US2014039343A1PendingUtilityA1

Biopsy system

52
Assignee: DEVICOR MEDICAL PRODUCTS INCPriority: Dec 13, 2006Filed: Aug 12, 2013Published: Feb 6, 2014
Est. expiryDec 13, 2026(~0.4 yrs left)· nominal 20-yr term from priority
A61B 2010/0225A61B 10/0283A61B 10/0096A61B 2017/00482A61B 10/0266A61B 90/98A61B 10/0275
52
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Claims

Abstract

A biopsy system includes various features. A tissue sample holder kit of the system comprises a rotatable member with chambers configured to receive tissue receiving features of a tissue sample tray. A biopsy device of the system includes user input features and user feedback features disposed on a body. A user interface of the system includes a graphical representation of a tissues ample holder. A biopsy site marker applier of the system includes markings associated with different biopsy device configurations. The biopsy system may undergo a multi-step initialization process. In operation, the biopsy system may execute pneumatic control algorithms including the use of vacuum, saline, and atmospheric air.

Claims

exact text as granted — not AI-modified
I/We claim: 
     
         1 . An apparatus comprising a tissue sample holder kit, the tissue sample holder kit comprising:
 (a) a rotatable member, wherein the rotatable member includes a plurality of chambers; and   (b) a first tissue sample tray including a plurality of tissue receiving features, wherein each tissue receiving feature is configured to removably fit within a corresponding chamber of the plurality of chambers of the rotatable member, wherein each tissue receiving feature is configured to receive a tissue sample.   
     
     
         2 . The apparatus of  claim 1 , further comprising a second tissue sample tray including a plurality of tissue receiving features, wherein each tissue receiving feature is configured to removably fit within a corresponding chamber of the plurality of chambers of the rotatable member, wherein each tissue receiving feature is configured to receive a tissue sample. 
     
     
         3 . The apparatus of  claim 2 , wherein the tissue receiving features of the second tissue sample tray are configured differently relative to the tissue receiving features of the first tissue sample tray. 
     
     
         4 . The apparatus of  claim 3 , wherein the tissue receiving features of the first tissue sample tray comprise strips defined by sidewalls, wherein the sidewalls are substantially non-tapered. 
     
     
         5 . The apparatus of  claim 4 , wherein the tissue receiving features of the second tissue sample tray comprise strips defined by sidewalls, wherein the sidewalls are substantially tapered. 
     
     
         6 . The apparatus of  claim 1 , further comprising a biopsy device, wherein the biopsy device comprises a needle and a cutter, wherein the rotatable member is configured to rotatably couple with the biopsy device, wherein the tissue receiving features are configured to receive tissue samples severed by the cutter. 
     
     
         7 . The apparatus of  claim 6 , wherein the rotatable member is rotatable to successively index the tissue receiving features relative to the cutter. 
     
     
         8 . A controller for a biopsy device, wherein the biopsy device includes a tissue sample holder defining a plurality of tissue sample chambers, wherein the controller comprises:
 (a) a user interface including a graphical representation of the tissue sample holder, wherein the graphical representation of the tissue sample holder includes graphical representations of the tissue sample chambers; and   (b) at least one user input operable to control one or more features of the biopsy device.   
     
     
         9 . The controller of  claim 8 , wherein the user interface is further configured to discretely illuminate each of the graphical representations of the tissue sample chambers to represent receipt of a tissue sample in the corresponding tissue sample chambers. 
     
     
         10 . The controller of  claim 8 , wherein the controller is operable to execute a control algorithm that comprises rotating the tissue sample holder to a position a first tissue sample chamber at a presentation position upon receipt of a first tissue sample in the first tissue sample chamber, then subsequently rotating the tissue sample holder to position a second tissue sample chamber for receipt of a second tissue sample. 
     
     
         11 . The controller of  claim 10 , wherein the at least one user input comprises an input operable to define the presentation position. 
     
     
         12 . The controller of  claim 11 , wherein the presentation position is selectable from a 12 o'clock position, a 3 o'clock position, a 6 o'clock position, and a 9 o'clock position. 
     
     
         13 . The controller of  claim 8 , wherein the at least one user input comprises an input operable to rotate the tissue sample holder in single chamber increments, to skip tissue sample chambers for receipt of tissue samples, wherein the user interface is further configured to discretely illuminate each of the graphical representations of the tissue sample chambers to represent skipped tissue sample chambers. 
     
     
         14 . The controller of  claim 13 , wherein the user interface is further configured to discretely illuminate each of the graphical representations of the tissue sample chambers in a first color to represent skipped tissue sample chambers, and wherein the user interface is further configured to discretely illuminate each of the graphical representations of the tissue sample chambers in a second color to represent receipt of a tissue sample in the corresponding tissue sample chambers. 
     
     
         15 . The controller of  claim 8 , wherein the at least one user input comprises an input operable to return the tissue sample holder to a home position. 
     
     
         16 . The controller of  claim 8 , wherein the tissue sample holder is configured to rotate relative to the biopsy device, wherein the graphical representation of the tissue sample holder includes graphical representations of the tissue sample chambers, wherein the graphical representation of the tissue sample holder is configured to rotate to indicate the corresponding rotation of the tissue sample holder. 
     
     
         17 . The controller of  claim 16 , wherein the biopsy device comprises a cutter having a cutter lumen, wherein the graphical representation of the tissue sample holder comprises a highlighted portion to indicate the corresponding position of the cutter lumen relative to the tissue sample chambers of the tissue sample holder. 
     
     
         18 . The controller of  claim 16 , wherein the graphical representations of the tissue sample chambers are configured to be filled with a first color to indicate that the corresponding tissue sample chamber is empty, wherein the biopsy device is operable to deposit a tissue sample within a tissue sample holder, wherein the graphical representations of the tissue sample chambers are configured to be filled with a second color to indicate that the biopsy device attempted to deposit a tissue sample in the corresponding tissue sample chamber. 
     
     
         19 . The controller of  claim 16 , wherein the biopsy device is operable to collect a tissue sample, wherein the graphical representation of the tissue sample holder comprises a counter operable to indicate the number of tissue samples that the biopsy device attempts to collect. 
     
     
         20 . The controller of  claim 19 , wherein the counter is configured to be displayed in a first color while the biopsy device attempts to collect a tissue sample, wherein the counter is configured to be displayed in a second color after the biopsy device attempts to collect a tissue sample. 
     
     
         21 . A method of operating a biopsy device to acquire a tissue sample, wherein the biopsy device comprises a cutter and a needle, wherein the cutter defines a first lumen, wherein the needle defines a second lumen adjacent to the cutter, wherein the cutter is translatable relative to the needle, wherein the method comprises:
 (a) retracting the cutter proximally to a retracted position;   (b) advancing the cutter from the retracted position to a distal position;   (c) communicating vacuum to the first lumen during the act of retracting the cutter;   (d) communicating vacuum to the second lumen during the act of retracting the cutter;   (e) communicating vacuum to the first lumen during the act of advancing the cutter;   (f) communicating vacuum to the second lumen for a first period of time during the act of advancing the cutter; and   (g) communicating one or both of saline or atmospheric air to the second lumen for a second period of time during the act of advancing the cutter.   
     
     
         22 . The method of  claim 21 , further comprising transitioning from vacuum to atmospheric air to the second lumen upon transition from the first period of time to the second period of time. 
     
     
         23 . The method of  claim 21 , further comprising pulsing one or both of saline or atmospheric air to the second lumen during the second period of time. 
     
     
         24 . The method of  claim 23 , wherein the pulses of saline are provided between the pulses of atmospheric air. 
     
     
         25 . The method of  claim 21 , further comprising communicating vacuum to the first lumen for a third period of time after the cutter reaches the distal position. 
     
     
         26 . The method of  claim 25 , further comprising communicating atmospheric air to the first lumen for a fourth period of time after the cutter reaches the distal position. 
     
     
         27 . The method of  claim 26 , further comprising sealing the first lumen after expiry of the fourth period of time. 
     
     
         28 . The method of  claim 26 , further comprising communicating saline then atmospheric air to the second lumen during the third period of time. 
     
     
         29 . The method of  claim 28 , further comprising sealing the second lumen during the fourth period of time and after expiry of the fourth period of time. 
     
     
         30 . The method of  claim 21 , wherein the needle comprises a lateral aperture, the method further comprising:
 (a) retracting the cutter proximally to a retracted position a second time such that the cutter is proximal to the lateral aperture of the needle;   (b) communicating atmospheric air to the first lumen after retracting the cutter proximally to a retracted position a second time;   (c) communicating vacuum to the second lumen after retracting the cutter proximally to a retracted position a second time; and   (d) deploying a marker through the lateral aperture of the needle.

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