Surgical instruments for applying multiple clips to tissue
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- INTUITIVE SURGICAL OPERATIONS INC
- Filing Date
- 2024-11-29
- Publication Date
- 2026-06-04
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Abstract
Description
International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT SURGICAL INSTRUMENTS FOR APPLYING MULTIPLE CLIPS TO TISSUECROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to the following International Applications: (1) PCT / US24 / 32191, filed June 3, 2024; (2) PCT / US24 / 32201, filed June 3, 2024, (3) PCT / US24 / 32207, filed June 3, 2024 (4) PCT / US24 / 32213, filed June 3, 2024 (5) PCT / US24 / 32221, filed June 3, 2024; and (6) PCT / US24 / 32233, filed June 3, 2024, the complete disclosures of which are incorporated herein by reference for all purposes.BACKGROUND
[0002] This description generally relates to endoscopic surgical instruments for dissecting, occluding and / or sealing tissue, and more particularly to endoscopic surgical instruments capable of applying multiple clips to vessels and / or tissue.
[0003] Minimally invasive medical techniques are intended to reduce the amount of extraneous tissue that is damaged during diagnostic or surgical procedures, thereby reducing patient recovery time, discomfort, and deleterious side effects. One effect of minimally invasive surgery, for example, is reduced post-operative hospital recovery times. The average hospital stay for a standard open surgery is typically significantly longer than the average stay for an analogous minimally invasive surgery (MIS). Thus, increased use of MIS could save millions of dollars in hospital costs each year. While many of the surgeries performed each year in the United States could potentially be performed in a minimally invasive manner, only a portion of the current surgeries uses these advantageous techniques due to limitations in minimally invasive surgical instruments and the additional surgical training involved in mastering them.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0004] Improved surgical instruments such as tissue access, navigation, dissection and sealing instruments have enabled MIS to redefine the field of surgery. These instruments allow surgeries and diagnostic procedures to be performed with reduced trauma to the patient. A common form of minimally invasive surgery is endoscopy, and a common form of endoscopy is laparoscopy, which is minimally invasive inspection and surgery inside the abdominal cavity. In standard laparoscopic surgery, a patient's abdomen is insufflated with gas, and cannula sleeves are passed through small (approximately one-half inch or less) incisions to provide entry ports for laparoscopic instruments.
[0005] Laparoscopic surgical instruments generally include an endoscope (e.g., laparoscope) for viewing the surgical field and tools for working at the surgical site. The working tools are typically similar to those used in conventional (open) surgery, except that the working end or end effector of each tool is separated from its handle by an extension tube (also known as, e.g., an instrument shaft or a main shaft). The end effector can include, for example, a clamp, grasper, scissor, stapler, cautery tool, linear cutter, or needle holder.
[0006] To perform surgical procedures, the surgeon passes working tools through cannula sleeves to an internal surgical site and manipulates them from outside the abdomen. The surgeon views the procedure from a monitor that displays an image of the surgical site taken from the endoscope. Similar endoscopic techniques are employed in, for example, arthroscopy, retroperitoneoscopy, pelviscopy, nephroscopy, cystoscopy, cisternoscopy, sinoscopy, hysteroscopy, urethroscopy, and the like.
[0007] Minimally invasive telesurgical robotic systems are being developed to increase a surgeon's dexterity when working on an internal surgical site, as well as to allow a surgeon to operate on a patient from a remote location (outside the sterile field). In a telesurgery system, the surgeon is often provided with an image of the surgical site at aInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT control console. While viewing a three dimensional image of the surgical site on a suitable viewer or display, the surgeon performs the surgical procedures on the patient by manipulating master input or control devices of the control console, which in turn control motion of the servo-mechanically operated slave instruments.
[0008] The servomechanism used for telesurgery will often accept input from two master controllers (one for each of the surgeon's hands) and may include two or more robotic arms on each of which a surgical instrument is mounted. Operative communication between master controllers and associated robotic arm 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 arm and instrument assemblies and back from the instrument and arm assemblies to the associated master controllers in the case of, for example, force feedback or the like. 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 the surgical instrument at the surgical site during robotic surgery. The driven linkage or "slave" is often called a robotic surgical manipulator, and exemplary linkage arrangements for use as a robotic surgical manipulator during minimally invasive robotic surgery are described in U. S. Pat. Nos. 7,594,912 (filed Sep. 30, 2004), 6,758,843 (filed Apr. 26, 2002), 6,246,200 (filed Aug. 3, 1999), and 5,800,423 (filed Jul. 20, 1995), the full disclosures of which are incorporated herein by reference in their entirety for all purposes. These linkages often manipulate an instrument holder to which an instrument having a shaft is mounted. Such a manipulator structure can include a parallelogram linkage portion that generates motion of the instrument holder that is limited to rotation about a pitch axis that intersects a remoteInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT center of manipulation located along the length of the instrument shaft. Such a manipulator structure can also include a yaw joint that generates motion of the instrument holder that is limited to rotation about a yaw axis that is perpendicular to the pitch axis and that also intersects the remote center of manipulation. By aligning the remote center of manipulation with the incision point to the internal surgical site (for example, with a trocar or cannula at an abdominal wall during laparoscopic surgery), an end effector of the surgical instrument can be positioned safely by moving the proximal end of the shaft using the manipulator linkage without imposing potentially hazardous forces against the abdominal wall. Alternative manipulator structures are described, for example, in U. S. Pat. Nos. 6,702,805 (filed Nov. 9, 2000), 6,676,669 (filed Jan. 16, 2002), 5,855,583 (filed Nov. 22, 1996), 5,808,665 (filed Sep. 9, 1996), 5,445,166 (filed Apr. 6, 1994), and 5,184,601 (filed Aug. 5, 1991), the full disclosures of which are incorporated herein by reference in their entirety for all purposes.
[0010] During the surgical procedure, the telesurgical system can provide mechanical actuation and control of a variety of surgical instruments or tools having end effectors that perform various functions for the surgeon, for example, holding or driving a needle, grasping a blood vessel, dissecting tissue, or the like, in response to manipulation of the master input devices. 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 a minimally invasive procedure and relatively simple in design to reduce possible points of failure. In addition, such mechanisms should provide an adequate range of motion to allow the end effector to be manipulated in a wide variety of positions.
[0011] Endoscopic surgical clip appliers are used for a number of minimally invasive or endoscopic surgical procedures to occlude, ligate and / or seal vessels and tissue.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT Applying surgical clips usually involves compressing the clip over the surgical site, such as a blood vessel. Once applied to the vessel, the compressed surgical clip terminates the flow of fluid therethrough.
[0012] Conventional surgical clips are designed to be compressed into a latched or locked position around a grasped vessel or other grasped tissue. Typically, the surgical instrument includes jaws that can be closed to engage bosses formed on the clips. These bosses are forced inwardly about a hinge section causing the first and second legs of the clip being applied to close around the grasped vessel. The tip section of the second leg then begins to contact a hook section. Upon opening of the jaws, the tip section snaps into and is conformably seated in the latching recess, at which point the clip is secured into a latched condition.
[0013] C Certain endoscopic surgical clip appliers include a surgical instrument having an end effector with movable jaws and a single clip that is installed within the end effector. These instruments are limited to a single discharge per instrument. In other words, once a clip has been discharged 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 with a cartridge that may be preloaded with about 2-10 clips. These clip appliers, however, are typically disposable and designed to be discarded after a 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] In addition, the clips in the clip cartridges typically take a “set” in the closedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT positioned over time (i.e., the legs of the clip tend to move closer towards each other into a closed or semi-closed position while they are stored in the clip cartridge). Unfortunately, these “multi-fire” clip appliers do not have the ability to securely hold the bosses of the clips within the jaws once they are advanced into the jaws. In such event, the clip applier may misfire and drop a clip into the surgical field.
[0016] Accordingly, while the new telesurgical systems and devices have proven highly effective and advantageous, still further improvements would be desirable. In general, it would be desirable to provide improved endoscopic clip appliers that are capable of discharging multiple clips without requiring either an instrument exchange or repositioning of the jaws. Additionally, it would be advantageous to provide such improved endoscopic clip appliers without sacrificing the overall instrument size, thereby allowing for the design of compact and maneuverable instruments.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 intended to neither identify key or critical elements of the claimed subject matter nor 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 comprises an elongate shaft, an end effector coupled to the shaft and comprising first and second opposing jaws and a drive member configured for distal translation from the shaftInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT into the end effector to deliver one or more surgical clips to the first and second j aws. The drive member comprises at least a first distal arm having first and second projections extending laterally towards each other and configured for removably coupling to a distal portion of the surgical clip.
[0019] In embodiments, the drive member comprises a second distal arm having first and second projections extending laterally towards each other and configured for removably coupling to a distal portion of the surgical clip. The drive member is configured to retain and control the upper and lower arms of the clip, which allows the drive member to position the clip arms within the jaws of the end effector and to retain the clip while 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 vessel or tissue. In addition, this allows the surgeon to reposition the jaws relative to the shaft after the clip has been advanced into the jaws.
[0020] In embodiments, the first and second projections of each distal arm of the drive member extend “inwardly” towards each other to create a space therebetween for coupling the distal arms with the upper and lower arms of the surgical clip. This inhibits the projections from catching on tissue as the clip is implanted and / or to internal components of the instrument as the drive member is advanced distally through the instrument to the jaws.
[0021] In embodiments, the surgical clip comprises first and second arms pivotally coupled to each other about a proximal hinge. The first and second arms of the clip each comprise an engagement member for removably coupling to the first and second projections of the first and second distal arms of the drive member. In certainInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT embodiments, the clip arms each comprise first and second opposing recessed surfaces and the projections are configured to extend at least partially into the first and second recessed surfaces. In other embodiments, the clip arms each comprise first and second openings or through-holes and the projections are configured to extend at least partially into opposing sides of the openings or through-holes.
[0022] In embodiments, the first and second projections of the distal arms are biased towards each other and the first and second arms of the clip each comprise a tapered surface proximal of the opening. The first and second projections of the distal arms of the drive member are configured to contact the tapered surfaces as the drive member translates distally relative to the clip. This allows the projections to cam along the ramped or tapered surfaces of the clip and gradually move further away from each other as they are driven distally towards the opening. Once the projections are aligned with the opening, they are biased inwardly into the opening to couple arms of the drive member to the arms of the clip.
[0023] In embodiments, the first and second jaws each comprise a disengagement feature such that proximal withdrawal of the drive member releases the projections of the drive member from the engagement members of the clip. In an exemplary embodiment, the disengagement feature comprises an elongate element extending along an inside surface of each of the first and second jaws. The elongate element comprises a distal end portion extending laterally towards the other jaw member and positioned to engage a portion of the clip as the drive member is withdrawn proximally. The elongate element is configured to exert sufficient force against the clip to cause the projections to move away from each other to disengage with the opening in the clip arms. This allows the drive member to be removed from the clip after it has been closed onto tissue or a vessel.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0024] In embodiments, the surgical clip comprises first and second projections extending from an external surface of the first and second arms of the clip, the first and second projections being configured to contact the disengagement feature on each of the first and second jaws when the drive member is translated proximally. The disengagement feature of each of the first and second jaws are configured to apply a sufficient force to the first and second projections to retain the surgical clip within the first and second jaws as the first and second projections disengage from the opening in each of the first and second arms.
[0025] In embodiments, the distal arms of the drive member each comprise a frame comprising first and second support members and the first and second projections extend inwardly into the space between the first and second support members. Thus, the clip engagement features are enclosed within the frame, which minimizes catching of tissue when the clip is implanted. The first and second projections may each taper inwardly from a first end adjacent the frame to a second end laterally spaced from the frame such that the second end has a smaller cross-sectional area than the first end. The second or inner end may comprise a mating feature, such as a ball detent or the like, for mating with the opening in each arm of the clip.
[0026] In embodiments, the frame of the first arm defines a first internal opening or window and the frame of the second arm defines a second internal opening or window. The first internal opening has a larger cross-sectional area than the second internal opening. The frame of the first arm has a first length and the frame of the second arm has a second length. The first length is greater than the second length such that the frames of the first and second arms generally do not contact the disengagement features of the first and second j aws as the drive member is withdrawn proximally relative to the first and second j aws. InInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT addition, the width of the internal openings of the frames are preferably less than the width of the disengagement feature such that even if the frames do contact the disengagement feature of the jaws, the internal openings or windows of the drive member do not get caught on the disengagement feature as the drive member is withdrawn proximately when the clip in held within the jaws.
[0027] In embodiments, the instrument further comprises a clip cartridge within the shaft. The clip cartridge comprises a housing with upper and lower walls extending substantially in a longitudinal direction relative to the shaft of the instrument, first and second surgical clips disposed within an interior of the housing between the upper and lower walls, first and second retainer tabs on the cartridge and configured to retain the first and second clips within the cartridge, wherein the retainer tabs are pivotally coupled to the housing and movable into an open position to release the first and second clips upon distal movement of the drive member and upper and lower ramps extending away from the upper and lower walls. Multiple surgical clips are configured to be slidably disposed within the housing of the clip cartridge.
[0028] In embodiments, each frame of the distal arms of the drive member is sized to cam along an outer surface of the first and second retainer tabs and the upper and lower ramps as the drive member is withdrawn proximally relative to the clip cartridge. Each frame of the distal arms has a first width in a direction substantially perpendicular to the longitudinal direction and the outer surface of the retainer tabs have a second width in said longitudinal direction, wherein the first width is less than the second width. The upper and lower ramps have a third width in said longitudinal direction, wherein the first width is less than the third width. In particular, the width of the internal openings of the frames are preferably less than the width of the retainer tabs such that the internal openings or windowsInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT of the drive member do not get caught on the retainer tabs as the drive member is withdrawn proximately relative to the clip cartridge.
[0029] In embodiments, the frames have asymmetrical shapes relative to each other to facilitate the engagement of the projections with the openings in the upper and lower arms of the clip. In an exemplary embodiment, the frame extending from the second distal arm of the drive member is longer than the frame extending from the first distal arm. In certain embodiments, the second frame may have a curved orientation, or may include a distal portion that extends at an angle relative to the proximal portion. This orients the frames such that the first frame may engage the distal portion of the upper arm of the clip at substantially the same time that the second frame engages the distal portion of the lower arm of the clip.
[0030] In embodiments, the first and second jaws each comprise a guide track extending from the wrist member to a distal end of the jaws. The guide tracks facilitate the advancement of the clip and the engagement elements of the drive member through the jaws and into position such that the jaws can open and / or close the clip. The end effector may further comprise first and second flexible bands, cables or ribbons extending from the wrist member to a distal end of each of the first and second jaws. The first and second ribbons comprise at least a semi-flexible material configured to bend when the first and second jaws articulate about the wrist member relative to the shaft. The ribbons constrain the drive member and the clip as they are advanced into the jaws and ensure that they stay within the guide tracks in the event that the jaws are articulated during clip advancement.
[0031] In another aspect, a surgical instrument for applying surgical clips to tissue comprises an elongate shaft, an end effector coupled to the shaft and comprising first and second opposing jaws and a drive member configured for distal translation from the shaftInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT into the end effector to deliver one or more surgical clips to the first and second j aws. The drive member comprises at least a first distal arm comprising first and second support members and at least one projection extending from one of the support members into a space between the support members. The projection is configured for removably coupling to a distal portion of a clip disposed within the shaft.
[0032] In embodiments, the drive member comprises a second distal arm comprising first and second support members and at least one projection extending from one of the support members into a space between the support members. In embodiments, each of the first and second distal arms comprises first and second projections extending towards each other into the space between the first and second support members.
[0033] In embodiments, the first and second distal arms each comprise a frame comprising the first and second support members and at least one lateral support member coupling the first support member to the second support member. The frames provide a rigid structure that can navigate the working channel provided by the wrist and jaw assemblies, while the internal projections constrain the clip. In an exemplary embodiment, the frames are generally stiffer in the loading / distal direction and more flexible in the unloading / proximal direction, which provides substantial benefit for loading (stability) and releasing sequences.
[0034] In embodiments, the drive member comprises first and second flexible components coupled to the first and second distal arms and disposed proximal to the distal arms. The frame comprises a first lateral support member coupled to the flexible component, a second lateral support member spaced distally from the first lateral support member and an opening between the first and second lateral support members. In an exemplary embodiment, the opening in the first distal arm has a larger cross-sectional areaInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT than the opening in the second distal arm.
[0035] In embodiments, the distal arms of the drive member include first and second engagement elements configured for removable coupling to the first and second jaws. Thus, the first and second engagement elements allow the distal arms of the drive member (and the clip therewith) to move with the first and second jaws as they are opened and closed.
[0036] In embodiments, the instrument further comprises a wrist member pivotally coupling the end effector with the elongate shaft such that at least a portion of the drive member is movable through the wrist member between the shaft and the end effector. The drive member may comprise a distal portion configured for removably engaging the surgical clip and a flexible portion that extends through the wrist member when the distal portion is within the end effector. The drive member may further comprise a proximal portion extending through the shaft, wherein the flexible portion allows the distal portion to articulate relative to the proximal portion when the end effector articulates about the wrist member.
[0037] In another aspect, a surgical instrument for applying surgical clips to tissue, comprises an elongate shaft and an end effector rotatably coupled to the shaft around an axis substantially perpendicular to the shaft and including first and second opposing jaws. The instrument further comprises a drive member configured for distal translation from the shaft into the end effector. The drive member comprises first and second asymmetric engagement elements for removably coupling to a distal portion of first and second arms of a surgical clip.
[0038] The asymmetric engagement elements are configured to extend around the non-tissue sides of the upper and lower arms of a surgical clip within the instrument, suchInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT as a clip positioned with a housing of a clip cartridge in the shaft. This allows the drive member to engage and attach to the distal portions of the upper and lower arms of the clip within the clip cartridge so that the drive member may advance the clip to the jaws.
[0039] In embodiments, the first and second engagement members each comprise a frame having first and second support members and at least one lateral support member extending between the first and second support members. In an exemplary embodiment, the first and second support members of the second engagement element are longer than the first and second support members of the first engagement element. In one embodiment, the frame of the second engagement element is non-planar and has a distal portion extending towards the first engagement the frame of the first engagement element. In other embodiments, both of the engagement elements are non-planar and have distal portions extending towards each other.
[0040] In embodiments, the drive member comprises a proximal component, a distal component configured for removably engaging a clip and a flexible component that extends between the proximal and distal components. The proximal component is oriented at an angle relative to the distal component. In an exemplary embodiment, the proximal component is oriented perpendicularly relative to the distal component.
[0041] In embodiments, the distal component of the drive member comprises the first and second asymmetric engagement elements and the flexible component comprises the first and second distal arms. The first and second distal arms may each have a proximal portion oriented substantially parallel to the proximal component and a distal portion oriented substantially parallel to the first and second asymmetric engagement elements. Thus, the first and second elongate members of the flexible component each comprise a twisted portion between the proximal and distal components of the drive member.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0042] In one embodiment, the twisted portion is located proximal of a midpoint between the proximal and distal components of the drive member. In another embodiment, the twisted portion is located distal of a midpoint between the proximal and distal components of the drive member. The midpoint between the proximal and distal components of the drive member twill experience the highest or peak strain when the flexible portion is articulated (i.e., when the jaws are articulated relative to the shaft) Locating the twisted portion distal or proximal of this midpoint reduces the overall strain experienced by the twisted portion during articulation, thereby increasing the robustness of the drive member.
[0043] In embodiments, the proximal component of the drive member comprises a first material and the distal and flexible components of the drive member comprise a second material. The material has a greater stiffness than the second material. This adds stiffness to the drive member and reduces the amount of flexible material (e.g., nitinol) required from drive member, thereby reducing the overall cost of the instrument. In addition, stainless steel is generally easier to manufacture for complex geometries than other materials, such as nitinol.
[0044] In another aspect, a surgical clip comprises a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions. The first and second arms each comprise a distal end portion spaced from the hinge and an engagement member on the distal end portion configured for removably coupling to a drive member of a surgical instrument. The engagement member comprises an opening extending through at least a portion of each of the first and second arms.
[0045] In embodiments, the engagement members of the first and second arms are configured to remain coupled to the drive member after the clip has been delivered to theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT jaws 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 vessel or tissue (i.e., in the event they have closed or partially closed in the clip cartridge). In addition, this allows the surgeon to reposition the jaws relative to the shaft after the clip has been advanced into the jaws
[0046] In one embodiment, the openings comprise a through-hole extending through each of the first and second arms of the clip. In another embodiment, the openings comprises a recessed surface in each the first and second arms of the clip.
[0047] In embodiments, the first and second arms of the clip each comprise a guide feature for aligning portions of first and second arms of the drive member with the openings. In an exemplary embodiment, the guide feature comprises a tapered contact surface proximal of the opening.
[0048] In embodiments, the guide feature extends from an outer surface of each of the arms of the clip and comprises first and second tapered contact surfaces extending on opposing sides of the arms of the clip such that a distal end of the guide feature has a greater thickness than a proximal end of the guide feature.
[0049] In embodiments, the arms of the drive member each comprise first and second fastening elements for securing the first and second arms of the clip in the closed position. The drive member is removable from the engagement members of the first and second ends when the first and second ends are in the closed position. For example, the drive member may be withdrawn from the clips and the jaws after the clip has been latched and sealed around a vessel at the target site.
[0050] In embodiments, the first and second fastening elements are secured together in the closed position with a first strength or force and the engagement elementsInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT are configured to couple to the drive element with a second strength or force. The force required to detach the fastening elements from each other (and unlatch the clip) is greater than the force required to detach the engagement element of the clip from the drive member. This allows a user to withdraw the drive member from the clip after the clip has been closed and latched around a vessel or tissue.
[0051] In embodiments, the clip comprises at least one guide feature on one of the first and second arms for aligning a drive member with the clip within a surgical instrument. The guide feature facilitates loading of the clip cartridge into the surgical instrument before, or during, a surgical procedure.
[0052] In embodiments, the first arm comprises a first engagement hook with a slot or recess and the second arm comprises a second engagement hook sized to advance into the slot to secure the arms in the closed position. This configuration provides a clip with a narrower profile than conventional surgical clips that include boss protrusions to lock the clip.
[0053] In certain embodiments, the clip is sized to ligate vessels having a diameter of about 1 mm to about 10 mm. In certain embodiments, the clip is designed with a sufficient length, strength and rigidity to ligate medium to large sized vessels, or vessels of up to 10 mm in diameter.
[0054] In embodiments, the maximum lateral width of the clip is less than about 2.0 mm, or about 0.6 mm to about 1.5 mm, or preferably about 0.8 mm to about 1.1 mm (conventional polymer clips designed to ligate vessels up to 10 mm in diameter typically have a maximum lateral width of 2.0 mm or greater). This relatively narrow profile allows the user to place the clips in closer proximity to each other and / or place more clips within a target location on the patient, e.g., a vessel, thereby providing a stronger seal on the vessel.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0055] In embodiments, the clip comprises a polymer material, such as a non¬ absorbable polymer or a resorbable or biodegradable polymer. Suitable materials for the clip include polyoxymethylene (POM), polyester, nylon, polyetheretherketone (PEEK), polyglycolic acid (PGA or PLGA), poly-L-lactic acid (PLEA), polyethylene (PE) or copolymers thereof. In a preferred embodiment, the clip comprises POM.
[0056] In another aspect, a surgical clip comprises a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions. The first arm comprises an inner surface opposing the second arm and first and second rows of gripping elements projecting from the inner surface. The first row of gripping elements is offset from the second row of gripping elements.
[0057] The gripping elements increase the tissue contact area of the vessel sides of the arms of the clip. This inhibits or prevents the clip from slipping relative to the tissue after the arms of the clip have been closed.
[0058] In embodiments, the second arm comprises an inner surface opposing the first arm and first and second rows of gripping elements projecting from the inner surface. The first row of gripping elements are offset from the second row of gripping elements. The gripping elements of the first and second arms are spaced from each other in the closed position.
[0059] In one embodiment, the gripping elements have a ramped surface that tapers such that an inner end of the gripping elements is spaced further away from the inner surface of the arms than an outer end of the gripping elements. The inner end of the gripping elements is longer than the outer end of the gripping elements. The “wedge-shaped” gripping elements is particularly useful for axial retention of small vessels when the clip is implanted.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0060] In embodiments, the inner surface of the first arm defines a centerline. The first row of gripping surfaces is disposed on a first side of the centerline and the second row of gripping surfaces is disposed on a second side of the centerline opposite the first side. In an exemplary embodiment, the inner end of the gripping surfaces in each of the first and second rows of gripping surfaces is spaced outwardly from the centerline.
[0061] In embodiments, the projections of the first arm interlock with the projections of the second arm. In an exemplary embodiment, the gripping elements comprise interlocking teeth.
[0062] 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 or may be learned by practice of the description.BRIEF DESCRIPTION OF THE DRAWINGS
[0063] The above and other aspects, features, and advantages of the present surgical instruments will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
[0064] FIG. 1 is a perspective view of a distal portion of a surgical instrument;
[0065] FIG. 2 is an exploded view of the surgical instrument of FIG. 1 with a clip cartridge configured for insertion through a longitudinal slot in the side of instrument shaft;
[0066] FIGS. 3 A and 3B illustrates a surgical instrument with a clip cartridge configured for insertion through a proximal end of the instrument;
[0067] FIG. 4 is a partial cross-sectional view of the surgical instrument of FIG. 1;
[0068] FIG. 5 illustrates an enlarged view of a portion of a clip cartridge and a driveInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT member of the surgical instrument;
[0069] FIG. 6A illustrates the drive member of the surgical instrument;
[0070] FIG. 6B illustrates distal engagement elements of the drive member;
[0071] FIG. 6C illustrates another embodiment of a drive member for a surgical instrument;
[0072] FIG. 6D illustrates another embodiment of a drive member for surgical instrument;
[0073] FIGS. 7A-7E illustrate alternative embodiments of drive members for the surgical instrument;
[0074] FIG. 8A illustrates a clip in the open position;
[0075] FIG. 8B illustrates a clip in the closed position;
[0076] FIG. 8C is a top view of one arm of a clip;
[0077] FIG. 8D is a side view of the clip in a partially closed position;
[0078] FIG. 8E is a side view of a distal hook on one arm of the clip;
[0079] FIG. 8F is a front view of a distal latch on another arm of the clip;
[0080] FIG. 8G is a front view of the distal hook;
[0081] FIG. 8H is a back view of the distal latch;
[0082] FIG. 81 is a close-up view of the hook and the latch in a closed position;
[0083] FIG. 9 A illustrates another embodiment of a clip in the open position;
[0084] FIG. 9B illustrates the clip of FIG. 9F in a closed position;
[0085] FIG. 9C is a top view of one arm of the clip;
[0086] FIG. 9D is a perspective view of the clip in a partially closed position;
[0087] FIG. 9E is a side view of a distal hook on one arm of the clip;
[0088] Fig. 9F is a front view of a distal latch on another arm of the clip;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0089] FIG. 9G is a front view of the distal hook;
[0090] FIG. 9H is a back view of the distal latch;
[0091] FIG. 91 is a close-up view of the hook and the latch in a closed position;
[0092] FIG. 9J is a top view of the latch;
[0093] FIG. 10A illustrates first and second jaws of the instrument of FIG. 1, with a clip attached to the drive member within the jaws;
[0094] FIG. 10B illustrates the jaws in an open position;
[0095] FIG. 10C illustrates the jaws in a closed position;
[0096] FIG. 10D is a top view of one of the jaws illustrating the four-bar linkage of the jaws;
[0097] FIG. 10E is a cross-sectional view of one of the jaws illustrating ramped leaf springs at the distal ends of the jaw;
[0098] FIG. 11 A is a cross-sectional view of the first and second jaws articulated in a yaw direction relative to the shaft;
[0099] FIG. 1 IB is a cross-sectional view of the end effector of the instrument, illustrating the drive member and the clip being advanced through a wrist assembly and into the jaws of the instrument;
[0100] FIG. 12A is a cross-sectional view of a portion of the surgical instrument, illustrating the clip cartridge and the drive member;
[0101] FIG. 12B is a close-up view of clip cartridge and the drive member, illustrating the distal engagement elements of the drive member in a distal position relative to upper and lower ramps on the clip cartridge;
[0102] FIGS. 13A and 13B illustrate the distal engagement elements of the drive member after proximal retraction to a proximal position relative to a distal set of upper andInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT lower ramps on the clip cartridge;
[0103] FIGS. 14A and 14B illustrate the distal engagement elements of the drive member passing through openings in the outer surface of the clip cartridge;
[0104] FIGS. 15A-15C illustrate the distal engagement elements of the drive member engaging with engagement features on the first or distal-most clip in the clip cartridge;
[0105] FIGS. 16A and 16B illustrate the drive member advancing the first clip through a wrist of the surgical instrument and into the jaws;
[0106] FIG. 17A illustrates the clip and the drive member engaged to the first and second jaws, with the jaws in the open position;
[0107] FIG. 17B illustrates a clip and the drive member of FIG. 6C engaged to the first and second jaws, with the jaws partially open;
[0108] FIG. 18A illustrates the first and second jaws in an articulated position about the wrist relative to the shaft;
[0109] FIG. 18B illustrates the drive member of FIG. 6C engages to the first and second jaws, with the jaws in an articulated position about the wrist relative to the shaft;
[0110] FIG. 19A illustrates the clip and the drive member engaged to the first and second jaws, with the jaws in the closed position;
[0111] FIG. 19B is a close-up view of the latch of the clip and the drive member engaged to one of the jaws;
[0112] FIG. 20 A illustrates the drive member being retracted from the end effector of the instrument after the clip has been latched;
[0113] FIG. 20B is a close-up view of the clips and the jaws in the closed position after the clips has been latched;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0114] FIG. 21 illustrates the drive member positioned for proximal retraction to engage a second clip in the clip cartridge;
[0115] FIG. 22 is a perspective view of a distal portion of an alternative embodiment of a surgical clip applier instrument;
[0116] FIG. 23 illustrates the surgical instrument of FIG. 22 with a clip cartridge configured for insertion through a longitudinal slot in the side of instrument shaft;
[0117] FIG. 24 illustrates the surgical instrument of FIG. 22 with a clip cartridge configured for insertion through a proximal end of the instrument;
[0118] FIG. 25 A is a perspective side view of another embodiment of a drive member for a surgical instrument;
[0119] FIG. 25B is a perspective side view of another embodiment of a drive member for the surgical instrument;
[0120] FIG. 25C is a perspective side view of another embodiment of a drive member for the surgical instrument;
[0121] FIG. 25D is a perspective side view of another embodiment of a drive member for the surgical instrument;
[0122] FIG. 25E is an enlarged view of the drive member of FIG. 25D, illustrating one method of attaching the distal portion of the drive member to a flexible portion of the drive member;
[0123] FIG. 25F is an enlarged view of the drive member of FIG. 25D, illustrating another method of attaching the distal portion of the drive member to a flexible portion of the drive member;
[0124] FIG. 25G illustrates the device of FIG. 25F with a partially transparent distal portion;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0125] FIG. 25H is a perspective view of another embodiment of a drive member for a surgical instrument;
[0126] FIG. 26A is a perspective view of an alternative embodiment of the distal portion of one of the drive members described above;
[0127] FIG. 26B is a schematic view of the drive member of FIG. 26 A illustrating the different lengths of the engagement members;
[0128] FIG. 26C illustrates the drive member of FIG. 26A coupled to a surgical clip;
[0129] FIG. 27A is a top view of the distal portion of a drive member for a surgical instrument;
[0130] FIG. 27B is a side perspective view of the distal portion of FIG. 27A;
[0131] FIG. 27C is a side view of the distal portion of FIG. 27A;
[0132] FIG. 27D is an enlarged view of a mating feature of the drive member of FIG. 27A;
[0133] FIG. 28A is a top view of the distal portion of a drive member for a surgical instrument;
[0134] FIG. 28B is a perspective view of the drive member of FIG. 28 A;
[0135] FIG. 28C in an enlarged view of a mating feature of the drive member within the jaw of the surgical instrument;
[0136] FIG. 29A is a top view of another embodiment of a drive member for a surgical clip applier instrument;
[0137] FIG. 29B is an enlarged view of a mating feature of the drive member of
[0138] FIGS. 29C and 29D illustrate steps in a clip release process for the drive member of FIG. 29A;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0139] FIG. 30A is a side view of a surgical clip configured for use with one of the drive members described herein;
[0140] FIG. 30B is a perspective view of the surgical clip of FIG. 30A in an open position;
[0141] FIG. 30C is an enlarged view of a first engagement hook of the surgical clip of FIG. 30 A;
[0142] FIG. 30D is another enlarged view of the engagement hook of FIG. 30C;
[0143] FIG. 30E is an enlarged view of a second engagement hook of the surgical clip of FIG. 30 A;
[0144] FIG. 30F is another enlarged view of the engagement hook of FIG. 30E;
[0145] FIG. 30G illustrates a clip stripping feature of the surgical clip of FIG. 30A;
[0146] FIG. 31 is a perspective view of a surgical clip in a configured for use with one of the drive members described herein;
[0147] FIG. 32 illustrates another embodiment of gripping elements for any of the surgical clips described herein;
[0148] FIG. 33A is a perspective view of another embodiment of a surgical clip of in an open position;
[0149] FIG. 33B illustrates the surgical clip of FIG. 33A in a closed position;
[0150] FIG. 33C is an enlarged view of a proximal portion of the surgical clip of FIG. 33A;
[0151] FIG. 34A is a perspective view of another embodiment of a surgical clip;
[0152] FIG. 34B is an enlarged view of the gripping elements of the clip of FIG.34A;
[0153] FIG. 35A is a side cross-sectional view of another embodiment of a surgicalInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT clip;
[0154] FIG. 35B is a top view of another embodiment of a surgical clip;
[0155] FIG. 36A is a side view of another embodiment of a surgical clip in an open position;
[0156] FIG. 36B is a side view of the clip of FIG. 36A in a closed position;
[0157] FIG. 37A is a side cross-sectional view of a clip cartridge, illustrating the drive member of FIG. 26 A engaged to the surgical clip of FIGS. 30A-30G;
[0158] FIG. 37B is an enlarged view of FIG. 37 A;
[0159] FIG. 37C illustrates the drive member passing through a distal portion of the clip cartridge;
[0160] FIG. 37D illustrates a distal tab that holds the distal-most clip within the cartridge;
[0161] FIG. 37E illustrates the clip and the drive member engaged to the first and second jaws, with the jaws in the closed position;
[0162] FIG. 37F illustrates the drive member being retracted from the end effector of the instrument after the clip has been latched;
[0163] FIG. 38 is a side cross-sectional view of the end effector and wrist assembly of a surgical instrument;
[0164] FIG. 39 illustrates the drive member of FIG. 26 A delivering the surgical clip of FIGS. 30A-30G to the jaws of the instrument;
[0165] FIG. 40 is a partial cross-sectional view of the drive member of FIG. 26A delivering the surgical clip of FIGS. 30A-30G to the jaws of the instrument;
[0166] FIG. 41 is an enlarged view of the jaws in an open position after the drive member has delivered the clip to the jaws;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0167] FIG. 42A is a side view of another embodiment of a clip cartridge and a plurality of surgical clips;
[0168] FIG. 42B is a perspective view of a distal portion of the clip cartridge of FIG. 42A;
[0169] FIG. 42C illustrates a drive member removing a distal clip from the clip cartridge of FIG. 42 A;
[0170] FIG. 43 A is a cross-sectional view of an actuator for a surgical clip applier;
[0171] FIG. 43B is a partially transparent view of the actuator of FIG. 43 A;
[0172] FIG. 44 is a perspective view of a representative teleoperated surgical instrument usable with an exemplary embodiment of the present teachings;
[0173] FIG. 45 illustrates a top view of an operating room employing a robotic surgical system;
[0174] FIG. 46 illustrates a simplified side view of a robotic arm assembly; and
[0175] FIG. 47 is a flow chart of a process for operating a surgical clip applier instrument with a control system.DETAILED DESCRIPTION
[0176] Particular embodiments of the present surgical instruments are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary and may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the devices and methods herein in virtually any appropriately detailed structure. Well-known functions or constructions areInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT not described in detail to avoid obscuring the present description in any unnecessary detail. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.
[0177] While the following is presented with respect to surgical instruments that are compatible with surgical clip cartridges, it should be understood that certain features of the presently described surgical instruments may be readily adapted for use in any type of surgical clamping, cutting, ligating, dissecting, clipping, cauterizing, suturing and / or sealing instrument, whether or not the surgical instrument applies a clip or other type of fastener. Additionally, the features of the presently described surgical ligating instruments may be readily adapted for use in surgical instruments that are actuated using any technique within the purview of those skilled in the art, such as, for example, manually activated surgical instruments, powered surgical instruments (e.g., electro-mechanically powered instruments), robotic surgical instruments, and the like.
[0178] The devices described herein, or certain components of the devices, may also be incorporated into a variety of different surgical instruments, such as those described in commonly assigned, co-pending US. Patent Application Nos. 16 / 205,128, 16 / 427,427, 16 / 678,405, 16 / 904,482, 17 / 081,088 and 17 / 084,981 and International Patent Nos. PCT / US2019 / 107646, PCT / US2019 / 019501, PCT / US2019 / 062344, PCT / US2020 / 54568,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT PCT / US2019 / 064861, PCT / US2019 / 062768, PCT / 2020 / 025655, PCT / US2020 / 056979, PCT / 2019 / 066513, PCT / US2020 / 020672, PCT / US2019 / 066530 and PCT / US2020 / 033481, the complete disclosures of which are incorporated by reference herein in their entirety for all purposes as if copied and pasted herein.
[0179] Fig. 1 illustrates the distal end portion of a surgical instrument 100 in accordance with an illustrative embodiment. Surgical instrument 100 includes an end effector 110, an elongated shaft 105 and a wrist assembly 140 coupling end effector 110 to shaft 105. The proximal end portion of elongate shaft 105 is operatively connected to an actuation mechanism (not shown), although as those skilled in the art reading this description will appreciate, components of the actuation mechanism may extend into, and / or pass through elongated shaft 105 and / or wrist assembly 140.
[0180] In certain embodiments, the surgical instruments described herein are adapted to be used with a robotic system for applying ligating clips. The surgical instruments will generally include an actuation mechanism that controls the orientation and movement of the end effector. The actuation mechanism will typically 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 compressing contact with the legs of a clip, thereby compressing the clip into a latched or locked position around a vessel or other tissue
[0181] End effector 110 includes a first jaw 111 and a second jaw 112 configured to move between an open position (as shown in Fig. 1) where the jaws are spaced apart from one another and a closed position to force the jaws into compressing contact with theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT legs of a clip to close and seal the dip around vessels or tissue. In certain embodiments, second jaw 112 is a movable jaw configured to move from an open position to a closed position relative to first jaw 111. In other embodiments, first jaw 111 is a movable jaw configured to move between open and closed positions relative to second jaw 112. In still other embodiments, both jaws 111, 112 are movable relative to each other.
[0182] The actuation mechanism may include input couplers (not shown) instead of, or in addition to, the stationary and movable handles. In certain embodiments, surgical instrument 100 will further include a backend mechanism 510 (see FIGS. 3 A and 56) coupled to the proximal end portion of elongate shaft 105. The backend mechanism typically provides a mechanical coupling between the drive tendons, rods or cables of the instrument and motorized axes of the mechanical interface of a drive system. Further details of known backend mechanisms and surgical systems are described, for example, in U. S. Pat. No. 8,597,280, U. S. Pat. No. 7,048,745, and U. S. Pat No. 10,016,244. Each of these patents is hereby incorporated by reference in its entirety.
[0183] The input couplers may interface with, and be driven by, corresponding output couplers (not shown) of a telesurgical surgery system, such as the system disclosed in U. S Pub. No. 2014 / 0183244A1, the entire disclosure of which is incorporated by reference herein. The input couplers are drivingly coupled with one or more input members (not shown) that are disposed within the instrument shaft 105. The input members are drivingly coupled with the end effector 110. Suitable input couplers can be adapted to mate with various types of motor packs (not shown), such as the stapler-specific motor packs disclosed in U. S. Pat. No. 8,912,746, or the universal motor packs disclosed in U. S. Pat. No. 8,529,582, the disclosures of both of which are incorporated by reference herein in their entirety. Further details of known input couplers and surgical systems are described,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT for example, in U. S. Pat. No. 8,597,280, U. S. Pat. No. 7,048,745, and U. S. Pat No.10,016,244. Each of these patents is hereby incorporated by reference in its entirety for all purposes.
[0184] While described herein with respect to an instrument configured for use with a robotic surgical system, it should be understood that the actuation and drive assemblies described herein may be incorporated into manually actuated instruments, electromechanical powered instruments, or instruments actuated in any other way. For example, the actuation mechanism may comprise a handle assembly for gripping by the user that includes a stationary handle and a moveable handle, which serves as an actuator for surgical instrument 100.
[0185] Referring now to FIGS. 2, 3A and 3B, instrument 100 may be provided with a clip cartridge 120 that comprises a plurality of surgical clips 122 and is installed into surgical instrument 100. In certain embodiments, cartridge 120 may be installed through a longitudinal slot 124 in the side of shaft 105 (FIG. 2). In other embodiments, cartridge 120 may be installed through a proximal opening 126 of a manual handle or a backend mechanism 510 of the instrument (see FIGS. 3A and 3B). In this latter embodiment, the staple cartridge 120 includes an enlarged distal end 121 that facilitates advancement of cartridge 120 through an internal channel (not shown) in backend mechanism 510 and an internal lumen (not shown) of instrument shaft 105. Staple cartridge 120 may also include a proximal handle 123 that facilitate the user’s grip on cartridge 120, allowing the user to advance distal end 121 through the shaft 105 to a suitable position just proximal of end effector 110.
[0186] Cartridge 120 may contain between about 1 to 20 clips, preferably between about 2 to 12 clips. Clip 122 preferably extend in a substantially parallel direction relativeInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT to the longitudinal axis of shaft 105. Cartridge 120 may be constructed from any suitable materials known in the art, such as a single-molded plastic body or a sheet metal construction. Cartridge 120 may be adapted to accommodate any suitable desired sizes and configurations of clips 122, including conventional clips (e.g., titanium, tantalum or stainless steel ligation clips, such as the Horizon™, Hemoclip® or the like and / or polymer clips, such as the Vas-Q-Clip®, the Week® Hem-o-lok® or the like). Alternatively, cartridge 120 may be adapted to accommodate the novel clips 300 described below and shown in FIGS. 8A-9D and FIGS. 34-39B.
[0187] Wrist assembly 140 is positioned between end effector 110 and elongated shaft 105. Wrist assembly 140 may provide a desired amount of motion, such as + / - 90 degrees in a pitch, yaw and / roll direction, preferably + / - about 60 to about 65 degrees in the pitch and yaw directions. Cables or other actuators (not shown) are drivingly coupled with the wrist assembly 140 and actuated to impart motion to wrist assembly 140. Differential movement of the cables can be used to actuate wrist assembly 140 to pitch and yaw at various angles. Additional details of articulation mechanisms usable with the embodiments disclosed herein are disclosed in Int'l. Pub. No. WO 2015 / 127250A1 and U. S. Publication No. 2017 / 0215977 Al, the complete disclosure of which is incorporated herein by reference for all purposes.
[0188] In one embodiment, wrist assembly 140 may include a linkage 142 that provides the pitch motions of the wrist assembly 140. For yaw motions of wrist assembly 140, the pulleys 419, 431 and linkages 408, 412 (discussed below in reference to FIG. 10D) are rotated together about a single axis. As shown in FIGS. 4 and 16A, wrist assembly 140 has first and second internal lumens 146, 148 to allow for movement of a drive member 130 and clips 122 therethrough.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0189] Referring now to FIG. 4, cartridge 120 is configured to extend through an internal lumen 132 in shaft 105. The internal lumen 132 may be a central lumen, a working channel or the like extending from a proximal portion (not shown) of the shaft 105, through the wrist assembly 140 into the end effector 110. In some embodiments, the cartridge 120 extends along one side of shaft 105 (i.e., substantially on one side of the longitudinal axis of shaft 105). Instrument 100 further comprises a drive member (or clip advancer) 130 that preferably extends through lumen 132 adjacent to cartridge 120. In certain embodiments, drive member 130 is disposed on the opposite side of the longitudinal axis from cartridge 120, which allows drive member 130 to translate proximally and distally within shaft 105 relative to cartridge 120, as discussed below. In other embodiments, drive member 130 and cartridge 120 may be disposed on the same side of the longitudinal axis, or cartridge 120 may be centered within lumen 132 along the longitudinal axis and drive member 130 disposed adjacent to cartridge 120 on either side.
[0190] In certain embodiments, drive member 130 is coupled to instrument shaft 105 such that drive member 130 is included as part of the overall instrument 100, which may be constructed of materials designed for re-use of the instrument in multiple surgical procedures. In other embodiments, drive member 130 is coupled to cartridge 120 such that drive member 130 is included as part of the clip cartridge 120, which may be constructed of materials designed for disposable or single-use applications. In either embodiment, drive member 130 is configured for longitudinal displacement relative to shaft 105 to advance clips 122 from cartridge 120 to jaws 111, 112 of end effector 110, as discussed in more detail below.
[0191] As shown in FIGS. 6A and 6B, drive member 130 comprises a proximal component 160 and a flexible component 162 coupling proximal component 160 with firstInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT and second clip engagement elements 164, 166. Proximal component 160 is configured to extend through shaft 105, and may have one or more proximal interfaces 163 (see FIG.2) for cooperating with an actuation mechanism (not shown) to advance drive member 130 distally and proximally relative to shaft 105. In certain embodiments, a distal portion of proximal component 160 may extend through a portion of wrist assembly 140. For example, in one such embodiment, this distal portion of proximal component 160 extends far enough through wrist assembly 140 to flex in at least the pitch direction, but typically not in the yaw direction. Flexible component 162 will typically flex in both the pitch and yaw directions.
[0192] Flexible component 162 preferably comprises a material that is stiff enough to push through wrist assembly 140 into jaws 111, 112. At the same time, these components comprise a material that is flexible and resilient enough to bend as end effector 110 is articulated relative to shaft 105 at wrist assembly 140. In a preferred embodiment, these components comprise nitinol, polymers, such as PEEK, spring steel or similar materials.
[0193] In one embodiment, flexible portion 160 comprises first and second arms 168, 170 that each include a clip engagement element 164, 166 at the distal ends thereof. Engagement elements 164, 166 are configured to extend laterally away from arms 168, 170 such that they are positioned substantially parallel with clip cartridge 120 within shaft 105 (see FIG. 5) for engaging with clips 122 (discussed below). Arms 168, 170 are preferably designed to move relative to each other between a first position, wherein the arms are closer to each other (see FIG. 6A), and a second position, wherein the arms are further apart from each other relative to the longitudinal axis of shaft 105 (see, for example, FIG. 12B). In certain embodiments, the arms 168, 170 are substantially parallel to each other in the firstInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT position. This allows arms 168, 170 to move into various positions relative to clip cartridge 122 that allow engagement elements 164, 166 to engage one or more clips 122 housed within cartridge 120.
[0194] In one embodiment, engagement elements 164, 166 each comprise a first disc portion 172 that is coupled to, or integral with, arms 168, 170. Elements 164, 166 further comprise a central shaft 174 extending laterally away from disc portion 172 and coupled to a second disc portion 176 (thereby forming a shape substantially resembling a “dumbbell”). The first and second disc portions 172, 176 of engagement elements 164, 166 preferably have a larger diameter than central shaft 174, which enables shaft 174 to removably couple to clips 122, as discussing in more detail below.
[0195] Referring now to FIG. 6C, another embodiment of a drive member 130a comprises a proximal component 160 and a flexible component 162 coupling proximal component 160 with a clip engagement mechanism that includes first and second distal clip engagement elements 164, 166 coupled to first and second proximal distal clip engagement elements 164a, 166a by elongate connection members 165, 167. Elongate connection members 165, 167 may be linear, or non-linear, and they may have sufficient flexibility to bend as drive member 130a is advanced through the wrist assembly and into the jaws 111, 112 of the instrument 100. Distal engagement elements 164, 166 are configured to extend laterally away from arms 168, 170 such that, they are positioned substantially parallel with clip cartridge 120 within shaft 105 (see FIG. 5) for advancing through guide tracks 440, 442 in jaws 402, 404 (see FIG. 11 A) and engaging with clips 122 (discussed below). Proximal engagement elements 164a, 166a are configured to extend laterally away from arms 168, 170 such that they advance through guide tracks 440, 442 in jaws 402, 404 and generally function to inhibit arms 168, 170 from buckling out of tracks 440, 442 (discussedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT in more detail below in reference to FIGS. 17B and 18B).
[0196] Referring now to FIGS. 17B and 18B, drive member 130a advances clip 300A through central lumens 146, 148 within wrist assembly 140 and into end effector 110. As arms 168, 170 of drive member 130a enter the jaw assembly 400, ribbons 420, 422 constrain arms 168, 170 such that the arms 168, 170 enter guide tracks 440, 442 of first and second jaws 402, 404 (see FIG. 16B). Drive member 130a is advanced distally until distal engagement elements 164, 166 (and hook 312 and latch of clip 310A) engage cutouts 454 in distal end portions 434, 436 of jaws 402, 404 (see FIGS. 19A and 19B).
[0197] As arms 168, 170 advance through guide tracks 440, 442, the portion of arms 168, 170 proximal to distal engagement elements 164, 166 will tend to buckle inwards outside of guide tracks 440, 442, particularly when jaws 402, 404 are articulated relative to the instrument shaft, as shown in FIG. 18B. Proximal engagement elements 164a, 166a inhibit this buckling and as they are designed to remain within guide tracks 440, 442. This provides proximal support to arms 168, 170 as the advance distally to the end of jaws 402, 404.
[0198] Referring now to FIG. 6D, another embodiment of a drive member 130b comprises a proximal component 160 and a flexible component 162 coupling proximal component 160 with clip engagement mechanisms 190, 192. In this embodiment, each clip engagement mechanism 190, 192 comprises a brace or frame having a first arm 190a that generally extends from flexible arms 168b, 170b, second and third arms 190b, 190c that extend laterally inward from first arm 190b and a fourth arm 190d that extends between second and third arms 190b, 190c. Second arm 190b is configured to advance through guide tracks 440, 442 and engage with clips 122 (similar to distal engagement elements 164, 166 in FIG. 6C) and third arm 190c is configured to advance through guide tracks 440,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 442 and inhibit arms 168b, 170b from buckling out of tracks 440, 442 (similar to proximal engagement elements 164a, 166a in FIG. 6C). Clip engagement mechanisms 190, 192 preferably comprise a single structure that provides enhanced stability to drive member 130b as its distal portion passes through the guide tracks in the jaws. The area of the window between arms 190a-190d is preferably sized such that it is narrower than distal ramps 154, 156 of cartridge in FIG. 5 so that the brace or frame can rides over these ramps drive member 130b is moved proximally after clip loading.
[0199] Braces 190, 192 are asymmetrical relative to each other to facilitate the engagement of the arms 168b, 170b of drive member 130b with the upper and lower arms 302, 304 of a clip 300 (shown in phantom lines in FIG. 6D and described in more detail below). In one embodiment, brace 190 has a substantially planar orientation that enables the brace 190 to engage the upper or non-vessel side of the distal portion of the upper arm 302 of a clip 300. Brace 192, however, has a non-planar configuration. In particular, brace 192 has a distal portion 193 that extends at an angle relative to its proximal portion 195 (or the distal portion may have a curved orientation). This orientation allows brace 192 to extend around the lower or non-vessel side of the lower arm 304 of the clip 300 to engage the distal portion of the clip. In certain embodiments, arm 170b may also have a longer length than arm 168b to facilitate the additional distal extension required to engage brace 192 to the distal end portion of lower arm 304 of the clip 300.
[0200] In an exemplary embodiment, drive member 130b comprises a substantially unitary structure that may, for example, be manufactured from a flat sheet of metal, such as nitinol or the like (although see alternative configurations for drive member 130b shown in FIGS. 25D-25G). Arms 168b, 170b are then twisted and shape-set to orient clip engagement mechanisms 190, 192 substantially perpendicular to proximal portion 160 andInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the longitudinal axis of the instrument (see the alternative embodiments for arms 168, 170b in FIGS. 25A-25C). This ensures that clip engagement mechanisms 190, 192 are oriented properly for passing through guide tracks 440, 442.
[0201] As shown in FIG. 5, clip cartridge 120 comprises a housing 134 having upper and lower walls 136, 138 and a longitudinal wall 150 on one side of housing 134 opposite drive member 130. The side of housing 134 opposite wall 150 is preferably open such that clips 122 can be viewed from this side of housing 134 and to allow drive member 130 to interact with the clips within cartridge 120. Housing 134 further includes first and second distal ramps or tabs 154, 156 extending from the distal end of housing 134. Tabs 154, 156 have sufficient rigidity to force engagement elements 164, 166 of drive member 130 to spread out and ride upwards along tabs 154, 156 when drive member 130 is pulled in the proximal direction (discussed below). At the same time, tabs 154, 156 have sufficiently flexibility to allow engagement elements 164, 166 to push through tabs 154, 156 and advance clips 122 through the distal end of cartridge 120 when drive member 130 advances in the distal direction and after drive member 130 is located within the interior of housing 134 (see FIG. 15B).
[0202] Housing 134 further includes retainer tabs 180 extending from longitudinal wall 150 into the interior of cartridge 120. Retainer tabs 180 are spaced from each other longitudinally along housing 120 so as to define discrete areas for retaining each clip 122 within housing 134 (see FIG. 12A). Retainer tabs 180 preferably have sufficient rigidity to hold clips 122 in place within cartridge 120, while having sufficient flexibility such that distal translation of drive member 130 causes clips 122 to bend tabs 180 and allow each clip 122 to separately advance with drive member 130 in the distal direction.
[0203] Housing 134 includes a series of upper and lower ramps or tabs 182, 184International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT that extend away from upper and lower walls 136, 138, respectively, in the proximal direction. Similar to internal tabs 180, upper and lower tabs 182, 184 are spaced from each other longitudinally along housing 120 such that they are disposed above and below each clip 122 within housing 134. In certain embodiments, tabs 182, 184 are pivotally coupled to upper and lower walls 136, 138 to allow for proximal movement of engagement elements 164, 166 over tabs 182, 184. In other embodiments, tabs 182, 184 are substantially stationary ramps. In these embodiments, arms 168, 170 of drive member 130 are configured to separate further away from each other such that elements 164, 166 ride along ramps 182, 184 as drive member 130 is translated in the proximal direction.
[0204] Housing 134 further includes upper and lower openings 186, 188 in upper and lower walls 136, 138 located proximally of each upper and lower tab 182, 184. These tabs 182, 184 and openings 186, 188 allow engagement elements 164, 166 to withdraw proximally over tabs 182, 184 and move into the interior of cartridge housing 134 through openings 186, 188, as discussed in more detail below. In addition, each set of tabs and openings provides a discrete location on the cartridge housing associated with one of the clips. In certain embodiments, the instrument or system may include a control system that detects when the engagement elements 164, 166 of drive member 130 are located adjacent to each of the clips within cartridge. This ensures that the user engages the distal-most clip within cartridge.
[0205] In an alternative embodiment, each of the clips within the cartridge may be advanced distally simultaneously with each other. For example, the clips may be spaced substantially equally from each other and the distal-most clip may be spaced from the jaws a distance substantially equal to the spacing between the clips. This allows the drive member 130 (or another drive member, such as a shuttle component (e.g., a ratchet and aInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT pawl) or a spring (such as a magazine spring) to move all of the clips forward distally the same distance, thereby allowing, for example, the drive member to advance the distal-most clip to jaws 111, 112 while the next clip is moved to the location previously possessed by the distal-most clip, etc. Thus, the drive member can be withdrawn proximally to the same longitudinal position within the instrument in order to couple with each clip within the cartridge, thereby increasing the speed and efficiency of delivering multiple clips to a target site.
[0206] FIGS. 7A-7E illustrate alternative embodiments of drive member 130. As shown in FIG. 7A, a drive member 200 comprises a proximal component 202, a flexible component 204 and first and second arms 206, 208 having distal engagement elements 210, 212. In this embodiment, flexible component 204 comprises wave or coiled features that allow arms 206, 208 to deflect towards and away from the longitudinal axis without yielding or permanent deformation of the material.
[0207] FIGS. 7B-7E illustrate alternative embodiments of drive members 220 that includes flexible portions 222 designed to provide a more defined pivot point for each drive member 210. The pivot point of flexible portions 222 is configured to be located within wrist assembly 140 of instrument 100 such that the distal arms 224, 226 are capable of pivoting relative to the proximal component 228 of each drive member 210 when end effector 110 is articulated relative to shaft 105, In some embodiments, arms 224, 226 may be configured to naturally extend substantially parallel to each other (FIG. 7C). In other embodiments, arms 224, 226 may be configured to naturally have a bowed configuration that facilitates the opening and closing of the arms 224, 226 (FIGS. 7B, 7D and 7E).
[0208] Referring now to FIGS. 8A-8I, one embodiment of a surgical clip 300 will now be described. Clip 300 includes first and second arms 302, 304 pivotally coupled toInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT each other about a pivot point or hinge 306 for movement between an open position (FIG.8A) and a closed position (FIG. 8B). Hinge 306 is preferably a living or integral hinge that comprises an opening 308 that creates two thinned pieces connected to arms 302, 304 to create a flexure bearing that allows arms 302, 304 to open and close. In certain embodiments, clip 300 is naturally biased towards the open position and configured to be closed by the force of jaws 111, 112, as discussed below. In other embodiments, clip 300 may be naturally biased towards the closed (but not latched) position and configured to be opened and then closed and latched by jaws 111, 112.
[0209] In certain embodiments, surgical clip 300 comprises a polymer material, such as a non-absorbable polymer or a resorbable or biodegradable polymer. Suitable materials for clip 300 include polyoxymethylene (POM), polyester, nylon, poly etheretherketone (PEEK), poly glycolic acid (PGA or PEG A), poly-L-lactic acid (PLEA), polyethylene (PE) or copolymers thereof. In a preferred embodiment, clip 300 comprises POM.
[0210] Surgical clip 300 may be designed, for example, to ligate vessels in a patient. In certain embodiments, clip 300 is sized to ligate vessels having a diameter of about 1 mm to about 10 mm. In certain embodiments, the clip 300 is designed with a sufficient length, strength and rigidity to ligate medium to large sized vessels, or vessels of up to 10 mm in diameter.
[0211] Clip 300 has been designed to eliminate the need for laterally protruding bosses and, therefore, has a thinner profile than conventional polymer clips. The maximum lateral width of clip 300 is less than about 2.0 mm, or about 0.6 mm to about 1.5 mm, or preferably about 0.8 mm to about 1.1 mm (conventional polymer clips designed to ligate vessels up to 10 mm in diameter typically have a maximum lateral width of 2.0 mm orInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT greater). This allows the user to piace the clips in closer proximity to each other and / or place more clips within a target location on the patient, e.g., a vessel, thereby providing a stronger seal on the vessel.
[0212] Of course, it will be recognized that the specific dimensions for the maximum lateral width of clip 300 will vary based on the function of clip. If clip 300 is, for example, designed to ligate smaller vessels (i.e., vessels having diameters of less than 3 mm), than the width of clip will be less than the dimensions described above. However, the overall length / width ratio of clip 300 will remain higher than conventional polymer clips.
[0213] First arm 302 includes a latch 310 and second arm 304 includes a hook 312 such that clip 300 can be compressed into a latched or locked position around a grasped vessel or other grasped tissue. In some embodiments, first and second arms 302, 304 include grip features or protrusions 314 extending on the vessel side of each arm. Protrusions 314 are preferably spaced from each other along each arm and provide gripping surfaces to secure clip 300 to the vessel once it is locked in the closed position. These gripping surfaces may also resist axial displacement of the clip.
[0214] Latch 310 includes a main body 342 sized to slide within a slot 340 in hook 312 that is defined by first and second arms 350, 352. Latch 310 further includes a locking protrusion 344 extending laterally outward from main body 342 that includes a shelf 346. As latch 310 is compressed against hook 310 by jaws 111, 112, the force applied is sufficient to temporarily deform hook 310 backward away from latch 310. This allows locking protrusion 344 to pass below slot 340 in hook 310. Once that has occurred, hook 310 will return to its original location such that protrusion 344 is below slot 340 and shelf 346 engages a lower surface 348 of one of arms 350, 352. This secures latch 310 to hookInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 312 and provides both visual and audible confirmation to the user that the latch 310 is now secured to the hook 312.
[0215] Clip 300 also includes one or more centering features for aligning latch 310 with hook 312 when the clip 300 is closed by jaws 111, 112. As shown in FIG. 8F, latch 310 includes a rib 334 extending from an internal or vessel-side surface of main body 342 of latch 310. Rib 334 extends downward along the vessel-side surface of latch 310 and is configured to engage the surfaces partially surrounding slot 340 in hook 312 (see FIG. 8G). Rib 334 aligns latch 310 with hook 312 during the process of latching with the instrument to ensure that clip 300 is in the correct position to lock. This configuration allows for a thinner profile clip as it eliminates the need for protruding bosses, as typically found in conventional polymer clips.
[0216] Referring to FIGS. 8 A and 8E, latch 310 on first arm 302 includes an engagement member 320 for removably coupling to engagement element 164 of drive member 130 and hook 312 on second arm 304 includes an engagement member 322 for removably coupling to engagement element 166 of drive member 130 (see FIG. 15A). Engagement members 320, 322 preferably allow engagement elements 164, 166 to secure drive member 130 to clip 300 during advancement of the clip 300 through wrist 140 into jaws 111, 112 and to control and retain clip 300 throughout the opening and closing of jaws 111, 112 (and consequently the opening and closing of clip 300), as well as any other articulation of end effector 110 relative to shaft 105 (i.e., roll, yaw or pitch movements of the end effector). At the same time, engagement features 320, 322 are designed to release engagement elements 164, 166 upon sufficient application of force to the drive member 130. As discussed below, this allows the user to remove drive member 130 from clip 300 after the clip 300 has been closed onto a vessel.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0217] One particular advantage of this feature is that the captured drive member 130 within jaws 111, 112 allows the drive member 130 and / or jaws 111, 112 to pull clip 300 open while it is disposed within the jaws. Conventional polymer clips tend to creep over time when stored in the clip cartridge (i.e., move into a more closed position). This prevents the clips from springing themselves open after they have been advanced into the jaws (as typically occurs with conventional polymer clips). This feature also facilitates relocation of the main locating “boss” features from the clip to the drive member, which allows for the design of a clip having a thinner profile than conventional clips (discussed in more detail below). In addition, this feature allows the joint between the engagement elements 164, 166 of drive member 130 and engagement features 320, 322 of clip 300 to rotate while jaws 111, 112 open and close.
[0218] In one embodiment, engagement features 320, 322 each comprise a snap fit feature that comprises a cutout or opening 324 sized to accommodate shaft 174 of engagement elements 164, 166 and protrusions 326 on either side of openings 324 that create a reduced-diameter entry to the openings 324 (see FIGS. 8E and 8H). This allows shafts 174 of engagement elements 164, 166 of drive member 130 to be advanced into openings 324 with a sufficient application of force (discussed below). At the same time, shafts 174 will remain secured within openings 324 until a sufficient withdrawal force is applied to drive member 130.
[0219] In certain embodiments, first and second arms 302, 204 include tapered ribs 330 extending towards the non-vessel side of the arms. These ribs 330 taper in two directions (i.e., laterally and vertically) to provide lateral and vertical guide features for drive member 130 to align engagement elements 164, 166 of drive member 130 with each clip 300. Specifically, ribs 330 taper inwardly from each lateral side of ribs 330 in theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT proximal direction to provide lateral alignment. In addition, ribs 330 taper towards arms 302, 304 in the proximal direction to provide vertical alignment. This allows the drive member 130 to center and / or align itself on clip 300 during engagement within cartridge 120.
[0220] Cip 300 has been designed such that the force required to remove latch 310 from hook 312 after it has been latched thereto is greater than the force required to remove drive member 130 from clip 300 (i.e., the latch mechanism is stronger than the engagement mechanism). Thus, locking protrusion 344 of latch 310 secures the latch 310 to hook 312 as drive member 130 is withdrawn proximally and engagement elements 164, 166 are withdrawn from engagement members 322, 320 of clip 300.
[0221] Clip 300 further includes a protrusion 332 extending from the side of hook 312 that facilitates guidance of clip 300 through a guide track 442 of jaw 404 as clip 300 is advanced into the jaws (see FIG. 11 A). In one embodiment, locking protrusion 344 on latch 310 is configured to also function as a guide protrusion that advances through guide track 440 of jaw 402. Protrusions 332, 344 may also function to engage tracks 440, 442 of jaws 402, 404 if drive member 130 becomes disengaged with clip 130 during advancement, thereby preventing premature disengagement of the clip 300 from jaws 111, 112. These protrusions 332 are preferably sized to be thinner than the boss protrusions on conventional clips.
[0222] Clip 300 also includes an anti-scissoring feature that ensures that latch 310 remains aligned with hook 312 after they are locked together. This feature includes a fin 354 extending on the upper surface of main body 342 of latch 312. When latch 310 is locked to hook 312, fin 354 is trapped within slot 340 of hook 312, which prevents any scissoring motion that could cause disengagement of the latch from the hook (see FIG. 81).International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT Providing a fin 354 that fits within a slot 340 allows for the design of a thinner profile clip than conventional clips that typically use boss-like projections around the hook to mitigate scissoring.
[0223] Referring now to FIGS. 9A-9J, another embodiment of a clip 300’ will now be described. Similar to the previous embodiment, clip 300’ includes first and second arms 302’ pivotally coupled to each other about a hinge 306’ for movement between an open position (FIG. 9A) and a closed position (FIG. 9B). Hinge 306’ is preferably a living or integral hinge that comprises an opening 308’ that creates two thinned pieces connected to arms 302’, 304’ to create a flexure bearing that allows arms 302’, 304’ to open and close. First arm 302’ includes a latch 310’ and second arm 304’ includes a hook 312’ such that clip 300’ can be compressed into a latched or locked position around a grasped vessel or other grasped tissue. In some embodiments first and second arms 302’, 304’ include grip features or protrusions 314’ extending on the vessel side of each arm (see FIG. 9D).
[0224] As particularly shown in FIGS. 9D and 91, latch 310’ comprises a main body 360 and two distal projections or bosses 362, 364 that form a central opening 363, such as a slot, recess or channel, for receiving a main body 380 of hook 312’. Latch 310’ further includes a shelf 370 within opening 363. As latch 310’ is compressed against hook 312’, the force applied is sufficient to temporarily deform hook 312’ backward away from latch 310’. This allows main body 380 of hook 312’ to pass over shelf 370 and into central slot 363 between bosses 362, 364. Once hook 312’ has passed over shelf 370, it is released from the deformed state so that it moves into slot 363 above shelf 370. Shelf 370 and main bosses 360, 362 secure latch 310’ to hook 312’.
[0225] In this embodiment, clip 300’ includes a secondary lock in the closed position. As shown, latch 310’ further comprises first and second projections 366, 368International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT extending downwards from bosses 362, 364 towards hook 312’. In one embodiment, projections 366, 368 comprises pointed or “beak-like” protrusions extending downward from bosses 362, 364. Arm 304’ includes a distal extension 384 on each side of arm 304’ spaced laterally outward from the two side surfaces 382 of hook 312’ (see FIGS. 9E and 9G). As latch 310’ secures to hook 312’, projections 366, 368 come into contact with extensions 384, which inhibits translation of upper arm 302’ relative to lower arm 304’ once they are closed / latched together, thereby providing a secondary lock to ensure that hook 312’ remains secured to latch 310’.
[0226] Similar to the previous embodiment, first arm 302’ includes an engagement member 320’ for removably coupling to engagement element 164 of drive member 130 and hook 312’ on second arm 304’ includes an engagement member 322’ for removably coupling to engagement element 166 of drive member 130 (see FIG. 15A). Engagement members 320’, 322’ preferably allow engagement elements 164, 166 to secure drive member 130 to clip 300’ during advancement of the clip 300’ through wrist 140 into jaws 111, 112 and to control and retain clip 300’ throughout, the opening and closing of jaws 111, 112 (and consequently the opening and closing of clip 300’), as well as any other articulation of end effector 110 relative to shaft 105 (i.e., roll, yaw or pitch movements of the end effector). At the same time, engagement features 320’, 322’ are designed to release engagement elements 164, 166 upon sufficient application of force to the drive member 130.
[0227] Referring now to FIGS. 10A-10E, one embodiment of a jaw assembly 400 for instrument 100 will now be described. As shown, jaw assembly 400 comprises first and second jaws 402, 404 that are pivotally coupled to each other at a hinge joint 406. First and second jaws 402, 404 are also capable of articulating together about an axisInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT substantially perpendicular to the longitudinal axis (e.g., the pitch axis), as shown in FIG.11 A. In addition, first and second jaws 402, 404 are designed to move relative to each other between an open position (as shown in FIGS. 10A and FIG. 10B) and a closed position, wherein the distal ends of the jaws are near, or in contact, with each other (see FIG. 10C). In the preferred embodiment, both jaws 402, 404 are movable jaws, although it will be recognized that one of the jaws may be a movable jaw configured to move between open and closed positions relative to the other jaw.
[0228] In one preferred embodiment, hinge 406 comprises 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 FIG. 10D). First link 408 comprises a slot pin 414 configured to slide through a slot 415 of first jaw 402 and a pin or screw 419 coupled to a first pulley 421. Similarly, second link 410 comprises a slot pin 416 configured to slide through a slot 417 of second jaw 404 (see FIG. 10B) and a pin or screw 423 that is coupled to first pulley 421.
[0229] As shown in FIG. 10D, third link 412 is positioned on the other side of jaws 402, 404 and includes a slot pin 425 configured to slide through a slot 427 of first jaw 402 on the other side of slot 415. In the preferred embodiment, slot pin 425 is the same slot pin as slot pin 414 and extends completely through jaw 402 from first link 408 to third link 412. Third link 412 has another pin or screw 429 coupled to a second pulley 431 opposite first pulley 419.
[0230] In one embodiment, jaw assembly 400 includes a pulley and linkage system that is based on a single axle, in which both jaw articulation and wrist yaw are rotated. The single pivot helps to minimize gaps that may form between sections of the linkage that can make it more difficult to advance clips into jaws 402, 404. The slots in the jaws are pushedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT on by an axle in the corner of a four bar linkage. Each jaw has its own four bar linkage that is substantially the same (but reversed) that spans between the two pulleys and acts as a differential. As shown in FIG. 10D, pulley 419 acts as the first “link” in the four bar linkage and, first link 408 acts as the second “link”, third link 412 acts as the” third link” and second pulley 431 acts as the fourth link. The slot pin 414, 425 is the “pivot” between the second and third links of the four-bar linkage.
[0231] When the two pulleys are driven together in the same direction, jaws 402, 404 will rotate in the yaw direction relative to shaft 105 together. Any differential motion between the pulleys, however, will drive the linkages to move the jaws relative to each other (i.e., open and close). The linkages may also be disposed close to the point of the links scissoring so that they amplify the force as the clip is closing (similar to a vise grip). A more complete description of this feature can be found in commonly assigned, copending US Provisional Application, filed concurrently with this application (Attorney Docket No. P06660-US-PRV).
[0232] Referring again to FIG. 11 A, jaw assembly 400 comprises first and second ribbons, bands, wires or cables 420, 422 extending from wrist assembly 140 to first and second jaws 402, 404, respectively. Ribbons 420, 422 preferably comprise a flexible material, such as nitinol, spring steel or the like, such that ribbons 420, 422 bend or flex when jaws 402, 404 are articulated about the jaw axis. Ribbons 420, 422 each have a proximal end 426, 428 coupled to wrist assembly 140 and a distal end 430, 432 extending into each of first and second jaws 402, 404. In certain embodiments, the distal ends 430, 432 may be secured to, or otherwise coupled to jaws 402, 404. In other embodiments, the ribbons 420, 422 extend on the inside of slot pins 416, 414 and have sufficient rigidity to remain in place within jaws 402, 404.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0233] As shown in FIGS. 11A and 11B, ribbons 420, 422 function to contain drive member 130 and clip 300 when these components have been driven into jaws 402, 404 and the jaws are articulated about the yaw axis of the instrument. More specifically, distal advancement of drive member 130 (and clip 300 therewith) passes between ribbons 420, 422 even when jaws 402, 404 are articulated relative to the longitudinal axis of the instrument 100 (see FIG. 11 A).
[0234] As show in FIGS. 11 A and 18, first and second jaws 402, 404 each include guide tracks 440, 442 that generally extend from a proximal portion of the jaws to the distal end 434, 436 of each jaw. Guide tracks 430, 432 generally extend inside of ribbons 420, 422. Guide tracks 430, 432 and ribbons 420, 422 ensure that arms 168, 170 of drive member 130 pass along guide tracks 430, 432 to distal ends 434, 436 as drive member 130 is advanced distally into jaws 402, 404.
[0235] Referring now to FIG. 10E, jaws 402, 404 may each include an engagement feature at their distal ends to secure the clips therein after they have been delivered by drive member 130. In one embodiment, the engagement features comprise ramped leaf springs 437 positioned on either side of guide tracks 440, 442. As shown, guide tracks 440, 442 taper inwardly in the distal direction such that the lateral width across guide tracks 440, 442 decreases distally. As engagement elements 164, 166 of drive member 130 and the clip advance distally through guide tracks 440, 442, they contact the outer surfaces 439, 441 of guide tracks 440, 442, which become narrower as the clip is advanced distally. The clip and engagement elements 164, 166 press against leaf springs 437 so that they are biased outwardly to allow the clip and engagement elements 164, 166 to move to the distal ends of the jaws. This spring pressure applied inwardly by leaf springs 437 retains the clip and engagement elements 164, 166 within the distal ends of the jaws and inhibits them fromInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT withdrawing proximally and / or falling out of the jaws.
[0236] As shown in FIGS. 10, 19B and 20B, jaws 402, 404 each have distal end portions 434, 436 that include a cutout 454. Cutouts 454 are disposed at the distal end of guide tracks 430, 432. Cutouts 454 preferably have a larger cross-sectional area than track guide tracks 430, 432. This ensures that the distal ends of latch 310 and hook 312 of clip 300 have sufficient clearance as they are coupled to jaws 402, 404 (as these elements are generally distal of engagement elements 164, 166 of drive member 130 as clip 300 is advanced distally into the jaws 402, 404. In addition, cutouts 454 facilitate removal of the clip 300 from jaws 402, 404 when clip 300 is closed and latched and drive member 130 has been decoupled from clip 300.
[0237] In one embodiment shown in FIG. 19B, cutouts 454 each include a longitudinal component 456 for receiving the hook 312 and latch 310 of clip 300 and a horizontal component 448 for receiving engagement elements 164, 166 of drive member 130. Horizontal components 448 are sized and configured to contain engagement elements 164, 166 within jaws 402, 404 (i.e., they prevent the engagement elements 164, 166 from passing distally of jaws 402, 404). In certain embodiments, horizontal components 448 have a lateral span that is less than the overall lateral span of engagement elements 164, 166 (i.e., from one end of outer shaft 172 to the other end of outer shaft 176). In other embodiments, horizontal components 448 have a longitudinal span that is smaller than the diameter of outer shafts 172, 176 of engagement elements 164, 166. In certain embodiments, both the longitudinal and lateral span of horizontal components 448 are small enough to contain engagement elements therein.
[0238] Referring now to FIGS. 4, 5 and 12A-21, a method for applying multiple clips to tissue or vessels in a patient will now be described. As shown in FIGS. 4 and 5,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT drive member 130 is generally positioned along the side of cartridge 120 such that engagement elements 164, 166 are located distal of tabs 154, 156 on the distal end of cartridge 120. To engage a clip 300 with the drive member 130, drive member 130 is withdrawn proximally such that engagement elements 164, 166 slide along tabs 154, 156 and spread out arms 168, 170 of drive member 130 such that engagement elements 164, 166 move along upper and lower surfaces 136, 138 of cartridge 120 (see FIGS. 12A and 12B).
[0239] Referring now to FIGS. 13A and 13B, as drive member 130 is withdrawn proximally, engagement elements 164, 166 slide over tabs 182, 184 of the first clip 300 within cartridge 130. In some embodiments, tabs 182, 184 are configured to spring inwardly to facilitate the movement of engagement elements 164, 166 over the tabs 182, 184. In other embodiments, arms 168, 170 are stretched further outward to allow this movement.
[0240] Referring now to FIGS. 14A and 14B, once engagement elements 164, 166 are proximal of tabs 182, 184, they will enter openings 186, 188 into the interior of cartridge 130. In some embodiments, this movement will occur automatically as engagement elements 164, 166 pass proximally of tabs 182, 184. In other embodiments, drive member 130 may be advanced distally to move engagement elements 164, 166 into openings 186, 188. Upper and lower tabs 182, 184 will generally direct engagement elements 164, 166 downward into cartridge 120.
[0241] As shown in FIGS. 15A-15C, drive member 130 is then moved further distally until engagement elements 164, 166 engage with 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 features 320, 322 by passing throughInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT protrusions 326 and into openings 324 of the latch 310 and hook 312 of clip 300. As drive member 130 is moved further distally, retaining tab 180 is flexed away such that clip 300A is released from cartridge 120. At this point, the first clip 300A is coupled to drive member 130 and no longer secured within cartridge 120 such that drive member 130 can move clip 300 into end effector 110. The proximal clip 300B remain secured within cartridge 120.
[0242] Referring now to FIGS. 16A and 16B, drive member 130 advances clip 300 through central lumens 146, 148 of within wrist assembly 140 and into end effector 110. As arms 168, 170 of drive member 130 enter the jaw assembly 400, ribbons 420, 422 constrain the movement of arms 168, 170 such that the arms 168, 170 enter guide tracks 440, 442 of first and second jaws 402, 404 (see FIGS. 17 and 18). Drive member 130 is advanced distally until engagement elements 164, 166 (and hook 312 and latch 310 of clip 310A) engage cutouts 454 in distal end portions 434, 436 of jaws 402, 404 (see FIGS. 19A and 19B).
[0243] Referring now to FIGS. 20A and 20B, when the surgeon has positioned the first clip 300A in the desired location to clamp onto tissue or a vessel, jaws 402, 404 are closed. As noted above, jaws 402, 404 provide sufficient force to close clip 300. A and to secure latch 310 into hook 312. Once that has occurred, drive member 130 may be withdrawn proximally by exerting sufficient force onto element 130 to withdraw engagement elements 162, 164 of drive member 130 from engagement elements 320, 322 of latch 310 and hook 312, respectively. Once disengagement of drive member 130 from clip 300A, drive member 130 may be withdrawn proximally back through wrist assembly 400 and into shaft 105 of instrument (see FIG. 20A).
[0244] Referring now to FIG. 21, to engage a second clip 300B from cartridge 120, engagement elements 164, 166 of drive member 130 are withdrawn over distal tabs 154,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 156 and past first upper and tower tabs 182a, 184a and second upper and lower tabs 182b, 184b to the second clip 300B. The process may be then repeated to advance second clip 300B to the jaws of the end effector, then a third clip 300C, etc.
[0245] Fig. 22 illustrates the distal end portion of an alternative embodiment of a surgical instrument 900 in accordance with an illustrative embodiment. Surgical instrument 900 includes an end effector 910, an elongated shaft 905 and a wrist assembly 940 coupling end effector 910 to shaft 905. The proximal end portion of elongate shaft 905 is operatively connected to an actuation mechanism (not shown), although as those skilled in the art reading this description will appreciate, components of the actuation mechanism may extend into, and / or pass through elongated shaft 905 and / or wrist assembly 940.
[0246] End effector 910 includes a first jaw 911 and a second jaw 912 configured to move between an open position (as shown in Fig. 22) where the jaws are spaced apart from one another and a closed position to force the jaws into compressing contact with the legs of a clip to close and seal the clip around vessels or tissue. In certain embodiments, second jaw 912 is a movable jaw configured to move from an open position to a closed position relative to first jaw 911. In other embodiments, first jaw 911 is a movable jaw configured to move between open and closed positions relative to second jaw 912. In still other embodiments, both jaws 911, 912 are movable relative to each other.
[0247] Referring now to FIGS. 23 and 24, instrument 900 may be provided with a clip cartridge 920 that comprises a plurality of surgical clips 922 and is installed into surgical instrument 900. In certain embodiments, cartridge 920 may be installed through a longitudinal slot 924 in the side of shaft 905 (FIG. 23). The longitudinal slot 924 is sized to accommodate cartridge 920. In some embodiments, the longitudinal slot 924 is disposed along a portion of the shaft 905 configured to have reduced contact with body fluids duringInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT surgery. In other embodiments, a cartridge 920A may be installed through an opening in a proximal end 1126 of shaft (FIG. 24). Cartridges 920, 902A may contain between about 1 to 20 clips, preferably between about 2 to 12 clips. Clips 922 preferably extend in a substantially parallel direction relative to the longitudinal axis of shaft 905.
[0248] Cartridges 920, 902A may be constructed from any suitable materials known in the art, such as a single-molded plastic body or sheet metal. Cartridges 920, 902A may be adapted to accommodate any suitable desired sizes and configurations of clips 922, including conventional clips (e.g., titanium, tantalum or stainless steel ligation clips, such as the Horizon™, Hemoclip® or the like and / or polymer clips, such as the Vas- Q-Clip®, the Week® Hem-o-lok® or the like). Alternatively, cartridge 920 may be adapted to accommodate the novel clips described herein.
[0249] Wrist assembly 940 is positioned between end effector 910 and elongated shaft 905. Wrist assembly 940 may provide a desired amount of motion, such as + / - 90 degrees in a pitch, yaw and / roll direction (discussed in further detail below). Cables or other actuators (not shown) are drivingly coupled with the wrist assembly 940 and actuated to impart motion to wrist assembly 940.
[0250] In certain embodiments, drive member 930 is coupled to instrument shaft 905 such that drive member 930 is included as part of the overall instrument 900, which may be constructed of materi als designed for re-use of the instrument in multiple surgical procedures. In other embodiments, drive member 930 is coupled to cartridges 920 or 920A such that drive member 930 is included as part of the clip cartridge 920 / 920A, which may be constructed of materials designed for disposable or single-use applications. In either embodiment, drive member 930 is configured for longitudinal displacement relative to shaft 905 to advance clips 922 from cartridges 920, 920 A to jaws 911, 912 of end effectorInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 910, as discussed in more detail below.
[0251] FIGS. 25A-25C, illustrate multiple embodiments of a drive member 1000 for use with any of the surgical instruments and robotic control systems described herein. As shown, drive member 1000 comprises a distal component 1030, a proximal component 1010 (see FIG. 25D) and a flexible component 1020 coupling proximal component 1010 with distal component 1030. Proximal component 1010 is configured to extend through shaft 105, and may have one or more proximal interfaces for cooperating with an actuation mechanism to advance drive member 1000 distally and proximally relative to shaft 105 (see FIG. 4). In certain embodiments, a distal portion of proximal component 1010 may extend through a portion of wrist assembly 140. For example, in one such embodiment, this distal portion of proximal component 1010 extends far enough through wrist assembly 140 to flex in at least the pitch direction. Flexible component 1020 will typically flex in both the pitch and yaw7directions.
[0252] Similar to the embodiments described above in FIG. 6D, distal component 1030 comprises first and second engagement elements 1032, 1034 configured for removably coupling with a surgical clip (discussed below). Flexible component 1020 comprises a proximal support member 1040 coupled to first and second arms 1042, 1044 extending between support member 1040 and engagement elements 1032, 1034.
[0253] Engagement elements 1032, 1034 comprise frames or braces that may be asymmetrical relative to each other to facilitate the engagement of arms 1042, 1044 of drive member 100 with the upper and lower arms of a clip (similar to the embodiment in FIG.6D). In this embodiment (different from the embodiment in FIG. 6D), the upper frame of engagement element 1032 also has a non-planar configuration with a distal portion that curves downward towards the lower frame (and vice versa). In addition, the lower frameInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT preferably has a longer length than the upper frame. This orientation allows the frames to extend around the non-vessel sides of the arms of the clip to engage the distal portions of the clip.
[0254] As shown in FIGS. 25A and 25B, arms 1042, 1044 generally comprise elongate rods having a proximal portion 1046 that extends from and is substantially coplanar with the support member 1040, and a distal portion 1048 that is coupled to and substantially coplanar with the engagement elements 1032, 1034. The elongate rods include square or rectangular cross-section. In some embodiments, the elongate rods may have rounded or tubular cross-section. Engagement elements 1032, 1034 generally extend in a plane that is transverse to, or substantially perpendicular to, the support member 1040. In an exemplary embodiment, arms 1042, 1044, are twisted and shape-set to orient engagement elements 1032, 1034 substantially perpendicular to proximal portion 1040 of flexible component 1020 and the longitudinal axis of the instrument. This ensures that clip engagement elements 1032, 1034 are oriented properly for passing through guide tracks 440, 442 in the jaws of the instrument. Thus, arms 1042, 1044 each comprise a twisted portion 1050 that allows arms 1042, 1044 to twist from the orientation of proximal support member 1040 to the perpendicular orientation of engagement elements 1032, 1034.
[0255] In embodiments, the twisted portion 1050 of arms 1042, 1044 is located either proximal (FIG, 25B) or distal (FIG. 25A.) of the midpoint between engagement components 1032, 1034 and support member 1040. The midpoint between engagement components 1032, 1034 and support member 1040 is the portion of arms 1042, 1044 that will experience the highest or peak strain when the flexible portion 1020 is articulated (i.e., when the jaws are articulated relative to the shaft and engagement components 1032, 1034 are located within the jaws and thus articulated relative to support member 1040 (see Fig.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 25C). Locating the twisted portion 1050 distal or proximal of this midpoint reduces the overall strain experienced by twisted portion 1050 during articulation, thereby increasing the robustness of the drive member 1000.
[0256] As shown in FIG. 25C, arms 1042, 1044 are flexible and may bend with respect to each other. In particular, arms 1042, 1044 may bend when distal component 1030 is located within the jaws 402, 404 of the instrument, and the jaws have articulated relative to the shaft 105 (e.g., similar to that shown in FIG. 18A).
[0257] FIG. 25H illustrates an alternative embodiment of drive member 1000. In this embodiment, arms 1042, 1044 do not include a twisted portion. Instead, arms 1042, 1044 are formed such that an upper surfaces 1043 of arms 1042, 1044 are coplanar with both the upper surface 1045 of proximal support member 1040 and with the engagement elements 1032, 1034. Thus, arms 1042, 1044 do not include a twisted portion, which further increases the ability of the drive member to endure strain when flexible portion 1030 is articulated.
[0258] Flexible and distal components 1020, 1030 preferably comprises a material that is stiff enough to push through wrist assembly 140 into jaws 111, 112. At the same time, these components comprise a material that is flexible and resilient enough to bend as end effector 110 is articulated relative to shaft 105 at wrist assembly 140. In a preferred embodiment, these components comprise nitinol, polymers, such as PEEK, spring steel or similar materials
[0259] Referring now to FIGS. 25D-25G, proximal component 1010 may comprise the same, or a different, material than distal and flexible components 1020, 1030. In one embodiment, proximal component 1010 comprises a stiffer material than distal and flexible components 1020, 1030, such as stainless steel or the like. This adds stiffness to driveInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT member 1000 and reduces the amount of material (e.g., nitinol) required from drive member 1000, thereby reducing the overall cost of the instrument. In addition, stainless steel is generally easier to manufacture for complex geometries than other materials, such as nitinol.
[0260] Proximal component 1010 may be integral with, or coupled to, flexible component 1020 in any suitable manner. In one embodiment, drive member 1000 comprises one or more screw fasteners 1022, 1024 to removably couple proximal component 1010 to flexible component 1020 (see FIG. 25E). In another embodiment, drive member 1000 comprises one or more swaged pins 1026, 1028 to removably couple proximal component 1010 to flexible component 1020 (see FIGS. 25F and 25G). Swaged pins 1026, 1028 may be configured to extend through beveled openings 1036 to attach to a distal extension arm 1038 of proximal component 1010. Distal extension arm 1038 may be configured to extend into an internal channel in flexible component 1020 such that swaged pins 1026, 1028 attach flexible component 1020 to proximal component 1010.
[0261] Referring now to FIGS. 26A-26C, another embodiment of the distal portion of any of the above-described drive members 130 will now be described. Similar to the embodiments described above, the embodiment of FIGS. 26A-26C may include a distal component 1030, a proximal component 1010 (see FIG. 25D) and a flexible component 1020 coupling proximal component 1010 with distal component 1030. In one embodiment, the proximal component 1010 is oriented at an angle relative to the distal component 1030 (see FIGS. 25A and 25B). In one such embodiment, proximal component 1010 is oriented at a substantially perpendicular angle relative to the distal component 1030. The proximal and distal arms 1042, 1044 of the drive member may also include a proximal portion oriented substantially parallel to the proximal component 1010 and a distal portion orientedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT substantially parallel to the distal component 1030 such that arms 1042, 1044 each comprise a twisted portion 1050 that allows arms 1042, 1044 to twist from the orientation of proximal support member 1040 to the perpendicular orientation of engagement elements 1032, 1034. In an alternative embodiment, the distal portion of FIGS. 26A-26C may include the flexible component 120 of FIG. 25H (e.g., non-twisted arms 143).
[0262] As shown, engagement components 1032, 1034 each comprise a frame 1060, 1062 extending from amis 1042, 1044, respectively. Frames 1060, 1062 each comprise a proximal lateral support member 1064 extending laterally inward (i.e,, towards the longitudinal axis of shaft 105) from arms 1042, 1044. Alternatively, lateral support members 1064 may be substantially centered on arms 1042, 1044. Frames 1060, 1062 further comprise first and second longitudinal support members or rails 1066, 1068 extending distally from lateral support member 164 and a distal lateral support member 1070 extending between rails 1066, 1068 to form a substantially rectangular frame.
[0263] This single frame structure provides enhanced stability to drive member as its distal portion passes through the guide tracks in the jaws. Frames 1060, 1062 are sized such that they are narrower than di stal ramps ( 154, 156 of FIG. 5) of cartridge so they can ride over these ramps as engagement components 1032, 1034 are moved proximally after clip loading (discussed above). In addition, frames 1060, 1062 provide a rigid structure that can navigate the working channel provided by the wri st and jaw assemblies, while the internal (“inboard”) features constrain the clip (discussed below). Directionally, frames 1060, 1062 are generally stiffer in the loading / distal direction and more flexible in the unloading / proximal direction, which provides substantial benefit for loading (stability) and releasing sequences (discussed below). In addition, the frames 1060, 1062 are less likely to become jammed with other internal components of the instrument as the drive memberInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT is translated proximally and distally through the instrument.
[0264] Frames 1060, 1062 are sized and shaped to cam along the outer surfaces of retainer tabs 154,156 and upper and lower tabs 182a, 184a, 182b, 184b, of clip cartridge 120 (similar to the discussion above related to drive member 130 see FIG. 5 and 21) as drive member 1000 is withdrawn proximally relative to clip cartridge 120. In particular, frames 1060,1062 (and / or their respective internal openings or windows 1090, 1092 FIG.26B) have a width in a direction substantially perpendicular to the longitudinal axis ofclip cartridge 120 that is less than the width of retainer tabs 154, 156 and less than the width of upper and lower tabs 182a, 184a, 182b, 184b. This ensures that frames 1060, 1062 (and in particular windows 1090, 1092), do not catch on these tabs as drive member is withdrawn proximally to engage subsequent clips in the cartridge.
[0265] Engagement components 1032, 1034 further comprise longitudinal support members or rails 1071, 1072 extending distally from distal lateral support member 1070, and first and second projections 1074, 1076 extending laterally inwardly towards each other from support members 1071, 1072, Projections 1074, 1076 generally taper inwards to form an inner end 1078 with a smaller cross-sectional area than an outer end 1080. Inner ends 1078 of projections 1074, 1076 are opposing and define a space therebetween (i.e., inner end 1078 of projection 1074 does not contact inner end 1078 of projection 1076). In some embodiments, projections 1074, 1076 have substantially triangular upper and lower surfaces and form a ball detent configured to engage with an opening, recess or hole in a surgical clip (discussed below). This ball and socket mating allows the clip to swivel while attached to the arms of the drive member, which facilitates distal advancement of the clip through the wrist and into the jaws of the instrument.
[0266] Projections 1074, 1076 are biased inwardly toward the midline between theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT projections to avoid lateral windows and to provide engagement with the openings in the clips (see FIG. 26C). Projections 1074, 1076 are configured to advance through guide tracks 440, 442 and engage with clips 122 (similar to distal engagement elements 164, 166 in FIG. 6C) and frames 1060, 1062 are configured to advance through guide tracks 440, 442 and inhibit arms 1042, 1044 from buckling out of tracks 440, 442 (similar to proximal engagement elements 164a, 166a in FIG. 6C). Distal support rails 1071, 1072 on engagement element 1030 extend laterally inward towards the distal support rails 1071, 1072 of engagement element 1032 (and vice versa). This configuration allows the engagement elements 1032, 1034 to more smoothly transition through the curved guide tracks 440, 442 of the jaws.
[0267] Similar to the embodiment of FIG. 6D, frames 1060, 1062 are generally asymmetrical relative to each other to facilitate the engagement of the arms 1042, 1044 of drive member 1000 with the upper and lower arms of a clip. In addition, proximal longitudinal support members 1066, 1068 of engagement element 1034 are longer than proximal longitudinal support members 1066, 1068 of engagement element 1032 (see FIG.26B). Thus, frame 1060 of engagement element 1032 has an internal opening 1090 (e.g., window) with a smaller area than the internal opening 1092 (e.g., window) of the frame 1062 of engagement element 1034. This orientation allows frame 1062 to extend around the lower or non-vessel side of the lower arm of the clip to engage the distal portion of the clip. In certain embodiments, arm 1044 may also have a longer length than arm 1042 to facilitate the additional distal extension required to engage frame 1062 to the distal end portion of the lower arm of the clip. The relative sizes / shapes of frames 1060, 1062, in particular the width and the cross-sectional area of the windows 1090, 1092) ensure that frames 1060, 1062 (and in particular windows 1090, 1092) do not substantially contact (orInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT get caught up on, even if the frames contact) the release members or strippers 480, 484 extending within the interior of the jaws 404, 406 as distal arms 1042, 1044 are withdrawn proximally relative to the jaws 404, 406 (see FIGS. 38 and 41, discussed in more detail below). For example, frames 1060,1062 (and / or their respective internal openings or windows 1090, 1092 FIG. 26B) have a width in a direction substantially perpendicular to the length of the strippers 480, 484 that is less than the width of the strippers 480, 484. This ensures that windows 1090, 1092, do not catch on the strippers 480, 484 as drive member is withdrawn proximally to engage subsequent clips in the cartridge.
[0268] As best shown in FIGS. 30C and 30E (and described in more detail below), projections 1074, 1076 of each engagement element 1032 are configured to cam along ramped or tapered surfaces 1242, 1244 extending on the outside of lateral components 1224, 1226, 1232, 1234 of each of the arms 1202, 1204 of the surgical clip 1200 as they are translated distally relative to the clip (see FIGS. 30C and 30E). This causes projections 1074, 1076 to expand outwardly until they reach openings or through-holes 1236, 1238 in the clip. At this point, projections 1074, 1076 spring into openings 1238 to attach engagement elements 1032, 1034 to each of the arms 1202, 1204 of the surgical clip. In certain embodiments, the lateral components 1224, 1226, 1232, 1234 of clip 1200 may also comprise a flexible or compressible material or shape that allows projections 1074, 1076 of drive member 1000 to compress these lateral components 1224, 1226, 1232, 1234 inwardly during the distal translation of projections 1074, 1076 along the outer surface of the lateral components 1224, 1226, 1232, 1234. After projections 1074, 1076 have engaged with openings 1236, 1238 in clip, these lateral components 1224, 1226, 1232, 1234 may spring back outward into their original shape to further secure projections 1074, 1076 to openings 1236, 1238. After the clip has been closed onto tissue or a vessel, drive memberInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 1000 may be proximally withdrawn from the jaws of the instrument. To release projections 1074, 1076 from openings 1236, 1238 in clip, the clip includes a release feature which engages an elongate clip stripper on the jaws (discussed below). The release and stripping features are configured to provide sufficient distal force to the clip to force projections 1074, 1076 to expand outward such that they release from openings 1236, 1238, allowing the drive member to be withdrawn without detaching the clip from the jaws.
[0269] FIGS. 27A-27D illustrate the distal portion of another embodiment of a drive member 1100 for use with the surgical instruments and surgical clips described herein. Similar to the embodiment shown in FIGS. 26A and 26B, drive member 1100 generally comprises a distal component 1110, a proximal component (not shown) and a flexible component 1120 coupling the proximal component with distal component 1110 (only one of the distal arms of flexible component 1120 is shown). Distal component 1110 comprises first and second engagement components (only one engagement component is shown) each comprising a frame 1112 extending from one of the arms of flexible component 1120, as discussed above. Similar to previous embodiments, distal components 1110 preferably comprise a single frame structure that provides enhanced stability to drive member as its distal portion passes through the guide tracks in the jaws. Directionally, frames 1112 are generally stiffer in the loading / distal direction and more flexible in the unloading / proximal direction, which provides substantial benefit for loading (stability) and releasing sequences (discussed below).
[0270] Each frame 1112 comprises a proximal lateral support arm 1114, first and second longitudinal support arms or rails 1116, 1118 extending distally from support arm 1114 and a distal lateral support arm 1120 extending between arms 1116, 1118 to form a substantially rectangular frame. In this embodiment, the frame 1112 is substantiallyInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT aligned with (or centered on) the arm of flexible component 1120, although it will be envisioned that frame 1112 may extend laterally away from flexible component 1120 similar to the previous embodiments. Support arms or rails 1116, 1118 are spaced laterally from each other and facilitate guidance of distal components 1110 through the jaw tracks. Distal lateral support arm 1120 is formed as a crossbar between rails 1116, 1118 and may¬ be used to aid in “clip stripping”, or release of a surgical clip from the distal components 1110 after the clip has been coupled to the jaws and / or closed onto tissue. Similar to the previous embodiment frame 1112 guides the distal aims of the drive member through guide tracks in the jaws and is less likely to jam onto internal components of the instrument.
[0271] Distal component 1110 further comprises first and second projections 1122 and 1124 extending distally and inwardly towards each other from rails 1116, 1118 into the interior space formed by frame 1112. Projections 1122, 1124 are preferably relatively stiff in the longitudinal direction, while more flexible in the lateral direction to allow them to flex and release form the clip more easily. As best shown in FIG. 27D, projections 1122, 1124 each have a distal end 1128 spaced from each other and comprising a mating feature 1130 for releasably coupling to a mating feature within an arm of a surgical clip, such as an opening, recess or hole (discussed below). In one embodiment, the mating feature 1130 comprises a ball / socket mating geometry with the surgical clip. Projections 1122, 1124 provide an “inboard” “ski-tip” mating feature for clip that is disposed laterally inside of frame 1112.
[0272] Projections 1122, 1124 preferably extend at an angle relative to the plane formed by each frame 1112 such that mating features 1130 may align with the corresponding mating features on the surgical clip (see FIG. 30C). In particular, projections 1122, 1124 of each frame 1112 extend inwardly towards the projections on theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT opposite distal component or arm. Projections 1122, 1124 are preferably formed such that they are relatively rigid in the longitudinal direction during loading (i.e., engagement with the surgical clip) and relatively flexible in the lateral direction during release of the clip. In particular, as distal components 1110 are translated distally to engage with the clip, the projections 1122, 1124 cam or ride along a tapered surface of the clip until mating features 1130 have engaged with the mating features on the clip to releasably couple the drive member to the clip. Once the clip has been secured to the jaws, proximal translation of the drive member 1100 causes projections 1122, 1124 to bend or flex outwardly (i.e., towards rails 1116, 1118) such that mating features 1130 disengage from the mating features on the clip, thereby allowing the drive member 1100 to be withdrawn from the jaws while maintaining the clips within the jaws.
[0273] In certain embodiments, projections 1122, 1124 extend at an angle relative to rails 1116, 1118 that forms an “elbow” joint 1132 therebetween (see FIG. 27D). This elbow joint 1132 reduces the twisting of frame 1112 when the distal component 1110 is located within the jaws and the jaws are articulated relative to the shaft of the instrument.
[0274] FIGS. 28A-28C illustrate another embodiment of a drive member 1140 for use with the surgical instruments and surgical clips described herein. Similar to the embodiments show above, drive member 1140 generally comprises a distal component 1150, a proximal component (not shown) and a flexible component 1160 coupling the proximal component with distal component 1110. Distal component 1150 comprises first and second engagement components (only one engagement component shown) each comprising a frame 1152 extending from one of the arms of flexible component 1160, as discussed above. Distal components 1150 preferably comprise a single frame structure that provides enhanced stability to drive member as its distal portion passes through theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT guide tracks in the jaws. Directionally, frames 1152 are generally stiffer in the loading / distal direction and more flexible in the unloading / proximal direction, which provides substantial benefit for loading (stability) and releasing sequences (discussed below).
[0275] Each frame 1152 comprises first and second longitudinal support arms or rails 1156, 1158 extending distally from flexible component 1160 and a distal lateral support arm or crossbar 1162 extending between arms 1156, 1158 to form a substantially rectangular frame. In this embodiment, frame 1152 includes first and second proximal connection members 1164, 1166 extending laterally outwardly from the arm of flexible component 1160 to rails 1156, 1158. Frame 1112 is substantially aligned with the arm of flexible component 1120, although it will be envisioned that frame 1112 may extend laterally away from flexible component 1120 similar to the previous embodiments. Support arms or rails 1156, 1158 are spaced laterally from each other and facilitate guidance of distal components 1150 through the jaw tracks. Distal lateral support arm 1162 is formed as a crossbar between rails 1156, 1158 and may be used to aid in “clip stripping”, or release of a surgical clip from the distal components 1150 after the clip has been coupled to the jaws and / or closed onto tissue
[0276] Similar to the previous embodiment, frame 1152 further includes first and second projections 1170, 1172 extending distally relative to frame 1152. In this embodiment, projections 1170, 1172 are coupled to rails 1156, 1158 such that they extend substantially parallel (or at an angle less than about 20 degrees) relative to rails 1156, 1158. Projections 1170, 1172 each have a distal end spaced from each other and comprising a mating feature 1178 for releasably coupling to a mating feature within an arm of a surgical clip, such as an opening, recess or hole (discussed below). In one embodiment, the matingInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT feature 1178 comprises a ball / socket mating geometry with the surgical clip.
[0277] Projections 1170, 1172 preferably extend at an angle relative to the plane formed by each frame 1152 such that mating features 1178 may align with the corresponding mating features on the surgical clip. In particular, projections 1170, 1172 of each frame 1152 extend inwardly towards the projections on the opposite distal component or arm. As distal component 1150 is translated distally to engage with the clip, the projections 1170, 1172 may cam or ride along a tapered surface of the clip until mating features 1178 have engaged with the mating features on the clip to releasably couple the drive member to the clip. Once the clip has been secured to the j aws, proximal translation of the drive member 1140 causes a proximal surface of the projections to engage a release surface 1180 within the jaw track 1182 such that mating features 1178 disengage from the mating features on the clip, thereby allowing the drive member 1150 to be withdrawn from the jaws while maintaining the clips within the jaws (see FIG. 28C).
[0278] Referring to FIGS. 29A-29D, another embodiment of a drive member 1190 will now be described. Drive member 1190 generally includes the same or similar components as previous embodiments include proximal, flexible and distal components (not shown). The distal component includes a frame 1192 that may be similar to, or different from, the frames describes above. The distal component further includes one or more projections 1194 extending into the interior portion of frame 1192, preferably extending away from the plane formed by frame 1192 and towards the other distal component of the drive member 1190. As shown, each projection 1194 has a non-linear or curved distal portion 1196 with an inner concave surface and an outer convex surface such that the projection initially extends away from frame and then curves back slightly towards frame at its distal tip 1198.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0279] In use, the distal tips 1198 of projections 1196 are sized and configured to engage and coupled to a mating feature 1199 on one of the arms of a surgical clip 1197 (see FIG. 29C). After the jaws have been closed such that the clip is closed onto tissue, pressure is applied to frame 1192 and projections 1194 such that the distal tip 1198 of projections 1196 bend away from the mating feature 1199 on the clip 1197 (see FIG. 29D). This allows the drive member to release from the clip and be withdrawn proximally from the jaws after the clip has been secured to tissue.
[0280] Referring now to FIGS. 30A-30G, another embodiment of a clip 1200 will now be described. Clip 1200 has been designed to eliminate the need for laterally protruding (e.g., outwardly facing) bosses and, therefore, has a thinner profile than conventional polymer clips. The maximum lateral width of clip 1300 is less than about 2.0 mm, or about 0.6 mm to about 1.5 mm, or preferably about 0.8 mm to about 1.1 mm (conventional polymer clips designed to ligate vessels up to 10 mm in diameter typically have a maximum lateral width of 2.0 mm or greater). This allows the user to place the clips in closer proximity to each other and / or place more clips within a target location on the patient, e.g., a vessel, thereby providing a stronger seal on the vessel. Similar to the previous embodiment, clip 1200 includes first and second arms 1202, 1204 pivotally coupled to each other about a hinge 1206 for movement between an open position (FIG.30A) and a closed position (not shown). Hinge 1206 is preferably a living or integral hinge that comprises an opening 1208 that creates two thinned pieces connected to arms 1202, 1204 to create a flexure bearing that allows arms 1202, 1204 to open and close. First arm 1202 includes a first engagement hook 1210 and second arm 1204 includes a second engagement hook 1212 such that clip 1200 can be compressed into a latched or locked position around a grasped vessel or other grasped tissue. For ease of reference, firstInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT engagement hook 1210 may sometimes be referred to as an “upper” engagement hook and second engagement hook 1212 may sometimes be referred to as a “lower” engagement hook, although it will be understood that these terms are relative to the user’s orientation relative to the clip (i.e., if the clip is flipped upside down, the terms upper and lower would be reversed). In some embodiments first and second arms 1202, 1204 include grip features or protrusions 1214 extending on the tissue / vessel side of each arm (see also FIGS. 32-35).
[0281] As particularly shown in FIGS. 30B, first engagement hook 1210 comprises two lateral portions 1262, 1264 that form a central opening 1263, such as a slot, recess or channel, for receiving a main body 1280 of second engagement hook 1212. First engagement hook 1210 further includes a shelf 1270 within opening 1263. As the first engagement hook 1210 is compressed against second engagement hook 1212, the force applied is sufficient to temporarily deform second engagement hook 1212 backward away from first engagement hook 1210. This allows main body 1280 of second engagement hook 1212 to pass over shelf 1270 and into central slot 1263 between lateral portions 1262, 1264. Once second engagement hook 1212 has passed over shelf 1270, it is released from the deformed state so that it moves into opening 1263 above shelf 1270. Shelf 1270 and lateral portions 1262, 1264 secure first engagement hook 1210 to second engagement hook 1212.
[0282] In this embodiment, clip 1200 includes a secondary lock in the closed position. As shown in FIG. 30B, first engagement hook 1210 further comprises first and second projections 1266, 1268 extending downwards from lateral portions 1262, 1264 towards second engagement hook 1212. In one embodiment, projections 1266, 1268 comprises pointed or “beak-like” protrusions extending downward from lateral portions 1262, 1264. Arm 1204 includes a distal extension 1284 on each side of arm 1204 spacedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT laterally outward from the two side surfaces 1282 of second engagement hook 1212. As first engagement hook 1210 secures to second engagement hook 1212, projections 1266, 1268 come into contact with extensions 1284, which reduces, minimizes or inhibits translation of upper arm 1202 relative to lower arm 1204 once they are closed / latched together, thereby providing a secondary lock to ensure that second engagement hook 1212 remains secured to first engagement hook 1210.
[0283] First arm 1202 includes an engagement member 1220 for removably coupling to one of the engagement elements 1030 of drive member 1000 and second aim 1204 includes an engagement member 1222 for removably coupling to the other of the engagement elements 1030 of drive member 1000 (see FIG. 26C). Engagement members 1220, 1222 allow engagement elements 1030, 1032 to secure drive member 1000 to clip 1200 during advancement of the clip 1200 through wrist 140 (e.g., even when the wrist is articulated on pitch or yaw relative to the shaft 105) into jaws 111, 112 and to control and retain clip 1200 throughout the opening and closing of jaws 111, 112 (and consequently the opening and closing of clip 1200), as well as any other articulation of end effector 110 relative to shaft 105 (i.e., roll, yaw or pitch movements of the end effector). At the same time, engagement members 1220, 1222 are designed to release engagement elements 1030, 1032 upon sufficient application of force to the drive member 1000.
[0284] As shown in FIG. 30E, lower / second engagement hook 1212 comprises first and second lateral components 1224, 1226 spaced from each other and extending on the lower side of arm 1204 opposite gripping features 1214. Similarly, upper / first engagement hook 1210 comprises first and second lateral components 1232, 1234 spaced from each other and extending on the upper side of arm 1202 opposite gripping elements 1214 (see FIG. 30C). Engagement members 1220, 1222 each comprise a recess, opening or hole forInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT receiving the inner ends of projections 1074, 1076 of the engagement elements 1032, 1034 of drive member 1000. In one embodiment, these engagement members comprise a through-holes 1236, 1238 that extends through both of the lateral components of the upper / first and lower / second engagement hooks 1210, 1212. Through-holes 1236, 1238 are sized and configured to receive the inner ends of projections 1074, 1076 (e.g., respective inner ends 1078) of drive member 1000, as discussed above.
[0285] Engagement members 1220, 1222 each further include inclined (e.g., ramped, tapered) surfaces 1242, 1244 extending on the outside of the lateral components 1224, 1226, 1232, 1234 towards hinge 1206. These inclined surfaces taper inwardly towards each other in the proximal direction. As discussed above, projections 1074, 1076 of drive member 1000 are configured to slide or cam along these inclined surfaces 1242, 1244 as drive member 1000 is advanced distally relative to clip 1200. This causes projections 1074, 1076 to flex laterally outwards such that they have sufficient space therebetween to advance distally to through-holes 1236, 1238. Once they reach the through-holes 1236, 1238, the natural inward biasing of projections 1074, 1076 causes them to flex inwardly having their respective inner ends 1078 disposed in through-holes 1236, 1238 to couple drive member 1000 to clip 1200. The ramped surfaces 1242, 1244 have the additional advantage that they will not catch onto tissue when implanted.
[0286] As discussed above and shown in FIG. 26C, in certain embodiments, the lateral components 1224, 1226, 1232, 1234 of clip 1200 may also comprise a flexible or compressible material or shape that allows projections 1074, 1076 of drive member 1000 to compress these lateral components 1224, 1226, 1232, 1234 inwardly during the distal translation of projections 1074, 1076 along the outer surface of the lateral components 1224, 1226, 1232, 1234. After projections 1074, 1076 have engaged with openings 1236,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 1238 in clip, these lateral components 1224, 1226, 1232, 1234 may spring back outward into their original shape to further secure projections 1074, 1076 to openings 1236, 1238.
[0287] As shown in FIG. 30G, lower and first engagement hooks 1212, 1210 may further include a clip stripping feature to assist or allow the release of drive member 1000 from clip 1200 when drive member 1000 is withdrawn proximally. In one embodiment, this clip stripping feature comprises a projection 1292 extending laterally outward from an external surface 1290 of each arm of the clip. Projection 1292 is configured to engage a release member or stripper 480, 482 (see FIGS. 38 and 41) extending within the interior of the jaws 404, 406 peripheral to distal guide ribbons 420, 422 when the drive member is withdrawn proximally from the jaws (e.g., after the arms of the clip have closed onto tissue or a vessel). The force applied by strippers 480, 484 against projection 1292 is sufficient to retain clip 1200 within the jaws as the projections 1074, 1076 of the drive member 1000 disengage from through-holes 1236, 1238, allowing the drive member to be withdrawn from the jaws without disengaging the clip from the tissue, vessel or jaws.
[0288] Referring now to FIG. 31, another embodiment of a clip 1300 will now be described. Clip 1300 has been designed to eliminate the need for laterally protruding (e.g., outwardly facing) bosses and, therefore, has a thinner profile than conventional polymer clips. The maximum lateral width of clip 1300 is less than about 2.0 mm, or about 0.6 mm to about 1.5 mm, or preferably about 0.8 mm to about 1.1 mm (conventional polymer clips designed to ligate vessels up to 10 mm in di meter typically have a maximum lateral width of 2.0 mm or greater). This allows the user to place the clips in closer proximity to each other and / or place more clips within a target location on the patient, e.g., a vessel, thereby providing a stronger seal on the vessel.
[0289] Of course, it will be recognized that the specific dimensions for theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT maximum lateral width of clip 1300 will vary based on the function of clip. If clip 1300 is, for example, designed to ligate smaller vessels (i.e., vessels having diameters of less than 3 mm), than the width of clip will be less than the dimensions described above. However, the overall length / width ratio ofclip 1300 will remain higher than conventional polymer clips.
[0290] Similar to the previous embodiment, clip 1300 includes first and second arms 1302, 1304 pivotally coupled to each other about a hinge 1306 for movement between an open position. Hinge 1206 is preferably a living or integral hinge that comprises an opening 1308 that creates two thinned pieces connected to arms 1302, 1304 to create a flexure bearing that allows arms 1302, 1304 to open and close. First arm 1302 includes an upper / first engagement hook 1310 and second arm 1304 includes a lower / second engagement hook 1312 such that clip 1300 can be compressed into a latched or locked position around a grasped vessel or other grasped tissue. In some embodiments first and second arms 1302, 1304 include grip features or protrusions 1314 extending on the vessel side of each arm.
[0291] First engagement hook 1310 comprises two distal rounded projections 1362, 1364 that form a central opening 1363, such as a slot, recess or channel, for receiving a rounded main body 380 of hook 1312. First engagement hook 1310 further includes a shelf 1370 within opening 1363. As first engagement hook 1310 is compressed against second engagement hook 1312, the force applied is sufficient to temporarily deform second engagement hook 1312 backward away from first engagement hook 1310. This allows main body 1380 of second engagement hook 1312 to pass over shelf 1370 and into central slot 1363 between projections 1362, 1364 Once second engagement hook 1312 has passed over shelf 1370, it is released from the deformed state so that it moves into slot 1363 aboveInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT shelf 1370. Shelf 1370 and rounded projections 1362, 1364 secure first engagement hook 1310 to second engagement hook 1312.
[0292] Similar to the previous embodiment, first arm 1302 includes an engagement member 1320 for removably coupling to engagement element 164 of drive member 130 and second arm 1304 includes an engagement member 1322 for removably coupling to the distal arms of the drive member 130.
[0293] Referring now to FIG. 32, another embodiment of a surgical clip 1400 will now be described. Clip 1400 may have any of the configurations described above for clips 300, 300’, 1200 and 1300. In this embodiment, clip 1400 comprise a plurality of gripping features configured to facilitate axial retention of small vessels between the arms 1402, 1404 of clip 1400 (e.g., inhibit or minimize slipping, sliding or axial movement of the clips relative to tissue or vessels). As shown, each of the arms 1402, 1402 comprise first and second rows 1410, 1412 of gripping elements 1414. Within each row, gripping elements 1414 are spaced from each other along the inside or tissue contacting surface of arms 1402, 1404. The gripping elements 1414 on first arm 1402 are disposed within the spaces between the gripping elements 1414 on second arm 1404 (and vice versa). In addition, the gripping elements 1414 of the first row 1410 of each arm are offset from the gripping elements 1414 of the second row 1412. The first and second arms 1402, 1404 include inner surface 1455 where the first and second rows 1410, 1412 of gripping elements 1414 are disposed on. The inner surface 1455 includes sloping ramps configured to receive corresponding gripping element. The inner surface 1455 of the first arm 1402 face the inner surface 1455 of the second arm 1404.
[0294] In one embodiment, each of the gripping elements 1410 comprise a wedgelike shape that comprises an inner end 1416 and an outer end 1418. Inner end 1416 has aInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT longer longitudinal length than outer end 1418 to form the wedge or partially triangular shape. In addition, the upper surface 1420 of each gripping element 1414 tapers towards the inner surface of the arms 1402, 1404 from a centerline of the arms towards their external surfaces such that inner ends 1416 are spaced further away from the inner surface of the arms than outer ends 1418. In some embodiments, outer ends 1418 may be flush with the inner surface of the arms. In other embodiments, outer ends 1418 may extend away from the inner surface of the arms. Similar to previous embodiments, projections 1074, 1076 also cause the engagement members on the clip to deflect laterally inwards at the same time. The engagement members also spring back into place once projections reach the through holes.
[0295] Referring now to FIGS. 33A-33C, another embodiment of a surgical clip 1450 will now be described. Clip 1450 may have any of the configurations described above for clips 300, 300’, 1200 and 1300. In this embodiment, clip 1450 comprise a plurality of gripping features on the inner surfaces of the arms 1452, 1454 of clip 1450 configured to maximize the surface area of these inner surfaces and inhibit or prevent the clip from slipping on tissue or vessels therebetween. As shown, each arm 1452, 1454 preferably comprises first and second rows 1456, 1458 of projections 1460 extending from the inner surface in the direction of the other arm. The rows of projections 1456, 1458 are disposed on either side of the centerline or midline of the inner surfaces of arms 1452, 1454. In this embodiment, the projections 1460 comprise teeth spaced from each other along each row. Within each row, gripping teeth 1460 are spaced from each other along inside surface of arms 1452, 1454. The teeth 1460 on upper arm 1452 are disposed within the spaces between the teeth 1460 on lower arm 1454 (and vice versa). In addition, the teeth 1460 of the first row 1456 of each arm are offset from the teeth 1460 of the secondInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT row 1458. Thus, the teeth of each arm interlock with each other.
[0296] As shown more clearly in FIGS. 33B and 33C, the teeth 1460 are sized such that there is a space or gap 1462 between the teeth of one arm and the teeth of another arm when the arms 1452, 1454 are in the closed position. This gap 1462 provides room for tissue or vessels that are clamped between the arms of clip 1450.
[0297] Referring now to FIGS. 34A-34B, another embodiment of a surgical clip 1500 will now be described. Clip 1500 may have any of the configurations described above for clips 300, 300’, 1200 and 1300. In this embodiment, clip 1500 comprises a plurality of gripping features on the inner surfaces of the arms 1502, 1504 of clip 1500 configured to maximize the surface area of these inner surfaces and inhibit, prevent or minimize the clip from slipping on tissue or vessels therebetween. As shown, each arm 1502, 1504 preferably comprise a plurality of teeth 1508, 1510 extending from the inner surface in the direction of the other arm. As with the previous embodiment, teeth 1508, 1510 are spaced from each other along inside surface of arms 1502, 1504. The teeth 1508 on upper arm 1502 are disposed within the spaces between the teeth 1510 on lower arm 1504 (and vice versa).
[0298] In this embodiment, teeth 1508, 1510 extend from one exterior side of the internal surfaces of arms beyond the midline or centerline 1512 of the inner surfaces. In one such embodiment, teeth 1510 extend from one side of the inner surface to the other side. Teeth 1510 may taper inwardly towards the inner surface of the arms from one side to the other side. In certain embodiments, the teeth on arm 1502 taper in the opposite direction as the teeth on arm 1504. Teeth 1508, 1510 create pockets therebetween to constrain tissue or a vessel clamped between the arms of the clip.
[0299] Referring now to FIGS. 35 A and 35B, another embodiment of a surgical-n -International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT clip 1530 will now be described. Clip 1500 may have any of the configurations described above for clips 300, 300’, 1200 and 1300. In this embodiment, clip 1500 comprises a plurality of gripping features on the inner surfaces of the arms of clip 1530 configured to maximize the surface area of these inner surfaces and inhibit, prevent or minimize the clip from slipping on tissue or vessels therebetween. As shown, each arm preferably comprise a plurality of teeth 1532, 1534 extending from the inner surface in the direction of the other arm. Teeth 1532 on the upper arm extend downwards on one side of the midline 1540 of the arms of the clip 1530 and teeth 1534 extend upwards on the other side of the midline 1540 to interlock with each other. Teeth 1532, 1534 are preferably sized to maintain a gap therebetween for constraining tissue or a vessel.
[0300] FIGS. 36A and 36B illustrate another embodiment of a surgical clip 1560. Similar to the previous embodiments, clip 1560 includes first and second arms 1562, 1564 pivotally coupled to each other about a hinge 1566 for movement between an open position and a closed position. Hinge 1566 is preferably a living or integral hinge that comprises an opening 1568 that creates two thinned pieces connected to arms 1562, 1564 to create a flexure bearing that allows arms 1562, 1564 to open and close. First arm 1562 includes a first engagement hook 1570 and second arm 1564 includes a second engagement hook 1570 such that clip 1550 can be compressed into a latched or locked position around a grasped vessel or other grasped tissue. In some embodiments first and second arms 1562, 1564 include grip features or protrusions (not shown) extending on the vessel side of each arm.
[0301] In this embodiment, clip 1560 comprises an engagement or mating component 1580 on proximal hinge 1566 for releasably coupling clip 1560 to a drive member (not shown). The drive member may comprise a mating feature for engagingInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT component 1580 and may, for example, comprise one or more of the drive members described in International Application No. PCT / US2024 / 32207, previously incorporated herein by reference.
[0302] As shown, mating component 1580 comprises first and second proximal extension member 1582, 1584 that form an opening or space 1586 therebetween. Extension members 1582, 1584 naturally move towards and away from each other as the clip 1560 is moved between the open position (FIG. 36A) and the closed position (FIG.36B). In the open position, space 1586 has a smaller cross-sectional area than in the closed position. Thus, the mating feature of the drive member can be engaged to clip in the open position. As the clip is closed, space 1586 enlarges to allow the mating feature of the drive member to disengage from the clip for proximal withdrawal from the jaws.
[0303] In certain embodiments, clip 1560 may further comprise one or more guide features 1590 for facilitating advancing of the clip through the guide tracks in the jaws of the instrument. In one such embodiment, guide features 1590 comprise trapezoidal projections extending from the outer surfaces of the arms of the clip. These projections and sized and shaped to ride through the guide tracks of the jaws as the clip is advanced to the distal end of the jaws.
[0304] Referring now to FIGS. 37A-41, a method for delivering one or more surgical clips 1200 to jaws 402, 404 with drive member 1000 will now be described. As shown in FIGS. 37A and 37C, clips 1200A, 1200B, etc. are disposed in a parallel row within clip cartridge 120, as described above. As discussed previously drive member 1000 is generally positioned along the side of cartridge 120 and may be withdrawn proximally into clip cartridge 120 as described in reference to FIGS. 13A-14B. Drive member 1000 is then moved distally until projections 1074, 1076 (e.g., respective inner ends 1078) ofInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT engagement elements 1030, 1032 engage with openings 1236, 1238 of the arms of the distal-most clip 1200A (FIGS. 37A and 37B).
[0305] Drive member 1000 advances clip 1200A through the central lumen 132 (e.g., inner lumen, working channel) of the shaft 105 and wrist assembly 140 and into end effector 110. As arms 1042, 1044 of drive member 1000 advance through wrist assembly 140, proximal guide ribbons 424 (only one shown in FIG. 38) constrain the movement of arms 1042, 1044 such that the arms pass through wrist assembly 140 into the jaws 402, 404 even when the wrist may be articulated around the pitch or yaw axes. Proximal guide ribbons 424 preferably comprise a proximal end portion 490 that is movably disposed within the instrument shaft 105 and a distal end portion 492 that is fixed to a clevis 498 of the instrument. This allows the ribbons 424 to flex and move as the end effector is articulated relative to the shaft of the instrument.
[0306] As arms 1042, 1044 of the drive member 1000 enter the jaw assembly 400, the distal ribbons 420, 422 also constrain the movement of arms 1042, 1044 such that the arms 1042, 1044 enter guide tracks 440, 442 of first and second jaws 402, 404 (see also FIGS. 17 and 18). Distal guide ribbons 420, 422 comprise a proximal end portion 426 that is fixed to the clevis 498 and a distal end portion 430 that is movably disposed within each of the jaw tracks. This allows the ribbons 420, 422 to flex and move as the jaws are opened and closed. Drive member 1000 is advanced distally until engagement elements 1030, 1032 (and first and second engagement hooks 1210, 1212 of clip 1200) engage cutouts 454 (see FIG. 39) in distal end portions 434, 436 of jaws 402, 404 (see also FIGS. 11A and 11B).
[0307] When the surgeon has positioned clip 1200 A in the desired location to clamp onto tissue or a vessel, jaws 402, 404 are closed (see FIG. 37E). As noted above,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT jaws 402, 404 provide sufficient force to close clip 1200 and to secure first engagement hook 1210 to second engagement hook 1212. Once that has occurred, drive member 1000 may be withdrawn proximally. In this embodiment, jaws 404, 406 each comprise a release member, disengagement feature or stripper 480, 484 extending within the interior of the jaws 404, 406 peripheral to distal guide ribbons 420, 422 (see FIG. 41). Thus, strippers 480, 484 are located peripheral to, or outside of, distal guide ribbons 420, 422 and guide tracks 440, 442 such that they do not interfere the clip 1200 as it is advanced distally to the distal portion of jaws 402, 404. Strippers 480, 484 are elongate rods, bands or the like that have a curved distal end 422, 486 that extends laterally inward (e.g., to engage the drive member 1000 when the drive member translate proximately). Curved distal ends 482, 486 of strippers 480, 484 are distal of the distal end portion of distal guide ribbons 420, 422 and are positioned such that when drive member 1000 is withdrawn proximally, distal ends 482, 486 contact and engage a portion of upper and second engagement hooks 1210, 1212 of clip 1200 (e.g., projection 1292 shown in FIG. 30G). Strippers 480, 484 preferably have a stiffness sufficient to provide a force against clip 1200. This force is preferably high enough to cause projections 1074, 1076, (e.g., respective inner ends 1078) of drive member 1000 to disengage or withdraw from openings 1236, 1238 of engagement hooks 1210, 1212 such that clip 1200 is released from drive member 1000. Once drive member 1000 has been disengaged from clip 1200, it may be withdrawn proximally back through wrist assembly 140 and into shaft 105 of instrument (see FIG. 37F). To engage a second clip 1200B from cartridge 120, engagement elements 1032, 1034 of drive member 1000 are withdrawn past first upper and lower tabs 182, 184 to the second clip 1200B (see FIGS.37A and 37B). The process may be then repeated to advance second clip 1200B to the jaws of the end effector, then a third clip (not shown), etc. The instrument is configured toInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT advance multiple clips into the end effector, as many clips as the cartridge holds.
[0308] Referring now to FIGS. 42A-42C, another embodiment of an instrument for applying multiple clips to tissue will now be described. In this embodiment, the instrument comprises a clip cartridge 1600 having an elongate housing 1602 with a distal end 1604 and a longitudinal slot 1606 extending along one side of housing 1602. A plurality of clips 1620 are arranged in parallel along the side of housing 1602 (rather than being disposed within the housing as in previous embodiments). The drive member is configured to translated distally along a path lateral to clip housing 1602 to engage clips 1620 and advance the clips to the jaws of the instrument (note that only engagement elements 164, 166 of drive member are shown).
[0309] In this embodiment, clips 1620 each comprises first and second arms 1622, 1624 pivotally coupled to each other about a hinge (not shown), as described above. Each of the arms 1622, 1624 comprises a projection or overhang feature 1630, 1632 that extends into slot 1606 of clip cartridge 1600. Projections 1630, 1632 may be shaped like a dovetail in certain embodiments. Thus, the dovetail projections 1630, 1632 ensure that clips 1600 stay retained to clip cartridge 1600 on their right side (facing distally) while the drive member has full access to engage clips on their left side. The dovetail projections 1630, 1632 also ensure that the arms 1622, 1624 of clips 1620 remain closed in cartridge 1600.
[0310] Referring now to FIGS. 43 A and 43B, a support member 1700 for housing a force transmission line (e.g., cable, rod, band or the like) will now be described. Support member 1700 is particularly suited for housing a force transmission line with a non-cylindrical shape, such as a rectangular or other irregular shaped rod). As shown, support member 1700 comprises an outer tube 1710 (which may comprise the shaft of the instrument) and an annular support component or seal 1712 that may, for example,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT comprise silicone. Support member 1700 further comprises first and second inner halves 1716,1718 sized to create a passage 1714 for the transmission line. In particular, inner halves 1716, 1718 are sized so that when compressed from the outside by annular silicone 1712, the two halves 1716 1718 (clamshells) compress to reduce or eliminate any gaps and therefore seal around the irregular shape of the transmission member. The inner halves 1716 1718 create a “choke seal” around the irregularly shaped transmission line and preferably comprise low friction plastics, metals or coated (low friction) metal for durability. Since the parts are not silicone, lower frictions can be achieved. Since the parts are select plastics or metals, the durability of the seal is dramatically improved. This “choke seal” also works when the transmission member is moved linearly thru the seal back and forth to transmit motion or force.
[0311] In some embodiments, annular silicone member 1712 may comprise one or more internal lumens 1720 for housing other force transmission lines, such as cables, that extend through the shaft. Internal lumens 1720 may have substantially circular cross-sections.
[0312] The surgical instruments described herein may be coupled to a proximal control system that monitors and controls the linkages or discs in wrist assembly for articulating end effector 110 and the jaws relative to shaft 105 and for translating drive member 130 distally and proximally to deliver clips to the jaws. In addition, the control system may monitor and control the longitudinal location of drive member 130 relative to each of the clips within cartridge 120. In particular, the control system may monitor the location of the distal engagement elements of the drive member along cartridge 120 to determine when the drive member should be translated distally or proximally.
[0313] For example, the control system may monitor and control drive memberInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT such that these engagement elements are translated proximally until they are located over the openings in the upper and lower cartridge housing associated with the first distal-most clip in the cartridge. The control system may then monitor and control drive member 130 such that the engagement elements are translated distally until the distal -most clip is located in the desired location within jaws 402, 404. The control system may monitor and control proximal withdrawal of the drive member 130 after the clip has been latched and secured to tissue and / or a vessel to prevent in advertent disengagement of the drive member and the clip prior to that occurrence. The control system may also monitor and control movement of the drive member to a location on the cartridge associated with the most distal clip remaining in the cartridge.
[0314] This control system may be a manual control system with user interfaces that allow the user to control each of the functions of the instrument, or it may be an automatic control system that monitors and controls these 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 within certain ranges or parameters.
[0315] In certain embodiments, the instrument may include sensors (not shown) for detecting a location of the engagement elements. The sensors may include any suitable sensors for detecting location, force and / or torque. In one embodiment, the sensors include fiber optic bend sensors, such as Fiber Bragg Gratings (FBG) for providing strain measurements in the jaws, the 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 on Jul. 13, 2005, and U. S. Pat. No. 6,389,187, filed on Jun. 17,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 1998, the completed disclosures of which are incorporated herein by reference for all purposes.
[0316] The control system may include one or more processors (e.g., microprocessor, microchip, or application-specific integrated circuit), one or more memory devices (e.g., random-access memory and / or read-only memory), and I / O interface and / or a communication interface. The processors may 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 with the prescribed range. The I / O devices can include one or more devices that enable the user to interact with the system (e.g., a user interface). The I / O devices can include, for example, a touchscreen display, a keypad, one or more selectors, one or more indicators.
[0317] Although described as a processor, it is to be appreciated that the controllers may be implemented in practice by any combination of hardware, software and firmware. Also, their functions as described herein may be performed by one unit, or divided up among different components, each of which may be implemented in turn by any combination of hardware, software and firmware.
[0318] With reference to Fig. 44, an exemplary embodiment of a teleoperated surgical instrument 500 that may support a previously described instrument is depicted. As shown, the instrument 500 generally includes a proximal housing 510 at its proximal end and coupled to shaft 520 of the instrument. Proximal housing 510 may include an instrument memory or storage device (not shown). The memory can perform a number of functions when the instrument is loaded on a manipulator arm (not shown) of a robotic control system. For example, the memory can provide a signal verifying that the instrument is compatible with that particular surgical system. Additionally, the memory may identifyInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the instrument and end effector type (whether it is a scalpel, a needle grasper, j aws, scissors, a clip applier, an electrocautery blade, or the like) to the surgical system so that the system can reconfigure its programming to take full advantage of the instrument's specialized capabilities. As further discussed below, the memory may include specifics on the architecture of the instrument, and include particular values that should be employed in control algorithms, such as tool compliance and gain values.
[0319] Proximal housing 510 also may include a force / torque drive transmission mechanism (not shown) for receiving output from the motors of the manipulator arm. The force / torque drive transmission mechanism transmits the output from the motors to an end effector 530 of the instrument through an instrument shaft 520 mounted to the transmission mechanism. Exemplary surgical robotic instruments, instrument / manipulator arm interface structures, and data transfer between the instruments and servomechanism is more fully described in U. S. Pat. No. 6,331,181, the full disclosure of which is incorporated herein by reference.
[0320] FIG. 47 illustrates a flow chart of a process 800 that may be carried out by a control system, such as a robotic control system (such as the one shown in FIGS. 45 and 46 and described below) that is coupled to a proximal housing or backend mechanism 510 of the surgical instrument. The robotic control system includes at least one processor that relays input commands from master controllers operated by the user to the first and second actuation systems within backend 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 devices
[0321] In one embodiment, the backend mechanism includes a first drive system for controlling articulation of the end effector relative to the shaft and a second drive systemInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT for controlling longitudinal translation of the drive member through the shaft to advance clips into the jaws and retract the drive member after the clips have been coupled to the jaws and / or closed and sealed onto a vessel. The backend mechanism may include a third drive system for opening and closing the jaws and / or a fourth drive or control system for monitoring and controlling the longitudinal location of the drive member (i.e., the clip advancer) within the instrument shaft.
[0322] In one embodiment of process 800, the control system may be operated to actuate the first drive system in the backend mechanism 510 to articulate the end effector, e.g., to straighten a bent wrist such that the end effector is substantially parallel to the shaft (see step 802). Once the wrist has been straightened, the control system may be operated to actuate the second drive system in the backend mechanism to advance the drive member distally to advance a first or distal-most clip into the jaws of the instrument (see step 804). In some embodiments, the jaws are opened prior to advancing the clip into the jaws. In other embodiments, the jaws may be closed or partially open. Once the clip has been coupled to the jaws (step 806), the control system may be operated to actuate the second drive system to retract the drive member proximally from the jaws so that it aligns with a second (or the next distal-most) clip in the clip cartridge (see step 808). In some embodiments, the clips will be advanced together such that the second clip is advanced to the position previously occupied by the first clip as the first clip is advanced into the jaws. In these embodiments, the drive member will be retracted to the same position relative to the instrument or clip cartridge to engage the second clip as the first clip. In other embodiments, the drive member may be retracted more proximally to engage the second clip (if the second clip was not advanced distally in the same operation as the first clip). In these embodiments, the control system may include sensors, controllers or otherInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT mechanisms for determining the location of the clip advancer to ensure that it is retracted to a position corresponding with the second clip in the cartridge (as discussed previously). It should be noted that any of the above-described drive systems may be independent of each other, or they may be combined with each other such that, for example, one drive system drives two functionalities, such as, for example rotation of the end effector and clamping of the jaws.
[0323] The control system may then be operated to actuate the first drive system to articulate the end effector to rotate the jaws relative to the shaft in order to, for example, position the jaws around a targeted vessel or tissue (step 810). The control system may then be operated to actuate the third drive system to close the jaws such that the clip is closed, latched and sealed around the target vessel or tissue (step 812).
[0324] Of course, it will be recognized that that the drive member and clips may be advanced (and the drive member retracted) through the wrist to the end effector while the wrist is bent (i.e., while 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 member to remain positioned in the wrist and the jaws during articulation of the end effector. Thus, in certain embodiments, the control system may be operated to first articulate the end effector such that the jaws are positioned around the target tissue or vessel and then advance the drive member and the first clip into the jaws.
[0325] As noted above, the present surgical instruments may be employed in a robotic teleoperated surgical system, illustrates, as an example, a top view of an operating room employing a robotic surgical system. The robotic surgical system in this case is a robotic surgical system 600 including a Console (“C”) utilized by a Surgeon (“S”) whileInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT performing a minimally invasive diagnostic or surgical procedure, usually with assistance from one or more Assistants (“A”), on a Patient (“P”) who is lying down on an Operating table (“O”).
[0326] The servomechanism used for telesurgery will often accept input from two master controllers (one for each of the surgeon's hands) and may include two or more robotic arms. A surgical instrument is mounted on each of the robotic arms. Operative communication between master controllers and associated robotic arm 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 arm and instrument assemblies and back in the case of, for example, force feedback or the like. One example of a robotic surgical system is the DA VINCI™ system commercialized by Intuitive Surgical, Inc. of Sunnyvale, California.
[0327] A variety of structural arrangements have been used to support the surgical instrument at the surgical site during robotic surgery. The driven linkage or "slave" is often called a robotic surgical manipulator, and exemplary linkage arrangements for use as a robotic surgical manipulator during minimally invasive robotic surgery are described in U. S. Pat. Nos. 7,594,912, 6,758,843, 6,246,200, and 5,800,423, the full disclosures of which are incorporated herein by reference in their entirety for all purposes. These linkages often manipulate an instrument holder to which an instrument having a shaft is mounted. Such a manipulator structure can include a parallelogram linkage portion that generates motion of the instrument holder that is limited to rotation about a pitch axis that intersects a remote center of manipulation located along the length of the instrument shaft. Such a manipulator structure can also include a yaw joint that generates motion of the instrument holder that is limited to rotation about a yaw axis that is perpendicular to the pitch axis andInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT that also intersects the remote center of manipulation. By aligning the remote center of manipulation with the incision point to the internal surgical site (for example, with a trocar or cannula at an abdominal wall during laparoscopic surgery), an end effector of the surgical instrument can be positioned safely by moving the proximal end of the shaft using the manipulator linkage without imposing potentially hazardous forces against the abdominal wall. Alternative manipulator structures are described, for example, in U. S. Pat. Nos. 6,702,805, 6,676,669, 5,855,583, 5,808,665, 5,445,166, and 5,184,601, the full disclosures of which are incorporated herein by reference in their entirety for all purposes.
[0328] During the surgical procedure, the telesurgical system can provide mechanical actuation and control of a variety of surgical instruments or tools having end effectors that perform various functions for the surgeon, for example, holding or driving a needle, grasping a blood vessel, dissecting tissue, or the like, in response to manipulation of the master input devices. Manipulation and control of these end effectors is a particularly beneficial aspect of robotic surgical systems. For this reason, it is desirable to provide surgical tools that include mechanisms that provide two or three degrees of rotational movement of an end effector to mimic the natural action of a surgeon's wrist. Such mechanisms should be appropriately sized for use in a minimally invasive procedure and relatively simple in design to reduce possible points of failure. In addition, such mechanisms should provide an adequate range of motion to allow the end effector to be manipulated in a wide variety of positions.
[0329] The Console includes a monitor 604 for displaying an image of a surgical site to the Surgeon, left and right manipulatable control devices 608 and 609, a foot pedal 605, and a processor 602. The control devices 608 and 609 may include any one or more of a variety of input devices such as joysticks, gloves, trigger-guns, hand-operatedInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT controllers, or the like. The processor 602 may be a dedicated computer that may be integrated into the Console or positioned next to it.
[0330] The Surgeon performs a 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 respectively 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 views the surgical site in 3-D on the Console monitor 604 as it is captured by a stereoscopic endoscope 640.
[0331] Each of the tools 638 and 639, as well as the endoscope 640, may be inserted through a cannula or other tool guide (not shown) into the Patient so as to extend down to the surgical site through a corresponding minimally invasive incision such as incision 666. Each of the robotic arms is conventionally formed of links, such as link 662, which are coupled together and manipulated through motor controlled or active joints, such as joint 663.
[0332] The number of surgical tools used at one time and consequently, the number of robotic arms being used in the system 600 will generally depend on the diagnostic or surgical procedure and the space constraints within the operating room, among other factors. If it is necessary to change one or more of the tools being used during a procedure, the Assistant may remove the tool no longer being used from its robotic arm, and replace it with another tool 331 from a Tray (“T”) in the operating room.
[0333] The monitor 604 may be positioned near 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 onto the operating site. To that end, images of the tools 638 and 639International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT may appear to be located substantially where the Surgeon's hands are located.
[0334] The processor 602 performs various functions in the system 600. One function that it performs is to translate and transfer the mechanical motion of control devices 608 and 609 to their respective robotic arms 628 and 629 through control signals overbus 610 so that the Surgeon can effectively manipulate their respective tools 638 and 639. Another important function is to implement various control system processes as described herein.
[0335] Robotic surgery systems and methods are further described in U. S. Pat. No.5,797,900, filed on May 16, 1997, issued on Aug. 25, 1998, U. S. Pat. No. 6,132,368, filed on Nov. 21, 1997, issued on Oct. 17, 2000, U. S. Pat. No. 6,331,181, filed on Oct. 15, 1999, issued on Dec. 18, 2001, U. S. Pat. No. 6,441,577, filed on Apr. 3, 2001, issued on Aug. 27, 2002, U. S. Pat. No. 6,902,560, filed on Jan. 6, 2004, issued on Jun. 7, 2005, U. S. Pat. No.6,936,042, filed on Apr. 16, 2002, issued on Aug. 30, 2005, and U. S. Pat. No. 6,994,703, filed on Dec. 4, 2002, issued on Feb. 7, 2006, the full disclosures of which are incorporated herein by reference for ail purposes. A suitable robotic surgical system currently in use is the da Vinci S Surgical System by Intuitive Surgical, Inc.
[0336] FIG. 46 illustrates, as an example, a side view of a simplified (not necessarily in proportion or complete) 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. The surgical instrument 750 is removably held in tool holder 740. The arm assembly 700 is mechanically supported by a base 701, which may be part of a patient-side movable cart or affixed to the operating table or ceiling. It includes links 702 and 703 which are coupled together and to the base 701 through setupInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT joints 704 and 705.
[0337] The setup joints 704 and 705 in this example are passive joints that allow manual positioning of the arm 700 when their brakes are released. For example, setup joint 704 allows link 702 to be manually rotated about axis 706, and setup joint 705 allows link 703 to be manually rotated about axis 707.
[0338] Although only two links and two setup joints are shown in this example, more or less of each may be used as appropriate in this and other robotic arm assemblies described herein. For example, although setup joints 704 and 705 are useful for horizontal positioning of the arm 700, additional setup joints may be included and useful for limited vertical and angular positioning of the arm 700. For major vertical positioning of the arm 700, however, the arm 700 may also be slidably moved along the vertical axis of the base 701 and locked in position.
[0339] The robotic arm assembly 700 also includes three active joints driven by motors. A yaw joint 710 allows arm section 730 to rotate around an axis 761, and a pitch joint 720 allows arm section 730 to rotate about an axis perpendicular to that of axis 761and orthogonal to the plane of the drawing. The arm section 730 is configured so that sections 731 and 732 are always parallel to each other as the pitch joint 720 is rotated by its motor. As a consequence, the instrument 770 may be controllably moved by driving the yaw and pitch motors so as to pivot about the pivot point 762, which is generally located through manual positioning of the setup joints 704 and 705 so as to be at the point of incision into the patient. In addition, an insertion gear 745 may be coupled to a linear drive mechanism (not shown) to extend or retract the instrument 750 along its axis 763.
[0340] Although each of the yaw, pitch and insertion joints or gears, 710, 720 and 745, is controlled by an individual joint or gear controller, the three controllers areInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT controlled by a common master / slave control system so that the robotic arm assembly 700 (also referred to herein as a “slave manipulator”) may be controlled through user (e.g., surgeon) manipulation of its associated master manipulator.
[0341] While several embodiments have been shown in the drawings, it is not intended that the description be limited thereto, as it is intended that the description be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of presently disclosed embodiments. Thus, the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.
[0342] Further, this description's terminology is not intended to limit the devices described herein. The term “force” is to be construed as encompassing both force and torque, unless otherwise indicated herein or clearly contradicted by context. The terms “tools” and “instruments” are used interchangeably herein to refer to the surgical instruments. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. The terms “comprising,” “having,” “including,” and “containing” 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 wholly contained within, attached to, or joined together, even if there is something intervening.
[0343] Spatially relative terms — such as “proximal” and “distal — may 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 positionsInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT (i.e., locations) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, the terms “proximal” and “distal” are relative terms, where the term “distal” refers to the portion of the object furthest from an 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. The term “proximal” indicates the relative proximity to the operator of the surgical instrument and refers to the portion of the object closest to the operator and furthest from the surgical site. In this application, an end effector refers to a tool installed at the distal end of an instrument, including but not limited to forceps or graspers, needle drivers, scalpels, scissors, spatulas, blades, and other tools, which may or may not use energy to cauterize tissue (i.e., a monopolar or bipolar tool).
[0344] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Various alternatives and modifications can be devised by those skilled in the art without departing from the description. Accordingly, the present description is intended to embrace all such alternatives, modifications and variances. As well, one skilled in the art will appreciate further features and advantages of the present description based on the above-described embodiments. Accordingly, the present description is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
[0345] For example, in a first aspect, a first embodiment is a surgical instrument for applying surgical clips to tissue comprising an elongate shaft, an end effector coupled to the shaft and comprising first and second opposing jaws and a drive member comprisingInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT at least a first distal arm having first and second projections extending laterally towards each other and configured for removably coupling to a distal portion of a surgical clip disposed within the shaft. The drive member is configured for distal translation from the shaft into the end effector to deliver the clip to the first and second opposing jaws.
[0346] A second embodiment is the first embodiment, wherein the drive member comprises a second distal arm having first and second projections extending laterally towards each other and configured for removably coupling to a distal portion of the surgical clip.
[0347] A third embodiment is any combination of the above embodiments, wherein the first and second projections have first and second opposing inner ends, respectively.
[0348] A fourth embodiment is any combination of the above embodiments, wherein the opposing inner ends define a space therebetween.
[0349] A fifth embodiment is any combination of the above embodiments, wherein the distal arms of the drive member each comprise a frame comprising first and second support members and the first and second projections extend transversely towards each other relative to the first and second support members.
[0350] A 6thembodiment is any combination of the above embodiments, wherein the first and second projections extend in a direction substantially perpendicular to the first and second support members.
[0351] A 7thembodiment is any combination of the above embodiments, wherein the first and second projections each taper inwardly from a first end adjacent the first and second support members to a second end laterally spaced from the first and second support members such that the second end has a smaller cross-sectional area than the first end.
[0352] An 8thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the first and second support members of the first arm have a first length and the first and second support members of the second arm have a second length, wherein the first length is longer than the second length.
[0353] A 9thembodiment is any combination of the above embodiments, wherein each frame comprises a lateral support member coupling the first support member to the second support member and disposed proximal of the first and second projections.
[0354] A 10thembodiment is any combination of the above embodiments, wherein the first and second support members each comprise a proximal component and a distal component, wherein the distal component extends at an angle relative to the proximal component.
[0355] An 11thembodiment is any combination of the above embodiments, wherein the distal components of the support members of the first arm extend towards the distal components of support members of the second arm.
[0356] A 12thembodiment is any combination of the above embodiments, further comprising the surgical clip.
[0357] 13thembodiment is any combination of the above embodiments, wherein the surgical clip comprises first and second arms pivotally coupled to each other about a proximal hinge, wherein the first and second arms of the clip each comprise an engagement member for removably coupling to the first and second projections of the first and second distal arms of the drive member.
[0358] A 14thembodiment is any combination of the above embodiments, wherein each of the engagement members comprises an opening in the first and second arms and the projections are configured to extend at least partially into opposing sides of the opening.
[0359] A 15thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT each of the engagement members comprise first and second opposing recessed surfaces in the first and second arms and the projections are configured to extend at least partially into the first and second recessed surfaces.
[0360] A 16thembodiment is any combination of the above embodiments, wherein the first and second arms of the clip each comprise a tapered surface proximal of the opening and the first and second projections of the distal arms of the drive member are configured to contact the tapered surface as the drive member translates distally relative to the clip.
[0361] A 17thembodiment is any combination of the above embodiments, wherein at least one of the first and second jaws is movable between an open position and a closed position relative to the other of the first and second jaws, wherein the first and second distal arms of the drive member are configured to move with the jaws between the open and closed positions.
[0362] An 18thembodiment is any combination of the above embodiments, wherein each of the first and second jaws comprises a disengagement feature such that proximal withdrawal of the drive member releases the projections of the drive member from the engagement members of the clip.
[0363] A 19thembodiment is any combination of the above embodiments, wherein the disengagement feature comprises an elongate element extending along an inside surface of each of the first and second jaws, wherein the elongate element comprises a distal end portion extending laterally towards the other jaw member.
[0364] An 20thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the distal end portion extends into a guide path within the jaws such that the arms of the drive member contact the distal end portion as the drive member is translated distally to a distal end of the jaws.
[0365] A 21stembodiment is any combination of the above embodiments, wherein the surgical clip comprises first and second projections extending from an external surface of the first and second arms of the clip, the first and second projections being configured to contact the disengagement feature on each of the first and second jaws when the drive member is translated proximally.
[0366] A 22ndembodiment is any combination of the above embodiments, wherein the disengagement feature of each of the first and second jaws are configured to apply a sufficient force to the first and second projections to retain the surgical clip within the first and second jaws as the first and second projections disengage from the opening in each of the first and second arms.
[0367] A 23rdembodiment is any combination of the above embodiments, wherein the frame of the first arm defines a first internal opening and the frame of the second arm defines a second internal opening, wherein the first internal opening has a larger cross-sectional area than the second internal opening.
[0368] A 24thembodiment is any combination of the above embodiments, wherein the frame of the first arm has a first length and the frame of the second arm has a second length, wherein the first length is greater than the second length such that the frames of the first and second arms do not contact the disengagement features of the first and second jaws as the drive member is withdrawn proximally relative to the first and second jaws.
[0369] A 25thembodiment is any combination of the above embodiments,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT further comprising a clip cartridge within the shaft and comprising: a housing with upper and lower walls extending substantially in a longitudinal direction relative to the shaft of the instrument; first and second surgical clips disposed within an interior of the housing between the upper and lower walls; first and second retainer tabs on the cartridge and configured to retain the first and second clips within the cartridge, wherein the retainer tabs are pivotally coupled to the housing and movable into an open position to release the first and second clips upon distal movement of the drive member; and upper and lower ramps extending away from the upper and lower walls.
[0370] A 26thembodiment is any combination of the above embodiments, wherein each frame of the distal arms of the drive member is sized to cam along an outer surface of the first and second retainer tabs and the upper and lower ramps as the drive member is withdrawn proximally relative to the clip cartridge.
[0371] A 27thembodiment is any combination of the above embodiments, wherein each frame of the distal arms has a first width in a direction substantially perpendicular to the longitudinal direction and the outer surface of the retainer tabs have a second width in said longitudinal direction, wherein the first width is less than the second width.
[0372] A 28thembodiment is any combination of the above embodiments, wherein the upper and lower ramps have a third width in said longitudinal direction, wherein the first width is less than the third width.
[0373] A 29thembodiment is a surgical instrument for applying surgical clips to tissue comprising an elongate shaft, an end effector coupled to the shaft and comprising first and second opposing jaws and a drive member comprising at least a first distal arm comprising first and second support members and at least one projection extending fromInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT one of the support members into a space between the support members. The projection is configured for removably coupling to a distal portion of a clip disposed within the shaft, wherein the drive member is configured for distal translation from the shaft into the end effector to deliver the clip to the first and second opposing jaws.
[0374] A 30thembodiment is the 29thembodiment and any combination of the above embodiments.
[0375] A 31stembodiment is any combination of the above embodiments, wherein the drive member comprises a second distal arm comprising first and second support members and at least one projection extending from one of the support members into a space between the support members.
[0376] A 32ndembodiment is any combination of the above embodiments, wherein each of the first and second distal arms comprises first and second projections extending towards each other into the space between the first and second support members.
[0377] A 33rdembodiment is any combination of the above embodiments, wherein the clip comprises first and second arms pivotally coupled to each other about a proximal hinge, wherein the first and second arms of the clip each comprise an engagement member for removably coupling to the first and second projections of the first and second distal arms of the drive member.
[0378] A 34thembodiment is any combination of the above embodiments, wherein the first and second distal arms each comprise a frame comprising the first and second support members and at least one lateral support member coupling the first support member to the second support member.
[0379] A 35thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the drive member comprises first and second flexible components coupled to the first and second distal arms and disposed proximal to the distal arms.
[0380] A 36thembodiment is any combination of the above embodiments, wherein each frame comprises a first lateral support member coupled to the flexible component, a second lateral support member spaced distally from the first lateral support member and an opening between the first and second lateral support members.
[0381] A 37thembodiment is any combination of the above embodiments, wherein the opening in the first distal arm has a larger cross-sectional area than the opening in the second distal arm.
[0382] A 38thembodiment is any combination of the above embodiments, wherein the first and second projections extend towards each other at a transverse angle relative to the first and second lateral support members.
[0383] A 39thembodiment is any combination of the above embodiments, wherein the first and second projections are substantially linear.
[0384] A 40thembodiment is any combination of the above embodiments, wherein the first and second projections each comprise a distal non-linear portion.
[0385] A 41stembodiment is any combination of the above embodiments, wherein at least one of the first and second jaws is movable between an open position and a closed position relative to the other of the first and second jaws, wherein the first and second distal arms of the drive member are configured to move with the jaws between the open and closed positions.
[0386] A 42ndembodiment is any combination of the above embodiments, wherein proximal withdrawal of the drive member releases the distal arms of the drive member from the engagement members of the clip.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT
[0387] A 43rd embodiment is any combination of the above embodiments, wherein each of the first and second jaws comprises a disengagement feature such that proximal withdrawal of the drive member releases the projections of the drive member from the engagement members of the surgical clip.
[0388] A 44th embodiment is any combination of the above embodiments, wherein the disengagement feature comprises an elongate element extending along an inside surface of each of the first and second jaws, wherein the elongate element comprises a distal end portion extending inwards towards the other jaw member.
[0389] A 45thembodiment is any combination of the above embodiments, wherein the surgical clip comprises first and second projections extending from an external surface of the first and second arms of the clip, the first and second projections being configured to contact the disengagement feature on each of the first and second jaws when the drive member is translated proximally.
[0390] A 46thembodiment is any combination of the above embodiments, wherein the disengagement feature of each of the first and second jaws are configured to apply a sufficient force to the first and second projections to retain the surgical clip within the first and second jaws as the first and second projections disengage from the opening in each of the first and second arms.
[0391] A 47thembodiment is any combination of the above embodiments, further comprising a wrist member pivotally coupling the end effector with the elongate shaft, wherein at least a portion of the drive member is movable through the wrist member between the shaft and the end effector.
[0392] A 48thembodiment is any combination of the above embodiments,International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT wherein the drive member comprises a distal portion configured for removably engaging the surgical clip and a flexible portion that extends through the wrist member when the distal portion is within the end effector.
[0393] A 49thembodiment is any combination of the above embodiments, wherein the drive member further comprises a proximal portion extending through the shaft, wherein the flexible portion allows the distal portion to articulate relative to the proximal portion when the end effector articulates about the wrist member.
[0394] A 50th embodiment is a surgical instrument for applying surgical clips to tissue comprising an elongate shaft, an end effector rotatably coupled to the shaft around an axis substantially perpendicular to the shaft and including first and second opposing jaws and a drive member configured for distal translation from the shaft into the end effector. The drive member comprises first and second distal arms with first and second asymmetric engagement elements for removably coupling to a distal portion of first and second arms of a surgical clip
[0395] A 51stembodiment is the 50thembodiment and any combination of the above embodiments.
[0396] A 52ndembodiment is any combination of the above embodiments, wherein the first and second engagement elements each comprise a frame having first and second support members and at least one lateral support member extending between the first and second support members.
[0397] A 53rdembodiment is any combination of the above embodiments, wherein the first and second support members of the second engagement element are longer than the first and second support members of the first engagement element.
[0398] A 54thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the frame of the second engagement element is non-planar and has a distal portion extending towards the first engagement element.
[0399] A 55thembodiment is any combination of the above embodiments, wherein the frame of the first engagement element is non-planar and has a distal portion extending towards the second engagement element.
[0400] A 56thembodiment is any combination of the above embodiments, wherein the drive member comprises a proximal component, a distal component configured for removably engaging a clip and a flexible component that extends between the proximal and distal components. The proximal component is oriented at an angle relative to the distal component.
[0401] A 57thembodiment is any combination of the above embodiments, wherein the distal component the first and second asymmetric engagement elements and the flexible component comprises the first and second distal arms, wherein the proximal component is oriented at a substantially perpendicular angle relative to the first and second first and second asymmetric engagement elements, and second elongate members coupling the distal arms to the proximal component.
[0402] A 58thembodiment is any combination of the above embodiments, wherein the first and second arms each have a proximal portion oriented substantially parallel to the proximal component and a distal portion oriented substantially parallel to the distal arms
[0403] A 59thembodiment is any combination of the above embodiments, wherein the first and second arms each comprise a twist between the proximal and distal components of the drive member.
[0404] A 60thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the twist is located proximal of a midpoint between the proximal and distal components of the drive member.
[0405] A 61stembodiment is any combination of the above embodiments, wherein the twist is located distal of a midpoint between the proximal and distal components of the drive member.
[0406] A 62ndembodiment is any combination of the above embodiments, wherein the proximal component of the drive member comprises a first material and the distal and flexible components of the drive member comprise a second material, wherein the first material has a greater stiffness than the second material.
[0407] A 63rdembodiment is surgical clip comprising a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions. The first and second arms each comprise a distal end portion spaced from the hinge and an engagement member on the distal end portion configured for removably coupling to a drive member of a surgical instrument, wherein the engagement member comprises an opening in each of the first and second arms.
[0408] A 64thembodiment is the 63rdembodiment and any combination of the above embodiments.
[0409] A 66thembodiment is any combination of the above embodiments, wherein the opening comprises a through-hole extending each of through the first and second arms of the clip.
[0410] A 67thembodiment is any combination of the above embodiments, wherein the opening comprises a recessed surface in the each of the first and second arms of the clip.
[0411] A 68thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the first and second arms of the clip each comprise a tapered surface for aligning portions of the first and second arms with the openings.
[0412] A 69thembodiment is any combination of the above embodiments, wherein the tapered surface is proximal of the opening.
[0413] A 70thembodiment is any combination of the above embodiments, wherein each of the first and second arms comprises first and second tapered surfaces extending on opposing surfaces of each of the first and second arms.
[0414] A 71stembodiment is any combination of the above embodiments, wherein the engagement members of the first and second arms are configured to remain coupled to the drive member in the open and closed positions.
[0415] A 72ndembodiment is any combination of the above embodiments, wherein the first and second arms further comprise first and second fastening elements for securing the first and second arms in the closed position, wherein the drive member is removable from the engagement members of the first and second ends when the first and second ends are in the closed position.
[0416] A 73rdembodiment is any combination of the above embodiments, wherein proximal withdrawal of the drive member releases the drive member from the engagement members of the clip when the clip is in the closed position.
[0417] A 74thembodiment is any combination of the above embodiments, wherein at least one of the first and second arms comprises an inner surface facing the other of the first and second arms with one or more gripping elements on the inner surface.
[0418] A 75thembodiment is any combination of the above embodiments, wherein the clip comprises a polymer material.
[0419] A 76thembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the clip has a maximum lateral width of less than about 2.0 mm.
[0420] A 77thembodiment is any combination of the above embodiments, wherein the maximum lateral width is less than about 1.5 mm.
[0421] A 78thembodiment is a surgical clip comprising a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions. The first arm comprises an inner surface opposing the second arm and first and second rows of gripping elements projecting from the inner surface, wherein the first row of gripping elements is offset from the second row of gripping elements.
[0422] A 79thembodiment is the 78thembodiment and any combination of the above embodiments.
[0423] An 80thembodiment is any combination of the above embodiments, wherein the second arm comprises an inner surface opposing the first arm and first and second rows of gripping elements projecting from the inner surface, wherein the first row of gripping elements is offset from the second row of gripping elements.
[0424] An 81stembodiment is any combination of the above embodiments, wherein the gripping elements of the first and second arms are spaced from each other in the closed position.
[0425] An 82ndembodiment is any combination of the above embodiments, whereinthe gripping elements have a ramped surface that tapers such that an inner end of the gripping elements is spaced further away from the inner surface of the arms than an outer end of the gripping elements.
[0426] An 83rdembodiment is any combination of the above embodiments, whereinInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT the inner end of the gripping elements is longer than the outer end of the gripping elements.
[0427] An 84thembodiment is any combination of the above embodiments, wherein the inner surface of the first arm defines a centerline and wherein the first row of gripping surfaces is disposed on a first side of the centerline and the second row of gripping surfaces is disposed on a second side of the centerline opposite the first side.
[0428] An 85thembodiment is any combination of the above embodiments, wherein the inner end of the gripping surfaces in each of the first and second rows of gripping surfaces is spaced outwardly from the centerline.
[0429] An 86thembodiment is any combination of the above embodiments, wherein the projections of the first arm interlock with the projections of the second arm.
[0430] An 87thembodiment is any combination of the above embodiments, wherein the gripping elements comprise interlocking teeth.
[0431] An 88thembodiment is any combination of the above embodiments, wherein the clip comprises a polymer material.
Claims
International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT CLAIMS1. A surgical instrument for applying surgical clips to tissue, the instrument comprising:an elongate shaft;an end effector coupled to the shaft and comprising first and second opposing jaws; anda drive member comprising at least a first distal arm having first and second projections extending towards each other and configured for removably coupling to a distal portion of a surgical clip disposed within the shaft, wherein the drive member is configured for distal translation from the shaft into the end effector to deliver the surgical clip to the first and second opposing jaws.
2. The surgical instrument of claim 1, wherein the drive member comprises a second distal arm having first and second projections extending laterally towards each other and configured for removably coupling to a distal portion of the surgical clip.
3. The surgical instrument of any one of claims 1 to 2, wherein the first and second projections of the first and second distal arms have first and second opposing inner ends, respectively.
4. The surgical instrument of claim 3, wherein the opposing inner ends define a space therebetweenInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 5. The surgical instrument of any one of claims 2 to 4, wherein the distal arms of the drive member each comprise a frame comprising first and second support members and the first and second projections extend transversely towards each other between the first and second support members.
6. The surgical instrument of claim 5, wherein the first and second projections extend in a direction substantially perpendicular to the first and second support members.
7. The surgical instrument of any one of claims 5 to 6, wherein the first and second projections each taper inwardly from a first end adjacent the first and second support members to a second end laterally spaced from the first and second support members such that the second end has a smaller cross-sectional area than the first end.
8. The surgical instrument of any one of claims 5 to 7, wherein the first and second support members of the first arm have a first length and the first and second support members of the second arm have a second length, wherein the first length is longer than the second length.
9. The surgical instrument of any one of claims 5 to 8, wherein each frame comprises a lateral support member coupling the first support member to the second support member and disposed proximal of the first and second projections.
10. The surgical instrument of any one of claims 5 to 9, wherein the first and second support members each comprise a proximal component and a distal component, wherein the distal component extends at an angle relative to the proximal component.- Ill -International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 11. The surgical instrument of claim 10, wherein the distal components of the support members of the first arm extend towards the distal components of support members of the second arm.
12. The surgical instrument of claim 2, further comprising the surgical clip.
13. The surgical instrument of claim 12, wherein the surgical clip comprises first and second arms pivotally coupled to each other about a proximal hinge, wherein the first and second arms of the surgical clip each comprise an engagement member for removably coupling to the first and second projections of the first and second distal arms of the drive member.
14. The surgical instrument of claim 13, wherein each of the engagement members comprises an opening in the first and second arms and the projections are configured to extend at least partially into opposing sides of the opening.
15. The surgical instrument of claim 13, wherein each of the engagement members comprise first and second opposing recessed surfaces in the first and second arms and the projections are configured to extend at least partially into the first and second recessed surfaces.
16. The surgical instrument of any one of claims 12 to 15, wherein the first and second arms of the surgical clip each comprise a tapered surface proximal of the opening and theInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT first and second projections of the distal arms of the drive member are configured to contact the tapered surface as the drive member translates distally relative to the surgical clip.
17. The surgical instrument of any one of claims 2 to 16, wherein at least one of the first and second jaws is movable between an open position and a closed position relative to the other of the first and second jaws, wherein the first and second distal arms of the drive member are configured to move with the jaws between the open and closed positions on the condition that the first and second arms are disposed within the first and second jaws.
18. The surgical instrument of claim 17, wherein each of the first and second jaws comprises a disengagement feature such that proximal withdrawal of the drive member releases the projections of the drive member from the engagement members of the surgical clip.
19. The surgical instrument of claim 18, wherein the disengagement feature comprises an elongate element extending along an inside surface of each of the first and second jaws, wherein the elongate element comprises a distal end portion extending inwards towards the other jaw member.
20. The surgical instrument of claim 17, wherein the distal end portion extends into a guide path within the jaws such that the arms of the drive member contact the distal end portion as the drive member is translated distally to a distal end of the jaws.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 21. The surgical instrument of claim 19 wherein the surgical clip comprises first and second projections extending from an external surface of the first and second arms of the clip, the first and second projections being configured to contact the disengagement feature on each of the first and second jaws on the condition that the drive member is translated proximally.
22. The surgical instrument of claim 20, wherein the disengagement feature of each of the first and second jaws is configured to apply a sufficient force to the first and second projections to retain the surgical clip within the first and second jaws as the first and second projections disengage from the opening in each of the first and second arms.
23. The surgical instrument of any one of claims 19 to 22, wherein the frame of the first arm defines a first internal opening and the frame of the second arm defines a second internal opening, wherein the first internal opening has a larger cross-sectional area than the second internal opening.
24. The surgical instrument of any one of claims 19 to 22, wherein the frame of the first arm has a first length and the frame of the second arm has a second length, wherein the first length is greater than the second length such that the frames of the first and second arms do not contact the disengagement features of the first and second jaws as the drive member is withdrawn proximally relative to the first and second jaws.
25. The surgical instrument of claim 23, wherein the internal opening of the frame of the first arm and the internal opening of the frame of the second arm each have a width and a length, wherein the disengagement feature of each of the first and second jaws has a widthInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT and a length, wherein the width of each internal opening is less than the width of each disengagement feature.
26. The surgical instrument of any one of claims 23 to 25, further comprising a clip cartridge within the shaft and comprising:a housing with upper and lower walls extending substantially in a longitudinal direction relative to the shaft of the instrument;first and second surgical clips disposed within an interior of the housing between the upper and lower walls;first and second retainer tabs on the cartridge and configured to retain the first and second clips within the cartridge, wherein the retainer tabs are pivotally coupled to the housing and movable into an open position to release the first and second clips upon distal movement of the drive member; andupper and lower ramps extending away from the upper and lower walls.
27. The surgical instrument of claim 26, wherein each frame of the distal arms of the drive member is sized to cam along an outer surface of the first and second retainer tabs and the upper and lower ramps as the drive member is withdrawn proximally relative to the clip cartridge.
28. The surgical instrument of claim 27, wherein each frame of the distal arms has a first width in a direction substantially perpendicular to the longitudinal direction and the outer surface of the retainer tabs have a second width in said longitudinal direction, wherein the first width is less than the second width.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 29. The surgical instrument of claim 28, wherein the upper and lower ramps have a third width in said longitudinal direction, wherein the first width is less than the third width.
30. The surgical instrument of claim 27, wherein the internal opening of the frame of the first arm and the internal opening of the frame of the second arm each have a width and a length, and the first and second retainer tabs on the cartridge have a width and a length, wherein the width of each internal opening is less than the width of the first and second retainer tabs.
31. A surgical instrument for applying surgical clips to tissue, the instrument comprising:an elongate shaft;an end effector coupled to the shaft and comprising first and second opposing jaws; anda drive member comprising at least a first distal arm comprising first and second support members spaced from each other and at least one projection extending from one of the support members into a space between the support members, the projection being configured for removably coupling to a distal portion of a clip disposed within the shaft, wherein the drive member is configured for distal translation from the shaft into the end effector to deliver the clip to the first and second opposing jaws.
32. The surgical instrument of claim 31, wherein the drive member comprises a secondInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT distal arm comprising first and second support members spaced from each other and at least one projection extending from one of the support members into a space between the support members.
33. The surgical instrument of claim 32, wherein each of the first and second distal arms comprises first and second projections extending towards each other into the space between the first and second support members.
34. The surgical instrument of claim 33, further comprising the surgical clip.
35. The surgical instrument of claim 34, wherein the clip comprises first and second arms pivotally coupled to each other about a proximal hinge, wherein the first and second arms of the clip each comprise an engagement member for removably coupling to the first and second projections of the first and second distal arms of the drive member.
36. The surgical instrument of any one of claims 32 to 35, wherein the first and second distal arms each comprise a frame comprising the first and second support members and at least one lateral support member coupling the first support member to the second support member.
37. The surgical instrument of any one of claims 32 of 36, wherein the drive member comprises first and second flexible components coupled to the first and second distal arms and disposed proximal to the distal arms.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 38. The surgical instrument of claim 37, wherein each frame comprises a first lateral support member coupled to the flexible component, a second lateral support member spaced distally from the first lateral support member and an opening between the first and second lateral support members.
39. The surgical instrument of claim 38, wherein the opening in the first distal arm has a larger cross-sectional area than the opening in the second distal arm.
40. The surgical instrument of claim 39, wherein the first and second projections extend towards each other at a transverse angle relative to the first and second lateral support members.
41. The surgical instrument of any one of claims 38 to 40, wherein the first and second projections are substantially linear.
42. The surgical instrument of any one of claims 38 to 40, wherein the first and second projections each comprise a distal non-linear portion.
43. The surgical instrument of any one of claims 31 to 42, wherein at least one of the first and second jaws is movable between an open position and a closed position relative to the other of the first and second jaws, wherein the first and second distal arms of the drive member are configured to move with the jaws between the open and closed positions on the condition that the first and second arms are disposed within the first and second jaws.
44. The surgical instrument of claim 43, wherein each of the first and secondInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT jaws comprises a disengagement feature such that proximal withdrawal of the drive member releases the projections of the drive member from the engagement members of the surgical clip.
45. The surgical instrument of claim 44, wherein the disengagement feature comprises an elongate element extending along an inside surface of each of the first and second jaws, wherein the elongate element comprises a distal end portion extending inwards towards the other jaw member.
46. The surgical instrument of claim 45, wherein the surgical clip comprises first and second projections extending from an external surface of the first and second arms of the clip, the first and second projections being configured to contact the disengagement feature on each of the first and second jaws on the condition that the drive member is translated proximally.
47. The surgical instrument of claim 46, wherein the disengagement feature of each of the first and second jaws are configured to apply a sufficient force to the first and second projections to retain the surgical clip within the first and second jaws as the first and second projections disengage from the opening in each of the first and second arms.
48. The surgical instrument of any one of claims 31 to 47, further comprising a wrist member pivotally coupling the end effector with the elongate shaft, wherein at least a portion of the drive member is movable through the wrist member between the shaft and the end effector.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 49. The surgical instrument of claim 48, wherein the drive member comprises a distal portion configured for removably engaging the surgical clip and a flexible portion that extends through the wrist member on the condition that the distal portion is within the end effector.
50. The instrument of claim 49, wherein the drive member further comprises a proximal portion extending through the shaft, wherein the flexible portion allows the distal portion to articulate relative to the proximal portion on the condition that the end effector articulates about the wrist member.
51. A surgical instrument for applying surgical clips to tissue, the instrument comprising:an elongate shaft;an end effector rotatably coupled to the shaft around an axis substantially perpendicular to the shaft and including first and second opposing jaws; anda drive member configured for distal translation from the shaft into the end effector, the drive member comprising first and second distal arms with first and second asymmetric engagement elements for removably coupling to a distal portion of first and second arms of a surgical clip, wherein the drive member is configured for distal translation from the shaft into the end effector to deliver the surgical clip to the first and second opposing jaws.
52. The surgical instrument of claim 51, wherein the first and second engagement elements each comprise a frame having first and second support members and at least one lateral support member extending between the first and second support members.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT53. The surgical instrument of claim 52, wherein the first and second support members of the second engagement element are longer than the first and second support members of the first engagement element.
54. The surgical instrument of any one of claims 52 to 53, wherein the frame of the second engagement element is non-planar and has a distal portion extending towards the first engagement element.
55. The surgical instrument of any one of claims 52 to 54, wherein the frame of the first engagement element is non-planar and has a distal portion extending towards the second engagement element.
56. The surgical instrument of any one of claims 51 to 55, wherein the drive member comprises a proximal component, a distal component configured for removably engaging the surgical clip and a flexible component that extends between the proximal and distal components, wherein the proximal component is oriented at an angle relative to the distal component.
57. The surgical instrument of claim 56, wherein the distal component comprises the first and second asymmetric engagement elements and the flexible component comprises the first and second distal arms, wherein proximal component is oriented at a substantially perpendicular angle relative to the first and second first and second asymmetric engagement elements.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT58. The surgical instrument of claim 57, wherein the first and second distal arms each have a proximal portion oriented substantially parallel to the proximal component and a distal portion oriented substantially parallel to the first and second asymmetric engagement elements.
59. The surgical instrument of claim 58, wherein the first and second distal arms each comprise a twist between the proximal and distal components of the drive member.
60. The surgical instrument of claim 59, wherein the twist is located proximal of a midpoint between the proximal and distal components of the drive member.
61. The surgical instrument of claim 59, wherein the twist is located distal of a midpoint between the proximal and distal components of the drive member.
62. The surgical instrument of any one of claims 56 to 61, wherein the proximal component of the drive member comprises a first material and the distal and flexible components of the drive member comprise a second material, wherein the first material has a greater stiffness than the second material.
63. A surgical clip comprising:a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions; andInternational Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT wherein the first and second arms each comprise a distal end portion spaced from the hinge and an engagement member on the distal end portion configured for removably coupling to a drive member of a surgical instrument, wherein the engagement member comprises an opening extending through at least a portion of each of the first and second arms.
64. The surgical clip of claim 63, wherein the opening comprises a through-hole extending through each of the first and second arms.
65. The surgical clip of claim 63, wherein the opening comprises a recessed surface in each of the first and second arms.
66. The surgical clip of any one of claims 64 to 65, wherein the first and second arms of the clip each comprise a tapered surface for aligning the drive member with each opening.
67. The surgical clip of claim 66, wherein the tapered surface is proximal of the openings.
68. The surgical clip of claim 67, wherein the first and second arms each comprise first and second tapered surfaces extending on opposing sides of each of the first and second arms.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 69. The surgical clip of any one of claims 63 to 68, wherein the first and second arms further comprise first and second fastening elements for securing the first and second arms to each other in the closed position.
70. The surgical clip of any one of claims 63 to 69, wherein proximal withdrawal of the drive member releases the drive member from the opening of the clip on the condition that the clip is in the closed position.
71. The surgical clip of any one of claims 63 to 70, wherein at least one of the first and second arms comprises an inner surface facing the other of the first and second arms with one or more gripping elements on the inner surface.
72. The surgical clip of any one of claims 63 to 71, wherein the clip comprises a polymer material.
73. The surgical clip of claim 72, wherein the clip has a maximum lateral width of less than about 2.0 mm.
74. The surgical clip of claim 73, wherein the maximum lateral width is less than about 1.5 mm.
75. A surgical clip comprising:a main body having first and second arms pivotally coupled to each other about a hinge between open and closed positions;International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT wherein the first arm comprises an inner surface opposing the second arm and first and second rows of gripping elements projecting from the inner surface, wherein the first row of gripping elements is offset from the second row of gripping elements.
76. The surgical clip of claim 75, wherein the second arm comprises an inner surface opposing the first arm and first and second rows of gripping elements projecting from the inner surface, wherein the first row of gripping elements is offset from the second row of gripping elements.
77. The surgical clip of claim 76, wherein the gripping elements of the first and second arms are spaced from each other in the closed position.
78. The surgical clip of any one of claims 76 to 77, wherein the gripping elements have a ramped surface that tapers such that an inner end of the gripping elements is spaced further away from the inner surface of the arms than an outer end of the gripping elements.
79. The surgical clip of claim 78, wherein the inner end of the gripping elements is longer than the outer end of the gripping elements.
80. The surgical clip of any one of claims 76 to 79, wherein the inner surface of the first arm defines a centerline and wherein the first row of gripping surfaces is disposed on a first side of the centerline and the second row of gripping surfaces is disposed on a second side of the centerline opposite the first side.International Application Client Ref.: P06707-W03 Farber Ref.: IS 060-3-PCT 81. The surgical clip of claim 80, wherein the inner end of the gripping surfaces in each of the first and second rows of gripping surfaces is spaced outwardly from the centerline.
82. The surgical clip of any one of claims 75 to 81, wherein the projections of the first arm interlock with the projections of the second arm.
83. The surgical clip of any one of claims 75 to 82, wherein the gripping elements comprise interlocking teeth.
84. The surgical clip of any one of claims 75 to 83, wherein the clip comprises a polymer material.