Abstract:
A biopsy device and method may be used to obtain a tissue sample, such as a breast tissue biopsy sample. A biopsy device may include an outer cannula having a distal piercing tip, a cutter lumen, and a cutter tube that rotates and translates past a side aperture in the outer cannula to sever a tissue sample. An exemplary sample capturing structure (e.g., platter, barrel, etc.) has a plurality of sample cavities (e.g., radially symmetric, revolver handgun orientation, etc.) that are aligned one at a time (e.g., manually, etc.) to capture and store one or more tissue 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 Application 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. END5375USCIP4-0544483], 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 first version of a biopsy device with a sample storage platter.  
         [0010]      FIG. 2  is a perspective view from a left side of the biopsy device of  FIG. 1  with a handle housing removed.  
         [0011]      FIG. 3  is an exploded view from an upper right-hand side vantage point of the sample storage platter and handle housing of the biopsy device of  FIG. 1 .  
         [0012]      FIG. 4  is an exploded view from a lower right-hand side vantage point of sample storage platter of  FIG. 3 .  
         [0013]      FIG. 5  is an exploded view of biopsy device of  FIG. 1  with the handle housing and sample storage platter omitted.  
         [0014]      FIG. 6  is a detail view of the firing mechanism of the assembled biopsy device of  FIG. 2  with omitted handle housing. 
     
    
     DETAILED DESCRIPTION  
       [0015]     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.  
         [0016]     Turning to the drawings, wherein like numerals denote like components throughout the several views, in  FIGS. 1-2 , an exemplary biopsy device  10  has a biopsy needle (probe)  12  extending distally from a manually positioned and actuated handle  14 . With particular reference to  FIG. 2 , a front trigger  16  downwardly extends pivotally from a handle base  18 . A rear handle  20  extends from the handle base  18  aft of the front trigger  16 . Actuation of front trigger  16  operates a firing mechanism  22  supported by the handle base  18  that longitudinally translates and rotates a hollow cutter  24  within a probe cannula  26  whose proximal end is attached to a probe mount  28  integral to the handle base  18 . The cutter  24  translates across a side aperture  30  near a distal piercing tip  32  of the probe cannula  26 . A sample storage platter  34  presents a plurality of radial sample cavities  36  that communicate with a central axial vacuum conduit  38  that is externally attached to a vacuum pump or institutional pneumatic supply (not shown). In particular, during an exemplary use of biopsy device  10 , a vacuum draws tissue samples into cavities  36  as described in greater detail below. In  FIG. 1 , a handle housing  40  mates to the handle base  18  to encompass the firing mechanism  22  and to support for rotation the sample storage platter  34 . Of course, these components are merely exemplary, and a variety of alternative components may be used in any other suitable combination. It will also be appreciated that some embodiments of a biopsy device  10  may be operable by a single hand of a user to obtain a biopsy sample.  
         [0017]     As shown in  FIGS. 3-4 , the handle housing  40  of the present example includes an upwardly open, cylindrical recess  42  shaped to closely receive the inserted sample storage platter  34 . A bottom surface  44  of the cylindrical recess  42  includes an anti-rotation hole  46  just aft of a central mounting hole  48 . A distally extending radial rib  50  and a proximally extending radial rib  52  form a longitudinally aligned diagonal on the bottom surface  44  for serving as an alignment feature, relatively spaced so that a cylindrical axle  54  may be received therebetween with an anti-rotation post  56  extending down into the anti-rotation hole  46  of the handle housing  40 . A central post  58  of the cylindrical axle  54  extends downwardly for being received by the central mounting hole  48  and serves as a hose nib for receiving a distal end of the axial vacuum conduit  38  from below the bottom surface  44  of the handle housing  40 . The central post  58  pneumatically communicates with a front port  60  on the cylindrical axle  54 . In addition, a screen (not shown), filter, or other structure may be provided within the front port  60 , between the front port  60  and an adjacent cavity  36  (e.g., as described below with respect to cylindrical body  74 , etc.), or elsewhere, to permit fluid (e.g., liquid, air, etc.) to be drawn through the port  60  while preventing tissue samples from being drawn into the port  60 . Alternatively, a storage platter  34  may be incorporated into a biopsy device  10  in any other suitable fashion using any other suitable structures or techniques.  
         [0018]     The sample storage platter  34  of the present example is assembled from a capped cylindrical bushing  62  whose top horizontal ring  64  resides within a top shallow annular recess  66  formed on a top surface  68  of a top disk  70  surrounding a central aperture  72  through which a cylindrical body  74  of the bushing  62  passes with an inner diameter  76  dynamically sealing for rotation to an upper portion of the cylindrical axle  54  adjacent to the front port  60 . In some embodiments, a screen (not shown), filter, or other structure is provided within the cylindrical body  74  of the bushing  62  to permit fluid (e.g., liquid, air, etc.) to be drawn through the cylindrical body  74  while preventing tissue samples from being drawn into the cylindrical body  74 . By way of example only, the cylindrical body  74  may itself be formed entirely of a screen. Other ways in which filtration may be provided will be apparent to those of ordinary skill in the art.  
         [0019]     The top disk  70  has a pair of upwardly extending and radially aligned drawer pull style grips  78  on opposite sides of the central aperture  72  for manual rotation of the sample storage platter  34  and/or removal of the storage platter  34  from the biopsy device  10 . It will be appreciated by those of ordinary skill in the art, though, that grips  78  are merely exemplary, and that grips  78  may be substituted or supplemented by any other suitable structure (like any other component described herein), or may be omitted altogether.  
         [0020]     By way of example only, an alternative embodiment may provide mechanically automated rotation and/or ejection of platter  34 . For instance, a mechanism (not shown) may be coupled with trigger  16  or some other component to cause platter  34  to rotate to present an empty cavity  36  to cutter  24  after a biopsy sample has been obtained. Such a mechanism may thus cause platter  34  to cycle the cavities  36  in an automatic fashion as each biopsy sample is obtained using biopsy device  10 . Suitable mechanisms for accomplishing such cavity  36  cycling, and ways in which such mechanisms may be incorporated into a biopsy device  10 , will be apparent to those of ordinary skill in the art. As another merely illustrative example, a transmission and clutch (neither shown) may be provided in communication with a motor  110 , whereby each actuation the trigger  16  combined with a subsequent release of the trigger  16  causes the clutch to couple the motor  110  with the platter  34  via the transmission in a manner sufficient to transfer rotation from the motor  110  to the platter  34  in a manner sufficient to align the next empty holding cavity  36  with the cutter  24 . Suitable gearing ratios and other methods for accomplishing such rotation of a platter  34  by a motor  110  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 the platter  34  during biopsy procedures.  
         [0021]     In the present example, a plurality of radially spaced indicating grooves  80  are formed on the top surface of the top disk  70  of platter  34  indicating the location of corresponding radial sample cavities  36 , though any other suitable indication may be used, to the extent that any indication is used. A top half of each cavity  36  is defined by grooves  82  formed on an undersurface  84  of the top disk  70 . A bottom half of each cavity  36  is formed as a groove  92  formed on an upper surface  94  of the bottom disk  90 . An O-ring seal  61  ( FIG. 3 ) serves as a dynamic seal for the cavities  36  formed by grooves  82 ,  92  of the top and bottom disks  70 ,  90 , reducing leakage between the outer opening defined by each cavity  36  and the cylindrical recess  42  during use of biopsy device  10 .  
         [0022]     Rotation of the bottom disk  90  is communicated to the top disk  70  by two pairs of posts  86  extending downwardly from the undersurface  84  of the top disk  70  and received into corresponding attachment holes  88  formed in a bottom disk  90 . A bottom surface  96  of the bottom disk  90  includes a downwardly projecting central cylindrical lip  98  about a central aperture  100  of the bottom disk  90 . The inner diameter of the cylindrical lip  98  has an O-ring recess  102  that receives an O-ring  104  positioned thereby to seal about the circumference of the cylindrical axle  54  below the front port  60 . An outer cylindrical lip  106  extends downwardly from the outer circumference of the bottom disk  90  and includes radially spaced bottom notches  108  that correspond to each groove  92  and interact when aligned with the radial ribs  50 ,  52  to serve as detents for tactile feedback of proper alignment of the front port  60  to a selected sample cavity  36 . In other embodiments, a platter  34  is formed as a single piece rather than having a top disk  70  and bottom disk  90 . Alternatively, a platter  34  may be constructed in any other suitable way using any other suitable components.  
         [0023]     Various components of the sample storage platter  34  may be formed of transparent or translucent materials to allow verification of a sample received within each cavity  36 . In addition, the materials may be selected for not interfering with various diagnostic imaging modalities. For example, omitting ferrous materials may avoid safety issues near a strong magnetic field of a magnetic resonance imaging (MRI) machine. In addition, materials may be chosen to avoid artifacts or blocking of an imaging modality (e.g., computer aided tomatography (CT), MRI, etc.) so that preliminary tests can be made to confirm calcifications have been sampled to confirm correlation to a targeted suspicious lesion. Other suitable materials and properties that may be used will be apparent to those of ordinary skill in the art.  
         [0024]     It should be appreciated that a filter may partially obstruct an inner end of each radial sample cavity  36  to allow air and liquid to be drawn away through the vacuum conduit  38  while retaining a sample in the sample storage platter  34 . The attachment of the top disk  70  to the bottom disk  90  may also be readily detachable for retrieval of each sample. Alternatively, a platter  34  may otherwise be configured or manipulated for removal of tissue samples therefrom.  
         [0025]     As shown in  FIGS. 2, 5  and  6 , the firing mechanism  22  of the present example employs the front trigger  16  for translation and a DC motor  110  with integral stored power for rotation of the cutter  24 . Forward and aft transverse supports  112 ,  114  extend upwardly from the handle base  18  to support the DC motor  110 . It will be appreciated, however, that the DC motor  110  is merely exemplary, and that a variety of alternative components may be used to rotate the cutter  24 . For instance, any other type of motor (e.g., pneumatic, etc.) may be used. In other embodiments, cutter  24  does not rotate, such that the biopsy device  10  simply lacks a motor  110  or similar device altogether. It should also be understood that the term “rotate” may include a cutter  24  oscillating or rocking back and forth about an axis defined by the cutter  24 .  
         [0026]     In other words, “rotation” need not be limited to one or more full rotations by a cutter  24  about an axis defined by the cutter  24 .  
         [0027]     Distal to the forward transverse support  112 , longitudinally aligned left and right trough tabs  116 ,  118  extend upwardly to laterally receive and grip a narrowed rectangular portion  120  of a support structure  122  having a longitudinally aligned and upwardly open channel  124  along a top surface of the narrowed rectangular portion  120  that is upwardly closed by an undersurface of the handle housing  40  to form a sample conduit between a proximal opening of the cutter  24  and the selected radial sample cavity  36 . Of course, a sample conduit between the cutter  24  and a selected radial cavity  36  may be provided in a variety of alternative ways by a variety of alternative structures, as will be appreciated by those of ordinary skill in the art.  
         [0028]     The support structure  122  also includes a transverse, downwardly projecting tab  126 , which is just distal to the narrowed rectangular portion  120 , and which has a shaft hole  128  that supports a proximal exposed portion of a distally projecting drive shaft  130  of the DC motor  110 . A transverse, upwardly projecting aft spur gear support  132  extends upwardly from the handle base  18  distal to and parallel with the downwardly projecting tab  126  to receive and support a distal end of the drive shaft  130 . A transversely aligned drive belt  134  resides between the tab  126  and gear support  132 , contacting a lower portion of the drive shaft  130  and going over a belt pulley  136  on a proximal end of a longitudinally aligned spur gear shaft  138 . Distal to the belt pulley  136 , a rivet shaped aft bearing  140  on the shaft  138  engages an upwardly open half cylinder recess  142  formed on top of the gear support  132 . A front end of the shaft  138  includes a rivet-shaped front bearing  144  that engages an upwardly open half cylinder recess  146  formed on top of a front gear support  148 . An elongate spur gear  150  resides between the aft and front gear supports  132 ,  148  for rotation by the shaft  138  centered therein. Activation of the DC motor  110  turns the drive belt  134  and thus the spur gear  150 .  
         [0029]     To the left of the spur gear  150 , forward and aft left-side longitudinally aligned rectangular tabs  152 ,  154  extend upwardly from the housing base  18  and are spaced to define an upwardly open left trigger vertical slot  156  to receive a left pivot pin  158  extending laterally from a horizontal pivot axis  160  of the front trigger  16 .  
         [0030]     To the right of the spur gear  150 , forward and aft right-side longitudinally aligned rectangular tabs  160 ,  162  extend upwardly from the housing base  18  and are spaced to define an upwardly open right trigger vertical slot  166  to receive a right pivot pin  168  extending laterally from the front trigger  16 . Left and right trigger fork tines  169 ,  170  extend upwardly from the horizontal pivot axis  160  of the front trigger  16 , and are allowed to move longitudinally within respective cavities formed beneath the handle housing  40  between the spur gear  150  and respective pairs of tabs  152 ,  154  and tabs  162 ,  164 .  
         [0031]     A cutter shuttle  172  has a transverse, flat half ring  174  arching overtop of and spaced away from the spur gear  150  and attached on lateral sides to longitudinally aligned left and right elongate skids  176 ,  178  that slide on top respectively of the left tabs  152 ,  154  and right tabs  162 ,  164 . An upwardly open rounded notch  180  formed at an apex of the half transverse flat ring  174  is engaged to a rivet-shaped cutter bearing  182  attached to a proximal end of the cutter  24 . A follower spur gear  184  just distal to the cutter bearing  182  is also attached to the cutter  24  and is in gear engagement with the elongate spur gear  150  for rotation of the cutter  24 . The cutter shuttle  172  may be urged distally by forward travel of the trigger tines  169 ,  170  as the forward trigger  16  is depressed aft. Upon release of the forward trigger  16 , a compression spring  186  that resides on the cutter  24  between the probe mount  28  and the follower spur gear  184  provides a retracting force to the cutter  24 . The cutter  24  maintains communication with the channel  24  during the range of translation.  
         [0032]     In one merely exemplary use, a clinician depresses the trigger  16  of the biopsy device  10  to advance the cutter  24 , closing the side aperture  30  in the probe  12 , and inserts the probe  12  into tissue adjacent to a suspicious lesion, by gripping the rear handle  20 , perhaps guided by ultrasonic imaging. Vacuum is provided through vacuum conduit  38  through the biopsy device  10  to side aperture  30  in the probe  12  to prolapse tissue into the side aperture  30 . With the DC motor  110  activated, the cutter  24  rotates as the front trigger  16  is depressed, translating the cutter  24  across the side aperture  30 , severing prolapsed tissue. Vacuum pressure draws the severed tissue sample into a distally aligned one of the radial sample cavities  36  in the sample storage platter  34 . Then the probe  12  is repositioned if desired for an additional sample, and the grips  78  are manipulated to reposition an empty radial sample cavity  36  in the sample storage platter  34 , and the process is repeated. Then the sample storage platter  34  may be lifted from the handle housing  40  for transport to pathology or on the spot imaging to verify appropriate samples. Although not shown, the packaging of individual platters  34  may serve as a fluid tight reusable package for transporting the used platter  34  to pathology. The samples may be extracted thereafter by pulling or drawing from the radial sample cavity  36  or by removal of the top disk  70  for direct access. Of course, these uses are merely exemplary, and those of ordinary skill in the art will appreciate that the biopsy device  10  of the present example and the numerous variations thereof may be used in a variety of alternative ways.  
         [0033]     In some embodiments, the cutter  24  remains in constant rotation, independent of any actuation of the front trigger  16 . 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 the motor  110  to cause rotation of cutter  24 . In other embodiments, a switch (not shown) may be operably coupled with the front trigger  16 , such that a motor  110  begins rotating the cutter  24  as soon as the front trigger  16  is moved from a default position or is otherwise engaged or actuated. Alternatively, any other suitable structures, devices, or methods of activating a motor  110  may be used. In other embodiments, drive motor  110  is omitted altogether, and cutter  24  rotates using some other device or technique, or simply does not rotate at all.  
         [0034]     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.  
         [0035]     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.  
         [0036]     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.  
         [0037]     For example, a thumbwheel may included that allows rotation of the probe cannula  26  to orient the side aperture  30 .  
         [0038]     For another example, while manual translation of the cutter  24  provides 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.  
         [0039]     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.  
         [0040]     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.  
         [0041]     Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.  
         [0042]     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.  
         [0043]     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.  
         [0044]     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.  
         [0045]     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.