Abstract:
A surgical access device includes a housing; an access member extending distally from the housing and being dimensioned for positioning within tissue, and defining a longitudinal axis; and a seal assembly disposed within the housing. The seal assembly includes first and second seal components respectively having first and second seal members. Each of the first and second seal members defines a passage for passage of a surgical object in substantial sealed relation therewith. The first and second seal components are capable of relative rotation about the longitudinal axis between a first position, in which passages of the first and second seal members are in substantial alignment, and a second position where the passages of the first and second seal members are offset to inhibit the communication of fluid through the seal assembly.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/162,358 filed on Mar. 23, 2009, 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 insertable into a patient&#39;s tissue. More specifically, the present disclosure relates to a surgical access device including a seal assembly adapted to accommodate the insertion of surgical instrumentation 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 cannula 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 saline or an insufflation gas, e.g., carbon dioxide, is often introduced into the surgical worksite to increase visibility or access to 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 thereby 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 is directed 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 being dimensioned for positioning within tissue, and defining a longitudinal axis; and a seal assembly disposed within the housing. The seal assembly includes first and second seal components respectively having first and second seal members. Each of the first and second seal members defines a passage for passage of a surgical object in substantial sealed relation therewith. The first and second seal components are capable of relative rotation about the longitudinal axis between a first position, in which passages of the first and second seal members are in substantial alignment, and a second position where the passages of the first and second seal members are out of alignment to inhibit the communication of fluid through the seal assembly. At least one of the first and second seal components may be at least partially receivable within the other of the first and second seal components. The seal members may be configured as multi-slit valves. The first seal component may include a first base member and a first cap extending proximally therefrom, and the second seal component may include a second base member and a second cap extending proximally therefrom. The first cap may define a transverse dimension that is smaller than a transverse dimension of the first base member, and the second cap defines a transverse dimension that is smaller than a transverse dimension of the second base member. The first base member may define an internal cavity configured and dimensioned to receive the second cap. 
     Detent means for releasably securing the first and second seal components in either of the first and second positions may be provided. The first seal component may include at least one detent configured and dimensioned for positioning within at least one recess on the second seal component. The seal assembly may include at least one bearing to facilitate relative rotation between the first and second seal components. 
     A method of performing a surgical procedure, includes the steps of: 
     accessing a body cavity with a surgical access device, the access device including first and second seal components respectively having first and second seal members, each of the first and second seal members defining a passage for passage of a surgical object; 
     positioning the first seal component and the second seal component at a first relative angular position whereby passages of the first and the second seal components are offset from each other to substantially prevent the passage of fluid; 
     moving, e.g., by rotating, the first seal component and the second seal component to a second relative angular position whereby passages of the first and the second seal components are in general alignment; 
     subsequent to the step of moving, introducing a surgical objects into the surgical worksite through the surgical access device to carry out the surgical procedure. 
     In another aspect of the present disclosure, a seal assembly adapted for use with a surgical access device is disclosed. The seal assembly includes first and second seal components respectively having first and second seal members. The first and second seal components are capable of relative rotation such that the seal assembly is movable from a first position, in which passages defined by the first and second seal members are in substantial alignment, to a second position, in which the passages defined by the first and second seal members are out of alignment to inhibit communication of fluid through the seal assembly. 
    
    
     
       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 including one embodiment of a seal assembly that includes first and second seal components in accordance with the principles of the present disclosure; 
         FIG. 2  is a side, perspective view of the seal assembly seen in  FIG. 1  illustrating the first and second seal components separated from each other and shown in a first condition in which passages of the seal members included on the first and second seal components are in substantial alignment; 
         FIG. 3  is a side, schematic view of the seal assembly seen in  FIG. 1  illustrating the first seal component separated from the second seal component; 
         FIG. 4  is a side, perspective view of an alternate embodiment of the seal assembly seen in  FIG. 1  including seal members configured as single-slit valves; 
         FIG. 5  is a side, perspective view of the seal assembly seen in  FIGS. 1-2  illustrating the first and second seal components separated from each other and shown in a second condition in which the passages of the seal members are offset from one another; 
         FIG. 6  is a side, perspective view of another embodiment of the seal assembly seen in  FIG. 1  including a plurality of bearings to facilitate repositioning of the seal assembly between the first and second positions; 
         FIG. 7  is a flow chart describing a method of using the surgical access device of  FIG. 1  during the course of an arthroscopic surgical procedure; 
         FIG. 8  is a side, schematic view of another embodiment of the seal assembly seen in  FIG. 1  including first and second seal components that are substantially identical in structure shown separated from each other; and 
         FIG. 9  illustrates another embodiment of the seal assembly seen in  FIG. 1  including a first seal component with a plurality of recesses and a second seal component including a plurality of detents. 
     
    
    
     DETAILED DESCRIPTION 
     In the drawings and in the description which follows, in which like references numerals identify similar or identical elements, the term “proximal” should be understood to refer 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 to include any surgical object or instrument that may be employed during the course of surgical procedure, including but not being limited to an obturator, a surgical stapling device, or the like; the term “filament” should be understood to refer 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 to refer 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  extending distally therefrom. The housing  1002  is configured and dimensioned to accommodate a seal 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 access point “P” formed in a patient&#39;s tissue “T”, e.g., a patient&#39;s knee. The access member  1006  defines a passageway  1008  extending longitudinally therethrough along a longitudinal axis “A.” The passageway  1008  is configured and dimensioned for the internal receipt of one or more surgical filaments “F” and/or a surgical object, or objects “I.” The access member  1006  defines an opening  1010  at a distal end  1012  thereof to allow the surgical filaments “F” and the surgical object “I” to pass therethrough. 
     Referring now to  FIGS. 2-5  as well, the seal assembly  100  will be discussed. The seal assembly  100  includes at least two seal components  102   a ,  102   b . The seal components  102   a ,  102   b  may be formed of any suitable biocompatible and at least semi-resilient material, and may be formed 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, fluorosilicone 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 seal components  102   a ,  102   b  from such materials permits the seal components  102   a ,  102   b  to resiliently accommodate the insertion, manipulation, and removal of the surgical filaments “F”, as well as surgical objects “I” that may vary in size. 
     The seal components  102   a ,  102   b  of the illustrated embodiments respectively include base members  104   a ,  104   b  and caps  106   a ,  106   b . In one embodiment of the seal assembly  100 , as seen in  FIG. 1-3  for example, the base member  104   a  of the seal component  102   a  includes an internal cavity  108  that defines an internal transverse dimension “D 1 .” The caps  106   a ,  106   b  extend proximally from the base members  104   a ,  104   b , respectively, and may be either substantially solid members, as illustrated, or hollow structures that define internal spaces. The caps  106   a ,  106   b  each define an outer transverse dimension “D 2 ” that substantially approximates the internal transverse dimension “D 1 ” of the cavity  108  such that the seal assembly  100  can be assembled as seen in  FIG. 1 , i.e., such that the cap  106   b  of the seal component  102   b  is received by the internal cavity  108  defined within the base member  104   a  of the seal component  102   a . While illustrated as substantially circular in configuration, the base members  104   a ,  104   b  and the caps  106   a ,  106   b  may exhibit any suitable geometrical configuration in alternate embodiments of the seal assembly  100 . 
     The proximal surfaces  110   a ,  110   b  of the caps  106   a ,  106   b  respectively include seal members  112   a ,  112   b  having respective passages  114   a ,  114   b . Although depicted as multi-slit valves  115   a ,  115   b  in the embodiment of the seal assembly  100  seen in  FIGS. 2 and 5 , for example, the seal members  112   a ,  112   b  may include any passage suitable for the intended purpose of substantially limiting the communication of fluids, e.g., saline or insufflation gas, through the seal assembly  100 , including but not limited to single slit-valves  116   a ,  116   b , as seen in  FIG. 4 . The passages  114   a ,  114   b  of the seal members  112   a ,  112   b  extend through the seal components  102   a ,  102   b  ( FIGS. 2-3 ), and are normally biased towards a closed condition, as seen in  FIG. 2  for example, to provide a substantially fluid-tight seal in the absence of surgical filaments “F” and/or the surgical object “I”. The seal members  112 ,  112   b  are also configured to help minimize the escape of fluid through the seal assembly  100  when the surgical filaments “F” and/or the surgical object “I” is inserted therethrough. 
     The seal components  102   a ,  102   b  are relatively rotatable from a first position, seen in  FIG. 2 , in which the respective passages  114   a ,  114   b  of the seal members  112   a ,  112   b  in substantial alignment, into a second position, seen in  FIG. 5 , in which the respective passages  114   a ,  114   b  of the seal members  112   a ,  112   b  are offset from one another. Rotating the seal components  102   a ,  102   b  interrupts and substantially closes off the path of any fluid communicated proximally through the surgical access device  1000  ( FIG. 1 ) to further help ensure against any substantial leakage of fluid. 
     In one embodiment, as seen in  FIGS. 1-5 , the seal assembly  100  includes a tactile member  118  to facilitate repositioning of a portion of the seal assembly  100  between the first and second positions. The tactile member  118  can be coupled to either the seal component  102   a , as seen in  FIGS. 1-5 , or seal component  102   b , and depends outwardly therefrom through an opening  1014  ( FIG. 1 ) in the housing  1002  of the surgical access device  1000  such that the practitioner can manually manipulate the relative position of the seal component  102   a ,  102   b . In alternate embodiments of the seal assembly  100 , relative movement between the seal component  102   a ,  102   b  may be effectuated in any suitable manner, including but not limited to the incorporation of a mechanized assembly, such as a motor and gear set. As seen in  FIG. 6 , in one embodiment of the seal assembly, referred to generally by reference character  200 , either or both of the seal components  202   a ,  202   b  may include bearings  218 , or any other suitable structure, to assist in the relative movement of the seal components  202   a ,  202   b  between the first and second positions. 
     With reference now to  FIGS. 1-7 , the use and function of the surgical access device  1000  during the course of an arthroscopic procedure will be discussed. Initially, a fluid, such as saline, is introduced into the surgical worksite. Thereafter, the access member  1006  is positioned within the percutaneous access point “P” formed in the patient&#39;s tissue “T”, and the surgical object “I” and/or the surgical filament “F” are introduced into the surgical worksite by passage through the housing  1002  and the access member  1006 . Either prior to the insertion of the surgical object “I” and/or the surgical filament “F” or at any other point during the course of the procedure, the practitioner may move the seal assembly  100  from the first position to the second position to regulate the leakage of any fluid. Subsequently, the practitioner can manipulate the surgical object “I” and/or the surgical filament “F” through the surgical access device  1000  to carry out the remainder of the procedure. 
       FIGS. 8-9  illustrate alternate embodiments of the seal assembly, referred to generally by reference numbers  300  and  400 . The seal assembly  300  includes seal components  302   a ,  302   b  that are substantially identical in structure. Specifically, the seal components  302   a ,  302   b  include base members  304   a ,  304   b  that each defines a cavity  308 . Including two seal components  302   a ,  302   b  that are substantially identical in structure allows for a substantial reduction in manufacturing costs, e.g., tooling costs, in that the total number of parts requiring fabrication is reduced by one. 
     The seal assembly  400  seen in  FIG. 9  includes base members  404   a ,  404   b  incorporating corresponding structure that is configured to selectively maintain the first and second positions of the seal components  402   a ,  402   b  described above and respectively seen in  FIGS. 2 and 5 . In the embodiment of the seal assembly  400  seen in  FIG. 9 , the base member  404   b  includes a pair of detents  420  formed on a proximal surface  422  thereof that are configured and dimensioned to engage either a first pair of recess  424  or a second pair of recesses  426  formed on a distal surface  428  of the base member  404   a . The detents  420  engage the first pair of recesses  424  when the seal assembly  400  is in the first position, i.e., when the respective passages  414   a ,  414   b  of the seal members  412   a ,  412   b  are in substantial alignment, and the second pair of recesses  426  when the seal assembly  400  is in the second position, i.e., when the respective passages  414   a ,  414   b  of the seal members  412   a ,  412   b  are offset from each other. The detents  422  and the respective first and second pairs of recesses  424 ,  426  are configured and dimensioned such that the first and second positions are maintained until a predetermined force has been applied to seal assembly  400 , e.g., through use of the tactile member  418 . 
     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 each embodiment of the seal assembly is illustrated as including two seal components, embodiments including three or more seal components arranged in accordance with the manner described above are also within the scope of the present disclosure. 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.