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 - 47 . (canceled) 
     
     
         48 . An apparatus configured to provide treatment to a region of tissue, the apparatus comprising:
 a transducer configured to be positioned proximate to the tissue and to administer high intensity focused ultrasound (“HIFU”) therapy to at least a region of the tissue, the transducer being configured to operate in at least an imaging mode and in a therapy mode, in the imaging mode the transducer being configured to provide a visual representation of at least a portion of the tissue, in the therapy mode the transducer being configured to treat a plurality of treatment sites with HIFU therapy; and   a controller operably coupled to the transducer, the controller being configured to operate the transducer in at least the imaging mode and the therapy mode, the controller being configured to determine prior to commencement of a HIFU treatment whether the HIFU treatment should be successful in treating the tissue based on an energy density of energy planned to be deposited into the treatment region.   
     
     
         49 . The apparatus of  claim 48 , wherein the transducer is configured to provide a visual representation of at least a portion of the tissue through an imaging method, the imaging method being selected from the group consisting of ultrasound energy, contrast agents and acoustic-photo detectors. 
     
     
         50 . The apparatus of  claim 48 , wherein the controller is configured to calculate a proposed ultrasound energy density for a proposed HIFU treatment of the tissue, the energy density for the proposed HIFU treatment being calculated by estimating an amount of energy to be deposited at the ultrasound treatment site and dividing the amount of energy to be deposited by one of a volume of the treatment region and a mass of the treatment region. 
     
     
         51 . The apparatus of  claim 50 , wherein the controller is configured to compare ultrasound energy density for the proposed HIFU treatment region to a reference ultrasound density. 
     
     
         52 . The apparatus of  claim 48 , further comprising:
 a positioning member coupled to the transducer and configured to position the transducer, the controller operably coupled to the positioning member.   
     
     
         53 . The apparatus of  claim 48 , wherein the controller is configured to monitor energy deposited by the transducer throughout the HIFU treatment. 
     
     
         54 . The apparatus of  claim 48 , further comprising:
 a display operably coupled to the controller, the controller being configured to present at least one image of the tissue on the display and to provide a visual cue on the display indicating a level of success for the HIFU treatment.   
     
     
         55 . The apparatus of  claim 54 , wherein the HIFU treatment should be successful if the energy density is at least equal to a reference energy density. 
     
     
         56 . An apparatus configured to treat tissue, the apparatus comprising:
 a probe including an acoustic membrane covering at least a portion of the probe and a transducer positioned within the acoustic membrane, the transducer being configured to emit at least 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 and in a therapy mode, wherein in the imaging mode the transducer being configured to sense from ultrasound energy at least one image of the tissue, wherein in the therapy mode the transducer being configured to treat with a high intensity focused ultrasound (“HIFU”) therapy a plurality of treatment sites, the controller being 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.   
     
     
         57 . The apparatus of  claim 56 , wherein the controller is configured to prevent operation of the transducer in the therapy mode based on a detection of an acoustic obstruction. 
     
     
         58 . A system configured to provide treatment to a region of tissue, the system comprising:
 one or more processors; and   one or more memories operatively coupled to the one or more processors and having computer readable instructions stored thereon which, when executed by at least one of the one or more processors, causes the at least one of the one or more processors 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. 
   
     
     
         59 . The system of  claim 58 , wherein the one or more memories further causes the at least one of the one or more processors to:
 prevent the planned HIFU treatment from commencing if the planned HIFU treatment is not likely to be successful based on the energy density.   
     
     
         60 . The system of  claim 59 , wherein the one or more memories further causes the at least one of the one or more processors to:
 monitor the planned HIFU treatment as the planned HIFU treatment progresses to permit a modification to the planned HIFU treatment.   
     
     
         61 . The system of  claim 60 , wherein the one or more memories further causes the at least one of the one or more processors to:
 calculate an updated energy density corresponding to the planned HIFU treatment with the modification; and   provide an updated indication of whether the planned HIFU treatment with the modification is likely to be successful based on the updated energy density.   
     
     
         62 . The system of  claim 61 , wherein the one or more memories further causes the at least one of the one or more processors 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.   
     
     
         63 . The system of  claim 58 , wherein the planned HIFU treatment is likely to be successful if the energy density is at least equal to a reference energy density. 
     
     
         64 . The system of  claim 58 , wherein the energy density is calculated by:
 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.