Patent Abstract:
A biopsy device comprises a probe body, a cannula extending distally from the probe body, a cutter moveable relative to the cannula to sever tissue, and a tissue sample holder coupled with the probe body. The tissue sample holder comprises a rotatable member having a plurality of recesses to receive tissue samples. The rotatable member can be operable to successively index each recess relative to a lumen defined by the cutter. A cover portion may be associated with the rotatable member and permits one or more recesses to be viewable through the cover. The recesses may be configured to carry one or more tissue samples as the rotatable member is rotated.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of co-pending and commonly-owned U.S. patent application Ser. No. 12/686,433, entitled “BIOPSY DEVICE WITH ROTATABLE TISSUE SAMPLE HOLDER,” filed Jan. 13, 2010, which is a continuation of U.S. Pat. No. 7,854,707, entitled “TISSUE SAMPLE REVOLVER DRUM BIOPSY DEVICE,” issued Dec. 21, 2010, the disclosures of which are hereby incorporated by reference in their entirety. 
     U.S. Pat. No. 7,854,707 is a continuation-in-part of commonly-owned U.S. Pat. No. 7,867,173, entitled “BIOPSY DEVICE WITH REPLACEABLE PROBE AND INCORPORATING VIBRATION INSERTION ASSIST AND STATIC VACUUM SOURCE SAMPLE STACKING RETRIEVAL,” issued Jan. 11, 2011, the disclosure of which is hereby incorporated by reference in its entirety. 
     U.S. Pat. No. 7,854,707 also claims priority to U.S. Pat. Appln. Ser. No. 60/874,792, entitled “BIOPSY SAMPLE STORAGE” to Hibner et al., filed Dec. 13, 2006, the disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates in general to biopsy devices, and more particularly to biopsy devices having a cutter for severing tissue, and even more particularly to biopsy devices for multiple sampling with a probe remaining inserted. 
     BACKGROUND OF THE INVENTION 
     When a suspicious tissue mass is discovered in a patient&#39;s breast through examination, ultrasound, MRI, X-ray imaging or the like, it is often necessary to perform a biopsy procedure to remove one or more samples of that tissue in order to determine whether the mass contains cancerous cells. A biopsy may be performed using an open or percutaneous method. 
     An open biopsy is performed by making a large incision in the breast and removing either the entire mass, called an excisional biopsy, or a substantial portion of it, known as an incisional biopsy. An open biopsy is a surgical procedure that is usually done as an outpatient procedure in a hospital or a surgical center, involving both high cost and a high level of trauma to the patient. Open biopsy carries a relatively higher risk of infection and bleeding than does percutaneous biopsy, and the disfigurement that sometimes results from an open biopsy may make it difficult to read future mammograms. Further, the aesthetic considerations of the patient make open biopsy even less appealing due to the risk of disfigurement. Given that a high percentage of biopsies show that the suspicious tissue mass is not cancerous, the downsides of the open biopsy procedure render this method inappropriate in many cases. 
     Percutaneous biopsy, to the contrary, is much less invasive than open biopsy. Percutaneous biopsy may be performed using fine needle aspiration (FNA) or core needle biopsy. In FNA, a very thin needle is used to withdraw fluid and cells from the suspicious tissue mass. This method has an advantage in that it is very low-pain, so low-pain that local anesthetic is not always used because the application of it may be more painful than the FNA itself. However, a shortcoming of FNA is that only a small number of cells are obtained through the procedure, rendering it relatively less useful in analyzing the suspicious tissue and making an assessment of the progression of the cancer less simple if the sample is found to be malignant. 
     During a core needle biopsy, a small tissue sample is removed allowing for a pathological assessment of the tissue, including an assessment of the progression of any cancerous cells that are found. The following patent documents disclose various core biopsy devices and are incorporated herein by reference in their entirety: U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US Patent Application 2003/0199753 published Oct. 23, 2003 to Hibner et al. 
     At present, a biopsy instrument marketed under the trade name MAMMOTOME is commercially available from DEVICOR MEDICAL PRODUCTS, INC. for use in obtaining breast biopsy samples. This device generally retrieves multiple core biopsy samples from one insertion into breast tissue with vacuum assistance. In particular, a cutter tube is extended into a probe to cut tissue prolapsed into a side aperture under vacuum assistance and then the cutter tube is fully retracted between cuts to extract the sample. 
     With a long probe, the rate of sample taking is limited not only by the time required to rotate or reposition the probe but also by the time needed to translate the cutter. As an alternative to this “long stroke” biopsy device, a “short stroke” biopsy device is described in the following commonly assigned patents and patent applications: U.S. Pat. No. 7,419,472, entitled “Biopsy Instrument with Internal Specimen Collection Mechanism,” issued Sep. 2, 2008 in the name of Hibner et al.; and U.S. Pat. No. 7,740,597, entitled “Biopsy Device with Sample Tube,” issued Jun. 22, 2010 in the name of Cicenas et al. The cutter is cycled across the side aperture, reducing the sample time. Several alternative specimen collection mechanisms are described that draw samples through the cutter tube, all of which allow for taking multiple samples without removing the probe from the breast. 
     In particular, in the cross referenced U.S. Pat. Pub. No. 2006/0074345, entitled “BIOPSY APPARATUS AND METHOD”, these tissue samples are drawn by vacuum proximally through the cutter tube into a serial tissue stacking assembly that preserves the order of sample taking, can be visually observed through a transparent lumen, and can serve as a transport container for samples taken during a pathology examination. 
     While these known tissue storage approaches have a number of advantages, it is believed that further improvements may be made in tissue storage and transport for core biopsy procedures. 
     SUMMARY OF THE INVENTION 
     The present invention addresses these and other problems of the prior art by providing a biopsy device that has a probe cannula that is inserted into tissue to obtain a core biopsy sample by translating a cutter with the probe cannula. A pneumatic pressure differential is used to draw a severed tissue sample proximally from the probe cannula into an individual sample container. Thereafter, another empty sample container is moved into position to accept the next tissue sample. 
     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed the same will be better understood by reference to the following description, taken in conjunction with the accompanying drawings in which: 
         FIG. 1  is an isometric view of a biopsy device with an attached sample revolver drum assembly consistent with the present invention. 
         FIG. 2  is an isometric view of the biopsy device of  FIG. 1  with a disposable probe assembly that includes the sample revolver drum assembly disengaged from a reusable handpiece that has a lower tray removed to expose a carriage frame assembly and a motor drive assembly. 
         FIG. 3  is an isometric view of the reusable handpiece of  FIG. 1  with a top cover detached with a left half cut away and with the lower handle tray detached to expose the motor drive assembly operatively engaged to the carriage frame assembly. 
         FIG. 4  is an isometric view of the motor drive assembly removed from the carriage frame assembly of  FIG. 3 . 
         FIG. 5  is a bottom isometric view of the top cover of the reusable handpiece of  FIG. 2 . 
         FIG. 6  is a top, left and aft isometric view of the carriage frame assembly of  FIG. 4 . 
         FIG. 7  is a top, left and forward view of the carriage frame assembly of  FIG. 4  with an upper frame disassembled. 
         FIG. 8  is a top, left and front isometric view of the carriage frame assembly of  FIG. 4  with the upper frame removed. 
         FIG. 9  is a bottom isometric view of the carriage frame assembly of  FIG. 8  with the upper frame removed. 
         FIG. 10  is a top, left and front isometric exploded view of the carriage frame assembly of  FIG. 4 . 
         FIG. 11  is a right front view of a transmission section of the motor drive assembly of  FIG. 4  with a distal bulkhead removed. 
         FIG. 12  is a front left exploded view of the transmission section of the motor drive assembly of  FIG. 4 . 
         FIG. 13  is a left front isometric view of the disposable probe assembly of  FIG. 1  with a hand-held distal portion partially disassembled from the sample revolver drum assembly. 
         FIG. 14  is an isometric view from below and to the left of the hand-held distal portion of the disposable probe assembly of  FIG. 13  with cover components omitted. 
         FIG. 15  is an isometric view of an exploded portion of the disposable probe assembly. 
         FIG. 16  is an isometric view of the sample revolver drum assembly of  FIG. 1 . 
         FIG. 17  is an exploded view of the sample revolver drum assembly of  FIG. 16 . 
         FIG. 18  is an isometric detail view of an indexer gear cover of the sample revolver drum assembly of  FIG. 16 . 
         FIG. 19A  is a left side diagrammatic view of a left cyclic arm shown in phantom down for engagement during a proximal stroke engaged to the indexer gear cover of  FIG. 18 . 
         FIG. 19B  is a left side diagrammatic view of the left cyclic arm shown in phantom at a proximal most position on the indexer gear cover of  FIG. 18 . 
         FIG. 19C  is a left side diagrammatic view of the left cyclic arm shown in phantom during a return distal stroke rotated upward for disengagement. 
         FIG. 20  is an isometric view of a revolver cylindrical drum assembly of the sample revolver drum assembly of  FIG. 16 . 
         FIG. 21  is an isometric view of the revolver cylindrical drum of the revolver cylindrical drum assembly of  FIG. 20 . 
         FIG. 22  is an isometric view of a revolver drum belt with a couple of removed sample vials of the revolver cylindrical drum assembly of  FIG. 20 . 
         FIG. 23  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with both carriages advanced for closing a side aperture in a probe cannula for insertion into tissue. 
         FIG. 24  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with an aft carriage retracted to vent the probe cannula to the atmosphere to begin a new sample taking cycle. 
         FIG. 25  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with a front carriage beginning to retract, opening the side aperture and beginning to switch to supplying vacuum to the probe cannula. 
         FIG. 26  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with both carriages retracted supplying vacuum pressure to the side aperture to prolapse tissue into the probe cannula. 
         FIG. 27  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with the front carriage being distally advanced to sever tissue. 
         FIG. 28  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with the front carriage fully distally translated to complete severing of a tissue sample with atmosphere pressure supplied to the side aperture through a lateral lumen. 
         FIG. 29  is a diagrammatic view of the hand-held distal portion of the disposable probe assembly of  FIG. 1  with the aft carriage distally advanced to retract the tissue sample with vacuum pressure. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Turning to the Drawings, wherein like numerals denote like components throughout the several views, in  FIGS. 1-2 , a biopsy device  10  includes a reusable handpiece  12 , and a disposable probe assembly  14 . A lower handle tray  16  is disassembled from upper portions of the reusable handpiece  12  to expose portions that operably engage the disposable probe assembly  14 . A sample revolver drum assembly  18  is prepared to receive the next tissue sample by an indexing assembly  19  attached to a hand-held distal portion  21  of the disposable probe assembly  14  that mounts to and is actuated by the reusable handpiece  12 . Tissue that is drawn by vacuum assistance into a side aperture  20  of a probe cannula  22  of the disposable probe assembly  14  is severed by a DC motor  24  ( FIG. 3 ) in the reusable handpiece  12  that also powers rotation and staging of the sample revolver drum assembly  18  to segregate and store the tissue samples in the order received. 
     With particular reference to  FIG. 1 , insertion of the probe cannula  22  into tissue is integrally supported by a piercing tip  26  attached at a distal end as well as a longitudinal jack hammer motion to the probe cannula  22  selected by positioning a slide button  28  distally and depressing a forward motor button  30 . In response, the DC motor  24  drives a transmission section  31  ( FIG. 2 ) grounded to a top cover  34  of the reusable handpiece  12  to longitudinally reciprocate an internal carriage frame assembly  32  ( FIG. 2 ) that is engaged for movement with the probe cannula  22  ( FIG. 3 ). With the slide button  28  proximally positioned, depression of the forward motor button  30  causes the DC motor  24  to advance and rotate a cutter tube  36 , depicted in  FIG. 1  as having been fully distally translated, closing the side aperture  20 . Depression of a reverse motor button  38  causes the cutter tube  36  to retract. Depression of a mode button  40  may cause other functions to be performed. An external conduit  42  extends from the disposable probe assembly  14  and is terminated by a filter/tube fitting  43 . Vacuum assistance passes through a lateral lumen  44  of the probe cannula  22  and distally communicates via internal vent holes  47  ( FIG. 23 ) and then enters a cutter lumen  46  that encompasses the cutter tube  36  and includes the side aperture  20 . An additional feature contemplated but not depicted includes using the mode button  40  to selectively communicate a saline supply to lateral lumen  44  to flush the probe cannula. It should be appreciated that the biopsy device  10  includes a minimum of “tethers” that would impede use, pose a tripping hazard, or extend set-up time. 
     Alternatively, instead of “hard-walled” lateral lumen  44  separated from the cutter lumen  46  along its length, applications consistent with the present invention may have a cylindrical probe cannula wherein the cutter tube  36  is positioned off-center to translate across a side aperture. A “soft-walled” lateral lumen may then be defined as a space between an outer diameter of the cutter tube and an inner diameter of the cylindrical probe cannula. 
     In  FIG. 2 , the disposable probe assembly  14  has a bottom cover  48  with a distal probe mount cover  50  that assists in supporting the probe cannula  22  while allowing the longitudinal jack hammer motion. A plurality of locking tabs  52  with locking edges  54  extend upwardly through pass-through slots  56  formed in the periphery of the lower handle tray  16  to resiliently extend outwardly into engaging contact with the slots  56 . Relieved areas  58  are formed behind each locking tab  52  in a top extension member  59  that surrounds a probe support body  60 . The combination covers a cavity defined by the bottom cover  48 , which allows depression of the locking tabs  52  to unlock the disposable probe assembly  14  to install another identical or similar assembly. 
     A proximal end of the cutter tube  36  receives a cutter gear  62  having distal and proximal reduced diameter bearing surfaces  64 ,  66  on each longitudinal side of a rotation spur gear section  68 , which engage the reusable handpiece  12  for rotation and for longitudinal translation through a distally open longitudinal aperture  70  formed in the lower handle tray  16 . 
     Reusable Handpiece. 
     In  FIGS. 3-13 , the reusable handpiece  12  is depicted in various states of disassembly to illustrate its operation. The transmission section  31  is part of a rigidly mounted motor drive assembly  76  that includes the motor  24  in between a planetary gearbox  78  and an encoder  80 . The battery or other power source and control circuitry are omitted in the depictions. The motor drive assembly also includes a right guide pin  82  and a left guide pin  84 . The motor drive assembly  76  is shown operably engaged to the longitudinally reciprocating carriage frame assembly  32  in  FIG. 3  and is disassembled from the longitudinally reciprocating carriage frame assembly in  FIG. 4 . In  FIG. 4 , the right guide pin  82  is inserted proximally through a right front pin guide  86  and then through a right rear pin guide  88 , both part of an upper frame  90  of the carriage frame assembly  32 . A proximal end of the right guide pin  82  resides within a distally projecting right pin receptacle  92  ( FIG. 12 ) formed as part of a distal bulkhead  94  of the transmission section  31 . A distal end of the right guide pin  82  is received by a right pin recess  96  ( FIG. 5 ) formed in the top cover  34 . Similarly, the left guide pin  84  is inserted proximally through a left front pin guide  98  and then through a left rear pin guide  100 , both part of the upper frame  90  of the carriage frame assembly  32 . A proximal end of the left guide pin  84  resides within a distally projecting left pin receptacle  102 , respectively formed as part of the distal bulkhead  94  of the transmission section  31 . A distal end of the left guide pin  84  is received by a left pin recess  104  ( FIG. 5 ) formed in the top cover  34 . 
     With particular reference to  FIGS. 3 ,  4 ,  6 ,  7  and  12 , a right front ring bearing  106  is inserted over a distal portion of the right guide pin  82  and is received within a cylindrical recess  108  formed on a distal side of the right front pin guide  86 . A right aft ring bearing  109  is inserted over a proximal portion of the right guide pin  82  and is received within a cylindrical recess  111  ( FIG. 6 ) formed on a proximal side of the right aft pin guide  88 . A left front ring bearing  110  is inserted over a distal portion of the left guide pin  84  and is received within a cylindrical recess  112  formed on a distal side of the left front pin guide  98 . A left aft ring bearing  113  ( FIG. 9 ) is inserted over a proximal portion of the left guide pin  84  and is received within a left cylindrical recess  115  ( FIG. 6 ) formed on a proximal side of the left rear pin guide  100  A right compression spring  114  is proximally received over the right guide pin  82  between the right front and rear pin guides  86 ,  88 . More particularly, the right compression spring  114  is distally positioned against the right front pin guide  86  and at its proximal end by a right downwardly projecting structure  116  ( FIG. 5 ) formed on an interior of the top cover  34  that closely encompasses a top portion of the right guide pin  82  without contacting other portions of the carriage frame assembly  32 . A left compression spring  118  is proximally received over the left guide pin  84  between the left front and rear pin guides  98 ,  100 . More particularly, the left compression spring  118  is distally positioned against the left front pin guide  98  at its distal end by a left downwardly projecting structure  120  ( FIG. 5 ) formed on the interior of the top cover  34  that closely encompasses a top portion of the left guide pin  84  without contacting other portions of the carriage frame assembly  32 . Thereby, the carriage frame assembly  32  is biased to a distal position relative to the top cover  34  and lower handle tray  16 . 
     In  FIGS. 3-5 , a forward projecting cylindrical resilient member  122  fastened to the upper frame  90  reduces noise by contacting the front interior of the top cover  34  slowing distal movement of the carriage frame assembly  32  prior to reaching full travel. The distal bulkhead  94  is restrained by being proximal to a top ridge  123 , a right ridge  125 , and a left ridge  127  ( FIG. 5 ) formed in the interior of the top cover  34  and to a bottom ridge  129  formed on an upper surface of the lower handle tray  16 . 
     Returning to  FIGS. 3-4  and  7 , the upper frame  90  has right and left front shaft apertures  124 ,  126  that respectfully receive for rotation a distal end of a rotation shaft  128  and a translation shaft  130 . The right front shaft aperture  124  is closed by the front portion of a right lower frame  131  of the carriage frame assembly  32 . The left front shaft aperture  126  is closed by the front portion of a left lower frame  132  of the carriage frame assembly  32 . A front (cutter) carriage  134  and an aft (straw) carriage  136  are received on the translation shaft  130  and are encompassed by the upper and lower frames  90 ,  132 . In  FIG. 6 , a proximal beveled and slotted end  138  of the rotation shaft  128  extends out of right aft shaft aperture  140  formed in the upper frame  90  for engagement to the transmission section  31  and is closed by an aft portion of the right lower frame  131 . A proximal slotted end  142  of the translation shaft  130  extends out of a left aft aperture  144  formed in the upper frame  90  for engagement to the transmission section  31  and is closed by the lower frame  132 . A threaded receptacle  146  on the aft end of the upper frame  90  receives a proximally projecting bolt  148  having an upwardly directed strike pin  148  at its proximal end. 
     In  FIGS. 7-10 , the carriage frame assembly  32  sequences translation of the front and aft carriages  134 ,  136 . With particular reference to  FIG. 10 , the front and aft carriages  134 ,  136  respectively include lower longitudinal grooves  152 ,  154  that slide upon a lower rail  156  upwardly presented on the left lower frame  132 . The front and aft carriages  134 ,  136  respectively include an upper longitudinal groove  158 ,  160  that slides upon a rail (not shown) downwardly presented on the upper frame  90 . The translation shaft  130  has a distal overrun portion  162  and a center overrun portion  164  separated by a front threaded portion  166  that a threaded bore  168  of a front main body portion  169  of the front carriage  134  traverses in response to rotation of the translation shaft  130 . A front translation compression spring  170  on the translation shaft  130  distal to the front carriage  134  compresses to allow the front carriage  134  to free wheel when being distally advanced and then biases the front carriage  134  aft to engage the front threaded portion  166  for being retracted upon reversal of rotation of the translation shaft  130 . 
     With particular reference to  FIGS. 8 and 10 , proximal to the center overrun portion  164  is an aft threaded portion  172  and then a proximal overrun portion  174  that a threaded bore  176  of a back main body portion  177  of the aft carriage  136  traverses in response to rotation of the translation shaft  130  as well as in response to a connection to the front carriage  134 . In particular, a front bracket  178  mounted on a right side of the front carriage  134  has a rightward front pin guide  180  that receives a distal end of a longitudinally aligned carriage limiting rod  182 . A distal threaded end  184  of the carriage limiting rod  182  extends distally out of the rightward front pin guide  180  and is prevented from backing out by a front nut  186 . A long compression spring  188  is received over a shaft  190  of the carriage limiting rod  182  proximal to the rightward front pin guide  180 . An aft bracket  192  is attached to a right side of the back main body portion  177  of the aft carriage  136  to extend a rightward aft pin guide  194  that receives the carriage limiting rod  182 , which extends a proximal threaded end  196  proximally out of the rightward aft pin guide  194  to receive an aft nut  198  that limits forward movement. The long compression spring  188  biases the aft carriage  136  away from the front carriage  134 , delaying retraction of a tissue sample until cutting is complete when full distal translation of the front carriage  134  pulls the aft carriage  136  onto the aft threaded portion  172 . 
     With particular reference to  FIG. 9 , a lengthwise engagement aperture  200 , defined between the right and left lower frames  131 ,  132 , presents engaging structures that actuate the disposable probe assembly  14  and the revolver drum assembly  18 . The rotation (spur) gear  128  exposes its left side to the lengthwise engagement aperture  200  for engagement with the rotation spur gear section  68  of the cutter gear  62  to impart a rotation. The front bracket  178  has a downward distal half cylinder recess  202  sized to grip the distal reduced diameter bearing surface  64  of the cutter gear  62  ( FIG. 2 ). The front bracket  178  further has a downward proximal half cylinder recess  204  proximally spaced and sized to grip the proximal reduced diameter bearing surface  66  of the cutter gear  62  ( FIG. 2 ) as well as a downwardly projecting front actuation finger  206  to the left side and below of the cutter gear  62  for effecting atmospheric pressure to the probe cannula  22 . Similarly, the aft bracket  192  has a downward distal half cylinder recess  208  and a downward proximal half cylinder recess  210  proximally spaced and sized to nonobstructively translate overtop of a tissue retraction tube  211 , as well as a downwardly projecting aft actuation finger  212  that selects vacuum pressure for communicating to the probe cannula  22 . 
     In  FIGS. 2-3  and  11 - 12 , the motor drive assembly  76  rotates rotation and translation shafts  128 ,  130  at a fixed ratio to optimize cutting performance of the cutter tube  36  when the slide button  28  is back. Alternatively, the motor drive assembly  76  imparts a jackhammer vibration to the carriage frame assembly  32  when the slide button  28  is forward. With particular reference to  FIGS. 11-12 , the planetary gearbox  78  extends proximally a keyed motor drive shaft  214  ( FIG. 12 ) through a drive shaft hole  216  formed in the distal bulkhead  94 . A slide spur gear  218  is received upon the keyed motor drive shaft  214  remaining engaged for rotation between a first distal (jack hammer) position and a second proximal (translation) position in accordance with a position of the slide button  28  whose distal and proximal feet  220 ,  222  straddle the slide spur gear  218 . In  FIG. 11 , the slide spur gear  218  is close to a proximal bulkhead  224  of the transmission section  31 , engaging a small spur  226  of a multiplier gear assembly  228 . The multiplier gear assembly  228  includes a longitudinal shaft  230  centrally attached to the small spur gear  226 . Proximal thereto, a cylindrical hub  232  is pinned to the longitudinal shaft  230  and in turn is encompassed by and pinned to a large spur gear  234  that rotates within a correspondingly sized, distally open recess  236  formed in proximally projecting container  237  integral to the proximal bulkhead  224 . A front cylinder bearing  238  received on a distal portion of the longitudinal shaft  230  is received by the proximal surface of the distal bulkhead  94 . 
     A first output drive shaft  240  distally presents a right angle prismatic end  242  shaped to engage the beveled and slotted end  138  of the rotation shaft  128  that passes through a lower right hole  244  in the distal bulkhead  94 . A cylindrical spacer  246  is received over a distal cylindrical portion  248  of the first output shaft  240 , taking up the space between the rotation shaft  128  and the proximal bulkhead  224 . A distally open recess  250 , formed as part of the container  237  that communicates from below with the recess  236 , is shaped to receive a proximal cylindrical end  252  of the first output drive shaft  240  and encompasses cylindrical bearing  254  as well as a small spur gear segment  256 , which is distal thereto and engages the large spur gear  234  of the multiplier gear assembly  228 . 
     A second output drive shaft  258  distally presents a right angle prismatic end  260  to engage the proximal slotted end  142  of the translation shaft  130  that extends through a low left hole  262  in the distal bulkhead  94 . A cylindrical spacer  264  is received over a distal cylindrical portion  266  of the second output drive shaft  258  proximal to the right angle prismatic end  260  and distal to a wider diameter hub segment  268  that is encompassed by and pinned to a large spur gear  270  that engages the small spur gear  226  of the multiplier gear assembly  228 . Proximal to the hub segment  268  is a wide spacer segment  272  and then a narrow cylindrical end  274  that receives a cylindrical bearing  276  that resides within a correspondingly-sized, distally open recess  278  that communicates from the left with the recess  236  and is formed as part of the same container  237 . 
     The distal and proximal bulkheads  94 ,  224  are structurally attached to one another in parallel alignment traverse to the longitudinal axis of the biopsy device  10  by cylindrical legs  280  molded to and proximally projecting from rectangular corners of the distal bulkhead  94  and fastened to the proximal bulkhead  224 . In addition, a pin  282  passes through holes  281 ,  283  longitudinally aligned in the distal and proximal bulkheads  94 ,  224  respectively along a top surface. 
     When the slide button  28  is moved distally to the jackhammer position, the sliding spur gear  218  disengages from the small spur gear  226  and engages a large spur gear  284  of a rotary camming gear assembly  286 . A camming shaft  286  from distal to proximal includes a distal cylindrical end  288 , a cam wheel  290 , a mid-shaft portion  292  that receives the upwardly directed strike pin  150  of the proximally projecting bolt  148 , a wide diameter hub  294  that is encompassed by and pinned to the large spur gear  284 , and a proximal cylindrical end  296 . A distal cylindrical bearing  298  is received within a proximally open container  300  projecting distally from the distal bulkhead  94  and in turn receives the distal cylindrical end  288  of the camming shaft  286 . A proximal cylindrical bearing  302  is received within a distally projecting and open cylinder  304  formed on the proximal bulkhead  224  and in turn receives the proximal cylindrical end  296  of the camming shaft  286 . 
     As the camming shaft  286  rotates clockwise as viewed from behind, the cam wheel  290  presents a proximal surface to the distal edge of the strike pin  150  that is more proximal until the interrupted portion of the camming wheel  290  is presented, allowing the strike pin  150  to return to a distal position under the urging of the distal biasing of the right and left compression springs  114 ,  118 . 
     Disposable Probe Assembly. 
     In  FIGS. 13-29 , the disposable probe assembly  14  has movable components that respond to the actuating motions of the reusable handpiece  12 . With particular reference to  FIGS. 13-15 , the distal portion  21  of the disposable probe assembly includes the probe cannula  22  that is supported by the probe support body  60 . The probe support body  60  includes a distal probe mount  306  that is received within the distal probe mount cover  50  of the bottom cover  48 . The front carriage  134  controls a vacuum valve  307 . In particular, proximal to and underlying a longitudinal axis of the disposable probe assembly  14  defined by a probe guide hole  308  passing through the distal probe mount  306 , a vertically open longitudinal trough  310  is formed into a necked portion  312  of the probe support body  60 . A cutter carriage-driven vacuum valve driver  313  has an elongate driver body  314  that longitudinally translates within the longitudinal trough  310  and upwardly presents an elongate slot  315  for being indirectly moved by the downwardly projecting front actuation finger  206  of the front carriage  136 . 
     With reference also to  FIG. 23 , a proximal block portion  316  is attached to the necked portion  312  of the probe support body  60 . A lower mounting  317  extends from the elongate driver body  314  distal to and longitudinally aligned with a distally open, longitudinally aligned vacuum valve bore  318  ( FIG. 23 ) formed in proximal block portion  316  of the probe support body  60 . Central and proximal ports  320 ,  321  communicate with the vacuum valve bore  318  from an underside of the proximal block portion  316  and a distal port  322  communicates laterally from a right side of the proximal block portion  316 . A right distal 90-degree fitting  319  communicates between the distal port  322  and an intake filter  323  within an outer hose fitting  324 . 
     A vacuum valve control rod  325  has a distal actuating portion  326  extending distally out of the valve bore  318  with a distal end positionable under the downwardly open portion of the longitudinal trough  310  and attached to the lower mounting  317  of the vacuum valve driver  313 . The vacuum valve control rod  325  also has a valve spool portion  327  that longitudinally translates within the valve bore  318  to selectively position between a first position and a second position. A proximal O-ring  328  near a proximal end of the valve spool portion  327  and a distal O-ring  329  are spaced such that the first position entails the O-rings  328 ,  329  bracketing the central and distal ports  320 ,  322  and the second position entails the O-rings  328 ,  329  bracketing the proximal and central ports  321 ,  320 , respectively. 
     The aft carriage  136  controls an air valve  351 . In particular, an air valve body  330  is attached to a left side of the proximal block portion  316  and includes a distally open longitudinal air valve bore  331  ( FIG. 23 ) depicted in  FIG. 14  as accessed by a distal left port  332 , a left center port  333 , and a left proximal port  334 . An air valve control rod  335  has a distal actuating portion  336  extending distally out of the air valve bore  331 . The valve control rod  335  also has a valve spool portion  337  that longitudinally translates within the air valve bore  331  to selectively position between a first position and a second position. A proximal O-ring  338  near a proximal end of the valve spool portion  337  and a distal O-ring  339  are spaced such that the first position entails the O-rings  338 ,  339  bracketing the central and distal ports  333 ,  332  and the second position entails the O-rings  338 ,  339  bracketing the proximal and central ports  334 ,  333 , respectively. 
     A valve connecting vacuum conduit  340  has one end attached to a lower center ninety-degree fitting  341  attached to the central port  320  of the vacuum valve bore  318  and the other end attached to an aft left ninety-degree fitting  342  that communicates with the left proximal port  334  of the air valve bore  331 . A distal conduit  343  is attached at one end to a center ninety-degree fitting  344  that communicates with the left center port  333  and at the other end at a probe union ninety-degree fitting  345  that communicates with the lateral lumen  44 . A vacuum supply conduit  346  is attached at one end to a distal ninety-degree fitting  347  that communicates with the proximal port  321  and at the other end to a vacuum supply (not shown). An air supply conduit  348  is attached at one end to a distal ninety-degree fitting  349  that communicates with the distal left port  332  and the other end to an air supply (not shown). 
     The front actuation finger  206  of the front carriage  136  ( FIGS. 9-10 ) is received within an upwardly open socket  350  formed on a left side of a cutter carriage-driven indexing shuttle  352  having a lateral concave recessed band  354  shaped to encompass with a clearance a lower portion of the rotation spur gear section  68  of the cutter gear  62 . An indexing arm  355  attached to the indexing shuttle  352  includes a proximally directed portion that proximally terminates in a rightward portion that terminates in an upward portion. In  FIG. 14 , a downwardly projecting vacuum actuator lug  356  ( FIG. 14 ) attached to an underside of the indexing shuttle  352  is received within the elongate slot  315  of the vacuum valve driver  314  to selectively communicate the vacuum supply to the probe cannula  22 . An air shuttle  358  longitudinally rides on a left edge of the necked portion  312  of the probe support body  60  and upwardly projects an air valve tab socket  360  positioned to receive the aft actuating finger  212  of the aft carriage  138 . A downward mounting arm  362  of the air shuttle  358  is attached to the distal actuating portion  336  of the air valve control rod  335  extending distally out of the air valve bore  331 . 
     A straw hook wire  364  supports a midpoint of a sample retraction tube  363  in place upon the probe support body  60  prior to engagement with the reusable handpiece  12 . A curled lower right end passes into leftwardly opening  365  along the top right surface of the proximal block portion  316  of the probe support body  60  into a small mounting block  366  extending upwardly from a right side with a downwardly inserted pin  368  passing through the curled lower right end to hold the straw hook wire  364  in place. The straw hook wire  364  has a horizontal portion attached to the curled end that passes under the sample retraction tube  363 , bending upward and then bending leftward and horizontally again through a lateral slot  370  in a vertical wire support member  372  formed onto a left side of the top surface of the proximal block portion  316 . It should be appreciated that engagement of the reusable handpiece  12  forces the left portions of the straw hook wire  364  out of engagement with the midpoint indented feature  350  as a rib feature  373  ( FIG. 9 ) deflects the left portion of the straw hook wire  364 . This facilitates commonality with disposable probe assemblies in which the straw hook wire  364  keeps a translating sample retraction straw in place prior to mounting to the reusable handpiece  12  (not shown). 
     With particular reference to  FIGS. 16-17 , the sample revolver drum assembly  18  includes a revolver cylindrical drum  380  encompassed by a detachable revolver drum belt  382  that in turn holds removable sample vials  384  forming a revolver cylindrical drum assembly  386  ( FIG. 20 ). A drum base  388  includes a half cylinder recess  389  which holds the sample revolver drum assembly  386  for rotation about the longitudinal axis and is closed by a top drum cover  390 , which may be transparent for monitoring progress in tissue collection or opaque. An indexer support base  392  of the indexing assembly  19  has a proximal surface fastened to a distal surface of the drum base  388  and extends a mounting flange  394  distally to attach to a proximal end of the hand-held distal portion  21  of the disposable probe assembly  14 . The sample retraction tube  363  passes over the mounting flange  394  and is gripped within a longitudinal groove  396  formed along a top, left side of the indexer support base  392  and passes through a hole  398  on a top left corner of a distal face of the drum base  388 . 
     A slotted distal drum axle  400  of the revolver cylindrical drum  380  is received within a smaller distal portion of the half cylinder recess  389  and a proximal drum axle  401  ( FIG. 21 ) is received within a smaller proximal portion of the half cylinder recess  389 . The slotted distal drum axle  400  receives an angled proximal end  402  of a shaft  404  that passes through a shaft hole  406  in the drum base  388 . A distal portion of the shaft  404  is received within a shaft recess  408  across the top of the indexer support base  392  that communicates with a half cylindrical gear recess  410  that encompasses a lower half of a large bevel gear  412  mounted on the shaft  404 . A small half cylindrical gear recess  414  receives a transversely oriented small bevel gear  416  that engages the large bevel gear  412 . A transverse shaft  418  has a left end mounted to the small bevel gear  416  and a right end mounted to a dual spur gear assembly  420  that rotates within a rightward transverse half cylindrical recess  422  formed in the indexer support base  392 . 
     With particular reference to  FIG. 18 , a top indexer gear cover  424  mounts overtop of the indexer support base  392  that contacts the top surfaces of the shaft  404  and left and right axle ends  426 ,  428  of the dual spur gear assembly  420  with a leftward slot  430  that exposes a top portion of the large bevel gear  412  and distally open left and right vertical slots  432 ,  434  that expose top surfaces of a left and right spur gear  436 ,  438  of the dual spur gear assembly  420 . In  FIG. 17-18 , a central beam  440 , defined between the left and right vertical slots  432 ,  434 , has a T-shaped hold down spring  442  mounted on top with its narrow end  444  mounted to a proximal end of the central beam  440 . A laterally wider end  446  extends overtop of both vertical slots  432 ,  434 . A cyclic spring gate  448  extends laterally to the left and right from a proximal end of the T-shaped hold down spring  442  and ramps downwardly and proximally. 
     With particular reference to  FIG. 18 , each side of the central beam  440  has a respective left and right lower pin guides  462 , formed as an upper surface of a wider lower portion. An upper pin guide  449  extends laterally out from the central beam  440  on each side and is spaced respectively above the lower pin guides  462 ,  470  to form a lower pin channel  451 . Although only the left upper pin guide  449  is depicted, it should be appreciated that the right side includes a mirror image upper pin guide. A rear ramped portion  453  of the upper pin guide  449  underlies and supports the cyclic spring gate  448 . 
     Left and right cyclic arms  450 ,  452  have distal ends mounted on respective ends of a transverse cyclic axle  454  whose central portion passes through a top end  456  of the index arm  355 . Left fore and aft cyclic pins  458 ,  460  extend rightward out of the left cyclic arm  450 . Right fore and aft cyclic pins  466 ,  468  extend leftward out of the right cyclic arm  452 . Each cyclic arm  450 ,  452  includes a respective left and right bottom rack segment  472 ,  474  close to the distal rotating end positioned to engage a respective spur gear  436 ,  438  under the downward urging of the laterally wider distal end  446  of the T-shaped hold spring  442 . 
     With reference to  FIG. 16 , the left cyclic arm  450  is at its distal most position. It should be appreciated that the left aft cyclic pin  460  is distal to the upper pin guide  449 . In  FIG. 19A , proximal movement of the right cyclic arm  450  presents the rack segment  472  to rotate the left spur gear  436  (not shown in  FIG. 19A ) top aft, held in engagement by the T-shaped hold down spring  442 . Proximal movement of the cyclic arms  450 ,  452  causes the dual spur gear assembly  420  and thus the small bevel gear  416  to rotate top aft, which in turn causes the large bevel gear  412  and revolver cylindrical drum assembly  386  to rotate top right, indexing the sample vial  384  to the sample retraction tube  363  in the hole  398 . In  FIG. 19B , the right cyclic arm  450  has reached its proximal most position, wherein the left aft pin  460  has pushed through the cyclic spring gate  448  and out of the lower pin channel  451 . In  FIG. 19C , upon distal movement of the right cyclic arm  450 , the left aft pin  460  rides up the cyclic spring gate  448 , rotating the right cyclic arm  450  out of engagement with the left spur gear  436 . It should be appreciated that the left aft pin  460  will drop off of the front of the upper pin guide  449  as the distal most position is reached and be positioned to enter again the lower pin channel  451  under the downward urging the T-shaped hold down spring  442 . 
     In  FIGS. 20-22 , the revolver cylindrical drum  380  includes radially spaced longitudinal recesses  476  shaped to receive respective cylindrical vial holders  478  formed in the revolver drum belt  382  that hold the sample vials  384 . Each vial holder  478  includes an elongate outward aperture  480  so that contents of the retained vial  384  may be viewed. In order that pathology may ascertain which sample vial  384  received the first and subsequent tissue samples, the revolver drum belt  382  terminates in first and second belt retaining ears  482 ,  484  that are drawn into longitudinal abutment and inserted into a longitudinal indexing and retention slot  486  formed in the revolver cylindrical drum  380  as the circled revolver drum belt  382  is slid longitudinally onto the revolver cylindrical drum  380 . A V-shaped slot  488  of the slotted distal drum axle  400  assures that the angled proximal end  402  of the shaft  404  is in an initial condition with a narrow aspect upward to receive the open side of the V-shaped slot  488 , which registers the retaining ears  482 ,  484  to a known position prior to commencing sampling. 
     In  FIGS. 23-29 , the operation of the reusable handpiece  12  and the hand-held distal portion  21  of the disposable probe assembly  14  are depicted sequentially in diagrammatic form to illustrate how the indexing assembly  19  and revolver drum assembly  18  are operated in conjunction with the taking of vacuum assisted core biopsy samples. In  FIG. 23 , the hand-held distal portion  21  of the disposable probe assembly  14  has both carriages  134 ,  136  distally advanced in an initial state for closing the side aperture  20  in the probe cannula  22  for insertion into tissue. The front carriage  134  also advances the cutter carriage-driven vacuum valve driver  313  to its distal position, switching the vacuum valve  307  distally to provide atmospheric pressure to the air valve  351  (i.e., atmosphere in distal port  322  and out center port  320  to left proximal port  334 ). The aft carriage  136  positions the air valve  351  to shut off the input from the vacuum valve  307 , instead causing the air supply conduit  348  to communicate through the left distal port  332  to the left center port  333  to the distal conduit  343  to pressurize the lateral lumen  44 . 
     In  FIG. 24 , the aft carriage  136  has proximally retracted, switching the air valve  351  so that the atmospheric pressure provided by the vacuum valve  307  now communicates through the left proximal port  334  to the left center port  334  to the distal conduit  343  to the lateral lumen  44 , venting the probe cannula  22  to begin a new sample taking cycle. 
     In  FIG. 25 , the front carriage  134  has begun to proximally retract while the aft carriage  136  remains at its proximal most position. The cutter tube  36  retracts exposing a portion of the side aperture  20  of the probe cannula  22  while the vacuum and air valves  307 ,  351  remain in the same state with the probe cannula  22  vented to the atmosphere. 
     In  FIG. 26 , the front carriage  134  has reached its proximal most position, fully retracting the cutter tube  36  to expose the side aperture  20  of the probe cannula  22 , which is now under vacuum pressure to prolapse tissue by having the front carriage  134  position the vacuum valve  307  to pass vacuum supply from the proximal port  321  through the center port  320  to the left central port  330  to the left distal port  332  to the lateral lumen  44 , drawing air through the internal vent holes  47 . 
     In  FIG. 27 , the front carriage  134  has begun to distally advance, severing tissue, while the vacuum valve  307  remains switched to vacuum supply and the air valve  351  remains in the state of passing the vacuum pressure through to the lateral lumen  44 . 
     In  FIG. 28 , the front carriage  134  has been fully distally advanced, causing the cutter tube  36  to completely sever the prolapsed tissue into a tissue sample and switching the vacuum valve  307  to vent to the atmosphere. With the aft carriage  136  still back, the air valve  351  passes the atmospheric pressure to the lateral lumen  44  to vent the probe cannula  46 . 
     In  FIG. 29 , the aft carriage  136  has been distally advanced, switching the air valve  351  to pass air pressure from the left distal port  332  to the left center port  333  to the lateral lumen  44 . The increased air pressure passes through the holes  47  to the distal end of the cutter lumen  47  causing the tissue sample to be blown proximally back up the cutter tube  36  out of the distal hand-held portion  21  of the biopsy device  10  into the sample revolver drum assembly  18 . 
     The clinicians benefit from being able to visually or diagnostically image the tissue samples while still being able to maintain the probe cannula  22  in tissue to take additional samples, insert therapeutic agents, deposit a marker, etc. Thus, a minimum of reinsertions and verifications of position are necessary, yet the clinician is reassured that proper samples are being taken. Moreover, avoidance of biohazards is provided by encasing the tissue samples for convenient transport for pathology assessment. Further, the individual storage allows correlating a particular sample taken at a specific position in the patient&#39;s breast. In addition, the apparatus is portable with a minimum of needed interconnections. 
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art, given the benefit of the present disclosure, that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims. 
     For example, while a rotating drum assembly provides an efficient means to capture a plurality of tissue samples, applications consistent with the present invention may include an uncircled belt that is drawn into a proximal portion of a biopsy device and then indexed to a next sample container with the filled sample containers on the belt moved out. 
     As another example, while automatically registering the next of a plurality of sample containers (e.g., vials) provides an efficient way of segregating tissue samples, applications consistent with the present invention may selectively uncouple the indexing of the next sample container. Instead, a manual selection may be made when the next sample container is to be positioned to receive the next sample. Alternatively, a separate control may be selected for the motor to drive the indexing arm or similar reciprocating element. 
     As another example, while a sample revolver drum assembly attached for movement with the proximal portions of the biopsy device has certain advantages, applications consistent with the present invention may include a revolver drum assembly coupled by flexible attachments, such as communicating a flexible drive capable for indexing motion. 
     As yet another example, while a detachable belt and detachable sample vials provide clinical flexibility, it should be appreciated that applications consistent with the present invention may include vials or similarly shaped sample containers that are immovably attached to a belt or a rigid outer cylinder wall structure. 
     As yet a further example, while a mechanical linkage is described herein for automatically indexing the samples, it should be appreciated that electromechanical positioning and control may be employed to sequencing sample storage.

Technology Classification (CPC): 0