US2021007796A1PendingUtilityA1

Systems, devices and methods for treating lung tumors

Assignee: ZIDAN MEDICAL INCPriority: Jul 10, 2019Filed: Jul 24, 2019Published: Jan 14, 2021
Est. expiryJul 10, 2039(~12.9 yrs left)· nominal 20-yr term from priority
A61B 18/1492A61B 2018/00982A61B 2018/1472A61B 2018/00541A61B 2218/002A61B 18/1815A61B 2018/00744A61B 2018/00577A61B 2018/00875A61B 2018/00077A61B 34/20A61B 34/10A61B 2018/00791A61B 2018/00285A61B 2018/00648A61B 18/1477A61B 2018/0063A61B 2018/0022A61B 2034/2055
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Claims

Abstract

A system for treatment of a target region of lung tissue including: a flow regulator configured to be interposed between a conductive fluid source and a conductive fluid outlet positionable at or in proximity of the target region of lung tissue, the flow regulator being further configured for controlling a flow rate or a bolus quantity of conductive fluid coming from the fluid source and delivered to the conductive fluid outlet; and a controller communicatively connectable with said flow regulator and with at least one sensor, with the at least one sensor being configured for detecting values taken by at least one control parameter representative of a physical property, wherein the physical property is one of temperature (T), pressure (p), electric impedance (Z), or electric conductivity (C) of material present at or in proximity of the target region of lung tissue.

Claims

exact text as granted — not AI-modified
1 . A system for treatment of a target region of lung tissue, the system comprising:
 a flow regulator configured to be interposed between a conductive fluid source and a conductive fluid outlet positionable at or in proximity of the target region of lung tissue, the flow regulator being further configured to control a flow rate or a bolus quantity of the conductive fluid coming from the fluid source and delivered to the conductive fluid outlet;   a controller configured to control the flow regulator and configured to receive values detected by a sensor, wherein the sensor detects values of a control parameter representative of a physical property which is at least one of: temperature (T), pressure (P), electric impedance (Z), and electric conductivity (C) of material present at or in proximity of the target region of lung tissue;   wherein the controller is configured to:   receive one or more of the values of the control parameter;   control the flow regulator based on the one or more of the values of the control parameter, so that to optimize the overall amount of conductive fluid to levels suitable for treating lung cancer, wherein the control the flow regulator comprises executing a control cycle including:
 controlling the flow regulator in a high delivery mode in which the flow rate of the conductive fluid delivered to the conductive-fluid outlet is no less than a set high flow rate, or the bolus quantity of conductive fluid delivered to the conductive fluid outlet is no less than a set high bolus quantity, and 
 controlling the flow regulator in a low delivery mode in which the flow rate of the conductive fluid delivered to the conductive fluid outlet is no greater than a set low flow rate smaller than the set high flow rate, or the bolus quantity of the conductive fluid delivered to the conductive fluid outlet is no greater than a set low bolus quantity smaller than the set high bolus quantity. 
   
     
     
         2 . The system according to  claim 1 , wherein the set low flow rate is less than half of the set high flow rate, or the set low bolus quantity is less than half of the set high bolus quantity. 
     
     
         3 . The system according to  claim 1 , wherein the set low flow rate is in a range of 0 to 5 ml/min or the set low bolus quantity is in a range of 0 to 10 ml. 
     
     
         4 . The system according to  claim 1 , wherein the set high flow rate is in a range of 2 to 16 ml/min or the set high bolus quantity is in a range of 0.3 to 60 ml. 
     
     
         5 . The system according to  claim 1 , wherein controlling the flow regulator further comprises repeatedly executing said control cycle. 
     
     
         6 . The system according to  claim 1 , wherein the sensor is configured to be positionable at the target region of the lung tissue. 
     
     
         7 . The system according to  claim 1 , further comprising at least one ablation element positionable at the target region of the lung tissue and connectable to an ablation source, and the controller is configured to control the ablation source to deliver ablation energy to the at least one ablation element. 
     
     
         8 . The system according to  claim 7 , wherein the controller is configured control the ablation source to deliver the ablation energy in a range of 20 to 200 Watts. 
     
     
         9 . The system according to  claim 7 , wherein the controller is configured to control the ablation source to deliver the ablation energy for a period of 30 to 1800 seconds. 
     
     
         10 . The system according to  claim 1 , wherein the control cycle includes
 verifying if one or more of the sensed values of the control parameter fall below a set low threshold, and   wherein said controlling the flow regulator to low delivery mode is executed if the one or more sensed values of the control parameter fall below the set low threshold.   
     
     
         11 . The system according to  claim 1 , wherein the control cycle includes verifying if one or more sensed values of the control parameter exceed a set high threshold, and
 wherein said controlling the flow regulator to high delivery mode is executed if the one or more sensed values of the control parameter exceed the set high threshold.   
     
     
         12 . The system according to  claim 1 , wherein the control cycle includes:
 periodically verifying if one or more of the sensed values of the control parameter fall below a set low threshold, and   switching the flow regulator from the high delivery mode to the low delivery mode in response to the one or more sensed values of the control parameter falling below the set low threshold.   
     
     
         13 . The system according to  claim 1 , wherein the control cycle includes:
 periodically verifying if one or more sensed values of the control parameter exceed a set high threshold, and   switching the flow regulator from low delivery mode to high delivery mode when the one or more sensed values of the control parameter exceed the set high threshold.   
     
     
         14 . The system according to  claim 1 , wherein the controller is configured to repeat the control cycle at least twice during a same treatment session. 
     
     
         15 . The system according to  claim 14 , wherein the controller is configured to control the flow regulator in the high delivery mode or in the low delivery mode for a respective time interval, and wherein a duration of said respective time intervals is either predetermined or determined by detection of a triggering event. 
     
     
         16 . The system according to  claim 15 , wherein the controller is configured to determine the duration of respective time interval by detection of the triggering event, wherein the detection of the triggering event comprises one or more of:
 detection that one or more values of the sensed parameter exceeds a set very high threshold,   detection that one or more values of the sensed parameter exceeds said set high threshold, and   detection that one or more values of the sensed parameter falls below a set low threshold.   
     
     
         17 . The system according to  claim 1 , wherein the cycle comprises a sub-routine including:
 a further step of verifying if one or more values of the sensed parameter falls below or above the set low threshold,   in case one or more values of the parameter sensed in the further step of verifying falls below the set low threshold rapidly, within a time interval between 0.1 to 10 seconds, assigning a decreased value to the set high flow rate or to the set high bolus quantity, and   repeating controlling the flow regulator to high delivery mode using the decreased value of the set high flow rate or the decreased value of set high bolus quantity.   
     
     
         18 . The system according to  claim 1 , wherein the step of controlling the flow regulator in the high delivery mode comprises:
 a further step of verifying if one or more values of the parameter sensed falls below or above the set low threshold,   in case one or more values of the parameter sensed in the said further step remains above the set low threshold for a time interval between 1 to 30 seconds, assigning an increased value to the set high flow rate or to the set high bolus quantity, and   repeating controlling the flow regulator to high delivery mode using the increased value of the set high flow rate or the increased value of set high bolus quantity.   
     
     
         19 . The system according to  claim 1 , wherein the controller commands the flow regulator cycles such that to maintain the sensed temperature in an interval between 60° C. to 115° C. 
     
     
         20 . The system according to  claim 1 , wherein the cycle comprises:
 determining occurrence of a safety relevant event if the one or more parameter values are above a set over-high threshold, which is greater than said high threshold;   in response to a determination of a safety relevant condition:   temporarily reduce power supplied to the ablation energy source and/or   control the flow regulator to a very high delivery mode in which the flow rate of conductive fluid delivered to the conductive fluid outlet is at least a set very high flow rate greater than the set high flow rate, or the bolus quantity of the conductive fluid delivered to the conductive fluid outlet at least a very set high bolus quantity greater than the high bolus quantity.

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