Abstract:
A surgical portal assembly is provided and includes a portal housing and a portal member mounted to the portal housing. The portal member dimensioned for positioning within tissue to access an underlying surgical site. The portal housing and portal member define a central longitudinal axis and a longitudinal passageway for passage of a surgical object. A seal mount is mounted to the portal housing and includes first and second seal members. Each of the first and second seal members has inner surfaces defining a passage for reception of the surgical object in substantial sealed reception. The first seal member adapted for angulating movement relative to the central longitudinal axis upon angulation of the surgical instrument while substantially maintaining the sealed reception of the surgical object. The second seal member being generally fixed from angulating movement.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to and the benefit of U.S. Provisional Application Ser. No. 61/263,059 filed on Nov. 20, 2009, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to a surgical portal apparatus for accessing an underlying body cavity, and, in particular, relates to a multi-seal system for use with an introducer which is intended for insertion into a patient&#39;s body, and to receive an instrument in sealing engagement therewith. 
         [0004]    2. Description of the Related Art 
         [0005]    Minimally invasive and laparoscopic procedures generally require that any instrumentation inserted into the body is sealed, i.e., provisions must be made to ensure that gases and/or fluids do not enter or exit the body through an endoscopic incision, such as, for example in surgical procedures where the surgical region is insufflated. For such procedures, the introduction of a tube into anatomical cavities, such as the peritoneal cavity, is usually accomplished by use of a system incorporating a trocar and cannula assembly. Since the cannula is in direct communication with the interior of the peritoneal cavity, insertion of the cannula into an opening in the patient&#39;s body to reach the inner abdominal cavity should be adapted to maintain a fluid tight interface between the abdominal cavity and the outside atmosphere. In view of the need to maintain the atmospheric integrity of the inner area of the cavity, a seal assembly for a cannula, which permits introduction of a wide range of surgical instrumentation and maintains the atmospheric integrity of the inner area of the cavity is desirable. In this regard, there have been a number of attempts in the prior art to achieve such sealing requirements. A difficulty encountered with conventional seal assemblies, however, is the inability of accommodating the wide range of sizes of instrumentation. In addition, angulation and/or manipulation of instrumentation within the cannula often present difficulties with respect to maintaining seal integrity. 
       SUMMARY 
       [0006]    Accordingly, the present disclosure provides a surgical portal assembly. The surgical port includes a portal housing and a portal member mounted to the portal housing. The portal member dimensioned for positioning within tissue to access an underlying surgical site. The portal housing and portal member define a central longitudinal axis and a longitudinal passageway for passage of a surgical object. A seal mount is mounted to the portal housing and includes first and second seal members. Each of the first and second seal members has inner surfaces defining a passage for reception of the surgical object in substantial sealed reception. The first seal member adapted for angulating movement relative to the central longitudinal axis upon angulation of the surgical instrument while substantially maintaining the sealed reception of the surgical object. The second seal member being generally fixed from angulating movement. 
         [0007]    In an embodiment, the seal mount includes a third seal member. The third seal member is generally fixed from angulating movement. The first seal member may be disposed between the second and third seal members. The second seal member may be in contacting relation with at least one of the first and third seal members 
         [0008]    In certain embodiments, each of the first, second and third seal members define a generally spherical segment. 
         [0009]    In an embodiment, the inner surfaces of the first seal member define an open aperture in the absence of the surgical object. 
         [0010]    In an embodiment, the first seal member is normally biased to an aligned position where the seal passage of the first seal member is in general longitudinal alignment with the central longitudinal axis. The first seal member may include resilient biasing segments extending in a general proximal direction and dimensioned to operatively engage the portal housing. The biasing segments adapted to bias the seal passage to the aligned position. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The foregoing features of the present disclosure will become more readily apparent and will be better understood by referring to the following detailed description of preferred embodiments, which are described hereinbelow with reference to the drawings wherein: 
           [0012]      FIGS. 1-2  are perspective views of a cannula assembly and a seal assembly in accordance with the principles of the present disclosure; 
           [0013]      FIG. 3  is a perspective view with parts separated of the cannula and seal assemblies of  FIG. 1 ; 
           [0014]      FIG. 4  is a perspective view of a seal mount depicted in  FIG. 3 ; 
           [0015]      FIG. 5A  is cross-sectional view with the components of the seal mount depicted in  FIG. 4  separated; 
           [0016]      FIG. 5B  is cross-sectional view of the seal mount depicted in  FIG. 4 ; 
           [0017]      FIG. 6  is a perspective view illustrating the seal mount depicted in  FIG. 3  within a seal housing; and 
           [0018]      FIG. 7  is a perspective view illustrating the cannula assembly and seal assembly accessing an, internal cavity with an instrument introduced therein. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0019]    The seal assembly of the present disclosure, either alone or in combination with a seal system internal to a cannula assembly, provides a substantial seal between a body cavity of a patient and the outside atmosphere before, during and after insertion of an instrument through the cannula assembly. Moreover, the seal assembly of the present invention is capable of accommodating instruments of varying diameters, e.g., from 5 mm to 15 mm, by providing a gas tight seal with each instrument when inserted. The flexibility of the present seal assembly greatly facilitates endoscopic surgery where a variety of instruments having differing diameters are often needed during a single surgical procedure. 
         [0020]    The seal assembly contemplates the introduction and manipulation of various types of instrumentation adapted for insertion through a trocar and/or cannula assembly while maintaining a fluid tight interface about the instrumentation to preserve the atmospheric integrity of a surgical procedure from gas and/or fluid leakage. Specifically, the seal assembly accommodates off-axial insertion of the surgical instrument relative to the seal housing axis. This feature of the present disclosure desirably minimizes the entry and exit of gases and/or fluids to/from the body cavity. Examples of instrumentation include clip appliers, graspers, dissectors, retractors, staplers, laser probes, photographic devices, endoscopes and laparoscopes, tubes, and the like. Such instruments will be collectively referred to herein as “instruments or instrumentation”. 
         [0021]    By virtue of its features, the seal assembly further defines a substantially reduced profile when assembled together and mounted to a cannula assembly. This reduced profile advantageously increases the working length of instruments introduced into the body cavity through the cannula assembly. In addition, the reduced profile permits enhanced angulation of a surgical instrument relative to the seal housing axis. 
         [0022]    In the following description, as is traditional the term “proximal” or “leading” refers to the portion of the instrument closest to the operator while the term “distal” or “trailing” refers to the portion of the instrument remote from the operator. 
         [0023]    Referring now to the drawings, in which like reference numerals identify identical or substantially similar parts throughout the several views,  FIGS. 1-2  illustrate the seal assembly  100  of the present disclosure mounted to cannula assembly  200 . Cannula assembly  200  may be any conventional cannula suitable for the intended purpose of accessing a body cavity and permit introduction of instruments therethrough, such as the one described in commonly-owned United States Patent Publication No. 2005/0212221, the contents of which hereby incorporated in its entirety by reference. Cannula assembly  200  is particularly adapted for use in laparoscopic surgery where the peritoneal cavity is insufflated with a suitable gas, e.g., CO.sub.2, to raise the cavity wall from the internal organs therein. Cannula assembly  200  is typically used with an obturator assembly (not shown) which is a sharp pointed instrument positionable within the passageway of the cannula assembly  200 . The obturator assembly is utilized to penetrate the abdominal wall and then subsequently removed from the cannula assembly to permit introduction of the surgical instrumentation utilized to perform the procedure. 
         [0024]    Cannula assembly  200  includes cannula sleeve  202  and cannula housing  204  mounted to an end of the sleeve  202 . Cannula sleeve  202  defines a longitudinal axis “a” extending along the length of sleeve  202 . Sleeve  202  further defines an internal longitudinal passage dimensioned to permit passage of surgical instrumentation. Sleeve  202  may be formed of stainless steel or other rigid materials such as a polymeric material or the like. 
         [0025]    Cannula housing  204  includes two components, specifically, housing flange  206  which is attached to the proximal end of cannula sleeve  202  and main housing  208  as shown in  FIG. 3 . Main housing  208  is connectable to housing flange  206  by one or more suitable connection methods, such as, for example, through a bayonet coupling consisting of radially spaced tongues  210  on the exterior of housing flange  206  and corresponding recesses  212  within the interior of main housing  208 . Main housing  208  further includes diametrically opposed housing grips  214  dimensioned and arranged for gripping engagement by the fingers of the user. Although shown and described as two components, cannula housing  204  may be a single component and attached to cannula sleeve  202  by any of the aforementioned means. 
         [0026]    With reference to  FIG. 3 , in conjunction with  FIGS. 1-2 , cannula housing  204  further includes duck bill or zero closure valve  216  which tapers distally and inwardly to a sealed configuration as shown in the figure. Valve  216  is configured to function in a manner that is conventional in the art. 
         [0027]    For a more detailed description of the cannula  200  and operative components associated therewith reference is again made to commonly-owned United States Patent Publication No. 2005/0212221. 
         [0028]    Referring now to  FIGS. 3-5B , in conjunction with  FIGS. 1-2 , seal assembly  100  will be discussed in detail. Seal assembly  100  includes seal housing, generally identified as reference numeral  102 , and seal mount  104  which is disposed within the seal housing  102 . Seal housing  102  houses the sealing components of the assembly and defines the outer valve or seal body of the seal assembly  100 . Seal housing  102  defines central seal housing axis “b-b” which is preferably parallel to the axis “a-a” of cannula sleeve  202  and, more specifically, coincident with the axis “a-a” of the cannula. Seal housing  102  incorporates three housing components, namely, proximal, distal and inner housing components  106 ,  108 ,  110 , respectively, which, when assembled together, form the seal housing  102 . Assembly of housing components  106 ,  108 ,  110  may be affected by any of the aforementioned connection means discussed with respect to cannula housing  204 . Further, seal housing  102  may be considered as having an upper housing portion  109  formed by components  106   108 , as shown separately in  FIG. 6 , and a detachable lower housing portion formed by component  110 . 
         [0029]    Proximal housing component  106  defines inner guide wall  112  and outer wall  114  disposed radially outwardly of the inner guide wall  112 . Inner guide wall  112  defines central passage  116  which is dimensioned to receive a surgical instrument “I” and laterally confine the instrument within seal housing  102 . Inner guide wall  112  is generally cylindrical in configuration and terminates in a distal arcuate surface  118 . Outer wall  114  defines first and second annular recesses  120 ,  122  adjacent its distal end. Recesses  120 ,  122  receive corresponding structure, e.g., annular lips  124 ,  126  of distal housing component  108  to facilitate connection of the two components. 
         [0030]    Inner housing component  110  is disposed within the interior of distal housing component  108  and securely connectable to the distal housing component  108  through a bayonet coupling. Such coupling includes radially spaced tongues  128  which depend radially inwardly to be received within correspondingly arranged grooves or recesses  130  on the exterior of inner housing component  110 . Coupling of distal and inner housing components  108 ,  110  is thereby affected through simple rotation of the components. 
         [0031]    In the embodiment illustrated in  FIG. 3 , seal assembly  100  includes an optional skirt seal  132  mounted about the proximal end of inner housing component  110  or on the upper surface of the inner housing component (constituting a lower component) of the seal housing. Skirt seal  132  functions in minimizing the loss of insufflation gases through seal assembly  102 . Skirt seal  132  also engages seal mount  104  and serves to bias the seal mount in a proximal direction against inner guide wall  112  of proximal housing  106  as will be discussed. Skirt seal  132  is preferably fabricated from a suitable elastomeric material or the like to provide a spring-like characteristic sufficient to appropriately bias seal mount  104 . 
         [0032]    In embodiments, seal mount  104  may be accommodated within an annular space  134  defined between inner and outer walls  112 ,  114  of proximal housing component  106 . In certain embodiments, seal mount  104  may be mounted in a manner which permits angulation of the seal mount  104  relative to seal axis “b-b”. 
         [0033]    Referring now to  FIGS. 4-5B , in conjunction with  FIG. 3 , the components of seal mount  104  will be discussed in further detail. Seal mount  104  includes first and second seal housings  138 ,  140  and a plurality of resilient seal members  141 ,  143 ,  145  mounted between the housings  138 ,  140 . In the illustrated embodiment seal members  141 ,  143 ,  145  include three (3) resilient seal members, a first seal member  141 , an second seal member  143  and a third seal member  145 . First and second seal housings  138 ,  140  and seal members  141 ,  143  and  145  each define a generally spherical configuration, e.g., a portion of a spherical or hemispherical configuration, as shown. First seal housing  138  is preferably seated within second seal housing  140  thereby at least partially enclosing seal member  141 ,  143  and  145 . First seal housing  138  may include a plurality of mounting legs  144  radially spaced about the outer periphery of the seal housing component  138 . Legs  144  define locking surfaces  146  which extend in general transverse relation to the axis “b-b” of seal assembly  200 . Similarly, second seal housing  140  includes a plurality of corresponding locking detents  148  spaced about the interior of the housing  140 . During assembly, the first, second and third seal members  141 ,  143  and  145 , respectively, are positioned within second seal housing  140 . First seal housing  138  is arranged above the second seal housing whereby mounting legs  144  of the first seal housing  138  are longitudinally aligned with the spaces defined between detents  148  of second seal housing  140 . First seal housing  138  is advanced within second seal housing  140  and the housings  138 ,  140  are rotated relative to each other whereby mouthing legs  144  are positioned beneath detents  148  thereby coupling the first and second seal housing  138  and  140 . Other means for coupling first and second seal housings  138 ,  140  are also envisioned such as, for example, with mechanical arrangements and/or adhesives and cements. 
         [0034]    Second seal housing  140  may include one annular internal ledge  158   a  extending along at least a portion of the inner periphery and, in some embodiments, may include a second annular internal ledge  158   c  (shown in phantom). Ledges  158   a  and  158   c  assist in securing seal members  141 ,  143 ,  145  within seal housings  138 ,  140  as will be discussed. 
         [0035]    First and third seal members  141 ,  145  each define an outer periphery with a respective substantially planar annular ledge  168   a  and  168   c . In one embodiment, annular ledge  168   a  of third seal member  145  rests on annular internal ledge  158   c  of second seal housing  140  and annular ledge  168   a  rests on outer periphery of third seal member  145  in the assembled condition of seal mount  104  ( FIG. 5B ). In another embodiment, instead of residing on outer periphery of third seal member  145 , annular internal ledge  168   c  of first seal may reside on second annular internal ledge  158   c  of the second seal housing  140  in the assembled condition of the components. Regardless of the mounting methodology, first and third seal members  141  and  145 , respectively, are mounted in fixed relation relative to seal mount  104  such that the first and third seal members  141  and  145 , respectively, will not angulate during corresponding movement of the surgical instrument “I”. The term “angulate” at least includes pivoting movement of the first and third seals relative to the central longitudinal axis. However, it is envisioned that first and third seal members,  141  and  145 , respectively, may rotate about the central longitudinal axis “a-a.” 
         [0036]    Second seal  143  is mounted between first and third seal members  141  and  145  and defines a width “w 2 ” across the second seal member  143  which is less than the corresponding widths “w 1 , w 3 ” of first and third seal members  141 ,  145 . The radii of curvature of the first, second and third seal members  141 - 145  may generally approximate each other. 
         [0037]    Second seal member  143  is devoid of an annular ledge. Second seal member  143  may angulate (e.g., move or slide in the direction of directional arrows “k” and may rotate about the central longitudinal axis) with respect to the longitudinal axis “b-b” within seal mount  104  and relative to first and third seal members  141  and  143 . A lubricous coating on the proximal and distal faces of the second seal member  143  may facilitate the angular movement of the second seal member  143 . 
         [0038]    Thus, during angular movement of the surgical instrument “I”, a substantial sealed relation is maintained about the surgical instrument “I” through the cooperative angular movement of the second seal member  143  even in the presence of any gapping or “cat-eyeing” occurring between the instrument and the first and third seal members  141  and  145 . 
         [0039]    Second seal member  143  may also include a plurality of radially spaced projecting elements  170  projecting in a general longitudinal direction from the periphery of the second seal member  143  toward first seal member  141 . Projecting elements  170  may comprise an elastomeric deformable material which deforms during angulation of the second seal member  143 , but will normally bias the second seal member  143  toward a position where a seal aperture  154  is generally aligned with the central longitudinal axis “a-a”. Projecting elements  170  may engage the underside of a peripheral edge of first seal member  141  during angulation of the second seal member  143 . The fixed characteristic of the peripheral edge of first seal member  141  will apply a counterforce to the projecting elements  170  whereby the second seal member  143  is normally biased toward an adjacent position. 
         [0040]    Projecting elements  170  may also engage an outer or lower surface of first seal member  141  to maintain a spaced relation between the first and second seal members  141  and  143 , respectively. The spaced relation may facilitate angulation of the second seal member  143  relative to the first seal member  141 . 
         [0041]    Seal members  141 ,  143  and  145  of seal mount  104  are secured in interposed relation between first and second seal housings  138 ,  140 . Each of the seal members  141 ,  143  and  145  may include a resilient layer or center material  160  (e.g., polyisoprene or natural rubber) with first and second layers of fabric  150 , 152  impregnated on the respective proximal and distal surfaces of the resilient center material  160 . Fabric layers  150  and  152  may be formed of any suitable fabric for example, a SPANDEX material containing about 20% LYCRA and about 80% NYLON available from Milliken. In embodiments, the first, second and third seal members  141 ,  143  and  145 , respectively, include resilient material and fabric material which resists deformation of the respective apertures  154 , as well as tearing of the seal members  141 ,  143  and  145 . A suitable seal member or seal type is disclosed in commonly assigned U.S. patent application Ser. No. 09/449,368, filed Nov. 24, 1999, the contents of which are incorporated herein by reference. A central aperture  154  for sealed reception of a surgical instrument “I” is defined by three central apertures  154   a - 154   c  defined by a corresponding seal member  141 ,  143  and  145  (as best shown in  FIG. 4 ). Each of the seal members  141 ,  143  and  145  (e.g., seal member  141 ) is arranged such that first the layer  150  extends or overlaps into a corresponding aperture, e.g., aperture  154   a  ( FIG. 5A ). In this manner, the fabric (which is stronger relative to the resilient material) is positioned to engage the surgical instrument “I” upon passage through aperture  154  of seal members  141 ,  143  and  145  thereby protecting the resilient material defining the aperture  154 . This advantageously minimizes the potential of piercing, penetrating or tearing of the resilient material by the instrument. Alternatively, an additional layer of fabric  151  on the proximal surface of seal member  141  may be superposed and arranged to drape within aperture  154 . 
         [0042]    Although each of seal members  141 ,  143  and  145  is disclosed as an impregnated fabric arrangement, it is appreciated that other seal types may be used and still achieve the objectives of the present disclosure. 
         [0043]    Seal assembly  100  may be associated with, or joined to, cannula assembly  200  in a variety of ways. In a preferred embodiment, seal housing  102  of seal assembly  100  and cannula housing  204  of cannula assembly  200  are adapted to detachably engage each other, e.g., through a bayonet lock or like mechanical means. As previously discussed, proximal and distal housing components  106 ,  108  may define an upper housing component  109  ( FIG. 6 ) which is mountable directly to cannula assembly  200 . Alternatively, inner housing portion  110  which defines a lower housing component may be directly mounted to cannula assembly  200  independent of the upper housing component  109 . Specifically, the lower housing component  110  which houses seal mount  104  may be mounted to cannula assembly independent of the remaining housing components. The upper housing may then be mounted to lower housing or cannula assembly  200  as needed. Even further, upper housing component  109  may be mounted to cannula assembly  200  without lower housing component  110 . Other means of joining seal assembly  100  to cannula assembly  200  will be readily apparent to one of ordinary skill in the art. 
         [0044]    Referring now to  FIG. 7 , use of the seal assembly  100  and cannula assembly  200  in connection with introduction of a surgical instrument will be discussed. Seal assembly  100  is mounted to cannula assembly  200  which is previously introduced into an insufflated abdominal cavity. An instrument “I” is inserted into seal assembly  100  through passage  116  of inner cylindrical guide wall  112  in seal housing  102 . If the axis of the instrument is not perfectly aligned (i.e., off-axial insertion of the instrument) with the axis “a-a” of cannula assembly  200  or axis “b-b” of seal assembly  100 , then the surgical instrument “I” will contact the inner guide wall  112  and/or the inner surface of first seal member  141 . Contact with the first seal member  141  can cause some deformation of the first seal member  141 . The instrument “I” may slide along the surface of the seal mount  104  and/or the first seal member  141 , to the aperture  154 . Second seal member  143  stretches to accommodate a diameter of surgical instrument “I”, as necessary. The surgical instrument “I” passes further distally into the cannula housing  204  passing through duckbill valve  216  and cannula sleeve  202  into the body cavity. Once the surgical instrument “I” is disposed within the aperture  154 , the second seal member  143  is free to move or “float” with respect to the first and third seal members  141 ,  145 , respectively, and the seal housing  102 , while allowing the first and third seal members  141  and  145 , respectively, and second seal member  143  to maintain sealing engagement with the instrument passed therethrough, as well as maintaining the seal around the seal mount  104 . 
         [0045]    While the invention has been particularly shown, and described with reference to the preferred embodiments, it will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the invention. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.