Handheld volumetric ultrasound scanning device

Abstract

An apparatus and related methods for ultrasonically scanning a tissue volume are described, the apparatus being particularly advantageous in the context of freehand ultrasound assisted biopsy of the breast although readily applied to non-biopsy contexts and other body parts. The apparatus comprises a casing configured and dimensioned for single-handed manipulation relative to a surface of the tissue, and a texturably couplant-porous material sheet extending across an opening of the casing. The texturably couplant-porous material sheet has an outer side and an inner side relative to the casing, the outer side for compressively contacting the tissue surface. The apparatus further comprises an ultrasound transducer positioned against the inner side of the texturably couplant-porous material sheet and being mechanically translatable thereacross for volumetrically scanning the tissue volume therethrough.

1 . An apparatus for ultrasonically scanning a tissue volume having a tissue surface, comprising:
 a casing configured and dimensioned for single-handed manipulation relative to the tissue surface;   a texturably couplant-porous material sheet extending across an opening of said casing and having an outer side and an inner side relative thereto, the outer side for compressively contacting the tissue surface; and   an ultrasound transducer positioned against the inner side of the texturably couplant-porous material sheet and being mechanically translatable thereacross for volumetrically scanning the tissue volume therethrough.   
     
     
         2 . The apparatus of  claim 1 , wherein said texturably couplant-porous material sheet comprises a taut fabric sheet. 
     
     
         3 . The apparatus of  claim 2 , wherein said taut fabric sheet is substantially inelastic and comprises a material selected from the group consisting of: polyester organza materials, polyester chiffon fabrics, and cloth fabrics. 
     
     
         4 . The apparatus of  claim 1 , wherein said texturably couplant-porous material sheet comprises at least one of a taut fabric sheet and a vented membrane. 
     
     
         5 . The apparatus of  claim 1 , wherein said texturably couplant-porous material sheet extends convexly outward with respect an inside of the casing, and wherein said ultrasound transducer is mechanically translatable in at least one direction along said outwardly convex texturably couplant-porous material sheet. 
     
     
         6 . The apparatus of  claim 1 , wherein said texturably couplant-porous material sheet extends concavely inward with respect an inside of the casing, and wherein said ultrasound transducer is mechanically translatable in at least one direction along said inwardly concave texturably couplant-porous material sheet. 
     
     
         7 . The apparatus of  claim 1 , wherein said casing comprises:
 a housing member to which said ultrasound transducer is moveably attached; and   a frame mateably connected to said housing member, said frame establishing the opening across which said texturably couplant-porous material sheet is extended;   wherein said texturably couplant-porous material sheet is affixed to said frame, and wherein said frame is manually removable from said housing member, whereby said frame and texturably couplant-porous material sheet form a disposable unit than can be removed and replaced between patients.   
     
     
         8 . The apparatus of  claim 7 , further comprising a transducer actuation assembly coupled to said ultrasound transducer and configured such that said ultrasound transducer is mechanically translatable in a swept, oscillatory manner across said texturably couplant-porous material sheet at a rate of 0.5 Hz-30 Hz. 
     
     
         9 . The apparatus of  claim 8 , further comprising:
 a control processor for controlling said actuation assembly such that said ultrasound transducer is oscillatorily swept at a first rate between a first pair of endpoints to scan a first volume within said tissue volume;   a first processor for processing ultrasound scan data from the ultrasound transducer to generate a volumetric representation of said first volume;   a display unit for displaying image information derived from said volumetric representation of said first volume; and   a second processor configured to determine a second pair of endpoints spaced closer together than said first pair of endpoints and corresponding to a lesion-containing subvolume of said first volume;   wherein said control processor is configured, upon said determination by said second processor, to control said actuation assembly such that said ultrasound transducer is oscillatorily swept at a second rate between said second pair of endpoints to scan said lesion-containing subvolume, wherein said second rate is higher than said first rate.   
     
     
         10 . The apparatus of  claim 9 , wherein said determining the second pair of endpoints comprises one of (i) receiving a user input indicative of said second pair of endpoints based on the displayed image information, and (ii) automatically segmenting a lesion from said volumetric representation of said first volume and establishing said second pair of endpoints based on said segmentation. 
     
     
         11 . The apparatus of  claim 10 , wherein said first pair of endpoints are spaced apart by a first distance in the range of 3 cm-9 cm, and wherein said second pair of endpoints are spaced apart by a second distance in the range of 0.5 cm-1 cm. 
     
     
         12 . The apparatus of  claim 1 , further comprising a display screen for displaying image information derived from said volumetric scans, wherein said display screen is attached to said casing and positioned thereon to be viewable by a user performing said single-handed manipulation. 
     
     
         13 . The apparatus of  claim 1 , said casing having a lower end near said opening, an upper end, and a neck region between said lower and upper ends, wherein said neck region is narrowably contoured relative to said lower and upper ends and dimensioned such that said casing is grippable at said neck region between one of (i) a thumb and a finger of a hand of a user, and (ii) two fingers of the hand of the user. 
     
     
         14 . The apparatus of  claim 13 , further comprising a first display screen for displaying first image information derived from said volumetric scans, wherein said first display screen is integral with said casing near said upper end and positioned to be viewable by the user performing said single-handed manipulation. 
     
     
         15 . The apparatus of  claim 14 , said casing further comprising a clamshell-style lid coupled thereto near said first display screen, said lid covering said first display screen in a closed position and not covering said first display screen in an open position, said apparatus further comprising a second display screen integral with an inner side of said lid, said second display screen being adjacently viewable with said first display screen when said lid is in said open position and displaying second image information derived from said volumetric scans. 
     
     
         16 . The apparatus of  claim 15 , wherein said first image information corresponds to a first plane within said tissue volume generally parallel to said texturably couplant-porous material sheet, and wherein said second image information corresponds to a second plane within said tissue volume generally perpendicular to said texturably couplant-porous material sheet. 
     
     
         17 . The apparatus of  claim 15 , further comprising a third display screen integral with an upper side of said lid and displaying third image information derived from said volumetric scans when said lid is in said closed position. 
     
     
         18 . A method for performing a medical procedure in which a generally elongate freehand percutaneous medical instrument is manipulated toward a target lesion in a tissue volume, comprising:
 manually maintaining a handheld ultrasound probe in compressive contact with a surface of the tissue volume, the handheld ultrasound probe comprising a texturably couplant-porous material sheet having a first side compressively contacting said surface and a second side opposite the first side, the handheld ultrasound probe further comprising an ultrasound transducer repetitively translated across the second side of the texturably couplant-porous material sheet to acquire volumetric ultrasound scans of the tissue volume therethrough;   viewing ultrasound images of said target lesion and at least a portion of the freehand percutaneous medical instrument on an ultrasound display that is updated in real time with said acquisition of said volumetric ultrasound scans; and   guiding said freehand percutaneous medical instrument toward said lesion based at least in part on the viewed ultrasound images.   
     
     
         19 . The method of  claim 18 , wherein said freehand percutaneous medical instrument is selected from the group consisting of: a freehand biopsy instrument, and a freehand brachytherapy applicator device. 
     
     
         20 . The method of  claim 18 , wherein said texturably couplant-porous material sheet comprises a taut fabric sheet that is substantially inelastic and comprises a material selected from the group consisting of: polyester organza materials, polyester chiffon fabrics, and cloth fabrics. 
     
     
         21 . The method of  claim 18 , wherein said texturably couplant-porous material sheet comprises at least one of a taut fabric sheet and a vented membrane. 
     
     
         22 . The method of  claim 18 , said handheld ultrasound probe comprising a casing having a lower end near said texturably couplant-porous material sheet, an upper end, and a neck region between said lower and upper ends, said neck region being narrowably contoured relative to said lower and upper ends, wherein said manually maintaining comprises gripping said neck region of said casing between one of (i) a thumb and a finger of a hand, and (ii) two fingers of the hand. 
     
     
         23 . The method of  claim 22 , wherein said ultrasound display comprises a first display screen that is integral with said casing near said upper end. 
     
     
         24 . The method of  claim 23 , said ultrasound display further comprising a second display screen flippably attached to said casing and having an open position in which said second display screen is viewably adjacent to said first display screen, wherein said viewing ultrasound images comprises (i) viewing a first ultrasound image on said first display screen corresponding to a first plane within said tissue volume, and (ii) viewing a second ultrasound image on said second display screen corresponding to a second plane within said tissue volume generally perpendicular to said first plane. 
     
     
         25 . A handheld volumetric ultrasound probe, comprising:
 a casing configured and dimensioned for single-handed manipulation within which is disposed a mechanically oscillated ultrasound transducer; and   a texturably couplant-porous material sheet extending across an opening of said casing for compressively contacting a tissue surface, said ultrasound transducer being mechanically oscillated across said texturably couplant-porous material sheet to volumetrically scan the tissue therethrough.   
     
     
         26 . The ultrasound probe of  claim 25 , wherein said texturably couplant-porous material sheet comprises a taut fabric sheet. 
     
     
         27 . The ultrasound probe of  claim 26 , wherein said taut fabric sheet is substantially inelastic and comprises a material selected from the group consisting of: polyester organza materials, polyester chiffon fabrics, and cloth fabrics. 
     
     
         28 . The ultrasound probe of  claim 25 , wherein said texturably couplant-porous material sheet comprises at least one of a taut fabric sheet and a vented membrane. 
     
     
         29 . The ultrasound probe of  claim 25 , said casing having a lower end near said opening, an upper end, and a neck region between said lower and upper ends, wherein said neck region is narrowably contoured relative to said lower and upper ends and dimensioned such that said casing is grippable at said neck region between one of (i) a thumb and a finger of a hand of a user, and (ii) two fingers of the hand of the user. 
     
     
         30 . The ultrasound probe of  claim 29 , further comprising a first display screen for displaying first image information derived from said volumetric scans, wherein said first display screen is integral with said casing near said upper end and positioned to be viewable by the user performing said single-handed manipulation. 
     
     
         31 . The ultrasound probe of  claim 30 , said casing further comprising a clamshell-style lid coupled thereto near said first display screen, said lid covering said first display screen in a closed position and not covering said first display screen in an open position, said apparatus further comprising a second display screen integral with an inner side of said lid for displaying second image information derived from said volumetric scans, said second display screen being adjacently viewable with said first display screen when said lid is in said open position. 
     
     
         32 - 38 . (canceled)