Abstract:
A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity including a compressible seal anchor member. The seal anchor member includes a leading portion that is expandable to facilitate transitioning between a first condition and a second condition. Insertion of the seal anchor member into a tissue tract is facilitated by the reduced dimensions of the leading portion while in the first condition. Anchoring of the seal anchor member within the tissue tract is facilitated by the expanded dimensions of the leading portion while in the second condition.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/416,781 filed on Nov. 24, 2010, and U.S. Provisional Application 61/481,316 filed on May 2, 1011, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates generally to an access device for use in a surgical procedure. More particularly, the present disclosure relates to a seal anchor member adapted for insertion into an incision, or a naturally occurring bodily orifice, in tissue, and for the sealed reception of one or more surgical objects such that a substantially fluid-tight seal is formed with both the tissue and the surgical object or objects. 
         [0004]    2. Background of Related Art 
         [0005]    A minimally invasive surgical procedure is one in which a surgeon enters a patient&#39;s body through a small opening in the skin or through a naturally occurring opening (e.g., mouth, anus, or vagina). Such procedures have several advantages over traditional open surgeries. In particular, as compared to traditional open surgeries, minimally invasive surgical procedures result in reduced trauma and recovery time for patients. Generally, such procedures are referred to as “endoscopic”, unless performed on the patient&#39;s abdomen, in which case the procedure is referred to as “laparoscopic”. Throughout the present disclosure, the term “minimally invasive” should be understood to encompass both endoscopic and laparoscopic procedures. 
         [0006]    During a typical minimally invasive procedure, surgical objects, such as surgical access devices (e.g., trocar and cannula assemblies) or endoscopes, are inserted into the patient&#39;s body through the incision in tissue. In general, prior to the introduction of the surgical object into the patient&#39;s body, insufflation gases are used to enlarge the area surrounding the target surgical site to create a larger, more accessible work area. Accordingly, the maintenance of a substantially fluid-tight seal is desirable so as to prevent the escape of the insufflation gases and the deflation or collapse of the enlarged surgical site. 
         [0007]    To this end, various valves and seals are used during the course of minimally invasive procedures and are widely known in the art. However, a continuing need exists for a seal anchor member that can be inserted directly into the incision in tissue and that can accommodate a variety of surgical objects while maintaining the integrity of an insufflated workspace. 
       SUMMARY 
       [0008]    Disclosed herein is a surgical apparatus for positioning within a tissue tract accessing an underlying body cavity. The surgical apparatus includes a compressible seal anchor member including a leading portion, a trailing portion, and an intermediate portion disposed between the leading and trailing portions. Two or more lumens longitudinally extend between the leading and trailing portions. The one or more lumens are configured and adapted to receive instrumentation therein in a substantially sealed relation. Associated with the leading portion is a flange that is transitionable between a first condition and a second condition. In particular, the flange is expandable to transition from a first dimension to a second dimension. A conduit may be in fluid communication with the flange associated with the leading portion. A source of fluid (e.g., gas or liquid) may be operably coupled to the conduit. In an embodiment, a plunger may be translated through the conduit to force a volume of fluid within the conduit into the flange associated with the leading portion. 
         [0009]    While the flange associated with the leading portion is in the first condition, the seal anchor member is placed within a tissue tract. The seal anchor member is anchored within the tissue tract by expanding the flange associated with the leading portion, and transitioning the flange to a second dimension. Surgical objects are inserted within the lumens, and a surgical procedure is performed. Once the surgical procedure is completed, the surgical objects may be removed. Removal of the seal anchor member is facilitated by contracting the flange associated with the leading portion to transition the flange back to its first dimension, e.g., its initial width and diameter. 
         [0010]    These and other features of the apparatus disclosed herein will become more readily apparent to those skilled in the art from the following detailed description of various embodiments of the present disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    Various embodiments of the present disclosure are described hereinbelow with reference to the drawings, wherein: 
           [0012]      FIG. 1  is a perspective view of a seal anchor member in accordance with the principles of the present disclosure shown in a first condition positioned relative to tissue; 
           [0013]      FIG. 2  is a cross-sectional view of the seal anchor member of  FIG. 1  taken along section-line  2 - 2  of  FIG. 1  illustrating a port that extends longitudinally therethrough; 
           [0014]      FIG. 3  is a view of the port of  FIG. 2  with a surgical object inserted therethrough; 
           [0015]      FIG. 4A  is a perspective view of the seal anchor member of  FIG. 1  shown in a first condition; 
           [0016]      FIG. 4B  is a perspective view of the seal anchor member of  FIG. 1  shown in a second condition; 
           [0017]      FIG. 5  is a bottom perspective view of the seal anchor member of  FIG. 1  shown in the second condition; 
           [0018]      FIG. 5A  is a bottom perspective view of the seal anchor member of  FIG. 1  shown operably coupled to a source of fluid; 
           [0019]      FIG. 5B  is a side view of a of the seal anchor member of  FIG. 1  shown with a plunger member in a first position relative to the seal anchor member; 
           [0020]      FIG. 5C  is a side view of the seal anchor member of  FIG. 1  shown with a plunger member in a second position relative to the seal anchor member; 
           [0021]      FIG. 6A  is a perspective view of the seal anchor member of  FIG. 1  shown in the first condition and positioned within a tissue tract; and 
           [0022]      FIG. 6B  is a perspective view of the seal anchor member of  FIG. 1  shown in the second condition and positioned within the tissue tract. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0023]    In the figures and in the description that follows, in which like reference numerals identify similar or identical elements, the term “proximal” will refer to the end of the apparatus that is closest to the clinician during use, while the term “distal” will refer to the end that is farthest from the clinician, as is traditional and known in the art. 
         [0024]    With reference to  FIGS. 1-6B , a seal anchor member  100  will now be described. Seal anchor member  100  defines a longitudinal axis “A” and includes respective trailing (proximal) and leading (distal) portions  102 ,  104 , and an intermediate section  106  disposed between the trailing and leading portions  102 ,  104 . Seal anchor member  100  includes one or more ports  108  that extend generally longitudinally between trailing and leading portions  102 ,  104 , respectively, and through seal anchor member  100 . 
         [0025]    The seal anchor member  100  may be substantially formed from a suitable foam material having sufficient compliance to form a seal about one or more surgical objects, shown generally as surgical object “I” ( FIG. 3 ), and also establish a sealing relation with the tissue. The foam is preferably sufficiently compliant to accommodate off axis motion of the surgical object “I”. In one embodiment, the foam includes a polyisoprene material. 
         [0026]    The trailing portion  102  includes a flange  114   a , and defines a first diameter D 1 . The leading portion  104  includes a flange  114   b , and defines a diameter that is transitionable between an initial width W, and diameter D i  in a first condition, e.g., unexpanded or deflated state, ( FIGS. 1 ,  4 A, and  6 A) and a final width, W f  and diameter D f , in a second condition, e.g., expanded or inflated state, ( FIGS. 4B ,  5 , and  6 B). In the first condition, the first diameter D 1  of the proximal portion  102  may be substantially equivalent to the initial diameter D i  of the leading portion  104 . 
         [0027]    In the first condition, as shown in  FIG. 1 , the trailing and leading portions  102 ,  104  define substantially planar surfaces. However, in other embodiments, either or both the trailing and leading portions  102 ,  104  may define surfaces that are substantially convex to facilitate the insertion of the seal anchor member  100  within tissue tract  12  defined by tissue surfaces  14  and formed in tissue “T”, e.g., an incision or naturally occurring bodily orifice. 
         [0028]    The intimidate portion  106  defines a radial dimension R and extends longitudinally between the leading portion  104  and the trailing portion  102  to define an axial dimension or length L. The radial dimension R of intermediate portion  106  varies along the length L. Accordingly, seal anchor member  100  defines a cross-sectional dimension that varies along length L, thereby facilitating anchoring of the seal anchor member  100  within tissue “T”. In other embodiments, however, the radial dimension R of the intermediate portion  106  may remain substantially uniform along its length L. 
         [0029]    The radial dimension R of the intermediate portion  106  may be appreciably less than the diameters of the proximal and distal portions  102 ,  104  in both the first and second conditions. Therefore, the seal anchor member  100  may define an “hour-glass” shape or configuration to facilitate anchoring of the seal anchor member  100  within the tissue “T”. However, in other embodiments, the radial dimension R of the intermediate portion  106  may be substantially equivalent to the diameters of the proximal and distal portions  102 ,  104 . In cross-section, the intermediate portion  106  may exhibit any suitable configuration, e.g., a substantially circular, oval, or oblong shape. 
         [0030]    Each port  108  is configured to removably receive the surgical object “I” in a substantially sealed relation. As shown in  FIG. 2 , prior to the insertion of the surgical object “I”, port  108  is in a first state in which the port  108  defines a first or initial dimension D P1 . D p1  will generally be about 0 mm such that the escape of insufflation gas (not shown) through port  108  of seal anchor member  100  in the absence of surgical object “I” is inhibited. For example, the port  108  may be a slit extending longitudinally through intermediate portion  106  and through the trailing and leading portions  102 ,  104 . As shown in  FIG. 3 , the introduction of the surgical object “I” through the port  108  transitions the port  108  to a second state in which the port  108  defines a second, larger dimension D P2  that substantially approximates the diameter D 1  of the surgical object “I” to facilitate forming a substantially fluid tight seal, between the port  108  and the surgical object “I”, to inhibit the escape of insufflation gas through the port  108  in the presence of surgical object “I” inserted therein. 
         [0031]    In particular, upon the introduction of surgical object “I” through port  108  as depicted in  FIG. 3 , the surgical object “I” exerts a force “F I ” upon port  108  that is directed radially outward. Force “F I ” acts to enlarge the dimensions of port  108  and thereby transition port  108  into the second state thereof in which port  108  defines a second, larger dimension D P2  that substantially approximates the diameter D I  of surgical object “I”. Consequently, an internal biasing force “F B ” is created that is directed radially inward, in opposition to force “F 1 ”. Internal biasing force “F B ” endeavors to return port  108  to reduce the internal dimension of port  108  and thereby return port  108  to the first state thereof. Internal biasing force “F B ” is exerted upon surgical object “I” and acts to create a substantially fluid-tight seal therewith. Although port  108  is shown and described as being biased toward an initially closed state, in other embodiments the port  108  may have an initially open state. 
         [0032]    D 1 , and thus D P2 , will generally lie within the range of about 5 mm to about 12 mm, as these dimensions are typical of the surgical objects used during the course of minimally invasive procedures. However, a seal anchor member  100  including a port  108  that is capable of exhibiting substantially larger, or smaller, dimensions in the second state thereof is not beyond the scope of the present disclosure. In addition, seal anchor  100  may be devoid of ports  108 . With this arrangement, ports  108  are created within seal anchor member  100  during the insertion of the surgical object “I”. In accordance with this embodiment, seal anchor member  100  is formed of a flowable or sufficiently compliable material such as a foam material, e.g., an open-cell polyurethane foam or a gel. 
         [0033]    The flange  114   b  is associated with the leading portion  104  of the seal anchor member  100 . As shown best in  FIG. 5A , a conduit  103  extends from the trailing portion  102  and terminates within the flange  114   b . The conduit  103  may be adapted to receive a tube  101  therein that is operably coupled to a source “S” of fluid. A clamp or a valve  107  may be operably coupled with the tube  101  to selectively inhibit the escape of fluid through the conduit  101 . The conduit  103  may receive the tube  101  in a substantially sealed relation to inhibit the escape of fluid through the conduit  103 . 
         [0034]    During use, the tube  101  may be inserted into the conduit  103 . After placement of the tube  101  into the conduit  103 , fluid may be pumped into the flange  114   b  associated with the distal portion  104 . The pumping of fluid into the flange  114   b  enlarges the dimensions of the distal portion  104  from an initial width W i  and diameter D i  in a first condition ( FIGS. 1 ,  4 A, and  6 A) and a final width W i  and diameter D f  in a second condition ( FIGS. 4B ,  5 , and  6 B). As shown best in  FIG. 5 , in second condition, e.g., the expanded state, the flange  114   b  may have a substantially toroidal shape. 
         [0035]    Contraction or deflation of the flange  114   b  may be achieved by reversing the flow of fluid from the source “S”, e.g., by applying a suctional force, or by removing the tube  101  and permitting the fluid to flow from the flange  114   b  proximally through the conduit  103  and out of the proximal region  102 . 
         [0036]    Alternatively, as shown in  FIGS. 5B and 5C , a plug  109  may be placed within the conduit  103 . The plug  109  is configured and adapted to translate through the length of the conduit  103 . As shown in  FIG. 5B , a plunger  111  may be distally translated, e.g., in the direction of arrow Z, through the conduit  103 , thereby forcing the volume of air contained within the conduit  103  into the flange  114   b . Contraction of the flange  10  may be achieved by further distally translating the plug  109  until it exits the conduit  103  and enters the interior of the flange  114   b . Once the plug  109  is within the flange  114   b , the air or fluid within the flange  114  is free to exit the flange  114   b  through the conduit  103 , thereby facilitating the contraction of the flange  114  back toward its initial width W i  and diameter D i . Alternatively, the plunger  111  may be operably coupled to the plug  109 , and may be proximally translated through the conduit  103  thereby contracting the flange  114   b . A protrusion  107  at or near the distal end of the conduit  103  may provide a tactile depth indication by providing resistance to the continued distal translation of the plug  109  by the plunger  111 . Continued distal advancement of the plug  109  by the plunger  111  would necessitate overcoming the resistance provided by the protrusion  107 . In an embodiment, the conduit  103  may be visible from outside of the seal anchor member  100 . 
         [0037]    The use and operation of the seal anchor member  100  during a surgical procedure will now be described with reference to  FIGS. 6A and 6B . As shown in  FIG. 6A , the seal anchor member  100  is inserted into tissue tract  12  within tissue “T” while the seal anchor member  100  is in its initial state, e.g., the flange  114   b  of the distal portion  104  has an initial diameter D i  and an initial width W i . Once placed within the tissue tract  12 , anchoring of the seal anchor member  100  within the tissue tract  12  is achieved by expanding the flange  114   b , in a manner as described above, to transition the flange  114   b  to a final width W f  and diameter D ft  to facilitate anchoring of the seal anchor member  100  within the tissue tract  12 . The surgical objects “I” may be inserted prior to or after expansion of the flange  114   b . Once the surgical procedure is complete, the flange  114  is contracted and transitioned back to its initial diameter D i  and initial width W i  to facilitate removal of the seal anchor member  100  from the tissue tract  12 . 
         [0038]    Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplifications of particular embodiments. It is to be understood, therefore, that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.