Abstract:
A surgical access apparatus includes an access member defining a longitudinal axis and having a longitudinal passageway for reception and passage of a surgical object, a seal member mounted to the access member and having inner seal portions defining an aperture to removably receive the surgical object in substantial fluid-tight sealing relation therewith and at least one cable member. The at least one cable member has a first cable end connected to a first radial section of the seal member and a second cable end connected to a second radial section of the seal member displaced from the first radial section. The first and second cable ends are adapted to be laterally displaced relative to the longitudinal axis during offset lateral movement of the surgical object, to thereby cause corresponding lateral displacement of the inner seal portions of the seal member whereby the inner seal portions maintain the substantial fluid tight sealing relation with the surgical object.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/044,955, filed on Apr. 15, 2008, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to a surgical seal of the type adapted for the sealed reception of a surgical object. In particular, this disclosure relates to a surgical seal for use with a surgical access member such as a cannula or trocar assembly. 
         [0004]    2. Background of the Related Art 
         [0005]    Many contemporary medical and surgical procedures are performed through access members. These devices incorporate narrow tubes or cannulas percutaneously inserted into a patient&#39;s body and have a central opening through which surgical objects are introduced and manipulated during the course of the procedure. Generally, such procedures are referred to as “endoscopic”, and, if performed on the patient&#39;s abdomen, the procedure is referred to as “laparoscopic”. Throughout the present disclosure, the term “minimally invasive” should be understood to encompass both endoscopic and laparoscopic procedures. 
         [0006]    Generally, during minimally invasive procedures, prior to the introduction of a 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 workspace. Accordingly, the maintenance of a substantially fluid-tight seal along the central opening of the access member, in both the presence and absence of a surgical object, is desirable so as to prevent the escape of the insufflation gases and the deflation or collapse of the enlarged surgical workspace. To this end, surgical access members generally incorporate one or more seals many varieties of which are known in the art. One such example may be seen in commonly assigned U.S. Pat. No. 5,512,053 to Pearson, the entire contents of which are hereby incorporated by reference. 
         [0007]    During the course of a minimally invasive procedure, a clinician will frequently move surgical objects laterally within the access member, and the seal disposed therein, to access different regions of the surgical workspace. This lateral movement may distort the seal, thereby potentially causing the escape of insufflation gas and compromising the integrity of the insufflated workspace. 
         [0008]    While many varieties of surgical seals are known in the art, a continuing need exists for a seal capable of maintaining the integrity of an insufflated workspace during lateral movement of a surgical object inserted therethrough. 
       SUMMARY 
       [0009]    Accordingly, the present disclosure is directed to a surgical access apparatus, including an access member defining a longitudinal axis and having a longitudinal passageway for reception and passage of a surgical object, a seal member mounted to the access member and having inner seal portions defining an aperture to removably receive the surgical object in substantial fluid-tight sealing relation therewith and at least one cable member. The at least one cable member has a first cable end connected to a first radial section of the seal member and a second cable end connected to a second radial section of the seal member displaced from the first radial section. The first and second cable ends are adapted to be laterally displaced relative to the longitudinal axis during offset lateral movement of the surgical object, to thereby cause corresponding lateral displacement of the inner seal portions of the seal member whereby the inner seal portions maintain the substantial fluid tight sealing relation with the surgical object. The first and second cable ends may be connected to respective first and second radial sections of the seal member at locations adjacent the inner seal portions. The first and second radial sections may be in general diametrically opposed relation. First and second cable members may be provided with each cable member having cable ends connected to spaced radial sections of the seal member. 
         [0010]    The first cable end may be connected to the first radial section at a first location and the second cable end may be connected to the second radial section at a second location with the first and second locations being substantially adjacent the aperture. 
         [0011]    The seal member may define at least one channel configured to at least partially receive the at least one cable member. The at least one channel may be defined within the seal member. Alternatively, the at least one channel is defined on an outer surface of the seal member. 
         [0012]    The at least one cable member may define a length that remains substantially constant during use of the surgical seal member. The at least one cable member may be formed of a substantially non-rigid material. 
         [0013]    The seal member may be formed of an elastomeric material such that the seal member resiliently transitions between first and second conditions upon the respective insertion and removal of the surgical object. The aperture of the seal member may define a first diameter in the first condition and a second diameter in the second condition. The at least one cable member is configured to displace the aperture of the seal member upon lateral manipulation of the surgical object inserted therethrough with the aperture being displaced in the direction of lateral manipulation such that the second diameter of the aperture remains substantially constant. 
         [0014]    The access member may include a cannula defining a longitudinal opening dimensioned for passage of the surgical object. A housing may be coupled to the cannula. The housing is configured to receive the seal member and defines at least one cable conduit. The at least one cable conduit is configured to permit displacement of the at least one cable member during lateral manipulation of the surgical object within the seal member. 
         [0015]    These and other features of the surgical seal disclosed herein will become more readily apparent to those skilled in the art from the following detailed description of various embodiments of the present disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein: 
           [0017]      FIG. 1A  is a top perspective view of a seal member in accordance with the principles of the present disclosure. 
           [0018]      FIG. 1B  is a top perspective view of one embodiment of the seal member of  FIG. 1A . 
           [0019]      FIG. 2A  is a top plan view of the seal member of  FIG. 1A  shown in a first condition. 
           [0020]      FIG. 2B  is a top perspective view of the seal member of  FIG. 1A  shown in a second condition with a surgical object inserted therethrough. 
           [0021]      FIG. 2C  is a top plan view of the seal member of  FIG. 1A  with first and second cable members. 
           [0022]      FIG. 3A  is a top perspective view of another embodiment of the seal member of  FIG. 1  including channels defined in the proximal surface thereof. 
           [0023]      FIG. 3B  is a side plan view of another embodiment of the seal member of  FIG. 1  including a channel defined in the periphery thereof. 
           [0024]      FIG. 3C  is a top plan view of another embodiment of the seal member of  FIG. 1  including channels defined within the seal member. 
           [0025]      FIG. 3D  is a side plan view of the seal member of  FIG. 3C ; 
           [0026]      FIG. 4A  is a perspective view with parts separated of a surgical access member for use in conjunction with the seal member of  FIG. 1 . 
           [0027]      FIG. 4B  is side cross-sectional view of the housing of the surgical access member taken along line  4 B- 4 B of  FIG. 4A . 
           [0028]      FIG. 5  is a top perspective view of the seal member of  FIG. 1  illustrating the forces exerted thereupon by a surgical object following insertion. 
           [0029]      FIG. 6  is a top plan view of a known, exemplary seal member upon lateral manipulation of a surgical object inserted therethrough. 
           [0030]      FIG. 7  is a top plan view of the seal member of  FIG. 5  upon lateral manipulation of the surgical object. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0031]    In the drawings and in the description which follows, in which like reference numerals identify similar or identical elements, the term “proximal” will refer to the end of the apparatus closest to a clinician during the use thereof, while the term “distal” will refer to the end which is furthest from the clinician, as is traditional and known in the art. 
         [0032]    With reference to  FIGS. 1A-1B , a seal member  100  is disclosed that defines respective proximal and distal surfaces  102 ,  104 , a periphery  106  and an aperture  108  that is configured to removably receive a surgical object “I” ( FIG. 2B ) such that a substantially fluid-tight seal is formed therewith. Seal member  100  includes at least one cable member  110  which is discussed in detail below. 
         [0033]    Seal member  100  may exhibit any configuration suitable for the intended purpose of receiving surgical object “I” so as to form a substantially fluid-tight seal therewith, including but not being limited to a substantially planar configuration, as seen in  FIGS. 1A , or a generally conical configuration, as seen in  FIG. 1B . 
         [0034]    Seal member  100  may be formed of any suitable biocompatible material that is at least semi-resilient in nature, including but not limited to elastomeric materials. Forming seal member  100  of such a material facilitates the resilient deformation of seal member  100 , and aperture  108  in particular, upon the insertion and removal of surgical object “I”. The resilient nature of seal member  100  allows seal member  100  to exhibit various degrees of deformation during use, thereby facilitating the accommodation of surgical objects of various sizes, as well as the maintenance of a substantially fluid-tight seal therewith during the axial or lateral manipulation thereof within seal member  100 , as discussed in further detail below. 
         [0035]    As seen in  FIGS. 2A-2B , prior to receiving surgical object “I”, seal member  100  is in a first condition in which aperture  108  of seal member  100  defines a first diameter “D 1 ” that is substantially less than the diameter “D” of surgical object “I”. Aperture  108  may be closed in the first position, i.e., such that “D 1 ” equals zero, to thereby prevent the escape of any insufflation gas through seal member  100  in the absence of surgical object “I”. Upon the insertion of surgical object “I”, aperture  108  deforms, or stretches, to accommodate the larger diameter “D” of surgical object “I”, thereby transitioning into a second condition. In the second condition, aperture  108  of seal member  100  defines a second diameter “D 2 ” that substantially approximates the diameter “D” of surgical object “I”, thereby forming a substantially fluid-tight seal with surgical object “I” and substantially preventing the escape of insufflation gas. The diameter “D” of the surgical object “I”, and thus the diameter “D 2 ” of the aperture  108  of seal member  100  in the second condition, will generally lie within the range of about 5 mm to about 15 mm, as is conventional in the art, although substantially greater and lesser values for diameter “D 2 ” are also within the scope of the present disclosure. 
         [0036]    Referring still to  FIGS. 2A-2B , cable member  110  of seal member  100  will be discussed. 
         [0037]    The cable member, or members,  110  may be formed of any suitable biocompatible material that is substantially non-rigid and substantially non-extensible in character, e.g. stainless steel, polymeric material, etc., such that the length of cable member  110  remains substantially constant during the use of seal member  100 . Cable member  110  has respective first and second ends  112 ,  114  that are attached to seal member  100  at respective first and second sections  116 ,  118  thereof. The first and second ends  112 ,  114  of cable member  110  are attached to the first and second sections  116 ,  118  at first and second locations  120 ,  122 , respectively, that are disposed substantially adjacent to aperture  108  and spaced apart from one another. Various arrangements for securing the first and second ends  112 ,  114  of the cable member  110  are envisioned. For example, seal member  100  may have posts embedded within the material of the seal member  100 . The first and second ends  112 ,  114  may be attached or secured to the posts. In the alternative, the first and second ends  112 ,  114  may be embedded within the seal member  100  during manufacture of the seal member  100 , such as, for example, during a molding process. Other means for attaching the first and second ends  112 ,  114  are also envisioned. The respective first and second sections  116 ,  118 , and consequently the respective first and second locations  120 ,  122 , are in substantially diametric opposition to each other. 
         [0038]    With reference now to  FIG. 2C , in one embodiment, a seal member  100   A  is disclosed that includes a first cable member  110   A  having respective first and second ends  112   A ,  114   A  attached to first and second sections  116   A ,  118   A  of seal member  100   A  at first and second locations  120   A ,  122   A , respectively. In this embodiment, seal member  100   A  further includes a second cable member  110   B  having respective first and second ends  112   B ,  114   B  attached to first and second sections  116   B ,  118   B  of seal member  100   A  at first and second locations  120   B ,  122   B , respectively. As with seal member  100  of  FIGS. 2A-2B , each of the first and second locations  120   A ,  122   A ,  120   B ,  122   B  are disposed substantially adjacent aperture  108   A  and spaced apart from one another. The incorporation of additional cable members, e.g., a second cable member  110   B , or three or more cable members, facilitates more uniform deformation of aperture  108   A  upon laterally manipulating a surgical object “I” ( FIG. 2B ) inserted therethrough, as discussed below. 
         [0039]    As seen in  FIGS. 3A-3D , in one embodiment, seal member  100  defines at least one channel  124  configured to at least partially receive cable member  110 . Channels  124  may be formed either in an outer surface of seal member  100 , e.g. proximal surface  102  ( FIG. 3A ), distal surface  104  (not shown) or periphery  106  ( FIG. 3B ), or within seal member  100  ( FIGS. 3C-3D ) such that cable member  110  is at least partially concealed by seal member  100 . 
         [0040]    Referring now to  FIG. 4A , a surgical access member, in the form of, e.g., a cannula assembly  10 , is illustrated that may be used in conjunction with seal member  100 . At a proximal end  12 , cannula assembly  10  includes a housing  14  that is configured to accommodate the seal  100  that is the subject of the present disclosure. Extending distally from housing  14  is a cannula or elongate member  16 . As illustrated, cannula assembly  10  may optionally further include a zero-closure valve  18 . 
         [0041]    Housing  14  may be any structure suitable for the intended purpose of accommodating seal member  100 . As seen in  FIG. 4B , in one embodiment, housing  14  defines at least one conduit  20  on an internal surface  22  thereof. Conduit  20  is configured to receive cable member  110  and to permit the displacement thereof during lateral manipulation of surgical object “I” within seal member  100 , as discussed in further detail below. Further information regarding seal housing  14  may be obtained through reference to commonly owned U.S. Pat. No. 7,169,130 to Exline et al., the entire contents of which are hereby incorporated by reference. 
         [0042]    Cannula  16  extends distally from housing  14  and defines a longitudinal passage  24  that is configured to permit a surgical object “I” ( FIG. 2B ), to pass therethrough, e.g., an obturator, trocar or endoscope. At its distal end  26 , cannula  16  defines an opening  28  that is configured to allow the surgical object “I” to pass therethrough. Conventionally, surgical objects generally define a diameter substantially within the range of about 3 mm to about 15 mm. Accordingly, longitudinal passage  24  will be dimensioned similarly, although substantially larger and smaller surgical objects and a cannula  16  defining a substantially larger or smaller longitudinal passage  24  and opening  28  are also within the scope of the present disclosure. 
         [0043]    Referring now to  FIGS. 2A ,  4 A and  5 - 7 , the use and function of seal member  100  will be described in conjunction with a surgical access apparatus, e.g., cannula assembly  10 . Initially, the target surgical site is insufflated with a suitable biocompatible gas, e.g., CO 2  gas, such that a larger internal workspace may be created within a patient, thereby providing greater access to the patient&#39;s internal organs and/or cavities. The insufflation may be performed with an insufflation needle or similar device, as is conventional in the art. Thereafter, a variety of surgical objects, depicted generally as surgical object “I”, are inserted into cannula assembly  10  and advanced distally through seal member  100  and elongate member  16  to percutaneously access the insufflated workspace and carryout the minimally invasive procedure. 
         [0044]    Subsequent to insufflation, seal member  100  substantially prevents the escape of insufflation gas, thereby maintaining the integrity of the insufflated workspace in both the absence and presence of surgical object “I”. As seen in  FIG. 2A , prior to the insertion of surgical object “I”, seal member  100  is in the first condition, in which aperture  108  defines a first diameter “D 1 ”. Upon the insertion of surgical object “I” ( FIG. 5 ), seal member  100 , and in particular the aperture  108  thereof, is subjected to a force “F R ” applied by surgical object “I” that is directed radially outward. Force “F R ” forces open aperture  108 , thereby transitioning seal member  100  into the second condition thereof in which aperture  108  defines a second, larger diameter “D 2 ” that substantially approximates the diameter “D” of surgical object “I”. In the second condition, aperture  108  exerts a biasing force “F B ” directed radially inward that attempts to return seal member  100  to the first condition. Biasing force “F B ” is exerted upon surgical object “I”, thereby creating a substantially fluid-tight seal therewith. 
         [0045]    As previously discussed, it is often necessary to axially or laterally manipulate surgical object during the course of a minimally invasive procedure to access different areas of a surgical workspace.  FIG. 6  describes the impact of such lateral manipulation upon a known seal “S”. As would be appreciated by one of ordinary skill, laterally manipulating surgical object “I” in the direction of arrow “A” can laterally distort the enlarged aperture  108 s of the seal “S”, thereby creating a leak path  128  and potentially resulting in the escape insufflation gas therethrough. Seal member  100  of the present disclosure mitigates this potentiality through the incorporation cable member, or members,  110 . 
         [0046]    As seen in  FIG. 7 , upon the lateral movement of surgical object “I” in the direction of arrow “A”, a force “F L ” is applied to seal member  100  at the first section  120  thereof. Force “F L ” attempts to distort aperture  108  in the direction of arrow “A” and thereby create a leak path  128  ( FIG. 6 ). Upon the application of force “F L ” to the first section  116 , the first end  112  of cable member  110  is subjected to force “F L ” through the connection between the first end  112  of cable member  110  and seal member  100  at first location  120 . Force “F L ” displaces the first section  116 , thereby displacing the first end  112  of cable member  110 , and ultimately the second end  114  thereof. Through the connection between the second end  114  of cable member  110  and seal member  100  at the second location  122 , the second section  118  of seal member  100  is subjected to the influence of force “F L ” and is also displaced in the direction indicated by arrow “A”. Consequently, aperture  108  deforms in a substantially uniform manner, maintaining its diameter D 2  in the second condition and minimizing the dimensions of leak path  128 , if any, such that the substantially fluid-tight seal formed with surgical object “I” is preserved and the escape of insufflation gas through seal member  100  is curtailed. The incorporation of additional cable members ( FIG. 2C ) further ensures uniform deformation of aperture  108  upon the lateral movement of surgical object “I” and the preservation of a substantially fluid-tight seal therewith. The present disclosure contemplates that that material comprising cable member  110 , and the configuration and dimensions thereof, may be such that the degree of distortion realized by the second section  118  of the seal member  100  will approximate that of the first section  116 , thereby substantially maintaining the diameter “D 2 ” of aperture  108  in the second condition during the lateral manipulation of surgical object “I”. 
         [0047]    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.