Replaceable shaft assembly for surgical stapler

Abstract

To provide a surgical stapler that increases reliability of clamped tissue without complex mechanisms.SOLUTION: A surgical stapling system may include a reload shaft. The shaft may include an elongate tubular member, and the tubular member may have a jaw assembly at a distal end thereof and a coupling collar at a proximal end thereof. A shaft assembly may also include an articulation joint coupling the jaw assembly to the distal end. A drive member and an articulation member extend within a tubular body of the shaft from the proximal end to the distal end. A firing member is connected to a distal end of a drive member such that advancement of the drive member advances the firing member to close the jaw assembly and fire staples from a reload part positioned in the jaw assembly. The shaft assembly may further include a lockout mechanism to prevent a firing operation on a previously fired reload part or not fired reload part.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application generally relates to surgical occlusion devices, particularly surgical staplers.

[0002] 〔Description of Related Application〕 This application is a claim of priority application of U.S. Patent Provisional Application No. 62 / 321,618, filed on April 12, 2016, currently pending (Title of Invention: RELOAD SHAFT ASSEMBLY FOR SURGICAL STAPLER). This U.S. Patent Provisional Application is hereby incorporated by reference in its entirety and made a part of this specification.

Background Art

[0003] Surgical staplers are used to approach or clamp tissue and staple the clamped tissue together. Thus, surgical staplers have a mechanism that positions and captures the tissue properly and drives staples into the tissue. As a result, this gives rise to, for example, a number of triggers and handles in association with complex mechanisms to enable proper stapling of the clamped tissue. These complex mechanisms increase the manufacturing burden for surgical staplers and may create potential sources of device failure and confusion for the user. Thus, reliable stapling of clamped tissue without complex mechanisms is desired.

Summary of the Invention

[0004] In a particular embodiment, a surgical stapler is provided. The surgical stapler has an elongated shaft, a jaw assembly, and a handle assembly. The elongated shaft has a proximal end and a distal end. The elongated shaft has a longitudinal axis between the proximal and distal ends. The jaw assembly is positioned at the distal end of the elongated shaft. The jaw assembly includes a first jaw, a second jaw, and a plurality of staples. The jaw assembly is selectively positionable in one of a closed configuration, an open configuration, and a firing configuration. The handle assembly is positioned at the proximal end of the elongated shaft.

[0005] In a particular embodiment, an elongated shaft has a jaw assembly located at its distal end and coupled at an articulated joint. The articulated joint allows the jaw assembly to articulate within a range of motion. The jaw assembly articulates due to the translation of the articulated member passing through the elongated shaft. The elongated shaft further has a drive member passing through the elongated shaft. The drive member has a flexible segment passing through the articulated joint. A launch member is coupled to the distal end of the drive member.

[0006] In a particular embodiment, the jaw assembly has a replaceable support and an anvil rotatably coupled to the replaceable support at the distal end of an elongated shaft. A launch member having an I-beam configuration is positioned within the jaw assembly. The jaw assembly may further include a lockout mechanism that prevents the launch member from being advanced if a non-launching replaceable is not positioned within the jaw assembly.

[0007] In various embodiments, the shaft coupler is preferably positioned at the proximal end of the shaft. The shaft coupler is preferably configured to engage with a coupler provided on the handle assembly within a plug-in coupling. The plug-in coupling simultaneously connects the articulating member, the driving member, and the elongated shaft. The shaft coupler may further include a shaft identification mechanism. The coupler may further include a lock-in mechanism that holds the shaft assembly connected to the handle assembly.

[0008] In various embodiments, a replacement part assembly for a surgical staple fastening system is provided. The replacement part assembly includes an elongated shaft, a jaw assembly, a launching member, an operating beam, and a replacement part lockout mechanism. The elongated shaft has a proximal end and a distal end. The elongated shaft has a defined longitudinal axis extending between the proximal and distal ends. The jaw assembly is positioned at the distal end of the elongated shaft. The jaw assembly includes a first jaw and a second jaw. The first jaw has a replacement part support configured to receive a staple replacement part. The second jaw is rotatably coupled to the first jaw. The second jaw has an anvil surface. The launching member is longitudinally slidable within the jaw assembly. The operating beam is longitudinally slidable within the elongated shaft. The operating beam has a proximal end and a distal end. The distal end of the operating beam is coupled to the launching member. The replacement part lockout mechanism includes a lockout lever that is rotatably coupled to the replacement part support and is rotatable between a locked position that prevents distal movement of the working beam relative to the elongated shaft and an unlocked position that allows distal movement of the working beam relative to the elongated shaft.

[0009] In various embodiments, a replacement assembly for a surgical stapling system is provided. The replacement assembly includes an elongated shaft, a jaw assembly, an operating beam, and a shaft coupler. The elongated shaft has a proximal end and a distal end and defines a longitudinal axis extending between the proximal and distal ends. The jaw assembly is positioned at the distal end of the elongated shaft. The jaw assembly includes a first jaw and a second jaw. The first jaw has a replacement support configured to receive a staple replacement. The second jaw is rotatably coupled to the first jaw. The second jaw has an anvil surface. The operating beam is longitudinally slidable within the elongated shaft. The operating beam has a proximal end and a distal end. The distal end of the operating beam is coupled to the jaw assembly. The shaft coupler is positioned at the proximal end of the elongated shaft. The shaft coupler has a locking member positioned within the shaft coupler. The locking member can be advanced radially outward by the distal movement of the proximal end of the operating beam.

[0010] In various embodiments, a replacement assembly for a surgical stapling system is provided. The replacement assembly includes an elongated shaft, a jaw assembly, an operating beam, and a shaft coupler. The elongated shaft has a proximal end and a distal end and defines a longitudinal axis extending between the proximal and distal ends. The jaw assembly is positioned at the distal end of the elongated shaft. The jaw assembly includes a first jaw and a second jaw. The first jaw has a replacement support configured to receive a staple replacement. The second jaw is rotatably coupled to the first jaw. The second jaw has an anvil surface. The operating beam is longitudinally slidable within the elongated shaft. The operating beam has a proximal end and a distal end. The distal end of the operating beam is coupled to the jaw assembly. The shaft coupler is positioned at the proximal end of the elongated shaft. The shaft handle is configured to be detachably coupled to the handle assembly. The shaft coupler has a lockout mechanism positioned within the shaft coupler. The lockout mechanism includes a lock ring and a lockout member. The lock ring is rotatable about its longitudinal axis. The lockout member is able to advance radially outward by the rotation of the lock ring.

[0011] In various embodiments, a replacement part assembly for a surgical staple fastening system is provided. The replacement part assembly includes an elongated shaft, a jaw assembly, an actuation beam, an articulation link, a support link, and an articulation latch mechanism. The elongated shaft has a proximal end and a distal end and defines a longitudinal axis extending between the proximal and distal ends. The jaw assembly is articulately coupled to the elongated shaft at the distal end of the elongated shaft. The jaw assembly includes a first jaw and a second jaw. The first jaw has a replacement part support configured to receive a staple replacement part. The second jaw is rotatably coupled to the first jaw. The second jaw has an anvil surface. The actuation beam is longitudinally slidable within the elongated shaft to actuate the jaw assembly. The actuation beam has a proximal end and a distal end. The articulation link is longitudinally slidable within the elongated shaft to articulate the jaw assembly relative to the elongated shaft. The articular movement link has a proximal end positioned adjacent to the proximal end of an elongated shaft and a distal end rotatably coupled to a jaw assembly. The support link is longitudinally slidable within the elongated shaft. The support link has a proximal end that extends longitudinally to the distal end rotatably coupled to the jaw assembly. The articular movement latch mechanism is positioned within the elongated shaft between the proximal and distal ends. The articular movement latch mechanism includes a latch release configuration in which the articular movement link and support link are slidable within the elongated shaft, and a latch configuration in which the actuating latch mechanism engages with the articular movement link and support link to prevent longitudinal sliding of the articular movement link and support link. [Brief explanation of the drawing]

[0012] [Figure 1] This is a perspective view of one embodiment of a surgical stapling system with the jaws in an open position. [Figure 2A] Figure 1 is a perspective view of several embodiments of a shaft assembly for a surgical stapling system. [Figure 2B]Figure 1 is a perspective view of several embodiments of a jaw assembly for a surgical stapling system. [Figure 3] Figure 1 is a perspective view of the jaw assembly located at the distal end of the shaft assembly for the surgical stapling system. [Figure 4] Figure 3 is a perspective view of the jaw assembly with a staple replacement section. [Figure 5] Figure 3 is a perspective view of the jaw assembly, showing the staple replacement section inserted. [Figure 6A] Figure 3 is a plan view of the anvil of the jaw assembly. [Figure 6B] Figure 3 is a plan view of the anvil plate for the jaw assembly. [Figure 7] Figure 3 is a perspective view of the disassembled and assembled anvil of the jaw assembly. [Figure 8] This is a perspective view of the upper jaw of the jaw assembly shown in Figure 3, in its initial and molded state. [Figure 9] Figure 3 is a perspective view of the anvil surface of the jaw assembly. [Figure 10] Figure 9 is a schematic diagram of the staple recess provided on the anvil surface. [Figure 11A] Figure 3 is a perspective view of the anvil of the jaw assembly. [Figure 11B] Figure 3 is a plan view of the anvil of the jaw assembly. [Figure 12] Figure 3 is a perspective view of the replacement support for the jaw assembly, showing the replacement part partially inserted. [Figure 13] Figure 3 is a perspective view of the replacement support for the jaw assembly, showing the state in which the replacement part is inserted. [Figure 14] Figure 3 is a side view of the closed beam of the jaw assembly. [Figure 15] Figure 14 is a front view of a partially cut-off closed beam, showing its flange positioned within the channel provided in the anvil of the jaw assembly shown in Figure 3. [Figure 16]It is an exploded perspective view of a replacement part used in the staple system of FIG. 1. [Figure 17] It is a perspective view from above of a replacement part used in the staple system of FIG. 1. [Figure 18] It is a perspective view from below of a replacement part used in the staple system of FIG. 1. [Figure 19] It is an exploded perspective view from below of a replacement part used in the staple system of FIG. 1. [Figure 20] It is a perspective view of a replacement part used in the staple system of FIG. 1. [Figure 21] It is a detailed plan view of a replacement part used in the staple system of FIG. 1. [Figure 22] It is a perspective view of a staple pusher for the replacement part of FIG. 16. [Figure 23] It is a perspective view of the staple pusher of the replacement part of FIG. 16. [Figure 24] It is a perspective view of a replacement part used in the staple system of FIG. 1. [Figure 25] It is a partial cutaway view of the Joe assembly of FIG. 3 in the closed form. [Figure 26] It is a perspective view of the replacement part of FIG. 16. [Figure 27] It is a perspective view of the Joe assembly of FIG. 3 in the closed form, showing the state where the replacement part is inserted. [Figure 28] It is an appreciation view of the Joe assembly of FIG. 3, showing the state where the replacement part is positioned for insertion. [Figure 29] It is a perspective view of the Joe assembly of FIG. 3, showing the state where the replacement part is inserted. [Figure 30] It is a plan view of the replacement part of FIG. 16. [Figure 31] It is a side view of the Joe assembly of FIG. 3, showing the state where the replacement part is inserted. [Figure 32A] It is a perspective view of the replacement part lockout mechanism of the shaft assembly. [Figure 32B] It is a side view of the replacement part lockout mechanism of the shaft assembly. [Figure 33] This is a side view of the lockout mechanism of the replacement part of the shaft assembly in the locked configuration. [Figure 34] This is a side view of the lockout mechanism of the replacement part of the shaft assembly in the unlocked position. [Figure 35] Figure 3 is a perspective view of the distal end of the elongated shaft at the joint connecting point with the jaw assembly. [Figure 36] This is a partially resected perspective view of one embodiment of a joint movement mechanism at the distal end of a long, slender shaft. [Figure 37] This is a partially resected perspective view of one embodiment of a joint movement mechanism at the distal end of a long, slender shaft. [Figure 38A] Figure 36 is a partially resected plan view of the articular joint in its position after joint movement. [Figure 38B] Figure 36 is a partially resected plan view of the articular joint in a position after another joint movement. [Figure 39] This is a partial resected perspective view of another embodiment of a joint movement mechanism at the distal end of an elongated shaft. [Figure 40] This is a partially resected perspective view of the embodiment of the articular joint shown in Figure 39, at the distal end of the elongated shaft. [Figure 41] Figure 39 is a partially resected plan view of the joint movement mechanism in its position after joint movement. [Figure 42] Figure 39 is a partially resected plan view of the articular joint in a position after another joint movement. [Figure 43] This is a partially resected plan view of the articular joint shown in Figure 39, located at the latching position. [Figure 44] Figure 1 is a side view of the proximal end of a shaft assembly positioned adjacent to a handle assembly for a stapler system. [Figure 45A] Figure 1 is a perspective view of the connection or coupling at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 45B] Figure 1 is a perspective view of the connection or coupling at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 45C] Figure 1 is a perspective view of the connection or coupling at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 45D] Figure 1 is a perspective view of the connection or coupling at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 46] Figure 1 is a disassembled and assembled perspective view of the proximal end of the shaft assembly of the stapler system. [Figure 47] Figure 1 is a cutaway side view of the proximal end of a shaft assembly positioned adjacent to the handle assembly for the stapler system. [Figure 48A] Figure 1 is a perspective view of the connection point between the proximal end of the shaft assembly and the handle assembly within the stapler system. [Figure 48B] Figure 1 is a perspective view of the connection point between the proximal end of the shaft assembly and the handle assembly within the stapler system. [Figure 49A] Figure 1 is a partial excision perspective view of the connection point at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 49B] Figure 1 is a partial excision perspective view of the connection point at the proximal end of the shaft assembly to the handle assembly within the stapler system. [Figure 50] Figure 1 is a perspective view showing a partial resection of the proximal end of the shaft assembly within the stapler system. [Figure 51] Figure 1 is a perspective view showing a partial resection of the proximal end of the shaft assembly within the stapler system. [Figure 52] Figure 1 is a disassembled and assembled perspective view of the proximal end of the shaft assembly within the stapler system. [Modes for carrying out the invention]

[0013] Referring to Figure 1, one embodiment of a surgical stapling system is shown. The surgical stapler 10 in the illustrated embodiment has an elongated shaft 20, a jaw assembly 30, and a handle assembly 40. Figure 1 shows the surgical stapler 10 with the jaw assembly 30 in the open position. It is preferable that the staple replacement section 50 is positioned within the jaw assembly. The illustrated surgical stapling system is shown with an electric handle, but it is envisioned that the elongated shaft 20 and jaw assembly 30 can be interchangeably used in a stapling system that includes a mechanical stapler handle. For example, various embodiments of the elongated shaft assembly 20 and jaw assembly 30 described herein are intended to be interchangeable with either the powered handle assembly described in U.S. Patent Application No. 15 / 486,008, filed April 12, 2017, currently pending (Title: SURGICAL STAPLER HAVING A POWERED HANDLE), or the mechanical manual handle assembly described in U.S. Patent Application No. 15 / 485,620, filed April 12, 2017, currently pending (Title: SURGICAL STAPLER HAVING ARTICULATION MECHANISM). These patent applications are incorporated herein by reference, and their entire contents are incorporated herein by reference.

[0014] Continuing to refer to Figure 1, the surgical stapler 10 as an illustrated embodiment is preferably sized and shaped for use in laparoscopic surgical procedures. For example, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be introduced into the surgical field through an access port or trocar cannula. In some embodiments, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be inserted through a trocar cannula with a relatively small working channel diameter, e.g., less than 8 mm. In other embodiments, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be inserted through a trocar cannula with a large working channel diameter, e.g., 10 mm, 11 mm, 12 mm, or 15 mm. In other embodiments, it is conceivable that certain aspects of the surgical stapler described herein can be incorporated into a surgical stapling device usable in open surgical procedures.

[0015] Continuing to refer to Figure 1, as shown in the figure, the elongated shaft 20 has a tubular member as a whole. The elongated shaft 20 extends from the proximal end to the distal end. The elongated shaft 20 defines the longitudinal central axis L of the surgical stapler 10 that extends between the proximal and distal ends.

[0016] Referring to Figure 2A, the stapling system is envisioned to include an elongated shaft of a desired length. The features of the jaw assembly and handle joint described herein are preferably substantially similar for each of these shaft assemblies, although the shaft body is preferably scale-changeable. For example, the stapling system may include a relatively short elongated shaft 20′, a medium-length elongated shaft 20, or a relatively long elongated shaft 20″. Each of these shaft lengths may have specific applicability for a subset of patients or procedures. For example, a short elongated shaft 20′ may be useful in pediatric procedures, and a long elongated shaft 20″ may be useful in obesity procedures.

[0017] Referring to Figure 2B, it is assumed that the stapling system may include jaw assemblies of a desired length. The features of the jaw assemblies and handle joints described herein are preferably substantially similar for each of these shaft assemblies, although the shaft body is preferably scale-changeable. For example, the stapling system may include a relatively short elongated shaft 30′, a medium-length elongated shaft 30, or a relatively long elongated shaft 30″. Each of these shaft lengths may have specific availability for a subset of patients or procedures. In a particular embodiment, the jaw assembly is assumed to have a length of approximately 45 mm. In another embodiment, the jaw assembly is assumed to have a length of approximately 60 mm.

[0018] Continuing to refer to Figure 1, in the illustrated embodiment, the jaw assembly 30 is coupled to the elongated shaft 20 at its distal end 24. The jaw assembly includes a first jaw 32 and a second jaw 34 rotatably coupled to the first jaw 32. In the illustrated embodiment, the jaw assembly 30 is articulated relative to the elongated shaft 20.

[0019] Continuing to refer to Figure 1, in the illustrated embodiment, the jaw assembly 30 can be operated from an open position (Figure 1) to a closed position, i.e., a stapled position, by an actuating member or beam that is slidable longitudinally within an elongated shaft. In the initial position, the beam is preferably positioned at the distal end 24 of the elongated shaft 20. With the beam in the initial position, the second jaw 34 is rotated away from the first jaw 32 so that the jaw assembly 30 is in the open position. The actuating beam engages with the second jaw 34 when the actuating member or beam is translated distally along the longitudinal axis L. When the actuating beam is translated distally from the initial position over a first distance, the jaw assembly can be operated from the open position to the closed position. With the jaw assembly 30 in the closed position, when the actuating beam is returned proximally over a first distance, the jaw assembly 30 can be returned to the open position. The distal end of the working beam can advance a staple slider configured to deploy staples from the first jaw 32, and as a result, when the working beam is translated further distally beyond the first distance, multiple staples will be deployed from the replacement section within the first jaw 32.

[0020] Continuing to refer to Figure 1, in the illustrated embodiment, the handle assembly is coupled to the elongated shaft 20 at its proximal end. As shown, the handle assembly 40 has a pistol grip configuration with a housing comprising a stationary handle 42 and a movable handle 44 or trigger rotatably coupled to the stationary handle 42. In other embodiments, it is conceivable that a surgical stapler instrument including the aspects described herein may have a handle assembly in other configurations, such as a scissor grip configuration or an in-line configuration. As will be described in more detail below, the handle assembly 40 houses an actuation mechanism configured to selectively advance the actuation shaft in response to the movement of the movable handle 44.

[0021] Referring to Figure 3, one embodiment of a jaw assembly located at the distal end of the shaft assembly 20 is shown. In the illustrated embodiment, the jaw assembly includes a replacement support 210 articulated to the distal end of the shaft assembly 20 at an articulated joint 230. An anvil 220 is rotatably coupled to the replacement support 210, which constitutes the upper jaw of the jaw assembly 30. A launching member 240 slides within the jaw assembly to initially close the anvil 220 against the replacement support 210, and then launch a staple from the replacement. In some embodiments, the launching member 240 has an I-beam configuration in which a vertical beam 242 straddles two horizontally protruding flanges 244, 246. Advantageously, in the I-beam configuration, one horizontal flange 244 can fit into a channel provided in the anvil 220, and the other flange 246 can fit into a channel provided in the replacement part or replacement part support, thereby closing the jaw assembly and maintaining a desired closing distance of the jaw assembly when the launching member is then advanced distally. In some embodiments, the launching member 240 may have a cutting edge 248 formed on or attached to the vertical beam of the I-beam configuration. This cutting edge can separate tissue when the staple is being launched, thereby forming staple lines on both sides of the separated tissue.

[0022] Referring to Figures 4 and 5, the replacement part support 210 is preferably sized to receive and hold the disposable replacement part 50. The replacement part 50 can be lowered and moved proximally into the replacement part support 210, until the fitting feature provided on the replacement part engages with the corresponding feature provided on the replacement part support 210.

[0023] Referring to Figures 6A, 6B, 7, and 8, various views of the anvil 220 of the jaw assembly 30 are shown. In a particular embodiment, the anvil 220 has an anvil plate 222 coupled to a top surface 224. The anvil plate preferably has a longitudinal channel 225 formed in the anvil plate into which the horizontal flange of the launching member fits, and a longitudinal slot 227 formed through the longitudinal channel 225 into which the vertical beam of the launching member fits. The top surface 224 is preferably made of a sheet of material which will later be molded to be positioned on top of the anvil plate. (Figure 8 shows a flattened sheet 2224' and a molded top surface 224). Advantageously, the addition of the top surface 224 to the anvil plate 222 increases the strength of the anvil of the jaw assembly.

[0024] Referring to Figures 9 and 10, various views of the anvil plate 222 of the jaw assembly 30 are shown. Multiple staple forming pockets 223 are provided on the anvil plate. In the illustrated embodiment, the staple forming pockets 223 are positioned in the form of two arrays of three rows each, and these arrays are positioned on each side of the slot for the firing member. Thus, the stapler can form three linear rows of staples in two sets, these sets separated from each other by a divided structure. In other embodiments, it is conceivable that the anvil may have staple forming pockets configured to form other numbers and forms of staples. The staple forming pockets have a tapered shape, with a relatively large staple introduction side narrowing to a relatively small staple forming side. Advantageously, this tapered shape can guide the staples to complete the forming and reduce the occurrence of poorly formed staples. Adjacent staple rows are preferably offset from each other in the longitudinal direction, so that all the relatively wide entry sides of the rows are offset from each other in a way that reduces the overall width of the set of staple rows.

[0025] Referring to Figures 11A and 11B, in a particular embodiment of the anvil 220, the top surface 224 is preferably joined to the anvil plate 222 by a welding operation along the weld line 226. Advantageously, this closed anvil formed by the welding operation covers the channel for the launch member.

[0026] Referring to Figures 12 and 13, the method of inserting the replacement part 50 into the replacement part support 210 is shown. The replacement part support preferably has a proximal jaw tab 212 that protrudes radially inward from the side wall of the replacement part support 210 adjacent to its proximal end. The replacement part preferably has a relatively short tapered proximal deck 510 that is positioned below the proximal jaw tab and sized to be held by them. Furthermore, the replacement part 50 preferably has a retaining tab 512 that protrudes laterally outward adjacent to its distal end. The replacement part support 210 preferably has a corresponding pair of retaining recesses 214, which are sized and shaped to receive the retaining tabs when the replacement part is positioned within the replacement part support.

[0027] Referring to Figures 14 and 15, one embodiment of a launch member 240 having an I-beam configuration is shown. In the illustrated embodiment, the launch member has a vertical beam 242 with a cutting edge formed at its leading edge. The cutting edge consists of a curved cutting edge 248. The trailing edge of the launch member 240 has a drive member interface 245, such as a notch or projection, which allows the launch member to be securely coupled to a drive member through an elongated shaft. The trailing edge of the launch member 240 may further have a lockout interface 247, such as a “tail” extending to the proximal side, which allows the replacement lockout to be positioned in an unlocked state when the launch member is in a proximal position. The launch member further has an upper horizontal flange 244 configured to fit into a channel 225 of an anvil and a lower horizontal flange 246 configured to engage with a replacement or replacement support. As shown in Figure 15, the launch member has an overall I-beam configuration, but in some embodiments, the horizontal flange may be curved or tapered to match the shape of the channel 225 of the anvil. In some embodiments, the launch member 240 may be further configured to reduce friction during the launch sequence by, for example, surface finishing, addition of a film lubricant, or application of a low-friction surface to the launch member, channel, or both.

[0028] Referring to Figures 16 to 19, one embodiment of a replacement section 50 used in a staple fastening system is shown. The replacement section 50 has a plurality of staples 520, which are positioned in a plurality of corresponding staple pockets 532 formed in a cartridge 530. The staple pockets 532 are arranged in two sets of three rows each, and each set is separated only by a slot formed through the cartridge 530. The staples 520 are fitted into a plurality of staple pushers 540 located below the staple pockets 532. A slider 550 with a ramp or inclined path 552 and a lockout rail 554 corresponding to each row of staple pushers 540 is positioned at the proximal end of the replacement section. The slider 550 is slidable longitudinally within the replacement section in response to the movement of the firing member. A jacket 560 is located below the cartridge, and this jacket holds the staples and staple pushers in place within the staple pockets. The jacket should preferably have a protruding hook 562 that engages with the cartridge.

[0029] Referring to Figure 20, in some embodiments, the replacement unit 50 may have a transport cover 570 that covers the top surface of the cartridge. Advantageously, the transport cover 570 can prevent one or more staples from falling out of the staple pocket or becoming misaligned before the replacement unit is used. The transport cover 570 is removed before the replacement unit 50 is positioned within the replacement unit support.

[0030] Referring to Figures 21 to 23, in some embodiments, the replacement section 50 may have certain staple alignment and holding features. For example, the staple pocket 532 formed in the cartridge 530 may have a staple guide 534 at its end that receives the legs of the staples 520 positioned within the cartridge. The staple pusher 540 may further have a nub 542 that is sized and shaped to rest within the staple guide 534. As shown in the figures, in some particular embodiments, the staple pusher 540 may be formed in three groups, so that one staple pusher 540 can push a single staple belonging to each of three adjacent staple rows. Furthermore, the upper surface 544 of each staple pusher 540 may have a staple saddle shape that receives the staple relatively reliably. By firmly positioning the staple 520 within the staple pusher 540 and engaging the staple legs and the nub 542 of the staple pusher with the staple guide, it is advantageous to reduce the occurrence rate of poorly positioned or poorly formed staples.

[0031] Referring to Figures 24 to 31, in various embodiments, the replacement part 50 and the jaw assembly are preferably configured to be securely coupled to each other so as to align the staple pocket of the replacement part 50 with the staple molding pocket of the anvil, thereby maintaining the position of the replacement part 50 within the jaw assembly during staple firing. The replacement part 50 preferably has a boss 538 protruding from its proximal end (Figure 24), and these upwardly protruding bosses 538 create a tissue gap between the anvil 220 and the upper surface of the cartridge 530 of the replacement part 50 when the jaw assembly is in the closed position (Figure 25). Furthermore, a retaining tab 512 (Figure 26) formed adjacent to the distal end of the replacement part is positioned within a recess 214 of the replacement part support 210 to prevent the replacement part from shifting distally during firing. Thus, the replacement part 50 can be quickly and reliably coupled to the replacement part support 210 (Figures 28 and 29). Furthermore, the proximal end of the cartridge 530 is preferably tapered to a reduced height to facilitate placement on the replacement support (Figure 30). In addition, the cartridge is preferably calibrated with a contour shape in which the lower distal end 514 protrudes below the replacement support (Figure 31). This low profile ensures secure engagement between the replacement and the replacement support.

[0032] Referring to Figures 32A, 32B, and 33 and 34, in certain embodiments the jaw assembly preferably includes a replacement lockout mechanism 580. The replacement lockout mechanism 580 can prevent the forward movement of the launching member if there is no replacement positioned within the jaw assembly or if an empty replacement is positioned within the jaw assembly. The replacement lockout mechanism 580 includes a lockout lever 582 rotatably coupled to the replacement support. The axis defined by this pivot extends laterally as a whole with respect to the longitudinal axis of the elongated shaft. With the launching member 240 fully retracted and the jaw assembly in the open configuration, a tail 247 protruding proximally from the launching member 240 maintains the lockout lever 582 pivoted to the unlocked position. In the illustrated embodiment, the proximal portion of the lockout lever 582 located on the proximal side of the pivot is forked or bifurcated to receive the launch member 240, so that the tail 247 can act on the surface of the lockout lever 582 located on the distal side of the pivot. If there is no inserted replacement part, when attempting to advance the launch member 240, the lockout lever can rotate around the pivot point 584 from the unlocked position to the locked position as the tail 247 of the launch member is advanced distally along the lockout lever (Figure 33). With the lockout lever 582 in the locked position, the proximal lock end 586 of the lockout lever strikes a lock recess provided in the drive member 26, thereby preventing further distal movement of the drive member.

[0033] Referring again to Figures 32A, 32B, and 33 and 34, when the unfired replacement part is inserted into the replacement part support (Figure 34), the tail 554 extending proximal to the slider 550 engages with the distal end of the lockout lever 582. As shown, the tail 554 acts on the underside of the distal portion of the lockout lever 582, which is located distal to the pivot point. This engagement between the slider tail 554 and the distal end of the lockout lever 582 causes the distal end of the lockout lever 582 to rotate away from the drive member 26, even if the tail 247 of the firing member 240 is no longer acting on the proximal portion of the lockout lever 582. Thus, the drive member 26 and the firing member 240 can be advanced distally to fire staples from the replacement part. At the completion of the firing stroke, the slider 550 remains at the distal end of the replacement part. Thus, when the jaw assembly is opened and returned to its original form and the firing element is retracted, the replacement part used after firing should be removed, and a new, unfired replacement part should be inserted to unlock the replacement part lockout.

[0034] Referring to Figures 35 to 37, one embodiment of an articulated joint 300 for connecting a jaw assembly 30 to the distal end of an elongated shaft 20 is shown. In the illustrated embodiment, the articulated joint 300 has an articulated rod 310 rotatably coupled to the jaw assembly, offset laterally from the longitudinal central axis of the shaft assembly. The pivot point is positioned along the longitudinal central axis. The articulated joint 300 further has a support link 320 rotatably coupled to the jaw assembly on the opposite side of the articulated rod, offset laterally from the longitudinal central axis of the shaft. A drive beam 26 extends longitudinally along the longitudinal central axis between the articulated rod 310 and the support link 320. At least a segment of the drive beam 26 that penetrates the articulated joint 300 is flexible. In some embodiments, the drive beam 26 is preferably coupled to a flexible segment consisting of a stack of shim material, which is flexible while maintaining the desired force transmission capability for staple firing. The articulated joint may further have one or more drive member supports 330 positioned laterally outward from the drive beam 26. In some embodiments, the drive supports 330 may be made of a soft plastic material (Figure 36). In other embodiments, the drive supports 330' may be made of a metal shim material (Figure 37). Advantageously, the metal shim drive supports 330' may be keyed into the shaft to provide support to the flexible segment of the drive member. Furthermore, the metal shim supports may have a relatively low profile configuration. The metal shim supports may have a low-friction coating, such as a TEFLON® coating, to reduce friction during firing.

[0035] Referring to Figures 38A and 38B, the articulation of the articulation joint for positioning the jaw assembly in a first articulation position and a second articulation position is shown. The articulation rod 310 can be translated proximal (Figure 38A) or distal (Figure 38B) to the shaft. By lateral offset positioning of the articulation rod 310, the jaw assembly articulates with respect to the shaft in response to the translation of the articulation rod. The support link 320 opposite the articulation rod 310 is passive but can guide the articulation of the jaw assembly and, advantageously, can help keep the flexible portion of the drive beam 26 closer to the center of the shaft at the articulation joint, thereby preventing the flexible portion of the drive beam 26 from buckling at the articulation bending portion at the articulation joint. In other embodiments, the articulation joint may have two articulation rods instead of an articulation rod and a support link. In embodiments with two articulated rods, the articulated latch mechanism is preferably positioned within the shaft so that, once the staple firing operation has begun, undesirable articulated movement can be prevented. For example, the latch or brake mechanism can hold the articulated rod so that it does not move any further once the drive beam 26 has been translated distally.

[0036] Referring to Figures 39 and 40, another embodiment of the articulated joint 300' for connecting a jaw assembly 30 to the distal end of an elongated shaft 20 is shown. The articulated joint 300' has an articulated latch mechanism 340 positioned within the elongated shaft. In the illustrated embodiment, the articulated joint 300' has an articulated rod 310' rotatably coupled to the jaw assembly, offset laterally from the longitudinal central axis of the shaft assembly. The pivot point is positioned along the longitudinal central axis. The articulated joint 300' further has a support link 320' rotatably coupled to the jaw assembly on the opposite side of the articulated rod, offset laterally from the longitudinal central axis of the shaft. The drive beam 26' extends longitudinally along the longitudinal central axis between the articulated rod 310' and the support link 320'. At least the segment of the drive beam 26' that penetrates the articulated joint 300' is flexible. In some embodiments, the drive beam 26' is preferably coupled to a flexible segment consisting of a stack of shim material, which is flexible while maintaining the desired force transmission capability for staple firing operations. The articulated joint may further have one or more drive member supports 330 positioned laterally outward of the drive beam 26'. In some embodiments, the drive supports 330 may be made of a soft plastic material (Figure 36). In other embodiments, the drive supports 330' may be made of a metal shim material (Figure 37). Advantageously, the metal shim drive supports 330' may be keyed into the shaft to provide support for the flexible segment of the drive member. Furthermore, the metal shim supports may have a relatively low profile. The metal shim bearing should preferably have a low-friction coating, such as a TEFLON® coating, to reduce friction during firing.

[0037] Referring to Figures 41 and 42, the articulation of the articulation joint for positioning the jaw assembly in a first articulation position and a second articulation position is shown. The articulation rod 310' can be translated proximal (Figure 41) or distal (Figure 42) to the shaft. By lateral offset positioning of the articulation rod 310', the jaw assembly articulates with respect to the shaft in response to the translation of the articulation rod. The support link 320' opposite the articulation rod 310' is passive but can guide the articulation of the jaw assembly and, advantageously, can help keep the flexible portion of the drive beam 26' closer to the center of the shaft at the articulation joint, thereby preventing the flexible portion of the drive beam 26' from buckling at the articulation bending portion at the articulation joint. In other embodiments, the articulation joint may have two articulation rods instead of an articulation rod and a support link.

[0038] Referring to Figures 39 to 43, the articulation latch mechanism 340 or brake mechanism of the articulation joint 300' can hold the articulation rod and support link so that they do not move any further once the drive beam 26' has been translated distally. In the illustrated embodiment, the latch mechanism 340 is positioned within the elongated shaft between its proximal and distal ends. The articulation latch mechanism 340 has a latch-release configuration that allows the articulation rod and support link to slide within the elongated shaft. Thus, when the articulation latch mechanism is in the latch-release configuration, the user can articulate the jaw assembly relative to the elongated shaft by operating the articulation control unit provided on the handle assembly. The articulation latch mechanism 340 further has a latch configuration (Figure 43) in which the articulation latch mechanism engages with the articulation rod and support link to prevent longitudinal sliding of the articulation link and support link relative to the elongated shaft. Thus, in the latched configuration, the jaw assembly is held in the position after joint movement, and the user is unable to articulate the jaw assembly relative to the elongated shaft.

[0039] Continuing to refer to Figures 39 to 43, in the illustrated embodiment, the joint movement latch mechanism 340 includes a first latch surface formed on the joint movement rod 310', for example, a first set of teeth 342. As shown, the first set of teeth 342 is positioned within the elongated shaft between the proximal and distal ends of the joint movement rod 310'. The joint movement latch mechanism 340 may further have a second latch surface formed on the support link 320', for example, a second set of teeth 344. As shown, in the illustrated embodiment of the elongated shaft assembly including the latch joint movement mechanism, the support link 320' may extend proximal within the shaft, penetrating the joint movement latch mechanism 340. In the illustrated embodiment, the second set of teeth 344 is positioned adjacent to the proximal end of the support link 320', between the proximal and distal ends of the support link.

[0040] In the illustrated embodiment, the articulated latch mechanism 340 further includes a first shoe 346 on which a mating surface, for example, a first claw surface 348, is formed. The first claw surface 348 is dimensioned and shaped to be engageable with a first plurality of teeth 342. The first shoe 346 may have an unfolding surface on the side opposite to the mating surface, which is in a sliding engagement relationship with the drive beam 26'. The articulated latch mechanism 340 further includes a second shoe 350 on which a mating surface, for example, a second claw surface 352, is formed. The second claw surface 352 is dimensioned and shaped to be engageable with a second plurality of teeth 344. The second shoe 350 may have an unfolding surface on the side opposite to the mating surface, which is in a sliding engagement relationship with the drive beam 26'. The joint movement latch mechanism 340 preferably further includes a latch contour shape formed on the drive beam 26' between the proximal and distal ends of the drive beam 26' and positioned within the elongated shaft. In the illustrated embodiment, the drive beam 26' has a recessed segment 360 formed therein, a tapered or inclined segment 362 located proximal to the recessed segment, and a latch segment 364 located proximal to the inclined segment. The recessed segment 360 has a first width in a direction perpendicular as a whole to the longitudinal axis of the elongated shaft, and the latch segment 364 has a second width greater than the first width. The joint movement latch mechanism preferably further includes a biasing member, such as a spring clip 370, which is coupled to the first and second shoes and biases the shoes 346, 350 to disengage them from the first and second sets of teeth 342, 344. The spring clip can also maintain the engagement between the deployment surfaces of the shoes 346, 350 and the latching contour shape of the drive beam 26'.

[0041] Continuing to refer to Figures 39 to 43, in operation, it is preferable to initially position the joint movement latch mechanism 340 in the unlocked position (Figures 39 to 42), thereby allowing the jaw assembly to articulate with respect to the elongated shaft to a desired orientation. During this initial positioning, the drive beam 26' is positioned proximal to the elongated shaft, corresponding to the open or partially closed position of the jaw assembly. In the unlocked position, the first and second shoes 346, 350 are positioned radially inward, adjacent to the recessed segment 360 of the drive beam 26'. Once the desired post-articulation position of the jaw assembly is selected, the user can then close the jaw assembly and fire it, resulting in distal movement of the drive beam 26' with respect to the elongated shaft. This distal movement of the drive beam 26' causes the inclined and latching segments 362, 364 to advance on the deployment surfaces of the first and second shoes 346, 350, thereby advancing these shoes radially outward (Figure 43). With the first and second shoes 346, 350 in their radially outward position, the first claw surface 348 engages with the first set of teeth 342, and the second claw surface 352 engages with the second set of teeth 344, thereby configuring the articulated latch mechanism into a latched position. Opening the jaw assembly after the firing sequence reverses this order, returning the articulated latch to an unlocked position. Thus, preferably by operating the drive member 26' to close the jaw assembly and fire it, the jaw assembly's post-articulation position is automatically latched. Advantageously, this latching mechanism can reduce or prevent the jaws from "wobbling" against the elongated shaft when the drive beam is being advanced around or retracted through the articular bending section. The illustrated embodiment of the articular latching mechanism includes a meshing array of teeth provided around the periphery, as well as an articular rod and support links defining a plurality of separate latching positions, but in other embodiments, the shoe, articular rod, and support links may be configured to frictionally engage with each other to define a continuous array of latching articular positions.Furthermore, while the illustrated embodiment includes two shoes, each capable of engaging with a corresponding set of teeth, in other embodiments, a single shoe may be advanceable to engage with a set of teeth of a single type provided on an articulating rod or support link.

[0042] Referring to Figures 44 and 45A to 45D, it is preferable that a coupler 46, located at the distal end of the handle assembly 40, is connected to the proximal end of the shaft assembly 20. The coupler 46 preferably has a plug-in connector with a lock-in mechanism. In the illustrated embodiment, the connection between the replaceable shaft 20 and the handle 40 consists of a plug-in connector, in which the user inserts the replaceable shaft 20 into the handle 40 axially, and then rotates the replaceable shaft 20 by approximately 90° to connect it. This plug-in connector operatively connects the two mechanical functions of the plug-in shaft 20 to the corresponding actuators of the handle 40. When the plug-in connector is fully connected, the articulated member within the shaft 20 is connected to the articulated adapter of the handle, and the drive member within the shaft 20 is connected to the actuating adapter. Furthermore, the handle 40 and shaft 20 are preferably configured with a latch mechanism provided at the coupler 46 to prevent the user from removing the shaft 20 once the operating adapter and drive member are activated. Furthermore, the connection at the coupler 46 is preferably equipped with a replacement part identification mechanism so that the handle's control system can detect whether a replaceable shaft has been connected and what the jaw length of the installed replacement part is. It is envisioned that the handle can be used with replaceable shafts 20 including jaw mechanisms of various lengths. In some embodiments, the same handle 40 can be used with either 45 mm or 60 mm long jaw assemblies.

[0043] In Figure 45A, the shaft 20 is positioned parallel to the coupler 46 provided on the handle, and the release knob of the coupler 46 is retracted to expose the plug-in channel 152 of the coupler 46 when the coupler 46 is rotated into place. The shaft 20 may have a retaining post 22 or boss that can be positioned within the plug-in channel 152. In the illustrated embodiment, the shaft has two bosses positioned 180° apart on its outer surface, and the coupler 46 has two plug-in channels 152 corresponding to these. In other embodiments, it is envisioned that other numbers and forms of bosses and plug-in channels can be used to achieve the desired coupling strength and ease of alignment.

[0044] Referring to Figure 45B, the shaft retaining post 22 is positioned within the insert channel 152. Referring to Figure 45C, the replaceable shaft 20 is rotated 90° relative to the handle, so that the shaft retaining shaft 22 reaches the connecting end of the insert channel 152. Referring to Figure 45D, the coupler release knob is released so that the retaining recess 154 provided in the release knob can hold the retaining post 22 of the replaceable shaft 20.

[0045] Referring to Figures 46 and 47, the shaft assembly preferably includes a tubular shaft, and the drive member or drive beam 26 and the articulated member 206 extend through this tubular shaft from the proximal end to the distal end. The drive member preferably passes through the center of the shaft assembly as a whole, while the articulated member is offset laterally. The proximal end of the tubular shaft preferably has a coupling collar 410 that can be coupled to a coupler 46 at the distal end of the handle. In the illustrated embodiment, the shaft assembly preferably includes a proximal shaft "lockout" mechanism. The lockout mechanism includes a lock ring positioned in a shaft coupler provided at the proximal end of the elongated shaft and at least one lockout member that can advance radially outward through the coupling collar 410. The lockout member is biasable radially outward but is initially held in a radially inward position by the lock ring. When the proximal end of the shaft is coupled to the handle assembly in a rotational sequence corresponding to the insert-type connector, the locking ring engages with a mating surface on the handle assembly and rotates relative to the elongated shaft. This rotation of the locking ring releases the lockout member. When the shaft is removed from the handle assembly, the lockout member expands radially. In this expanded position, the lockout member prevents the elongated member from being reattached to the handle assembly. Thus, this lockout mechanism can help restrict the unintentional reuse of the elongated shaft assembly.

[0046] Referring to Figures 48A and 48B, the engagement state of the insert-type coupling between the shaft assembly and the handle is shown. The coupler of the handle preferably has a rotating sleeve that can be coupled to the coupling collar 410, and the actuating adapter 124, the articulation adapter 204, and the identification sleeve 208 are positioned within this rotating sleeve. During the insert coupling, the drive member of the shaft 26 engages with the actuating adapter 124, the articulation member 206 of the shaft engages with the articulation adapter 204, and the shaft identification member engages with the identification sleeve 208. Figures 49A and 49B show the respective coupling states with the shaft in the coupling configuration.

[0047] Referring to Figures 50 and 51, in place of or in addition to the lockout mechanism described with reference to Figures 46 and 47, certain embodiments with an elongated shaft may include a lock-in or retaining mechanism that operates when the actuating adapter 124 first moves distally. As shown, a locking member 24 is rotatably coupled to the proximal end of the shaft 20. The locking member 24 may have an inclined or tapered locking surface at its proximal edge. As shown in Figure 50, the shaft 20 is coupled to the coupler 46 but in an unlocked configuration. In the unlocked configuration, the shaft 20 can be removed from the coupler 46 via the plug-in connector by reversing the sequence of operations in Figures 45A to 45D. Once the actuating adapter 124 moves forward to actuate the stapler, the actuating adapter 124 interacts with the inclined surface of the locking member 24 to advance the locking member radially outward to the locked position. In the locked position (Figure 51), the locking member 24 engages with a locking shelf-like projection provided on the coupler 46 to lock into the shaft. When the shaft 20 is locked into the handle 40, the shaft 20 cannot be removed from the handle 40 until the operating adapter 124 returns to a position where it is fully retracted to the proximal side (typically corresponding to the complete closure of the jaw assembly and its return to the jaw-open configuration following the stapling cycle).

[0048] Thus, the "lock-in" feature prevents the user from removing the shaft from the handle once the drive member 26 is driven forward. Once the lock member 24 is positioned in the slot or shelf projection of the rotating insert of the coupler 46, the release knob of the coupler 46 cannot be pulled back. This locking action on the coupler prevents the user from rotating the shaft 20 and disengaging it from the insertion connection of the coupler 46.

[0049] Referring to Figure 52, the proximal end of the shaft assembly has a shaft coupler or coupling collar 410 provided at the proximal end of the tubular shaft. Thus, the stapling system described herein can be easily modified for use with shaft assemblies of various diameters. In some embodiments, the inner diameter of the shaft coupler can be easily resized to accommodate various tubular shafts without requiring different handle assemblies to accommodate shaft assemblies of various diameters.

[0050] While this application discloses certain preferred embodiments and examples, as will be understood by those skilled in the art, the present invention extends beyond the specifically disclosed embodiments to other modified embodiments and / or uses of the invention, as well as obvious modifications and equivalents thereof. Furthermore, various features of these inventions can be used individually or in combination with other features of these inventions other than those explicitly described above. Thus, the scope of the invention disclosed herein is not intended to be limited by the specific disclosed embodiments described above, but rather to be determined solely by a fair interpretation of the claims.

Claims

1. A replacement assembly for a surgical stapling system, The replacement assembly is An elongated shaft having a proximal end and a distal end, with a longitudinal axis extending between the proximal and distal ends, A jaw assembly positioned at the distal end of the elongated shaft, wherein the jaw assembly is A first jaw comprising a replacement support configured to receive a staple replacement section, A second jaw pivotably coupled to the first jaw, the second jaw having an anvil surface, A jaw assembly having, An operating beam that is slidable in the longitudinal direction within the elongated shaft, the operating beam having a proximal end and a distal end, the distal end of the operating beam being coupled to the jaw assembly, A shaft coupler located at the proximal end of the elongated shaft, wherein the shaft coupler is configured to be detachably connected to the handle assembly, and the shaft coupler includes a lockout mechanism disposed therein, The lockout mechanism comprises a lock ring rotatable about its longitudinal axis, A replacement assembly comprising a lockout member that can advance radially outward by the rotation of the lock ring.

2. The replacement assembly according to claim 1, wherein the lockout member is extendable through the port of the shaft coupler to a locked position radially outward of the shaft coupler.

3. The replacement assembly according to claim 2, wherein when the lockout member is in the locked position, the lockout mechanism prevents the shaft coupler from coupling to the handle coupler.

4. The replacement assembly according to claim 2, wherein the lockout member is biased radially outward, and in the initial position, the lockout member is held radially inward by the lock ring.

5. The replacement assembly according to claim 1, wherein the shaft coupler comprises a connecting collar positioned at the proximal end of the elongated shaft.

6. The replacement part assembly according to claim 1, wherein the jaw assembly further comprises a replacement part lockout mechanism.

7. The replacement assembly according to claim 1, wherein the jaw assembly is coupled to the elongated shaft in the articular joint.

8. The replacement assembly according to claim 7, wherein the joint motion coupling further comprises a joint motion latch fastening mechanism disposed within the elongated shaft.

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