Abstract:
In accordance with the present invention there is provided an applier for a surgical device and method that gives the surgeon improved control when applying the device. The applier includes an enclosure to constrain the device, a cover on the end of the enclosure, a restraining element to prevent proximal movement of the device while the enclosure moves proximally, and a force element connecting the cover to the enclosure. The force element causes the cover and enclosure to retract proximally as one unit, but has enough flexibility to allow the cover to lift off of the enclosure when a second force larger than that generated by the force element is placed on the cover to urge it distally. The force element places a force at a distal end of the surgical device as the applier ejects the surgical device.

Description:
[0001]     This application is related to the following copending provisional patent applications: provisional application No. 60/507,800 filed on Sep. 30, 2003; provisional application 60/507,798 filed on Sep. 30, 2003; and provisional application 60/507,616 filed on Sep. 30, 2003; which are hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates, in general, to devices and methods for surgically modifying organs and vessels. More particularly, it relates to anastomosis devices for joining two organs such as, for example, two separate lengths of small bowel to each other, a section of small bowel to the stomach, or the common bile duct to the duodeneum in a procedure called a choledochoduodenostomy.  
       BACKGROUND OF THE INVENTION  
       [0003]     Creating an anastomosis, or the surgical formation of a passage between two normally distinct vessels, is a critical step of many surgical procedures. This is particularly true of gastric bypass procedures in which two portions of small intestine are joined together and another portion of small intestine is joined to the stomach of the patient. This is also true of surgery to alleviate blockage in the common bile duct by draining bile from the duct to the small intestine during surgery for pancreatic cancer.  
         [0004]     For many anastomosis, surgeons use circular staplers, linear staplers, or manual sutures. However, to reduce incision size and to make the surgical process less technically demanding and time consuming, an expandable medical device that deforms to hold tissue portions together when the device is ejected from a constraining enclosure has been described. U.S. application 2003/0120292 to Adrian Park et al, which is hereby incorporated herein by reference, describes such a device.  
         [0005]     The expandable medical device disclosed in 2003/0120292 is constrained by a sleeve to an advantageous small-diameter tubular shape. A surgeon applies the expandable medical device by maneuvering the sleeve through the tissue portions requiring anastomosis, moving a nose assembly distally away from the sleeve, and ejecting the device with a ram. Ejecting the device removes the constraint on the device, allowing the device to assume a roughly ring shape. The larger ends of the ring shape hold the two tissue portions together in an effective anastomosis.  
         [0006]     The constrained expandable medical device, which may be made of a shape memory material such as nitinol, exerts a force against the inner diameter of the sleeve and tends to warp towards its roughly ring-shaped deployed position. When the device is ejected, the forces generated by the device in transition from a tubular shape to a ring shape urge the expandable medical device distally. This device movement makes surgical control harder to achieve when placing the device through the otomies of two tissue portions requiring anastomosis. Applicants have recognized a need to apply a restraining force to the distal end of the expandable medical device to improve surgical control when applying it. An applier to place the expandable medical device while restraining the tendency of the device to move distally during ejection, and a method of using the applier would be desirable. It would be further advantageous to provide a flexible force element urging the distal nosepiece, or cover, towards the ejecting device as the device is ejected to control distal movement of the device. The present invention provides such an applier and method.  
       SUMMARY OF THE INVENTION  
       [0007]     In accordance with the present invention there is provided an applier for a surgical device and method that gives the surgeon improved control when applying the device. The applier includes an enclosure to constrain the device, a cover on the end of the enclosure, a restraining element to prevent proximal movement of the device while the enclosure moves proximally, and a force element connecting the cover to the enclosure. The force element causes the cover and enclosure to retract proximally as one unit, but has enough flexibility to allow the cover to lift off of the enclosure when a second force larger than that generated by the force element is placed on the cover to urge it distally. The force element places a force at a distal end of the surgical device as the applier ejects the surgical device.  
       BRIEF DESCRIPTION OF THE FIGURES  
       [0008]     The novel features of the invention are set forth with particularity in the appended claims.  
         [0009]     The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:  
         [0010]      FIG. 1  is an isometric view of an applier according to an embodiment of the invention containing an expandable medical device.  
         [0011]      FIG. 2  is an isometric of an applier according to a second embodiment of the invention.  
         [0012]      FIG. 3  is an isometric view of the applier of  FIG. 2  with interior portions revealed.  
         [0013]      FIG. 4  is an isometric view of the distal side of the handle of the applier of  FIG. 3 .  
         [0014]      FIG. 5  is an isometric view of an applier according to a third embodiment of the invention.  
         [0015]      FIG. 6  is an isometric view of the interior portions of the embodiment of  FIG. 5 .  
         [0016]      FIG. 7  is an isometric view of the path retainer on the applier of  FIG. 5  depicting details of the guide path.  
         [0017]      FIG. 8  is a cross-sectional view of the embodiment of  FIG. 1  in the loaded position.  
         [0018]      FIG. 9  is an isometric view of embodiment of  FIG. 1  with the device in the flared position.  
         [0019]      FIG. 10  is a cross-sectional view of the embodiment of  FIG. 1  with the device in the flared position.  
         [0020]      FIG. 11  is an isometric view of the embodiment of  FIG. 1  after the device has been applied.  
         [0021]      FIG. 12  is a cross-sectional view of the embodiment of  FIG. 1  after the device has been applied.  
         [0022]      FIG. 13  is a cross-section view of the embodiment of  FIG. 2  with the device in the loaded position.  
         [0023]      FIG. 14  is an isometric view of the applier of  FIG. 2  with the device in the flared position.  
         [0024]      FIG. 15  is a cross-sectional view of the applier of  FIG. 2  with the device in the flared position.  
         [0025]      FIG. 16  is an isometric view of the applier of  FIG. 2  after the device has been applied.  
         [0026]      FIG. 17  is a cross-section view of the applier of  FIG. 2  after the device has been applied.  
         [0027]      FIG. 18  is a cross-sectional view of the applier of  FIG. 5  with the device in the loaded position.  
         [0028]      FIG. 19  is an isometric view of the path retainer of  FIG. 7  showing the relationship between the guide path and the guide clip when the device is being flared.  
         [0029]      FIG. 20  is a cross-sectional view of the applier of  FIG. 5  flaring the device.  
         [0030]      FIG. 21  is a cross-sectional view of the applier of  FIG. 5  with the device flared and restrained by the bullet nose.  
         [0031]      FIG. 22  is an isometric view of the path retainer of  FIG. 7  showing the relationship between the guide path and the guide clip when the device is flared and restrained by the bullet nose.  
         [0032]      FIG. 23  is a cross-sectional view of the applier of  FIG. 5  with the device being ejected.  
         [0033]      FIG. 24  is a cross-sectional view of the retainer of  FIG. 7  showing the relationship between the guide path and the guide clip when the device is being ejected.  
         [0034]      FIG. 25A  is an isometric view of a distal end of an applier showing a bullet nose having a blunt surface.  
         [0035]      FIG. 25B  is an isometric view of a distal end of an applier showing a bullet nose having a fluted surface.  
         [0036]      FIG. 25C  is an isometric view of a distal end of an applier showing a bullet nose having a convex surface.  
         [0037]      FIG. 25D  is an isometric view of a distal end of an applier showing a bullet nose having a concave surface.  
         [0038]      FIG. 25E  is an isometric view of a distal end of an applier showing a bullet nose having an offset swept, asymmetric surface.  
         [0039]      FIG. 25F  is an isometric view of a distal end of an applier showing a bullet nose having a spherical surface. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0040]      FIG. 1  depicts an applier  10  configurable to apply an expandable medical device  12 . Applier  10  has an enclosure, or a tube  14  for containing expandable medical device  12  and internal components of applier  10 . Tube  14  may be created from a moldable plastic, and at least a portion of tube  14  may be translucent or transparent to allow visualization of device  12  or other internal components. Translucency or transparency could also allow light from a light source placed internal to tube  14  to pass externally to tube  14  to illuminate a work area. Guide slot  16  is positioned on tube  14  near the proximal end of tube  14 . Guide slot  16  may have a shape to present stop positions or cam surfaces to the user to guide the user in proper placement of the components of applier  10  during actuation of applier  10 . In applier  10  as depicted in  FIG. 1 , the shape of guide slot  16  roughly approximates the letter “Z” and extends about at least a portion of the circumference of tube  14 . A locator pin  18  moves within guide slot  16  and locates portions of components of applier  10 .  FIG. 1  depicts locator pin  18  as a socket-head cap screw; however, locator pin  18  and guide slot  16  may comprise any cam-follower mechanism able to direct movement of components of applier  10 . Knob  20  extends from the proximal end of applier  10  for control by the user. Tube handle  24  attaches to tube  14 , also for grasping by the user to manipulate applier  10 . A cap in the form of bullet nose  22  is placed at the distal end of tube  14 . Bullet nose  22  protrudes from the distal end of tube  14 , and has a distal end shaped to engage and dilate small stoma in tissue. This distal end shape may be conical, but could also be rounded, asymmetrical, pointed, or any shape to facilitate entry into tissue. Bullet nose  22  also possesses on its proximal surface a device taper  70 . Device taper  70  is shown substantially conical in shape with the taper facing proximally towards expandable medical device  12  when expandable medical device  12  is loaded within applier  10 . Device taper  70  may also take different surface shapes, such as, for example, a convex curved shape, which may facilitate flaring and deployment of expandable medical device  12 .  
         [0041]      FIG. 1  further displays the internal mechanism  26  of applier  10  in isometric view. Pusher rod  28  extends distally from knob  20  and is hollow for at least a portion of its length to enclose other components. Pusher rod slot  30  opens into the internal portions of pusher rod  28  and is elongated to allow differential motion between pusher rod  28  and other components of internal mechanism  26 , as will be seen. Pusher rod  28  possesses a guide bushing  32  near its proximal end to mate with tube  14  in such a way as to allow longitudinal movement and rotational movement between pusher rod  28  and tube  14 . Locator pin  18  extends from guide bushing  32 . A restraint element, called device pusher  34 , is affixed to pusher rod  28  near the distal end of pusher rod  28 , and restrains expandable medical device  12  from proximal movement when tube  14  moves proximally. Although device pusher  34  is shown with a substantially flat distal surface, device pusher  34  may alternately possess a tapered distal surface to assist in deploying device  12 .  
         [0042]     Bullet nose rod  36  is attached to and extends from bullet nose  22  proximally through pusher rod  28 . A slip-fit clearance between bullet nose rod  36  and pusher rod  28  allows longitudinal movement between bullet nose rod  36  and pusher rod  28 . Bullet nose rod slot  38  is cut into bullet nose rod  36  and aligns in operation with pusher rod slot  30 .  
         [0043]     Bullet nose rod  36  may take any of several configurations to facilitate manufacture and use. For example, bullet nose rod  36  may be integrally molded with bullet nose  22  to become one component. Alternatively, bullet nose rod  36  may have a threaded attachment to bullet nose  22  or may itself be composed of two components that are extendable for adjustability.  
         [0044]     A force element embodied by spring  40  connects bullet nose rod  36  to tube handle  24  by engaging bullet nose rod slot  38 . Spring  40  applies mechanical force urging bullet nose rod  36  and bullet nose  22  proximally. Since tube handle  24  affixes to tube  14 , spring  40  applies mechanical force tending to hold bullet nose  22  and tube  14  together, but allowing relative displacement of bullet nose  22  away from tube  14  under a force opposing and greater than the force generated by spring  40 .  
         [0045]      FIG. 2  displays another embodiment of applier  10 . As in the embodiment of applier  10  seen in  FIG. 1 , tube handle  24  attaches at the proximal end of tube  14 . However, in the embodiment of  FIG. 2 , tube handle  24 , rather than tube  14 , carries guide slot  16 . A leg  41  extending from spring  40  fastens to tube handle  24  through a small opening of tube handle  24 , and may curve about a portion of tube handle  24  to locate it into position.  
         [0046]      FIG. 3  shows internal mechanism  26  of the embodiment of  FIG. 2 . Tube  14  has been shown in phantom in  FIG. 3  for clarity, however, tube handle  24  remains to show positional relationships of components. Pusher rod  28  extends distally from knob  20  similarly to the embodiment of  FIG. 2 . Device pusher half  35  locates at the distal end of pusher rod  28 , affixed to pusher rod  28  by a snap ring  46 . A second device pusher half  35 , omitted for better visibility of associated components, mates with device pusher half  35  to enclose the distal end of pusher rod  28  and to form device pusher  34 . A cover rod shown as bullet nose rod  36 , extending from the cover shown as bullet nose  22 , inserts into a distal end of device pusher  34 . Clearance exists between device pusher  34  and pusher rod  28  so that longitudinal motion can occur between bullet nose rod  36  and device pusher  34 . Bullet nose  22  protrudes from the distal end of bullet nose rod  36 . As is possible in the embodiment of  FIG. 1 , bullet nose  22  can combine with bullet nose rod  36  into one component, or bullet nose  22  can be a separate component attached to bullet nose rod  36  in a manner to allow an adjustable length between bullet nose  22  and bullet nose rod  36 . The design can allow length adjustability by, for example, a threaded connection between bullet nose  22  and bullet nose rod  36 . Also, as in the embodiment of  FIG. 1 , bullet nose rod slot  38  is cut into the end of bullet nose rod  36 . An embodiment of locater pin  18  extends radially from the surface of pusher rod  28  near the proximal side of pusher rod  28 . Tube handle  24  attaches to the proximal end of tube  14 .  
         [0047]     Spring  40  hooks to bullet nose rod slot  38  to connect bullet nose rod  36  and tube handle  24 . Spring  40  applies mechanical force urging bullet nose rod  36  and bullet nose  22  proximally. Since tube handle  24  affixes to tube  14 , spring  40  applies mechanical force tending to hold bullet nose  22  and tube  14  together, but allowing relative displacement of bullet nose  22  away from tube  14  under an opposing force greater than that applied by spring  40 . In the embodiment of  FIG. 3 , spring  40  passes through a spring slot  48  created by the mating pusher halves  35 .  
         [0048]      FIG. 4  displays a view of tube handle  24  used in the embodiment of  FIG. 2 . The view is taken from the distal end of tube handle  24 . A guide slot  16  of the tube handle  24  shown in  FIG. 3  is also seen in  FIG. 4 . Guide slot  16  comprises a longitudinal slot  42  following the axis of handle  24  at the proximal side of tube handle  24 , opening into a horizontal slot  44  near the distal end of handle  24 . A pin stop  45 , in the embodiment of  FIG. 4 , is a wall to prevent further distal movement of locator pin  18  without a preliminary rotational movement of pusher rod  28 . Guide slot  16  has clearance for movement of locator pin  18  through longitudinal slot  42  and through horizontal slot  44 , and so allows translation of locator pin  18  and rotation of locator pin  18  about the axis of pusher rod  28  when pusher rod  28  is rotated.  
         [0049]      FIG. 5  shows a third embodiment of applier  10 . As in the other embodiments, applier  10  of  FIG. 5  carries a tube  14  with attached tube handle  24  at its distal end. Pusher rod  28  carries knob  20  at its proximal end and bullet nose  22  at its distal end. The embodiment of  FIG. 5  is shown with an access port  50  open through the entire length of applier  10 . Other embodiments of applier  10  could have an access port  50  as well. Attached to tube  14  at the proximal end of tube  14  is path retainer  52 , to direct movements of pusher rod  28 , as will be seen.  
         [0050]     Access port  50  may be used for placement of a tool to facilitate surgery. A surgeon may place, for example, through access port  50 , a tool such as a guide wire to guide applier  10  within the body, a laser or surgical tool to effect further treatment, a fiber optic to give light to the surgical site, a fiber optic with an attached camera to visualize the surgical site, a wire to convey electrical energy, or a tube to convey pneumatic energy. Access port  50  may be sealed by, for example, an elastomeric plug when not in use if it becomes necessary to preclude passage of gas for reasons such as, for example, maintenance of pneumoperitenium.  
         [0051]      FIG. 6  shows the embodiment of  FIG. 5  with tube  14  in phantom for clarity. In the embodiment shown in  FIG. 6 , pusher rod  28  has knob  20  at its proximal end and bullet nose  22  at its distal end. Device pusher  34  attaches near the distal end of pusher rod  28 . Spring  40  connects to tube  14  through path retainer  52 , and to pusher rod  28 ; however, spring  40  could alternately attach directly to tube  14  or to any component affixed to tube  14 . As in previous embodiments, spring  40  applies a force tending to urge bullet nose  22  towards tube  14 , so that bullet nose  22  and tube  14  are engaged with a preload but can be deflected apart by a force large enough to overcome the preload. Guide clip  54  affixes to pusher rod  28  and engages path retainer  52  in a way to permit relative motion between guide clip  54  and path retainer  52 . Guide clip  54 , although affixed to pusher rod  28 , has stationary guide clip leg  58  and deflectable guide clip leg  59  ( FIG. 7 ) to slidingly engage portions of path retainer  52 . Stationary guide clip leg  58  remains substantially fixed relative to pusher rod  28 , while deflectable guide clip leg  59  deflects outward, guided by cam surfaces on path retainer  52 .  
         [0052]      FIG. 7  shows a close view of path retainer  52  used in the embodiment of applier  10  of  FIG. 5 . This view shows the face of path retainer  52  that faces the interior of tube  14 . The proximal end of spring  40  and positioning guide clip  54  are also shown in  FIG. 7 . Path retainer  52  has a control path  56  to direct and control movement of pusher rod  28  through action of guide clip  54 . Control path  56  consists of four paths for guidance and control of pusher rod  28 . The four paths are flair path  60 , return path  62 , ejection path  64 , and finish path  66 . Rails  75  on the surface of path retainer  52  separate the paths. A flair stop  61  is at the distal end of return path  62 , while clearance slot  63  opens between return path  62  and ejection path  64  near the proximal end of the paths. A distal clearance slot  65  opens between flair path  60  and return path  62  near the distal end of the paths. Stationary guide clip leg  58  and deflectable guide clip leg  59  are shown preloaded and compressed together by two of rails  75  to ride in flair path  60 . In the relaxed state, stationary guide clip  58  and deflectable guide clip leg  59  spread to a distance to encompass the width between finish path  66  and flair path  60 . In actuation of the mechanism, control path  56  permits consecutive relaxing and opening of deflectable guide clip leg  59  towards the relaxed, non-preloaded state. Stationary guide clip leg  58  remains within flair path  60 , while deflectable guide clip leg  59  moves towards and into finish path  66 .  
         [0053]     Each embodiment of applier  10  has an operation sequence, as will be seen. The embodiments share commonality in that bullet nose  22  applies force generated by spring  40  to flair expandable medical device  12 . When expandable medical device  12  is not extending beyond the distal end of tube  14 , bullet nose  22  covers the end of tube  14  and is held in position by force applied by spring  40 . When a force acts on bullet nose  22  and opposes the force of spring  40  and is greater than the force applied by spring  40 , spring  40  deflects to allow bullet nose  22  to lift off of tube  40 .  
         [0054]     The embodiment of applier  10  shown in  FIG. 1  operates as shown in  FIGS. 8 through 12 .  FIG. 8  depicts the  FIG. 1  embodiment loaded with a medical device, such as an expandable medical device  12 . Tube  14  contains expandable medical device  12 . Expandable medical device  12  can be used to hold two tissue portions together to effect a therapeutic surgical treatment.  
         [0055]     A surgeon can grasp applier  10  and place it into a patient&#39;s body. The surgeon can, for example, grasp the applier  10  by placing an index and middle finger on tube handle  24  and a thumb on knob  20 . The surgeon maneuvers any embodiment of applier  10  to a portion of the body near organs needing surgical treatment, such as anastomosis. The surgeon may, for example, first divide a section of small intestine as a part of a medical procedure such as a gastric bypass operation. Or, the surgeon may anastomose bowel left behind by removal of a cancerous portion of bowel. The surgeon may create an otomy in a section of small intestine and extend applier  10  through the section of small intestine to a position where another otomy is desired. The surgeon may then make a second otomy in the wall of the same section and a third otomy in another section of intestine to be anastomosed. Applier  10  then can extend through the second and third otomies in the two sections of small intestine. The walls carrying the second and third otomies can be shown as proximal tissue portion  68  and distal tissue portion  69 . Attaching these tissue portions can create an intestinal anastomosis when the tissue portions are portions of lumens of intestine. After extending applier  10  through proximal tissue portion  68  and distal tissue portion  69 , a surgeon can operate applier  10  to effect a medical procedure such as an anastomosis.  
         [0056]     The surgeon urges tube handle  24  towards knob  20 . Tube handle  24 , affixed to tube  14 , pulls tube  14  towards knob  20 . Reactive force, placed by the surgeon on knob  20 , transfers through pusher rod  28 , to device pusher  34 , to expandable medical device  12 . As tube  14  slips proximally, device pusher  34  restrains any proximal movement of expandable medical device  12 . Spring  40 , connected between tube handle  24  and bullet nose rod  36 , applies a force tending to pull bullet nose rod  36  in a proximal direction. With applier  10  in this first position when application is beginning, bullet nose rod  36  pulls bullet nose  22  proximally to maintain preloaded contact with tube  14 , so that bullet nose  22  travels proximally with tube  14  as one unit relative to device pusher  34 . Bullet nose rod  36  telescopes into the inner diameter of pusher rod  28 . When bullet nose  22  reaches the distal end of expandable medical device  12 , device taper  70  contacts expandable medical device  12  to flare it. Expandable medical device  12  applies a reactive force to bullet nose  22 . When the distal reactive force overcomes the force applied by spring  40 , the reactive force elongates spring  40  and separates bullet nose  22  slightly from tube  14 . Flaring expandable medical device  12  begins to emerge from the opening created between tube  14  and bullet nose  22 , as shown in  FIGS. 9 and 10 .  
         [0057]      FIGS. 9 and 10  show flared expandable medical device  12  emerging from applier  10 . As bullet nose  22  moves towards expandable medical device  12 , device taper  70  presents a ramp to facilitate the flaring and opening of expandable medical device  12 . Device taper  70  applies force to an internal portion of expandable medical device  12  to flare expandable medical device  12  and increase the diameter of the distal end of expandable medical device  12 . In addition, the restraint that bullet nose  22  places on expandable medical device  12  prevents expandable medical device  12  from ejecting from tube  14  before expandable medical device  12  is placed into the correct position adjacent to tissue portions requiring surgical treatment. The surgeon can use the flared portion of expandable medical device  12 , as it is captured by the force exerted by bullet nose  22 , to pull distal tissue portion  69  towards proximal tissue portion  68  to effect treatment such as an anastomosis. Applier  10  with the extending, flared portion of captured expandable medical device  12  can be utilized as a tool to manipulate tissue.  
         [0058]     As tube  14  moves towards knob  20 , the proximal, axial portion of “Z”-shaped guide slot  16  moves relative to locator pin  18 . When expandable medical device  12  is flared to the correct position for tissue manipulation, the circumferential portion of guide slot  16  abuts locator pin  18 , preventing any further movement of tube  14  towards knob  20 . To continue any further linear movement, the surgeon must now rotate tube  14  relative to locator pin  18 .  
         [0059]      FIG. 9  shows that the circumferential portion of guide slot  16  moves relatively past locator pin  18 . When the distal, axial portion of guide slot  16  aligns with locator pin  18 , further movement of tube  14  towards knob  20  is permitted. After rotating tube  14  relative to knob  20  to produce the relative circumferential motion of guide slot  16  and locator pin  18 , and placing distal tissue portion  69  and proximal tissue portion  68  near the distal end of applier  10  as shown in  FIG. 10 , the surgeon is ready to eject expandable medical device  12  from applier  10 .  
         [0060]      FIGS. 11 and 12  show the embodiment of applier  10  shown in  FIG. 1  with expandable medical device  12  ejected. To eject expandable medical device  12 , the surgeon continues movement of tube  14  towards knob  20 . Spring  40  continues to pull bullet nose  22  proximally, while bullet nose rod  36 , attached to bullet nose  22 , slides freely through pusher rod  28 . Bullet nose  22  is still preloaded against flared expandable medical device  12 , and expandable medical device  12  continues to emerge from the distal end of tube  14 . When the proximal end of bullet nose rod slot  38 , where spring  40  attaches, reaches the proximal end of pusher rod slot  30 , force is now applied by spring  40  to pusher rod  28 . Spring  40  now extends between pusher rod  28  and tube handle  24 . Further proximal motion of tube  14  relative to pusher rod  28  extends spring  40 . Spring  40  no longer preloads bullet nose  22  against expandable medical device  12 . If the proximal end of bullet nose rod slot  30  moves proximal to the proximal end of pusher rod slot  38 , force applied to the proximal end of bullet nose  22  by tissue portions or by expandable medical device  12  is no longer overcome by force from spring  40 , so bullet nose  22  now is forced distally. There is no longer any relative motion between bullet nose  22  and pusher rod  28 , so there is therefore no relative motion between bullet nose  22  and device pusher  34 . However, in this later advanced position as expandable medical device  12  is nearing ejection, tube  14  moves relative to bullet nose  22  and device pusher  34 . The space between device pusher  34  and bullet nose  22 , containing expandable medical device  12 , emerges from tube  14  to complete ejection of expandable medical device  12  as tube  14  is pulled proximally. Expandable medical device  12  assumes the correct orientation and geometry to perform a useful surgical procedure. The relative positions of components of applier  10  after ejection of expandable medical device  12  are shown in  FIGS. 11 and 12 .  
         [0061]      FIGS. 13 through 17  depict the operation of the embodiment of applier  10  shown in  FIG. 2 .  FIG. 13  shows the embodiment of applier  10  loaded with expandable medical device  12 . To begin to eject expandable medical device  12 , the surgeon urges tube handle  24  towards knob  20 . Tube handle  24 , affixed to tube  14 , pulls tube  14  towards knob  20 . Reactive force placed by the surgeon on knob  20  transfers through pusher rod  28 , snap ring  46 , and device pusher  34  to expandable medical device  12 . As tube  14  slips proximally, device pusher  34  restrains any rearward movement of expandable medical device  12 . Simultaneously, force applied by spring  40 , connected between tube handle  24  and bullet nose rod  36 , urges bullet nose rod  36  proximally through device pusher  34 . Bullet nose rod  36  pulls bullet nose  22  proximally to maintain preloaded contact with tube  14 , so that tube  14  and bullet nose  22  proceed proximally as one unit. When bullet nose  22  reaches the distal end of expandable medical device  12 , device taper  70  contacts expandable medical device  12  to flare it. Expandable medical device  12  applies a reactive force to bullet nose  22  greater than that applied by spring  40  to elongate spring  40  and separate bullet nose  22  slightly from tube  14 . Flaring expandable medical device  12  begins to emerge from the opening created between tube  14  and bullet nose  22 , as shown in  FIG. 14  and  15 .  
         [0062]      FIG. 15  shows in section view flared expandable medical device  12  emerging from the embodiment of applier  10 . Because spring  40  continues to urge bullet nose  22  proximally towards tube  14 , device taper  70  presents a ramp to facilitate the flaring and opening of expandable medical device  12 . In addition, the restraint that bullet nose  22  places on expandable medical device  12  prevents expandable medical device  12  from ejecting from tube  14  before expandable medical device  12  is placed into the correct position adjacent to tissue portions to be surgically treated. The surgeon can use the flared portion of expandable medical device  12 , as it is captured by the force exerted by bullet nose  22 , to pull a distal tissue portion  69  towards a proximal tissue portion  68  to effect treatment such as an anastomosis. Applier  10  with the extending, flared portion of captured expandable medical device  12  can be utilized as a tool to manipulate tissue during a surgical procedure.  
         [0063]     As tube handle  24  moves proximally, guide slot  16  within tube handle  24  moves proximally relative to locator pin  18  through longitudinal slot  42 . When expandable medical device  12  is flared to the correct position, pin stop  45  abuts locator pin  18 , preventing any further movement of tube  14  towards knob  20 . To continue any further linear movement, the surgeon must now rotate tube  14  relative to locator pin  18 . Horizontal slot  44  ( FIG. 5 ) has clearance to allow this rotation. After locator pin  18  has rotated past pin stop  45 , further movement of tube  14  towards knob  20  is permitted, and the surgeon is ready to completely eject expandable medical device  12  from applier  10 .  
         [0064]      FIG. 16  and  17  show cross-sectional views of expandable medical device  12  ejected from applier  10  and engaging proximal tissue portion  68  to distal tissue portion  69 . To finish ejection of expandable medical device  12 , the surgeon continues movement of tube  14  towards knob  20 . Spring  40  continues to pull bullet nose  22  proximally, while bullet nose rod  36 , attached to bullet nose  22 , slides freely through device pusher  34 . Bullet nose  22  is still preloaded against flared expandable medical device  12  by force exerted by spring  40 . When the proximal end of bullet nose rod  36 , where spring  40  attaches, reaches the distal end of pusher rod  28 , force is now applied to pusher rod  28 . Bullet nose  22  can no longer follow tube  14  proximally, and is no longer preloaded to tube  14 . Further proximal motion of tube  14  relative to pusher rod  28  extends spring  40 . There is no longer relative motion between bullet nose  22  and device pusher  34 . Tube  14 , however, moves relative to bullet nose  22  and device pusher  24 . The space between device pusher  34  and bullet nose  22 , containing expandable medical device  12 , emerges from tube  14  to eject expandable medical device  12  as tube  14  is pulled proximally.  
         [0065]      FIGS. 18 through 23  demonstrate the operation of the embodiment of applier  10  shown in  FIG. 5 .  FIG. 18  shows the  FIG. 5  embodiment of applier  10  in the loaded position with expandable medical device  12  placed within tube  14 . Force applied by spring  40  holds bullet nose  22  against the distal end of tube  14 . A surgeon moves tube  14  proximally towards knob  20  against the force of spring  40  by grasping tube handle  24  as in previous embodiments. Tube  14  moves proximally relative to pusher rod  28  and device pusher  34 . Device pusher  34  restrains proximal movement of expandable medical device  12 . As tube  14  moves proximally, a gap opens between tube  14  and bullet nose  22 . Expandable medical device  12  begins to emerge from the distal end of tube  14 .  
         [0066]      FIG. 19  also shows an isometric view of path retainer  52  and guide clip  54 . Path retainer  52  is attached to tube  14  and moves proximally with guide clip  54 . As path retainer  52  moves proximally, control path  56  moves relative to guide clip  54  to control movements of tube  14 . When tube  14  moves proximally from the position shown in  FIG. 18 , flair path  60  moves past stationary guide clip leg  58  and deflectable guide clip leg  59  until flair stop  61  abuts guide clip  54 . Flair stop  61  prevents further proximal motion of tube  14 . When flair stop  61  abuts guide clip  54 , the deflectable guide clip leg  59  will move through distal clearance slot  65  to return path  62 . Applier  10  now takes the position shown in  FIG. 20 , with expandable medical device  12  emerging from the distal end of tube  14 . Releasing force from tube  14  will allow spring  40  to move tube  14  distally into the position shown in  FIG. 21 .  
         [0067]      FIG. 21  shows a sectional view of the embodiment of applier  10  of  FIG. 6  with expandable medical device  12  flared from the distal end of tube  14 . When the surgeon releases force from tube handle  24 , spring  40  pulls tube  14  distally towards bullet nose  22 . Device taper  70  contacts expandable medical device  12  to assist in flaring expandable medical device  12 . Force from spring  40  is applied to device  12 .  
         [0068]     This embodiment of applier  10  in the configuration of  FIG. 21 , much like previous embodiments, may be used to capture distal tissue wall  69  to approximate it to a proximal tissue wall to perform a surgical procedure such as an anastomosis. A surgeon can use applier  10  with the flared expandable medical device  12  as a tool to manipulate tissue.  
         [0069]      FIG. 22  shows path retainer  52  and guide clip  54  as applier  10  is in the flared position of  FIG. 21 . Path retainer  52  has moved to the initial position relative to guide clip  54  while deflectable guide clip leg  59  was within return path  62 . Deflectable guide clip leg  59  then moved through clearance slot  63  to ejection path  64  when path retainer  52  reached the initial position with guide clip  54  at its proximal end.  
         [0070]      FIG. 23  shows expandable medical device  12  ejected by applier  10 . After expandable medical device  12  has been placed into position, the surgeon may now eject device  12  by pulling tube handle  24  towards knob  20  to again urge tube  14  proximally relative to pusher rod  28 . When device pusher  34  contacts the proximal end of expandable medical device  12 , expandable medical device  12  is prevented from further proximal movement. Tube  14  moves proximally from expandable medical device  12  to deploy it.  
         [0071]      FIG. 24  depicts the action of path retainer  52  moving proximally past guide clip  54  while applier  10  deploys expandable medical device  12 . Ejection path  64  moves proximally past deflectable guide clip leg  59 . As there exists no stop at the distal end of ejection path  64 , tube  14  can move further proximally to a position allowing device pusher  34  to completely eject expandable medical device  12 . The curve of guide rail  75  adjacent to ejection path  64  places a side force on deflectable guide clip leg  59 , moving it closer to stationary guide clip leg  58 . The force generated by moving deflectable guide clip leg  59  can give tactile feedback to the surgeon that tube  14  is approaching the end of its allowable proximal movement. After tube  14  has reached its most proximal position and device  12  has been ejected, the surgeon may now release any force pulling tube handle  24  towards knob  20 . Spring  40  will pull tube  14  distally relative to knob  20 , while finish path  66  moves distally past deflectable guide clip leg  59 . Applier  10  has ejected expandable medical device  12 .  
         [0072]     One will recognize that these descriptions of movement of portions of applier  10  describe relative movement of the elements with respect to each other. For example, movement of tube  14  proximally towards knob  20  can also be described as movement of knob  20  distally towards tube  14 . As another example, movement of tube  14  proximally past device pusher  34  could also be described as distal movement of device pusher  34  within a stationary tube  14 . In the latter example, expandable medical device  12  is described as restrained from proximal movement by device pusher  34  when tube  14  moves proximally past. Changing the stationary element from device pusher  34  to tube  14  changes the description to one of expandable medical device  12  urged distally by distally advancing device pusher  34 .  
         [0073]     It will be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure that may be employed to implement the claimed invention. 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 tube  14  relative to device pusher  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 applier  10  attached to a controlled robotic arm that moves the mechanism of applier  10  to effect an anastomosis. Robotics would allow a surgeon distant from the surgical site to perform a procedure.  
         [0074]     As a further example of an equivalent structure, tube  14  could become a flexible tube, and the mechanisms within applier  10  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 laproscopically or endoscopically.  
         [0075]     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 laproscopically 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 pneumoperiteneum is desired as in, for example, endoscopic surgery.  
         [0076]     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 pneumoperiteneum. 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 anastomosis.  
         [0077]     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.  
         [0078]     As other examples of equivalent structures, the surface of distal taper  71  on bullet nose  22  may take many forms advantageous for various types of tissue manipulation, as illustrated in  FIGS. 25A through 25F .  FIG. 25A  represents a conical tipped nose that is blunted for low tissue trauma and for good visibility past the distal end.  FIG. 25B  depicts a nose that is fluted to allow torque to be applied to tissue.  FIG. 25B  depicts four flutes, although three or any other number of flutes may suffice.  FIG. 25C  depicts a nose having a convex curve for rapid dilation of an otomy in a short space, while  FIG. 25D  shows a nose having a concave surface for gentle dilation of friable tissue. An offset swept nose, shown in  FIG. 25E , 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.  FIG. 25F  shows a spherical nose 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 as depicted in  FIG. 25D  may also posses flutes as depicted in  FIG. 25B . Other combinations may occur to one skilled in the art.  
         [0079]     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.