Abstract:
An adaptor for an endoscopic device includes (a) a cylindrical core extending from a first end to a second end along a central axis and (b) a collar slidably received over the core. The second end includes first and second slots defining first and second arms which radially expandable toward the axis and away from the axis. The second end is sized and dimensioned to engage an end of a first conduit of a biopsy device. The collar extendes from a first end to a second end and being movable from a first position in which the second end of the collar is axially separated from the arms and a second position in which a portion of the collar is positioned over the arms radially compressing the arms to lockingly grasp a free end of a first conduit positioned therebetween to create a fluid-tight seal about the first conduit.

Description:
PRIORITY CLAIM 
       [0001]    The present application claims the priority to the U.S. Provisional Application Ser. No. 61/705,333, entitled “Biopsy Channel Attachment Adaptor” filed on Sep. 25, 2012. The specification of the above-identified application is incorporated herewith by reference. 
     
    
     BACKGROUND 
       [0002]    Bronchos copy is a technique of visualizing the inside of the airways for diagnostic and therapeutic purposes and includes an insertion of a bronchoscope into a patient&#39;s airways through the nose or mouth to allow a physician to examine the airways for abnormalities. An endobronchial ultrasound device may be used to provide further information to aid in diagnosis. Sizes and dimensions of biopsy channels provided in these ultrasound devices vary by manufacturer. Presently, endobronchial ultrasound devices are formed with one of a luer connection and a flange connection to permit engagement thereof with another medical device. A medical device designed for use with a biopsy channel of a particular ultrasound device is not necessarily compatible with a biopsy channel of any other ultrasound device. Thus, the physician is limited to only one particular model of the ultrasound device for use in a treatment procedure. There is a need for an adaptor which can provide a secure, fluid-tight connection between the treatment device and any suitable ultrasound device. 
       SUMMARY OF THE INVENTION 
       [0003]    The present invention relates to an adaptor for an endoscopic device including a cylindrical core extending from a first end to a second end along a central axis, the second end including first and second slots defining first and second arms, the arms being radially expandable toward the central axis and away from the central axis, the second end being sized and dimensioned to engage an end of a first conduit of a biopsy device and a collar slidably received over the core, the collar extending from a first end to a second end and being movable from a first position in which the second end of the collar is axially separated from the arms and a second position in which a portion of the collar is positioned over the arms radially compressing the alms to lockingly grasp a free end of a first conduit positioned therebetween to create a fluid-tight seal about the first conduit. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]    Several embodiments of the invention will be described in the following by way of example and with reference to the accompanying drawings in which: 
           [0005]      FIG. 1  shows a first perspective view of an adaptor according to an exemplary embodiment of the present invention; 
           [0006]      FIG. 2  shows a second perspective view of the adaptor of  FIG. 1 ; 
           [0007]      FIG. 3  shows a first cross-sectional view of the adaptor of  FIG. 1 ; 
           [0008]      FIG. 4  shows a second cross-sectional view of the adaptor of  FIG. 1 ; 
           [0009]      FIG. 5  shows a first partial see-through view of the adaptor of  FIG. 1 ; and 
           [0010]      FIG. 6  shows a second partial see-through view of the adaptor of  FIG. 1 ; 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    The present invention 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 invention relates to endoscopic devices and, more particularly, relates to devices for Endobronchial Ultrasound Aspiration (“EBUS”) or for Endobronchial Ultrasound Fine Needle Aspiration (“EBUS FNA”). In particular, the invention relates to an adaptor removably attachable to a distal end of a known biopsy conduit to permit engagement of the biopsy conduit with a conduit of the EBUS device. In an exemplary embodiment, the adaptor according to the invention is removably attached to a distal end of an endobronchial ultrasound endoscopy biopsy conduit to provide a secure, leak-proof connection to the conduit of the EBUS device. The exemplary adaptor according to the invention comprises a substantially cylindrical core with a first end including a plurality of slots distributed about a circumference thereof to define a plurality of arms. This configuration permits the arms to bend radially inward and outward toward and away from, respectively, a central axis of the adaptor. In an exemplary embodiment, the arms are biased toward a radially expanded configuration. A rubber seal fitted within the core includes a conduit extending along the central axis of the adaptor. In an operative configuration, the core with the rubber seal positioned therein is placed over a distal end of the biopsy conduit until the arms are seated over an outer surface thereof. A collar is then slid over the core toward the first end and over at least a portion of the arms to force the arms into a radially compressed configuration over the biopsy conduit forming a fluid-tight seal therewith without damaging the biopsy conduit. A second end of the adaptor opposite the first end includes a luer configured permitting attachment of the conduit of the EBUS device. As will be described in greater detail later on, any of a variety of luer fittings may be used to permit attachment of the biopsy conduit with any known device. Although the exemplary embodiments specifically describe an adaptor interfacing with a biopsy device, it will be understood by those of skill in the art that the adaptor of the present invention may be utilized with any medical device having a first conduit requiring attachment to a second medical device having a second conduit having the same dimensions or different dimensions than the first conduit. 
         [0012]    As shown in  FIGS. 1-5 , an adaptor  100  according to an exemplary embodiment of the present invention comprises a core  102  extending from a first end  104  to a second end  106  along a central longitudinal axis  108 . The core  102  may be formed of ABS or a moldable plastic, although other materials may also be used without deviating from the scope of the invention. A channel  110  extends through the core  102  and has first and second openings  112 ,  114  at the first and second ends  104 ,  106 , respectively. The first opening  112  is dimensioned to permit insertion therethrough of an elongated shaft, for example, a EBUS device (not shown). As will be described in greater detail later on, the EBUS device may be secured to the adaptor via a luer connection as would be understood by those skilled in the art. The second opening  114  is dimensioned to permit slidable insertion of the core  102  over a distal end  12  of a biopsy cannula  10 . The second end of the core  102  includes a plurality of slots  116  separating the second end of the core  102  into a plurality of deflectable arms  118 . In an exemplary embodiment, the core  102  includes six slots  116  distributed evenly over a circumference of the second end  106  to define six arms  118 , although a greater or lesser number of arms  118  may be used to increase or decrease the maximum and minimum diameter of the second opening  114 . The arms  118  may be biased toward a radially expanded configuration in which the arms  118  are moved radially outward from the central axis  108 . As will be described in greater detail later on, movement of a collar  130  toward the second end  106  over at least a portion of the arms  118  draws the arms to radially inward to reduce a diameter of the opening  114 . An inner wall of each of the arms  118  according to this embodiment includes an abutment  120  configured to lockingly engage a flange  14  at the distal end  12  of the cannula  10 , as will be described in greater detail later on. 
         [0013]    A seal  122  is positioned within the channel  110  with an outer diameter of the seal  122  substantially the same as a diameter of the channel  110  to prevent rotational or axial movement of the seal  122  within the core  102 . The seal  122  may be formed of a suitably compressible material such as, for example, rubber or silicone. An opening  124  in the seal  122  is substantially aligned with the central longitudinal axis  108 . In an exemplary embodiment, the seal  122  may include first and second components  122   a ,  122   b  to aid in manufacturing thereof, as those skilled in the art will understand. In another embodiment, however, the seal  122  may be have a uni-body construction. The seal  122  prevents leakage of fluid flowing to/from the biopsy cannula  10  and a EBUS device (not shown) attached to the adaptor  100 . Specifically, as will be described in greater detail with respect to the exemplary method below, the seal  122  directly contacts the biopsy cannula  10  in an operative configuration to seal around the biopsy cannula  10 . 
         [0014]    The collar  130  which is slidably mounted over an outer surface of the core  102  is substantially cylindrical and extends from a first end  132  to a second end  134 . The diameter of the collar  130  at the first and second ends  132 ,  134  is selected to prevent and/or limit radial compression of the core  102  at these locations. A mid-portion  136  of the core located between the first and second ends  132 ,  134  has a reduced diameter selected to radially compress the arms  118  when positioned thereover. In an exemplary embodiment, a diameter of the collar  130  is larger at the first and second ends  132 ,  134 , respectively, tapers from the first and second ends  132 ,  134  toward the reduced diameter of the mid-portion  136 . Thus, movement of the collar  130  in the direction A over the arms  118  gradually compresses the arms  118  over the distal end  12  of the cannula  10 . In an exemplary embodiment, the collar  130  is formed of a substantially rigid material (e.g., an injection molded plastic, etc.). In an alternate embodiment, the collar  130  may be formed of a substantially flexible material that may be rigid enough to radially compress the arms  118  while being flexible enough to deflect under a counter force applied thereto by the arms  118 . Specifically, the collar  130  is able to flex radially outward when a counter-force applied to the collar  130  by the arms  118  exceeds a predetermined threshold. As those skilled in the art will understand, this configuration prevents the arms  118  from permanently damaging the cannula  10  while still maintaining a fluid-tight seal therewith. A diameter of the mid-portion  136  is also selected to prevent the arms  118  from applying excessive force to the cannula  10  (i.e., a compressive force in excess of the capacity of the cannula  10 ). 
         [0015]    An inner wall of the collar  130  according to this embodiment of the invention includes teeth  138  configured to prevent the collar  130  from disengaging the core  102 . Specifically, the teeth  138  extend through an elongated slot (not shown) extending through the side wall of the core  102 . The slot (not shown) extends parallel to the axis  108  and is closed at the first and second ends  104 ,  106 . The teeth  138  are slidable along the length of the slot (not shown). 
         [0016]    The first end  104  of the core  102  includes a luer connection  140  permanently attached thereto with a luer channel  142  open to the channel  110  of the core  102  and to a channel  16  of a cannula  10  attached thereto in an operative configuration. As would be understood by those skilled in the art, the luer connection  140  may be formed in a desired shape and size to permit attachment thereof to a desired device (e.g., the EBUS device). The luer connection  140  may comprise a male luer or female luer connector having any of a barb, threading, locking ring, etc. to conform to the requirements of a particular device to be attached thereto, as those skilled in the art will understand. 
         [0017]    In accordance with an exemplary method according to the invention, the collar  130  is initially positioned away from the arms  118  toward the first end  104  of the core  102 . In this embodiment, the arms  118  are freed to move under their natural bias to the expanded configuration in which a diameter of the second end  114  of the core  102  is greater than a diameter of the distal end  12  of a cannula  10  to be coupled thereto. The adaptor  100  is then positioned over the distal end  12  until the distal end  12  engages the seal  122  preventing further movement of the adaptor  100  in the direction A. An operator then maintains a force holding the core  102  against the distal end  12  while simultaneously sliding the collar  130  in the direction A until engagement of the teeth  138  with an end of the slot (not shown) prevents further movement thereof The exemplary adaptor  100  according to the invention permits single-handed use by the operator. Movement of the collar in the direction A causes the collar  130  to apply an increasingly compressive force on the arms  118  moving the arms toward a radially compressed configuration in which they grip the outer surface of the cannula  10 . Engagement of the abutments  120  of the arms  118  with the flange  14  of the cannula  10  prevents the cannula  10  from sliding out of engagement with the adaptor  100 . A EBUS device (not shown) may then be attached to the luer connection  140  in a desired position and orientation relative to the cannula  10 . To remove the adaptor  100  from the cannula  10 , the operator moves the collar in a direction opposite the direction A until the radially compressive force on the arms is eliminated and the arms  118  are freed to return to their biased, radially expanded configuration. The cannula  10  may then be safely detached from the adaptor  100 . 
         [0018]    In an exemplary embodiment the cannula  10  may be a biopsy channel within a working channel of an EBUS device. In a first alternate embodiment of the invention, the adaptor  100  may include a structure (e.g., a hypotube, etc.) insertable into a biopsy port of the endobronchial ultrasound device. The hypotube may have a length and/or diameter selected to permit the hypotube to contact a side wall of the biopsy port if a side load is applied to the biopsy device. Specifically, the hypotube (not shown) may extend from the luer  140  to a position within the biopsy channel  16  by a predetermined distance. 
         [0019]    In another alternate embodiment of the invention, the luer  140  may be attached to the adaptor  100  in a manner such that the adaptor  100  acts as a shock absorber if a physician or other user of the endobronchial ultrasound device applies a large side load to the biopsy device. In one embodiment, for example, the core  102  may be formed of a silicone or rubber material to permit deformation thereof under application of a side load thereto. Deflection of the core  102  in this manner prevents the application of the side load onto the luer  140 . In another embodiment, the core  102  may include a flexible gasket (not shown) configured to absorb any forces applied thereto, as those skilled in the art will understand. 
         [0020]    In yet another alternate embodiment of the invention, the adaptor  100  comprises a mechanical feature (e.g., an abutment, teeth, etc.) on any portion of the adaptor  100  which contacts the cannula  10  in an operative configuration to prevent and/or limit rotation of the cannula  10  relative thereto. In another embodiment, an operator ensures contact between the cannula  10  and the seal  122  frictionally engaging the two to prevent rotation of the cannula  10  relative to the seal  122 . In yet another embodiment, rotation may be prevented by using a two-shot molding process with an elastomeric second shot material to add a high friction surface (e.g.,) on the adaptor  100  so that contact between the high friction surface and the cannula  10  prevents rotation thereof. 
         [0021]    Although the invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. 
         [0022]    It will be appreciated by those skilled in the art that various modifications and alterations of the invention can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be apparent to those skilled in the art.