Patent Publication Number: US-2010125283-A1

Title: Universal needle guide

Description:
TECHNICAL FIELD 
     The present disclosure relates generally to a needle guide suitable for use in a stereotactic biopsy system and more particularly to a single needle guide compatible with multiple needle gauges. 
     BACKGROUND 
     Stereotactic breast biopsy systems are a precise, minimally invasive diagnostic tool for use in performing fine-needle aspiration and needle core biopsies of the human breast to determine whether a breast lesion is benign or malignant. Needle biopsies, unlike more invasive surgical procedures, are typically performed on an out-patient basis with local anesthesia. Stereotactic breast biopsy systems, for example, generally include an ergonomically contoured table that comfortably supports the patient in a stable, fixed position that exposes the patient&#39;s breast. Stereotactic breast biopsy systems also generally include a diagnostic imaging system for targeting the lesion to be biopsied. The location of the target lesion is used by a guidance system to guide insertion of the biopsy needle into the patient&#39;s breast tissue. 
     The biopsy needle used in a stereotactic breast biopsy is typically a component of a biopsy gun, which is supported by the guidance system in an appropriate holder. The biopsy needle is relatively long requiring the holder to include a support bracket to reduce deflection of the biopsy needle during deployment and use. The support bracket typically includes a needle guide at a distal end thereof through which the biopsy needle passes. The needle guide minimizes movement or deflection of the biopsy needle during a biopsy to ensure that the biopsy needle is inserted into the correct location of the patient&#39;s breast adjacent the target lesion. 
     Typical biopsy needle guides include an upper support portion having a hole through which the biopsy needle extends and a lower attachment portion that is removably secured to the support bracket. Each needle guide is configured with a predetermined sized hole that receives a corresponding sized needle. In other words, individual needle guides are only compatible with one needle diameter or gauge. That is, a 9 gauge needle guide is needed for 9 gauge needles and a 12 gauge needle guide is needed for 12 gauge needles. Not only does this require users to carry multiple needle guides, but it requires the user to remove the needle guide and replace it every time a different needle gauge is needed during a biopsy. Therefore, the limitations specifically minimized and/or eliminated by the present disclosure include the need for multiple needle guides due to the single gauge compatibility of current needle guides. 
     In addition, there exists a need to provide a needle guide that may be secured in the Z direction, as current needle guides are attached in the X and Y directions, and are therefore subject to accidental movement or repositioning of the needle guide. 
     SUMMARY 
     A universal needle guide is disclosed comprising a body, a first needle aperture and a second needle aperture. The body includes an upper support portion and at least one attachment portion. The first needle aperture defines a first diameter disposed in the upper support portion. The second needle aperture defines a second diameter that is selectively alignable with the first needle aperture. The second diameter is smaller than the first diameter. Multiple arrangements are disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The features and inventive aspects of the present disclosure will become more apparent upon reading the following detailed description, claims, and drawings, of which the following is a brief description: 
         FIG. 1  is a perspective view of a universal needle guide. 
         FIG. 2  is a perspective view of another arrangement of a universal needle guide after a faceplate has been engaged. 
         FIG. 3  is a perspective view of another arrangement of a universal needle guide with a slidably engaged faceplate. 
         FIG. 4  is a perspective view of another arrangement of a universal needle guide with a slidably engaged plate. 
         FIG. 5  is a perspective view of another arrangement of a universal needle guide with a rotary collar. 
         FIG. 6A  is an exploded view of a universal needle guide with a push plug actuator. 
         FIG. 6B  is an elevational side view of a universal needle guide with a fully actuated push plug. 
     
    
    
     DETAILED DESCRIPTION 
     Referring now to the drawings, illustrative embodiments of the present disclosure are shown in detail. Although the drawings represent embodiments of the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate and explain the disclosure. Further, the embodiments set forth herein are not intended to be exhaustive or otherwise limit or restrict the disclosure to the precise forms and configurations shown in the drawings and disclosed in the following detailed description. 
       FIG. 1  illustrates a universal needle guide  10  compatible with biopsy devices having at least two needle diameters or gauges. In one exemplary arrangement, the universal needle guide  10  is a unitary member that may be formed through injection molding, although some or all components of the guide could be formed separately and assembled prior to use. While an exemplary universal needle guide  10  is shown in  FIG. 1 , the features illustrated in the Figure are not intended to be limiting. 
     The universal needle guide  10  in  FIG. 1 , includes a body  12  having an upper support portion  14 , a faceplate  16 , and at least one attachment portion  18 ,  20 . The upper support portion  14  has a front surface  22 , and a back surface  24 . In one embodiment, the front surface  22  is recessed to accommodate the faceplate  16 , discussed in further detail below. The upper support portion  14  also includes a first needle aperture  26  extending therethrough, defining a first diameter D 1 . The first needle aperture  26  may be countersunk to define a countersunk surface  28  that facilitates alignment of a biopsy needle with the first needle aperture  26  as it passes through. 
     In one arrangement, faceplate  16  is pivotally attached to a surface of the upper support portion  14 . For example, in  FIG. 1  faceplate  16  is pivotally attached to a top surface  30  of the upper support portion  14 . However, the faceplate  16  could also be attached to the bottom surface  32  or either side surface  34  and  36  of the upper support portion  14  as shown in  FIG. 2 . In one embodiment, the faceplate  16  is pivotally attached using a living hinge  38 ; however, other types of mounts and fasteners could be used. Additionally, other methods of attachment such as slidable engagement, see  FIGS. 3 and 4  discussed below, are also contemplated. In  FIG. 1  when the faceplate  16  is pivoted about the living hinge  38  it is configured to align with the upper support portion  14 . 
     The faceplate  16  has a front surface  40 , a back surface  42  and a second needle aperture  44  that extends therethrough, defining a second diameter D 2 , best seen in  FIG. 2 . The second diameter D 2  of the second needle aperture  44  is less than the first diameter D 1  of the first needle aperture  26 . The second needle aperture  44  is positioned complimentary to the first needle aperture  26  so that the two apertures align when the faceplate  16  and the upper support portion  14  are mated. The second needle aperture  44  also may be countersunk to define a countersunk surface  46 , best seen in  FIG. 2 , that facilitates alignment of a biopsy needle with the second needle aperture  44  as it passes through. The disparate diameters of the faceplate  16  and the upper support portion  14  allow the universal needle guide  10  to be selectively compatible with a larger gauge needle when the faceplate  16  is in an open position, as illustrated in  FIG. 1 , and a smaller needle gauge when the faceplate  16  and the upper support portion  14  are mated, as illustrated in  FIG. 2 . 
     To ensure precise alignment of the biopsy needle when the faceplate  16  and upper support portion  14  are engaged, the faceplate  16  may further include a sleeve  48  that extends from second needle aperture  44 . The sleeve  48 , as best seen in  FIG. 1 , is aligned with the second needle aperture  44  and configured to extend through the recessed front surface  22  of the upper support portion  14  and align with the first needle aperture  26  when the faceplate  16  and the upper support portion  14  are mated. Thus, sleeve  48  helps prevent improper movement of the biopsy needle by further guiding the needle through the upper support portion  14  when the second needle aperture  44  is being used. Preventing improper movement is important in any biopsy procedure because improper movement of the biopsy needle relative to the guide during positioning could result in improper positioning. 
     To further ensure proper alignment of the biopsy needle and to prevent improper movement of the biopsy needle, the faceplate  16  and the upper support portion  14  can be lockingly engaged. In one arrangement, as shown in  FIG. 1 , the universal needle guide  10  may include a detent  50  disposed in the front surface  22  of the upper support portion  14  and configured to lockingly engage a complimentary locking tab  52  disposed on the faceplate  16 . The locking tab  52  and detent  50  secure the faceplate  16  and the upper support portion  14  in a mated position during use, best illustrated in  FIG. 2 . The upper support position  14  may also include a release notch  54  that enables a user to switch between different needle gauges while continuing to use the same needle guide  10 . Although one embodiment uses a tab and detent locking mechanism other locking mechanisms could be recognized by one of ordinary skill in the art. 
     The attachment portion of the universal needle guide  10  may include a lower attachment portion  18  and/or a slitted cannula  20 . In  FIGS. 1-5  the universal needle guide includes both the lower attachment portion  18  and the slitted cannula  20  so that the guide is compatible with various stereotactic table designs. Further, use of both a lower attachment portion  18  and a slitted cannula  20  serves to lock the universal needle guide  10  in at least two different directions. However, other embodiments of the universal needle guide  10  could be manufactured for a specific table design and include only one attachment portion. 
     In one exemplary arrangement, the lower attachment portion  18  extends downwardly from what would be generally considered the bottom surface  32  of the upper support portion  14 . In  FIG. 1  the lower attachment portion  18  includes a generally rectangular periphery  58  that defines an opening  59  to receive a portion of a stereotactic table. A detent  60  may also be included within the rectangular periphery  58  to lockingly engage the lower attachment portion  18  and the stereotactic table. The lower attachment portion  18  attaching in the z direction serves to lock the universal needle guide in both the x and y axes. However, as shown in  FIG. 2  and  FIG. 3  other configurations may be employed. For example, in  FIG. 2  the lower attachment portion  18 ′ includes a generally c-shaped cradling aperture  62  and a positioning slot  64 . In  FIG. 3 , the lower attachment portion  18 ″ includes a periphery  66  that defines an opening  67  to accommodate various sized rails. A clip  68  may extend from the periphery  66  to lockingly engage the lower attachment portion  18 ″ and the stereotactic table. A detent  69  may also be included within the periphery  66  to lockingly engage the lower attachment portion  18 ″ and the stereotactic table. 
     In general, the lower attachment portion  18  is removably secured to a support bracket (not shown) that is attached to the guidance system (also not shown) used in most stereotactic biopsy systems. Due to the density of breast tissue, for example, the forces imposed on the biopsy needle are not necessarily along the needle axis, but include a component of force perpendicular to the needle axis. Thus, the lower attachment portion  18  minimizes the movement of the universal needle guide  10  relative to the support bracket (i.e., the x and y axes) when the biopsy needle is deployed. 
     The slitted cannula  20  is aligned with the first needle aperture  26  and extends outwardly from the back surface  24  of the upper support portion  14 . The slitted cannula  20  is spring loaded or otherwise configured to be compatible with various sized support structures (not shown) disposed on stereotactic biopsy tables and serves to retain the universal needle guide  10  in the z direction. The outer surface  70  of the slitted cannula  20 , best seen in  FIG. 2 , has a release mechanism  72  disposed thereon. To remove the slitted cannula  20 , once engaged with a stereotactic biopsy table, the release mechanism  72  can be moved in a generally forward direction. Moving the release mechanism  72  causes the slitted cannula  20  to narrow and release from the stereotactic biopsy table. The needle guide  10  can then be removed and disposed. 
     The location of the slitted cannula  20  also aids in preventing deflection of the needle during positioning because after the biopsy needle is aligned with the first needle aperture  26  or second needle aperture  44 , depending on the needle gauge being used, the biopsy needle further extends into the slitted cannula  20 . 
       FIG. 3  illustrates another embodiment of a needle guide  110 . Needle guide  110  includes a faceplate  116  that is slidably engaged with an upper support portion  114 . In one embodiment, the front surface  122  of the upper support portion  114  is recessed defining a periphery  124  of the upper support portion  114 . In  FIG. 3  the periphery  124  defines the bottom surface  132  and two side surfaces  134  and  136  of the upper support portion  114  leaving the top surface  138  open to accommodate the sliding faceplate  116 . Other embodiments could include a periphery  124  defined by the top surface  138 , bottom surface  132 , and one of the side surface  134  or  136  such that the faceplate  116  is slidably engaged with the remaining side surface. In the arrangement shown in  FIG. 3 , the faceplate  116  is free to slide along the peripheral sides  134  and  136  of the upper support portion  114  such that the first needle aperture  126  and the second needle aperture  144  align when the faceplate  116  and the upper support portion  114  are slidably aligned. The two side surfaces  134  and  136  may include rails to accommodate the sliding faceplate  116 . 
     In  FIG. 3  the universal needle guide  110  may include a flexible detent  150  (shown in phantom) disposed in the bottom surface  132  or a top surface  138  of the upper support portion  114  and is configured to lockingly engage a complimentary locking tab  152  disposed on the faceplate  116 . The locking tab  152  and detent  150  secure the faceplate  116  and the upper support portion  114  in a mated position during use to prevent improper movement of the biopsy needle during positioning within a patient. Although one embodiment uses a tab and detent locking mechanism, other locking mechanisms could be recognized by one of ordinary skill in the art. 
       FIG. 4  is another embodiment of a universal needle guide  210  having at least one sliding plate. In  FIG. 4  an upper support portion  214  is defined by a bottom surface  232  and two side surfaces  234  and  236 . The first plate  202  is positioned within the upper support portion  214  such that the first plate  202  abuts the bottom surface  232  and the two side surfaces  234  and  236 , but does not extend the height of the side surfaces  234  and  236 . The first plate  202  also has a substantially v-shaped notch  226  centered on a top surface  204  of the first plate  202  and extending downwardly therefrom. A second plate  206  may also have a complimentary v-shaped notch  244  centered on the bottom surface  208  of the second plate  206  and extending upwardly therefrom. However, it is understood that the v-shaped notch  244  of the second plate  206  may be omitted. The second plate  206  is slidably engaged with the side surfaces  234  and  236  of the upper support portion  214 . 
     The second plate  206  is free to slide along the sides  234  and  236  of the upper support portion  214  such that a bottom surface  208  moves toward the top surface  204 . In one arrangement, the v-shaped notches  226  and  244  align. When the second plate  206  is slid upwardly, the space between the first plate  202  and the second plate  206  increases allowing the universal needle guide  210  to support a larger needle gauge. When the second plate  206  is slid downwardly, the universal needle guide  210  is capable of supporting a smaller needle gauge. Although  FIG. 4  illustrates a first plate  202  and a second plate  206  both slidably engaged with the upper support portion  214 , first plate  202  could be stationary. In one embodiment, the second plate  206  may include at least one locking tab  216  on at least one side  218  of second plate  206  to lock second plate  206  in a specific position. The locking tab  216  is positioned complementary to a plurality of notches  220  on at least one of side surfaces  234  and  236 ; however, other types of locking mechanisms could be used. 
     Other embodiments of the universal needle guide  210  may include various shaped openings or an opening in only one of the first plate  202  or second plate  206  so long as the biopsy needle is properly aligned between and supported by the plates to prevent movement during deployment. 
       FIG. 5  illustrates a universal needle guide  310  rotatably compatible with multiple needle gauges. The upper support portion  314  has a front surface  322 , a back surface  324 , and a needle aperture  326  extending therethrough. The upper support portion  314  also includes a chuck unit comprising a barrel  316  disposed within the needle aperture  326 , at least one clamping rods  318  positioned within the barrel  316 , and a rotary collar  320  raised around the periphery of the barrel  316 . A biopsy needle can be inserted into the axial center of the barrel  316  and the collar  320  can be turned clockwise causing the clamping rods  318  to move inwardly, thereby frictionally engaging the biopsy needle. To release the biopsy needle or increase the diameter of the needle aperture  326  to accommodate a larger needle gauge, the rotary collar  320  can be rotated counterclockwise. The relationship between the rotation of the collar  320  and the clamping rods  318  could be that of any chuck unit known to one of ordinary skill in the art. Thus, the rotary collar  320  allows the universal needle guide  310  to be compatible with various needle gauges by allowing the user to selectively narrow or increase needle aperture  326 . 
       FIGS. 6A and 6B  illustrate a universal needle guide  410  having a plug  412  that is slidably engaged with a first needle aperture  426 . Like previous embodiments, the upper support portion  414  has a front surface  422 , a back surface  424 , and the first needle aperture  426  extends therethrough. The plug  412  has a head  416  containing a second needle aperture  444  and pair of flexible legs  418  configured to facilitate alignment of the biopsy needle.  FIG. 6A  shows an exploded view of the plug  412  and the universal needle guide  410 . 
     In this embodiment of the universal needle guide  410 , the plug  412  has a non-actuated configuration and an actuated configuration. In the non-actuated configuration, the legs  418  extend inwardly from an outer surface of head  416  a predetermined length. The legs  418  define a diameter D 3  that is at least slightly larger than the first needle aperture  426 . Because the plug  412  is not actuated, a space  428  remains between the legs  418  facilitating alignment of a larger gauge biopsy needle. A biopsy needle (not shown) is inserted into the second needle aperture  444  while the plug  412  is in a non-actuated configuration. 
     To move the plug  412  into the actuated configuration shown in  FIG. 6B , the legs  418  of the plug  412  are slidably engaged with the first needle aperture  426  such that the sidewalls defining the first needle aperture  426  force the flexible legs  418  toward on another, thereby compressing the space  428 . By compressing the space  428 , the flexible legs  418  are forced to grip around the biopsy needle when the plug  412  has been pushed inwardly and is fully seated within the first needle aperture  426 . As shown in  FIG. 6B , the head  416  of the plug  412  is larger than the inner diameter of the first needle aperture  426  such that when the head  416  is pushed inwardly, it may abut the front surface  422 , but it will never be disposed within the first needle aperture  426 . The forward movement of the plug  412  forces the legs  418  further into the first needle aperture  426  causing a reduction in the space  428  between the legs  418  allowing the universal needle guide  410  to accommodate a smaller gauge biopsy needle. 
     Although certain preferred embodiments of the present disclosure have been described, the disclosure is not limited to the illustrations described and shown herein, which are deemed to be merely illustrative of the best modes of carrying out the disclosure. A person of ordinary skill in the art will realize that certain modifications and variations will come within the teachings of this disclosure and that such variations and modifications are within its spirit and the scope as defined by the claims.