Surgical stapling device and tool assembly with SLED-detecting mechanical lockout

Abstract

A surgical stapling device and tool assembly includes an anvil assembly with a stepped portion defining a first axial stop, and a cartridge assembly facing the anvil assembly and operably coupled to a drive assembly of the surgical stapling device. The cartridge assembly includes a plurality of staples disposed in a cartridge housing, and a knife assembly with a knife and a body having at least a first flange and a distal projection configured to engage a seat of an actuation sled.

Description

A0013159W001SURGICAL STAPLING DEVICE AND TOOL ASSEMBLY WITH SLED-DETECTING MECHANICAL LOCKOUT CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 760,756, filed February 20, 2025, the entire content of which is incorporated herein by reference.BACKGROUND

[0002] Surgical stapling devices configured for endoscopic use are commonly used during surgical procedures to minimize patient trauma and reduce patient recovery times. Typically, endoscopic stapling devices include a tool assembly and a drive assembly that is movable in relation to the tool assembly to actuate the tool assembly. The tool assembly includes an anvil and a cartridge assembly that are coupled to each other by a pivot member and movable in relation to each other between unclamped and clamped positions in response to movement of the drive assembly from a retracted position to an advanced position. The cartridge assembly includes a staple cartridge that includes a cartridge body that supports staples. A drive assembly may then actuate a sled through the cartridge that causes the staples to be ejected into clamped tissue. Once the tissue is stapled, or concurrently with the stapling, the tissue is cut via a knife of the stapler.SUMMARY

[0003] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0004] In one aspect, the disclosure relates to a surgical stapling device. The surgical stapling device includes an elongate shaft supporting a drive assembly, an anvil assembly comprising an inner surface with a stepped portion defining a first axial stop, and a cartridge assembly facing the anvil assembly and defining a longitudinal axis. The cartridge assembly is operably coupled to the drive assembly and includes a cartridge housing, a plurality of staples disposed in the cartridge housing and ejectable from the cartridge assembly into tissue for treatment, and a knife assembly.A0013159W001The knife assembly includes a knife, a body having a first flange and a distal projection, wherein the distal projection is configured to engage a seat of an actuation sled for moving the knife assembly radially out of alignment with the first axial stop, wherein the knife assembly is movable longitudinally by the drive assembly to define: a locked configuration, wherein the first flange is in registry with the first axial stop and proximally spaced therefrom, and an unlocked configuration, wherein the first flange is radially offset from the first axial stop for advancement through the cartridge housing.

[0005] In another aspect, the disclosure relates to a tool assembly for a surgical stapling device. The tool assembly includes an anvil assembly with an anvil channel and an axial stop position radially inward of the anvil channel and at a proximal end of the anvil channel, an actuation sled with a plurality of fins to push staples and a seat defining a ramped surface, and a knife assembly with a body, a flange coupled to the body, and a knife. The tool assembly further includes a distal projection extending distally from the body, wherein the distal projection is configured to engage the seat of the actuation sled to radially shift the flange to be aligned with the anvil channel rather than the axial stop.

[0006] In another aspect, the disclosure relates to a tool assembly for a surgical stapling device. The tool assembly includes an anvil assembly with an anvil channel and an axial stop positioned radially inward of the anvil channel and at a proximal end of the anvil channel, and a knife assembly. The knife assembly includes a body, a first flange coupled to a first radial end of the body, a second flange coupled to a second radial end of the body, a distal projection extending distally from the body, wherein the distal projection is configured to engage a seat of an actuation sled to radially shift the first flange to be aligned with the anvil channel rather than the axial stop, a knife positioned between the first flange and the distal projection, and a driving wall positioned on a distal side of the body and between the distal projection and the second flange.

[0007] It is to be understood that both the foregoing general description and the following Detailed Description are explanatory and are intended to provide further aspects and examples of the disclosure as claimed.BRIEF DESCRIPTION OF THE DRAWINGSA0013159W001

[0008] The following drawing figures, which form a part of this application, are illustrative of aspects of systems and methods described below and are not meant to limit the scope of the disclosure in any manner, which scope shall be based on the claims.

[0009] FIG. 1 is a perspective view of a surgical device in the form of a surgical stapler having a tool assembly in accordance with various aspects described herein.

[0010] FIG. 2 is a perspective view of the tool assembly of FIG. 1.

[0011] FIG. 3 is a partially exploded view of the tool assembly of FIG. 1 and illustrating a cartridge assembly and an anvil assembly in accordance with various aspects described herein.

[0012] FIG. 4 is a perspective view of a knife assembly in the cartridge assembly of FIG. 3 in accordance with various aspects described herein.

[0013] FIG. 5 is a perspective view of an actuation sled in the cartridge assembly of FIG. 3 in accordance with various aspects described herein.

[0014] FIG. 6 is a perspective view of a cartridge housing in the cartridge assembly of FIG. 3 in accordance with various aspects described herein.

[0015] FIG. 7 is a side cross-sectional view of the tool assembly of FIG. 1 and illustrating the knife assembly in a retracted position.

[0016] FIG. 8 is a perspective cross-sectional view of the tool assembly of FIG. 7 schematically illustrating the knife assembly in the retracted position.

[0017] FIG. 9 is another perspective cross-sectional view of the tool assembly of FIG. 7 illustrating the knife assembly engaging with the actuation sled.

[0018] FIG. 10 is a side cross-sectional view of the tool assembly, similar to FIG. 7, with the knife assembly in the unlocked configuration.

[0019] FIG. 11 is a partial cutaway view of the tool assembly of FIG. 7 schematically illustrating the knife assembly in the stop position and locked configuration.

[0020] FIG. 12 is a side cross-sectional view of the tool assembly of FIG. 7 illustrating the knife assembly in the stop position and locked configuration.

[0021] While examples of the disclosure are amenable to various modifications and alternative forms, specific aspects have been shown by way of example in the drawings and are described in detail below. The intention is not to limit the scope of the disclosure to the particular aspects described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure and the appended claims.A0013159W001DETAILED DESCRIPTION

[0022] Surgical staplers may be utilized for both tissue stapling and tissue cutting procedures. For instance, a surgical stapler may be used to initially clamp tissue for treatment, e.g., between an anvil and a cartridge. Once clamped, the tissue is stapled along one or more staple lines, which may be linear, circular, arced, or the like. Such a surgical stapler may also include a knife assembly within the cartridge, which is translated distally to cut and separate the stapled tissue along a cut line. The stapling and cutting processes may be performed as separate actions, e.g., by separate user actuations. The stapling and cutting processes may also be performed in response to a single user actuation. For instance, an actuation sled may be provided and concurrently translated with the knife assembly, wherein the tissue is stapled and cut by sequential action of the actuation sled ejecting the staples and the knife assembly encountering the stapled tissue. Such activation and performance of the stapling and cutting process is often referred to as “firing” the stapling device.

[0023] During assembly or manufacturing of the surgical stapler or cartridge, the actuation sled is incorporated. In some instances, however, the actuation sled may not be positioned correctly, may be omitted, or may accidently fall out of the cartridge prior to use. In such a case, it is beneficial to prevent undesired firing, e.g., advancement of the knife assembly, when the actuation sled is not present. Aspects of the disclosure provide for a surgical stapler and tool assembly with a knife body that is movable both longitudinally and radially within the tool assembly. When the actuation sled is not present, if the knife body is driven to move distally, the knife body is retained by one or more axial stops and prevented from advancing through the cartridge. When the actuation sled is present, the knife body engages with a seat on the actuation sled and moves radially outward when driven longitudinally, bringing the knife body out of alignment with the axial stops and releasing the knife body for advancement. In this manner, the surgical stapler may automatically detect a presence or absence of the actuation sled, and respectively release or lock the knife accordingly.

[0024] As may be used herein, the term “clinician” generally refers to medical personnel including doctors, nurses, surgeons, and support personnel. Additionally, the term “proximal” is used generally to refer to a portion of a surgical device that is closer to a clinician during use of the device in its customary fashion, while the term “distal” is used generally to refer to that portionA0013159W001of the device that is farther from the clinician during use of the device in its customary fashion. Further still, the term “advanced” or “advancing” will be used to refer to a component of a surgical device moving distally during use of the device in its customary fashion, while the term “retract” or “retracting” will refer to that portion of the device moving proximally during use.

[0025] Additionally, the term “radial” as may be used herein is defined with respect to a longitudinal axis, where “radially inward” refers to a direction toward the longitudinal axis, and “radially outward” refers to a direction away from the longitudinal axis. All directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description when the device in in an upright position and are not intended to limit the disclosure.

[0026] Turning to FIG. 1 , one example of a surgical device 1 is shown in the form of a surgical stapler 10 with a handle assembly 12, an elongate body or shaft 14, and a tool assembly 16. The handle assembly 12 may include a handgrip 18 and one or more actuation buttons 19. In the example shown, the handle assembly 12 supports a power supply, e.g., a single-use or rechargeable battery pack, or a wired power cable, for providing electrical power to operate components of the surgical stapler 10. In some implementations, the handle assembly 12 may include one or more actuators for manual operation of one or more components of the surgical stapler 10, e.g., a rotatable lever, a knob, or a handle trigger. The surgical stapler 10 may further include combinations of manually powered components and electrically powered components.

[0027] The handle assembly 12 may support a motor and control circuitry to drive the mechanisms of the surgical stapler 10. The actuation buttons 19 are operable to activate the motor to actuate various functions of the tool assembly 16, e.g., approximation of the tool assembly 16, and stapling and cutting of tissue. The elongate body 14 of the surgical stapler 10 defines a longitudinal axis 15 and includes a proximal portion 14A and a distal portion 14B. The proximal portion 14A of the elongate body 14 is coupled to the handle assembly 12, and the distal portion 14B of the elongate body 14 supports the tool assembly 16. In some examples, the tool assembly 16 is pivotably coupled to the distal portion 14B of the elongate body 14 to facilitate articulation of the tool assembly 16 in relation to the elongate body 14.

[0028] The tool assembly 16 includes an anvil assembly 20 and a cartridge assembly 22. The cartridge assembly 22 may be pivotably supported in relation to the anvil assembly 20 to facilitate movement of the tool assembly 16, such as a fully open position, an unclamped position, a closed position, or a clamped position in some non-limiting examples. The tool assembly 16 may alsoA0013159W001include a mounting assembly 24 for coupling the tool assembly 16 to the elongate body 14. The mounting assembly 24 may also support the tool assembly 16 for articulation, or for opening and closing the tool assembly 16.

[0029] With general reference to FIGS. 2-3, the tool assembly 16 is shown in further detail. The cartridge assembly 22 includes a cartridge housing 26 and a staple cartridge 28 disposed within the cartridge housing 26. The cartridge housing 26 includes side walls 30 and a bottom wall 32 defining a channel 34. In some examples, the staple cartridge 28 may be removably received within the cartridge housing 26 and is replaceable to facilitate reuse of the surgical stapler 10 after each firing of the surgical stapler 10. Additionally or alternatively, the entire tool assembly 16 may be removably attached to the shaft and replaced as a single unit after each firing.

[0030] In some examples, the anvil assembly 20 and the cartridge assembly 22 are coupled to the mounting assembly 24 by screws or pins 25. The mounting assembly 24 can be formed from mounting members 24A, 24B that are coupled together with rivets, screws, pins, adhesives, welding, or the like. In examples, the mounting assembly 24 is fixedly coupled to the anvil assembly 20 and pivotably supports the cartridge assembly 22.

[0031] In the example shown, the cartridge assembly 22 includes a cartridge body 38, an actuation sled 52, staples 42, pushers 44, and a staple guard 46. The cartridge body 38 defines a knife slot 48 and staple receiving pockets 50 that are positioned on each side of the knife slot 48. The staple receiving pockets 50 may be aligned in two or more rows on opposite sides of the knife slot 48. Corresponding longitudinal slots may be provided in the cartridge housing 26 and the staple guard 46 and in registry with the knife slot 48.

[0032] The cartridge body 38 may include one or more laterally extending protrusions 51 that are received within recesses 36 of the cartridge housing 26 to position the staple cartridge 28 therein. The staples 42 and the pushers 44 are received within the staple receiving pockets 50 of the cartridge body 38, and the staple guard 46 is secured to the bottom of the cartridge body 38 to retain the staples 42 and pushers 44 therein.

[0033] The actuation sled 52 is positioned within the cartridge housing 26 and is longitudinally movable from a sled retracted position to a sled advanced position. The actuation sled 52 includes angled fins that are positioned to sequentially engage the pushers 44 as the actuation sled 52 advances distally through the sled advanced position. Such sequential engagement provides forA0013159W001lifting the pushers 44 within the staple receiving pockets 50 and ejecting the staples 42 from the cartridge body 38.

[0034] A knife assembly 100 is also positioned within the cartridge housing 26 and includes a body 102 (e.g., a beam) and a knife 104. The knife assembly 100 is arranged proximally of the actuation sled 52 for engagement therewith. The knife assembly 100 is also movable longitudinally with the actuation sled 52 for co-advancement through the cartridge housing 26.

[0035] FIGS. 4-6 illustrate additional details of the knife assembly 100, the actuation sled 52, and the cartridge housing 26. In FIG. 4, the knife assembly 100 is shown having a first flange 105 and a second flange 106 for securing or guiding the body 102 within the cartridge housing 26. The flanges 105, 106 may be generally perpendicular to the body 102 that extends between the flanges. In some implementations, the body 102 can include a single flange. The body 102 also defines a recess for carrying the knife 104 as shown. The knife 104 may be formed by etching or machining the body 102. In some examples, the knife assembly 100 may be described as an I-beam with an integrated knife 104.

[0036] The body 102 additionally defines a distal projection 110 for engaging the actuation sled 52 (FIG. 3). As shown, the distal projection 110 terminates in a partially hooked portion 112. In some implementations, the distal projection 110 can also have a rounded, squared, or beveled geometric profile. For example, the hooked portion 112 may be formed as a partially downwardprojecting nose protrusion 112A.

[0037] In the example depicted, the distal projection 110 extends distally from the body 102. For instance, the distal projection 110 may extend along an extension axis 111 that is parallel to the longitudinal axis 15. The thickness of the distal projection 110 may be same or substantially the same as the body 102. The height (measured in the radial direction) of the distal projection 110 may be between about 10%-40% of the height of the body 102. The length of the distal projection 110 is measured along the extension axis 111 between the distal end of the body 102 (e.g., the distal vertical wall depicted below the distal projection 110) to the distal-most point of the distal projection 110. For instance, the length of the distal projection 110 may be considered the distance that the distal projection 110 extends in the distal direction from the body 102. The length of the distal projection 110 may be between 20-80% of the maximum length of the body 102.

[0038] The distal projection 110 may also extend from the body 102 at a position more central than the knife 104. In the example depicted, a center of the distal projection 110 is positionedA0013159W001closer to the longitudinal axis 15 than the knife 104. For instance, knife 104 is positioned between the distal projection 110 and the first flange 105. The length and position of the distal projection 110 is particularly configured such that the distal projection 110 interacts as intended with the seat 60 of the actuation sled 52, as discussed further herein.

[0039] The nose protrusion 112A may be described as extending at a protrusion angle (a) relative to the extension axis 111. For example, the nose protrusion 112A extends along a protrusion axis 113. The protrusion angle (a) referred to here is for the quadrant on the proximal side of the intersection of the extension axis 111 and the protrusion axis 113 and on the side from which the nose protrusion 112A protrudes. In the example depicted, the protrusion angle (a) is greater than 90 degrees, such that the nose protrusion 112A protrudes both distally and away from the first flange 105. In some examples, the protrusion angle (a) is between 95 degrees and 120 degrees.

[0040] The nose height (HN) is the radial height of the nose protrusion 112A measured in the radial direction from the wall of the distal projection 110 from which the nose protrusion 112A protrudes (e.g., the lower wall in the example depicted). The nose height (HN) is configured based in part, and in combination with the seat 60 of the actuation sled 52, to raise the first flange 105 to a position that unlocks the knife assembly 100 for firing, as discussed further herein. The nose height (HN) may between 10%-40% of the height of the distal projection 110 in some examples.

[0041] The knife assembly 100 also includes a driving wall 114 positioned on the distal side of the body 102. The driving wall 114 assists in driving the actuation sled 52 when the driving wall 114 contacts the actuation sled 52. The driving wall 114 may be a substantially flat and / or vertical wall (e.g., extending in the radial direction). The driving wall 114 is positioned on the opposite side of the distal projection 110 from the knife 104. For instance, the knife 104 is on one side of the distal projection 110 (in the radial direction) and the driving wall 114 is on the other side of the distal projection 110 (in the radial direction).

[0042] In FIG. 5, the actuation sled 52 is shown including a center projection 53, inner fins 54 spaced from the center projection 53, and outer fins 55 spaced from the inner fins 54. The center projection 53 may include an upward-extending wall disposed between the inner fins 54. The inner fins 54 and the outer fins 55 each include angled fin surfaces 56 as shown. While two inner fins 54 and two outer fins 55 are shown, any number of fins may be provided. Inter-fin surfaces 57 are disposed in between the inner and outer fins 54, 55, and between the inner fins 54 and the centerA0013159W001projection 53. As shown, the inter-fin surfaces 57 and are substantially flat surfaces extending from a distal end of actuation sled 52 to a proximal end of actuation sled 52.

[0043] In addition, the actuation sled 52 defines a seat 60 configured to receive the distal projection 110 (FIG. 4) of the knife assembly 100. The seat 60 is shown as a ramped surface 62 that the nose protrusion 112A of the hooked portion 112 may slide over and engage. The ramped surface 62 increases in height in the distal direction. The seat 60 extends between a proximal seat wall 64 and a distal seat wall 65. The distal seat wall 65 is also the proximal wall of the center projection 53. The proximal seat wall 64 and the distal seat wall 65 may be substantially vertical walls (e.g., extending in the radial direction perpendicular to the longitudinal axis). During firing, the pushers 44 (FIG. 3) slide up the angled fin surfaces 56 as actuation sled 52 advances distally.

[0044] In FIG. 6, a bottom perspective view of the cartridge housing 26 illustrates the bottom wall 32 and the knife slot 48. The bottom wall 32 includes a lower stepped portion 39 extending at least radially. The lower stepped portion 39 may be configured to engage the second flange 106 of the knife assembly 100. In the depicted example, the bottom wall 32 also includes a radial curvature that may also engage the knife assembly, such as by abutting or retaining engagement.

[0045] FIGS. 7-12 generally illustrate the knife assembly 100 during operation of the surgical stapler 10. In FIG. 7, a schematic view of the tool assembly 16 illustrates the knife assembly 100 and actuation sled 52 disposed within the cartridge housing 26. The cartridge housing 26 is illustrated in dashed line, and in a partial cutaway view, for visual clarity. The knife assembly 100 is longitudinally movable, such as by a drive assembly. The knife assembly 100 may be moved to a retracted position (shown in FIGS. 7-8), an advance position (shown in FIG. 10), and a stop position (shown in FIGS. 11-12). In the retracted position, the knife assembly 100 is positioned proximally from the actuation sled 52 (or where the actuation sled 52 should be properly positioned if the actuation sled 52 is missing). The advance position is where the distal projection 110 is fully engaged with the seat 60 of the actuation sled 52 (or the position where the distal projection 110 would be fully engaged with the actuation sled 52 if the actuation sled 52 is missing). The stop position is where the distal edge of the first flange 105 is at the same distal position as the axial stop 71. If the actuation sled 52 is properly incorporated and positioned, the knife assembly 100 shifts radially to an unlocked configuration and continue to be translated distally . If the actuation sled 52 is not properly incorporated, the knife assembly 100 does not shift and remains in a lockedA0013159W001configuration where the axial stop prevents further distal translation of the first flange 105 and therefore the knife assembly 100.

[0046] With reference to FIGS. 7-8, the anvil assembly 20 includes an inner surface with a stepped portion defining a first axial stop 71 that is positioned radially inward from an anvil channel 70 that receives the first flange 105 when an actuation sled 52 is properly installed and positioned in the surgical stapling device 10. In addition or alternatively, the lower stepped portion 39 of the cartridge housing 26 may define a second axial stop 72 that is positioned radially outward from a channel that receives the second flanges 106. When the knife assembly 100 is in the retracted position, the first flange 105 is in registry with (e.g., radially aligned with) the first axial stop 71 and proximally spaced therefrom. The second flange 106 is in registry with (e.g., radially aligned with) the second axial stop 72 and proximally spaced therefrom. The actuation sled 52 is arranged distally of the knife assembly 100.

[0047] As shown in FIG. 7, the ramped surface 62 of seat 60 of the actuation sled 52 increases in height in the distal direction between the proximal seat wall 64 and the distal seat wall 65. The ramped surface 62 extends along a ramp axis 61 that is at an elevated ramp angle (0) from the extension axis 111 (or longitudinal axis 15). In some examples, the ramp angle (0) is between 10-60 degrees. The ramp angle (0) is also selected or configured to properly shift the first flange 105 radially outward (e.g., vertically as shown) such that the first flange 105 is radially aligned with the anvil channel 70 rather than the axial stop 71. The radial (e.g., vertical) shift is thus a combination of the length of the ramped surface 62 (e.g., the longitudinal distance between the proximal seat wall 64 and the distal seat wall 65), the ramp angle (0), and the nose height (HN).

[0048] As also shown in FIG. 7, the anvil assembly 20 may also include a biasing element 74, such as spring. The biasing element 74 biases the first flange 105 radially inward (e.g., downwards as depicted in FIG. 7). The biasing element 74 may be positioned such that the biasing element 74 biases the first flange 105 inward in both the retracted position and the advance position. In other examples, such as the one depicted, the biasing element 74 is positioned to bias the first flange 105 inward in the advance position but not in the retracted position. By biasing the first flange 105 inward, the biasing element 74 prevents the first flange 105 from entering (or being aligned with) the anvil channel 70 when the actuation sled 52 is not present. For instance, without the biasing element 74, the first flange 105 may shift from movement of the surgical stapling device 10 (such as holding it upside down from the orientation depicted). In the example depicted, the biasingA0013159W001element 74 is in the form of a leaf spring that is connected to the anvil assembly 20 at a proximal end and a distal end. In some examples, the leaf spring may only be connected at one end. Other types of springs or configurations are also possible that bias the first flange 105 radially inward.

[0049] FIG. 9 illustrates the knife assembly 100 moving distally from the retracted position when the actuation sled 52 is present within the cartridge housing 26. The hooked portion 112 may engage the seat 60 of the actuation sled 52 by sliding distally along the ramped surface 62. For instance, the nose protrusion 112A is in contact with the ramped surface 62 as the distal projection 110 engages the seat 60 of the actuation sled 52. Such engagement leads to radial motion of the body 102 of the knife assembly 100 such that the first and second flanges 105, 106 become radially offset from the respective first and second axial stops 71, 72. For instance, the first flange 105 and the second flanges 106 shift radially from the locked configuration towards the unlocked configuration.

[0050] When the knife assembly 100 is in the advance position shown in FIG. 10, the knife assembly 100 is fully engaged with the actuation sled 52. For instance, the distal projection 110 has fully slid up on the ramped surface 62 of the seat 60 such that the distal-most surface of the distal projection 110 is in contact with the distal seat wall 65. At this point, the driving wall 114 is also in contact with the proximal seat wall 64 of the actuation sled 52 such that the knife assembly 100 can drive the actuation sled 52 distally. This distal movement of the knife assembly 100 to engage the actuation sled 52 may be caused during a clamping phase of the surgical stapling device 10 (e.g., when tissue is clamped between the cartridge and anvil). Thus, the mechanical detection of the actuation sled 52 and transition from the unlocked position may occur prior to a firing phase.

[0051] Once the distal projection 110 has slid far enough up the ramped surface 62, the knife assembly 100 is in the unlocked configuration such that the first flange 105 is positioned to enter the anvil channel 70. For instance, in the unlocked configuration, the first flange 105 is unaligned with, or radially offset from, the first axial stop 71. The second flange 106 is also unaligned with the second axial stop 72 as shown. The radial shift of the knife assembly 100 also causes the first flange 105 to compress the biasing element 74, thus allowing for the first flange 105 to remain in its radially shifted position that is aligned with the anvil channel 70 rather than the axial stop 71.

[0052] As the knife assembly 100 continues to move distally with the actuation sled 52, the first flange 105 enters the anvil channel 70 and avoids the axial stop 71. Thus, firing of the staples by the surgical stapling device 10 can continue as intended.A0013159W001

[0053] In FIGS. 11-12, the actuation sled 52 is not present in the cartridge housing 26 and the knife assembly 100 has reached the stop position. For instance, the actuation sled 52 may have been dislodged from the cartridge housing 26, such as during transport or assembly of the surgical stapling device 10. In an example where a drive assembly causes distal motion of the knife assembly 100 without the actuation sled 52 present, at least one of the first flange 105 or the second flange 106 remains in registry with (e.g., radially aligned with) the corresponding at least one of the first axial stop 71 or the second axial stop 72. For instance, because the ramped surface 62 does not raise the knife assembly 100, the knife assembly 100 remains in the locked configuration. Accordingly, the knife assembly 100 is retained in the stop position without advancing through the tool assembly 16, preventing undesired motion of the knife assembly 100. For example, as the distal projection 110 advances distally, the first flange 105 contacts the first axial stop 71 and / or the second flange 106 contacts the second axial stop 72.

[0054] During operation of the surgical stapling device 10, movement of the drive assembly 13 (FIG. 1) may advance the knife assembly 100 distally from the retracted position to engage the actuation sled 52. The knife assembly 100 and the actuation sled 52 remain engaged for continued advancement through the cartridge body 38 to continue firing of the stapling device 10. In an example where the actuation sled 52 is not present within the cartridge housing 26, the knife assembly 100 moves longitudinally from the retracted position to the stop position, preventing or locking further advancement of the knife assembly 100.

[0055] 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 of the disclosure. 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 disclosure. Also, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

[0056] Further, as used herein and in the claims, the phrase “at least one of element A, element B, or element C” is intended to convey any of: element A, element B, element C, elements A and B, elements A and C, elements B and C, and elements A, B, and C. In addition, one having skill in the art will understand the degree to which terms such as “about” or “substantially” convey inA0013159W001light of the measurements techniques utilized herein. To the extent such terms may not be clearly defined or understood by one having skill in the art, the terms “about” and “substantially” shall mean plus or minus ten percent or, if in relation to an angle, plus or minus ten degrees.

[0057] Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the appended claims. While various aspects have been described for purposes of this disclosure, various changes and modifications may be made which are well within the scope of the disclosure. Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the claims.

[0058] Further aspects of the disclosure are provided by the following clauses:

[0059] A surgical stapling device, comprising: an elongate shaft supporting a drive assembly; an anvil assembly comprising an inner surface with a stepped portion defining a first axial stop; and a cartridge assembly facing the anvil assembly and defining a longitudinal axis, the cartridge assembly operably coupled to the drive assembly and comprising: a cartridge housing; a plurality of staples disposed in the cartridge housing and ejectable from the cartridge assembly into tissue for treatment; and a knife assembly comprising: a knife; and a body having a first flange and a distal projection, wherein the distal projection is configured to engage a seat of an actuation sled for moving the knife assembly radially out of alignment with the first axial stop; wherein the knife assembly is movable longitudinally by the drive assembly to define: a locked configuration, wherein the first flange is in registry with the first axial stop and proximally spaced therefrom; and an unlocked configuration, wherein the first flange is radially offset from the first axial stop for advancement through the cartridge housing.

[0060] The surgical stapling device as described herein, further comprising the actuation sled disposed within the cartridge housing and defining the seat configured to engage the distal projection of the knife assembly.

[0061] The surgical stapling device as described herein, wherein the actuation sled comprises a ramped surface facing the distal projection and defining the seat.

[0062] The surgical stapling device as described herein, wherein the distal projection comprises a hooked portion, wherein distal motion of the hooked portion along the ramped surface causes the knife assembly to move radially outward into the unlocked configuration.A0013159W001

[0063] The surgical stapling device as described herein, wherein, when the knife assembly is in the unlocked configuration, the distal projection of the knife assembly is engaged with the seat of the actuation sled, and the first flange is unaligned with the first axial stop, for coadvancement of the actuation sled and the knife assembly through the cartridge housing.

[0064] The surgical stapling device as described herein, wherein, when the knife assembly does not engage the seat of the of the actuation sled, the first flange abuts the first axial stop during distal movement, which prevents advancement of the knife assembly through the cartridge housing.

[0065] The surgical stapling device as described herein, wherein the body of the knife assembly further comprises a second flange opposite the first flange, and wherein the cartridge housing comprises a second axial stop in registry with the second flange when the knife assembly is in the locked configuration.

[0066] The surgical stapling device as described herein, wherein the knife is positioned between the first flange and the distal projection.

[0067] A tool assembly, for a surgical stapling device, comprising: an anvil assembly comprising: an anvil channel; and an axial stop position radially inward of the anvil channel and at a proximal end of the anvil channel; an actuation sled comprising: a plurality of fins to push staples; and a seat defining a ramped surface; and a knife assembly comprising: a body; a flange coupled to the body; a knife; and a distal projection extending distally from the body, wherein the distal projection is configured to engage the seat of the actuation sled to radially shift the flange to be aligned with the anvil channel rather than the axial stop.

[0068] The tool assembly as described herein, wherein the knife is positioned between the distal projection and the flange.

[0069] The tool assembly as described herein, wherein the distal projection includes a hooked portion with a nose protrusion.

[0070] The tool assembly as described herein, wherein the nose protrusion extends in both a distal and radial direction from the distal projection.

[0071] The tool assembly as described herein, wherein the seat is defined on a proximal side of a center projection of the actuation sled.

[0072] The tool assembly as described herein, wherein the ramped surface is defined between a proximal seat wall and distal seat wall.A0013159W001

[0073] The tool assembly as described herein, wherein the knife assembly further comprising a driving wall positioned on a distal side of the body, wherein when the knife assembly is fully engaged with the actuation sled, the driving wall contacts the proximal seat wall of the actuation sled.

[0074] The tool assembly as described herein, further comprising a biasing element that biases the flange of the knife assembly toward radial alignment with the axial stop.

[0075] A tool assembly, for a surgical stapling device, comprising: an anvil assembly comprising: an anvil channel; and an axial stop positioned radially inward of the anvil channel and at a proximal end of the anvil channel; a knife assembly comprising: a body; a first flange coupled to a first radial end of the body; a second flange coupled to a second radial end of the body; a distal projection extending distally from the body, wherein the distal projection is configured to engage a seat of an actuation sled to radially shift the first flange to be aligned with the anvil channel rather than the axial stop; a knife positioned between the first flange and the distal projection; and a driving wall positioned on a distal side of the body and between the distal projection and the second flange.

[0076] The tool assembly as described herein, further comprising: the actuation sled comprising: a plurality of fins to push staples; and a center projection; and the seat, positioned on a proximal side of the center projection, comprising: a proximal seat wall; a distal seat wall; and a ramped surface defined between the proximal seat wall and the distal seat wall.

[0077] The tool assembly as described herein, wherein the distal projection includes a nose protrusion extending both distally and radially towards the second flange, wherein the nose protrusion slides along the ramped surface of the actuation sled to cause the radial shift of the first flange.

[0078] The tool assembly as described herein, wherein the anvil assembly further comprises a biasing element that biases the first flange of the knife assembly toward radial alignment with the axial stop.

[0079] The following examples are illustrative of the techniques described herein.

[0080] Example 1. A surgical stapling device, comprising: an elongate shaft supporting a drive assembly; an anvil assembly comprising an inner surface with a stepped portion defining a first axial stop; and a cartridge assembly facing the anvil assembly and defining a longitudinal axis, the cartridge assembly operably coupled to the drive assembly andA0013159W001comprising: a cartridge housing; a plurality of staples disposed in the cartridge housing and ejectable from the cartridge assembly into tissue for treatment; and a knife assembly comprising: a knife; and a body having a first flange and a distal projection, wherein the distal projection is configured to engage a seat of an actuation sled for moving the knife assembly radially out of alignment with the first axial stop; wherein the knife assembly is movable longitudinally by the drive assembly to define: a locked configuration, wherein the first flange is in registry with the first axial stop and proximally spaced therefrom; and an unlocked configuration, wherein the first flange is radially offset from the first axial stop for advancement through the cartridge housing.

[0081] Example 2. The surgical stapling device of example 1, further comprising the actuation sled disposed within the cartridge housing and defining the seat configured to engage the distal projection of the knife assembly.

[0082] Example 3. The surgical stapling device of example 2, wherein the actuation sled comprises a ramped surface facing the distal projection and defining the seat.

[0083] Example 4. The surgical stapling device of example 3, wherein the distal projection comprises a hooked portion, wherein distal motion of the hooked portion along the ramped surface causes the knife assembly to move radially outward into the unlocked configuration.

[0084] Example 5. The surgical stapling device of example 2, wherein, when the knife assembly is in the unlocked configuration, the distal projection of the knife assembly is engaged with the seat of the actuation sled, and the first flange is unaligned with the first axial stop, for co-advancement of the actuation sled and the knife assembly through the cartridge housing.

[0085] Example 6. The surgical stapling device of example 1, wherein, when the knife assembly does not engage the seat of the of the actuation sled, the first flange abuts the first axial stop during distal movement, which prevents advancement of the knife assembly through the cartridge housing.

[0086] Example 7. The surgical stapling device of example 1, wherein the body of the knife assembly further comprises a second flange opposite the first flange, and wherein the cartridge housing comprises a second axial stop in registry with the second flange when the knife assembly is in the locked configuration.

[0087] Example 8. The surgical stapling device of example 1, wherein the knife is positioned between the first flange and the distal projection.A0013159W001

[0088] Example 9. A tool assembly for a surgical stapling device, comprising: an anvil assembly comprising: an anvil channel; and an axial stop position radially inward of the anvil channel and at a proximal end of the anvil channel; an actuation sled comprising: a plurality of fins to push staples; and a seat defining a ramped surface; and a knife assembly comprising: a body; a flange coupled to the body; a knife; and a distal projection extending distally from the body, wherein the distal projection is configured to engage the seat of the actuation sled to radially shift the flange to be aligned with the anvil channel rather than the axial stop.

[0089] Example 10. The tool assembly of example 9, wherein the knife is positioned between the distal projection and the flange.

[0090] Example 11. The tool assembly of example 9, wherein the distal projection includes a hooked portion with a nose protrusion.

[0091] Example 12. The tool assembly of example 11, wherein the nose protrusion extends in both a distal and radial direction from the distal projection.

[0092] Example 13. The tool assembly of example 9, wherein the seat is defined on a proximal side of a center projection of the actuation sled.

[0093] Example 14. The tool assembly of example 13, wherein the ramped surface is defined between a proximal seat wall and distal seat wall.

[0094] Example 15. The tool assembly of example 14, wherein the knife assembly further comprising a driving wall positioned on a distal side of the body, wherein when the knife assembly is fully engaged with the actuation sled, the driving wall contacts the proximal seat wall of the actuation sled.

[0095] Example 16. The tool assembly of example 14, further comprising a biasing element that biases the flange of the knife assembly toward radial alignment with the axial stop.

[0096] Example 17. A tool assembly, for a surgical stapling device, comprising: an anvil assembly comprising: an anvil channel; and an axial stop positioned radially inward of the anvil channel and at a proximal end of the anvil channel; a knife assembly comprising: a body; a first flange coupled to a first radial end of the body; a second flange coupled to a second radial end of the body; a distal projection extending distally from the body, wherein the distal projection is configured to engage a seat of an actuation sled to radially shift the first flange to be aligned with the anvil channel rather than the axial stop; a knife positioned between the firstA0013159W001flange and the distal projection; and a driving wall positioned on a distal side of the body and between the distal projection and the second flange.

[0097] Example 18. The tool assembly of example 17, further comprising: the actuation sled comprising: a plurality of fins to push staples; and a center projection; and the seat, positioned on a proximal side of the center projection, comprising: a proximal seat wall; a distal seat wall; and a ramped surface defined between the proximal seat wall and the distal seat wall.

[0098] Example 19. The tool assembly of example 18, wherein the distal projection includes a nose protrusion extending both distally and radially towards the second flange, wherein the nose protrusion slides along the ramped surface of the actuation sled to cause the radial shift of the first flange.

[0099] Example 20. The tool assembly of example 17, wherein the anvil assembly further comprises a biasing element that biases the first flange of the knife assembly toward radial alignment with the axial stop.

Claims

A0013159W001CLAIMSWhat is claimed is:

1. A surgical stapling device (10), comprising:an elongate shaft (14) supporting a drive assembly (12);an anvil assembly (20) comprising an inner surface with a stepped portion defining a first axial stop (71); anda cartridge assembly (22) facing the anvil assembly (20) and defining a longitudinal axis (15), the cartridge assembly (22) operably coupled to the drive assembly (15) and comprising:a cartridge housing (26);a plurality of staples disposed in the cartridge housing (26) and ejectable from the cartridge assembly (22) into tissue for treatment; anda knife assembly (100) comprising:a knife (104); anda body (102) having a first flange (105) and a distal projection (110), wherein the distal projection (110) is configured to engage a seat (60) of an actuation sled (52) for moving the knife assembly (100) radially out of alignment with the first axial stop (71);wherein the knife assembly (100) is movable longitudinally by the drive assembly to define:a locked configuration, wherein the first flange (105) is in registry with the first axial stop (71) and proximally spaced therefrom; andan unlocked configuration, wherein the first flange (105) is radially offset from the first axial stop (71) for advancement through the cartridge housing (26).

2. The surgical stapling device (10) of claim 1, further comprising the actuation sled (52) disposed within the cartridge housing (26) and defining the seat (60) configured to engage the distal projection (110) of the knife assembly (100).A0013159W0013. The surgical stapling device (10) of claim 2, wherein the actuation sled (52) comprises a ramped surface (62) facing the distal projection (110) and defining the seat (60).

4. The surgical stapling device (10) of claim 3, wherein the distal projection (110) comprises a hooked portion (112), wherein distal motion of the hooked portion (112) along the ramped surface (62) causes the knife assembly (100) to move radially outward into the unlocked configuration.

5. The surgical stapling device (10) of claim 3, wherein the ramped surface (62) is defined between a proximal seat wall (64) and a distal seat wall (65).

6. The surgical stapling device (10) of claim 5, wherein the knife assembly (100) further comprises a driving wall (114) positioned on a distal side of the body (102), wherein when the knife assembly (100) is fully engaged with the actuation sled (52), the driving wall (114) contacts the proximal seat wall (64) of the actuation sled (52).

7. The surgical stapling device (10) of claim 2, wherein, when the knife assembly (100) is in the unlocked configuration, the distal projection (110) of the knife assembly (100) is engaged with the seat (60) of the actuation sled (52), and the first flange (105) is unaligned with the first axial stop (71), for co-advancement of the actuation sled (52) and the knife assembly (100) through the cartridge housing (26).

8. The surgical stapling device (10) of claim 1, wherein, when the knife assembly (100) does not engage the seat (60) of the of the actuation sled (52), the first flange (105) abuts the first axial stop (71) during distal movement, which prevents advancement of the knife assembly (100) through the cartridge housing (26).

9. The surgical stapling device (10) of claim 1, wherein the body (102) of the knife assembly (100) further comprises a second flange (106) opposite the first flange (105), and wherein the cartridge housing (26) comprises a second axial stop (72) in registry with the second flange (106) when the knife assembly (100) is in the locked configuration.A0013159W00110. The surgical stapling device (10) of claim 1, wherein the knife is positioned between the first flange (105) and the distal projection (110).

11. The surgical stapling device (10) of claim 1, wherein the anvil assembly 20 further comprises an anvil channel (70), with the first axial stop (71) positioned radially inward of the anvil channel (70) and at a proximal end of the anvil channel (70), wherein the distal projection (110) is further configured to radially shift the first flange (105) to be aligned with the anvil channel (70) rather than the first axial stop (71).

12. The surgical stapling device (10) of claim 11, wherein the knife (104) is positioned between the distal projection (110) and the first flange (105).

13. The surgical stapling device (10) of claim 11, wherein the seat (60) is defined on a proximal side of a center projection (53) of the actuation sled (52).

14. The surgical stapling device (10) of claim 11, further comprising a biasing element (74) that biases the flange (105) of the knife assembly (100) toward radial alignment with the axial stop (71).

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