Stapling staple cartridge for surgical instrument

Abstract

The present disclosure provides a staple cartridge for a surgical instrument having staples and a staple pusher. The staple pusher has a recess forming a pocket in a top surface thereof for receiving at least a back span of the staple. The pocket is at least partially surrounded by a circumferential support element in the staple pusher body to support the back span. The pockets provide additional vertical space and support for the staples such that a smaller staple cartridge can provide substantially similar performance to conventional staple cartridges, allowing for a more compact and easy-to-handle surgical instrument. Further, pockets in the staple pusher allow the staples to have a greater bending radius than conventional staples, providing additional support for the staples and minimizing deformation of the staples during use.

Description

[0001] This application is a divisional application of Chinese patent application 2020800403237 (PCT / US2020 / 033481) entitled “Stapling Magazine for Surgical Instruments” filed on May 18, 2020.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 855,371, filed May 31, 2019, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0004] The field of the present disclosure relates to medical instruments, and more particularly to tissue sealing instruments used in surgery. More particularly, the present disclosure relates to a surgical stapling instrument / surgical anastomosis instrument having a more compact staple cartridge for holding staples. Background Art

[0005] Minimally invasive medical technology aims to reduce the amount of extracorporeal tissue damaged during diagnostic or surgical procedures, thereby reducing patient recovery time, discomfort and harmful side effects. For example, one effect of minimally invasive surgery is to reduce the postoperative hospitalization recovery time. The average hospitalization time for standard open surgery is usually significantly longer than the average hospitalization time for similar minimally invasive surgery (MIS). Therefore, increasing the use of MIS can save millions of dollars in hospital costs each year. Although many operations performed in the United States each year are likely to be performed in a minimally invasive manner, due to the limitations of minimally invasive surgical instruments and the additional surgical training involved in mastering these instruments, only a portion of the operations currently use these advantageous technologies.

[0006] Improved surgical instruments (such as tissue access, navigation, dissection and sealing instruments) enable MIS to redefine the area of ​​surgery. These instruments allow surgical and diagnostic procedures to be performed with reduced trauma to the patient. A common form of minimally invasive surgery is endoscopy, and a common form of endoscopy is laparoscopy, which is minimally invasive examination and surgery inside the abdominal cavity. In standard laparoscopic surgery, the patient's abdomen is insufflated with gas, and a cannula sleeve is passed through a small (approximately one-half inch or less) incision to provide an entry port for laparoscopic instruments.

[0007] Laparoscopic surgical instruments typically include an endoscope (e.g., a laparoscope) for viewing the surgical field and tools for working at the surgical site. The working tools are generally similar to those used in conventional (open) surgery, except that the working end or end effector of each tool is separated from its handle by an extension tube (also referred to as, for example, an instrument shaft or spindle). The end effector may include, for example, clamps, graspers, scissors, staplers, cautery tools, linear cutters, or needle holders.

[0008] To perform a surgical procedure, the surgeon passes working tools through a cannula sleeve to the internal surgical site and manipulates them from outside the abdomen. The surgeon views the procedure from a monitor that displays images of the surgical site acquired from the endoscope. Similar endoscopic techniques are used, for example, for arthroscopy, retroperitoneoscopy, pelvicoscopy, nephroscopy, cystoscopy, cisternscopy, sinoscopy, hysteroscopy, urethroscopy, and the like.

[0009] Minimally invasive telesurgery robotic systems are being developed to increase the dexterity of surgeons when working within an internal surgical site, as well as to allow surgeons to operate on patients from a remote location (outside the sterile field). In a telesurgery system, the surgeon is typically provided with an image of the surgical site at a console. While viewing the three-dimensional image of the surgical site on a suitable viewer or display, the surgeon performs the surgical procedure on the patient by manipulating the master input device or control device of the console, which in turn controls the motion of the servomechanically operated slave instruments.

[0010] Servomechanisms used for telesurgery typically accept inputs from two master controllers (one for each hand of the surgeon) and may include two or more robotic arms, with surgical instruments mounted on each robotic arm. Operational communications between the master controllers and the associated robotic arms and instrument assemblies are typically achieved through a control system. The control system typically includes at least one processor that relays input commands from the master controllers to the associated robotic arms and instrument assemblies and back from the instrument and arm assemblies to the associated master controllers, such as with force feedback or the like. An example of a robotic surgical system is the DAVINCI system commercially available from Intuitive Surgical, Inc. of Sunnyvale, California. TM system.

[0011] During robotic surgery, a variety of structural arrangements have been used to support surgical instruments at the surgical site. Drive linkages or "followers" are often referred to as robotic surgical manipulators, and exemplary linkage arrangements used as robotic surgical manipulators during minimally invasive robotic surgery are described in U.S. Patents Nos. 7,594,912 (filed September 30, 2004), 6,758,843 (filed April 26, 2002), 6,246,200 (filed August 3, 1999), and 5,800,423 (filed July 20, 1995), the entire disclosures of which are incorporated herein by reference in their entirety for all purposes. These linkages typically manipulate an instrument holder that is mounted to an instrument having an axis. Such a manipulator structure may include a parallelogram linkage portion that produces movement of the instrument holder that is limited to rotation about a pitch axis that intersects a remote manipulation center positioned along the length of the instrument axis. Such a manipulator structure may also include a yaw joint that produces movement of the instrument holder that is constrained to rotation about a yaw axis that is perpendicular to the pitch axis and also intersects the remote manipulation center. By aligning the remote manipulation center with the incision point to the surgical site (e.g., during laparoscopic surgery, using a trocar or cannula at the abdominal wall), the end effector of the surgical instrument can be safely positioned by moving the proximal end of the shaft using the manipulator linkage without applying potentially damaging forces to the abdominal wall. Alternative manipulator structures are described, for example, in U.S. Patent Nos. 6,702,805 (filed November 9, 2000), 6,676,669 (filed January 16, 2002), 5,855,583 (filed November 22, 1996), 5,808,665 (filed September 9, 1996), 5,445,166 (filed April 6, 1994), and 5,184,601 (filed August 5, 1991), the entire disclosures of which are incorporated herein by reference in their entirety for all purposes.

[0012] During a surgical procedure, a remote surgical system can provide mechanical actuation and control of various surgical instruments or tools having an end effector, which performs various functions for the surgeon in response to manipulation of a master input device, such as holding or driving a needle, grasping a blood vessel, dissecting tissue, or the like. The manipulation and control of these end effectors is a particularly beneficial aspect of a robotic surgical system. To this end, it is desirable to provide a surgical tool that includes a mechanism that provides three degrees of rotational movement of the end effector to mimic the natural movements of the surgeon's wrist. Such a mechanism should be appropriately sized for use in minimally invasive surgical procedures and be relatively simple in design to reduce possible points of failure. In addition, such a mechanism should provide a sufficient range of motion to allow the end effector to be manipulated in a variety of positions.

[0013] Surgical clamping and cutting instruments (e.g., non-robotic linear clamping, stapling / staple and cutting devices, also known as surgical staplers / surgical staplers; and electrosurgical vascular sealing devices) have been used in many different surgical procedures. For example, surgical staplers can be used to remove cancerous or abnormal tissue from the gastrointestinal tract. Many known surgical clamping and cutting devices (including known surgical staplers) have opposing clamps that clamp tissue and an articulated knife that cuts the clamped tissue.

[0014] Surgical clamping and cutting instruments are often deployed into restrictive body cavities (e.g., through cannulas into the interior of the pelvis). Therefore, it is desirable that surgical clamping and cutting instruments be both compact and easy to operate to best access and visualize the surgical site. However, known surgical clamping and cutting instruments may not be compact or easy to operate. For example, known surgical staplers may lack ease of operation in terms of multiple degrees of freedom (e.g., roll, pitch, and yaw) and the associated desired range of motion.

[0015] Conventional surgical clamping and cutting instruments typically include a stapler cartridge designed to fit within a removable fixture of an end effector. The stapler cartridge typically includes multiple rows of stapler assemblies, each row of stapler assemblies including staples and stapler pushers. The stapler pushers hold the staplers in place prior to use and then push the staplers into the tissue when the instrument is actuated. However, the size and shape required for the stapler cartridge limits the ability of designers to reduce the size and shape of the entire surgical instrument.

[0016] Surgical staplers generally include two vertical legs connected by a backspan. In some clinical applications, it is desirable to increase the height of the vertical legs because longer legs can be pushed deeper into tissue, thereby improving tissue sealing and / or hemostasis at the surgical site.

[0017] One of the features of a conventional stapler cartridge that limits its minimum size (and also limits the height of the stapler) is the design of the stapler pusher in the cartridge. Typically, the back span of the stapler typically coincides with the top surface of the stapler pusher. In order to accommodate taller staples, the pusher can be shortened, the cartridge can be made taller, or some combination of the two. However, the pusher can only be shortened to the extent that it becomes too weak to withstand the required load or is prone to shaking during actuation. Similarly, limitations on the size of the entire device may prevent the stapler cartridge from being taller or larger.

[0018] Therefore, although the new remote surgical systems and devices have proven to be highly effective and advantageous, further improvements are still needed. In general, it is desirable to provide improved surgical instruments that are more compact and easy to operate to improve the efficiency and ease of use of minimally invasive systems. To this end, it would be beneficial to create a staple pusher designed to accommodate higher staples to enhance the sealing performance of the surgical device and / or to create a smaller staple cartridge to allow a more compact and easy to operate design of the surgical instrument. Summary of the invention

[0019] A simplified summary of the claimed subject matter is presented below in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview of the claimed subject matter. It is neither intended to indicate key or critical elements of the claimed subject matter nor to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts of the claimed subject matter in a simplified form as a prelude to the more detailed description that is presented later.

[0020] The present disclosure provides a stapler magazine for surgical instruments, which includes a stapler pusher and staplers. The stapler pusher has a main body with an upper surface and a lower surface and a recess in the upper surface. The stapler has a first leg and a second leg and a back span connecting the first leg to the second leg. At least a portion of the back span of the stapler is configured to fit in the recess of the stapler pusher. Preferably, the recess forms a recess in the stapler pusher body, and the back span of the stapler resides completely in the recess and below the upper surface of the stapler pusher. This provides additional vertical space for the stapler, so that higher staplers can be used in a stapler magazine of a given size, thereby enhancing the sealing performance of the stapler during surgical use. Alternatively, a smaller stapler magazine can be designed to be used with staplers of the same height, thereby allowing a more compact and easy-to-operate surgical instrument.

[0021] In one embodiment, the staple pusher body includes a support element extending above a recess or pocket in the top surface of the body. The support element preferably includes a substantially circumferential wall around the pocket to provide additional support to the staple along the backspan and the bending radius between the legs and the backspan. In an exemplary embodiment, the circumferential wall is an extension of the pusher body, extending above the pocket and almost completely around the pocket. The support minimizes the transmission of undesirable forming loads to the backspan, thereby allowing the staples to remain in place before use and minimizing potential deformation of the staples during use. In addition, the circumferential support element maintains sufficient staple pusher height to ensure anti-shake stability and structural robustness of the components.

[0022] Preferably, the distance between the top surface and the bottom surface of the staple pusher (i.e., the maximum height of the staple pusher) is greater than the distance between the bottom surface of the staple pusher and the center surface of the recess (i.e., the minimum height of the recess). Applicants have discovered that there is a critical ratio between these two distances that maximizes the height of the staple relative to a given surgical instrument size while providing adequate support for the staples and allowing a sufficient volume of material in the staple pusher to withstand structural loads during use. The critical ratio of (i) the distance from the bottom of the staple pusher to the bottom surface of the recess to (ii) the total height of the staple pusher is preferably less than about 0.6 to about 1.0. In one embodiment, the ratio is about 0.53 to about 1.0.

[0023] In certain embodiments, the transition between each of the first leg and the second leg and the back span is defined by an arc having a curvature radius of at least 0.015 inches (more preferably between about 0.015 inches and 0.030 inches). The recess of the staple pusher preferably includes a first curvilinear surface or ramp and a second curvilinear surface or ramp, which are connected together by a center surface therebetween. The curved transition of the staples preferably extends along the ramp of the pusher so that they reside substantially in a recess below the upper surface of the staple pusher body. Compared to conventional staples in surgical instruments, this configuration allows the staples to be designed to have a larger curvature radius between the legs and the back span. The transition with a larger curvature radius facilitates staple formation in some cases at least by allowing additional wall support to be designed around the staples. The additional wall support effectively allows the staple pusher to be made taller without losing the length of the pusher.

[0024] In another aspect of the present invention, a surgical instrument according to the present disclosure includes an end effector, the end effector including a first clamp and a second clamp, the first clamp and the second clamp being configured to move relative to each other between an open position and a closed position. The surgical instrument also includes a stapler magazine coupled to one of the first clamp or the second clamp. The stapler magazine includes a stapler pusher and a stapler, the stapler pusher having a body with an upper surface and a lower surface and a recess in the upper surface, the stapler having a first leg and a second leg and a back span connecting the first leg to the second leg. The back span of the stapler is configured to fit within the recess of the stapler pusher, preferably so that it resides completely within the recess and below the upper surface of the stapler pusher.

[0025] In some embodiments, the surgical instrument further includes a drive member configured to be translated distally by the end effector and, in some embodiments, retracted proximally by the end effector. The drive member has a central portion that translates through a channel in the fixture. The central portion may be, for example, a cutting An instrument (e.g., a knife) configured to act as a clamp Cutting between the first clamp and the second clamp when the tool is in the closed position The drive member further comprises at least one outer portion that is laterally spaced from the central portion and has an inclined surface or ramp configured to engage the staple assembly. The staple cartridge comprises an elongated housing having a guide rail extending substantially perpendicular to the longitudinal axis of the housing. The staple pusher comprises a body having a substantially circumferential surface having a groove sized and aligned to receive the guide rail of the staple cartridge. As the drive member translates distally, the drive member ramp pushes the staple pusher and the staples in a direction perpendicular to the longitudinal axis of the housing to push the staples into the tissue.

[0026] In another aspect of the present invention, the surgical instrument further comprises an actuation mechanism in contact with the central portion of the drive member. The actuation mechanism is configured to advance the drive member distally through the end effector and to retract the drive member proximally through the end effector. In an exemplary embodiment, the actuator comprises a control device of a robotic telesurgery system that can be responsive to manipulation of a primary input device remote from the surgical instrument, such as allowing mechanical actuation and control of the surgical instrument to perform various functions, such as grasping a blood vessel, dissecting tissue, or the like.

[0027] In another embodiment of the present invention, a staple support for a surgical instrument includes a body having an upper surface and a lower surface and a recess in the upper surface, the recess forming a recess for receiving at least a portion of the staples. The staple support also includes a support element around at least a portion of the recess to provide additional support to the staples. The support element preferably includes a substantially circumferential wall around the recess. In an exemplary embodiment, the circumferential wall and the staple pusher body are integral. The recess in the staple support body preferably includes a first curved surface or ramp and a second curved surface or ramp, the first curved surface or ramp and the second curved surface or ramp being connected together by a central surface therebetween. The curved surface preferably has a bending radius suitable for providing support for the bend.

[0028] It should be understood that both the foregoing general description and the following detailed description are exemplary and illustrative only, rather than limiting on the present disclosure. Additional features of the present disclosure will be explained in part in the following description or may be learned through the practice of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0030] Figure 1 A perspective view of an illustrative surgical instrument with an end effector mounted to an elongated shaft is shown.

[0031] Figure 1A is a perspective top view of a distal portion of an illustrative surgical instrument with the clamp in an open position;

[0032] Figure 1B is a partially isolated bottom perspective view of a representative staple cartridge for an illustrative surgical instrument;

[0033] Figure 1C shows a portion of the drive member and the formation Figure 1B An enlarged view of the cooperative relationship between a plurality of staple pushers and staples of a portion of a staple cartridge;

[0034] Figure 1D yes Figure 1A a perspective bottom view of a distal portion of a surgical instrument;

[0035] Figure 2 is a perspective view of a staple pusher and a staple according to one embodiment of the present invention;

[0036] Figure 3 yes Figure 2 A perspective top view of a staple pusher;

[0037] Figure 4is a semi-transparent view of a portion of a staple cartridge having a staple pusher and staples according to an embodiment of the present disclosure;

[0038] Figure 5 is a perspective view of an end portion of an illustrative surgical instrument with parts removed;

[0039] Fig. 6A is used for Figure 1 A front view of a drive member of an illustrative surgical instrument;

[0040] Figure 6B yes Fig. 6A A side view of a driving member;

[0041] Fig. 7A is based on Figure 1 A partial cross-sectional perspective view of an actuation mechanism for driving a member of a surgical instrument;

[0042] Figure 7B is based on Figure 1 A partial cross-sectional side view of an actuation mechanism for a drive member of a surgical instrument;

[0043] Figure 8 yes Figure 1 a cross-sectional side view of an end portion of an illustrative surgical instrument;

[0044] Fig. 9 shows a top view of an operating room employing a robotic surgical system utilizing aspects of the present invention; and

[0045] Fig.10 Shown is a simplified side view of a robotic arm assembly that may be used with various aspects of the present invention. DETAILED DESCRIPTION

[0046] This specification and the accompanying drawings illustrate exemplary embodiments and should not be considered as limiting, and the claims define the scope of the present disclosure, including equivalents. Without departing from the scope of the present specification and the claims, various mechanical, compositional, structural and operational changes, including equivalents, may be made. In some cases, well-known structures and technologies are not shown or described in detail to avoid confusing the present disclosure. The same numbers in two or more figures represent the same or similar elements. In addition, the elements and their associated aspects described in detail with reference to an embodiment, whenever feasible, can be included in other embodiments that are not specifically shown or described. For example, if an element is described in detail with reference to an embodiment and is not described with reference to a second embodiment, the element can still be claimed to be included in the second embodiment. In addition, the description herein is for illustrative purposes only and does not necessarily reflect the actual shape, size or size of the system or illustrated components.

[0047] Note that, as used in this specification and the appended claims, the singular forms "a," "an," and "the," as well as any singular use of any word, include plural referents unless expressly and unambiguously limited to one referent. As used herein, the term "include" and its grammatical variations are intended to be non-limiting, such that enumeration of items in a list does not exclude other like items that can be substituted or added to the listed items.

[0048] Although the following disclosure is presented with respect to a linear surgical stapler in which staples are sequentially fired, it should be understood that the features of the surgical instruments currently described can be easily adapted for use in any type of surgical clamping, cutting, or sealing instrument, whether or not the surgical clamping and cutting instrument uses fasteners. For example, the drive member and actuation mechanism currently described can be used in an electrosurgical instrument, wherein the clamp includes an electrode for applying energy to tissue to treat (e.g., cauterize, ablate, fuse, or cut) tissue. The surgical clamping and cutting instrument can be a minimally invasive (e.g., laparoscopic) instrument or an instrument for open surgery.

[0049] Furthermore, the features of the presently described surgical stapling instruments may be readily adapted for use in surgical instruments activated using any technique within the capabilities of those skilled in the art, such as manually activated surgical instruments, powered surgical instruments (e.g., electromechanical powered instruments), robotic surgical instruments, etc.

[0050] Figure 1 1 is a perspective view of an illustrative surgical instrument 100 having a handle assembly 102 and an end effector 110 mounted on an elongated shaft 106 of the surgical stapling instrument 100, according to certain embodiments of the present disclosure. The end effector 110 includes a first clamp 111 and a second clamp 112. The handle assembly 102 includes a stationary handle 102a and a movable handle 102b that serves as an actuator of the surgical instrument 100.

[0051] In some embodiments, the handle assembly 102 may include an input coupling (not shown) instead of or in addition to the stationary handle and the movable handle. The input coupling provides a mechanical connection between the driving tendons or cables of the instrument and the motor axis of the mechanical interface of the drive system. The input coupling can interact with and be driven by the corresponding output coupling (not shown) of the remote surgical system, such as the system disclosed in U.S. Patent Publication No. 2014 / 0183244A1, the entire disclosure of which is incorporated herein by reference. The input coupling is drivingly coupled to one or more input members (not shown) arranged in the instrument shaft 106 and the end effector 110. Suitable input couplings can be adapted to be compatible with various types of motor groups (not shown), such as the stapler-specific motor group disclosed in U.S. Patent No. 8,912,746, or the universal motor group disclosed in U.S. Patent No. 8,529,582, the disclosures of both of which are incorporated herein by reference in their entirety. Further details of known input couplings and surgical systems are described in, for example, US Pat. No. 8,597,280, US Pat. No. 7,048,745, and US Pat. No. 10,016,244. Each of these patents is incorporated herein by reference in its entirety.

[0052] The actuation mechanism of the surgical instrument 100 can use a drive cable used in conjunction with a motor and pulley system. It is well known that powered surgical systems (including robotic surgical systems) utilize drive cables connected to motor and pulley systems for various functions, including the opening and closing of clamps, and the movement and actuation of end effectors. Further details of known drive cable surgical systems are described in, for example, U.S. Patent No. 7,666,191 and U.S. Patent No. 9,050,119, both of which are incorporated herein by reference in their entirety. Although described herein with respect to instruments configured for use with robotic surgical systems, it should be understood that the wrist assembly described herein can be incorporated into manually actuated instruments, electromechanical powered instruments, or instruments actuated in any other manner.

[0053] Figure 1A The distal end portion of the surgical instrument 100 is shown, including an end effector 110 having a first clamp 111 and a second clamp 112, a U-shaped clamp 140 for mounting the clamps 111, 112 to the instrument, and an articulation mechanism, such as a wrist 160. The first clamp 111 includes an anvil 115 having a staple-forming recess 116 (see FIG. Figure 1DIn some embodiments, the second clamp 112 is a movable clamp configured to move from an open position to a closed position relative to the first clamp 111. In other embodiments, the first clamp 111 is a movable clamp configured to move between an open position and a closed position relative to the second clamp 112. In other embodiments, both clamps 111, 112 are movable relative to each other. In the open position, a new staple cartridge 122 (sometimes referred to as a reload and Figure 1B 114 and 115. The movable jaws 111 and 112 may be loaded into the movable jaws 112 and tissue may be positioned between the jaws 111, 112. In the closed position, the jaws 111, 112 cooperate to clamp tissue such that the cartridge 122 and the anvil 115 are in close cooperative alignment.

[0054] Reference now Figure 1B and Figure 1C , a representative staple cartridge 122 may include a plurality of stapler assemblies, each stapler assembly including one or more staplers 124, the one or more staplers 124 being supported on corresponding stapler drivers or pushers 126, which are provided in corresponding stapler holes 127 formed in the cartridge 122. In certain embodiments, the cartridge 122 may also include a shuttle 123 having an inclined distal surface 125, which, when moved distally, sequentially acts on the stapler pushers 126 to cam them upward, thereby moving the staplers 124 to deform and contact the anvil 115 (see Figure 1D The shuttle 123 may be a drive member 150 ( Fig. 6A and Figure 6B The cartridge 122 may be removably received within the removable fixture 112 or, in a single-use embodiment, may be manufactured as part of the removable fixture 112.

[0055] Reference now Figure 1B and Figure 4 , a preferred embodiment of the cartridge 122 will now be described. As shown, the cartridge 122 includes a housing extending substantially along a longitudinal axis and including a plurality of compartments forming pockets within the housing to receive stapler assemblies. The stapler assemblies each include at least one (preferably 2-4) stapler pusher 126 removably coupled to at least one (preferably 2-4) staplers 124. The stapler assemblies are preferably positioned within the compartments such that the stapler pushers 126 are located proximate to a bottom surface 240 of the housing 202 and the legs of the staplers 124 face toward a top surface 242 of the housing 202. For ease of reference, the top surface of the housing faces toward the retaining fixture 111 (see Figure 1As described above, the entire staple cartridge 122 can be loaded into the removable fixture 112 for use in a procedure, as described in more detail below.

[0056] Reference now Figure 2-Figure 4 , a preferred embodiment of a stapler 124 and a stapler pusher 126 according to the present disclosure will now be described. The stapler pusher 126 includes an elongated body 202 having a substantially flat bottom surface 204 and a top surface 206. The body 202 preferably includes a substantially unitary member having a geometry that is primarily designed to provide support to the stapler 124, the unitary member fitting within the cartridge 122 to perform its function and withstand the loads applied to the pusher 126 during deployment. Therefore, the body 202 will preferably have a length and width that are only slightly greater than the corresponding length and width of the back span of a surgical stapler used in clinical applications. However, those skilled in the art will recognize that the body 202 is not limited to Figure 2 and Figure 3 The precise geometry shown in . Additionally, the body 202 may be formed from two or more parts that are suitably coupled together.

[0057] The recess in the top surface 206 forms a recess 210 in the body 202 for receiving the stapler 124. The recess 210 preferably includes a first outer curved surface or ramp 212 and a second outer curved surface or ramp 214 connected to a central (substantially flat) surface 216. The curved surfaces 212, 214 allow a larger bending radius of the stapler legs and more support for the stapler 124 in the recess 210, as discussed in more detail below. However, the recess 210 can have other suitable sizes and / or geometries to accommodate different staplers and / or adapt to different clinical applications. For example, although the applicant has found that the above-mentioned radius of curvature is advantageous, the angle of the surface 212, 214 relative to the flat portion of the surface 216 can be anywhere between about 90 degrees and about 135 degrees, depending on the size and shape of the stapler 124 and / or the desired clinical application.

[0058] In an exemplary embodiment, the top surface 206 of the staple pusher 126 is generally inclined upward at both ends of the pusher 126 so that it substantially conforms to the geometry of the surface 216 and the curved surfaces 212, 214 of the recess 210. Applicants have found that this configuration provides sufficient support to allow the pusher 126 to perform its function. However, the present invention is not limited to this configuration and the top surface 206 may include other configurations or geometries as long as it forms a suitable recess 210 for the stapler 124 according to the present invention. For example, the top surface 206 may be substantially planar so that the central section of the top surface 206 is higher than shown in the figure (i.e., a shallower recess has less or no upward inclination at the end of the top surface 206 to conform to the geometry of the recess 210).

[0059] The stapler 124 includes a first leg and a second leg 230, 232 and a back span 234 therebetween. The legs 230, 232 are generally formed to be slightly open to allow their tips to bear on the end of the bin 122 and to hold the stapler 124 in the bin 122 before deployment. In the present invention, the bending radius between each of the legs 230, 232 and the back span 234 is preferably at least about 0.015 inches, more preferably between about 0.015 inches and about 0.030 inches. The configuration of the recess 210 allows the bending radius of the stapler 126 to be greater than that of conventional staplers in surgical instruments. In some cases, the larger bending radius of the present invention can minimize the deformation of the stapler 126 during use. In addition, increasing the bending radius of the stapler 124 allows additional wall support around the stapler, thereby effectively allowing the pusher 126 to be made taller without jeopardizing its longitudinal length (i.e., the length of the back span 234). This is important because the longitudinal spacing of the staples 124 within the cartridge 122 is preferably designed so that the staples 124 are very close to each other to ensure proper hemostasis at the surgical site. As a result, the longitudinal length of the pusher 126 is preferably not significantly longer than the back span 234 of the staples 124. Otherwise, the staples 124 will be spaced farther apart from each other within the cartridge 122, potentially compromising the sealing efficiency of the surgical device.

[0060] The staple pusher 126 includes an outer surface 218 that substantially surrounds the body 202 between the top and bottom surfaces 204, 206 (except for the groove 250 discussed below). As shown, the outer surface 218 extends above the recess 210 to form a substantially circumferential wall 220 surrounding the recess 210 to provide support for the staples 124 (see FIG. Figure 2). The pocket 210 is preferably deep enough so that the entire back span 234 of the stapler 126 fits within the pocket 210. In addition, the curved radius between each of the legs 230, 232 and the back span 234 of the stapler 124 also preferably fits within the pocket 210 along the curved surface 212. This additional support ensures that the stapler 124 will remain in contact with the pusher 126 prior to use. In addition, it provides support for the stapler 124 during use to minimize deformation of the legs 230, 232.

[0061] The circumferential wall 220 may have other configurations. For example, the wall 220 may be configured to surround only a portion of the backspan 210 (i.e., a central wall on either side of the pocket 210 without any material at either end of the pusher body 202) or the wall 220 may be formed only at the ends of the pusher 126 without any material in the center. Alternatively, the wall 220 may have gaps at certain points along its perimeter, or it may not actually be a wall surrounding the pocket, but rather a series of support posts extending upward from the pusher body 204 above the pocket 210 in appropriate locations to provide support for the staples 124.

[0062] The applicant has found that there are certain key dimensions for the staple pusher 126, which provide sufficient support and material strength to perform its function while maximizing the height of the staples 124 in the bin 122 of a given size. The exact size will vary depending on the size and function of the bin 122. However, the applicant has found that a certain size ratio will maximize performance. To this end, the maximum height of the pusher 126 can be defined as the distance from the lower surface 204 to the top surface 206 at the end of the pusher 126 (that is, the distance at which the top surface 206 extends the farthest from the bottom surface 204). The minimum height of the recess 210 can be defined as the distance from the lower surface 204 of the body 202 to the center surface 216 of the recess 210. The applicant has found that there is a critical ratio between these two distances, which maximizes the height of the staple relative to a given surgical instrument size while providing sufficient support for the staples and allowing a sufficient volume of material in the staple pusher to withstand structural loads during use. The critical ratio of (i) the distance from the bottom of the staple pusher 204 to the pocket bottom surface 216 to (ii) the overall height of the staple pusher is preferably less than about 0.6 to 1. In one embodiment, the ratio is about 0.53 to 1.

[0063] like Figure 3As shown, the staple pusher 126 also includes a groove 250 in the outer surface 218 for receiving a substantially linear protrusion, rib or guide (not shown) in the cartridge 122. The groove 250 extends from the bottom surface 204 to the top surface 206 and is sized to engage with the cartridge guide and allow the staple pusher 126 to move in a direction substantially perpendicular to the longitudinal axis of the cartridge housing 202. The groove 250 ensures that when the drive member 150 is translated distally, the staple pusher 126 and the staples 124 are not moved distally but are driven upward along the staple cartridge guide, so that when the movable clamp 112 engages the fixed clamp 110, the staples 124 are ultimately driven into the tissue.

[0064] In other embodiments, the pusher 124 may be formed without the groove 250. In these embodiments, other mechanisms may be used to ensure that the staple pusher 124 is driven upward into the fixed fixture 110 during actuation. For example, the cartridge 122 may include a guide rail or other material at the distal end of each pusher 126 or at each staple assembly to prevent the staple assembly from moving distally when the drive member 150 engages them. In this configuration, the pusher 124 will not have a groove and the circumferential wall 220 may extend completely around the pocket 210.

[0065] Figure 4 A semi-transparent view of a portion of the staple cartridge 122 is shown. As shown, the bottom surface 204 of the staple pusher 126 preferably resides near the bottom surface 240 of the staple cartridge 122. The pusher 126 and the staples 124 are configured such that the tips of the staple legs 230, 232 preferably reside substantially near the top surface 242 of the staple cartridge 122.

[0066] In the present invention, the recess 210 of the staple pusher 126 provides additional vertical space for the staple 124. Therefore, the staple cartridge 122 can be designed to have a higher staple than conventional staples and / or the entire cartridge can have an overall profile (e.g., diameter) smaller than a conventional staple cartridge. In an exemplary embodiment, the staple cartridge 122 of the present invention preferably has a diameter less than 12 mm, more preferably about 8 mm. This smaller diameter cartridge allows the design of smaller, more compact surgical instruments, which provides more ease of operation for surgeons during surgical operations. In addition, smaller and more compact surgical instruments are less likely to contact and less likely to damage the adjunct tissue in the surgical field.

[0067] In certain embodiments, the clamps 111, 112 are attached to the surgical instrument 100 via a suitable coupling device, such as a U-shaped clamp 140. The U-shaped clamp 140 includes an upper portion and a lower portion that cooperate when assembled to form a protrusion 145 that is configured to engage the tab 113 of the clamp 111 (see Figure 1A ) to securely mount the clamp 111 in a fixed position on the instrument 100. The clevis 140 also includes an opening for receiving the pivot pin 130, which defines a pivot axis about which the clamp 112 pivots, as described in more detail below. A more complete description of a suitable clevis 140 for use with the present invention can be found in commonly assigned, co-pending provisional patent applications Nos. 62 / 783,444 (filed December 21, 2018), 62 / 783,481 (filed December 21, 2018), 62 / 783,460 (filed December 21, 2018), and 62 / 783,471 (filed December 21, 2018). Submitted on December 21, 2011), 62 / 747,912 (filed October 19, 2018) and 62 / 783,429 (filed October 19, 2018) 21, 2007, the entire disclosure of which is incorporated herein by reference in its entirety for all purposes. Of course, those skilled in the art will recognize that other coupling mechanisms known to those skilled in the art can be used with the present invention to attach the clamps 111, 112 to the proximal portion of the surgical instrument 100.

[0068] Reference now Figure 5 , the end effector 110 can be articulated in multiple directions by an articulation mechanism. In some embodiments, the articulation mechanism can be a wrist 160 as shown, but other articulation mechanisms are also contemplated. As shown, a preferred embodiment of the wrist 160 includes a plurality of articulation joints 162, 164, 166, etc., which define a hole 167, an actuation mechanism (in some embodiments, a coil 120 and a drive cable 171, see Fig. 6A ) can pass through the hole 167. When leaving the articulated wrist 160, the coil 120 enters and passes through the internal passage (not shown) of the U-shaped clip 140, and finally engages the proximal surface of the upper shoe 152 of the drive member 150 (see Fig. 7A ). Other articulation mechanisms known to those skilled in the art may replace wrist 160. Other exemplary articulation mechanisms are shown, for example, in commonly assigned, co-pending U.S. Publication No. 2015 / 0250530 and International Application No. PCT / US19 / 62344 (filed on November 20, 2019), the entire disclosures of which are incorporated herein by reference in their entirety for all purposes.

[0069] like Fig. 6A and Figure 6BAs shown, a preferred embodiment of the drive member 150 may include a body having an upper protrusion or base plate 152, a lower protrusion or base plate 154, a central portion 156, and a first lateral portion and a second lateral portion 159. The lateral portion 159 is a fin that forms the shuttle 123 shown previously. The lateral portions 159 of the drive member 150 each include a distal inclined surface or ramp 161 that engages with the pusher 126 to drive the pusher 126 (and the associated stapler 124) vertically or perpendicularly to the longitudinal axis of the shaft 106 when the drive member 150 is translated distally. In a preferred embodiment, the shuttle fin 159 is integrated into the lower base plate 154 of the drive member 150. Integrating the shuttle fin 159 into the drive member 150 provides more flexibility in the design of the staple cartridge 122. For example, this can allow a reduction in the size of the staple cartridge 122 and the surgical instrument 100 and / or increase the length of the staples 124 for a given size of the surgical instrument 100.

[0070] like Fig. 7A and Figure 7B As shown, the actuation assembly 190 includes a drive cable 171, a coil 120, a sheath 121 surrounding the coil 120, and a drive rod 175. The drive cable 171 includes an enlarged distal end 173. The upper base plate 152 of the drive member 150 includes a hole 158 into which the drive cable 171 is routed. When the exemplary surgical instrument 100 is assembled, the coil 120 and the protective sheath 121 are slid over the free end of the drive cable 171. The free end of the drive cable 171 is attached to the drive rod 175, thereby fixing the coil 120 and the protective sheath 121 between the drive member 150 and the drive rod 175 (as shown in FIG. 1 ). Figure 7B As shown). The sheath 121 can promote stability, smooth movement, and prevent bending when the surgical instrument 100 is actuated. The sheath 121 can be made of polyimide or any other suitable material with the necessary strength requirements, such as various reinforced Plastics, nickel-titanium alloys (such as NITINOL TM ), polyterephthalamide (poly para-phenyleneterphtalamide) materials (e.g., KEVLAR commercially available from DuPont TM ). Other suitable materials can be envisioned by those skilled in the art.

[0071] The enlarged distal end 173 of the drive cable 171 resides within the enlarged distal portion 159 of the hole 158 in the upper base plate 152 of the drive member 150, so that when the drive cable 171 is pulled proximally (i.e., along the Figure 7BThe proximal side 157 of the distal end 173 that is enlarged (in the direction of arrow "B" in FIG. 1 ) can exert a retraction force on the upper base plate 152. The drive rod 175 is operably connected to an actuator (e.g., movable handle 102b) that allows distal translation and proximal retraction of the actuation assembly 190. Those skilled in the art will recognize that in a manually actuated instrument, the actuator can be a movable handle, such as Figure 1 The movable handle 102b shown; in a power instrument, the actuator may be a button (not shown) that causes the motor to act on the drive rod; and in a robotic system, the actuator may be a control device, such as the following combination Fig. 9 and Fig.10 Any suitable rear-end actuation mechanism for driving components of a surgical stapling instrument may be used. For additional details on an exemplary actuation mechanism using a push / pull drive cable, see, for example, commonly assigned, co-pending International Application No. WO 2018 / 049217, the disclosure of which is incorporated herein by reference in its entirety.

[0072] Now refer to Figure 8 , the upper base plate 152 of the drive member 150 is substantially aligned with and translates through the channel 118 in the fixed fixture 111, and the lower base plate 154 of the drive member 150 is substantially aligned with and translates through the channel (not shown) and below the fixture 112. Fig. 7A and Figure 7B As shown, a hole 158 is formed through the upper base plate 152 to receive the drive cable 171, as will be described in more detail below. The proximal surface 153 of the upper base plate 152 is configured to be engaged by the coil 120 of the actuation assembly 190 so that the coil 120 can apply a force to the upper base plate 152 to move distally (i.e., along the axis of the actuator assembly 190). Figure 7B The drive member 150 is advanced in the direction of the arrow "A" in FIG. 14. The knife 128 can be formed on the drive member 150 along the distal edge between the upper base plate 152 and the central portion 156.

[0073] During actuation of the exemplary surgical instrument 100, the drive rod 175 applies a force to the coil 120, thereby causing the coil 120 to apply a force to the upper base plate 152 of the drive member 150, moving the upper base plate 152 distally (i.e., along the Figure 7BThe drive member 150 is first closed by translating the distal end 173 of the drive cable 171 (in the direction of the arrow "A"), and then the stapler 124 is ejected from the magazine 122 to staple the tissue. After the stapling is completed, the drive rod 175 applies a force in the proximal direction to achieve the retraction of the drive member. During the retraction, the enlarged distal end 173 of the drive cable 171 is blocked by the wall 157 of the enlarged portion 159 of the hole 158, causing the drive cable 171 to apply a force to the upper base plate 152 of the drive member 150, thereby translating the drive member 150 in the proximal direction. In some embodiments, the surgical instrument may be designed so that the drive member 150 does not retract in the proximal direction after the stapler is fired. It will be understood by those of ordinary skill in the art that the drive member 150, the drive cable 171, and the drive rod 175 all move in unison and remain in the same relative position to each other.

[0074] In use, in the open configuration, the drive member 150 is positioned proximal to the cam surface 114 formed on the movable clamp 112. As the drive member 150 translates in the distal direction, the movable clamp 112 will rotate about the pivot 117 toward the closed position. Once the drive member 150 has contacted the cam surface 114 of the movable clamp 112, the lower portion 154 of the drive member 150 is located under the cam surface 114, and the drive member 150 pushes the movable clamp 112, causing the movable clamp 112 to pivot toward the closed position. In the closed position, the drive member 150 has translated distally past the cam surface 114. In this position, the tissue is clamped, and further advancement of the drive member will cut and staple the tissue. Of course, those skilled in the art will recognize that the drive member 150 can be any structure that can push at least one of the shuttle or knife of the surgical stapling instrument with the necessary force to effectively cut or staple human tissue. The drive member 150 may be an I-beam, an E-beam, or any other type of drive member capable of performing similar functions. The drive member 150 is movably supported on the surgical stapling instrument 100 so that when the surgical stapling instrument is fired (e.g., actuated), the drive member 150 may pass distally through the staple cartridge and the upper fixing clamp 111 and the lower clamp 112.

[0075] As an example, Fig. 9 A top view of an operating room employing a robotic surgical system is shown. In this case, the robotic surgical system is robotic surgical system 300, which includes a control console ("C") used by a surgeon ("S") to perform minimally invasive diagnostic or surgical procedures on a patient ("P") lying on an operating table ("O"), typically with the assistance of one or more assistants ("A").

[0076] The console includes a monitor 304 for displaying an image of the surgical site to the surgeon, left and right manipulable control devices 308 and 309, a foot pedal 305, and a processor 302. Control devices 308 and 309 may include one or more of any of a variety of input devices, such as a joystick, a glove, a trigger gun, a manually operated controller, or the like. Processor 302 may be a dedicated computer that may be integrated into the console or located next to the console.

[0077] The surgeon performs minimally invasive surgery by manipulating control devices 308 and 309 (also referred to herein as “master manipulators”) such that the processor 302 causes their respective associated robotic arm assemblies 328 and 329 (also referred to herein as “slave manipulators”) to correspondingly manipulate their respective removably coupled surgical instruments 338 and 339 (also referred to herein as “tools”) while the surgeon views the surgical site captured by the stereoscopic endoscope 340 in 3-D on the console monitor 304.

[0078] Each of tools 338 and 339, as well as endoscope 340, can be inserted into the patient through a cannula or other tool guide (not shown) so as to extend down to the surgical site through a corresponding minimally invasive incision, such as incision 366. Each of the robotic arms is generally formed of links, such as link 362, which are coupled together and manipulated by motor-controlled or movable joints, such as joint 363.

[0079] The number of surgical tools used at one time, and therefore the number of robotic arms used in system 300, will generally depend on factors such as the diagnostic or surgical procedure and the space limitations in the operating room. If during a procedure it is necessary to replace one or more of the tools in use, the assistant can remove the tool no longer in use from the tool's robotic arm and replace it with another tool 331 from a tray ("T") in the operating room.

[0080] Monitor 304 can be positioned near the surgeon's hand so that monitor 304 will display a directional projection image so that the surgeon feels that he or she is actually looking directly at the operating site. To this end, the images of tools 338 and 339 may appear to be located substantially where the surgeon's hand is.

[0081] Processor 302 performs various functions in system 300. One important function it performs is to convert and transmit the mechanical motion of control devices 308 and 309 to their respective robotic arms 328 and 329 via control signals on bus 310 so that surgeons can effectively manipulate their respective tools 338 and 339. Another important function is to implement the various control system processes as described herein.

[0082] Although described as a processor, it should be understood that the processor 302 may be implemented in practice by any combination of hardware, software, and firmware. In addition, the processor functions described herein may be performed by one unit, or divided between different components, each of which may in turn be implemented by any combination of hardware, software, and firmware. For additional details on the robotic surgical system, see, for example, co-owned U.S. Patent No. 6,493,608, "Aspects of a Control System of a Minimally Invasive Surgical Apparatus," and co-owned U.S. Patent No. 6,671,581, "Camera Referenced Control in a Minimally Invasive Surgical Apparatus," which are incorporated herein by reference in their entirety for all purposes.

[0083] As an example, Fig.10 A simplified (not necessarily to scale or complete) illustrative robotic arm assembly 400 (representing robotic arm assemblies 328 and 329) holding a surgical instrument 450 (representing tools 338 and 339) for performing a surgical procedure is shown in side view. The surgical instrument 450 is removably held in a tool holder 440. The arm assembly 400 is mechanically supported by a base 401, which can be part of a patient-side mobile cart or fixed to an operating table or ceiling. It includes links 402 and 403, which are coupled together and to the base 401 by mounting joints 404 and 405.

[0084] In this example, the mounting joints / setup joints 404 and 405 are passive joints that allow manual positioning of the arm 400 when their brakes are released. For example, the mounting joint 404 allows the link 402 to be manually rotated around the axis 406, and the mounting joint 405 allows the link 403 to be manually rotated around the axis 407. Although only two links and two mounting joints are shown in this example, more or fewer links and mounting joints may be used as appropriate in this and other robotic arm assemblies in conjunction with the present invention. For example, while the mounting joints 404 and 405 may be used for horizontal positioning of the arm 400, additional mounting joints may be included and used for limited vertical and angular positioning of the arm 400. However, for the primary vertical positioning of the arm 400, the arm 400 may also be slidably moved and locked in place along the vertical axis of the base 401.

[0085] The mechanical arm assembly 400 also includes three movable joints driven by motors. The yaw joint 410 allows the arm segment 430 to rotate around an axis 461, and the pitch joint 420 allows the arm segment 430 to rotate around an axis perpendicular to the axis 461 and / or an axis orthogonal to the plane of the drawing. The arm segment 430 is configured so that when the pitch joint 420 is rotated by its motor, the arm segments 431 and 432 are always parallel to each other. Therefore, the instrument 450 can be controllably moved by driving the yaw and pitch motors to pivot around a pivot point 462, which is typically positioned by manual positioning of the mounting joints 404 and 405 so as to be located at the incision point in the patient's body. In addition, the insertion gear 445 can be coupled to a linear drive mechanism (not shown) to extend or retract the instrument 450 along the axis 463 of the instrument 450.

[0086] Although each of the yaw, pitch, and insertion joints or gears 410, 420, and 445 is controlled by a separate joint or gear controller, the three controllers are controlled by a common master / slave control system such that the robotic arm assembly 400 (also referred to herein as a "slave manipulator") can be controlled by manipulation of its associated master manipulator by a user (e.g., a surgeon). A more complete description of an exemplary robotic surgical system for use with the present invention may be found in commonly assigned U.S. Patent Nos. 9,295,524, 9,339,344, 9,358,074, and 9,452,019, the complete disclosures of which are incorporated herein by reference in their entirety for all purposes.

[0087] All issued patents, published patent applications, and non-patent publications mentioned in this specification are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual issued patent, published patent application, or non-patent publication was specifically and individually indicated to be incorporated by reference.

[0088] Although several embodiments of the present disclosure are shown in the accompanying drawings, the present disclosure is not intended to be limited thereto, as the scope of the present disclosure is as broad as the art allows, and this specification should be read as such. Therefore, the above description should not be interpreted as limiting, but merely as an example of the presently disclosed embodiments. Therefore, the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

[0089] Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. Features shown or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Various alternatives and modifications may be devised by those skilled in the art without departing from the present disclosure. Therefore, the present disclosure is intended to cover all such alternatives, modifications, and variations. Likewise, those skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Therefore, except as indicated in the appended claims, the present disclosure is not limited by what has been specifically shown and described.

Claims

1. A surgical instrument comprising: an end effector including a first gripper and a second gripper configured to move relative to each other between an open position and a closed position; as well as A stapler cartridge coupled to one of the first clamp or the second clamp and comprising one or more stapler assemblies, wherein each stapler assembly comprises: a staple pusher having a surface with recesses; as well as A stapler having a first leg and a second leg and a back span connecting the first leg to the second leg, wherein at least a portion of the back span is configured to fit within the recess of the stapler pusher.

2. The surgical instrument of claim 1 , wherein the surface is a first surface, the staple pusher having a second surface opposite the first surface, wherein a distance from the second surface of the staple pusher to an inner surface of the recess is less than approximately 60% of a distance between the first surface and the second surface of the staple pusher.

3. The surgical instrument of claim 1, wherein the recess forms a pocket in the staple pusher, wherein the backspan of the stapler is configured to reside entirely within the pocket and below the surface of the staple pusher.

4. The surgical instrument of claim 1, wherein a transition between each of the first and second legs and the back span of the stapler has a bend radius of at least approximately 0.015 inches.

5. The surgical instrument of claim 4, wherein the bend radius is approximately 0.015 inches to 0.030 inches.

6. The surgical instrument of claim 1, wherein the staple pusher defines a curved portion between the backspan and the legs, and wherein the curved portion resides substantially in the recess and below the surface of the staple pusher.

7. The surgical instrument of claim 1, wherein the recessed portion of the staple pusher comprises a first curved surface and a second curved surface connected together by a center surface therebetween.

8. The surgical instrument of claim 1, wherein the staple pusher comprises a support element extending above the recess, wherein the support element comprises a wall at least partially surrounding the recess.

9. The surgical instrument of claim 8, wherein the support element substantially surrounds the recess.

10. The surgical instrument of claim 1, further comprising an elongated shaft and a drive member configured to be translated distally by the end effector.

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