Abstract:
A surgical access apparatus adaptable to permit the sealed insertion of either the surgeon&#39;s hand and/or surgical instruments during laparoscopic and endoscopic surgical procedures includes an access member having a passageway therethrough and first and second seal members mounted across the passageway. The first and second seal members each has an aperture in non-overlapping relation to each other in the absence of the object positioned therein. The outer seal portion of the first seal member may include a plurality of expansible ribs and corresponding recesses arranged along respective lines of intersection with the axis of the first seal member.

Description:
BACKGROUND 
   1. Field of the Disclosure 
   The present disclosure relates generally to surgical devices for facilitating sealed access across a body wall and into a body cavity and, more particularly, to a surgical access apparatus adaptable to form a seal about either the surgeon&#39;s hand and/or surgical instruments during laparoscopic and endoscopic surgical procedures. 
   2. Description of the Related Art 
   Minimally invasive surgical procedures including both endoscopic and laparoscopic procedures permit surgery to be performed on organs, tissues and vessels far removed from an opening within the tissue. Laparoscopic and endoscopic procedures generally require that any instrumentation inserted into the body be sealed, i.e. provisions must be made to ensure that gases do not enter or exit the body through the incision as, e.g., in surgical procedures in which the surgical region is insufflated. These procedures typically employ surgical instruments which are introduced into the body through a cannula. The cannula has a seal assembly associated therewith. The seal assembly provides a substantially fluid tight seal about the instrument to preserve the integrity of the established pneumoperitoneum. 
   Minimally invasive procedures have several advantages over traditional open surgery, including less patient trauma, reduced recovery time, reduced potential for infection, etc. . . . However, despite its recent success and overall acceptance as a preferred surgical technique, minimally invasive surgery, such as laparoscopy, has several disadvantages. In particular, surgery of this type requires a great deal of surgeon skill in order for the surgeon to manipulate the long narrow endoscopic instruments about a remote site under endoscopic visualization. In addition, in laparoscopic surgery involving the intestinal tract, it is often preferable to manipulate large sections of the intestines to perform the desired procedure. These manipulations are not practical with current laparoscopic tools and procedures accessing the abdominal cavity through a trocar or cannula. 
   To address these concerns, recent efforts have focused on hand-assisted laparoscopic techniques and procedures. These procedures incorporate both laparoscopic and conventional surgical methodologies. The hand assisted technique is performed in conjunction with a hand access seal which is an enlarged device positionable within the incision in, e.g., the insufflated abdominal cavity. The device includes a seal for forming a seal about the surgeon&#39;s arm upon insertion while permitting surgical manipulation of the arm within the cavity. However, known hand access seals are quite cumbersome and incorporate elaborate sealing mechanisms. Moreover, these hand access seals are ill-adapted to accommodate radial manipulation of the surgeon&#39;s arm within the seal. 
   SUMMARY 
   Accordingly, the present disclosure relates to a surgical access apparatus adaptable to permit the sealed insertion of either the surgeon&#39;s hand and/or surgical instruments during laparoscopic and endoscopic surgical procedures. In one preferred embodiment, the surgical access apparatus includes an access member having a passageway therethrough and first and second seal members mounted across the passageway. The first seal member includes an inner seal portion and an outer seal portion. The inner seal portion has an aperture for substantial sealed reception of an object inserted therein and is arranged about a first seal axis. The outer seal portion includes at least one expansible rib dimensioned to facilitate movement of the aperture to a displaced position radially displaced from the first seal axis upon insertion of the object therethrough. The second seal member also has an inner portion defining an aperture for substantial sealed reception of the object and is arranged about a second seal axis radially displaced from the first seal axis. Preferably, the apertures of the first and second seal members are in non-overlapping relation and form a substantial seal within the passageway of the access member in the absence of the object inserted within the aperture of the first member. The first seal member is adapted to move to the displaced position upon insertion of the object therethrough whereby the apertures of the first seal member and the second seal member overlap. The outer seal portion of the first seal member may include a plurality of expansible ribs. The expansible ribs may be arranged along respective lines of intersection with the first seal axis of the first seal member. 
   In another preferred embodiment, the surgical access apparatus includes an access member having a passageway therethrough and a seal member mounted across the passageway. The seal member includes an inner seal portion and an outer seal portion. The inner seal portion has an aperture for substantial sealed reception of an object inserted therein and is arranged about a seal axis. The outer seal portion includes at least one expansible rib dimensioned to facilitate movement of the aperture to a displaced position radially displaced from the seal axis upon insertion of the object therethrough. The at least one expansible rib is generally arranged along a line of intersection with the seal axis of the seal member. The access member may further include a second seal member mounted adjacent the first seal member. The second seal member has an inner portion defining an aperture for substantial sealed reception of the object and is arranged about a second seal axis radially displaced from the first-mentioned seal axis. The first seal member is preferably adapted to move to the displaced position upon insertion of the object therethrough whereby the apertures of the first seal member and the second seal member overlap. 
   In another preferred embodiment, the surgical hand access apparatus includes a liner base adapted for insertion through an opening within body tissue for at least partial positioning within the body and an access housing mountable to the liner base. The access housing includes a housing member for positioning outside the body and defines a passageway dimensioned for permitting passage of either a surgeon&#39;s hand or arm of a surgeon, a first seal member mounted to the housing member and a second seal member mounted within the housing member adjacent the first seal member. The first seal member includes an inner seal portion and an outer seal portion. The inner seal portion has an aperture for substantial sealed reception of either the surgeon&#39;s hand or arm. The second seal member also has an inner portion defining an aperture for substantial sealed reception of either the surgeon&#39;s hand or arm. The first and second seal members form a substantial seal within the passageway of the housing member in the absence of the hand or arm of the surgeon. However, during insertion of either the surgeon&#39;s hand or arm within the aperture of the first seal member, the inner seal portion of the first seal member is adapted to move to position the aperture thereof in at least partial overlapping relation with the aperture of the second seal member to permit passage of the surgeon&#39;s hand or arm through the housing member. The outer seal portion of the first seal member includes at least one expansible rib (preferably, a plurality of ribs) dimensioned to facilitate movement of the aperture of the first seal member to a displaced position radially displaced from the first seal axis. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Preferred embodiments of the present disclosure will be better appreciated by reference to the drawings wherein: 
     Preferred embodiments of the present disclosure will be better appreciated by reference to the drawings wherein: 
       FIG. 1  is a perspective of the hand access apparatus in accordance with the principles of the present disclosure illustrating the access housing and liner base; 
       FIG. 2  is a cross sectional view of the access apparatus in accordance with the embodiment of  FIG. 1  taken along lines  2 - 2  of  FIG. 1 ; 
       FIG. 3  is a top plan view of a first seal within the access housing; 
       FIG. 4  is a side plan view of the first seal; 
       FIG. 5  is a top plan view of a second seal within the access housing; 
       FIG. 5A  is a top plan view of an alternate embodiment of the second seal; 
       FIG. 6  is a top plan view of the first and second seals with the second seal depicted in phantom; 
       FIGS. 7-8  are views illustrating insertion of the hand access apparatus within an incision; and 
       FIG. 9  is a cross-sectional view similar to the view of  FIG. 2  illustrating radial movement of the first seal during insertion of an object within the access housing. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The surgical access apparatus of the present disclosure provides a substantial seal between the body cavity of a patient and the outside atmosphere before, during and after insertion of an object through the apparatus. Moreover, the access apparatus of the present disclosure is adapted for positioning within an incision and may retract the tissue defining the incision to permit access to the underlying tissue. The access apparatus is particularly adapted for accommodating the hand and/or arm of a surgeon during a hand assisted laparoscopic procedure and establishing a gas tight seal with the arm when inserted. However, the access apparatus may be adapted to receive other objects, such as surgical instruments. The access apparatus is further adapted to substantially close in the absence of the object to maintain the integrity of the insufflated peritoneal cavity. 
   Although the specific focus of this disclosure will be on a preferred laparoscopic procedure, it will be noted that laparoscopic surgery is merely representative of a type of operation wherein a procedure can be performed in a body cavity with access through a body wall. 
   In the following description, as is traditional the term “proximal” refers to the portion of the instrument closest to the operator, while the term “distal” refers to the portion of the instrument remote from the operator. 
   Referring now to  FIGS. 1-2 , hand access apparatus  10  includes two main components, namely, access housing  12  and liner base  14  which is mounted to the access housing  12 . Access housing  12  is positioned external to the body, preferably, in contact with the outer skin of the body and consists of outer frame or housing member  16 , seal support  18  disposed within the housing member  16  and first and second seals  20 ,  22 . Housing member  16  preferably defines outer flange  24  dimensioned for engagement by the surgeon and lower U-shaped flange  26 . U-shaped flange  26  contacts the skin of the patient upon application of access apparatus  10 . U-shaped flange  26  also serves to mount liner base  14 . Housing member  16  defines housing axis “a” and internal longitudinal passageway  28  extending through the housing member  16 . Housing member  16  may be a single piece component or alternatively incorporate multiple pieces assembled together by conventional means. In one preferred embodiment, housing member  16  incorporates two components  16   a ,  16   b  as depicted in  FIG. 2 . Housing component  16   b  serves as a cover for enclosing first and second seals  20 ,  22  and is connected to housing component  16   a  in fixed relation. 
   Seal support  18  of access housing  12  is an elongated annular collar which extends at least partially within housing member  16 . The upper surface  30  of seal support  18  includes a plurality (two are shown) of upstanding posts  32  peripherally spaced about the periphery of the upper surface  30 . 
   Referring now to  FIGS. 3-4 , in conjunction with  FIGS. 1-2 , first seal  16  includes outer seal portion  34  and inner seal portion  36 . Outer seal portion  34  defines a plurality of apertures  38  which receive corresponding posts  32  of seal support  18  to mount first seal  20  to the seal support  18 . Outer seal portion  34  also includes a plurality of ribs  40  radially displaced about the outer seal portion  34 . Ribs  40  define an undulating arrangement as shown in  FIG. 4 . The undulating arrangement permits expansion of outer seal portion  34  particularly during offset manipulation of the object relative to housing axis “a”. Ribs  40  are each preferably arranged along a line of intersection “b” with housing axis “a” to permit uniform expansion and movement of first seal  20 . Ribs  40  may take other shapes and forms such as, for example, a sinusoidal configuration, pyramidal, convex, concave etc. . . . 
   Inner seal portion  36  defines internal aperture or opening  42 . Aperture  42  is arranged about first seal axis “c” ( FIG. 2 ) which is preferably radially offset from housing axis “a”. Aperture  42  may be any suitable geometrical shape including circular, elliptical, square, rectangular, or any other polygonal arrangement. In the preferred embodiment, aperture  42  is generally D-shaped. Inner seal portion  36  is adapted to radially move upon insertion of an object though aperture  42  as facilitated by ribs  40  to permit the aperture  42  to assume a position in general alignment with housing axis “a”. 
   With reference to  FIG. 5 , in conjunction with  FIGS. 1-2 , second seal  22  includes outer seal portion  44  and inner seal portion  46 . Outer seal portion  44  also includes apertures  48  disposed about its periphery for reception of posts  32  of seal support  18  to mount the second seal  22  within housing member  16 . Inner seal portion  46  defines opening or aperture  50  which may be of any geometrical shape, but, preferably, is generally D-shaped. Aperture  50  is arranged to be a mirror image of aperture  42  of first seal  20 . Aperture  50  is arranged about second seal axis “d” which is radially offset from housing axis “a”. Alternatively, as depicted in  FIG. 5A , aperture  50  may be centrally located within second seal  22  with second seal axis “d” coincident with axis “a” of housing member  16 . This arrangement may minimize the degree of movement required by first seal  20  and also positions the object in the center of housing member  16  during use. Second seal  22  may optionally include expansible ribs of the type aforedescribed in connection with first seal  20 . 
   First and second seals  20 ,  22  are each adapted to form a substantial seal about an object inserted through their apertures  42 ,  50  and may stretch to accommodate larger size objects. First and second seals  20 ,  22  are preferably in juxtaposed contacting relation. First and second seals  20 ,  22  may be formed of an elastomeric material including commercially available MONOPRENE™. In one preferred embodiment, seals  20 ,  22  are fabricated from a resilient material, e.g., polyisoprene, with each having at least one layer of fabric material positioned adjacent the resilient material. Seals  20 ,  22  may be fabricated from an elastomeric material molded with a fabric material. A friction resisting coating may be applied to seals  20 ,  22 . Such seal is disclosed in commonly-assigned U.S. patent application Ser. No. 10/165,373 filed Jun. 6, 2002, the contents of which are incorporated in its entirety by reference. 
     FIG. 6  illustrates in plan view the arrangement of first and second seals  20 ,  22  (with second seal  22  shown in phantom) prior to insertion of an object within the apertures  42 ,  50  of the seals  20 ,  22 . As shown, apertures  42 ,  50  of first and second seals  20 ,  22  are in non-overlapping relation, and arranged so that the respective apertures of the first and second seal do not overlap. With this arrangement and with first and second seals  20 ,  22  in contacting relation, the seals  20 ,  22  substantially seal longitudinal passageway  28  of housing member  16  to prevent escape of insufflation gases through access housing  12 . 
   Referring again to  FIGS. 1-2 , liner base  14  of access apparatus  10  will be discussed. Liner base  14  is intended for positioning within the incision of the patient to line the incision and/or retract the tissue defining the incision thereby providing access to the underlying body cavity. Liner base  14  includes liner member  52 , and lower ring  54  and upper ring  56  mounted to respective ends of liner member  52 . Liner member  52  may be a sheet of flexible material including, for example, polyethylene, polypropylene, etc., arranged in a tubular or sleeve-like configuration. 
   Liner member  52  may also include an elastomeric material and may incorporate rigid runners embedded within the material to increase its rigidity. Although in the preferred embodiment, liner member  52  is tubular, it is envisioned that the liner member  52  may incorporate several pieces, e.g., individual tabs or the like. Liner member  52  may or may not be impervious to fluids. Liner member  52  is adapted to line the incision so as to prevent contamination of the incision by any tissue which may be removed through the access apparatus, or in the course of the surgery. Generally, liner member  52  may also serve to retract the incision during placement of the liner base  14 , so that the patient&#39;s skin, fascia, and other tissue are drawn back, allowing access to the surgical site. 
   Lower ring  54  of liner member  52  is adapted for positioning through the incision and beneath the abdominal wall to engage the interior wall portions to thereby secure liner base  14  relative to the incision. Lower ring  54  is preferably flexible to facilitate passage through the incision and possesses sufficient resiliency to return to its original configuration upon entering the abdominal cavity. Lower ring  54  is preferably annular or ring-like in configuration and may be fabricated from a resilient or elastomeric material. Lower ring  54  may be fixedly secured to the end of liner member  52  through conventional means. 
   Upper ring  56  is substantially identical to lower ring  54 , i.e., upper ring  56  is also annular or ring-like in configuration and is attached to the other end of liner member  52  by conventional means. Upper ring  56  is received within U-shaped flange  26  of access housing  12  and is secured between the flange  26  and lower surface  58  of seal support  18  to secure liner base  14  to access housing  12 . Other means for attaching upper ring  56  to access housing  12  are also envisioned. 
   In further embodiments, seal support  18  discussed above in connection with  FIGS. 1-9  is mounted to a different base for retracting the incision and preferably lining the incision. For example, the base  14  may comprise a flexible sleeve for lining the incision and an inflatable member at a proximal end of the sleeve for tensioning the sleeve. Other structures for the base  14  may be used as appreciated by those of ordinary skill in the art. The access apparatus  10  discussed above may also include an additional seal for sealing around the object inserted through the apparatus, such as a septum seal. 
   Operation 
   The use of the access apparatus  10  in connection with a hand assisted laparoscopic surgical procedure will be discussed. The peritoneal cavity is insufflated and an incision is made within the cavity, with e.g., a trocar, to provide access to the cavity as is conventional in the art. Thereafter, as depicted in  FIGS. 7-8 , liner base  14  is introduced within the incision. Specifically, lower ring  54  is passed through the incision “i” and placed within the body cavity. As noted, lower ring  54  may be contracted upon itself to facilitate passage through the incision “i” and then released to permit the lower ring  54  to return to its normal condition (under the influences of its inherent resiliency) within the cavity. Liner member  52  extends from lower ring  54  through the incision to line the incision as previously discussed. 
   With reference to  FIG. 9 , the procedure is continued by positioning access housing  12  adjacent the external body tissue with the outer surface of U-shaped flange  26  engaging the tissue surrounding the incision. Thereafter, an object such as the surgeon&#39;s hand or arm “o” is introduced within access housing  12  and advanced through aperture  42  of first seal  20 . As noted, inner seal portion  36  of first seal  20  moves radially as facilitated by expansion of ribs  40  to permit aperture  42  to at least partially overlap with aperture  50  of second seal  22  thereby permitting the surgeon to continue advancing his arm through access housing  12  and liner base  14 . The surgeon continues to advance his arm though aperture  50  of second seal  22  and within the abdominal cavity. 
   With access apparatus  10  in this position of  FIG. 9 , hand assisted surgery may then be effected by continued advancement of the surgeon&#39;s hand and arm through seals  20 ,  22  of access housing  12  and into the body cavity. Seals  20 ,  22  form a fluid tight seal about the arm. The desired hand assisted procedure may then be performed. 
   It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.