Abstract:
The present invention relates to surgical instruments and a method for applying an adhesive or sealant to an anastomosis site immediately prior and/or during anastomotic surgical stapling. The present invention further relates to surgical instruments, devices, and methods for applying sealant to a target tissue of a surgical site being anastomotically joined so as to prevent leakage.

Description:
FIELD OF THE INVENTION 
     The present disclosure relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to apply a non-mechanical biocompatible wound closure material to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections. 
     BACKGROUND OF THE INVENTION 
     Throughout the years the medical field has utilized various techniques in an effort to join or bond body tissue together. Historically, suturing was the accepted technique for rejoining severed tissues and closing wounds. Suturing was historically achieved with a surgical needle and a suturing thread, and more recently, with a variety of polymeric or metallic staples. The intended function of sutures is to hold the edges of a wound or tissue against one another during the healing process so as to reduce discomfort, pain, scarring and the time required for healing. Staples have recently been used to replace suturing when joining or anastomosing various body structures, such as, for example, the bowel. The surgical stapling devices employed to apply these staples are generally designed to simultaneously cut and seal an extended segment of tissue in a patient. 
     Linear or annular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more rows of surgical fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of an anastomosis. Linear surgical stapling devices generally include a pair of jaws or finger-like structures between which body tissue to be joined is placed. When the surgical stapling device is actuated and/or “fired,” firing bars move longitudinally and contact staple drive members in one of the jaws, and surgical staples are pushed through the body tissue and into and against an anvil in the opposite jaw thereby crimping the staples closed. A knife blade may be provided to cut between the rows/lines of staples. 
     Annular surgical stapling devices generally include an annular staple cartridge assembly including a plurality of annular rows of staples (typically two), an anvil assembly operatively associated with the annular cartridge assembly, and an annular blade disposed internal of the rows of staples. In general, an end-to-end anastomosis stapler typically places an array of staples into the approximated sections of a patient&#39;s bowels or other tubular organs. The resulting anastomosis contains an inverted section of bowel which contains numerous “B” shaped staples to maintain a secure connection between the approximated sections of bowel. 
     Anastomotic leaks may result in significant morbidity and frequently death. In addition to the use of surgical staples, sealants, e.g., synthetic or biological sealants, can be applied to the surgical site to guard against leakage. The biological sealants are typically applied to the outer surface of the anastomosis by using a dual lumen syringe or spray nozzle in a separate step. Still, the delivery of the sealant is compromised by an inability to get it at or between individual staple sites, and along staple lines and tissue seams. Typically, the biological sealants are manually applied to the outer surface of the staple line by a physician by spraying on, brushing on, swabbing on, or any combinations thereof. This manual application of biological sealant can lead to non-uniformity of the thickness of sealant across the staple line and/or omitting a portion of the intended coverage area due to inability to see or reach the desired location. In addition the manual application of the sealant is difficult to perform uniformly and efficiently, particularly because the sealants are designed to cure very quickly. 
     The biological sealants are known to be applied to the outer surface of the anastomosis by using a dual lumen syringe or spray nozzle in a separate step. The efficacy of fibrin sealant in prevention of leak after bariatric surgery has been shown in nonrandomized studies, as shown in the following references:
     Liu C D, Glantz G J, Livingston E H. Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg. 2003; 13:45-48.   Lee M G, Provost D A, Jones D B. Use of fibrin sealant in laparoscopic gastric bypass for the morbidly obese. Obes Surg. 2004; 14:1321-1326.   Papavramidis S T, Eleftheriadis E E, Papavramidis T S, et al. Endoscopic management of gastrocutaneous fistula after bariatric surgery by using a fibrin sealant. Gastrointest Endosc. 2004; 59:296-300.   Garcia-Caballero M, Carbajo M, Martinez-Moreno J M, et al. Drain erosion and gastro-jejunal fistula after one-anastomosis gastric bypass: endoscopic occlusion by fibrin sealant. Obes Surg. 2005; 15:719-722.   Sapala J A, Wood M H, Schuhknecht M P. Anastomotic leak prophylaxis using a vapor-heated fibrin sealant: report on 738 gastric bypass patients. Obes. Surg. 2004; 14:35-42.   

     However, prospective, randomized, multicenter, clinical trials in laparoscopic bypass surgery (not lower anterior resection or sigmoidectomy) have shown that there was little difference in leak rates between fibrin glue and control groups, as shown in the below references:
     Silecchia G, Boru C E, Mouiel J, et al. Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial. Obes Surg. 2006; 16:125-131.   Silecchia G, Boru C E, Mouiel J, et al. The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial. Surg Endosc. 2008; 22:2492-2497.   

     One possible underlying reason for the poor performance of the sealant is that the delivery of the sealant is not optimized or is compromised by an inability to get it at or between individual staple sites, and along staple lines and tissue seams. 
     U.S. Pat. No. 8,281,975, entitled “Surgical apparatus and structure for applying sprayable wound treatment material” to Criscuolo and Bettuchi, discloses an apparatus for forming an anastomosis between adjacent sections of tissue. The apparatus includes a body portion; an actuation assembly operatively supported at a proximal end of the body portion; an anvil assembly movably mounted at the distal end of the body portion for movement toward and away from the body portion; an approximation assembly extending between the body portion and the anvil assembly for moving the anvil toward and away from the tubular body portion; a dispersion assembly operatively associated with the approximation assembly, the dispersion assembly including at least one angled surface defining at least one channel interposed between the anvil assembly and the body portion and being configured to dispense a fluid therefrom; and at least one conduit for conducting wound treatment material to the dispersion assembly. 
     The disadvantages of the Criscuolo apparatus relate to the conduit and the dispersion assembly being built into the body of the apparatus. Thus, the system can be clogged with tissue, blood, body fluids, and other matter during the installation of the apparatus within the intestine in preparation to the circular anastomosis, and thereby rendering the apparatus incapable of the delivery of the sealant as intended. Moreover, if the dispersion assembly exit nozzles became clogged by the rapidly curing sealant, for instance due to the minor delay or complication during the anastomotic procedure, the delivery of the sealant will be prevented with no recourse. In addition, the sterilization and cleaning of the apparatus becomes complicated once a rapidly curing sealant is introduced into the narrow channels and orifices of the conduit and the dispersion assembly. Further, the size of the dispersion assembly is fixed by the size of the approximation assembly on which it is formed and thus the dispersion assembly cannot be readily adjusted or adapted for different spraying pattern, spray coverage, and the like to accommodate different anatomy of the patient and different needs of the surgeon performing the anastomosis. 
     U.S. Pat. No. 8,152,042 discloses a number of embodiments for improving sealing at the anastomotic site. In some embodiments, a washer or structural body is wrapped completely around the anvil shaft, with staples driven through the structural body to release the sealant. 
     U.S. Pat. No. 7,972,357 to Bettuchi and entitled “Extraluminal sealant applicator and method” and U.S. Pat. No. 7,744,624 disclose apparatus for applying sealant to a target tissue of a surgical site. The apparatus includes a handle, a conduit and an end effector. The handle has means configured and adapted for operating the end effector and dispensing biological sealant to the surgical site via the end effector. The conduit stores and/or carries sealant towards the end effector. The end effector is configured to clamp around a body organ or tissue and apply and confine biological sealant in a substantially uniform manner. More specifically, the references disclose a system for applying sealant to a target tissue of a surgical site, comprising: a two-part sealant comprising a first part and a second part; an apparatus comprising: a handle; an end effector in operative association with the handle, the end effector including a first jaw member, a second jaw member, and a sealant-applying structure configured for applying sealant to the target tissue; the first jaw member being in fluid communication with a first conduit and a second conduit to convey sealant to the sealant-applying structure; the second jaw member being in fluid communication with a third conduit and a fourth conduit to convey sealant to the sealant-applying structure; the first and third conduits configured for conveying the first part of the two-part sealant to the sealant-applying structure; and the second and fourth conduits configured for conveying the second part of the two-part sealant to the sealant-applying structure. The Bettuchi apparatus is bulky and is only capable of applying the sealant on the outside and around the tissue joint, with additional difficulty in precisely targeting the application of the sealant. 
     U.S. Pat. No. 8,096,458 entitled “Pouch used to deliver medication when ruptured” describes a surgical stapling device, comprising: a handle portion; an elongate body portion; and a head portion located at the distal end of the body portion, the head portion including an anvil assembly, a staple cartridge assembly and a knife blade, the staple cartridge assembly having an annular array of staples, the anvil assembly being connected to the body portion along a shaft, the anvil assembly including: an anvil plate defining a plurality of staple forming pockets therein and a recess; and a wound treatment material disposed substantially within the recess. 
     U.S. Pat. No. 8,241,308 entitled “Tissue fastening devices and processes that promote tissue adhesion” discloses a fastener for fastening tissue segments having tissue surfaces, the fastener comprising: a first fastener member defining a fluid opening configured to receive a therapeutic agent, a plurality of fluid ports configured to deliver the therapeutic agent to the tissue segments, and a passageway between the fluid opening and the plurality of fluid ports; and a second fastener member having a substantially flat base and a post extending from the base proximate a center of the base, the post defining an opening for receiving and retaining the first fastener member such that the tissue segments to be fastened are retained between the first and second fastening members, the substantially flat base extending radially beyond a periphery of the post; wherein a longitudinal axis extends through the fluid opening, the fluid ports being radially arranged about the axis. 
     SUMMARY OF THE INVENTION 
     The present invention relates to surgical instruments and a method for applying an adhesive or sealant to an anastomosis site immediately prior and/or during anastomotic surgical stapling. The present invention further relates to surgical instruments, devices, and methods for applying sealant to a target tissue of a surgical site being anastomotically joined so as to prevent leakage. As used herein, sealant is intended to encompass a broad range of biologically compatible materials including tissue adhesives, tissue sealing compositions, etc. 
     The present invention, in one embodiment, relates to a device for applying a two part adhesive or sealant to an anastomosis site prior to stapling with a circular anastomosis surgical stapling instrument, the device having a hollow housing having a top surface and an opposing bottom surface with at least two separate channels within said housing, a plurality of nozzles disposed circumferentially on the top surface and on the bottom surface with the nozzles in fluid communication with the channels, a manifold connector attached to the housing, the connector being in fluid communication with the channels and adapted to be connected to a dual lumen cannula supplying sealant components, and a coupler adapted to mount the device to the circular anastomosis surgical stapling instrument. The coupler can be adapted to mount the device to a shaft between an anvil and a stapling head of the circular anastomosis surgical stapling instrument. The housing can have a generally a semicircular shape, with a housing gap dividing the housing into two housing arms. 
     The present invention, in another embodiment, relates to a method of performing anastomosis by preparing the anastomosis site for performing anastomotic stapling, connecting the manifold connector described above to a multi-lumen cannula, preferably dual lumen cannula, coupling the device to the shaft of circular anastomosis surgical stapling instrument between the anvil and the stapling head of the circular anastomosis surgical stapling instrument, connecting the dual lumen cannula to the source of a two part sealant, delivering the two part sealant from the source via the dual lumen cannula into the device, ejecting the two part sealant from the nozzles, depositing the two part sealant onto the anastomosis site, removing the device from the shaft, firing the circular anastomosis surgical stapling instrument delivering staples and performing anastomosis. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  shows a prospective view of a surgical anastomosis stapling instrument or stapling device for performing a circular anastomosis stapling operation. 
         FIG. 2  shows schematic prospective view of one step during performing low anastomosis of colon to rectum using the anastomotic stapler. 
         FIGS. 3A-3D  shows schematic cross-sectional view of several steps during performing anastomosis using the anastomotic stapler. 
         FIG. 4A  shows a prospective top view, and  FIG. 4B  shows a cross-sectional top view of embodiments of the present invention. 
         FIGS. 4C and 4D  show top views of the present invention. 
         FIG. 4E  shows a dual lumen embodiment. 
         FIGS. 5A-5I  show schematic top views of embodiments of the present invention and installation onto the anastomotic stapler. 
         FIG. 6A-6C  show schematic cross-sectional views of embodiments of the present invention in operation during anastomosis using the anastomotic stapler. 
         FIG. 7  shows schematic cross-sectional view of an embodiment of the present invention in operation during anastomosis using the anastomotic stapler. 
         FIGS. 8A and 8B  show schematic top and bottom views of an embodiment of the present invention. 
         FIG. 9  shows schematic top view of an embodiment of the present invention. 
         FIGS. 10A-10D  show schematic cross-sectional view of an embodiment of the present invention in operation during anastomosis using the anastomotic stapler. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to  FIG. 1 , a generic surgical anastomosis stapling instrument or stapling device for performing a circular anastomosis stapling operation is shown, with the figure taken from the U.S. Pat. No. 5,271,544 “Surgical anastomosis stapling instrument”, assigned to Ethicon, Inc., Somerville, N.J., and incorporated herein by reference in its entirety for all purposes. Various modifications and iterations of the shown stapling device are known in the art, having similar features. The circular anastomosis surgical stapling instrument  50  includes a distal stapling head assembly  60  connected by a longitudinally curved support shaft assembly  70  to a proximal actuator handle assembly  80 . The stapling instrument includes an anvil assembly or anvil  100  which is slidable longitudinally relative to the stapling head assembly  60  and mounted on an axially extending moveable shaft  104 . An optional rotatable adjusting knob  82  is provided at the proximal end of the actuator handle assembly  80  for adjusting the spacing between the stapling head assembly  60  and the anvil assembly  100 . An optional movable indicator  84  is visible through an optional window  85  on top of the handle assembly  80  to indicate the staple height selected by rotation of the adjusting knob  82 . The indicator  84  is movable indicating that the anvil gap is within a desired operating range of the stapling instrument  50 . The position of the indicator  84  also indicates whether the selected staple height is large or small. 
     A staple actuating lever  86  is pivotally mounted on the actuator handle assembly  80  for driving the surgical staples from the stapling head assembly  60  when the anvil assembly  100  is closed to provide the desired staple height. A pivotal latching member  88  is mounted on the handle assembly  80  for locking the staple actuating lever  86  against movement to preclude actuation of the stapling head assembly  60  when the anvil gap is outside of a predetermined range. 
     The anastomosis can be performed by a variety of techniques known in the art. In one exemplary technique, low anastomosis of colon to rectum using the anastomotic stapler is performed. Briefly, and referring to  FIGS. 2 and 3A , after stapler  50  is inserted through the anus (not shown), the descending colon  210  is fixated around anvil  100  with purse string sutures tied around the shaft  104  and the rectal stump  220  is fixated around stapling head  60  with purse string sutures also tied around the shaft  104  resulting in the assembly shown in FIGS.  2  and  3 A-C. Anvil  100  is then pulled towards stapling head  60  as schematically shown in  FIG. 3B , and then the staples  90  are deployed to join the tissue of the descending colon  210  and rectal stump  220  at their respective serosal surfaces, with simultaneous action of circular scalpel (not shown) within the stapler cutting away excessive tissue (inverted bowel) closest to shaft  104 , resulting in anastomosis as shown in  FIG. 3C . Stapler  50  is then removed resulting in anastomotic joint as shown in  FIG. 3D . The diameter of the shaft  104  is shown schematically in  FIG. 3D  by arrows. 
     Referring now to  FIG. 4A  showing a prospective view,  FIG. 4B  showing a prospective cross-sectional view, and  FIGS. 4C-D  showing schematic top view of embodiments of the present invention, a sealant delivery device  300  comprises a hollow housing  301  having in one embodiment a semicircular or open circle or horseshoe shape of diameter  302  (diameter  302  is shown in  FIG. 4D ) with a housing gap  340  separating semicircular arms  310  and  312  having top surface  320  and opposing bottom surface  322 . Other shapes of hollow housing  301  are contemplated, including square, hexagon, polygon, ellipse, and other shapes. Top surface  320  and/or optionally bottom surface  322  as well have arrays of circumferentially oriented exit openings, such as exit apertures, ejection ports, or nozzles  330  and  332  for spraying or ejecting sealant upwards from top surface  320  and optionally downwards from bottom surface  322 , either perpendicularly or under angle to top surface  320  and bottom surface  322 . Nozzles  330  and  332  comprise passages connecting channels  360  and  362  to top surface  320  and opposing bottom surface  322 . In certain embodiments nozzles  330  and  332  are represented by vias formed in top surface  320  and bottom surface  322  perpendicularly or under angle to top surface  320  and bottom surface  322  and providing connection of channels  360  and  362  to surfaces of housing  301 . In a preferred embodiment, first component nozzles  330  are used to deliver a first component of a two-part sealant, and second component nozzles  332  are used to deliver a second component of the two-part sealant, with both components sprayed simultaneously, mixing at or near the serosal surfaces. No mixing of components of the two-part sealant occurs inside sealant delivery device  300 . In one embodiment, nozzles  330  and  332  are all positioned only on one surface of hollow housing  301 , such as only on top surface  320  or only on bottom surface  322 . 
     A manifold connector  350 , either integrally formed on housing  301  or attached to housing  301  is adapted to be connected to the sealant components supply line, with two separate conduits or channels  360  and  362  running within housing  301  inside and along circular or semicircular arms  310  and  312  and having an entrance inside manifold connector  350 . Channels  360  and  362  are in fluid communication with nozzles  330  and  332  respectively but are completely separated from each other within housing  301 . In one embodiment, nozzles  330  and  332  are positioned in an interdigitated arrangement along the circumference of arms  310  and  312  as shown in  FIGS. 4A-4C , with nozzle  330  for the first component followed along the circumference with nozzle  332  for the second component and so on. In another embodiment, nozzles  330  and  332  are positioned in an arrangement shown in  FIG. 4D  wherein pairs of nozzles  330  and  332  are positioned at the approximately same angular locations around the circumference of arms  310  and  312 . Other ways of positioning of nozzles  330  and  332  around the circumference of arms  310  and  312  providing for a good mixing and good coverage of the serosal surfaces are possible, such as, for instance, two nozzles  330  followed by one nozzle  332 , etc. (not shown). 
     A flexible dual lumen conduit or cannula  400 , with one embodiment schematically shown in  FIG. 4E , having at least two or optionally more than two lumens  401  and  402  can be connected to manifold connector  350  providing supply of first component of the two-part sealant to channel  360  and of second component of the two-part sealant to channel  362  without mixing of the components within sealant delivery device  300  (not shown in  FIG. 4E ). Optionally protruding connectors  411  and  412  (having a circular, semi-circular, rectangular, or any other appropriate shape to match up with the channels  360  and  362  having corresponding and matching shape) on manifold connector  350  provide a liquid tight seal and connection between lumens  401  and  402  of dual lumen cannula  400  and channels  360  and  362  of sealant delivery device  300 . Dual lumen cannula  400  can be further coupled at the distal end  405  to a source of two-part sealant, such as a two-barrel syringe (not shown). 
     An optional locking feature  420  can be provided on dual lumen cannula  400  with a protrusion  421  adapted to fit into slot  423  on manifold connector  350 . Locking feature  420  enables establishing locked connection of dual lumen cannula  400  to sealant delivery device  300  in registration of channels  360  and  362  connected to lumens  401  and  402  via protruding connectors  411  and  412 . Other designs of locking feature  420  are possible and easily designed by a person skilled in the art. In another embodiment protruding connectors  411  and  412  have different sizes and/or shapes uniquely mating to lumens  401  and  402  resulting in connection of dual lumen cannula  400  to manifold connector  350  only possible with mating corresponding protruding connector to corresponding lumens, such as connector  411  to lumen  401  and connector  412  to lumen  402 . In one embodiment, connector  411  and lumen  401  have circular cross-section, while connector  412  and lumen  402  have square cross-section. In one embodiment, markings such as arrows  430  and  431  are positioned on dual lumen cannula  400  and manifold connector  350  to facilitate connecting dual lumen cannula  400  to manifold connector  350  in registration. 
     An optional connector  370  is positioned on sealant delivery device  300 . A tether  371  (shown in  FIG. 4C ) such as a lanyard, suture, or any flexible string, can be used so that the device can be easily removed after delivering the solutions of first component and second component of the two-part sealant (such as fibrinogen and thrombin) and just prior to firing the stapler. 
     In some embodiments, to provide for a better coverage of the area corresponding to housing gap  340  separating semicircular arms  310  and  312 , higher density of nozzles is provided in the areas immediately close to housing gap  340 , as shown in  FIG. 4D . 
     As illustrated in  FIGS. 4A-D , a coupler  382  is positioned substantially at the center of sealant delivery device  300 . Coupler  382  is adapted to enable removable positioning of sealant delivery device  300  onto shaft  104  in the area between serosal surfaces which are about to be joined together by stapling, said area generally indicated by horizontal arrows on  FIG. 2  and  FIG. 3A . In some embodiments, coupler  382  has a generally semicircular or horseshoe shape formed by arms  380  separated by a coupler gap  384  with internal diameter  389  of coupler opening  385  in the coupler  382  substantially equal or smaller by 0.1-20% than the diameter of shaft  104 . Coupler  382  can be quickly snappably affixed or locked onto and when needed removed from shaft  104 . In one embodiment internal diameter  389  of coupler opening  385  is equal to diameter of shaft  104 . 
     Coupler gap  384  has the dimensions to enable removable positioning of sealant delivery device  300  onto shaft  104 . In some embodiments, the dimension of coupler gap  384  is selected to enable sealant delivery device  300  to be snappably affixed or locked onto and when needed removed from shaft  104 . In some embodiments, the dimension of coupler gap  384  is equal to diameter of shaft  104 , or smaller than the diameter of shaft  104  by 1% to 50%. In one embodiment, the dimension of coupler gap  384  is equal to 70% or 90% the diameter of shaft  104 . In some embodiments, coupler arms  380  are flexible enough to accommodate passing of shaft  104  through coupler gap  384  when positioning sealant delivery device  300  onto shaft  104  and when removing sealant delivery device  300  from shaft  104 . 
     In some embodiments, housing gap  340  has the dimensions so as to enable easy passage of shaft  104  when affixing sealant delivery device  300  to shaft  104  and when removing sealant delivery device  300  from shaft  104 . In some embodiments, the dimension of housing gap  340  is equal to diameter of shaft  104 , or larger than the diameter of shaft  104  by 1% to 30%. In one embodiment, the dimension of housing gap  340  is equal to 110% of the diameter of shaft  104 . In some embodiments, the dimension of housing gap  340  is smaller than the diameter of shaft  104  by 1% to 75%. 
       FIG. 5A  shows installation of sealant delivery device  300  on shaft  104  with shaft  104  just past housing gap  340 .  FIG. 5B  shows installation of sealant delivery device  300  on shaft  104  with shaft  104  passed through coupler gap  384  and is within coupler opening  385  snappably affixed to coupler  382 . 
     Referring now to  FIG. 5C-5E , in some embodiments, housing gap  340  has the dimensions ranging from substantially zero to about 90% of the diameter of shaft  104 . In such embodiments, arms  310  and  312  are sufficiently flexible or moveable on optional hinges  319  to open wide enough to accommodate passing of shaft  104  through housing gap  340  when positioning sealant delivery device  300  onto shaft  104  and when removing sealant delivery device  300  from shaft  104 .  FIG. 5C  shows sealant delivery device  300  and shaft  104  prior to attaching;  FIG. 5D  shows sealant delivery device  300  being attached onto shaft  104  with arms  310  and  312  opening to at least the diameter of shaft  104  to accommodate passage of shaft  104 ;  FIG. 5E  shows sealant delivery device  300  fully attached to shaft  104  in position for sealant delivery with arms  310  and  312  fully closed and housing gap  340  very small or substantially zero. Advantageously, this embodiment enables full circular coverage of serosal surfaces with sealant due to very small housing gap  340 . Nozzles  330  and  332  are not shown in  FIGS. 5C-5E . 
     Referring now to  FIG. 5F , an embodiment of the present invention is shown whereby coupler is integrated into sealant delivery device  300  as a radial cutout  341 . In this embodiment, sealant delivery device  300  has housing  301  having polygonal, elliptical, disk, or any other shape, with shape of a disk shown in  FIG. 5F , with a radial cutout  341  extending from periphery of housing  301  to the center of housing  301 , with housing gap  340  transitioning into coupler gap  384  both having dimensions approximately equal to diameter of shaft  104 . Optionally one or more locking elements  386  are provided to enable snappable attachment to shaft  104  and securement of shaft  104  in the center of device  300 . Optional locking element  386  represents a small protrusion or bump within radial cutout  341 , which requires additional force for shaft  104  to pass over during sealant delivery device  300  installation onto shaft  104  or removal from shaft  104 . In certain embodiments there are 1 or 2 locking elements  386  which can have height from 0.1 to 2 mm, such as 0.5 mm. 
     Referring now to  FIGS. 5G-I , an embodiment of the present invention is shown whereby, similarly to embodiments  5 C-E, housing gap  340  has the dimensions substantially close to zero, and similarly to embodiment  5 F, coupler is integrated into sealant delivery device  300  as coupler opening  385  formed by semicircular cutouts in arms  310  and  312 . In this embodiment, arms  310  and  312  are sufficiently moveable on optional hinges  319  providing enough flexibility to open wide enough to accommodate passing of shaft  104  through housing gap  340  when positioning sealant delivery device  300  onto shaft  104  and when removing sealant delivery device  300  from shaft  104 .  FIG. 5G  shows sealant delivery device  300  and shaft  104  prior to attaching;  FIG. 5H  shows sealant delivery device  300  being attached onto shaft  104  with arms  310  and  312  opening to at least the diameter of shaft  104  to accommodate passage of shaft  104 ;  FIG. 5I  shows sealant delivery device  300  fully attached onto shaft  104  in position for sealant delivery with arms  310  and  312  fully closed and housing gap  340  very small or substantially zero. Advantageously, this embodiment enables full circular coverage of serosal surfaces with sealant due to very small housing gap  340 . 
     Referring now to  FIG. 6 , the positioning of sealant delivery device  300  onto shaft  104  in the area between serosal surfaces which are about to be stapled is further illustrated, with positioning being similar to the areas indicated by horizontal arrows on  FIG. 2  and  FIG. 3A . Referring to  FIGS. 6A-6C , sealant delivery device  300   a ,  300   b , and  300   c  is positioned on shaft  104  between serosal surfaces  211  and  221  which are about to be anastomotically stapled together as shown in sequences In  FIGS. 3A-3D . Dual lumen cannula  400  is shown connected to sealant delivery device  300  for delivery of two part sealant.  FIG. 6A  shows sealant delivery device  300   a  having diameter Da smaller vs. the diameter of the tubular tissue structure (such as descending colon  210  and rectal stump  220 ), or alternatively similar to anvil  100  diameter.  FIG. 6B  shows sealant delivery device  300   b  having diameter Db about equal to the diameter of the tubular tissue structure (such as descending colon  210  and rectal stump  220 ), or larger than anvil  100  diameter.  FIG. 6C  shows sealant delivery device  300   c  having diameter Dc larger than the diameter of the tubular tissue structure (such as descending colon  210  and rectal stump  220 ), or alternatively much larger relative to anvil  100  diameter. The direction of the spray of the components of the two-part sealant from ejection ports or nozzles  332  and  330  (not shown) is schematically indicated by arrows. 
     For optimized coverage, in some embodiments nozzles are directing spray at 90 degrees or perpendicular to top surface  320  and bottom surface  322 . In some embodiments, nozzles can direct spray at 45-80 degrees relative to top surface  320  and bottom surface  322 , with the direction of spray towards serosal surfaces. As can be seen from schematic representation in  FIG. 6 , for optimal coverage, in some embodiments nozzles  332  and  330  are directed orthogonally to sealant delivery device  300  with sprays perpendicular to top surface  320  and bottom surface  322 . In certain embodiments, nozzles  332  and  330  are directed angularly for better coverage. 
     Referring now to  FIG. 7 , the spray arrows directed substantially perpendicularly to top surface  320  and bottom surface  322  to show the spray coverage mostly to areas  217  i.e. to serosal surface about to be stapled together. The spray arrows directed angularly show that in this case the spray coverage is not limited to areas  217  but also covers areas  218  which are in immediate vicinity of the anastomosis. Advantageously, after stapling, sealant from areas  218  provides additional securement and sealing of the anastomotic joint, in addition to the sealant deposited in the areas  217 . 
     In addition to the angular direction of nozzles as shown in  FIG. 7 , in some embodiments nozzles  332  and  330  are directed angularly for better overlap of deposition between first component and second component of sealant, so that the area onto which the first component spray is directed is also covered by the second component and vice versa (not shown in  FIG. 7 ). 
     In some embodiments, nozzles  332  and  330  are made larger and/or denser as they go further from manifold  350  to make the spray more uniform to accommodate drop in pressure along arms  310  and  312 .  FIG. 8  shows higher density of nozzles  330 ,  332  in the proximity to housing gap  340 , farthest away from manifold  350 . 
     In one embodiment (not shown), nozzles  332  and  330  close to housing gap  340  are aimed angularly so that some spray also covers the area on serosal surfaces corresponding to housing gap  340  between arms  310  and  312 . 
     In use, after the surgical site is ready for performing anastomotic stapling, for example after purse string sutures have been applied to the tubular segments and prior to stapling, sealant delivery device  300  is connected to dual lumen cannula  400  at manifold  350  and fixably positioned onto shaft  104 , dual lumen cannula  400  is connected to the source of two part sealant, the two part sealant is delivered to sealant delivery device  300  and ejected or sprayed from nozzles  330  and  332  simultaneously or sequentially to the serosal surfaces which are about to be stapled together, such as, in one example, towards proximal colon and distal colon, or in another example, descending colon  210  and rectal stump  220 , resulting in coating of the serosal surfaces. Sealant delivery device  300  is then removed from shaft  104  by pulling on dual lumen cannula  400  or by using lanyard or tether  371  attached to lanyard or tether connector  370 . Surgical stapling instrument  50  is then fired delivering staples and performing anastomosis. 
     The two part sealant, such as for instance a sealant comprising fibrinogen and thrombin, is expected to cure or cross-link immediately before, during, and after firing of staples, with at least some curing and preferably most of the curing occurring after the deployment of staples. Timing of curing can be varied and changed according to the surgeons&#39; preferences. Advantageously, during stapling, some sealant will be driven between individual staple sites, and along staple lines and tissue seams to fill remaining cavities, holes, non-uniformities, and pores, thus improving the quality of the seal and preventing anastomotic leaks. 
     Referring to  FIG. 8 , in one embodiment, only the first component, e.g. either fibrinogen or thrombin, of a two part sealant is sprayed from top surface  320  and only the second component, e.g. either thrombin or fibrinogen is sprayed from bottom surface  322 . As shown in  FIG. 8A , in the top view of sealant delivery device  300  there are only nozzles  330  on top surface  320  to deliver the first component. As shown in  FIG. 8B , in the bottom view of sealant delivery device  300  there are only nozzles  332  on bottom surface  322  to deliver the second component. The nozzles location and their respective delivery angles facilitate deposition of first component, such as fibrinogen onto one serosal surface and second component, such as thrombin onto another serosal surface. In this embodiment, the solutions are prevented from reacting with one another until the device  300  is removed and stapling occurs. Advantageously, there is more time to perform necessary preparations for stapling without the threat of premature reacting of the two part sealant, such as premature formation of fibrin. 
     Referring now to  FIG. 9 , in one embodiment, sealant delivery device  300  is adapted to not being removed from shaft  104  before stapling, but only being disconnected from dual lumen cannula  400  (not shown) supplying two part sealant, such as fibrinogen and thrombin. In this embodiment, sealant delivery device  300  is affixed onto shaft  104  via a circular opening  390 , and manifold has a low profile and is embedded into housing  301  forming a port  351 . Diameter of circular opening  390  is substantially equal to or slightly greater than diameter of shaft  104  to ensure a good fit with possibility of slidable repositioning. In this embodiment, sealant delivery device  300  stays on shaft  104  during and after stapling and action of the circular cutter removing excess of the inverted bowel. Sealant delivery device  300  is removed together with surgical stapling instrument  50 . 
     Referring now to  FIG. 10 , the operation of this embodiment during anastomosis is further illustrated. As shown in  FIG. 10A , sealant delivery device  300  is connected to dual lumen cannula  400 , dual lumen cannula  400  is used to deliver two part sealant to serosal surfaces  221  and  211 , after which dual lumen cannula  400  is separated from port  351  and removed from the surgical site, and immediately thereafter anvil  100  is approximated to stapling head assembly  60 , as shown in  FIG. 10B . Advantageously, the thickness of sealant delivery device  300  is less than the thickness of layers of tissue being stapled, and the diameter  302  of sealant delivery device  300  is smaller than the cut performed by circular cutter (not shown) removing excess of the inverted bowel. As shown in  FIG. 10C , sealant delivery device  300  is positioned between anvil  100  and stapling head assembly  60  after staples  90  are deployed (with the tissue of the inverted bowel removed by circular cutter not shown). As shown in  FIG. 10D , sealant delivery device  300  stays attached to surgical stapling instrument  50  after surgical stapling instrument  50  is removed. 
     In certain embodiments, the diameter of the hollow housing  301  is from about 8 mm to about 40 mm, such as 15 mm or 25 mm. In certain embodiments, the diameter of the coupler opening  385  is from about 4 mm to about 15 mm, such as 5 mm or 7 mm. In certain embodiments, housing gap  340  has the dimensions from zero to about 15 mm, more preferably from 1 mm to about 12 mm, such as 4 mm, 5 mm, or 6 mm. In certain embodiments, coupler gap  384  has the dimensions from zero to about 10 mm, more preferably from 1 mm to about 12 mm, such as 3 mm, 4 mm, or 5 mm. In certain embodiments, thickness of the hollow housing  301  is from about 1 mm to about 5 mm, more preferably 2 mm to 3 mm, such as 2.5 mm. In certain embodiments, the width of arms  310  and  312  is from about 2 mm to about 8 mm, such as 3 mm or 5 mm. In certain embodiments, channels  360  and  362  have cross-sectional area of from about 0.25 mm 2  to about 10 mm 2 , such as 0.5 mm 2 , 1 mm 2  or 2 mm 2 . In certain embodiments, nozzles  330  and  332  have diameter of from 0.1 mm to 1 mm, such as 0.3 mm, 0.5 mm. In certain embodiments, there are 5 to 20 nozzles  330  and 5 to 20 nozzles  332  on top surface  320  and the same amount of nozzles on bottom surface  322 . In some embodiments there are 10 nozzles  330  and 10 nozzles  332  on top surface  320  and same amount of nozzles on bottom surface  322 . In some embodiments there are 10 or more nozzles  330  on top surface  320  and 10 or more nozzles  332  on bottom surface  322 , with no nozzles  332  on top surface  320  and no nozzles  330  on bottom surface  322 . In some embodiments nozzles  330  and  332  are spaced equidistantly from each other in a circumferential arrangement on the periphery of hollow housing  301 , with distance between neighboring nozzles of the same type being from 2 mm to about 6 mm, such as 4 mm. 
     Advantageously, different sized and configurations of sealant delivery device  300  can be utilized with the same type of circular anastomosis surgical stapling instrument  50 , thus providing the surgeon with the possibility to accommodate different anatomical dimensions and individual requirements for performing anastomosis. 
     Sealant delivery device  300  can be made by machining, injection molding, additive or rapid prototyping techniques, such as 3D printing, and other methods known in the art. The device materials are typically biocompatible polymeric materials, such as polyethylene, PET, polypropylene, Teflon or PTFE, silicone, or biocompatible metal such as stainless steel or nitinol, and other materials known in the art. Nozzles  330  and  332  can be made by any known techniques, such as drilling, laser machining, or molding apertures in place. 
     Two-part sealant is preferably a biologically compatible sealant, such as synthetic sealant or biologics-based sealant, such as for example fibrin glue which comprises fibrinogen, thrombin, and optionally any other additives such as stabilizers, thickeners, growth factors, fibrinolytic inhibitors etc. as known in the art. Thickeners can be added to fibrinogen and/or thrombin solutions to increase viscosity. The increased viscosity will reduce any run-off of the solutions from the serosal surfaces and allow for better targeting. Alternatively very low temperature of the solution (such as 5° C.) can be used which makes it both viscous and slower to react. Fibrinogen and thrombin solutions can be used in a variety of mixing ratios, such as 1:1 fibrinogen: thrombin or 2:1 or 5:1 or 10:1 or 20:1 or 50:1. Having lower concentration of thrombin can be advantageous to reduce curing or reaction rate so that most of reaction will occur after the firing of the stapling instrument  50 . Examples of two part sealant include, EVICEL® Fibrin Sealant (Human), available from Johnson &amp; Johnson Wound Management Worldwide, a division of Ethicon, Inc., Somerville, N.J.; TISSEEL Fibrin sealant, Baxter Healthcare Corporation, Westlake Village, Calif.; other sources of fibrin sealant such as animal sourced or recombinant fibrinogen and/or thrombin. 
     Example 1 
     A sealant delivery device according to embodiments shown in  FIGS. 4A-B  was made of polymeric material by using rapid prototyping techniques, with diameter of the hollow housing  301  being 19 mm; diameter of the coupler opening  385  being 6 mm; size of the housing gap  340  being 5.5 mm; size of the coupler gap  384  being 3.5 mm; the width of arms  310  and  312  being 3.5 mm; the thickness of the hollow housing  301  being 2.5 mm. The device had ten nozzles  330  and eleven nozzles  332  on top surface  320  and the same amount of nozzles on the bottom surface  322 . The sealant delivery device was then tested by affixing it to a circular surgical stapling instrument and supplying EVICEL® Fibrin Sealant (Human), available from Johnson &amp; Johnson Wound Management Worldwide, a division of Ethicon, Inc., Somerville, N.J. to the sealant delivery device via a two lumen cannula  400 , resulting in spraying of the two part sealant in direction perpendicular to top surface  320  and bottom surface  322  and towards model serosal surfaces. The connection was made in a way that ensured coupling of lumens to ports on the device. It was observed that the sealant delivery device did not clog and successfully ejected and sprayed components of two part sealant, which formed fibrin on the model serosal surfaces. 
     While the invention has been described above with reference to specific embodiments thereof, it is apparent that many changes, modifications, and variations can be made without departing from the inventive concept disclosed herein. Accordingly, it is intended to embrace all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims. All patent applications, patents, and other publications cited herein are incorporated by reference in their entirety.