Abstract:
Medical systems, devices and methods are disclosed for suturing a perforation in tissue, that may be employed endoscopically and/or laparoscopically, and that offer simple, reliable and controllable placement of suture around a perforation for complete closure thereof. One embodiment of the medical device generally includes an endcap for use with an endoscope to suture an opening in tissue using a tissue anchor. The endcap has a tubular shape defined by an annular sidewall, and the sidewall defines an interior space. A side port is further defined by the annular sidewall and is in communication with the interior space. The side port is sized to receive and locate the tissue within the interior space for suturing. A support rib is positioned within the interior space and distal to the side port. The support rib and sidewall define a piercing aperture therebetween that supports the tissue being sutured.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 61/109,337 filed on Oct. 29, 2008, entitled “ENDOSCOPE ENDCAP FOR SUTURING TISSUE” the entire contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to medical systems, devices and procedures for suturing tissue, and more particularly to endoscopically suturing openings in tissue. 
       BACKGROUND OF THE INVENTION 
       [0003]    Openings or perforations in the walls of internal organs and vessels may be naturally occurring, or formed intentionally or unintentionally. These openings may be used to gain access to adjacent structures of the body, such techniques being commonly referred to as transluminal procedures. For example, culdoscopy was developed over 70 years ago, and involves transvaginally accessing the peritoneal cavity by forming an opening in the cul de sac. This access to the peritoneal cavity allows medical professionals to visually inspect numerous anatomical structures, as well as perform various procedures such as biopsies or other operations, such as tubal ligation. Many transluminal procedures for gaining access to various body cavities using other bodily lumens have also been developed. Natural orifices such as the mouth, nose, ear, anus or vagina may provide access to such bodily lumens and cavities. The bodily lumen(s) of the gastrointestinal tract are often endoscopically explored and can be utilized to provide access to the peritoneal cavity and other body cavities, all in a minimally invasive manner. 
         [0004]    Compared to traditional open surgery or laparoscopic surgery, transluminal procedures are less invasive by eliminating abdominal incisions (or other exterior incisions) and incision related complications, while also reducing postoperative recovery time, reducing pain, and improving cosmetic appearance. At the same time, there remain challenges to transluminal procedures, including providing a suitable conduit to the openings and body cavities, robust medical devices that are maneuverable via the conduit and operable within the body cavity, sterility of the conduit, maintaining insufflation of the body cavity, proper closure of the opening, and prevention of infection. For example, when an opening is formed in a bodily wall of the gastrointestinal tract, such as in the stomach or intestines, spillage of the stomach contents, intestinal contents or other bodily fluids into the adjacent body cavity can occur. Travel of bacteria laden fluids outside of the gastrointestinal tract may cause unwanted and sometimes deadly infection. 
         [0005]    In order to permanently close naturally occurring, intentionally or unintentionally formed perforations and allow the tissue to properly heal, numerous medical devices and methods have been developed employing sutures, adhesives, clips, tissue anchors and the like. One such class of devices aims to endoscopically close perforations, such as those within the gastrointestinal tract. Accordingly, various medical devices have been proposed that attach to the endoscope to facilitate perforation closure. Some of these medical devices employ suction to orient the tissue for suturing or anchor placement, while others employ tissue graspers or other devices to orient the tissue. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    The present invention provides medical devices, systems and methods for suturing a perforation in tissue, that may be used endoscopically and/or laparoscopically, and that offer simple, reliable and controllable placement of sutures around a perforation for complete closure thereof. One embodiment of a medical device, constructed in accordance with the teachings of the present invention, generally includes an endcap for use with an endoscope to suture an opening in tissue using a tissue anchor. The endcap has a tubular shape defined by an annular sidewall, and the sidewall defines an interior space. A side port is further defined by the annular sidewall and is in communication with the interior space. The side port is sized to receive and locate the tissue within the interior space for suturing. A support rib is positioned within the interior space and distal to the side port. The support rib extends laterally from a first position on the sidewall to a second position on the sidewall. The support rib and sidewall define a piercing aperture therebetween which is sized to be larger than a length of the tissue anchor, allowing the anchor to freely exit the interior space via the piercing aperture and side port. 
         [0007]    According to more detailed aspects of the medical devices, the piercing aperture and the side port are located on the same lateral side of the endcap and preferably engage each other over a line. The support rib is preferably oriented longitudinally, and bisects a portion of the interior space that is distal to the side port. The endcap may also include an end wall, wherein the support rib preferably extends between the end wall and the first and second positions along the sidewall. In preferred constructions, a majority of the end wall is exposed to the endoscope permitting visualization through the end wall, and thus the endcap is preferably formed of an optical-grade plastic. The edge of the support rib defines a support surface, and together with a portion of the sidewall that is exposed by the side port, define an annular support surface for supporting the tissue during suturing. 
         [0008]    One embodiment of a medical system, constructed in accordance with the teachings of the present invention, generally includes an endoscope, a needle assembly and an endcap. The endoscope has a working channel defining a longitudinal axis. The needle assembly has a needle defining a distal end and a needle lumen. A tissue anchor is slidably received within the needle lumen, and a suture is attached to the tissue anchor. The needle assembly is slidably received within the working channel of the endoscope. The endcap has an annular sidewall defining a proximal interior space, and an intermediate interior space, and a distal interior space. The proximal interior space is sized to receive a distal end of the endoscope. The side wall defines a side port in communication with the intermediate interior space and is sized to receive the tissue therein. The endcap includes a support rib bisecting the annular sidewall and the distal interior space to define an anchor ejection portion of the distal interior space. The anchor ejection portion is sized to receive the tissue anchor therein when the tissue anchor is in a lengthwise orientation. 
         [0009]    According to more detailed aspects of the medical systems, the anchor ejection portion of the distal interior space is circumferentially aligned with the working channel of the endoscope. The anchor ejection portion of the distal interior space is in direct communication with the side port without any intervening structure therebetween. The area between the ejection portion of the distal interior space and the intermediate interior space defines a piercing aperture that is preferably sized to pass the tissue anchor therethrough in its lengthwise orientation. 
         [0010]    Methods for suturing an opening in tissue utilizing the medical devices and systems described above is also provided in accordance with the teachings of the present invention. The endcap of the medical device is fitted to the distal end of the endoscope. The endoscope and medical device are introduced to a first site proximate the opening, and the tissue is positioned within the intermediate interior space of the endcap. The needle assembly is advanced distally through the tissue and the piercing aperture. A tissue anchor is deployed into the distal interior space, and the needle assembly is retracted proximally through the tissue. The endoscope and medical device can then be moved along the periphery of the opening while the tissue remains within the intermediate interior space, whereby the tissue anchor passes directly back through the piercing aperture and exits the side port. The needle assembly is advanced distally through the tissue at a second site proximate the opening and a second tissue anchor is deployed. The free ends of the suture are tightened to close the opening. 
         [0011]    According to more detailed aspects of the methods, the free ends of the suture are pulled proximally to draw the tissue anchors closer together and close the opening. Preferably, the plurality of tissue anchors are connected to a single suture, and each tissue anchor is slidably attached to the suture. The method may thus further comprise the steps of positioning the plurality of tissue anchors around the opening and tensioning the ends of the suture to reduce the distance between the tissue anchors and compress the tissue around the opening to close the opening in a purse-string fashion. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings: 
           [0013]      FIG. 1  is a perspective view of a medical system constructed in accordance to the teachings of the present invention; 
           [0014]      FIG. 2  is an exploded view of the medical system depicted in  FIG. 1 ; 
           [0015]      FIG. 3  is a cross-sectional view of a medical device forming a portion of the medical system depicted in  FIGS. 1 and 2 ; 
           [0016]      FIG. 4  is a cross-sectional view of the medical device depicted in  FIG. 3 ; 
           [0017]      FIG. 5  is a side view of a tissue anchor forming a portion of the medical system depicted in  FIGS. 1 and 2 ; 
           [0018]      FIGS. 6-13  are views illustrating use of the medical system depicted in  FIGS. 1 and 2  to close an opening in tissue in accordance with teachings of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0019]    In the present application, the term “proximal” refers to a direction that is generally towards a physician during a medical procedure, while the term “distal” refers to a direction that is generally towards a target site within a patient&#39;s anatomy during a medical procedure. 
         [0020]    Turning now to the figures,  FIGS. 1-2  depict a medical system  20  for suturing closed a perforation  10  in tissue  12  (see, e.g.,  FIG. 6 ), constructed in accordance with the teachings of the present invention. The medical system  20  generally comprises an endoscope  22 , a needle assembly  24  and a medical device  26  adapted for use with the endoscope  22 . The endoscope  22  may be any scope known to those skilled in the art, and therefore may have various lengths, diameters and functionality. The endoscope  22  generally defines a longitudinal axis  14 , and a working channel  28  extends longitudinally through the endoscope  22 . The needle assembly  24  is received within the working channel  28 , and as best seen in  FIG. 2  includes a needle  30  with a needle lumen  32  receiving one or more tissue anchors  34  having suture  36  connected thereto. A stylet  38  or other pushing element is typically fitted within the needle lumen  32  to eject the anchors  34 , as is known in the art. Likewise, a needle sheath  40  may also be provided to shield and control exposure of the piercing distal tip  42  of the needle  30 . 
         [0021]    The medical device  24  generally includes an endcap  42  having a tubular or annular sidewall  44  defining an interior space  46  accessible via a side port  48  for suturing the tissue  12  with the needle assembly  24 . A proximal portion  46   p  of the interior space  46  is sized to receive the distal end of the endoscope  22 . The endcap  42  may be structured to frictionally engage the endoscope  22  for selective retention of the endcap  42  on the endoscope  22 , although other means for connecting the endcap  42  to the endoscope  22  may be employed, as is known in the art. The endoscope  22  and medical device  24  are therefore adapted to be traversed through the body of a patient in this connected configuration shown in the figures. 
         [0022]    Turning now to  FIGS. 3 and 4 , the medical device  26  has been shown in cross-section. The annular sidewall  44  defines an interior space  46 , portions of which include the proximal interior space  46   p,  an intermediate interior space  46   i  and a distal interior space  46   d.  Adjacent the intermediate interior space  44   i,  the sidewall  42  defines the side port  46  through which the tissue  12  enters the interior space  46 . The medical device  26  preferably also includes an endwall  50  located at the distal end of the sidewall  44 . The endwall  50  encloses the distal interior space  46   d,  and is preferably constructed of an optical-grade plastic that permits the endoscope  22  to visualize through the endcap  26 , discussed in greater detail herein. 
         [0023]    The medical device  26  also includes a support rib  52  which bisects the annular sidewall  44  in the distal interior space  46   d.  On one side of the support rib  52 , there is an anchor ejection portion  54  of the distal interior space  46   d,  which is defined by the space between the support rib  52  and sidewall  44 . The anchor ejection portion  54  of the distal interior space  46   d  is sized to receive the needle assembly  24 , and in particular the needle  30  and the tissue anchor  34 . As best seen in  FIG. 4 , the support rib  52  extends from a first position  52   a  on the sidewall to a second position  52   b  on the sidewall. Thus, the support rib  52  and sidewall  44  also define a piercing aperture  56  therebetween, which is the area where the anchor ejection portion  54  meets the intermediate interior space  46   i.  The edge  58  of the support rib  52  defines a support surface, and together with the portion of the sidewall that is exposed by the side port  48 , defines an annular support surface for supporting tissue during suturing, as will be described in further detail herein. The anchor ejection portion  54  meets the side port  48  over a line, namely the curved line of the piercing aperture  56  defined by the sidewall  44 . 
         [0024]    The piercing aperture  54  is semi-circular in shape (although it may have other shapes depending upon the tubular or annular shape of the endcap  42 ) defined by a largest diameter D 1  and a smallest diameter D 2 . Preferably the largest diameter D 1  is greater than a length L A  of the tissue anchor  34  (shown in  FIG. 5 ) while the smallest diameter D 2  is less than the length L A  of the tissue anchor  34 . This helps to orient the tissue anchor  34  within the anchor ejection portion  54  of the distal interior space  46   d.  In another embodiment, both the largest diameter D 1  and the smallest diameter D 2  may be greater than a length L A  of the tissue anchor  34 . In either case, the anchor ejection portion  54  of the distal interior space  46   d  is sized to receive the tissue anchor  34  therein while the tissue anchor  34  is in a lengthwise orientation, meaning its axis  37  extends laterally and is generally perpendicular to the longitudinal axis  14  (i.e. within about 15 degrees of perpendicular). Likewise, the tissue anchor  34  can pass through piercing aperture  56  in its lengthwise orientation. It will be recognized by those skilled in the art that the anchor ejection portion  54  of the distal interior space  46   d  is in direct and immediate communication with the side port  48  without any intervening structure therebetween, permitting easy passage of the tissue anchor  34 . 
         [0025]    The sidewall  44  preferably has a circular cross-sectional shape as shown, and the first and second positions  52   a,    52   b  on the sidewall  44  span an arc A SR  of less than about 180 degrees, although in other embodiments A SR  can be about 180 degrees. The side port  48  spans a second arc A SP  which is greater than the first arc A SR  bisected by the support rib  52 . Accordingly, and as best seen in  FIG. 4 , the edge  58  of the support rib  52  and the exposed sidewall  44  define a support surface that has a general D-shape (see, e.g., the un-hatched area shown in  FIG. 4 ). 
         [0026]    As best seen in  FIG. 3 , the support rib  52  also extends longitudinally and engages the endwall  50 . The longitudinal length of the support rib  52  positions its support surface (namely edge  58 ) proximate the longitudinal position of the side port  48 . In the depicted embodiment, the endwall  50  has a semi-spherical shape to provide an atraumatic tip to the medical system  20 , although the endwall  50  may take other shapes such as flat or conical. Notably, a majority of the endwall  50  is exposed to the endoscope  22  (see, e.g.,  FIG. 8 ) thereby permitting visualization through the endwall  50 . As such, the medical device  26 , and in particular endcap  42 , is preferably formed of an optical-grade plastic that permits visualization therethrough. Suitable plastics include but are not limited to acrylic, polyacrylates, polyacrylonitrile, polyvinylchloride, polyetherketone, and polyethylene. 
         [0027]    As shown in  FIG. 5 , the tissue anchor  34  is preferably of a form where the anchor member is slidable relative to the suture  36 . One preferred tissue anchor  34  shown in  FIG. 5 , and includes a wire loop  35  which slidably receives the suture  36 . Further details of this and other tissue anchors are disclosed in U.S. patent application Ser. No. 11/946,565 filed Nov. 25, 2007 and U.S. Pat. No. 5,123,914 issued Jun. 23, 1992, the entire contents of which are incorporated by reference herein. 
         [0028]    One preferred method for utilizing the medical system  20  and its medical device  26  will now be described with reference to  FIGS. 6-13 . As shown in  FIG. 6 , an upper portion of the gastrointestinal tract  15 , such as the esophagus  16  and stomach  17 , may be accessed via the mouth (not shown). A cutting instrument, with or without the aid of an endoscope or other visualization device, may be employed to form an opening  10  in the gastric wall or gastric tissue  12 . Wire guides, dilators and other medical devices may be employed through the opening  10  to perform a translumenal procedure. These initial steps of the method have been described for reference purposes and to give context, and, it will be recognized that the medical system  20  of the present invention may be used to endoscopically suture any tissue within the body. Likewise, the medical system  20  may be employed through any natural orifice as (e.g., the mouth, anus, vagina, ears, nose.) as well as intentionally formed orifices such as those made during laparoscopic or similar procedures. The bodily opening  10  defined by the tissue of an internal bodily lumen may be intentionally formed or may be naturally occurring, and the internal bodily lumen may comprise a portion of the gastrointestinal tract or any other internal bodily lumen, as will be recognized by those skilled in the art. 
         [0029]    The medical device  26  and its endcap  42  are fitted on the distal end of the endoscope  22  as shown in  FIGS. 1 and 6 . The medical system  20  is introduced to a position proximate the opening  10 , and the distal portion of the endcap  42  is passed through the opening  10  as shown in  FIG. 7 . As shown in  FIG. 8 , the medical system  20  is manipulated such that the tissue  12  passes through the side port  48  and is positioned within the interior space  46 , and in particular the intermediate interior space  46   i.  The visualization element  23  of the endoscope  22  is capable of visualizing the placement of the tissue  12  within the interior space  46 , and when there is no tissue  12  within the interior space  46 , it can visualize distally beyond the medical device  26  through the endwall  50  of the endcap  42 . 
         [0030]    With the medical system  20  positioned at a first site along the tissue  12  proximate the opening  10  as shown in  FIG. 8 , the needle assembly  24  and its needle  30  will be advanced distally through the working channel  28  of the endoscope  22 , through the tissue  12 , through the piercing aperture  56  and into the anchor ejection portion  54  of the distal interior space  46   d.  Notably, the proximal edge  58  of the support rib  52 , as well as the exposed portion of the sidewall  44 , support the tissue  12  as the needle  30  is advanced therethrough. At the proximal end of the medical system  20 , the stylet  38  of needle assembly  24  may be moved relative to the needle  30  to deploy the tissue anchor  34  into the anchor ejection portion  54  of the distal interior space  46   d.    
         [0031]    The needle assembly  24  may then be retracted proximally through the working channel  28  of the endoscope  22  such that it is removed from the tissue  12  while leaving the tissue anchor  34  on the distal side of the tissue  12 , as shown in  FIG. 10 . The suture  36  will pass through the tissue  12 , and one end of the suture will continue through the working channel  28  and/or the needle  30  for connection to additional tissue anchors  34  and to the proximal end of the medical system  20 . The other free end of the suture  36  will pass through the side port  48  and along the exterior of the medical system  20  to a location outside of the body, whereby both ends of the suture  36  may be manipulated by the medical professional. 
         [0032]    Due to the construction of the medical device  26  and its endcap  46 , the tissue anchor  34  is capable of moving through the anchor ejection portion  54  of the distal interior space  46  in its lengthwise orientation shown in  FIG. 10 . Likewise, the piercing aperture  56  and the side port  48  permit the tissue anchor  34  to pass directly therethrough such that the medical system  20  may be slid along the periphery of the opening  10  in the tissue  12  to a second site proximate the opening  10 . When the medical system is moved, the tissue anchor  34  will simply exit the medical device  26  via the side port  48  and remain at the first site where it was deployed. The medical system  20  need not be slid along the periphery of the opening  10 , but may also be moved laterally away from the tissue  12  so that it exits the interior space  46 , whereafter a second site may be identified and targeted for deployment of additional tissue anchors  34 . 
         [0033]    As shown in  FIG. 11 , multiple tissue anchors  34  may be deployed around the periphery of the opening  10  in the tissue  12 , while the suture  36  largely remains on the proximal side of the tissue  12 . The plurality of tissue anchors  34  may be deployed around the opening  10 , such as in a generally circular configuration, although any number and any configuration of anchor deployment may be used, such as zig-zag configurations. Both of the free ends  36   a,    36   b  of the suture  36  extend proximally through the bodily lumen and external orifice for individual manipulation by the medical professional to close the opening  10 . In particular, the ends  36   a,    36   b  may be tensioned to reduce the distance between the tissue anchors  34  and compress the tissue  12  around the opening  10  to close the opening  10  in a purse-string fashion, as shown in  FIG. 13 . A suture lock  60  may be employed to connect the ends  36   a,    36   b  of the suture  36  together and maintain the tension thereon, although the suture  36  may also be tied using knots or other techniques or devices as will be readily appreciated by those skilled in the art. Several exemplary suture locks are disclosed in U.S. patent application Ser. Nos. 12/125,525 filed May 22, 2008 and 12/191,001 filed Aug. 13, 2008, the disclosures of which are incorporated herein by reference in their entirety. 
         [0034]    It will be recognized by those skilled in the art that, while the methods described above generally include placing the tissue devices in tissue through an internal bodily lumen, it will be recognized that the systems, devices and methods may be used on any layer of material (e.g. fabrics, cloth, polymers, elastomers, plastics and rubber) that may or may not be associated with a human or animal body and a bodily lumen. For example, the systems, devices and methods can find use in laboratory and industrial settings for placing devices through one or more layers of material that may or may not find application to the human or animal body, and likewise closing holes or perforations in layers of material that are not bodily tissue. 
         [0035]    The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.