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Bioimpedance measurement system and method

Bioimpedance measurement system and method description/claims

This Application is a Divisional of U.S. Utility patent application Ser. No. 11/283,057, filed Nov. 18, 2005, entitled BIOIMPEDANCE MEASUREMENT SYSTEM AND METHOD, the entirety of which is incorporated herein by reference.

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The present invention relates to a system and method for treating tissue using cooled medical devices using electrical impedance measurements with the device.

Effectiveness of cryotreatment of endocardial tissue is significantly affected by the contact of the catheter tip or thermally transmissive region to the tissue. Ex-vivo studies show a correlation between the lesion sizes created and the tip or thermally-transmissive region to tissue contact quality. A larger lesion size can be achieved with the same device by improving the tip to tissue pressure or contact. Various methods have been used to assess tip or thermally-transmissive region contact, using RF catheters and/or ultrasound imaging. However, none of these methods has proved entirely satisfactory.

The problem extends to all areas of tissue treatment wherein the tissue undergoes some change or “physiological event” during the course of treatment. In addition to contact quality assessment, in treatment devices that employ fluid flows, detection and containment of leaks is a critical problem, especially in the operation of cryogenic devices for therapeutic purposes, lest a leak of coolant enter the body and thereby cause significant harm. Known catheters which employ inflatable balloons often inflate the balloons to relatively high pressures that exceed the ambient pressure in a blood vessel or body lumen. However, to contain the coolant, these catheters generally employ thicker balloons, dual-layered balloons, mechanically rigid cooling chambers, and other similar unitary construction containment mechanisms. These techniques however, lack robustness, in that if the unitary balloon, cooling chamber, or other form of containment develops a crack, leak, rupture, or other critical structural integrity failure, coolant may egress from the catheter. To minimize the amount and duration of any such leaks, it is desirable to use a fluid detection system that detects a gas or liquid expulsion or egress from the catheter shaft and signals a control unit to halt the flow of cryogenic fluid.

Furthermore, since many treatment systems and methods are applied in internal body lumens, organs or other unobservable tissue regions, the orientation and attitude of the device structure relative to the tissue is of significant importance in ensuring the effective and efficient treatment of tissue. This applies to many tissue treatment systems, both surgical and non-surgical, using a variety of modalities, including cooling through cryotreatment, heat or electrically induced heating, ultrasound, microwave, and RF, to name a few.

This collection of problems may be resolved in part by developing a specialized transducer suitable for the “body” environment in which it operates. For many physiological events, there is no specialized transducer. The events in question include changes in the natural state of tissue, such as temperature, dielectric or conductivity changes, structural changes to the cells and cell matrix, dimensional changes, or changes in the operation of, or interplay between, tissue regions and/or foreign bodies, such as blood flow in an artery having a treatment device inserted therein.

All of these changes may be correlated to, or affected by, relative changes in the bioelectrical impedance of the tissue region.

It would be desirable to provide an apparatus and method of assessing lesion quality, monitoring and detecting any occurrences of fluid egress, determining blood vessel occlusion, determining tissue composition as well as assessing the quality of the contact between the tip or thermally-transmissive region of a cryogenic device and the tissue to be treated.

The present invention advantageously provides methods and systems for detecting fluid egress, assessing lesion quality, determining tissue composition or structure, and providing tissue contact assessment.

In an exemplary embodiment, a method is provided for detecting fluid egress including the steps of positioning a catheter at a tissue treatment site, where the catheter includes a shaft, which has a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion define at least one fluid pathway between the distal end portion and the proximal end portion, and the shaft has a plurality of electrodes, applying an electrical current between at least two of the plurality of electrodes, measuring impedance voltage between the at least two of the plurality of electrodes and, processing the measured impedance voltage resulting from the applied electrical current to determine if fluid egress is present.

The processing step of the method for detecting fluid egress may include the steps of establishing a normal impedance voltage range, monitoring to determine if the impedance voltage varies outside of the impedance voltage range, and generating a signal if the impedance voltage measurement varies outside of the impedance voltage range. A control unit, a microprocessor, an impedance-measuring device or the like may perform the processing step. In another embodiment of the method, the treatment portion of catheter may include a cooling chamber in fluid communication with the at least one fluid pathway and having the first electrode located near the distal side of the cooling chamber, and the second electrode located near the proximal side of the cooling chamber.

In another exemplary embodiment, a method is provided for accessing lesion quality including the steps of positioning a catheter at a tissue treatment site, where the catheter includes a shaft, which has a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion define at least one fluid pathway therebetween, and the shaft has a treatment portion that includes a first electrode and a second electrode, and measuring a baseline impedance, activating the catheter such that the treatment portion cools the tissue, applying an electrical current between the first and second electrodes, and processing the measured impedance voltage caused by the applied electrical current to determine the amount of treated tissue after each activation of the catheter.

The processing step of the method for accessing lesion quality may be performed by a control unit, a microprocessor, an impedance measuring device or the like. In another embodiment of the method, the treatment portion of catheter may include a cooling chamber in fluid communication with the at least one fluid pathway and having the first electrode located near the distal side of the cooling chamber, and the second electrode located near the proximal side of the cooling chamber.

In still another exemplary embodiment, a method is provided for accessing tissue composition including the steps of positioning a catheter at a tissue treatment site, where the catheter includes a shaft, which has a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion define at least one fluid pathway therebetween, and the shaft has a treatment portion that includes a first electrode and a second electrode, activating the catheter such that the treatment portion cools the tissue, applying an electrical current between the first and second electrodes, measuring a impedance voltage between the first and second electrodes, and processing the measured impedance caused by the applied electrical current, establishing a normal impedance range for a tissue type, monitoring the impedance to determine if the impedance varies into a tissue type impedance range, and generating an impedance signal that can be processed to identify the tissue type impedance range.

The processing step of the method for accessing tissue composition may be performed by a control unit, a microprocessor, an impedance measuring device or the like. In another embodiment of the method, the treatment portion of catheter may include a cooling chamber in fluid communication with the at least one fluid pathway and having the first electrode located near the distal side of the cooling chamber, and the second electrode located near the proximal side of the cooling chamber.

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