Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/860,580, filed Jul. 31, 2013, the entire disclosure of which is incorporated by reference herein. 
     
    
     TECHNICAL FIELD 
       [0002]    The present application is directed to various embodiments of instrument or hand access surgical site seal caps that improve a surgical seal while providing greater flexibility for manipulation of instruments and tactile feel to the surgeon and thus enhanced accuracy when either a hand or an instrument is disposed through the seal cap. 
       SUMMARY 
       [0003]    The present disclosure relates to instrument or hand access surgical site seal caps that provide various configurations to effect improvements in the surgical seal while providing the above-mentioned greater flexibility for manipulation of instruments and tactile feel to the surgeon and thus enhanced accuracy when either a hand or an instrument is disposed through the seal cap. 
         [0004]    In one exemplary embodiment, the present disclosure relates to an instrument or hand access surgical site seal cap that includes a port assembly that includes a proximal seal retaining portion and a distal seal retaining portion. First and second composite seals are engaged within the port assembly and each have a J-shaped configuration. The first composite seal and the second composite seal interface each other such that the J-shaped configuration of the first and second composite seals are each vertically disposed and interface each other to form a surgical site access location that effects a seal when an instrument or a hand is, or an instrument and a hand are, disposed therethrough. 
         [0005]    In another exemplary embodiment, an instrument or hand access surgical site seal cap includes a port assembly that includes a proximal seal retaining portion and a distal seal retaining portion. The port assembly includes a plurality of layers of a flexible material having various patterns of access ports for hand access and large cross-sectional area instrument access, wherein the patterns of the access ports include football, oval, or cone-shaped access patterns. 
         [0006]    In another exemplary embodiment, the present disclosure relates to an instrument or hand access surgical site seal cap that includes a flexible bag having a proximal end that is open and that is connected to a proximal circular interlock rim and has a distal end that is open and that is connected to a distal snap-on cap. A lanyard is positioned on an external surface of the flexible bag, the lanyard looping around the external surface of the bag. The lanyard includes a sliding, releasable lock that is positioned on the lanyard and is moved along a portion of the length of the lanyard until an aperture having a desired diameter is formed in the flexible bag by the lanyard. The desired aperture has a cross-sectional area corresponding to an approximate cross-sectional area of an instrument or a hand that is intended to be inserted through, and sealed by, the site seal cap. 
         [0007]    In yet another exemplary embodiment, an instrument or hand access surgical site seal cap includes a flexible bag. A proximally positioned interlock rim includes two rigid members, the first rigid member defining a circular twist rim. A snap on cap is positioned distally from the interlock rim. A lanyard is located at a proximal end of the flexible bag. The proximal end extends proximally from the interlock rim. 
         [0008]    In yet another exemplary embodiment, an instrument or hand access surgical site seal cap includes a surgical site port structural member and a plurality of flexible interlocking wedges. The wedges are positioned adjacent to one another spanning a 360° circle within the surgical site port structural member. Each wedge defines first and second vertical lateral surfaces that intersect at an apex. Each wedge tapers from a height at a base of the wedge to a height at the apex such that the first lateral surface and the second lateral surface form an arched profile and each wedge defines a generally contoured pyramidal configuration. 
         [0009]    In a further exemplary embodiment, an instrument or hand access surgical site seal cap includes a surgical site port structural member and a plurality of flexible triangular wedges alternately spaced apart with respect to one another within the surgical site port structural member. Each triangular wedge defines a respective apex that converges at a vertical centerline of the surgical site port structural member. Each wedge defines first and second vertical lateral surfaces that intersect at the apex. The wedges define a first lateral surface and a second lateral surface that intersect at the respective apex. Each wedge tapers from a height at a base of the wedge to a height at the apex such that first lateral surface and second lateral surface form an arched profile and each wedge defines a generally contoured pyramidal configuration. 
         [0010]    In a still further exemplary embodiment, an instrument or hand access surgical site seal cap includes a retaining housing encasing a flexible material that is divided into a plurality of segments such that a plurality of vertical access pierce slits are formed at the interfaces between each segment and an adjacent segment. Each segment includes a respective arcuate spring support formed within the flexible material of the respective segment. 
         [0011]    In another exemplary embodiment, an instrument or hand access surgical site seal cap includes a housing and a soft material mounted in the housing. The soft material defines pierce slits to form a plurality of soft material segments, wherein the pierce slits have a curled wave-like vertical profile to form interlocking ribs to improve sealing capability of the seal. 
         [0012]    The present invention, in accordance with various embodiments thereof, may also relate to a surgical access device comprising a foam structure defining a plurality of generally triangular wedges circumferentially arranged about a longitudinal axis so as to seal the surgical incision, the plurality of generally triangular wedges defining, adjacent their respective apices, a central opening for sealed reception of a surgical object, and a second opening defined between a pair of adjacent wedges, the second opening configured to receive and seal with a surgical instrument inserted into the second opening. 
         [0013]    In various embodiments, each wedge has a first vertical surface on a first side and a second vertical surface on a second side. The first vertical surface of a first wedge may abut a second vertical surface of a second wedge. The first vertical surface of the first wedge and the second vertical surface of the second wedge may form a slit between the first and second wedges, and the slit formed between the first vertical surface of the first wedge and the second vertical surface of the second wedge may extend fully between an upper surface and a lower surface of the surgical access device. The second opening may be in communication with at least a part of the slit. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure: 
           [0015]      FIG. 1  is a perspective cross-sectional view of an instrument or hand access surgical site seal cap according to one exemplary embodiment of the present disclosure that includes a generally cylindrical site access port assembly having composite interfacing J-shaped layers that effect a seal; 
           [0016]      FIG. 2  is a perspective view of the instrument or hand access surgical site seal cap of  FIG. 1 ; 
           [0017]      FIG. 3  is a perspective cross-sectional view of an instrument or hand access surgical site seal cap according to another exemplary embodiment of the present disclosure that includes several layers of a flexible material having various patterns of access ports for hand access and large cross-sectional area instrument access; 
           [0018]      FIG. 4  is a perspective plan view of the entire instrument or hand access surgical site seal cap of  FIG. 3 ; 
           [0019]      FIG. 5  is a an enlarged plan view of the instrument or hand access surgical site seal cap of  FIGS. 3 and 4  further including access ports for small cross-sectional area instrument access; 
           [0020]      FIG. 6A  is a plan view of a flexible material layer included within the instrument or hand access surgical site seal cap of  FIGS. 3 ,  4  and  5  and configured to enable hand access; 
           [0021]      FIG. 6B  is a plan view of a flexible material layer included within the instrument or hand access surgical site seal cap of  FIGS. 3 ,  4  and  5  that is configured with small access ports to enable access for small cross-sectional area instruments and which underlies the flexible material layer for hand access of  FIG. 6A ; 
           [0022]      FIG. 6C  is a plan view of a flexible material layer included within the instrument or hand access surgical site seal cap of  FIGS. 3 ,  4  and  5  that is configured with small access ports to enable access for small cross-sectional area instruments and an alternative pattern which underlies the flexible material layer for hand access of  FIG. 6A ; 
           [0023]      FIG. 7  is an exploded view of several of the layers of flexible material of the instrument or hand access surgical site seal cap of  FIGS. 3 ,  4  and  5  and configured to enable small cross-sectional area instruments, large cross-sectional area instruments and hand access according to one exemplary embodiment of the present disclosure; 
           [0024]      FIG. 8  is a plan view of the several layers of flexible material of  FIG. 7 ; 
           [0025]      FIG. 9  is an exploded view of several layers of flexible material of the instrument or hand access surgical site seal cap of  FIGS. 3 ,  4  and  5  and configured to enable small cross-sectional area instruments and hand access according to one exemplary embodiment of the present disclosure; 
           [0026]      FIG. 10  is a perspective view of an instrument or hand access surgical site seal cap in an extended position showing the interfacing configuration of a snap-on cap to a wound retractor according to one exemplary embodiment of the present disclosure; 
           [0027]      FIG. 11  is a perspective view of the instrument or hand access surgical site seal cap of  FIG. 10  in a collapsed configuration prior to sealing the shaft of an instrument; 
           [0028]      FIG. 12  is a perspective view of the instrument or hand access surgical site seal cap of  FIG. 11  in an extended configuration subsequent to sealing the shaft of an instrument; 
           [0029]      FIG. 13  is a perspective view of an instrument or hand access surgical site seal cap according to one exemplary embodiment of the present disclosure which includes two sealing locations; 
           [0030]      FIG. 14  is an exploded perspective view of the instrument or hand access surgical site seal cap of  FIG. 13 ; 
           [0031]      FIG. 15  is a perspective view of the instrument or hand access surgical site seal cap of  FIGS. 13 and 14  in an extended configuration prior to sealing the shaft of an instrument; 
           [0032]      FIG. 16  is a plan view of an instrument or hand access surgical site seal cap that includes a plurality of flexible interlocking wedges adjacent to one another within a cylindrical surgical site port according to one exemplary embodiment of the present disclosure; 
           [0033]      FIG. 17  is a perspective view of the instrument or hand access surgical site seal cap of  FIG. 16  illustrating one of the flexible interlocking wedges in a raised position above the cylindrical surgical site port; 
           [0034]      FIG. 18  is a plan view of the instrument or hand access surgical site seal cap of  FIGS. 16 and 17  illustrating positioning of a small cross-sectional area instrument and a large cross-sectional area instrument within the surgical site seal cap; 
           [0035]      FIG. 19  is a perspective view of an instrument or hand access surgical site seal cap that includes a plurality of flexible wedges alternately spaced apart with respect to one another within a cylindrical surgical site port according to one exemplary embodiment of the present disclosure; 
           [0036]      FIG. 20  is a perspective cross-sectional view of the instrument or hand access surgical site seal cap of  FIG. 19  taken through two of the flexible wedges; 
           [0037]      FIG. 21  is a perspective frontal view of one of the flexible wedges of  FIGS. 19 and 20  showing a series of ribs extending along lateral surfaces of the flexible wedge; 
           [0038]      FIG. 22  is a perspective rear view of the flexible wedge of  FIG. 21  showing a hollow internal volume within the flexible wedge; 
           [0039]      FIG. 23  is a perspective view of an instrument or hand access surgical site seal cap having a series of flexible arcuate spring supports positioned within a soft rubber-like material such that the supports limit horizontal movement of the material but allow vertical movement according to one exemplary embodiment of the present disclosure; 
           [0040]      FIG. 24  is an elevation cross-sectional view of the instrument or hand access surgical site seal cap of  FIG. 23  showing the flexible arcuate spring supports positioned within the soft rubber-like material; 
           [0041]      FIG. 25  is a plan view of the instrument or hand access surgical site seal cap of  FIGS. 23 and 24  showing the central intersection of pierce slits in the rubber-like material that are positioned between the flexible arcuate spring supports; 
           [0042]      FIG. 26  is a plan view of the instrument or hand access surgical site seal cap of  FIG. 25  illustrating the deformation of the flexible arcuate spring supports when a hand or an instrument is disposed symmetrically through the central intersection of the pierce slits; 
           [0043]      FIG. 27  is a plan view of the instrument or hand access surgical site seal cap of  FIG. 25  illustrating the deformation of the flexible arcuate spring supports when a hand or an instrument is disposed asymmetrically through the central intersection of the pierce slits and an instrument having a small cross-sectional area is disposed asymmetrically through one of the pierce slits in the rubber-like material; and 
           [0044]      FIG. 28  is a cross-sectional view of an alternate exemplary embodiment of the instrument or hand access surgical site seal cap of  FIGS. 23-27  wherein the pierce slits have a curled wave-like vertical profile to form interlocking ribs to improve the seal capability. 
       
    
    
     DETAILED DESCRIPTION 
       [0045]    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 description, and as is traditional when referring to relative positioning on an object, the term “proximal” or “trailing” refers to the end of the apparatus that is closer to the user and the term “distal” or “leading” refers to the end of the apparatus that is further from the user. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. 
         [0046]    The present disclosure relates to various embodiments of instrument or hand access surgical site seal caps that enable access to a surgical site with either a surgeon&#39;s hand and/or one or more instruments. 
         [0047]    As defined herein, a surgical site includes an incision in a patient or a natural orifice through which a surgical procedure may be performed. 
         [0048]      FIGS. 1 and 2  illustrate an instrument or hand access surgical site seal cap  100  according to one exemplary embodiment of the present disclosure. Surgical site seal cap  100  includes a generally cylindrical site access port assembly  102  that includes an upper or proximal seal retaining portion  104  and a lower or distal seal retaining portion  106 . Alternatively, one skilled in the art will readily appreciate that the site access port assembly  102  may have a polygonal, oval or rectangular (form of polygonal) configuration according to the intended usage The upper seal retaining portion  104  has a J-shaped cross-section defining an inwardly projecting rim portion  108  having an upper surface  108   a  and a lower surface  108   b . Upper seal retaining portion  104  further defines a peripheral wall  110  that includes an inner vertical surface  112 . 
         [0049]    Lower or distal seal retaining portion  106  has a generally irregular J-shaped cross-section that includes an inwardly projecting rim portion  114  having an upper or proximal surface  114   a  and a lower or distal surface  114   b . Lower or distal seal retaining portion  106  defines a peripheral wall  116 . 
         [0050]    A vertically projecting rim portion  118  is spaced circumferentially around the upper surface  114   a  of, and engages with, a slot defined in the peripheral wall  110  of the upper or proximal seal retaining portion  104 . 
         [0051]    One end  122  of a first composite seal  120  is engaged within the space formed by the lower surface  108   b  of the upper seal retaining portion  104  and the upper surface  114   a  of the lower seal retaining portion  106 . A projection  124  extending vertically downward from the lower surface  108   b  penetrates into the first composite seal  120  to enhance stability. 
         [0052]    Similarly, one end  132  of a second composite seal  130  is engaged within the space formed by the lower surface  108   b  of the upper seal retaining portion  104  and the upper surface  114   a  of the lower seal retaining portion  106 . In a similar manner, a projection  134  extending vertically downward from the lower surface  108   b  penetrates into the second composite seal  130  to enhance stability. 
         [0053]    The first composite seal  120  and the second composite seal  130  each have a J-shaped cross-section and are disposed such that second end  126  of the first seal portion  120  and second end  136  of the second seal portion  130  are each vertically disposed and interface each other to form a surgical site access location  140  that is configured as a straight line and thus effects a seal. 
         [0054]    Each seal  120 ,  130  includes a closed cell foam core  142  defining the J-shaped cross-section. The core  142  of each seal  120 ,  130  is encased by a top and bottom dipped liquefied medical grade material elastomeric sheeting  144  such as silicone membrane used for breast implants such as a medical grade plastic including, but not limited to, polyisoprene, urethane, silicone, or any other material suitable for the intended purpose of facilitating off-axis movement of an inserted surgical instrument or clinician&#39;s hand, e.g., a flowable or sufficiently compliable material, such as an open-cell polyurethane foam, a thermoplastic elastomer (TPE), or a gel. 
         [0055]    The aforementioned components of site access port assembly  102  may be rigid members as described above or alternatively made from a disposable, compressible, and/or flexible type material, for example, but not limited to, a suitable foam or gel material having sufficient compliance to form a seal about one or more surgical objects, shown generally as surgical object, and also establish a sealing relation with the tissue. The foam is preferably sufficiently compliant to accommodate off axis motion of the surgical object. In one embodiment, the foam may be at least partially constituted of polyisoprene, urethane, or silicone, or the like. Alternatively, site access port assembly  102  may be formed of a biocompatible gel material. Suitable portal members are disclosed in commonly assigned U.S. patent application Ser. No. 12/244,024, filed Oct. 2, 2008, now abandoned, published as U.S. Patent Application Publication No. 2009/0093752 A1, the entire contents of which is hereby incorporated by reference herein. A hand or instrument is able to access a surgical site by insertion through the surgical site access location  140 . 
         [0056]    Turning now to  FIGS. 3-9 , there is disclosed an instrument or hand access surgical site seal cap  200  according to another exemplary embodiment of the present disclosure that is generally similar to the instrument or hand access surgical site seal cap  100  described above. 
         [0057]    In a similar manner, surgical site seal cap  200  includes a generally cylindrical site access port assembly  202  that includes an upper or proximal seal retaining portion  204  and a lower or distal seal retaining portion  206 . Due to the similarities, the site access port assembly  202  is not described in more detail. 
         [0058]    However, in place of the two interfacing J-shaped composite seals  120  and  130 , the surgical site seal cap  200  includes several layers of a flexible material having various patterns of access ports for hand access and large cross-sectional area instrument access. 
         [0059]    More particularly, in one exemplary embodiment, as best illustrated in  FIG. 3 , surgical site seal cap  200  includes an upper layer  210  of flexible material such as a medical-grade plastic or a foam core encased by a top and bottom dipped liquefied medical grade material elastomeric sheeting, such as polyisoprene, urethane, silicone, or any other material suitable for the intended purpose of facilitating off-axis movement of an inserted surgical instrument or clinician&#39;s hand, e.g., a flowable or sufficiently compliable material, such as an open-cell polyurethane foam, a thermoplastic elastomer (TPE), or a gel. 
         [0060]    The layer  210  defines therein a first port  212  that is generally football or oval shaped and a second port  214  that is defined therein and is spaced apart from the first port  212 . The second port  214  has a cone-shaped configuration with an aperture area that is greater than the aperture area of the first port  212 . 
         [0061]    The difference in aperture areas enables instruments of different cross-sectional areas or a surgeon&#39;s hand to be inserted through the ports  212  and  214 . 
         [0062]    Although shown in a football or oval shape configuration, one skilled in the art will readily appreciate that the ports  212  and  214  can be made in any shape depending on the application. 
         [0063]    As illustrated in  FIG. 5 , an alternate embodiment of layer  210 , designated as layer  220 , further defines a first small instrument port  222  and a second small instrument port  224 . The layer  220  includes an alternatively football or oval shaped second port  226  in contrast to second port  214 . 
         [0064]      FIGS. 6A ,  6 B,  6 C illustrate alternate patterns of ports defined in various flexible material layers of the instrument or hand access surgical site seal cap  200 . More particularly,  FIG. 6A  illustrates a flexible material layer  230  included within the instrument or hand access surgical site seal cap  200  and includes the cone-shaped port  214  defined therein which is configured to enable hand access. 
         [0065]      FIG. 6B  illustrates another flexible material layer  240  included within the instrument or hand access surgical site seal cap  200  that is configured with small access ports  242  and  244  to enable access for small cross-sectional area instruments and which underlies the flexible material layer  230  for hand access of  FIG. 6A . The flexible material layer  240  further includes a curved bar-bell shaped port  246  defined therein that is disposed adjacent the small access ports  242  and  244  and enables either hand or large instrument access. 
         [0066]      FIG. 6C  illustrates yet another flexible material layer  250  that includes the small access ports  242  and  244  and the curved bar-bell shaped port  246 . The flexible material layer  250  further includes a third small instrument access port  252  defined in the flexible material layer  250  such that the curved bar-bell shaped port  246  is disposed between the small ports  242 ,  244  and the third small port  252  and in closer proximity to the third small instrument access port. The flexible material layer  250  may be disposed to underlie the flexible material layers  230  and  240 . 
         [0067]      FIG. 7  is an exploded view of a stack  260  of several of the layers of flexible material of the instrument or hand access surgical site seal cap  200  and which are configured to enable small cross-sectional area instruments, large cross-sectional area instruments and hand access according to one exemplary embodiment of the present disclosure. More particularly, five flexible material layers  262   a ,  250   a ,  250   b ,  250   c  and  262   b  are illustrated disposed in a stacked configuration in the stack  260  from top to bottom, respectively. The first flexible material layer  262   a  and the fifth flexible material layer  262   b  are substantially similar to each other and each defines a central aperture  264  surrounded by three small instrument apertures  266 ,  268  and  270  spaced apart 120° with respect to each other and each one equidistant from the center of the central aperture  264 . 
         [0068]    The second, third and fourth flexible material layers  250   a ,  250   b  and  250   c  are substantially similar to the flexible material layer  250  of  FIG. 6C  and are oriented such that the access ports in each layer are shifted 120° with respect to the access ports in the adjacent stacked layer. It is further contemplated that more or less than the five flexible material layers can be employed depending upon the specific application contemplated by the user. In some embodiments, the outermost layers are of a different thickness than the innermost layers, for example thicker. 
         [0069]      FIG. 8  is a plan view of the several flexible material layers  262   a ,  250   a ,  250   b ,  250   c  and  262   b  as they appear stacked in the order described above with respect to  FIG. 7  with the first layer  262   a  being on top. 
         [0070]    The access ports described above such as the small access ports  242  and  244  and the curved bar-bell shaped port  246 . or the first access port  212  or the second access port  214 , etc., could be any shape including round, oval, slits, etc. depending on the intended usage. 
         [0071]      FIG. 9  is an exploded view of an alternate embodiment of a stack  280  of several layers of flexible material of the instrument or hand access surgical site seal cap  200  of  FIGS. 3 ,  4  and  5  and which are configured to enable small cross-sectional area instruments and hand access. 
         [0072]    More particularly, stack  280  includes a first flexible material layer  282   a  and a fourth flexible material layer  282   b  that are substantially the same as to the flexible material layer  220  described above with respect to  FIG. 5 . A second flexible material layer  284   a  and a third flexible material layer  284   b  which are similar to each other each includes a football or oval shaped access port  286  defined therein and a first narrow slit access port  288  and a second narrow slit access port  290  that are disposed adjacent to the oval shaped access port  286  on either end and to one side of the oval shaped access port  286 . 
         [0073]    The first flexible material layer  282   a  and the second flexible material layer  284   a  are disposed such that the first small instrument port  222  and second small instrument port  224  and the football or oval shaped second port  212  of the first layer  282   a  generally coincide with the football or oval shaped access port  286  and first narrow slit access port  288  and second narrow slit access port  290  of the second flexible material layer  284   a.    
         [0074]    Similarly, the third flexible material layer  284   b  and the fourth flexible material layer  282   b  are disposed such that the football or oval shaped access port  286  and first narrow slit access port  288  and second narrow slit access port  290  of the third flexible material layer  284   b  generally coincide with the first small instrument port  222  and second small instrument port  224  and the football or oval shaped second port  212  of the fourth layer  282   b.    
         [0075]    However, the third layer  284   b  and the fourth layer  282   b  are disposed such that their respective access ports are oriented 180° with respect to the respective access ports of the first layer  282   a  and second layer  284   a.    
         [0076]    The flexible materials included within the surgical site seal cap  200  may be made from the flexible materials described above. 
         [0077]    Again, the football or oval shaped access port  286 , first narrow slit access port  288 , second narrow slit access port  290 , first small instrument port  222 , second small instrument port  224 , football or oval shaped second port  226 , first narrow slit access port  288  and second narrow slit access port  290  could be any shape including round, oval, slits, etc. depending on the intended usage. 
         [0078]      FIG. 10  illustrates an instrument or hand access surgical site seal cap  300  in an extended position showing the interfacing configuration of a snap-on cap to a wound retractor according to one exemplary embodiment of the present disclosure. More particularly, instrument or hand access surgical site seal cap  300  includes a flexible bag  302  having a proximal or first end  304  that is open and that is connected to a proximal circular interlock rim  308  and having a distal or second end  306  that is open and that is connected to a distal circular snap-on cap  310 . 
         [0079]    A lanyard  312  is positioned on the external surface of the flexible bag  302  and loops around the external surface of the bag  302 . A sliding, releasable lock  314  is positioned on the lanyard  312  and is moved along at least a portion of the length of the lanyard  312  until an aperture  316  having a desired diameter is formed in the flexible bag  302  by the lanyard  312 . The desired aperture  316  has a cross-sectional area corresponding to the approximate cross-sectional area of an instrument or a hand that is intended to be inserted through, and sealed by, the site seal cap  300 . 
         [0080]    A wound retractor  320  is positioned distally of the snap on cap  310 . The snap on cap  310  is snapped or locked on to the wound retractor  320 . The interlock rim  308  includes a plurality of distally protruding projections  318  that are configured to engage with a plurality of proximally positioned reception grooves  322  defined in the snap on cap  310 . 
         [0081]    When the interlock rim  308 , the snap on cap  310  and the wound retractor  320  are sequentially engaged to one another into a collapsed configuration by twisting interlock rim  308  in the direction of arrow with respect to the snap on cap  310  as shown in  FIG. 11 , the flexible bag  302 , due to the excess of material now available, forms an iris configuration around the aperture  316 . 
         [0082]    Referring now to  FIG. 12 , the aperture  316  of the flexible bag  302  is positioned around the shaft  324  of an instrument  326  and the lanyard  312  is further tightened around the shaft  324  by moving the lock  314  to provide a seal around the shaft  324 . The surgical site seal cap  300  is then moved vertically downward in the direction of arrow B along the shaft  324 , and the shaft  324  may be moved vertically upward in the opposite direction, to tighten the seal at the aperture  316  and to form the flexible bag  302  into a cone shaped extended configuration extending vertically upward (opposite to arrow B) as shown in  FIG. 12  subsequent to sealing of the shaft  324 . 
         [0083]    Although described as effected by a lanyard, the resulting cinching effect produced by the lanyard  312  can be produced by any conventional known means for pursing or reducing the diameter. 
         [0084]      FIGS. 13-15  illustrate an instrument or hand access surgical site seal cap  400  according to one exemplary embodiment of the present disclosure that is similar to the surgical site seal cap  300  described above with respect to  FIGS. 10-12  except that surgical site seal cap  400  includes a proximally located lanyard and two sealing locations. More particularly, surgical site seal cap  400  includes a flexible bag  402  and proximally positioned interlock rim  404  that includes two rigid members  406  and  408  and an O-ring seal  410 . The first rigid member  406  is a circular twist rim  406  that defines an aperture  412  for receiving a projection  414  extending from the second rigid member  408  that is a circular interlock that is positioned distally from the circular rim  406 . The O-ring seal  410  is positioned between the circular rim  406  and the circular interlock  408 . The proximally positioned interlock rim  404  engages with a groove  430  disposed in the vicinity of proximal end  428  of, and on an external surface of, the flexible bag  402 . 
         [0085]    A snap on cap  416  is positioned distally from the interlock rim  404 . The snap on cap  416  includes a circular engaging rim  418  that receives the circular interlock  408 . The snap on cap  416  further includes a snap on cap base  420  that is positioned distally from the circular engaging rim  418  and an O-ring seal  422 . The O-ring seal  422  is positioned between the circular engaging rim  418  and the snap on cap base  420 . A lanyard  424  is located at proximal end  428  of the flexible bag  402 . The proximal end  428  extends proximally from the interlock rim  404 . 
         [0086]    If there is no instrument or hand present, the circular twist rim  406  is twisted with respect to the circular interlock  408  to seal wound protector  432  to which the snap on cap  416  attaches. Upon insertion of an instrument (not shown) into the proximal aperture  426 , the lanyard  424 , which is positioned at proximal aperture  426  defined at proximal end  428 , is tightened to form a seal and the circular twist rim  424  is loosened to allow access to the wound protector  432  and surgical cavity (not shown) via distal aperture  434  of the flexible bag  402 . 
         [0087]    Although described as effected by a lanyard, in a similar manner as described above with respect to lanyard  312 , the resulting cinching effect produced by the lanyard  424  can be produced by any conventional known means for pursing or reducing the diameter. 
         [0088]      FIG. 16  illustrates an instrument or hand access surgical site seal cap  500  that includes a plurality of flexible interlocking triangular wedges adjacent to one another within a cylindrical surgical site port according to one exemplary embodiment of the present disclosure. More particularly, instrument or hand access surgical site seal cap  500  includes a plurality of flexible triangular interlocking wedges, e.g., first wedge  510 , second wedge  520 , third wedge  530 , fourth wedge  540 , fifth wedge  550 , sixth wedge  560 , seventh wedge  570  and eighth wedge  580 . 
         [0089]    Although shown with eight wedges, one skilled in the art will readily appreciate more or fewer than eight wedges may be used depending on the application. 
         [0090]    As best illustrated in  FIG. 17 , the wedges  510 - 580  are positioned adjacent to one another spanning a 360° circle within a cylindrical surgical site port structural member  502 . One of the flexible interlocking wedges, i.e., wedge  510 , is illustrated in a raised position above the cylindrical surgical site port structural member  502 . 
         [0091]    Each wedge  510  . . .  580  defines a respective apex or tip  515  . . .  585 , respectively, that all converge at the vertical centerline of the cylindrical surgical site port structural member  502 . Each wedge defines first and second vertical lateral surfaces that intersect at the apex. More particularly, first to eighth wedges  510  . . .  580  define a first lateral surface  511 ,  521 ,  531 ,  541 ,  551 ,  561 ,  571  and  581  and a second lateral surface  512 ,  522 ,  532 ,  542 ,  552 ,  562 ,  572  and  582  that intersect at the respective apices  515  . . .  585 . 
         [0092]    Each wedge  510  . . .  580  tapers from a height H1 at base  515  to a height H2 at the respective apices  515  . . .  585  such that first lateral surface  511 ,  521 ,  531 ,  541 ,  551 ,  561 ,  571  and  581  and second lateral surface  512 ,  522 ,  532 ,  542 ,  552 ,  562 ,  572  and  582  form an arched profile and each wedge defines a generally contoured pyramidal configuration. 
         [0093]    First lateral surface  511  of wedge  510  is disposed adjacent to second lateral surface  582  of eighth wedge  580  to define a first radial access split to enable access of an instrument or a surgeon&#39;s hand therethrough. Similarly, second lateral surface  512  of wedge  510  is disposed adjacent to first lateral surface  521  of second wedge  520  to define a second radial access split. 
         [0094]    Those skilled in the art will recognize that, and understand how, third, fourth, fifth, sixth, seventh and eighth radial access splits are defined between the third through eighth wedges  530  . . .  580 , respectively. 
         [0095]      FIG. 18  illustrates the instrument or hand access surgical site seal cap  500  of  FIGS. 16 and 17  wherein a small cross-sectional area instrument  591  having a circular cross section is positioned in the radial access split formed between first lateral surface  511  of first wedge  510  and second lateral surface  582  of eighth wedge  580 . 
         [0096]    In addition, a large cross-sectional area instrument  592  having a rectangular cross-section is positioned generally in the radial access split formed between second lateral surface  522  of second wedge  520  and first lateral surface  531  of third wedge  530  and between second lateral surface  562  of sixth wedge  560  and first lateral surface  571  of seventh wedge  570 . 
         [0097]    Thus the surgical site seal cap  500  enables either symmetric or asymmetric positioning of a large or a small instrument or a surgeon&#39;s hand through the seal cap. The wedges  510  . . .  580  may be formed of a medical grade plastic or medical grade foam which may or may not be encased in a silicone material as described above or formed of a medical balloon material, e.g., latex, silicone rubber, Mylar®, polyethylene, polyurethane, a flexible polymeric material, or a composite material, such as a polyethylene and nylon composite, or any other resilient material suitable for the intended purpose of permitting insertion and manipulation, e.g., off-axis manipulation, of a surgical instrument or clinician&#39;s hand 
         [0098]      FIGS. 19 and 20  illustrate an instrument or hand access surgical site seal cap  600  that is similar to the surgical site access cap  500  described above with respect to  FIGS. 16-18  except that instrument or hand access surgical site seal cap  600  includes a plurality of flexible triangular wedges, e.g., first triangular wedge  610 , second triangular wedge  620  and third triangular wedge  630 , alternately spaced apart with respect to one another within a cylindrical surgical site port structural member  602  according to one exemplary embodiment of the present disclosure. 
         [0099]    The cylindrical surgical site port structural member  602  includes an upper cylindrical portion  604  and a corresponding circular ring base member  606  that engages the lower end of the upper cylindrical portion  604 . 
         [0100]    Turning now to  FIGS. 21-22 , each triangular wedge  610 ,  620 ,  630  defines a respective apex or tip  615 ,  625 ,  635 , respectively, that converge at the vertical centerline of the cylindrical surgical site port structural member  602 . Each wedge defines first and second vertical lateral surfaces that intersect at the apex. More particularly, first, second and third wedges  610 ,  620 ,  630  define a first lateral surface  611 ,  621 ,  631 , and a second lateral surface  612 ,  622 ,  632  that intersect at the respective apices  615 ,  625 ,  635 . 
         [0101]    In a similar manner as with respect to surgical site seal cap  500  described above, each wedge  610 ,  620 ,  630  tapers from a height H3 at base  650  to a height H4 at the respective apices  615 ,  625 ,  635  such that first lateral surface  611 ,  621 ,  631  and second lateral surface  612 ,  622 ,  632  form an arched profile and each wedge defines a generally contoured pyramidal configuration. 
         [0102]    The wedges  610 - 630  each include a set of reinforcing ribs  615 ,  625 ,  635 , respectively, that extend horizontally along the first lateral surfaces  611 ,  621 ,  631 , extending around the apices  615 ,  625 ,  635  and further extending horizontally along the second lateral surfaces  612 ,  622 ,  632 , respectively. 
         [0103]    As illustrated in  FIG. 22 , the rear portion or base  650  of each wedge  610 ,  620 ,  630  defines an aperture or hollow internal volume  610 ′,  620 ′,  630 ′, respectively, such that each wedge  610 ,  620 ,  630  is effectively hollow. 
         [0104]    Returning to  FIGS. 19 and 20 , the wedges  610 - 630  are disposed within the upper cylindrical portion  604  of the cylindrical surgical site port structural member  602  equally spaced apart along the circumference of the upper cylindrical portion  604  to form a first triangular wedge-shaped space  661  between the first wedge  610  and the second wedge  620 , a second triangular wedge-shaped space  662  between the second wedge  620  and the third wedge  630 , and a third triangular wedge-shaped space  663  between the third wedge  630  and the first wedge  610 . In the exemplary embodiment of instrument or hand access surgical site seal cap  600 , each wedge  610 ,  620 ,  630  forms a 60° angle at the respective apex  615 ,  625 ,  635  such that the first, second and third triangular wedge-shaped spaces  661 ,  662 ,  663  also form a 60° angle at their respective apices. 
         [0105]    Thus, as can be appreciated, instrument or hand access surgical site seal cap  600  enables passage of either small or large cross-sectional area instruments or a surgeon&#39;s hand either symmetrically or asymmetrically through the spaces  661 ,  662 ,  663  or through the vertical slit defined by the intersection of the apices  615 ,  625 ,  635 . 
         [0106]    Again, the wedges  610 ,  620 ,  630  and the respective reinforcing ribs  616 ,  626 ,  636  may be formed of a medical grade plastic or medical grade foam which may or may not be encased in a silicone material as described above or formed of a medical balloon material, e.g., latex, silicone rubber, Mylar®, polyethylene, polyurethane, a flexible polymeric material, or a composite material, such as a polyethylene and nylon composite, or any other resilient material suitable for the intended purpose of permitting insertion and manipulation, e.g., off-axis manipulation, of a surgical instrument or clinician&#39;s hand. 
         [0107]    Turning now to  FIGS. 23-27 ,  FIG. 23  illustrates an instrument or hand access surgical site seal cap  700  having a series of flexible arcuate spring supports positioned within a soft rubber-like material such that the supports limit horizontal movement of the material but allow vertical movement according to one exemplary embodiment of the present disclosure. 
         [0108]    More particularly, surgical site seal cap  700  includes a cylindrical retaining housing  702  which encases a flexible correspondingly cylindrically-shaped material  704  that is divided into a plurality of segments. The cylindrical retaining housing  702  extends vertically in the z-direction as defined by the x-y-z coordinates in  FIG. 23 . The x and y coordinates define a horizontal plane. 
         [0109]    In the exemplary embodiment of  FIGS. 23-27 , the flexible material  704  is divided into three equal segments, i.e., first segment  710 , second segment  720  and third segment  730 . As a result of the division of the flexible material  704  into equal segments, a first access pierce slit  712  is formed at the interface between first segment  710  and second segment  720 . A second access pierce slit  723  is formed at the interface between second segment  720  and third segment  730 . Similarly, third access pierce slit  731  is formed at the interface between third segment  730  and first segment  710 . 
         [0110]    Each segment  710 ,  720 ,  730  spans an angle θ1, θ2, θ3, respectively, defined between the respective access pierce slits  712 ,  723 ,  731 , that is equal to 120° having an origin or vertex  750  at the common intersection of the pierce slits  712 ,  723 ,  731 . 
         [0111]    The segments  710 ,  720 ,  730  each further include a respective bow-shaped or arcuate spring support  761 ,  762 ,  763  formed within the flexible material of the respective segment  710 ,  720 ,  730 . 
         [0112]    The first bow-shaped support  761  defines a first arm  761   a  and a second arm  761   b  extending from a common base  761   c . The arms  761   a  and  761   b  straddle the pierce slits  712  and  731 , respectively, while the base  761   c  interfaces the common origin  750 . 
         [0113]    Similarly, the second bow-shaped support  762  defines a first arm  762   a  and a second arm  762   b  extending from a common base  762   c . The arms  762   a  and  762   b  straddle the pierce slits  712  and  723 , respectively, while the base  762   c  interfaces the common origin  750 . 
         [0114]    Further, the third bow-shaped support  763  defines a first arm  763   a  and a second arm  763   b  extending from a common base  763   c . The arms  763   a  and  763   b  straddle the pierce slits  723  and  731 , respectively, while the base  763   c  interfaces the common origin  750 . 
         [0115]    Again, the soft rubber-like material  704  may be formed of a medical grade plastic or medical grade foam which may or may not be encased in a silicone material as described above or formed of a medical balloon material, e.g., latex, silicone rubber, Mylar®, polyethylene, polyurethane, a flexible polymeric material, or a composite material, such as a polyethylene and nylon composite, or any other resilient material suitable for the intended purpose of permitting insertion and manipulation, e.g., off-axis manipulation, of a surgical instrument or clinician&#39;s hand. 
         [0116]      FIG. 24  is an elevation cross-sectional view along the X-axis of the instrument or hand access surgical site seal cap  700  showing the flexible bow-shaped or arcuate spring supports  761  and  763  positioned within the soft rubber-like material  704  between lower surface  701  and upper surface  702 . The lower edge of each spring support  761  and  763  is positioned at an elevation Z1 in the z-direction above the lower surface  701  while the upper edge of each spring support  761  and  763  is positioned at an elevation Z2 in the Z-direction above the lower surface  701 . Spring support  762 , not shown, is similarly positioned within the rubber-like material  704 . 
         [0117]    As a result of the location within the soft rubber-like material  704 , the spring supports  761 ,  762 ,  763  limit movement in the Z-direction while allowing motion in the X and Y directions. The spring supports  761 ,  762 ,  763  also provide an additional counter force against a penetrating object along the seal or access pierce slits  712 ,  723 ,  731 , as illustrated in  FIGS. 26 and 27  and described below. 
         [0118]      FIG. 25  is a plan view of the instrument or hand access surgical site seal cap  700  showing the central intersection at origin or vertex  750  at the common intersection of the pierce slits  712 ,  723 ,  731  in the rubber-like material  704  that are positioned between the flexible arcuate spring supports  761 ,  762 ,  763  when there is neither an instrument or the hand of a surgeon positioned through the seal cap  700 . 
         [0119]      FIG. 26  is a plan view of the instrument or hand access surgical site seal cap  700  illustrating the deformation of the flexible arcuate spring supports  761 ,  762 ,  763  when a hand or an instrument  768  is disposed symmetrically through the central intersection  750  of the pierce slits  712 ,  723 ,  731 . In this case, the common bases  761   c ,  762   c ,  763   c  are equally deflected away from the central intersection  750  in the horizontal x-y plane while maintaining a seal by the material  704  around the hand or instrument  768 . 
         [0120]      FIG. 27  is a plan view of the instrument or hand access surgical site seal cap  700  illustrating the deformation of the flexible arcuate spring supports  761 ,  762 ,  763  when a hand or an instrument  768 ′ is disposed asymmetrically through the central intersection  750  of the pierce slits  712 ,  723 ,  731  and an instrument  770  having a small cross-sectional area is disposed asymmetrically through one of the pierce slits, e.g., pierce slit  731 , in the rubber-like material  704 . The flexible arcuate spring supports  761 ,  762 ,  763  distort in the horizontal x-y plane in a manner to mimic the circumference of the hand or instrument  768 ′ and of the instrument  770 . 
         [0121]      FIG. 28  is cross-sectional view of an alternate exemplary embodiment of the instrument or hand access surgical site seal cap  700  of  FIGS. 23-27 . More particularly, instrument or hand access surgical site seal cap  800  includes soft rubber-like material  804  mounted in a cylindrical housing  802 . 
         [0122]    The soft rubber-like material  804  includes pierce slits, e.g. pierce slit  812 , that have a curled wave-like vertical profile to form interlocking ribs  844  to improve the seal capability. 
         [0123]    The cylindrical housing  802  may further include one or more anchor points  821  and  822  disposed on opposite sides of the housing  802  to partially penetrate into the soft-rubber-like material  804 . The anchor points  821  and  822  may have a J-shaped profile which is oriented to increase the vertical shear strength at the anchor points  821  and  822 . 
         [0124]    In a similar manner, the soft rubber-like material  804  may be formed of a medical grade plastic or medical grade foam which may or may not be encased in a silicone material as described above or formed of a medical balloon material, e.g., latex, silicone rubber, Mylar®, polyethylene, polyurethane, a flexible polymeric material, or a composite material, such as a polyethylene and nylon composite, or any other resilient material suitable for the intended purpose of permitting insertion and manipulation, e.g., off-axis manipulation, of a surgical instrument or clinician&#39;s hand. 
         [0125]    The cylindrical housing  802  may be made from rigid members or alternatively made from a disposable, compressible, and/or flexible type material, for example, but not limited to, a suitable foam or gel material having sufficient compliance to form a seal about one or more surgical objects, shown generally as surgical object, and also establish a sealing relation with the tissue. The foam is preferably sufficiently compliant to accommodate off axis motion of the surgical object. In one embodiment, the foam may be at least partially constituted of polyisoprene, urethane, or silicone, or the like. Alternatively, cylindrical housing  802  may be formed of a biocompatible gel material. Again, suitable portal members are disclosed in commonly assigned U.S. patent application Ser. No. 12/244,024, filed Oct. 2, 2008, now abandoned, published as U.S. Patent Application Publication No. 2009/0093752 A1, the entire contents of which has already been hereby incorporated by reference above. 
         [0126]    The foregoing materials may be applied to each of the embodiments of the instrument or hand access surgical site access caps  100  to  800  described above. 
         [0127]    While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as examples of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. 
         [0128]    Persons skilled in the art will understand that the various apparatus, and corresponding methods of use described herein, and shown in the accompanying drawings, constitute non-limiting, exemplary embodiments of the present disclosure, and that additional components and features may be added to any of the embodiments discussed herein above without departing from the scope of the present disclosure. 
         [0129]    Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one exemplary embodiment may be combined with those of another embodiment without departing from the scope of the present disclosure, and will appreciate further features and advantages of the presently disclosed subject matter based on the above-described embodiments and the claims. Accordingly, the present disclosure is not limited by what has been particularly shown and described. 
         [0130]    Although the foregoing disclosure has been described in some detail by way of illustration and example, for purposes of clarity or understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Technology Category: 1