# US 10,245,009 B2 · Apparatus for safely and accurately excising core tissue samples from palpated nodules or surface lesions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,245,009 B2 - Document ID: US10245009B2 - Status: Granted - Kind: B2 - Application number: 14/756,173 - Filed: 2015-08-11 - Published: 2016-03-03 - Granted: 2019-04-02 - Earliest claimed: 2014-08-26 - Assignees: Stephen Henry Miller; Jonathan Keith Jay - Applicants: Stephen Henry Miller; Jonathan Keith Jay - Inventors: Stephen Henry Miller; Jonathan Keith Jay - Web page: https://patentgrep.com/patent/US10245009B2 ## CPC - A61B 10/0241: {for prostate} - A61B 10/0233: {Pointed or sharp biopsy instruments} - A61B 2010/0208: {Biopsy devices with actuators, e.g. with triggered spring mechanisms} - A61B 2017/3405: {using mechanical guide means} - A61B 2090/034: {abutting on parts of the device itself} - A61B 2090/036: {abutting on tissue or skin} - A61B 2090/0801: {Prevention of accidental cutting or pricking} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Apparatus for safely and accurately positioning the fingertip of a physician (or technician) performing a biopsy procedure, e.g., to excise a core tissue samples of the male prostate or other internal organs, to avoid injury (e.g., a needle stick) from the sharpened distal end of a biopsy needle assembly. Such apparatus comprises an open tubular member defining an elongated passageway through which a biopsy needle assembly, when actuated, can be made to pass and to extend a predetermined distance along an external path in order to effect the core sampling of a biological mass of interest. The tubular housing supports a safety flange at its distal end, such flange having a flat surface adapted to be engaged by the fingertip of the physician prior to actuation of the biopsy needle assembly. Preferably, the engaged surface of the safety flange defines a physical fiducial adapted to be sensed by the user's fingertip, such fiducial being located a predetermined safe distance from the external path traveled by the needle assembly, whereby the physician is assured that his or her fingertip is safely spaced from the needle assembly when actuated, and the distal end of the tubular housing is precisely positioned relative to a biological mass of interest. ## Claims ### Claim 1 An apparatus for biopsying a biological mass that has been palpated by the fingertip of a user, said apparatus comprising; a housing (2) defining a housing passageway (2A) and extending along a central axis (A) between a proximal end (2B) and a distal end (2C), a cannula (20) defining a cannula passageway and being slidably disposed in said housing passageway (2A), a stylet (10) defining a slot for being slidably disposed in said cannula passageway of said cannula (20) and for sliding outwardly from said distal end (2C) of said housing (2) into the biological mass with a segment of the biological mass expanding into said slot and said slot containing a biopsy of the biological mass when said cannula (20) is slid through said housing passageway (2A) outwardly from said distal end (2C) of said housing (2) to cut the segment of the biological mass, a first flange (4A) extending from said distal end (2C) of said housing (2) at a first acute angle for protecting the fingertip when sliding each of said cannula (20) and said stylet (10) through said housing passageway (2A) outwardly from the distal end (2C) of the housing (2) and retracting back into the housing passageway (2A) with the biopsy of the biological mass being disposed in said slot, characterized by, a distal fiducial (6) protruding upwardly from said first flange (4A) for merely touching by the fingertip of the human to precisely position the fingertip on the biological mass without moving the flange and indicate to the human it is safe to cut the biopsy of the biological mass, a second flange (4B) extending from said proximal end (2B) of said housing (2) at a second acute angle for guiding said cannula (20) and said stylet (10) into said housing passageway (2A), and a proximal fiducial (6) protruding downwardly from said second flange (4B) for detection by the fingertip. ### Claim 2 (depends on 1) An apparatus as set forth in claim 1 wherein said first flange (4A) is arcuate in shape and has a width (y) of between one-eighth an inch (⅛″) and three-eighths an inch (⅜″). ### Claim 3 (depends on 1) An apparatus as set forth in claim 1 wherein said second flange (4B) is arcuate in shape and has a width (y) of between one-eighth an inch (⅛″) and three-eighths an inch (⅜″). ### Claim 4 (depends on 1) An apparatus as set forth in claim 1 wherein said first acute angle is between about 10° and about 30°. ### Claim 5 (depends on 1) An apparatus as set forth in claim 1 wherein said second acute angle is between about 10° and about 30°. ### Claim 6 An apparatus for biopsying a biological mass that has been palpated by the fingertip of a user, said apparatus comprising; a housing (2) defining a housing passageway (2A) and extending along a central axis (A) between a proximal end (2B) and a distal end (2C), a cannula (20) defining a cannula passageway and being slidably disposed in said housing passageway (2A), a stylet (10) defining a slot for being slidably disposed in said cannula passageway of said cannula (20) and for sliding outwardly from said distal end (2C) of said housing (2) into the biological mass with a segment of the biological mass expanding into said slot and said slot containing a biopsy of the biological mass when said cannula (20) is slid through said housing passageway (2A) outwardly from said distal end (2C) of said housing (2) to cut the segment of the biological mass, a first flange (4A) extending from said distal end (2C) of said housing (2) at a first acute angle for protecting the fingertip when sliding each of said cannula (20) and said stylet (10) through said housing passageway (2A) outwardly from the distal end (2C) of the housing (2) and retracting back into the housing passageway (2A) with the biopsy of the biological mass being disposed in said slot, characterized by, a distal fiducial (6) protruding upwardly from said first flange (4A) for merely touching by the fingertip of the human to precisely position the fingertip on the biological mass without moving the flange and indicate to the human it is safe to cut the biopsy of the biological mass, a second flange (4B) extending from said proximal end (2B) of said housing (2) at a second acute angle for guiding said cannula (20) and said stylet (10) into said housing passageway (2A), and said first acute angle being different from said second acute angle. ### Claim 7 (depends on 6) An apparatus as set forth in claim 6 wherein said first acute angle is of about 15° and said second acute angle is of about 25°. ### Claim 8 (depends on 6) An apparatus as set forth in claim 6 wherein said first acute angle is of about 25° and said second acute angle is of about 15°. ### Claim 9 An apparatus for biopsying a biological mass that has been palpated by the fingertip of a user, said apparatus comprising; a housing (2) of a cylindrical shape defining a housing passageway (2A) and extending along a central axis (A) between a proximal end (2B) and a distal end (2C), a cannula (20) of a cylindrical shape extending between ends and defining a cannula passageway and being slidably disposed in said housing passageway (2A), said cannula (20) including a sharpened end having a crescent shape as viewed in cross section to define a point and curving from said point to define said sharpened end, said distal end (2C) of said housing (2) being at an acute angle to said central axis (A) for disposing said sharpened end of said cannula (20) generally parallel to said distal end (20) of said housing (2), a stylet (10) of a cylindrical shape having a pointed end and defining a slot of a rectangular shape spaced from said pointed end for being slidably disposed in said cannula passageway of said cannula (20) and for sliding outwardly from said distal end (2C) of said housing (2) with said pointed end puncturing into the biological mass with a segment of the biological mass expanding into said slot and said slot containing a biopsy of the biological mass when said cannula (20) is slid through said housing passageway (2A) outwardly from said distal end (2C) of said housing (2) to cut the segment of the biological mass, and a first flange (4A) extending outwardly and upwardly from said distal end (2C) of said housing (2) at a first acute angle for protecting the fingertip when sliding each of said cannula (20) and said stylet (10) through said housing passageway (2A) outwardly from said distal end (2C) of said housing (2) and retracting back into said housing passageway (2A) with the biopsy of the biological mass, a second flange (4B) extending outwardly and downward from said proximal end (2B) of said housing (2) at a second acute angle for guiding said cannula (20) and said stylet (10) into said housing passageway (2A), characterized by, a distal fiducial (6) of a spherical shape protruding upwardly from said first flange (4A) for touching by the fingertip of the human to precisely position the fingertip on the biological mass and indicate to the human it is safe to cut the biopsy of the biological mass, a proximal fiducial (6) of a spherical shape protruding downwardly from said second flange (4B) for touching by the fingertip of the human to precisely position the fingertip on the biological mass and indicate to the human it is safe to cut the biopsy of the biological mass, said flanges (4A, 4B) being arcuate in shape and having a width (y) of between one-eighth (⅛″) and three-eighths (⅜″), said first acute angle being different from said second acute angle, and each of said angles being between about 10° and about 30°.