Abstract:
An obturator assembly includes a housing configured for operable engagement by a user, a sleeve mounted to the housing and extending therefrom and having a longitudinal lumen, an image passing member positioned adjacent the distal end of the sleeve and adapted to permit an optical image to pass through the image passing member and into the longitudinal lumen of the sleeve, a penetrating member adapted for longitudinal movement relative to the image passing member through a longitudinal stroke of movement to at least partially extend the penetrating member beyond the image passing member and an adjustment member operatively connected to the penetrating member. The adjustment member is movable to selectively vary a longitudinal length of the stroke of movement of the penetrating member, to thereby selectively control extension of the penetrating member relative to the image passing member. The adjustment member may also be movable to selectively vary at least one of a retracted position and an extended position of the penetrating member relative to the image passing member.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/997,855 filed on Oct. 5, 2007, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present invention relates to an apparatus for penetrating and for observing penetration of body tissue. More particularly, the present invention relates to a trocar assembly configured for receiving an endoscope or laparoscope therethrough to provide visual observation during penetration of the peritoneum or other body tissue. 
         [0004]    2. Description of the Related Art 
         [0005]    Endoscopic surgical procedures, that is, surgical procedures performed through tubular sleeves or cannulas, have been utilized for many years. Initially, endoscopic surgical procedures were primarily diagnostic in nature. More recently as endoscopic technology has advanced, surgeons are performing increasingly complex and innovative endoscopic surgical procedures. In endoscopic procedures, surgery is performed in any hollow viscus of the body through a small incision or through narrow endoscopic tubes (cannulas) inserted through small entrance wounds in the skin. In laparoscopic procedures surgery is performed in the interior of the abdomen. 
         [0006]    Laparoscopic procedures generally utilize instrumentation that is internally sealed to inhibit gases from entering or exiting the body through the laparoscopic or endoscopic incision. This is particularly true in surgical procedures in which the surgical region is insufflated. Moreover, laparoscopic and endoscopic procedures often require the surgeon to act on organs, tissues and vessels far removed from the incision, thereby requiring that any instruments to be used in such procedures be of sufficient size and length to permit remote operation. Typically, after the surgical region is insufflated, trocars are used to puncture the body cavity and include a cannula which remains in place for use during endoscopic procedures. 
         [0007]    Generally, trocars used during such procedures include a stylet having a sharp tip for penetrating the body cavity positioned coaxially within protective tubes to protect a patient or surgeon from inadvertent contact with the tip. An example of a known trocar is described in commonly assigned, U.S. Pat. No. 6,685,630 to Sauer, et al, the entire contents of which are herein incorporated by reference. Sauer &#39;630 discloses a trocar assembly for observing the penetration of the peritoneum or other body portions. The trocar assembly provides a window structure for passing optical images to an imaging system inserted into or formed within the trocar assembly, which provides a clear and bright image of the body tissue being penetrated. The assembly also includes a light pipe for passing illumination light to body tissue. The assembly may additionally include a cutting tip for penetration of body tissue. 
       SUMMARY 
       [0008]    Accordingly, the present disclosure is directed to an obturator assembly including a housing configured for operable engagement by a user, a sleeve mounted to the housing and extending therefrom and having a longitudinal lumen, an image passing member positioned adjacent the distal end of the sleeve and adapted to permit an optical image to pass through the image passing member and into the longitudinal lumen of the sleeve, a penetrating member adapted for longitudinal movement relative to the image passing member through a longitudinal stroke of movement to at least partially extend the penetrating member beyond the image passing member and an adjustment member operatively connected to the penetrating member. The adjustment member is movable to selectively vary a longitudinal length of the stroke of movement of the penetrating member, to thereby selectively control extension of the penetrating member relative to the image passing member. 
         [0009]    An elongated member may extend through the sleeve and be operatively connected to the penetrating member. The elongated member is movable to cause the penetrating member to move through the stroke of movement. The adjustment member is operatively connected to the elongated member. The adjustment member may be adapted for rotational movement relative to the longitudinal axis. The adjustment member and the elongated member may include cooperative threaded portions whereby rotation of the adjustment member causes the elongated member to translate in a longitudinal direction. The adjustment member may be mounted to the housing and be adapted to rotate relative to the housing. The housing may include an opening for accessing the adjustment member. 
         [0010]    The obturator assembly may further include a drive member disposed within the housing and movable to drive the elongated member to cause the penetrating member to move through the stroke of movement and a trigger mechanism having a trigger and a biasing member mounted within the housing and operatively engageable with the drive member. The trigger may be operatively connected to the drive member and movable from an initial position to an actuated position to cause corresponding retracting movement of the drive member against biasing forces of the biasing member. Upon movement of the trigger to the actuated position, the drive member is released and is distally advanced in response to the biasing forces of the biasing member to advance the elongated member to cause movement of the penetrating member through the stroke of movement. A release member may be associated with the trigger and releasably engageable with the drive member to retract the drive member during movement of the trigger to the actuated position thereof. The release member is adapted to release the drive member when the trigger is at the actuated position to permit the drive member to distally advance in response to the biasing forces of the biasing member. The drive member may be normally biased to a position in operative engagement with the release member. 
         [0011]    Also provided is an obturator assembly including a housing configured for operable engagement by a user, a sleeve mounted to the housing and extending therefrom, the sleeve defining a longitudinal axis and proximal and distal ends, and having a longitudinal lumen, an image passing member positioned adjacent the distal end of the sleeve and adapted to permit an optical image to pass through the image passing member and into the longitudinal lumen of the sleeve, a penetrating member adapted for longitudinal movement relative to the image passing member through a longitudinal stroke of movement to at least partially extend the penetrating member beyond the image passing member, and an adjustment member operatively connected to the penetrating member. The adjustment member movable to selectively vary at least one of a retracted position and an extended position of the penetrating member relative to the image passing member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure, wherein: 
           [0013]      FIG. 1  is a perspective view of a trocar assembly including a cannula mounted on an obturator assembly according to an embodiment of the present disclosure; 
           [0014]      FIG. 2  is a perspective view of the trocar assembly of  FIG. 1  wherein the cannula and obturator assembly are separated; 
           [0015]      FIG. 3  is a perspective view of the obturator assembly of  FIGS. 1 and 2 ; 
           [0016]      FIG. 4  is an enlarged view of portion  4  of  FIG. 3 ; 
           [0017]      FIG. 5  is a side view of the interior of the obturator assembly of  FIGS. 1-3 ; 
           [0018]      FIG. 6  is an exploded perspective view of the interior of the obturator assembly of  FIGS. 1-5 ; 
           [0019]      FIG. 7  is a perspective view of an assembled obturator sleeve of the obturator assembly of  FIGS. 1-6 ; 
           [0020]      FIG. 8  is an exploded perspective view of the obturator sleeve of the obturator assembly of  FIGS. 1-6 ; 
           [0021]      FIG. 9  is an exploded perspective view of the blade assembly of the obturator assembly of  FIGS. 1-6 ; 
           [0022]      FIG. 10  is an exploded perspective view of the proximal and distal ends of the obturator sleeve of  FIGS. 7 and 8 . 
           [0023]      FIG. 11  is a cross-sectional side view of the obturator assembly of  FIGS. 1-6 ; 
           [0024]      FIG. 12  is an enlarged view of portion  12  of  FIG. 11 ; 
           [0025]      FIG. 12A  is a cross-sectional end view of the obturator assembly of  FIG. 12  taken along line  12 A- 12 A; 
           [0026]      FIG. 12B  is a side view of the inside of a housing half of the obturator assembly of  FIGS. 1-6 ; 
           [0027]      FIG. 13  is a cross-sectional side view of the obturator assembly of  FIGS. 1-6  and  11 , in a partially actuated condition; 
           [0028]      FIG. 14  is a cross-sectional side view of the obturator assembly of  FIGS. 1-6 ,  11 , and  13 , in a fully actuated condition; 
           [0029]      FIG. 15  is an enlarged view of portion  15  of  FIG. 14 ; 
           [0030]      FIG. 16  a cross-sectional side view of a portion of the obturator assembly of  FIGS. 1-6 ,  11 ,  13  and  14 , wherein the obturator sleeve is in an adjusted position; 
           [0031]      FIG. 17  is an enlarge view of a distal end of the obturator sleeve of  FIG. 16 ; 
           [0032]      FIG. 18  is a perspective view of an alternate embodiment of the obturator assembly of the present disclosure; 
           [0033]      FIG. 19A  is a cross-sectional end view of the obturator assembly of  FIG. 18 , including a housing in a closed position; and 
           [0034]      FIG. 19B  is a cross-sectional end view of the obturator assembly of  FIGS. 18 and 19  including the housing in an open position. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0035]    The apparatus of the present disclosure is provided to penetrate body tissue, e.g., the abdominal wall, and to provide a simultaneous forward directional view of the body tissue being penetrated. Referring initially to  FIGS. 1 and 2 , a trocar assembly  10  includes an obturator assembly  12  and a cannula assembly  14 . As will be discussed below, trocar assembly  10  is configured to receive an endoscope (not shown) therethrough in order to provide observation of the body tissue being penetrated. Cannula assembly  14  may include any known cannula configurations capable of receiving obturator assembly  12 , including cannulas having insufflation ports, release valves and the like. As used herein, the term obturator assembly refers to the tissue penetrating assembly of the trocar assembly. 
         [0036]    Referring now to  FIGS. 3 and 4 , obturator assembly  12  includes housing  16  and an obturator sleeve  20  extending distally therefrom. Obturator housing  16  includes a handle  17  and a barrel portion  18 . Handle  17  may be knurled, formed or otherwise configured for operable engagement by a user. Housing  16  further includes a trigger  52  operably mounted thereto and positioned for operable engagement by the user. Secured to the distal end  20   b  of obturator sleeve  20  is an image passing member  28 . 
         [0037]    Turning now to  FIGS. 5-10 , various views of obturator assembly  12  are shown. Referring initially to  FIG. 5 , an obturator sleeve  20  is slidably mounted within barrel portion  18  of obturator assembly  12 . Obturator sleeve  20  includes a blade assembly  30  that is operably connected to an actuating assembly  40 . A trigger assembly  50  is operably connected to actuating assembly  40  to move blade assembly  30  between a non-deployed position ( FIG. 14 ) and a deployed position ( FIG. 13 ). 
         [0038]    With reference to  FIGS. 8 and 9 , blade assembly  30  includes an elongated member  32  having proximal and distal ends  32   a,    32   b  and defining a lumen  33  therethrough. Lumen  33  is configured for receiving an endoscope therein. A cutting blade or other penetrating member  34  is mounted on distal end  32   b  thereof and extends distally therefrom. Cutting blade  34  may be securely affixed or selectively engageable with distal end  32   b.  A pusher member  36  is mounted on proximal end  32   a  of elongated member  32 . Elongated member  32  may include one or more openings  33   a  for securing pusher member  36  thereto. Pusher member  36  defines a substantially annular body having proximal and distal end  36   a,    36   b.  Proximal end  36   a  of pusher member  36  defines a thread portion  37 . Threaded portion  37  defines notches  37   a,    37   b  ( FIG. 13 ). Distal end  36   b  of pusher member  36  defines an engagement portion  38  including a flange  38   a.  As will be discussed in further detail below, flange  38   a  is configured to engage a first spring  47 . 
         [0039]    Referring now to  FIGS. 8 and 10 , a mounting sleeve  22  includes proximal and distal ends  22   a,    22   b  and defines a lumen  21  therebetween. An image passing member  28  is mounted on distal end  22   b  of mounting sleeve  22 . Distal end  22   b  may define any number of openings or slots  21   b  configured for securing image passing member  28  thereto. Distal end  22   b  of mounting sleeve  22  includes notches  23  configured to permit retraction of cutting blade  34  therein. Mounted about proximal end  22   a  of mounting sleeve  22  is a mounting member  24 . Proximal end  22   a  may define an opening or detent  21   a  for securing mounting member  24  therewith. 
         [0040]    Mounting member  24  defines a substantially annular member having a flanged proximal end  24   a  configured to be retained within barrel portion  18  of housing  16  ( FIG. 14 ). Distal end  24   b  of mounting member  24  include tabs  25   a,    25   b  extending distally therefrom. Tabs  25   a,    25   b  are configured to be received within notches  37   a,    37   b,  respectively, formed in threaded portion  37  of pusher assembly  36 . As will be discussed below, receipt of tabs  25   a,    25   b  of mounting member  22  within notches  37   a,    37   b  of pusher member  36  prevents rotation of blade assembly  30 . Notches  37   a,    37   b  are sized to permit longitudinal movement of tabs  25   a,    25   b  therein as blade assembly  30  is advanced and retracted during actuation. Distal end  24   b  of mounting member  24  may further include projections  26   a,    26   b  thereon for engaging barrel portion  18  of housing  16 , thereby preventing rotation of mounting member  24 . 
         [0041]    With particular reference to  FIG. 10 , image passing member  28  defines a transparent optical window that may be fabricated from a variety of materials such as polystyrene, polymethylmethacrylate (PMMA), polyurethane, transparent epoxies and/or glass or other transparent materials. (When made of plastic material, the cost is reduced.) Image passing member  28  may include any number of configurations. Image passing member  28  may define an image directing member, including a lens, an optical prism, an optical mirror, or like image directing medium. As shown, image passing member  28  defines a substantially dome shaped lens defining a slot  28   a  therein for receiving cutting blade  34  ( FIG. 9 ). Image passing member  28  may further include tabs  28   b  configured to be selectively received within openings  21   b  formed in distal end  22   b  of mounting sleeve  22 . Image passing member  28  may be configured to allow close to a 360° forward angle of view. Image passing member  28  may further be configured to allow for passage of illumination light from the obturator sleeve  20  to body tissue. 
         [0042]    With reference now to  FIGS. 6 and 8 , actuating assembly  40  includes an adjustment member  42 , a hammer or other drive member  46 , a first spring  47  for biasing hammer  46  during actuation, and a second spring  49  for returning blade assembly  30  to a non-deployed position ( FIG. 12 ). Adjustment member  42  includes proximal and distal ends  42   a,    42   b  and defines a lumen  43  therebetween. Lumen  43  is configured to receive proximal end  36   a  of pusher member  36 . Distal end  42   b  of adjustment member  42  defines an adjustment nut  44 . Adjustment nut  44  includes a number of protrusions  44   a  extending radial therefrom. As will be discussed below, protrusions  44   a  are configured to engage tabs  17  ( FIG. 12A and 12B ) formed in housing  16  to prevent rotation of adjustment member  42  when obturator assembly  12  is fully assembled. Distal end  42   b  of adjustment member  42  further includes ridges  43   b  for engaging hammer  46 . Proximal end  42   a  of adjustment member  42  includes an internally thread portion  43   a  ( FIG. 14 ) for engaging threaded portion  37  of pusher member  36 . 
         [0043]    Still referring to  FIGS. 6 and 8 , hammer  46  defines a substantially annular member configured to be slidably received over the proximal end  42   a  of adjustment member  42 . Hammer  46  includes a flanged distal end  46   b  configured for engaging ridges  43   b  formed on adjustment member  42 . Hammer  46  further includes a spring engaging proximal end  46   a  for engaging spring  47  upon actuation of obturator assembly  12 . 
         [0044]    Turning back to  FIGS. 5 and 6 , as discussed above, trigger assembly  50  includes trigger  52  operably mounted within housing  16  of obturator assembly  12 . Trigger  52  defines a substantially planar member having a finger rest  54 , a hammer engaging lever  56  and a spring engagement flange  58 . Trigger  52  further includes ridges  53   a,    53   b  configured to engage housing  16  and to permit trigger  52  to be slidably received therein. Finger rest  54  is situated on a distal end  52   b  of trigger  52 . Finger rest  54  is configured to be operably engaged by one or more fingers of a user. Proximal end  56   a  of hammer engaging lever  56  is mounted on a proximal end  52   a  of trigger  52 . Lever  56  extends distally along trigger  52 . Hammer engaging lever  56  includes a hammer engagement tab  56   a  and a ramp engagement tabs  56   b.  As will be discussed below, ramp engagement tabs  56   b  are configured to engage a ramp  17   b  ( FIG. 12B , shown in phantom in  FIGS. 11 and 13 ) formed in housing  16 . As trigger  52  is retracted proximally, ramp engagement tab  56   b  engages ramp  17   b.  As tab  56   b  moves proximally along ramp  17   b  lever  56  is biased towards trigger  52 , thereby causing the release of hammer  46 . It is envisioned that trigger assembly  50  may included any suitable release member capable of retracting and releasing hammer  46 . Spring engagement flange  58  is formed within proximal end  52   a  of trigger  52 . Flange  58  is configured to engage a spring  59 . Spring  59  is operably mounted between trigger  52  and housing  16  and is configured to return trigger  52  to an initial, pre-fired position following actuation of obturator assembly  12 . 
         [0045]    With particular reference now to  FIG. 6 , prior to final assembly of obturator assembly  12 , adjustment member  42  is received over pusher assembly  36  until inner threads  43   a  of adjustment member  42  engage threaded portion  37  of pusher assembly  36 . As will be discussed in further detail below, rotation of adjustment member  42  relative to pusher assembly  36  adjusts the position of cutting blade  34  relative to image passing member  28 , thereby adjusting the length of stroke of blade assembly  30 . Hammer  46  and first spring  47  may then be received over proximal end  42   a  of adjustment member  42 . Mounting sleeve  22 , including image passing member  28  and mounting member  24  mounted thereon, may then be inserted into elongated member  32  of blade assembly  30  through proximal end  32   a.  Upon complete insertion of mounting sleeve  22  within elongated member  32 , tabs  25   a,    25   b  formed in mounting member  24  are received within notches  37   a,    37   b  formed in thread portion  37  of pusher member  36 . As discussed above, this configuration prevents the rotation of obturator sleeve  20  relative to housing  16 . In this initial condition, image passing member  28  extends beyond cutting blade  34 , thereby preventing exposure of the cutting surface. 
         [0046]    Once assembled, obturator sleeve  20  is ready to be received within housing  16 . Second spring  49  is inserted over the distal end  20   b  of obturator sleeve  20  and is received about engagement portion  38  of pusher member  36 . A bushing  11  is also received over distal end  20   b  of obturator sleeve  20  to center obturator sleeve  20  within barrel portion  18  of housing  16  and to reduce the friction therebetween as blade assembly  30  is actuated. Proximal end  20   a  of obturator sleeve  20  receives an introducer member  13  thereon, configured for receiving an endoscope, laparoscope or the like. Introducer member  13  includes a sealing ring  13   a  mounted on a distal end thereof for sealing the connection between introducer member  13  and mounting member  24 . Referring now to  FIGS. 11-15 , the operation of obturator assembly will be described in detail. In a first, or initial condition ( FIGS. 11 and 12 ), prior to squeezing of trigger  52  of trigger assembly  50 , cutting blade  34  of blade assembly  30  is received within slot  28   a  of image passing member  28 . Second spring  49  engages engagement portion  38  of pusher member  36 , thereby maintaining blade assembly  30  in the retracted or initial position. Initial squeezing of trigger  52  causes hammer engaging tab  56   a  of hammer engaging lever  56  to engage hammer  56  ( FIG. 13 ). Continued proximal movement of trigger  52  causes the retraction of hammer  46  relative to pusher member  36 . The continued squeezing of trigger  52  also causes ramp engagement tabs  56   b  to engage ramps  17   a  formed in housing  16 . Engagement of tabs  56   b  with ramp  17   b  causes hammer engaging lever  56  to be biased towards trigger  52 . Ramp  17   b  is configured such that hammer engaging tab  56   a  of lever  56  biases away from hammer  46  until eventually hammer engaging tab  56   a  disengages hammer  46  ( FIG. 14 ). As hammer  46  is retracted proximally along obturator sleeve  20  during the squeezing of trigger  52 , first spring  45  compresses, thereby creating a biasing force acting distally on hammer  46 . Upon disengagement of hammer engaging tab  56   a  from hammer  46 , hammer  46  is rapidly urged forward. Flanged distal end  46   b  of hammer  46  rapidly impacts ridges  43   b  formed on adjustment member  42 , thereby forcing adjustment member  42  distally. Stop surfaces  18   a  ( FIG. 12B ) formed in housing  16  prevent excessive distal movement of adjustment member  42 . 
         [0047]    Distal advancement of adjusting member  42  causes the distal advancement of blade assembly  30 . During advancement of blade assembly  30  cutting blade  34  is exposed from within slot  28   a  formed in image passing member  28 . The length of time cutting blade  34  is exposed or in an actuated position is limited because while blade assembly  30  is advanced, second spring  49  is compressed. Once the initial distal biasing force on blade assembly  30  has dissipated, return of second spring  49  to an uncompressed condition causes the retraction of blade assembly  30  to its retracted or initial position ( FIGS. 11 and 12 ). The advancement of cutting blade  34  from an initial position to an actuated position and back again is referred to as the stroke of movement. Once released, spring  59  mounted between trigger  52  and housing  16  causes trigger  52  to also return to its initial position. In this manner, obturator assembly  12  is reset and ready for continued actuation. 
         [0048]    Referring now to  FIGS. 16 and 17 , as briefly discussed above, the length and/or relative position of stroke of movement of cutting assembly  30  may be adjusted prior to complete assembly of obturator assembly  12 , e.g., to account for different lengths of components due to manufacturing tolerances thereof. Prior to insertion within housing  16 , adjustment member  42  may be rotated relative to pusher member  36 . Depending on the configuration of threaded portion  37  of pusher member  36  and internal threads  43   a  formed on adjustment member  42 , rotation of adjustment member  42  relative to pusher member  36  in a first direction causes the stroke of blade assembly  30  to increase in length, while rotation of adjustment member  42  in a second direction causes the stroke to decrease in length. In addition, adjustment obturator assembly  12  via adjustment member  42  enables precise initial positioning of the various components, e.g., cutting blade  34 . In this manner, and using cutting blade  34  as an example, regardless of manufacturing tolerances, each assembled device will be assured of having cutting blade  34  be fully positioned within slot  28   a  when in the retracted position and extend a desired distance beyond slot  28   a  when in the extended position, thus providing consistent performance between different devices, which, due to manufacturing tolerance, might otherwise provide inconsistent performance relative to each other, resulting in certain devices being discarded upon testing. 
         [0049]    Referring now to  FIGS. 18 ,  19 A,  19 B, in an alternate embodiment of the present disclosure obturator assembly  112  includes an adjustment member  142  may be rotated subsequent assembly of obturator assembly  112 . Housing  116  defines a first and second opening  116   a,    116   b  therein for accessing adjustment member  142 . Housing  116  may further include doors or latches  117   a,    117   b  for covering adjustment member  142  during actuation. Doors  117   a,    117   b  may be pivotally mounted with housing  116 . Doors  117   a,    117   b  may include tabs  118   a,    118   b  for engaging protrusions  144   a  formed on adjustment nut  144  of adjustment member  142 , thereby preventing rotation of adjustment member  142  once adjustment member  142  has been rotated sufficiently to set blade assembly (not shown) to a desired stroke length. Doors  117   a,    117   b  may also include grip members  119   a,    119   b  for permitting a user access to adjustment member  142 . With particular reference to  FIGS. 19A and 19B , doors  117  may be pivotally mounted to barrel portion  118  of housing  116 . It is envisioned that housing  116  may include only a single opening  116   a.  It is further envisioned that openings  116   a,    116   b  be completely open and not include a door or other cover. In this manner, adjustment member  142  may be readily accessed during a procedure to adjust the length of the stroke of blade assembly  30 . 
         [0050]    It will be understood that various modifications can be made to the embodiments of the present disclosure herein disclosed without departing from the spirit and scope thereof. For example, various diameters for the cannula assembly, the obturator assembly, as well as various diameter endoscopes are contemplated. Also, various modifications may be made in the configuration of the parts. Therefore, the above description should not be construed as limiting the invention but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure as defined by the claims appended hereto.