Abstract:
A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition to facilitate securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract and a second compressed condition to facilitate at least partial insertion of the seal anchor member within the tissue tract. The seal anchor member has proximal and distal ends defining elongated perimeters. At least one port extends between the proximal and distal ends and is adapted for reception of an object whereby compressible material defining the at least one port is adapted to deform to establish a substantial sealed relation with the object.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61,231,781 filed on Aug. 6, 2009, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates 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 the Related Art 
         [0005]    Today, many surgical procedures are performed through small incisions in the skin, as compared to the larger incisions typically required in traditional procedures, in an effort to reduce both trauma to the patient and recovery time. 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 gasses 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 inhibit 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 an incision in tissue in a narrow area, such as a cavity between two ribs, and that can accommodate a variety of surgical objects while maintaining the integrity of an insufflated workspace. 
       SUMMARY 
       [0008]    A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition and a second compressed condition. The first expanded condition facilitates a securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract, and the second compressed condition facilitates an at least partial insertion of the seal anchor member within the tissue tract. The seal anchor member may be formed of a foam material, which may be at least partially constituted of a material selected from the group consisting of polyisoprene, urethane, and silicone. Alternatively, the seal anchor member may be formed of a gel material. 
         [0009]    The seal anchor member includes proximal and distal ends that define elongated, e.g., oval or oblong, perimeters to facilitate the positioning of the seal anchor member within a tissue tract accessing an underlying body cavity. At least one of the proximal and distal ends of the seal anchor member may exhibit an arcuate configuration, which may be either concave or convex. The seal anchor member may be rolled, twisted, or otherwise deformed to fit nonlinearly into the tissue tract. The seal anchor member may also be cut to better suit a surgical procedure. 
         [0010]    At least one port extends between the proximal and distal ends and is adapted for the reception of an object whereby compressible material defining the at least one port is adapted to deform to establish a substantial sealed relation with the object. The at least one port may contain at least an undercut to protect against fluid leaks. The seal anchor member may include a plurality of ports that may be configured linearly with respect to the major axis of the perimeter of at least one of the distal and proximal ends. Each port may be spaced equally from its neighboring ports. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein: 
           [0012]      FIG. 1  is a top, perspective view of a surgical apparatus in accordance with the principles of the present disclosure shown in an expanded condition illustrating a seal anchor member positioned relative to the tissue; 
           [0013]      FIG. 2  is a side, schematic view of the seal anchor member of  FIG. 1 ; 
           [0014]      FIG. 3  is a cross-sectional view of the seal anchor member of  FIG. 1  taken along section line  3 - 3  of  FIG. 1  illustrating a plurality of ports defining undercuts; 
           [0015]      FIG. 4  is a side, schematic view of a port of the seal anchor member of  FIG. 2  with a surgical object inserted therethrough; 
           [0016]      FIG. 5  is a perspective, schematic view of the seal anchor member of  FIG. 1  shown in a compressed condition prior to the insertion thereof into an incision in tissue; 
           [0017]      FIG. 6  is a perspective, schematic view of the seal anchor member of  FIG. 1  shown in the expanded condition and subsequent to its insertion into the incision; 
           [0018]      FIG. 7  is a top, plan view of the seal anchor member of  FIG. 1  in a rolled state; and 
           [0019]      FIGS. 8A-8D  are perspective views of a surgical apparatus in accordance with another embodiment of the present disclosure illustrating a seal anchor member cut to varying lengths. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0020]    In the drawings and in the description which follows, in which like references numerals identify similar or identical elements, the term “proximal” will refer to the end of the apparatus which is closest to the clinician during use, while the term “distal” will refer to the end which is furthest from the clinician, as is traditional and known in the art. 
         [0021]    With reference to  FIGS. 1-4 , a surgical apparatus  10  for use in a surgical procedure, e.g., a minimally invasive procedure is illustrated. Surgical apparatus  10  includes seal anchor member  100  having proximal end  102  and distal end  104 . Seal anchor member  100  includes one or more ports  108  that extend through seal anchor member  100  between proximal end  102  and distal end  104 . 
         [0022]    Seal anchor member  100  is 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. 4 ), and also establish a sealing relation with tissue “T”. The foam is sufficiently compliant to accommodate motion of the surgical object “I”. In one embodiment, the foam includes a polyisoprene material. 
         [0023]    Proximal end  102  of seal anchor member  100  defines a first major axis D 1  and distal end  104  defines a second major axis D 2 . In one embodiment of seal anchor member  100 , the respective first and second major axes D 1 , D 2  of the proximal and distal ends  102 ,  104  are substantially equivalent, as seen in  FIG. 2 , although an embodiment of seal anchor member  100  in which axes D 1 , D 2  are different is also within the scope of the present disclosure. As depicted in  FIG. 1 , positioning members  114  of proximal and distal ends  102 ,  104  may define arcuate surfaces 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. Alternatively, proximal and distal ends  102 ,  104  may define substantially planar surfaces or substantially arcuate surfaces. Embodiments are contemplated herein in which either or both of proximal and distal ends  102 ,  104  define surfaces that are either or both arcuate or planar. The arcuate surfaces may be either or both concave or convex. 
         [0024]    Intermediate portion  106  extends between proximal and distal ends  102 ,  104  to define a dimension, or length, “L” therealong. Intermediate portion  106  further defines a dimension “R” substantially parallel to major axes D 1 , D 2 . The dimension “R” of intermediate portion  106  may remain substantially uniform along the dimension “L” thereof. Alternatively, the dimension “R” of intermediate portion  106  may vary along the dimension, or length, “L” thereof, thereby defining a cross-sectional dimension that varies along its length “L”, which facilitates the anchoring of seal anchor member  100  within tissue “T”. 
         [0025]    The dimension “R” of intermediate portion  106  is appreciably less than the respective major axes D 1 , D 2  of proximal and distal ends  102 ,  104  to assist in anchoring seal anchor member  100  within tissue “T”, as discussed in further detail below. However, in an alternate embodiment, the dimension “R” of intermediate portion  106  may be substantially equivalent to the respective major axes D 1 , D 2  of proximal and distal ends  102 ,  104 . In cross section, intermediate portion  106  may exhibit any suitable elongated configuration, e.g., substantially oval or oblong, for insertion into a narrow incision. 
         [0026]    Each port  108  is configured to removably receive the surgical object “I”. Prior to the insertion of surgical object “I”, port  108  is in a first state in which port  108  defines a first or initial dimension D P1 . Port  108  may define an opening within seal anchor member  100  having an initial open state. Alternatively, D P1  may 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 substantially inhibited. For example, port  108  may be a slit extending the length “L” of seal anchor member  100  through proximal and distal ends  102 ,  104 . 
         [0027]    Upon the introduction of surgical object “I”, port  108  transitions to a second state in which port  108  defines a second, larger dimension D P2  that substantially approximates the diameter D 1  of surgical object “I” such that a substantially fluid-tight seal is formed therewith, thereby substantially inhibiting the escape of insufflation gas (not shown) through port  108  of seal anchor member  100  in the presence of surgical object “I”. 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. Seal anchor member  100  may include a plurality of generally tubular port segments (not shown) defining ports  108 . 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. 
         [0028]    Ports  108  may include ports  108   a , which contain at least one undercut  118  that collects insufflation gas that leaks through the substantially fluid-tight seal between a surgical instrument “I” and a port  108   a . Each undercut  118  defines a diameter D P3  greater than D P2  and a length along a port  108   a  less than “L”. Insufflation gas that leaks through a substantially fluid-tight seal between an instrument “I” and a port  108   a  may collect in an undercut  118  to inhibit further leakage of the gas through the substantially fluid-tight seal. Ports  108  may also include ports  108   b , which do not contain undercuts  118 , or any combination of ports  108   a  and ports  108   b.    
         [0029]    Generally, ports  108  are arranged linearly with respect to major axis D 1 . Ports  108  may alternatively be arranged linearly with respect to major axis D 2  or dimension “R”. However, embodiments in which ports  108  are arranged nonlinearly, e.g., an oval or zigzag pattern, are also within the scope of this disclosure. Each port  108  may be spaced equally from its neighboring ports. However, embodiments in which ports  108  are spaced unequally are also within the scope of this disclosure. 
         [0030]    Referring now to  FIGS. 1 and 5 , seal anchor member  100  is adapted to transition from an expanded condition ( FIG. 1 ) to a compressed condition ( FIG. 5 ) so as to facilitate the insertion and securement thereof within tissue tract  12  in tissue “T”. In the expanded condition, seal anchor member  100  is at rest and the respective major axes D 1 , D 2  of the proximal and distal ends  102 ,  104  of seal anchor member  100 , as well as the dimension “R” of the intermediate portion  106  are such that the seal anchor member  100  cannot be inserted within tissue tract  12 . However, as seen in  FIG. 5 , in the compressed condition, proximal and distal ends  102 ,  104  of seal anchor member  100  as well as intermediate portion  106  are dimensioned for insertion into tissue tract  12 . 
         [0031]    Seal anchor member  100  is formed of a biocompatible compressible material that facilitates the resilient, reciprocal transitioning of seal anchor member  100  between the expanded and compressed conditions thereof. In one embodiment, the compressible material is a “memory” foam. An external force “F” is applied to seal anchor member  100  to cause the seal anchor member  100  to assume the compressed condition. External force “F” is directed inwardly and when seal anchor member  100  is subjected thereto, e.g., when seal anchor member  100  is squeezed, seal anchor member  100  undergoes an appreciable measure of deformation, thereby transitioning into the compressed condition. 
         [0032]    As depicted in  FIG. 5 , as seal anchor member  100  is compressed under the influence of external force “F”, an internal biasing force “F B1 ” is created within seal anchor member  100  that is directed outwardly, opposing force “F”. Internal biasing force “F B1 ” endeavors to expand seal anchor member  100  and thereby return seal anchor member  100  to the expanded condition thereof. Accordingly, as long as seal anchor member  100  is subject to external force “F” greater than biasing force “F B1 ”, seal anchor member  100  is compressed, and as long as external force “F” equals biasing force “F B1 ”, seal anchor member  100  remains in the compressed condition. Upon the removal of external force “F”, biasing force “F B1 ” acts to return seal anchor member  100  to the expanded condition. 
         [0033]    The compressible material comprising seal anchor member  100  also facilitates the resilient transitioning of port  108  between its first state ( FIGS. 1-3 ) and its second state ( FIG. 5 ). As previously discussed, prior to the insertion of surgical object “I”, port  108  is in its first state in which port  108  defines a first or initial dimension D P1 . Port  108  may incorporate a slit extending the length “L” of seal anchor member  100 . In this first state, port  108  is at rest and is not subject to any external forces. However, upon the introduction of surgical object “I” through port  108  as depicted in  FIG. 4 , the surgical object “I” exerts a force “F 1 ” upon port  108  that is directed radially outward. Force “F 1 ” 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 1  of surgical object “I”. Consequently, an internal biasing force “F B2 ” is created that is directed radially inward, in opposition to force “F 1 ”. Internal biasing force “F B2 ” 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 B2 ” is exerted upon surgical object “I” and acts to create a substantially fluid-tight seal therewith. The significance of forces “F B1 ” and “F B2 ” will be discussed in further detail below. 
         [0034]    Referring again to  FIG. 1 , one or more positioning members  114  may be associated with either or both of proximal end  102  and distal end  104  of seal anchor member  100 . Positioning members  114  may be composed of any suitable biocompatible material that is at least semi-resilient such that positioning members  114  may be resiliently deformed and may exhibit any suitable elongated configuration, e.g., substantially oblong or oval. Prior to the insertion of seal anchor member  100 , positioning members  114  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. 6 ). Subsequent to the insertion of seal anchor member  100  within tissue tract  12 , the resilient nature of positioning members  114  allows positioning members to return to their normal, e.g., substantially oblong or oval, 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  also may engage the walls defining the body cavity to further facilitate securement of seal anchor member  100  within the body tissue. For example, positioning member  114  at leading end  104  may engage the internal peritoneal wall and positioning member  114  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  may be associated with intermediate portion  106 . 
         [0035]    The use of seal anchor member  100  will be discussed during the course of a typical minimally invasive procedure. Initially, the peritoneal cavity (not shown) is insufflated with a suitable biocompatible gas, such as CO 2  gas, 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. 
         [0036]    Prior to the insertion of seal anchor member  100  within tissue tract  12 , seal anchor member  100  is in its expanded condition in which the dimensions thereof prohibit the insertion of seal anchor member  100  into tissue tract  12 . To facilitate insertion, the clinician transitions seal anchor member  100  into the compressed condition by applying a force “F” thereto, e.g., by squeezing seal anchor member  100 . Force “F” acts to reduce the dimensions D 1  and D 2  of the proximal and distal ends  102 ,  104 , respectively, to D 1 ′ and D 2 ′ ( FIG. 5 ) including positioning members  114  (if provided) and to reduce the dimension “R” of intermediate portion  106  to “R” such that seal anchor member  100  may be inserted into tissue tract  12 . As best depicted in  FIG. 6 , subsequent to its insertion, distal end  104 , positioning member  114  (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. 
         [0037]    During the transition from the compressed condition to the expanded condition, the dimensions of seal anchor member  100 , i.e., the respective dimensions D 1 ′, D 2 ′ ( FIG. 5 ) of the proximal and distal ends  102 ,  104  are increased to D 1  and D 2  ( FIG. 6 ) and the dimension “R′” is increased to “R”. The expansion of distal end  104  is relatively uninhibited given the disposition thereof beneath tissue “T”, and accordingly, distal end  104  is permitted to expand substantially, if not completely. However, as seen in  FIG. 5 , the 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 inhibiting the escape of insufflation gas around seal anchor member  100  and through tissue tract  12 . 
         [0038]    In the expanded condition, the respective dimensions D 1 , D 2  of the proximal and distal ends  102 ,  104  are larger than the dimension “R” of the intermediate portion  106 . Subsequent to insertion, the dimension D 2  of distal end  104  and positioning member  114  is also substantially larger than the dimensions of the tissue tract  12 . Consequently, seal anchor member  100  may not be removed from tissue tract  12  in the expanded condition and thus, seal anchor member  100  will remain anchored within the tissue “T” until it is returned to its compressed condition. 
         [0039]    After successfully anchoring seal anchor member  100  within the patient&#39;s tissue “T”, one or more surgical objects “I” may be inserted through ports  108 .  FIG. 6  illustrates a surgical object “I” introduced through one of ports  108 . As previously discussed, prior to the insertion of surgical object “I”, port  108  is in its first state in which port  108  defines an initial dimension D P1  which may be negligible in that port  108 , in one embodiment, is a slit. Accordingly, prior to the escape of insufflation gas through port  108 , in the absence of surgical object “I” is minimal, thereby preserving the integrity of the insufflated workspace. 
         [0040]    Surgical object “I” may be any suitable surgical instrument and, accordingly, may vary in size. Suitable surgical objects to be introduced within one or more of the ports  108  include minimally invasive grasper instruments, forceps, clip-appliers, staplers, cannula assemblies, etc. Upon the introduction of surgical object “I”, port  108  is enlarged, thereby transitioning into its second state in which port  108  defines a second dimension D P2 ( FIG. 4 ) that substantially approximates the diameter D 1  of surgical object “I”, thereby creating a substantially fluid-tight seal with surgical object “I” and substantially inhibiting the escape of insufflation gas (not shown) through port  108  of seal anchor member  100  in the presence of a surgical object “I”, as previously discussed. 
         [0041]    Turning now to  FIGS. 8A-8D , a surgical apparatus, in accordance with an alternate embodiment of the present disclosure, is generally designated as  20 . Surgical apparatus  20  is substantially identical to surgical apparatus  10  and thus will only be discussed in detail herein to the extent necessary to identify differences in construction and operation thereof. 
         [0042]    As seen in  FIG. 8A , surgical apparatus  20  comprises a seal anchor member  200  defining a plurality of ports  208 . If seal anchor member  200  defines more ports  208  than are required for a particular surgical procedure, seal anchor member  200  may be cut to have a fewer number of ports  208 .  FIGS. 8B-8D  illustrate resulting seal anchor members  210 ,  220 , and  230  when seal anchor member  200  is cut along segment lines  8 B- 8 B,  8 C- 8 C, and  8 D- 8 D respectively. Seal anchor member  200  and resulting seal anchor members  210 ,  220 , and  230 , may be used in a surgical procedure in a substantially similar manner to seal anchor member  100  as discussed hereinbefore. 
         [0043]    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.