the heart tissue.
22. The method as in claim 1 , further comprising using drug delivery means coupled with the ablation device to deliver at least one drug to the heart tissue to enhance treatment of the cardiac arrhythmia.
23. The method as in claim 1 , further comprising inserting at least one needle into the heart tissue to enhance the application of energy to the heart tissue.
24. The method as in claim 23 , further comprising extending the at least one needle from a retracted position before applying the energy and retracting the at least one needle to the retracted position when the energy has been applied.
25. The method as in claim 1 , further comprising: measuring the application of energy to the heart tissue using at least one closed circuit feedback loop; and regulating the application of energy to the heart tissue based on the measurement.
26. The method as in claim 1 , further comprising applying fluid to the heart tissue to enhance the application of energy to the heart tissue.
27. The method as in claim 1 , wherein the suction force applied creates a fluid gradient in epicardial tissue which improves ablation energy transmission to the tissue.
28. The method as in claim 1 , wherein the tissue contacting member is configured to visibly collapse when suction creates a desired vacuum level, whereby the user can confirm that the desired amount of suction has been achieved.
29. The method as in claim 1 , further comprising the step confirming that the suction has secured the contacting member to the tissue by observing a change in the sound generated by a vacuum pump pneumatically coupled with the tissue contacting member.
30. The method as in claim 1 , further comprising the step confirming that the suction has secured the contacting member to the tissue by observing the absence of suction sounds emanating from the tissue contacting member.
31. The method as in claim 1 , further comprising applying suction creating a vacuum between −200 and −760 mmHG.
32. The method as in claim 1 , wherein the ablation device includes a plurality of electrodes, and an energy source that includes less electrodes than the ablation device.
33. The method as in claim 32 wherein the ablation device includes at least two plugs, with each plug providing power to a subset of the plurality of electrodes on the ablation device.
34. The method as in claim 33 further comprising the steps: connecting the first plug of the ablation device to the energy source, applying ablation energy to the tissue, unplugging the first plug from the energy source, plugging the second plug of the ablation device in to the energy source, and applying ablation energy to the tissue.
35. The method as in claim 1 , wherein the tissue securing member comprises at least one insulation material for preventing a portion of the heart tissue from being treated.