Abstract:
A staple housing includes an array of staples each in a staple delivery position or “ready position” ready to be fired into target tissue. A staple driver is advanceable to drive the ready-position staples from the staple head into the tissue using staple pushers. During use, the staples in the ready positions are simultaneously fired into the target tissue using the staple pushers, forming an array of staples in the target tissue. After the array has been fired, one or more feed mechanisms within the staple housing advance a second group of staples from one or more staple storage locations into the ready positions in preparation for firing of the second group of staples.

Description:
PRIORITY 
       [0001]    This is a continuation of U.S. patent application Ser. No. 12/268,216, filed Nov. 10, 2008, which is a continuation-in-part of U.S. application Ser. No. 11/900,757, filed Sep. 13, 2007, which claims the benefit of U.S. Provisional Application No. 60/825,534, filed Sep. 13, 2006, all of which are incorporated by reference herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Surgical procedures used to modify the shape and/or size of a stomach are effective in reducing weight and resolving associated co morbidities. Unfortunately these surgical procedures are invasive and are associated with high levels of peri-operative and post operative complications. 
         [0003]    Some procedures have been introduced which utilize natural body orifices for surgery to reduce the invasiveness of these procedures. Natural orifices include, but are not limited to the esophagus, anus and vagina. These procedures are less invasive by nature but have limitations as will be described below. 
         [0004]    Natural orifice procedures have largely been directed at the gastrointestinal (GI) tract, but also include procedures which exit the GI tract, and perform surgeries normally done laparoscopically. Access to the peritoneal space for example can be accomplished by penetrating the stomach wall. 
         [0005]    One primary means of stomach modification is by the use of surgical or laparoscopic staplers. These devices are able to surgically or laparoscopically appose multiple layers of tissue and connect them by use of multiple staple rows. Early procedures stapled across the outside of the stomach, which brought the mucosa of two sides of the stomach into apposition. There was, and is, a high rate of failure of these staple lines due to the nature of the GI tract. Staple line dehiscence was common and resulted in inadequate clinical results. The solution was to surgically staple the tissue and cut between the staple lines. This enabled edge to edge healing to occur, and provided for a robust tissue bridge. The separation/cutting of tissues is now common for surgical procedures such as Roux-En-Y Gastric Bypass, Sleeve Gastrectomy, and Vertical Banded Gastroplasty. However, less invasive procedures allowing stomach partitioning using natural orifice access are highly desirable. 
         [0006]    Some existing procedures attempt to partition the stomach from the inside by connecting tissue within the stomach. To date these procedures have demonstrated a high failure rate. Improved devices and methods for creating robust stomach partitions using natural orifice access are disclosed in commonly owned U.S. application Ser. No. 11/900,757, filed Sep. 13, 2007, which was published as US 2008-0190989 and which is entitled ENDOSCOPIC PLICATION DEVICE AND METHOD. 
         [0007]    As described in the &#39;757 application, when an area of the stomach wall is drawn inwardly (bringing a two-layer “pinch” or fold of tissue toward the stomach interior), corresponding regions of serosal tissue on the exterior of the stomach are positioned facing one another. The applications discloses plication procedures in which two or more such areas or pinches of the stomach wall are engaged/grasped and drawn inwardly using instruments passed into the stomach via the mouth. The two or more pinches of tissue are held in complete or partial alignment with one another as staples or other fasteners are driven through the pinches, thus forming a four-layer tissue plication. Over time, adhesions formed between the opposed serosal layers create strong bonds that can facilitate retention of the plication over extended durations, despite the forces imparted on them by stomach movement. 
         [0008]    One or more such plications may be formed for a variety of purposes. For example, plications may be used to induce weight loss by creating a barrier or narrowing within the stomach that will restrict the flow of food from the proximal stomach towards the distal stomach. For example, as discussed in the &#39;757 application, a partition or barrier may be oriented to extend across the stomach, leaving only a narrow exit orifice through which food can flow from the proximal stomach to the distal stomach, or a similar antral barrier may be formed that will slow stomach emptying of stomach contents into the pylorus. In other cases, partitions or plications may be used to form a proximal pouch in the stomach or to reduce stomach volume to cause sensations of fullness after a patient eats relatively small quantities. Plications might also be used as a treatment for GERD to create a shield between the stomach and esophagus that will minimize reflux. Plications might also be used to close perforations in the stomach wall. 
         [0009]    The present application describes an improved tissue acquisition instrument useful for engaging areas or pinches of tissue and supporting the engaged areas of tissue in complete or partial alignment as the areas are fastened to one another using fasteners, staples, sutures, etc. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of an embodiment of a tissue acquisition device, showing the graspers in the retracted position; 
           [0011]      FIG. 2A  is a top perspective view of the acquisition head of the device of  FIG. 1 ; 
           [0012]      FIG. 2B  is a perspective view of the acquisition head, taken in longitudinal cross-section, of the acquisition head of the device of  FIG. 2A . 
           [0013]      FIG. 3  is a perspective view of the acquisition head, showing one of the graspers in the deployed position; 
           [0014]      FIG. 4  is a perspective view similar to  FIG. 3 , showing both graspers in the deployed position; 
           [0015]      FIGS. 5A-5C  are a series of perspective views of the distal portion of the acquisition head, showing both graspers in retracted, partially deployed, and fully deployed positions, respectively. 
           [0016]      FIG. 6  is a perspective view of the proximal portion of the acquisition head, with the graspers in the retracted position. 
           [0017]      FIG. 7  is a perspective view similar to  FIG. 7  but with the housing eliminated to permit viewing of the graspers and associated features. 
           [0018]      FIG. 8  is a perspective view of a distal portion of the acquisition head, with the graspers in the retracted position. 
           [0019]      FIG. 9  is a perspective view of the proximal portion of the acquisition head, with the graspers in the deployed position. 
           [0020]      FIG. 10  is a perspective view similar to  FIG. 10  but with the housing eliminated to permit viewing of the graspers and associated features. 
           [0021]      FIG. 11  is a perspective view of a distal portion of the acquisition head, with the graspers in the deployed position. 
           [0022]      FIG. 12  is a top plan view of a proximal portion of the acquisition head, with the proximal portion of the housing shown in cross-section to permit viewing of the cable channels. 
           [0023]      FIGS. 13A-13C  are a sequence of transverse cross-section views of the acquisition head, schematically illustrating use of the device to acquire and grasp tissue. 
           [0024]      FIG. 13D  illustrates use of a tissue fastening device to secure the layers of tissue acquired and grasped in  FIGS. 13A-13C . 
       
    
    
     DETAILED DESCRIPTION 
       [0025]    The present application describes a device and method for acquiring two or more areas or pinches of tissue and for supporting the acquired tissue until it has been fastened together using staples or other fasteners, or treated in some other way. Generally speaking, the disclosed device operates to acquire tissue using vacuum pressure, and to then hold or retain the acquired tissue in place using mechanical graspers. The device and method may be used in to procedure for joining tissue areas together to form tissue structures within, to remodel, or to partition a body cavity, hollow organ or tissue tract. The application will discuss the device and method in connection with use in the stomach for formation of plications such as for stomach partitioning or other purposes, although they may be used for applications other than stomach remodeling or partitioning. 
         [0026]    Referring to  FIG. 1 , an exemplary embodiment of a tissue acquisition device  100  includes a tissue acquisition head  10  positioned at the distal end of an elongate shaft  12 . The shaft is of sufficient length to allow it to be advanced into the target body cavity (e.g. stomach) through a natural orifice (e.g. the mouth). While not shown in the drawing, the device  100  preferably includes articulation features allowing the head to be articulated to facilitate positioning of the head relative to target tissue. 
         [0027]    Acquisition head  10  comprises a housing having a pair of vacuum chambers  14   a ,  14   b . One or more vacuum sources  16  are fluidly coupled to the vacuum chambers  14   a ,  14   b , preferably in a manner that allows a user to selectively apply vacuum pressure to the vacuum chambers  14   a ,  14   b  at different times. As shown in  FIG. 2B , head  10  includes a pair of vacuum channels  15 , each fluidly coupled with a plurality of holes  17  extending into an associated one of the vacuum chambers  14   a ,  14   b . Vacuum pressure is applied to the vacuum channels  15  via openings  19  (see also  FIG. 6 ) in the head  10 . Each opening  19  is continuous with a lumen or channel through the shaft  12  to the vacuum source. 
         [0028]    Controls on the vacuum source  16  or the shaft  12  allow a user to select which vacuum chamber  14   a ,  14   b  is to receive vacuum pressure at any given moment in the procedure. For example, each opening  19  in the handle may be continuous with a dedicated lumen in the shaft, where each lumen has a valve that may be opened to apply vacuum through that lumen to the associated one of vacuum chambers  20   a ,  20   b . Alternatively, each opening  19  in the handle may be continuous with a dedicated lumen that is connected to its own source of vacuum pressure, so that vacuum pressure to a given vacuum chamber is initiated by activating the appropriate vacuum source. 
         [0029]    The acquisition head further includes retention elements that function to mechanically engage a portion of the tissue that has been acquired by the vacuum chamber. Referring to  FIGS. 3 and 4 , channels  18  within the acquisition head  10  house advanceable and retractable graspers  20   a ,  20   b  that function as retention elements in the illustrated embodiment. Each grasper  20   a ,  20   b  shown includes a plurality of arcuate fingers  26  that extend into a corresponding one of the vacuum chambers  14   a ,  14   b . In alternate embodiments, the graspers can have a variety of other configurations, including those that do not extend into the vacuum chamber but that instead clamp an outer section of the tissue drawn into the chamber against the exterior surface of the acquisition head. 
         [0030]    A least one actuator  22  is positioned on the handle  12  ( FIG. 1 ) allowing for independent control of each of the graspers  20   a ,  20   b . During the course of a procedure, a user may use the actuator(s)  22  to first deploy the grasper  20   b  as in  FIG. 3  to engage tissue drawn into vacuum chamber  14   b , and to later advance the graspers  20   a  ( FIG. 4 ) to engage a second pinch of tissue subsequently drawn into the vacuum chamber  14   a.    
         [0031]      FIGS. 5A-5C  illustrate advancement of the graspers  20   a ,  20   b  from the retracted position ( FIG. 5A ), to a semi-deployed position ( FIG. 5B ), to a fully deployed position ( FIG. 5C ). Each of the fingers  26  includes a curved guide channel  28  (most visible in  FIGS. 5B and 5C ). A pair of guide pins  30  (only the distal ends of which are visible in  FIGS. 5A-5C ) extend longitudinally through each side of the head  10 . Each of the guide pins  30  extends through the guide channels on that side of the head  10 . As the fingers  26  move to the deployed position, their guide channels slide over the guide pins  30 , ensuring that the free ends of the fingers track downwardly into the corresponding vacuum chamber. 
         [0032]      FIGS. 5A-5C  further illustrate movement of drive links  24 , which pivot laterally outwardly to drive the graspers  20   a ,  20   b  to the deployed position. The mechanism for driving the links  24  for advancing and retracting the graspers  20   a ,  20   b  will next be described with respect to  FIGS. 6-11 . Attention is first directed to  FIGS. 6 and 10 , in which the housing of the head  10  has been omitted to permit clear viewing of the graspers and associated features. A longitudinally extending pin  32  connects the fingers  26  of each grasper  20   a ,  20   b . Each of the drive links  24  has a first end coupled to the distal end of one of the pins  32 , and a second end coupled to an arm rotator pin  34  which is oriented longitudinally relative to the housing. 
         [0033]    A cable link  38  is attached to the proximal end of the arm rotator pin  34 , at pivot location  36 . Cable link has ends pivotable about the pivot location  36 . A spring  40  extends between one end of the cable link  38  and a pin  42  mounted to the housing of the head  10 . The other end of the cable link  38  includes an end pin  46  to which a pull cable  44  is secured. Referring to  FIG. 12 , a pull cable  44  extends from end pin  46 , around a cylindrical cable guide  48 , into a cable channel  50  (also see  FIG. 6 ) and through the shaft  12  ( FIG. 1 ) where it is coupled to actuator  22 . 
         [0034]    To deploy one of the graspers  20   a ,  20   b , actuator  22  is manipulated to pull the cable  44  associated with the grasper to be deployed. Tension on the cable  44  rotates the cable link  38  about pivot  36  from the position shown in  FIG. 7  to the position shown in  FIG. 10 . Rotation of the cable link  38  rotates the arm rotator pin  34 , thus causing link  24  to pivot laterally outwardly from the position shown in  FIG. 8  to the position shown in  FIG. 11 . This movement of the link  24  pivots the pin  32  laterally outwardly, and thereby advances the attached fingers  26  to the deployed position. 
         [0035]    The spring  40  serves to bias the cable link  38  in the position shown in  FIG. 7 , thus keeping the graspers  20   a ,  20   b  biased in the retracted position. It can be seen by comparing  FIGS. 7 and 10  that when the cable link  38  is rotated by the cable  44 , the spring expands from its resting position to a position in tension. When the actuator  22  is caused to release the tension on the cable  44 , the spring returns to its resting state, thereby returning the graspers to the retracted position. 
         [0036]      FIGS. 13A-13D  schematically illustrate use of the acquisition device to place two two-layer folds of tissue in apposition for fastening together using a tissue fastener such as a stapler, clip applier, suture device etc, although the acquisition device may be used for procedures as well. 
         [0037]    During use of the acquisition device, the head  10  of the device  100  is introduced into a patient (e.g. into the stomach through an endogastric overtube) and advanced towards tissue to be acquired. A first one of the vacuum chambers  14   b  is positioned adjacent to the target tissue, and the vacuum source is activated relative to that chamber, thus drawing the target tissue into the chamber as shown in  FIG. 13A . Once a sufficient volume of tissue has been drawn into the chamber, the actuator is used to drive the grasper  20   b  into the chamber  14   b  as shown in  FIG. 13B . When the tissue has been securely acquired by the first grasper, vacuum pressure in chamber  14   b  is released and the vacuum head (with the first tissue pinch securely engaged in chamber  14   b ) is repositioned to position the vacuum chambers  14   a  at a second area of target tissue. Vacuum is again initiated to draw tissue into the second chamber  14   a . After the desired volume of tissue has been drawn into the chamber  14   a , grasper  20   a  is advanced to retain the tissue within chamber  14   a . At this time the vacuum may again be released. 
         [0038]    Once tissue has been secured in each chamber as shown in  FIG. 13C , the acquisition head  10 , with the two tissue pinches retained by its graspers, is manipulated to place the layers L of the tissue pinches or folds P in tension. A fastening instrument  60  is positioned as shown in  FIG. 13D  to drive fasteners transversely through the four layers of tissue comprising the acquired tissue pinches. Fastening instrument  60  may be a stapler having a cartridge  62  and anvil  64 . Commonly owned U.S. Pat. No. 7,934,631, entitled MULTI-FIRE STAPLING SYSTEMS AND METHODS FOR DELIVERING ARRAYS OF STAPLES, and filed on the same date as the present application, describes a stapler that may be used for this purpose. The tissue acquisition device may be part of a tissue reconfiguration or partitioning system that also includes the disclosed stapler, or any of a variety of mechanisms for applying a fastening element (e.g. clips, sutures, staplers, two-part fasteners etc.) to the acquired tissue. 
         [0039]    It should be recognized that a number of variations of the above-identified embodiments will be obvious to one of ordinary skill in the art in view of the foregoing description. Moreover, features of the disclosed embodiments may be combined with one another and with other features (including those taught in the prior applications referenced herein) in varying ways to produce additional embodiments. Accordingly, the invention is not to be limited by those specific embodiments and methods of the present invention shown and described herein. The applications and methods listed are not limited to the treatment of diseases or procedures listed. Modifications of the above described methods and tools and variations of this invention that are obvious to those of skill in the art are intended to be within the scope of this disclosure. 
         [0040]    Any and all patents, patent applications and printed publications referred to above, including those relied upon for purposes of priority, are incorporated herein by reference.