CIRCULAR STAPLING DEVICE INCLUDING BUTTRESS MATERIAL

[0001] The present disclosure relates to surgical stapling devices and, more particularly, to structures and methods for removably attaching buttress material to circular surgical stapling devices for use in anastomosis procedures.

[0002] Fasteners have been used to replace suturing when joining various body structures such as, for example, the bowel or bronchus. Surgical stapling devices employed to apply these fasteners are generally designed to simultaneously cut and seal tissue to reduce the time and risks involved with anastomosis procedures.

[0003] Circular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more surgical fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of anastomoses. Circular surgical stapling devices generally include an annular fastener cartridge assembly that supports a plurality of annular rows of fasteners, an annular anvil assembly operatively associated with the fastener cartridge assembly which provides a surface against which the fasteners are formed upon a firing of the circular stapling device, and an annular blade for cutting tissue.

[0004] For most procedures, the use of bare fasteners, with the fasteners in direct contact with the patient's tissue, is generally acceptable. The integrity of the tissue will normally serve to prevent the fasteners from tearing out of the tissue and compromising the sealing before healing has occurred. However, in some surgical operations buttress materials are employed by surgeons in combination with circular stapling devices to bridge, repair and/or reinforce tissue defects within a patient. In particular, buttress materials reduce the trauma suffered by the patient, reduce the instances of leakage, reduce the instances of bleeding, and create a relatively strong bond between adjacent body tissues.

[0005] Accordingly, there is a need for reliably and removably attaching buttress material onto a circular stapling device so that the buttress material does not interfere with the operation of the device, remains on the device until after the fasteners are fired, and is convenient and easy to install and use.

[0006] According to one aspect, a circular stapling device includes a handle assembly, an elongate body that extends from the handle assembly, and an end effector mounted on a distal end of the elongate body and including a cartridge assembly and an anvil assembly.

[0007] The anvil assembly includes a circular anvil head that supports a crush ring, an anvil cap that supports an o-ring, and a circular anvil buttress member. In embodiments, the o-ring is formed of an elastomeric material including nitrile.

[0008] The anvil cap connects to the anvil head and is movable relative to the anvil head between an approximated position and an unapproximated position. The crush ring is spaced from the anvil cap when the anvil cap is disposed in the approximated position and movable into engagement with the anvil cap to move the anvil cap to the unapproximated position. The anvil cap defines a groove in a bottom surface of the anvil cap and the o-ring is secured within the groove. The o-ring is disposed in a compressed condition when the anvil cap is disposed in the approximated position and an uncompressed condition when the anvil cap is disposed in the unapproximated position.

[0009] The anvil cap includes a snap feature and the anvil head defines a first recess and a second recess. The snap feature is selectively positionable within one of the first recess and the second recess. The snap feature is positionable within the first recess when the anvil cap is disposed in the approximated position and is positionable within the second recess when the anvil cap is disposed in the unapproximated position. The first recess and the second recess are separated by a ramped partition. The snap feature cams over the ramped feature as the anvil cap moves from the approximated position to the unapproximated position. The snap feature flexes outwardly from the first recess as the snap feature cams over the ramped partition and flexes inwardly into the second recess after camming over the ramped partition. The snap feature maintains the anvil cap secured to the anvil head when the snap feature is disposed in the second recess.

[0010] The circular anvil buttress member includes a body portion and an extension portion that extends from the body portion. The body portion is supported on a tissue engaging surface of the anvil head. The extension portion is secureable between the o-ring and the anvil head when the anvil cap is disposed in the approximated position. The extension portion is releasable from between the o-ring and the anvil head when the anvil cap is disposed in the unapproximated position so that the body portion separates from the tissue engaging surface of the anvil head. The extension portion includes one or more tabs. The o-ring is compressed against the one or more tabs when the anvil cap is disposed in the approximated position to maintain the body portion supported on the tissue engaging surface of the anvil head.

[0011] In another aspect, then anvil assembly includes a circular anvil head that supports a crush ring, and anvil cap that connects to the anvil head and supports an o-ring, and a circular anvil buttress member.

[0012] The anvil cap is movable relative to the anvil head between an approximated position and an unapproximated position. The crush ring is spaced from the anvil cap when the anvil cap is disposed in the approximated position and movable into engagement with the anvil cap to move the anvil cap to the unapproximated position. The anvil cap defines a groove in a bottom surface of the anvil cap. The o-ring is secured within the groove. The o-ring is disposed in a compressed condition when the anvil cap is disposed in the approximated position and in an uncompressed condition when the anvil cap is disposed in the unapproximated position. In embodiments, the o-ring is formed of an elastomeric material including nitrile.

[0013] The anvil cap includes a snap feature and the anvil head defines a first recess and a second recess. The snap feature is selectively positionable within one of the first recess and the second recess. The snap feature is positionable within the first recess when the anvil cap is disposed in the approximated position and is positionable within the second recess when the anvil cap is disposed in the unapproximated position. The first recess and the second recess are separated by a ramped partition. The snap feature cams over the ramped feature as the anvil cap moves from the approximated position to the unapproximated position. The snap feature flexes outwardly from the first recess as the snap feature cams over the ramped partition and flexes inwardly into the second recess after camming over the ramped partition. The snap feature maintains the anvil cap secured to the anvil head when the snap feature is disposed in the second recess.

[0014] The circular anvil buttress member includes a body portion and an extension portion that extends from the body portion. The body portion is supported on a tissue engaging surface of the anvil head. The extension portion is secureable between the o-ring and the anvil head when the anvil cap is disposed in the approximated position. The extension portion is releasable from between the o-ring and the anvil head when the anvil cap is disposed in the unapproximated position so that the body portion separates from the tissue engaging surface of the anvil head. The extension portion includes one or more tabs. The o-ring is compressed against the one or more tabs when the anvil cap is disposed in the approximated position to maintain the body portion supported on the tissue engaging surface of the anvil head.

[0015] According to yet another aspect, the present disclosure is directed to a method for releasing an anvil buttress member from an anvil assembly of a circular stapling device. The method includes the step of providing a circular stapling device including an elongate member having an end effector mounted on a distal end of the elongate body. The end effector includes an anvil assembly that includes an anvil head and an anvil cap that supports an o-ring. The anvil assembly includes an extension portion of an anvil buttress member secured between the o-ring and the anvil head so that a body portion of the anvil buttress member is supported on a tissue engaging surface of the anvil head. The method involves moving the o-ring relative to anvil head to release the anvil buttress member from the anvil assembly. Another step includes moving a crush ring supported on the anvil head into engagement with the anvil cap to move the o-ring relative to the anvil head. Yet another step involves spacing the o-ring and the anvil head relative to one another in response to engagement of the crush ring with the anvil head to provide a gap between the o-ring and the anvil head sufficient to enable the extension portion of the anvil buttress member to be released from between the o-ring and the anvil head.

[0016] Other aspects, features, and advantages will be apparent from the description, drawings, and claims.

[0024] As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the device that is closer to the clinician and the term “distal” refers to the end of the device that is farther from the clinician. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.

[0025] Referring initially to FIG. 1, a circular surgical stapling device for use with a buttress material is disclosed herein and is generally designated as 10. In embodiments, the surgical stapling device 10 is adapted for reuse and, in certain embodiments, the surgical stapling device 10 is adapted for a single use and can be disposable.

[0026] The circular stapling device 10 includes a handle assembly 20, a tubular elongate body 30, and an end effector 40. The end effector 40 can be provided as a removable and replaceable assembly. The handle assembly 20 includes a rotatable advancing member 22 and a pivotable trigger member 24 that are operatively coupled to any number of drivers supported by the surgical stapling device 10 to effectuate a firing of the surgical stapling device 10. The elongate body 30 extends distally from a distal end portion of the handle assembly 20 to a proximal end portion of the end effector 40 so that the elongate body 30 is disposed between the handle assembly 20 and the end effector 40. In some embodiments, the elongate body 30 has a linear shape along the length of the elongate body 30, and in certain embodiments, the elongate body 30 has a curved shape along the length of the elongate body 30.

[0027] The end effector 40 includes a fastener cartridge assembly 100, an anvil assembly 200, and a shaft 300. The shaft 300 includes a proximal end portion that is secured to the fastener cartridge assembly 100 and a distal end portion that is secured to the anvil assembly 200. In embodiments, the fastener cartridge assembly 100 and/or the anvil assembly 200 may be replaced and the circular stapling device 10 may be reused. In embodiments, the end effector 40 supports a knife assembly with a substantially cylindrical knife 400 (FIG. 6) adapted to cut tissue.

[0028] Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al. and commonly owned U.S. Patent Application Publication No. 2011/0174099, the entire contents of which are incorporated herein by reference, for a detailed discussion of the construction and operation of exemplary circular stapling devices.

[0029] Turning now to FIGS. 2-6, the anvil assembly 200 includes a circular anvil head 210, an o-ring 215, an anvil cap 220, a circular anvil buttress member 230, a crush ring member 240, an anvil plate 250, and a ring assembly 260.

[0030] With continued reference to FIG. 4, the circular anvil head 210 includes a head body 212 that supports the crush ring member 240, the ring assembly 260, and the anvil plate 250. The head body 212 has a connector 214 that extends proximally from the head body 212 and is dimensioned to operatively couple to a distal end portion 302 of the shaft 300. The connector 214 defines a pair of opposed channels 214a. One or more engaging passages 216 are defined by the head body 212 and extend through the head body 212. As shown in FIGS. 5-6, a distal surface of the head body 212 includes one or more ramped partitions 218 that separate a first recess 218a and a second recess 218b defined on opposite sides of the ramped partition 218.

[0031] Referring again to FIG. 4, the anvil cap 220 includes a cap body 222 that is supported on the distal surface of the anvil head 210 so that the o-ring 215 is positionable between the cap body 222 and the anvil head 210. In particular, the cap body 222 defines an annular groove 222a within which the o-ring 215 is dimensioned to be received. The cap body 222 includes one or more engaging features 224 and one or more snap features 226 that extend proximally from the cap body 222. Referring also to FIGS. 5-6, the snap feature 226 includes a tooth 226a that extends radially inwardly. The first and second recesses 218a, 218b of the anvil head 210 are each dimensioned to receive the tooth 226a to facilitate securement of the anvil cap 220 to the anvil head 210. The cap body 222 defines an opening 228 dimensioned to enable the snap feature 226 to flex radially outwardly to permit the anvil cap 220 to move relative to the anvil head 210 between approximated and unapproximated positions.

[0032] The anvil plate 250 secures to the proximal surface of the anvil head 210 and has an annular body 252 that defines an opening 254 therethrough. The annular body 252 has a tissue engaging surface 256 that defines a plurality of fastener forming pockets 256a. The plurality of fastener forming pockets 256a is arranged in an annular array about the tissue engaging surface 256 of the annular body 252.

[0033] The circular anvil buttress member 230 is selectively supported on the anvil plate 250 and has an annular body portion 232 and one or more extension portions 234 that extends radially from the body portion 232. The body portion 232 is dimensioned to overly the tissue engaging surface 256 of the anvil plate 250 and defines a central opening 236 therethrough. The extension portion 234 includes a plurality of spaced apart tabs 234a that extend radially outwardly about the body portion 232. The plurality of spaced apart tabs 234a are selectively positionable between the proximal surface of the anvil cap 220 and the distal surface of the anvil head 210 to selectively secure the annular body portion 232 against the tissue engaging surface 256 of the anvil plate 250 when the anvil cap 220 is disposed in the approximated position. As described in greater detail below, the extension portion 234 is releasable from the between the anvil cap 220 and the anvil head 210 when the anvil cap 220 is moved to the unapproximated position so that the body portion 232 separates from the tissue engaging surface 256 of the anvil plate 250.

[0034] The crush ring member 240 is supported on the anvil head 210 and includes a generally annular body 242 having a plurality of tab members 244 that secure to a proximal surface of the anvil head 210 and extend from the body 242 at radially spaced locations along an outer surface of the body 242. The crush ring member 240 is dimensioned to be spaced from the one or more engaging features 224 of the cap body 222 when the anvil cap 220 is disposed in the approximated position and movable into engagement with the one or more engaging features 224 to move the anvil cap 220 to the unapproximated position. The annular body 242 defines an aperture 246 therethrough that is dimensioned to receive the connector 214 of the head body 212 when the crush ring member 240 is secured to the anvil head 210.

[0035] As illustrated in FIG. 4, the ring assembly 260 is supported between the anvil head 210 and the anvil plate 250. The ring assembly 260 includes a first annular member 270, a second annular member 280, and a third annular member 290.

[0036] The first annular member 270 includes a body 272 having a proximal surface 272a and a distal surface 272b with a central opening 274 defined by an inner surface 272c that extends between the proximal surface 272a and the distal surface 272b of the body 272. The body 272 includes a plurality of annularly spaced apart projections 276 that extend distally from the distal surface 272b of the body 272. Each projection 276 includes a pair of opposed support arms 276a that extend from the projection 276. The opposed support arms 276a are disposed substantially transverse to the projection 276.

[0037] The second annular member 280 includes a body 282 having a proximal surface 282a and a distal surface 282b with a central opening 284 defined by an inner surface 282c that extends between the proximal surface 282a and the distal surface 282b of the body 282. The body 282 includes a pair of opposed nubs 286 that extend from the inner surface 282c and are dimensioned to slide within the channels 214a defined in the connector 214 of the anvil head 210. The body 282 includes a plurality of ledges 288 extend from an outer surface 282d of the body 282 and radially about the outer surface 282d of the body 282. Adjacent ledges 288 define a passage 285 therebetween that is dimensioned to receive the projections 276 of the first annular member 270 such that the opposed support arms 276a of the projections 276 are supported against the adjacent ledges 288 on the distal surface 282b of the second annular member 280 when the first and second annular members 270, 280 are secured together. The portion of the outer surface 282d of the body 282 positioned proximally of the ledges 288 is dimensioned to be seated within the central opening 274 defined by the first annular member 270 when the first and second annular members 270, 280 are secured together. As shown in FIGS. 5 and 6, at least portions of the proximal surfaces of the first and second annular members 270, 280 are substantially aligned when the first and second annular members 270, 280 are secured together.

[0038] The third annular member 290 includes a body 292 having a proximal surface 292a and a distal surface 292b with a central opening 294 defined by an inner surface 292c that extends between the proximal surface 292a and the distal surface 292b of the body 292. As shown in FIGS. 5 and 6, when the annular members of the ring assembly 260 are secured together, the inner surface 292c of the third annular member 290 radially surrounds an outer surface of the ledges 288 of the second annular member 280 and retains the projections 276 of the first annular member 270 within the passages 285 of the second annular member 280. In this regard, the distal surface 272b of the first annular member 270 engages the proximal surface 292a of the third annular member 290 and at least portions of the distal surface 292b of the third annular member 290 and the distal surface 282b of the second annular member 280 are disposed in substantial alignment and in contact with a proximal surface of the crush ring 240.

[0039] During operation of the surgical stapling device 10, the anvil assembly 200 and the cartridge assembly 100 are approximated by the actuation of advancing member 22 until the anvil assembly 200 and the cartridge assembly 100 are suitably clamped against tissue of a patient. The trigger member 24 is then actuated to fire the surgical stapling device 10. Upon a firing of the surgical stapling device 10, the legs of the fasteners supported within the cartridge assembly 100 are advanced through the clamped tissue and any buttress material clamped against tissue including the anvil buttress member 230 and any buttress material that may supported on the cartridge assembly. As the fasteners are distally advanced, the legs of the fasteners are formed by the fastener forming pockets 256a defined in the anvil plate 250 to secure the buttress material including the anvil buttress member 230 to the tissue.

[0040] Referring again to FIGS. 5-6, the knife 400 is simultaneously or thereafter advanced into the anvil assembly 200 to sever the clamped tissue and to advance into engagement with the proximal surface 272a of the first annular member 270 of the ring assembly 260. Upon engagement with the first annular member 270, the knife 400 distally drives the entire ring assembly 260 toward the anvil cap 220. Notably, as the ring assembly 260 is moved distally, the pair of opposed nubs 286 of the second annular member 280 slide through the channels 214a of anvil head 210 such that the ring assembly 260 drives the crush ring member 240 distally into engagement with the one or more engaging features 224 of the anvil cap 220.

[0041] The distal movement of the crush ring member 240 into engagement with the one or more engaging features 224 of the anvil cap 220 separates the proximal surface of the cap body 222 of the anvil cap 220 from the distal surface of the head body 212 of the anvil head 210 so that the o-ring 215 separates from the extension portions 234 of the anvil buttress member 230. In particular, the teeth 226a of the snap features 226 cam against the ramped partitions 218 so that each snap feature 226 flexes radially outwardly into the opening 228 of the cap body 222 from the first recess 218a of the head body 212 to enable the anvil cap 220 to separate from the anvil head 210 as the anvil cap 220 moves from the approximated position to the unapproximated position. After camming over the ramped partitions 218, the teeth 226a of the snap features 226 snap or flexes radially inwardly into the second recess 218b of the head body 212 to maintain the anvil cap 220 secured to the anvil head 210. The separation of the cap body 222 and the head body 212 creates a space or gap “G” between the proximal surface of the cap body 222 and a distal surface of the head body 212 to free the extension portion 234 of the anvil buttress member 230 from between the anvil head 210 and the o-ring 215 so that the anvil buttress member 230 is secured to the tissue independent of the surgical stapling device 10.

[0042] As illustrated in FIG. 7, an embodiment of an anvil assembly is generally referred to as anvil assembly 500 and is substantially similar to anvil assembly 200 and thus, anvil assembly 500 is described herein only to the extent necessary to describe the differences in construction and operation of the anvil assembly 500. Anvil assembly 500 includes a circular anvil head 210, an o-ring 215, an anvil cap 220, a circular anvil buttress member 230, a crush ring member 240, and an anvil plate 250. Notably, anvil assembly 500 does not include ring assembly 260 and thus, when the circular knife 400 is advanced into the anvil assembly 500 during operation, the blade of the circular knife 400 directly engages the proximal surface of crush ring member 240 to drive the crush ring member 240 distally into engagement with the anvil cap 220. In particular, as noted above, the distal movement of the crush ring member 240 into engagement with the one or more engaging features 224 of the anvil cap 220 separates the proximal surface of the cap body 222 of the anvil cap 220 from the distal surface of the head body 212 of the anvil head 210 so that the o-ring 215 separates from the extension portions 234 of the anvil buttress member 230 to free the anvil buttress member 230.

[0043] Although a manually operated handle assembly is shown in FIG. 1, in any of the embodiments disclosed herein, the handle assembly can be powered by a motor and an external or internal power source. One or more drive shafts extending through the elongate body can drive the various functions (i.e., approximation, stapling and cutting) of the instrument.

[0044] In any of the embodiments disclosed herein, one or more of the crush ring 240 and parts of the ring assembly 260 could be eliminated. Furthermore, the circular knife may directly move the anvil cap 220 above to release the buttress member.

[0045] Persons skilled in the art will understand that the structures and methods specifically described herein and illustrated in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, 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, and that such modifications and variations are also intended to be included within the scope of the present disclosure. Indeed, any combination of any of the presently disclosed elements and features is within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not to be limited by what has been particularly shown and described.