The present invention relates to surgical tools and procedures generally and relates more particularly to the use of electrosurgical ablation to treat atrial fibrillation.
In patients with chronic atrial fibrillation having tachycardia that resistant to medical treatment, the Maze III procedure has been employed. This procedure controls propagation of the depolarization wavefronts in the right and left atria by means of surgical incisions through the walls of the right and left atria. The incisions create blind or dead end conduction pathways, which prevent re-entrant atrial tachycardias from occurring. While the Maze procedure is successful in treating atrial fibrillation, the procedure is quite complex and is currently practiced by only a few very skilled cardiac surgeons in conjunction with other open-heart procedures. The procedure also is quite traumatic to the heart, as in essence the right and left atria are cut into pieces and sewed back together, to define lines of lesion across which the depolarization wavefronts will not propagate.
It has been suggested that procedures similar to the Maze procedure could be instead performed by means of electrosurgical ablation, for example, by applying RF energy to internal or external surfaces of the atria to create lesions across which the depolarization wavefronts will not propagate. Such procedures are disclosed in U.S. Pat. No. 5,895,417, issued to Pomeranz, et al., U.S. Pat. No. 5,575,766, issued to Swartz, et al., U.S. Pat. No. 6,032,077, issued to Pomeranz, U.S. Pat. No. 6,142,944, issued to Swanson, et al. and U.S. Pat. No. 5,871,523, issued to Fleischman, et al, all incorporated herein by reference in their entireties. Hemostat type electrosurgical or cryo-ablation devices for use in performing such procedures are described in U.S. Pat. No. 5,733,280 issued to Avitall, U.S. Pat. No. 6,237,605 issued to Vaska, et al, U.S. Pat. No. 6,161,543, issued to Cox, et al., PCT published Application No. WO99/59486, by Wang and in pending U.S. patent application Ser. No. 09/747,609 filed Dec. 22, 2000 by Hooven, et al., all incorporated herein by reference in their entireties. In order for such procedures to be effective it is desirable that the electrosurgically created lesions are continuous along their length and extend completely through the tissue of the heart. These goals may be difficult to accomplish employing dry ablation electrodes or electrodes applied only to the interior or exterior surfaces of the heart tissue.
According to the present invention, a maze type procedure may be performed using a set of bipolar electrosurgical hemostats, which apply ablation energy (e.g. RF energy) across the walls of the left and right atria by means of delivery means (e.g. electrodes) located on either side of the atrial walls. In a preferred embodiment of the invention, the hemostats are provided with elongated RF electrodes having various straight and curved configurations. In the particular embodiment of the invention described herein, a collection of straight and curved bipolar electrosurgical hemostats is provided in order to allow the physician to produce lines of lesion that approximate the incisions that would occur during the Maze III procedure as described in the book ‘Cardiac Surgery Operative Technique’ by Donald B. Doty, M. D. at pages 410-419, incorporated herein by reference in its entirety, and hereafter referred to as the “Doty reference”. Other specific sets of hemostats may correspondingly be provided according to the invention to allow approximation of lines of lesion of the incisions that would be provided by other forms of the Maze procedure.
The invention as disclosed herein is describing the context of an open chest surgery, with patient undergoing cardiopulmonary bypass. As described, the procedure does include a limited number of surgical incisions, in conjunction with the creation of various straight and curved lesions using the bipolar electrosurgical hemostat set of the present invention. However, the present invention is also believed applicable to closed chest procedures, in which the heart is observed thoracoscopically and access is provided by means of thoracoscopic surgical ports. It is believed that ultimately, the invention may also applicable to closed chest, beating heart surgery, dispensing with the necessity of cardiac bypass.
The invention as disclosed in the present application includes a set of four pre-configured straight and curved hemostats, particularly optimized for performing an electrosurgical procedure mimicking the incisions provided according to Maze III surgical procedure. The set of hemostats is described in more detail below.
The hemostat includes two elongated handle members 12 and 14, each provided with a finger loop at its proximal end. A conventional hemostat locking mechanism 14 is also provided. The handles of the hemostat may be fabricated of stainless steel or other readily resterilizable material. Alternatively, the handles 11 and 12 might be fabricated of a biocompatible plastic and/or the hemostat may be disposable.
To the jaws 18 and 19 of the hemostat extend distally from the pivot or hinge 16, and carry elongated electrosurgical electrodes 24 and 25. When the jaws are parallel to one another, electrodes 25 and 25 are preferably spaced approximately 0 to 7 mm from one another, more preferably 1 to 5 mm from one another, to facilitate uniform contact allng opposite sides of a patient's atrial wall. In use, the atrial wall is compressed between electrodes 24 and 25, and R-F energy is applied between the electrodes in order to create an elongated continuous lesion extending through the cardiac tissue. Using the hemostat of
The electrodes 24 and 25 are preferably configured to allow fluid-assisted tissue ablation, of the type generally described in U.S. Pat. No. 6,096,037, U.S. Pat. No. Mulier, incorporated herein by reference in its entirety. To this end, each of the electrodes is provided with an electrical conductor, 20, 23 allowing delivery of R-F electrical energy to the electrodes 24 and 25, respectively and with a fluid lumen 21, 22 allowing for delivery of saline solution or other conductive fluid to and along the length of electrodes 24 and 25. Various alternative embodiments of the electrodes and jaws of the hemostat of
In use in a preferred embodiment of the invention, one jaw of the hemostat of
It is anticipated that in some versions of the present invention which employ a more limited access approach to the heart, the distal tips of hemostat jaws themselves may be sharpened and used to pierce the atrial wall, eliminating the necessity of a separate incision.
It should be understood that the above-described cross sectional illustrations of the configurations of the jaws of the hemostat of
For purposes of understanding the basic method of the present invention as illustrated, it should be assumed that the operation is undertaken as an open chest operation, with the heart stopped and the patient on full bypass. Modifications to the procedure, in case of a limited access, stopped heart procedure and/or a limited access, beating heart procedure, are also generally described.
In closed chest, limited access procedures, it is anticipated that the lesion produced may be made by inserting the jaw of an electrosurgical hemostat as illustrated in conjunction
The hemostats as illustrated in
While all of the hemostats disclosed in the present application are preferably provided with R-F electrodes to create elongated lesions, it is believed the invention may also usefully be practiced in conjunction with hemostats employing microwave, heat, cyro-ablation, laser or other ablative techniques to create the various lesions provided by the method. Further, while the hemostats disclosed in the present application are provided with a single elongated electrode extending along each jaw, embodiments in which multiple electrodes arrayed along each jaw are employed are also believed useful in practicing the invention in some cases.
Therefore, the above disclosure should be considered as exemplary, rather than limiting, with regard to the following claims.
This application is a divisional of U.S. patent application Ser. No. 10/015,690, filed Dec. 12, 2001, now U.S. Pat. No. 6,807,968, which claims the benefit of, and incorporated by reference an entirety of, U.S. Application Ser. No. 60/286,953, filed on Apr. 26, 2001.
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Number | Date | Country | |
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20050033280 A1 | Feb 2005 | US |
Number | Date | Country | |
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60286953 | Apr 2001 | US |
Number | Date | Country | |
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Parent | 10015690 | Dec 2001 | US |
Child | 10923073 | US |