Patent Publication Number: US-2021161516-A1

Title: Surgical access assembly and method of use therefor

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a division of U.S. patent application Ser. No. 16/213,329, filed Dec. 7, 2018, the disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     Technical Field 
     The present disclosure relates to a surgical access assembly, and more particularly, to a surgical access assembly including a sleeve assembly and a sealing assembly adaptably engaging each other in a sealing relation and a method of use therefor. 
     Background of Related Art 
     Various surgical procedures are performed in a minimally invasive manner. This includes forming a small opening through a body wall of the patient, e.g., in the abdomen, and inserting a seal anchor through the opening to provide a substantially fluid-tight seal between a body cavity of a patient and the atmosphere. Due to the relatively small interior dimensions of the access devices used in endoscopic procedures, only the elongated, small diametered instrumentation such as, e.g., trocar and cannula assemblies, may be used to access the internal body cavities and organs. 
     However, minimally invasive surgery such as, e.g., laparoscopy, has several limitations. In particular, surgery of this type requires a great deal of skill in manipulating the long narrow endoscopic instruments to a remote site under endoscopic visualization. To this end, hand-assisted laparoscopic techniques and procedures have been developed. These procedures include both laparoscopic and conventional surgical methodologies. The hand-assisted technique is performed utilizing a seal anchor in conjunction with a sleeve assembly, which is an enlarged device that protects the incised opening from, for example, infection and contamination. In general, prior to the introduction of the surgical object into the patient&#39;s body, insufflation gases are used to enlarge the area surrounding the target surgical site to create a larger, more accessible work area. 
     The maintenance of a substantially fluid-tight seal is desirable to inhibit the escape of the insufflation gases and the deflation or collapse of the enlarged surgical site. Accordingly, there is a need for a surgical access assembly used in a hand-assisted minimally invasive procedure that can maintain the integrity of an insufflated workspace. 
     SUMMARY 
     In accordance with an embodiment of the present disclosure, a surgical access assembly includes a sleeve assembly, a base member, and a sealing assembly. The sleeve assembly includes a proximal ring, a distal ring, and a sleeve defining a passage therethrough. The sleeve extends between the proximal and distal rings. The base member includes an annular body including a coupling member. The annular body defines an opening in communication with the passage of the sleeve, and a circumferential groove configured to support the proximal ring of the sleeve assembly. The sealing assembly includes an annular frame and a seal dimensioned to cover the opening of the base member in a sealing relation. The coupling member of the base member releasably secures the sealing assembly to the base member. The annular frame of the sealing assembly is configured to be in registration with the annular body of the base member such that the proximal ring is interposed between the base member and the sealing assembly. 
     In an embodiment, the seal may include a body configured to be received in the opening of the base member and an overhang extending radially outward from the body. 
     In another embodiment, the annular frame and the body of the seal may define a gap therebetween. The gap may be dimensioned to receive at least a portion of the proximal ring of the sleeve assembly. 
     In yet another embodiment, the annular body of the base member may include lips disposed radially inward of the proximal ring of the sleeve assembly. The lips may be configured to retain the proximal ring within the circumferential groove of the annular body. 
     In an embodiment, the sealing assembly may be hingedly coupled with the base member. In particular, the annular frame of the sealing assembly may include a hook. The annular body of the base member may define an aperture dimensioned to receive the hook. 
     In another embodiment, the hook may be deflectable such that the hook is selectably movable through the aperture of the base member. 
     In an embodiment, the seal of the sealing assembly may be formed of gel or silicone. 
     In another embodiment, the proximal ring of the sleeve assembly may have a kidney-shaped cross-section. 
     In yet another embodiment, the sleeve of the sleeve assembly may be rollable about the proximal ring. 
     In still yet another embodiment, the annular body of the base member may include a first planar surface extending radially outward from the circumferential groove, and the annular frame of the sealing assembly may include a second planar surface configured to be in planar contact with the first planar surface when the base member and the sealing assembly are in registration with each other. 
     In another embodiment, the annular body of the base member may include a fastening member extending proximally from the first planar surface, and the second planar surface of the sealing assembly may define a slot dimensioned to receive the fastening member. 
     In an embodiment, at least one of the fastening member of the base member or the second planar surface of the sealing assembly may be formed of an elastic material. 
     In another embodiment, the annular frame of the sealing assembly may include a support disposed radially inward of the second planar surface. 
     In an embodiment, the seal may be over-molded onto the support. 
     In another embodiment, the base member may include a tab on an outer wall thereof, and the annular frame may define a slot dimensioned to slidably rotate the sealing assembly relative to the base member. 
     In yet another embodiment, the annular frame may further define an axially extending notch in communication with the slot. The axially extending notch may be configured to lead the tab of the base member into the slot of the annular frame. 
     In accordance with another aspect of the present disclosure, a method of accessing an internal body cavity includes positioning a sleeve assembly at least partially in the internal body cavity; rolling a sleeve of the sleeve assembly such that proximal and distal portions of the sleeve assembly engage an outer epidermal tissue and an internal peritoneal wall of tissue, respectively; placing a proximal ring of the sleeve assembly in a circumferential groove defined in a base member; placing a sealing assembly in registration with the base member such that a body portion of a seal of the sealing assembly covers an opening defined in the base member in sealing relation, and an overhang of the seal extending radially outward from the body portion of the seal engages the proximal ring of the sleeve assembly; releasably securing the sealing assembly with the base member; and introducing an object into the internal body cavity through the sealing assembly. 
     In an embodiment, releasably securing the sealing assembly with the base member may include hingedly coupling the sealing assembly with the base member. 
     In another embodiment, releasably securing the sealing assembly with the base member may include rotating the sealing assembly relative to the base member by placing a tab on an outer wall of the base member into a circumferential slot defined in an inner wall of the sealing assembly. 
     In yet another embodiment, releasably securing the sealing assembly with the base member may include placing a fastener extending proximally from the base member into a slot defined in the sealing assembly. 
     In still yet another embodiment, the method may further include insufflating the internal body cavity. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the present disclosure are described hereinbelow with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of a surgical access assembly in accordance with an embodiment of the present disclosure, illustrating an open state; 
         FIG. 2  is a partial perspective view of the surgical access assembly of  FIG. 1 ; 
         FIG. 3  is a perspective view of the surgical access assembly of  FIG. 1 , illustrating a closed state; 
         FIGS. 4 and 5  are perspective views of a sleeve assembly of the surgical access assembly of  FIG. 1 , illustrating use thereof; 
         FIG. 6  is a partial perspective view of a surgical access assembly in accordance with another embodiment of the present disclosure with parts removed; 
         FIG. 7  is a partially enlarged perspective view of the surgical access assembly of  FIG. 6 ; 
         FIG. 8  is a top view of the surgical access assembly of  FIG. 6 ; 
         FIG. 9  is a perspective view of a sealing assembly and a base member in accordance with another embodiment of the present disclosure; 
         FIG. 10  is a top view of the base member of  FIG. 9 ; and 
         FIG. 11  is a partial cross-sectional view of the sealing assembly and the base member of  FIG. 9 , illustrating a locking mechanism. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal,” as is conventional, will refer to that portion of the instrument, apparatus, device or component thereof which is farther from the user while, the term “proximal,” will refer to that portion of the instrument, apparatus, device or component thereof which is closer to 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. 
     With reference to  FIG. 1 , there is illustrated a surgical access assembly  100  in accordance with an embodiment of the present disclosure. The surgical access assembly  100  is configured to receive an object such as, e.g., a hand of a clinician, while maintaining the integrity of an insufflated workspace. The surgical access assembly  100  includes a sleeve assembly  120 , a base member  150 , and a sealing assembly  180 . The sleeve assembly  120  is adapted for insertion within a tissue tract, e.g., through an opening in the abdominal or peritoneal lining, as well as a naturally occurring orifice. The sleeve assembly  120  protects the opening from, for example, infection and contamination. The base member  150  is configured to support the sleeve assembly  120 . The sealing assembly  180  is configured to be releasably coupled with the base member  150 . Such a configuration enhances integrity of an insufflated workspace by inhibiting, e.g., inadvertent detachment, of the sleeve assembly  120  from the sealing assembly  180 . 
     With continued reference to  FIG. 1 , the sleeve assembly  120  includes a distal ring  122 , a proximal ring  124 , and a flexible sleeve  126  defining a passage therethrough. The distal and proximal rings  122 ,  124  are concentrically arranged and are connected to opposing ends of the sleeve  126 . The distal and proximal rings  122 ,  124  are formed of relatively flexible materials to facilitate compression and expansion of the distal and proximal rings  122 ,  124 . For example, the distal and proximal rings  122 ,  124  may be made from an elastomer such as polyurethane, polyethylene, silicone, and the like. The resilient nature of the distal and proximal rings  122 ,  124  allows the distal and proximal rings  122 ,  124  to return to their normal, substantially annular configuration after compression or deformation by the clinician. In particular, the distal and proximal rings  122 ,  124  are adapted to engage the walls defining the body cavity. The distal ring  122  is configured to engage the internal peritoneal wall, and the proximal ring  124  is configured to engage the outer epidermal tissue. 
     The sleeve  126  has elastomeric properties to facilitate securement of the sleeve assembly  120  to the opening in tissue “T” ( FIG. 4 ). The proximal ring  124  is rollable to gather flexible sleeve  126  around the proximal ring  124 . For example, the proximal ring  124  is rollable, e.g., in an outward direction “O” ( FIG. 4 ) to shorten the sleeve  126  and in an inward direction to lengthen the sleeve  126 , or vice versa. The sleeve  126  may be shortened such that the proximal ring  124  engages the outer epidermal tissue adjacent the opening in tissue “T,” and the distal ring  122  positioned in the body cavity engages the internal peritoneal wall. In this manner, the sleeve assembly  120  is securely fixed to tissue “T.” 
     With continued reference to  FIG. 3 , proximal ring  124  may have, e.g., a kidney-shaped, cross-sectional profile. Kidney-shaped cross-section facilitates rolling of the sleeve  126  about the proximal ring  124 . The distal ring  124 , on the other hand, may be an O-ring having a circular cross-section. However, other cross-sectional profiles are also contemplated for the proximal and distal rings  122 ,  124 . It is also envisioned that the O-ring may be an inflatable balloon. In addition, the proximal and distal rings  122 ,  124  may vary in size. For example, the dimensions of the proximal and distal rings  122 ,  124  may be selectively chosen to be larger than that of a desired opening. In this manner, the proximal and distal rings  122 ,  124  may have sufficient footing to maintain the elastic sleeve  126  that has been stretched. 
     By having dimensions of the proximal and distal rings  122 ,  124  larger than that of the desired the opening in tissue “T,” the sleeve assembly  120  is adapted to retract/dilate the opening to a desired dimension. More retraction is possible through shortening of the sleeve  126  by rolling the proximal ring  124  outward, while less retraction is possible by rolling the proximal ring  124  inward. Reference may be made to U.S. Pat. No. 9,149,178, the entire contents of which are incorporated herein by reference, for a detailed description of the construction and operation of the sleeve assembly  120 . 
     With reference now to  FIG. 2 , the base member  150  is annular and has a circumferential groove (not shown) dimensioned to support the proximal ring  124  of the sleeve assembly  120  therein. The base member  150  includes lips  154  circumferentially arranged to concentrically support the proximal ring  124  of the sleeve assembly  120  within the circumferential groove. The base member  150  further includes a cup  156  configured to be hingedly coupled with the sealing assembly  180 . In addition, the base member  150  further includes a coupling member  160  defining an aperture  162  dimensioned to releasably receive a hook  190  of the sealing assembly  180 . 
     With continued reference to  FIG. 2 , the sealing assembly  180  includes a seal  188  and a frame  182  supporting the seal  188  thereon. The seal  188  may be formed of materials such as, e.g., gel or silicone, having sufficient compliance to form a seal about an object such as, e.g., a hand of a clinician, inserted therethrough. The seal  188  may define, e.g., a diametrically extending slit  189  ( FIG. 3 ), to facilitate insertion of the object therethrough. The seal  188  may be over-molded onto the frame  182 . The seal  188  includes a body portion  188   a  dimensioned to cover the aperture  155  defined by the base member  150  in a sealing relation, and an overhang portion  188   b  extending radially outward from the body portion  188   a.  The sealing assembly  180  may define a circumferential groove or a cutout (not shown) dimensioned to receive at least a portion of the proximal ring  124  of the sleeve assembly  120 . 
     The frame  182  of the sealing assembly  180  includes the hook  190  configured to be received in the aperture  162  defined in the coupling member  160  of the base member  150 , and a finger (not shown) configured to be hingedly coupled with the cup  156  of the base member  150 . The finger may diametrically oppose the hook  190 . The hook  190  includes a stop  194  configured to engage the coupling member  160  to secure the sealing member  180  with the base member  150 . However, the hook  190  is deflectable such that when the hook  190  is pressed radially inward, the stop  194  may pass through the aperture  162  to transition the sealing assembly  180  to an open position ( FIG. 1 ) from a closed position ( FIG. 3 ). 
     In use, the peritoneal cavity (not shown) is insufflated with a suitable biocompatible gas such as, e.g., CO 2  gas, such that the cavity wall is raised and lifted away from the internal organs and tissue housed therein, thereby providing greater access thereto. The insufflation may be performed with an insufflation needle or similar device, as is conventional in the art. Either prior or subsequent to insufflation, an opening is made in tissue “T,” the dimensions of which may be varied dependent upon the nature of the procedure. 
     With reference now to  FIG. 4 , compressed distal ring  122  ( FIG. 3 ) of the sleeve assembly  120  is inserted through the opening in tissue “T”. Subsequent to its insertion, the distal ring  122  expands to its expanded state beneath tissue “T.” At this time, the proximal ring  124  may be rolled in the direction of arrow “O,” such that the distal ring  122  engage the internal peritoneal wall, and the proximal ring  124  engages the outer epidermal tissue. In this manner, the sleeve  126  is securely disposed within the opening in tissue “T”. Depending on the nature of the procedure being performed, the opening in tissue “T” may be retracted by further rolling the sleeve  126  about proximal ring  124 . 
     At this time, the proximal ring  124  of the sleeve assembly  120  is placed in the circular groove of the base member  150  such that at least a portion of the proximal ring  124  extends proximally from the base member  150 . Thereafter, the sealing member  180  may be hingedly coupled to the base member  150  by securing the finger of the frame  182  of the sealing member  180  to the cup  156  of the base member  150 . Thereafter, the hook  190  diametrically opposing the finger may be inserted into the aperture  162  of the base member  150  to place the sealing member  180  in the closed position ( FIG. 3 ). In this manner, a fluid-tight seal is established between the body cavity and the atmosphere. 
     At this time, one or more surgical objects including the clinician&#39;s hand may be inserted through the slit  189  defined in the seal  188  which maintains insufflation in the workspace by establishing a seal against the hand or a surgical object. With the object inserted through the surgical access assembly  100  and into the body cavity of the patient, the clinician may rotate the hand to a desired orientation with respect to tissue “T,” while maintaining a fluid-tight seal between a body cavity of a patient and the atmosphere. Upon completing the surgical procedure, the user may remove the surgical access assembly  100  from the opening of the patient. 
     With reference now to  FIGS. 6 and 7 , another embodiment of a surgical access assembly in accordance with another embodiment of the present disclosure is shown generally as a surgical access assembly  200 . In the interest of brevity, portions of the surgical access assembly  200  substantially identical to the surgical access assembly  100  will not be described herein to avoid obscuring the present disclosure in unnecessary detail. The surgical access assembly  200  includes the sleeve assembly  120 , a base member  250  configured to support the proximal ring  124  of the sleeve assembly  120 , and a sealing assembly  280  configured to establish a fluid-tight seal between the body cavity and the atmosphere when an object such as, e.g., a hand of a clinician, is inserted therethrough. 
     With continued reference to  FIGS. 6 and 7 , the base member  250  is annular and includes a grooved portion  254  configured to support the proximal ring  124  of the sleeve assembly  120 , and a base portion  256  extending radially outward from the grooved portion  254 . The base portion  256  includes coupling members  258  configured to secure the seal member  280  to the base member  250 . In particular, each coupling member  258  may include a rivet-like profile including a head portion  258   a.  The coupling members  258  may be evenly spaced apart about the base member  250 . 
     The seal member  280  includes a frame  282  having an annular base  294  and a support  296  disposed radially inward of the annular base  294 . The annular base  294  has a substantially flat surface extending radially outward such that when the annular base  294  is in superposed relation with the base portion  256  of the base member  250 , the annular base  294  and the base portion  256  are in planar contact for enhanced stability and securement. The annular base  294  defines circumferentially arranged bores or slots  291  dimensioned to receive respective coupling members  258  of the base member  250 . The coupling members  258  and/or the annular base  294  may be formed of compressible and/or resilient material to provide, e.g., snap-fit configuration, whereby when the base portion  256  and the annular base  294  are pressed together, the head portion  258   a  of the coupling member  258  having larger dimensions than a width of the slot  291  extends through the slot  291  and secures the annular base  294  to the base portion  256 . 
     With reference to  FIG. 8 , it is further contemplated that each slot  291  may be tapered, thereby providing a varying width in each slot  291 . In this manner, after inserting the head portions  258   a  of the coupling members  258  through the respective slots  291  of the frame  282 , the frame  282  may be rotated relative to the base member  250  (e.g., in the direction of arrow “Y”) to further secure the frame  282  against the base member  250 . 
     The sealing assembly  280  further includes a seal  288 . The seal  288  may be formed of materials such as, e.g., gel or silicone, having sufficient compliance to form a seal about an object such as, e.g., a hand of a clinician, inserted therethrough. In particular, the seal  288  may be over-molded onto the support  296  of the frame  282 . The seal  288  includes a body  288   a  disposed in the opening defined by the base member  250 , and an overhang  288   b  extending radially outward from the body  288   a  such that the overhang  288   b  is over-molded onto the support  296  of the frame  282 . Under such a configuration, the sealing assembly  280  defines a gap  297  between the body  288   a  and the support  296  in order to facilitate securement of the proximal ring  124  between the sealing assembly  280  and the base member  250 . The seal  288  may define, e.g., a slit  289 , dimensioned to receive an object such as, e.g., a hand of a clinician, inserted therethrough. The use of the surgical access assembly  200  is substantially identical to the use of the surgical access assembly  100  and, thus, will not be described herein. 
     With reference now to  FIGS. 9-11 , a sealing assembly and a base member in accordance with another embodiment of the present disclosure is shown generally as a base member  350  and a sealing assembly  380 . In the interest of brevity, portions of the base member  350  and the sealing assembly  380  substantially identical to the base members  150 ,  250  and the sealing assemblies  180 ,  280  will not be described herein to avoid obscuring the present disclosure in unnecessary detail. The base member  350  and the sealing assembly  380  are configured for use with the sleeve assembly  120  ( FIG. 1 ). The base member  350  is configured to support the proximal ring  124  of the sleeve assembly  120 . The sealing assembly  380  is configured to establish a fluid-tight seal between the body cavity and the atmosphere when an object such as, e.g., a hand of a clinician, is inserted therethrough. The proximal ring  124  is releasably securable between the base member  350  and the sealing assembly  380 . 
     With particular reference to  FIG. 9 , the base member  350  is annular and defines an opening  352 . The base member  350  includes a grooved portion  354  configured to support the proximal ring  124  of the sleeve assembly  120 . The grooved portion  354  includes an inner portion  355   a  having circumferentially arranged of lips  358  configured to retain the proximal ring  124  within the grooved portion  354 , and an outer wall  355   b  having tabs  360  extending radially outward. For example, the outer wall  355   b  may include, e.g., two, tabs  360  diametrically opposing each other. 
     The sealing assembly  380  includes an annular frame  382  having an inner wall  394  defining a groove  396  dimensioned to slidably receive the corresponding tab  360  of the base member  350  such that the sealing assembly  380  and the base member  350  are rotatable relative to each other. The inner wall  394  further defines an axially extending notch  397  in communication with the groove  396 . The axially extending notch  397  is dimensioned to lead the tab  360  of the base member  350  into the groove  396 . Under such a configuration, when the tabs  360  are inserted into the respective axially extending notches  397  and the sealing assembly  380  is rotated relative to the base member  350 , the sealing assembly  380  is securely coupled to the base member  350 . In this manner, the proximal ring  124  of the sleeve assembly  120  is securely interposed between the base member  350  and the sealing assembly  380 . Optionally, the sealing assembly  380  may include external tabs  391  circumferentially arranged thereabout to enhance gripping by the clinician. 
     The sealing assembly  380  further includes a seal  388  formed of materials such as, e.g., gel or silicone, having sufficient compliance to form a seal about an object such as, e.g., a hand of a clinician, inserted therethrough. The seal  388  may be over-molded onto the frame  382 . The seal  388  covers the opening  352  defined by the base member  350 . The seal  388  may define a slit (not shown) dimensioned to receive an object such as, e.g., a hand of a clinician, inserted therethrough. The use of the base member  350  and the sealing assembly  380  is substantially identical to the use of the base members  150 ,  250  and the sealing assemblies  180 ,  280  of the surgical access assemblies  100 ,  200  and, thus, will not be described herein. 
     Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. For example, while the surgical access assemblies  100 ,  200  are shown for use in hand-assisted procedures, introduction of various types of instrumentation adapted for insertion through the sealing assembly  180 ,  280 ,  380 , while maintaining a substantially fluid-tight interface about the instrument to help preserve the integrity of an insufflated workspace from gas and/or fluid leakage is further contemplated. Examples of instrumentation include, but are not limited to, clip appliers, graspers, dissectors, retractors, staplers, laser probes, photographic devices, endoscopes and laparoscopes, tubes, and the like. 
     It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown or described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variations are also included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.