Devices and methods for remote temperature monitoring in fluid enhanced ablation therapy
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Publication Number
US-11583330-B2
Publication Date
2023-02-21
Expiration Date
Abstract
Devices and methods for monitoring the temperature of tissue at various locations in a treatment volume during fluid enhanced ablation therapy are provided. In one embodiment, an ablation device is provided having an elongate body, at least one ablation element, and at least one temperature sensor. The elongate body includes a proximal and distal end, an inner lumen, and at least one outlet port to allow fluid to be delivered to tissue surrounding the elongate body. The at least one ablation element is configured to heat tissue surrounding the at least one ablation element. The at least one temperature sensor can be positioned a distance away from the at least one ablation element and can be effective to output a measured temperature of tissue spaced a distance apart from the at least one ablation element such that the measured temperature indicates whether tissue is being heating to a therapeutic level.
Core Innovation
A method for ablating tissue includes inserting an elongate body into a tissue mass, the elongate body having an inner lumen extending therethrough and an insulating tube extending through the inner lumen. The insulating tube prevents fluid flowing through the inner lumen from contacting a sidewall of the elongate body, while a plurality of temperature sensors are coupled to the elongate body such that each sensor contacts the sidewall of the elongate body. The temperature sensors are positioned axially along the elongate body so that each sensor outputs a measured temperature at a spaced apart location in the tissue mass.
Heated fluid is delivered by heating fluid flowing through the insulating tube with a heating assembly disposed therein. The heated fluid is delivered through at least one outlet port formed in the elongate body and into tissue surrounding the elongate body. The monitoring step uses the plurality of temperature sensors to indicate whether the tissue is being heated to a therapeutic level based on the measured temperatures of surrounding tissue at the spaced apart locations.
The disclosed approach is supported by fluid-enhanced ablation therapy systems that remotely monitor tissue temperature at locations spaced from an ablation element during therapy. Temperature sensors can be positioned axially proximal and distal along the elongate body, with multiple sensors enabling temperature mapping, including optionally sensors positioned at distal ends of retractable elastic tines for 3D thermal mapping. Feedback from the measured temperatures is used to confirm a therapeutic dose, determine when to terminate therapy, and adjust operating parameters including fluid flow rate, fluid temperature, and ablative energy.
Claims Coverage
The document includes one independent method claim and discloses multiple dependent claim refinements. The independent claim centers on in-lumen heating with an insulating tube and multi-sensor axial temperature monitoring to indicate attainment of a therapeutic heating level, using the measured temperatures of tissue at spaced apart locations.
Axially spaced temperature sensing of therapeutic-level heating
Monitoring a temperature of the surrounding tissue with a plurality of temperature sensors coupled to the elongate body, positioned axially along the elongate body so that each sensor outputs a measured temperature of tissue in the tissue mass at a spaced apart location to indicate whether the tissue is being heated to a therapeutic level.
Insulating tube preventing fluid contact with the elongate sidewall
An insulating tube extending through the inner lumen preventing fluid flowing through the inner lumen from contacting a sidewall of the elongate body, with temperature sensors coupled to the elongate body such that each sensor contacts the sidewall of the elongate body.
Heating fluid within an insulating tube and delivering through outlet port(s)
Heating fluid flowing through the insulating tube with a heating assembly disposed therein, delivering the heated fluid through at least one outlet port formed in the elongate body and into tissue surrounding the elongate body.
Across the independent claim, the key inventive concept is combining heated-fluid delivery using an insulating tube and in-tube heating assembly with a plurality of axially positioned temperature sensors that measure surrounding tissue temperatures at spaced apart locations to indicate whether tissue reaches a therapeutic heating level.
Stated Advantages
Larger uniform therapeutic volume compared with conventional RF and unheated-saline perfusion.
Faster treatment compared with conventional RF and unheated-saline perfusion.
Improved confirmation of therapeutic dose using feedback based on measured tissue temperatures.
Therapy termination can be determined based on measured temperature indication of therapeutic-level heating.
Documented Applications
Fluid-enhanced ablation therapy (SERF) for ablating tissue in a tissue mass with remotely monitored temperature at locations spaced from the ablation element during therapy.
Temperature mapping using axially proximal and distal temperature sensors, including optionally sensors positioned at distal ends of retractable elastic tines for 3D thermal mapping.
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