Abstract:
A device for producing anastomoses between a first hollow organ and a second hollow organ including a sheath and an adhesive applicator that can be positioned next to the sheath in order to apply an adhesive to the adhesive bonding section. A method for producing anastomoses between a first hollow organ and a second hollow organ includes folding the first hollow organ over a sheath, positioning the second hollow organ over the first hollow organ, producing a first connection between the hollow organs by applying a high frequency (RF) voltage, and producing a second connection between the hollow organs by applying a tissue adhesive.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to PCT/EP 2010/004259, filed Jul. 13, 2010 and published as WO 2011/006639, which claims priority to DE102009032972.2, filed Jul. 14, 2009. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The disclosed embodiments relate to surgical instruments, and more particularly to surgical instruments used to form anastomoses. 
       BACKGROUND OF THE INVENTION 
       [0003]    An anastomosis is a connection between two anatomical structures. For example, in the course of an organ transplantation, severed blood vessels can be connected with each other by means of anastomoses. 
         [0004]    Various methods for producing such anastomoses in surgery are known. The connection can be produced with the use of suturing techniques. Furthermore, there are approaches that allow the organic connection with the use of adhesion techniques. In one example, fibrin sealants are used, thus making possible the highly advantageous connection of organs, in particular hollow organs. However, the tolerability of these sealants or glues is problematic because they may exhibit thrombogenic and toxic properties. 
         [0005]    Clamping techniques have also been used to provide a connection at a suitable site. Various aids such as rings, cuffs or stents have been used to aid in producing anastomoses. The disadvantage of these clamping techniques is that they generally remain in the hollow organ to be connected and can trigger rejection reactions and there is also danger of the formation of a thrombus. 
         [0006]    From publication WO 03/061487 A1 it is known to connect hollow organs with the application of a suitable high-frequency current (RF current). When the RF current is being applied the tissue structures are being welded together. The cell substance coagulates causing the protein structures to be welded together, so that a controlled, safe, and fast connection can be produced. For the application of the RF current, publication WO 03/061487 A1 describes an instrument comprising an interior sheath and an exterior sheath. Each of these sheaths comprises an electrode which is annular in shape and to which a suitable RF voltage can be applied. Consequently, this is a bipolar electrosurgical instrument. For connecting the ends or end sections of a blood vessel, the first end is passed through the interior sheath and folded over in such a manner that the tissue comes to be placed on the outside of the interior sheath. The second end of the vessel is pulled over the interior sheath and pulled onto the end section of the blood vessel located thereon. The exterior sheath can be opened and slipped over the interior sheath and the tissue located thereon. Consequently, the exterior sheath forms a type of cuff that encloses the individual end sections of the blood vessel. Both the interior sheath and the exterior sheath have an electrode for the application of the RF current. These electrodes are located opposite each other. When the RF current is being applied it flows through the tissue, i.e., the superimposed end sections, thus welding the vessel in place. One problem of the technique described in WO 03/061487 A1 is that the produced connections are frequently not sufficiently stable. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The disclosed embodiments relate to a device for producing anastomoses as well as to a method for producing anastomoses. It is the object of the disclosed embodiments to provide a device for producing an anastomosis between a first and a second hollow organ, that is simple to operate and is suitable for producing high-quality anastomoses. 
         [0008]    In one embodiment the anastomoses device produces one or more anastomoses between a first hollow organ and a second hollow organ, where each of the hollow organs has an outer surface and an inner surface. In another embodiment, the anastomoses device includes a sheath, over which the first hollow organ can be folded in such a manner that at least one adhesive bonding section of the inner surface of the first hollow organ comes to be located on the outside and on which the second hollow organ can be positioned over the first hollow organ. 
         [0009]    The device may also include an adhesive applicator that can be positioned next to the sheath in order to apply an adhesive to the adhesive bonding section. The adhesive applicator may also facilitate the application of the adhesive. In one disclosed embodiment of the anastomoses device, the sheath acts as the holding device to initially fixate and/or position at least the first hollow organ, for example a blood vessel, in such a manner that the adhesive can be applied. At least a part of the adhesive applicator is positioned next to the sheath for the application of the adhesive. This part may be a nozzle or an outlet that can preferably be arranged opposite the bonding section or the adhesive bonding section so that a preferably direct application of the adhesive thereto can be accomplished. In one embodiment, the adhesive is applied to a section of the folded over inner surface of the first follow organ, namely the bonding section. During a subsequent step, this bonding section may be glued to a section of the inner surface of the second hollow organ. 
         [0010]    In accordance with one disclosed embodiment, the anastomoses device can be used for first applying adhesive to the first hollow organ, and then the second hollow organ can be pulled over the first hollow organ. In another embodiment, the first and the second hollow organs can first be positioned, and then the adhesive can be applied to the bonding section. It is a particular feature of the disclosed embodiments that the anastomoses device allows for local, exactly positioned, application of the adhesive. 
         [0011]    The anastomoses device may comprise a guide, in which the adhesive applicator or parts of the adhesive applicator are arranged so as to be movable between an accommodation position for accommodating at least the first hollow organ through the sheath and an application position for applying the adhesive. For inserting the first hollow organ into the sheath and for the fold-over procedure it is necessary that sufficient space be available. Therefore, it is advantageous if interfering parts of the adhesive applicator are arranged so that they can be moved back and forth in order to space them sufficiently apart from the sheath when the hollow organ is being accommodated. 
         [0012]    In the application position, the first hollow organ can be held in place between the adhesive applicator and the sheath. Consequently, in one embodiment, it is advantageous for the guide of the adhesive applicator to be configured such that at least part of the adhesive applicator may act to fix the first hollow organ in place between the adhesive applicator and the sheath so that the hollow organ cannot slide out of the device. 
         [0013]    For introducing the adhesive between the first and the second hollow organs, the adhesive applicator may include at least one adhesive channel. The adhesive channel may be an adhesive capillary. In one embodiment at least one end section of the adhesive channel is arranged or can be arranged essentially parallel to the sheath. Thus, after positioning the first and the second hollow organs in an overlapping region, the adhesive may be introduced between these organs. In one embodiment, this is an overlapping of the inner surfaces of the two hollow organs. 
         [0014]    In another embodiment, the anastomoses device may have at least two adhesive channels that are at a defined distance from each other and can be alternately positioned on the sheath. It is advantageous if several adhesive channels are available for the application of adhesive on different sides of the sheath. In one embodiment, there are two adhesive channels that can be alternately positioned on the sheath. The guide may be designed appropriately for such positioning. 
         [0015]    The at least one adhesive channel may have a flattened end for the application of the adhesive. This means that the end section of the adhesive channel that is to be used for the application of the adhesive to the tissue, is to act in particular on the inner surface of the first hollow organ so that the second hollow organ can be slipped over without problems. In one embodiment, the device for producing anastomoses makes it possible to first receive the first hollow organ, then provide the adhesive applicator at the appropriate site, and, thereafter, position the second hollow organ. Consequently, no great effort is required for inserting the adhesive applicator between the hollow organs. In one embodiment, the position of the adhesive applicator can be monitored visually. 
         [0016]    The adhesive channel may include at least one abutment for positioning the second hollow organ or a section thereof in the longitudinal direction of the sheath. The longitudinal direction of the sheath is defined by the two orifices that connect the sheath channel with each other and that receive the first hollow organ. After positioning the first hollow organ, positioning of the second hollow organ may pose problems. Therefore, in one embodiment, the adhesive applicator features an abutment that, when the second hollow organ is being slipped over the sheath and over the first hollow organ, prevents any poor positioning such as the open ends of the hollow organs not being parallel to each other. 
         [0017]    The adhesive channel may include an elbow section having, in particular, an inside angle less than or equal to 90 degrees as the abutment for the second hollow organ. In one embodiment, the at least one adhesive channel has a deformation where the second hollow organ can be positioned. 
         [0018]    The sheath can be held on an actuating device and be designed in such a manner that it can be disassembled into at least two parts such that the parts can be moved from a closed state for the formation of an essentially closed pipe section into an open state for removing the connected hollow organ. When the first hollow organ is being accommodated it can be advantageous if the sheath can be disassembled. In one embodiment, after connecting the two hollow organs to form one hollow organ, it must be possible to either disassemble or disconnect the sheath in order to remove the device from the hollow organ. 
         [0019]    The anastomoses device may comprise a compression ring that is arranged so as to enclose the sheath, at least in sections, or be arranged in order to fixate the hollow organs, in compression position, in place between the compression ring and the sheath. The compression ring also has the advantage that it holds the hollow organs in place on the sheath. In one embodiment, the compression ring can be arranged and designed in such a manner that it holds the hollow organs in intimate contact with each other such that no adhesive may penetrate through a compression gap between the hollow organs. Therefore, an accommodation region for the adhesive can be created, said region being sealed relative to the interior region of the hollow organs. 
         [0020]    In one embodiment, the anastomoses device is an electrosurgical device that comprises electrodes. The sheath may comprise an interior electrode, and the compression ring may comprise an exterior electrode for the application of an RF current. In another embodiment, the anastomoses device may be used to produce a first connection as a result of the applied RF current and a second connection as a result of the adhesive. It has been found that bipolar anastomoses of vessels in adaptation to Payr&#39;s Cuff technique display only limited tensile strength. In order to eliminate this disadvantage, the disclosed embodiments provide that an additional adhesive connection be provided, the connection connecting additional sections, in particular in the region of the end sections of the hollow organs, and thus increasing the strength of the overall connection. In one embodiment, the RF current can be applied by means of the compression ring. Following the application of the RF current and the resultant first continuous connection of the organs, the adhesive may be introduced. The produced welding connection may act as a delimiting feature so that the adhesive will not spread further into the organ that is to be connected. 
         [0021]    The adhesive applicator may be detachably connected to the device, thus making device handling easier. In one embodiment, known RF instruments are upgraded with the adhesive applicator in accordance with the disclosed embodiments. Furthermore, it is possible to attach the potentially interfering adhesive applicator to the device only when said applicator is required. For example, in one embodiment, attaching the adhesive applicator may only be advantageous when a welding connection has already formed between the organs with the use of RF current. 
         [0022]    The adhesive applicator may include a feed line of non-adhesive material. For example, the non-adhesive material may be polytetrafluoroethylene (PTFE). An appropriate selection of material can prevent the adhesive from clogging the feed line. 
         [0023]    The adhesive applicator may include an adhesive reservoir and a compressor for the application of the adhesive. The compressor is used to provide a propellant by means of which the adhesive is driven through the feed line so that the adhesive can be applied at a suitable site of the hollow organs. The compressor may be a syringe. 
         [0024]    The disclosed embodiments also include a method for producing anastomoses between a first hollow organ and a second hollow organ, where each of the hollow organs has an inner surface. The method in accordance with the disclosed embodiments may include a folding over of the first hollow organ over a sheath, so that at least one adhesive bonding section of the inside surface of the first hollow organ comes to be on the outside. Furthermore, the method may include a positioning of the second hollow organ over the first hollow organ and a formation of a first connection with the hollow organs. The first connection may include applying an RF voltage. A second connection may be produced between the hollow organs by applying a tissue adhesive. 
         [0025]    In one embodiment, the tissue adhesive is introduced between the superimposed hollow organs. The tissue bonding section may be covered, at least in sections, with the tissue adhesive. The method, in accordance with the disclosed embodiments, may result in the formation of two connections between the hollow organs. In one embodiment, the first connection is due to electrosurgical coagulation, whereas the second connection is produced by chemical means. Due to this dual connection, the produced anastomosis can be subjected to substantially more strain, in particular to more tensile forces than were previously attainable. 
         [0026]    The first connection can include the application of the RF voltage to the sheath, in particular an interior electrode of the sheath, and an exterior electrode. In one embodiment, the exterior electrode contacts at least one of the hollow organs so that an applied RF current passes through the hollow organs, thus connecting them to each other. 
         [0027]    The method can include an application of a compression ring and an application of a predefined force by means of the compression ring. The compression ring can be used to fixate the hollow organs in place on the sheath so that the organs are held in the prespecified position. Furthermore, the compression ring can be used for applying a predefined force that aids the formation of the first connection. The compression ring may also ensure that, while the second connection is being produced, the tissue adhesive does not enter the inside/lumen of the hollow organ(s). 
         [0028]    In one embodiment, the second connection can be produced by injecting the tissue adhesive into an intermediate space between the hollow organs. While the tissue adhesive is being injected, the compression ring may be particularly helpful because it holds the hollow organs together in a fluid-tight manner relative to the outside region. 
         [0029]    In one example, the second connection may be produced after the first connection has been produced. To this extent, the aforementioned effect can be utilized in a particularly positive manner. The first connection can be produced in such a manner that an adhesive region remains between the first and the second hollow organs for the accommodation of the tissue adhesive, in which case the adhesive region is sealed in a fluid-tight manner relative to the inside region of the hollow organs. 
         [0030]    The adhesive region may be a region between the hollow organs, said region being located distally to the first connection (i.e., on the side on which the hollow organs are open). This adhesive region may include the already mentioned adhesive bonding section, for example. The connection produced with the use of RF coagulation may seal the hollow organs in such a manner that the adhesive cannot penetrate into the lumen. Preventing penetration into the lumen, may be ensured even if the adhesive is injected into the adhesive region at a relatively high pressure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0031]      FIG. 1  is an adhesive applicator in accordance with a disclosed embodiment; 
           [0032]      FIG. 2  is a side view of the distal end of an adhesive applicator in accordance with  FIG. 1 ; 
           [0033]      FIG. 3  is a side view of the distal end of an adhesive applicator in accordance with  FIG. 1 ; 
           [0034]      FIG. 4  is an electrosurgical instrument for producing anastomoses with an adhesive applicator in accordance with  FIG. 1 , showing the adhesive applicator being positioned on the instrument; 
           [0035]      FIG. 5  is an electrosurgical instrument for producing anastomoses with an adhesive applicator in accordance with  FIG. 1 , showing the adhesive applicator being positioned on the instrument; 
           [0036]      FIG. 6  is an electrosurgical instrument in accordance with  FIG. 5 , showing the adhesive applicator in position; 
           [0037]      FIG. 7  is an electrosurgical instrument in accordance with  FIG. 6 , showing the compression forceps opened; 
           [0038]      FIG. 8  is an electrosurgical instrument in accordance with  FIG. 6 , showing the compression forceps closed; 
           [0039]      FIG. 9  is a schematic representation of the longitudinal section of a device for producing anastomoses in accordance with a disclosed embodiment; and 
           [0040]      FIG. 10  is a schematic representation in accordance with  FIG. 9 , showing the instrument being removed. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]    In the description hereinafter, the same reference signs are used for the same parts and for parts having the same function. 
         [0042]      FIG. 1  shows an adhesive applicator  10  that can be detachably connected to a device for producing anastomoses, e.g., an electrosurgical instrument  1  ( FIGS. 4 through 8 ). 
         [0043]    The adhesive applicator  10  includes an adapter  19  with adhesive capillaries  12 ,  12 ′, a feed pipe  18 , and a coupling piece  20 . The coupling piece  20  represents the proximal end of the adhesive applicator  10 , whereby the coupling piece  20  is connected with the adhesive capillaries  12 ,  12 ′ via the feed pipe  18  and a feed line  17 . The coupling piece  20  may be Y-shaped and includes an adhesive connecting orifice  21  and a propellant connecting orifice  25 . Via the adhesive connecting orifice  21 , an adhesive can be introduced into the feed pipe  28 . A propellant may be pumped into the feed pipe  18  via the propellant connecting orifice  25  in a time-delayed manner driving the adhesive through the feed pipe  18  in the direction toward the distal end of the adhesive applicator  10 . In one embodiment, the adhesive capillaries  12 ,  12 ′ and/or the feed line  17  consist of stainless steel, and the feed pipe  18  is made of non-adhesive material such as, for example, PTFE. In one embodiment, the feed pipe  18  is flexible and has a length of not more than 50 cm. Preferably, the feed pipe  18  has a length of 10 cm to 30 cm. Any adhesion inside the adhesive applicator  10  is prevented due to the configuration, the selection of material, and the length of the feed pipe  18 , the feed line  17  and the adhesive capillaries  12 ,  12 ′. 
         [0044]    An adhesive reservoir (not shown) that is connected to the adhesive connecting orifice  21  may be a tube containing the adhesive. A compressor or a corresponding compressor system connected to the propellant connecting orifice  25  may be a commercially available medical syringe, for example. 
         [0045]    As shown in  FIGS. 2 and 3 , the feed pipe  18  terminates distally in the feed line  17  that is passed through the adapter  19 . The feed line  17  terminates on the distal end in the first adhesive capillary  12  and the second adhesive capillary  12 ′. Consequently, the feed line  17  branches into the two adhesive capillaries  12 ,  12 ′. The last section of the feed line  17  extends essentially perpendicularly with respect to the longitudinal direction of the adapter  19 . Directly downstream of the division into the two adhesive capillaries  12 ,  12 ′, there may be adjoining a downward inclined first connecting section  16  having a first elbow section  15  and a first vertical section  14  or a downward inclined second connecting section  16 ′ having a second elbow section  15 ′ and a second vertical section  14 ′. The vertical sections  14 ,  14 ′ extend essentially parallel to the vertically extending end section of the feed line  17 . Hence, the orifices of the adhesive capillaries  12 ,  12 ′ point upward. 
         [0046]    The adhesive applicator  10  may be a part of the electrosurgical instrument  1  and can be connected with said instrument.  FIGS. 4 and 5  show the electrosurgical instrument  1  while the adhesive applicator  10  is being positioned. The electrosurgical instrument  1  includes a sheath  50  for the accommodation of a first vessel section  2 , as well as two sheath actuating devices  51 ,  51 ′ by means of which the sheath  50  (that is divided into two parts) can be brought into an opened and a closed position. In the closed position, the sheath  50  forms a pipe in which the first vessel section  2  (e.g., a blood vessel) can be placed. After the first vessel section  2  has been inserted through the sheath  50 , the vessel can be folded over in such a manner that the folded over end encloses the sheath  50 .  FIG. 4  shows a folded over tissue section  3  of the first tissue section  2 . The inner surface of the folded over tissue section  3  faces outward. In the position shown in  FIG. 4 , the adhesive applicator  10  is shown in a receiving position, in which the vertical sections  14 ,  14 ′ are at a distance from the sheath  50 . The folding over procedure can be performed without any interference of the adhesive applicator  10 . 
         [0047]      FIG. 5  also shows the folded over tissue section  3  that is positioned on the sheath  50 . 
         [0048]      FIG. 6  shows the adhesive applicator  10  in an application position in which the vertical sections  14 ,  14 ′ are located on the folded over tissue section  3  and fixate said tissue section  3  in place between the vertical sections  14 ,  14 ′ and the sheath  50 . The vertical sections  14 ,  14 ′ are alternately positioned relative to the sheath  50  and extend essentially parallel to the sheath channel of the sheath  50 . The orifices of the nozzles of the adhesive capillaries  12 ,  12 ′ point upward. 
         [0049]    In  FIG. 7 , a second vessel section  2 ′ that is to be connected to the first vessel section  2  is pulled over the folded over tissue section  3 . Furthermore, a compression forceps  30  is attached to the adapter  19  at this point. The compression forceps  30  has a first branch  31  and a second branch  31 ′ that are alternately attached relative to the sheath  50 .  FIG. 8  shows the branches  31 ,  31 ′ in attached state, in which case said branches are in a compression position, thus fixating the vessel sections  2 ,  2 ′ in place on the sheath  50  so as to be resiliently pretensioned. 
         [0050]    When positioning the second vessel section  2 ′, the adhesive capillaries  12 ,  12 ′ are placed tightly enough on the folded over tissue section  3  so that the second vessel section  2 ′ is slipped over said adhesive capillaries  12 ,  12 ′. The elbow sections  15 ,  15 ′ act as limiting features. They simplify any positioning of the second vessel section  2 ′ along a longitudinal direction  56  of the sleeve  50 . The second vessel section  2 ′ may be slipped over the sheath  50  until the open end abuts against the elbow sections  15 ,  15 ′. 
         [0051]      FIG. 9  shows a schematic longitudinal cross-section along the longitudinal direction  56  of the sheath  50  through the vessel sections  2 ,  2 ′ and the electrosurgical instrument  1 , i.e., through the sheath  50 , the compression forceps  30 , and the adhesive capillaries  12 ,  12 ′. The vessel sections  2 ,  2 ′ are placed in the electrosurgical instrument  1 , and the compression forceps  30  is in compression position. A substantial section of the first vessel section  2  extends inside the sheath  50 . The folded over tissue section  3  is situated folded over on the outside surface of the sheath  50 , whereby the inner surface of tissue section  3  faces outward. Situated on this section of the inner surface of the first vessel section  3  is a section of the inner surface of the second vessel section  2 ′. Overall, the vessel sections  2 ,  2 ′ extend along the longitudinal axis  56 . Close to the upper end of the sheath  50 , the sheath  50  is enclosed by the compression forceps  30 . The branches  31 ,  31 ′ fixate the sections of the first and the second vessel sections  2 ,  2 ′ in place on the sheath  50 . On the side facing the sheath  50 , the first branch  31  includes a first exterior electrode  33 , and the second branch  31  includes a second exterior electrode  33 ′. The sheath  50  comprises an annular interior electrode  32  that extends along the outside surface. The exterior electrodes  33 ,  33 ′ are arranged opposite the interior electrode  32 . They contact the overlapping vessel sections  2 ,  2 ′ and can be connected to an RF generator so that an RF voltage can be applied to said vessel sections. An applied RF current flows through the vessel sections  2 ,  2 ′ and results in a fusion of the tissue. An annular tissue connection  5  is formed, said connection connecting the vessel sections  2 ,  2 ′. 
         [0052]      FIG. 9  shows the vessel sections  2 ,  2 ′ with the annular tissue connection  5 . The adhesive capillaries  12 ,  12 ′ are inserted on the open end of the overlapping vessel sections  2 ,  2 ′ beyond the tissue connection  5 . By way of the capillaries, it is possible to introduce the adhesive that connects the vessel sections  2 ,  2 ′. 
         [0053]      FIG. 10  shows the adhesive connection  6  between the vessel sections  2 ,  2 ′. Preferably, the adhesive is introduced between the vessel sections  2 ,  2 ′ in such a manner that the adhesive connection  6  also extends in an annular manner along the tissue connection  5 . Following the application of the adhesive, the electrosurgical instrument  10  comprising the sheath  50  and the adhesive capillaries  12 ,  12 ′ can be removed. The tissue connection  5  that is produced chronologically prior to the adhesive connection  6  prevents the penetration of the adhesive into the inside of the connected vessels. The adhesive connection  6  strengthens the bond between the vessel sections  2 ,  2 ′. Because of the adhesive connection  6 , the vessel sections  2 ,  2 ′ can also absorb higher stress in the longitudinal direction. 
         [0054]    Although the disclosed embodiments has been described here in conjunction with an electrosurgical instrument  1 , the disclosed embodiments can also be used without the electrosurgical instrument  1 . 
         [0055]    Although an adhesive applicator is described including only two adhesive capillaries  12 ,  12 ′. It should be understood that several adhesive capillaries  12 ,  12 ′ on the electrosurgical instrument  1  or on any other medical device may be included. In another embodiment, the device for producing anastamoses includes a guide by which the capillaries  12 ,  12 ′ can be rotated about the sheath  50  in order to produce a continuous adhesive connection  6 . In a method in accordance with the disclosed embodiments an adhesive connection  6  is to be produced, the connection may extend ring-like around the sheath  50 . However, in another embodiment the adhesive connection  6  may only be applied in sections.