Patent Abstract:
There is provided a penetratable toothed fastener for clamping tissue during surgery. The toothed fastener includes first and second legs each having longitudinal rows of transverse teeth and a securing member configured to pass through the transverse teeth to hold first and second legs closed relative to each other and about tissue. A locking mechanism is provided to retain the securing member within the first and second legs of the toothed fastener. The toothed fastener additionally includes receptacles for the receipt of medicant materials and holes in the teeth to dispense the materials to clamped tissue.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority to U.S. Provisional patent application No. 61/049,820, the disclosure of which is hereby incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to a fluid delivery system for surgical instruments. More particularly, the present disclosure relates to a fastener for releasing treatment material to clamped tissue. 
         [0004]    2. Background of Related Art 
         [0005]    During certain surgical procedures as is often necessary to clamp tissue, such as, vascular tissues, to prevent leakage therethrough during surgeries. The procedure typically involves placing clips or clamps within an applicator device and applying the clamps to the tissue on one side of an area, for example a diseased section of vascular tissue or colonic tissue, and placing another set of clamps on the opposing side of the diseased section. Thereafter, the diseased section can be excised and the resulting free ends of the tissue reattached. 
         [0006]    During surgery certain problems may arise. For example, manipulation of surrounding tissue, as well as fluid pressure within the tissue, may cause loosening of the clamp and resulting leakage or even possible detachment of the clamp. Additionally, it is often desirable to provide certain medicament or treatment materials such as, for example, biomechanical mediums or antimicrobials solutions to the tissues during the surgery. 
         [0007]    Therefore, it is desirable to provide a mechanical fastening device having a securing mechanism for maintaining the fastening devices in a closed position during the surgery. It is further desirable to provide a mechanical fastening device capable of applying medicament or treatment materials to the tissues during the surgery. 
       SUMMARY 
       [0008]    There is disclosed a toothed fastener for securing tissue. The toothed fastener generally includes an upper leg and a lower leg, each of the upper and lower legs having a row of teeth, each tooth having a proximal face and a distal face. The toothed fastener further includes a longitudinally extending securing member. A hole of predetermined diameter is formed in each of the proximal and distal faces and is of sufficient size to allow passage of the securing member therethrough. The upper or lower legs are movable from an open position to a closed positions placing all the holes in longitudinal alignment such that the securing member can pass through all the holes in the teeth of the upper and lower legs. 
         [0009]    In a specific embodiment, each tooth has a pair of spaced apart holes formed in each of the distal and proximal faces. In this embodiment, the securing member has first and second legs for passage through the pair of spaced apart holes. The securing member includes a backspan such that the first and second legs extend distally from the backspan. 
         [0010]    In one embodiment, the hole formed in the distal face of the distal most tooth is sized to engage the securing member in a friction fit fashion. 
         [0011]    In a particular embodiment, each of the teeth are hollow or define a receptacle for receipt of material such that passage of the securing member through the holes of the teeth releases the material into the space between the first and second legs. The material may be contained within a puncturable capsule. 
         [0012]    In the disclosed toothed fastener each leg has a base, each base having an opening to the interior of the tooth for passage of material into the tooth. A membrane is provided covering the openings in each leg to retain the material within the teeth. 
         [0013]    In one embodiment, a connector is affixed to a proximal end of each of the first and second legs. In a specific embodiment, the connector is a living hinge. In a more specific embodiment, the living hinge is formed integrally with the proximal ends of the first and second legs. 
         [0014]    There is also disclosed a system for applying a fastener to tissue including an applicator having a first and a second jaw and a toothed fastener positionable within the first and second jaws. The toothed fastener includes an upper leg and a lower leg, each of the upper and lower legs having a row of transverse, longitudinally extending teeth, each tooth having a proximal face and a distal face. The toothed fastener also includes a longitudinally extending securing member. A hole of predetermined diameter is formed in each of the proximal and distal faces and is of sufficient size to allow passage of the securing member therethrough. The upper or lower legs are movable from an open position spaced apart to a closed position substantially adjacent each other placing all the holes in longitudinal alignment such that the securing member passes through all the holes in the teeth of the upper and lower legs. The first and second jaws of the applicator are operable to move the upper and lower legs between the open and closed positions. 
         [0015]    In one embodiment of the system, each tooth has a pair of spaced apart holes formed in the proximal and distal faces and the securing member is a staple bar having a backspan and first and second legs extending distally from the backspan. The first and second legs being configured to pass through the pairs of spaced apart holes to secure the upper and lower legs in the closed position. 
         [0016]    The applicator further includes a pusher, engageable with the backspan of the staple bar, to drive the staple bar distally relative to the toothed fastener. 
         [0017]    The present disclosure contemplates a fluid delivery system having an actuating handle assembly, a pair of jaws operably connected to the handle assembly, the pair of jaws each having teeth defining openings, and a puncturing member receivable in the openings of the teeth, the teeth defining at least one receptacle containing a fluid. In certain embodiments, the pair of jaws includes a first jaw and a second jaw arranged for clamping onto tissue. The fluid may be a medicament, tissue sealant or tissue adhesive. The fluid may be disposed in a puncturable capsule, the securing member having a tip for puncturing the puncturable capsule. 
         [0018]    The present disclosure contemplates a tissue fastener having a first leg and a second leg pivotably connected to one another, the first leg and second leg each having teeth defining openings, and a securing member receivable in the openings of the teeth. A surgical instrument for applying the tissue fastener to tissue includes a pair of jaws and a handle assembly operably arranged to move the jaws between a closed position for clamping tissue and an open position for releasing the tissue. The jaws of the instrument are arranged to receive the tissue fastener and securing member. The surgical instrument includes a pusher for advancing the securing member through the openings in the teeth of the fastener. The teeth may define at least one receptacle containing a fluid. The fluid may be a medicament, tissue sealant or tissue adhesive. 
         [0019]    In a further aspect, a toothed fastener comprises an upper leg and a lower leg, each of the upper and lower legs having a row of transverse longitudinally extending teeth, each tooth having a proximal face and a distal face; a longitudinally extending securing member; and a hole of predetermine diameter formed in each of the proximal and distal faces. The upper or lower legs are movable from an open position spaced apart to a closed position wherein all of the holes are in longitudinal alignment enabling the securing member to pass through the holes to maintain the fastener in the closed position. 
         [0020]    In certain embodiments, each of the teeth are hollow for receipt of material such that the material is released into spaces defined between the upper and lower legs. The material may be contained within a puncturable capsule. Each of the upper and lower legs may have a base, each base having an opening to the interior of the tooth for passage of material into the tooth. In certain embodiments, a membrane covering the openings in each leg to retain the material within the teeth. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0021]    Various embodiments of the presently disclosed toothed fastener are disclosed herein with reference to the drawings, wherein: 
           [0022]      FIG. 1  is a perspective view of one embodiment of a toothed fastener and applicator instrument; 
           [0023]      FIG. 2  is a perspective view of the toothed fastener of  FIG. 1 ; 
           [0024]      FIG. 3  is a perspective view of an alternative, two part toothed fastener; 
           [0025]      FIG. 4  is a perspective view of the toothed fastener of  FIG. 1  with parts separated; 
           [0026]      FIG. 5  is a side sectional view taken along line  5 - 5  of  FIG. 2 ; 
           [0027]      FIG. 6  is an end sectional view taken along line  6 - 6  of  FIG. 5 ; 
           [0028]      FIG. 7  is a perspective view of the distal end of one leg of the toothed fastener of  FIG. 1 ; 
           [0029]      FIG. 8  is a perspective view of the toothed fastener of  FIG. 1  in an initial position on the applicator; 
           [0030]      FIG. 9  is a perspective view similar to  FIG. 8  during initial puncturing and securement; 
           [0031]      FIG. 10  is a side sectional view taken along line  10 - 10  of  FIG. 9 ; 
           [0032]      FIG. 11  is a perspective view of the toothed fastener during final puncturing and securement; and 
           [0033]      FIG. 12  is a side sectional taken along line  12 - 12  of  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0034]    Embodiments of the presently disclosed fluid delivery system will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user. 
         [0035]    Referring to  FIG. 1  there is disclosed a toothed fastener for use in a surgical instrument  12 . Surgical instrument  12  can be of the type for open surgery or laparoscopic surgery. In the present disclosure, surgical instrument  12  generally includes a handle  14  having an elongate tubular member  16  extending distally from handle  14 . The surgical instrument has an end effector at a distal end of the tubular member  16 , including an upper jaw  18  and a fixed jaw  20  that are movable with respect to one another. An actuator or trigger  22  is movably mounted on handle  14  and is operable to drive a securing and puncturing mechanism of fastener  10  into position as described in detail herein below. The handle  14  has a clamping handle  15  for moving the upper and lower jaws  18  and  20  to clamp tissue therebetween. Surgical instrument  12  additionally includes a rotation collar  24 , affixed to elongate tubular member  16 , to orient upper and lower jaws  18  and  20  during surgery. 
         [0036]    Referring now to  FIG. 2 , fastener  10  generally includes an upper leg  26  and a lower leg  28 . In this embodiment, upper leg  26  and lower leg  28  are connected by a flexible, living hinge  30 . Living hinge  30  allows upper leg  26  and lower leg  28  to move between an open position substantially spaced apart to a closed position wherein upper leg  26  is substantially adjacent to lower leg  28 . Upper leg  26  generally includes a base  32  having a row of transverse teeth  34  extending lengthwise along base  32 . The teeth  34  are hollow so as to define a receptacle in each tooth. Upper leg  26  additionally includes a distal most tooth  36  (or differ slightly to incorporate a locking mechanism as described in more detail herein below). Base  32  includes a plurality of base openings  38  that communicate with a corresponding receptacle in a corresponding tooth, and distal most tooth  36 . Openings  38  are provided to receive materials to be dispensed to tissue as described in more detail herein below. 
         [0037]    Lower leg  28  also includes a base  40  having a row of transverse teeth  42 . The teeth  42  are also hollow so as to define a receptacle in each tooth. Lower leg  28  also includes a distal most tooth  44  on base  40 . It should be noted here in that, while the following specific descriptions of configurations, features and/or components of legs  26  and  28  may be given with respect to one of legs  26  and  28 , legs  26  and  28  may have the same or different configurations, features and components and are identical in all respects. Teeth  42  of lower leg  28  each include a distal face  46  and proximal face  48 . Similarly, distal most tooth  44  includes a distal face  50  and a proximal face  52 . Pairs of holes  54  are provided through distal face  46  and proximal face  48  of hollow teeth  42 . Living hinge  30  is also provided with a pair of holes  56  which are similar in size and spacing to holes  54 . Additionally, in a particular embodiment, distal most tooth  44  has a pair of spaced apart holes  58  in proximal face  52 . Distal face  50  of distal most tooth  44  as a pair of spaced apart holes  60  which can differ from holes  54  and  58  in size and may form part of a locking mechanism as described in more detail herein below. In the alternative, holes  60  may be similar to holes  54  and  58  and the pair of spaced apart holes in a distal face of distal most tooth  36  in upper leg  26  may differ from the pairs of spaced apart holes in teeth  34  to form the disclosed locking mechanism. 
         [0038]    Upper leg  26  may be provided with a longitudinally extending membrane  62  which serves to cover base openings  38  and secure materials within hollow teeth  34  and  36 . 
         [0039]    Referring for the moment to  FIG. 3 , there is disclosed an alternative, two-part toothed fastener  64  which is substantially identical to toothed fastener  10  except for the lack of a living hinge. Fastener  64  generally includes an upper leg  66  and a lower leg  68 . Upper leg  66  includes a base  70  and a row of transverse, hollow teeth  72 . Upper leg  66  also includes a hollow distal most tooth  74 . A membrane  76  is provided across base  70  and functions similar to membrane  62  described hereinabove. Similarly, lower leg  68  includes a base  78  having rows of transverse, longitudinally extending hollow teeth  80  and a hollow distal most tooth  82 . Each of hollow teeth  80  includes a distal face  84  and a proximal face  86 . Hollow distal most tooth  82  also includes a proximal face  88  and a distal face  90 . A pair of spaced apart, holes  92  are provided in distal faces  84  and proximal faces  86  of teeth  80 . Likewise, proximal face  88  of distal most tooth  82  includes a pair of spaced apart holes  94 . In a specific embodiment, distal face  90  includes a pair of spaced apart distal holes  96  which differ in size from holes  94  and  92  and serve as a locking mechanism which functions similar to that which will be described herein below with respect to toothed fastener  10 . As shown, upper leg  66  includes a membrane  76 . As noted hereinabove, descriptions of the upper and lower legs of the various embodiments of the toothed fastener include similar components, such as the addition of a membrane to lower leg  68 , except for variations in distal most tooth  74  and distal most tooth  82 . Additionally, the operation of toothed fastener  64 , with the exception of a living hinge, functions the same as that described with respect to toothed fastener  10  hereinbelow. 
         [0040]    Referring now to  FIG. 4 , toothed fastener  10  also includes a securing member  100  which serves several functions. Securing member  100  has a backspan  102  and a pair of legs  104  and  106  extending distally from backspan  102 . Legs  104  and  106  terminate in distal tips  108  and  110 . Securing member  100  is provided to secure upper leg  26  and lower leg  28  in the closed position. Specifically, in the closed position, holes provided in teeth  34  and  36  of upper leg  26  are in direct longitudinal alignment with holes  54 ,  58  and  60  in lower leg  28 . Thus, by driving securing member  100 , and specifically legs  104  and  106 , distally through holes  56  in backspan  30  and through holes  54 ,  58  and  60  in lower leg  28  and the corresponding holes in upper leg  26 , upper leg  26  is secured in the closed position relative to lower leg  28 . Additionally, as tips  108  and  110 , of legs  104  and  106 , passed through the holes of the teeth as described herein, tips  108  and  110  puncture capsules of material, such as capsules  112  in upper leg  26  and capsules  114  ( FIG. 4 ) in lower leg  28 , to release materials contained therein onto tissue captured between upper leg  26  and lower leg  28 . Capsules  112  and  114  may contain a variety of materials for treatment or joining of tissue, such as, for example, biomedical mediums, antimicrobial solutions, etc. Materials disclosed in WO 2006/044800, the disclosure of which is hereby incorporated by reference herein, may be used. Lower leg  28  is provided with a membrane  116  to secure capsules  114  within hollow teeth  42  and  44 . Finally, tips  108  and  110 , in conjunction with smaller diameter holes  60  in distal face  50  of distal most tooth  44 , may act as a locking mechanism to prevent staple bar  100  from “backing out of” upper leg  26  and lower leg  28  as described below. The leg  104  and leg  106  may be sized to functionally engage the interior surface of the fastener teeth inside holes  60 , or the leg  104  and/or leg  106  have a textured surface for engaging inside the holes  60 , or both. 
         [0041]    Referring now to  FIGS. 5-7 , the details of teeth  34  and  36  of upper leg  26  will now be described. As noted hereinabove, upper leg  26  includes a distal face  118  of teeth  34  and proximal and distal faces,  120  and  122 , respectively, of teeth  36 . Teeth  34  include holes  124  which are similar in size to holes  54  in teeth  42  of lower leg  28 . Similarly, distal most tooth  36  includes a pair of spaced apart holes  126  formed in proximal face  120  which are also substantially the same as holes  54 . Distal face  122  of distal most tooth  36  includes a pair of spaced apart holes  128  which, together with tips  108  and  110  of securing member  100 , may form a locking mechanism to secure staple bar  102  within upper and lower legs  26  and  28 . Specifically, holes  124  and  126  may have a diameter d 1  which is greater than the diameter d 2  of pair of holes  128  in distal face  122  of distal most tooth  36 . Diameter d 1  of holes  124  and  126  are sized to be greater than the diameter of legs  104  and  106  of staple bar  100  so as to allow materials released from capsules  112  and  114  into the space between upper leg  26  and lower leg  28  in the closed position. Diameter d 2  of pair of holes  128  may be sized so as to grasp tips  108  and  110  of staple bar  100  in friction fit fashion thereby locking staple bar  100  in position within upper leg  26  and lower leg  28 . The teeth of upper leg  26  define receptacles for a fluid material. The lower leg  28  has teeth defihning receptacles and holes that are similar to those discussed above. 
         [0042]    Referring now to FIGS.  1  and  8 - 12 , the use of toothed fastener  10  in applicator  12  will now be described. As shown in  FIG. 1 , toothed fastener  10  is attached to jaws  18  and  20  of applicator  12 , such as, for example, by a snap-fit. Once jaws  18  and  20  have been properly positioned around tissue (not shown), clamp handle  15  can be actuated to initially move the jaws to the closed position relative to one another. As best shown in  FIG. 8 , this brings upper leg  26  into close cooperative alignment with lower leg  28 . In this position, teeth  34  of upper leg  36  interengage or interdigitate with teeth  42  of lower leg  28 . Depending upon the longitudinal orientation of upper leg  26  relative to lower leg  28  within upper jaw  18  and lower jaw  20 , one of distal most tooth  36  of upper leg  26  or distal most tooth  44  of lower leg  28  will become a distally most extending tooth of toothed fastener  10 . It should be noted that, depending upon which distal most tooth  36  or  44  becomes the distally most extending tooth, that tooth may be provided with holes of the smaller diameter d 2  in the distal face thereof to secure securing member  100 . Securing member  100  is in a proximal most position within elongate tubular member  16 . Applicator  12  is provided with a pusher  130  positioned against backspan  102  of securing member  100 . 
         [0043]    Referring now to  FIG. 9 , as trigger  22  is actuated, pusher  130  urges securing member  100  distally within elongate tubular member  16 . As securing member  100  moves distally, tips  108  and  110  of legs  104  and  106  pass through holes  56  in living hinge  30 . Referring specifically to  FIG. 10 , as legs  104  and  106  (not shown) moves distally tips  108  and  110  passed through holes  54  in teeth  42  of lower leg  28  and holes  124  of teeth  34  of upper leg  26 . As legs  104  and  106  pass through holes  54  and  124 , tips  108  and  110  of legs  104  and  106  penetrate or puncture capsules  112  and  114  of material M thereby releasing material M into the spaces defined between teeth  42  and  34 . In this manner, toothed fastener  10  is capable of delivering material M to tissues captured between upper leg  26  and lower leg  28 . Additionally, the passage of legs  104  and  106  through holes  54  and  124  serve to secure upper leg  26  in the closed position relative to lower leg  28 . 
         [0044]    Referring now to  FIGS. 11 and 12  and initially with regard to  FIG. 11 , as pusher  130  advances securing member  100  completely through upper leg  26  and lower leg  28 , tips  110  and  108  passed through holes  128  in distal face  122  of distal most tooth  36 . As noted hereinabove, holes  128  may have a diameter d 2  which is sufficiently small to engage tips  110  and  108  in friction fit fashion. In this manner, securing member  100  is “locked” into position within upper or lower legs  26  and  28 , respectively, thereby preventing staple bar  100  from inadvertently pulling out of upper and lower legs  26  and  28 . Additionally, the friction fit of tips  110  and  108  within holes  128  serves to seal holes  128  against any leakage of material M therethrough. 
         [0045]    Referring to  FIG. 12  as leg  106  passes through holes  126  in proximal face  120 , capsule  112  is punctured and material and is released. As shown, when distal most tooth  44  of lower leg  28  is not the distally most extending tooth of tooth fastener  10 , holes  60  in distal face  50  are of the same diameter as holes  54  in proximal face  52  to allow passage of material M therethrough as capsule  114  is penetrated. When the jaws of the surgical instrument are released from the tissue, through operation of the clamp handle  15 , the toothed fastener is secured onto the tissue, as the securing member  100  is retained in the teeth of upper leg  26  and teeth of lower leg  28 . Further, the material has been deployed to the tissue site. 
         [0046]    It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the teeth of the legs may be formed with a single hole in each of the proximal and distal faces for receipt of a single bar therthrough. Further, the tips of the staple bar may be enlarged to engage the distal most hole in rivet fashion. Additionally, the holes of the teeth may be covered be a penetratable membrane and the material provided as a fluid within the teeth. 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.

Technology Classification (CPC): 8