Patent Publication Number: US-2016220234-A1

Title: Multiple sample biopsy device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/111,821, filed Feb. 4, 2015, the disclosure of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     Needle biopsy procedures are common for the diagnosis and the staging of disease. For example, a percutaneous biopsy needle may be introduced through an incision in the skin to a target tissue site. In certain clinical situations it may be difficult to acquire a suitable sample via a single pass of the needle to the target site. The more cells or tissue that can be acquired, the greater the potential for a definitive diagnosis. Multiple insertions of the biopsy needle, however, may increase a risk of infection and/or seeding of healthy tissue with unhealthy tissue. 
     SUMMARY OF THE DISCLOSURE 
     The present disclosure is directed to a device for acquiring a tissue sample, comprising an outer sheath extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough along with an inner needle extending longitudinally from a proximal end to a distal end and sized and shaped to be slidably received within the lumen of the outer sheath to be moved between an insertion configuration and a tissue collecting configuration and a handle assembly connected to a proximal end of the outer sheath and including a first port configured to be connected to a fluid flushing source and a second port configured to be connected to a collection element so that, when the inner needle is drawn proximally relative to the outer sheath to the tissue collection configuration, the sample is flushable into the collection element. 
     In an embodiment, the needle includes a notch extending laterally therein along a distal portion thereof so that, in the insertion configuration the notch is proximal of the distal end of the outer sheath and in the tissue collecting configuration the notch is distal of the distal end of the outer sheath 
     In an embodiment, the handle assembly may include a first handle member connected to the proximal end of the outer sheath and a second handle member connected to the proximal end of the inner needle, the first handle member including a handle lumen through which a portion of the second handle is slidably received. 
     In an embodiment, the first and second handle members may be longitudinally movable relative to one another to move the device between the insertion configuration and the tissue collection configuration. 
     In an embodiment, the first and second ports may be diametrically opposed from one another along a housing of the first handle member so that in the sample collection configuration the notch of the needle is aligned between the first and second ports. 
     In an embodiment, the first and second handle members may be rotatable relative to one another about a longitudinal axis of the device to move the device between a locked configuration, in which the needle and the outer sheath are not movable relative to one another between the insertion and sample collection configurations, and an unlocked configuration in which the needle and the outer sheath are movable relative to one another between the insertion and sample collection configurations. 
     In an embodiment, the first and second handle members may be keyed relative to one another and include a corresponding groove and pin. 
     In an embodiment, one of the inner sleeve and the outer sheath may extend along a substantially straight line. 
     In an embodiment, one of the inner sleeve and the outer sheath may extend along a curve. 
     In an embodiment, the handle assembly may include a spring biasing the device toward the insertion configuration. 
     The present disclosure is also directed to a biopsy needle, comprising an outer sheath extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough along with an inner needle extending longitudinally from a proximal end to a distal end and sized and shaped to be slidably received within the lumen of the outer sheath to be moved between an insertion configuration and a tissue collecting configuration, the needle including a notch extending laterally therein along a distal portion thereof, in the insertion configuration the notch is proximal of the distal end of the outer sheath and in the tissue collecting configuration the notch is distal of the distal end of the outer sheath and a handle assembly including a first handle member connected to a proximal end of the outer sheath and a second handle member connected to the proximal end of the inner needle, the first and second handle members longitudinally movable relative to one another to move the inner needle and the outer needle relative to one another between the insertion configuration and the tissue collection configuration, the first handle including a first port configured to be connected to a fluid flushing source and a second port configured to be connected to a tissue collection element so that, when the tissue sample is received within the notch and the inner needle is drawn proximally relative to the outer sheath to a sample collection configuration, the tissue sample is flushable from the notch into the tissue collection element. 
     In an embodiment, the handle assembly may include a spring element biasing the inner needle and outer sleeve toward the insertion configuration. 
     In an embodiment, the first and second handle members may be rotatable relative to one another about a longitudinal axis of the device to move the device between a locked configuration, in which the needle and the outer sheath are not movable relative to one another between the insertion and sample collection configurations, and an unlocked configuration in which the needle and the outer sheath are movable relative to one another between the insertion and sample collection configurations. 
     In an embodiment, the first and second handle members may be keyed relative to one another and include a corresponding groove and pin 
     In an embodiment, the first and second ports may be diametrically opposed from one another along a housing of the first handle member so that in the sample collection configuration the notch of the needle is aligned between the first and second ports. 
     In an embodiment, one of the inner needle and the outer sheath may extend along a curve. 
     The present disclosure is also directed to a method for acquiring a tissue sample, comprising inserting a distal portion of a biopsy device to a target tissue site within a patient body via a skin incision, the distal portion of the biopsy device including an outer sheath and an inner needle slidably received therein, the inner needle including a notch extending laterally therein along a distal portion thereof, moving the device from the insertion configuration, in which the notch of the inner needle is proximal of a distal end of the outer sheath, to a tissue collecting configuration in which the notch extends distally past the distal end of the outer sheath to collect a first tissue sample therein, advancing the outer sheath distally over the notch of the inner needle back to the insertion configuration to capture the first tissue sample in the notch, moving the inner needle proximally relative to the outer sheath until the notch is aligned between a first port and a second port of a handle assembly connected to a proximal end of the outer sheath, and flushing the first tissue sample from the notch by passing a fluid through the first port into the notch and collecting the first tissue sample in a tissue storage element connected to the second port. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary aspects and together with the description, serve to explain the principles of the disclosed examples. 
         FIG. 1  shows a perspective view of a device according to an exemplary embodiment of the present disclosure; 
         FIG. 2  shows a partial longitudinal cross-sectional view of a distal portion of the device of  FIG. 1 ; 
         FIG. 3  shows a longitudinal side view of a curved outer sheath of the device of  FIG. 1 ; 
         FIG. 4  shows a longitudinal side view of a curved inner needle of the device of  FIG. 1 ; 
         FIG. 5  shows a perspective view of a handle assembly of the device of  FIG. 1 ; 
         FIG. 6  shows a side view of the handle assembly of  FIG. 5 , in a locked configuration; and 
         FIG. 7  shows a side view of the handle assembly of  FIG. 5 , in an unlocked configuration. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure is directed to a biopsy device. Exemplary embodiments of the present disclosure describe a biopsy device comprising an outer sheath through which an inner sampling needle may be slidably received so that the inner needle may be removed from and inserted into the target site via the outer sheath, as desired, to collect multiple tissue samples from the target site. A tissue sample may be flushed from the inner needle and collected within a collection vial connected to a handle housing of the device so that the inner needle may be reinserted to the target site to collect additional tissue samples. It should be noted that the terms “proximal” and “distal” are intended to refer to a direction toward (proximal) and away from (distal) a user of the device. 
     As shown in  FIGS. 1-7 , a biopsy device  100  according to an exemplary embodiment of the present disclosure comprises an outer sheath  102  and an inner needle  104  slidably received within a lumen  106  of the sheath  102  so that the needle  104  and the sheath  102  are movable relative to one another between an insertion/withdrawal configuration and a tissue collecting configuration. The needle  104  includes an opening or notch  110  extending laterally through a distal portion thereof for collecting a tissue sample therein. The device  100  further comprises a proximal portion including a handle assembly  112  which, when the sheath  102  and the needle  104  are inserted to a target tissue in a patient body via an incision in the skin, remains outside of the patient body. The handle assembly  112  is configured to move the sheath  102  and the needle  104  between the insertion/withdrawal configuration, in which the needle  104  is housed substantially within the sheath  102  so that the notch  110  is covered by a portion of the sheath  102 , and the tissue collecting configuration, in which the notch  110  is distal of a distal end  118  of the sheath  102  to collect a tissue sample from the target tissue therethrough into the notch  110 . The handle assembly  112  also includes a flushing port  114  and a collection port  116  connectable to, for example, a fluid flushing syringe and a collection vial, respectively, to permit the tissue sample collected in the notch  110  to be drawn back through the lumen  106  and into the handle assembly  112  so that the tissue sample may be flushed therefrom into the collection vial connected to the collection port  116  without removing the outer sheath  102  from the patient body. Thus, multiple tissue samples may be obtained using the device  100  without having to reinsert the device  100  into the patient body. This reduces the risk of infection and seeding of healthy tissue with unhealthy tissue. 
     The sheath  102  extends longitudinally from a proximal end  120  to the distal end  118  and includes the lumen  106  extending longitudinally therethrough from the proximal end  120  to the distal end  118 . The distal end  118  may include a sharpened tapered tip to facilitate piercing of the target tissue. In one exemplary embodiment, the sheath  102  may extend along a substantially straight line. In another exemplary embodiment, the sheath  102  may extend along a curve so that the sheath  102  may extend into the target tissue off-axis and/or may be rotated about a longitudinal axis of the device  100  to collect tissue at different orientations. The sheath  102  may be formed of a metal material such as stainless steel or nitinol, which may be formed into a desired shape such as, for example, a curve. 
     The needle  104  extends longitudinally from a proximal end to a distal end  124 , which may be tapered for piercing tissue as it is inserted therethrough. The notch  110  extends along a distal portion of the needle  104  so that when the needle  104  is advanced distally out of the sheath  102 , the notch  110  is exposed to receive a tissue sample therein. Similarly to the outer sheath  102 , the needle  104  may extend along a substantially straight line or may extend along a curve to be inserted into tissue off-axis and/or rotated to collect tissue from different orientations. The needle  104  may be formed of any suitable metal such as, for example, stainless steel or nitinol. 
     The needle  104  is sized and shaped to be slidably received within the lumen  106  of the outer sheath  102  so that the needle  104  may be moved between the insertion/withdrawal configuration and the tissue collecting configuration. In the insertion/withdrawal configuration, the needle  104  may be housed substantially within the outer sheath  102  so that the distal end  124  of the needle  104  does not extend distally past the distal end  118  of the outer sheath  102 . In this insertion/withdrawal configuration, the sheath  102  extends over the needle  104  so that the notch  110  thereof is covered by an interior surface of the sheath  102  to prevent any tissue from being collected therein. In the tissue collecting configuration, the needle  104  is moved distally relative to the outer sheath  102  so that the distal end  124  of the needle  104  extends distally past the distal end  118  of the sheath  102  into the target tissue. Thus, a sample of the target tissue may be collected within the notch  110 . Upon collection of the tissue sample within the notch  110 , the device  100  is once again moved to the insertion/withdrawal configuration to capture the tissue sample therewithin. In particular, the sheath  102  may be advanced over the needle  104  so that the sharpened distal end  118  of the sheath  102  cuts the tissue sample from the surrounding tissue as it is being moved distally over the needle  104 . 
     The handle assembly  112  further includes a first handle member  126  connected to the proximal end  120  of the sheath  102  and a second handle member  128  connected to the proximal end of the needle  104 . The first and second handle members  126 ,  128  are movable relative to one another to move the sheath  102  and the needle  104  between the insertion/withdrawal configuration and the tissue collecting configuration. The first and second handle members  126 ,  128  are also releasably coupled to one another so that the second handle member  128  may be disengaged from the first handle member  126  to draw the needle  104  proximally relative to the outer sheath  102  from the insertion/withdrawal configuration to a sample retrieving configuration in which a tissue sample collected within the notch  110  may be flushed and collected within a collection vial or other tissue sample collecting reservoir via the ports  114 ,  116 , as will be described in further detail below. 
     The first handle member  126  may include an elongated housing  130  including a handle lumen extending longitudinally therethrough and fingerloops  132  at a proximal end  134  thereof. Each of the first and second ports  114  include luer lock fittings, or any other connection features, for connecting the first and second ports  114 ,  116  to, for example, a fluid flushing syringe and collection vial, respectively. The first and second ports  114 ,  116  may extend from a portion of the housing  130  on, for example, diametrically opposing sides of the housing  130  so that, in the sample retrieving configuration, the second handle  128  may be moved proximally relative to the first handle  126  until the notch  110  of the needle  104  is aligned between the first and second ports  114 ,  116 . The first and second ports  114  are open to the handle lumen  122  so that, when the notch  110  is positioned therebetween, fluid (e.g., saline) may be passed through the first port  114  and into the notch  110  to flush the tissue sample therefrom, through the second port  116  into the collection vial connected thereto. Although the first and second ports  114 ,  116  are described as being connectable to a fluid syringe and collection vial, respectively, it will be understood by those of skill in the art that the first and second ports  114 ,  116  may be connected to any of a variety of fluid flushing sources and tissue collection or storage elements. 
     The second handle member  128  may include a handle shaft  136  extending longitudinally and a fingerloop  138  at a proximal end  140  thereof, the fingerloop  138  may be particularly sized and shaped to receive a thumb of a user therein. The handle shaft  136  is sized and shaped to be slidably received within the handle lumen  122  so that the first and second handle members  126 ,  128  are movable between the insertion/withdrawal configuration and the tissue collecting configuration and between the insertion/withdrawal configuration and the sample retrieving configuration. In one exemplary embodiment, the handle assembly  112  may further include a spring  142  housed within the handle lumen  122  between portions of the housing  130  and the handle shaft  136  so that the device  100  may be “cocked” to facilitate a rapid firing of the device  100 . The spring  142  biases the device  100  toward the insertion/withdrawal configuration so that when the second handle member  128  is drawn proximally relative to the first handle  126  (cocking the device  100 ), a tension is applied to the spring  142 . Thus, when the device  100  is “fired” by pushing the second handle  128  distally with respect to the first handle  126  to move the device  100  from the insertion/withdrawal configuration to the tissue collecting configuration, the spring  142  is compressed and quickly reverts toward its biased configuration, moving the sheath  102  distally over the needle  104  so that the device  100  is once again in the insertion/withdrawal configuration. As discussed above, movement of the sheath  102  distally over the needle  104  cuts the tissue sample received within the notch  110  from a surrounding tissue while capturing the tissue sample therein. 
     The first and second handle members  126 ,  128  are also releasably coupled to one another so that, upon collection of a tissue sample within the notch  110 , the first and second handle members  126 ,  128  may be disengaged from one another to permit the second handle member  128  to be drawn proximally out of the first handle member  126  until the device  100  is in the sample retrieving configuration. The handle lumen  122  and the handle shaft  136  may be keyed relative to one another so that, the second handle member  128  is rotatable about a longitudinal axis thereof relative to the first handle  126  (e.g., approximately 90 degrees) between a locked and unlocked position. In particular, in the cocking and firing positions described above, the handle assembly  112  is in the locked position. Rotation of the second handle  128  relative to the first handle  126  unlocks the handle assembly  112 , permitting the second handle  128  to be withdrawn from the first handle  126 . In one example, the handle lumen  122  and the handle shaft  136  may include a corresponding groove and pin configured to permit movement between the locked and unlocked positions. 
     According to an exemplary method for collecting a tissue sample using the device  100 , a distal portion of the device  100  is inserted into a patient body in the locked insertion/withdrawal configuration. In particular, the sheath  102  and the needle  104  are inserted to a target tissue site within a patient body via an incision in the skin so that the handle assembly  112  remains outside of the patient body. Once inserted into the target tissue site, the device  100  may be cocked by drawing the second handle  128  proximally relative to the first handle  126 . The device  100  is then fired by pushing the second handle  128  distally relative to the first handle  126  so that the device  100  is moved from the insertion/withdrawal configuration to the tissue collecting configuration. As the notch  110  is moved distally past the distal end  118  of the sheath  102 , a first tissue sample is received within the notch  110 . As described above, the spring  142  biases the device  100  toward the insertion/withdrawal configuration so that upon firing of the device  100 , the spring  142  quickly reverts to its biased configuration, moving the sheath  102  distally over the needle  104  to capture the tissue sample within the notch  110 . 
     Once the first tissue sample has been collected and captured within the notch  110 , the second handle  128  may be rotated about the longitudinal axis relative to the first handle  126  to move the handle assembly  112  to the unlocked configuration. In the unlocked configuration, the second handle  128  may be withdrawn from the first handle  126  until the notch  110  of the needle  104  is aligned between the first and second ports  114 ,  116  of the first handle  126  so that the tissue sample may be flushed from the notch  110  via, for example, a fluid flushing syringe connected to the first port  114  and collected within, for example, a collection vial connected to the second port  116 . The first tissue sample is flushed into the collection vial without removing the sheath  102  from the target tissue site. Thus, once the tissue sample has been flushed from the notch  110 , the needle  104  may be reinserted into the sheath  102  and the handle assembly  112  once again moved to the locked configuration so that the device  100  may be cocked and fired to collect a second tissue sample. In embodiments in which the sheath  102  and/or the needle  104  extend along a curve, the device  100  may be rotated prior to firing the device  100  a second time, so that the second tissue sample may be collected from a different area of the target tissue. The first and second ports  114 ,  116  permit multiple samples to be collected by the device  100 , without having to remove and insert the device  100  from the patient body, reducing the risk of infection and/or seeding of healthy tissue with unhealthy tissue. 
     It will be apparent to those skilled in the art that variations can be made in the structure and methodology of the present disclosure, without departing from the scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided that they come within the scope of the appended claims and their equivalents.