Patent Publication Number: US-8968249-B2

Title: Introducer seal assembly

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. Application continuation of U.S. application Ser. No. 12/613,816, filed on Nov. 6, 2009, now U.S. Pat. No. 7,951,118 which is a continuation of U.S. application Ser. No. 11/069,098, filed Mar. 1, 2005, now U.S. Pat. No. 7,632,250, which is a continuation-in-part of U.S. patent application Ser. No. 10/264,556 filed on Oct. 4, 2002, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/379,651 filed on May 10, 2002. The disclosures are hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to valve system adapted to permit the introduction of surgical instrumentation into a patient&#39;s body. In particular, the present disclosure relates to a valve system for use with an introducer which is intended for insertion into a patient&#39;s body, and to receive an instrument in sealing engagement therewith. 
     2. Description of the Related Art 
     Minimally invasive and laparoscopic procedures generally require that any instrumentation inserted into the body is sealed, i.e., provisions must be made to ensure that gases and/or fluids do not enter or exit the body through an endoscopic incision, such as, for example in surgical procedures where the surgical region is insufflated. For such procedures, the introduction of a tube into anatomical cavities, such as the peritoneal cavity, is usually accomplished by use of a system incorporating a trocar and cannula assembly. Since the cannula is in direct communication with the interior of the peritoneal cavity, insertion of the cannula into an opening in the patient&#39;s body to reach the inner abdominal cavity should be adapted to maintain a fluid tight interface between the abdominal cavity and the outside atmosphere. In view of the need to maintain the atmospheric integrity of the inner area of the cavity, a seal assembly for a cannula, which permits introduction of a wide range of surgical instrumentation and maintains the atmospheric integrity of the inner area of the cavity is desirable. In this regard, there have been a number of attempts in the prior art to achieve such sealing requirements. A difficulty encountered with conventional seal assemblies, however, is the inability of accommodating the wide range of sizes of instrumentation. In addition, angulation and/or manipulation of instrumentation within the cannula often present difficulties with respect to maintaining seal integrity. 
     SUMMARY 
     Accordingly, the present disclosure provides a seal assembly which will allow a surgeon to efficaciously utilize instruments of varying diameter in a surgical procedure. This seal assembly obviates the need for multiple adapters to accommodate instruments of varying diameter by providing an apertured resilient seal member which is mounted in a gimbal-like assembly, thereby facilitating alignment of the instrument with the aperture of the seal member. 
     In a preferred embodiment, a seal assembly for use with an access device includes a seal housing defining a central longitudinal axis. The seal housing includes an inner wall and an outer wall. The inner wall defines a longitudinal opening to permit passage of instrumentation through the seal housing. A gimbal mount is at least partially accommodated within a space defined between the inner wall and the outer wall of the seal housing. The gimbal mount includes a seal member defining an aperture for substantial sealed reception of a surgical instrument. The gimbal mount is adapted for angular movement relative to the central longitudinal axis upon angulation of the surgical instrument while substantially maintaining the sealed reception of the surgical instrument. The gimbal mount preferably defines a general hemispherical configuration. 
     The seal housing may include a skirt seal which is positioned adjacent the gimbal mount and adapted to minimize passage of fluids through the seal housing. The skirt seal may extend to contact the gimbal mount, and bias the gimbal mount in a general proximal direction. The skirt seal is dimensioned and configured to bias the gimbal mount against the inner wall of the seal housing. Preferably, the inner wall of the seal housing defines a distal arcuate surface in contacting relation with a corresponding inner arcuate surface of the gimbal mount. 
     The preferred seal member includes a resilient member and a protective layer juxtaposed relative to the resilient member. The protective layer of the seal member extends at least partially within the aperture to protect portions of the seal member defining the aperture during passage of the surgical instrument. 
     The protective layer may include a fabric material. 
     The seal housing is adapted to be detachably mounted to a cannula assembly for providing a substantially fluid-tight seal when the instrument is inserted into the seal assembly and through the cannula assembly. 
     In an alternate embodiment, the seal assembly for use with an access device includes a seal housing defining a central longitudinal axis and having proximal and distal ends. The seal housing includes an inner wall defining an opening to permit passage of instrumentation through the seal housing. A gimbal mount is disposed within the seal housing. The gimbal mount is adapted for angular movement within the seal housing about an axis of rotation. The gimbal mount includes a seal defining an aperture for sealed reception of a surgical instrument. A skirt member is engageable with a peripheral portion of the gimbal mount, and is dimensioned to bias the gimbal mount in a proximal direction against the seal housing. The seal housing defines a distal angulating surface which is in contacting relation with the gimbal mount. Preferably, the gimbal mount defines an interior surface corresponding to the distal angulating surface of the seal housing, and in contacting relation therewith. The interior surface traverses the distal angulating surface upon angular movement of the gimbal mount. The gimbal mount may also define a general hemispherical configuration. 
     In another embodiment, the seal assembly for use with an access device includes a seal housing defining a central longitudinal axis and a longitudinal passageway for permitting passage of a surgical instrument, and a generally hemispherical seal element disposed within the seal housing. The seal element defines a seal axis and an aperture for sealed reception of the surgical instrument. The seal element is adapted for angular movement within the seal housing to accommodate angular movement of the surgical instrument whereby the seal axis intersects the central longitudinal axis of the seal housing. 
     The seal assembly is adapted to be associated with a cannula assembly. The cannula assembly typically includes a tubular cannula and a cannula housing within which is positioned a cannula seal assembly. The cannula seal assembly typically provides structure which is adapted to provide a fluid-tight seal in the absence of a surgical instrument. Suitable cannula seal assemblies include a spring loaded flapper valve, a trumpet valve, a duck bill valve, or the like. The seal assembly of the invention may be associated with the cannula housing by any suitable means, e.g., a bayonet lock. 
     In use, the seal assembly may be associated with a cannula assembly at any point the surgeon desires flexibility in the instrument sizes he may utilize therethrough. Thus, for example, if the surgeon is utilizing a 15 mm cannula assembly in an endoscopic surgical procedure and determines that it would be advantageous to have the flexibility to use instruments ranging in size from 5 to 15 mm through that cannula assembly, the seal assembly may be secured to the cannula assembly. Thereafter, instruments ranging in diameter from 5 to 15 mm may be efficaciously introduced therethrough. The cylindrical guide wall guides the instrument toward the aperture of the resilient seal member. The gimbal mount angularly repositions itself with respect to the housing in response to the manipulation of the instrument. 
     The movement of the gimbal mount relative to the housing which is accommodated by the gimbal-like structure also facilitates seal maintenance once an instrument is being used within the body cavity. In particular, as an instrument is manipulated, the resilient seal member moves through movement of the gimbal mount relative to the housing, thereby ensuring that the resilient seal member maintains a fluid-tight seal around the instrument shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing features of the present disclosure will become more readily apparent and will be better understood by referring to the following detailed description of preferred embodiments, which are described hereinbelow with reference to the drawings wherein: 
         FIGS. 1-2  are perspective views of a cannula assembly and a seal assembly in accordance with the principles of the present disclosure; 
         FIG. 3  is a perspective view with parts separated of the cannula and seal assemblies of  FIG. 1 ; 
         FIG. 4  is a side cross-sectional view of the cannula and seal assemblies; 
         FIGS. 5-6  are top and bottom perspective views of the gimbal mount of the seal assembly; 
         FIGS. 7-8  are cross-sectional views of the gimbal mount; 
         FIG. 9  is a perspective view illustrating the components of the gimbal mount; 
         FIGS. 10-12  are perspective views illustrating the range of movement of the gimbal mount within the seal housing; 
         FIG. 13  is a view illustrating the cannula assembly and seal assembly accessing an internal cavity with an instrument introduced therein; and 
         FIG. 14  is a side cross-sectional view of the cannula and seal assemblies illustrating a range of movement of the surgical instrument. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     The seal assembly of the present disclosure, either alone or in combination with a seal system internal to a cannula assembly, provides a substantial seal between a body cavity of a patient and the outside atmosphere before, during and after insertion of an instrument through the cannula assembly. Moreover, the seal assembly of the present invention is capable of accommodating instruments of varying diameters, e.g., from 5 mm to 15 mm, by providing a gas tight seal with each instrument when inserted. The flexibility of the present seal assembly greatly facilitates endoscopic surgery where a variety of instruments having differing diameters are often needed during a single surgical procedure. 
     The seal assembly contemplates the introduction and manipulation of various types of instrumentation adapted for insertion through a trocar and/or cannula assembly while maintaining a fluid tight interface about the instrumentation to preserve the atmospheric integrity of a surgical procedure from gas and/or fluid leakage. Specifically, the seal assembly accommodates angular manipulation of the surgical instrument relative to the seal axis. This feature of the present disclosure desirably minimizes the entry and exit of gases and/or fluids to/from the body cavity. Examples of instrumentation include clip appliers, graspers, dissectors, retractors, staplers, laser probes, photographic devices, endoscopes and laproscopes, tubes, and the like. Such instruments will be collectively referred to herein as “instruments or instrumentation”. 
     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 the drawings, in which like reference numerals identify identical or substantially similar parts throughout the several views,  FIGS. 1-2  illustrate the seal assembly  100  of the present disclosure mounted to cannula assembly  200 . Cannula assembly  200  may be any conventional cannula suitable for the intended purpose of accessing a body cavity and permit introduction of instruments therethrough. Cannula assembly  200  is particularly adapted for use in laparoscopic surgery where the peritoneal cavity is insufflated with a suitable gas, e.g., CO 2 , to raise the cavity wall from the internal organs therein. Cannula assembly  200  is typically used with an obturator assembly (not shown) which is a sharp pointed instrument positionable within the passageway of the cannula assembly  200 . The obturator assembly is utilized to penetrate the abdominal wall and then subsequently removed from the cannula assembly to permit introduction of the surgical instrumentation utilized to perform the procedure. 
     Cannula assembly  200  includes cannula sleeve  202  and cannula housing  204  mounted to an end of the sleeve  202 . Cannula sleeve  202  defines a longitudinal axis “a” extending along the length of sleeve  202 . Sleeve  202  further defines an internal longitudinal passage dimensioned to permit passage of surgical, instrumentation. Sleeve  202  may be formed of stainless steel or other rigid materials such as a polymeric material or the like. Sleeve  202  may be clear or opaque. The diameter of sleeve  202  may vary, but typically ranges from 10 to 15 mm for use with the seal assembly  100  of the present disclosure. 
     Cannula housing  204  includes two components, specifically, housing flange  206  which is attached to the proximal end of cannula sleeve  202  and main housing  208  as shown in  FIGS. 3-4 . Main housing  208  is connectable to housing flange  206  through a bayonet coupling consisting of radially spaced tongues  210  on the exterior of housing flange  206  and corresponding recesses  212  within the interior of main housing  208 . Tongues  210  are receivable within recesses  212 . Thereafter, housing flange  206  and main housing  208  are rotated to securely lock the tongues  210  within the recesses  212 . Other conventional means, e.g., a snap fit, ultrasonic welding or any other means envisioned by one skilled in the art including, e.g., adhesive means, may be incorporated to connect housing flange  206  and main housing  208 . Main housing  208  further includes diametrically opposed housing grips  214  dimensioned and arranged for gripping engagement by the fingers of the user. Although shown and described as two components, cannula housing  204  may be a single component and attached to cannula sleeve  202  by any of the aforementioned means. 
     With reference to  FIG. 3 , in conjunction with  FIGS. 1-2 , cannula housing  204  further includes duck bill or zero closure valve  216  which tapers distally and inwardly to a sealed configuration as shown in the figure. Valve  216  opens to permit passage of the surgical instrumentation and closes in the absence of the instrumentation. Valve  216  is preferably adapted to close upon exposure to the forces exerted by the insufflation gases in the internal cavity. Other zero closure valves are also contemplated including single or multiple slit valve arrangements, trumpet valves, flapper valves, etc. 
     Referring now to  FIGS. 3-4 , in conjunction with  FIGS. 1-2 , seal assembly  100  will be discussed in detail. Seal assembly  100  includes seal housing, generally identified as reference numeral  102 , and gimbal mount  104  which is disposed within the seal housing  102 . Seal housing  102  houses the sealing components of the assembly and defines the outer valve or seal body of the seal assembly  100 . Seal housing  102  defines central seal housing axis “b” which is preferably parallel to the axis “a” of cannula sleeve  202  and, more specifically, coincident with the axis “a” of the cannula. Seal housing  102  incorporates three housing components, namely, proximal, distal and inner housing components  106 ,  108 ,  110 , respectively, which, when assembled together, form the seal housing  102 . Assembly of housing components  106 ,  108 ,  110  may be affected by any of the aforementioned connection means discussed with respect to cannula housing  204 . Further, seal housing  102  may be considered as having an upper housing portion  109  formed by components  106   108 , as shown separately in  FIGS. 10-12 , and a detachable lower housing portion formed by component  110 . 
     Proximal housing component  106  defines inner guide wall  112  and outer wall  114  disposed radially outwardly of the inner guide wall  112 . Inner guide wall  112  defines central passage  116  which is dimensioned to receive a surgical instrument and laterally confine the instrument within seal housing  102 . Inner guide wall  112  is generally cylindrical in configuration and terminates in a distal arcuate surface  118 . Outer wall  114  defines first and second annular recesses  120 ,  122  adjacent its distal end. Recesses  120 ,  122  receive corresponding structure, e.g., annular lips  124 ,  126  of distal housing component  108  to facilitate connection of the two components. As appreciated, proximal housing component  106  may also incorporate locking tabs which engage corresponding structure of distal housing component  108  upon relative rotation of the components  106 ,  108  to securely connect the components. 
     Inner housing component  110  is disposed within the interior of distal housing component  108  and securely connectable to the distal housing component  108  through a bayonet coupling. Such coupling includes radially spaced tongues  128  which depend radially inwardly to be received within correspondingly arranged grooves or recesses  130  on the exterior of inner housing component  110 . Coupling of distal and inner housing components  108 ,  110  is thereby affected through simple rotation of the components. 
     With continued reference to  FIGS. 3 and 4 , seal assembly  100  further includes skirt seal  132  mounted about the proximal end of inner housing component  110  or on the upper surface of the inner housing component (constituting a lower component) of the seal housing. Skirt seal  132  functions in minimizing the loss of insufflation gases through seal assembly  102 . Skirt seal  132  also engages gimbal mount  104  and serves to bias the gimbal mount in a proximal direction against inner guide wall  112  of proximal housing  106  as will be discussed. Skirt seal  132  is preferably fabricated from a suitable elastomeric material or the like to provide a spring-like characteristic sufficient to appropriately bias gimbal mount  104 . 
     With particular reference to  FIG. 4 , gimbal mount  104  is accommodated within an annular space  134  defined between inner and outer walls  112 ,  114  of proximal housing component  106 . Gimbal mount  104  is mounted in a manner which permits angulation of the gimbal mount  104  relative to seal axis “b”. Specifically, gimbal mount  104  is free to angulate about an axis or center of rotation “c” through a range of motion defined within the confines of annular space  134 . An annular stop  136  may extend within annular space  134 . Annular stop  136  is positioned to limit the degree of angulation of gimbal mount  104  if desired. The range of movement of gimbal mount  104  will be discussed in greater detail hereinbelow. 
     Referring now to  FIGS. 5-9 , in conjunction with  FIG. 4 , the components of gimbal mount  104  will be discussed in further detail. Gimbal mount  104  includes first and second gimbal housings  138 ,  140  and resilient seal member  142  which is mounted between the housings  138 ,  140 . In a preferred arrangement, first and second gimbal housings  138 ,  140  and seal member  142  each define a general hemispherical configuration as shown. First gimbal housing  138  is preferably seated within second gimbal housing  140  and secured to the second gimbal housing  140  through a snap fit connection or the like. Preferably, first gimbal housing  138  includes a plurality of mounting legs  144  radially spaced about the outer periphery of the housing component  134 . Legs  144  define locking surfaces  146  which extend in general transverse relation to the axis “b” of seal assembly  200 . Similarly, second gimbal housing  140  includes a plurality of corresponding locking detents  148  spaced about the interior of the housing  140 . Upon insertion of first gimbal housing  138  within second gimbal housing  140 , mounting legs  144  slide along locking detents  148  whereby upon clearing the detents  148 , locking surfaces  146  of the mounting legs  146 -securely engage the locking detents  148  to fix first gimbal housing  138  within second gimbal housing  140  and securing resilient seal member  142  between the components in sandwiched relation. As appreciated, first gimbal housing  138  may be sufficiently resilient to deflect upon insertion to permit mounting legs  144  to clear locking detents  148  and return to their initial position to engage the detents  148 . 
     As mentioned hereinabove, seal member  142  of gimbal mount  104  is secured in interposed relation between first and second gimbal housings  138 ,  140 . Seal member  142  preferably comprises a resilient center material (e.g., polyisoprene or natural rubber) with first and second layers of fabric  150 , 152  impregnated on the respective proximal and distal surfaces of the resilient center material. Fabric may be of any suitable fabric for example, a SPANDEX material containing about 20% LYCRA and about 80% NYLON available from Milliken. A suitable seal member or seal type is disclosed in commonly assigned U.S. patent application Ser. No. 09/449,368, filed Nov. 24, 1999, the contents of which are incorporated herein by reference. Seal member  142  defines central aperture  154  for sealed reception of a surgical instrument. In a preferred arrangement, first layer  150  is arranged to extend or overlap into aperture  154 . In this manner, the fabric (which is stronger relative to the resilient material) is positioned to engage the surgical instrument upon passage through aperture  154  of seal member  142  thereby protecting the resilient material defining the aperture. This advantageously minimizes the potential of piercing, penetrating or tearing of the resilient material by the instrument. Alternatively, an additional layer of fabric  151  on the proximal surface of seal member  142  may be superposed and arranged to drape within aperture  154 . Seal member  142  includes an annular depression  156  on its distal surface; i.e., within second layer  152  of fabric. Depression  156  receives ledge  158  of second gimbal housing  140  to facilitate fixation of seal member  142  between first and second gimbal housings  138 ,  140 . 
     Although seal member  142  is disclosed as an impregnated fabric arrangement, it is appreciated that other seal types may be used and still achieve the objectives of the present disclosure. Further,  FIG. 6  illustrates annular depressions  153 ,  155  which have been pressed by a molding tool into layer  153 . One or more similar depressions may be pressed into layer  150  to assist positioning of fabric during manufacture of seal member  142 . 
     With reference now to  FIGS. 10-12 , in conjunction with  FIG. 4 , gimbal mount  104  is free to move within the annular space  134  defined between inner and outer walls  112 , 114  to permit angulation of the instrument relative to the seal axis “b” while still maintaining a seal thereabout. Specifically, gimbal mount  104  is adapted for swiveling movement about a center of rotation “c” which is coincident with the axis of seal assembly  100 . In this regard, the axis of the aperture  154  of seal member  142  intersects the axis “b” of the seal assembly  100  during angulation of the instrument. During angulation, gimbal mount  104  is only in contact with seal housing  102  along distal arcuate surface  118  of proximal housing  106  as well as along skirt seal  132 . Specifically, the arcuate inner surface of first gimbal housing  138  rides along distal arcuate surface  118  of inner wall  112  in contacting relation therewith (under the bearing influence of skirt seal  132 ) to permit gimbal mount  104  to swivel within seal housing  102 . Preferably, there is no other contact of gimbal mount  104  with any of the other components of seal housing, which thereby substantially minimizes resistance to the angulating movement. A lubricant may be provided between distal arcuate surface  118  and the inner surface of first gimbal housing  138  to facilitate angulation. 
     In a preferred arrangement, gimbal mount  104  may angulate or rotate through an angle inclusive of about 25°, more preferably about 22.5° relative to seal axis “b”. Annular stop  136  may further restrict angulation by a couple of degrees of movement to be inclusive of an angle of about 19° relative to axis “b”. 
     Seal assembly  100  may be associated with, or joined to, cannula assembly  200  in a variety of ways. In a preferred embodiment, seal housing  102  of seal assembly  100  and cannula housing  204  of cannula assembly  200  are adapted to detachably engage each other, e.g., through a bayonet lock or like mechanical means. As previously discussed, proximal and distal housing components  106 ,  108  may define an upper housing component  109  which is mountable directly to cannula assembly  200 . Alternatively, inner housing portion  110  which defines a lower housing component may be directly mounted to cannula assembly  200  independent of the upper housing component  109 . Specifically, the lower housing component  110  which houses gimbal mount  104  may be mounted to cannula assembly independent of the remaining housing components. The upper housing may then be mounted to lower housing or cannula assembly  200  as needed. Even further, upper housing component  109  may be mounted to cannula assembly  200  without lower housing component  110 . Other means of joining seal assembly  100  to cannula assembly  200  will be readily apparent to one of ordinary skill in the art. 
     Referring now to  FIGS. 13-14 , use of the seal assembly  100  and cannula assembly  200  in connection with introduction of a surgical instrument will be discussed. Seal assembly  100  is mounted to cannula assembly  200  which is previously introduced into an insufflated abdominal cavity. An instrument is inserted into seal assembly  100  through passage  116  of inner cylindrical guide wall  112  in seal housing  102 . If the axis of the instrument is not perfectly aligned with the axis “a” of cannula assembly  200  or axis “b” of seal assembly  100 , then the surgical instrument will contact the inner guide wall  112  and/or the inner surface of seal member  142 . Contact with the seal member  142  can cause some deformation of the seal member  142 . The instrument slides along the surface of the gimbal mount  104  and/or the seal member  142 , to the aperture  154 . Aperture  154  stretches to accommodate the instrument diameter, as necessary. The instrument passes further distally into the cannula housing  204  passing through duckbill valve  216  and cannula sleeve  202  into the body cavity. Once the instrument is disposed within the aperture  154 , and the friction at the skirt seal  132 , gimbal mount  104  and arcuate surface  118  is overcome, gimbal mount  104  swivels with respect to seal housing  102  as the instrument is manipulated. The gimbal mount  104  is free to swivel relative to housing  102 , while allowing seal member  142  to maintain sealing engagement with the instrument passed therethrough, as well as maintaining the seal around the gimbal mount  104 . Preferably, the seal member  142  includes resilient material and fabric material which resists deformation of the aperture  154 , as well as tearing of the seal member  142 . 
     While the invention has been particularly shown, and described with reference to the preferred embodiments, it will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the invention. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.