Methods and devices for controlling ablation therapy
Inventors
Assignees
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Publication Number
US-11871979-B2
Publication Date
2024-01-16
Expiration Date
Abstract
Devices and methods for controlling ablation therapy are provided herein. In one embodiment, an ablation device is provided that includes an elongate body having proximal and distal ends, and an inner lumen extending therethrough. The inner lumen can be configured to receive fluid therein and to deliver fluid to the distal end of the elongate body. The device can also include an ablation element positioned at a distal end of the elongate body that is configured to heat surrounding tissue, and a heater element disposed within the inner lumen adjacent to a distal end of thereof, the heater element being configured to heat fluid flowing through the inner lumen.
Core Innovation
The disclosed invention provides a method of ablating tissue using a catheter having an elongate body with a blunt distal portion positioned in contact with tissue without penetrating the tissue. Ablative energy is delivered through an ablation element on the blunt distal portion while simultaneously delivering fluid through the catheter and the elongate body, and the fluid is heated to a temperature greater than 37° C and less than 70° C by a heater element disposed in a distal portion of the elongate body distal to the catheter.
Fluid delivery is performed through one or more outlet ports formed in the ablation element while tissue temperature in contact with the blunt distal portion is detected. The temperature is detected using a temperature sensor disposed on the distal-most end surface of the blunt distal portion of the elongate body, and the system is directed to controlling ablation temperatures to avoid excessive tissue temperature and related complications described in the background.
The disclosure contrasts temperature profiles in prior art showing that uncontrolled cooling reduces lesion depth and that compensatory increases in power can cause tissue overheating. It therefore provides a regulated fluid-heating approach in which the distal heater element and temperature sensing at the tissue interface are used to manage ablation temperature within a regulation window and to reduce risk associated with tissue overheating above 100° C.
Claims Coverage
The independent claim covers an ablating-tissue method that combines non-penetrating catheter positioning, heated fluid delivery through outlet ports in an ablation element, and tissue-interface temperature sensing at the distal-most surface while delivering ablative energy. The inventive features focus on coordinated heated-fluid temperature limits, distal heater placement, and distal-most tissue-interface temperature detection; additional dependent claims add geometric and sensing/coordination refinements.
Non-penetrating blunt distal portion positioning
Positioning a blunt distal portion of an elongate body disposed at a distal end of the catheter in contact with tissue without penetrating the tissue while passing the catheter through an existing passageway within a body.
Ablation with heated fluid delivered through outlet ports
Delivering ablative energy to the tissue through an ablation element on the blunt distal portion while simultaneously delivering fluid through the catheter and the elongate body, the fluid being heated to a temperature greater than 37° C and less than 70° C by a heater element disposed in a distal portion of the elongate body distal to the catheter, and delivering the fluid through one or more outlet ports formed in the ablation element.
Distal-most tissue-interface temperature sensing
Detecting the temperature of the tissue in contact with the blunt distal portion using a temperature sensor disposed on the distal-most end surface of the blunt distal portion of the elongate body.
Power and fluid heating coordination to prevent excessive tissue heating
Coordinating a power level of an ablation element with heating of a fluid so that any portion of the tissue is not heated above about 100° C.
Power and fluid heating coordination for desired lesion depth
Coordinating the power level of an ablation element with heating of a fluid such that a treatment lesion of a desired depth is created.
Inner-lumen fluid delivery
Delivering fluid through an inner lumen within the elongate body.
Distal heater element disposed in the inner lumen
Placing the heater element inside the inner lumen to heat the fluid.
Substantially planar distal-most surface of the blunt distal portion
Making the distal-most surface of the blunt distal portion of the elongate body substantially planar.
Overall, the claim set centers on non-penetrating catheter contact with a blunt distal portion, heated fluid delivery through outlet ports in an ablation element with the fluid held in the specified 37° C to <70° C window, and tissue-interface temperature detection using a temperature sensor on the distal-most end surface. Dependent features further constrain temperature safety (about 100° C) and add coordinated power/heating for desired lesion depth, including inner-lumen delivery and distal heater placement in the inner lumen, and a substantially planar distal-most surface.
Stated Advantages
Avoids excessive tissue temperatures by limiting tissue heating (not heated above about 100° C).
Helps create a treatment lesion of a desired depth.
Documented Applications
Cardiac ablation, including atrial fibrillation and atrial flutter, involving ablation of myocardium.
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