Abstract:
The present invention provides suture retention devices for retaining a suture on a bodily wall, e.g. for affixing the suture to the skin such as during the creation of an external percutaneous fluidic connection. In one embodiment, a device includes a base member and a swivel member. In another embodiment, the device includes a base member, first and second jaws, and a key. Operation of the swivel member or key serves to lock the suture to the device, and hence maintain tension on the suture while affixed to the skin.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. application Ser. No. 14/103,323 filed on Dec. 11, 2013, and claims the benefit of U.S. Provisional Application Ser. No. 61/736,205 filed on Dec. 12, 2012, entitled “SUTURE RETENTION MECHANISM,” the entire contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to external percutaneous connections to an internal organ or bodily lumen, and more particularly to a retention mechanism for sutures used in such external percutaneous connections. 
       BACKGROUND OF THE INVENTION 
       [0003]    Many types of external percutaneous connections form to 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. PEG tubes are typically inserted through a small incision in the abdomen into the stomach. These tubes may be sutured in place, or large support bolsters having adhesive pad are used to anchor the tube in place such that a portion extends into the stomach, and an opposing portion extends out of the stomach and through the skin for external access. Sutures are often utilized to affix the stomach to the abdominal wall, e.g. prior to placing a gastric tube, in a procedure known as gastropexy. The suture or sutures are used to pull the stomach adjacent the abdominal wall, and then tied (sewn to the skin) to maintain the relative positioning while the tube is placed. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    The present invention provides suture retention devices for retaining a suture on a bodily wall, e.g. for affixing the suture to the skin such as during the creation of an external percutaneous fluidic connection. In one embodiment, a device includes a base member and a swivel member. The base member has an upper surface, a lower surface, and a bore extending from the upper surface to the lower surface. The bore defines a bore surface that includes a base jaw surface. The swivel member is rotatably attached to the base member for rotation between an open position and a closed position relative to the base member. The swivel member includes a swivel jaw surface in communication with the bore. The swivel jaw surface is engaged with the base jaw surface in the closed position such that a suture passing through the bore is fixed to the device. The swivel jaw surface is disengaged from the base jaw surface in the open position such that the suture is not fixed to the device. 
         [0005]    According to further detailed aspects, the base member defines a recess in communication with the bore, the recess receiving the swivel member. The recess in the base member receives the swivel member in the closed position such that the base member and swivel member together have a disc shape. The recess preferably opens to the upper surface of the base member. The base member includes a side surface extending from the upper surface to the lower surface, and the recess may also open to the side surface. 
         [0006]    According to still further detailed aspects, the device may also include a lock selectively fixing the swivel member to the base member. The lock may include a flexible tab formed on the swivel member and corresponding aperture formed in the base member. The swivel jaw surface and the base jaw surface each preferably include a series of teeth sized and structured to mesh in the closed position to fix the suture to the device. The swivel jaw surface moves towards the upper surface as the swivel jaw moves from the open position to the closed position. The swivel jaw surface selectively engages the base jaw surface as the swivel jaw approaches the closed position to draw the suture towards the upper surface. 
         [0007]    In another embodiment, the device includes a base member, first and second jaws, and a key. The base member has an upper surface, a lower surface, and a bore extending from the upper surface to the lower surface. The base member also includes an internal recess in communication with the bore. The first jaw defines a first jaw surface and a second jaw defines a second jaw surface. The first and second jaws are positioned within the internal recess of the base member and are positioned to engage a suture passing through the bore. At least one of the jaws is slidably mounted within the recess and preferably is biased towards the other jaw. The key is selectively attachable to the base member, and the device includes an unlocked configuration where the key is attached to the base member and extends through the bore and into the recess between the first and second jaws to space the first and second jaw surfaces apart from one another. The device also includes a locked configuration where the key is detached from the base member and removed from the recess such that the first and second jaws surfaces engage the suture passing through the bore to fix the position of the suture relative to the base member. 
         [0008]    According to further detailed aspects, the key includes a passageway extending therethrough that receives the suture. The key includes a key body and a locking tab projecting transversely to the key body, and the upper portion of the bore has an asymmetrical opening sized to permit passage of the key therethrough only when the key has a prescribed rotational position that aligns the locking tab relative to the asymmetrical opening. The key includes a handle sized larger than the asymmetrical opening such that the handle cannot pass through the upper portion of the bore. 
         [0009]    According to still further detailed aspects, the first jaw is preferably biased by a spring positioned between the first jaw and a side surface of the base member. The base member may include a rod extending between opposing side surfaces of the base member, and the first jaw is the one jaw slidably mounted within the recess includes an aperture that slidably receives the rod. The second jaw may also be slidably mounted within the recess and includes an aperture that slidably receives the rod. Preferably, the base member includes a pair of spaced apart rods extending between opposing side surfaces of the base member, and the first and/or second jaw includes a pair of apertures that slidably receives the rods. The first and second jaw surfaces are preferably defined by first and second sets of elongated serrations sized and structured to mesh to define a tortuous engagement surface. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a plan view of an embodiment of a device for retaining a suture on a bodily wall; 
           [0011]      FIG. 2  is a plan view of a base member forming part of the device of  FIG. 1 ; 
           [0012]      FIG. 3  is a plan view of swivel member forming a portion of the device of  FIG. 1 ; 
           [0013]      FIG. 4  is a side view of the swivel member shown in  FIG. 3 ; 
           [0014]      FIG. 5  is a cross-sectional view of the device of  FIG. 1 ; 
           [0015]      FIG. 6  is a plan view of the device of  FIG. 1  shown in an open configuration; 
           [0016]      FIG. 7  is a cross-sectional view of the device as shown in  FIG. 6 ; 
           [0017]      FIG. 8  is a plan view of another embodiment of a device for retaining a suture on a bodily wall; 
           [0018]      FIG. 9  is a plan view of a base member forming a portion of the device of  FIG. 8 ; 
           [0019]      FIG. 10  is a plan view of jaw members forming a portion of the device of  FIG. 8 ; 
           [0020]      FIG. 11  is a plan view of top wall forming a portion of the base member depicted in  FIG. 9 ; 
           [0021]      FIG. 12  is a plan view of a key forming a portion of the device of  FIG. 8 ; 
           [0022]      FIG. 13  is a cross-sectional view of the device depicted in  FIG. 8 ; 
           [0023]      FIG. 14  is a plan view of the device of  FIG. 8  shown in a partially closed configuration; 
           [0024]      FIG. 15  is a cross-sectional view of the device shown in  FIG. 14 ; and 
           [0025]      FIG. 16  is a cross-sectional view of the device of  FIG. 8  showing a closed configuration. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    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). 
         [0027]    Turning now to the figures,  FIGS. 1-7  depict an embodiment of a device  20  for retaining a suture  100  ( FIG. 5 ) on a bodily wall, such as in gastropexy. As seen in  FIG. 1 , the device  20  generally comprises a base member  30  and swivel member  60 . As will be described further herein below, the swivel member  60  is rotatably attached to the base member  30  for rotation between open and closed configurations to fix the suture  100 . Generally, the device  20  and the base member  30  include an upper surface  32  and a lower surface  34 . The lower surface  34  is intended to rest against the bodily wall (such as the abdomen) while a suture  100  (which is typically fixed to another bodily wall or structure such as the stomach wall using an anchor) passes through a bore  36  from the lower surface  34  to the upper surface  32  where it can be manipulated by the operator such as a medical professional. 
         [0028]    As best seen in  FIG. 2 , the base member  30  generally comprises an upper base portion  30   a  and lower base portion  30   b.  The upper base member portion  30   a  is generally C-shaped or U-shaped, while the lower base member portion  30   b  is generally ringed-shaped (e.g, annular). The upper and lower base member portions  30   a,    30   b  may be integrally and unitarily formed such as in a molding process, or alternatively they may be separately formed and attached together by adhesives, welding or bonding techniques known to the skilled artisan. Preferably the device  30  is formed of a plastic material suitable for being maintained against a bodily wall of a mammalian patient, such as polytetrafluorethylene (PTFE), expanded polytetrafluorethylene (EPTFE), polyethylene ether keytone (PEEK), polyvinylchloride (PVC), polycarbonate (PC), polyamide including Nylon(™), polyimide, polyurethane, polyethylene (high, medium or low density), and elastomers such as Santoprene(™), although suitable ceramics or metals or combinations of any of the foregoing may be employed. 
         [0029]    The bore  36  extending through the base member  30  defines a bore surface, which as shown is formed by a lower bore surface  38  defined in the lower base member portion  30   b,  and an upper bore surface  40  defined by the upper base member portion  30   a.  The upper bore surface  40  defines a base jaw surface  42  which is formed by a plurality of elongated teeth  44  that generally have a triangular cross-section, and are arranged in a vertical series as shown in  FIG. 2 . The base member  30 , and in particular the upper base member portion  30   a,  defines a recess  46  in communication with the bore  36 , and which is sized to receive the swivel member  60 . That is, the recess  46  leaves two flanges  48  in the upper base member portion  30   a  that help define the C-shape or U-shape. The flanges  48  define apertures  50  sized to receive pins  68  ( FIG. 3 ) from the swivel member  60  for providing the pivotal attachment and rotation of the swivel member  60  relative to the base member  30 . 
         [0030]    It can also be seen in  FIG. 2  that the recess  46  and the shape of the upper base member portion  30   a  leaves an upper surface  52  of the lower base member portion  30   b  exposed. In turn, this surface  52  defines an aperture  54  which has a general L-shape (best seen in  FIG. 5 ) and which is used to form a portion of a lock to selectively fix the swivel member  60  to the base member  30 . 
         [0031]    Turning now to  FIG. 3 , the swivel member  60  is generally T-shaped to correspond with the recess  46  in the base member  30 . The T-shape is generally defined by a cross portion  60   a  and a stem portion  60   b.  The swivel member  60  generally has an upper surface  62 , a lower surface  64 , and a side surface  66 . The upper surface  62  is designed to be flush with the upper surface  32  of the base member  30  when the device is in its closed configuration. Likewise, the side surface  66  is design to match the generally annular side surface of the base member  30 , such that the device  20  has a general disc shape when the device  20  is in its closed position (see  FIG. 1 ). As used herein, disc shape refers to a shape that is has a diameter or width that is larger than a thickness or height, such as a plate or other flat object. Although a round disc shape is shown, the device may have a polygonal disc shape such as square. 
         [0032]    The stem portion  60   b  of the swivel member  60  includes two pins  68  projecting laterally therefrom, and which are sized and positioned to be placed through the apertures  50  in the base member  30 . The pins  68  may be integrally and unitarily formed with the swivel member  60 , or may be separately formed and attached. Still further, the pins  68  may be combined into a single pin which is placed through the apertures  50  and the base member  30  and a corresponding aperture in the stem  60   b  of the swivel member  60 . In this case, the single pin can be attached to the stem  60   b  by friction fit or other mechanical connections such as adhesives, welding or bonding techniques. The stem portion  60   b  of the swivel member  60  generally includes an end surface  70  that is opposite the side surface  66  of the cross member  60   a.  The end surface  70  defines a swivel jaw surface  71  formed by a plurality of teeth  72  arranged linearly in series and corresponding to the teeth  44  of the base jaw surface  42 . That is, the swivel jaw surface  70  and the base jaw surface  42  have teeth  72 ,  44  that are sized and structured to mesh in the closed position to fix the suture  100  to the device  20 , as will be discussed herein with reference to  FIGS. 5-7 . As best seen in  FIG. 4 , the swivel member  60  also includes an L-shaped tab  72  projecting downwardly from the lower surface  64 . The tab  72  is structured to selectively engage the L-shaped opening  54  in the base member  30 , to selectively lock the swivel member  60  to the base member  30 . 
         [0033]    As best seen in  FIG. 5 , when the device  20  is in its closed configuration, the swivel member  60  is fit within the recess  46  of the base member  30  such that the upper surfaces  32 ,  62  are generally coplanar (as are the side surfaces which form an annular disc-shape) while the locking tab  74  of the swivel member  60  is engaged with the opening  52  in the base member  30  to maintain their relative positioning and fixation of the suture. Notably, the swivel jaw surface  71  and the base jaw surface  42  are sized and structured to mesh in this closed position such that the series of teeth  44 ,  72  (having inter-meshed triangular cross-sections) form a tortuous pathway that frictionally engages and fixes the suture  100  that passes through the bore  36  of the device  20 . 
         [0034]    The locking tab  74  is preferably formed of a plastic material and has a size and structure that permits elastic deformation of the tab  74  such that it can move radially (to the right on the page in  FIG. 5 ) for withdrawal from the aperture  52  to move the swivel member  60  to an open configuration, as shown in  FIGS. 6 and 7 . As seen in the figures, the relative sizing of the upper base member portion  30   a  (i.e. thickness) the pins  68  and corresponding apertures  50  and the relative sizes of the stem portion  60   b  and cross-portion  60   a  of the swivel member  60  are such that the swivel member  60  can rotate through about  180  degrees to the position shown in  FIGS. 6 and 7 . In this open configuration, the suture  100  runs through the bore  36  and may be slid therethrough, such as for tensioning the body structures attached to the suture  100  below the lower surface  34  of the base member  30 . The teeth  44  of the base jaw surface  42  may slightly engage the upper surface  62  of the swivel member  60 , and any friction therebetween can be overcome through appropriate tensioning of the suture  100 . 
         [0035]    Notably, as swivel member  60  is rotated from the open configuration ( FIGS. 6-7 ) towards the closed configuration ( FIGS. 1, 5 ), i.e. as the swivel member  60  is rotated downwardly towards the right on the page in  FIG. 7 , the swivel jaw surface  71  rotates upwardly and to the left on the page such that the closing action of the device  20  serves to begin engaging the suture  100 . This movement slightly increases the tension on the suture  100  in an upwardly direction, as the teeth  44 ,  72  begin to engage each other. In this way, when the lower end of the suture  100  is affixed to a bodily structure (such as the stomach wall) the closing action of the device  20  will serve to slightly increase tension already placed on the suture  100 , thereby insuring a secure level of tension on the suture  100  and on the bodily walls (such as the stomach wall to the abdominal wall). The teeth  44  and/or teeth  72  are preferably constructed to be elastically deformable such that, as they are rotated into the closed configuration and along the opposing jaw surface  42 ,  71 , they may slightly deflect while passing along the opposing teeth  44 ,  72 . In the closed position shown in  FIG. 5 , the teeth  44 ,  72  are intermeshed and securely engage the suture  100  such that the suture  100  is fixed to the device and additional tension on either end of the suture  100  will not allow movement of the suture  100  relative to the device  20 . To release the suture  100 , the swivel member  60  may again be rotated from the closed position to the open position by sufficient force on the swivel member  60 , which causes the tab  74  to deflect outwardly and become dislodged from the aperture  52  in the base member  30 , as previously discussed. 
         [0036]    Turning now to  FIG. 8 , another embodiment of the device  120  for retaining a suture  100  on a bodily wall is depicted. The device generally includes a base member  130  and a key  170  selectively attachable to the base member  130 . The device includes an unlocked configuration where the key is attached to the base member (as shown in  FIG. 8 ) to allow the suture to slide relative to the device  120 . In a fully locked configuration ( FIG. 16 ), the key  170  is detached from the base member  130  such that the suture  100  is fixed to the base member  130  as it extends therethrough from a bottom surface  144  to a top surface  156 . 
         [0037]    As shown in  FIG. 9 , the base member  130  includes side walls  131 ,  132 ,  133 ,  134  arranged to form a box-like shape, i.e. square or rectangular, and defines an interior space  136 . A bottom wall  142  is connected to the side walls  131 ,  132 ,  133 ,  134  to close off the bottom and define the lower surface  144  of the base member  130 . These walls are preferably integrally and unitarily formed, although they may be separately formed and joined by adhesives, friction fit, welding, bonding or other mechanical connecting techniques known to those skilled in the art. One side wall, shown as wall  132  in  FIG. 9 , defines a pocket  140  for receiving a biasing member, as will be described in further detail below. One or more rods  138 , two in the currently preferred embodiment, extend between opposing side walls  132 ,  134  to serve as rails or guiding members, as will also be discussed further below. 
         [0038]    Turning to  FIG. 10 , the device  120  also includes a first jaw  146  and a second jaw  148  which are sized to fit within the interior space  136  of the base member  130 . The first jaw  146  defines a first jaw surface  150  formed by a plurality of teeth  151 , and likewise the second jaw  148  includes a second jaw surface  152  formed by a plurality of teeth  153 . As with the prior embodiments, the teeth  151 ,  153  preferably have a triangular cross-section and are formed as a series of laterally extending and vertically spaced teeth for gripping the suture  100 . 
         [0039]    The first and second jaws  146 ,  148  include a pair of spaced apart passageways  147 ,  149  that are sized to slidably receive the rods  138  in the base member  130 . In this way, the first and second jaws  146 ,  148  are translatable along the rods  138  for moving between open and closed positions corresponding to the above-mentioned unlocked and locked configurations. Alternatively, only one of the jaws  146 ,  148  needs to be slidable, and thus the other jaw may be formed unitarily and/or integrally with the base member  130  and corresponding side walls. 
         [0040]    The rods  138  may be inserted through the jaws  146 ,  148  and then together inserted into space  136 , or alternatively the jaws  146 ,  148  may be inserted into the space  136  and the rods  138  inserted through openings formed into the side walls that correspond to passageways  147 ,  149  of the jaws  146 ,  148 . The rods  138  may be connected to the side walls by adhesives, friction fit, snap-fit, welding, bonding or other mechanical connection structures and techniques known to the skilled artisan. 
         [0041]    The base member  130  also includes an upper wall  154  shown in  FIG. 11 . The upper wall  154  and the lower wall  142 , together with the interior space  136 , define a bore  160  extending through the base member  130  from the upper surface  156  to the lower surface  144 . In particular, the upper wall  156  includes an upper hole  162  that is aligned with a lower hole  161  formed in the bottom wall  142  (see  FIGS. 11, 13 ). The bore  160  permits the suture  100  to pass through the base member  130  by extending through the lower hole  161 , the interior space  136 , and the upper hole  162 . The upper hole  162  is also designed to serve as a key hole to permit operation of the device  120  between its locked and unlocked configurations. In particular, the upper aperture  162  is asymmetrical, and in the embodiment shown in  FIG. 11  includes two opposing wings  164  which extend away from a central axis of the upper hole  162 . The upper wall  154  may be connected to the side walls by adhesives, friction fit, welding, bonding or other mechanical connection structures and techniques known to the skilled artisan 
         [0042]    The key  170  is best seen in  FIG. 12 . The key  170  generally includes a key body  172  and a handle  174  fixedly attached to the key body  172  for manipulation by the operator. The key body  172  and handle  174  define a passageway  176  extending vertically through the key  170 . The key  170 , and in particular the key body  172 , is sized and shaped to extend through the interior space  136  and hold the first and second jaw members  146 ,  148  in a spaced apart, unlocked, configuration. The passageway  176  through the key  170  is aligned with the lower hole  161  in the bottom wall  142 , such that the suture  100  can pass through the entire device  120 , namely from the bottom surface  144 , through the lower hole  161  and through the passageway  176  in the key  170  to a position above the top surface  156  of the base member  130 . The key body  172  also includes a pair of locking tabs  178  projecting outwardly therefrom. It can also be seen that the locking tabs  178  of the key  170  are sized to be passed through wings  164  of the upper hole  162  and rotated such that upward movement of the key  170  is blocked by the upper wall  154  (i.e. when the tabs  178  are not aligned with the wings  164  of hole  162 ). 
         [0043]    Turning now to  FIG. 13 , the unlocked configuration of the device is shown. It can be seen that the base member  130  has been shown assembled with the side walls  131 ,  132 ,  133 ,  134  enclosed by the lower wall  142  and the upper wall  154 . The first and second jaws  146 ,  148  are fitted within the interior space  136  of the base member  130 , and slidably attached thereto via the rods  138 . The second jaw  148  is biased towards the first jaw  146 . In the depicted embodiment, the second jaw  148  includes a pocket  180  aligned with the pocket  140  formed in the side wall  132 . A spring  182  is fitted within the pockets  140 ,  180  in order to bias the second jaw  148  towards the first jaw  146 . In the unlocked configuration, the key  170  is attached to the base member  130  such that it extends through the bore  160 , and in particular the upper hole  162  in upper wall  154 , through the interior space  136 , and is sized to rest against the bottom wall  142 . The suture  100  passes through the passageway  176  in the key  170 , as well as through the bore  160  in the base member  130 . 
         [0044]    As shown in  FIGS. 14 and 15 , once the suture  100  has been fed through the device  120  they are positioned at the desired location with the desired tension on the suture  100 , the key  170  can be removed from the base member  130  to begin transitioning the device  120  from the unlocked configuration to the locked configuration. Generally, the key  170  is rotated by the operator by grasping the handle  174  and rotating it such that the locking tabs  178  are aligned with the wings  164  of the upper hole  164 . The key  170  then may be vertically lifted (i.e. moved away from the bottom wall  142 ). The lower portion of the key body  172  is slightly tapered as shown, and thus the spring bias on second jaw  148  will also help to force the key  170  upwardly. When the key  170  is fully removed as shown in  FIG. 16 , the spring  182  will force the second jaw  148  to slide fully against the first jaw  146 . The first and second jaw surfaces  150 ,  152  will engage to define a tortuous pathway that is laterally offset from the bore  160 , and namely laterally offset from the upper hole  162  and the lower hole  161 . The key  170  may continue to be slid upwardly along the suture  170  until the suture  170  completely passes through the passageway  176  formed in the key  170 . The suture  100  may then be cut such that it is positioned adjacent the upper surface  156  of the base member  130 , as shown in  FIG. 16 . Trimming the suture  100  may be desirable before and/or after removing the key  170 . 
         [0045]    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. The drawings are generally to scale and proportional, and the relative sizes and dimensions of the depicted structures are expressly included herein. Numerous modifications or variations are possible in light of the above teachings, and it will be recognized by the skilled practitioner that certain features of the described embodiments may be applied to other embodiments of the invention. 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.