Patent Publication Number: US-2021186486-A1

Title: Anvil assemblies and delivery systems

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a Divisional Application which claims the benefit of and priority to U.S. patent application Ser. No. 15/974,087, filed May 8, 2018, which is a Continuation Application claiming the benefit of and priority to U.S. patent application Ser. No. 14/790,227, filed on Jul. 2, 2015, now U.S. Pat. No. 9,974,536, issued May 22, 2018, the entire content of each of which are being incorporated herein by reference. 
    
    
     BACKGROUND 
     Technical Field 
     The present disclosure relates to an anvil assemblies for use with a surgical stapling device. More particularly, the present disclosure relates to a delivery system for trans-oral delivery of the anvil assemblies. 
     Background of Related Art 
     Trans-oral delivery systems for delivering an anvil assembly to a surgical site, e.g., the stomach, typically include a guide suture threaded through one or more openings in the head of the anvil assembly to facilitate trans-oral insertion of the anvil assembly. The guide suture, which includes ends that remain external of the patient&#39;s mouth, may be used by the surgeon to dislodge the anvil assembly if the anvil assembly becomes stuck during trans-oral delivery of the anvil assembly and/or to retrieve the anvil assembly in the event of a patient emergency, e.g., cardiac arrest. Improved methods for securing the guide suture to the anvil assembly to facilitate detachment of the guide suture from the anvil assembly once the anvil assembly is delivered to the surgical site and/or the stapling procedure has been performed are desirable. 
     SUMMARY 
     An anvil delivery system is provided. The anvil delivery system includes a delivery assembly an anvil assembly selectively securable to the delivery assembly and including a center rod assembly selectively securable to the delivery assembly and a head assembly pivotally secured to the center rod assembly between a first tilted position and an operative position. The anvil delivery system further including a suture extending from the anvil delivery system through the head assembly and distally of the head assembly, wherein the suture retains the head assembly in the first tilted position. 
     In embodiments, the head assembly includes a housing that defines a first proximal opening and a second proximal opening, the suture extending through each of the first and second proximal openings. The delivery assembly may include a flexible member and an adapter. The suture may extend through the adapter. The suture may be frictionally secured between the flexible member and the adapter. The suture may extend from the first proximal opening through the adapter and to the second proximal opening. A first portion of the suture may cross over a second portion of the suture between the head assembly and the adapter. The suture may include a loop extending distally of the head assembly. The head assembly may be movable to a second tilted position opposite the first tilted position. 
     Also provided is a method of securing an anvil assembly in a first tilted position. The method includes receiving a first end of a suture through a first opening in a head assembly of an anvil assembly, receiving the first end of the suture through a bore in an adapter secured to a center rod assembly of the anvil assembly, receiving the first end of the suture back through a second opening in the head assembly, and tying the first end of the suture to a second end of the suture adjacent the head assembly. 
     In embodiments, the method further includes moving the head assembly relative to the center rod assembly prior to tying the first end of the suture to the second end of the suture. Moving the head assembly relative to the center rod assembly may include pivoting the head assembly to a first tilted position. Receiving the first end of the suture through a first opening may include receiving the first end of the suture into a first distal opening and out a first proximal opening. Receiving the first end of the suture through a second opening may include receiving the first end of the suture into a second proximal opening and out of a second distal opening. 
     Another method of securing an anvil assembly in a first tilted position is also provided. The method includes receiving a first end of a suture through a first opening in a head assembly of an anvil assembly, receiving a second end of the suture through a second opening in the head assembly, receiving the first and second ends of the suture through a bore in an adapter, and securing the adapter to a flexible member such that the suture is secured within the bore. 
     In embodiments, receiving the first and second ends of the suture through a bore includes receiving the first end of the suture through a first bore in a first direction and receiving the second end of the suture through the first bore in a second direction, then receiving the first end of the suture through a second bore in the second direction and receiving the second end of the suture through the second bore in the first direction. Securing the adapter to the flexible member may include receiving a first end of the adapter within an open end of the flexible member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the presently disclosed anvil assembly and anvil assembly delivery system are disclosed herein with reference to the drawings wherein: 
         FIG. 1  is a perspective view of a surgical stapling device including an embodiment of an anvil assembly according to the present disclosure; 
         FIG. 2  is a first perspective side view of the anvil assembly of  FIG. 1 ; 
         FIG. 3  is a second perspective side view of the anvil assembly shown in  FIGS. 1 and 2 ; 
         FIG. 4  is an exploded side view of the anvil assembly of  FIGS. 1-3 ; 
         FIG. 5  is an end view of the anvil assembly of  FIGS. 1-4 ; 
         FIG. 6  is a cross-sectional side view of a distal end of the tilt anvil assembly of  FIGS. 1-6  taken along line  6 - 6  of  FIG. 5 ; 
         FIG. 7  is a cross-sectional side view of a distal end of the anvil assembly of  FIGS. 1-6  taken along line  7 - 7  of  FIG. 5 ; 
         FIG. 8  is an enlarged side view of the cam latch member of the anvil assembly of  FIGS. 1-7 ; 
         FIG. 9  is a top view of the anvil assembly of  FIGS. 1-7  supported on an anvil delivery system; 
         FIG. 10  is an enlarged exploded view of the anvil delivery system of  FIG. 9 ; 
         FIG. 11  an enlarged top view of the anvil delivery system of  FIGS. 9 and 10 , including the anvil assembly of  FIGS. 1-7 ; 
         FIG. 12  is a cross-sectional side view of the anvil assembly and anvil assembly delivery system of  FIG. 11  taken along lines  12 - 12  of  FIG. 11 ; 
         FIG. 13  is a cross sectional side view of the anvil assembly of  FIGS. 1-7 , in a pre-fired tilted position supported on the anvil delivery system of  FIGS. 9-12 ; 
         FIG. 14  is an enlarged view of the indicated area of detail shown in  FIG. 13 ; 
         FIG. 15  is an illustration of the anvil assembly and anvil delivery system of  FIGS. 11 and 12  being inserted trans-orally into a patient; 
         FIG. 16  is an enlarged side view of the distal head portion of the surgical stapling device of  FIG. 1  with the anvil assembly removed; 
         FIG. 17  is an enlarged side view of the distal head portion of the surgical stapling device of  FIG. 1  with the anvil assembly of  FIGS. 1-7  received thereon; 
         FIG. 18  is an enlarged cross-sectional side view of the distal head portion of the surgical stapling device of FIG. land the anvil assembly of  FIGS. 1-7  in a pre-fired non-tilted operative position; 
         FIG. 19  is an enlarged cross-sectional side view of the distal head portion of the surgical stapling device of FIG. land the anvil assembly of  FIGS. 1-7  in a post-fired non-titled operative position; 
         FIG. 20  is an enlarged cross-sectional side view of the distal end of the anvil assembly of  FIGS. 1-7  in the post-fired operative position; 
         FIG. 21  is an enlarged cross-sectional side view of the distal end of the anvil assembly of  FIGS. 1-7  in a post-fired tilted position; 
         FIG. 22  is a cross-sectional side view of the anvil assembly of  FIGS. 1-7  in a post-fired tilted position supported on an anvil retainer of the surgical instrument of  FIG. 1 ; 
         FIG. 22A  is another cross-sectional side view of the anvil assembly of  FIGS. 1-7  in a post-fired tilted position supported on an anvil retainer of the surgical instrument of  FIG. 1   
         FIG. 23  is an enlarged view of the indicated area of detail shown in  FIG. 22A ; 
         FIG. 24  is a side view of the anvil assembly of  FIG. 22  supported on the anvil retainer of the surgical stapling device of  FIG. 1 ; 
         FIG. 25  is a perspective side view of an anvil assembly according to another embodiment of the present disclosure in an operative position; 
         FIG. 26  is a perspective bottom view of the anvil assembly of  FIG. 25 , in a first tilted position and with a backup plate/cutting ring assembly removed; 
         FIG. 27  is a top view of the anvil assembly of  FIG. 25  and a distal portion of the anvil delivery system of  FIG. 11  with parts separated, and a suture as the suture is secured to the anvil assembly and anvil delivery system in a first configuration; 
         FIG. 28  is a top view of the anvil assembly, anvil delivery assembly, and suture of  FIG. 27 , with the anvil delivery system secured to the anvil assembly and the suture secured to the anvil assembly and the anvil delivery system in the first configuration; 
         FIG. 29  is a top view of the anvil assembly of  FIG. 25  and a distal portion of the anvil delivery system of  FIG. 11  with parts separated, and a suture as the suture is secured to the anvil assembly and anvil delivery system in a second configuration; 
         FIG. 30  is a top view of the anvil assembly, anvil delivery assembly, and suture of  FIG. 29 , with an adapter of the anvil delivery system secured to the anvil assembly and as the suture is secured to the anvil assembly and the anvil delivery system in the second configuration; 
         FIG. 31  is a top view of the anvil assembly, anvil delivery assembly, and suture of  FIG. 29 , with the anvil delivery system secured to the anvil assembly and the suture secured to the anvil assembly and the anvil delivery system in the second configuration; 
         FIG. 32  is a top view of the anvil assembly, anvil delivery assembly, and suture of  FIG. 29 , with the anvil delivery system secured to the anvil assembly and the suture secured to the anvil assembly and the anvil delivery system in a third configuration; and 
         FIG. 33  is a perspective side view of the anvil assembly, anvil delivery assembly, and suture of  FIG. 32 , further including a suture reel. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Embodiments of the presently disclosed anvil assembly delivery system will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. Throughout this description, the term “proximal” will refer to the portion of the instrument closest to the operator and the term “distal” will refer to the portion of the instrument furthest from the operator. 
       FIG. 1  illustrates an embodiment of a surgical stapling device configured for use with tilt anvil assemblies and anvil delivery systems according to the present disclosure. Although the anvil assemblies and anvil delivery systems of the present disclosure will be described with reference to surgical stapling device  10 , it is envisioned that the anvil assemblies and anvil delivery systems may be modified for use with alternative surgical stapling devices. 
     Briefly, the surgical stapling device  10  includes a proximal handle assembly  12 , an elongated central body portion  14  including a curved elongated outer tube  14   a,  and a distal head portion  16 . Alternately, in some surgical procedures, e.g., the treatment of hemorrhoids, it is desirable to have a substantially straight, shortened, central body portion. The length, shape and/or the diameter of the body portion  14  and the distal head portion  16  may also be varied to suit a particular surgical procedure. 
     With reference still to  FIG. 1 , the handle assembly  12  includes a stationary handle  18 , a firing trigger  20 , a rotatable approximation knob  22  and an indicator  24 . A pivotally mounted trigger lock  26  is fastened to the handle assembly  12  and is manually positioned to prevent inadvertent firing of the stapling device  10 . The indicator  24  is positioned on the stationary handle  18  and includes indicia, e.g., color coding, alpha-numeric labeling, etc., to identify to a surgeon whether the device is approximated and is ready to be fired. The head portion  16  includes an anvil assembly  110  and a shell assembly  31 . For a more detailed discussion of an exemplary surgical stapler, please refer to commonly owned U.S. Pat. No. 7,364,060 to Milliman, the content of which is incorporated herein by reference in its entirety. 
     Referring now to  FIGS. 2-7 , an anvil assembly according to an embodiment of the present disclosure is shown generally as anvil assembly  110 . The anvil assembly  110  is shown in a non-titled position or operative position. The anvil assembly  110  includes a head assembly  112  and a center rod assembly  114 . The head assembly  112  includes a post  116 , a housing  118 , a backup member or plate  120 , a cutting ring  122 , a cutting ring cover  123 , an anvil plate  124 , a spacer or washer  125 , a cam latch member  126 , and a retainer member  127 . The post  116  is monolithically formed with and centrally positioned within the housing  118 . Alternately, the housing  118  and the post  116  may be formed separately and fastened together using a known fastening technique, e.g., welding. 
     As will be discussed in further detail below, the housing  118  includes openings  119   a,    119   b  sized and dimensioned to receive one or more sutures “S”. During use, a first suture “S 1 ” ( FIG. 9 ) is inserted through openings  119   a  and is used to retain the head assembly  112  in a retracted or first tilted position ( FIG. 9 ) during insertion of the anvil assembly  110  within a patient. A second suture “S 2 ” ( FIG. 9 ) is inserted through the openings  119   b.  The second suture “S 2 ” is configured to facilitate guiding the anvil assembly  110  trans-orally within a patient. During trans-oral insertion of the anvil assembly  110 , the second suture “S 2 ” extends from the mouth “M” ( FIG. 15 ) of patient, permitting the anvil assembly  110  to be retrieved trans-orally. 
     With reference still to  FIGS. 2-7 , the anvil plate  124  is supported in an outer annular recess  128  of the housing  118  and includes a plurality of staple deforming pockets  130  for receiving and deforming staples. At least one tab  124   a  extends radially outwardly from the anvil plate  124  and is received within a cutout  132  formed in an outer rim of the housing  118 . The tab  124   a  and the cutout  132  function to align or properly position the anvil plate  124  within the annular recess  128  of the housing  118 . 
     With particular reference to  FIGS. 6 and 7 , the head assembly  112  will be described in detail. The backup plate  120  includes a central opening  134  which is positioned about the post  116  within an inner annular recess  136  of the housing  118  between the post  116  and the outer annular recess  128 . The backup plate  120  includes a raised platform  120   a.  The cutting ring  122  includes an opening  122   a  having a configuration substantially the same as the platform  120   a.  Although the platform  120   a  is illustrated as having a circular shape, other configurations are envisioned, e.g., square, rectangular, triangular, etc. In one embodiment, the cutting ring  122  is formed from polyethylene and is fixedly secured to the backup plate  120  using, for example, an adhesive, to form a backup plate/cutting ring assembly. The backup plate  120  is formed from a hard material, e.g., a metal. Alternately other materials of construction may be used to construct the backup plate  120  and the cutting ring  122 . Further, the backup plate  120  and the cutting ring  122 , in the alternative, can be formed as a single or unitary structure. 
     Still referring to  FIGS. 6 and 7 , a cutting ring cover  123  is secured to an outwardly facing or proximal surface of the cutting ring  122  using, for example, an adhesive. In one embodiment, the cutting ring cover  123  is formed from a material or materials, having a hardness greater than that of the cutting ring, e.g., mylar. In one embodiment, the cutting ring cover  123  includes two layers of mylar (not shown) which are joined together using an adhesive and a polypropylene coating. Alternately, the cutting ring  122  does not include a cover. The cutting ring  122  and the backup plate  120  are slidably mounted about the post  116 . The backup plate  120  includes a pair of inwardly extending fingers  138  which will be described in further detail below. 
     With reference still to  FIGS. 6 and 7 , the retainer member  127  is positioned in the inner annular recess  136  between the backup plate  120  and a back wall  118   a  of the housing  118 . In one embodiment, the retainer member  127  is annular and includes a plurality of deformable tabs  127   a  which engage a rear surface of the backup plate  120 . The retainer member  127  prevents the backup plate  120  and the cutting ring  122  from moving or being pushed into the inner annular recess  136  of the housing  118  until a predetermined force sufficient to deform the tabs  127   a  has been applied to the backup plate/cutting ring assembly. The predetermined force can be close to but is less than the force applied by an annular cutting blade of a surgical stapling device when it engages, for example, the cutting ring of the anvil assembly  110 . In one embodiment by way of example, the predetermined force is between about ten pounds and about ninety pounds and can be about thirty (30) pounds. When the predetermined force is reached, e.g., during cutting of tissue, the backup plate  120  is urged into the inner annular recess  136  and compresses the retainer member  127 . 
     It is envisioned that other crushable, deformable, collapsible or movement restricting members may be used to retain the backup plate/cutting ring assembly in a fixed position until a predetermined force has been applied to the backup plate/cutting ring assembly. An exemplary retaining member is described in commonly owned U.S. patent application Ser. No. 14/078,766, the content of which is incorporated by reference herein in its entirety. 
     Turning back to  FIG. 4 , the anvil center rod assembly  114  includes a center rod  152 , a plunger  154 , and plunger spring  156 . A first end of center rod  152  includes a pair of arms  159  which define a cavity  159   a.  Each arm  159  has a transverse throughbore  158  which is aligned with a central longitudinal axis of the center rod  152 . Alternately, the throughbores  158  can be offset from the longitudinal axis of the center rod  152 . The post  116  of the head assembly  112  is dimensioned to be positioned within the cavity  159   a  and also includes a transverse throughbore (not shown). A pivot member  162  pivotally secures the post  116  to the center rod  152  via the throughbores  158  such that the head assembly  112  may be pivotally mounted to the anvil center rod assembly  114 . 
     Turning briefly to  FIG. 8 , the cam latch member  126  includes a body  126   a  having a throughbore  126   b.  The throughbore  126   b  is dimensioned to receive the pivot member  162  such that the cam latch member  126  is pivotally mounted within the transverse slot  172  ( FIG. 3 ) of the post  116  about the pivot member  162 . Referring now to  FIGS. 3, 6 and 7 , the cam latch member  126  includes a body portion  126   c  which extends partially from the transverse slot  172  of the post  116  and is positioned to be engaged by a finger  166  of the plunger  154 . The body portion  126   c  is configured such that the distance between the surface of the body portion  126   c  and the throughbore  126   b  increase in a clockwise direction about the cam latch member  126 . In this manner, the plunger  154  is able to move forward as the cam latch member  126  rotates in a clockwise direction. Additionally, this configuration of the body portion  126   c  permits the plunger  154  to be retracted as the cam latch member  126  rotates in a counter-clockwise direction. The cam latch member  126  also includes an edge  126   f,  including a tab  126   b.  A leading portion of edge  126   f  is configured to be urged into engagement with an inner periphery  120   b  of the backup plate  120  by an engagement finger  166  of the plunger  154  when the head assembly  112  is in its non-tilted or operative position. The tab  126   g  is configured to engage the backwall  118   a  of the housing  118  to prevent the cam latch member  126  from rotating counter-clockwise relative to the housing  118 . 
     With reference to  FIG. 6 , the plunger  154  is slidably positioned in a bore  164  formed in the first end of center rod  152 . The finger  166  of the plunger  154  is offset from the pivot axis of head assembly  112  and is biased into engagement with the body portion  126   c  of the cam latch  126 . Engagement of the finger  166  with the body portion  126   c  of the cam latch member  126  presses a leading portion of the edge  126   f  against an inner periphery of the back plate  120  to urge the head assembly  112  to an operative or non-tilted position on the center rod  152 . 
     Turning to  FIG. 7 , in the pre-fired operative position of the head assembly  112 , i.e. when the head assembly  112  has been pivoted to its non-tilted position, the fingers  138  formed on the backup plate  120  engage the protrusions  152   b  adjacent the top surface  152   a  of the center rod  152  to prevent the head assembly  112  from pivoting about the pivot member  162 . The head assembly  112  may be tilted a degrees ( FIG. 13 ) relative to the anvil center rod assembly  114  in the pre-fired tilted position. In one embodiment, the head assembly  112  is tilted about seventy degrees (70°) in its pre-fired tilted position; however it should be understood that tilting the head assembly  112  to other degrees is also contemplated. Titling of the head assembly  112  relative to the anvil center rod assembly  114  causes the body portion  126   c  of the cam latch member  126  to engage the finger  166  of the plunger  154 . As the cam latch member  126  rotates with the tilting of the head assembly  112 , the plunger  154  is retracted within the bore  164  of the anvil center rod assembly  114 , thereby compressing the spring  156 . In this manner, the finger  166  of the plunger  154  is distally biased against the body portion  126   c  of cam latch member  126 . 
     With reference to  FIGS. 3 and 4 , a second end of the center rod  152  includes a bore  180  defined by a plurality of the flexible arms  182 . The flexible arms  182  each include an opening  182   a  dimensioned to receive a projection formed on or connected to a shell assembly  31  ( FIG. 18 ). Alternatively, the openings  182   a  may be configured to receive a suture for permitting retrieval of the anvil assembly  110 . The proximal ends of each of the flexible arms  182  include an internal shoulder  184  dimensioned to releasably engage the shell assembly  31  of the surgical stapling device  10  to secure the anvil assembly  110  to the surgical stapling device  10 . A plurality of splines  186  are formed about the center rod  152 . The splines  186  function to align the anvil assembly  110  with the staple holding portion of the surgical stapling device  10 . The center rod  152  also includes an annular recessed portion  190  to facilitate grasping of the anvil assembly  110  by a surgeon with a grasper (not shown). The recessed portion  190  may include a roughened or knurled surface or an overmold to facilitate grasping of the anvil assembly  110 . 
     With reference now to  FIGS. 9-12 , a system for delivering the anvil assembly  110  within a patient is shown generally as anvil delivery system  50 . The anvil delivery system  50  includes a flexible tube or member  52  and an adapter  62 . The flexible tube  52  includes an open end  52   a.  The adapter  62  and the anvil assembly  110  are supported on the open end  52   a  of the flexible tube  52 . The open end  52   a  of the flexible tube  52  includes a throughbore  53  extending therethrough configured to receive a locking pin  54 . The open end  52   a  further includes an opening  55 . The closed end  52   b  of the flexible tube  52  is configured for trans-orally receipt in a patient. The flexible tube  52  may include markings or other gradations  56  along the length thereof to indicate to a surgeon how much of the flexible tube  52  has been received within the patient during insertion and/or to indicate the length of the flexible tube  52  remaining in the patient upon removal. 
     With particular reference to  FIG. 10 , the adapter  62  includes a first end  62   a  configured to be received within the open end  52   a  of the flexible tube  52  and a second end  62   b  configured to be received with in the bore  180  formed in the center rod  152  of the anvil assembly  110 . The first end  62   a  includes a series of annular rings  64  configured to frictionally retain the first end  62   a  of the adapter  62  within the open end  52   a  of the flexible tube  52 . The second end  62   b  of the adapter  62  includes a longitudinal guide member  66  configured to be received between the flexible arms  182  formed in the center rod  152  of the anvil assembly  110 . In addition, the second end  62   b  of the adapter  62  is sized to allow the center rod  154  of the anvil assembly  110  to freely slide into and off of the second end  62   b  of the adapter  62 . The adapter  62  further includes a first throughbore  70  formed in a central hub portion  62   c  as well as second and third throughbores  72 ,  74  formed in the first end  62   a.  The first throughbore  72  is configured to align with the throughbore  53  formed in the open end  52   a  of the flexible tube  52  and is sized to receive the locking pin  54 . 
     With particular reference now to  FIGS. 10, 13 and 14 , the anvil assembly  110  is supported on the anvil delivery system  50 . Securing the anvil assembly  110  to the anvil delivery system  50  requires that the first suture “S 1 ” is thread through the openings  119   a  formed on the head assembly  112  such that the first and second ends “S 1a ” “S 1b ” of the suture “S 1 ” are positioned on opposites of the center rod  152 . Next, the second end  62   b  of the adapter  62  is positioned within the throughbore  180  of the center rod  152  such that the longitudinal guide  66  is received between two of the arm members  182 . Each of the first and second ends “S 1a ”, “S 1b ” of the suture “S 1 ” is inserted through the opening  55  formed in the open end  52   a  of the flexible tube  52 . The head assembly  112  is then rotated to a first tilted position while first and second ends “S 1a ”, “S 1b ” of suture “S 1 ” are pulled through the opening  55 . The first end  62   a  of the adapter  62  is then inserted into the open end  52   a  of the flexible member  52 . The frictional contact between the annular rings  64  of the first end  62   a  of the adapter  62  and an inner surface of the flexible tube  52  secures the adapter  62  to the flexible tube  52  and prevents the first suture “S 1 ” from loosening. It is envisioned that more than one suture may be used to secure the head assembly  112  in a pre-fired tilted position. 
     With reference now to  FIG. 15 , a method for delivering the anvil assembly  110  to a surgical site within a patient will be described. In one method, the anvil assembly  110  is provided in the first tilted position supported on the anvil delivery system  50  and ready for delivery. Alternatively, a clinician secures the anvil assembly  110  to the anvil delivery system  50  as discussed above. Once the anvil assembly  110  has been secured to the flexible tube  52 , the surgeon inserts the closed end  52   b  of the flexible tube  52  in the patient&#39;s mouth “M” and moves the closed end  52   b  along with the flexible tube  52  down through esophagus “E” to a surgical site, i.e., the stomach “St”. 
     After insertion, the surgeon then makes a first incision “I 1 ” at the surgical site (stomach “St” as shown) to create an inner access to the closed end  52   b  of the flexible tube  52  and then pulls the open end  52   b  of the flexible tube  52  through the first incision “I 1 ”. In some procedures it may be beneficial to pull the flexible tube  52  through the incision “I 1 ” until the center rod  152  of the anvil assembly  110  advances through the first incision “I 1 ”. When the anvil assembly  110  is properly positioned at the surgical site, the surgeon releases the anvil delivery system  50  from the anvil assembly  110  by cutting the suture “S 1 ” and separating the anvil assembly  110  from the second end  62   b  of the adapter  62 . The flexible tube  52  (with the fitting  62 ) may then be pulled from the body through the first incision “I 1 ”. 
     Severing of the suture “S 1 ” permits the plunger  154  to extend from within the bore  164 , thereby causing the finger  166  to engage the body portion  126   c  of the cam latch member  126 . Rotation of the cam latch member  126  causes the edge  126   f  of the cam latch member  126  to move into engagement with the inner periphery of the backup plate  120 , thereby urging the head assembly  112  to return to a non-tilted operative position. Additionally, the distal end of the stapling device  10  may be configured to engage the finger  166  of the plunger  154  as the anvil assembly  110  is attached to the surgical stapling device  10 . In this manner, the distal end of the surgical stapling device  10  urges the plunger  154  distally, thereby ensuring the rotation of the head assembly  112  to a non-tilted position. 
     With particular reference to  FIG. 15 , in one method, a second incision “I 2 ” is then formed at the surgical site such that the distal head portion  16  of surgical stapling device  10  may be received therethrough. Alternatively, the distal head portion  16  of the surgical stapling device  10  may be received through the first incision “I 1 ” once the anvil deliver system  50  has been removed from the first incision “I 1 ”. 
     Turning briefly to  FIGS. 16 and 17 , the anvil assembly  110  is operably received on an anvil retainer  32  extending from the shell assembly  31  formed on a distal end of the surgical stapling device  10 . Once the anvil assembly  110  is received on the surgical stapling device  10 , the surgical stapling device  10  operates in the manner discussed in the &#39;060 patent. 
     The operation of the anvil assembly  110  will now be described with reference to  FIGS. 18-23 . When the anvil assembly  110  is in its pre-fired non-tilted position, the backup plate  120  is spaced from the backwall  118   a  of the housing  118  by the retainer  127  and the protrusions  152   b  of the center rod  152  engage the fingers  138  of the backup plate  120  to prevent tilting of the head assembly  112  about the pivot member  162 . The finger  166  of the plunger  154  is urged by the spring  156  into engagement with the body portion  126   c  of the cam latch member  126  to urge the cam latch member  126  in a clockwise direction, about the pivot member  162  such that the edge  126   f  of the cam latch member  126  engages the inner periphery  120   b  of the backup member  120 . 
     The firing of the surgical stapling device  10  causes a knife blade  33  ( FIG. 19 ) of the surgical stapling device  10  to engage the cutting ring  122  to move the cutting ring  122  and backup plate  120  into annular recess  136  of housing  118  of the head assembly  112 . Arrows “W” in  FIG. 19  indicate how cutting ring  122  and backup plate  120  move as a result of the firing of surgical stapling device  10 . When such movement occurs, deformable tabs  127   a  of retainer  127  are deformed against backwall  118   a  of housing  118  and fingers  138  of backup member  120  move away from protrusions  152   b  of center rod  152 . Further, inner periphery  120   b  of backup plate  120  moves past edge  126   f  of cam latch member  126  such that cam latch member  126  is urged to pivot about pivot member  162  in the direction indicated by arrow “X” in  FIG. 21  by plunger  154  to a position in which body portion  126   d  is positioned in front of and engages backup plate  120 . Engagement of plunger  154  with cam latch member  126  urges the head assembly  112  to a second tilted position ( FIGS. 22 and 23 ). It is noted that the head assembly  112  will not immediately tilt upon firing of surgical stapling device  10  because, upon firing, the head assembly  112  is in an approximated position, i.e., the head assembly  112  is in close alignment with shell assembly  31  of stapling device  10 , and, therefore, does not provide room for head assembly  112  to pivot. As such, the head assembly  112  will only begin to tilt when anvil assembly  110  and shell assembly  31  of surgical stapling device  10  are being unapproximated. 
     As the head assembly  112  pivots towards its forward or second tilted position, the finger  166  of the plunger  154  maintains the curved surface  126   e  of the cam latch member  126  in contact with the backup plate  120  to prevent the backup plate  120  from sticking to the knife blade  33  ( FIG. 19 ) as the knife blade  33  is retracted. It is noted that the curved surface  126   e  of the cam latch member  126  is configured to eliminate any gap and ensure contact between the curved surface  126   e  of the cam latch member  126  and the backup plate  120  to hold the backup plate  120  in place during and after the knife blade  33  is retracted such that the cutting ring and backup plate assembly stay in their correct position during continued tilting of the anvil assembly  112 . The anvil assembly  110  is configured such that the anvil head assembly tilts to a forward or second tilted position β degrees ( FIG. 23 ) relative to the center rod assembly  114 . In one embodiment, the head assembly  112  is tilted about seventy degrees (70°) to its second tilted position such that the total pivoting movement of the head assembly  112  from the retracted or first tilted position to the forward or second tilted position is about one-hundred and forty degrees (140°). It should, however, be noted that the tilting of the head assembly  112  to other degrees is also contemplated. 
     As described above, the anvil assemblies of the present disclosure are configured to be delivered to a surgical site, e.g., the stomach “St” ( FIG. 15 ), trans-orally. During trans-oral delivery of the anvil assemblies, a retaining suture, i.e., first suture “S 1 ”, retains the head assembly of the anvil assembly in a first tilted position and a proximal guide suture, i.e., second suture “S 2 ”, which includes first and second ends “S 2a ”, “S 2b ” that remain external of the patient&#39;s mouth “M”, permits the surgeon to dislodge or retrieve the anvil assembly  110  from the patient during trans-oral delivery. 
     As described above and with reference to  FIG. 11 , second suture “S 2 ” is threaded through openings  119   b  in housing  118  of head assembly  112  of anvil assembly  110 . Detaching second suture “S 2 ” from anvil assembly  110  requires pulling on first end “S 2a ” of second suture “S 2 ” such that second end “S 2b ” of second suture “S 2 ” travels from a location externally of the patient&#39;s mouth “M” ( FIG. 15 ) where it is accessible by the surgeon, through the patient&#39;s mouth “M” and upper gastrointestinal (GI) tract, e.g., esophagus “E” and stomach “St” ( FIG. 15 ) (collectively referred to as the patient&#39;s body lumen) and through the openings  119   b  in housing  118  of head assembly  112  of anvil assembly  110  before having to travel back through the upper GI tract and out the patient&#39;s mouth “M”. 
     With reference now to  FIGS. 25-33 , an anvil assembly according to an alternate embodiment of the present disclosure is shown generally as anvil assembly  210 . The anvil assembly  210  is configured to be secured in a first tilted position ( FIG. 26 ) for delivery and delivered using a single suture “S” ( FIG. 27 ). As will be described in further detail below, the suture “S” may be secured to anvil assembly  210  in various configurations that permit detaching of the suture “S” from the anvil assembly  210  following trans-oral delivery of anvil assembly  210  using a single cutting action and/or without creating loose pieces of the suture “S”. Further, by using the single suture “S” and securing the anvil assembly  210  in the manners described below, no portion of the suture “S” travels from the patient&#39;s mouth “M” ( FIG. 15 ), through the upper GI tract, e.g., esophagus “E” ( FIG. 15 ) and stomach “St” ( FIG. 15 ) during withdrawal. Instead, the portion of the suture “S” that does not remain attached to the anvil delivery system  50  is retracted directly from the upper GI tract and through the mouth “M”. 
     The various configurations for securing the anvil assembly  210  in the first tilted position using a single suture “S” and the methods for attaching the single suture “S” to the anvil assembly  210  in the various configurations will be described as they relate to anvil delivery system  50  ( FIG. 11 ) described hereinabove; however, it is envisioned that aspects of the various configurations and methods may be modified for use with various anvil assemblies and anvil delivery systems. It is also envisioned that the methods of securing the anvil assembly  210  in the first tilted position described herein may be performed at any time prior to trans-oral insertion of the anvil assembly  210 , including, but not limited to, during assembly of a kit including the anvil assembly  210  and the anvil delivery system  50 , or by a clinician during the surgical procedure. 
     Referring initially to  FIGS. 25 and 26 , anvil assembly  210  is substantially similar to anvil assembly  110  ( FIG. 2 ) described hereinabove, and will only be described in detail as relates to the differences therebetween. The anvil assembly  210  includes head assembly  212  pivotally secured to a center rod assembly  214  between a first tilted position ( FIG. 26 ), an operative position ( FIG. 25 ), and a second tilted position (see, for example, anvil assembly  110  in  FIG. 24 ). A housing  218  of the head assembly  212  defines first and second proximal openings  215   a,    215   b,  first and second intermediate openings  217   a,    217   b,  and first and second distal openings  219   a,    219   b.  As will be described in further detail below, each of the first and second proximal and distal openings  215   a,    215   b,    219   a,    219   b  are configured to receive the suture “S”. 
     Although when describing the various methods of securing the head assembly  212  using the suture “S” initial reference will be made to the first proximal and distal openings  215   a ,  219   a  of the housing  218  of the head assembly  212  of the anvil assembly  210 , the second proximal and distal openings  215   b,    219   b  of the housing  218  are mirror images of the first proximal and distal openings  215   a,    219   a,  therefore, the description of the various methods may instead refer initially to the second proximal and distal openings  215   b,    219   b.    
       FIGS. 27 and 28  illustrate a first method for securing the anvil assembly  210  in the first tilted position by tying the suture “S” in a first configuration. With reference initially to  FIG. 27 , a first end “S a ” of the suture “S” is received into the first distal opening  219   a  of the housing  218  of the head assembly  212  and out of the first proximal opening  215   a  of the housing  218  before being passed through the first throughbore  70  of the adapter  62  of anvil delivery system  50 . The first end “S a ” of the suture “S” is then received into the second proximal opening  215   b  of the housing  218  and out the second distal opening  219   b  of the housing  218 . 
     If the adapter  62  of the anvil delivery system  50  has not already been secured to the center rod assembly  214  of the anvil assembly  210 , the adapter assembly  62  is secured to the center rod assembly  214  by receiving the second end  62   b  of the adapter assembly  62  within a bore  280  of center rod  252  of center rod assembly  214 . In the first method of securing the head assembly  212  of the anvil assembly  210  in the first tilted position, the adapter  62  may be secured to the anvil assembly  210  prior to or subsequent the suture “S” being received through the adapter  62 . 
     The first end “S a ” of the suture “S” and the second end “S b ” of the suture “S” are then crossed back over one another and pulled tight, as indicated by arrows “B” and “C”, respectively, in  FIG. 27 . As the first and second ends “S a ”, “S b ” of the suture “S” are pulled tight, the head assembly  212  of the anvil assembly  210  moves to the first tilted position. Alternatively, the head assembly  212  may be manually moved to the first tilted position prior to tightening the first and second ends “S a ”, “S b ” of the suture “S”. Once the head assembly  212  is in the first tilted position, the first and second ends “S a ”, “S b ” of the suture “S” are crossed back over one another to form a knot “K” between the first and second distal openings  219   a,    219   b  of the housing  218  ( FIG. 28 ). The knot “K” is tightened by continuous tensioning of the suture ends “S a ”, “S b ” of the suture “S” to secure the head assembly  212  of the anvil assembly  210  in the first tilted position. 
     In the first method of securing the head assembly  212  of the anvil assembly  210  in the first tilted position, the adapter assembly  62  of the anvil delivery system  50  may be secured to the flexible member  52  of the anvil delivery system  50  at any time by receiving the first end  62   a  of the adapter assembly  62  with the open end  52   a  of the flexible member  52 . 
     Either of the first or second ends “S a ”, “S b ” of the suture “S” may be cut adjacent the knot “K”, as indicated by line “D”, to form a single strand of the suture “S” that extends distally from anvil assembly  210 . Alternatively, the first and second ends “S a ”, “S b ” of the suture “S” may be tied together to form a loop (not shown). The first and/or second ends “S a ”, “S b ” of the suture “S”, or the loop, may then be used to facilitate trans-oral insertion of the anvil assembly  210  into a patient, as described above with regards to anvil assembly  110 . As detailed above, during trans-oral insertion of the anvil assembly  210 , the first and/or second ends “S a ”, “S b ” of the suture “S” remain external of the patient to permit the surgeon to dislodge or retrieve the anvil assembly  210 . 
     Once the anvil assembly  210  is received at the operative site, e.g., within a patient, the head assembly  212  of the anvil assembly  210  may be moved to the operative position by cutting either length of the suture “S” that extends between the first and second proximal openings  215   a,    215   b  of the housing  218  of the head assembly  212  and the first throughbore  70  in the adapter  62  of the anvil delivery system  50 . The suture “S” may be cut at any point between the knot “K” and the adapter  62 . When only one of the lengths of the suture “S” that extends between the first and second proximal openings  215   a,    215   b  and the first throughbore  70  is cut, the suture “S” may be removed from the patient, in its entirety, by pulling on the first and/or second ends “S a ”, “S b ” of the suture “S”, e.g., the portion of the suture “S” that extends from the mouth “M” of the patient. When both lengths of the suture “S” that extend between the first and second proximal openings  215   a,    215   b  and the first throughbore  70  are cut, only the portion of the suture “S” distal of the cut is removed from the patient by pulling on the first and/or second ends “S a ”, “S b ” of the suture “S”. 
       FIGS. 29-31  illustrate a second method for securing the anvil assembly  210  in the first tilted position by tying the suture “S” in a second configuration. With reference initially to  FIG. 29 , a loop “L” is formed in the midpoint of the suture “S” by tying a knot “K” in the suture “S”. A first end “S a ” of the suture “S” is then received into the first distal opening  219   a  of the housing  218  of the head assembly  212  of the anvil assembly  210  and out the first proximal opening  215   a  of the housing  218  while a second end “S b ” of the suture “S” is received into the second distal opening  219   b  of the housing  218  and out the second proximal opening  215   a  of the housing. In this manner, the knot “K” formed in the suture “S” is positioned between the first and second distal openings  219   a,    219   b  of the housing  218 . 
     The first and second ends “S a ”, “S b ” of the suture “S” are then received through the first throughbore  70  of the adapter  62  of the anvil delivery system  50  from opposite directions and then through the second throughbore  72  of the adapter  62  from opposite directions. Alternatively, both the first and second ends “S a ”, “S b ” of the suture “S” may be received through the first throughbore  70  of the adapter  62  of the anvil delivery system  50  in the same direction and then through the second throughbore  72  of the adapter  62  in the same or opposite directions. 
     If the adapter  62  of the anvil delivery system  50  is not already secured to the center rod assembly  214  of the anvil assembly  210 , the adapter  62  is secured to the center rod assembly  214 , as described above. The adapter  62  may be secured to the anvil assembly  210  prior or subsequent to the suture “S” being received through the adapter  62 . 
     The head assembly  212  of the anvil assembly  210  may then be moved to the first tilted position by pulling outwardly on the portions of the suture “S” extending from the first throughbore  70  of the adapter  62 , as indicated by arrows “E” and “F” in  FIG. 29 . Alternatively, the head assembly  212  may be moved to the first tilted position manually. When the head assembly  212  is moved to the first tilted position manually, pulling on the portions of the suture “S” that extend from the first throughbore  70  of the adapter  62  tightens the suture “S”. 
     To secure the head assembly  212  of the anvil assembly  210  in the first tilted position, the portions of the suture “S” that extend from the second throughbore  72  of the adapter  62 , i.e., the first and second ends “S a ”, “S b ”, are pulled outwardly, as indicated by arrows “G” and “H” in  FIG. 30 , to tighten the suture “S” about the first end  62   a  of the adapter  62 . To maintain the suture “S” in the tightened condition, the first end  62   a  of the adapter  62  is inserted within the open end  52   a  of the flexible member  52  of the anvil delivery system  50 . As the first end  62   a  of the adapter  62  is inserted within the open end  52   a  of the flexible member  52 , the adapter  62  is secured to the flexible member  52  by a friction fit and the suture “S” is secured between the adapter  62  and the flexible member  52 . 
     In an alternative method, the first and seconds “S a ”, “S b ” of the suture “S” are received directly from the head assembly  212  of the anvil assembly  210  through the second throughbore  72  of the adapter  62  of the anvil delivery system  50  without being received through the first throughbore  70  of the adapter  62 . In this manner, continuous tension must be applied to the first and seconds “S a ”, “S b ” of the suture “S” to maintain the head assembly  212  in the first tilted position until the adapter  62  is secured to the flexible member  52 . 
     Once the suture “S” is tightened and the adapter  62  of the anvil delivery system  50  is secured to the flexible member  52  of the anvil delivery system  50 , the first and second ends “S a ”, “S b ” of the suture “S” that extend from between the flexible member  52  and the adapter  62  may be trimmed. Alternatively, the first and second ends “S a ”, “S b ” of the suture “S” that extend from between the flexible member  52  and the adapter  62  may be wrapped around the center rod assembly  214  of the anvil assembly, around the adapter  62 , and/or around the flexible member  52 . 
     During a surgical procedure in which the anvil assembly  210  is trans-orally inserted into patient, the loop “L” of the suture “S” may be used to facilitate insertion of the anvil assembly  210  into the patient. Alternatively, the suture “S” may be cut adjacent to the knot “K” formed in the suture “S” to form a single strand of the suture “S” that extends distally from the anvil assembly  210  and the single strand of the suture “S” may be used to facilitate insertion of the anvil assembly  210 . 
     Once the anvil assembly  210  is received at the operative site, e.g., within a patient, the head assembly  212  of the anvil assembly  210  is moved to the operative position by cutting both lengths of the suture “S” that extend between the first and second proximal openings  215   a,    215   b  in the housing  218  of the head assembly  212  and the first throughbore  70  in the adapter  62  of the anvil delivery system  50 . The suture “S” may be cut at any point between the head assembly  212  and the adapter  62 . After the suture “S” is cut, the portion of the suture “S” that extends distally of the cut may be removed from the patient by pulling on the portion of the suture “S” that extends distally from the head assembly  212 . 
       FIG. 32  illustrates a variation to the second method for securing the anvil assembly  210  in the first tilted position using a single suture “S”, as described above. During the variation to the second method, after receiving the first and second ends “S a ”, “S b ” of the suture “S” through the housing  218  of the head assembly  212  of the anvil assembly  210 , the first and second ends “S a ”, “S b ” of the suture “S” are crossed over or overlapped with one another one or more times before the first and second ends “S a ”, “S b ” of the suture “S” are received through the first throughbore  70  of the adapter  62  of the anvil delivery system  50 . In this manner, a single cut may be made to the suture “S” along any portion of the overlapping lengths of the suture “S” to sever the suture “S”, and permit the head assembly  212  of the anvil assembly to move to the operative position. 
     Turning to  FIG. 33 , the head assembly  212  of the anvil assembly  210  is shown attached to the anvil delivery system  50  and secured in the first tilted position using the variation of the second method described above. A suture reel  300  is shown supporting the portion of the suture “S” extending distally from the anvil assembly  210 . An exemplary suture reel is disclosed in U.S. patent application Ser. No. 14/078,814, the content of which is incorporated by reference herein in its entirety. The anvil assembly  210 , anvil delivery system  50  and the suture reel  300  may be provided in a kit. The kit may include the anvil assembly  210  secured to the anvil delivery system  50  using any of the above described methods in any of the above described configurations. Alternatively, the components of the kit may be provided separate from one another and/or partially assembled. 
     Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.