Abstract:
An apparatus for performing anastomosis procedures comprises of an end-effector to engage a lumen for attaching a tubular structure to said lumen to create a connective branch or an anastomosis. The apparatus includes a contractible and expandable member coupled to the end-effector to secure engagement of the end-effector with the lumen. A pair of wedge members operates to deploy a staple to attach the tubular structure to the lumen. The pair of wedge members operates in opposing directions to deploy the staple.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims benefit of and is a non-provisional application of U.S. Provisional Application No. 61/842,163 (Attorney Docket No. 383-1), filed on Jul. 2, 2013, and U.S. Provisional Application No. 61/856,638 (Attorney Docket No. 383-2), filed on Jul. 19, 2013, which are incorporated herein by reference in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to medical devices, and more particularly to surgical stapling or clip applying systems for attaching or connecting tubular structures (e.g., blood vessels, segments of intestines, prostheses, etc.) in anastomosis procedures. 
       BACKGROUND 
       [0003]    An anastomosis procedure is a surgical procedure where two separate tubular or hollow structures are surgically grafted together to form a continuous fluid connection, vascular branch or joint between them to facilitate or restore fluid flow. Anastomosis procedures may be used to create bypasses to occluded vessels or passages (e.g., arteries, veins, intestines, etc.), so as to restore flows to and/or from organs in the bodies of patients. Devices that can perform or assist with such important surgical operations are highly desired to reduce the burden and/or time required for performing such complex anastomosis surgical procedures. 
       SUMMARY OF THE INVENTION 
       [0004]    An apparatus for performing anastomosis procedures comprises of an end-effector to engage a lumen for attaching a tubular structure to said lumen to create a connective branch or an anastomosis. The apparatus includes a contractible and expandable member coupled to the end-effector to secure engagement of the end-effector with the lumen. A pair of wedge members operates to deploy a staple to attach the tubular structure to the lumen. The pair of wedge members operates in opposing directions to deploy the staple or the wedge members operate in a scissor-like motion to deploy the staple. During deployment, the contractible and expendable member provides support to the lumen as the staple is deployed to attach the tubular structure to the lumen. The contractible and expandable member is placed in a contracted state when the end-effector is inserted through the lumen for engagement. The contractible and expandable member is placed in an expanded state to secure the engagement of the end-effector with the lumen. The end-effector can be operated telescopically by extending from a first length to a second length, retracting from the second length to the first length, or varying at a length between the first length and the second length. The end-effector may be substantially rigid, substantially flexible, or substantially steerable. The wedge members may deploy the staple by urging the legs members of the staple in respective arcuate motions for staple deployment. 
         [0005]    A staple for performing anastomosis procedures includes a base member with a hinge element near each of ends of the base member, wherein the hinges are oriented substantially on laterally opposite sides of the base member. A leg member extends from each of the hinge elements, wherein each leg member includes a first tine and a second tine. During deployment, each leg member pivots or rotates respectively about the hinge member in an arcuate motion. In a deployed state, the leg member of one end of the base member overlaps or crosses with another leg member of another end of the base member. The hinge elements are non-collinear with the axis of the base member. Each of the hinge elements becomes twisted after the staple is deployed due to the respective rotation of the leg members. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    The present invention will be readily understood by the following detailed description, taken in conjunction with accompanying drawings, illustrating by way of examples of the invention. The figures are merely exemplary and not limiting. The objects and elements in the drawings are not necessarily drawn to scale, proportion, precise orientation or positional relationships; instead, emphasis is focused on illustrating the principles of the invention. Descriptive terms such as “upper,” “lower,” “upward,” “downward”, “forward”, “backward”, and the like are intended for the convenience of the reader and refer to the orientation and/or motion of parts as illustrated and described; they do not necessarily limit the orientation or operation of the features, aspects, or embodiments of the invention. The drawings illustrate the design and utility of various features, aspects, or embodiments of the present invention, in which like element are typically referred to by like reference symbols or numerals. The drawings, however, depict the features, aspects, or embodiments of the invention, and should not be taken as limiting in their scope. With this understanding, the features, aspects, or embodiments of the invention will be described and explained with specificity and details through the use of the accompanying drawings in which: 
           [0007]      FIG. 1A  through  FIG. 1C  illustrate an example of a surgical stapling/clip applying device with specially configured staples/clips for attaching a tubular structure (e.g., harvested vessel, prosthesis, etc.) to a lumen (e.g., artery, vein, intestine, etc.) in an anastomosis surgical procedure, in accordance with features, aspects, or embodiments of the present invention. 
           [0008]      FIG. 2A  through  FIG. 2C  illustrate activation of the surgical stapling/clip applying device to allow insertion of an effector into a target lumen to begin the attachment or stapling/clip applying process of a tubular structure to the target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0009]      FIG. 3A  through  FIG. 3D  illustrate the use of a guide wire to position the surgical stapling/clip applying device for insertion into a target lumen for attaching, stapling, or clipping a tubular structure to the target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0010]      FIG. 4  illustrate a close-up view of an expandable and contractible support member of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0011]      FIG. 5A  and  FIG. 5B  illustrate close-up views of an expandable and contractible support member of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0012]      FIG. 6A  and  FIG. 6B  illustrate the end-effector of the surgical stapling/clip applying device engaging with a target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0013]      FIG. 7A  and  FIG. 7B  illustrate the operation of the surgical stapling/clip applying device in applying staples/clips to connect or attach a tubular structure to a target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0014]      FIG. 8A  and  FIG. 8B  illustrate the surgical stapling/clip applying device positioned to deploy specially configured staples/clips to attach or connect a tubular structure to a target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0015]      FIG. 9A  illustrates one example of a tubular structure (e.g., harvested vessel, prosthesis, etc.), in accordance with features, aspects, or embodiments of the present invention. 
           [0016]      FIG. 9B  illustrates a tubular structure (e.g., harvested vessel, prosthesis, etc.) with specially configured staples/clips of the surgical stapling device, in accordance with features, aspects, or embodiments of the present invention. 
           [0017]      FIG. 10A  illustrates an isometric or perspective view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0018]      FIG. 10B  illustrates a side view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0019]      FIG. 10C  illustrates a top view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0020]      FIG. 11A  illustrates an isometric or perspective view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0021]      FIG. 11B  illustrates a side view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0022]      FIG. 11C  illustrates a top view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention. 
           [0023]      FIG. 12A  illustrates a close-up view of the tubular structure with deployed staples/clips, in accordance with features, aspects, or embodiments of the present invention. 
           [0024]      FIG. 12B  illustrates, for greater clarity, a further close-up view of the tubular structure with a deployed staple/clip, in accordance with features, aspects, or embodiments of the present invention. 
           [0025]      FIG. 13A  illustrates a tubular structure to be attached or connected to a target lumen with an undeployed staple/clip, in accordance with features, aspects, or embodiments of the present invention. 
           [0026]      FIG. 13B  illustrates a tubular structure attached or connected to a target lumen with a deployed staple/clip, in accordance with features, aspects, or embodiments of the present invention. 
           [0027]      FIG. 14A  illustrates the staple/clip deployment mechanisms of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0028]      FIG. 14B  illustrates a close-up view of the staple/clip deployment mechanisms of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0029]      FIG. 15A  illustrates, for clarity, one leg/tine of the staple/clip being deployed by the staple/clip deployment mechanisms of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0030]      FIG. 15B  illustrates, for clarity, a close-up view of one leg/tine of the staple/clip being deployed by the staple/clip deployment mechanisms of the surgical stapling/clip applying device, in accordance with features, in accordance with features, aspects, or embodiments of the present invention. 
           [0031]      FIG. 15C  illustrates the staple/clip being deployed by the staple/clip deployment mechanisms of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0032]      FIG. 15D  illustrates a slightly zoomed-out view of the end-effector to show details of the staple/clip deployment mechanisms, in accordance with features, aspects, or embodiments of the present invention. 
           [0033]      FIG. 16A  through  FIG. 16C  illustrate the staple/clip deployment mechanisms (sequentially) deploying the staples/clips, in accordance with features, aspects, or embodiments of the present invention. 
           [0034]      FIG. 16D  illustrates staples deployed to attach or connect a tubular structure to a target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0035]      FIG. 17A  and  FIG. 17B  illustrate the surgical stapling/clip applying device attaching or connecting a tubular structure to a target lumen, in accordance with features, aspects, or embodiments of the present invention. 
           [0036]      FIG. 18A  illustrates a cross-sectional view of the staple/clip applying inner support members/structures of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0037]      FIG. 18B  illustrates a stapling/clip support member/structure of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0038]      FIG. 18C  illustrates a distal staple/clip retaining, constraining, or supporting member of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0039]      FIG. 18D  illustrates a cross-sectional view of the staple/clip outer support members/structures of the surgical stapling/clip applying device, in accordance with features, aspects, or embodiments of the present invention. 
           [0040]      FIG. 18E  illustrates a cross-sectional view of the distal portion of the surgical stapling/clip applying device illustrating various structures and members of the device located at the distal end of the device, in accordance with features, aspects, or embodiments of the present invention. 
       
    
    
       [0041]    As can be appropriated, the use of same or similar symbols or numerals in different figures indicates similar, equivalent, or identical items or features. 
       DETAILED DESCRIPTION 
       [0042]    In the following detailed description, specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be readily understood by those skilled in the art that the present invention may be practiced without these specific details. Alternatively, some of the well-known parts, components, hardware, methods of operations, and procedures may not be described in detail or elaborated so as to avoid obscuring the present invention; but, nevertheless, they are within the spirit and scope of the present invention. 
         [0043]    As mentioned, an anastomosis procedure is a surgical procedure where two separate tubular or hollow structures are surgically grafted together to form a continuous fluid connection, vascular branch or joint between them to facilitate or restore fluid flow in various passages, capillaries, or vessels in a patient. Devices that can perform or assist with such surgical operations are highly desired to reduce the burden and/or time required for performing anastomosis surgical procedures. For example, a vascular anastomosis procedure involves creating an anastomosis (e.g., a junction, bypass, or the like) between blood vessels to create or restore blood flow. An anastomosis surgical operation may be necessary when a patient suffers from coronary artery disease (CAD). In such a condition, an occlusion or stenosis in a coronary artery restricts blood flow to the heart muscle. In order to treat CAD, the area where the occlusion occurs is bypassed to reroute blood flow by grafting a vessel, such as a harvested artery or vein, or, in some situation, a prosthesis to provide an alternative route or passage. An anastomosis procedure is performed between a graft vessel or prosthesis and two target vessels in order to bypass the blocked coronary artery. In such a scenario, the bypass circumvents the occlusion and restores adequate blood flow to the heart muscle to prevent cardiac malfunctions. This treatment is commonly known as a coronary artery bypass grafting procedure (CABG). Accordingly, devices that can perform or assist with such important surgical operations are highly desired to reduce the burden and/or time required for performing such anastomosis surgical procedures. 
         [0044]    By way of example,  FIGS. 1A through 1C  illustrate an anastomosis stapling/clip applying device  100  for attaching a tubular structure (e.g., a harvested vessel, a prosthesis, etc.) to a lumen  150  (e.g., a blood vessel, a segment of an intestine, etc.) to create a connection for a bypass to facilitate or restore fluid flow. As illustrated in  FIG. 1A , the anastomosis stapling/clip applying device  100  is generally an elongated and tapered instrument comprising of a placement control handle assembly  102 , a deployment control handle assembly  104 , a deployment shaft assembly  106 , a placement shaft member  108 , and an application shaft member  110 . The anastomosis stapling/clip applying device  100  is designed and constructed to engage with a lumen  150 . As such, the substantially elongated and tapered construction is optimized to facilitate maneuverability in substantially small and tight spaces or volumes and to engage with substantially small target lumens. Some sections or portions of the anastomosis stapling/clip applying device  100  may be flexible and/or steerable. As illustrated in  FIG. 1B , the placement control handle assembly  102  may include a control plunger member or control articulation member  122 , which may be used to articulate the application shaft member  110  in various manners of articulation (e.g., extending and/or contracting the distal portion of the application shaft member  110 , twist or turn the distal portion of the application shaft member  110 , steer the distal portion of the application shaft member  110 , etc.). The handle assembly  102  may also include a handle support member  124  to assist with the control and placement of the stapling device  100  and the operation of the various control and placement mechanisms of the stapling device  100 . The handle assembly  102  may further include a through port  126  that provides a pathway from the proximal portion of the stapling device  100  all the way through to the distal tip of the application shaft member  110 . For example, in some applications, a guidewire member may be inserted into the through port  126  and maneuvered or threaded through the pathway or passage of the through port  126  all the way to the distal tip of the application shaft member  110  to assist with placement of the application shaft member  110  to engage a target lumen  150  for an anastomosis surgical procedure. 
         [0045]    Also illustrated in  FIG. 1B , the deployment control handle assembly  104  may include a deployment control knob member  142 . To be discussed in further detail, the deployment control knob member  142  may be operated to deploy staples or clips to attach or connect a tubular structure (e.g., a harvested vessel, a prosthesis, etc.) to a lumen  150  (e.g., a blood vessel, a segment of an intestine, etc.) to create a connection or branch for a bypass to facilitate or restore fluid flow. Referring to  FIG. 1C , the application shaft member  110  may be slidably coupled to placement shaft member  108 . Both of these members  108  and  110  may be used to engage the stapling device  100  to the target lumen  150 . Further illustrated in  FIG. 1C , the application shaft member  110  includes an expandable and contractible support member  160 . As will be discussed in further detail, once the application shaft member  110  has been inserted into the target lumen  150 , (initially with the support member  160  in a contracted configuration) the support member  160  can be made to expand into substantially a disc-like support structure or configuration, which can hold the application shaft member  110  in place and properly engaged with the lumen  150 . Also, in the expanded configuration, the support member  160  provides certain amount of stiffness and support to an opening  152  of the lumen  150  to assist with the attachment of a tubular structure  902  (see  FIG. 9A  and  FIG. 9B ) to the lumen  150  as staples or clips are applied by the stapling device  100 . 
         [0046]      FIGS. 2A through 2C  illustrate activation of the control plunger member or control articulation member  122  (e.g., pushing down the control plunger member  122 ) to extend a portion of the application shaft member  110 . As such, the expandable and contractible support member  160  is placed into a contracted configuration, and the distal or tip portion of the application shaft member  110  may be correspondingly placed in its minimum diameter configuration to facilitate insertion of the distal or tip portion of the application shaft member  110  through the opening  152  of the lumen  150 . As illustrated in  FIG. 2A  and  FIG. 2B , the control plunger member  122  is pushed “down” (e.g., pushed closer to the handle support member  124 ), and the tip portion of the application shaft member  110  is extended with the support member  160  contracted, as illustrated in  FIG. 2A  and  FIG. 2C . 
         [0047]      FIG. 3A  through  FIG. 3D  illustrate a guidewire  302  is used to assist with placing the application shaft member  110  through the opening  152  of the lumen  150  to engage the stapling device  100  with the lumen  150  for attaching a tubular structure  902  (see  FIG. 9A  and  FIG. 9B ) to the lumen  150 . Although a guidewire may be used to facilitate engagement of the stapling device  100  with a lumen  100 , it may not be required. Since the stapling device  100  is a substantially elongated and tapered, the application shaft member  110  may be sufficiently small, controllable, and/or maneuverable (for example, in some embodiments or configurations, the application shaft member  110  may be sufficiently stiff, flexible, or steerable) that may not require the assistance of a guidewire to locate and pass through the opening  152  to engage with the lumen  150 . Continuing with this example, a guidewire  302  is inserted through the port  126  of the stapling device  100 , as illustrated in  FIG. 3A . The guidewire  302  is pushed or threaded through a pathway or passage of the port  126  all the way through the distal portion or tip of the application shaft member  110 , as illustrated in  FIG. 3B . The guidewire is then maneuvered into and through the open  152  of the lumen  150 . The application shaft member  110  is pushed along to follow the guidewire  302  into and through the opening  152  into the lumen  150 , as illustrated in  FIG. 3C  and  FIG. 3D . As can be appropriated, the application shaft member  110  may be maneuvered into and through the opening  152  without the assistance or aid of a guidewire  302 . 
         [0048]      FIG. 4  illustrates that the expandable and contractible support member  160  may be constructed of a mesh-like material or any other suitable material or construction to facilitate expandability and contractibility of the component.  FIG. 5A  and  FIG. 5B  illustrate that when the application shaft member  110  is contracted, pulled, or tensioned (e.g., pulling or releasing (may be spring loaded) the control plunder handle  122  from the “pushed” position to an extended or “pulled” position), the expandable and contractible support member  160  is placed into an expanded configuration, such as a substantially disc-like configuration. In the expanded configuration, the support member  160  can support the engagement of the stapling device  100  with the lumen  150  as well as support the application of staples to attach a tubular structure (e.g., a harvested vessel, a prosthesis, etc.) to the lumen  150  (e.g., a blood vessel, a segment of an intestine, etc.).  FIG. 6A  and  FIG. 6B  illustrate the expanded support member  160  being used to properly and securely engage the stapling device  100  with the lumen  150 . 
         [0049]      FIG. 7A  and  FIG. 7B  illustrate the start of staple deployment for the attachment of a tubular structure inside of the stapling device  100  to the lumen  150 . Picking up from the illustration of  FIG. 6B ,  FIG. 7A  illustrates the stapling device  100  has engaged with the lumen  150 . Refer to  FIG. 8A  for a close-up view of this process.  FIG. 7B  illustrates that the deployment shaft assembly  106  is advanced forward to engage with the lumen to attach a tubular structure  902  (see example illustrated in  FIG. 9A  and  FIG. 9B ) with specially configured staples  802 . Refer to  FIG. 8B  for a close-up view of this process. Details of the specially configured staples  802  are illustrated in  FIG. 10A  through  FIG. 10C  and  FIG. 11A  through  FIG. 11C . 
         [0050]      FIG. 10A  illustrates an isometric or perspective view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention.  FIG. 10B  illustrates a side view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention.  FIG. 10C  illustrates a top view of a specially configured staple/clip of the surgical stapling/clip applying device in its undeployed configuration, in accordance with features, aspects, or embodiments of the present invention.  FIG. 11A  illustrates an isometric or perspective view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention.  FIG. 11B  illustrates a side view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention.  FIG. 11C  illustrates a top view of a specially configured staple/clip of the surgical stapling/clip applying device in its deployed configuration, in accordance with features, aspects, or embodiments of the present invention. As illustrated in these figures, the specially configured staples  802  include a base element  812 , two hinge elements  814 , two stabilizing elements or two first tine elements  816 , two curved features or two elbow elements  818 , and two legs or two second tine elements  820 . The deployment, application, and features of the specially configured staples  802  will be discussed in greater detail. 
         [0051]    For now, the interactions of the staples  802  and the tubular structure  902  for attachment with the lumen  150  will be illustrated. For sake of clarity,  FIG. 12A  illustrates the deployed specially configured staples  802  on the tubular structure (without illustrating the lumen  150  being attached with the tubular structure  902 ). For greater clarity and simplicity,  FIG. 12B  illustrates one deployed specially configured staple  802  on the tubular structure (without illustrating the lumen  150  being attached with the tubular structure  902 ).  FIG. 13A  illustrates a specially configured staple  802  and the tubular structure  902  positioned on the lumen  150  prior to staple deployment.  FIG. 13B  illustrates the specially configured staple  802  having been deployed to attach or fasten the tubular structure  902  onto the lumen  150 . In some applications, the size of the specially configured staples  802  may be tailored specifically to the thickness of the lumen  150 , such that there may be a customized fit to the deployed staples  802  with the thicknesses of the tubular structure  902  and the thickness of the lumen  150 . In other applications, the specially configured staples  802  may not be specifically sized to the thickness of the tubular structure  902  and the thickness of the lumen  150 . As such, in some applications the legs or second tines  820  of the staples  802  may be imbedded into the tissue of the lumen  150  after deployment of the staples  802 . In some other applications, the legs or second tines of the staples  802  may “hang-out” with some amount of clearance or space with or between the tissue of the lumen  150  after deployment of the staples  802 . In whichever scenario, the staples  802  will securely attach or fasten the tubular structure  902  to the lumen  150 . As illustrated in  FIG. 11A  and  FIG. 11B , the legs or second tines  820  of the deployed specially configured staple  802  substantially overlap or cross to provide greater strength of security for attaching or fastening the tubular structure  902  to the lumen  150 . 
         [0052]    Staple deployment will be illustrated and discussed.  FIG. 14A  and  FIG. 14B  illustrate the specially configured staple  802  and the staple deployment mechanisms of the deployment assembly  106 . For sake of clarity, the outer shaft member of the deployment assembly  106  is removed to illustrate some of the inner components of the deployment assembly  106 . For sake of simplicity, only one specially configured staple  802  is illustrated. As illustrated in  FIG. 14A  and  FIG. 14B , wedge members  1402  are activated to deploy the specially configured staple  802 . Wedge members  1402  act in pairs in a scissor-like operation to deploy staple  802 . For greater clarity and simplicity,  FIG. 15A  and  FIG. 15B  illustrate the movement of one of the wedge members  1402  to urge or push one of the legs or tines for the deployment of the staple  802 . As can be appreciated from  FIG. 15A  and  FIG. 15B , as the wedge member  1402  is activated (in this example, the wedge  1402  is moved from right to left) it urges or pushes the staple  802  near its curved or elbow element  818  to a substantially semi-circular or arcuate motion about its hinge element  814 . As movement or motion of the leg or tine  820  is initiated, the stabilizing element or first tine engages with the tubular structure  902  and then the tissue of the lumen  150  to stabilize and/or anchor the tine structure as the second tine element engages or pierces the tubular structure  902  and then the tissue of the lumen  150 . In effect, the first tine helps to ensure stable movement or swing of the semi-circular or arcuate motion of the entire leg or tine element of the staple  802 . Expressed in another way, the first tine  816  “bites” into or anchors “down-into” the tubular structure  902  and/or the tissue of the lumen  150  to prevent unstable movement and/or twisting of the relative slender length of the leg or tine of the staple  802 .  FIG. 15C  and  FIG. 15D  illustrate the typical deployment operation as both wedge elements  1402  are operated at substantially the same time to urge or push both legs or tines of the staple  802  for stapling or clipping the tubular structure  902  to the lumen  150 . As can be appreciated from  FIG. 10A  through  FIG. 10C  and  FIGS. 11A through 11C , the hinge elements  814  and the pivot points of the legs or tines of the staple  802  are offset from each other at a distance about the width of the base member  812 . In other words, the hinge elements  813  or pivot points are typically non-collinear along the axis of the base member  812 . Also, the hinge elements  813  may be positioned or oriented on the opposite sides of the based member  812 . Typically, the hinge elements  813  are positioned at or near of ends of the base member  812 . Alternatively, the hinge elements  813  can be positioned substantially anywhere along the length of the base member  812 . When the staple is deployed, the legs or tines of the staple would not interfere with one another; however, as discussed previously, the legs or tines overlap or cross (as seen from the side view) to provide greater strength of security for attaching or fastening the tubular structure  902  to the lumen  150 . 
         [0053]      FIG. 16A  through  FIG. 16C  illustrates sequential activation and deployment of the staples  802  by the wedge members  1402 , without illustrating the lumen  150  for sake of simplicity.  FIG. 16D  illustrates that the staples have been deployed to attach the tubular structure  902  to the lumen  150 . Sequential activation and deployment of the staples  802  by the wedge members  1402  may be controlled by the deployment control knob member  142  working in concert with the deployment control index member  1702  (see  FIG. 17A ). For example, activation of the wedge members  1402  may be done by twisting the deployment control knob member  142 , and advancing the wedge members  1402  from one staple  802  to the next staple  802  may be done by activating the deployment control index member  1702 , as illustrated in  FIG. 17A . Optionally, activation of the wedge members  1402  may be done by twisting the deployment control knob member  142  in first direction, while advancing the wedge members  1402  to another staple  802  may be accomplished by twisting the deployment control knob member in a second direction that is opposite to the first direction, as illustrated in  FIG. 17B . In such an optional configuration, the deployment control knob control index member  1702  may not be necessary. 
         [0054]      FIG. 18A  through  FIG. 18E  provide further structural details of the deployment shaft member assembly  106 .  FIG. 18A  illustrates a cross-sectional view of the deployment shaft member assembly  106 . As illustrated, the deployment shaft member assembly  106  includes an inner support tube member  1812  and a staple or clip support arm member  1814 . In some embodiments, the inner support tube member  1812  may act as a structure member of the deployment shaft member assembly  106 . Also, in some embodiments, the support arm member  1814  may provide detachable support to the specially configured staples or clips  802 .  FIG. 18B  illustrates a side-view of the staple or clip support arm member  1814  and staples  802  to show the staples  802  being coupled to staple support arm member  1814 . Each of the staples  802  may be detachably supported by a support finger member  1816 . Once the staples/clips  802  are deployed, they can slide-off the support finger member  1816 . In addition, the support finger member  1816  may also be substantially flexible to allow easy decoupling or detachment of the staples/clips  802  once they are deployed. Furthermore, once the staples  802  are deployed, the deployment shaft assembly member  106  may be withdrawn or slide-away from the deployment position; as such, withdrawing the deployment shaft assembly member  106  may also facilitate detachment of the staples  802  from the stapling device  100 . In addition to the support arm member  1814 , the staples  802  may also be supported or secured by a staple or clip constraint member  1818  configured with staple/clip support elements  1820  to hold or support the staples/clips  802  in their undeployed state. Once the staples/clips  802  are deployed the staple/clip support elements  1820  no longer hold or support the staples/clips  802  in their deployed state. In other words, the staple/clip support elements  1820  are configured or shaped to hold or support the staples/clips  802  when the staples/clips are in their undeployed configuration (see  FIG. 10A  through  FIG. 10C  for staples in undeployed configuration and  FIG. 11A  through  FIG. 11C  for staples in deployed configuration). As such, the undeployed staples  802  may be secured with only the support arm member  1814  or the constraint member  1818  with the support features  1820  or the combination of the support arm member  1814  and the constraint member  1818 .  FIG. 18D  illustrates a cross-sectional view of the staple/clip outer support tube member  1821  of the stapling device  100  with the staple support element  1820  to provide additional details of the structure and construction of the deployment shaft assembly  106 . To provide further perspective of the structures and construction of the stapling device  100 ,  FIG. 18E  illustrates a cross-sectional view of the distal portion of the surgical stapling/clip applying device illustrating the various structures and members of the device located at the distal portion of the device. 
         [0055]    Multiple features, aspects, and embodiments of the invention have been disclosed and described herein. Many combinations and permutations of the disclosed invention may be useful in anastomosis surgical procedures, and the invention may be configured to support various grafting procedures. One of ordinary skill in the art having the benefit of this disclosure would appreciate that the foregoing illustrated and described features, aspects, and embodiments of the invention may be modified or altered, and it should be understood that the invention generally, as well as the specific features, aspects, and embodiments described herein, are not limited to the particular forms or methods disclosed, but also cover all modifications, equivalents and alternatives. Further, the various features and aspects of the illustrated embodiments may be incorporated into other embodiments, even if not so described herein, as will be apparent to those ordinary skilled in the art having the benefit of this disclosure. 
         [0056]    Although particular features, aspects, and embodiments of the present invention have been illustrated and described, it should be understood that the above discussion is not intended to limit the present invention to these features, aspects, and embodiments. It will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, the present invention is intended to cover alternatives, modifications, and equivalents that may fall within the spirit and scope of the following claims and their equivalents.