Abstract:
A biopsy device and method may be used to obtain a tissue sample, such as a breast tissue biopsy sample. The biopsy device includes an outer cannula having a distal piercing tip, a cutter lumen, and a cutter tube that is rotated by an integral motor and manually translated past a side aperture in the outer cannula to sever a tissue sample. A sample capturing structure (e.g., sample barrel) has a plurality of sample cavities (e.g., radially symmetric, revolver handgun orientation) that are manually aligned one at a time to capture one or more samples.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation-in-part of the co-pending and commonly-owned U.S. patent application Ser. No. 11/198,558, “BIOPSY DEVICE WITH REPLACEABLE PROBE AND INCORPORATING VIBRATION INSERTION ASSIST AND STATIC VACUUM SOURCE SAMPLE STACKING RETRIEVAL” to Hibner et al., filed Aug. 5, 2005, the disclosure of which is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    Embodiments of the present invention relate 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. 
         [0003]    During a core needle biopsy, a small tissue sample may be 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 each 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 U.S. Pub. No. 2003/0199753, published Oct. 23, 2003 to Hibner et al. 
         [0004]    Some biopsy devices may be regarded as “long stroke” or “short stroke.” For instance, several “short stroke” biopsy devices are described in the following published patent applications: U.S. patent application Ser. No. 10/676,944 (U.S. Pub. No. 2005/0215921), entitled “Biopsy Instrument with Internal Specimen Collection Mechanism,” filed Sep. 30, 2003 in the name of Hibner et al.; and U.S. patent application Ser. No. 10/732,843, (U.S. Pub. No. 2004/0153003), entitled “Biopsy Device with Sample Tube,” filed Dec. 10, 2003 in the name of Cicenas et al. The disclosure of each of those published patent applications is incorporated by reference herein. In some embodiments, 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, which may allow for taking multiple samples without removing the probe from the breast. 
         [0005]    In U.S. patent application Ser. No. 10/953,834, entitled “Biopsy Apparatus and Method” to Hibner et al., filed Sep. 29, 2004 (U.S. Pub. No. 2006/0074345), the disclosure of which is hereby incorporated by reference in its entirety, tissue samples are drawn by vacuum proximally through the cutter tube into a serial tissue stacking assembly that preserves the order of sample taking, that can be visually observed through a transparent lumen, and that serves as a transport container to take for a pathology examination. Yet another biopsy device is disclosed in co-pending U.S. Patent Application Ser. No. 60/869,736, entitled “Biopsy System” to Hibner et al., filed Dec. 13, 2006, the disclosure of which is hereby incorporated by reference in its entirety. 
         [0006]    Additional sample storage devices are disclosed in co-pending U.S. Patent 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. Still more sample storage devices are disclosed in U.S. patent application Ser. No. [ATTY. DOCKET NO. END5375USCIP5-0544485], entitled “Trigger Fired Radial Plate Specimen Retrieval Biopsy Instrument” to Garrison, filed on even date herewith, the disclosure of which is hereby incorporated by reference in its entirety. 
         [0007]    While a variety of tissue storage devices has been made and used, it is believed that no one prior to the inventor has made or used a device as recited in the present claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    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: 
           [0009]      FIG. 1  is a perspective view from a right side of a biopsy device with sample extraction tool. 
           [0010]      FIG. 2  is an exploded view of the biopsy device of  FIG. 1 . 
           [0011]      FIG. 3  is an isomeric view of a left handle body, proximal portion of a handle, and probe of the biopsy device of  FIG. 1 . 
           [0012]      FIG. 4  is right, aft isometric view of the biopsy device of  FIG. 1  with a right handle body omitted. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
         [0014]    Turning to the drawings, wherein like numerals denote like components throughout the several views, in  FIGS. 1-4 , with particular reference to  FIG. 1 , a biopsy device  10  includes a sample storage barrel  12  rotated about a central axis, which in the illustrative version is longitudinal, parallel to and slightly offset from a longitudinal axis of a core biopsy probe  14 . The probe  14  includes a cutter lumen  16  having a side aperture  18  just proximal to a distal piercing tip  20 . In other embodiments, tip  20  is blunt, and in additional non-exhaustive embodiments, tip  20  is open. A lateral lumen  22  attached alongside the cutter lumen  16  communicates distally to an area within the cutter lumen  16  proximate to the side aperture  18  for providing vacuum assistance for prolapsing tissue into the side aperture  18 , and proximally communicates to a vacuum hose nib  24  on a proximal portion  26  of a handle  28 . An upper portion of the sample storage barrel  12  is exposed out of a barrel cavity  30  of a distal portion  32  of the handle  28 . The proximal portion  26  of the handle abuts a proximal surface of the sample storage barrel  12 . A slide trigger  34  is depicted as at a distal position upon an upper surface of the distal portion  32  of the handle  28 , positioning a cutter tube  36  distally within the cutter lumen  16 , depicted closing the side aperture  18 . Of course, any other suitable configurations, components, and relationships between such components, may be used in addition to or as an alternative to the above-described components. It will also be appreciated that certain embodiments of the biopsy device  10  may be configured such that the biopsy device may be manipulated by a single hand of a user during use of the biopsy device  10  (e.g., while using the biopsy device  10  to obtain tissue samples). 
         [0015]    The sample storage barrel  12  of the present example may be disengaged from the barrel cavity  30  and perhaps replaced with an empty barrel  12  for capturing additional tissue samples. A sample extraction tool  38  may be employed to simultaneously push the tissue samples out of the disengaged sample storage barrel  12 . It should be appreciated that four pusher rods  40  extending in parallel and radially spaced fashion from a tool handle  42  are depicted in the illustrative version; however, various numbers may be configured as desired. In other words, a sample storage barrel  12  may be configured to hold any suitable number of tissue samples, and an extraction tool  38  may have any suitable number of pusher rods (which need not necessarily correspond with the number of tissue samples a storage barrel is capable of holding). Other suitable configurations for a sample extraction tool  38  will be apparent to those of ordinary skill in the art. 
         [0016]    With particular reference to  FIG. 2 , a proximal end of the core biopsy probe  14  is received with a union sleeve  44  that is engaged with a sleeve recess  46  defined in both a left and right handle body  48 ,  50  that communicates proximally to a translation yoke cavity  52 , which in turn communicates with a longitudinally aligned sample passage  54  to proximally terminate in an O-ring groove  56 . 
         [0017]    In  FIG. 3 , a proximal O-ring  58  received in the O-ring groove  56  dynamically seals to a distal face of the sample storage barrel  12 , and more particularly to a selected one of four sample holding chambers  60  that are longitudinally parallel and radially spaced through the sample storage barrel  12 . The proximal end of the cutter tube  36  remains within the sample passage  54  while being translated to distal and proximal positions by fore and aft downward projecting transverse gripping flanges  62 ,  64  attached by a longitudinal rib (not shown) that extends through a top longitudinal slot  66  formed between the left and right handle bodies  48 ,  50  extending from the slide trigger  34 . Other suitable configurations, components, and relationships between such components, will be apparent to those of ordinary skill in the art. 
         [0018]    In the present example, cutter tube  36  is translated by manual actuation of slide trigger  34  (e.g., by manually translating slide trigger  34  distally or proximally) to sever tissue prolapsed into side aperture  18 . However, it will be appreciated that a motor (not shown) or other device may be used to translate cutter tube  36 . As shown in  FIG. 4 , a compression spring  68  is received over a portion of the cutter tube  36  between the fore transverse gripping flange  62  and a distal face of the translation yoke cavity  52 , providing a proximal restoring force when the slide trigger  34  is distally actuated. Of course, as with any other component described herein, any suitable alternative or supplement to compression spring  68  may be used, or it may be omitted altogether. 
         [0019]    With further reference to  FIG. 2 , a cutter spur gear  70  is attached to a portion of the cutter tube  36  that resides between the fore and aft transverse gripping flanges  62 ,  64 . A longitudinally elongate rotation drive motor cavity  72  is defined by left and right channels  74 ,  76  along a bottom of the left and right handle bodies  48 ,  50  and encompasses a rotation drive motor  78 . Drive motor  78  may receive power from any suitable source. A drive pulley  80  extending distally from the rotation drive motor  78  receives a lower loop of a rotation drive belt  82 . An upper loop of the rotation drive belt  82  passes over a proximal extending pulley  84  of an elongate rotation spur gear  86  whose distal and proximal shaft ends are received respectively in distal and proximal hub recesses  88 ,  90  formed between the left and right handle bodies  48 ,  50  and communicating inwardly to the translation yoke cavity  52 . The elongate rotation spur gear  86  is in gear engagement with the cutter spur gear  70  along the length of its translation to impart a rotation to the cutter tube  36 . It will be appreciated, however, that any suitable alternative mechanism may be used to rotate cutter tube  36 , to the extent that cutter tube  36  is configured to rotate at all. 
         [0020]    In some embodiments, cutter tube  36  remains in constant rotation, independent of any actuation of slide trigger  34 . For instance, a user actuated switch (not shown) may be provided on/in biopsy device  10 , as a foot switch, or otherwise, for a user to activate drive motor  78  to cause rotation of cutter tube  36 . In other embodiments, a switch (not shown) may be operably coupled with slide trigger  34 , such that drive motor  78  begins rotating cutter tube  36  as soon as slide trigger  34  is moved distally from a default position or is otherwise engaged or actuated. Alternatively, any other suitable structures, devices, or methods of activating a drive motor  78  may be used. In other embodiments, drive motor  78  is omitted altogether, and cutter tube  36  rotates using some other device or technique, or simply does not rotate at all. 
         [0021]    The sample storage barrel  12  of the present example is assembled from a barrel body  92  having four sample holding chambers  60  and having radially spaced longitudinal ridges to serve as surfaces for manually rotating the barrel  12 . A blocking disk  94  is fastened to a proximal face of the barrel body  92  by two small bolts  96 . A tight pattern of small through holes  98  registered to each sample holding chamber  60  forming a fluid filter. With a vacuum applied to a sample holding chamber  60  that is aligned with the vacuum hose nib  24  and the cutter tube  36 , a tissue sample that has been severed by the cutter tube  36  will be drawn into the sample holding chamber  60 . To the extent that fluid is also drawn into the sample holding chamber  60 , the fluid may pass proximally through holes  98 ; yet holes  98  may be sized to prevent proximal passage of the tissue sample. It will therefore be appreciated that blocking disk  94  of the present example retains a biopsy tissue sample in each sample holding chamber  60  that is rotated into alignment with the sample passage  54 . The barrel body  92  includes a distally directed axle end  99  ( FIG. 3 ) that is received within a barrel hub recess  100  formed in the left and right handle bodies  48 ,  50  above the sample passage  54 . The blocking disk  94  includes a proximally directed axle end  102  that is received for rotation in an upper central hole  104  in a transverse oval cap  106 . Still other suitable variations, substitutes, and supplements for sample storage barrel  12  will be apparent to those of ordinary skill in the art. 
         [0022]    A vacuum orifice  108  positioned just below the upper central hole  104  aligns with the fluid filter  98  in the blocking disk  94  registered to the selected sample holding chamber  60 , the orifice  108  communicating with the vacuum hose nib  24  supported by a distally open oval cup  110 . The proximal portion  26  of the handle  28  is assembled by a snap fit ridges  112  extending proximally from the transverse oval cap  106  into the distally open oval cup  110  and then attached to the left and right handle bodies  48 ,  50  by two large fasteners  114 . A distal transverse cap  116  having proximally extending snap fit ridges  118  engages the distal openings in the left and right handle bodies  48 ,  50 , which are laterally attached to one another by inwardly expending pins  120  from one received in locking holes  122  in the other. It will be appreciated, however, that these components may be configured in any other suitable way and may have any other suitable relationships. 
         [0023]    While the barrel  12  of the present example is rotated manually (e.g., such as by a user rotating the barrel  12  by directly pushing it to rotate it in a desired direction, etc.), barrel  12  may be rotated in a variety of ways in other embodiments. For instance, a mechanism (not shown) may be provided in communication with slide trigger  34 , whereby each distal actuation of slide trigger  34  combined with a subsequent proximal retraction of slide trigger  34  causes barrel  12  to rotate in a manner sufficient to align the next empty holding chamber  60  with cutter tube  36 . As another merely illustrative example, a transmission and clutch (neither shown) may be provided in communication with drive motor  78 , whereby each distal actuation of slide trigger  34  combined with a subsequent proximal retraction of slide trigger  34  causes the clutch to couple the drive motor  78  with the barrel  12  via the transmission in a manner sufficient to transfer rotation from the drive motor  78  to the barrel  12  in a manner sufficient to align the next empty holding chamber  60  with cutter tube  36 . Suitable gearing ratios and other methods for accomplishing such rotation of barrel  12  by drive motor  78  will be apparent to those of ordinary skill in the art. Furthermore, one or more locking mechanisms (not shown) may be provided on or within biopsy device  10  to prevent inadvertent rotation of barrel  12  during biopsy procedures. 
         [0024]    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. 
         [0025]    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. 
         [0026]    For example, a thumbwheel may be included that allows rotation of the probe  14  cannula to orient the side aperture  18 . 
         [0027]    For another example, while a motorized rotation mechanism is depicted, applications consistent with the present invention may include a transmission that converts the translation motion further into a rotation motion imparted to the cutter tube. For another example, while manual translation of a cutter tube  36  may provide certain advantages such as tactile feedback to the clinician, applications consistent with the present invention may include motorized translation or rotation that is converted from the translation motion of the cutter. Furthermore, hydraulic, pneumatic, or any other type of rotation and/or translation devices may be used. 
         [0028]    Embodiments of the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. Embodiments may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application. 
         [0029]    By way of example only, embodiments described herein may be processed before surgery. First, a new or used instrument may be obtained and if necessary cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed an sealed container, such as a plastic or TYVEK bag. The container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. the sealed container may keep the instrument sterile until it is opened in a medical facility. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam. 
         [0030]    Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.