Patent Publication Number: US-2017348000-A1

Title: Surgical fixation assemblies, systems and kits

Description:
RELATED APPLICATIONS 
     This application claims priority from U.S. Patent Application Ser. No. 62/346,019, filed 6 Jun. 2016, which is incorporated herein in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally relates to surgical staple assemblies, surgical rivet assemblies, surgical fastening devices, surgical fastening systems, and surgical fastening kits. 
     BACKGROUND 
     Gastrointestinal (GI) perforations can form along the GI tract due to a number of causes such as, for example, diverticulitis, appendicitis, peptic ulcers, non-steroidal anti-inflammatory drugs (NSAIDS), steroids, and trauma. The decision to perform corrective surgery is contingent upon a thorough assessment of the benefits versus the risks associated with post-operative sequelae. Current surgically corrective actions primarily include the use of open and laparoscopic approaches. Although laparoscopic surgery is minimally invasive and substantially reduces the risk of surgical complications when compared to some open procedures, the use of trocars to provide access to the abdominal cavity still presents surgical risks. Risks include the perforation of healthy organs upon percutaneous entry into the abdomen and wound infection. Current flexible endoscopic based therapies include the use of endoscopic clip delivery systems which has significant perforation size limitations and a suturing system that is effective, but requires extensive training even for an experienced endoscopist to become a proficient operator. 
     There is a need for surgical fastening devices and systems that minimize or eliminate the above-mentioned risks and complications by not requiring percutaneous entry to make gastrointestinal perforation repairs, while still offering ease of use for an endoscopist. 
     The present disclosure generally provides surgical staples, surgical staple assemblies, surgical fastening devices, surgical fastening systems, surgical rivet assemblies, and surgical fastening kits. An embodiment provides a surgical duplex staple assembly comprising a first staple and a second staple. The first staple comprises a base having a back surface and a front surface. The base has a top portion, a bottom portion, a left side portion, and a right side portion. The first staple further includes a left prong extending from the left side portion and a right prong extending from the right side portion. The second staple comprises a base having a back surface and a front surface. The second staple has a top portion, a bottom portion, a left side portion and a right side portion. The second staple further includes a top prong extending from the top portion and a bottom prong extending from the bottom portion. In a deployed position, the left and right prongs of the first staple penetrate through the approximated tissue and are retroflexed onto the back surface of the second staple. Further, the top and bottom prongs of the second staple penetrate through the approximated tissue and are retroflexed onto the back surface of the first staple. Other embodiments of a staple include a 4-pronged first staple and a second staple backing without prongs. In a deployed position, the prongs of the first staple penetrate through the approximated tissue and retroflex onto the back surface of the second staple backing. The first or second staple can include different numbers of prongs. 
     Other embodiments provide surgical fastening devices that can be used to deploy the duplex staple assembly described above, rivet assemblies as disclosed herein, or other fastening devices and other fasteners. In an embodiment, a fastening device comprises a casing have a first and a second carrier disposed therein that are connected by a carrier compression spring. The first carrier is configured to house a plurality of first staples or rivets of a rivet assembly. The first carrier has a distal end defining an exit opening through which the plurality of first staples or rivets can be sequentially deployed. The second carrier is configured to house a plurality of second staples or secondary heads of rivet assemblies therein. Each of the plurality of second staples is configured to fasten to a respective one of the plurality of first staples. Similarly, each of the secondary heads is configured to fasten to a respective one of the plurality of rivets. Similar to the first carrier, the second carrier has a distal end defining an exit opening through which the plurality of second staples or secondary heads can be sequentially deployed. The fastening device further comprises a first plunger disposed within the first carrier that actuates deployment of the plurality of first staples or rivets. The fastening device also includes a second plunger disposed within the second carrier that actuates deployment of the plurality of second staples or secondary heads. 
     In another embodiment, a fastening device comprises a clamp comprising opposing first and second arms. The first arm has an exit port at a distal end thereof through which a staple or rivet of a rivet assembly is deployed. The second arm has an exit port at a distal end thereof through which a complementary staple or secondary head of a rivet assembly is deployed. The fastening device further includes a spring-loaded casing in operable association with the clamp and located between the first and second arms of the clamp in a stowed position. The spring-loaded casing has a first section configured to house a plurality of first staples or rivets and a second section configured to house a plurality of complementary second staples or secondary heads. The first section has a distal access port facing the distal end of the first arm through which the first arm can capture a first staple or rivets of the plurality of first staples or rivets. Similarly, the second section has a distal access port facing the distal end of the second arm through which the second arm can capture a complementary second staple or secondary head of the plurality of complementary second staples or secondary heads. The fastening device also includes a rod in slidable relation with the clamp and located distal to the spring-loaded casing. 
     Other embodiments of the present disclosure provide surgical fastening systems and surgical fastening kits that include suitable combinations of the above-described staples, rivet assemblies, fastening devices, and endoscopes to which fastening devices are attached. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is perspective view of a duplex staple assembly in a non-deployed position according to an embodiment of the present disclosure. 
         FIG. 2  is a perspective view of the duplex staple assembly of  FIG. 1  in a deployed position with tissue not depicted for the purpose of clarity. 
         FIG. 1A  is perspective view of a duplex staple assembly in a non-deployed position according to an embodiment of the present disclosure. 
         FIG. 2A  is a perspective view of the duplex staple assembly of  FIG. 1A  in a deployed position with tissue not depicted for the purpose of clarity. 
         FIG. 3  is a perspective view of a fastening device attached to the distal end of an endoscope in a non-deployed position according to an embodiment of the present disclosure. 
         FIG. 4  is a perspective view of the fastening device of  FIG. 3  in a deployed position with tissue not depicted for the purpose of clarity. 
         FIG. 5  is an exploded view of the fastening device of  FIG. 3 . 
         FIG. 6  is a bottom view of another embodiment of a fastening device in a stowed position according to an embodiment of the present disclosure with the casing exposed for the purpose of clarity. 
         FIG. 7  is a bottom view of the fastening device of  FIG. 6  in a non-stowed position. 
         FIG. 8  is a front view of the fastening device of  FIG. 6  attached to the distal portion of an endoscope. 
         FIG. 9  is a side view of the fastening device and endoscope illustrated in  FIG. 8 . 
         FIG. 10  is a perspective view of the fastening device of  FIG. 6  in a non-deployed position attached to an endoscope and having forceps extending through a channel of the endoscope. 
         FIG. 11  is a perspective view of the fastening device of  FIG. 10  in a deployed position. 
         FIG. 12  is a schematic side view of a rivet assembly in a non-deployed position according to an embodiment of the present disclosure. 
         FIG. 13  is a schematic side view of the rivet assembly of  FIG. 12  in a deployed position. 
         FIG. 14  is a schematic side view of another embodiment of a rivet assembly in a non-deployed position according to an embodiment of the present disclosure. 
         FIG. 15  is a schematic side view of the rivet assembly of  FIG. 14  in a deployed position. 
         FIG. 16  is a perspective view of a fastening device in a non-deployed position (with tissue not depicted for the purpose of clarity) attached to an endoscope according to an embodiment of the present disclosure. 
         FIG. 17  is a perspective view of the fastening device of  FIG. 16  in a deployed position with tissue not depicted for the purpose of clarity. 
         FIG. 18  is an exploded view of the fastening device of  FIG. 16 . 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure generally relates to surgical staple assemblies, surgical rivet assemblies, surgical fastening devices, surgical stapling systems and surgical fastening kits. Such devices are configured for placement in a patient&#39;s body and are therefore sterile and constructed of biocompatible materials. The present disclosure refers to the term “substantially” with respect to certain orientations or positions. By “substantially” is meant that the orientation or position of the element need not have the mathematically exact described orientation or position but can have an orientation or position that is recognizable by one skilled in the art as generally or approximately having the described orientation or position. The disclosure also refers to the term “top,” “bottom,” “left” and “right,” with respect to a staple. These terms refer to portions of the staple or when the staple is in a non-deployed, upright position as illustrated in  FIG. 1 . Further, with respect to a staple, staple assembly or rivet assembly, the term “non-deployed” or “pre-deployed” refers to the position of the staples, staple assemblies or rivet assemblies when they have not been deployed in the body and coupled together to fixate tissue between the staples, staple assemblies or rivet assemblies. The term “deployed” refers to the position of the fastened tissue when the staples, staple assemblies or rivet assemblies have been deployed in the body and coupled together to fixate tissue between the staples, staple assemblies or rivet assemblies. With respect to a fastening device or fastening system, the term “non-deployed” refers to the position of the fastening device or fastening system before a staple, staple assembly or rivet assembly has been deployed in the body to fixate tissue. The term “deployed” refers to the position of the fastening device or fastening system when a staple, staple assembly or rivet assembly has been deployed into the body and has fastened tissue together. 
     As stated above, in certain embodiments, the present disclosure provides surgical staples that can be used to repair tissue in a patient&#39;s body.  FIG. 1  depicts a duplex staple assembly  10  comprising a first staple  12  and a second staple  32 . First staple  12  comprises a base  14  having a back surface  16 , a front surface  18 , a top portion  20 , a bottom portion  22 , a left side portion  24  and a right side portion  26 . First staple  12  also has a left prong  28  extending from left side portion  24  of base  14  and a right prong  30  extending from right side portion  26  of base  14 . Second staple  32  comprises a base  34  having a back surface  36 , a front surface  38 , a top portion  40 , a bottom portion  42 , a left side portion  44  and a right side portion  46 . Second staple  32  also has a top prong  48  extending from top portion  40  of base  34  and a bottom prong  50  extending from bottom portion  42 .  FIG. 1  illustrates the duplex staple assembly in a non-deployed or pre-deployed position. Referring to  FIG. 2 , in a deployed position (tissue between staples not shown for purposes of clarity), left prong  28  and right prong  30  of first staple  12  are retroflexed onto back surface  36  of second staple  32  and top prong  48  and bottom prong  50  (not shown) of second staple  32  are retroflexed onto back surface  16  of first staple  12 . Referring to  FIG. 5 , the face of plunger  68  of an exemplary fastening device  60  is in the shape of a cross. This pattern is a curved indentation that performs the action of plastically deforming the staple prongs from the opposing staple, bending the prongs back (retroflexing) on the back of the opposite staple after the prongs have passed through the tissue. 
     In certain embodiments, top portion  20 , bottom portion  22 , left side portion  24 , and right side portion  26  of first staple  12  each define a substantially central indentation ( 21 ,  23 ,  25 , and  27  respectively) as shown in  FIG. 1 . Left prong  28  extends from substantially central indentation  25  of left side portion  24  and right prong  30  extends from substantially central indentation  27  of right side portion  26  of first staple  12 . Top portion  40 , bottom portion  42 , left side portion  44  and right side portion  46  of second staple  32  also each define a substantially central indentation ( 41 ,  43 ,  45 , and  47 ). Top prong  48  extends from substantially central indention  41  of top portion  40  and bottom prong  50  extends from substantially central indentation  43  of bottom portion  42  of second staple  32 . As shown in  FIG. 2 , left prong  28  and right prong  30  of first staple  12  are disposed in the respective substantially central indentation  45  and  47  of left side portion  44  and right side portion  46  of second staple  32  and are retroflexed onto the back surface of the second staple in a deployed position. Top prong  48  and bottom prong  50  of second staple  32  are disposed in the respective substantially central indentation  21  and  23  of top portion  20  and bottom portion  22  of first staple  12  and are retroflexed onto the back surface of first staple  12  in a deployed position. Although only two prongs are illustrated for each of the first and second staples, the staples can each have more than two prongs. 
     Referring to  FIG. 5 , the face of plunger  68  of an exemplary fastening device  60  is in the shape of a cross. This pattern is a curved indentation that performs the action of plastically deforming the staple prongs from the opposing staple, bending the prongs back (retroflexing) on the back of the opposite staple after the prongs have passed through the tissue. 
     A duplex staple assembly can provide a redundant stapling approach that differs from existing staples. The staples can have a large tissue contact surface that allows for the stapling load to be distributed over the surface of the approximated tissue to be repaired. For example, the front surface of the staples, which is the surface that contacts tissue, can have a surface area of between approximately 9 mm 2  and approximately 36 mm 2 . The front surfaces of the staples can have larger surface areas to accommodate larger portions of the anatomy, such as the large intestine. 
     Referring to  FIGS. 1A and 2A , a staple assembly  700  can comprise a staple  702  and a staple back  704 . Staple  702  comprises a base  714  having a back surface  716 , a front surface  718 , a top portion  720 , a bottom portion  722 , a left side portion  724  and a right side portion  726 . First staple  702  also has a left prong  728  extending from left side portion  724  of base  14 , a right prong  730  extending from right side portion  726  of base  714 , a top prong  732  extending from top portion  720  of base  714  and a bottom prong  734  extending from bottom portion  722 . Staple back  704  comprises a base  714  having a back surface  735 , a front surface  738 , a top portion  740 , a bottom portion  742 , a left side portion  744  and a right side portion  746 .  FIG. 1A  illustrates the staple assembly  700  in a non-deployed or pre-deployed position. Referring to  FIG. 2A , in a deployed position (tissue between staple and staple back not shown for purposes of clarity), left prong  728 , right prong  730 , top prong  732 , and bottom prong  734  of staple  702  are retroflexed onto back surface  735  of staple back  704 . 
     In either embodiment of a staple assembly illustrated in  FIG. 1, 2, 1A or 2A , the prongs of one staple are retroflexed onto the back of the opposing staple or staple back thereby preventing excessive damage to the stapled tissue caused by the endpoints of the opposing staple prongs or one of the staples. Such qualities are beneficial when used in patients with excessively inflamed and friable tissue, preventing the staple from ripping through the tissue due to causes such as GI peristaltic activity or increases in intraluminal pressure and limiting the recurrences of perforations. 
     Certain embodiments of the present disclosure provide a fastening device that can be used to load and discharge surgical staples. Such surgical staples can be surgical duplex staple assemblies as described herein, other surgical staples or rivet assemblies as disclosed herein. Referring to  FIG. 3 , in an embodiment, a fastening device  60  comprises a casing  62  that is sized and configured to house a plurality of staples as disclosed herein, a plurality of rivet assemblies as disclosed herein, or other surgical staples and fasteners. Preferably, casing  62  or another suitable casing of a surgical fastening device has a length of between approximately 20 mm and approximately 36 mm, a width of between approximately 10 mm and approximately 15 mm and a height of between approximately 5 mm approximately 7 mm. Fastening device  60  further includes a first carrier  64  and second carrier  66  opposite first carrier  64 , both of which are disposed within casing  62 . First carrier comprises a first plunger  68  disposed therein and second carrier  66  comprises a second plunger  70  disposed therein. As depicted in  FIG. 5 , a plurality of first staples  12  can be sequentially disposed in first carrier  64  and a plurality of second staples  32  can be sequentially disposed in second carrier  66 . A carrier clamp can be actuated using a steel cable system that is operated outside the body by an endoscopist. The operation controls can be a hand operated cable system that connects to the fastening device actuator by running through a small diameter tube external to the shaft of the endoscope, but secured safely to the shaft using, for example, small clip-on spring loaded band-style clamps affixed at multiple locations along the endoscope&#39;s length. The arrows depicted in  FIG. 3  indicate the direction in which the carriers are urged together to deploy a staple, rivet assembly or other fastener. 
       FIG. 5  is an exploded view of exemplary components of fastening device  60  illustrated in  FIG. 3 . Casing  62  comprises a base  72  attached to a cover  74  via fasteners  76  and a rear casing  73  attached to both base  72  and cover  74 . First carrier  64  and second carrier  66  each define a plurality of openings sized and configured to accept guide rails  71  which ensure that carriers  64  and  66  are aligned in casing  62 . First carrier  64  also comprises a first staple plunger  68  disposed therein and second carrier  66  comprises a second staple plunger  70  disposed therein. Also housed within first carrier  64  is a first staple loader  78  and a first staple plunger tension spring  80 . Similarly, housed within second carrier  66  is a second staple loader  82  and a second staple plunger tension spring  84 . The plurality of first staples  12  are retained by first staple retainer  86  and the plurality of second staples  32  are retained by second staple retainer  88 . First and second staple retainers  86  and  88  are coupled to respective first and second carrier covers  90  and  92  respectively which, in turn, are attached to respective first and second carriers  64  and  66 . Portions of first and second staple retainers  86  and  88  are disposed within a staple retainer guide rail  98  to ensure staple retainers  86  and  88  are aligned in casing  62  during and after staple deployment. Positioned between first and second carrier covers  90  and  92  are carrier compression springs  94  and  96 , which allow carriers  64  and  66  to return to a non-deployed configuration after a staple has been discharged from the carriers. The aforementioned components of a surgical fastening device are only exemplary and components can be replaced with different components or excluded all together so long as the fastening device has a low profile and can be attached to the bottom portion of the distal end of a flexible endoscope so as to not occlude the operator&#39;s field of view as described in more detail below. Further, the above described components can be used to deploy rivet assemblies as disclosed herein and other fasteners. 
     In further detail, the cover fasteners secure the endoscopic fastening device cover to the endoscopic fastening device base. The endoscopic fastening device cover protects the inner components of the fastening device and provides support for the guide rails. The guide rails guide the translational pinching motion of the carriers during the stapling action. The staple plunger deploys the staple into the approximated tissue and deforms the prongs of the opposing staple using the curved indentation on the face of the plunger so that the staple can be permanently fixated in the approximated tissue. The staple plunger tension spring maintains a tension force on the staple loader so that the staple in the carrier can be loaded into the distal end of the carrier just prior to being deployed into the tissue. The staple loader slides along the interior of the carrier progressing the staples in the direction of the distal end of the carrier as the staples are deployed. The carrier serves multiple functions such as acting as a reservoir for the staples, securing the approximated tissue for staple deployment with the pinching action, and acting as the primary support for the staple plunger. A duplex staple assembly is deployed into approximated tissue to fixate opposing tissue together during perforation repair. The staple retainer secures staples in place to prevent the loaded staple from falling out of the open end of the carrier while also keeping the staples in-line and preventing them from jamming the fastening device due to staple overlap. The proximal end of the staple retainer is connected to the spring-loaded staple retainer guide rail. The carrier cover closes the interior of the carrier preventing the staples and staple retainer from falling out of the carrier while also serving as a guide for the translation retracting motion of the staple retainer. The carrier compression spring opposes the carrier cover and ensures that the carrier is resting in the open position. The staple retainer compression spring  99  opposes the staple retainer guide rail and ensures that the fastening device retainer is fully extended when not in use to prevent staples from falling out of the distal end of the carrier. The staple retainer cable pin  33  inserts through a center hole of the staple retainer guide rail and the rear casing where it is attached to a cable that is controlled by the operator. It allows for the actuation of the fastening device retainer guide rail that retracts the staple retainer for staple deployment. The staple retainer guide rail retracts the staple retainer for staple deployment while also serving a guide rail for the pinching motion of the carriers. The rear casing covers the rear portion of the endoscopic fastening device while also providing a normal force for the staple retainer compression spring. The carrier slide-crank cap  75  secures the top carrier slide-crank  77  and the bottom carrier slide-crank  79  to the casing base while also serving as the pivot point of both slide cranks. The top carrier slide-crank serves as the cable driven actuation motion that causes the carrier to have a pinching motion by converting a translational motion of the cable (operated by the endoscopist) into a rotational motion about the slide-crank cap. The cable is connected to a small hole on the proximal end of the top carrier slide-crank. A slotted hole on the distal end of the top carrier slide-crank attaches to a cylindrical peg (not shown) on the bottom side of the carrier allowing the conversion of the rotational scissor like motion of the carrier slide-crank into a translational motion that has a force vector 90 degrees from the cable force vector during staple deployment. The casing base serves as the base for all interior components within the casing. A carrier fastener  81  inserts through a hole in the bottom of the casing base and screws into the bottom of the carrier slide-crank cap. 
     As shown in  FIG. 3 , fastening device  60  has a low profile and can be attached to the bottom portion  102  of the distal end  104  of a flexible endoscope  100 . Endoscope  100  can define a plurality of channels  106  that extend through the lumen of endoscope  100 . Such channels can accommodate different types of surgical instrumentation such as suction or biopsy devices or can be used to deliver air or water to the surgical site or surgical pathway. As shown in  FIG. 3 , channel  106   a  has a lens  108  attached to the distal end thereof to allow the operator to view the surgical pathway or the surgical site. Because fastening device  60  is low profile, it can be attached to bottom portion  102  of distal end  104  of endoscope  100 , as shown in  FIG. 3 , without occluding or obstructing channels  106  and the operator&#39;s field of view.  FIG. 3  illustrates fastening device  60  in an open or non-deployed configuration and  FIG. 4  illustrates fastening device  60  in a closed or deployed configuration. The fastening device can either be manually attached to the distal end of an endoscope by the operator or pre-attached to an endoscope during manufacturing. 
       FIGS. 6 and 7  depict another embodiment of a fastening device that can be used to deploy staples as disclosed herein, rivet assemblies as disclosed herein other surgical staples or surgical fasteners. Fastening device  200  comprises a clamp  202  that has opposing first and second arms  204  and  206 . Each arm has an exit port  208  and  210  at a respective distal end  212  and  214  thereof. Fastening device  200  also includes a spring-loaded casing  216  in operable association with clamp  202  and located between first and second arms  204  and  206  of clamp  202  in a stowed position ( FIG. 6 ). The cover of the casing is not shown for the purpose of clarity in  FIGS. 6 and 7 . Spring-loaded casing  216  has a first section  218  and a second section  220 . First section  218  has a distal access port  222  facing first arm  204  and second section  206  also has a distal access port  224  facing second arm  206 . First section  218  is sized and configured to house a plurality of first staples or rivets of rivet assemblies and second section  220  is sized and configured to house a plurality of complementary second staples or secondary heads of rivet assemblies. Fastening device  200  further includes a rod  226  in slidable relation with clamp  202  and located distal to spring-loaded casing  216 . 
     In the stowed configuration illustrated in  FIG. 6 , first and second arms  204  and  206  of clamp  202  are positioned over respective access ports  222  and  224  to allow staples  230  to be loaded into the respective distal ends  212  and  214  of first and second arms  204  and  206 . Once the staples are loaded into clamp  202 , as depicted in  FIG. 7 , springs  236  and  238  can advance the next pair of staples into position for loading onto clamp  202 . The loaded clamp can be advanced along the sliding direction (indicated by the arrow in  FIG. 7 ) towards the perforation site in the patient&#39;s body so that the fastening device may install the staples into the tissue. Although  FIGS. 6 and 7  depict surgical staplers, rivet assemblies and other fasteners could be used as well. 
     As with other fastening devices described herein, fastening device  200  preferably has a low profile configuration and can be attached to the distal end of an endoscope  228  such as a flexible endoscope as illustrated in  FIGS. 8 and 9 . The fastening device can either be manually attached to the distal end of an endoscope by the operator or pre-attached to an endoscope during manufacturing. As can be seen from  FIGS. 8 and 9 , in a stowed position, fastening device  200  maintains a low profile so that the outer diameter preferably does not exceed the nominal inner diameter of the lower esophageal spincter (approximately 13 mm), allowing easy passage from the esophagus to the stomach. 
     Surgical fastening devices as described herein can be used for various surgical purposes, including to close gastrointestinal perforations. For example,  FIGS. 10 and 11  depict fastening device  200  attached to the distal end of an endoscope  240 . Once delivered to the perforation site  242  in the gastric wall  244  of a patient&#39;s body, the tissue is approximated using endoscopic forceps  246 . Fastening device  200  can then staple or fixate the approximated tissue. Fastening device  200  can be equipped with a reservoir of staples  230  or rivet assemblies to allow the repair to be completed without removing fastening device  200  to reload it. 
     The present disclosure also provides surgical fastening systems that include the duplex staple assembly disclosed herein and a surgical fastening device to deploy the duplex staple assembly. Such fastening systems can also include an endoscope to which the surgical fastening device is attached. Other embodiments provide a surgical fastening system that includes a surgical fastening device as described herein and staples, rivet assemblies as disclosed herein, or other fastneres, that can be deployed by the surgical fastening device. Such surgical stapling systems can also include an endoscope to which the surgical fastening device is attached. 
     Referring to  FIG. 12  and  FIG. 13 , certain embodiments provide a rivet assembly  300  comprising a rivet  302  and a secondary head  304 . Rivet  302  comprises a primary head  306 , a shaft  308  extending from the primary head  306  and an expandable tail  310  extending from the shaft  308 . Secondary head  304  comprises a secondary head body  312  defining a substantially central hole  314  that is sized and configured to receive tail  310  of rivet  302  in a deployed configuration. As seen in  FIGS. 12 and 13 , during tissue repair, rivet  302  is deployed in a manner so that it penetrates the approximated tissue  316  and tail  310  inserts into substantially central hole  314  of secondary head  304 . Rivet assembly  300  can be used with a deployment device that expands the tail  310  of rivet  302 , which prevents disengagement of secondary head  304  from rivet  302 . 
     After deployment of rivet assembly  300 , the approximated tissue  316  is compressed and secured between the primary head  306  of rivet  302  and secondary head  304  as seen in  FIG. 13 . Such rivet assemblies can be deployed along the perforation line of the tissue until the tissue defect is repaired. The rivets can be part of a kit including rivets having different lengths to allow for repair of tissue varying in thicknesses. 
     Referring to  FIGS. 14 and 15 , in certain embodiments, a rivet assembly  400  comprises a rivet  402  and a secondary head  404 . Rivet  402  comprises a primary head  406 , a shaft  408  extending from primary head  406 , and a ridged tail  410  having one or more outer ridges extending from ridged shaft  408 . In certain embodiments, shaft  408  has one or more outer ridges as well. Secondary head  404  comprises a secondary head body  412  defining a substantially central hole  416  that is sized and configured to receive tail  410  of rivet  402  and internal locking tabs  418  radially extending into substantially central hole  416 . Internal locking tabs  418  secure ridged ridged tail  410  and also can secure ridged shaft  408  in place as rivet  402  is advanced during the insertion process. During tissue repair, rivet  400  is deployed in a manner so that ridged shaft  408  and ridged tail  410  penetrate the approximated tissue  420  and insert into the substantially central hole  416  of secondary head  404 . Ridged tail  410  passes through the secondary head body  412  of secondary head  404 . As ridged shaft  408  and ridged tail  410  of rivet  402  advance through tissue, the internal tabs  418  of secondary head  404  prevent rivet  402  from backing out and the compression pressure increases. Rivet insertion depth determines the final tissue approximation distance compression force, securing the tissue between the primary head of the rivet and the secondary head. Such ridged rivets can be deployed along the perforation line of tissue until the tissue defect is repaired in the same manner as other rivets described herein. 
     Rivets and staples as described herein can be fabricated from dissolvable material. 
     Referring to  FIG. 16-18 , a surgical fastening kit is provided. Such a kit includes a plurality of rivet cartridges  502 . Each rivet cartridge  502  comprises a plurality of rivets  504 . Each rivet  504  comprises a primary head  506 , a shaft  508  extending from primary head  506 , and a tail  510  extending from shaft  508 . The surgical kit also includes a plurality of secondary head cartridges  512 . Each secondary head cartridge  512  comprises a plurality of secondary heads  514 . Each secondary head  514  defines an opening sized to receive the tail  510  of one of the rivets  504 . In addition or alternatively, the kit includes a plurality of staple cartridges  516  and a plurality of staple back cartridges  518 . Each staple cartridge  516  comprises a plurality of staples  520  and each staple back cartridge  518  comprises a plurality of staple backs  524 . The kit also includes a tension-loaded fastening device  526  comprising a first arm  528  defining a compartment  530  sized to receive one of the plurality of rivet cartridges  502  or one of the plurality of staple cartridges  516 . The tension-loaded fastening device  526  also includes a second arm  532  opposing first arm  528  and that defines a compartment  534  sized to receive one of the plurality of secondary head cartridges  512  or one of the plurality of staple back cartridges  518 . The tension-loaded fastener device  526  is configured to attach or is pre-attached to a bottom portion of a distal end of a flexible endoscope defining a plurality of channels such that the tension-loaded fastener device does not occlude a field of view of a camera, a light source or the plurality of channels of the endoscope as shown in  FIGS. 16 and 17 . 
     In certain embodiments as disclosed above, the rivet tail comprises an outer ridge and each of the secondary heads comprises an internal tab that engages the outer ridge of the tail in a deployed configuration. In certain embodiments, the rivet shaft also comprises one or more outer ridges. 
     In more detail with reference to  FIG. 18 , rivet cartridge  502  holds a plurality of rivets and deploys a single rivet through an opening  540  at a distal portion of rivet cartridge  502 . Secondary head cartridge  512  holds a plurality of secondary heads and deploys a single secondary head with each deployment. Rivet shaft  508  and rivet tail  510  of rivet  504  penetrates through approximated tissue as illustrated in  FIGS. 14 and 15 . Secondary head  514  securely holds a rivet  504  to allow the approximated tissue to be held tightly together as illustrated in  FIG. 15 . Staple cartridge  516  holds a plurality of staples and deploys a single staple through the substantially square-shaped opening  542  at a distal portion of staple cartridge  516 . Staple back cartridge  518  holds a plurality of staple backs and deploys a single staple back with each deployment. Staple  520  penetrates through approximated tissue and staple back  524  securely holds staple  52  to allow the approximated tissue to be held tightly together. An advancer  536  advances the reservoir of staples, staple backs, rivets, or secondary heads within the respective cartridges so that these fasteners are in the proper position as they are deployed into tissue. An elastic band  538  provides actuation force for each advancer  536 . A plunger  544  is actuated to deploy a rivet  504  or staple  520  into tissue and a plunger retraction spring  546  retracts plunger  544  after each deployments. First arm  528  of tension-loaded fastening device  526  holds the rivet cartridge  502  and, optionally, the staple cartridge  516 . Second arm  532  holds the secondary head cartridge  512  and, optionally, the staple back cartridge  518 . 
     The kit also includes a tension-loaded fastening device  526  comprising a first arm  528  defining a compartment  530  sized to receive one of the plurality of rivet cartridges  502  or one of the plurality of staple cartridges  516 . The tension-loaded fastening device  526  also includes a second arm  532  opposing first arm  528  and that defines a compartment  534  sized to receive one of the plurality of secondary head cartridges  512  or one of the plurality of staple back cartridges  518 . An endoscope interface bracket  542  couples to a bottom portion of a distal end of a flexible endoscope defining a plurality of channels such that the tension-loaded fastener device does not occlude a field of view of a camera, a light source or the plurality of channels of the endoscope as illustrated in  FIGS. 16 and 17 . 
     As such, tension-loaded fastening device  526  can attach to the distal end of a flexible endoscope  600 . Controlled by an endoscopist, the fastening device deploys staple components or rivet components from respective cartridges into the approximated tissue. The cartridges store a plurality of staple components or rivet components in the reservoir of each cartridge with one staple component or rivet component loaded in the fastening device&#39;s deployment chamber. Once emptied, the cartridges can be removed and replaced with cartridges loaded with staple components and rivet components. 
     The use of surgical fastening devices as described herein may give rise to less post-operative complications associated with percutaneous incisions, such as shorter operating times, reduced infection and reduced cosmetic patient concerns. Using devices as disclosed herein with a flexible endoscope allows the devices to perform surgical repairs on the lower esophagus, gastric wall, small intestine, large intestine, and rectum due to the tortuous anatomy of the upper and lower GI tracts. In particular, surgical stapling devices can be used to perform a natural orifice transluminal endoscopic surgery procedure by allowing an operator to access the peritoneal cavity from the GI tract to perform organ resections of the liver, pancreas, spleen and kidney. Other uses include endoscopic tumor biopsy and resection of tumors located in the peritoneal or retroperitoneal space, lymph node biopsy for cancer staging, visual inspection of the peritoneal cavity in place of or complementing open or laparoscopic exploratory surgery, repair of anastomotic leaks which is common following bariatric surgery, cholesystectomy, endoscopic hernia repair, Salpingo-oofrectomy, adhesiolysis, resection of tumor on the vertebrae, removal of endometriosis, and removal of a heterotopic rest. 
     Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments. Further, while certain features of embodiments may be shown in only certain figures, such features can be incorporated into other embodiments shown in other figures or otherwise disclosed in the specification. Additionally, when describing a range, all points within that range are included in this disclosure. In addition, unless otherwise specified, none of the steps of the methods of the present invention are confined to any particular order of performance.