This disclosure relates to surgical stapling devices having a clamping member for setting a tissue gap. More particularly, this disclosure relates to surgical stapling devices having a clamping member with an adjustable height for adjusting a tissue gap.
Surgical stapling devices for stapling tissue are well known in the art and typically include a handle assembly, a body portion extending distally from the handle assembly, and a tool assembly supported on a distal end of the body portion. The tool assembly includes first and second jaws which are movable in relation to each other between open and closed or approximated positions. The first jaw includes an anvil assembly and the second jaw supports a cartridge which houses a plurality of staples. The cartridge can also include a knife for severing tissue. In known devices, the stapling apparatus includes a clamping member that is engaged with the first and second jaws and is movable along the first and second jaws to set a tissue gap between the anvil assembly and the cartridge during a stapling procedure. However, the size of the tissue gap appropriate for a surgical procedure depends on the thickness of the tissue being treated which will change from procedure to procedure, and may change along the length of the first and second jaws.
A continuing need exists in the art for a surgical stapling device capable of changing the size of the tissue gap set by the clamping member to accommodate tissues of varying thickness.
A surgical stapling device includes a body portion, a tool assembly, and a drive assembly. The body portion defines a longitudinal axis and has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the body portion. The tool assembly includes an anvil assembly, a channel member pivotally supported relative to the anvil assembly, and a staple cartridge releasably disposed within the channel member. The tool assembly is movable from an open position to an approximated position. The staple cartridge supports a plurality of staples and includes an actuation sled that is movable between a retracted position and an advanced position to eject the plurality of staples from the staple cartridge. The drive assembly is movably supported within the tool assembly from a retracted position to an advanced position to move the tool assembly from the open position to the approximated position and to maintain the tool assembly in the approximated position. The drive assembly includes a clamping member and an adjustment member. The clamping member includes a first clamping surface configured to engage the anvil assembly. The adjustment member includes a second clamping surface configured to engage the staple cartridge. The first clamping surface is spaced from the second clamping surface to define a clamping height. The adjustment member is moveable relative to the clamping member between a first position and a second position to change the clamping height.
In certain aspects of the disclosure, the first position of the adjustment member is longitudinally spaced from the second position of the adjustment member. The first position of the adjustment member may be vertically spaced from the second position of the adjustment member. The channel member may define a slot and the adjustment member may include a flange. The flange may be receivable within the slot of the channel member. The anvil assembly may define a slot and the clamping member may include a pair of flanges. The pair of flanges of the clamping member may be receivable within the slot of the anvil assembly.
In some aspects of the disclosure, the drive assembly includes a drive beam and a securement mechanism for securing the adjustment member relative to the drive beam. The securement member may include an adjustment knob and a thread screw extending from the adjustment knob. Movement of the drive assembly beyond the partially advanced position may move the actuation sled from a retracted position to an advanced position to eject the plurality of staples from the staple cartridge. The clamping member may include an upper flange and a lower flange interconnected by a vertical strut. The clamping member may be positioned to engage the actuation sled to move the actuation sled distally within the staple cartridge as the drive assembly moves from the retracted position towards a fully advanced position. The adjustment member may include an inclined surface and the clamping member may include an inclined surface. Movement of the adjustment member relative to the clamping member may slide the inclined surfaces relative to each other.
A drive assembly for a surgical stapling assembly includes a clamping member, a drive beam extending from the clamping member, and an adjustment member. The clamping member includes an upper flange portion and a vertical strut. The upper flange includes a first clamping surface configured to engage an anvil assembly. The drive beam extends from the clamping member and is configured for operable engagement with an actuation mechanism. The adjustment member is disposed relative to the clamping member and includes a second clamping surface configured to engage a staple cartridge. The first clamping surface is spaced from the second clamping surface to define a clamping height. The adjustment member is moveable relative to the clamping member between a first position and a second position to change the clamping height.
In certain aspects of the disclosure, the upper flange portion is configured to be received within a slot of the anvil assembly. The adjustment member may include a flange portion configured to be received within a slot of a staple cartridge. The drive assembly may further include a securement mechanism for securing the drive beam relative to the adjustment mechanism. The securement mechanism may be a threaded screw. The first position of the adjustment member may be longitudinally spaced from the second position of the adjustment member. The first position of the adjustment member may be vertically spaced from the second position of the adjustment member.
Various aspects of the disclosure are described herein with reference to the drawings, wherein:
The disclosed surgical stapling device 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. However, it is to be understood that the disclosed aspects of the disclosure are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel.
The disclosed surgical stapling device includes a drive assembly having a dynamic clamping member that is configured with an adjustable clamp height for adjusting a maximum tissue gap between tissue contact surfaces of anvil and cartridge assemblies of the stapling device.
As will be described in further detail below, the surgical stapling device 10 includes an adjustment mechanism 128 that is engaged with a drive assembly 120 (
The loading unit 100 is substantially as described in U.S. Pat. No. 9,016,539 (“the '539 patent”). Accordingly, the components of the loading unit 100 which are common to that which is disclosed in the '539 patent will only be described herein to the extent necessary to fully disclose the aspects of the drive assembly 120 and its method of operation.
The anvil assembly 114 of the jaw assembly 106 of the tool assembly 104 defines a channel 151 (
The staple cartridge 116a of the jaw assembly 106 includes a cartridge body 156 supported in a cartridge holder 158, a plurality of staples “S”, and a staple firing assembly 160. The staple firing assembly 160 includes an actuation sled 162 (
The channel member 118 is pivotally secured to the anvil assembly 114, and includes an inner clamping surface 118a (
In certain aspects of the disclosure, the drive beam 124 and/or the adjustment beam 126 of the drive assembly 120 is formed from a plurality of stacked sheets that are formed of a resilient or flexible material, e.g., stainless steel.
The dynamic clamping member 122 of the drive assembly 120 includes an upper flange portion 132, a lower flange portion 134, and a vertical strut 136 interconnecting the upper flange portion 132 and the lower flange portion 134. The upper flange portion 132 is sized and dimensioned to be slidably received within the channel 151 (
The adjustment beam 126 of the drive assembly 120 extends along a length of the drive beam 124. A proximal portion 126a of the adjustment beam 126 defines an opening 127 for receiving the securement mechanism 128. As shown, the securement mechanism 128 includes the adjustment knob 128a and a threaded screw 128b, and the opening 127 is configured to securely receive the threaded screw 128b. Although shown as a threaded connection, it is envisioned that the adjustment beam 126 may be secured relative to the drive beam 124 in any suitable manner. The opening 127 in the adjustment beam 126 is positioned to align with any one of the openings 131 in the tab 130 of the drive beam 124.
An engagement portion 140 is formed on a distal end 126b of the adjustment beam 126 of the drive assembly 120. The engagement portion 140 of the adjustment beam 126 includes a pair of extensions 142 that are spaced apart from one another to form a slot 141 for receiving the vertical strut 136 of the dynamic clamping member 122. Each of the extensions 142 includes an adjustment flange 144 that is configured to be received within the channel 161 (
Although the clamp height “CH” is shown and described as having a fixed distance once the adjustment beam 126 is secured relative to the drive beam 124, it is envisioned that the adjustment beam 126 may be moved relative to the drive beam 124 during the stapling procedure, i.e., as the drive assembly 120 is advanced through the jaw assembly 106, to adjusted the clamping height “CH” as the drive assembly 120 is advanced. The adjustment of the clamping height “CH” may be manual or automatic. For example, in smart staplers, i.e., staplers with sensors, the sensors will sense the tissue thickness and change the tissue gap as the stapler is fired, and in non-smart staplers, a biasing member maintains a specific pressure on the tissue independent of the tissue gap height.
Although the adjustment mechanism shown and described above relates to powered surgical staplers, the aspects of the disclosure may be modified for use on manually actuated stapling devices.
Although shown and described as used with hand-held actuation mechanisms, it is envisioned that the aspects of the disclosure may be modified for use remotely, i.e., with robotic systems (not shown).
The drive assembly 220 includes a dynamic clamping assembly 222, a drive beam 224, and an adjustment beam 226 (
As shown in
The dynamic clamping assembly 322 includes a clamping member 323 and a lower flange member 334. The clamping member 323 includes an upper flange portion 332 and a vertical strut 336. The lower flange member 334 is supported within a slot 325 of in the vertical strut 336. More particularly, the lower flange member 334 is movable vertically within the slot 325 perpendicular to a longitudinal axis of the dynamic clamping assembly 322, as indicated by arrow “C” in
An adjustment member 326 (
A plug member 324 secures the spring member 328 within the cylindrical passage 237. Longitudinal movement of the plug member 324 relative to the vertical strut 336 increase and decrease the compressive force on the spring member 328. By reducing the biasing force provided by the spring member 328 to the adjustment member 326, the adjustment member 326 is able to move relative to the lower flange member 334. For example, the bias on the spring member 328 may be effected by a threaded rod (not shown) extending through the loading unit, e.g., loading unit 100 (
When the adjustment member 326 is in its distal-most position, as shown in
The dynamic clamping assembly 422 includes a clamping member 423 and a lower flange member 434. The clamping member 423 includes an upper flange portion 432 and a vertical strut 436. The lower flange member 434 is supported within a slot 425 of the vertical strut 436 and is movable vertically within the slot 425 perpendicular to a longitudinal axis of the dynamic clamping assembly 422, as indicated by arrow “G” in
An adjustment member 426 extends through a cylindrical passage 427 (
The adjustment member 426 includes an inclined surface 426a that is positioned to engage the lower flange member 434 depending on the longitudinal position of the adjustment member 426 relative to the clamping member 423. When the adjustment member 426 is in its distal-most position, as shown in
The dynamic clamping assembly 522 includes a clamping member 523 and a lower flange member 534. The clamping member 523 includes an upper flange portion 532 and a vertical strut 536. The lower flange member 534 is supported within a slot 525 of the vertical strut 536 and is movable vertically within the slot 525 perpendicular to a longitudinal axis of the dynamic clamping assembly 522. In this manner, a clamping height “CH” defined between a clamping surface 532a (
An adjustment member 526 extends through a cylindrical passage 527 in the vertical strut 536 and through the lower flange member 534. The adjustment member 526 includes an inclined surface 526a configured to engage the lower flange member 534 depending on the longitudinal position of the adjustment member 526 relative to the clamping member 523. The adjustment member 526 is moveable along a longitudinal axis of the dynamic clamping assembly 522 by a threaded adjustment shaft 528. By rotating the adjustment shaft 528, the adjustment member 526 moves relative to the lower flange member 534.
When the adjustment member 526 of the dynamic clamping assembly 522 is in its distal-most position, as shown in
The dynamic clamping assembly 622 includes a clamping member 623 and a lower flange member 634. The clamping member 623 includes an upper flange portion 632 and a vertical strut 636. The lower flange member 634 is supported within a slot 625 of the vertical strut 636 and is movable vertically within the slot 625 perpendicular to a longitudinal axis of the dynamic clamping assembly 622. In this manner, a clamping height “CH” defined between a clamping surface 632a (
An adjustment member 626 (
When the adjustment member 626 of the drive is in its distal-most position, as shown in
The dynamic clamping assembly 722 includes a clamping member 723 and a lower flange member 734. The clamping member 723 includes an upper flange portion 732 and a vertical strut 736. The lower flange member 734 is supported within a slot 725 of the vertical strut 736 and is movable vertically within the slot 725, i.e., perpendicular to a longitudinal axis of the dynamic clamping assembly 722. In this manner, a clamping height “CH” defined between a clamping surface 732a (
An adjustment member 726 extends through and from a cylindrical passage 727 in the vertical strut 736 and through the lower flange member 734. The adjustment member 726 includes a conical portion 726a that is configured to engage an inclined surface 734b of the lower flange member 734. Depending on the longitudinal position of the adjustment member 726 relative to the clamping member 723, the clamping height “CH” may be adjusted. The adjustment member 726 may be moveable along a longitudinal axis of the dynamic clamping assembly 722 by a threaded engagement (not shown) with the vertical strut 736 of the clamping member 723. When the adjustment member 726 is in its proximal-most position relative to the clamping member 723, as shown in
The dynamic clamping assembly 822 includes a clamping member 823 and a lower flange member 834. The clamping member 823 includes an upper flange portion 832 and a vertical strut 836. The lower flange member 834 is supported within a slot 825 of the vertical strut 836. More particularly, the lower flange member 834 is movable vertically within the slot 825, i.e., perpendicular to a longitudinal axis of the dynamic clamping assembly 822. In this manner, a clamping height “CH” defined between a clamping surface 832a (
An adjustment member 826 extends through and from a cylindrical passage 827 in the vertical strut 836 and through the lower flange member 834. The adjustment member 826 includes an inclined surface 826a that is configured to engage an inclined surface 834b of the lower flange member 834. Depending on the longitudinal position of the adjustment member 826 relative to the clamping member 823 the clamping height “CH” may be adjusted. The adjustment member 826 is moveable along a longitudinal axis of the dynamic clamping assembly 822 to adjust a clamping height “CH” of the dynamic clamping assembly 822.
When the adjustment member 826 is in its distal-most position, as shown in
The drive assembly 920 includes a dynamic clamping assembly 922 having a clamping member 923 and a lower flange member 934. The clamping member 923 includes an upper flange portion 932 and a vertical strut 936. The lower flange member 934 is received about and supported by the vertical strut 936 and is movable vertically relative to the vertical strut 936, i.e., perpendicular to a longitudinal axis of the clamping member 922. In this manner, a clamping height “CH” defined between a clamping surface 932a (
An adjustment member 926 is supported within a cylindrical recess 925 defined by the vertical strut 936 and the lower flange member 934. The adjustment member 926 includes a cam member 926a. Depending on the rotational orientation of the adjustment member 926 relative to the clamping member 923, i.e., the position of the cam member 926a relative to the clamping member 923, the clamping height “CH” may be adjusted. The adjustment member 926 is rotatable about its central axis to adjust a clamping height “CH” of the dynamic clamping assembly 922.
When the adjustment member 926 is oriented with the cam member 926a in a six o'clock position, as shown in
It is envisioned that the orientation of the cam member 926a may be adjusted by moving an adjustment beam 928a of the drive assembly 920 relative to a drive beam 928 of the drive assembly 920. This may include a slotted, geared, or ratcheted arrangement, or other suitable configuration.
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 aspects. It is envisioned that the elements and features illustrated or described in connection with the exemplary aspects may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
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