Remote Magnetic Navigation for Accurate, Real-time Catheter Positioning and Ablation in Cardiac Electrophysiology Procedures

This protocol utilizes a new remote navigation system based on magnetic driving forces, which has been recently introduced as a new robotic tool for human cardiac electrophysiology procedures. This is accomplished by first position in the patient on the operation table where medical staff obtains right and left BA femoral axis and catheters are manually positioned into the cardiac chambers. A system based on eight coil core electromagnet generates a dynamic magnetic field, which allows remote navigation of very flexible magnetized catheters by rapid changes in the magnetic field magnitude.

A magnetized catheter is introduced into the cardiac chambers for 3D geometrical reconstruction using an electro anatomical mapping system. Then the arrhythmia circuit is characterized using remote navigation and electrophysiological maneuvers like entrainment mapping. Finally, the results show successful remote radio frequency delivery at the target site localized during the mapping step.

New remote navigation systems were developed to facilitate navigation and increase the stability while the operator is away from the patient table. However, the first generation of these systems have several limitations. A recently developed catheter navigation system utilizes eight electromagnets positioned around the patient's torso.

This allows for rapid near realtime movement of the catheter tip based on rapid dynamic changes of the magnetic fields generated by these electromagnets. The catheter guidance Control and imaging CGCI system employs a powerful electromagnets to produce a highly agile magnetic field within an effective control area, optimized to focus and contain the magnetic field almost entirely within the magnetic chamber. The system produces no magnetic field when it's not in magnetic guidance mode.

The magnetic field generators provide torque and force for moving, positioning and directing the tip of a catheter equipped with a permanent magnet pellet attached at this tip. The robotic system includes an operation console, the CGCI controller computer, and a motorized linear catheter advancement mechanism. The system uses a standard three axis joystick, which is used to rotate the magnetic field and manually advance or retract the catheter.

A 3D controller is used to push the catheter in any screen oriented direction. The X-ray C arm may be rotated or extracted at the operation console using the x-ray dialogue. The operation console unifies the display of the CGCI system inside NEX EP recording system, intracardiac ultrasound and x-ray.

It allows the direct keyboard and mouse control over the inside Navi system and EP recording system. Typically, the center screen is used for the inside screen and the CECI overlay graphics. The patient is prepared outside of the magnetic chamber.

Medical staff obtains right and left vein femoral axis under local anesthesia for left atrial flatter procedures. A decap, colar and an screwing catheter are initially positioned into the coronary sinus and in the right Atrial septum respectively. An intravascular cardiac Echo echocardiography probe is also positioned into the right aum.

Next, conventional workup of the arrhythmia mechanism is performed. Once left atrial flatter mechanism is confirmed. Transseptal axis to the left atrium is achieved using a transseptal sheath and continuous size monitoring.

A multipolar catheter is also placed into the left atrium through the transseptal puncture. For remote navigation, use a magnetic ablation catheter introduced through a special sheath With electrodes. The motorized device adds Or removes catheters lock.

The device consists of a sterilizable wheel drive Gearbox and a motor base. It also includes a disposable sheath clip and leg mount. The sheath is mounted in the clip and the catheter is inserted into the sheath and manually advanced into the left atrium, which is confirmed by the mapping system and fluoroscopy.

Next, the catheter line is placed between the rollers of the wheel drive gearbox by pulling back on the thumb lever. The X-ray C arm is moved to its operational position within the magnetic chamber. Patient's stable is now advanced to localize the Torx within the magnetic field.

Next, the operator leaves the operation room and takes control From the operation console. The magnetic catheter And the special sheath with electrodes are now shown on the center screen all CGCI and inside Navi operational functions are available at the CGCI operation console. The operator uses a left hand three axis joystick to control the amount of catheters lack.

A right hand. 3D controller is used to a steer the catheter to a specific site within the left atrium by changing the direction of the magnetic field. The yellow magnetic arrow indicates the direction of the magnetic field.

A magnetic icon displays the coil power values as colors. Green indicates a strong positive feel, and red indicates a strong negative field. Next 3D.

Geometry is constructed by remotely moving the catheter within the left atrium and pulmonary veins, activation voltage, and first force spacing. Interval maps are generated to characterize the reran circuit ablation Targets are identified and localized on the 3D geometry. In automated magnetic guidance mode, the operator can automatically guide the catheter to a specific target by double clicking on an inside label.

This represents an essential feature to create remote and automatic ablation lines. In automated mode, the system displays a targeting dialogue. This indicates the intended target range time and targeting search status.

Manual intervention of an automatic search is possible by using the joystick or 3D controller to terminate the arrhythmia. Radio frequency energy is delivered to a specific site level as target point, either manually or automatically guided the arrhythmia terminates and sign ahy is restore upon interruption of the reentry circuit. No.Reinduction by fast atrial pacing confirms the elimination of the arrhythmia.

The procedure terminates after removing catheters, heath and compressing puncture sites for hemostasis. This electromagnet based system allows rapid reproducible navigation, accurate and stable catheter position on selected targets within the cardiac chambers. These fixtures are important in the creation of transmural lesions and to guide the catheter to anatomical difficult sites, especially without extensive manual catheter experience.

This may result in more effective and safer ablation Procedures.