Abstract:
Described is a barrier application device comprising a handle, an introducer assembly slidably and rotatably coupled to the handle, a beam assembly coupled to a distal end of the handle, and a flag coupled to the beam assembly. A method of using a barrier application device comprises providing a device comprising a handle, an introducer assembly slidably and rotatably coupled to the handle, a beam assembly coupled to a distal end of the handle, and a flag coupled to the beam assembly, and placing a barrier on the flag, sliding the introducer assembly along the handle from a retracted position to an extended position at least partially covering the beam assembly, and rotating the handle relative to the introducer assembly until the flag and the barrier are wound around the beam assembly.

Description:
BACKGROUND 
       [0001]    After a surgical procedure, organs and/or tissues adjacent to a surgical site may adhere to the surgical site by fibrous bands of tissue know as adhesions. Adhesions may result in delayed healing, post-operative pain and/or infection, and potentially a need for further surgical intervention. Thus, there is a need for a barrier for preventing adhesion to the surgical site. 
         [0002]    Adhesion formation can be prevented or limited by providing a physical barrier between the traumatized surgical site and adjacent organs and/or tissue, The physical barrier can be applied to sites of potentially adhesiogenic tissue and organ structures to serve as a temporary barrier separating opposing tissue/organ surfaces. These barriers are often provided as films that are applied at the conclusion of the surgical procedure. 
         [0003]    While such film-like barriers would be useful, it may be difficult to apply such a barrier during a surgical procedure. For example, during laparoscopic procedures the surgery is performed by using a camera that is mounted on laparoscope that is inserted through a small surgical port called a trocar. The surgical site is viewed on a monitor and surgical instruments access the site through additional trocars. Conventional trocars vary in diameter from 5 mm to 12 mm in diameter. To minimize trauma and scarring both the surgeon and patient prefer to use as small a trocar as possible. As a consequence it becomes challenging to be able to insert a film-like barrier through a trocar and a deliver it to a surgical site while viewing on a monitor. For example, the film-like barrier will need to be introduced into the body in a collapsed state and then expanded back to its original form. It may be difficult to collapse the barrier (e.g., depending on its material properties, size and/or shape) and/or expand (e.g., depending on its collapsed orientation/configuration, if it comes into contact with liquid, etc.). 
         [0004]    In addition, there are other factors that could complicate the delivery of a film-like barrier in a laparoscopic procedure. For example, due to the confined spaces in laparoscopic surgery, the film-like barrier may adhere to unintended organs and/or tissue. In addition, the film-like barrier may be sticky when it comes in contact with a liquid such as blood or saline used for irrigation causing the film-like barrier to inadvertently adhere to the trocar, unintended tissue/organ or itself. Multiple barriers may be needed to adequately cover the surgical site. Therefore, there exists a need for an improved barrier application device for effectively deploying a barrier at a surgical site. 
       SUMMARY OF THE INVENTION 
       [0005]    In an exemplary embodiment, a device according to the present invention comprises a handle, an introducer assembly slidably and rotatably coupled to the handle, a beam assembly coupled to a distal end of the handle, and a flag coupled to the beam assembly. The device may be utilized to deploy a barrier at a surgical site. 
         [0006]    In an exemplary embodiment, the handle includes a grip portion and a shaft. portion. The grip portion may include a frictional surface. The grip portion may include an orientation indicator. The orientation indicator may include at least one of a projection, a recess, a symbol and a color. 
         [0007]    In an exemplary embodiment, the introducer assembly includes an introducer tube and an introducer stop. The introducer tube may include a distal end with a distal opening that is contiguous with a slot formed along at least a portion of a length of the introducer tube. The distal end may be beveled. The introducer stop may have an external diameter greater than an external diameter of the introducer tube. 
         [0008]    In an exemplary embodiment, the device further comprises a sleeve coupled to a distal end of the handle. 
         [0009]    In an exemplary embodiment, the device further comprises a flex joint coupled to the beam assembly and the handle. The flex joint may be biased in a non-deflected state coaxial with the handle and movable to a deflected state at an angle relative to the handle. The angle may be between 0°-360° relative to an X-axis, between 0°-180° relative to a Y-axis, or 0°-180° relative to a Z-axis. 
         [0010]    In an exemplary embodiment, the beam assembly includes a flag recess adapted to receive the flag. The beam assembly may include a distal tip adapted to engage the distal opening on the introducer tube. The distal tip may include a rounded distal surface. 
         [0011]    In an exemplary embodiment, wherein the flag includes at least one tab. The at least one tab may include at least one inner tab and at least one outer tab. The at least one tab may be a flap biased toward a folded position. 
         [0012]    In an exemplary embodiment, the flag includes a pocket disposed at least partially in the flag recess. The pocket may include a least one slit. 
         [0013]    In an exemplary embodiment, the flag is a hydrophobic mesh. 
         [0014]    In an exemplary embodiment, a method according to the present invention comprises providing a device comprising: a handle; an introducer assembly slidably and rotatably coupled to the handle; a beam assembly coupled to a distal end of the handle; and a flag coupled to the beam assembly, and placing a barrier on the flag, sliding the introducer assembly along the handle from a retracted position to an extended position at least partially covering the beam assembly, and rotating the handle relative to the introducer assembly until the flag and the barrier are wound around the beam assembly. 
         [0015]    In an exemplary embodiment, the barrier is an adhesion barrier. In an exemplary embodiment, the adhesion barrier is a Seprafilm. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1A  shows an exemplary embodiment of a barrier application device according to the present invention; 
           [0017]      FIG. 1B  shows an exemplary embodiment of a barrier application device according to the present invention; 
           [0018]      FIG. 2  shows an exemplary embodiment of an introducer assembly for a barrier application device according to the present invention; 
           [0019]      FIG. 3  shows an exemplary embodiment of a beam assembly and a flag for a barrier application device according to the present invention; 
           [0020]      FIG. 4  shows an exemplary embodiment of a barrier application device according to the present invention prior to use; 
           [0021]      FIG. 5  shows an exemplary embodiment of a barrier application device according to the present invention prior to use; 
           [0022]      FIG. 6  shows an exemplary embodiment of a barrier application device according to the present invention prior to use; 
           [0023]      FIG. 7  shows an exemplary embodiment of a barrier application device according to the present invention during use; 
           [0024]      FIG. 8  shows an exemplary embodiment of a barrier application device according to the present invention during use; and 
           [0025]      FIG. 9  shows an exemplary embodiment of a barrier application device according to the present invention during use, 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Exemplary embodiments of a barrier application device according to the present invention may be used to retain a barrier and deploy the barrier at a surgical site. In an exemplary embodiment, the barrier may be adapted to adhere to the surgical site to prevent organs and/or tissue from adhering to the surgical site. In an exemplary embodiment, a barrier may be Seprafilm® Adhesion Barrier made by Genzyme Corporation. In another exemplary embodiment, a barrier may be Gynecare Interceed® made by Ethicon, Inc. 
         [0027]      FIGS. 1A and 1B  show an exemplary embodiment of a barrier application device  10  according to the present invention. The application device  10  comprises a handle  12  including a grip portion  12 . 1  and a shaft  12 . 2  extending therefrom. In an exemplary embodiment, the grip portion  12 . 1  is ergonomically shaped (e.g., cylindrical, conical, frusto-conical or any combination thereof) for being gripped and handled by a user. In an exemplary embodiment, a gripping surface (not shown), such as a frictional material or an array of projections, may be disposed on the grip portion to enhance the grip of the user and preventing slipping during use. An orientation indicator  12 . 1 . 1  may be disposed on the grip portion  12 . 1 . In an exemplary embodiment, the orientation indicator  12 . 1 . 1  may be a projection, recess, symbol or any other feature and may have a color different from a color of the grip portion  12 . 1  to provide visual feedback to the user. The shaft  12 . 2  extends distally from a distal end of the grip portion  12 . 1 . In an exemplary embodiment the shaft  12 . 2  is coaxially aligned with the grip portion  12 . 1 . In an exemplary embodiment, the handle  12  is made from acrylonitrile butadiene styrene. 
         [0028]    An introducer assembly  14  is slidably and rotatably coupled to the handle  12 .  FIG. 2  shows an exemplary embodiment of the introducer assembly  14  according to the present invention. In an exemplary embodiment, the introducer assembly  14  is slidably coupled to the shaft  12 . 2  and includes an introducer tube  14 . 1  and an introducer stop  14 . 2 . In an exemplary embodiment, the introducer tube  14 . 1  is a hollow cylinder that includes a distal end  14 . 1 . 1  that is beveled. The distal end  14 . 1 . 1  includes a distal opening  14 . 1 . 1 . 1  which is contiguous with a slot  14 . 1 . 2  formed along at least a portion of a length of the introducer tube  14 . 1 . In an exemplary embodiment, the introducer tube  14 . 1  is made from stainless steel. 
         [0029]    In an exemplary embodiment, the introducer stop  14 . 2  has an outer diameter larger than an outer diameter of the introducer tube  14 . 1 . As explained further below, the introducer stop  14 . 2  is adapted to abut an insertion device (e.g., a trocar) which provides access to a surgical site. Further, the introducer stop  14 . 2  may provide one or more features, such as ridges  14 . 2 . 1 , to enhance a grip and prevent slipping when the user is holding the introducer stop  14 . 2 . In an exemplary embodiment, the introducer stop  14 . 2  is overmolded on the introducer tube  14 . 1  and is made from acrylonite butadiene styrene. 
         [0030]    As explained further below, the introducer assembly  14  is slidable relative to the shaft  12 . 2  between a retracted position (shown in  FIGS. 1A-B ) and an extended position, and the introducer assembly  14  is freely rotatable relative to the shaft  12 . 2 . 
         [0031]    Referring back to the exemplary embodiment shown in  FIGS. 1A-B , a sleeve  16  is coupled to a distal end of the handle  12 . For example, the sleeve  16  may be disposed on a distal end of the shaft  12 . 2  to prevent the introducer  14  from sliding distally off the distal end of the shaft  12 . 2 . In an exemplary embodiment, the sleeve  16  may be made from polypropylene. 
         [0032]    In an exemplary embodiment, a flex joint  18  may be coupled to a distal end of the shaft  12 . 2 . In an exemplary embodiment, the flex joint  18  may be a cylindrical element having a proximal female end adapted to engage a distal end of the shaft  12 . 2  and a distal female end adapted to engage a proximal end of a beam assembly  20 . In an exemplary embodiment, the distal end of the shaft  12 . 2  and/or the proximal end of the beam assembly  20  may include one or more barbs adapted to engage the proximal and distal ends, respectively, of the flex joint  18 . The distal end of the shaft  12 . 2  and/or the proximal end of the beam assembly  20  may include one or more holes or recesses (radially or axially formed) to receive a corresponding projection(s) on the flex joint  18  (e.g., when the flex joint  18  is being molded). In another exemplary embodiment, the flex joint  18  may be inserted into an open distal end of the sleeve  16 . The flex joint  18  may be biased in a non-deflected state (shown in  FIGS. 1A-B ) in which the flex joint  18  is coaxially aligned with the shaft  12 . 2 . When a force is applied, the flex joint  18  may be capable of bending 360° around the X-axis and approximately 180° around the Y-axis, and approximately 180° around the Z-axis. When the force is removed, the flex joint  18  may return to the non-deflected state. In an exemplary embodiment, the flex joint  18  is made from thermoplastic elastomer. In an exemplary embodiment, a tensile strength of the flex joint  18  is greater than approximately 9.1 N. 
         [0033]    In art exemplary embodiment, a beam assembly  20  is coupled to the flex joint  18  and a flag  22  is coupled to the beam assembly  20 .  FIG. 3  shows an exemplary embodiment of the beam assembly  20  according to the present invention. In an exemplary embodiment, the beam assembly  20  comprises a first beam  20 . 1  and a second beam  20 . 2 . In an exemplary embodiment, the first beam  20 . 1  has a semi-circular cross-section, and the second bean  20 . 2  has a complementary semi-circular cross-section. When the first beam  20 . 1  is coupled to the second beam  20 . 2 , an axial space is formed between the beams  20 . 1 ,  20 . 2  which acts as a flag recess  20 . 3  in which the flag  22  is disposed. 
         [0034]    In an exemplary embodiment, the first beam  20 . 1  includes a first distal tip  20 . 1 . 2 , and the second beam  20 . 2  includes a second distal  20 . 2 . 2 . In an exemplary embodiment, each of the first and second distal tips  20 . 1 . 2 ,  20 . 2 . 2  is substantially semi-spherical or a halved tear-drop. When the first beam  20 . 1  is coupled to the second beam  20 . 2 , the first distal tip  20 . 1 . 2  and the second distal tip  20 . 2 . 2  are axially aligned to form a distal tip  20 . 4 . In an exemplary embodiment, at least a portion of the distil tip  20 . 4  may be received by the distal opening  14 . 1 . 1 . 1  when the introducer assembly  14  is in the extended position. In an exemplary embodiment, the first and second beams  20 . 1 ,  20 . 2  are made from acrylonite butadiene styrene. In an exemplary embodiment, the orientation indicator  12 . 1 . 1  may be disposed on the first beam  20 . 1  and/or the second beam  20 . 2 . For example, one of the beams could be a different color or include a symbol. 
         [0035]      FIG. 3  shows an exemplary embodiment of a flag  22  according to the present invention. In an exemplary embodiment, the flag  22  is substantially rectangular and includes an inner tab  22 . 1  and at least one outer tab  22 . 2  spaced radially from the inner tab  22 . 1 . As explained further below, the flag  22  is adapted to receive a barrier, and the tabs  22 . 1 ,  22 . 2  are adapted to retain the barrier against the flag  22  until the barrier is deployed. In an exemplary embodiment, the inner tab  22 . 1  is adapted to fold about the  X-axis and the at least one outer tab  22 . 2  is adapted to fold about the Z-axis. In an exemplary embodiment, the tabs  22 . 1 ,  22 . 2  are flaps that are biased toward a folded position to engage a barrier when placed on a surface of the flag  22 . The tabs  22 . 1 ,  22 . 2  can be opened to an open position to receive the barrier. In an exemplary embodiment, one or more slits  22 . 4  may be formed (e.g., cut) between the inner tab  22 . 1  and the flag  22 . As explained further below, during assembly, the inner tab  22 . 1  may be folded along the at least one slit  22 . 3  toward the at least one outer tab  22 . 2  to create a pocket for receiving the barrier. In an exemplary embodiment, the flag  22  is made from a hydrophobic polyester mesh. The mesh and the hydrophobic material may prevent surface tension from adhering to the barrier B, and the hydrophobic material may further help shed water and blood from the flag  22  that may be encountered during the surgical procedure. In an exemplary embodiment, the orientation indicator  12 . 1 . 1  may be disposed on the flag  22  as, for example, text or a symbol. 
         [0036]    In an exemplary embodiment of manufacturing and assembling the application device  10 , the handle  12  is injection molded. The introducer tube  14 . 1  is made and the introducer stop  14 . 2  is overmolded thereon to form the introducer assembly  14 . The introducer assembly  14  is then coupled to the handle  12  by sliding the introducer assembly  14  onto the shaft  12 . 2 . The sleeve  16  is then coupled to the distal end of the shaft  12 . 2 . 
         [0037]    The flag  22  is made from a polyester mesh which is laser cut into a predetermined shape (e.g., including the tabs and slits). The first and second beams  20 . 1  and  20 . 2  are overmolded on to portions of the flag  22 , as shown in  FIG. 3 . For example the first beam  20 . 1  may be molded on a first side of the slit  22 . 3 , and the second beam  20 . 2  may be molded on a second side of the slit  22 . 3 . The inner tab  22 . 1  may be folded toward the outer tab  22 . 2  to create a pocket  22 . 3  (shown in  FIG. 4 ), and the first and second beams  20 . 1 ,  20 . 2  are coupled together (e.g., via a snap-fit, friction fit, latch, hook, etc.). 
         [0038]    The beam assembly  20  with the flag  22  is placed with the handle/introducer/sleeve assembly into a mold for the flex joint  18 . The flex joint  18  is then overmolded onto a distal portion of the sleeve  16  and a proximal portion of the beam assembly  20 . 
         [0039]    The fully assembled application device  10  may then be placed in a sterile enclosure. 
         [0040]      FIGS. 4-9  shows an exemplary embodiment of a use of a barrier application device  10  according to the present invention. As shown in  FIG. 4 , the introducer assembly  10  is in a retracted position relative to the beam assembly  20  so that the beam assembly  20  is exposed. A proximal end of the introducer tube  14 . 1  may abut a distal end of the grip portion  12 . 1  of the handle  12  as a proximal stop. A barrier B may be placed on the flag  22  such that a first lateral edge of the barrier B is inserted into the pocket  22 . 3  under the inner tab  22 . 1 . The one or more slits  22 . 4  may provide a visual feedback that the first lateral edge of the barrier B has been properly inserted through the first and second beams  20 . 1 ,  20 . 2  and into the pocket  22 . 3 . 
         [0041]    As shown in  FIG. 5 , the introducer assembly  14  is moved from the retracted position to the extended position. The introducer assembly  14  may be rotated so that the slot  14 . 1 . 2  aligns with the flag recess  20 . 3  in the beam assembly  20 . As the introducer assembly  14  moves from the retracted position to the extended position, the slot  14 . 1 . 2  may receive the flag  22  and the barrier B thereon. In an exemplary embodiment, the beveled distal end  14 . 1 . 1  of the introducer tube  14 . 1  may facilitate the alignment of the slot  14 . 1 . 2  and the flag recess  20 . 3  such that the flag  22  (and the barrier B thereon) will not be crimped or folded by an impact of the introducer tube  14 . 1  and the flag  22 . That is, the impact of the flag  22  on the beveled distal end  14 . 1 . 1  may induce rotation of the introducer assembly  14  to align the slot  14 . 1 . 2  and the flag recess  20 . 3 . In an exemplary embodiment, a distal end of the introducer stop  14 . 2  may abut a proximal end of the sleeve  16  to define the extended position of the introducer assembly  14 . In another exemplary embodiment, the distal tip  20 . 4  may have a larger cross-section than the distal end  14 . 1 . 1  of the introducer tube  14 , and the distal end  14 . 1 . 1  of the introducer tube  14  may abut the distal tip  20 . 4  of the beam assembly  20  to define the extended position. In this exemplary embodiment, the distal tip  20 . 4  may provide a bearing surface for rotation of the introducer tube  14 . In the extended position, a distal surface of the beveled portion of the distal end  14 . 1 . 1  may be proximal of a distal surface of the distal tip  20 . 4  of the beam assembly  20 . This may prevent the beveled edge from damaging tissue/organ when inserted into the surgical site. 
         [0042]    As shown in  FIG. 6 , when the introducer assembly  14  is in the extended position, the handle  12  is rotated relative to the introducer assembly  14  which causes the flag  22  and the barrier B to roll around the beam assembly  20 . In an exemplary embodiment, a second lateral edge of the barrier B may be inserted beneath the at least one outer tab  22 . 2 , and the flag  22  and barrier B may be rolled until they are no longer visible out of the slot  14 . 1 . 2 . As the handle  12  is rotated relative to the introducer assembly  14 , at least one of the beams  20 . 1 ,  20 . 2  engage the barrier B, which prevents the barrier B from disengaging the flag  22 . In another exemplary embodiment, an adhesive could be disposed on the flag  22  and/or at least one of the beams  20 . 1 ,  20 . 2  to engage the barrier B. In yet another exemplary embodiment, at least one of the beams  20 . 1 ,  20 . 2  may include a barb adapted to engage the barrier B. 
         [0043]    When the flag  22  and the barrier B are substantially retained in the introducer assembly  14 , the application device  10  may be deployed to the surgical site and the introducer assembly  14  may be moved from the extended position to the retracted position. In an exemplary embodiment, when the application device  10  is deployed to the surgical site, it is inserted into a trocar, and the introducer stop  14 . 2 . abuts a portion of the trocar which causes the introducer assembly  14  to retract as the handle  12  is inserted distally toward the surgical site. 
         [0044]    As shown in  FIG. 7 , the introducer assembly  14  is in the retracted position, and the flag  22  and the barrier B may at least partially unravel. The orientation indicator  12 . 1 . 1  provides a visual feedback regarding the orientation of the flag  22  and the barrier B. For example, the position of the orientation indicator  12 . 1 . 1  on the grip portion  12 . 1  may indicate a position in which an exposed surface of the barrier B is oriented. 
         [0045]    As shown in  FIG. 8 , the handle  12  may be rotated to align the barrier B with the surgical site. The flag  22  prevents a non-exposed surface of the barrier B from adhering to an organ or tissue as the handle  12  is rotated. Further, the beam assembly  20  may be deflected via the flex joint  18  to properly orient and position the harder B. A rounded distal surface of the distal tip  20 . 4  may prevent trauma to organs and/or tissue during use of the application device  10 . 
         [0046]    As shown in  FIG. 9 , when the barrier B is applied to the surgical site, a further surgical tool may be used to manipulate the barrier B, e.g., to ensure that it adheres to the surgical site. 
         [0047]    After the barrier B has been deployed, the handle  20  is pulled proximally relative to the introducer assembly  14 , and the handle  20  is rotated until the flag  22  is substantially within the introducer assembly  14  and can be removed from the surgical site. 
         [0048]    In an exemplary embodiment, an unused barrier may be applied to the flag  22  and the application device  10  may be reused. 
         [0049]    In another exemplary embodiment, the shaft  12 . 1  may include one or more projections adapted to engage the introducer tube  14 . 1 . The projections may prevent free sliding of the introducer assembly  14  relative to the shaft  12 . 1  and/or provide tactile feedback (e.g., resistance) when inserting the application device  10  into a trocar. 
         [0050]    While the exemplary embodiments of the application device have been described with respect to a barrier, those of skill in the art will understand that other materials may be retained and deployed by the application device according to the present invention. For example, gauze, a sponge, or any other thin, flexible material may be retained and deployed by the application device of the present invention in a manner similar to as described above with respect to a barrier. 
         [0051]    Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.