Abstract:
A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity, comprising a compressible seal anchor member including a leading end configured for insertion within the tissue tract and a trailing end configured to remain outside of the tissue tract, the compressible seal anchor member having at least one longitudinal port extending between the leading and trailing ends for substantially sealed reception of an object therein, the compressible seal anchor member including a bore for receipt of a dilator.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/292,974 filed on Jan. 7, 2010, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates generally to a seal for use in a surgical procedure. More particularly, the present disclosure relates to a seal anchor member adapted for insertion into an incision 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]    Minimally invasive procedures are continually increasing in number and variation. Multiple instrument access through a single incision involves performing laparoscopic surgery through a small single incision, often hidden in a site such as the umbilicus. By utilizing a single incision, the potential for wound related complications may be less than it would be if multiple operative sites were to be used. Patients may also benefit from reduced postoperative pain and better cosmetic results. 
         [0006]    Some aspects of laparoscopic procedures involving multiple instrument access through a single incision are similar to other laparoscopic procedures. The patient is typically under general anesthesia, insufflated, and laparoscopic visualization is utilized. The maintenance of a substantially fluid-tight seal is desirable to inhibit the escape of insufflation gases and the deflation or collapse of the enlarged surgical site. 
         [0007]    Due to the number and variety of laparoscopic techniques, accommodation of multiple surgical instruments within a single incision may necessitate providing a larger sized diameter access port to the internal cavity. It is desirable that an access system be readily inserted and easily advanced into the body while being effectively anchorable and in a sealed relationship with the tissue tract. 
       SUMMARY 
       [0008]    Disclosed herein is a surgical apparatus for positioning within a tissue tract accessing an underlying body cavity including a seal anchor member. The seal anchor member defines a central longitudinal axis and includes leading and trailing ends, and at least one longitudinal port extending between the leading and trailing ends and being adapted for the substantially sealed reception of an object, e.g., a surgical instrument, therein. 
         [0009]    The seal anchor member has a volume and an adjustable compressibility for that volume. The seal anchor member is adapted to transition between a first volume and a second volume. By compressing the seal anchor member to a smaller volume, placement of the seal anchor member within a tissue tract is facilitated. Upon insertion of the seal anchor member within the tissue tract, the seal anchor member is adapted to transition from a compressed insertion volume to an expanded working volume to facilitate a substantially sealed relationship between the seal anchor member and the tissue tract. 
         [0010]    In an embodiment, the seal anchor member includes a longitudinally disposed lumen. An empty lumen facilitates the compressibility of the seal anchor member by reducing the amount of compressible material to be compressed and thus reducing the internal biasing force against compression of the seal anchor member, i.e., increasing the compressibility of the seal anchor member. The greater the compressibility of the seal anchor member, the less force is required to place the seal anchor member within a tissue tract. 
         [0011]    Once the seal anchor member is placed within the tissue tract, it may be desirable to decrease the compressibility of the seal anchor member. By decreasing the compressibility of the seal anchor member, the pressure exerted between the seal anchor member and the tissue tract is increased and the maintenance of a sealed relationship between the seal anchor member the tissue tract is facilitated. 
         [0012]    Compressibility of the seal anchor member is reduced by placing a dilator within the lumen. For a given compressive pressure applied to the seal anchor member, the seal anchor member will compress to a lesser extent with the dilator placed within the lumen as compared to when the lumen is empty. Consequently, placement of the dilator within the lumen of a seal anchor member placed within a tissue tract increases the pressure exerted between the seal anchor member and the tissue surfaces of the tissue tract to facilitate a substantially sealed relationship between the seal anchor member and the tissue surfaces, as compared to when the lumen of the seal anchor member is empty. In some embodiments, placement of the dilator within the lumen may also expand the seal anchor member, e.g., the diameter of the seal anchor member will be increased. 
         [0013]    In a further embodiment, the present invention is directed to a surgical apparatus for positioning within a tissue tract accessing an underlying body cavity, comprising: a compressible seal anchor member including a leading end configured for insertion within the tissue tract and a trailing end configured to remain outside of a tissue tracts, the compressible seal anchor member having at least one longitudinal port extending between the leading and trailing ends for substantially sealed reception of an object therein, the compressible seal anchor member including a bore for receipt of a dilator. The compressible seal anchor may have an outer surface between the leading and trailing ends, the outer surface configured to contact the tissue tract. The compressible seal anchor member may have a first volume without the dilator being received in the bore and a second volume with the dilator being received within the bore, the first volume being less than the second volume. The compressible seal anchor member may be more easily inserted into the tissue tract when the dilator is not received within the bore due to its lesser volume. The compressible seal anchor member may provide a first radial pressure without the dilator being received in the bore and a second radial pressure with the dilator being received within the bore, the second radial pressure being greater than the first radial pressure. The compressible seal anchor member may provide for improved sealing with, and retention within, the tissue tract when the dilator is received within the bore due to the greater radial pressure. The object may be a cannula, and the at least one longitudinal port extending between the leading and trailing ends of the compressible seal anchor member may provide for substantially sealed reception of the cannula therein. The compressible seal anchor member may have a first degree of compressibility and the dilator has a second degree of compressibility, e.g., the first degree of compressibility being greater than the second degree of compressibility. The compressible seal anchor member may be formed of a foam material, and the dilator may be substantially rigid. 
         [0014]    These and other features of the current disclosure will be explained in greater detail in the following detailed description of the various embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    Various embodiments of the present disclosure are described hereinbelow with reference to the drawings, wherein: 
           [0016]      FIG. 1  is a perspective view of a seal anchor member in accordance with the present disclosure shown in a first condition relative to a tissue tract; 
           [0017]      FIG. 2  is a perspective view of the seal anchor member of  FIG. 1  shown in a second condition prior to incision into the tissue tract; 
           [0018]      FIG. 3  is a perspective view of a dilator; 
           [0019]      FIG. 4  is a perspective view of the seal anchor member of  FIG. 1  shown in the first condition with the dilator of  FIG. 2  inserted therein; and 
           [0020]      FIG. 5  is another embodiment of a seal anchor member in accordance with the present disclosure. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0021]    Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following descriptions, and as is traditional when referring to relative positioning on an object, the term “proximal” will refer to the end of the apparatus that is closest to the clinician during use, and the term “distal” will refer to the end that is farthest from the clinician during use. 
         [0022]    With reference to  FIGS. 1-4 , a surgical apparatus  10  for use in a surgical procedure, e.g., a minimally invasive procedure, is illustrated. The surgical apparatus  10  includes a seal anchor member  100  defining a longitudinal axis “A” and having trailing (or proximal) and leading (or distal) ends  102 ,  104  and an intermediate portion  106  disposed between the trailing and leading ends  102 ,  104 . The seal anchor member  100  includes one or more ports  108  that extend longitudinally between the trailing end  102  and the leading end  104 . Each port  108  is adapted to receive instrumentation (e.g., surgical instruments and/or cannulae) therein in a substantially sealed relation. In addition to ports  108 , the seal anchor member  100  also includes a lumen  115  adapted and configured to receive a dilator  200  ( FIG. 3 ). 
         [0023]    Proximal end  102  of the seal anchor member  100  defines a first diameter D 1  and distal end  104  defines a second diameter D 2 . In an embodiment, the respective first and second diameters D 1 , D 2  of the trailing and leading ends  102 ,  104  are substantially equivalent, as seen in  FIG. 1 . However, in other embodiments of the present disclosure, the trailing and leading ends  102 ,  104  may have respective diameters D 1 , D 2  that are different. Either or both of trailing and leading ends  102 ,  104 , respectively, define surfaces that are substantially arcuate to assist in the insertion of seal anchor member  100  within a tissue tract  12  defined by tissue surfaces  14  and formed in tissue “T”, e.g., an incision, as discussed in further detail below. 
         [0024]    Intermediate portion  106  defines a radial dimension “R” and extends longitudinally between proximal and distal ends  102 ,  104 , respectively, to define an axial dimension or length “L”. Seal anchor member  100  defines a cross-sectional dimension that varies along length “L”, i.e., an hour glass configuration, which facilitates the anchoring of seal anchor member  100  within tissue “T”. In alternative embodiments, the radial dimension “R” of the intermediate portion  106  may be substantially equivalent to the respective diameters D 1 , D 2  of the proximal and distal ends,  102 ,  104 , respectively. Moreover, in cross-section, intermediate portion  106  may exhibit any suitable configuration, e.g., substantially circular, oval, oblong, or non-circular. Additionally, the intermediate portion  106  may be thinned to ease insertion. 
         [0025]    Each port  108  of the seal anchor member  100  is configured to receive a surgical object therein. Prior to the insertion of the surgical object, port  108  is in a first state in which port  108  defines a first or initial dimension. The port  108  may incorporate a slit extending the longitudinal length of the seal anchor member  100 . The ports  108  are substantially closed in the absence of a surgical object inserted therein thereby inhibiting the escape of insufflation gas through the port  108 . Upon the introduction of a surgical object into the port  108 , the port  108  transitions to a second state to substantially approximate the diameter of the surgical object such that a substantially fluid-tight seal is formed therewith, thereby substantially inhibiting the escape of insufflation gas through port  108 . 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, a thermoplastic elastomer (TPE) or a gel. The formation of a seal anchor member  100  may involve a process whereby an inert gas, such as carbon dioxide or nitrogen is infused into the material so as to form a foam structure. Seal anchor  100  may also be coated with a lubricious coating, e.g., Parylene N or C, to ease insertion of instruments and/or cannulae therethrough. 
         [0026]    As shown in  FIGS. 1 ,  2 , and  4 , the lumen  115  is centered at longitudinal axis “A” of the seal anchor member  100  and is adapted to receive dilator  200  therein. Dilator  200  ( FIG. 3 ) includes a generally cylindrical body section  201 , a generally conical tip  202 , and a generally flat top surface  203 . The shape of the dilator  200  facilitates insertion of the dilator  200  into the lumen  115  of the seal anchor member  200 . Upon the introduction of the dilator  200  into lumen  115 , the lumen  115  substantially approximates the diameter of the dilator  200  such that a substantially fluid-tight seal is formed therewith, thereby substantially inhibiting the escape of insufflation gas through lumen  115 . While the seal anchor member  100  is described herein as having a single longitudinally disposed lumen, it is envisioned that a plurality of lumens may be used and that the lumens may have different orientations within the seal anchor member. 
         [0027]    Anchoring of the seal anchor member  100  within the tissue tract  12  is achieved by applying a compressive force “F”, as shown in  FIG. 2 , to reduce the dimensions of the seal anchor member  100 , and then inserting the seal anchor member  100  within the tissue tract  12 . Application of an external, compressive force “F” to the seal anchor member  100  transitions from an initial condition to a compressed condition. In the initial condition, the seal anchor member  100  is at rest and the trailing end  102  has a radial dimension D 1 , the leading end  104  has a radial dimension D 2 , and the intermediate portion  106  has a radial dimension R. In the compressed condition, as shown in  FIG. 2 , the trailing end  102  has a radial dimension D 1 ′, the leading end  104  has a radial dimension D 2 ′, and the intermediate portion  106  has a radial dimension R′. 
         [0028]    As depicted in  FIG. 2 , as seal anchor member  100  is compressed under the influence of external force “F”, an internal biasing force “F B1 ” within seal anchor member  100  is directed outwardly, opposing force “F”. Internal biasing force “F B1 ” acts to expand seal anchor member  100  and thereby return seal anchor member  100  to its initial, expanded condition. Accordingly, as long as seal anchor member  100  is subject to external force “F” that overcomes the internal biasing force “F B1 ”, seal anchor member  100  remains in the compressed condition. Upon the removal of external “F”, however, biasing force “F B1 ” urges seal anchor member  100  to its initial condition. 
         [0029]    Referring again to  FIG. 1 , one or more positioning members  114   a,    114   b  may be associated with either or both of trailing (or proximal) end  102  and distal (or leading) end  104  of seal anchor member  100 . Positioning members  114   a,    114   b  may be composed of any suitable biocompatible material that is at least semi-resilient such that positioning members  114   a,    114   b  may be resiliently deformed and may exhibit any suitable configuration, e.g., substantially annular or oval. Prior to the insertion of seal anchor member  100 , positioning members  114   a,    114   b  are deformed in conjunction with the respective proximal and distal ends  102 ,  104  of seal anchor member  100  to facilitate the advancement thereof through tissue tract  12  ( FIG. 2 ). Subsequent to the insertion of seal anchor member  100  within tissue tract  12 , the resilient nature of positioning members  114   a,    114   b  allows positioning members to return to their normal, substantially annular configuration, thereby aiding in the expansion of either or both of the respective proximal and distal ends  102 ,  104  and facilitating the transition of seal anchor member  100  from its compressed condition to its expanded condition. Positioning members  114   a,    114   b  also may engage the walls defining the body cavity to further facilitate securement of seal anchor member  100  within the body tissue “T”. For example, positioning member  114   b  at leading end  104  may engage the internal peritoneal wall and positioning member  114   a,    114   b  adjacent trailing end  102  may engage the outer epidermal tissue adjacent the incision  12  within tissue “T”. In another embodiment of seal anchor member  100 , one or more additional positioning members  114   a,    114   b  may be associated with intermediate portion  106 . 
         [0030]    The use and function of seal anchor member  100  will be discussed during the course of a typical minimally invasive procedure. Initially, the peritoneal cavity is insufflated with a suitable biocompatible gas such as, e.g., carbon dioxide, such that the cavity wall is raised and lifted away from the internal organs and tissue housed therein, providing greater access thereto. The insufflation may be performed with an insufflation needle or similar device, as is conventional in the art. Either prior or subsequent to insufflation, a tissue tract  12  is created in tissue “T”, the dimensions of which may be varied dependent upon the nature of the procedure. 
         [0031]    In an embodiment, the seal anchor member  100  in its initial state may be configured and dimensioned to facilitate insertion of the seal anchor member  100  into the tissue tract  12 . In another embodiment, the seal anchor member  100  in its initial state may have dimensions prohibiting the insertion of the seal anchor member  100  into the tissue tract  12 . Insertion of the seal anchor member  100  may be facilitated by transitioning the seal anchor member  100  into the compressed condition by applying a force “F” thereto that is greater than the internal biasing force “F B1 ”, e.g., by squeezing seal anchor member  100 . Force “F” acts to reduce the radial dimensions of the proximal and distal ends  102 ,  104 , respectively, to D 1 ′ and D 2 ′ ( FIG. 2 ) including positioning members  114   a,    114   b  (if provided) and to reduce the radial dimension of intermediate portion  106  to R′ such that the seal anchor member  100  may be inserted into tissue tract  12 . Subsequent to the insertion of the seal anchor member  100 , distal end  104 , positioning member  114   a,    114   b  (if provided) and at least a section  112  of intermediate portion  106  are disposed beneath the tissue “T”. Seal anchor member  100  is caused to transition from the compressed condition to the expanded condition by removing force “F” therefrom. Expansion of the section  112  of the intermediate portion  106  is limited by the tissue surfaces  14  ( FIG. 1 ) defining tissue tract  12 , thereby subjecting intermediate portion  106  to an external force “F” that is directed inwardly. As discussed above, this creates an internal biasing force “F B1 ” that is directed outwardly and exerted upon tissue surfaces  14 , thereby creating a substantially fluid-tight seal between the seal anchor member  100  and tissue surfaces  14  and substantially preventing the escape of insufflation gas around seal anchor member  100  and through tissue tract  12 . 
         [0032]    In the initial condition, the respective radial dimensions D 1 , D 2  of the proximal and distal ends  102 ,  104  are substantially larger than the radial dimension R of the intermediate portion  106  thereby giving seal anchor member  100  an “hour-glass” configuration. Subsequent to insertion, the radial dimension D 2  of distal end  104  and positioning member  114   a,    114   b  is also substantially larger than the dimensions of the tissue tract  12 . Consequently, removal of the seal anchor member  100  from tissue tract  12  in the expanded condition is inhibited and thus, seal anchor member  100  will remain anchored within the tissue “T” until it is returned to its compressed condition. 
         [0033]    The lumen  115  defines an empty space within the seal anchor member  100 . By providing an empty space within the seal anchor member  100 , the internal biasing force of the seal anchor member resisting compression is reduced. Accordingly, the force necessary to compress the seal anchor member is less than would be required in the absence of the lumen  115 . By reducing the amount of material of the seal anchor member, the force necessary to compress the seal anchor member is reduced and placement of the seal anchor member within the tissue tract is facilitated. 
         [0034]    In certain situations, e.g., after placement of the seal anchor member  100  within the tissue tract, it may be desirable to decrease the compressibility of the seal anchor member. Dilator  200  may be inserted within the lumen  115  to resist compression of the seal anchor member  100 . Dilator  200  may be placed within lumen  115  subsequent to insertion of the seal anchor member  100  within tissue tract  12  to facilitate a substantially sealed relationship between the tissue surfaces  14  of the tissue tract  12  and the seal anchor member  100 . In addition to decreasing the compressibility of the seal anchor member  100 , the placement of the dilator  200  within the lumen  115  may increase the radial dimensions of the seal anchor member  100 . 
         [0035]    Dilator  200  may be formed from the same material as the seal anchor member  100 . For example, the dilator  200  may be formed of a flowable or sufficiently compliable material, such as a foam material, e.g., an open-cell polyurethane foam, a thermoplastic elastomer (TPE) or a gel. Alternatively, the dilator  200  may be formed of a different material having the same or different compressibility properties. For example, the dilator  200  may be formed from a rigid material. 
         [0036]    It is envisioned that alternative means may be used to change the compressibility of the seal anchor member. With reference to  FIG. 5 , an alternative to dilator  200  will now be described. Seal anchor member  300 , as shown in  FIG. 5 , differs from seal anchor member  300  in that lumen  115  is operatively coupled to a valve  310 . Valve  310  is adapted to adjust the air pressure within lumen  115  such that the internal biasing force of the seal anchor member  300  may be adjusted. By adjusting the internal biasing force of the seal anchor member  300 , the compressibility of the seal anchor member  300  may be adjusted. It may be desirable to have less air within the lumen  115  prior to insertion of the seal anchor member  300  within tissue tract  12 . Subsequent to placement of the seal anchor member  300  within the tissue tract  12 , the air pressure within the seal anchor member  300  may be increased to facilitate a substantially sealed relationship between the seal anchor member  300  and the tissue tract  12 . 
         [0037]    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.