Abstract:
The present invention provides devices for safely closing an opening in tissue using suture. In one embodiment, the device includes an elongated main body constructed to permit visualization longitudinally through the main body from the proximal end to the distal end, the distal end defining a support surface to support the suture and protect distal body structures. A flange is connect to the main body adjacent the proximal end and projects laterally therefrom in first and second lateral directions. First and second guide holes extend longitudinally through the flange, and are structured to direct a suturing instrument longitudinally towards the support surface for passing the suture.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 61/739,496 filed on Dec. 19, 2012, entitled “PORT CLOSURE DEVICE” the entire contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to suturing percutaneous openings, such as openings used to access an internal organ, body cavity or bodily lumen, such as in laparoscopy or gastropexy. 
       BACKGROUND OF THE INVENTION 
       [0003]    Among the most significant advances in medical surgical techniques has been the adoption, and now-routine performance, of a variety of minimally invasive procedures. These minimally invasive procedures are distinguishable from conventional open surgical procedures in that access to a body cavity of a patient is achieved through a relatively small incision through the tissue, such as the skin and underlying fascia layers. A tubular medical device (or tubular portion of a device) may be inserted or introduced through the incision into the body cavity for carrying out a medical procedure. Laparoscopy is one such procedure and is commonly used to treat a variety of internal bodily structures. Many other types of external percutaneous connections also provide a patient or medical staff with access to an internal organ or bodily lumen. For example, semi-permanent connections are made through the skin for placement of IV lines, catheters, dialysis lines, colostomy bags in the like. Percutaneous endoscopic gastrostomy tubes, commonly known as PEG tubes, are used as a means of feeding when a person is unable to eat. Gastropexy is a procedure to suture the stomach to the skin around and access site, e.g. for longer term placement of such connection tubes. 
         [0004]    The puncture at the access site is typically closed by suturing, or by manually providing pressure on the site until clotting and/or wound sealing occurs. Suturing is more often utilized for larger punctures, whereas manual pressure is more often utilized in connection with smaller punctures. The manual method, however, can take half an hour or more, and requires the patient to remain substantially immobilized for at least that period of time while pressure is applied by medical personnel to the access site. In addition, it may be necessary for the patient to remain in the hospital for a period of time thereafter for observation. Furthermore, there may be a possibility of clot formation at the puncture site. 
         [0005]    Utilizing sutures to close the opening may have procedure variability, which may require additional time to close the vessel. When sutures are utilized to close a larger vascular access site, they typically are of the “purse-string” type. In this type of suture, a single thread is stitched to surround the access site, and then pulled tight (like a purse-string) to close the access site. Performing this suture typically requires a good deal of skill and practice on the part of the physician. It also may be difficult to perform this type of suturing in a key-hole type procedure, or in other types of surgery where there is limited access to the wound site. Damage to the underlying body structures is also a concern when suturing such openings, as is the proper suturing of the fascia layers beneath the skin. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    The present invention provides devices for safely closing an opening in tissue using sutures. In one embodiment, the device includes an elongated main body having a sidewall extending from a proximal end to a distal end and defining a longitudinal axis extending therebetween. The main body is constructed to permit visualization longitudinally through the main body from the proximal end to the distal end, the distal end defining a support surface. A flange is connect to the main body adjacent the proximal end and projects laterally therefrom in first and second lateral directions. A first wing of the flange projects in the first direction and has a first guide hole extending longitudinally therethrough, while a second wing of the flange projects in the second direction and has a second guide hole extending longitudinally therethrough. The first guide hole is structured to direct a suturing instrument longitudinally through the first guide hole towards the support surface, and the second guide hole is also structured to direct the suturing instrument longitudinally through the second guide hole towards the support surface. 
         [0007]    According to further detailed aspects, the first and second guide holes are laterally spaced away from the longitudinal axis. The sidewall defines an access opening adjacent the distal end that is structured to provide access to the support surface from an exterior of the sidewall. The support surface is positioned along the longitudinal axis, and preferably includes a longitudinally facing surface. The support surface may further include a laterally facing surface connected to the longitudinally facing surface. Optionally, the support surface may define a catch structured to engage a suture. 
         [0008]    According to still further detailed aspects, the sidewall of the main body is preferably a tubular member defining an interior space. The sidewall may include an access hole adjacent the proximal end to provide access to the interior space. The main body includes a proximal end wall closing off a proximal section of the main body, and includes a distal end wall closing off a distal section of the main body. The distal end wall is positioned proximal to the support surface. 
         [0009]    In one construction, the first wing of the flange is longitudinally spaced away from the support surface a first height, and the first guide hole is laterally spaced away from the longitudinal axis a first width, and the guide hole extends longitudinally along a first guide axis that is angled relative to the longitudinal axis such that the first guide axis intersects the longitudinal axis adjacent the support surface. Likewise, the second wing of the flange may be longitudinally spaced away from the support surface a second height, while the second guide hole is laterally spaced away from the longitudinal axis a second width, and the guide hole extends longitudinally along a second guide axis that is angled relative to the longitudinal axis such that the second guide axis intersects the longitudinal axis adjacent the support surface. In another construction, the first wing of the flange is longitudinally spaced away from the support surface a first height, and the first guide hole is laterally spaced away from the longitudinal axis a first width, wherein the first guide axis is generally parallel to the longitudinal axis to accommodate a curved suturing instrument. 
         [0010]    In another embodiment, a medical system is provided for closing an opening in tissue. The medical system includes a first elongate suturing instrument having a first operative end and a suture releasably connected thereto. An elongated main body has a sidewall extending from a proximal end to a distal end and defines a longitudinal axis extending therebetween. The main body is constructed to permit visualization longitudinally through the main body from the proximal end to the distal end, where the distal end defines a support surface. A flange is connect to the main body adjacent the proximal end and projects laterally therefrom in first and second lateral directions. A first wing of the flange projects in the first direction and has a first guide hole extending longitudinally therethrough. A second wing of the flange projects in the second direction and has a second guide hole extending longitudinally therethrough. The medical system has a first deployed configuration wherein the first suturing instrument passes longitudinally through the first guide hole and tissue such that its first operative end is located adjacent the support structure to leave the suture of a distal side of the tissue. The medical system has a second deployed configuration wherein one of the first suturing instrument and a second elongate suturing instrument having a second operative end passes longitudinally through the second guide hole and its operative end is located adjacent the support structure. 
         [0011]    In one construction, the first suturing instrument extends in a straight line, and the first guide hole extends longitudinally along a first guide axis that is angled relative to the longitudinal axis such that the first guide axis intersects the longitudinal axis adjacent the support surface. In another construction, the first guide hole is laterally spaced away from the longitudinal axis, and the first suturing instrument is curved. Here, the first guide hole extends longitudinally along a first guide axis that is generally parallel to the longitudinal axis. The guide hole may be elongated in the lateral direction, while tapering inwardly in a distal longitudinal direction. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a side view of a medical device for closing and opening in tissue; 
           [0013]      FIG. 2  is a cross-sectional view of the device shown in  FIG. 1 , taken from the side; 
           [0014]      FIG. 3  is front view of the device of  FIG. 1 ; 
           [0015]      FIG. 4  is a top view of the device of  FIG. 1 ; 
           [0016]      FIG. 5  is a cross-sectional view of the device of  FIG. 1 , taken from the front and showing the device applied to the opening in the tissue; 
           [0017]      FIG. 6  is a front view of a medical system employing the medical device of  FIG. 1 , and depicting operation thereof; 
           [0018]      FIG. 7  is a front view of a medical system depicted in  FIG. 6 , showing further operation thereof; 
           [0019]      FIG. 8  is an enlarged side view of the area denoted by the circle  8  in  FIG. 7 ; 
           [0020]      FIGS. 9-12  are front views of the medical system of  FIG. 6  showing further operation thereof; 
           [0021]      FIGS. 13 and 14  are side views of the medical system depicted in  FIG. 6 , showing further operation thereof; 
           [0022]      FIG. 15  is a front view of an alternate embodiment of the medical system of  FIG. 6 ; and 
           [0023]      FIG. 16  is a top view, partially cut-away, of the medical device forming a portion of the medical system of  FIG. 15 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    The terms “proximal” and “distal” as used herein are intended to have a reference point relative to the user. Specifically, throughout the specification, the terms “distal” and “distally” shall denote a position, direction, or orientation that is generally away from the user and towards a target site, and the terms “proximal” and “proximally” shall denote a position, direction, or orientation that is generally towards the user and away from a target site. Thus, “proximal” and “distal” directions, portions of a device, or bodily regions, may depend on the point of entry for the procedure (e.g., percutaneously or laparoscopically or endoscopically). 
         [0025]    Turning now to the figures,  FIGS. 1-3  depict a medical device  30  for closing an opening in tissue  12  ( FIG. 5 ). The medical device  30  generally includes an elongated main body  32  defined by a side wall  34 , which in the depicted embodiment is tubular and defines an interior space  36 . The main body  32  and side wall  34  extend from a proximal end  38  to a distal end  40  and define a longitudinal axis L extending therebetween. As best seen in  FIG. 2 , the main body  32  further includes a proximal end wall  42  and a distal end wall  44  to enclose the interior space  36 . 
         [0026]    Preferably the medical device  30  is manufactured using injection molding and high density polyethylene or other hard plastic. In particular, the material is preferably a clear plastic to permit visualization longitudinally through the main body  32  from the proximal end  38  to the distal end  40 . However, it will also be recognized that only the proximal end wall  42  and distal end wall  44  may be formed of a clear material, such as another clear plastic or optical glass (which can be magnifying) to enclose the interior space  36  while permitting visualization therethrough. The side wall  34  preferably has a circular cross-section that slightly narrows as it extends distally, and preferably has an average outer diameter of about 2 cm. The flange preferably has a longitudinal thickness of about 5 mm. The proximal end wall  42  preferably has a diameter of about 1.5 cm. The side wall  34  preferably has a thickness of about 0.25 cm. 
         [0027]    The main body  32  also defines a support surface  46  at a location distally beyond the distal end wall  44 . Generally, the support surface faces longitudinally and is used to support suturing while protecting body structures located distal to the medical device  30 . The side wall  34  extends distally beyond the distal end wall  44  and is connected to the support surface  46 . In particular, the side wall  34  includes an access opening  48  distal to the distal end wall  44  which provides access to the support surface  46  from the exterior of the device  30 . In particular, the access opening  48  extends from a front of the device  30  around to opposing lateral sides such that the support surface  46  may be accessed from two opposing lateral sides of the device  30 . The remaining portion  50  of the side wall  34  generally forms an L-shape with the support surface  46  as best seen in  FIGS. 1 and 2 . A portion of the lateral sides may also remain as shown in the figures (e.g. about 180 to 250 degrees of the side wall  34  may be removed to form the opening  48 ). 
         [0028]    The medical device  30  also includes a flange  52  which extends in laterally opposite directions away from the longitudinal axis L and away from the main body  32 , and defines a transverse axis T. The lateral length of the flange  52  is preferably about 1 cm to 10 cm. A first wing  54  of the flange  52  defines a first guide hole  56  that extends longitudinally therethrough, and similarly a second wing  58  of the flange (projecting in a laterally opposite direction from the first wing  54 ) defines a second guide hole  60  extending longitudinally therethrough. The first guide hole  56  is spaced a first width w 1  away from the longitudinal axis L and is angled relative to the longitudinal axis L. As shown in  FIG. 3 , the first guide hole  56  extends along a guide hole axis GH 1  that is angled relative to the transverse axis T by an angle α 1 . Likewise, the second guide hole  60  extends along a guide hole axis GH 2  that is angled relative to the transverse axis T by an angle α 2 . The dimensions of w 1 , w 2 , α 1 , α 2  are selected such that the guide hole axis GH 1  and GH 2  intersect the longitudinal axis L at a point near the support surface  46 . As will be described further hereinbelow, this structure allows suturing needles or other suturing instruments to be placed through the guide holes  56 ,  60  and guided to the support surface  46  where the suture can be exchanged while the underlying body structures are protected. 
         [0029]    As also seen in  FIG. 3 , a first height h 1  depicts a typical height (also referred to as depth) of the skin and tissue being sutured (see, e.g., tissue  12  in  FIG. 5 ). This height has been shown to the transverse axis T, although the tissue will generally contact the distal surface of the flange  52  and thus h 1  can also refer to this distance. At the same time, the tissue may become slightly compressed when employing the device  30  and thus h 1  may be selected according to a known range of variation. A second height h 2  refers to the remaining length of the medical device  30 , and is generally the distance between the support surface  46  and the distal side (or interior side) of the tissue. A height h 3  refers to the longitudinal height of the openings  48  formed in the side wall  34  of the main body  32  which provides access to the support surface  46  from the lateral sides of the main body  32 . 
         [0030]    The lateral location of the first and second guide holes  56 ,  60  (w 1 , w 2 ) and the height of the access opening  48  (h 3 ) are selected such that the guide hole axes (GH 1  and GH 2 ) define a clear path to the support surface  46 . The free depth (h 2 ) of the main body  32  (i.e. the depth below the tissue) is selected to be sufficiently long so that the path the needle makes through the tissue (generally defined here as GH 1  and GH 2 ) extends entirely through the tissue and does not pass radially through the already formed opening  14  in the tissue  12  (see  FIG. 4 ). Preferably, the height h 2  is selected to be about equal to (i.e. within 15%) the height h 1  to achieve the foregoing. Preferably, the combined height h 1 +h 2  is in the range of about 10 to 30 cm. That is, the medical device  30  may come in various sized for different types (thicknesses) of tissue, for example 10 cm, 15 cm, 20 cm, 25 cm in total height. As such, the lateral spacing (w 1 , w 2 ) of the first and second guide holes  56 ,  60  is accordingly adjusted. The angles α 1 , α 2  may likewise be adjusted for each size device but preferably remains in a range of about 15 to 45 degrees. 
         [0031]    As shown in the top view of  FIG. 4 , the flange  52  generally defines first and second guide holes  56 ,  60  spaced laterally away from the main body  32 . The proximal end wall  42  provides visualization straight through the device  30 , and in particular down to the support surface  46  where the guide axes GH 1  and GH 2  intersect each other and the longitudinal axis L. The proximal end wall  42  may further include a magnifying element  62  which provides enhanced viewing of the suture passing that will be taking place at the support surface  46 . Similarly, as shown in  FIG. 5 , the main body  30  and its side wall  32  may further define a visualization port  64  at or proximal to the flange  52  which provides access to the interior space  36 . In particular, a visualization element  10  (such as a small scope or fiber-optic visualization device) may be inserted through the hole  64  to get closer to and more clearly visualize the distal end  44  of the medical device  30 . As can also be seen in  FIG. 5 , the side wall  34 , proximal end wall  42  and distal end wall  44  generally create a seal with the tissue  12  in its opening  14  such that fluids or gases cannot pass through the opening  14 . At the same time, the flange  52  controls the medical device  30  relative to the tissue  12 , and its guide holes  56 ,  60  can guide a suturing instrument through the tissue  12  and distally to the support surface  46  located below the tissue  12  for exchange of sutures, anchors or other tissue closing devices. 
         [0032]    Operation of the medical system  20  and the medical device  30  will now be described with reference to  FIGS. 6-14 . As shown in  FIG. 6 , the medical device  30  is placed within the opening  14  in the tissue  12  such that the flange  52  abuts a proximal surface of the tissue  12  and the main body  32  extends through the opening  14  such that its distal end  40  is positioned distally beyond the tissue  12 . In addition to the medical device  30 , the medical system  20  includes a suturing element which has been depicted in the figures as a suturing needle  80 . The needle  80  carries a suture  82  at its distal (operative) end, e.g. using a slot, hole or simply having the suture  82  running though the needle  80 . The needle  80  is passed distally through the first guide hole  56  such that it pierces the tissue  12  as shown in  FIG. 6 . 
         [0033]    As shown in  FIG. 7 , the needle  80  continues to move distally through the tissue  12  and along the exterior of the main body  32  of the medical device  30 . The needle  80  continues to be moved until it passes through the access opening  48  in the side wall  34 , and preferably until it reaches the support surface  46 . At this point, the suture  82  may be held in place while the needle  80  is moved proximally to leave the suture  82  at the distal end  40  of the medical device  30 , e.g. laying on the support surface  46 . 
         [0034]    Preferably, the medical device  30  and its support surface  46  may further include a suture catch  70  designed to facilitate engagement of the suture  82  with the support surface  46 . As best seen in the enlarged view of  FIG. 8 , the suture catch  70  may simply include an L-shaped tab comprising a longitudinal leg  72  and a lateral leg  74 . Many variations of the catch  70  will be readily apparent to the skilled artisan. For example, the catch  70  may simply include the longitudinal leg  72  with an optional slot or slit formed therein. Likewise magnetic elements may be utilized in conjunction with a magnetic element on the distal end of the suture  82 . 
         [0035]    Turning now to  FIG. 9 , the needle  80  is moved proximally such that it passes again back through the tissue  12  and first guide hole  56  while the suture  82  remains at the distal end  40  of the medical device, preferably engaged with the support surface  46  and/or its catch  70 . As shown in  FIG. 10 , the needle  80 , or a second suturing instrument (such as a second needle  90 ) is passed through the second guide hole  60  in the flange  52  of the medical device  30 . The second guide hole  60  directs the needle  80 ,  90  through the tissue  12  and along the exterior of the main body  32  until it reaches the access opening  48  at the distal end  40  of the medical device  30 . While  FIGS. 9 and 10  depict the first needle  80  being withdrawn proximally, it will be recognized that the first needle  80  could be left in the position shown in  FIG. 7  while the second needle  90  is passed through the second guide hole  60 . In such a case, the suture  82  may be passed directly from the first needle  80  to the second needle  90 . 
         [0036]    As shown in  FIG. 11 , the first and second needle  80 ,  90  is moved distally until it reaches the support surface  46  (and/or catch  70  if present) and is used to engage the suture  82 . Again, the distal end of the needle  80 ,  90  preferably has structure for engaging the suture  82 , although a snare or other grasping device may be used in conjunction with the needle  80 ,  90  and used to grasp the suture  82 . As shown in  FIG. 12 , the needle  80 ,  90  is used to engage the suture  82  and pull it proximally back through the tissue  12  and second guide hole  60  until it is located proximal to the flange  52  for manipulation by the medical professional. 
         [0037]    Turning now to  FIGS. 13 and 14 , the medical device  30  has been shown from the side, and still placed within the opening  14  and the tissue  12 , and with the suture  82  extending distally through the tissue and looping back proximally again to the tissue at a second location opposite the opening  14  in the tissue  12 . The medical device  30  may then be manipulated, such as by grasping the proximal end  38  and rotating it such that the suture  82  is released from the catch  70  or is otherwise moved through the access opening  48  in the main body  32 . Typically this rotation will be about a transvers axis such the axis T shown, although it may also include rotation about the longitudinal axis L and/or twisting and rocking. The medical device  30  may then be moved proximally back through the opening  14  and the suture  82  to be manipulated to close the opening  14  in the tissue  12 . 
         [0038]      FIGS. 15 and 16  show an alternate embodiment of the medical system  120  and medical device  130 . The medical system  120  and device  130  are substantially similar to the previous embodiment, and similar reference numerals (but in the hundreds) have been used, and only the notable differences will be discussed herein. In this embodiment, the suturing instrument  180  (or instruments) are curved, such as a curved needle. Other suturing instruments that are capable of bending, such as a bendable trocar or piercing catheter, may likewise be used. The first and second guide holes  156 ,  160  are similarly adapted for use with a curved suturing instrument  180 . In particular, the first and second guide holes  156 ,  160  are preferably aligned to extend longitudinally parallel to the longitudinal axis L. Further, the guide holes preferably narrow or taper in the distal direction. As best seen in the top view of  FIG. 16 , (only the first guide hole  156  being shown) the guide holes  156 ,  160  are preferably elongated in a lateral direction. Stated another way, the guide holes  156 ,  160  have a larger lateral width at their proximal end which reduces in size as the holes move distally through the flange  152 . This structure promotes placement of the curved needle  180  through the guide holes  156 ,  160  in a manner such that the curvature is concavely facing the main body  132 , which assists the user in placing the needle  180  through the guide holes  156 ,  160  such that the needle extends distally through the tissue  12  and curves laterally inwardly towards the longitudinal axis L. That is, such that the curved needle  180  passes through access opening  148  and crosses the longitudinal axis L at or near the support surface  146 . It will also be recognized that in this embodiment the first and second guide holes  156 ,  160  may be placed laterally closer to the main body  132  while still insuring that the needle  180  passes fully through the tissue  12  without passing through a lateral surface of the opening  14  formed in the tissue  12 . 
         [0039]    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.