Core needle biopsy device for collecting multiple samples in a single insertion

Abstract

A core needle biopsy device including a needle assembly, a cutter drive assembly, a piercer drive assembly and a piercer retraction assembly. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximal to the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch. The cutter drive assembly is configured to selectively fire the cutter. The piercer drive assembly is configured to selectively fire the piercer. The piercer retraction assembly is configured to retract the piercer independently of the cutter while the needle assembly is disposed within a patient to expose the notch of the piercer to an exterior of a patient.

1 .- 20 . (canceled) 
     
     
         21 . A biopsy device, comprising:
 (a) a body;   (b) a needle assembly including a piercer and a cutter, the piercer defining a notch, the cutter being slidably disposed on an exterior of the piercer to sever a tissue sample within the notch of the piercer; and   (c) a drive assembly, including:
 (i) a motor driven needle cocking assembly, the needle cocking assembly including a lead screw having a first threaded portion and a second threaded portion, the first threaded portion being configured to engage a cutter actuation member to compress a cutter spring in communication with the cutter, the second threaded portion being configured to engage a piercer actuation member to compress a piercer spring in communication with the piercer, and 
 (ii) a motor driven release assembly, a portion of the release assembly being movable relative to the piercer actuation member and the cutter actuation member to sequentially release the piercer spring and the cutter spring, thereby firing the piercer and the cutter in a predetermined sequence. 
   
     
     
         22 . The biopsy device of  claim 21 , the release assembly including a first actuator and a second actuator, the release assembly being configured to move the first actuator and the second actuator relative to the piercer actuation member and the cutter actuation member to release the piercer actuation member and the cutter actuation member respectively. 
     
     
         23 . The biopsy device of  claim 22 , the first actuator and the second actuator each including a cylindrical protrusion. 
     
     
         24 . The biopsy device of  claim 21 , the release assembly including a rotatable drive rod, the release assembly being configured to release the piercer spring and the cutter spring in response to rotation of the drive rod. 
     
     
         25 . The biopsy device of  claim 21 , the release assembly including a body, a first latch actuator, a second latch actuator, a first latch member, a second latch member, and a secondary lead screw, the secondary lead screw being configured to drive movement of the body to translate the first latch actuator and the second latch actuator relative to the first latch member and the second latch member, respectively. 
     
     
         26 . The biopsy device of  claim 21 , the needle assembly defining a first axis, the lead screw defining a second axis, the first axis being offset relative to the second axis. 
     
     
         27 . The biopsy device of  claim 21 , the first threaded portion including threads having a first pitch, the second threaded portion including threads having a second pitch, the first pitch being different relative to the second pitch. 
     
     
         28 . The biopsy device of  claim 21 , the drive assembly further including a carriage nut disposed on the lead screw, the carriage nut including a threaded portion, the carriage nut being axially movable with the drive assembly. 
     
     
         29 . The biopsy device of  claim 28 , the piercer drive assembly being axially movable in response to axial movement of the carriage nut. 
     
     
         30 . A biopsy device, comprising:
 (a) a needle assembly, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip, the piercer being slidably disposed within the cutter to sever a tissue sample;   (b) a cutter drive associated with the cutter;   (c) a piercer drive associated with the piercer;   (d) a drive assembly configured to sequentially move both the cutter drive and the piercer drive, the drive assembly including a dual pitch lead screw, the dual pitch lead screw being configured to translate the cutter drive and the piercer drive simultaneously to compress a first spring and a second spring; and   (e) a release assembly, the release assembly including a drive rod being movable relative to a portion of the cutter drive and the piercer drive to sequentially release the first spring and the second spring.   
     
     
         31 . The biopsy device of  claim 30 , the dual pitch lead screw including a first threading defining a first pitch and a second threading defining a second pitch, the first pitch being in an opposite direction of the second pitch. 
     
     
         32 . The biopsy device of  claim 30 , the dual pitch lead screw being further configured to move the piercer drive relative to the cutter drive to retract the piercer relative to the cutter. 
     
     
         33 . The biopsy device of  claim 30 , the piercer defining a notch, the cutter including and end portion defining a tissue collection feature, the dual pitch lead screw being further configured to move the piercer drive relative to the cutter drive to retract the notch of piercer relative to the cutter and into alignment with the tissue collection feature of the end portion. 
     
     
         34 . The biopsy device of  claim 30 , the cutter drive extending laterally from a portion of the cutter, the piercer drive extending laterally from a portion of the piercer drive. 
     
     
         35 . The biopsy device of  claim 30 , the cutter drive extending laterally from a portion of the cutter, the piercer drive extending laterally from a portion of the piercer drive, the dual pitch lead screw being laterally offset relative to a longitudinal axis defined by the piercer. 
     
     
         36 . The biopsy device of  claim 30 , the drive rod of the release assembly including a plurality of threads, the plurality of threads being configured to engage a nut member to drive translation of the nut member. 
     
     
         37 . A biopsy device, comprising:
 (a) a body;   (b) a needle assembly including a piercer and a cutter, the piercer defining a notch, the cutter being slidably disposed on an exterior of the piercer to sever a tissue sample within the notch of the piercer; and   (c) a drive assembly, including:
 (i) a needle cocking assembly in communication with a drive motor, the needle cocking assembly including a lead screw having a first threaded portion and a second threaded portion, the first threaded portion being configured to engage a cutter actuation member to compress a cutter spring in communication with the cutter, the second threaded portion being configured to engage a piercer actuation member to compress a piercer spring in communication with the piercer, and 
 (ii) a release assembly including a drive rod, the drive rod being rotatable relative to the piercer actuation member and the cutter actuation member to sequentially release the piercer spring and the cutter spring, thereby firing the piercer and the cutter in a predetermined sequence. 
   
     
     
         38 . The biopsy device of  claim 37 , the release assembly further including a nut member, the drive rod being configured to drive translation of the nut member relative to the piercer actuation member and the cutter activation member to sequentially release the piercer spring and the cutter spring. 
     
     
         39 . The biopsy device of  claim 37 , the release assembly further including a release motor, the release motor being separate from the drive motor. 
     
     
         40 . The biopsy device of  claim 37 , the drive rod including a cylindrical shaft with one or more engagement portions protruding from the cylindrical shaft, the one or more engagement portions being configured to drive movement of a portion of the needle cocking assembly.