Patent Publication Number: US-2013253277-A1

Title: Surgical access assembly and method of use therefor

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/615,504, filed on Mar. 26, 2012, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to a surgical access assembly, and more particularly, to a surgical access assembly including an access port and a seal anchor detachably engaging each other in a sealing relation and a method of use therefor. 
     2. 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. 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. 
     When compared to the larger incisions typically found in traditional procedures, both trauma to the patient and recovery time are reduced for procedures involving small incisions. 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 an access port, which is an enlarged device that protects the opening from, for example, infection and contamination. 
     The maintenance of a substantially fluid-tight seal is desirable to prevent the escape of the insufflation gases and the deflation or collapse of the enlarged surgical site. Accordingly, there is a need for an access assembly used in a hand-assisted minimally invasive procedure that can accommodate a variety of surgical objects while maintaining the integrity of an insufflated workspace. 
     SUMMARY 
     In accordance with an embodiment of the present disclosure, there is provided a surgical access assembly including an access port and a seal anchor. The access port includes first and second rings and a sleeve extending between the first and second rings. The sleeve includes an inner surface having an attaching member. The seal anchor is adapted to be at least partially disposed in the access port. The seal anchor includes a base portion configured to detachably engage the attaching member of the access port. 
     The base portion of the seal anchor may include a second attaching member adapted to be detachably attached to the attaching member of the access port. The attaching member of the access port and the second attaching member of the seal anchor may be a refastenable tape or a hook and loop fastener. Alternatively, at least one of the attaching member of the access port and the second attaching member of the seal anchor may be an adhesive tape. 
     The attaching member may be an annular ring disposed on the inner surface of the sleeve. The base portion of the seal anchor may define a groove configured to receive therein the second attaching member of the seal anchor. Under such configuration, the second attaching member of the seal anchor may be an annular member peripherally arranged about the lumen defined in the seal anchor. In addition, the second attaching member of the seal anchor may define a slit in alignment with the lumen. The seal anchor may define a lumen dimensioned to receive surgical instruments therethrough. 
     The first ring of the access port may have a kidney shaped cross-sectional profile, and the second ring of the access port may be an O-ring. Furthermore, the second ring may be an inflatable balloon. The first and second rings may be elastic. In particular, the seal anchor may be made of a compressible material. It is also contemplated that the attaching member of the access port may extend along a length of the sleeve of the access port. 
     In accordance with another aspect of the present disclosure, there is provided a method of accessing an internal body cavity including providing a surgical access assembly including an access port and a seal anchor. In particular, the access port includes first and second rings and a sleeve extending between the first and second rings. The sleeve includes an inner surface having an attaching member. In addition, the seal anchor is adapted to be at least partially disposed in the access port. The seal anchor includes a base portion including a second attaching member corresponding to the attaching member of the access port. The method further includes positioning a first ring of the access port into the body cavity, rolling the sleeve of the access port about the second ring such that the first and second rings engage an internal peritoneal wall of tissue and an outer epidermal tissue, respectively, positioning the seal anchor at least partially within the access port in a sealing relation therewith, and introducing a surgical instrument to the body cavity through the seal anchor. 
     In another embodiment, positioning the seal anchor at least partially within the access port may include placing the seal anchor within the second ring and aligning the second attaching member of the seal anchor with the attaching member of the access port. In addition, positioning the seal anchor at least partially within the access port may also include placing the seal anchor on the outer epidermal tissue. It is further contemplated that the method may further include insufflating the 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; 
         FIG. 1A  is an exploded perspective view of an access port of the surgical access assembly of  FIG. 1 ; 
         FIG. 2  is a longitudinal cross-sectional view of a seal anchor of the surgical access assembly of  FIG. 1  taken along section line  2 - 2  of  FIG. 1  illustrating a longitudinally extending lumen of the seal anchor; 
         FIG. 3  is a longitudinal cross-sectional view of a seal anchor in accordance with an embodiment of the present disclosure; 
         FIG. 4  is a longitudinal cross-sectional view of a seal anchor in accordance with an embodiment of the present disclosure; 
         FIG. 5  is a longitudinal cross-sectional view of a seal anchor in accordance with an embodiment of the present disclosure; 
         FIG. 6  is a longitudinal cross-sectional view of a seal anchor in accordance with an embodiment of the present disclosure; 
         FIG. 7  is a longitudinal cross-sectional view of the access port of the surgical access assembly of  FIG. 1 ; 
         FIGS. 8 and 9  are longitudinal cross-sectional views of the access port of  FIG. 7  illustrating insertion of the access port in tissue; 
         FIG. 10  is a longitudinal cross-sectional view of the surgical access assembly of  FIG. 1  secured in a sealing relation to tissue; and 
         FIGS. 11-13  are longitudinal cross-sectional views of an access port in accordance with another embodiment of the present disclosure. 
     
    
    
     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  10  in accordance with an embodiment of the present disclosure. Surgical access assembly  10  includes a seal anchor  100  and an access port  200 . Access port  200  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. Access port  200  protects the opening from, for example, infection and contamination. In addition, access port  200  may serve to retract the opening, as will be discussed below. Seal anchor  100  is detachably attached to and at least partially disposed in access port  200  to provide a substantially fluid-tight seal between a body cavity of a patient and the atmosphere. Both access port  200  and seal anchor  100 , however, may be used as a stand-alone device for insertion of endoscopic instruments. 
     With continued reference to  FIG. 1 , seal anchor  100  is configured to receive surgical instruments of varying diameter therethrough. Seal anchor  100  is formed from elastic/compressible type material having sufficient compliance to form a seal about a surgical object and to establish a sealing relation with access port  200 . Furthermore, such material enables seal anchor  100  to accommodate off-axis motion of the surgical object extending therethrough. 
     Seal anchor  100  contemplates introduction of various types of instrumentation adapted for insertion through a trocar and/or cannula assembly while maintaining a substantially fluid-tight interface about the instrument to help preserve the atmospheric integrity of a surgical procedure from gas and/or fluid leakage. 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. Such instruments will collectively be referred to as “instruments” or “instrumentation.” 
     Seal anchor  100  includes proximal and distal end portions  102 ,  104  and an intermediate portion  106  extending between proximal and distal end portions  102 ,  104 . Seal anchor  100  defines at least one lumen or channel  108  that extends longitudinally between proximal and distal end portions  102 ,  104 . Proximal and distal end portions  102 ,  104  define substantially planar surfaces. However, proximal and distal end portions  102 ,  104  may define surfaces that are substantially arcuate to assist in the insertion of seal anchor  100  within tissue. The radial dimension of intermediate portion  106  is appreciably less than those of respective proximal and distal end portions  102 ,  104 . Under such configuration, seal anchor  100  defines an hourglass shape or profile to assist in anchoring seal anchor  100  within tissue when seal anchor  100  is used as a stand-alone device. 
     Seal anchor  100  is adapted to transition from an expanded condition to a deformed condition to facilitate insertion and securement of the surgical instruments in tissue. Seal anchor  100  is formed of a biocompatible compressible material that facilitates the resilient, reciprocal transitioning of seal anchor  100  between the expanded and deformed conditions thereof. Seal anchor  100  is biased to the initial condition, and thus in the absence of any force applied to seal anchor  100 , seal anchor  100  is in the expanded condition. 
     Lumen  108  is configured to removably receive a surgical object “I” ( FIG. 10 ). Prior to the insertion of surgical object “I,” lumen  108  is in a first state in which lumen  108  defines a first or initial dimension that substantially prevents escape of insufflation gas through lumen  108  in the absence of surgical object “I.” Upon insertion of surgical object “I” through lumen  108 , lumen  108  transitions to a second state in which lumen  108  defines a second, larger dimension that substantially approximates the diameter of surgical object “I” such that a substantially fluid-tight seal is formed with surgical object “I.” In particular, the compressible material comprising seal anchor  100  facilitates the resilient transitioning of lumen  108  between its first closed state and its second state. An example of a seal anchor is disclosed in commonly assigned U.S. patent application Ser. No. 12/939,204, filed on Nov. 4, 2010, the entire contents of which are fully incorporated herein by reference. 
     With reference now to  FIG. 2 , seal anchor  100  further includes an attaching member  110  at distal end portion  104  thereof. Attaching member  110  may be an annular member peripherally arranged about lumen  108 . Attaching member  110  detachably couples seal anchor  100  to access port  200 , as will be discussed in detail hereinbelow ( FIG. 10 ). Attaching members  110  may include, for example, a refastenable tape or a hook and loop fastener commercially available under the trade name Velcro™. Alternatively, attaching member  110  may include a double-sided adhesive tape to detachably attach seal anchor  100  to access port  200 . 
     With reference to  FIG. 3 , a seal anchor  500  in accordance with an embodiment of the present disclosure is illustrated. In the interest of brevity, the present embodiment will focus on the differences between seal anchor  500  and the previously described seal anchor  100 . Attaching member  510  detachably couples seal anchor  500  to access port  200 . Seal anchor  500  includes proximal and distal end portions  502 ,  504  and an intermediate portion extending between proximal and distal end portions  502 ,  504 . Proximal and distal end portions  502 ,  504  define substantially planar surfaces. Intermediate portion  506  defines a lumen  508  extending therethrough. 
     In contrast to seal anchor  100 , distal end portion  504  of seal anchor  500  defines a peripherally arranged circumferential groove  530 . Attaching member  510  has an annular configuration dimensioned to be disposed in circumferential groove  530 . A depth of groove  530  corresponds to a thickness of the material chosen for attaching member  510 . In this manner, the effect of the thickness of attaching member  510  on the sealing relation between distal end portion  504  of seal anchor  500  and access port  200  is minimized. 
     Furthermore, attaching member  510  disposed in groove  530  may be, for example, substantially flush with distal end portion  504  of seal anchor  500 . The compressive nature of seal anchor  500  enables the user to press attaching member  510  that is substantially flush with distal end portion  504  of seal anchor  500  against attaching member  250  of access port  200  to enable substantially fluid-tight seal with access port  200 . 
     Attaching member  510  may include, for example, a refastenable tape or a hook and loop fastener commercially available under the trade name Velcro™. Alternatively, attaching member  510  may include a double-sided adhesive tape to detachably attach seal anchor  500  to access port  200 . 
     With reference now to  FIG. 4 , a seal anchor  700  in accordance with an embodiment of the present disclosure is illustrated. Attaching member  710  detachably couples seal anchor  700  to access port  200 . In contrast to seal anchors  100 ,  500  discussed hereinabove, seal anchor  700  defines a circular groove  730  at a distal end portion  704  of seal anchor  700 . In particular, circular groove  730  extends radially outward from the center of distal end portion  704 . Circular attaching member  710  is dimensioned to be disposed in circular groove  730 . In addition, attaching member  710  may further define a slit  760  in alignment with lumen  708 , to enable passage of surgical instruments “I” therethrough. Under such configuration, seal anchor  700  may provide a greater contact surface with attaching member  250 . 
     Attaching member  710  may include, for example, a refastenable tape or a hook and loop fastener commercially available under the trade name Velcro™. Alternatively, attaching member  710  may include a double-sided adhesive tape to detachably attach seal anchor  700  to access port  200 . 
     With reference now to  FIG. 5 , a seal anchor  800  in accordance with an embodiment of the present disclosure is illustrated. In contrast to the previously described seal anchors  100 ,  500 ,  700 , seal anchor  800  includes attaching member  810  disposed adjacent proximal end portion  802 . Under such configuration, attaching member  810  enables seal anchor  800  to be detachably attached to access port  200  in a sealing relation, while at least partially inserted through the opening in tissue “T.” In this manner, a lower profile of surgical access assembly may be effected. For example, when seal anchor  800  is at least partially inserted through the opening in tissue “T,” proximal end portion  802  may be flush with proximal ring  230  of access port  200 . 
     It is further contemplated that, a further reduction in profile of surgical access assembly may be effected through a use of, for example, a seal anchor  900 , as shown in  FIG. 6 . Seal anchor  900  includes a proximal end portion  902  and an attaching member  910  in a superposed relation therewith. Proximal end portion  902  and attaching member  910  define a lumen  908  dimensioned for passage of surgical instruments “I” therethrough. In contrast to the previously discussed seal anchors  100 ,  500 ,  700 ,  800 , seal anchor  900  does not have intermediate portion  106 ,  506 ,  706 ,  806  which gives seal anchors  100 ,  500 ,  700 ,  800  the hourglass shape or profile. Under such configuration, seal anchor  900  may be disposed entirely within proximal ring  230 . 
     With reference back to  FIGS. 1 and 1A , access port  200  includes a distal ring  220 , a proximal ring  230  and a flexible sleeve  210  having a length extending between distal and proximal rings  220 ,  230 . Distal and proximal rings  220 ,  230  are formed of relatively flexible materials to facilitate compression and expansion of distal and proximal rings  220 ,  230 . For example, distal and proximal rings  220 ,  230  may be made from an elastomer such as polyurethane, polyethylene, silicone, and the like. The resilient nature of distal and proximal rings  220 ,  230  allows distal and proximal rings  220 ,  230  to return to their normal, substantially annular configuration. Furthermore, distal and proximal rings  220 ,  230  are adapted to engage the walls of tissue defining the body cavity to further facilitate securement of access port  200  within the body tissue. For example, distal ring  220  engages the internal peritoneal wall T I , and proximal ring  230  engages the outer epidermal tissue T O  ( FIG. 9 ). 
     With reference now to  FIG. 7-9 , sleeve  210  has elastomeric properties to facilitate securement of access port  200  with the opening. Proximal ring  230  is rollable to gather flexible sleeve  210  around proximal ring  230 . For example, proximal ring  230  is rollable in the outward direction (as shown by arrow “X”) to shorten sleeve  210  and in the inward direction to lengthen the sleeve  210 , or vice versa. Sleeve  210  may be shortened such that proximal ring  220  engages the outer epidermal tissue T O  adjacent the opening in tissue “T” and distal ring  230  positioned in the body cavity engages internal peritoneal wall T I  ( FIG. 9 ). In this manner, access port  200  is securely fixed to the tissue. 
     With continued reference to  FIG. 7-9 , proximal ring  230  has a kidney-shaped cross-sectional profile. Kidney-shaped cross-section facilitates rolling of sleeve  210  about proximal ring  230  and inhibits unrolling of sleeve  210  over proximal ring  230  by providing a flattened edge disposed on the outer epidermal tissue T O . Distal ring  220 , on the other hand, may be an O-ring having a circular cross-section. However, other cross-sectional profiles are also contemplated for proximal and distal rings  230 ,  220 . It is also envisioned that the O-ring may be an inflatable balloon. 
     With particular reference to  FIG. 9 , distal and proximal rings  220 ,  230  can vary in size. The dimensions of distal and proximal rings  220 ,  230  may be selectively chosen to be greater than that of the opening ( FIG. 9 ). In this manner, distal and proximal rings  220 ,  230  may have sufficient footing to maintain elastic sleeve  210  that has been stretched and retained at a distance greater than the natural distance. 
     By having diameters of distal and proximal rings  220 ,  230  larger than that of the opening, access port  200  is adapted to dilate the opening to provide a desired diameter and provides positive securement of access port  200  in the opening. More retraction is possible through shortening of sleeve  210  by rolling proximal ring  230  outward, while less retraction is possible by rolling proximal ring  230  inward. 
     With reference back to  FIG. 7 , access port  200  further includes an attaching member  250  corresponding to attaching member  110  of seal anchor  100 . For example, attaching members  110 ,  250  may each include a refastenable tape or a hook and loop fastener commercially available under the trade name Velcro™. Alternatively, at least one of attaching members  110 ,  250  may include a double-sided adhesive tape to detachably attach seal anchor  100  to access port  200 . Attaching member  250  is circumferentially disposed on an inner surface of sleeve  210 . In particular, attaching member  250  is disposed adjacent proximal ring  230 . Under such configuration, when sleeve  210  is rolled about proximal ring  230  to place proximal ring  230  in contact with the outer epidermal tissue T O  or to retract the wound, attaching member  250  is at least partially disposed on the outer epidermal tissue T O  ( FIG. 9 ). At this time, attaching member  110  of seal anchor  100  is aligned with and disposed on attaching member  250  of access port  200 . Attaching members  110 ,  250  enable seal anchor  100  to be detachably attached to access port  200  in a sealing relation. While seal anchor  100  has been used in describing the sealing relation between seal anchor  100  and access port  200 , seal anchors  500 ,  700 ,  800 ,  900  may be used with access port  200 . 
     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. 
     Prior to the insertion of access port  200  within tissue, access port  200  is in its expanded condition in which the dimensions thereof inhibit the insertion of access port  200  into tissue tract. To facilitate insertion, the user transitions distal ring  220  into the compressed condition by, e.g., squeezing distal ring  220 , as shown in  FIG. 8 . Subsequent to its insertion, distal ring  220  is disposed beneath tissue “T.” At this time, proximal ring  230  may be rolled in the direction of arrow “X,” as shown in  FIG. 8 , such that distal ring  220  engages internal peritoneal wall T I  and proximal ring  230  engages the outer epidermal tissue T O  to secure access port  200  within the opening in tissue “T,” as shown in  FIG. 9 . Depending on the nature of the procedure being performed, the opening in the wound may be retracted by rolling sleeve  210  about proximal ring  230 . At this time, attaching member  250  is at least partially disposed on the outer epidermal tissue T O . 
     Then, seal anchor  100  is at least partially placed within proximal ring  230  of access port  200 . In particular, attaching member  110  of seal anchor  100  is directly aligned with and disposed on attaching member  250 , whereby seal anchor  100  is detachably secured to access port  200  while providing a sealing relation therebetween. Prior to the insertion of surgical object, lumen  108  defines a first or initial dimension that substantially prevents escape of insufflation gas through lumen  108  in the absence of surgical object “I.” Upon insertion of surgical object “I” through lumen  108 , lumen  108  transitions to a second state in which lumen  108  defines a second, larger dimension that substantially approximates the diameter of surgical object “I” such that a substantially fluid-tight seal is formed with surgical object “I.” 
     Thereafter, one or more surgical objects may be inserted through lumen  108  of seal anchor  100 , as shown in  FIG. 10 . With surgical instruments “I” inserted through lumen  108  and into the body cavity of the patient, the user may swivel or rotate surgical instrument “I” to a desired orientation with respect to tissue “T.” During the surgical procedure, surgical instrument “I” and seal anchor  100  may be removed from access port  200 , to enable passage of the surgeon&#39;s hand through the wound to access the body cavity of the patient. Upon completing the surgical procedure, the user may remove the surgical access assembly  10  from the opening of the patient. 
     With reference now to  FIGS. 11-13 , an access port  300  in accordance with an embodiment of the present disclosure is illustrated. In the interest of brevity, the present embodiment will focus on the differences between access port  300  and the previously described access port  200 . Access port  300  includes a distal ring  320 , proximal ring  330 , and a flexible sleeve  310  having a length extending between distal and proximal rings  320 ,  330 . Distal and proximal rings  320 ,  330  are formed of relatively flexible materials to facilitate compression and expansion of distal and proximal rings  320 ,  330 . Access port  300  further includes an attaching member  350  corresponding to attaching member  110  of seal anchor  100 . Attaching member  350  may be a refastenable tape or a hook and loop fastener commercially available under the trade name Velcro™. Alternatively, attaching members  110 ,  350  may include a double-sided adhesive tape to detachably attach seal anchor  100  to access port  300 . 
     In particular, attaching member  350  is disposed on an inner wall of sleeve  310 , and extends substantially the entire length of sleeve  310 . In this manner, regardless of the amount of retraction desired (by rolling sleeve  310  about proximal ring  330 ), at least a portion of attaching member  350  is disposed on the outer epidermal tissue T O  to enable securement of seal anchor  100  thereon ( FIGS. 12 and 13 ), while providing a sealing relation therebetween. However, it is contemplated that the length of attaching member  350  may be tailored to meet the particular need of a surgical procedure being performed. The operation and use of access port  300  is substantially similar to access port  200 . Thus, the operation and use of access port will not be discussed herein in the interest of brevity. 
     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.