Anvil assemblies and delivery systems

ANVIL ASSEMBLIES AND DELIVERY SYSTEMS

BACKGROUND

Technical Field

[0001] 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 ofRelated Art

[0002] 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’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

[0003] An anvil delivery system is provided. The anvil delivery system includes a delivery assembly, an anvil assembly selectively securable to 1he 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

Date Reçue/Date Received 2023-03-20 delivery assembly through the head assembly and distally of the head assembly, wherein the suture retains the head assembly in the first tilted position.

[0004] 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.

[0005] 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 lying the first end of the suture to a second end of the suture adjacent the head assembly.

[0006] In embodiments, the method further includes moving the head assembly relative to the center rod assembly prior to tying die 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 die first end of the suture through a second opening may include

Date Reçue/Date Received 2023-03-20 receiving the first end of the suture into a second proximal opening and out of a second distal opening.

[0007] 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.

[0008] In embodiments, receiving the first and second ends of the suture through a bore includes receiving the first end of foe suture through a first bore in a first direction and receiving foe second end of foe suture through the first bore in a second direction, then receiving the first end of foe suture through a second bore in foe second direction and receiving the second end of the suture through the second bore in foe first direction. Securing the adapter to the flexible member may include receiving a first end of the adapter within an open end of foe flexible member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Various embodiments of foe presently disclosed anvil delivery system including foe anvil assembly and delivery assembly are disclosed herein with reference to the drawings wherein:

[0010] FIG. 1 is a perspective view of a surgical stapling device including an embodiment of an anvil assembly according to foe present disclosure;

[0011] FIG. 2 is a first perspective side view of foe anvil assembly of FIG. 1 ;

[0012] FIG. 3 is a second perspective side view of foe anvil assembly shown in FIGS. 1 and 2;

Date Reçue/Date Received 2023-03-20

[0013] FIG. 4 is an exploded side view of the anvil assembly of FIGS. 1 -3;

[0014] FIG. 5 is an end view of foe anvil assembly of FIGS. 1-4;

[0015] FIG. 6 is a cross-sectional side view of a distal end of foe tilt anvil assembly of

FIGS. 1-6 taken along line 6-6 of FIG. 5;

[0016] FIG. 7 is a cross-sectional side view of a distal end of foe anvil assembly of FIGS.

1-6 taken along line 7-7 of FIG. 5;

[0017] FIG. 8 is an enlarged side view of foe cam latch member of foe anvil assembly of

FIGS. 1-7;

[0018] FIG. 9 is a top view of foe anvil delivery system including foe anvil assembly of

FIGS. 1-7 supported on a delivery assembly;

[0019] FIG. 10 is an enlarged exploded view of foe delivery assembly of FIG. 9;

[0020] FIG. 11 an enlarged top view of the delivery assembly of FIGS. 9 and 10, including foe anvil assembly of FIGS. 1-7;

[0021] FIG. 12 is a cross-sectional side view of the anvil assembly and delivery assembly of FIG. 11 taken along lines 12-12 of FIG. 11;

[0022] FIG. 13 is a cross sectional side view of the anvil assembly of FIGS. 1-7, in a prefired tilted position supported on foe delivery assembly of FIGS. 9-12;

[0023] FIG. 14 is an enlarged view of foe indicated area of detail shown in FIG. 13;

[0024] FIG. 15 is an illustration of foe anvil assembly and delivery assembly of FIGS. 11 and 12 being inserted trans-orally into a patient;

[0025] FIG. 16 is an enlarged side view of foe distal head portion of foe surgical stapling device of FIG. 1 with the anvil assembly removed;

[0026] FIG. 17 is an enlarged side view of foe distal head portion of foe surgical stapling device of FIG. 1 with foe anvil assembly of FIGS. 1-7 received thereon;

Date Reçue/Date Received 2023-03-20

[0027] FIG. 18 is an enlarged cross-sectional side view of toe distal head portion of the surgical stapling device of FIG. 1 and the anvil assembly of FIGS. 1-7 in a pre-fired non-tilted operative position;

[0028] FIG. 19 is an enlarged cross-sectional side view of the distal head portion of the surgical stapling device of FIG. 1 and the anvil assembly of FIGS. 1-7 in a post-fired non-titled operative position;

[0029] 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;

[0030] FIG. 21 is an enlarged cross-sectional side view of the distal end of ihe anvil assembly of FIGS. 1-7 in a post-fired tilted position;

[0031] FIG. 22 is a cross-sectional side view of the anvil assembly of FIGS. 1 -7 in a postfired tilted position supported on an anvil retainer of the surgical instrument of FIG. 1;

[0032] 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

[0033] FIG. 23 is an enlarged view of the indicated area of detail shown in FIG.22A;

[0034] 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;

[0035] FIG. 25 is a perspective side view of an anvil assembly according to another embodiment of the present disclosure in an operative position;

[0036] 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;

[0037] FIG. 27 is a top view of the anvil assembly of FIG. 25 and a distal portion of the delivery assembly of FIG. 11 with parts separated, and a suture as the suture is secured to the anvil assembly and delivery assembly in a first configuration;

Date Reçue/Date Received 2023-03-20

[0038] FIG. 28 is a top view of the anvil assembly, delivery assembly, and suture of FIG. 27, with the delivery assembly secured to the anvil assembly and the suture secured to the anvil assembly and the delivery assembly in the first configuration;

[0039] FIG. 29 is a top view of the anvil assembly of FIG. 25 and a distal portion of the delivery assembly of FIG. 11 with parts separated, and a suture as the suture is secured to the anvil assembly and delivery assembly in a second configuration;

[0040] FIG. 30 is a top view of the anvil assembly, delivery assembly, and suture of FIG. 29, with an adapter of tire delivery assembly secured to the anvil assembly and as the suture is secured to the anvil assembly and the delivery assembly in the second configuration;

[0041] FIG. 31 is atop view of the anvil assembly, delivery assembly, and suture of FIG. 29, with the delivery assembly secured to the anvil assembly and the suture secured to the anvil assembly and the delivery assembly in the second configuration;

[0042] FIG. 32 is a top view of the anvil assembly, delivery assembly, and suture of FIG. 29, with the delivery assembly secured to the anvil assembly and tire suture secured to tire anvil assembly and the delivery assembly in a third configuration; and

[0043] FIG. 33 is a perspective side view of the anvil assembly, delivery assembly, and suture of FIG. 32, further including a suture reel.

DETAILED DESCRIPTION OF EMBODIMENTS

[0044] Embodiments of the presently disclosed anvil 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 tire portion of the instrument furthest from the operator.

Date Reçue/Date Received 2023-03-20

[0045] FIG. 1 illustrates an embodiment of a surgical stapling device configured for use with tilt anvil assemblies and delivery assemblies according to the present disclosure. Although the anvil assemblies and delivery assemblies of the present disclosure will be described with reference to surgical stapling device 10, it is envisioned that the anvil assemblies and delivery assemblies may be modified for use with alternative surgical stapling devices.

[0046] Briefly, foe surgical stapling device 10 includes a proximal handle assembly 12, an elongated central body portion 14 including a curved elongated outer tube 14a, and a distal head portion 16. Alternately, in some surgical procedures, e.g., foe 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 foe distal head portion 16 may also be varied to suit a particular surgical procedure.

[0047] 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 foe handle assembly 12 and is manually positioned to prevent inadvertent firing of foe stapling device 10. The indicator 24 is positioned on foe stationary handle 18 and includes indicia, e.g., color coding, alpha-numeric labeling, etc., to identify to a surgeon whether foe 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. Patent No. 7,364,060 to Milliman.

[0048] Referring now to FIGS. 2-7, an anvil assembly according to an embodiment of the presort disclosure is shown generally as anvil assembly 110. The anvil assembly 110 is shown in anon-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 7

Date Reçue/Date Received 2023-03-20 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.

[0049] As will be discussed in further detail below, the housing 118 includes openings 119a, 119b sized and dimensioned to receive one or more sutures “S”. During use, a first suture “Si” (FIG. 9) is inserted through openings 119a 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 “S2* (FIG. 9) is inserted through die openings 119b. The second suture “S2” is configured to facilitate guiding the anvil assembly 110 trans-orally within a patient. During transoral insertion of the anvil assembly 110, the second suture “S2” extends from the mouth “M” (FIG. 15) of patient, permitting the anvil assembly 110 to be retrieved trans-orally.

[0050] 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 124a 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 124a and foe cutout 132 function to align or properly position the anvil plate 124 within foe annular recess 128 of the housing 118.

[0051] With particular reference to FIGS. 6 and 7, foe head assembly 112 will be described in detail. The backup plate 120 includes a central opening 134 which is positioned about foe post 116 within an inner annular recess 136 of foe housing 118 between the post 116 and the outer annular recess 128. The backup plate 120 includes a raised platform 120a. The cutting ring 122 includes an opening 122a having a configuration substantially foe same as foe platform 120a. Although foe platform 120a is illustrated as having a circular shape, other configurations are 8

Date Reçue/Date Received 2023-03-20 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 Ihe 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.

[0052] 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. [0053] 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 118a of the housing 118. In one embodiment, foe retainer member 127 is annular and includes a plurality of deformable tabs 127a 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 127a 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 9

Date Reçue/Date Received 2023-03-20 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.

[0054] It is envisioned that other ciushable, 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 Serial No. 14/078,766.

[0055] 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 159a. 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 159a 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.

[0056] Turning briefly to FIG. 8, the cam latch member 126 includes a body 126a having a throughbore 126b. The throughbore 126b 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 126c 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 126c is configured such that the distance between the surface of the body portion 126c and the throughbore 10

Date Reçue/Date Received 2023-03-20

126b 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 126c permits tire 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 126f, including a tab 126b. Λ leading portion of edge 126f is configured to be urged into engagement with an inner periphery 120b of the backup plate 120 by an engagement finger 166 of the plunger 154 when tire head assembly 112 is in its non-tilted or operative position. The tab 126g is configured to engage the backwall 118a of the housing 118 to prevent the cam latch member 126 from rotating counter-clockwise relative to the housing 118.

[0057] 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 tire pivot axis of head assembly 112 and is biased into engagement with the body portion 126c of the cam latch 126. Engagement of foe finger 166 with foe body portion 126c of foe cam latch member 126 presses a leading portion of foe edge 126f against an inner periphery of the back plate 120 to urge foe head assembly 112 to an operative or non-tilted position on foe center rod 152.

[0058] Turning to FIG. 7, in the pre-fired operative position of the head assembly 112, i.e. when foe head assembly 112 has been pivoted to its non-tilted position, foe fingers 138 formed on foe backup plate 120 engage foe protrusions 152b adjacent foe top surface 152a of the center rod 152 to prevent the head assembly 112 from pivoting about foe pivot member 162. The head assembly 112 may be tilted a degrees (FIG. 13) relative to the anvil center rod assembly 114 in foe pre-fired tilted position. In one embodiment, foe 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. Tiding of foe head assembly 112 relative to foe anvil center rod assembly 114 causes foe body portion 126c of foe cam latch member 126 to 11

Date Reçue/Date Received 2023-03-20 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 126c of cam latch member 126.

[0059] With reference to FIGS. 3 and 4, a second aid 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 182a dimensioned to receive a projection formed on or connected to a shell assembly 31 (FIG. 18). Alternatively, the openings 182a may be configurai to receive a suture for permitting retrieval of the anvil assembly 110. The proximal ends of each of die 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 ofthe surgical stapling device 10. Thecenterrod 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.

[0060] With reference now to FIGS. 9-12, an assembly for delivering the anvil assembly 110 within a patient is shown generally as delivery assembly 50. The delivery assembly 50 includes a flexible tube or member 52 and an adapta 62. The flexible tube 52 includes an open end 52a. The adapter 62 and the anvil assembly 110 are supported on the open end 52a of the flexible tube 52. The open end 52a of the flexible tube 52 includes a throughbore 53 extending therethrough configured to receive a locking pin 54. The open aid 52a further includes an opening 55. The closed end 52b 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 12

Date Reçue/Date Received 2023-03-20 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.

[0061] With particular reference to FIG. 10, the adapter 62 includes a first end 62a configured to be received within the open end 52a of the flexible tube 52 and a second end 62b configured to be received with in the bore 180 formed in the center rod 152 of the anvil assembly 110. The first end 62a includes a series of annular rings 64 configured to frictionally retain the first end 62a of the adapter 62 within the open end 52a of the flexible tube 52. The second end 62b of the adapter 62 includes a longitudinal guide member 66 configured to be received between the flexible arms 182 formed in tire center rod 152 of the anvil assembly 110. In addition, the second end 62b 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 62b of foe adapter 62. The adapter 62 further includes a first throughbore 70 formed in a central hub portion 62c as well as second and third throughbores 72, 74 formed in the first end 62a. The first throughbore 72 is configured to align with the throughbore 53 formed in the open end 52a of the flexible tube 52 and is sized to receive the locking pin 54.

[0062] With particular reference now to FIGS. 10,13 and 14, the anvil assembly 110 is supported on the delivery assembly 50. Securing the anvil assembly 110 to the delivery assembly 50 requires that the first suture “Si” is thread through the openings 119a formed on the head assembly 112 such that the first and second ends “Su”, “Sib” of the suture “Si” are positioned on opposites of die center rod 152. Next, the second end 62b of die adapter 62 is positioned within the throughbore 180 of die center rod 152 such that die longitudinal guide 66 is received between two of the ann members 182. Each of the first and second ends “Sia”, “Sib” of die suture “Si” is inserted through die opening 55 formed in the open end 52a of die flexible tube 52. The head assembly 112 is then rotated to a first tilted position while first and second ends “Sia”, “Sib” of 13

Date Reçue/Date Received 2023-03-20 suture “Si” are pulled through Ihe opening 55. The first end 62a of the adapter 62 is then inserted into the open end 52a of the flexible member 52. The frictional contact between the annular rings 64 of the first end 62a of the adapter 62 and an inner surface of the flexible tube 52 secures 1he adapter 62 to the flexible tube 52 and prevents the first suture “Si” 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. [0063] 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, tire anvil assembly 110 is provided in the first tilted position supported on the delivery assembly 50 and ready for delivery. Alternatively, a clinician secures the anvil assembly 110 to the delivery assembly 50 as discussed above. Once ihe anvil assembly 110 has been secured to the flexible tube 52, the surgeon inserts the closed end 52b of the flexible tube 52 in the patient’s mouth “M” and moves the closed end 52b along with the flexible tube 52 down through esophagus “E” to a surgical site, i.e., the stomach “St”.

[0064] After insertion, the surgeon then makes a first incision “Ii” at the surgical site (stomach “St” as shown) to create an inner access to the closed end 52b of the flexible tube 52 and then pulls the open end 52b of the flexible tube 52 through the first incision “Ii”. In some procedures it may be beneficial to pull the flexible tube 52 through the incision “ΙΓ until the center rod 152 of the anvil assembly 110 advances through the first incision “11”. When the anvil assembly 110 is properly positioned at the surgical site, tire surgeon releases foe delivery assembly 50 from the anvil assembly 110 by cutting foe suture “Si” and separating the anvil assembly 110 from foe second end 62b of foe adapter 62. The flexible tube 52 (with foe fitting 62) may then be pulled from the body through foe first incision “Ii”.

[0065] Severing of foe suture “Si” permits foe plunger 154 to extend from within foe bore 164, thereby causing the finger 166 to engage foe body portion 126c of the cam latch member 126. 14

Date Reçue/Date Received 2023-03-20

Rotation of the cam latch member 126 causes the edge 126f 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.

[0066] With particular reference to FIG. 15, in one method, a second incision “h” 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 “ΙΓ once the delivery assembly 50 has been removed from the first incision “Ii”.

[0067] 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 suigical 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 ‘060 patent.

[0068] 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 118a of the housing 118 by the retainer 127 and the protrusions 152b 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 126c of the cam latch member 126 to urge tiie cam latch member 126 in a clockwise direction, about the pivot member 162 such that foe edge 126f of the cam latch member 126 engages the inner periphery 120b of the backup member 120.

Date Reçue/Date Received 2023-03-20

[0069] 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 127a of retainer 127 are deformed against backwall 118a of housing 118 and fingers 138 of backup member 120 move away from protrusions 152b of center rod 152. Further, inner periphery 120b of backup plate 120 moves past edge 126f 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 126d 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.

[0070] As the head assembly 112 pivots towards its forward or second tilted position, the finger 166 of the plunger 154 maintains foe curved surface 126e of foe cam latch member 126 in contact with foe backup plate 120 to prevent the backup plate 120 from sticking to foe knife blade 33 (FIG. 19) as the knife blade 33 is retracted. It is noted that foe curved surface 126e of foe cam latch member 126 is configured to eliminate any gap and ensure contact between foe curved surface 126e of the cam latch member 126 and foe backup plate 120 to hold foe backup plate 120 in place during and after foe knife blade 33 is retracted such that foe cutting ring and backup plate 16

Date Reçue/Date Received 2023-03-20 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 tire tilting of Ihe head assembly 112 to other degrees is also contemplated. [0071] 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 “Si”, retains the head assembly of the anvil assembly in a first tilted position and a proximal guide suture, i.e., second suture “S2”, which includes first and second ends “S2a”, “Sa” that remain external of the patient’s mouth “M”, permits the surgeon to dislodge or retrieve the anvil assembly 110 from the patient during transoral delivery.

[0072] As described above and with reference to FIG. 11, second suture “S2” is threaded through openings 119b in housing 118 of head assembly 112 of anvil assembly 110. Detaching second suture “S2” from anvil assembly 110 requires pulling on first end “S2a” of second suture “S2” such that second end “Sa” of second suture “S2” travels from a location externally of the patient’s mouth “M” (FIG. 15) where it is accessible by the surgeon, through the patient’s mouth “M” and upper gastrointestinal (GI) tract e g·, esophagus “E” and stomach “St” (FIG. 15) (collectively referred to as tire patient’s body lumen) and through foe openings 119b in housing 118 of head assembly 112 of anvil assembly 110 before having to travel back through foe upper GI tract and out foe patient’s mouth “M”.

Date Reçue/Date Received 2023-03-20

[0073] 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’s mouth “M” (FIG. 15), through the upper Gl tract, e.g., esophagus “E” (FIG. 15) and stomach “St” (FIG. 15) during withdrawal. Instead, foe portion of foe suture “S” that does not remain attached to the delivery assembly 50 is retracted directly from the upper GI tract and through the mouth “M”.

[0074] The various configurations for securing foe anvil assembly 210 in foe first tilted position using a single suture “S” and foe methods for attaching the single suture “S” to the anvil assembly 210 in foe various configurations will be described as they relate to delivery assembly 50 (FIG. 11) described hereinabove; however, it is envisioned that aspects of foe various configurations and methods may be modified for use with various anvil assemblies and delivery assemblies. 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 foe anvil assembly 210, including, but not limited to, during assembly of a kit including foe anvil assembly 210 and the delivery assembly 50, or by a clinician during foe surgical procedure.

[0075] 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 18

Date Reçue/Date Received 2023-03-20 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 215a, 215b, first and second intermediate openings 217a, 217b, and first and second distal openings 219a, 219b. As will be described in further detail below, each of the first and second proximal and distal openings 215a, 215b, 219a, 219b are configured to receive the suture “S”.

[0076] 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 215a, 219a of the housing 218 of the head assembly 212 of the anvil assembly 210, the second proximal and distal openings 215b, 219b of the housing 218 are mirror images of the first proximal and distal openings 215a, 219a, therefore, foe description of foe various methods may instead refer initially to foe second proximal and distal openings 215b, 219b.

[0077] FIGS. 27 and 28 illustrate a first method for securing foe anvil assembly 210 in foe first tilted position by tying foe suture “S” in a first configuration. With reference initially to FIG. 27, a first end “Sa” of foe suture “S” is received into foe first distal opening 219a of foe housing 218 of the head assembly 212 and out of the first proximal opening 215a of the housing 218 before being passed through foe first foroughbore 70 of foe adapter 62 of anvil delivery system 50. The first end “S_a” of foe suture “S” is then received into the second proximal opening 215b of the housing 218 and out foe second distal opening 219b of foe housing 218.

[0078] If foe adapter 62 of the delivery assembly 50 has not already been secured to the center rod assembly 214 of foe anvil assembly 210, foe adapter assembly 62 is secured to foe center rod assembly 214 by receiving foe second end 62b of the adapter assembly 62 within a bore 280 of center rod 252 of center rod assembly 214. In foe first method of securing foe head assembly

Date Reçue/Date Received 2023-03-20

212 of tiie 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.

[0079] The first end “Sa” of the suture “S” and the second end “Sb” 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” “Sb” 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”, “Sb” of the suture “S”. Once the head assembly 212 is in the first tilted position, the first and second ends “S_a”, “Sb** of the suture “S’* are crossed back over one another to form a knot “K” between the first and second distal openings 219a, 219b of the housing 218 (FIG. 28). The knot “K” is tightened by continuous tensioning of the suture ends “S_a”, “Sb” of the suture “S” to secure the head assembly 212 of the anvil assembly 210 in the first tilted position.

[0080] 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 delivery assembly 50 may be secured to the flexible member 52 of the delivery assembly 50 at any time by receiving the first end 62a of the adapter assembly 62 with the open end 52a of the flexible member 52.

[0081] Either of the first or second ends “Sa”, “Sb” 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”, “Sb” of the suture “S” may be tied together to form a loop (not shown). The first and/or second ends “S_a”, “Sb” 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 transoral insertion of the anvil assembly 210, the first and/or second ends “S_a”, “Sb” of the suture “S” remain external of the patient to permit the surgeon to dislodge or retrieve the anvil assembly 210.

Date Reçue/Date Received 2023-03-20

[0082] 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 215a, 215b of the housing 218 of the head assembly 212 and the first throughbore 70 in the adapter 62 of the delivery assembly 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 215a, 215b and 1he 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”, “Sb” 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 foe first and second proximal openings 215a, 215b and the first throughbore 70 are cut, only foe portion of the suture “S” distal of the cut is removed from foe patient by pulling on foe first and/or second ends “S_a”, “Sb” of the suture “S”. [0083] FIGS. 29-31 illustrate a second method for securing the anvil assembly 210 in foe first tilted position by tying the suture “S” in a second configuration. With reference initially to FIG. 29, a loop “L” is formed in foe midpoint of the suture “S” by tying a knot “K” in foe suture “S”. A first end “S_a” of the suture “S” is then received into the first distal opening 219a of the housing 218 of foe head assembly 212 of foe anvil assembly 210 and out foe first proximal opening 215a of foe housing 218 while a second end “Sb” of the suture “S” is received into the second distal opening 219b of foe housing 218 and out foe second proximal opening 215a of foe housing. In this manner, the knot “K” formed in the suture “S” is positioned between foe first and second distal openings 219a, 219b of foe housing 218.

[0084] The first and second ends “S_a”, “Sb” of the suture “S” are then received through the first throughbore 70 of foe adapter 62 of foe delivery assembly 50 from opposite directions and then through foe second throughbore 72 of foe adapter 62 from opposite directions. Alternatively, 21

Date Reçue/Date Received 2023-03-20 both the first and second ends “S_a”, “Sb” of die suture “S” may be received through the first throughbore 70 of the adapter 62 of the delivery assembly 50 in the same direction and then through the second throughbore 72 of the adapter 62 in the same or opposite directions.

[0085] If the adapter 62 of the delivery assembly 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.

[0086] 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”.

[0087] 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”, “Sb”, are pulled outwardly, as indicated by arrows “G” and “H” in FIG. 30, to tighten the suture “S” about the first end 62a of the adapter 62. To maintain die suture “S” in the tightened condition, the first end 62a of the adapter 62 is inserted within the open end 52a of die flexible member 52 of die delivery assembly 50. As die first end 62a of die adapter 62 is inserted within the open end 52a 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.

[0088] In an alternative method, the first and seconds “S_a”, “Sb” of die suture “S” are received direcdy from the head assembly 212 of the anvil assembly 210 through the second 22

Date Reçue/Date Received 2023-03-20 throughbore 72 of the adapter 62 of the delivery assembly 50 without being received through die first throughbore 70 of the adapter 62. In this manner, continuous tension must be applied to the first and seconds “S_a”, “Sb” 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.

[0089] Once foe suture “S” is tightened and foe adapter 62 of foe deliveiy assembly 50 is secured to foe flexible member 52 of foe delivery assembly 50, foe first and second ends “S_a”, “Sb” of foe suture “S” that extend from between foe flexible member 52 and foe adapter 62 may be trimmed. Alternatively, foe first and second ends “S_a”, “Sb” of foe suture “S” that extend from between foe flexible member 52 and foe adapter 62 may be wrapped around foe center rod assembly 214 of foe anvil assembly, around foe adapter 62, and/or around foe flexible member 52. [0090] During a surgical procedure in which foe anvil assembly 210 is trans-orally inserted into patient, foe loop “L” of foe suture “S” may be used to facilitate insertion of foe anvil assembly 210 into foe patient. Alternatively, foe suture “S” may be cut adjacent to the knot “K” formed in the suture “S” to form a single strand of foe suture “S” that extends distally from foe anvil assembly 210 and the single strand of foe suture “S” may be used to facilitate insertion of foe anvil assembly 210.

[0091] Once foe anvil assembly 210 is received at foe operative site, e.g., within a patient, foe head assembly 212 of foe anvil assembly 210 is moved to the operative position by cutting both lengths of the suture “S” that extend between foe first and second proximal openings 215a, 215b in foe housing 218 of the head assembly 212 and foe first throughbore 70 in foe adapter 62 of foe delivery assembly 50. The suture “S” may be cut at any point between foe head assembly 212 and the adapter 62. After foe suture “S” is cut, foe portion of foe suture “S” that extends distally of the cut may be removed from foe patient by pulling on foe portion of the suture “S” that extends distally from foe head assembly 212.

Date Reçue/Date Received 2023-03-20

[0092] 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”, “Sb” of the suture “S” through the housing 218 of the head assembly 212 of the anvil assembly 210, the first and second ends “Se”, “Sb” of the suture “S” are crossed over or overlapped with one another one or more times before the first and second ends “S_a”, “Sb” of the suture “S” are received through the first throughbore 70 of the adapter 62 of the delivery assembly 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.

[0093] Turning to FIG. 33, the head assembly 212 of the anvil assembly 210 is shown attached to the delivery assembly 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 Serial No. 14/078,814. The anvil assembly 210, delivery assembly 50 and the suture reel 300 may be provided in a kit The kit may include the anvil assembly 210 secured to the delivery assembly 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.

10094] 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 foe scope of foe pressât disclosure. As well, one skilled in foe art will 24

Date Reçue/Date Received 2023-03-20 appreciate further features and advantages of the disclosure based on die above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by Ihe appended claims.

Date Reçue/Date Received 2023-03-20