CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application is related to four co-pending and commonly-owned application filed on even date herewith, the disclosure of each is hereby incorporated by reference in its entirety: 
        “Anastomosis Wire Ring Device”, Ser. No. ______ to Don Tanaka, Mark Ortiz and Darrel Powell;     “Applier For Fastener For Single Lumen Access Anastomosis”, Ser. No. ______ to Mark Ortiz;     “Unfolding Anastomosis Ring Device”, Ser. No. ______ to Jean Beaupre; and     “Single Lumen Access Deployable Ring for Intralumenal Anastomosis”, Ser. No. ______ to Mark Ortiz.       
 
     
    
     FIELD OF THE INVENTION  
       [0006]     The present invention relates, in general, to surgery and, more particularly, to a method of performing a surgical procedure on the digestive system.  
       BACKGROUND OF THE INVENTION  
       [0007]     The percentage of the world population suffering from morbid obesity is steadily increasing. Severely obese persons are susceptible to increased risk of heart disease, stroke, diabetes, pulmonary disease, and accidents. Because of the effect of morbid obesity to the life of the patient, methods of treating morbid obesity are being researched.  
         [0008]     Numerous non-operative therapies for morbid obesity have been tried with virtually no permanent success. Dietary counseling, behavior modification, wiring a patient&#39;s jaws shut, and pharmacologic methods have all been tried, and though temporarily effective, failed to correct the condition. Further, introducing an object in the stomach, such as an esophago-gastric balloon, to fill the stomach have also been used to treat the condition; however, such approaches tend to cause irritation to the stomach and are not effective long-term.  
         [0009]     Surgical treatments of morbid obesity have been increasingly used with greater success. These approaches may be generalized as those that reduce the effective size of the stomach, limiting the amount of food intake, and those that create malabsorption of the food that it is eaten. For instance, some patients benefit from adjustable gastric bands (AGB) that are advantageously laparoscopically placed about the stomach to form a stoma of a desired size that allows food to fill an upper portion of the stomach, causing a feeling of satiety. To allow adjustment of the size of the stoma after implantation, a fluid conduit communicates between an inwardly presented fluid bladder of the AGB to a fluid injection port subcutaneously placed in front of the patient&#39;s sternum. A syringe needle may then inject or withdraw fluid as desired to adjust the AGB.  
         [0010]     Although an effective approach to obesity for some, other patients may find the lifestyle changes undesirable, necessitated by the restricted amount of food intake. In addition, the medical condition of the patient may suggest the need for a more permanent solution. To that end, surgical approaches have been used to alter the portions of the stomach and/or small intestine available for digesting food. Current methods of performing a laparoscopic anastomoses for a gastric bypass include stapling, suturing, and placing biofragmentable rings, each having significant challenges. For instance, suturing is time consuming, as well as being technique and dexterity dependent. Stapling requires placement of an anvil, which is a large device that cannot be introduced through a trocar port. Having to introduce the port through a laparotomy presents an increased incidence of wound site infection associated with intralumenal content being dragged to the laparotomy entry site.  
         [0011]     As an example of the latter approach, in U.S. Pat. No. 6,543,456 a method for gastric bypass surgery includes the insertion of proximal and distal anastomosis members (e.g., anvils) transorally with grasping forceps. The stomach and the small intestine are transected endoscopically by a surgical severing and stapling instrument to create a gastric pouch, a drainage loop, and a Roux limb. An endoscopically inserted circular stapler attaches to the distal anastomosis member to join the drainage loop to a distal portion of the intestine, and the circular stapler attaches to the proximal anastomosis member to join the Roux limb to the gastric pouch. Thereafter, the anastomosis members are removed to create an orifice between joined portions of the stomach and intestine. This method reduces the number of laparoscopic ports, avoids a laparoscopic insertion of an anastomosis instrument (e.g., circular stapler) into an enlarged surgical port, and eliminates the need for an enterotomy and an enterotomy closure.  
         [0012]     While methods such as that described are a marked improvement over generally known gastric bypass and similar surgical treatments for morbid obesity, it would be desirable to achieve a gastric bypass with yet fewer procedural steps and with fewer laparoscopic insertions. Such an approach is described in U.S. patent application Publ. No. US 2003/0032967 to Park et al., wherein gastrointestinal or enteric (including biliary) anastomosis is achieved by insertion of a sheath that perforates the walls of two tissue passages, such as the stomach and small intestine. A three-dimensional woven tube of wire of having a thermal shape memory effect (SME) is presented by a cannula of the sheath on both sides of the openings. Use of SME material in a cuff-like arterial bypass has been previously used, as described in U.S. Pat. Nos. 5,676,670, 5,797,920 and 6,007,544. Deployment of the woven tube causes the outer loops or ends of the tube to fold or loop back to hold the luminal interface of the anastomosis site in apposition. Thereby, the need for a mechanical compression component in a delivery system is reduced or avoided, reducing the size and complexity of the delivery device.  
         [0013]     While this generally known ring device is a significant advancement in the treatment of morbid obesity, it is believed that further improvements would be desirable for clinical effectiveness. In particular, the known ring device is a woven tube, or stent, that is purported to be a self-actuating anastomotic ring. Thus, an applier described for inserting the known ring device merely positions the ring device at the anastomotic site and deploys the ring device by pushing it off of a cannula, relying upon SME attributes of the ring device to cause actuation. Unfortunately, the generally known ring device sometimes will not actuate or transform from its stressed cylindrical state to its relaxed clamping state, perhaps due to irregularities in undulations of its woven designs create friction. One particular difficulty of known SME anastomotic rings are that they are designed to move from a generally cylindrical shape to a hollow rivet shape (“ring shape”) by having wires that form the device move across one another. In particular, wires must move within a nodal point (i.e., an indentation or valley) created by the wire bend and must climb back out of the indentation. In some instances, the device fails to fully actuate on its own due to these sources of friction.  
         [0014]     While improvements to the ring device are also desirable, what would mitigate the shortcomings of the generally known ring device is a surgical tool, or applier, that affirmatively and rapidly forms the attachment at an anastomotic surgical site, without having to wait for SME actuating to slowly, if at all, effect attachment. However, such an applier would advantageously allow a single lumen access, unlike the previously known anastomosis procedures that required insertion of anvils and circular staplers.  
         [0015]     Moreover, it is believed that having to rely upon an SME actuation sufficiently strong to move from the stressed, unactuated position to the relaxes, actuated position limits the range of material properties and dimensions that otherwise may be selected. For instance, a thinner gauge wire strand may advantageously provide sufficient holding strength until the anastomosis attachment heals, yet releases easily later for letting the now unnecessary ring device to pass out of the patient. Yet, this thinner gauge wire strand would be unable to incorporate sufficient SME strength to overcome internal friction and to draw together apposite tissue walls during actuation.  
         [0016]     In addition, a current challenge for using a single lumen anastomosis procedure is that it is desired for clinical efficiency and for minimizing patient recovery time that the anastomosis site be approached from one side of the apposite pair of tissue walls of two adjacent tissue passages (e.g., stomach and small intestine). Yet, only one of the tissue walls and a proximal side of a deployed ring device are readily visible from this vantage point, when viewed by an endoscope or similar optical imaging device. Confirming that a successful anastomotic attachment has occurred is highly desirable.  
         [0017]     Consequently, there is a general need for an approach to anastomosis that will use existing trocar ports (e.g., 12 mm size) with a minimum of suturing. Moreover, aspects of the method should have application to endoscopic surgery. To that end, a significant need exists for an anastomosis device that reliably and effectively deploys and actuates to eliminate the need for surgical stapling and suturing to form an anastomosis.  
       BRIEF SUMMARY OF THE INVENTION  
       [0018]     The invention overcomes the above-noted and other deficiencies of the prior art by providing a  
         [0019]     In one aspect of the invention, a surgical instrument has an actuating member that is moveable between a cylindrical, unactuated position and a hollow rivet forming shape for implanting an anastomotic ring device. A handle of the instrument has an actuation mechanism produces a compressive actuating force that is transferred down an elongate cannula that distally supports the actuating member to actuate the actuating member. Thereby, the anastomotic ring device is affirmatively placed into position without having to rely solely upon a self-actuating capability of the ring device.  
         [0020]     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0021]     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.  
         [0022]      FIG. 1  is perspective view of an applier having an anastomotic ring device installed thereon being inserted laparoscopically to an anastomosis target site on each of two portions of a patient&#39;s small intestine.  
         [0023]      FIG. 2  is a perspective detail view of the applier with sheath retracted and anastomosis target site of  FIG. 1 , depicting the anastomotic ring device in its undeployed, unactuated state.  
         [0024]      FIG. 3  is a perspective, exploded and partially cutaway view of a distal portion of the applier of  FIG. 1 .  
         [0025]      FIG. 4  is a perspective, exploded view of a proximal portion of the applier of  FIG. 1  with a left housing half omitted.  
         [0026]      FIG. 5  is perspective view of the applier of  FIG. 1  with the left housing half omitted and an outer tube of the cannula partially cutaway to expose an intermediate tube and inner rod that actuate a molded actuating member that actuates the omitted anastomotic ring device, also to expose a deployment illuminator that allows confirming actuation of an anastomotic ring device by viewing through the translucent tissue walls.  
         [0027]      FIG. 6  is a perspective view of the applier of  FIG. 5  with the triggers and molded actuating member in an actuated position.  
         [0028]      FIG. 7  is a perspective view of the applier of  FIG. 1  in a partially actuated state.  
         [0029]      FIG. 8  is a detail perspective view of a distal portion of the applier of  FIG. 7  with tissue walls partially cutaway.  
         [0030]      FIG. 9  is a perspective view of the applier of  FIG. 1  in a fully actuated state.  
         [0031]      FIG. 10  is a detail perspective view of the distal portion of the applier of  FIG. 9  with tissue walls partially cutaway.  
         [0032]      FIG. 11  is a detail perspective view of the distal portion of the applier returned to unactuated state and withdrawn proximally to deploy the actuated anastomotic ring device. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]     Turning to the Drawings, wherein like numerals denote like components throughout the several views,  FIG. 1  depicts an applier  10  that advantageously laparoscopically or endoscopically deploys and actuates an anastomotic ring device  12  from a generally cylindrical shape to one having properties of a hollow rivet, or ring, capable of forming an astomotic attachment at an anastomosis target site, such as in a bariatric gastric bypass of a morbidly obese patient  16 . In the illustrative version, the anastomotic ring device  12  comprises a shape memory effect (SME) material such as nitinol that further assists in actuation to an engaging hollow rivet shape.  
         [0034]     It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping a handle of the applier  10 . It will be further appreciated that for convenience and clarity, spatial terms such as “right”, “left”, “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. In addition, aspects of the invention have application to surgical procedures performed endoscopically and laparoscopically, as well as an open procedure. Use herein of one of these or similar terms should not be construed to limit the present invention for use in only one category of surgical procedure.  
         [0035]     Anastomotic Ring Device Applier.  
         [0036]     In  FIG. 2 , the applier  10  has the anastomotic ring device  12  advantageously retained in a generally cylindrical shape upon a cannula  13  protected by an outer tube (or sheath)  18  that covers the ring device  12  until a knob  19  is rotated, drawing back the outer tube  18  to expose the ring device  12  prior to actuation. The ring device  12  is received upon a molded actuation member  20  that is connected at its midpoint to a stationary tube  22 . Distal to the molded actuation member  20  is a tapered tip  24 . This tapered tip  24  may include a distal piercing surface  26  to assist in forming an anastomotic opening  28  through apposite tissue walls  30 ,  32  of two gastrointestinal passages. As discussed below, the tapered tip  24  may advantageously include illumination features that allow confirmation of placement and actuation of the anastomotic ring device  12  when viewed from a proximal direction through translucent tissue walls  30 ,  32 .  
         [0037]     The molded actuation member  20  may be formed as a generally rectangular piece that is wrapped around a mandrel. Then the longitudinal edges that come together may be adhered or fused together. Alternatively, snap rings may be attached over each longitudinal end (i.e., proximal and distal) and the midpoint to hold the molded actuation member  20  together.  
         [0038]     With reference to  FIGS. 2-5 , a handle  34 , proximal to the cannula  13 , includes a pair of longitudinally aligned triggers  36 ,  38 . The proximal trigger  36 , shown at its most proximal, unfired position, is coupled to proximal leaves  40  of the molded actuation member  20  via an intermediate tube  42  of the cannula  13 . Distal movement of the proximal trigger  36  thus causes longitudinal distal movement of the intermediate tube  42  and proximal leaves  40 , which outwardly actuate like an umbrella by a cantilevered, hinged relationship to a central portion  44  of the molded actuation member  20 , which in turn is mechanically grounded to a distal end of the stationery tube  22  that extends out of the intermediate tube  42 . Similarly, the distal trigger  28 , shown at its most distal, unfired position, is coupled to distal leaves  46  of the molded actuation member  20  via an internal tube  48  that is coupled for movement within and extends distally out of the stationary tube  22 . Proximal movement of the distal trigger  38  causes longitudinal proximal movement of the internal tube  48  and distal leaves  50  of the molded actuation member  20 , which outwardly actuate by a hinged relationship to the central portion  44 .  
         [0039]     It should be appreciated that thus either trigger  36 ,  38  may be moved individually to actuate only a proximal or a distal portion of the actuating member  20 . Thus, the proximal leaves  40  may be actuated within a proximal lumen in order to use the cannula  13  to position the proximal lumen to the distal lumen prior to inserting the tapered tip  24  into the distal lumen. Alternatively, the cannula  13  may be inserted into the distal lumen, the distal leaves  46  may be actuated, and the distal lumen drawn back into contact with the proximal lumen.  
         [0040]     Inserting the cannula  13  into the distal lumen and later withdrawing the cannula  13  from both the distal and proximal lumens is facilitated by incorporating a tapered tip  24  with a distal piercing surface  26  in the form of a veress needle that avoids inadvertent damage to tissue and may advantageously inflate the lumens. The veress needle has a syringe knife tip within which a ball translates. As the veress needle  26  is pressed against the tissue walls  30 ,  32 , the ball springedly withdraws into the veress needle  26  exposing the piercing surfaces. Once through, tissue more distal is generally not positioned under tension and is displaced by the extended ball rather than traumatically encountering the knife tip. The veress needle  26  may advantageously be in pneumatic communication with a hollow internal tube  48  with the ball presenting a lateral orifice when extended. Thus, air pressure may be introduced into the proximal and distal lumens so that the actuating member may actuate without being impeded by collapsed tissue and also be withdrawn without impediment. An air port on the handle  34  that communicates with the veress needle  26  provides a port for the insufflation. For a relatively small port (e.g., {fraction (1/16)} inch), the port may be left unclosed when not in use without allowing a significant amount of air loss through the instrument  10 .  
         [0041]     As depicted in  FIG. 3  in phantom, the tapered tip  24  may further include a distal sheath  51  that cooperates with the outer tube  18  to shield the actuating member  20  during insertion and removal from the patient.  
         [0042]     As best viewed in  FIGS. 4-5 , within the handle  34 , a cavity  52  includes proximal and distal apertures  54 ,  56  to allow the longitudinal movement of the proximal and distal triggers  36 ,  38  respectively. Each trigger  36 ,  38  includes a right opening aperture  58  that engage for longitudinal movement a leftward projecting track  60  formed within the cavity  52  of a right half shell of the handle  34 .  
         [0043]     Moving from most distal to most proximal, a first, second and third lateral ridge  62 ,  64 ,  66  across the bottom of the cavity  52  define a first, second, third, and fourth cavity segment  68 ,  70 ,  72 ,  74  respectively. A first block  76 , formed from left and right halves  78 ,  80  is positioned for movement within the first cavity segment  68 . A longitudinal central hole  82  defined between the two halves  78 ,  80  engages and moves with a terminating proximal end  84  of the intermediate tube  42 .  
         [0044]     The stationary tube  22  passes out proximally from the intermediate tube  42  into the second cavity segment  70 . A second spacer block  90  locked within the second cavity segment  70  has a longitudinal central hole  92  defined between its left and right halves  94 ,  95  that engages the stationary tube  22 , locking it into place relative the handle  34 .  
         [0045]     The internal tube  48  passes proximally out of the stationary tube  22  on through the third and fourth cavity segments  72 - 74  into sliding contact with a hole  86  passing through a proximal end  88  of the handle  34 . A third sliding block  96  has a longitudinal central hole  98  defined between its upper and lower halves  100 ,  102  that engage and move with the internal tube  48 . A lower portion  104  of the distal trigger  38  is attached to a distal face of the third sliding block  96 . A fourth sliding block  106  within the fourth cavity segment  74  has a longitudinal central hole  108  that slidingly contacts the internal tube  48 . A lower portion  114  of the proximal trigger  36  is attached to a proximal face of the fourth sliding block  106 . A link  116  is attached to the left sides of the first and fourth sliding blocks  76 ,  106 .  
         [0046]     In  FIG. 6 , the triggers  36 ,  38  have been slid toward one another to actuate the molded actuating member  20 . Specifically, the distal trigger  38  has been moved proximally, moving the third sliding block  96  and internal tube  48 , the distal terminating end of the latter being attached to tapered tip  24 . The tapered tip thus moves toward the distal end of the intermediate tube  42 . The proximal trigger  36  has been moved distally, moving fourth sliding block  106 , link  116 , first sliding block  76 , and intermediate tube  42  also distally. The distal portion of the molded actuating member  20  is compressed between the inwardly moving tapered tip  24  and the central portion  44  that is arrested by the stationary tube  22 . The distal leaves  50  actuate lateral to the longitudinal axis, and move toward and interdigitate with the proximal leaves  40 , the latter having been actuated by distal movement of the intermediate tube  48  compressing against the central portion  44 . This movement expedites actuating of an anastomotic ring device (not shown in  FIG. 6 ).  
         [0047]     In use, the tapered tip  24  of the applier  10  is inserted through a trocar port into a tissue passage that has been placed proximate to another tissue passage that are to be anastomotically joined (See  FIGS. 1-2 ). The tapered tip  24  and a distal half of the molded actuating member  20  and anastomotic ring device  12  are inserted through an anastomotic opening  28  formed therebetween and then the applier is actuated, with a partially actuated applier  10  being depicted in  FIGS. 7-8 . Positioning of the distal and proximal lumens is facilitated by separately actuating half of the actuating member  20  and by inflating the lumens by passing pressurized air through the instrument  10 . With particular reference to  FIG. 8 , the proximal and distal leaves  40 ,  50  are shown as having gripping slots  118  that grip respective petals  120  of the anastomotic ring device  12 , especially in its unactuated, generally cylindrical shape. An inwardly directed retention tip  121  or other gripping features in the gripping slots  118  may be incorporated to enhance retention. These gripping slots  118  assist in preventing the anastomotic ring device  12  from slipping off of the applier  10  or being inappropriately placed thereon for actuation. In  FIGS. 9-10 , the applier  10  has been fully actuated, forming the anastomotic ring device  12  into a hollow rivet shape to form the anastomotic attachment between tissue walls  30 ,  32 . The fully actuated proximal and distal leaves  40 ,  50  cause the petals  120  to disengage from the gripping slots  118 . Thereafter, the applier  10  is returned to an unactuated condition and the actuated anastomotic ring device  12  deployed by withdrawing the tapered tip  24  from the anastomotic opening  28  and ring device  12 , as depicted in  FIG. 11 .  
         [0048]     Deployment Illumination.  
         [0049]     In  FIGS. 7, 9 , a distal portion of the anastomotic ring device  12  are depicted in phantom to illustrate their actuated position. This phantom depiction is also suggestive of a clinical advantage of being able to view the deployment condition from a proximal point of view. Typically, an endoscope will view the anastomotic opening  28  from a proximal position. Returning to FIGS,  2 - 7 , adding a deployment illumination feature to the applier  10  provides this ability to view deployment through translucent tissue walls. Specifically, an illumination power source (e.g., battery)  150  and control (e.g., switch)  152  are incorporated into the handle  34  with a conductor, depicted as a twisted wire pair  154  passing through the internal tube  48  to the tapered tip  24 , which includes a proximally directed electroluminescence device  156 . Alternatively conductive ink traces may be applied longitudinally down portions of the applier  10  to provide an electrical circuit to the tapered tip  24 . An externally accessible push button  158  drives the power source  150  against the control  152 , creating an illumination circuit with the electroluminescence device  156 .  
         [0050]     Alternatively or in addition, the molded actuating member  20  may be formed of a fluorescent or electroluminescent material that is either stimulated prior to insertion or receives light from a light source of the applier  10 .  
         [0051]     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.  
         [0052]     As one example of an equivalent structure that may be used to implement the present invention, hydraulics, electronics, or pneumatics may be used to move cannula  13  relative to handle  34 . Computer control could be used with electronics and a feedback loop to move tube  14  and to selectively tension a force element based on the amount of tissue force applied. As a further example of an equivalent structure that may be used to implement the present invention, robotics could be used with anastomosis device  10  attached to a controlled robotic arm that moves the mechanism of anastomosis device  10  to effect an anastomosis.  
         [0053]     As a further example of an equivalent structure, cannula  13  could become a flexible tube, and the mechanisms within cannula  13  may become flexible to maneuver through a long lumen, such as a section of small bowel, to effect an anastomosis through a long, flexible lumen. Such a long, flexible tube may be used laparoscopically or endoscopically.  
         [0054]     As a further example of an equivalent structure, applier  10  could have a long, rigid, curved tube, or a long, rigid, straight tube, and applier  10  could be placed through an obturator port and used laparoscopically or endoscopically. Length and curvature becomes advantageous in endoscopic or laproscopic surgery, especially when performing a surgical procedure on a bariatric patient. In either a rigid or a flexible form of an applier  10 , restriction of gas flow through the instrument becomes advantageous when maintenance of a pneumoperitoneum is desired as in, for example, endoscopic surgery.  
         [0055]     As a further example of an equivalent structure and method that may be used to implement the present invention, applier  10  may have a geometry small enough to be conveniently placed through the opening of a hand port used for hand-assisted laproscopic surgery, such as, for example, the Lap-Disk® hand port sold by Ethicon Endo-Surgery in Cincinnati, Ohio. A surgeon using applier  10  through a hand port may use an endoscope through a secondary port for visualization, and may also maintain a pneumoperitoneum. The surgeon may also make use of trocars, graspers, cutters, and other endoscopic instruments inserted through auxiliary ports to assist in grasping lumens or creating otomies in lumens to perform surgical procedures such as anastomoses.  
         [0056]     As a further example of an equivalent structure and method that may be used to implement the present invention, a long, rigid version of applier  10 , or a long, flexible embodiment of applier  10  may be used through an auxiliary port while tissue is manipulated by the surgeon using a hand placed through a hand port.  
         [0057]     As other examples of equivalent structures, the surface of tapered tip  24  may take many forms advantageous for various types of tissue manipulation, such as a conical tipped nose that is blunted for low tissue trauma and for good visibility past the distal end. As another example, a nose that is fluted to allow torque to be applied to tissue. As yet a further example, a nose may have a convex curve for rapid dilation of an otomy in a short space or a nose having a concave surface for gentle dilation of friable tissue. An offset swept nose may be used because of its asymmetry for better visibility to one side and may be used to assist in manipulation by using its asymmetry to minimally grasp tissue. A spherical nose may be used to produce a short length for operation in limited space and to reduce the chance of tissue trauma. Combinations of these surfaces may also be advantageous, for example, a nose having a concave surface may also possess flutes. Other combinations may occur to one skilled in the art.
A surgical tool or applier facilitates laparoscopic or endoscopic implantation through a single bodily tissue lumen of an anastomotic ring device for forming a hollow rivet type of attachment between tissue lumens. In addition to forming a puncture between apposite tissue walls at the anastomosis site, the applier assists or wholly actuates the anastomotic ring device and is retracted to deploy the actuated ring device. Illumination incorporated into a distal portion of a cannula enables confirmation of deployment.