Methods and devices for automated biopsy and collection of soft tissue

Abstract

Instruments for performing percutaneous biopsy procedures are disclosed, which have advantageous features for improving functionality and performance over prior art devices. These instruments comprise two types, single-use devices, and multiple-use devices having active tissue capture capability. Improved features include the ability to retrieve and evaluate multiple tissue samples during a single insertion procedure, without physical handling of the samples, as well as constructional features, such as a molded tissue cassette housing, variant vacuum port embodiments suited for different tissue environments, and a method for backflushing the instrument to remove biological debris, among others.

1 - 26 . (canceled)  
     
     
         27 . A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising: 
 a. a disposable elongated probe component comprising 
 i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a drive unit, and  
 ii. an elongated tissue cutting member which is disposed within the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and  
   b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture thereof.    
     
     
         28 . The system of claim  1  wherein the driver component has a third driver motor configured to rotate the tissue cutting member within the tubular section.  
     
     
         29 . The system of claim  2  wherein the third driver motor rotates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.  
     
     
         30 . The system of claim  1  wherein the driver component has a third driver motor configured to oscillate the tissue cutting member within the tubular section.  
     
     
         31 . The system of claim  1  including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member to withdraw tissue therethrough.  
     
     
         32 . The system of  claim 31  wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member configured to receive tissue withdrawn through the tissue cutting member.  
     
     
         33 . The system of  claim 32  wherein the tissue collector is located between the tissue cutting member and the vacuum source.  
     
     
         34 . The system of  claim 27  wherein the first driving motor is configured to rotate the tubular section in discrete steps about the longitudinal axis thereof.  
     
     
         35 . The system of claim  1  wherein the distal extremity of the tubular section of the probe component has a circular transverse cross-section.  
     
     
         36 . The system of claim  1  wherein at least one of the driving motors is electrically powered.  
     
     
         37 . The system of  claim 27  including a control module which has an electrical source and a vacuum source.  
     
     
         38 . The system of  claim 37  wherein the control module controls the rotation of the tubular section.  
     
     
         39 . The system of claim  1  wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.  
     
     
         40 . A method for collecting one or more tissue specimens from a target site within a patient, comprising: 
 a. providing a biopsy device having: 
 i. a disposable elongated probe component comprising 
 an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and  
 an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and  
 
 ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member;  
   b. advancing the probe component at least partially into or adjacent to tissue at the target site;    c. rotating the tubular section about its longitudinal axis to provide a desired aperture orientation;    d. applying a vacuum within the tubular section to draw tissue at the tissue site through the aperture of the tubular section into the interior thereof;    e. advancing the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from the tissue extending into the tubular section; and    f. transporting a cut tissue specimen through the inner lumen of the tissue cutting member.    
     
     
         41 . The method of  claim 40  wherein the longitudinal motion of the tissue cutting member includes rotational or oscillation motion.  
     
     
         42 . The method of  claim 40  wherein the tubular section is rotated about its longitudinal axis in discrete rotational increments.  
     
     
         43 . The method of  claim 42  wherein the discrete rotational increments are about 90 degrees.  
     
     
         44 . A tissue biopsy system for collecting one or more tissue specimens from a targeted site within a patient, comprising: 
 a. a disposable elongated probe component comprising 
 i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and  
 ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein  
   b. a driver component which is configure to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof.    
     
     
         45 . The system of  claim 44  wherein the driver component has a third driver motor configured to rotate the tissue cutting member.  
     
     
         46 . The system of  claim 45  wherein the third driver motor rotates the tissue cutting member as the tissue cutting member moves longitudinally.  
     
     
         47 . The system of  claim 44  wherein the driver component has a third driver motor configured to oscillate the tissue cutting member.  
     
     
         48 . The system of  claim 45  wherein the third driver motor oscillates the tissue cutting member as the tissue cutting member moves longitudinally.  
     
     
         49 . The system of  claim 44  including a vacuum source connected in fluid communication with the inner lumen of the tubular section of the probe component to withdraw tissue therethrough.  
     
     
         50 . A tissue biopsy device for accessing one or more tissue specimens from a target site within a patient, comprising: 
 a. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a distal tip and which has an aperture proximal to the distal tip configured to receive tissue from the target site, and    b. an elongated tissue cutting member which is slidably disposed within the elongated tubular section, which has a distal end with at least one tissue cutting edge, which has an inner lumen extending therein and which is configured for longitudinal movement within the tubular section; and    c. a proximal housing which contains a proximal portion of the elongated tissue cutting member, a driving shuttle secured to the proximal portion of the elongated tissue cutting member and a first drive member engaging the shuttle to move the elongated tissue cutting member and a second drive member secured to a proximal portion of the tubular section within the housing configured to rotate the tubular section about its longitudinal axis.    
     
     
         51 . The system of  claim 27  wherein the third driver motor oscillates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.