Surgical instrument for applying plurality of clips to tissue
By designing endoscopic surgical instruments that can rotate and articulate, the problems of difficulty in applying and fixing multiple clips in existing technologies have been solved, achieving efficient and flexible clip application and improving the operational efficiency and safety of minimally invasive surgery.
Patent Information
- Application Number
- CN202480036781.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-06-02
- Filing Date
- 2024-06-03
- Publication Date
- 2026-01-20
AI Technical Summary
Existing endoscopic surgical clip applicators have limitations in minimally invasive surgery, such as the inability to release multiple clips simultaneously without changing instruments or repositioning the jaws. Furthermore, clips tend to become deformed when stored in the clip cartridge, leading to application failures.
An endoscopic surgical instrument is designed, including an elongated shaft, a wrist assembly, and an end effector. The drive component is movable between an open position and a closed position, and the surgical clamps are delivered to the jaws via the drive component. The jaws are allowed to rotate and articulate relative to the shaft, enabling the automatic application and release of multiple clamps.
It improves surgical efficiency, reduces workflow disruptions for surgeons, enhances the flexibility and maneuverability of instruments in minimally invasive surgery, ensures that the clamps are firmly held in the jaws, and avoids clamp fixation problems.
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Figure CN121368458A_ABST
Abstract
Description
Cross Reference to Related Applications
[0001] This application claims the benefit of the following U.S. provisional applications: (1) Serial No. 63 / 505,738, filed June 2, 2023; (2) Serial No. 63 / 505,740, filed June 2, 2023; (3) Serial No. 63 / 505,742, filed June 2, 2023; (4) Serial No. 63 / 505,870, filed June 2, 2023; (5) Serial No. 63 / 505,875, filed June 2, 2023; and (6) Serial No. 63 / 505,735, filed June 2, 2023, the entire disclosures of which are hereby incorporated by reference for all purposes. BACKGROUND
[0002] The present description relates generally to endoscopic surgical instruments for dissecting, occluding, and / or sealing tissue, and more particularly to endoscopic surgical instruments capable of applying multiple clips to blood vessels and / or tissue.
[0003] Minimally invasive medical techniques aim to reduce the amount of collateral tissue that is damaged during a diagnostic or surgical procedure, thereby reducing patient recovery time, discomfort, and harmful side effects. For example, one effect of minimally invasive surgery is a reduced post-operative hospital stay. The average hospital stay for a standard open surgery is typically significantly longer than the average hospital stay for a similar minimally invasive surgery (MIS). Thus, increasing the use of MIS can save millions of dollars in hospital costs each year. Despite the potential for many surgeries performed each year in the United States to be performed in a minimally invasive manner, only a fraction of surgeries currently use these advantageous techniques due to limitations in minimally invasive surgical instruments and the additional surgical training involved in mastering them.
[0004] Improved surgical instruments such as tissue accessing, navigating, dissecting, and sealing instruments have revolutionized the field of surgery with MIS. These instruments allow surgical and diagnostic procedures to be performed in a manner that reduces trauma to the patient. A common form of minimally invasive surgery is endoscopy, and a common form of endoscopy is laparoscopy, which is a minimally invasive inspection and surgery performed inside the abdominal cavity. In a standard laparoscopic procedure, the patient’s abdomen is inflated with gas, and trocar sheaths are passed through small (approximately half an inch or less) incisions to provide entry ports for laparoscopic instruments.
[0005] Laparoscopic surgical instruments generally include an endoscope (e.g., a laparoscope) for viewing a surgical area, as well as 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 spaced from its handle by an elongate tube (also referred to as, e.g., an instrument shaft or main shaft). The end effector can include, for example, forceps, graspers, scissors, staplers, cauterizing tools, linear cutters, or needle holders.
[0006] To perform a surgical procedure, the surgeon passes the working tools through the cannula sheaths to the internal surgical site and manipulates them from outside the abdomen. The surgeon views the surgical procedure from a monitor that displays images of the surgical site taken by the endoscope. Similar endoscopic techniques are used, for example, in arthroscopy, retroperitoneoscopy, pelvoscopy, nephroscopy, cystoscopy, cisternoscopy, sinoscopy, hysteroscopy, urethroscoopy, etc.
[0007] Minimally invasive teleoperated surgical robotic systems are being developed to increase the surgeon's dexterity when working at an internal surgical site and to allow the surgeon to operate on a patient from a remote location (outside the sterile field). In a teleoperated surgical system, the surgeon is typically provided with an image of the surgical site at a control console. While viewing a three-dimensional image of the surgical site on a suitable viewer or display, the surgeon performs a surgical procedure on the patient by manipulating master input or control devices of the control console, which in turn control the motion of slave instruments operated by servomechanisms.
[0008] Servomechanisms for teleoperated surgery will typically accept input from two master controllers, one for each of the surgeon's hands, and can include two or more robotic arms, each of which mounts a surgical instrument. Operative communication between the master controllers and the associated robotic arms and instrument assemblies is 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 in the case of, e.g., force feedback. One example of a robotic surgical system is the DA VINCI™ system commercialized by Intuitive Surgical, Inc. of Sunnyvale, California.
[0009] A variety of structural arrangements have been used to support surgical instruments at a surgical site during robotic surgery. Slave linkages or "slaves" are commonly referred to as robotic surgical manipulators, and exemplary linkage arrangements for use as robotic surgical manipulators during minimally invasive robotic surgery are described in U.S. Patent No. 7,594,912 (filed September 30, 2004), U.S. Patent No. 6,758,843 (filed April 26, 2002), U.S. Patent No. 6,246,200 (filed August 3, 1999), and U.S. Patent No. 5,800,423 (filed July 20, 1995), the entire disclosures of which are hereby incorporated by reference herein in their entireties for all purposes. These linkages generally manipulate an instrument holder that mounts an instrument with a shaft. Such manipulator structures can include a parallelogram linkage portion that produces motion of the instrument holder that is constrained to rotation about a pitch axis that intersects a remote center of manipulation located along the length of the instrument shaft. Such manipulator structures can also include a yaw joint that produces motion 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 center of manipulation. By aligning the remote center of manipulation with the incision point of an internal surgical site (e.g., with a trocar or cannula at the abdominal wall during laparoscopic surgery), the end effector of a surgical instrument can be safely positioned by using the manipulator linkage to move the proximal end of the shaft without applying potentially dangerous forces to the abdominal wall. Alternative manipulator structures are described in U.S. Patent No. 6,702,805 (filed November 9, 2000), U.S. Patent No. 6,676,669 (filed January 16, 2002), U.S. Patent No. 5,855,583 (filed November 22, 1996), U.S. Patent No. 5,808,665 (filed September 9, 1996), U.S. Patent No. 5,445,166 (filed April 6, 1994), and U.S. Patent No. 5,184,601 (filed August 5, 1995), the entire disclosures of which are hereby incorporated by reference herein in their entireties for all purposes.
[0010] During a surgical procedure, a teleoperational surgical system can provide mechanical actuation and control of various surgical instruments or tools having end effectors that perform various functions for the surgeon in response to manipulation of master input devices, such as holding or driving a needle, grasping a blood vessel, dissecting tissue, etc. Manipulation and control of these end effectors is a particularly beneficial aspect of robotic surgical systems. Such mechanisms should be appropriately sized for use in minimally invasive surgery and designed to be relatively simple to reduce potential points of failure. In addition, such mechanisms should provide a sufficient range of motion to allow the end effectors to be manipulated in a variety of positions.
[0011] Endoscopic surgical clip appliers are used in many minimally invasive or endoscopic surgical procedures to occlude, ligate, and / or seal blood vessels and tissue. Applying surgical clips generally involves compressing the clip on a surgical site, such as a blood vessel. Once applied to a blood vessel, the compressed surgical clip terminates fluid flow through the blood vessel.
[0012] Conventional surgical clips are designed to be compressed around grasped blood vessels or other grasped tissue into a latched or locked position. Typically, the surgical instrument includes jaws that can be closed to engage tabs formed on the clip. These tabs are forced inward around a hinge section, thereby closing the first and second leg portions of the applied clip around the grasped blood vessel. The tip section of the second leg portion then comes into contact with the hook section. Upon opening of the jaws, the tip section snaps into and fittingly seats in the latching recess, at which point the clip is secured to the latched state.
[0013] Certain endoscopic surgical clip appliers include surgical instruments having end effectors with movable jaws and a single clip mounted within the end effector. These instruments are limited to a single discharge per instrument. In other words, once the clip is released and applied to tissue, the surgeon must remove the surgical instrument from the cannula and manually reload a new clip into the instrument or use a completely different surgical clip applier (i.e., a new instrument).
[0014] Other laparoscopic clip appliers have been developed that have magazines that can be preloaded with about 2 to 10 clips. However, these clip appliers are typically disposable and designed to be discarded after the procedure. Some existing endoscopic surgical clip appliers are "straight" or "non-wristed" instruments that do not allow the user to change the orientation of the jaws relative to the shaft of the instrument during or after clip advancement.
[0015] Additionally, over time, the clips in the clip magazine will typically "set' in the closed position (i.e., the legs of the clip tend to move closer to each other into the closed or semi-closed position when the clip is stored in the clip magazine). Unfortunately, once the clip is advanced into the jaw, these "clip-on-a-string" clip appliers do not have the ability to securely hold the clip's tab in the jaw. In this case, the clip applier can fire unsuccessfully and drop the clip into the surgical field.
[0016] Accordingly, while new teleoperational surgical systems and devices have proven to be very effective and advantageous, there is a continuing need for further improvements. In general, it would be desirable to provide an improved endoscopic clip applier that is capable of releasing multiple clips without requiring the exchange of the instrument or repositioning of the jaws. Additionally, it would be advantageous to provide such an improved endoscopic clip applier without sacrificing the overall size of the instrument, thereby allowing for the design of a compact and steerable instrument. SUMMARY
[0017] The following presents a simplified summary of the claimed subject matter 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 identify 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.
[0018] In one aspect, a surgical instrument for applying surgical clips to tissue includes an elongate shaft, a wrist assembly, and an end effector rotatably coupled to the wrist assembly about an axis substantially perpendicular to the shaft and including first and second jaws movable between open and closed positions. The instrument includes a drive member configured for translation from a distal end of the shaft into the end effector to deliver one or more surgical clips to the first and second jaws. The drive member includes a distal component for removable coupling to a clip and a flexible component positioned within the wrist assembly when the distal component is positioned within the end effector.
[0019] The drive member is configured to deliver the clip through the end effector, which is articulated relative to the shaft of the instrument. This allows the surgeon, for example, to deliver one or more surgical clips onto tissue or a blood vessel without having to change the orientation of the jaws during clip advancement, which reduces the disruption to the surgeon's workflow. Providing at least one degree of rotation of the end effector relative to the shaft enables the end effector to correspond to at least a portion of the natural motion of the surgeon's wrist, thereby facilitating the positioning of the jaws in the optimal position for performing the sealing / occluding function, particularly in laparoscopic procedures in which the instrument has been inserted through a small entry point into the abdominal cavity.
[0020] In embodiments, the distal portion of the drive member and the flexible portion can move through a wrist assembly between the shaft and the end effector. In one such embodiment, the wrist assembly includes one or more linkages for articulating the end effector about first and second axes, respectively. The first and second axes can be, for example, yaw and pitch axes. The one or more linkages can each include an internal channel or tube sized to allow the drive member and the clip to translate therethrough. This allows the user to deliver the surgical clip through the wrist assembly onto the tissue or blood vessel such that the end effector can be rotated about at least two axes relative to the shaft, thereby further increasing the ability of the surgeon to reposition the jaws relative to the target blood vessel or tissue.
[0021] In one such embodiment, the instrument includes a flexible tube extending through the wrist member, the flexible tube defining an internal channel for the drive member to pass through. The flexible tube can be configured to bend within the wrist member as the wrist member articulates the end effector relative to the shaft of the instrument.
[0022] In embodiments, the flexible portion of the drive member is configured to bend as the wrist member articulates the end effector relative to the shaft. In one such embodiment, the flexible portion includes one or more elongate rods that couple the proximal portion to the distal portion and that are equal to or greater in length than the length of the wrist assembly. The rods can include any suitable material that allows the flexible portion to bend or flex while maintaining sufficient rigidity to advance the clip through the wrist member and into the jaws of the instrument.
[0023] In embodiments, the distal portion of the drive member includes one or more engagement elements configured to removably couple the drive member to one or more clips within the clip magazine in the shaft. The engagement elements allow the drive member to secure to the clip in the magazine, advance the clip to the jaws, and then release from the clip before, during, or after the clip is closed and locked onto the tissue or blood vessel.
[0024] In one such embodiment, the engagement element includes a first retainer tab and a second retainer tab extending from a distal end portion of the drive member. The retainer tabs are biased inwardly toward the longitudinal axis of the shaft (or outwardly away from the longitudinal axis) and are configured to removably couple to a proximal end portion of the surgical clip, such as a proximal articulating portion of the clip and / or a proximal handle or protrusion extending from the clip. The drive member retains and controls the clip, which allows the drive member to position the clip within the jaws of the end effector and to maintain the clip as the end effector is opened and closed and / or articulated relative to the shaft of the instrument. This allows the surgeon to fully open the clips after they have been advanced into the jaws so that they can be effectively positioned around a target blood vessel or tissue. Additionally, this allows the surgeon to reposition the jaws relative to the shaft after the clips have been advanced into the jaws.
[0025] The engagement element can also include a third retainer tab and a fourth retainer tab extending from the distal end portion of the drive member. The third and fourth retainer tabs are biased inwardly toward the longitudinal axis of the shaft and are configured to provide additional security to the coupling between the drive member and the clip.
[0026] The drive member can include a housing sized to substantially enclose the clip magazine. The drive member can be coupled to the instrument shaft and configured to be advanced distally and proximally therethrough. In this embodiment, the instrument and drive member can be designed, for example, as a reusable device. Alternatively, the drive member can be coupled to the clip magazine. In this embodiment, the clip magazine and drive member can be designed, for example, as a single-use disposable device.
[0027] In embodiments, the first and second jaws each include a guide track extending from the wrist member to a distal end of the jaw. The guide track facilitates advancement of the clip and the engagement element of the drive member through the jaw and into position so that the jaw can open and / or close the clip.
[0028] In embodiments, the first and second jaws each have an engagement feature for securing the first and second arms of the clip to the jaw. The engagement feature ensures that the drive member can be released from the clip after the clip has been delivered to the jaw. In one such embodiment, the engagement feature includes a leaf spring coupled to the guide track that secures the arms of the clip within the jaw and prevents them from moving distally of the jaw. Additionally, the force required to withdraw the drive member from the clip is less than the force required to release the clip from the leaf spring, which allows the drive member to be withdrawn from the end effector after the clip has been secured to the jaw.
[0029] In another aspect, a surgical instrument for applying surgical clips to tissue includes an elongated shaft and an end effector coupled to the shaft and including first and second jaws movable between open and closed positions. The instrument includes a clip magazine within the shaft and including first proximal and second distal clips spaced apart from each other along a longitudinal axis. A drive member is configured to translate through the shaft to the end effector and includes first and second engagement elements for advancing the proximal and distal clips distally through the shaft.
[0030] In embodiments, the proximal and distal clips are spaced apart from each other a distance substantially equal to the distance between the distal clip and the jaws of the instrument. The drive member is configured to advance the distal clip from a first position within the clip magazine into the jaws of the instrument. The drive member is further configured to advance the proximal clip from a second position to the first position vacated by the distal clip. This allows the drive member to automatically advance the proximal clip forward distally in the clip magazine. The drive member can then be withdrawn proximally from the jaws and coupled to the proximal clip after the distal clip has been closed and latched to tissue and / or a blood vessel, which increases the speed and efficiency of applying multiple clips to a target site.
[0031] In embodiments, the first engagement element of the drive member is configured to removably couple to a proximal end portion of the clip, such as a hinge and / or a proximal handle or protrusion extending from the clip. In embodiments, the first engagement element includes first and second retainer tabs extending from a distal end portion of the drive member. The retainer tabs can be biased inwardly or outwardly and are configured to removably couple the drive member to the proximal end portion of the clip.
[0032] In one embodiment, the second engagement element of the drive member includes a pusher tab that is biased inwardly toward the longitudinal axis of the instrument. As the drive member moves distally through the shaft, the pusher tab is positioned to engage a proximal surface of the proximal clip and advance the proximal clip distally. This automatically moves the proximal clip to a position to be coupled to the first engagement element as the drive member is withdrawn from the jaws and back into the shaft of the instrument.
[0033] In embodiments, the clip magazine includes one or more windows or openings substantially aligned with each clip. These windows provide space for the pusher tab of the drive member to pivot into the clip magazine to contact and engage each clip. These windows also provide discrete positions along the magazine corresponding to each of the clips in the housing.
[0034] In another aspect, a surgical instrument for applying surgical clips to tissue includes an elongated shaft having a longitudinal axis and an end effector coupled to the shaft and including first and second jaws movable between open and closed positions. The instrument includes a clip magazine within the shaft that includes at least one clip having an engagement feature. A drive member is configured to translate through the shaft to the end effector and includes an engagement element for contacting and engaging the engagement feature of the surgical clip to advance the surgical clip distally.
[0035] In embodiments, the engagement feature of the surgical clip includes one or more protrusions extending laterally outward from the surgical clip. In one such embodiment, the surgical clip includes first and second arms pivotally coupled to one another at a proximal articulating portion, and the one or more protrusions extend from the proximal articulating portion.
[0036] The engagement element of the drive member includes a pusher tab that is biased inward toward the longitudinal axis of the shaft. The pusher tab is configured to contact and engage the proximal end of the one or more protrusions of the surgical clip so that the drive member can advance the clip distally through the clip magazine.
[0037] In embodiments, the drive member includes a second engagement element for removably coupling to the clip. The second engagement element is used to advance the clip from the clip magazine into the first and second jaws. In certain embodiments, the first engagement element advances the proximal clip through the magazine, and the second clip is advanced while the distal clip is advanced into the jaws. This allows multiple clips to be applied to a target site within a patient without the need to change instruments or clip magazines.
[0038] In embodiments, the second engagement element includes first and second retainer tabs extending from a distal end portion of the drive member, wherein the first and second tabs are biased inward toward the longitudinal axis. The retainer tabs can be configured to secure to a proximal end portion of the clip. The proximal end portion can be part of a proximal articulating portion of the clip, or it can be an engagement feature extending proximally from the clip.
[0039] In one embodiment, the drive member is disposed within a clip magazine, which can be, for example, disposable. In another embodiment, the drive member is movably coupled to the shaft, which can be, for example, reusable.
[0040] In certain embodiments, the drive member is coupled to an actuator configured to translate the drive member in a proximal direction and a distal direction. The actuator can include, for example, a handle of the surgical instrument that allows a surgeon to manually advance and retract the drive member and / or open and close the jaws of the instrument.
[0041] In embodiments, the actuator is configured for coupling to a robotic teleoperational control system. The robotic teleoperational control system can include a control system coupled to the actuator and configured to translate the drive member proximally and distally relative to the end effector. Additionally, the control system can include one or more actuators for opening and closing the jaws. For example, in one configuration, the actuator will be manipulated by a robotic manipulator assembly to move the jaws of the end effector between an open position and a closed position. In the closed position, the jaws are actuated into compressive contact with the legs of the clip, thereby compressing the clip into a latched or locked position about a blood vessel or other tissue.
[0042] In embodiments, the control system can monitor and control the longitudinal position of the drive member relative to each of the clips within the cartridge. In particular, the control system can monitor the position of the engagement element along the cartridge to determine when the drive member should be translated distally or proximally.
[0043] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the description. Additional features will be set forth in part in the description which follows, and in part will become apparent to those having ordinary skill in the art upon examination of the following or can be learned from practice of the description. BRIEF DESCRIPTION OF DRAWINGS
[0044] The foregoing and other aspects, features, and advantages of the present surgical instrument will become more apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which:
[0045] FIG. 1 is a perspective view of a distal portion of a surgical instrument;
[0046] FIG. 2 is FIG. 1 is an exploded view of a surgical instrument in which the clip cartridge is configured for insertion through a longitudinal slot in a side of the instrument shaft;
[0047] FIG. 3A and FIG. 3B illustrates a surgical instrument having a clip cartridge configured for insertion through a proximal end of the instrument;
[0048] FIG. 4 is FIG. 1 is a partial cross-sectional view of a surgical instrument;
[0049] FIG. 5 illustrates a magnified view of a portion of the clip cartridge and drive member of a surgical instrument;
[0050] FIG. 6A illustrates a drive member of a surgical instrument;
[0051] FIG. 6B illustrates a distal engagement element of a drive member;
[0052] FIG. 7A to FIG. 7E An alternative embodiment of a drive member for a surgical instrument is illustrated;
[0053] FIG. 8A A clip in an open position is illustrated;
[0054] FIG. 8B A clip in a closed position is illustrated;
[0055] FIG. 8C is a top view of one arm of the clip;
[0056] FIG. 8D is a side view of the clip in a partially closed position;
[0057] FIG. 9A is a side view of a distal hook on one arm of the clip;
[0058] FIG. 9B is a front view of a distal latch on the other arm of the clip;
[0059] FIG. 9C is a front view of the distal hook;
[0060] FIG. 9D is a rear view of the distal latch;
[0061] FIG. 9E is a close-up view of the hook and latch in a closed position;
[0062] FIG. 10A An alternative embodiment of a surgical instrument is illustrated; FIG. 1 first and second jaws of the instrument of
[0063] FIG. 10B The jaws in an open position are illustrated;
[0064] FIG. 10C The jaws in a closed position are illustrated;
[0065] FIG. 10D is a top view of one of the jaws, illustrating a four-bar linkage of the jaw;
[0066] FIG. 10E is a cross-sectional view of one of the jaws, illustrating a ramped leaf spring at a distal end of the jaw;
[0067] FIG. 11A is a cross-sectional view of the first and second jaws articulated in the yaw direction relative to the shaft;
[0068] FIG. 11Bis a cross-sectional view of an end effector of an instrument illustrating a drive member and a clip being advanced through a wrist assembly and into a jaw of the instrument;
[0069] FIG. 12A is a cross-sectional view of a portion of a surgical instrument illustrating a clip magazine and a drive member;
[0070] FIG. 12B is a close-up view of the clip magazine and drive member illustrating a distal engagement element of the drive member in a distal position relative to an upper ramp and a lower ramp on the clip magazine;
[0071] FIG. 13A and FIG. 13B illustrates the distal engagement element of the drive member after being retracted proximally relative to a set of distal upper and lower ramps on the clip magazine to a proximal position;
[0072] FIG. 14A and FIG. 14B illustrates the distal engagement element of the drive member passing through an opening in an outer surface of the clip magazine;
[0073] FIG. 15A to FIG. 15C illustrates the distal engagement element of the drive member engaging with an engagement feature on a first clip or distal-most clip in the clip magazine;
[0074] FIG. 16A and FIG. 16B illustrates the drive member advancing the first clip through a wrist of the surgical instrument and into a jaw;
[0075] FIG. 17 illustrates the clip and drive member engaged with a first jaw and a second jaw with the jaws in an open position;
[0076] FIG. 18 illustrates the first jaw and the second jaw articulated relative to a shaft about a wrist in an articulated position;
[0077] FIG. 19A illustrates the clip and drive member engaged with a first jaw and a second jaw with the jaws in a closed position;
[0078] FIG. 19B is a close-up view of a latch of a clip and a drive member engaged to one of the jaws;
[0079] FIG. 20A illustrates the drive member being retracted from an end effector of the instrument after the clip is latched;
[0080] FIG. 20B is a close-up view of the clip and the jaws in a closed position after the clip is latched;
[0081] FIG. 21illustrating a drive member positioned to retract proximally to engage a second clip in the clip magazine;
[0082] FIG. 22 is a perspective view of a distal portion of an alternative embodiment of a surgical clip applier instrument;
[0083] FIG. 23 illustrating a FIG. 22 surgical instrument having a clip magazine configured to be inserted through a longitudinal slot in a side of the instrument shaft;
[0084] FIG. 24 illustrating a FIG. 22 surgical instrument having a clip magazine configured to be inserted through a proximal end of the instrument;
[0085] FIG. 25 is an exploded view of the clip magazine and surgical instrument of FIG. 22
[0086] FIG. 26A is a cross-sectional view of the surgical instrument of FIG. 22 with the clip magazine installed;
[0087] FIG. 26B is a magnified view of a portion of the surgical instrument illustrating the clip magazine and a drive member and a distal engagement element of the drive member engaged with engagement features on a first clip or distal-most clip in the clip magazine;
[0088] FIG. 26C is a magnified view of a proximal engagement element of the drive member and a single clip within the magazine;
[0089] FIG. 27 illustrating a clip magazine configured for loading into a longitudinal slot or proximal opening of the surgical instrument of FIG. 22 ;
[0090] FIG. 28 illustrating a clip magazine configured for loading into a proximal opening of the shaft of the surgical instrument of FIG. 22 ;
[0091] FIG. 29A to FIG. 29C is a magnified view of a distal portion of the clip magazine and a single clip;
[0092] FIG. 30 illustrating a drive member of the surgical instrument;
[0093] FIG. 31 illustrating a distal portion of the drive member of FIG. 30 ;
[0094] FIG. 32 illustrating a proximal portion of the drive member of FIG. 30 ;
[0095] FIG. 33A to FIG. 33C Figure illustrates an alternative embodiment of a drive member for a surgical instrument;
[0096] FIG. 34 Figure illustrates the clip in a partially open position;
[0097] FIG. 35A Figure illustrates the clip in a fully open position;
[0098] FIG. 35B Figure illustrates the clip in a closed position;
[0099] FIG. 36A and FIG. 36B Figure illustrates a drive member coupled to a proximal portion of the clip;
[0100] FIG. 37A Figure illustrates another embodiment of a clip;
[0101] FIG. 37B Figure illustrates another embodiment of a drive member for use with the clip of FIG. 37A Figure illustrates another embodiment of a drive member for use with the clip of
[0102] FIG. 38A to FIG. 38C Figure illustrates another embodiment of a clip and drive member;
[0103] FIG. 39A and FIG. 39B Figure illustrates yet another embodiment of a clip and drive member;
[0104] FIG. 40A Figure illustrates a first jaw and a second jaw of a surgical clip applier instrument in an open position;
[0105] FIG. 40B Figure illustrates the first jaw and the second jaw in a closed position;
[0106] FIG. 40C is a partial cross-sectional view of the jaws in an open position;
[0107] FIG. 40D is a partial cross-sectional view of the jaws in a closed position;
[0108] FIG. 41A Figure illustrates another embodiment of a first jaw and a second jaw in an open position;
[0109] FIG. 41B Figure illustrates the jaws of FIG. 41A in a closed position;
[0110] FIG. 42 Figure illustrates a wrist assembly and drive cable for a surgical clip applier;
[0111] FIG. 43A is a partial cross-sectional view of the jaws in an open position; FIG. 42A partial cross-sectional view of the wrist assembly and drive cable;
[0112] FIG. 43B It is a partial cross-sectional view of the wrist assembly and drive cable, in which the wrist assembly articulates relative to the axis of the device;
[0113] FIG. 44A The diagram illustrates the inner tube inside the wrist assembly;
[0114] FIG. 44B An alternative embodiment of the inner tube for the wrist assembly is illustrated.
[0115] FIG. 45A yes FIG. 44A A three-dimensional view of the inner tube;
[0116] FIG. 45B The illustration shows the inner tube within the wrist assembly during joint movement.
[0117] FIG. 46 It is a 3D diagram of the drive cable used to open and close the jaws;
[0118] FIG. 47A The illustration shows some of the removed drive cables;
[0119] FIG. 47B The illustration shows a drive cable with heat shrink tubing on the flexible portion of the drive cable.
[0120] FIG. 47C The illustration shows a drive cable with an additional layer of heat shrink tubing.
[0121] FIG. 48A It is a cross-sectional view of the instrument, illustrating the drive component that pushes the clamp through the axis of the instrument;
[0122] FIG. 48B This is an enlarged view of the drive component connected to the clamp;
[0123] FIG. 49A It is a cross-sectional view of the device, illustrating the drive mechanism that pushes the clamp through the wrist assembly;
[0124] FIG. 49B yes FIG. 49A A magnified view;
[0125] FIG. 49C The illustration shows a drive member that pushes the clamp through the wrist assembly during joint movement of the wrist relative to the axis;
[0126] FIG. 49D yes FIG. 49C A partial cross-sectional view;
[0127] FIG. 50A and FIG. 50Billustrating the clip advancing through guide tracks in the jaws;
[0128] FIG. 51 illustrating the clip secured to the distal end of the jaws as the drive member is withdrawn proximally from the jaws;
[0129] FIG. 52A to FIG. 52C illustrating the jaws of the latching clip in a closed position;
[0130] FIG. 53 is a perspective view of the inner tube in an articulating orientation;
[0131] FIG. 54A to FIG. 54C illustrating the clip advancing through the wrist assembly in a substantially orthogonal orientation relative to the wrist axis;
[0132] FIG. 55A to FIG. 55C illustrating the clip advancing through the wrist assembly in a substantially 45 degree orientation relative to the wrist axis;
[0133] FIG. 56 is a perspective view of a representative teleoperated surgical instrument that can be used with the exemplary embodiments of the present teachings;
[0134] FIG. 57 illustrating a plan view of an operating room employing a robotic surgical system;
[0135] FIG. 58 illustrating a simplified side view of a robotic arm assembly; and
[0136] FIG. 59 is a flowchart of a process for operating a surgical clip applier instrument having a control system. DETAILED DESCRIPTION
[0137] A specific embodiment of the surgical instrument is described below with reference to the drawings; however, it is to be understood that the disclosed embodiment is merely exemplary and can be embodied in various forms. Accordingly, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present devices and methods in virtually any appropriately detailed structure. Well-known functions or constructions are not described in detail to avoid obscuring the present description in an unnecessary manner. Like numbers refer to like elements throughout. Additionally, whenever possible, like reference numerals will be used in different drawings to refer to the same or like elements. Moreover, unless specifically stated otherwise, elements and their associated aspects as described throughout can be included in any other embodiment unless specifically stated otherwise.
[0138] Although the following is presented with respect to a surgical instrument that is compatible with a surgical clip magazine, it should be understood that certain features of the presently described surgical instrument can be readily adapted for use in any type of surgical clipping, cutting, ligating, dissecting, grasping, cauterizing, suturing, and / or sealing instrument, whether the surgical instrument applies clips or other types of fasteners. Additionally, features of the presently described surgical ligating instrument can be readily adapted for use in any technically actuated surgical instrument, such as, for example, manually actuated surgical instruments, powered surgical instruments (e.g., electromechanical powered instruments), robotic surgical instruments, etc., within the knowledge of one skilled in the art.
[0139] The devices described herein, or certain components of the devices, can also be incorporated into various different surgical instruments, such as those described in co-pending U.S. Patent Application No. 16 / 205,128, U.S. Patent Application No. 16 / 427,427, U.S. Patent Application No. 16 / 678,405, U.S. Patent Application No. 16 / 904,482, U.S. Patent Application No. 17 / 081,088, and U.S. Patent Application No. 17 / 084,981, as well as International Patent No. PCT / US2019 / 107646, International Patent No. PCT / US2019 / 019501, International Patent No. PCT / US2019 / 062344, International Patent No. PCT / US2020 / 54568, International Patent No. PCT / US2019 / 064861, International Patent No. PCT / US2019 / 062768, International Patent No. PCT / 2020 / 025655, International Patent No. PCT / US2020 / 056979, International Patent No. PCT / 2019 / 066513, International Patent No. PCT / US2020 / 020672, International Patent No. PCT / US2019 / 066530, and International Patent No. PCT / US2020 / 033481, the entire disclosures of which are incorporated by reference herein in their entireties for all purposes, as if reproduced and pasted herein.
[0140] FIG. 1 A distal end portion of a surgical instrument 100 is illustrated in accordance with an illustrative implementation. The surgical instrument 100 includes an end effector 110, an elongated shaft 105, and a wrist assembly 140 coupling the end effector 110 to the shaft 105. A proximal end portion of the elongated shaft 105 is operatively connected to an actuation mechanism (not shown), although as will be appreciated by those skilled in the art upon reading the present description, components of the actuation mechanism can extend into and / or through the elongated shaft 105 and / or the wrist assembly 140.
[0141] In certain implementations, the surgical instruments described herein are adapted for use with a robotic system to apply a ligation clip. The surgical instrument will generally include an actuation mechanism that controls the orientation and movement of the end effector. The actuation mechanism will generally be controlled by a robotic manipulator assembly that is controlled remotely by a user. For example, in one configuration, the actuation mechanism will be manipulated by the robotic manipulator assembly to move the jaws of the end effector between an open position and a closed position. In the closed position, the jaws are actuated into compressive contact with the legs of the clip, thereby compressing the clip into a latched or locked position around a blood vessel or other tissue.
[0142] End effector 110 includes a first jaw 111 and a second jaw 112, the first jaw 111 and the second jaw 112 being configured in an open position (e.g., FIG. 1 The clamp 111 moves between an open position (shown as an example) and a closed position, in which the jaws are spaced apart from each other, and in a closed position, the jaws are forced into pressing contact with the legs of the clamp to close and seal the clamp around a blood vessel or tissue. In some embodiments, the second jaw 112 is a movable jaw configured to move relative to the first jaw 111 from an open position to a closed position. In other embodiments, the first jaw 111 is a movable jaw configured to move relative to the second jaw 112 between an open position and a closed position. In yet another embodiment, the two jaws 111, 112 are movable relative to each other.
[0143] The actuation mechanism may include an input connector (not shown) as an alternative to or addition to the fixed handle and the movable handle. In some embodiments, the surgical instrument 100 will further include a rear-end mechanism 510 (see [link to relevant documentation]). FIG. 3A and FIG. 56 The rear-end mechanism 510 is coupled to the proximal end portion of the elongated shaft 105. Rear-end mechanisms typically provide mechanical connection between the drive tendon, rod, or cable of an instrument and the motorized shaft of the mechanical interface of the drive system. Further details of known rear-end mechanisms and surgical systems are described, for example, in U.S. Patent Nos. 8,597,280, 7,048,745, and 10,016,244. Each of these patents is incorporated herein by reference in its entirety.
[0144] The input connector can engage with and be driven by a corresponding output connector (not shown) of a remote surgical system, such as the system disclosed in U.S. Patent Application No. 2014 / 0183244A1, the entire disclosure of which is incorporated herein by reference. The input connector is drivenly connected to one or more input members (not shown) disposed within instrument shaft 105. The input members are drivenly connected to end effector 110. Suitable input connectors can be adapted to cooperate with various types of motor assemblies (not shown), such as the suture-specific motor assembly disclosed in U.S. Patent No. 8,912,746, or the general-purpose motor assembly disclosed in U.S. Patent No. 8,529,582, the disclosures of which are incorporated herein by reference in their entirety. Further details of known input connectors and surgical systems are described, for example, in U.S. Patent Nos. 8,597,280, 7,048,745, and 10,016,244. Each of these patents is incorporated herein by reference in its entirety for all purposes.
[0145] While described herein with respect to instruments configured for use with robotic surgical systems, it should be understood that the actuation assemblies and drive assemblies described herein can be incorporated into manually actuated instruments, electromechanically powered instruments, or instruments actuated in any other manner. For example, the actuation mechanism can include a handle assembly for user gripping that serves as an actuator for the surgical instrument 100, including a fixed handle and a movable handle.
[0146] Referring now to FIG. 2 , FIG. 3A and FIG. 3B , the instrument 100 can be provided with a clip magazine 120 that includes a plurality of surgical clips 122 and is mounted into the surgical instrument 100. In certain embodiments, the magazine 120 can be mounted through a longitudinal slot 124 in the side of the shaft 105 FIG. 2 . In other embodiments, the magazine 120 can be mounted through a proximal opening 126 of the manual handle or the rear end mechanism 510 of the instrument (see FIG. 3A and FIG. 3B . In this latter embodiment, the clip magazine 120 includes an enlarged distal end 121 that facilitates advancement of the magazine 120 through an internal passage (not shown) in the rear end mechanism 510 and an internal lumen (not shown) of the instrument shaft 105. The clip magazine 120 can also include a proximal handle 123 that facilitates user gripping of the magazine 120, allowing the user to advance the distal end 121 through the shaft 105 to a suitable position just proximal of the end effector 110.
[0147] The magazine 120 can hold between about 1 and 20 clips, preferably between about 2 and 12 clips. The clips 122 preferably extend in a direction that is substantially parallel with respect to the longitudinal axis of the shaft 105. The magazine 120 can be constructed of any suitable material known in the art, such as a one-piece molded plastic body or a sheet metal structure. The magazine 120 can be adapted to hold any suitable desired size and configuration of clips 122, including conventional clips (e.g., titanium, tantalum or stainless steel ligating clips such as Horizon™, Hemoclip® and / or polymer clips such as Vas-Q-Clip®, Weck® Hem-o-lok® and the like). Alternatively, the magazine 120 can be adapted to hold the novel clip 300 described below and shown in FIG. 8A to FIG. 9D and FIG. 34 to FIG. 39B .
[0148] Wrist assembly 140 is positioned between end effector 110 and elongated shaft 105. Wrist assembly 140 can provide the desired amount of motion, such as + / -90 degrees in pitch, yaw, and / or roll, preferably about + / -60 to about + / -65 degrees in pitch and yaw. A cable or other actuator (not shown) is drivenly coupled to and actuated to impart motion to wrist assembly 140. Differential motion of the cable can be used to actuate wrist assembly 140 to pitch and yaw at various angles. Further details of the articulation mechanism that can be used with the embodiments disclosed herein are disclosed in International Publication No. WO 2015 / 127250A1 and U.S. Publication No. 2017 / 0215977 A1, the full disclosure of which is incorporated herein by reference for all purposes.
[0149] In one embodiment, the wrist assembly 140 may include a linkage 142 that provides pitch movement for the wrist assembly 140. To achieve yaw movement of the wrist assembly 140, pulleys 419, 431 and linkages 408, 412 (hereinafter referred to) are used. FIG. 10D (Discussion) Rotate together about a single axis. For example... FIG. 4 and FIG. 16A As shown, the wrist assembly 140 has a first internal cavity 146 and a second internal cavity 148 to allow the drive member 130 and the clamp 122 to move through them.
[0150] Now refer to FIG. 4 The cartridge 120 is configured to extend through an internal lumen 132 in the shaft 105, preferably along one side of the shaft 105 (i.e., substantially on one side of the longitudinal axis of the shaft 105). The device 100 also includes a drive member (or clamping actuator) 130, which preferably extends through the lumen 132 adjacent to the cartridge 120. In some embodiments, the drive member 130 is positioned on the side of the longitudinal axis opposite to the cartridge 120, which allows the drive member 130 to translate proximally and distally relative to the cartridge 120 within the shaft 105, as discussed below. In other embodiments, the drive member 130 and the cartridge 120 may be positioned on the same side of the longitudinal axis, or the cartridge 120 may be centered along the longitudinal axis within the lumen 132, and the drive member 130 may be positioned adjacent to the cartridge 120 on either side.
[0151] In some embodiments, the drive member 130 is coupled to the instrument shaft 105 such that the drive member 130 is included as part of an integral instrument 100, which may be constructed of a material designed for reuse in multiple surgical procedures. In other embodiments, the drive member 130 is coupled to a cartridge 120 such that the drive member 130 is included as part of a clamp cartridge 120, which may be constructed of a material designed for single-use or single-use applications. In any embodiment, the drive member 130 is configured for longitudinal displacement relative to the shaft 105 to advance the clamp 122 from the cartridge 120 to the jaws 111, 112 of the end effector 110, as discussed in more detail below.
[0152] like FIG. 6A and FIG. 6B As shown, the drive member 130 includes a proximal component 160 and a flexible component 162, the flexible component 162 connecting the proximal component 160 to a first clamping element 164 and a second clamping element 166. The proximal component 160 is configured to extend through the shaft 105 and may have one or more proximal interfaces 163 (see...). FIG. 2 This is for use in conjunction with an actuation mechanism (not shown) to advance the drive member 130 distally and proximally relative to the shaft 105. In some embodiments, the distal portion of the proximal member 160 may extend through a portion of the wrist assembly 140. For example, in one such embodiment, this distal portion of the proximal member 160 extends sufficiently through the wrist assembly 140 to flex at least in the pitch direction, but generally not in the yaw direction. The flexible member 162 will generally flex in both the pitch and yaw directions.
[0153] The flexible components 162 preferably comprise a material with sufficient rigidity to push through the wrist assembly 140 into the jaws 111, 112. Simultaneously, these components comprise a material with sufficient flexibility and resilience to bend as the end effector 110 articulates relative to the axis 105 at the wrist assembly 140. In a preferred embodiment, these components comprise nitinol, polymers such as PEEK, spring steel, or similar materials.
[0154] In one embodiment, the flexible portion 160 includes a first arm 168 and a second arm 170, each including clamping elements 164, 166 at its distal end. The clamping elements 164, 166 are configured to extend laterally away from the arms 168, 170 such that they are positioned substantially parallel to the clamping magazine 120 within the shaft 105 (see [link]). FIG. 5 ), for engagement with clamp 122 (discussed below). Arms 168, 170 are preferably designed to move relative to each other between a first position and a second position, in which the arms are closer to each other (seeFIG. 6A In this second position, the arms are further away from each other relative to the longitudinal axis of shaft 105 (e.g., see...). FIG. 12B In some embodiments, arms 168, 170 are substantially parallel to each other in a first position. This allows arms 168, 170 to move relative to the cassette 122 to positions that allow engaging elements 164, 166 to engage with one or more clips 122 housed within the cassette 120.
[0155] In one embodiment, engaging elements 164, 166 each include a first disc portion 172 that is coupled to or integral with arms 168, 170. Elements 164, 166 also include a central shaft 174 that extends laterally away from the disc portion 172 and is coupled to a second disc portion 176 (thus forming a generally “dumbbell” shape). The first disc portion 172 and the second disc portion 176 of engaging elements 164, 166 preferably have a larger diameter than the central shaft 174, which allows the shaft 174 to be removably coupled to clamp 122, as discussed in more detail below.
[0156] like FIG. 5 As shown, the clamp 120 includes a housing 134 having an upper wall 136 and a lower wall 138, and a longitudinal wall 150 on the side of the housing 134 opposite to the drive member 130. The side of the housing 134 opposite to the wall 150 is preferably open, allowing the clamp 122 to be viewed from that side of the housing 134 and permitting the drive member 130 to interact with the clamp within the clamp 130. The housing 134 also includes a first distal ramp or tab 154 and a second distal ramp or tab 156 extending from the distal end of the housing 134. The tabs 154, 156 have sufficient rigidity to force the engagement elements 164, 166 of the drive member 130 to open and slide upward along the tabs 154, 156 (discussed below) when the drive member 130 is pulled in the proximal direction. Meanwhile, tabs 154 and 156 have sufficient flexibility to allow engaging elements 164 and 166 to push past tabs 154 and 156 and advance clamp 122 through the distal end of housing 120 after the drive member 130 has advanced in the distal direction and is located inside housing 134 (see [link]). FIG. 15B ).
[0157] The housing 134 also includes retainer tabs 180 extending from the longitudinal wall 150 into the interior of the housing 120. The retainer tabs 180 are longitudinally spaced apart from each other along the housing 120 to define discrete areas for retaining each clip 122 within the housing 134 (see [link to housing 134]). FIG. 12A). The retainer tabs 180 preferably have sufficient rigidity to hold the clips 122 in place within the cartridge 120, while having sufficient flexibility such that distal translation of the drive member 130 causes the clips 122 to bend the tabs 180 and allow each clip 122 to individually advance with the drive member 130 in the distal direction.
[0158] The housing 134 includes a series of upper ramps or tabs 182 and lower ramps or tabs 184 that extend in the proximal direction away from the upper wall 136 and the lower wall 138, respectively. Similar to the internal tabs 180, the upper tabs 182 and the lower tabs 184 are longitudinally spaced apart from one another along the housing 120 such that they are disposed above and below each clip 122 within the housing 134. In certain embodiments, the tabs 182, 184 are pivotally coupled to the upper wall 136 and the lower wall 138 to allow the engagement elements 164, 166 to move proximally over the tabs 182, 184. In other embodiments, the tabs 182, 184 are substantially fixed ramps. In these embodiments, the arms 168, 170 of the drive member 130 are configured to further separate from one another such that the elements 164, 166 slide along the ramps 182, 184 as the drive member 130 translates in the proximal direction.
[0159] The housing 134 also includes an upper opening 186 in the upper wall 136 and a lower opening 188 in the lower wall 138 proximal of each upper tab 182 and lower tab 184. These tabs 182, 184 and openings 186, 188 allow the engagement elements 164, 166 to be withdrawn proximally over the tabs 182, 184 and to move through the openings 186, 188 to the interior of the cartridge housing 134, as discussed in greater detail below. Additionally, each set of tabs and openings provides a discrete position on the cartridge housing associated with one of the clips. In certain embodiments, the instrument or system can include a control system that detects when the engagement elements 164, 166 of the drive member 130 are positioned proximate to each of the clips within the cartridge. This ensures that the user engages the most distal clip within the cartridge.
[0160] In an alternative embodiment, each clamp in the magazine can advance distally simultaneously to each other. For example, the clamps can be spaced substantially equally apart, and the distal clamp can be spaced from the jaws by a distance substantially equal to the distance between the clamps. This allows the drive member 130 (or another drive member, such as a shuttle component (e.g., ratchet and pawl) or a spring (e.g., a magazine spring)) to move all the clamps forward and distally by the same distance, thereby allowing, for example, the drive member to advance the distal clamp into jaws 111, 112 while the next clamp is moved to the position previously occupied by the distal clamp, and so on. Thus, the drive member can be retracted proximally to the same longitudinal position within the instrument to engage with each clamp in the magazine, thereby increasing the speed and efficiency of delivering multiple clamps to the target site.
[0161] FIG. 7A to FIG. 7E An alternative embodiment of the drive member 130 is illustrated. For example... FIG. 7A As shown, the drive member 200 includes a proximal component 202, a flexible component 204, and a first arm 206 and a second arm 208 having distal engagement elements 210, 212. In this embodiment, the flexible component 204 includes wave-like or coiled features that allow the arms 206, 208 to deflect toward and away from the longitudinal axis without yielding or permanently deforming the material.
[0162] FIG. 7B to FIG. 7E An alternative embodiment of the drive member 220 is illustrated, which includes a flexible portion 222 designed to provide a more defined pivot point for each drive member 210. The pivot point of the flexible portion 222 is configured to be located within the wrist assembly 140 of the device 100, such that the distal arms 224, 226 are pivotable relative to the proximal portion 228 of each drive member 210 when the end effector 110 articulates relative to the axis 105. In some embodiments, the arms 224, 226 may be configured to extend substantially parallel to each other naturally ( FIG. 7C In other embodiments, arms 224, 226 may be configured to naturally have an arcuate shape that facilitates the opening and closing of arms 224, 226. FIG. 7B , FIG. 7D and FIG. 7E ).
[0163] Now refer to FIG. 8A to FIG. 9E The surgical clip 300 will now be described. Clip 300 includes a first arm 302 and a second arm 304, which are pivotally connected to each other about a pivot point or hinge 306 for use in an open position ( FIG. 8A ) and closed position ( FIG. 8BThe hinge 306 preferably is a living hinge or a unitary hinge that includes an opening 308 that creates two reduced members connected to the arms 302, 304 to create a flexible support that allows the arms 302, 304 to open and close. In certain embodiments, the clip 300 is naturally biased toward the open position and is configured to be closed by the force of the jaws 111, 112, as discussed below. In other embodiments, the clip 300 can be naturally biased toward the closed (but unlatched) position and is configured to be opened by the jaws 111, 112 and then closed and latched.
[0164] In certain embodiments, the surgical clip 300 comprises a polymeric material, such as a non-absorbable polymer or a resorbable or biodegradable polymer. Suitable materials for the clip 300 include polyoxymethylene (POM), polyester, nylon, polyether ether ketone (PEEK), polyglycolic acid (PGA or PLGA), polylactic acid (PLLA), polyethylene (PE), or copolymers thereof. In preferred embodiments, the clip 300 comprises POM.
[0165] The surgical clip 300 can be designed to, for example, ligate a blood vessel within a patient. In certain embodiments, the clip 300 is sized to ligate a blood vessel having a diameter of about 1 mm to about 10 mm. In certain embodiments, the clip 300 is designed to have sufficient length, strength, and stiffness to ligate a medium to large vessel, or a vessel up to 10 mm in diameter.
[0166] The clip 300 is designed to eliminate the need for a laterally protruding boss, and thus has a thinner profile than conventional polymeric clips. The clip 300 has a maximum lateral width of less than about 2.0 mm, or from about 0.6 mm to about 1.5 mm, or preferably from about 0.8 mm to about 1.1 mm (conventional polymeric clips designed to ligate vessels up to 10 mm in diameter typically have a maximum lateral width of 2.0 mm or greater). This can allow the user to deploy the clips within a target location on a patient in closer proximity to one another and / or to deploy more clips within the target location, for example, to provide improved access to the target site.
[0167] Of course, it should be recognized that the specific dimensions of the maximum lateral width of the clip 300 will vary based on the function of the clip. If the clip 300 is designed to, for example, ligate smaller vessels (i.e., vessels less than 3 mm in diameter), then the width of the clip will be less than the dimensions described above. However, the overall length / width ratio of the clip 300 will remain higher than conventional polymeric clips.
[0168] The first arm 302 includes a latch 310 and the second arm 304 includes a hook 312, such that the clip 300 can be pinched around a grasped blood vessel or other grasped tissue into a latched or locked position. In some embodiments, the first arm 302 and the second arm 304 include gripping features or protrusions 314 that extend on the vessel side of each arm. The protrusions 314 are preferably spaced apart from each other along each arm and provide gripping surfaces to secure the clip 300 to a blood vessel once the clip 300 is locked in the closed position. These gripping surfaces can also resist axial displacement of the clip.
[0169] Referring now to FIG. 9B and FIG. 9C , the latch 310 includes a body 342 that is sized to slide within a slot 340 in the hook 312, which is defined by a first arm 350 and a second arm 352. The latch 310 also includes a locking protrusion 344 that extends laterally outward from the body 342, which includes a shelf 346. When the latch 310 is pinched against the hook 310 by the jaws 111, 112, the applied force is sufficient to temporarily deform the hook 310 rearward away from the latch 310. This allows the locking protrusion 344 to pass under the slot 340 in the hook 310. Once this has occurred, the hook 310 will return to its original position such that the protrusion 344 is under the slot 340 and the shelf 346 engages a lower surface 348 of one of the arms 350, 352 (see FIG. 9A ). This secures the latch 310 to the hook 312 and provides both a visual and audible confirmation to the user that the latch 310 has now been secured to the hook 312.
[0170] The clip 300 also includes one or more centering features for aligning the latch 310 with the hook 312 when the clip 300 is closed by the jaws 111, 112. As shown in FIG. 9D , the latch 310 includes a rib 334 that extends from an inner or vessel side surface of the body 342 of the latch 310. The rib 334 extends downward along the vessel side surface of the latch 310 and is configured to engage a surface in the hook 312 that partially surrounds the slot 340 (see FIG. 9C ). The rib 334 aligns the latch 310 with the hook 312 during the process of latching with the instrument to ensure that the clip 300 is in the correct position to be locked. This configuration allows for a thinner profile clip as it eliminates the need for a protruding boss that would normally be found in conventional polymer clips.
[0171] Referring to FIG. 8A and FIG. 9AThe latch 310 on the first arm 302 includes an engagement member 320 for removably coupling to the engagement element 164 of the drive member 130, and the hook 312 on the second arm 304 includes an engagement member 322 for removably coupling to the engagement element 166 of the drive member 130 (see FIG. 15A ). The engagement members 320, 322 preferably allow the drive member 130 to be secured to the clip 300 during advancement of the clip 300 through the wrist 140 into the jaws 111, 112, and control and maintain the clip 300 throughout the entire period of opening and closing of the jaws 111, 112 (and thus the clip 300) and any other articulation of the end effector 110 relative to the shaft 105 (i.e., roll, yaw, or pitch motion of the end effector). At the same time, the engagement features 320, 322 are designed to release the engagement elements 164, 166 upon application of sufficient force to the drive member 130. As discussed below, this allows the user to remove the drive member 130 from the clip 300 after the clip 300 has been closed onto a blood vessel.
[0172] One particular advantage of this feature is that the captured drive member 130 within the jaws 111, 112 allows the drive member 130 and / or the jaws 111, 112 to pull the clip 300 open while the clip is disposed within the jaws. Conventional polymer clips tend to creep (i.e., move to a more closed position) over time while stored in the clip magazine. This prevents the clips from springing open on their own after they are advanced into the jaws, as typically occurs with conventional polymer clips. This feature also facilitates the repositioning of the primary positioning "boss" feature from the clip to the drive member, which allows the clip to be designed with a thinner profile than conventional clips (discussed in greater detail below). Additionally, this feature allows the junction between the engagement elements 164, 166 of the drive member 130 and the engagement features 320, 322 of the clip 300 to rotate as the jaws 111, 112 open and close.
[0173] In one embodiment, the engagement features 320, 322 each include a snap-fit feature that includes a cutout or opening 324 sized to receive the shaft 174 of the engagement element 164, 166, and protrusions 326 on either side of the opening 324 that create a reduced diameter entrance to the opening 324 (see FIG. 9A and FIG. 9D ). This allows the shaft 174 of the engagement elements 164, 166 of the drive member 130 to be advanced into the opening 324 upon application of sufficient force (discussed below). At the same time, the shaft 174 will remain secured within the opening 324 until sufficient withdrawal force is applied to the drive member 130.
[0174] In certain embodiments, the first and second arms 302, 304 include tapered ribs 330 extending toward the non-vascular side of the arms (see FIG. 8C 、 FIG. 8D 、 FIG. 9A and FIG. 9B ). These ribs 330 taper in two directions (i.e., laterally and vertically) to provide lateral and vertical guide features for the drive member 130 to align the engagement elements 164, 166 of the drive member 130 with each of the clips 300. Specifically, the ribs 330 taper inward in the proximal direction from each lateral side of the ribs 330 to provide lateral alignment. Additionally, the ribs 330 taper in the proximal direction toward the arms 302, 304 to provide vertical alignment. This allows the drive member 130 to self-center and / or align on the clips 300 during engagement within the cartridge 120.
[0175] The clip 300 is designed such that the force required to remove the latch 310 from the hook 312 after the latch 310 is latched to the hook 312 is greater than the force required to remove the drive member 130 from the clip 300 (i.e., the latching mechanism is stronger than the engagement mechanism). Thus, the locking protrusion 344 of the latch 310 secures the latch 310 to the hook 312 as the drive member 130 is withdrawn proximally and the engagement elements 164, 166 are withdrawn from the engagement members 322, 320 of the clip 300.
[0176] The clip 300 also includes protrusions 332 extending from the sides of the hook 312 that help guide the clip 300 through the guide tracks 442 of the jaw 404 as the clip 300 is advanced into the jaw (see FIG. 11A ). In one embodiment, the locking protrusion 344 on the latch 310 is configured to also serve as a guide protrusion that advances through the guide tracks 440 of the jaw 402. The protrusions 332, 344 can also be used to engage the tracks 440, 442 of the jaws 402, 404 in the event that the drive member 130 disengages from the clip 130 during advancement, thereby preventing premature disengagement of the clip 300 from the jaws 111, 112. These protrusions 332 are preferably sized to be thinner than the boss protrusions on conventional clips.
[0177] The clip 300 also includes a shear prevention feature that ensures that the latch 310 remains aligned with the hook 312 after the latch 310 and hook 312 are locked together. This feature includes a fin 354 extending on the upper surface of the body 342 of the latch 312. When the latch 310 is locked to the hook 312, the fin 354 is captured within the slot 340 of the hook 312, which prevents any shear motion that could cause the latch to disengage from the hook (see FIG. 9E ). Providing the fin 354 that fits within the slot 340 allows for the design of a thinner profile clip compared to conventional clips that typically use boss-like protrusions around the hook to mitigate shear.
[0178] Now refer to FIG. 10A to FIG. 10E An embodiment of the jaw assembly 400 for the instrument 100 will now be described. As shown, the jaw assembly 400 includes a first jaw 402 and a second jaw 404, which are pivotally connected to each other at a hinge joint 406. The first jaw 402 and the second jaw 404 are also capable of articulating together about an axis substantially perpendicular to the longitudinal axis (e.g., the pitch axis), such as... FIG. 11A As shown. Additionally, the first jaw 402 and the second jaw 404 are designed to be in the open position (e.g., FIG. 10A and FIG. 10B (As shown) The jaws move relative to each other in the closed position, in which the distal ends of the jaws approach or contact each other (see...). FIG. 10C In a preferred embodiment, both jaws 402 and 404 are movable jaws, but it should be recognized that one of the jaws may be a movable jaw configured to move relative to the other jaw between an open position and a closed position.
[0179] In a preferred embodiment, hinge 406 includes a first link 408 and a second link 410 on one side of jaw assembly 400, and a third link 412 on the other side of jaw assembly 400 (see [link]). FIG. 10D The first link 408 includes a slotted pin 414 configured to slide through a slot 415 in the first jaw 402 and a pin or screw 419 connected to the first pulley 421. Similarly, the second link 410 includes a slotted pin 416 configured to slide through a slot 417 in the second jaw 404 (see [link to second link]). FIG. 10B ) and a pin or screw 423 connected to the first pulley 421.
[0180] like FIG. 10D As shown, the third link 412 is positioned on the other side of jaws 402, 404, and includes a slotted pin 425 configured to slide through a slot 427 located on the other side of slot 415 in the first jaw 402. In a preferred embodiment, slotted pin 425 is the same slotted pin as slotted pin 414 and extends from the first link 408 completely through jaws 402 to the third link 412. The third link 411 has another pin or screw 429 connected to a second pulley 431 opposite to the first pulley 419.
[0181] In one embodiment, the jaw assembly 400 includes a single-axis based pulley and linkage system, both jaw articulation and wrist yaw are rotated about this single axis. The single pivot helps to minimize gaps that can form between segments of the linkage that can make it more difficult to advance the clip into the jaws 402, 404. The slots in the jaws are pushed by the shafts in the corners of the four-bar linkage. Each jaw has its own substantially identical (but reversed) four-bar linkage that straddles between two pulleys and acts as a differential. As shown in FIG. 10D
[0182] When the two pulleys are driven together in the same direction, the jaws 402, 404 will rotate together in the yaw direction relative to the shaft 105. However, any differential motion between the pulleys will drive the linkage to move the jaws relative to each other (i.e., open and close). The linkages can also be set to shear at a point close to the linkages so that they amplify the force when the clip is closed (similar to a vise-grip). A more complete description of this feature can be found in the co-pending, commonly assigned U.S. Provisional Application (Attorney Docket No. P06660-US-PRV) filed concurrently with the present application.
[0183] Referring again to FIG. 11A , the jaw assembly 400 includes a first strap, band, wire, or cable 420 and a second strap, band, wire, or cable 422 extending from the wrist assembly 140 to the first jaw 402 and the second jaw 404, respectively. The straps 420, 422 preferably comprise a flexible material such as Nitinol, spring steel, or the like such that the straps 420, 422 bend or flex when the jaws 402, 404 are articulated about the jaw axis. The straps 420, 422 each have a proximal end 426, 428 coupled to the wrist assembly 140 and a distal end 430, 432 extending into each of the first jaw 402 and the second jaw 404. In certain embodiments, the distal ends 430, 432 can be fixed to or otherwise coupled to the jaws 402, 404. In other embodiments, the straps 420, 422 extend inside the slot pins 416, 414 and have sufficient rigidity to remain in place within the jaws 402, 404.
[0184] As shown in FIG. 11A and FIG. 11B As shown, the straps 420, 422 are used to accommodate the drive member 130 and clip 300 when they have been driven into the jaws 402, 404 and the jaws are articulated about the yaw axis of the instrument. More specifically, distal advancement of the drive member 130 (and with it the clip 300) passes between the straps 420, 422 even when the jaws 402, 404 are articulated relative to the longitudinal axis of the instrument 100 (see FIG. 11A ).
[0185] As shown in FIG. 11A and FIG. 18 , the first jaw 402 and the second jaw 404 each include a guide track 440, 442 that generally extends from a proximal portion of the jaw to a distal end 434, 436 of each jaw. The guide tracks 430, 432 generally extend on the inside of the straps 420, 422. The guide tracks 430, 432 and the straps 420, 422 ensure that the arms 168, 170 of the drive member 130 pass along the guide tracks 430, 432 to reach the distal end 434, 436 when the drive member 130 is distally advanced into the jaws 402, 404.
[0186] Referring now to FIG. 10E , the jaws 402, 404 can each include an engagement feature at their distal ends to secure the clip in the jaw after it has been delivered by the drive member 130. In one embodiment, the engagement feature includes a ramped leaf spring 437 positioned on either side of the guide tracks 440, 442. As shown, the guide tracks 440, 442 are tapered inwardly in the distal direction, such that the lateral width across the guide tracks 440, 442 decreases distally. As the engagement elements 164, 166 of the drive member 130 and the clip are advanced distally through the guide tracks 440, 442, they contact the outer surfaces 439, 441 of the guide tracks 440, 442 that narrow as the clip is advanced distally. The clip and engagement elements 164, 166 press against the leaf springs 437, such that the leaf springs 437 are biased outwardly to allow the clip and engagement elements 164, 166 to move to the distal end of the jaw. This spring pressure exerted inwardly by the leaf springs 437 holds the clip and engagement elements 164, 166 within the distal end of the jaw and inhibits their proximal withdrawal and / or falling out of the jaw.
[0187] As shown in FIG. 10A , FIG. 19B and FIG. 20BAs shown, the jaws 402, 404 each have a distal end portion 434, 436 that includes a cutout 454. The cutout 454 is disposed at the distal end of the guide rails 430, 432. The cutout 454 preferably has a larger cross-sectional area than the guide rails 430, 432. This ensures that the distal ends of the latches 310 and hooks 312 of the clip 300 have sufficient clearance when they are coupled to the jaws 402, 404 (as these elements are generally distal of the engagement elements 164, 166 of the drive member 130 when the clip 300 is being advanced distally into the jaws 402, 404). Additionally, the cutout 454 facilitates removal of the clip 300 from the jaws 402, 404 when the clip 300 has been closed and latched and the drive member 130 has been uncoupled from the clip 300.
[0188] In the embodiment shown in FIG. 19B , the cutouts 454 each include a longitudinal portion 456 for receiving the hooks 312 and latches 310 of the clip 300 and a horizontal portion 448 for receiving the engagement elements 164, 166 of the drive member 130. The horizontal portion 448 is sized and configured to house the engagement elements 164, 166 within the jaws 402, 404 (i.e., they prevent the engagement elements 164, 166 from passing distally beyond the jaws 402, 404). In certain embodiments, the horizontal portion 448 has a lateral span that is less than the overall lateral span of the engagement elements 164, 166 (i.e., from one end of the outer shaft 172 to the other end of the outer shaft 176). In other embodiments, the horizontal portion 448 has a longitudinal span that is less than the diameter of the outer shafts 172, 176 of the engagement elements 164, 166. In certain embodiments, both the longitudinal and lateral spans of the horizontal portion 448 are small enough to house the engagement elements therein.
[0189] Referring now to FIG. 4 , FIG. 5 and FIG. 12A to FIG. 21 , a method of applying a plurality of clips to a tissue or blood vessel within a patient will now be described. As shown in FIG. 4 and FIG. 5 , the drive member 130 is generally positioned along the side of the cartridge 120 such that the engagement elements 164, 166 are distal of the tabs 154, 156 on the distal end of the cartridge 120. To engage the clip 300 with the drive member 130, the drive member 130 is withdrawn proximally such that the engagement elements 164, 166 slide along the tabs 154, 156 and cause the arms 168, 170 of the drive member 130 to splay such that the engagement elements 164, 166 move along the upper and lower surfaces 136, 138 of the cartridge 120 (see FIG. 12A and FIG. 12B ).
[0190] Referring now to FIG. 13A andFIG. 13B As the drive member 130 is withdrawn proximally, the engagement elements 164, 166 slide over the tabs 182, 184 at the first clip 300 within the cartridge 130. In some embodiments, the tabs 182, 184 are configured to spring inwardly to allow the engagement elements 164, 166 to move over the tabs 182, 184. In other embodiments, the arms 168, 170 are further splayed outwardly to allow such movement.
[0191] Referring now to FIG. 14A and FIG. 14B Once the engagement elements 164, 166 are proximal of the tabs 182, 184, the engagement elements 164, 166 will enter openings 186, 188 leading to the interior of the cartridge 130. In some embodiments, this movement will occur automatically as the engagement elements 164, 166 pass proximally over the tabs 182, 184. In other embodiments, the drive member 130 can be advanced distally to move the engagement elements 164, 166 into the openings 186, 188. The upper tab 182 and the lower tab 184 generally guide the engagement elements 164, 166 downwardly into the cartridge 120.
[0192] As shown in FIG. 15A to FIG. 15C , the drive member 130 is then further moved distally until the engagement elements 164, 166 engage the engagement features 320, 322 of the first clip 300A (see also FIG. 9). More specifically, the inner shaft 174 of each element 162, 164 passes through the snap-fit design of the features 320, 322 by passing over the protrusions 326 and into the openings 324 of the latches 310 and hooks 312 of the clip 300. As the drive member 130 is further moved distally, the retention tabs 180 flex away, allowing the clip 300A to be released from the cartridge 120. At this point, the first clip 300A is coupled to the drive member 130 and is no longer secured within the cartridge 120, allowing the drive member 130 to move the clip 300 into the end effector 110. The proximal clip 300B remains secured within the cartridge 120.
[0193] Referring now to FIG. 16A and FIG. 16B , the drive member 130 advances the clip 300 through the central lumens 146, 148 within the wrist assembly 140 and into the end effector 110. As the arms 168, 170 of the drive member 130 enter the jaw assembly 400, the straps 420, 422 constrain the movement of the arms 168, 170 such that the arms 168, 170 enter the guide rails 440, 442 of the first jaw 402 and the second jaw 404 (see FIG. 17 and FIG. 18). The drive member 130 is advanced distally until the engagement elements 164, 166 (and the hook 312 and the latch 310 of the clip 310A) engage the cutouts 454 in the distal end portions 434, 436 of the jaws 402, 404 (see FIG. 19A and FIG. 19B ) until the engagement elements 164, 166 (and the hook 312 and the latch 310 of the clip 310A) engage the cutouts 454 in the distal end portions 434, 436 of the jaws 402, 404 (see
[0194] Referring now to FIG. 20A and FIG. 20B , when the surgeon has positioned the first clip 300A in the desired position to clamp onto tissue or a blood vessel, the jaws 402, 404 are closed. As described above, the jaws 402, 404 provide sufficient force to cause the clip 300A to close and secure the latch 310 into the hook 312. Once this has occurred, the drive member 130 can be withdrawn proximally by applying sufficient force to the member 130 to withdraw the engagement elements 162, 164 of the drive member 130 from the engagement elements 320, 322 of the latch 310 and the hook 312, respectively. Once the drive member 130 is disengaged from the clip 300A, the drive member 130 can be withdrawn proximally through the wrist assembly 400 and into the shaft 105 of the instrument (see FIG. 20A ).
[0195] Referring now to FIG. 21 , to engage the second clip 300B from the magazine 120, the engagement elements 164, 166 of the drive member 130 are withdrawn past the distal tabs 154, 156 and through the first upper tab 182a and the first lower tab 184a and the second upper tab 182b and the second lower tab 184b to the second clip 300B. The process can then be repeated to advance the second clip 300B to the jaws of the end effector, followed by the third clip 300C, and so on.
[0196] FIG. 22 A distal end portion of an alternative embodiment of a surgical instrument 1100 according to the illustrative embodiments is illustrated. The surgical instrument 1100 includes an end effector 1110, an elongated shaft 1105, and a wrist assembly 1140 coupling the end effector 1110 to the shaft 1105. The proximal end portion of the elongated shaft 1105 is operatively connected to an actuation mechanism (not shown), although as will be appreciated by those skilled in the art in light of the present disclosure, components of the actuation mechanism can extend into and / or through the elongated shaft 1105 and / or the wrist assembly 1140.
[0197] The end effector 1110 includes a first jaw 1111 and a second jaw 1112 configured to be in an open position (as FIG. 22between an open position, in which the jaws are spaced apart from one another, and a closed position, which serves to force the jaws into compressive contact with the legs of the clip to close and seal the clip around the vessel or tissue. In certain embodiments, the second jaw 1112 is a movable jaw configured to move relative to the first jaw 1111 from the open position to the closed position. In other embodiments, the first jaw 1111 is a movable jaw configured to move relative to the second jaw 1112 between the open position and the closed position. In still other embodiments, both jaws 1111, 1112 can be movable relative to one another.
[0198] Referring now to FIG. 23 and FIG. 24 , the instrument 1100 can be provided with a clip magazine 1120 that includes a plurality of surgical clips 1122 and is mounted into the surgical instrument 1100. In certain embodiments, the magazine 1120 can be mounted through a longitudinal slot 1124 in the side of the shaft 1105 FIG. 23 and FIG. 27 . In other embodiments, the magazine 1120A can be mounted through an opening in the proximal end of the shaft 1126 FIG. 24 and FIG. 28 . The magazine 1120 can hold between about 1 and 20 clips, preferably between about 2 and 12 clips. The clips 1122 preferably extend in a direction that is substantially parallel relative to the longitudinal axis of the shaft 1105.
[0199] The magazine 1120 can be constructed of any suitable material known in the art, such as a one-piece molded plastic body or a sheet metal. The magazine 1120 can be adapted to hold any suitable desired size and configuration of clips 1122, including conventional clips (e.g., titanium, tantalum or stainless steel ligating clips such as the Horizon™, Hemoclip® and / or polymer clips such as the Vas-Q-Clip®, Weck® Hem-o-lok® and the like). Alternatively, the magazine 1120 can be adapted to hold the novel clip 1300 described herein and illustrated in FIG. 8A to FIG. 9D and FIG. 34 to FIG. 39B .
[0200] The wrist assembly 1140 is positioned between the end effector 1110 and the elongated shaft 1105. The wrist assembly 1140 can provide a desired amount of motion, such as + / - 90 degrees in the pitch, yaw and / or roll directions (discussed in greater detail below). Cables or other actuators (not shown) are drivingly coupled with the wrist assembly 1140 and are actuated to impart motion to the wrist assembly 1140.
[0201] In some embodiments, the drive member 1130 is coupled to the instrument shaft 1105 such that the drive member 1130 is included as part of an integral instrument 1100, which may be constructed of a material designed for reuse in multiple surgical procedures. In other embodiments, the drive member 1130 is coupled to a cartridge 1120 such that the drive member 1130 is included as part of a clamp cartridge 1120, which may be constructed of a material designed for single-use or single-use applications. In any embodiment, the drive member 1130 is configured for longitudinal displacement relative to the shaft 1105 to advance the clamp 1122 from the cartridge 1120 to the jaws 1111, 1112 of the end effector 1110, as discussed in more detail below.
[0202] like FIG. 25 , FIG. 26A and FIG. 26B As shown, the clip 1220 includes a housing 1134 having an upper wall 1136 and a lower wall 1138 for retaining a plurality of clips 1122 within the housing 1134. The housing 1134 also includes a series of internal chambers 1150 for holding each clip (in) FIG. 26A Clamps 1122A, 1122B, and 1122C are housed within housing 1134. The internal chambers 1150 are preferably spaced substantially equally from each other, and the farthest chamber 1150 housing the farthest clamp 1122A is preferably spaced from jaws 1111 and 1112 by a distance substantially equal to the distance between the clamps. This allows the drive member 1130 to move all clamps forward and distally by the same distance, thereby allowing, for example, the drive member 1130 to advance clamp 1122A into jaws 1111 and 1112 while moving clamp 1122B to a position previously occupied by clamp 1122A, and so on. This design improves the speed and efficiency of delivering multiple clamps to a target area. Further details of this operation will be discussed below.
[0203] The housing 1134 may include one or more longitudinal walls extending between the upper wall 1136 and the lower wall 1138. In one embodiment, the housing 1134 includes a longitudinal wall 1152 on the opposite side of the thruster protrusion 1182 of the drive member 1130 (see [link to relevant documentation]). FIG. 26C (Discussed in more detail below). The housing 1134 may also have a second longitudinal wall (not shown) on one side adjacent to the thruster tab 1182, or this side may be substantially open (or include a window or opening within the second longitudinal wall) such that the clamp 1122 can be accessed from this side of the housing 1134 by the thruster tab 1182 of the drive member 1130, as... FIG. 26B and FIG. 26C As shown.
[0204] In one embodiment, the housing 1134 may further include overhanging features 1154 extending toward the longitudinal axis from each side of the upper wall 1136 and the lower wall 1138 (see [link to previous embodiment]). FIG. 26B These overhanging features ensure that the clamp is contained within the housing 1134 of the cartridge, but still allow the clamp to move distally through the housing 1134. The upper and lower overhanging features 1154 are preferably spaced apart from each other sufficiently to retain the clamp 1122 within the housing 1134, while allowing the pusher tab 1182 and retainer tabs 1170, 1172 of the drive member 1130 to access the clamp (discussed below).
[0205] like FIG. 29A As shown, the cartridge 1120 includes a series of ratchet tabs 1183 positioned proximally at each clip 1300. The ratchet tabs 1183 are biased inward to ensure that the clips are not dragged backward or proximally when the drive member 1130 retracts proximally to engage another clip. Simultaneously, the ratchet tabs 1183 define a ramp surface that allows the clips positioned proximally at each ratchet tab to move distally along the ramp to the next distal position to engage with the drive member 1130.
[0206] like FIG. 30 to FIG. 32 As shown, the drive member 1130 includes a proximal part 1160, a distal part 1164, and a flexible part 1162 that couples the proximal part 1160 to the distal part 1164. The distal part 1164 is generally configured to be removably coupled to one or more surgical clips 1122 in the cartridge 1120 (discussed below). The proximal part 1160 is configured to extend through the shaft 105 and may have one or more proximal interfaces (not shown) for cooperating with an actuation mechanism (not shown) to advance the drive member 1130 distally and proximally relative to the shaft 1105.
[0207] The flexible component 1162 preferably comprises a material with sufficient rigidity to have sufficient compressive strength to push through the wrist assembly 1140 into the jaws 1111, 1112. Simultaneously, the flexible component 1162 comprises a material with sufficient flexibility and resilience to bend when the end effector 1110 articulates relative to the axis 1105 at the wrist assembly 1140. In a preferred embodiment, the flexible component 1162 comprises nitinol, a polymer such as PEEK, spring steel, or a similar material.
[0208] In one embodiment, the flexible member 1162 includes a plurality of rods 1168 that extend between the proximal end member 1160 and the distal end member 1164 and have a length at least as long as the wrist assembly 1140. The rods 1168 are configured to flex as the wrist assembly 1140 articulates the end effector 1110 relative to the shaft 1105 such that the distal end member 1164 of the drive member 1130 can be positioned within the end effector 1110 as the wrist assembly 1140 is articulated. This allows the drive member to position the clips 1122 within the jaws 1111, 1112 of the end effector 1110 and maintain the clips 1122 as the jaws 1111, 1112 are opened and closed and / or articulated relative to the shaft of the instrument. Thus, the surgeon can fully open the clips after they have been advanced into the jaws so that they can be effectively positioned around a target blood vessel or tissue. Additionally, this allows the surgeon to reposition the jaws relative to the shaft after the clips have been advanced into the jaws.
[0209] FIG. 33A to FIG. 33C An alternative embodiment of the flexible member of the drive member 1130 is illustrated. As shown, the flexible member 1162A includes a plurality of strips 1168A that extend between the distal end member and the proximal end member of the drive member 1130. The strips 1168 can be any suitable shape, such as circular, rectangular, square, etc. In one embodiment, the strips 1168 are substantially rectangular and comprise Nitinol, stainless steel spring, or similar material. FIG. 33A
[0210] FIG. 33B Another embodiment of the flexible member 1162B is illustrated that includes a laser cut tube to form an accordion-type shape that allows the flexible member 1162B to bend relative to the distal end member and the proximal end member of the drive member 1130. FIG. 33C Another embodiment of the flexible member 1162C is illustrated that includes a flexible conduit-like structure formed from a reinforced polymer jacket material. The retainer tabs 1170C, 1172C and the flexible tabs 1174C, 1176C can be formed, for example, by cutting away the jacket material.
[0211] Referring now to FIG. 31 The distal end member 1164 of the drive member 1130 includes engagement elements for removably coupling the drive member 1130 to the surgical clips within the cartridge 1120. In one embodiment, the engagement elements include a first retainer tab 1170 and a second retainer tab 1172 that extend distally from the drive member 1130. The retainer tabs 1170, 1172 are located on either side of the lateral axis of the drive member 1130 and are preferably biased inwardly toward the longitudinal axis of the shaft 1105 with sufficient force to retain and control the clips 1122 held within the tabs 1170, 1172 (see, e.g.,FIG. 36A and FIG. 36B ).
[0212] In certain embodiments, the distal component 1164 also includes an upper retainer tab 1174 and a lower retainer tab 1176 that extend distally from the drive member 1130 and are spaced apart from one another, above and below the retainer tabs 1170, 1172. The retainer tabs 1174, 1176 are located on the upper and lower portions of the drive member 1130 and are biased inwardly to provide additional security in coupling the drive member 1130 to the clips 1122 (in addition to the tabs 1170, 1172). The tabs 1174, 1176 can also be used to guide the drive member 1130 within the clip cartridge 1120 by flexing upwardly and downwardly as the drive member 1130 is withdrawn proximally into the housing 1134 of the cartridge 1120 (see FIG. 26B ).
[0213] The distal component 1164 also includes an annular collar 1178 that provides structure for the retainer tabs 1170, 1172, 1174, and 1176. The collar 1178 is sized to slide around the cartridge housing 1120. Additionally, the collar 1178 is sized to fit through the inner tube 1430 of the wrist assembly 1140 (discussed in greater detail below).
[0214] Referring now to FIG. 26C and FIG. 32 , the proximal component 1160 of the drive member 1130 includes a structural frame 1180 that is sized to slide around the housing 1134 of the clip cartridge 1120. The proximal component 1160 also includes a series of advancer tabs 1182 on either side of the cartridge 1120 (see also FIG. 32 ) that are biased inwardly toward the longitudinal axis of the shaft. The advancer tabs 1182 are configured to snap inwardly behind the proximal clips 1122B, 1122C, etc. within the cartridge 1120 so that distal advancement of the drive member 1130 also advances the proximal clips as the distal-most clip 1122A is advanced into the jaws 1111, 1112. As noted above, the clips are spaced substantially equally apart from one another within the cartridge 1120 so that advancement of the distal-most clip 1122A into the jaws 1111, 1112 also causes the next proximal clip 1122B to advance into the previous position of the distal-most clip 1122A. This positions the clip 1122B to be engaged by the retainer tabs 1170, 1172 when the drive member 1130 is withdrawn proximally after releasing the distal-most clip 1122A (discussed below).
[0215] Referring now to FIG. 34 to FIG. 39B Various embodiments of the surgical clip 1300 will now be described. AsFIG. 34 to FIG. 36B As shown, one embodiment of the clamp 1300 includes a first arm 1302 and a second arm 1304, which are pivotally connected to each other about a pivot point or hinge 1306 for use in the open position ( FIG. 35A ) and closed position ( FIG. 35B The hinge 1306 is preferably a live hinge or an integral hinge, which includes an opening 1308 that creates two thinner sections connected to the arms 1302, 1304 to create flexible supports that allow the arms 1302, 1304 to open and close. In some embodiments, the clamp 1300 is naturally biased toward the open position and configured to be closed by the force of the jaws 1111, 1112, as discussed below. In other embodiments, the clamp 1300 may be naturally biased toward the closed (but not latched) position and configured to be opened and then closed and latched by the jaws 1111, 1112.
[0216] In some embodiments, the surgical clip 1300 comprises a polymeric material, such as a non-absorbable polymer or a reabsorbable or biodegradable polymer. Suitable materials for the clip 300 include polyoxymethylene (POM), polyester, nylon, polyetheretherketone (PEEK), polyglycolic acid (PGA or PLGA), polylactic acid (PLLA), polyethylene (PE), or copolymers thereof. In a preferred embodiment, the clip 300 comprises polyoxymethylene (POM). The surgical clip 1300 may be designed, for example, to ligate blood vessels within a patient's body. In some embodiments, the clip 1300 is sized to ligate blood vessels having a diameter of about 3 mm to about 10 mm.
[0217] The first arm 1302 includes a latch 1310, and the second arm 1304 includes a hook 1312, such that the clamp 3100 can be pressed into a latched or locked position around a grasped blood vessel or other grasped tissue. In some embodiments, the first arm 1302 and the second arm 1304 include gripping features or protrusions 1314 extending on the blood vessel side of each arm. The protrusions 1314 are preferably spaced apart from each other along each arm and provide gripping surfaces to secure the clamp 1300 to the blood vessel once the clamp 1300 is locked in the closed position. These gripping surfaces also resist axial displacement of the clamp.
[0218] Now refer to FIG. 35A and FIG. 35BThe latch 1310 includes a first protrusion or boss 1320 and a second protrusion or boss 1322 extending laterally outward from the latch 1310. When the latch 1310 is pressed against the hook 1310 by the jaws 1111, 1112, the applied force is sufficient to temporarily deform the hook 1310 rearward away from the latch 1310. This allows the locking bosses 1320, 1322 to pass under the hook 1312. Once this has occurred, the hook 1310 will return to its original position such that the bosses 1320, 1322 are under the hook 1310, and the lower surface 1324 of the hook 1310 engages with the bosses to secure the latch 1310 to the hook 1312 and provide the user with visual and audible confirmation that the latch 1310 is now secured to the hook 1312.
[0219] Clamp 1300 can be designed such that the force required to remove latch 1310 from hook 1312 after latch 1310 is latched to hook 1312 is greater than the force required to remove drive member 1130 from clamp 1300 (i.e., the latching mechanism is stronger than the engaging mechanism). Therefore, bosses 1320, 1322 of latch 1310 secure latch 1310 to hook 1312 when drive member 1130 is retracted proximally and engaging tabs 1170, 1172 are retracted from clamp 1300. In an alternative embodiment, the jaws of the instrument include engaging features that secure clamp 1300 to jaws when drive member 1130 is retracted proximally and released from clamp (discussed in more detail below).
[0220] like FIG. 35A As shown, the clamp 1300 also includes protrusions 1332 extending from both sides of the hook 1312, which facilitate guiding the clamp 1300 through the guide rail 1442 of the jaws 1404 (see Figure 1332) when the clamp 1300 is pushed into the jaws. FIG. 50B In one embodiment, the bosses 1320, 1322 on the latch 1310 are also configured to serve as guide protrusions that advance through the guide rails 1440 of the jaws 1402. These bosses engage the rails 1440, 1442 of the jaws 1402, 1404 when the drive member 1130 disengages from the clamp 1130 during advance, thereby preventing the clamp 1300 from prematurely disengaging from the jaws 1111, 1112.
[0221] In certain embodiments, the arms 1302, 1304 of the clip 1300 each include one or more protrusions 1326 extending from a proximal end portion of the arms (distal to the hinges 1306). In one embodiment, the protrusions 1326 extend on both sides of each of the arms 1302, 1304. The protrusions 1326 are designed to engage the pusher tabs 1182 of the drive member 1130. In particular, the pusher tabs 1182 are designed to snap inward against the clip 1300 just proximal to the protrusions 1326. Because the tabs 1182 are biased inward, distal movement of the drive member 1130 will cause the tabs to contact and engage the proximal side of the protrusions 1326, thereby allowing the drive member 1130 to advance the clip within the cartridge 1120 (see FIG. 26C ).
[0222] FIG. 36A and FIG. 36B FIG. 13 illustrates the drive member 1130 coupled with the clip 1300. As shown, the retainer tabs 1170, 1172, 1174, 1176 are biased inward such that they snap onto the proximal end portion of the clip 1300 (around the hinges 1306). This allows the drive member 1130 to hold and control the clip 1300 as it is advanced distally through the wrist assembly 1140 into the end effector 1110. Additionally, this allows the drive member 1130 to maintain control of the clip 1300 as the arms 1302, 1304 of the clip 1300 are opened within the jaws 1111, 1112.
[0223] FIG. 37A and FIG. 37B FIG. 14 illustrates an alternative embodiment of the clip 1300A and the distal component 1164A of the drive member 1130A. As shown, the clip 1300A includes a proximal handle 1360 to facilitate engagement with the retainer tabs 1170A, 1712A of the drive member 1130A. The drive member 1130A can further include an internal recess 1362 disposed between the tabs 1170A, 1170B that is designed to engage and removably couple to a distal protrusion 1364 on the handle 1360. This design provides a secure coupling between the distal component 1164A of the drive member 1130A and the clip 1300A.
[0224] FIG. 38A to FIG. 38C FIG. 15 illustrates yet another embodiment of the drive member 1130B and the clip 1300B. As shown, the clip 1300B includes a proximal handle 1370 having an engagement feature 1372 that is designed to removably couple to an internal recess or engagement feature 1374 disposed within the retainer tabs 1170B, 1172B of the drive member 1130B.
[0225] FIG. 39A and FIG. 39B Another embodiment of the drive member 1130C and the clamp 1300C is illustrated. In this embodiment, the clamp 1300C includes a proximal opening 1181 sized to receive retainer tabs 1170C and 1172C of the drive member 1130C. In this embodiment, the retainer tabs 1170C and 1172C can be biased outward from the longitudinal axis. Therefore, the retainer tabs 1170C and 1172C move distally into the proximal opening 1181 and are then biased outward to secure the tabs 1170C and 1172C within the opening 1181.
[0226] Now refer to FIG. 40A to FIG. 40D An embodiment of the jaw assembly 1400 will now be described. The jaw assembly 1400 can be used with instrument 100, instrument 1100, or any other suitable clamping applicator instrument. As shown, the jaw assembly 1400 includes a first jaw 1402 and a second jaw 1404 pivotally connected to each other at a first pivot pin 1407 and a second pivot pin 1409. The first jaw 1402 and the second jaw 1404 are preferably designed in an open position (e.g., Figure 40A (As shown) The jaws move relative to each other in the closed position, in which the distal ends of the jaws are substantially parallel to each other (see...). Figure 40B In a preferred embodiment, both jaws 1402 and 1404 are movable jaws, but it should be recognized that one of the jaws may be a movable jaw configured to move relative to the other jaw between an open position and a closed position.
[0227] The instrument 1100 includes an actuator rod or cable actuator 1410 extending through a shaft 1105 and a wrist assembly 1140 into jaws 1402, 1404 for opening and closing the jaws. The cable actuator 1410 preferably extends laterally outside the housing 1120, the drive member 1130, and the inner tube 1430 passing through the wrist assembly 1140 (see further discussion below). Figure 42 The longitudinal translation (i.e., push / pull) of the cable driver 1410 causes the jaws 1402, 1404 to open and close. In some embodiments, the jaws 1402, 1404 can be opened by distal movement of the cable driver 1410 (and closed by proximal movement of the cable driver 1410). In other embodiments, the jaws 1402, 1404 can be closed by distal movement of the cable driver 1410 (and opened by proximal movement of the cable driver 1410).
[0228] Now refer to Figure 40C and Figure 40DThe cable driver 1410 is coupled to a support member 1421 that includes a first slot pin 1412 and a second slot pin 1414 that extend laterally outward from the support member 1421. The slot pins 1412, 1414 are configured to slide within first and second curved slots 1416, 1418 in the first and second jaws 1402, 1404, respectively. The slot pins 1412, 1414 are configured to slide distally and proximally similarly to the distal and proximal movement of the cable driver 1410, such that, for example, distal advancement of the cable driver 1410 causes the slot pins 1412, 1414 to slide to the distal ends of the slots 1416, 1418, thereby causing the jaws to pivot about the pivot pins 1407, 1409 to the open position (see Figure 40C ). Similarly, proximal withdrawal of the cable driver 1410 causes the slot pins 1412, 1414 to slide to the proximal ends of the slots 1416, 1418, thereby causing the jaws to pivot about the pivot pins 1407, 1409 to the closed position (see Figure 40D ).
[0229] Figure 41A and Figure 41B An alternative embodiment of a jaw assembly 1400A is illustrated. The jaw assembly 1400A is similar in most respects to the assembly 1400, except that it includes a first actuator rod or cable driver 1410 and a second actuator rod or cable driver 1411 that extend laterally outward of the cartridge 1120, the drive member 1130, and the inner tube 1430 that passes through the wrist assembly 1140 (see further discussion of the Figure 42 B below). The cable driver 1411 operates in the same manner as the driver 1410. Longitudinal translation of the cable driver 1411 together with the driver 1410 causes the slot pins to slide in the slots of the upper and lower jaws 1402, 1404, thereby causing the jaws to pivot between the open and closed positions.
[0230] In certain embodiments, the slot is substantially linear. In other embodiments, the slot can be non-linear and / or curved. For example, a non-linear slot can have a curvature from the proximal end to the distal end. The non-linear slot can be shaped such that the grasping force applied by at least one of the first jaw and the second jaw is substantially proportional to the force applied to the pin as the pin is translated from the proximal end to the distal end of the non-linear slot. In certain embodiments, the non-linear slot is shaped such that the first jaw and the second jaw apply a substantially constant grasping force therebetween as the pin is translated from the proximal end to the distal end of the slot. This provides a constant mechanical advantage between the force applied to the pin and the force applied by the jaws to the tissue held therebetween, allowing the user (or robotic system) to more easily adjust the force applied by the jaws to the tissue. Additionally, this design allows for a substantially constant grasping force to be applied by the jaws regardless of the angle between the jaws. A more complete description of a non-linear slot can be found in commonly-assigned U.S. Patent Application Serial No. 17 / 081,088 to the same assignee as the present application, the complete disclosure of which is incorporated by reference herein.
[0231] As shown in FIGS. 14A and 14B, the first jaw 1402 and the second jaw 1404 each include a guide track 1440, 1442 that extends generally from a proximal portion of the jaw to a distal end 1434, 1436 of each jaw. The guide tracks 1440, 1442 are configured to receive the tabs 1320, 1322, and 1324 of the clip 1300, which slide along the guide tracks 1440, 1442 as the clip 1300 is distally conveyed by the drive member 1130. This ensures that each arm 1302, 1304 of the clip 1300 is properly conveyed into each jaw 1402, 1404 (discussed in greater detail below). Figure 49B Figure 50B As shown in FIGS. 14A and 14B, the first jaw 1402 and the second jaw 1404 each include a guide track 1440, 1442 that extends generally from a proximal portion of the jaw to a distal end 1434, 1436 of each jaw. The guide tracks 1440, 1442 are configured to receive the tabs 1320, 1322, and 1324 of the clip 1300, which slide along the guide tracks 1440, 1442 as the clip 1300 is distally conveyed by the drive member 1130. This ensures that each arm 1302, 1304 of the clip 1300 is properly conveyed into each jaw 1402, 1404 (discussed in greater detail below).
[0232] The jaws 1402, 1404 can each include an engagement feature at their distal ends to secure the clip in the jaw after the clip has been conveyed by the drive member 1130. The engagement features allow the drive member 1130 to be released from the clip after the clip has been secured to the jaws 1402, 1404. Thus, the force required to disengage the retainer tabs 1170, 1172, 1174, 1716 from the clip is less than the force required to disengage the clip from the engagement features. Additionally, these engagement features ensure that the clip does not fall from the jaws 1402, 1404 until they have been closed and latched onto the tissue or vessel at the target site.
[0233] In one embodiment, the engagement features include ramped leaf springs (not shown) located in or near the guide tracks 1440, 1442. These leaf springs are similar in design to those discussed above with respect to the jaw assembly 400 and in U.S. Patent No. 9,993, 1 17, the complete disclosure of which is incorporated by reference herein. Figure 10E The guide rails 1440, 1442 taper inwardly in the distal direction such that the lateral width across the guide rails 1440, 1442 decreases distally. As the clips are advanced distally through the guide rails 1440, 1442, they contact the outer surface of the guide rails 1440, 1442 that narrows as the clips are advanced distally. The clips press against the leaf springs such that the leaf springs are biased outwardly to allow the clips to move to the distal end of the jaws. This spring pressure exerted inwardly by the leaf springs holds the clips within the distal end of the jaws and inhibits their proximal withdrawal and / or falling out of the jaws.
[0234] Additionally, the jaws 1402, 1404 each have a distal portion 1434, 1436 that includes a cutout 1454 (see Figure 52C ). The cutout 1454 is disposed at the distal end of the guide rails 1440, 1442. The cutout 1454 preferably has a larger cross-sectional area than the guide rails 1440, 1442 and is used to accommodate the hooks 1312 and latches 1310 of the clip 1300. This ensures that the jaws can be opened and removed from the clip 1300 after the clip has been closed and latched onto tissue or a blood vessel.
[0235] Referring now to Figure 42 , Figure 43A and Figure 43B , the wrist assembly 1140 will now be described. The wrist assembly 1140 can be used within the instrument 100, the instrument 1100, or any other suitable clip applier instrument. The wrist assembly 1140 includes a plurality of linkages or discs that allow the end effector 1110 and the shaft 1105 to articulate in at least two axes that are perpendicular to the longitudinal axis of the shaft 1105 (i.e., a "yaw" axis and a "pitch" axis). As shown, the wrist assembly 1140 includes a distal linkage or disc 1450 coupled to the jaws 1111, 1112, a proximal linkage or disc 1452 coupled to the shaft 1105, and an intermediate linkage or disc 1454 therebetween. In one embodiment, the intermediate disc 1454 is rotatably coupled to the proximal disc 1452 to allow rotation about one of the axes (see Figure 41B ) and rotatably coupled to the distal disc 1450 to rotate about the other of the axes (see Figure 44A ).
[0236] In preferred embodiments, the distal disk 1450 is fixed to the end effector 1110 and the proximal disk 1452 is fixed to the shaft 1105. Thus, rotation or articulation occurs only between the intermediate disk 1454 and the proximal disk 1450 and between the intermediate disk 1454 and the distal disk 4152. This configuration "decouples" the end effector 1110 and the jaws 1111, 1112 from the wrist assembly 1140 so that the end effector 1110 itself does not articulate, which provides the surgeon with more control and precision in positioning the jaws 1111, 1112 in the proper orientation to apply a clip to tissue or a vessel.
[0237] The actuator rod / cable 1410 (and in certain embodiments the rod 1411) extends through the wrist assembly 1140, preferably through a flexible sheath 1484 (see Figure 46 ), which is anchored to the distal disk 1450 and slidingly coupled through an internal cutout in each of the remaining disks 1452 and 1454 (see Figure 43A ). The flexible sheath 1484 guides and supports the actuator cable / rod 1410 to transmit pushing forces through the articulating wrist and to the jaws without buckling. Suitable materials for the sheath 1484 include, but are not limited to, laser cut stainless steel tubing or polymeric tubing materials. The sheath 1484 must be flexible enough to conform to the curvature of the articulating wrist while still having sufficient radial stiffness to adequately accommodate the actuation cable / rod and its pushing / pulling forces. In certain embodiments, the actuator rod 1410 is fixed or anchored to the support member 1421 and slidingly coupled through the flexible sheath 1484, which slidingly couples through the intermediate disk 1454 and the proximal disk 1452. This allows the proximal end of the rod 1410 and the proximal end of the sheath 1484 to pass in and out of the wrist assembly 1140 as the wrist assembly 1140 articulates. As shown in Figure 43B , the length of at least a portion of the rod 1410 and the sheath 1484 must increase as the distance between the shaft 1105 and the end effector 1110 increases (discussed in greater detail below) as the wrist assembly 1140 articulates. Providing a sliding fit between the rod 1410, the sheath 1484, and the intermediate disk 1454 and the proximal disk 1452 allows the length of the rod 1410 and the sheath 1484 to increase as the wrist assembly 1140 to accommodate this articulation.
[0238] Referring now to Figure 44A and Figure 44B , the inner tube 1430 extends from the shaft 1105 to the end effector 1110 and provides a flexible, smooth passageway for the drive member 1130 and the clip 1300 therethrough, even when the wrist assembly 140 articulates so that the end effector 1110 and the shaft 1105 are not oriented in parallel directions (seeFigure 43B The same applies. In some embodiments, tube 1430 includes an embedded coil surrounded by and bonded to a resilient polymer protective sheath. This provides an overall flexible structure that suppresses kinking during sharp turns of the wrist assembly 1140. Suitable materials for the polymer protective sheath include, but are not limited to, durable and highly resilient polymers such as Pebax Shore 35D, Tecoflex Shore 80A, and Pellethane Shore 80A. Suitable materials for the embedded coil include, but are not limited to, stainless steel or nitinol with a diameter of 0.005 to 0.010 mm.
[0239] The inner tube 1430 is preferably configured to have a cross-section adapted to actuator rods 1410 and / or 1411. In one embodiment, the tube 1430 includes a cross-section having a semi-circular portion 1460 and a generally linear portion 1462, providing a generally D-shaped cross-section (see [link]). Figure 45A This cross-section allows the actuator rod 1410 to extend laterally outward along the linear portion 1462 in the tube 1430, thereby providing space within the wrist assembly 1140 for the drive member 1130 and the clamp 1300 to pass through.
[0240] In another embodiment, the tube 1430 includes a cross-section having a first substantially linear portion 1462 and a second substantially linear portion 1466, and a first semicircular portion 1468 and a second semicircular portion 1470 extending between the linear portions 1462 and 1466 (see [link]). Figure 44B This cross-section allows two actuator rods 1410, 1411 to extend along the linear portions 1462, 1466.
[0241] Now refer to Figure 46 as well as Figures 47A-47C Embodiments of actuator rods or cable drivers 1410, 1411 will now be described. Actuator rods 1410, 1411 can be used with instrument 100, instrument 1100, or any other suitable clamping applicator instrument. Figure 47A As shown, the rod 1410 includes a proximal component 1472, a distal component 1474, and an intermediate flexible component 1476. The flexible component 1476 is designed to bend or articulate within the wrist assembly 1140. At least a portion of the flexible component 1476 may also be designed to expand or contract in the longitudinal direction to accommodate increases or decreases in the distance between the shaft 1105 and the end effector 1110 when the wrist assembly 1140 articulates.
[0242] In one embodiment, the flexible component 1476 includes a braided tungsten cable 1478, while the rigid components 1472, 1474 include stainless steel pins or tubes. The braided tungsten cable 1478 can be secured to the stainless steel pins or tubes by any suitable method such as crimping, welding, etc.
[0243] like Figure 47B As shown, the flexible component 1476 may include a flexible PTFE heat shrink tubing 1480 surrounding the cable 1478 to accommodate cable strands when the lever 1410 is compressed, for example, during a push of the lever 1410. The lever 1410 may include a second heat shrink tubing 1482 (see...). Figure 47C The second heat shrink tubing 1482 covers the tubing 1480 and extends over a portion of the rigid members 1472, 1474 to provide a continuous gripping cable outer diameter.
[0244] like Figure 46 As shown, a flexible sheath 1484 is disposed on the second heat-shrink tubing 1482 to provide a sliding engagement between the underlying cable 1478 and the sheath 4182. This allows the lever 1410 to flex and bend within the wrist assembly 1140, and / or to contract and expand along its length. This also prevents the gripping cable from buckling when the lever 1410 is pushed. Suitable materials for the sheath 1484 include, but are not limited to, laser-cut stainless steel tubing or polymer tubing materials.
[0245] Now refer to Figures 26A-26C as well as Figures 49A-53 B, now we will describe a method for applying multiple clips to tissues or blood vessels within a patient's body. For example... Figure 26B As shown, the drive member 1130 is first retracted proximally, causing the retainer tabs 1174 and 1176 to flex outward and slide on the upper surface 1136 and lower surface 1138 of the housing 1134 of the clamp. This allows the retainer tabs 1170 and 1172 to spring inward to clamp and secure the clamp 1300. Simultaneously, the pusher tab 1182 springs inward to contact and engage the proximal surface of the clamp (see...). Figure 26C ).
[0246] The drive member 1130 is then advanced distally until the distal member 1164 has advanced beyond the distal end of the housing 1134. When this occurs, the distal clamp 1300A is advanced forward by retainer tabs 1170, 1172, while the proximal clamps 1300B, 1300C, etc., are moved forward by pusher tab 1182. Once the distal member 1164 has moved to the distal end of the housing 1134, retainer tabs 1174, 1176 spring downwards and upwards to secure to the upper and lower surfaces of clamp 1300A (see [link to relevant documentation]). Figure 48B ).
[0247] like Figure 49BThe drive member 1130 is then advanced distally to advance the distal clip 1300A into the end effector 1110. The drive member 1130 and the clip 1300A pass through the inner tube 1430 as they pass through the wrist assembly 1140. As previously described, even when the end effector 1110 is articulated relative to the shaft 1105 (see Figure 49C and Figure 49D ), the inner tube 1430 is able to bend and flex and provide a smooth conduit for the drive member 1130 and the clip 1300A.
[0248] In preferred embodiments, the clip 1300A is oriented at an angle of about 30 degrees to 60 degrees, preferably about 45 degrees, relative to a plane passing through the shaft 1105 or wrist axis (see Figures 55A-55C ). This angle provides less contact between the clip 1300A and the inner surface of the tube 1430 as the wrist assembly 1140 is articulated, as compared to, for example, a situation where the clip 1300A is oriented at a right angle relative to the wrist axis (see, for example, Figures 54A-54C ). Reducing the amount of contact between the clip and the tube 1430 reduces the force required to push the clip through the wrist assembly and into the jaw.
[0249] As the distal clip 1300A is moved into the jaw 1402, 1404, the pusher tab 1182 is advancing a more proximal clip (1300B, 1300C, etc.) distally to the next distal position within the clip magazine 1120. These clips will then be in position to engage with the retainer tabs 1170, 1172 after the distal clip 1300A is released and the drive member 1130 is withdrawn proximally to its original position (see Figure 26B ).
[0250] Referring now to Figure 50A and Figure 50B , the drive member 1130 advances the clip 1300 into the jaw 1402, 1404 such that the latches 1310 and hooks 1312 slide through the guide rails 1440, 1442. This ensures that the arms 1302, 1304 of the clip 1300 open and advance to the distal end of the jaw 1402, 1404, thereby seating the clip 1300 in position to be closed and latched by the jaw 1402, 1404 (see Figures 52A-52C ). As the arms 1302, 1304 of the clip 1300 slide through the guide rails 1440, 1442, they engage with ramped leaf springs at the distal end of the jaw 1402, 1404. These leaf springs secure the arms 1302, 1304 of the clip 1300 to the jaw.
[0251] After the clip has been delivered to the jaw, the drive member 1130 can be released from the clip 1300 and withdrawn proximally into the shaft 1105 to retrieve another clip 1300B (see Figure 51 and Figure 52B ). In some embodiments, the drive member 1130 is withdrawn while the jaw is open. In other embodiments, the drive member 1130 can be withdrawn after the jaw is closed.
[0252] The surgical instrument described herein can be coupled to a proximal control system that monitors and controls the linkage or disc in the wrist assembly for articulating the end effector 110 and the jaws relative to the shaft 105 and for translating the drive member 130 distally and proximally to deliver a clip to the jaw. Additionally, the control system can monitor and control the longitudinal position of the drive member 130 relative to each of the clips within the magazine 120. In particular, the control system can monitor the position of the distal engagement elements of the drive member along the magazine 120 to determine when the drive member should be translated distally or proximally.
[0253] For example, the control system can monitor and control the drive member such that the engagement elements are translated proximally until they are above the openings in the upper and lower magazine housings associated with the first distal-most clip in the magazine. The control system can then monitor and control the drive member 130 such that the engagement elements are translated distally until the distal-most clip is in the desired position within the jaws 402, 404. After the clip has been latched and secured to the tissue and / or blood vessel, the control system can monitor and control the proximal withdrawal of the drive member 130 to prevent the drive member from inadvertently disengaging from the clip before this occurs. The control system can also monitor and control the movement of the drive member to the upper magazine position associated with the next distal-most clip remaining in the magazine.
[0254] The control system can be a manual control system with a user interface that allows the user to control each of the functions of the instrument or it can be an automatic control system that monitors and controls the functions. In some embodiments, the control system is a combination of manual and automatic that allows the user to adjust or control certain functions while automatically limiting those functions to a particular range or parameter.
[0255] In certain embodiments, the instrument can include a sensor (not shown) for detecting the position of the engagement element. The sensor can include any suitable sensor for detecting position, force, and / or torque. In one embodiment, the sensor includes a fiber optic bend sensor, such as a fiber Bragg grating (FBG), for providing strain measurements in the jaws, tension bands, and / or other components of the surgical instrument. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in U.S. Patent Application Publication No. 2006 / 0013523, filed July 13, 2005, and U.S. Patent No. 6,389,187, filed June 17, 1998, the entire disclosures of which are hereby incorporated by reference for all purposes.
[0256] The control system can include one or more processors (e.g., microprocessors, microchips, or application specific integrated circuits), one or more storage devices (e.g., random access memory and / or read only memory), and I / O interfaces and / or communication interfaces. The processor(s) can include one or more computer-readable storage devices and / or software applications that store program instructions that allow the processor(s) to compare the detected torque or force to the prescribed range. The I / O device(s) can include one or more devices that enable a user to interact with the system (e.g., a user interface). The I / O device(s) can include, for example, a touchscreen display, a keyboard, one or more selectors, one or more indicators.
[0257] Although described as a processor, it should be understood that the controller can be implemented in practice through any combination of hardware, software, and firmware. Moreover, their functions as described herein can be performed by one unit, or divided into different components, each of which can be implemented by any combination of hardware, software, and firmware.
[0258] Referring to Figure 56 An exemplary embodiment of a teleoperated surgical instrument 500 that can support the previously described instruments is depicted. As shown, the instrument 500 generally includes a proximal housing 510 at its proximal end that is coupled to a proximal end of a shaft 520 of the instrument. The proximal housing 510 can include an instrument memory or storage device (not shown). The memory can perform a variety of functions when the instrument is loaded onto a manipulator arm (not shown) of a robotic control system. For example, the memory can provide a signal that verifies that the instrument is compatible with that particular surgical system. Additionally, the memory can identify the instrument and end effector type (whether it is a surgical knife, needle grasp, jaw, scissors, clip applier, cautery blade, etc.) to the surgical system so that the system can reconfigure its programming to take advantage of the specialized functions of the instrument. As discussed further below, the memory can include details about the architecture of the instrument and include specific values that should be employed in the control algorithms, such as tool compliance and gain values.
[0259] The proximal housing 510 can also include a force / torque drive transmission mechanism (not shown) for receiving output from the motors of the manipulator arms. The force / torque drive transmission mechanism transmits the output from the motors through an instrument shaft 520 mounted to the transmission mechanism to an end effector 530 of the instrument. An exemplary surgical robotic instrument, instrument / manipulator arm interface structure, and data transmission between the instrument and servomechanism are described more completely in U.S. Patent No. 6,331,181, the entire disclosure of which is incorporated herein by reference.
[0260] Figure 59 A flowchart of a process 800 that can be performed by a control system, such as a robotic control system (such as the robotic control system shown in FIG. 1 and described below) coupled to a proximal housing or back end mechanism 510 of a surgical instrument is illustrated. The robotic control system includes at least one processor that relays input commands from a master controller operated by a user to first and second actuation systems within the back end mechanism. The actuation systems then provide mechanical actuation and control of the instrument to perform various functions, such as articulation and clip application, in response to manipulation of the master input device. Figure 57 and Figure 58 The robotic control system includes at least one processor that relays input commands from a master controller operated by a user to first and second actuation systems within the back end mechanism. The actuation systems then provide mechanical actuation and control of the instrument to perform various functions, such as articulation and clip application, in response to manipulation of the master input device.
[0261] In one embodiment, the back end mechanism includes a first drive system for controlling articulation of the end effector relative to the shaft and a second drive system for controlling longitudinal translation of a drive member through the shaft to advance a clip into the jaw and retract the drive member after the clip has been coupled to the jaw and / or closed and sealed onto a blood vessel. The back end mechanism can include a third drive system for opening and closing the jaw and / or a fourth drive or control system for monitoring and controlling the longitudinal position of the drive member (i.e., clip advancer) within the instrument shaft.
[0262] In one embodiment of the process 800, the control system can be operated to actuate a first drive system in the rear end mechanism 510 to articulate the end effector, e.g., straighten a curved wrist, so that the end effector is substantially parallel to the shaft (see step 802). Once the wrist is straightened, the control system can be operated to actuate a second drive system in the rear end mechanism to advance a drive member distally to advance a first clip or the distal-most clip into the jaw of the instrument (see step 804). In some embodiments, the jaw is open prior to advancing the clip into the jaw. In other embodiments, the jaw can be closed or partially open. Once the clip has been coupled to the jaw (step 806), the control system can be operated to actuate the second drive system to retract the drive member proximally from the jaw so that the drive member is aligned with a second (or next distal-most) clip in the clip magazine (see step 808). In some embodiments, the clips will be advanced together so that when the first clip is advanced into the jaw, the second clip is advanced into the position previously occupied by the first clip. In these embodiments, the drive member will be retracted to the same position relative to the instrument or clip magazine as when the first clip was engaged to engage the second clip. In other embodiments, the drive member can be further retracted proximally to engage the second clip (if the second clip was not advanced distally at the same operation as the first clip was operated). In these embodiments, the control system can include sensors, controllers, or other mechanisms for determining the position of the clip advancer to ensure it is retracted to a position corresponding to the second clip in the magazine (as previously described). It should be noted that any of the above drive systems can be independent of one another, or they can be combined with one another so that, for example, one drive system drives two functions, such as, for example, rotation of the end effector and clamping of the jaw.
[0263] The control system can then be operated to actuate the first drive system to articulate the end effector to rotate the jaw relative to the shaft, e.g., to position the jaw around a target blood vessel or tissue (step 810). The control system can then be operated to actuate the third drive system to close the jaw so that the clips are closed, latched, and sealed around the target blood vessel or tissue (step 812).
[0264] Of course, it will be appreciated that the drive members and clips can be advanced through the wrist to the end effector as the wrist is bent (i.e., as the end effector is rotated in the yaw, pitch, or roll directions). As discussed above, the drive members described herein include flexible portions that bend or flex within the wrist of the instrument to allow the drive members to remain positioned within the wrist and jaws during articulation of the end effector. Thus, in certain embodiments, the control system can be operated to first articulate the end effector so that the jaws are positioned around the target tissue or blood vessel, and then advance the drive members and first clip into the jaws.
[0265] As noted above, the present surgical instruments can be used in a robotic teleoperated surgical system. Figure 57 A top view of an operating room employing a robotic surgical system as an example is illustrated. The robotic surgical system in this case is the da Vinci® Surgical System 600, which includes a console ("C") used by a surgeon ("S") in performing minimally invasive diagnostic or surgical procedures on a patient ("P") lying on an operating table ("O"), often assisted by one or more assistants ("A").
[0266] Servos for remote surgery typically accept input from two master controllers, one for each of the surgeon's hands, and can include two or more robotic arms. A surgical instrument is mounted on each of the robotic arms. Operational communication between the master controllers and the associated robotic arms and instrument assemblies is 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 in the case of, for example, force feedback. One example of a robotic surgical system is the DA VINCI™ system commercialized by Intuitive Surgical, Inc. of Sunnyvale, California.
[0267] A variety of structural arrangements have been used to support surgical instruments at a surgical site during robotic surgery. Slave linkages or "slaves" are commonly referred to as robotic surgical manipulators, and exemplary linkage arrangements for use as robotic surgical manipulators during minimally invasive robotic surgery are described in U.S. Patent No. 7,594,912, U.S. Patent No. 6,758,843, U.S. Patent No. 6,246,200, and U.S. Patent No. 5,800,423, the entire disclosures of which are hereby incorporated by reference herein in their entireties for all purposes. These linkages generally manipulate an instrument holder that mounts an instrument with a shaft. Such manipulator structures can include a parallelogram linkage portion that produces motion of the instrument holder that is constrained to rotation about a pitch axis that intersects a remote center of manipulation located along the length of the instrument shaft. Such manipulator structures can also include a yaw joint that produces motion 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 center of manipulation. By aligning the remote center of manipulation with the incision point of an internal surgical site (e.g., with a trocar or cannula at the abdominal wall during laparoscopic surgery), the end effector of a surgical instrument can be safely positioned by moving the proximal end of the shaft using the manipulator linkage without applying potentially dangerous forces to the abdominal wall. Alternative manipulator structures are described in U.S. Patent No. 6,702,805, U.S. Patent No. 6,676,669, U.S. Patent No. 5,855,583, U.S. Patent No. 5,808,665, U.S. Patent No. 5,445,166, and U.S. Patent No. 5,184,601, the entire disclosures of which are hereby incorporated by reference herein in their entireties for all purposes.
[0268] During a surgical procedure, a teleoperated surgical system can provide mechanical actuation and control of various surgical instruments or tools having end effectors that perform various functions for the surgeon in response to manipulation of master input devices, such as holding or driving a needle, grasping a blood vessel, dissecting tissue, etc. Manipulation and control of these end effectors is a particularly beneficial aspect of robotic surgical systems. To this end, it is desirable to provide a surgical tool that includes a mechanism that provides two or three rotational degrees of freedom of motion of the end effector to mimic the natural motions of a surgeon's wrist. Such a mechanism should be appropriately sized for use in minimally invasive surgery and relatively simple in design to reduce potential 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.
[0269] The console includes a monitor 604 for displaying images of the surgical site to the surgeon, left and right steerable control devices 608 and 609, a foot pedal 605, and a processor 602. The control devices 608 and 609 can include any one or more of a variety of input devices such as joysticks, gloves, trigger-guns, hand-operated controllers, etc. The processor 602 can be a special-purpose computer that can be integrated into the console or located proximate to the console.
[0270] The surgeon performs the minimally invasive surgical procedure by manipulating the control devices 608 and 609 (also referred to herein as "master manipulators") so that the processor 602 causes their respective associated robotic arm assemblies 628 and 629 (also referred to herein as "slave manipulators") to manipulate their respective removably coupled surgical instruments 638 and 639 (also referred to herein as "tools") accordingly, while the surgeon observes the 3D surgical site on the console monitor 604 as it is being filmed by the stereoscopic endoscope 640.
[0271] Each of the tools 638 and 639 and the endoscope 640 can be inserted into the patient through a cannula or other tool guide (not shown) so as to extend through a corresponding minimally invasive incision, such as the incision 666, up to the surgical site. Each of the robotic arms is conventionally formed of links, such as the link 662, which are coupled together and manipulated by motor-controlled joints, or active joints, such as the joint 663.
[0272] The number of surgical tools used at one time, and thus the number of robotic arms used in the system 600, will generally depend on the diagnostic or surgical procedure and the space constraints and other factors within the operating room. If it becomes necessary to replace one or more of the tools being used during the procedure, an assistant can remove the tool that is no longer being used from its robotic arm and replace it with another tool 331 in a tray ("T") in the operating room.
[0273] The monitor 604 can be positioned close to the surgeon's hands so that it will display a projected image that is oriented so that the surgeon feels that he or she is actually looking directly down at the operating site. To this end, the images of the tools 638 and 639 can appear to be located substantially where the surgeon's hands are located.
[0274] The processor 602 performs various functions in the system 600. One function it performs is to translate and transmit the mechanical motions of the control devices 608 and 609 to their corresponding robotic arms 628 and 629 through control signals on the bus 610 so that the surgeon can effectively manipulate their corresponding tools 638 and 639. Another important function is to implement the various control system processes as described herein.
[0275] Robotic surgical systems and methods are further described in U.S. Patent No. 5,797,900, filed May 16, 1997 and issued August 25, 1998, U.S. Patent No. 6,132,368, filed November 21, 1997 and issued October 17, 2000, U.S. Patent No. 6,331,181, filed October 15, 1999 and issued December 18, 2001, U.S. Patent No. 6,441,577, filed April 3, 2001 and issued August 27, 2002, U.S. Patent No. 6,902,560, filed January 6, 2004 and issued June 7, 2005, U.S. Patent No. 6,936,042, filed April 16, 2002 and issued August 30, 2005, and U.S. Patent No. 6,994,703, filed December 4, 2002 and issued February 7, 2006, the entire disclosures of which are hereby incorporated by reference herein for all purposes. A suitable robotic surgical system currently in use is the da Vinci S Surgical System of Intuitive Surgical, Inc.
[0276] Figure 58 A simplified (not necessarily to scale or complete) side view of an illustrative robotic arm assembly 700 (which is representative of robotic arm assemblies 628 and 629) holding a surgical instrument 750 (which is representative of tools 638 and 639) for performing a surgical procedure is shown as an example. The surgical instrument 750 is removably held in a tool holder 740. The arm assembly 700 is mechanically supported by a base 701, which can be part of a patient-side movable cart or fixed to a surgical table or ceiling. It includes links 702 and 703, which are coupled together by set joints 704 and 705 and to the base 701.
[0277] The set joints 704 and 705 in this example are passive joints, which allow the arm 700 to be manually positioned when their brakes are released. For example, the set joint 704 allows the link 702 to be manually rotated about an axis 706, and the set joint 705 allows the link 703 to be manually rotated about an axis 707.
[0278] While only two links and two set joints are shown in this example, it should be understood that more or fewer links and set joints can be used as appropriate in the robotic arm assembly described herein and other robotic arm assemblies. For example, while set joints 704 and 705 are useful for horizontal positioning of arm 700, additional set joints can be included and used for limited vertical and angular positioning of arm 700. However, for primary vertical positioning of arm 700, arm 700 can also be moved in a slidable manner along the vertical axis of base 701 and locked in place.
[0279] Robotic arm assembly 700 also includes three active joints driven by motors. Yaw joint 710 allows arm segment 730 to rotate about axis 761, while pitch joint 720 allows arm segment 730 to rotate about an axis perpendicular to axis 761 and normal to the plane of the drawing. Arm segment 730 is configured so that segments 731 and 732 are always parallel to each other when pitch joint 720 is rotated by its motor. Thus, instrument 770 can be moved in a controlled manner by driving the yaw and pitch motors in order to pivot about pivot point 762, which is typically positioned by manually positioning set joints 704 and 705 so as to be located at the incision point into the patient. In addition, insertion gear 745 can be coupled to a linear drive mechanism (not shown) to extend or retract instrument 750 along its axis 763.
[0280] While each of yaw joint 710, pitch joint 720, and insertion gear 745 are controlled by separate joint or gear controllers, the three controllers are controlled by a common master / slave control system so that robotic arm assembly 700 (also referred to herein as a "slave manipulator") can be controlled by a user (e.g., a surgeon) manipulating its associated master manipulator.
[0281] While several embodiments have been shown and described, it is not intended that the description be limited thereto, as it is intended to cover in the appended claims all such modifications and equivalents. Accordingly, the above description should not be construed as limiting, but merely as exemplification of presently disclosed embodiments. The scope of the embodiments should therefore be determined not with reference to the above description but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosure of all patents and publications referred to in this specification are hereby incorporated by reference.
[0282] Furthermore, the terms of the present description are not intended to limit the devices described herein. Unless otherwise indicated herein, or unless clearly contradicted by context, the term "force" shall be interpreted to include both forces and torques. The terms "tool" and "instrument" can be used interchangeably herein to refer to a surgical instrument. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. The terms "comprise," "have," "including," and "contain" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. The terms "connected" and "coupled" are to be construed as partly or fully contained within, attached to, or joined to, even if there is something intervening.
[0283] Spatially relative terms—such as "proximal" and "distal"—can be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational settings) of the devices in use or operation in addition to the positions and orientations shown in the drawings. For example, the terms "proximal" and "distal" are relative terms where the term "distal" refers to the portion of the object that is farthest from the operator of the instrument and closest to the surgical site, such as the opening of the tool cover or the end effector of the instrument, and the term "proximal" refers to the portion of the object that is closest to the operator of the surgical instrument and farthest from the surgical site. In this application, end effector refers to the tool mounted at the distal end of the instrument, including but not limited to forceps or graspers, needle drivers, scalpels, scissors, spatulas, blades, and other tools, which can or can not use energy (i.e., monopolar or bipolar tools) to cauterize tissue.
[0284] Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the drawings are non-limiting example implementations. Features shown or described with respect to one example implementation can be combined with features of other implementations. Various alternatives and modifications will be apparent to those skilled in the art without departing from the present description. Accordingly, the present description is intended to embrace all such alternatives, modifications, and variations. Similarly, based on the above description, those skilled in the art will appreciate that further features and advantages of the present description will be or will become apparent. Therefore, the present description is not limited to the details described herein, but rather the claims are intended to cover all alternatives, modifications, and variations. Accordingly, the description is meant to be taken only by way of example and the true scope of the description is meant to be indicated by the claims.
[0285] For example, in a first aspect, a first implementation is a surgical instrument for applying a surgical clip to tissue. The instrument includes an elongated shaft, a wrist assembly coupled to a distal end of the shaft, an end effector rotatably coupled to the wrist assembly about an axis substantially perpendicular to the shaft and including first and second jaws movable between open and closed positions, and a drive member configured for distal translation from the shaft into the jaws of the end effector. The drive member includes a distal component for removably coupling to the surgical clip and a flexible component positioned within the wrist when the distal component is positioned within the end effector.
[0286] A second implementation is the first implementation, wherein the drive member includes a proximal component coupled to an actuator configured to translate the drive member relative to the shaft.
[0287] A third implementation is any combination of the first two implementations, wherein the flexible component of the drive member is configured to bend when the wrist assembly articulates the end effector relative to the shaft.
[0288] A fourth implementation is any combination of the first three implementations, the flexible component including one or more elongated rods coupling the proximal component to the distal component, wherein the length of the rods is equal to or greater than the length of the wrist assembly.
[0289] A fifth implementation is any combination of the first four implementations, wherein the elongated rods are sufficiently rigid to distally advance the surgical clip through the wrist assembly to the first and second jaws and sufficiently flexible to bend within the wrist assembly when the wrist assembly articulates relative to the shaft and the end effector.
[0290] A sixth implementation is any combination of the first five implementations, wherein the distal component includes an engagement element configured to removably couple to one or more clips within a clip magazine in the shaft.
[0291] A seventh implementation is any combination of the first six implementations, wherein the engagement element includes first and second tabs configured to removably couple to a proximal portion of the surgical clip.
[0292] An eighth implementation is any combination of the first seven implementations, wherein the first and second tabs are inwardly biased toward a longitudinal axis of the shaft.
[0293] A ninth implementation is any combination of the first eight implementations, wherein the distal component further includes an annular collar proximal of the first and second tabs.
[0294] The tenth embodiment is any combination of the preceding nine embodiments, wherein the second jaw comprises an internal cavity for receiving the clip magazine, and wherein the drive member comprises a housing having an internal chamber and is configured to advance over the clip magazine such that the clip magazine is disposed in the internal chamber of the drive member.
[0295] The eleventh embodiment is any combination of the preceding ten embodiments, wherein the wrist assembly comprises first and second linkages for articulating the end effector about first and second axes, respectively, wherein the first and second axes are substantially perpendicular to the longitudinal axis.
[0296] The twelfth embodiment is any combination of the preceding eleven embodiments, wherein the first and second linkages each comprise an internal passageway for translation of the drive member and the plurality of clips.
[0297] The thirteenth embodiment is any combination of the preceding twelve embodiments, further comprising a first actuator coupled to a proximal end of the drive member and a second actuator coupled to the wrist assembly.
[0298] The fourteenth embodiment is any combination of the preceding thirteen embodiments, further comprising a robotic control system coupled to the first and second actuators and configured to translate the drive member along the longitudinal axis relative to a shaft of the instrument and articulate the end effector relative to the shaft.
[0299] In another aspect, the first embodiment is a surgical instrument for applying surgical clips to tissue. The instrument comprises an elongated shaft having a longitudinal axis, an end effector coupled to the shaft and comprising first and second jaws movable between open and closed positions, a clip magazine within the shaft and comprising first and second proximal and distal clips spaced apart from one another along the longitudinal axis, and a drive member configured to translate through the shaft to the end effector. The drive member comprises first and second engagement elements for advancing the first and second clips distally through the shaft.
[0300] The second embodiment is the first embodiment, wherein the second engagement element is configured to contact and engage the second proximal clip when the first engagement element contacts and engages the first distal clip.
[0301] The third embodiment is any combination of the preceding two embodiments, wherein the drive member is configured to advance the first distal clip from a first position in the clip magazine to the first and second jaws and the second proximal clip from a second position in the clip magazine to the first position.
[0302] The fourth embodiment is any combination of the first three embodiments, wherein the first engagement element is configured to removably couple to the proximal end portion of the first distal clip.
[0303] The fifth embodiment is any combination of the first four embodiments, wherein the second engagement element comprises a pusher tab configured to engage and distally translate the second proximal clip upon distal translation of the drive member.
[0304] The sixth embodiment is any combination of the first five embodiments, wherein the first engagement element comprises a first retainer tab and a second retainer tab that are inwardly biased toward the longitudinal axis and configured to removably couple to the proximal end portion of the first clip.
[0305] The seventh embodiment is any combination of the first six embodiments, wherein the first clip and the second clip are spaced apart from each other by a first distance that is substantially equal to a second distance between the first clip and the first jaw and the second jaw.
[0306] The eighth embodiment is any combination of the first seven embodiments, wherein the drive member is disposed within the clip magazine.
[0307] The ninth embodiment is any combination of the first eight embodiments, wherein the drive member is movably coupled to the shaft.
[0308] The tenth embodiment is any combination of the first nine embodiments, wherein the clip magazine comprises an engagement element positioned to inhibit proximal movement of the second clip.
[0309] The eleventh embodiment is any combination of the first ten embodiments, further comprising an actuator coupled to a proximal end of the drive member.
[0310] The twelfth embodiment is any combination of the first eleven embodiments, further comprising a robotic control system coupled to the actuator and configured to translate the drive member along the longitudinal axis relative to the shaft of the instrument.
[0311] The thirteenth embodiment is any combination of the first twelve embodiments, further comprising a controller configured to detect a longitudinal position of the drive member relative to the magazine.
[0312] In another aspect, the first implementation is a surgical instrument for applying a surgical clip to tissue. The instrument includes an elongated shaft having a longitudinal axis, an end effector coupled to the shaft and including a first jaw and a second jaw movable between an open position and a closed position, a clip magazine within the shaft and including a surgical clip, wherein the surgical clip includes an engagement member, and a drive member configured to translate through the shaft to the end effector. The drive member has an engagement element for contacting and engaging the surgical clip to advance the surgical clip distally.
[0313] The second implementation is the first implementation, wherein the engagement member of the surgical clip includes one or more protrusions extending laterally outward from the surgical clip.
[0314] The third implementation is any combination of the first two implementations, wherein the surgical clip includes a first arm and a second arm pivotally coupled to each other at a proximal articulation portion, wherein the one or more protrusions extend from the proximal articulation portion.
[0315] The fourth implementation is any combination of the first three implementations, wherein the engagement element of the drive member includes an advancer tab biased inwardly toward the longitudinal axis of the shaft, wherein the advancer tab is configured to contact and engage the surgical clip proximally of the one or more protrusions.
[0316] The fifth implementation is any combination of the first four implementations, wherein the surgical clip includes one or more protrusions extending laterally therefrom, and the first jaw and the second jaw each include a guide track for receiving the one or more protrusions.
[0317] The sixth implementation is any combination of the first five implementations, wherein the guide track extends from a proximal end portion of the jaw to a distal end portion of the jaw.
[0318] The seventh implementation is any combination of the first six implementations, wherein the drive member further includes a second engagement element for removably coupling the drive member to the surgical clip.
[0319] The eighth implementation is any combination of the first seven implementations, wherein the second engagement element includes a first tab and a second tab extending from a distal end portion of the drive member, wherein the first tab and the second tab are biased inwardly toward the longitudinal axis.
[0320] The ninth implementation is any combination of the first eight implementations, wherein the surgical clip includes a first protrusion and a second protrusion extending laterally away from the longitudinal axis from the clip.
[0321] The tenth embodiment is any combination of the preceding nine embodiments, wherein the clip comprises a first arm and a second arm pivotally coupled to one another about a proximal articulation portion, and wherein the protrusion extends from the proximal articulation portion.
[0322] The eleventh embodiment is any combination of the preceding ten embodiments, wherein the first tab and the second tab are configured to contact an articulation portion of the clip proximally of the first protrusion and the second protrusion, such that distal movement of the drive member causes the first tab and the second tab to contact the protrusions and advance the clip distally.
[0323] The twelfth embodiment is any combination of the preceding eleven embodiments, wherein the clip comprises a first arm and a second arm pivotally coupled to one another about a proximal articulation portion, the clip further comprising a protrusion extending proximally from the proximal articulation portion, and wherein the first tab and the second tab are configured to be secured to the protrusion.
[0324] The thirteenth embodiment is any combination of the preceding twelve embodiments, wherein the first tab and the second tab are configured to be secured to a proximal portion of the clip, such that distal movement of the drive member causes the first tab and the second tab to contact the proximal portion and advance the clip distally.
Claims
1. A surgical instrument for applying surgical clips to tissue, the instrument comprising: an elongated shaft; a wrist assembly coupled to a distal end of the shaft; an end effector rotatably coupled to the wrist assembly about an axis substantially perpendicular to the shaft and comprising first and second jaws movable between open and closed positions; and a drive member configured for distal translation from the shaft into the jaws of the end effector, the drive member comprising a distal component for removable coupling to a surgical clip and a flexible component positioned within the wrist when the distal component is positioned within the end effector.
2. The apparatus of claim 1, wherein, the drive member comprising a proximal component coupled to an actuator configured to translate the drive member relative to the shaft.
3. The apparatus of claim 1, wherein, the flexible component of the drive member configured to bend when the wrist assembly articulates the end effector relative to the shaft.
4. The apparatus of claim 2, wherein, the flexible component comprising one or more elongated rods coupling the proximal component to the distal component, wherein the length of the rods is equal to or greater than the length of the wrist assembly.
5. The apparatus of claim 4, wherein, the elongated rods are sufficiently rigid to distally advance the surgical clip through the wrist assembly to the first and second jaws and sufficiently flexible to bend within the wrist assembly when the wrist assembly articulates relative to the shaft and the end effector.
6. The apparatus of claim 1, wherein, the distal component comprising an engagement element configured to removably couple to one or more clips within a clip magazine in the shaft.
7. The apparatus of claim 6, wherein, the engagement element comprising first and second tabs configured to removably couple to a proximal portion of the surgical clip.
8. The apparatus of claim 7, wherein, the first and second tabs are inwardly biased toward a longitudinal axis of the shaft.
9. The apparatus of claim 8, wherein, the distal component further comprising an annular collar proximal to the first and second tabs.
10. The apparatus of claim 1, wherein, the second jaw comprising an internal cavity for receiving a clip magazine and wherein the drive member comprises a housing having an internal chamber and the drive member is configured to advance over the clip magazine such that the clip magazine is disposed in the internal chamber of the drive member.
11. The apparatus of claim 1, wherein, the wrist assembly comprising first and second linkages for articulating the end effector about first and second axes, respectively, wherein the first and second axes are substantially perpendicular to a longitudinal axis.
12. The apparatus of claim 11, wherein, the first and second linkages each comprising an internal passageway for translation of the drive member and a plurality of clips.
13. The instrument of claim 1, further comprising a first actuator coupled to a proximal end of the drive member and a second actuator coupled to the wrist assembly.
14. The instrument of claim 13, further comprising a robotic control system coupled to the first and second actuators and configured to translate the drive member relative to the shaft of the instrument along a longitudinal axis and articulate the end effector relative to the shaft.
15. A surgical instrument for applying surgical clips to tissue, the instrument comprising: an elongated shaft having a longitudinal axis; an end effector coupled to the shaft and including first and second jaws movable between open and closed positions; a clip magazine within the shaft and including first and second distal and proximal clips spaced apart from one another along the longitudinal axis; and a drive member configured to translate through the shaft to the end effector, the drive member having first and second engagement elements for distally advancing first and second clips through the shaft.
16. The surgical instrument of claim 15, wherein, the second engagement element configured to contact and engage the second proximal clip when the first engagement element contacts and engages the first distal clip.
17. The surgical instrument of claim 15, wherein, the drive member configured to advance the first distal clip from a first position in the clip magazine to the first and second jaws and the second proximal clip from a second position in the clip magazine to the first position.
18. The surgical instrument of claim 15, wherein, the first engagement element configured to removably couple to a proximal end portion of the first distal clip.
19. The surgical instrument of claim 18, wherein, the second engagement element including an advancer tab configured to engage and distally translate the second proximal clip as the drive member distally translates.
20. The surgical instrument of claim 18, wherein, the first engagement element including first and second retainer tabs inwardly biased toward the longitudinal axis and configured to removably couple to a proximal end portion of the first clip.
21. The surgical instrument of claim 15, wherein, the first and second clips spaced apart from one another by a first distance substantially equal to a second distance between the first clip and the first and second jaws.
22. The surgical instrument of claim 15, wherein, the drive member disposed within the clip magazine.
23. The surgical instrument of claim 15, wherein, the drive member movably coupled to the shaft.
24. The surgical instrument of claim 15, wherein, the clip magazine including an engagement element positioned to inhibit proximal movement of the second clip.
25. The surgical instrument of claim 15, further comprising an actuator coupled to a proximal end of the drive member.
26. The surgical instrument of claim 25, further comprising a robotic control system coupled to the actuator and configured to translate the drive member relative to the shaft of the instrument along a longitudinal axis.
27. The surgical instrument of claim 26, further comprising a controller configured to detect a longitudinal position of the drive member relative to the magazine.
28. A surgical instrument for applying surgical clips to tissue, the instrument comprising: an elongated shaft having a longitudinal axis; an end effector coupled to the shaft and comprising first and second jaws movable between open and closed positions; a clip cartridge within the shaft and comprising a surgical clip, wherein the surgical clip comprises an engagement member; and a drive member configured to translate through the shaft to the end effector, the drive member having an engagement element for contacting and engaging the engagement member of the surgical clip to distally advance the surgical clip.
29. The surgical instrument of claim 28, wherein, The engagement member of the surgical clip comprises one or more protrusions extending laterally outward from the surgical clip.
30. The surgical instrument of claim 29, wherein, The surgical clip comprises first and second arms pivotally coupled to one another at a proximal articulation portion, wherein the one or more protrusions extend from the proximal articulation portion.
31. The surgical instrument of claim 30, wherein, The engagement element of the drive member comprises an advancer tab biased inward toward the longitudinal axis of the shaft, wherein the advancer tab is configured to proximally contact and engage the surgical clip at the one or more protrusions.
32. The surgical instrument of claim 28, wherein, The surgical clip comprises one or more protrusions extending laterally therefrom and the first and second jaws each comprise a guide track for receiving the one or more protrusions.
33. The surgical instrument of claim 32, wherein, The guide track extends from a proximal end portion of the jaw to a distal end portion of the jaw.
34. The surgical instrument of claim 28, wherein, The drive member further comprises a second engagement element for removably coupling the drive member to the surgical clip.
35. The surgical instrument of claim 34, wherein, The second engagement element comprises first and second tabs extending from a distal end portion of the drive member, wherein the first and second tabs are biased inward toward the longitudinal axis.
36. The surgical instrument of claim 35, wherein, The surgical clip comprises first and second protrusions extending laterally away from the longitudinal axis from the clip.
37. The surgical instrument of claim 36, wherein, The clip comprises first and second arms pivotally coupled to one another about a proximal articulation portion, and wherein the protrusions extend from the proximal articulation portion.
38. The surgical instrument of claim 37, wherein, The first and second tabs are configured to proximally contact the articulation portion of the clip such that distal movement of the drive member causes the first and second tabs to contact the protrusions and distally advance the clip.
39. The surgical instrument of claim 35, wherein, The clip comprises first and second arms pivotally coupled to one another about a proximal articulation portion, the clip further comprising a protrusion extending proximally from the proximal articulation portion, and wherein the first and second tabs are configured to be secured to the protrusion.
40. The surgical instrument of claim 35, wherein, The first and second tabs are configured to be secured to a proximal portion of the clip such that distal movement of the drive member causes the first and second tabs to contact the proximal portion and distally advance the clip.
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