Abstract:
In accordance with the present invention there is provided an applier for a surgical device and method that provides automated ejection of the device and gives the surgeon use of the applier with one operative control. The applier includes a handle, a tube movable relative to the handle, and an ejector shaft driven by a force element for ejecting the device. It may include a cap called a bullet nose or probe tip. The cap may have a tapered distal surface to ease entry into small otomies in tissue. Using a button or knob to move the tube automatically triggers the ejector shaft to eject the device when the tube is in the correct position.

Description:
[0001]     This application is related to the following copending patent: application Ser. No. 60/507,799; application Ser. No. 60/507,800; and application Ser. No. 60/507,616; which are hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates, in general, to appliers for surgical devices and to methods for surgically modifying organs and vessels. More particularly, it relates to appliers for 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. United States 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 sheath to an advantageous small-diameter tubular shape. A surgeon applies the expandable medical device by maneuvering the sheath through the tissue portions requiring anastomosis, moving a nose piece distally away from the sheath, and ejecting the device from the applier. Ejecting the device removes the constraint on the device, allowing the device to assume a ring shape. The larger ends of the ring shape hold the two tissue portions together in an effective anastomosis.  
         [0006]     A device such as that disclosed in 2003/0120292 may be made from a material such as superelastic nitinol. Devices made of superelastic nitinol can deform a great extent without yielding. When external forces tending to deform such devices are released, the devices return to their original geometry.  
         [0007]     Applying an expandable medical device with the applier of 2003/0120292 requires two actions: separating the nosepiece and the sheath; and urging the expandable medical device distally relative to the sheath. Applicants have recognized the need for an applier that can operate with one control by the surgeon so that the surgeon controls one action while the applier performs the other action automatically at the proper time. Applicants have further recognized the need for an applier with a means to urge the device distally when the sheath is retracted, and a method for using the applier, so that the user needs only to use one control to activate the applier. More particularly, applicants have recognized the need for an instrument with a force element to urge the device distally when the sheath is retracted. This invention provides such an applier and a method for using it.  
       SUMMARY OF THE INVENTION  
       [0008]     In accordance with the present invention there is provided an applier for a surgical device and method that provides automated ejection of the device and gives the surgeon use of the applier with one operative control. The applier includes a handle, a tube movable relative to the handle, and an ejector shaft driven by a force element for ejecting the device. It may include a cap called a bullet nose or probe tip. The cap may have a tapered distal surface to ease entry into small otomies in tissue. Using a button or knob to move the tube automatically triggers the ejector shaft to eject the device when the tube is in the correct position. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0009]     The novel features of the invention are set forth with particularity in the appended claims.  
         [0010]     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:  
         [0011]      FIG. 1  is an isometric view of an applier according to an embodiment of the invention.  
         [0012]      FIG. 2  is an isometric view of the applier of  FIG. 1  with portions cut away for better visibility.  
         [0013]      FIG. 3  is a cross-sectional view of the applier of  FIG. 1  with an expandable medical device in the loaded position.  
         [0014]      FIG. 4  is a cross-sectional view of the applier of  FIG. 1  with the expandable medical device partially deployed.  
         [0015]      FIG. 5  is a cross-sectional view of the applier of  FIG. 1  with the expandable medical device fully deployed.  
         [0016]      FIG. 6  is an isometric view of an applier according to a second embodiment of the invention.  
         [0017]      FIG. 7A  is an isometric view of a distal end of an applier showing a probe tip having a blunt surface.  
         [0018]      FIG. 7B  is an isometric view of a distal end of an applier showing a probe tip having a fluted surface.  
         [0019]      FIG. 7C  is an isometric view of a distal end of an applier showing a probe tip having a convex surface.  
         [0020]      FIG. 7D  is an isometric view of a distal end of an applier showing a probe tip having a concave surface.  
         [0021]      FIG. 7E  is an isometric view of a distal end of an applier showing a probe tip having an offset, swept, asymmetric surface.  
         [0022]      FIG. 7F  is an isometric view of a distal end of an applier showing a probe tip having a spherical surface. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]      FIG. 1  shows an embodiment of an applier  10  used to eject an expandable medical device  44  ( FIG. 2 ). Components of applier  10  visible in  FIG. 1  from the exterior include a frame, or handle  12 , an actuator button  14 , a device retainer, or tube  16 , and a cap, called probe tip  18 , at the distal end of tube  16 .  
         [0024]     In the embodiment of  FIG. 1 , handle  12  comprises two handle halves. Handle  12  may be molded from engineering plastic and may be split into two halves to ease the assembly process of applier  10 . The handle halves may be held together by a snap fit or by, for example, fasteners such as screws.  
         [0025]     Tube  16  has a proximal portion located within handle  12 , a distal portion extending from handle  12 , and a longitudinal axis  13 . Tube  16  can translate relative to handle  12  and rotate relative to handle  12  about longitudinal axis  13  of tube  16 . Tube  16  may be made from metal or engineering plastic. At least a portion of tube  16  may be transparent or translucent to allow passage of light, either to utilize a light source internal to tube  16  to illuminate a surgical site, or to allow better visualization of internal components.  
         [0026]     Actuator button  14  attaches to tube  16  by a press fit within a slot on tube  16 , fasteners, or other commonly used attachment means. A surgeon uses actuator button  14  to translate tube  16  proximally towards handle  12  and to rotate tube  16  about longitudinal axis  13  of tube  16  as will be seen. Actuator button  14  can be made from engineering plastic and designed to deflect or flex. The deflection enables actuator button  14  to rock slightly proximally to distally about an axis perpendicular to longitudinal axis  13  of tube  16 .  
         [0027]     Probe tip  18  is fixed relative to handle  12 . The distal end of probe tip  18  may be tapered as shown in  FIG. 1 , or rounded, or have several shapes to facilitate entry through an opening in tissue or to assist in dilating tissue. The proximal end of probe tip  18  may also be chamfered, tapered, or rounded to help in operation of applier  10  as will be seen.  
         [0028]      FIG. 2  shows applier  10  of  FIG. 1  with portions removed for better visualization of components. Actuator button  14  is shown exploded away from applier  10  to reveal a roughly “Z”-shaped slot  20  in handle  12 . Slot  20  contains a flaring portion  24  of slot  20 . Slot  20  also contains an actuation portion  26 , reachable by actuator button  14  by rotation about longitudinal axis  13  of tube  16 . Handle  12  also possesses, revealed under exploded actuator button  14 , a lock stop  22  and a rotation stop  23  at a distal end. Lock stop  22  and rotation stop  23  abut a boss raised on actuator button  14  when actuator button  14  is in a locked position.  
         [0029]      FIG. 2  further shows a probe tip shaft  28 . Probe tip shaft  28  extends from supports within handle  12  distally to fix to probe tip  18 , locating probe tip  18  relative to handle  12 . Probe tip shaft  28  may attach to probe tip  18  by a threaded assembly. Handle  12  also contains the proximal portion of a pusher rod to eject expandable medical device  44 , called ejector shaft  30 . Ejector shaft  30  locates concentrically within tube  16 , and extends distally from handle  12  to a point proximal of probe tip  18 . Probe tip shaft  28  locates within the inner diameter of ejector shaft  30 . At the proximal end of ejector shaft  30 , ejector flange  32  flairs radially to a diameter larger than that of ejector shaft  30 . Ejector flange  32  may consist of a washer pressed on a turned-down diameter of ejector shaft  30  and retained by a second washer, as shown in  FIG. 2 . Alternately, flaring a proximal end of ejector shaft  30  in a formed or molded part may form ejector flange  32 .  
         [0030]     Shown distal of ejector shaft  30  in  FIG. 2  is a constraining member to prevent forward movement of ejector shaft  30 , called stop latch  34 . Stop latch  34  pins to handle  12  and rotates about the pinned junction. Stop latch  34  has a stop end  36  movable away and towards ejector flange  32 . Stop latch  34  further has a cam surface  38 . The proximal end of tube  16  contacts stop latch  34  along cam surface  38  to rotate stop latch  34 .  
         [0031]      FIG. 2  further shows a force element in the form of ejector spring  40  compressed between a wall on handle  12  and a proximal side of ejector flange  32 . Ejector spring  40  urges ejector shaft  30  distally. A second force element, latch spring  42 , applies a force to rotate stop latch  34  so that stop end  36  bears against the distal side of ejector flange  32 . In the embodiment shown, latch spring  42  is a leaf spring between a wall of handle  12  and stop latch  34 . Latch spring  42  could also be, for example, a torsion spring having a torsional axis along the axis of rotation of stop latch  34 .  
         [0032]     Expandable medical device  44  locates near the distal end of applier  10  between the distal end of ejector shaft  30  and probe tip  18 . Expandable medical device  44  may be, for example, an expandable medical device such as that described in United States Application number 2003/0120292. Such an expandable medical device will normally assume a ring-shaped appearance, but force applied by tube  16  will force the expandable medical device to assume a cylindrical shape.  
         [0033]      FIG. 3  depicts a cross-section view of applier  10  of  FIG. 1 , showing applier  10  containing expandable medical device  44 . A surgeon uses applier  10  of  FIG. 1  to eject expandable medical device  44  to perform a surgical procedure, such as, for example, anastomosis of two body lumens. A surgeon grasps applier  10  and places it into a patient&#39;s body. The surgeon maneuvers applier  10  to a portion of the body near organs needing surgical treatment such as an 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 as part of an operation to remove a section of intestine for cancer. The surgeon creates an otomy in a section of small intestine and extends applier  10  through the section of small intestine to a position where another otomy is desired. The surgeon then makes a second otomy in the wall of the same section of small intestine and a third otomy in another section of intestine to be anastomosed. Applier  10  can then 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  46  and distal tissue portion  48 . Attaching these two tissue portions creates an intestinal anastomosis when the tissue portions are lumens of intestine. After extending applier  10  through proximal tissue portion  46  and distal tissue portion  48 , a surgeon can operate applier  10  to effect a medical procedure such as an anastomosis.  
         [0034]     Applier  10  may be in a locked position. Such a locked position may be achieved by having actuator button  14  rotated slightly into the shorter section, or flaring portion  24  of Z-shaped slot  20  ( FIG. 2 ), and leaving actuator button  14  in the undeflected position. Actuator button  14 , in an undeflected position, tilts distally slightly so that a boss raised on actuator button  14  contacts lock stop  22  and rotation stop  23 . In the locked position, linear movement of actuator button  14  is precluded by lock stop  22  and rotational movement of actuator button  14  about the axis of tube  16  is precluded rotation stop  23 . Slight pressure tilting actuator button  14  moves the boss away from lock stop  22  to permit movement of actuator button  14 . This tilting or rocking motion is about an axis perpendicular to longitudinal axis  13  of tube  16 .  
         [0035]     By urging actuator button  14  proximally, the surgeon begins to move tube  16  proximally towards stop latch  34 . Initially, stop latch  34  is in a first position abutting ejector flange  32  of ejector shaft  30  to prevent distal movement of ejector shaft  30 . A proximal portion of proximally moving tube  16  contacts cam surface  38  of stop latch  34  and begins to rotate stop latch  34  about the pivot point of stop latch  34 . Latch spring  42  deflects while still applying a slight force tending to oppose the rotation of stop latch  34 . Stop end  36  of stop latch  34  rotates away from ejector flange  32  to a second position permitting ejector spring  40  to move ejector shaft  30  distally. Ejector shaft  30  moves distally until ejector flange  32  reaches a boss within handle  12  that prevents further distal movement. Ejector shaft  30  drives expandable medical device  44  distally past the distal end of tube  16  to create the configuration shown in  FIG. 4 . Expandable medical device  44  and ejector shaft  30  have moved relative to tube  16  a predetermined distance designed to best facilitate use of expandable medical device  44 .  
         [0036]     Actuator button  14  still remains in flaring portion  24  of slot  20 , better depicted in  FIG. 2 . Slight rotation of actuator button  14  about longitudinal axis  13  of tube  16  moves actuator button into the longer section, or actuation portion  26  of Z-shaped slot  20  ( FIG. 2 ). The rotation of actuator button  14  rotates tube  16  about longitudinal axis  13  of tube  16 , and moves actuator button  14  away from a position distal to lock stop  22 . Applier  10  then becomes ready to eject expandable medical device  44 .  
         [0037]      FIG. 4  shows a partially ejected expandable medical device  44 . Moving tube  16  proximally exposes a gap between tube  16  and probe tip  18 . Expandable medical device  44 , driven by ejector shaft  30 , has moved towards probe tip  18 . The tapered proximal end of probe tip  18  helps to flair expandable medical device  44  outwardly through the gap. The surgeon may move actuator button  14  slightly distally, moving tube  16  slightly distally against expandable medical device  44  to retain it in position. The surgeon may use applier  10  with the flared expandable medical device  44  as a tool to manipulate tissue. The surgeon may pull distal tissue portion  48  towards proximal tissue portion  46  using expandable medical device  44 .  
         [0038]      FIG. 5  shows completely ejected expandable medical device  44 . To eject expandable medical device  44 , the surgeon moves actuator button  14  proximally, moving tube  16  proximally to release the proximal portion of expandable medical device  44 . The distal end of ejector shaft  30  then becomes a restraint element to restrain proximal movement of expandable medical device  44  as tube  16  moves past expandable medical device  44 . The embodiment of expandable medical device  44  shown in  FIG. 5  will expand, assume a ring shape, and force distal tissue portion  48  to proximal tissue portion  46  after the proximal portion of expandable medical device  44  is released from the confines of tube  16 . In the embodiment of expandable medical device  44  shown in  FIG. 5 , the inner diameter of expandable medical device  44  after application is larger than the outer diameter of probe tip  18 .  
         [0039]     The application of expandable medical device  44  is now complete. Because ejector spring  40  moves ejector shaft  30  distally, the surgeon needed only to move actuator button  14  proximally to eject expandable medical device  44 . A second control to move ejector shaft  30  distally is not needed because proximal motion of tube  16  triggers, through stop latch  34 , an automatic ejection of expandable medical device  44  by force applied by ejector spring  40 .  
         [0040]     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. One example of an equivalent structure that may be used to implement the present invention is shown in  FIG. 6 . In the embodiment of  FIG. 6 , “U”-shaped deflection beam  60  replaces stop latch  34  and latch spring  42 . Deflection beam  60  is deflectable and has a restrainer stop  62  at a proximal end. Deflection beam  60  also has a restrainer cam surface  64 .  
         [0041]      FIG. 6  further depicts a knob  66  attached to tube  16 . Additionally,  FIG. 6  displays an o-ring  68  on knob  66  and a series of o-ring grooves  70  on handle  12 , useful for tactile feedback as will be discussed.  
         [0042]     When expandable medical device  44  is loaded into the applier  10  of  FIG. 6 , ejector shaft  30  is held in the most proximal position by restrainer stop  62 . As in the previous embodiment, ejector spring  40  applies a force urging ejector shaft  30  distally. Deflection beam  60 , in a first, undeflected position, holds ejector shaft  30  from distal movement. Movement of tube  16  causes a proximal surface of tube  16  to contact restrainer cam surface  64 , deflecting deflection beam  60  towards longitudinal axis  13  of tube  16  as shown in phantom in  FIG. 6 . The deflection drives restrainer stop  62  to a second position, inwardly towards longitudinal axis  13  and away from the purchase that restrainer stop  62  has on ejector shaft  30 . When ejector shaft  30  becomes released and no longer held by restrainer stop  62 , ejector spring  40  moves ejector shaft  30  distally as in the previous embodiment.  
         [0043]     A surgeon moves tube  16  proximally in the embodiment of  FIG. 6  by grasping knob  66 . O-ring  68  moves through the series of o-ring grooves  70  to cause tactile feedback to the surgeon. O-ring  68  can cause tube  16  to detent at an advantageous position such as the position tube  16  is in at the point when deflection beam  60  releases ejector shaft  30 .  
         [0044]     As a further example of equivalent structures that may be anticipated, tube  16  and components contained within tube  16  may become long and 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.  
         [0045]     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 become advantageous in endoscopic or laparoscopic 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. Such restriction may be accomplished by, for example, a seal or flow restrictor.  
         [0046]     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-Disks 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.  
         [0047]     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.  
         [0048]     It is also conceivable that the desired result of triggering an ejection of expandable medical device  44  simply by moving a device retainer could be achieved by other means. Applier  10  may also, instead of a compression spring shown as ejector spring  40  as a force element, use an extension spring attached between handle  12  and ejector shaft  30 . Springs may be replaced by other means. Such means may include a small motor set to start driving the expandable medical device  44  to an ejected position when a moving device retainer trips a switch. Other means of achieving the same result will occur to those skilled in the art.  
         [0049]     As another example of an equivalent structure, probe tip  18  and probe tip shaft  28  could have open distal and proximal ends and a lumen extending therethrough, so that a guidewire, fiber optic, or other useful surgical instrument may be placed through applier  10 .  
         [0050]     An embodiment of applier  10  may be attached to and utilized with computer-controlled robotic equipment. The robotic equipment enables a surgeon distant from the surgery site to use applier  10  to perform a procedure.  
         [0051]     As other examples of equivalent structures, the surface of the distal taper on probe tip  18  may take many forms advantageous for various types of tissue manipulation, as illustrated in  FIGS. 7A through 7F .  FIG. 7A  represents a conical tipped nose that is blunted for low tissue trauma and for good visibility past the distal end.  FIG. 7B  depicts a nose that is fluted to allow torque to be applied to tissue.  FIG. 7B  depicts four flutes, although three or any other number of flutes may suffice.  FIG. 7C  depicts a nose having a convex curve for rapid dilation of an otomy in a short space, while  FIG. 7D  shows a nose having a concave surface for gentle dilation of friable tissue. An offset swept nose, shown in  FIG. 7E , 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. 7F  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. 7D  may also posses flutes as depicted in  FIG. 7B . Probe tip  18  may possess a knife or a piercing element to create an otomy. Other combinations of shapes may occur to one skilled in the art.  
         [0052]     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.