Irrigated split tip electrode catheter

Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...

Reexamination Certificate

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C600S374000, C607S122000

Reexamination Certificate

active

06171275

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to electrophysiology catheters and more particularly to an irrigated split-tip electrode catheter for use in electrocardiology ablation and mapping procedures.
BACKGROUND OF THE INVENTION
The heart has a natural pacemaker and conduction system which causes the heart muscle to contract, or beat, in an orderly rhythmical manner. The normal pacing rate for an adult at rest is about 60 to 70 beats per minute. There are many physiologic abnormalities which cause one or more chambers of the heart to beat more rapidly (tachycardia or flutter) or chaotically (fibrillation). A patient cannot live with ventricular fibrillation because there would be no blood pumped through the arteries, but may live with atrial fibrillation so long as the chaotic impulses are filtered out at the AV node and do not reach the ventricals. A patient may also live with atrial flutter and various forms of tachycardia but quality of life may be considerably compromised.
Many of these arrhythmias can be treated effectively by ablation using radio-frequency (RF) energy. Other arrhythmias are less effectively treated, requiring more RF lesions for a successful outcome or resulting in no successful outcome. RF ablation is performed with a catheter having one or more electrodes which deliver the RF energy to the cardiac tissue. In operation the catheter is guided through a vein or artery into the heart chamber and positioned at one or more sites, determined by an electrophysiologist, to correct the arrhythmia. The catheter delivers energy from an external source (generator) to the tissue, generating sufficient heat to kill the tissue, which is thereafter replaced by scar tissue. In a successful ablation procedure, the lesions formed interrupt the electrical pathways that cause the arrhythmia so that heart rhythm is improved or returns to normal.
SUMMARY OF THE INVENTION
The present invention provides a deflectable split tip catheter for mapping electrical pathways in the heart and for delivering RF energy to ablate heart tissue to interrupt aberrant electrical pathways. The catheter comprises an elongated catheter body, a tip section at the distal end of the catheter body and a control handle at the proximal end of the catheter body. A split tip electrode, comprised of a plurality of electrode members, is carried at the distal end of the tip section. Means are provided for securing the split tip electrode to the tip section. Means are also provided for passing a fluid through at least one member of the split tip electrode. Means are further provided for controllably deflecting the tip section. Preferably, means are also provided for monitoring the temperature of each electrode member.
The elongated body of the catheter comprises at least one lumen, preferably a central lumen through which a plurality of electrode lead wires, an infusion tube and at least one puller wire may extend. The tip section comprises a section of flexible tubing having at least one lumen, including preferably at least one off-axis lumen, and more preferably multiple lumens including at least one off-axis lumen, through which an infusion tube, electrode lead wires and at least one puller wire may extend.
The split tip electrode is formed in whole or in part by an assembly of distal electrode members (referred herein as a distal electrode assembly) with or without a proximal cup electrode. The distal electrode assembly includes a distal portion with an exterior surface, preferably comprising a rounded or bullet-shaped distal end, and a proximal portion forming a recessed stem. In a preferred embodiment of the invention, the distal electrode assembly comprises four electrode members arranged symmetrically about the longitudinal axis of the tip section forming a “quad tip electrode”, each member forming a quadrant of the distal electrode assembly. Each electrode member is electrically connected to an associated electrode lead wire. Each electrode member is separated from other electrode members by insulation or the like.
A preferred split tip electrode comprises a cup electrode having a distal cylindrical portion which forms a ring electrode and a proximal portion forming a recessed stem. The cup electrode is hollow for receiving and securing therein the recessed stem of the distal electrode assembly. The cup electrode is electrically isolated from the electrode members of the distal electrode assembly. The cup electrode may be secured directly to the flexible tubing of the tip section or to a short section of a generally rigid plastic bridge tubing which receives at its distal end the recessed stem of the cup electrode. In the latter embodiment, the bridge tubing receives at its proximal end, a recessed distal end of the flexible tubing of the tip section.
A split tip electrode comprising a distal electrode assembly without a cup electrode may be connected to the tip section tubing by means of a generally hollow section of bridge tubing made of a generally rigid material that will not deform as a result of temperatures reached during an ablation procedure. The bridge tubing receives at its distal end at least a portion of the recessed stem of the distal electrode assembly and at its proximal end, a recessed distal end of the tip section tubing. If desired, one or more ring electrodes may be carried on the bridge tubing and/or on the tip section tubing.
A preferred means for passing a fluid through one or more electrode members of the tip electrode assembly comprises an infusion tube that extends through the catheter body and tip section and into a passageway, preferably an axial passageway, in the tip electrode assembly. The passageway extends from the proximal end of the composite tip electrode a portion of the distance to the distal end where the passageway branches into one or more generally transverse channels which extend(s) through at least one, and preferably each, of the electrode members. Rather than having one or more generally transverse channels in each electrode member, one or more electrode members may be made of a porous material through which fluid from an infusion tube may pass.


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Huang, S.K., et al, “Increase in the Lesion Size and Decrease in the Impedance Rise with a Saline Infusion

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