Ablation catheter system with safety features

Abstract

A medical system for delivering treatment or therapy to a patient has a kill switch for interrupting the delivery. The kill switch, which can disrupt the delivery directly or can cause an error message to be generated that disrupts the delivery, can be activated by the operator or remotely. In an ablation catheter system, a kill switch mechanism immediately and abruptly terminates delivery of ablation treatment or therapy.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This patent application is a continuation-in-part of co-pending, commonly assigned, U.S. patent application Ser. No. 13 / 415,454, filed Mar. 8, 2012, which in turn is based upon and claims the benefit of the priority of the filing date of co-pending, commonly assigned U.S. Patent Application Ser. No. 61 / 450,236, filed Mar. 8, 2011, each of which applications is incorporated herein in its entirety.FIELD OF INVENTION[0002]The present invention relates generally to systems, catheters, and methods for performing targeted tissue ablation in a subject. More particularly, the present invention provides an ablation system having a quick cut-off mechanism, also known as a “kill switch”.BACKGROUND OF THE INVENTION[0003]Tissue ablation is used in numerous medical procedures to treat a patient. Ablation can be performed to remove undesired tissue such as cancer cells. Ablation procedures may also involve the modification of tissue without removal, such...

AI Technical Summary

Benefits of technology

[0011]It is also an object of the invention to provide an improved steerable ablation catheter system where the energy at the distal tip of the ablation catheter can be terminated immediately and abruptly.

[0167]Each and every functionality and component described above could be operational all within or on a standard ablation catheter and together would prevent routine and random resterilization by outside facilities and / or the operator's medical institution. Only the original manufacturer would be able to reset the timer contained within the device, replace the battery, evaluate each and every component, resterilize and repackage and resell said catheter at a discount. Overall, this would provide a significant quality control measure as well as a potential cost saving to the facility.

Problems solved by technology

Atrial fibrillation refers to a type of cardiac arrhythmia where there is disorganized electrical conduction in the atria causing rapid uncoordinated contractions that result in ineffective pumping of blood into the ventricle and a lack of synchrony.

This condition overwhelms the atrioventricular node, resulting in an irregular and rapid heartbeat.

As a result, blood pools in the atria and increases the risk of blood clot formation.

Atrial fibrillation treatment options are limited.

Three known treatments, lifestyle change, medical therapy and electrical cardioversion, all have significant limitations.

Electrical cardioversion attempts to restore sinus rhythm but has a high recurrence rate.

In addition, if there is a blood clot in the atria, cardioversion may cause the clot to leave the heart and travel to the brain or to some other part of the body, which may lead to a stroke.

Inadvertent ablation misapplications in treating such problems may result in complete heart block and require implantation of a permanent pacemaker, a known possible complication of the procedure.

In addition, other untoward events may occur during ablative procedures in which the body may exhibit early signs (such as a change in heart rate, oxygen saturation, and / or blood pressure), which may indicate perforation.

When this occurs, the device or catheter creates a hole in the heart wall leading to fluid accumulation in the pericardial sac and a life-threatening condition called cardiac tamponade.

However, there is an inherent delay in this procedure, which could result in damage to a patient, such as heart block, perforation, or phrenic nerve paralysis, if the ablation energy is not terminated quickly enough.

In addition, it is not very practical for the sterile catheter operator to have direct and immediate control over any switching mechanism contained on the non-sterile generator or console to terminate therapy as they are concurrently configured.

Also, these ablation generators and consoles are typically not easily accessible to the operator and, if placed in such a location, would potentially be disruptive to lab staff and operations.

Alternatively there could be foot control for the doctor or operator to terminate the ablation energy, but using a foot control may be awkward and difficult to control (especially because two foot pedals would potentially be used in concert: one for fluoroscopy and the other for an on / off switch).

In addition, accidentally stepping on the on / off foot pedal switch as it currently functions can potentially turn on therapy and cause inadvertent ablative therapy delivery with unintended injury to the heart, its conduction, and other structures.

However, none of these medical devices is an ablation catheter system useful for a cardiac ablation procedure, nor do any of the devices meet the unique demands characteristic of use of an ablation catheter in a catherization laboratory setting.

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