Abstract:
Herein is provided an anastomosis device which includes a cylindrical support housing having a tapered section being formed of a plurality of compliant fingers integrally formed around the circumference of an end of the cylindrical section which can flex at their connection point to the cylindrical section. Each compliant finger holds a suture needle. The device includes a push rod having a cam head at one end of the rod section. The cam head is located adjacent to the tapered portion. In operation the anastomosis device is aligned with the anatomical tubular structure undergoing an anastomosis process. When a back end of the push rod is pushed towards the tapered section of the support housing, the cam head section bears against an inner surface causing each compliant finger to flex radially outwards forcing the suture needles to simultaneously pierce the wall of the anatomical tubular structure.

Description:
CROSS REFERENCE TO RELATED U.S. PATENT APPLICATION 
       [0001]    This patent application relates to U.S. provisional patent application Ser. No. 61/353,974 filed on Jun. 11, 2010, entitled DEVICE FOR PERFORMING END-TO-END ANASTOMOSIS, filed in English, which is incorporated herein in its entirety by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates to a device for accomplishing the surgical process of anastomosis i.e. connecting two structures (commonly tubular structures) to restore continuity after resection or to bypass an unresectable disease process. More particularly the present disclosure relates to a device and process for connecting the structures in an end-to-end fashion. 
       BACKGROUND OF THE INVENTION 
       [0003]    A common requirement in many surgical procedures is the resection or bypass of a diseased organ. Often the diseased section is a part of a tubular structure (e.g. artery, bowel, esophagus) and after the resection it is required to reattach the resulting two healthy ends. This procedure is termed as anastomosis and is a fairly easy task to perform in the setting of an open surgery. However, in minimally invasive surgery (MIS) where the procedure is performed through small incisions in the patient&#39;s skin, anastomosis is an extremely difficult skill to learn and execute. Typical anastomosis time in a MIS procedure ranges anywhere from half an hour up to two hours. Needless to say, the long anastomosis time has a negative impact on the patient due to increased anesthesia requirement. For the surgeon, laparoscopic anastomosis is extremely difficult to learn and perform, and is very fatiguing in nature. Increased anastomosis time is also a burden on the healthcare provider as it takes up valuable operating room time and adds to the personnel cost. 
         [0004]    U.S. Pat. No. 6,358,258 issued to Arcia et al. discloses an anastomosis device that utilizes multiple flexible needles (designed of Nitinol material) that are deployed through multiple curved guide channels. The design utilizes multiple push rods for actuation and is suitable for end-side type anastomosis. 
         [0005]    U.S. Pat. No. 7,029,481 issued to Burdulis et al. discloses an anastomosis device that utilizes multiple needles that are simultaneously pierced through the tissue using a pneumatic cylinder. The needles latch onto small crimps on the opposite end and pull the sutures through the tissue upon retraction. The other end of the device utilizes multiple flexible needles deployed using curved channels and multiple push rods. The design needs custom needles as the sutures are attached to the distal tip of the needle as opposed to the proximal end found in conventional sutures. 
         [0006]    U.S. Patent Application US2008/0275472, to Yossepowitch et al. discloses an anastomosis device that utilizes multiple needle deployment through the use of flexible needle and curved guide channels. The design utilizes multiple push rods and requires custom needles to function. Even though the two ends of the design are attached through a flexible coupler, the design lacks a good suture management scheme and will suffer from suture tangling. Similar to U.S. Pat. No. 7,029,481, the design needs custom needles as the sutures are attached to the distal tip of the needle as opposed to the proximal end found in conventional sutures. 
         [0007]    Thus, there is a need for an automated/assisted laparoscopic anastomosis device that can reduce procedure time and operating costs. The device will also be of interest to the surgeons as it would minimize the dependence on a surgeon&#39;s dexterity and experience and will reduce the learning curve of this complex task. 
       SUMMARY OF THE INVENTION 
       [0008]    The present disclosure provides an anastomosis device, comprising: 
         [0009]    a) a support housing having an interior chamber and having a longitudinal axis, said support housing having a compliant flexible section, and a plurality of suture needles mounted on an outer surface of said compliant flexible section, said suture needles being aligned with, and around, said longitudinal axis; 
         [0010]    b) an introducer including a circular disc section rigidly affixed to said support housing adjacent to an end of the compliant flexible section, the circular disc section having a diameter selected to match an interior diameter of an anatomical tubular structure undergoing an anastomosis process; and 
         [0011]    c) a deformation mechanism mounted in said interior chamber and configured such that when said introducer is seated in said anatomical tubular structure and the deformation mechanism is activated the deformation mechanism bears outwardly against an interior surface of said compliant flexible section to drive said plurality of suture needles radially outwards away from the longitudinal axis forcing said plurality of suture needles to pierce through a wall of the anatomical tubular structure simultaneously around a circumference of said anatomical tubular structure. 
         [0012]    In a further embodiment of the present invention, there is provided an anastomosis device, comprising: 
         [0013]    a) a support housing having an interior chamber and having a cylindrical section having a longitudinal axis and a tapered section, the tapered section being formed of a plurality of compliant fingers integrally formed around a circumference of an end of the cylindrical section and tapering down from a diameter of said cylindrical section toward said longitudinal axis, a connection of each compliant finger to said cylindrical section being designed to flex, each of said compliant fingers having a lengthwise groove to receive therein a longitudinal section of a suture needle with a curved end portion of each suture needle located at a distal end of said compliant finger and sutures being attached to the longitudinal section of each suture needle; 
         [0014]    b) an introducer including a disc section rigidly affixed to said support housing adjacent an end of the tapered section, the disc section having a diameter selected to match an interior diameter of an anatomical tubular structure undergoing an anastomosis process; and 
         [0015]    c) a push rod including a rod section and a cam head section at one end of the rod section and the push rod having a passageway extending therethrough, the push rod being seated in said interior chamber with the cam head section located adjacent to said tapered portion, wherein in operation the anastomosis device is aligned with the anatomical tubular structure undergoing an anastomosis process with the disc section of the introducer being inserted into an end of the anatomical tubular structure and the anastomosis device is inserted far enough to ensure the curved ends of the plurality of suture needles are at least a pre-selected distance from the end of the anatomical tubular structure, and when so located, when a back end of the push rod section is pushed towards the tapered section of the support housing the cam head section bears against an inner surface each of the plurality of compliant fingers causing each compliant finger flex radially outwards forcing the plurality of suture needles to simultaneously pierce circumferentially through a wall of the anatomical tubular structure. 
         [0016]    In a further embodiment of the present invention, there is provided an anastomosis device, comprising: 
         [0017]    a) a support housing having an interior chamber and having a longitudinal axis, said support housing having a compliant flexible section, and a plurality of suture needles mounted on an outer surface of said compliant flexible section, said suture needles being aligned with, and around, said longitudinal axis, said support housing including a cylindrical section having first and second opposed ends, wherein said compliant flexible section is a tapered section attached at said first opposed end, the tapered section being formed of a plurality of compliant fingers integrally formed around a circumference of said first end of the cylindrical section and tapering down from a diameter of said cylindrical section toward said longitudinal axis, a connection of each compliant finger to said first section being designed to flex radially outwardly when the deformation mechanism bears against the inner surface of said plurality of compliant fingers, 
         [0018]    b) an introducer including a circular disc section rigidly affixed to said support housing adjacent to an end of the compliant flexible section, the circular disc section having a diameter selected to match an interior diameter of an anatomical tubular structure undergoing an anastomosis process; and 
         [0019]    c) a deformation mechanism in said interior chamber, said deformation mechanism comprising a push rod integrally formed with said plurality of compliant fingers, said push rod aligned with said longitudinal axis, said compliant fingers tapering down from said diameter of said cylindrical section towards a front end of said push rod to join with said front end of said push rod, said deformation mechanism configured such that when said introducer is seated in said anatomical tubular structure and a back end of said push rod is pushed towards said tapered section of said support housing said plurality of compliant fingers flex outwards forcing the plurality of suture needles to simultaneously pierce said anatomical tubular structure. 
         [0020]    In a further embodiment of the present invention, there is provided an anastomosis surgical kit, comprising an anastomosis device and a laparoscopic deployment tool. 
         [0021]    A further understanding of the functional and advantageous aspects of the invention can be realized by reference to the following detailed description and drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    Preferred embodiments of the invention will now be described, by way of example only, with reference to the drawings, in which: 
           [0023]      FIG. 1  shows an exemplary embodiment of two tubular structures after the anastomosis has been performed; 
           [0024]      FIG. 2  is a perspective view of an embodiment of an anastomosis device constructed in accordance with the present invention; 
           [0025]      FIG. 3  is a perspective view of the device of  FIG. 2  but absent a component to show a plurality of suture needles which form part of the device; 
           [0026]      FIG. 4  shows an exploded perspective view of the device of  FIG. 2 ; 
           [0027]      FIG. 5  shows a perspective view of the anastomosis device in its deployed configuration; 
           [0028]      FIG. 6  shows a perspective view of the anastomosis device configured to be deployed to perform an end-end anastomosis using a laparoscopic deployment tool; 
           [0029]      FIG. 7  shows the laparoscopic deployment tool of  FIG. 6  latched to the anastomosis device and ready to be inserted into the first healthy end of a vessel; 
           [0030]      FIG. 8  shows the anastomosis device after it has been inserted into the first healthy end of a vessel and has been deployed through the use of the laparoscopic deployment tool; 
           [0031]      FIG. 9  shows a perspective view of the anastomosis device where the suture needles have been deployed on each of vessels being sutured together with the laparoscopic deployment tool being retracted; 
           [0032]      FIG. 10  is a perspective view of a second embodiment of an anastomosis device constructed in accordance with the present invention; and 
           [0033]      FIG. 11  shows a section view of the device of  FIG. 10 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0034]    Without limitation, the majority of the systems described herein are directed to an anastomosis device and method of using the same. As required, embodiments of the present invention are disclosed herein. However, the disclosed embodiments are merely exemplary, and it should be understood that the invention may be embodied in many various and alternative forms. 
         [0035]    The Figures are not to scale and some features may be exaggerated or minimized to show details of particular elements while related elements may have been eliminated to prevent obscuring novel aspects. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention. For purposes of teaching and not limitation, the illustrated embodiments are directed to an anastomosis device and method of using the same. 
         [0036]    As used herein, the term “about”, when used in conjunction with ranges of dimensions, temperatures or other physical properties or characteristics is meant to cover slight variations that may exist in the upper and lower limits of the ranges of dimensions so as to not exclude embodiments where on average most of the dimensions are satisfied but where statistically dimensions may exist outside this region. For example, in embodiments of the present invention dimensions of components of an anastomosis device are given but it will be understood that these are not meant to be limiting. 
         [0037]    As used herein, the process of “anastomosis” refers to the process of reattaching two healthy ends of an anatomical tubular structure (such as blood veins, arteries, intestines etc.) after a resection has been carried out to remove a diseased or injured section.  FIG. 1  shows an exemplary embodiment of two tubular structures after the anastomosis has been performed. 
         [0038]    As used herein, the phrase “anastomosis device” refers to a device for performing the process of anastomosis which forms the subject matter of the present invention. 
         [0039]    Herein is disclosed an anastomosis device that facilitates the task of tissue approximation through simultaneous deployment of multiple sutures in a circumferential fashion.  FIG. 2  shows the preferred embodiment of the anastomosis device  10 . The disclosed anastomosis device  10  uses conventional sutures with a flexible center support  12 . The center support  12  is designed of compliant material (preferably plastics) and performs two functions in the system: it holds the needles in place (in its collapsed form) and it bends outward to allow the needles to pierce the tissue (when deployed).  FIG. 2  shows the disclosed anastomosis device  10  with the center support  12  in its collapsed form. The center support  12  includes an opening  14  and two latches  16  on the proximal end. The opening  14  and latches  16  are utilized to attach the anastomosis device  10  to a laparoscopic deployment tool  80  shown in  FIG. 6  (explained later). 
         [0040]    The center support  12  includes a plurality of compliant fingers  18  that are designed to flex at one section (preferably  20 ) along its length. Each finger  18  is capable of holding a needle in groove  22 . The introducer  40  allows easy insertion of the anastomosis device  10  into the target anatomy and throughout the deployment process keeps the needles properly aligned using grooves  42 . Introducer  40  and center support  12  are rigidly attached to each other through the use of a pin  36  and a hole  46  ( FIG. 4 ) and therefore act as a single entity in the mechanism. The center support  12  can also include suture management channels  24   a  and  24   b  (in the form of grooves) that minimize problems such as suture tangling. The push rod  32  includes a cam head  30  and is designed such that it can easily translate into and out of the center support  12  through the use of a laparoscopic deployment tool. The proximal shaft  44  of the introducer  40  acts as a guiding means for push rod  32 . 
         [0041]      FIG. 3  shows the preferred embodiment of the anastomosis device showing the needles  50  (introducer  40  hidden for brevity) mounted on the housing support  12 . One preferred embodiment of needle  50  will include a ¾ circular section  52  and a straight profile  54  that would snug fit into groove  22 .  FIG. 4  shows a view of the anastomosis device disassembled showing more details of the introducer  40  and the push rod  32 . 
         [0042]      FIG. 5  shows the anastomosis device  10  in its deployed form. It can be noticed that in order to deploy the sutures, the push rod  32  linearly translates towards the distal end of the center support  12  along its longitudinal axis. As the push rod  32  translates, cam surface  30  applies an outward acting force on flexible fingers  18  of the center support  12 . Flexible fingers  18  are designed so as to bend at a certain section  20  along their length (defined by a slightly narrow profile) and as a result that area acts as a hinge joint for the fingers. The resulting effect is the simultaneous outward motion of needles  50  and piercing of the target vessel. Optionally, push rod  32  can be designed with a built in locking mechanism so that it stays in its distal position after the deployment and the laparoscopic deployment tool can be released from center support  12 . 
         [0043]      FIG. 6  shows a scenario where the anastomosis device is deployed to perform an end-end anastomosis. It can be seen that in the preferred embodiment two center supports  10  are attached to each other through two flexible couplings  70   a  and  70   b.  The flexible couplings  70   a  and  70   b  are made of compliant material, preferably plastic. The flexible couplings  70   a  and  70   b  have two functions: to retain the center supports  10  and to provide a path for suture routing and management. In the preferred embodiment, half of the sutures  72   a  from center support  10  can be routed on coupling  70   a  and other half  72   b  on coupling  70   b  to the second center support  10 . It is noted that  72   a  and  72   b  are multiple sutures. Each of  72   a  and  72   b  may contain three (3) or more sutures; as such, the anastomosis device  10  may have a total of six (6) or more sets of needles and sutures. 
         [0044]    Note that a suture from a needle  50  on the first support  10  is terminated at the respective needle  50  on the second support system  10 . The flexible couplings  70   a  and  70   b  therefore allows these sutures to be routed from first center support  10  to the second center support  10  while minimizing problems such as suture tangling etc. At the same time, flexible couplings  70   a  and  70   b  allow needle deployment in cases where the two healthy ends of vessels  60  and  62  are not in a perfect alignment. 
         [0045]      FIG. 6  also shows a laparoscopic deployment tool  80  that is designed with a dexterous end-effector  88 . The dexterous end-effector  88  allows the center support  12  to be oriented in multi degrees-of-freedom utilizing two joints  84  and  86  for easy introduction into the target vessel. Once inserted, the laparoscopic deployment tool  80  gets latched to the center support  10  through the use of keys  92  and latches  16  to maintain a firm contact. The surgeon then uses the laparoscopic deployment tool  80  to introduce the center support  10  into the target vessel ( 60  or  62 ). The dexterous end-effector  88  is preferably cylindrical shaped and includes a push rod  90 . In one embodiment, push rod  90  can be an integrated unit with a small actuator built into it. In another embodiment, push rod  90  can be actuated using a cable based mechanism that routes through the two joints  84  and  86  with the actuator located on the proximal end of the tool  80 . The laparoscopic deployment tool  80  can also include another cable that is routed through joints  84  and  86  and once actuated causes a radial motion of keys  92  towards the longitudinal axis of the dexterous end-effector  88 . Once anastomosis tool  10  and laparoscopic tool  80  are latched, the actuator translates the push rod  90  such that it comes in contact with push rod  32  (inside tool  10 ) and causes a linear motion of cam surface  30  in the direction of distal end. As a result, compliant fingers  18  deform and needles  50  pierce through the vessel ( 60  or  62 ). The laparoscopic tool  80  can then be de-latched from anastomosis tool  10  using the cable actuation for keys  92 , retracted from the vessel ( 60  or  62 ) and inserted into the other vessel to deploy the second set of needles. 
         [0046]      FIG. 7  shows the laparoscopic deployment tool  80  latched to the anastomosis device  10  and ready to be inserted into the first healthy end  60  of the vessel. The size of introducer  40  is such that it facilitates easy insertion into the first healthy end  60  of the tubular anatomical structure. 
         [0047]      FIG. 8  shows the anastomosis device  10  after it has been inserted into the first healthy end  60  and needles  50  have been deployed through the use of the laparoscopic deployment tool  80  using push rod  90 . As can be seen from the figure, actuation of the laparoscopic deployment tool  80  causes the push rod  90  to linearly translate and in effect cause the linear translation of the push rod  32  inside the anastomosis device  10 . The translation of push rod  32  causes the cam surface  30  to apply a simultaneous outward acting force on flexible fingers  18  which in turn cause needles  50  to puncture the first healthy end  60 . The surgeon then disengages the laparoscopic deployment tool  80  from  12  and inserts it into the other unit  10  (towards end  62 ). 
         [0048]      FIG. 9  shows the case where needles  50  have been deployed on each end and the laparoscopic deployment tool  80  has been retracted from anastomosis device  10 . The surgeon can then use standard laparoscopic graspers to pull needles  50  and sutures  72   a  and  72   b  through the tissues  60  and  62 . Once this step is complete, the center support  10  from each end of the vessel is extracted and the surgeon performs the knot tying on the sutures using standard methods. In another embodiment, a secondary automated tool can be used to assist in knot-tying task to make the procedure easier and expedite the anastomosis process. 
         [0049]      FIG. 10  is a perspective view of a second embodiment of an anastomosis device  100  constructed in accordance with the present disclosure. In this embodiment, the separate push rod  32  (including cam surface  30 ) of  FIG. 2  has been eliminated from the device. Instead, the functionality of push rod  32  has been achieved through the redesign of compliant fingers  118  on the device to include integrated push rod  130 . In this embodiment, compliant fingers  118  are designed such that they all merge and join at a single push rod  130 . Push rod  130  is preferably designed as a hollow cylindrical shaft with a cut out section  138  ( FIG. 11 ). Push rod  130  acts as an integral component with compliant fingers  118  while translating freely over pin  136  (that joins flexible support  112  and introducer  40  ( FIG. 2 )). Once device  100  is latched to laparoscopic tool  80 , push rod  90  applies an axial force at surface  132  of push rod  130  which causes the compliant fingers  118  to flex radially outwards and causes needles  50  to puncture the tissue. This design results in a device that is substantially cheaper to produce while achieving a similar functionality. 
         [0050]      FIG. 11  shows a section view of the device of  FIG. 10  showing the cut out section  138 , pin  136  and surface  132 . 
         [0051]    The anastomosis device  10  uses a flexible center support system that can be easily manufactured using low cost materials such as plastics. The system design is simple and therefore can be mass produced at low cost using standard fabrication techniques such as injection molding. The design utilizes conventional needles and sutures and does not require custom materials as needed in some other designs. The center support system is the low cost component and is therefore designed as a one-time use disposable device. The laparoscopic deployment tool  80  can be designed such that it can be re-sterilized and reused. Thus the anastomosis device  10  and laparoscopic deployment tool  80  may be sold separately or together as a kit. 
         [0052]    Manual suturing is still considered a gold standard for anastomosis and the anastomosis device disclosed herein and its method of use will have a good acceptance amongst surgeons. 
         [0053]    The anastomosis device  10  and the laparoscopic deployment tool  80  have a good market potential that is evident from the fact that even after centuries of technological development, only a handful of automated/assisted anastomosis devices exist in the market. Most of these devices are designed for open surgery and find little or no use in an MIS approach. MIS has already become a preferred surgical approach due to its benefits to the patient. It is evident that the number of procedures performed through this approach will increase in the coming years. At the same time, without any improvement to the laparoscopic anastomosis technique, present anastomosis time of the order of hours will have a huge social and financial burden. Thus an anastomosis device that can potentially reduce anastomosis time from hours to minutes will have a good market potential and financial value. 
         [0054]    The anastomosis device  10  disclosed herein has advantages over existing devices and technologies in terms of its simplicity and low cost. The anastomosis device  10  is also suitable for varying diameter arteries/vessels and can be scaled up or down to account for those differences. 
         [0055]    As used herein, the terms “comprises”, “comprising”, “includes” and “including” are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in this specification including claims, the terms “comprises”, “comprising”, “includes” and “including” and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components. 
         [0056]    The foregoing description of the preferred embodiments of the invention has been presented to illustrate the principles of the invention and not to limit the invention to the particular embodiment illustrated. It is intended that the scope of the invention be defined by all of the embodiments encompassed within the following claims and their equivalents.