Abstract:
The present disclosure relates to devices for introducing a port within a body cavity. The system includes a compressible port that collapses radially for positioning into an introducer that is inserted into an incision. Methods for using the devices are also described.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/238,228 filed on Aug. 31, 2009, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates generally to a port assembly for use in minimally invasive surgical procedures, such as endoscopic or laparoscopic type procedures, and more particularly to a device and a method for introducing an instrument within a body cavity. 
         [0004]    2. Background of Related Art 
         [0005]    Minimally invasive procedures are continually increasing in number and variation. In particular, certain techniques involve a surgeon operating through a single entry point, typically a patient&#39;s navel by providing a device that permits multiple instrument access through a single incision. These procedures are similar to other laparoscopic surgeries in that the patient is under general anesthesia, insufflated, and laparoscopic visualization is utilized. Since the procedure is performed through the navel, patients benefit from less post-operative pain, fewer complications, and better cosmetic results than is achievable from a traditional multi-port laparoscopic procedure. 
         [0006]    Once an incision is made in a patient&#39;s skin, typically inferior to the patient&#39;s umbilicus, the patient is typically prepared for laparoscopic surgery using the Kelly clamp method. The Kelly clamp method involves spreading, separating, and dividing subcutaneous tissue, i.e., dissection. A surgeon&#39;s ability to properly place an access device that provides multiple instrument access through a single incision may be complicated due to the limited length of the Kelly&#39;s clamp&#39;s arm and handle. Furthermore, since the device is held in the palm of a surgeon&#39;s hand, sufficient visibility may not be possible without overly dilating the incision thereby compromising the seal. Improper loading of the Kelly clamp may result in the clamp&#39;s tips, typically formed from metal, coining into unintentional contact with the surgical area resulting in injury. Removal of the Kelly clamp after installation of the port may also present similar challenges. 
       SUMMARY 
       [0007]    Disclosed herein are devices and methods for introducing a port within a body cavity. 
         [0008]    In an embodiment, a method of introducing a port within a body cavity is disclosed including the steps of placing a compressible port into a membrane, the membrane connected to a substantially rigid rod positioned within a lumen of the compressible port; advancing the port into a body cavity by moving the rod axially through the lumen compressing the compressible port into the body cavity, and once the compressible port is in place, removing the rod through the lumen, thereby removing the membrane and leaving the compressible port within the body cavity. The depth of advancement of the rigid tube within the body cavity may be determined and controlled by utilizing tactile feedback features on the rigid tube. The rod may be adapted to advance incrementally through the introducer. The introducer may include a slot adapted to receive an insufflation valve stern. 
         [0009]    In another embodiment, a method of introducing a port within a body cavity is disclosed including the steps of placing a compressible port into a membrane, pulling the membrane into a substantially rigid tube, thereby compressing the compressible port and advancing the compressible port into a body cavity, and removing the membrane from the rigid tube while leaving the port within the body cavity. 
         [0010]    In still another embodiment, a method of introducing a port within a body cavity is disclosed including the steps of enclosing a compressible port within a vacuum bag, reducing a pressure within the vacuum bag, thereby compressing the compressible port, pulling the bag through a rigid tube inserted into a body cavity, and removing the vacuum bag while leaving the compressible port within the body cavity. 
         [0011]    In a further embodiment, a method of introducing a port within a body cavity is disclosed including the steps of enclosing a compressible port within a vacuum bag, reducing a pressure within the vacuum bag relative to a pressure outside of the bag, thereby compressing the compressible port, pulling the vacuum bag containing the compressible port through a rigid tube inserted into a body cavity, and removing the vacuum bag while leaving the compressible port within the body cavity. 
         [0012]    In an embodiment, a system for introducing a port within a body cavity is disclosed including a compressible port, an introducer that is substantially rigid, and a rod positioned within a lumen of the compressible port and attached to a membrane attached to a distal end of the rod, wherein the compressible port is coupled to the membrane and adapted to compress and radially collapse into the introducer upon displacing the rod axially through the introducer. 
         [0013]    In another embodiment, a system for introducing a port within a body cavity includes an introducer having a proximal end and a distal end, the proximal end having a wider diameter than the distal end, and a compressible port coupled to a membrane, the membrane adapted to pass through the introducer from the proximal end to the distal end and to pass over an exterior of the introducer upon exiting the distal end. The system may have the proximal end of the introducer configured and dimensioned to be recognizable through tactile feedback, thereby allowing a clinician to position the introducer within a body cavity. 
         [0014]    In a further embodiment, a system for introducing a port within a body cavity includes an introducer configured and dimensioned to receive a compressible port housed within a vacuum bag, the vacuum bag adapted to create a pressure differential between an interior of the vacuum bag relative to an exterior of the vacuum bag, thereby compressing the compressible port upon reduction of the pressure in the interior of the vacuum bag. The vacuum bag may be adapted to be removed from the introducer after placement of the compressible port within a body cavity. 
         [0015]    In a still further embodiment, a system for introducing a port within a body cavity includes placing a distal end of the compressible port within a heat sensitive membrane such that the distal end is compressed upon the application of heat to the heat sensitive membrane. Compression of the distal end of the compressible port facilitates placement of the compressible port within the incision of the patient. Upon satisfactory placement of the compressible port, the membrane may be removed from the surgical site by opening the membrane along a perforation made along a side of the membrane. 
         [0016]    The various aspects of the present disclosure will be more readily understood from the following detailed description when read in conjunction with the appended figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Embodiments of the disclosure will be described with reference to the accompanying drawings in which: 
           [0018]      FIG. 1  is an isometric view of an introducer; 
           [0019]      FIG. 2  is an isometric view of a compressible port; 
           [0020]      FIG. 3  is an embodiment of a port introducer in accordance with the present disclosure; 
           [0021]      FIG. 4A  is another embodiment of a port introducer in accordance with the present disclosure shown in a first state; 
           [0022]      FIG. 4B  is the port introducer of  FIG. 4A  shown in a second state; 
           [0023]      FIG. 5  is yet another embodiment of a port introducer in accordance with the present disclosure; 
           [0024]      FIG. 6A  is a still further embodiment of a port introducer in accordance with the present disclosure shown in a first state; and 
           [0025]      FIG. 6B  is the port introducer of  FIG. 6A  shown in a second state. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Particular embodiments of the present disclosure will be described herein with reference to the accompanying figures. In the following description, well known functions or constructions are not described in detail to avoid obscuring the present disclosures with unnecessary detail. As shown in the figures and as described throughout the following descriptions, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the device that is closer to the user and the term “distal” refers to the end of the apparatus that is farther from the user. 
         [0027]    An introducer  12  ( FIG. 1 ) is configured and dimensioned to receive a compressible port  10  ( FIG. 2 ), that is formed from a compliant material and has a plurality of throughholes  17  and optionally an insufflation valve stem  20  within one of the throughholes  17 , within the compressible port  10 . The introducer  12  has a funnel shape to facilitate the translation of the compressible port  10  from a larger opening  22  to a smaller opening  23 . The larger opening  22  may be tapered. A slot  19  may be formed along a side of the introducer  12  to accommodate the insufflation valve stem  20  therethrough. Tactile and/or visual indicators placed on the introducer  12  may assist a clinician in determining the relative position of the compressible port  10  therein. Such indicators may include an indicator line  18   a  or a bump  18   b.    
         [0028]    A port introducer  100  and a method of use will now be described with reference to  FIG. 3 . The port introducer  100  includes a vacuum bag  11  adapted to receive the compressible port  10  therein. The vacuum bag  11  includes a valve  16  and a stress concentration line  21  that can be used to separate the vacuum bag  11  by pulling a tab  21   a.    
         [0029]    By drawing air out of the vacuum bag  11  through the valve  16 , the volume of the vacuum bag is reduced which in turn causes a corresponding reduction in size of the compressible port  10  placed within the vacuum bag  11 . Once the volume of the vacuum bag  11  containing the compressible port  10  therein has been reduced in size, the vacuum bag  11  may be placed into an introducer, such as introducer  12  described above, that has been placed within an incision made within a patient. To assist in determining the relative position of the compressible port  10  within the vacuum bag  11  and within the incision, the vacuum bag  11  may be formed from a transparent material. Once the compressible port  10  is positioned as desired, the vacuum bag  11  may be removed from the surgical site by pulling the tab  21   a  thereby opening the vacuum bag  11  along the stress concentration line  21  while leaving the compressible port  10  within the incision. The compressible port  10  expands to substantially approximate the shape and size of the incision. 
         [0030]    Another embodiment of a port introducer will now be described with reference to  FIGS. 4A and 4B . A port introducer  200  includes a membrane  13  adapted to grasp the compressible port  10  therein. The membrane  13  has a generally tubular shape and is formed from a flexible material and is configured and adapted to be placed in the introducer  12 . As shown in  FIG. 4A , the compressible port  10  may be stored within the introducer  12  in an uncompressed state prior to use. 
         [0031]    Deployment of the compressible port  10  is achieved by placing the introducer  12  containing the membrane  13  having the compressible port  10  placed therein within the incision of the patient. The compressible port  10  may be incrementally advanced through the introducer  12  and into the incision by pulling on a distal portion  13   a  of the membrane  13 , as seen in  FIG. 4B . 
         [0032]    In yet another embodiment, a port introducer  300  will now be described with reference to  FIG. 5 . As seen in  FIG. 5 , a rod R is placed within one of the throughholes  17  of the compressible port  10 . A membrane  14  adapted to grip the compressible port  10  therein is coupled to the rod R such that advancement of the rod R will result in translation of the compressible port  10 . The membrane  14  may be coupled to the rod R at a distal point  25  of the rod R. The port introducer  300  may be placed within the introducer  12  and advanced through the introducer  12  and into the patient&#39;s incision by pushing on the rod R. Once the compressible port  10  is positioned as desired with the incision of the patient, the rod R may be removed through the throughhole  17  thereby removing the rod R along with the membrane  14  from the surgical site. 
         [0033]    In a still further embodiment, a port introducer  400  including a membrane  40  will now be described with reference to  FIGS. 6A and 6B . The membrane  40  has a generally tubular shape and is adapted to shrink in response to the application of heat. The membrane  40  includes a perforation  41  along a side of the membrane  40 . 
         [0034]    By placing the membrane  40  around a distal portion  10   a  of the compressible port  10 , the distal portion  10   a  can be compressed through the application of heat to the membrane  40 . Upon the application of heat to the membrane  40 , the membrane  40  compresses the distal portion  10   a  to facilitate placement of the compressible port  10  within the incision of the patient, optionally by translating the compressible port  10  through the introducer  12 . Once the compressible port  10  is in a desired position within the incision, the membrane  40  can be removed by opening the membrane  40  along the perforation  41  allowing the membrane to be removed from the surgical site. Membrane  40  will reduce in size in the radial and axial dimension. 
         [0035]    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 particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.