Patent Publication Number: US-2010114033-A1

Title: Surgical access device

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/111,842, filed on Nov. 6, 2008, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to a surgical access device that is removably positionable within a tissue tract formed in a patient&#39;s tissue. More specifically, the present disclosure relates to a surgical access device that includes a valve assembly adapted to accommodate the insertion of surgical objects and/or surgical filaments, while substantially limiting the communication of fluids therethrough. 
     2. Background of the Related Art 
     Many surgical procedures are performed through access devices, e.g., trocar and cannula assemblies. These devices incorporate narrow tubes or cannulae percutaneously inserted into a patient&#39;s body, through which one or more surgical objects may be introduced to access a surgical worksite. Generally, such procedures are referred to as “endoscopic,” unless the procedure is related to the examination/treatment of a joint, in which case the procedure is referred to as “arthroscopic”, or to the examination/treatment of a patient&#39;s abdomen, in which case the procedure is referred to as “laparoscopic.” 
     During these procedures, surgical filaments are often used to repair openings in skin, internal organs, blood vessels, and the like, as in the case of meniscal repair, and to join various tissues together, as in the reattachment of ligaments or tendons to bone. Additionally, a fluid, such as an insufflation gas or saline, is often introduced into the surgical worksite to increase visibility or access to the tissue that is the subject of the procedure. Accordingly, the establishment and maintenance of a substantially fluid-tight seal is desirably to curtail the escape of such fluids and preserve the integrity of the surgical worksite. To this end, surgical access devices generally incorporate a seal through which the surgical object and/or surgical filaments are inserted. 
     While many varieties of seals are known in the art, there exists a continuing need for a seal that can accommodate a variety of differently-sized surgical objects and/or surgical filaments while substantially limiting the escape of fluids. 
     SUMMARY 
     Accordingly, the present disclosure relates to a surgical access device for use during a surgical procedure. The surgical access device includes a housing, an access member extending distally from the housing and defining a longitudinal opening, and having proximal and distal ends, and a valve at least partially disposed within the housing and having a passage for reception of a surgical object, The valve including a proximal collar segment, a distal tapered segment extending contiguously from the proximal collar segment and a fluid resistive shelf generally defined at a juncture defined by the proximal collar segment and the distal tapered segment. At least the fluid resistive shelf and the distal tapered segment cooperate to substantially minimize egress of fluids from the operative site about the valve. 
     The valve may be dimensioned whereby the passage is substantially closed in the absence of the surgical object. The distal tapered segment of the valve may define a substantially frusto-conical shape. The valve may include at least one internal slit with the at least one internal slit defining the passage. The valve may include a plurality of intersecting slits with the slits defining the passage. 
     The proximal collar segment of the valve may include a recessed portion defining an internal wall. The internal wall tapers radially inwardly from proximal to distal to assist in guiding the surgical object towards the passage of the valve. The valve may be a solid member. 
     An instrument seal may be mounted relative to the housing. The instrument seal defines a seal aperture for reception of the surgical object in substantial sealed relation therewith. At least one of the instrument seal and the valve includes structure configured and dimensioned to maintain the relative position of the instrument seal and the valve. The valve may include a recess configured and dimensioned to engage a corresponding ridge formed on the instrument seal. The valve may include a lip configured and dimensioned to accommodate the instrument seal such that the instrument seal is at least partially positionable within the valve. 
     A surgical procedure is also disclosed. The surgical procedure may include the steps of: 
     accessing an operative site with a surgical access device, the surgical access device including an access member defining a longitudinal opening and having proximal and distal ends, and a valve including a proximal collar segment, a distal tapered segment extending contiguously from the proximal collar segment, and a fluid resistive shelf defined at a juncture defined by the proximal collar segment and the distal tapered segment; 
     introducing fluids into the operative site; 
     substantially minimizing egress of fluids from the operative site and about the valve through engagement of the fluids with the fluid resistive shelf and the distal tapered segment; and 
     introducing a surgical object through the valve and through the longitudinal opening of the access member to perform a surgical task. 
     These and other features of the surgical access device and valve assembly disclosed herein will become more readily apparent to those skilled in the art from the following detailed description of various embodiments of the present disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the present disclosure are described herein below with references to the drawings, wherein: 
         FIG. 1  is a side, schematic view of a surgical access device incorporating one embodiment of a valve assembly including a valve in accordance with the principles of the present disclosure; 
         FIG. 2  is a side, perspective view of the valve seen in  FIG. 1  removed from the surgical access device and prior to the insertion of a surgical object; 
         FIG. 3  is a side, perspective view of an alternative embodiment of the valve shown in  FIG. 2 ; 
         FIG. 4  is a top view of the valve shown in  FIGS. 1 and 2 ; 
         FIG. 5  is a bottom view of the valve shown in  FIGS. 1 ,  2  and  4 ; 
         FIG. 6  is a side, perspective view of the valve shown in  FIGS. 1 ,  2 ,  4 , and  5  with a surgical object inserted therethrough; 
         FIG. 7  is a side, perspective view of an alternative embodiment of the valve shown in  FIG. 2  shown prior to the insertion of a surgical object; 
         FIG. 8  is a side, perspective view of another embodiment of the valve assembly seen in  FIG. 1  including an instrument seal positionable proximally of, and illustrated spaced from, the valve shown in  FIG. 7  prior to the insertion of a surgical object; 
         FIG. 9  is a bottom view of an alternative embodiment of the instrument seal seen in  FIG. 8 ; 
         FIG. 10  is a bottom view of another embodiment of the instrument seal seen in  FIG. 8 ; 
         FIG. 11  is a side, perspective view of another embodiment of the valve assembly shown in  FIG. 8  with parts separated, wherein the valve includes a lip configured and dimensioned to at least partially accommodate the instrument seal, and shown prior to the insertion of a surgical object; 
         FIG. 12  is a side, perspective view of the valve assembly shown in  FIG. 11  illustrating the valve assembled together with the instrument seal; and 
         FIG. 13  is a side, perspective view of the valve assembly shown in  FIG. 8  illustrating the valve and the instrument seal separated from each other with a surgical object inserted therethrough. 
     
    
    
     DETAILED DESCRIPTION 
     In the drawings, and in the following description, in which like reference characters identify similar or identical elements, the term “proximal” should be understood as referring to the end of the disclosed surgical access device, or any component thereof, that is closest to a practitioner during use, while the term “distal” should be understood as referring to the end that is farthest from the practitioner during use. Additionally, the term “surgical object” should be understood as referring to any surgical object or instrument that may be employed during the course of surgical procedure, including but not limited to an obturator, a surgical stapling device, or the like; the term “filament” should be understood as referring to any elongate member suitable for the intended purpose of joining tissue, including but not limited to sutures, ligatures, and surgical tape; and the term “tissue” should be understood as referring to any bodily tissue, including but not limited to skin, fascia, ligaments, tendons, muscle, and bone. 
       FIG. 1  illustrates a surgical access device  1000  including a housing  1002  at a proximal end  1004  thereof, and an access member  1006  that extends distally from the housing  1002 . The housing  1002  is configured and dimensioned to accommodate a valve assembly, one embodiment of which is shown and referred to generally by reference character  100 , and may be any structure suitable for this intended purpose. 
     The access member  1006  is dimensioned for positioning with a percutaneous tissue tract  10  formed in a patient&#39;s tissue “T” to provide access to a surgical worksite “W.” The access member  1006  defines a longitudinal opening  1008  that extends longitudinally therethrough and defines a longitudinal axis “A.” The longitudinal opening  1008  is configured and dimensioned for the internal receipt of one or more surgical objects “I” and/or surgical filaments “F.” The access member  1006  defines an opening  1010  at a distal end  1012  thereof to allow the surgical object “I” and/or the surgical filaments “F” to pass therethrough. 
     Referring now to  FIGS. 2-6  as well, the valve assembly  100  will be discussed. The valve assembly  100  includes a valve  102 , which may be formed from any suitable material that is at least semi-resilient in nature, and fabricated through any suitable method of manufacture, including but not limited to molding, casting, and electrical discharge machining (EDM). Examples of suitable materials include, but are not limited to elastomeric materials such as natural rubber, synthetic polyisoprene, butyl rubber, halogenated butyl rubbers, polybutadiene, styrene-butadiene rubber, nitrile rubber, hydrogenated nitrile rubbers, chloroprene rubber, ethylene propylene rubber, ethylene propylene diene rubber, epichlorohydrin rubber, polyacrylic rubber, silicone rubber, fluorsilicone rubber, fluoroelastomers, perfluoroelastomers, polyether block amides, chlorosulfonated polyethylene, ethylene-vinyl acetate, thermoplastic elastomers, thermoplastic vulcanizers, thermoplastic polyurethane, thermoplastic olefins, resilin, elastin, and polysulfide rubber. Forming the valve  102  from such materials permits the valve  102  to resiliently accommodate the insertion, manipulation, and removal of surgical objects “I” and/or surgical filaments “F” that may vary in size, e.g., outer dimensions. The valve  102  may be either solid, as illustrated in  FIGS. 2-6 , or alternatively, the valve  102  may include one or more internal spaces. 
     The valve  102  includes a proximal collar segment  104 , a distal segment  106  extending contiguously from the proximal collar segment  104 , a fluid resistive shelf  107  generally defined at the juncture of the distal segment  106  and the proximal collar segment  104 , and a passage  108  for reception of the surgical object “I” and/or surgical filaments “F” ( FIG. 1 ). The passage  108  extends through the proximal collar segment  104  and the distal segment  106 , and is normally biased towards a closed condition, which is shown in  FIG. 2 . In the closed condition, the passage  108  provides a substantially fluid-tight seal, and thus, substantially prevents the communication of fluid through the valve  102  in the absence of the surgical object “I.” Additionally, the configuration of the passage  108  may assist in minimizing the escape of fluid through the valve assembly  100  when the surgical object “I” and/or surgical filaments “F” are inserted therethrough. Although depicted as including a plurality of intersecting slits  110  in the embodiment of the valve assembly  100  shown in  FIG. 2 , the passage  108  may be configured in any manner suitable for the intended purpose of substantially limiting the communication of fluids, e.g., insufflation gas or saline, through the valve assembly  100 . As an illustrative example, the passage  108  may be configured as a single-slit valve  112  ( FIG. 3 ). 
     The distal segment  106  of the valve  102  includes an outer wall  114  that inwardly tapers in a distal direction. As will be discussed in further detail below, the tapered configuration of the distal segment  106  and the fluid resistive shelf  107  cooperate to substantially minimize the egress, communication, or escape of fluid through the valve assembly  100 , and thus, the establishment and maintenance of a substantially fluid tight seal. In the embodiments of the valve assembly  100  seen in  FIGS. 2-6 , the outer wall  114  extends in a substantially linear fashion such that the distal segment  106  defines a generally frusto-conical configuration. Alternatively, however, the outer wall  114  may be substantially arcuate. 
     With reference now to  FIGS. 1-2  and  FIGS. 4-6 , the use and function of the surgical access device  1000  ( FIG. 1 ) will be discussed during the course of a surgical procedure performed with the surgical object “I.” Initially, the access member  1006  is positioned within the tissue tract  10  formed in the patient&#39;s tissue “T”, and a fluid, e.g., an insufflation gas, is introduced into the surgical worksite “W” through the surgical access device  1000 . As previously discussed, the passage  108  of the valve  102  is biased towards a closed position ( FIG. 2 ), thus establishing a substantially fluid-tight seal and substantially preventing the escape of any fluid through the valve  102  prior to insertion of the surgical object “I.” 
     As the fluid fills the surgical worksite “W”, the fluid exerts pressure, represented generally by the reference character “P” ( FIG. 2 ), on the valve assembly  100  as it tries to escape proximally through the surgical access device  1000 . Specifically, the pressure “P” acts on the outer wall  114  of the distal segment  106  and the fluid resistive shelf  107  of the valve  102 . The inward distal tapering of the outer wall  114  results in a component of the pressure “P” being directed inwardly in the direction of arrows  1  ( FIG. 2 ), thus compressing the distal segment  106  of the valve  102  and assisting in the maintenance of the substantially fluid-tight seal established by the passage  108 . 
     Following insufflation of the surgical worksite “W”, the practitioner inserts the surgical object “I” through the surgical access device  1000 , as seen in  FIG. 6 . As the surgical object “I” is advanced distally through the valve assembly  100 , the passage  108  is forced open. However, the bias created by the resilient material comprising the valve  102  forces the passage  108  into engagement with the surgical object “I” such that communication of fluid through the valve  102  is substantially inhibited. Additionally, the pressure “P” acting on the outer wall  114  of the distal segment  106  continues to compress and force the distal segment  106  inwardly in the direction of arrows  1  and into engagement with the surgical object “I”, thereby assisting in the establishment and maintenance of a substantially fluid-tight seal between the surgical object “I” and the valve  102 . The practitioner can then manipulate the surgical object “I” through the surgical access device  1000  to carry out the remainder of the procedure. 
       FIG. 7  illustrates an alternative embodiment of the valve assembly, referred to generally by reference character  200 , including a valve  202 . The valve  202  is substantially identical to the valve  102  discussed above with respect to  FIGS. 1-6 , and accordingly, will only be discussed with respect to its differences therefrom. 
     The valve  202  includes a proximal collar segment  204  with a recessed portion  206 , a distal segment  208 , and a passage  210 . The passage  210  is formed in a concave internal wall  212  defined by the recessed portion  206 , and extends through the valve  202 . The concave configuration of the internal wall  212  facilitates insertion of the surgical object “I” through the valve assembly  200 . More specifically, upon the introduction of the surgical object “I” to the valve assembly  200 , a distal end  214  of the surgical object “I” engages the concave internal wall  212 . The contour of the concave internal wall  212  guides the surgical object “I” towards the passage  210 . For example, a surgical object “I” inserted into the surgical access device  1000  ( FIG. 1 ) including valve  202  in an off-axis orientation, i.e., such that the surgical object “I” forms an angle with the longitudinal axis “A”, would be urged into a substantially vertical orientation upon engagement with the concave internal wall  212  of the valve  202 . As the surgical object “I” is passed through the valve assembly  200 , the concave configuration of the wall  212  reduces friction between the surgical object “I” and the valve  202 , thus reducing the force necessary to advance the surgical object “I” through the valve assembly  200  and further facilitating insertion of the surgical object “I.” Additionally, reducing friction between the surgical object “I” and the valve  202  also reduces “spurting” of fluid through the valve  202 . 
       FIGS. 8-9  illustrate another embodiment of the valve assembly, referred to generally by reference character  300 , including a fluid valve  202  and an instrument seal  302 . Although illustrated as the valve  202  ( FIG. 7 ), in alternative embodiments of the valve assembly  300 , it is envisioned that the valve  102  ( FIGS. 1-6 ) may be employed as the fluid valve component of the valve assembly  300 . 
     The instrument seal  302  may be formed of any suitable material that is at least semi-resilient in nature, acceptable examples of which were discussed above with respect to the valve  102  shown in  FIGS. 1-6 . Forming the instrument seal  302  from such materials permits the instrument seal  302  to resiliently accommodate the insertion, manipulation, and removal of surgical instrumentation that may vary in size, e.g., outer dimensions. 
     The instrument seal  302  includes a seal aperture  304  extending therethrough. The seal aperture  304  is normally biased towards a closed condition, seen in  FIG. 8 , in which the seal aperture  304  defines a transverse dimension “D” that is substantially smaller than an outer dimension “DI” defined by the surgical object “I.” Accordingly, upon insertion of the surgical object “I” through the instrument seal  302  ( FIG. 13 ), the seal aperture  304  is enlarged to substantially approximate the outer dimension “DI” of the surgical object “I,” thereby establishing a substantially fluid-tight seal between the surgical object “I” and the instrument seal  302  and substantially preventing the communication of fluid, such as insufflation gas, through the instrument seal  302 . While the seal aperture  304  is illustrated as defining a substantially annular opening, in alternate embodiments of the valve assembly  300 , the instrument seal  302  may include any valve member suitable for the intended purpose of receiving the surgical object “I” such that a substantially fluid-tight seal is formed therewith. For example, the seal aperture  304  may include a plurality of intersecting slits  306 , as seen in  FIG. 9 , a single-slit (not shown), as discussed above with respect to  FIG. 3 . 
     When the valve assembly  300  is disposed within the housing  1002  of the surgical access device  1000  ( FIG. 1 ), the instrument seal  302  is positioned proximally of the valve  202 . In one embodiment of the valve assembly  300 , one or both of the valve  202  and the instrument seal  302  may include structure adapted to maintain the position of the instrument seal  302  relative to the valve  202 . As an example, the instrument seal  302  may include a ridge  308  ( FIG. 10 ) formed on a distal surface  310  that is configured and dimensioned to engage a corresponding recess  312  ( FIG. 8 ) formed in a proximal surface  314  of the valve  202 . Additionally, or alternatively, the valve  202  may include a raised lip  316  ( FIG. 11 ) defining an internal dimension “D 1 ” that substantially approximates an outer dimension “D 2 ” of the instrument seal  302  such that the valve  202  and the instrument seal  302  may be assembled as shown in  FIG. 12 , i.e., with the instrument seal  302  at least partially positioned within the valve  202 . 
     With reference now to  FIGS. 1 ,  8 - 9 , and  12 , the use and function of the valve assembly  300  will be discussed during the course of a surgical procedure performed with the surgical object “I” in connection with the surgical access device  1000  shown in  FIG. 1 . Following placement of the access member  1006  within the tissue tract  10  formed in the patient&#39;s tissue “T”, a fluid, such as an insufflation gas, is introduced into the surgical worksite “W” through surgical access device  1000 . As previously discussed, the respective passages  210 ,  304  of the valve  202  and the instrument seal  302 , respectively, are biased towards the closed positions seen in  FIG. 8 . 2), thus establishing a substantially fluid-tight seal and substantially preventing the escape of any fluid through the valve assembly  300  prior to insertion of the surgical object “I.” 
     As the fluid fills the surgical worksite “W”, the fluid exerts pressure “P” on the valve assembly  300  as the fluid tries to escape proximally through the surgical access device  1000  ( FIG. 1 ). Specifically, the pressure “P” acts on the outer wall  216  of the distal segment  208  of the valve  202 . The distal tapering of the outer wall  216  directs a component of the pressure “P” inwardly in the direction of arrows  1 , thus compressing the distal segment  208  of the valve  202  and assisting in the maintenance of the substantially fluid-tight seal established by the passage  210 . 
     Following insufflation of the surgical worksite “W”, the practitioner inserts the surgical object “I” through the surgical access device  1000 , as seen in  FIG. 12 . As the surgical object “I” is advanced distally through the valve assembly  100 , the seal aperture  304  of the instrument seal  302  is enlarged, and the passage  210  of the valve  202  is forced open. However, the resilient nature of the material comprising the valve  202  and the instrument seal  302  allows the valve  202  and the instrument seal  304  to substantially approximate the outer dimension “DI” of the surgical object “I” such that the substantially fluid-tight seal established prior to the insertion of the surgical object “I” is maintained. Additionally, as previously described, the pressure “P” acting on the outer wall  216  of the distal segment  208  of the valve  202  continues to compress and force the distal segment  208  inwardly in the direction of arrows  1  and into engagement with the surgical object thereby further ensuring the maintenance of the substantially fluid-tight seal formed between the surgical object “I” and the valve assembly  300 . The practitioner can then manipulate the surgical object “I” through the surgical access device  1000  to carry out the remainder of the procedure. 
     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. For example, although the valve members discussed above have been illustrated as substantially circular in configuration, the valve members may exhibit any suitable geometrical configuration. Additionally, persons skilled in the art will appreciate that the features illustrated or described in connection with one embodiment may be combined with those of another, and that such modifications and variations are also intended to be included within the scope of the present disclosure.