Method and apparatus for the treatment of tissue

Abstract

A method and apparatus is disclosed for determining the success of a proposed HIFU Treatment, of an ongoing HIFU Treatment, and/or of a completed HIFU Treatment. An energy density of a given HIFU Treatment may be used as a comparison factor between the given HIFU Treatment and other HIFU Treatments and as a predictor of the success of the given HIFU Treatment. One exemplary energy density is the amount of energy deposited in the treatment region divided by the volume of the treatment region. Another exemplary energy density is the amount of energy deposited in the treatment region divided by the pre-treatment mass of the treatment region. A method and apparatus is disclosed to detect the presence of focal hyperechoic features and non-focal hyperechoic features. A method and apparatus is disclosed to detect the presence of an acoustic obstruction.

1 . A method of providing treatment to a treatment region of tissue, the method comprising the steps of: 
 planning a proposed HIFU Treatment of the treatment region; and    determining prior to commencement of the proposed HIFU Treatment whether the proposed HIFU Treatment should be successful in treating the tissue of the treatment region.    
     
     
         2 . The method of  claim 1 , wherein the determination of whether the proposed HIFU Treatment should be successful is based at least on an energy density of the energy planned to be deposited into the treatment region.  
     
     
         3 . The method of  claim 1 , wherein the step of determining prior to commencement of the proposed HIFU Treatment whether the proposed HIFU Treatment should be successful in treating the tissue of the treatment region, comprises the steps of: 
 calculating an energy density for the proposed HIFU Treatment;    comparing the calculated energy density to a reference energy density;    indicating that the proposed HIFU Treatment should be successful if the calculated energy density is greater than or equal to the reference energy density; and    presenting the proposed HIFU Treatment to a reviewer for review if it is indicated that the proposed HIFU Treatment should be successful.    
     
     
         4 . The method of  claim 1 , wherein the step of planning the proposed HIFU Treatment of the treatment region comprises the steps of: 
 generating a representation of the tissue;    indicating a location of the treatment region on the representation of the tissue; and    providing a plurality of proposed treatment sites within the treatment region, each of the proposed treatment sites having a proposed amount of energy to be deposited thereto.    
     
     
         5 . The method of  claim 4 , wherein the step of determining prior to commencement of the proposed HIFU Treatment whether the proposed HIFU Treatment should be successful in treating the tissue of the treatment region, comprises the steps of: 
 calculating an energy density for the proposed HIFU Treatment;    comparing the calculated energy density to a reference energy density;    indicating that the proposed HIFU Treatment should be successful if the calculated energy density is greater than or equal to the reference energy density; and    presenting the proposed HIFU Treatment to a reviewer for review if it is indicated that the proposed HIFU Treatment should be successful.    
     
     
         6 . The method of  claim 5 , wherein the representation of the tissue includes a plurality of two-dimensional ultrasound images of the tissue.  
     
     
         7 . The method of  claim 5 , wherein the representation of the tissue includes a three-dimensional model of the tissue.  
     
     
         8 . The method of  claim 5 , wherein the proposed treatment sites are automatically located based on the representation of the tissue.  
     
     
         9 . The method of  claim 8 , further comprising the steps of: 
 modifying the proposed HIFU Treatment if the calculated energy density is less than the reference energy density to produce a modified proposed HIFU Treatment;    calculating an energy density for the modified proposed HIFU Treatment;    comparing the calculated energy density for the modified proposed HIFU Treatment to the reference energy density;    indicating that the modified proposed HIFU Treatment should be successful if the calculated energy density for the modified proposed HIFU Treatment is greater than or equal to the reference energy density; and    presenting the modified proposed HIFU Treatment to a reviewer for review if it is indicated that the modified proposed HIFU Treatment should be successful.    
     
     
         10 . The method of  claim 5 , further comprising the steps of: 
 modifying the proposed HIFU Treatment to exclude at least one of the treatment sites to protect a first portion of the tissue;    calculating an energy density for the modified proposed HIFU Treatment;    comparing the calculated energy density for the modified proposed HIFU Treatment to the reference energy density;    indicating that the modified proposed HIFU Treatment should be successful if the calculated energy density for the modified proposed HIFU Treatment is greater than or equal to the reference energy density.    
     
     
         11 . The method of  claim 10 , wherein the tissue includes the prostate of the patient and the first portion of the tissue includes the neuro-vascular bundle.  
     
     
         12 . The method of  claim 5 , further comprising the steps of: 
 preventing the proposed HIFU Treatment from commencing if the calculated energy density is less than the reference energy density; and    providing an override option whereby the reviewer may request that the proposed HIFU Treatment commence even though the calculated energy density is less than the reference energy density.    
     
     
         13 . The method of  claim 5 , further comprising the steps of: 
 commencing the proposed HIFU Treatment;    calculating an updated energy density based on an amount of energy deposited into the treatment region and an amount of energy planned to be deposited into the treatment region;    preventing the commenced proposed HIFU Treatment from progressing if the calculated updated energy density is less than the reference energy density; and    providing an override option whereby the reviewer may request that the commenced proposed HIFU Treatment progress even though the calculated updated energy density is less than the reference energy density.    
     
     
         14 . The method of  claim 12 , further comprising the step of generating a post treatment image for each treatment site subsequent to the treatment of that treatment site during the HIFU Treatment, wherein the reviewer selects the override option based on the presence of hyperechoic features in at least one post treatment image.  
     
     
         15 . A method of determining the success of a given HIFU Treatment of a given treatment region, the method comprising the steps of: 
 providing a HIFU System to administer the given HIFU Treatment, the HIFU System including a transducer configured to provide a HIFU Therapy to a plurality of treatment sites and a controller configured to control the position and operation of the transducer;    calculating an energy density for the given HIFU Treatment;    comparing the calculated energy density to a reference energy density; and    classifying the given HIFU Treatment as a successful HIFU Treatment based on the calculated energy density being greater than or equal to the reference energy density.    
     
     
         16 . The method of  claim 15 , wherein the treatment region includes at least two treatment sub-portions, each treatment sub-portion including a subset of the plurality of treatment sites.  
     
     
         17 . The method of  claim 15 , wherein the HIFU Treatment is a proposed HIFU Treatment and the step of calculating the energy density for the proposed HIFU Treatment includes the steps of: 
 estimating an amount of energy to be deposited at each of the plurality of treatment sites;    summing the amount of energy to be deposited at each of the plurality of treatment sites; and    dividing the summed amount of energy to be deposited by one of a volume of the treatment region and a mass of the treatment region.    
     
     
         18 . The method of  claim 17 , further comprising the steps of: 
 preventing the HIFU Treatment from commencing if the calculated energy density is less than the reference energy density; and    providing an override option whereby the reviewer may request that the HIFU Treatment commence even though the calculated energy density is less than the reference energy density.    
     
     
         19 . The method of  claim 15 , wherein the HIFU Treatment is a current HIFU Treatment and the step of calculating the energy density for the current HIFU Treatment includes the steps of: 
 estimating an amount of energy deposited at each of the plurality of treatment sites which have received HIFU Therapy;    estimating an amount of energy to be deposited at each of the plurality of treatment sites which have yet to receive HIFU Therapy;    summing the amount of energy deposited at each of the plurality of treatment sites which have received HIFU Therapy and the amount of energy to be deposited at each of the plurality of treatment sites which have yet to receive HIFU Therapy; and    dividing the summed amount of energy by one of a volume of the treatment region and a mass of the treatment region.    
     
     
         20 . The method of  claim 19 , further comprising the step of: 
 preventing the HIFU Treatment from progressing if the calculated energy density is less than the reference energy density; and    providing an override option whereby the reviewer may request that the HIFU Treatment progress even though the calculated energy density is less than the reference energy density.    
     
     
         21 . The method of  claim 15 , wherein the HIFU Treatment is a completed HIFU Treatment and the step of calculating the energy density for the completed HIFU Treatment includes the steps of: 
 estimating an amount of energy deposited at each of the plurality of treatment sites;    summing the amount of energy deposited at each of the plurality of treatment sites; and    dividing the summed amount of energy deposited by one of a volume of the treatment region and a mass of the treatment region.    
     
     
         22 . An apparatus for treating tissue, the apparatus comprising: 
 a transducer which is positionable proximate to the tissue, the transducer being configured to emit ultrasound energy and to sense ultrasound energy;    a positioning member coupled to the transducer and configured to position the transducer; and    a controller operably coupled to the transducer and to the positioning member, the controller being configured to position the transducer with the positioning member and to operate the transducer in an imaging mode wherein images of the tissue are obtained from ultrasound energy sensed by the transducer and in a therapy mode wherein a plurality of treatment sites are treated with a HIFU Therapy with the transducer; the controller being further configured to plan a HIFU Treatment of a treatment region of the tissue to determine prior to commencement of the HIFU Treatment whether the HIFU Treatment should be successful in treating the tissue of the treatment region based on an energy density of the energy planned to be deposited into the treatment region.    
     
     
         23 . The apparatus of  claim 22 , wherein the controller is further configured to monitor the HIFU Treatment as the HIFU Treatment progresses to determine whether the HIFU Treatment should be successful in treating the tissue of the treatment region based on an amount of energy deposited into the treatment region and an amount of energy planned to be deposited in the treatment region.  
     
     
         24 . The apparatus of  claim 22 , further comprising a display operably coupled to the controller, the controller being configured to present the images of the tissue on the display and to provide a visual cue on the display of whether the planned HIFU Treatment should be successful in treating the tissue based on the amount of energy planned to be deposited into the treatment region and the amount of energy deposited in the treatment region.  
     
     
         25 . The apparatus of  claim 22 , wherein the HIFU Treatment should be successful if the energy density is at least equal to a reference energy density.  
     
     
         26 . A computer-readable medium providing instructions for directing a processor to: 
 receive image information from a transducer;    generate at least one image from the received image information;    determine a treatment region based on the received image information;    plan a HIFU Treatment of at least a portion of the treatment region, the HIFU Treatment including a plurality of treatment sites;    calculate an energy density corresponding to the planned HIFU Treatment;    provide an indication of whether the planned HIFU Treatment is likely to be successful based on the energy density; and    control the transducer to conduct the planned HIFU Treatment.    
     
     
         27 . The computer readable medium of  claim 26 , wherein the instructions further direct the processor to prevent the planned HIFU Treatment from commencing if the planned HIFU Treatment is not likely to be successful based on the energy density.  
     
     
         28 . The computer readable medium of  claim 26 , wherein the instructions further direct the processor to monitor the planned HIFU Treatment as the planned HIFU Treatment progresses and to permit a modification to the planned HIFU Treatment.  
     
     
         29 . The computer readable medium of  claim 28 , wherein the instructions further direct the processor to calculate an updated energy density corresponding to the planned HIFU Treatment with the modification and to provide an updated indication of whether the planned HIFU Treatment with the modification is likely to be successful based on the updated energy density.  
     
     
         30 . The computer readable medium of  claim 29 , wherein the instructions further direct the processor to prevent a further progression of the planned HIFU Treatment with the modification if the updated energy density does not indicate that the planned HIFU Treatment with the modifications is likely to be successful.  
     
     
         31 . The computer readable medium of  claim 26 , wherein the planned HIFU Treatment is likely to be successful if the energy density is at least equal to a reference energy density.  
     
     
         32 . The computer readable medium of  claim 26 , wherein the energy density is calculated by the steps of: 
 estimating an amount of energy to be deposited at each of the plurality of treatment sites;    summing the amount of energy to be deposited at each of the plurality of treatment sites; and    dividing the summed amount of energy to be deposited by one of a volume of the treatment region and a mass of the treatment region.    
     
     
         33 . A method of providing treatment to a treatment region of tissue with a HIFU Treatment, the HIFU Treatment including the provision of HIFU Therapy at spaced apart intervals to a plurality of treatment sites within the treatment region, the method comprising the steps of: 
 driving the HIFU Treatment to generate a focal hyperechoic feature for a given treatment site; and    maintaining the HIFU Treatment at a level to maintain the generation of subsequent focal hyperechoic features at subsequent treatment sites.    
     
     
         34 . The method of  claim 33 , further comprising the step of pausing the HIFU Treatment if a non-focal hyperechoic feature is generated.  
     
     
         35 . The method of  claim 34 , further comprising the step of reducing the total acoustic power for subsequent treatment sites of the HIFU Treatment if a non-focal hyperechoic feature is generated which migrates from the respective focal zone.  
     
     
         36 . A method of providing treatment to a treatment region of tissue with a HIFU Treatment, the HIFU Treatment including the provision of HIFU Therapy at spaced apart intervals to a plurality of treatment sites within the treatment region, the method comprising the steps of: 
 distinguishing between a focal hyperechoic feature and a non-focal hyperechoic feature;    continuing the HIFU Treatment upon the observance of the focal hyperechoic feature; and    pausing the HIFU Treatment upon the observance of the non-focal hyperechoic feature.    
     
     
         37 . The method of  claim 36 , wherein the step of distinguishing between a focal hyperechoic feature and a non-focal hyperechoic feature includes the steps of: 
 generating a post-treatment image of a first treatment site;    comparing a region of interest of the treatment region in the post-treatment image to the region of interest of the treatment region in a pre-treatment image;    classifying the region of interest as containing a hyperechoic feature based on the comparison of the region of interest of the treatment region in the post-treatment image and the pre-treatment image; and    comparing a location of the region of interest to a location of the treatment site, wherein the hyperechoic feature is classified as a focal hyperechoic feature if the location of the region of interest generally coincides with the location of the treatment site.    
     
     
         38 . An apparatus for treating tissue, the apparatus comprising: 
 a probe including an acoustic membrane covering at least a portion of the probe and a transducer positioned behind the acoustic membrane, the transducer being configured to emit ultrasound energy and to sense ultrasound energy; and    a controller operably coupled to the transducer, the controller being configured to operate the transducer in an imaging mode wherein at least one image of the tissue is obtained from ultrasound energy sensed by the transducer and in a therapy mode wherein a plurality of treatment sites are treated with a HIFU Therapy with the transducer; the controller being further configured to detect the presence of an acoustic obstruction adjacent the acoustic membrane by detecting a repetitive pattern based on the at least one image of the tissue.    
     
     
         39 . The apparatus of  claim 38 , wherein the controller is further configured to prevent operation of the transducer in therapy mode based on a detection of an acoustic obstruction.  
     
     
         40 . A method of treating tissue in a treatment region, the method comprising the steps of: 
 imaging the treatment region with an ultrasound transducer;    automatically detecting an acoustic obstruction proximate to the ultrasound transducer; and    preventing the commencement of a HIFU Treatment based upon the detection of the acoustic obstruction proximate to the ultrasound transducer.    
     
     
         41 . The method of  claim 40 , wherein the step of detecting the acoustic obstruction comprises the steps of: 
 analyzing a portion of an image for a repetitive pattern, and    determining the presence of the acoustic obstruction based on the presence of the repetitive pattern in the portion of the image.    
     
     
         42 . The method of  claim 41 , wherein the transducer is positioned within a probe behind an acoustic membrane of the probe and wherein the step of analyzing a portion of the image for a repetitive pattern comprises the steps of: 
 analyzing a first portion of the image at about a position corresponding to the acoustic membrane and the tissue to determine if a first intensity characteristic associated with the first portion meets or exceeds a first upper threshold;    analyzing a second portion of the image at about 1.5 times the position corresponding to the acoustic membrane and the tissue to determine if a second intensity characteristic associated with the second portion is below a first lower threshold; and    analyzing a third portion of the image at about twice the position corresponding to the acoustic membrane and the tissue to determine if a third intensity characteristic associated with the third portion meets or exceeds a second upper threshold.    
     
     
         43 . The method of  claim 42 , wherein the position corresponding to the acoustic membrane corresponds to an interface between the tissue and the acoustic membrane of the probe.  
     
     
         44 . A method of treating tissue in a treatment region with a HIFU Treatment, the method comprising the steps of: 
 initiating a HIFU Therapy to treat a portion of the tissue with an ultrasound transducer;    obtaining an image of the treatment region subsequent to attempting to treat the portion of the tissue with HIFU Therapy;    automatically detecting an acoustic obstruction proximate to the ultrasound transducer; and    pausing the HIFU Treatment.    
     
     
         45 . The method of  claim 44 , wherein the step of detecting the acoustic obstruction comprises the steps of: 
 analyzing a portion of an image for a repetitive pattern, and    determining the presence of the acoustic obstruction based on the presence of the repetitive pattern in the portion of the image.    
     
     
         46 . The method of  claim 45 , wherein the transducer is positioned within a probe behind an acoustic membrane of the probe and wherein the step of analyzing a portion of the image for a repetitive pattern comprises the steps of: 
 analyzing a first portion of the image at about a position corresponding to the acoustic membrane and the tissue to determine if a first intensity characteristic associated with the first portion meets or exceeds a first upper threshold;    analyzing a second portion of the image at about 1.5 times the position corresponding to the acoustic membrane and the tissue to determine if a second intensity characteristic associated with the second portion is below a first lower threshold; and    analyzing a third portion of the image at about twice the position corresponding to the acoustic membrane and the tissue to determine if a third intensity characteristic associated with the third portion meets or exceeds a second upper threshold.    
     
     
         47 . The method of  claim 46 , wherein the position corresponding to the acoustic membrane corresponds to an interface between the tissue and the acoustic membrane of the probe.