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WO2025198972A1 - Control devices for robotic surgery systems - Google Patents

Control devices for robotic surgery systems

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Publication number
WO2025198972A1
WO2025198972A1PCT/US2025/020075US2025020075WWO2025198972A1WO 2025198972 A1WO2025198972 A1WO 2025198972A1US 2025020075 WUS2025020075 WUS 2025020075WWO 2025198972 A1WO2025198972 A1WO 2025198972A1
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WIPO (PCT)
Prior art keywords
instrument
control input
shaft
movement
input device
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PCT/US2025/020075
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French (fr)
Inventor
Kristopher Yee
Michael Turner
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Intuitive Surgical Operations Inc
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Intuitive Surgical Operations Inc
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Publication date
Application filed by Intuitive Surgical Operations IncfiledCriticalIntuitive Surgical Operations Inc
Publication of WO2025198972A1publicationCriticalpatent/WO2025198972A1/en
Pendinglegal-statusCriticalCurrent
Anticipated expirationlegal-statusCritical

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Abstract

Systems, devices and methods are provided for controlling surgical instruments remotely, such as in a robotic surgery system. One such robotic surgical system comprises a robotic arm configured for coupling to the surgical instrument and a primary input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument. The system further comprises a secondary control input comprising an adaptor and a handle. The adaptor is configured for removable coupling to the input device such that movement of the handle of the secondary control input causes movement of the input device to provide the desired movement of the robotic arm. The secondary control input substantially resembles the surgical instrument being controlled, allowing the user to quickly understand how to manipulate the controls and move the instrument as they expect it to move.

Description

CONTROL DEVICES FOR ROBOTIC SURGERY SYSTEMS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application Serial Nos. 63/566,478 and 63/566,479, both filed on March 18, 2024, the complete disclosures of which are incorporated herein by reference for all purposes.
TECHNICAL FIELD
[0002] This description generally relates to remotely controlled surgery systems and input devices for such systems and more particularly to input devices designed to correspond to, or substantially resemble, the surgical instruments controlled by such devices.
BACKGROUND
[0003] 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 a 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.
[0004] 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.
[0005] 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 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, 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.
[0006] 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.
[0007] 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. It would be further desirable to provide improved robotic systems that generally correspond to, or resemble, the individual surgical instruments being controlled to allow the user to easily and intuitively operate a variety of different surgical instruments used during a procedure. SUMMARY
[0008] 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.
[0009] In one aspect, a robotic surgical system for use with a surgical instrument comprises a robotic arm configured for coupling to the surgical instrument and a primary input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument. The further comprises a secondary control input comprising an adaptor and a handle, wherein the adaptor is configured for removable coupling to the input device such that movement of the handle of the control input causes movement of the input device to provide the desired movement of the robotic arm. A controller is configured to control the robotic arm based on the movement of the input device.
[0010] In various embodiments, the secondary control input substantially resembles the surgical instrument being controlled and may include user interfaces that provide varying degrees of freedom that generally match the degrees of freedom of the surgical instrument. This allows the user to quickly understand how to manipulate the controls and move the instrument as they expect it to move.
[0011] In various embodiments, the primary input device comprises a first electrical connection coupling the input device to the controller. The adaptor of the secondary control input comprises a second electrical connection configured for removable coupling to the first electrical connection. The secondary control input comprises at least one user interface coupled to the second electrical connection such that movement of the user interface generates an electrical signal transmitted from the second electrical connection through the first electrical connection to the controller. This allows the surgeon to control a surgical instrument with either the primary or the secondary controls and to easily and intuitively operate a variety of different surgical instruments used during a procedure.
[0012] In various embodiments, the primary input device comprises a first end and a second end. The system further comprises a monitor for providing a view of a surgical site within the patient and an endoscope coupled to the monitor and having a distal viewing end facing a first direction for providing the view of the surgical site on the monitor.
[0013] In one such embodiment, the secondary control input is removably coupled to the first end of the input device. The surgical instrument has a distal end facing a second direction and the second direction is between about 0 degrees to about 90 degrees relative to the first direction. This allows the surgeon to, for example, operate an instrument that is generally aligned with the view provided by the endoscope on the monitor.
[0014] In another embodiment, the control input is removably coupled to the second end of the input device. The surgical instrument has a distal end facing a second direction and the second direction is between about 90 degrees to about 270 degrees relative to the first direction and wherein the control input is removably coupled to the second end of the input device. The secondary control input allows the user to, for example, operate an instrument that is introduced opposed to the surgical view (i.e., the controls become flipped 180 degrees to control an instrument inverted relative to the endoscope).
[0015] In various embodiments, the system further comprises a second control input removably coupled to the first end of the primary input device such that movement of the first control input in a first direction causes movement of the instrument in the first direction and movement of the second control input in a second direction causes movement of the instrument in the second direction. Providing first and second control inputs that are “inverted” relative to each other allows the surgeon to choose either control and operate the instrument based on his/her expectations, i.e., how they perceive the surgical view and their available controls. Some users perceive the instruments as if they are standing behind the instrument. Some users perceive the instruments as if they are manipulating them within the endoscope’s field of view.
[0016] In various embodiments, the surgical instrument is a first instrument having a distal end facing away from the view on the monitor. The system further comprising a second instrument having a distal end facing towards the view on the monitor. The first control input is configured to control the first instrument and the second control input is configured to control the second instrument. This allows the user to easily and rapidly switch between the primary input device and the removable secondary control input to control instruments based on their orientation in the patient relative to the view provided by the endoscope.
[0017] In various embodiment, the secondary control unit comprises a handle configured for grasping by the user. In one such embodiment, the handle comprises a substantially cylindrical shape. In another embodiment, the handle comprises a shaft with an end effector. In yet another embodiment, the handle comprises a shaft and first and second arms extending laterally away from the shaft and pivotally coupled to the shaft. By simply feeling the shape of the handle with the user’s hands, the control input focuses the user’s perception of the controls and disambiguates the controls, allowing the user to quickly understand how to manipulate the controls and move the instrument as they expect it to move. This eliminates the confusion of an ambiguous/universal control input. This also eliminates differences between populations of users that prefer “regular” versus “inverted” controls, by making their reference for motion more specific.
[0018] In various embodiments, the system further comprising a second surgical instrument which may have a distal end facing substantially in the first direction (i.e., the direction of the endoscope). Movement of the primary input device provides a desired movement of the second surgical instrument.
[0019] In an exemplary embodiment, the surgical instrument comprises a circular stapling instrument comprising a staple assembly and an anvil removably coupled to the staple assembly. The circular stapling instrument may be introduced opposed to the surgical view provided by the endoscope on the monitor. For example, in a lower anterior bowl resection, the endoscope is introduced inferiorly while the circular stapler is inserted superiorly. Movement of the secondary control input may cause movement of the staple assembly and/or the anvil. Since the secondary control input is “inverted” relative to the primary input device, movement of the secondary control input will result in a corresponding movement of the circular stapler (as viewed by the surgeon on the monitor).
[0020] In another aspect, a robotic surgical system for use with a surgical instrument comprises a robotic arm configured for coupling to the surgical instrument and a primary input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument. The system further comprises a secondary control input comprising an adaptor and a handle. The adaptor is configured for removable coupling to the input device. The secondary control input further comprises a user input configured such that movement of the user input causes the desired movement of the robotic arm. The system includes a controller configured to control the robotic arm based on the movement of the user interface.
[0021] In various embodiments, the primary input device comprises a first electrical connection coupling the input device to the controller. The adaptor of the secondary control input comprises a second electrical connection configured for removable coupling to the first electrical connection. The secondary control input comprises at least one user interface coupled to the second electrical connection such that movement of the user interface generates an electrical signal transmitted from the second electrical connection through the first electrical connection to the controller. This allows the surgeon to control a surgical instrument with either the primary or secondary controls. The secondary control input may be used as a “regular” or an “inverted” control device for a surgical instrument.
[0022] In one embodiment, the input device comprises a shaft and the adaptor of the secondary control input comprises a tube having an internal channel with a diameter greater than a diameter of the shaft of the input device. The handle comprises a gripping member extending transversely to the shaft of the input device. In an exemplary embodiment, the gripping member extends substantially in a vertical direction relative to the user and the user input comprises a button disposed on an upper surface of the gripping member. The handle is designed for gripping by a user’s hand and may be moved up/down, left/right or forwards/backwards in order to transmit suitable signals to the controller for similar movements by the instrument.
[0023] In an exemplary embodiment, the user input is disposed on the gripping member. The secondary control device may comprise a second user input on the gripping member. In an exemplary embodiment, the second user input is a switch disposed on the upper surface of the gripping member. For example, if the instrument is a circular stapling instrument, the button may cause actuation of the drive mechanism that deploys the staples and/or the knife against the anvil. In addition, or alternatively, the secondary control device may comprise a slide that is moved forwards or backwards (relative to the user) by the user’s thumb to provide additional controls to the instrument.
[0024] In another embodiment, the secondary control input is particularly useful for controlling a needle delivery instrument having a needle that extends from a shaft, such as a biopsy needle or the like. In this embodiment, the secondary control input comprises a handle and an adaptor configured for coupling to the handle to the primary control input. The secondary control input may be used as a “regular” or an “inverted” control device for a surgical instrument. The adaptor may include electrical connections that are removably attached to electrical connections in the primary control device to provide the control input signals to processor via the electrical connections. [0025] In an exemplary embodiment, the handle of the secondary control input is pivotally coupled to the adaptor at a joint. The handle comprises a finger slider that is slidably disposed within a channel or track in the handle to control the longitudinal movement of the needle relative to the instrument shaft. The secondary control device may further include a linear encoder or potentiometer within the track to provide positional sensing of the input from the control input with respect to the position of the needle or the instrument within the patient’s body. The finger slider is extremely intuitive to the user as the motion of moving the slider forward, for example, is the same motion as the needle moving forward relative to the shaft of the instrument.
[0026] In another embodiment, the secondary control input is particularly useful for controlling a needle driver or holder, such as one that comprises a shaft having an end effector with a needle holder extending therefrom. The needle holder may comprise, for example, a pair of jaws that open and close relative to each other to hold a needle that may be used, for example, for suturing tissue.
[0027] In this embodiment, the secondary control input comprises a handle and an adaptor configured for coupling the handle to either end of the primary control device. Thus, the secondary control input may be used as a “regular” or an “inverted” control device for a surgical instrument. The handle is configured such that the user may place it into the palm of their hand (as opposed to just their fingers in the finger loops). Thus, the handle comprises a pair of arms coupled to the adaptor by a universal joint. The arms may be squeezed together, and they may be rotated relative to the adaptor. The universal joint and the circular track between the secondary control input and the primary input device allows for roll and sweeping motion that is performed to rotate the needle through tissue. This allows the user to rely on non-robotic muscle memory, thereby decreases the learning curve and decreases the mental load on the user. Because this interface utilizes larger muscle groups (such as the palm) as opposed to just the fingers to conduct the suturing, it induces lower fatigue to the user over the length of the procedure.
[0028] In another embodiment, the secondary control input is particularly useful for controlling an instrument with multiple functions, such as a bipolar clamping instrument comprising first and second jaws for clamping tissue, one or more electrodes for coagulation or sealing of tissue and a cutting element or knife for severing tissue. In some embodiments, the clamping may further include a fluid line to provide integrated suction and/or saline delivery.
[0029] In this embodiment, the secondary control input comprises a handle and an adaptor configured for coupling the handle to either end of the primary control device. Thus, the secondary control input may be used as a “regular” or an “inverted” control device for a surgical instrument. The handle comprises a shape that enables the user to easily grasp the handle with the palm of their hand, while freeing their fingers and thumbs to manipulate various control inputs on the handle. The handle may be pivotally coupled to the adaptor at a joint to allow relative movement of the handle to be translated to movement of the end effector relative to the shaft.
[0030] In an exemplary embodiment, the handle comprises a first control input at the base of handle, a second control input on the side of handle and one or more additional control inputs on the inside surface of the handle. All these control inputs may be easily manipulated by the user’s fingers or thumb while grasping the handle with the palm of the hand. The control inputs may provide multiple functionalities to the instrument, such as opening and closing the jaws to seal tissue, driving the knife to cut tissue, providing electrical energy to coagulate and seal tissue (e.g., cautery) and providing suction and/or saline delivery to the surgical site.
[0031] In another embodiment, the secondary control input particularly useful for controlling an instrument with multiple functions, such as instruments designed to deliver an anchor, such as a tacker, staple, clip or the like into tissue. The secondary control input comprises a handle and an adaptor configured for coupling the handle to either end of the primary control device. Thus, the secondary control input may be used as a “regular” or an “inverted” control device for a surgical instrument. The handle comprises a pistol grip shape and is pivotally coupled to the adaptor at a universal joint to articulate the end effector relative to the shaft of the instrument. The pistol grip shape enables the user to easily grasp the handle with the palm of their hand, while freeing their fingers and thumbs to manipulate various control inputs on handle 964. For example, the handle may include a first control input, such as a trigger, and second and third control inputs, such as buttons, for providing multiple functionalities to the instrument, such as delivering a tissue anchor and providing suction and/or saline delivery to the surgical site.
[0032] 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
[0033] 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:
[0034] FIG. 1 illustrates a top view of an operating room employing a robotic surgical system; and
[0035] FIG. 2A illustrates a simplified side view of a robotic arm assembly.
[0036] FIG. 2B illustrates an input device for the robotic surgical system;
[0037] FIG. 3 illustrates the orientation of a surgical instrument that is generally in line with a surgical view provided by an endoscope;
[0038] FIG. 4 illustrates the orientation of a surgical instrument that is substantially opposite or inverted relative to a surgical view provided by an endoscope;
[0039] FIG. 5 illustrates an input device with an unergonomic wrist position used to operate the instrument of FIG. 4;
[0040] FIGS. 6 and 7 illustrate lateral movement of the input device of FIG. 4 with a manipulated coordinate system;
[0041] FIGS. 8 and 9 illustrate longitudinal movement of two instruments with the input device of FIG. 4 with a manipulated coordinate system;
[0042] FIG. 10 illustrates lateral movement of two instruments with the input device of FIG. 4 with a manipulated coordinate system.
[0043] FIG. 11 illustrates one embodiment of a removable control input for use with the input device of FIG. 4;
[0044] FIG. 12 illustrates another embodiment of a control input;
[0045] FIGS. 13 illustrates operation of the control input of FIG. 11 as an additional control input;
[0046] FIG. 14 illustrates another embodiment of a removable control input;
[0047] FIG. 15A illustrates a representative circular stapling device;
[0048] FIG. 15B illustrates a representative circular stapling device with a proximal housing configured for remote control;
[0049] FIG. 16 illustrates a control input for a stapling assembly of the circular stapling device of FIG. 15 A;
[0050] FIGS. 17 illustrates another embodiment of a control input;
[0051] FIG. 18A is a perspective view of a biopsy needle;
[0052] FIG. 18B is a perspective view of a control input for the biopsy needle of
FIG. 18 A; [0053] FIG. 19A is a perspective view of a needle driver or holder;
[0054] FIG. 19B is a perspective view of a control input for the needle holder of
FIG. 19 A;
[0055] FIG. 20A is a perspective view of a bipolar jaw instrument;
[0056] FIG. 20B is a perspective view of a control input for the bipolar jaw instrument of FIG. 20 A;
[0057] FIG. 21A is a perspective view of an instrument with an end effector configured for delivering a tissue anchor;
[0058] FIG. 21B is a perspective view of a control input for the instrument of FIG. 21A;
[0059] FIG. 22 is a partial cross-sectional view of a staple assembly for the circular stapler of FIG. 15 A;
[0060] FIG. 23 is an exploded view of an end effector of the circular stapler;
[0061] FIG. 24A is an enlarged view of a staple pusher;
[0062] FIG. 24B is an end view of a housing for the staple assembly;
[0063] FIG. 25 illustrates the end effector of the circular stapler in an initial position;
[0064] FIG. 26 illustrates the end effector with a plurality of staples engaging an anvil;
[0065] FIG. 27 illustrates the end effector with a knife deploying past the distal end of the channel to cut tissue;
[0066] FIGS. 28A-28D illustrate the operation of an alternative embodiment of a circular stapler;
[0067] FIGS. 29A-29D illustrate the operation of an alternative embodiment of a circular stapler;
[0068] FIGS. 30A-30C illustrate the operation of an alternative embodiment of a circular stapler;
[0069] FIG. 31 is a partial cross-sectional view of another alternative embodiment of a circular staple;
[0070] FIG. 32 illustrates the circular stapler of FIG. 31 deploying a plurality of staples;
[0071] FIG. 33 illustrates the circular stapler of FIG. 31 deploying the knife to cut tissue;
[0072] FIGS. 34A-34D schematically illustrate operation of the devices described herein for sealing and cutting intestinal tissue;
[0073] FIGS 35A-35C illustrate the operation of another alternative embodiment of a circular stapler;
[0074] FIGS. 36A-36C illustrate one embodiment of a collapsible anvil for a circular stapler;
[0075] FIG. 37 illustrates another embodiment of a collapsible anvil for a circular stapler;
[0076] FIGS. 38A-38C illustrate the deployment of an anvil head of the anvil of FIG. 37;
[0077] FIGS. 39A and 39B illustrates another embodiment of an anvil for a circular stapler;
[0078] FIG. 40A illustrates another embodiment of an anvil for a circular stapler in an expanded configuration;
[0079] FIG. 40B illustrates the anvil of FIG. 40A in an expanded configuration;
[0080] FIGS. 41 A and 41B illustrate another embodiment of a collapsible anvil for a circular stapler;
[0081] FIGS. 42A-42C illustrate deployment of the anvil of FIGS. 41A-41C.
[0082] FIGS. 43A and 43B illustrate another embodiment of a collapsible anvil for a circular stapler;
[0083] FIGS. 44A-44C illustrate another embodiment of a collapsible anvil for a circular stapler;
[0084] FIGS. 45 A and 45B illustrate another embodiment of a collapsible anvil for a circular stapler;
[0085] FIGS. 46A-46C illustrates deployment of the anvil of FIGS 45A and 45B;
[0086] FIG. 47 is a perspective view of the distal end portion of a delivery instrument for the anvil;
[0087] FIG. 48 illustrates the delivery instrument with closed jaws for advancing the anvil to a target region within a patient;
[0088] FIG. 49 illustrates the delivery instrument after expanding the anvil at the target region; [0089] FIG. 50 illustrates the delivery instrument manipulating a shaft of an anvil of a circular stapler; and
[0090] FIG. 51 illustrates the jaws of the delivery instrument grasping the anvil shaft.
DETAILED DESCRIPTION
[0091] 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 herein in virtually any appropriately detailed structure. Well-known functions or constructions are 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 oilier 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.
[0092] While the following is presented with respect to control systems and input devices for delivering and manipulating circular stapling instruments, it should be understood that certain features of the presently described surgical instruments may be readily adapted for use in control systems and control inputs for any type of surgical instrument, including but not limited to forceps, scissors, needle holders, cutting instruments, retractors, suturing devices, clip appliers, and clamping, cutting, ligating, dissecting, clipping, cauterizing, suturing and/or sealing instruments. The system and devices described herein, or certain components of the system and devices, may also be incorporated into a variety of different surgical instruments, such as those described in commonly assigned, co-pending U.S. Provisional Patent Application Nos. 63/499,396, 63/458,510, 63/499,786, 63/505,738, 63/505,742 and 63, 505,735; U.S. NonProvisional Patent Application Nos. 12/945,541, 16/205,128, 16/331,734, 16/339,704, 16/427,427, 16/678,405, 16/904,482, 17/081,088, 17/130,464 and 17/084,981; and International Patent Nos. PCT/US2017/056075, PCT/US2017/050760, PCT/US2019/107646, PCT/US2019/019501,
PCT/US2019/062344, PCT/US2020/54568, PCT/US2019/064861, PCT/US2019/062768,
PCT/2020/025655, PCT/US2020/056979, PCT/2019/066513, PCT/US2020/020672,
PCT/US2019/066530, PCT/US2020/033481, PCT/US2021/65544, PCT/US2021/65308the complete disclosures of which are incorporated by reference herein in their entirety for all purposes as if copied and pasted herein.
[0093] FIG. 1 illustrates, as an example, a top view of an operating room employing a representative robotic surgical system 100 including a Console (“C”) utilized by a Surgeon (“S”) while 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”).
[0094] 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.
[0095] 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 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, 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.
[0096] 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, clamping and stapling 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.
[0097] The Console includes a monitor 104 for displaying an image of a surgical site to the Surgeon, left and right manipulatable input devices 108 and 109, a foot pedal 105, and a processor 102. The input devices 108 and 109 may include any one or more of a variety of input devices such as those described below in FIGS. 11-21B. The processor 102 may be a dedicated computer that may be integrated into the Console or positioned next to it.
[0098] The Surgeon performs a minimally invasive surgical procedure by manipulating the input devices 108 and 109 (also referred to herein as “master manipulators”) so that the processor 102 causes their respectively associated robotic arm assemblies, 128 and 129, (also referred to herein as “slave manipulators”) to manipulate their respective removably coupled surgical instruments 138 and 139 (also referred to herein as “tools”) accordingly, while the Surgeon views the surgical site in 3-D on the Console monitor 104 as it is captured by a stereoscopic endoscope 140.
[0099] Each of the tools 138 and 139, as well as the endoscope 140, 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 166. Each of the robotic arms is conventionally formed of links, such as link 162, which are coupled together and manipulated through motor controlled or active joints, such as joint 163.
[00100] The number of surgical tools used at one time and consequently, the number of robotic arms being used in the system 100 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 131 from a Tray (“T”) in the operating room.
[00101] The monitor 104 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 138 and 139 may appear to be located substantially where the Surgeon's hands are located.
[00102] The processor 102 performs various functions in the system 100. One function that it performs is to translate and transfer the mechanical motion of control devices 108 and 109 to their respective robotic arms 128 and 129 through control signals overbus 110 so that the Surgeon can effectively manipulate their respective tools 138 and 139. Another important function is to implement various control system processes as described herein.
[00103] 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, US. 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 all purposes. A suitable robotic surgical system currently in use is the da Vinci S Surgical System by Intuitive Surgical, Inc.
[00104] FIG. 2 A illustrates, as an example, a side view of a simplified (not necessarily in proportion or complete) illustrative robotic arm assembly 200 (which is representative of robotic arm assemblies 128 and 129) holding a surgical instrument 250 (which is representative of tools 138 and 139) for performing a surgical procedure. The surgical instrument 250 is removably held in tool holder 240. The arm assembly 200 is mechanically supported by a base 201, which may be part of a patient-side movable cart or affixed to the operating table or ceiling. It includes links 202 and 203 which are coupled together and to the base 201 through setup joints 204 and 205.
[00105] The setup joints 204 and 205 in this example are passive joints that allow manual positioning of the arm 200 when their brakes are released. For example, setup joint 204 allows link 202 to be manually rotated about axis 206, and setup joint 205 allows link 203 to be manually rotated about axis 207.
[00106] 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 204 and 205 are useful for horizontal positioning of the arm 200, additional setup joints may be included and useful for limited vertical and angular positioning of the arm 200. For major vertical positioning of the arm 200, however, the arm 200 may also be slidably moved along the vertical axis of the base 201 and locked in position.
[00107] The robotic arm assembly 200 also includes three active joints driven by motors. A yaw joint 210 allows arm section 230 to rotate around an axis 261, and a pitch joint 220 allows arm section 230 to rotate about an axis perpendicular to that of axis 261and orthogonal to the plane of the drawing. The arm section 230 is configured so that sections 231 and 232 are always parallel to each other as the pitch joint 220 is rotated by its motor. As a consequence, the instrument 270 may be controllably moved by driving the yaw and pitch motors so as to pivot about the pivot point 262, which is generally located through manual positioning of the setup joints 204 and 205 so as to be at the point of incision into the patient. In addition, an insertion gear 245 may be coupled to a linear drive mechanism (not shown) to extend or retract the instrument 250 along its axis 263.
[00108] Although each of the yaw, pitch and insertion joints or gears, 210, 220 and 245, is controlled by an individual joint or gear controller, the three controllers are controlled by a common master/slave control system so that the robotic arm assembly 200 (also referred to herein as a “slave manipulator”) may be controlled through user (e.g., surgeon) manipulation of its associated master manipulator.
[00109] FIG. 2B illustrates a representative input device 108 for the robotic surgical system. It will be understood that the robotic surgical system may include one, or two or more such input devices. In an exemplary embodiment, the robotic surgical system may include two such input devices 108, 109; one for each of the surgeon’s hands, as shown in FIG. 1.
[00110] Input device 108 generally comprises a mounting assembly 190 for mounting a device control 180 to a connector 170 of the robotic surgical system. Device control 180 contains the necessary internal sensors and electronics to transmit movements of device control 180 through connector 170 to processor 102 (see FIG. 1). Mounting assembly 190 is designed to locate device control 180 in an ergonomic position for the surgeon to grip and manipulate device control 180 with his/her hand 330 while viewing monitor 104 (see FIG. 1). This ergonomic position generally provides device control 180 in a position such that the surgeon can grip and manipulate device control 180 with his/her hand 300 and view monitor 104 without substantially bending his/her wrist (i.e., the user’s hand faces the same direction as the user’s eyes).
[00111] In the representative embodiment, mounting assembly 190 comprises a housing 176 for receiving device control 180 such that device control 180 may be removably attached to mounting assembly 190. Housing 176 has a first end 177 facing the user and input 180 is mounted to first end. Housing 176 has a second end 179 facing away from the user that generally does not have an electrical connection for a control input.
[00112] Housing 176 is preferably coupled to connector 190 such that control input 190 has one or more degrees of freedom for movement such that surgeon can optimize the position of control input 190 during the procedure. In the representative embodiment, mounting assembly 190 comprises a longitudinal bar or rod 174 coupling housing 176 to a movement assembly 192 that, in turn, is pivotally coupled to connector 170. Mounting assembly 190 may, for example, allow the user to move device control 180, and housing 176 therewith, forwards, backwards, laterally, rotationally, upwards and/or downwards. Such movements are translated through connector 170 to processor 102 to cause robotic arm assembly 200 to provide similar movements to the instrument 250 (see FIG. 2).
[00113] Device control 180 comprises a shaft 182 that may be rotatably coupled to housing 176 and configured to rotate around the longitudinal axis of shaft 182 by the user’s hand 330. Rotation of shaft 182 may, for example, cause processor 102 to provide the necessary control input to cause robotic arm assembly 200 to rotate surgical instrument 250. Control input 190 further includes a pair of lateral arms 184, 185 that are configured to pivot inwards and outwards relative to shaft 182 by, for example, the user pinching arms 184, 185 together and/or allowing them to move apart (i.e., arms 184, 185 are generally biased laterally outward from shaft 182). This pinching movement may, for example, cause processor 202 to provide the necessary control input to cause robotic arm assembly 200 to move the end effector of surgical instrument 250, e.g., opening and closing jaws of the instrument 250. Control input 190 further includes a button 188 positioned on shaft 182. Button 188 represents a third control input that allows the user to manipulate a third movement of instrument 250, such as clamping jaws, advancing a cutting element and/or firing staples in a surgical stapling instrument.
[00114] In some embodiments, the system may include other device control inputs, such as foot pedals and the like, to provide additional control inputs to surgical instrument 250 and/or the endoscope used for the procedure. In some embodiments, the pedals are color designated, usually indicating a cautery action (blue) and cut action (yellow) for bipolar instruments. Sometimes these actions are instrument specific. For example, with a surgical stapler that performs a clamping step (blue), and then a fire step (yellow). The connotation for these colors is generally the same: blue is a lower risk or reversable action, while yellow indicates a high risk, non-reversable action.
[00115] Referring now to FIG. 3, processor 102 is generally configured for a surgical procedure wherein the instrument 302 that is controlled by input device 108 is generally aligned with the view 306 provided by the endoscope 300. In other words, the instrument 304 is positioned within the patient in the same general direction 308 as the view on monitor 250 from endoscope 300 and the user’s perception of the surgical space. Thus, as a surgeon rotates shaft 182 of device control 180 in a clockwise direction, instrument 304 also appears to rotate in a clockwise direction on monitor 250. Similarly, if the surgeon moves shaft 182 of device control 180 away from him/her, instrument 302 appears to move away from the surgeon on monitor 250. FIG. 3 illustrates this concept.
[00116] In some surgical procedures, however, instrument 302 is introduced opposed to the surgical view. For example, in a lower anterior bowl resection, endoscope 300 is introduced inferiorly while instrument 302 (e.g., a circular stapler) is inserted superiorly in the direction shown by arrow 310. FIG. 4 illustrates this concept.
[00117] These procedures pose a control challenge because the surgeon is attempting to control an instrument opposed to his/her view. Thus, the surgical controls used to control the instrument are flipped by 180 degrees. The user’s expectation is influenced by how they perceive the surgical view and their available controls. Some users perceive the instruments as if they are standing behind the instrument. Some users perceive the instruments as if they are manipulating them within the endoscope’s field of view. Overall, this potential confusion could lead to user frustration, inefficient workflow, and inadvertent tissue damage/patient harm. In other words, as a surgeon rotates shaft 182 of device control 180 in a clockwise direction, instrument 304 appears to rotate in a counterclockwise direction on monitor 250. Similarly, if the surgeon moves shaft 182 of device control 180 away from him/her, instrument 304 appears to move towards the surgeon on monitor 250. To compensate for this, the surgeon could choose to stand on the other side of control input 190 such that the movements of device control 180 are aligned with the movements of the instrument 302 on monitor 250 (see FIG. 5). Unfortunately, this hand 330 position is unergonomic and thus not optimal, particularly for a longer surgical procedure.
[00118] Another method of compensation for this would be to manipulate the coordinate system of the controls, such that the output is the opposite of the input (i.e., clockwise rotation of instrument 302 results in clockwise rotation of the instrument on the view of monitor 250). However, this manipulation can cause confusion to the surgeon. For example, it would be unclear if moving device control 180 to the left (arrow 312 in FIG. 6) causes an end effector 304 of instrument 302 to move “instrument-left” (screen right) as shown in FIG. 6 (arrow 314), or whether this motion would cause the end effector 306 to move screen left as shown in FIG. 7 (arrow 316). Similarly, it would be unclear whether motion of device control 180 away from the user causes the instrument to move forward or away from the user on the monitor 250.
[00119] This issue is compounded when multiple instruments are used, particularly when one instrument is aligned with the endoscope and the other instrument is opposed to the endoscope. For example, as shown in FIGS. 8 and 9, movement of input device 108 away from the user (arrow 344) would cause an instrument 340 that is aligned with the endoscope to move away from the user on the screen (arrow 342). However, it would be unclear to the user if this same motion would cause an instrument 302 that is opposed to the endoscope to move towards the user (arrow 346 in FIG. 9) or away from the user (in the direction of arrow 348 in FIG. 8).
[00120] Similar confusion could be caused by movement of the end effector to the right or the left. As shown in FIG. 10, movement of input device 108 to the left of the user (in the direction of arrow 350) causes an end effector 349 of an instrument 340 that is aligned with the endoscope to move left on the screen (in the direction of arrow 352). However, it would be unclear to the user if this same motion would cause an end effector 304 of an instrument 302 opposed to the endoscope to move left or right on the screen (arrows 354).
[00121] An additional problem that could arise is when the instrument is not directly in the field of view, such as when covered in tissue during a lower anterior resection (LAR). During an LAR, the circular stapler is inserted into the anus and completed encompassed by the rectum/colon, with only slight edges of the instrument revealing itself behind the bowel wall. The tissue obscures the instrument, not allowing the user to know the direction/orientation of the instrument distal end. This could also lead to inadvertent tissue damage/patient harm if such an instrument was being manipulated via robotically.
[00122] Referring now to FIG. 11, an additional or secondary control input 402 for input device 108 will now be described. As shown, secondary control input 402 comprises an adaptor 404 configured to removably couple to second end 179 of housing 176 of input device 108. As discussed earlier, second end 179 of housing 176 is on the opposite side of housing 176 from first end 177, wherein the first or primary control input 180 is typically mounted to an adaptor 400 (see FIG. 13). In some embodiments, secondary control input 402 may be mounted to input device 108 without any other device control input on first end 177, as shown in FIG. 11. In other embodiments, both secondary control input 402 and primary control input 180 may be mounted on both sides of input device 108 so that the user can choose to access either input device (see FIG. 13).
[00123] Adaptor 404 may comprise any suitable connection means that allows second control input 402 to be removably attached to second end 179 of housing. In an exemplary embodiment, adaptor 404 comprises a tube having a central channel (not shown) having a diameter sized to allow the tube to slide over second end 179 of housing. The tube of adaptor 404 may, for example, attach via a compression fit or the like, such that movement of second control input 402 causes movement of housing 176.
[00124] Second control input 402 comprises a shaft 406 that couples adaptor 404 to a proximal handle 408. Handle 408 may comprise any shape suitable for grasping by the user to manipulate control input 402 and housing 176 therewith. In the representative embodiment, handle 408 comprises a cylindrical shape having a larger diameter than shaft 406 to facilitate gripping the handle by a hand of the user. Movement of handle 408 to the left, right, up, down, forward or backwards moves input device 108 in the opposite direction, and causes processor 102 to provide the necessary control inputs to cause robotic arm assembly 200 to move surgical instrument 250. In some embodiments, rotation of handle 408 may, for example, rotate input device 108 and cause processor 102 to provide the necessary control input to cause robotic arm assembly 200 to rotate surgical instrument 250.
[00125] Control input 402 is located on the opposite side of input device 108 relative to the monitor such that, for example, movement of control input 402 to the right, causes second end 179 to move to the right and first end 177 to move to the left. This allows the user to, for example, easily and intuitively operate instruments that are introduced opposed to the surgical view (i.e., the controls become flipped 180 degrees). By simply feeling the shape of handle 408 with the user’s hands, control input 408 focuses the user’s perception of the controls and disambiguates the controls, allowing the user to quickly understand how to manipulate the controls and move the instrument as they expect it to move. This eliminates the confusion of an ambiguous/universal control input. This also eliminates differences between populations of users that prefer “regular” versus “inverted” controls, by making their reference for motion more specific.
[00126] In addition, by introducing to the users the shape of the instrument, it is no longer a question as to what and how they are to manipulate the instrument. The shape allows them to know exactly what direction the instrument is pointing, eliminating the risk when the instrument isn’t in the field of view. Since control input 408 is placed on the opposite side of control device 180, it does not get in the way of the native controls, allowing the user to simply swap between input devices to naturally put into place the controls required for each instrument (see FIG. 13).
[00127] In the embodiment shown above, secondary control input 402 is only mechanically attached to input device 108 such that the user physically moves input device 108 via control input 402 to cause processor 202 to make the corresponding movements of the instrument. In an alternative embodiment, adaptor 404 includes electrical connections that may be, for example, removably attached to electrical connections in housing 176. In this embodiment, control input 402 may be configured to directly provide the control input signals to processor via the electrical connections.
[00128] FIG. 12 illustrates an alternative embodiment of a secondary control input 410 having an adaptor 412 configured for attachment to the second or opposite end 179 of housing 176 of input device 108. Adaptor 412 may comprise any suitable connection means that allows control input 410 to be removably attached to second end 179 of housing 176. In an exemplary embodiment, adaptor 412 comprises a tube having a central channel (not shown) having a diameter sized to allow the tube to slide over second end 179 of housing 176. The tube of adaptor 412 may, for example, attach via a compression fit or the like, such that movement of control input 410 causes movement of housing 176.
[00129] In this embodiment, control input 410 includes a shaft 414 that couples adaptor 412 to an end effector 416. End effector 416 can comprise any suitable shape and preferably comprises a similar shape as the end effector of the instrument being controlled by the user with control input 410. In the representative embodiment, end effector 416 has a pair of jaws that open and close relative to each other. However, it should be understood that end effector 416 may also comprise a shape similar to forceps, scissors, a needle holder, a cutting instrument, a retractor, a suturing device, a clip applier, a clamp, a cautery device or the like.
[00130] FIG. 14 illustrates yet another embodiment of a control input 440 having an adaptor 442 configured to attachment to the second or opposite end 179 of housing 176 of input device 108. Adaptor 442 may comprise any suitable connection means that allows control input 440 to be removably attached to second end 179 of housing 176. In an exemplary embodiment, adaptor 442 comprises a tube having a central channel (not shown) having a diameter sized to allow the tube to slide over second end 179 of housing 176. The tube of adaptor 442 may, for example, attach via a compression fit or the like, such that movement of control input 440 causes movement of housing 176.
[00131] In this embodiment, control input 440 further includes electrical connections attached to electrical connections in housing 176, and has a similar shape to the control input shown in FIG. 2B except that it is designed for removable attachment to the second or opposite end 179 of housing 176. Namely, control input 440 has shaft 482 that is rotatably coupled to housing adaptor 442 and configured to rotate around the longitudinal axis of shaft 182 by the user’ s hand. Rotation of shaft 482 may, for example, cause processor 102 to provide the necessary control input to cause robotic arm assembly 200 to rotate surgical instrument 250. Control input 440 further includes a pair of lateral arms 484, 485 that are configured to pivot inwards and outwards relative to shaft 482 by, for example, the user pinching arms 484, 485 together. This pinching movement may, for example, cause processor 202 to provide the necessary control input to cause robotic arm assembly 200 to move the end effector of surgical instrument 250, e.g., opening and closing jaws of the instrument 250. Control input 190 further includes a button 488 positioned on shaft 482. Button 488 represents a third control input that allows the user to manipulate a third movement of instrument 250, such as clamping jaws, advancing a cutting element and/or firing staples in a surgical stapling instrument.
[00132] Fig. 15A illustrates a distal portion of a surgical circular stapling instrument 500 in accordance with an illustrative embodiment. Surgical instrument 500 includes an end effector 510, an elongated shaft 505 and, in some embodiments, a wrist assembly (not shown) coupling end effector 510 to shaft 505. End effector 510 generally comprises a circular stapling assembly 520, an anvil 530 and a capturing device (not shown) for advancing and retracting anvil 530 relative to stapling assembly 520. The anvil shaft 534 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. The capturing device (not shown) is configured to advance and withdraw through this internal channel to translate anvil 530 along a longitudinal axis relative to staple assembly 520 to approximate or un-approximate anvil 530 relative to staple assembly 520. The anvil head 530 includes a tissue contacting surface 536 defining staple forming pockets (not shown) for receiving staples deployed by staple assembly 520 [00133] Staple assembly 520 comprises a housing having a substantially cylindrical main body with an internal channel for receiving a cutting element assembly, a staple pusher and a staple cartridge (not shown). Stapling assembly 520 may be removably coupled to shaft 505, or permanently affixed thereto. In certain embodiments, stapling assembly 520 is a disposable component of instrument 520 and may be removably attached to shaft 505. In other embodiments, staple cartridge is a disposable component of instrument and may be removably coupled to staple assembly 520. In other embodiments, the entire instrument 520 is manufactured together and may be either a disposable or reusable instrument.
[00134] Any of the control input devices described herein may be used to control instrument 500. In particular, the inverted control input devices described in FIGS. 11-14 may be used because instrument 500 is typically inserted in the opposite direction as the endoscope. For example, when performing a lower colon procedure using instrument 500, the surgeon typically inserts anvil 532 of the circular stapler into the proximal end of the lumen, proximal of the staple line from the anus, while the endoscope is inserted through the esophagus and the GI tract. Thus, the view from the endoscope is inverted relative to the direction that instalment 500 faces as it is manipul ted by the surgeon.
[00135] With reference to FIG. 15B, an exemplary embodiment of a teleoperated surgical instrument 550 that may support the circular stapler instruments described herein will now be described. As shown, instrument 550 generally includes a proximal housing 561 at its proximal end and coupled to shaft 570 of the instrument and a circular stapling assembly 580 at the distal end of shaft 570. Circular stapling assembly 580 may comprise any known stapling assembly including the one described above in reference to FIG. 15 A.
[00136] Proximal housing 561 may include an instrument memory or storage device (not shown). The memory can perform a number of functions when the instruments are 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 identify the instrument and end effector type (whether it is a delivery instrument, circular stapler 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.
[00137] Proximal housing 561 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 580 of the instrument through an instrument shaft 570 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.
[00138] In certain embodiments, surgical instrument 550 may provide force/torque feedback to the user that can be used as a deployment diagnostic to optimize placement of the anvil or the stapling assembly at the target location. In one such embodiment, a plurality of force/torque sensors are disposed on the anvil and/or the staple assembly . The force/torque sensors are coupled to a controller located within housing 561 or remote from housing in a robotically teleoperated surgical system, such as the one described above.
[00139] In one embodiment, instrument 550 includes one or more force/torque sensors located on a component of an anvil delivery instrument. The sensors are configured to detect a force or torque applied to the anvil during deployment of the anvil into the expanded configuration. Alternatively, the sensors may detect the force or torque applied by the proximal actuator to the anvil delivery instrument. The controller is configured to receive this force/torque information from sensors and to provide user input on the amount of force applied to tissue during expansion of the anvil. In certain embodiments, the controller may include a processor that is configured to alert the user and/or automatically override the actuator within the instrument to stop the expansion of the anvil if, for example, the force exerted thereon exceeds a threshold amount.
[00140] In another such embodiment, instrument 550 includes one or more force/torque sensors located on the anvil itself. The sensors are configured to detect a force or torque applied to the anvil head as the instrument manipulates the anvil to the target site within the patient, or as the anvil head is moved into the expanded configuration. The controller is configured to receive this force/torque information from sensors and to provide user input on the amount of force applied to tissue during manipulation and/or expansion of the anvil. In certain embodiments, the controller may include a processor that is configured to alert the user and/or automatically to stop or alter the movement of the anvil if, for example, the force exerted thereon exceeds a threshold amount.
[00141] Alternatively, the processor in the controller may be configured to control the rate of expansion or collapse of the anvil by the user. For example, instrument 550 may include one or more sensors that provide velocity or rotational or longitudinal movement of the actuator that expands and contracts the anvil head. These sensors may transmit this information to controller and controller may be configured to ensure that the anvil is expanded or collapsed at a specified rate, and/or below a threshold rate. Alternatively, the controller may control the entire movement of the actuator such that, for example, the user simply engages with an ON/OFF type user interface (e.g., a button). Once the interface is engaged by the user, the controller takes over the operation of the actuator and ensures that anvil is expanded or collapsed at a specified rate.
[00142] The input couplers within housing 561 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 570. The input members are drivingly coupled with the end effector 580. 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, 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.
[00143] Referring now to FIGS. 22 and 23, in certain embodiments, stapling assembly 520 comprises a housing 550 having a substantially cylindrical main body 552 with an internal channel 554 for receiving a cutting element assembly 560, a staple pusher 570 and a staple cartridge 580. Housing 550 couples the stapling assembly 520 to shaft 505. In some embodiments, housing 550 may comprise an inclined surface 553 that tapers inwardly in the proximal direction to accommodate a stapling assembly 520 having a larger diameter than shaft 505.
[00144] Stapling assembly 520 may be removably coupled to shaft 505, or permanently affixed thereto. In certain embodiments, stapling assembly 520 is a disposable component of instrument 520 and may be removably attached to shaft 505. In other embodiments, staple cartridge 580 is a disposable component of instrument and may be removably coupled to staple assembly 520. In other embodiments, the entire instrument 520 is manufactured together and may be either a disposable or reusable instrument.
[00145] In an exemplary embodiment, housing 550 includes one or more keying features within channel 554 that inhibit or prevent rotation of stapler pusher 570 and cutting element assembly 560. In a preferred embodiment, the keying features comprise one or more projections 556 extending into channel 554 that cooperate with slots 572 in stapler pusher 570 (see FIGS. 24A and 24B). In one embodiment, cutting element assembly 560 also includes slots 561 aligned with slots 572 such that projections 556 extend through both sets of slots 561, 572 to inhibit or prevent rotation of stapler pusher 570 and cutting element assembly 560 relative to housing 550. Alternatively, housing 550 may further include additional projections (not shown) that extend into corresponding slots in cutting element assembly 560.
[00146] As shown in FIGS. 22 and 23, anvil 530 includes an anvil head 532 and an anvil shaft 534. Anvil shaft 534 is removably and slidably securable within internal channel 554 of housing 550. Capturing device 540 is configured to advance and withdraw through and internal bore 558 in housing 550 to translate anvil 530 along a longitudinal axis relative to staple assembly 520 to approximate or un-approximate anvil 530 relative to staple assembly 520. Anvil head 532 includes a tissue contacting surface 536 defining staple forming pockets (not shown) for receiving staples 2000, as discussed below in reference to FIGS. 25-27.
[00147] As shown in FIG. 24A, staple pusher 570 defines a substantially cylindrical shape and is coaxially and slidably disposed within internal channel 554 of housing 550. Staple pusher 570 includes a main body 574 and at least one annular array of distally extending fingers 576 extending from body 574. Each finger 576 is configured to be received within a slot of a staple cartridge 580 to engage staples 2000, as discussed above. Staple pusher 570 is configured to advance relative to housing 550 to engage, drive and eject staples 2000 against the staple forming pockets of anvil 530. As shown in FIG 22, fingers 576 of staple pusher 570 are preferably recessed proximally from the distal end of housing 550 to provide room for staple cartridge 580.
[00148] Staple cartridge 580 may include one, two or more than two annular arrays or rows of fingers with staple receiving slots (not shown) for receiving one or more sets of concentric staple arrays 2000 (see FIG. 23). Staple cartridge 580 is removably or permanently coupled to staple pusher 570 such that staple pusher 570 may drive staples 2000 from cartridge 580 into tissue (discussed in more detail below). In particular, distal fingers 576 of staple pusher 570 are configured to advance into the slots of cartridge 580 to drive staples 2000 distally.
[00149] In certain embodiments, staple cartridge 580 comprises an annular main body 582 with circumferential slots 584 that extend between the distal end of an array of distal fingers 576 on staple pusher 570 and the inner surface of housing 550. Slots 584 function to align staples 2000 with fingers 576 of staple pusher 570 such that distal movement of staple pusher 570 causes staples 2000 to move distally to engage and deform against tissue contacting surface 536 of anvil 530.
[00150] Referring to FIG. 23, cutting element assembly 560 generally comprises an annular pusher 564 and an annular cutting element or knife 566 at the distal end of pusher 564. Pusher 564 is configured to advance relative to housing 550 to drive knife 566 through tissue disposed between anvil 530 and stapling assembly 520.
[00151] Instrument 500 further includes a driver 590 for advancing cutting element assembly 560 and staple pusher 570 towards anvil 530. Driver 590 comprises an internal lumen 598 extending therethrough. Capturing device 540 is configured for advancement through internal lumen 598 to engage and translate anvil 530 towards and away from stapling assembly 520. Driver 590 has a proximal end suitably coupled to an actuation mechanism (not shown) for rotating driver 590 relative to end effector 510. In some embodiments, instrument 500 comprises a wrist assembly (not shown) pivotally coupling end effector 510 with shaft 505. At least a portion of driver 590 is movable through the wrist assembly between shaft 505 and end effector 510. In one such embodiment, the wrist assembly comprises one or more linkages for articulating the end effector around first and second axes, respectively. The first and second axes may be, for example, yaw and pitch axes.
[00152] In embodiments, driver 590 comprises the distal portion described above for engaging the staple and knife pushers and a flexible portion (not shown) that extends through the wrist member when the distal portion is within end effector 510. The flexible portion allows the distal portion to articulate relative to the proximal portion when end effector 510 articulates about the wrist member. The drive member further comprises a proximal portion (not shown) extending through the shaft and configured for coupling to an actuator, such as instrument handle or an external control system. In various embodiments, the flexible portion of driver 590 comprises a bendable laser cut hypo tube that extends through shaft 505 of instrument 500. The hypo tube has sufficiently flexibility to bend as the end effector 510 is rotated relative to shaft 505.
[00153] As shown in FIGS. 22 and 23, driver 590 comprises an elongate rod 591 that includes proximal and distal sets of external threads 592, 594 (with proximal being defined as the direction towards shaft 505). In an exemplary embodiment, distal threads 594 of driver 590 are spaced from proximal threads 592 by a gap 596 (discussed in more detail below).
[00154] Referring again to FIGS. 22 and 25, staple pusher 150 comprises a proximal shaft 575 slidably disposed within channel 554 of housing 550. Shaft 575 includes internal threads 578 configured to cooperate and engage with proximal threads 592 of driver 590 such that rotation of driver 590 causes longitudinal movement of stapler pusher 570. Similarly, cutting element assembly 560 comprises a proximal shaft 568 disposed within central bore 558 of housing 550. Shaft 568 includes internal threads 569 to cooperate and engage with distal threads 594 of driver 590 such that rotation of driver 590 causes longitudinal movement of cutting element assembly 560.
[00155] Referring now to FIGS. 25-27, in an initial position prior to deployment of staples 2000 and knife 566, the distal surface of knife 566 is proximally recessed from the distal surface of staple cartridge 580 (see FIGS. 25 and 26). As driver 590 is rotated, it causes both knife pusher 564 and stapler pusher 570 to advance distally. Since knife 566 is proximally recessed from the distal surface of staple cartridge 580, the staples 2000 are driven into the tissue and against tissue contacting surface 536 of anvil 530 before knife 566 extends distally of housing 550 (see FIG. 26). Thus, staples 2000 are fully formed through the tissue before the knife 566 cuts into the tissue. This ensures that the tissues structures are sealed or attached to each other before the knife 566 cuts through them, ensuring that the tissue structures have not displace relative to each other or instrument 500 between the time the staples are formed and the knife cuts the tissue.
[00156] As shown in FIG. 26, after the staples 2000 have been fully formed, internal threads 578 of staple pusher 570 move distally of proximal threads 592 of driver 590 such that they are aligned with gap 596. This causes staple pusher 570 to disengage from driver 590 such that further rotation of driver 590 does not move stapler pusher 570 in the distal direction.
[00157] Referring now to FIG. 27, after the staples 2000 have been fully formed in the tissue, driver 590 continues to rotate to advance knife pusher 564 and knife 566 in the distal direction until knife 566 extends beyond the distal end of housing 550 and severs the tissue. [00158] Referring now to FIGS. 34A -34D, instrument 500 is particularly useful for j oining two tubular structures in a patient, such as arteries, veins, and/or intestinal tissue 2002. For example, in a lower colon procedure, the surgeon typically uses a conventional Linear stapler with two rows of staples placed on either side of the affected intestinal lesion to be removed and stapled. The target area is cut at the same time as the adjacent ends are staple . After removing die affected area, the surgeon typically inserts anvil 530 of instrument 500 into the proximal end of the lumen, proximal of the staple line. This is done by inserting anvil head 532 into an entrance that has been cut into the proximal lumen by the surgeon. In some embodiments, anvil 530 is placed transanally by placing anvil head 532 at the distal end of instrument 500 and inserting instrument 500 through the rectum. The proximal end of the intestine is then tied to anvil shaft 534 using a purse string suture or other conventional tying device and the proximal and distal ends of the intestine are tightened within the gap by closing the gap between anvil 530 and staple cartridge 580
[00159] As shown in FIG. 34A, anvil 530 is positioned within a first section 2004 of separated intestinal tissue 2092 and staple assembly 520 is positioned with a second section 2006 of the intestinal tissue. As shown in FIGS. 34B and 34C, staple pusher 570 is advanced distally such that staples 2000 pass through first and second sections 2004, 2006 and deform against anvil 530 to join and seal the tissue sections 2004, 2006. At this point, tissue sections 2004, 2006 are stable and generally do not move relative to each other or instrument 500. As shown in FIG. 34D, knife 566 is then advanced distally to sever tissue structures 2004, 2006 inwardly from staples 200 to complete the anastomosis.
[00160] Referring now to FIGS. 35A-35C, an alternative embodiment of circular stapler 500 will now be described. In this embodiment, distal threads 594 of driver 590 have a different pitch than proximal threads 592 of driver 590 such that each single rotation of driver 590 moves staple pusher 570 a different distance than knife pusher 564. In addition, this configuration may provide a stronger mechanical advantage to either stapler pusher 570 or knife pusher depending on which thread has a higher thread count per inch. In one embodiment, proximal threads 592 have a shorter distance between adjacent threads, i.e., a higher thread count per inch, than the distance between adjacent threads of distal threads 594. Thus, staple pusher 570 will be provided with a higher mechanical advantage than knife pusher 564. In addition, knife pusher 564 will travel further (and/or faster) than staple pusher 592 for each single rotation of driver 590.
[00161] In an exemplary embodiment, the ratio of the thread count per inch between distal threads 594 and proximal threads 592 is about 1 to 1.25 to about 1 to 2, or about 1 to 1.5. Thus, the ratio of the force applied by driver 590 to knife pusher 564 relative to staple pusher 570 is about 1 to 1.25 to about 1 to 2.0, or about 1 to about 1.5.
[00162] As shown in FIG. 35 A, in the initial position, the distal surface of knife 566 is recessed further from the distal surface of staple pusher 570 to account for the increased travel distance of knife 566. Rotation of driver 590 causes both pushers to move distally until staples 2000 are fully formed (see FIG. 35B). At this point, the distal surface of knife 566 is still proximal of the distal surface of staple assembly 520. In addition, proximal threads 592 of driver 590 have disengaged from 578 internal threads of stapler pusher 570 such that staple pusher 570 no longer advances distally. As shown in FIG. 35C, further rotation of driver 590 causes knife 566 to advance distal of staple assembly 520 to sever tissue between staple assembly 520 and anvil 530.
[00163] Referring now to FIGS. 28A-28D, an alternative embodiment of a circular stapling instrument 2100 will now be described. As shown, instrument 2100 includes a staple assembly 2102 having a driver 2104, a staple pusher 2106 and a knife pusher 2108 as described above. In this embodiment, driver 2104 includes a single set of threads 2110 rather than two sets of threads as described with instrument 2100. In addition, driver 2104 is disposed laterally outward from staple pusher 2106 and knife pusher 2108. Staple pusher 2106 comprises screw threads 2112 on a laterally outward surface of staple pusher 2106 and knife pusher 2108 comprises threads 2114 on a laterally outward surface of knife pusher 2108. Threads 2112 are positioned proximally of threads 2110.
[00164] As shown in FIG. 28 A, threads 2106 of driver 2104 initially engage only the distal threads 2110 on staple pusher 2106. As driver 2104 is rotated, it advances stapler pusher 2106 in the distal direction (see FIG. 28B). Once stapler pusher 2106 has advanced to the point where staples 2130 are formed against anvil 2122, threads 2110 of driver 2104 disengage from the distal threads 2112 of staple pusher 2106 and driver threads 2110 contact threads 2114 of knife pusher 2108 to advance knife pusher 2108 distally (see FIG. 28C). Further rotation of driver 2104, then causes distal movement of knife pusher 2108 until the knife 2120 contacts and severs tissue between anvil 2122 and the distal surface of staple assembly 2102 (see FIG. 28D).
[00165] Referring now to FIGS. 29A-29D, in this embodiment, an instrument 2200 includes a staple assembly 2202 having a driver 2204, a staple pusher 2206 and a knife pusher 2208 as described above. In this embodiment, driver 2204 includes a single set of threads 2210 and is disposed laterally inward from staple pusher 2206 and knife pusher 2208 (similar to the embodiment shown in FIGS. 22 and 23). Staple pusher 2206 comprises screw threads 2212 on a laterally inward surface of staple pusher 2206 and knife pusher 2208 comprises threads 2214 on a laterally inward surface of knife pusher 2208. Threads 2214 are positioned proximally of threads 2212.
[00166] As shown in FIG. 29 A, threads 2210 of driver 2204 initially engage only the distal threads 2212 on staple pusher 2206. As driver 2204 is rotated, it advances stapler pusher 2206 in the distal direction and threads 2210 move proximally (see FIG. 29B). Once stapler pusher 2206 has advanced to the point where staples 2220 are formed against anvil 2222, threads 2210 of driver 2204 disengage from the distal threads 2212 of staple pusher 2206 engage the proximal threads 2214 of knife pusher 2208 (see FIG. 29C). Further rotation of driver 2204, then causes distal movement of knife pusher 2208 until the knife 2230 contacts and severs tissue between anvil 2222 and the distal surface of staple assembly 2202 (see FIG. 29D).
[00167] Referring now to FIGS. 30A-30C, in this embodiment, an instrument 2250 includes a staple assembly 2252 having a driver (not shown), a staple pusher 2256 and a knife pusher 2258 as described above. In this embodiment, the driver includes a single set of threads 2260 and is disposed laterally inward from staple pusher 2256 and laterally outward from knife pusher 2258 (i.e., between staple pusher 2256 and knife pusher 2258). Staple pusher 2256 comprises screw threads (not shown) on a laterally inward surface of staple pusher 2256 and knife pusher 2258 comprises threads (not shown) on a laterally outward surface of knife pusher 2258. The knife pusher threads are positioned proximally of the staple pusher threads
[00168] As shown in FIG. 30 A, threads 2260 of the driver initially engage only the distal threads on staple pusher 2256. As driver 2254 is rotated, it advances stapler pusher 2256 in the distal direction and threads 2260 move proximally (see FIG. 30B). Once stapler pusher 2256 has advanced to the point where the staples are formed against anvil 2270, threads 2260 of driver 2254 disengage from the distal threads of staple pusher 2256 and engage the proximal threads of knife pusher 2258 (see FIG. 30C). Further rotation of driver 2254, then causes distal movement of knife pusher 2258 until the knife 2272 contacts and severs tissue between anvil 2270 and the distal surface of staple assembly 2252 (see FIG. 30D).
[00169] Referring now to FIGS. 31-33, another embodiment of a circular stapling instrument 2300 will now be described. As shown, instrument 2300 comprises a circular stapling assembly 2320, an anvil 2330 and a capturing device 2340 for advancing and retracting anvil 2330 relative to stapling assembly 2320. Stapling assembly 2320 comprises a housing 2350 having a substantially cylindrical main body with an internal channel for receiving a cutting element assembly 2360, a staple pusher 2370 and a staple cartridge 2380.
[00170] Similar to the embodiment shown in FIGS. 22 and 23, anvil 2330 includes an anvil head and an anvil shaft. The anvil shaft is insertable into an inner bore of housing 2350 and is removably and slidably securable within this bore. Capturing device 2340 is configured to translate through the bore to translate anvil 2334 along a longitudinal axis relative to staple assembly 2320 to approximate or un-approximate anvil 2330 relative to staple assembly 2320. The anvil head includes a tissue contacting surface defining staple forming pockets (now shown) for receiving the staples, as discussed previously.
[00171] Staple pusher 2370 defines a substantially cylindrical shape and is coaxially and slidably disposed within an internal channel of housing 2350. Cutting element assembly 2360 generally comprises an annular pusher and an annular cutting element or knife. Pusher 2364 is configured to advance relative to housing 2350 to drive the knife through tissue disposed between anvil 2330 and staple assembly 2320.
[00172] Instrument 2300 further includes first and second drivers 2390, 2392 for advancing cutting element assembly 2360 and staple pusher 2370, respectively, towards anvil 2330. In this embodiment, drivers 2390, 2392 comprise compressive drive mechanisms configured to advance longitudinally through housing 2350 to advance staple pusher 2370 and the knife pusher. In an exemplary embodiment, these compressive drive mechanisms comprise a bendable laser cut hypo tube that extends through shaft 2305 of instrument 2300. The hypo tubes have a proximal end (not shown) suitably coupled to an actuator that advances and retracts drivers 590, 592. The hypo tubes may be configured to extend through a wrist (not shown) of the instrument. Therefore, they have sufficiently flexibility to bend as the end effector 2310 is rotated relative to shaft 2305.
[00173] Referring now to FIG. 31, the distal surface of knife 2366 is initially recessed from the distal end of housing 2350. In one embodiment, the distal surface of knife 2366 is recessed from the distal end of staples 2000 and substantially aligned with the distal surface of staple pusher 2370. In this embodiment, drivers 590, 592 may be configured to simultaneously drive staple pusher and knife pusher such that the staples 2000 contact anvil 2330 before knife 2366 cuts the tissue. Thus, staples 2000 are fully formed through the tissue before the knife 2366 cuts into the tissue. This ensures that the tissues structures are sealed or attached to each other before the knife 2366 cuts through them, ensuring that the tissue structures have not moved relative to each other or instrument 2300 between the time the staples are formed and the knife cuts the tissue.
[00174] In an alternative embodiment, the distal surface of knife 2366 may, or may not, be recessed from the distal surface of staple assembly 2320. In this embodiment, first and second drivers 2390, 2392 advance the knife and staple pushers sequentially. Specifically, first driver 2390 advances staple pusher until the staples engage anvil 2330 and are fully formed through the tissue. After that occurs, second driver 2392 advances knife pusher to drive knife 2366 through the tissue. Alternatively, second drive 2392 may advance staple pusher 2370 at a faster rate than knife pusher 2360 (even if they start at the same relative location) such that the staples contact the tissue before the knife.
[00175] Referring now to FIGS. 36A-36C, another embodiment of an anvil 1130 for a circular stapler includes an anvil head 1132 and an anvil shaft 1134. Anvil shaft 1134 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. The capturing device (not shown) is configured to advance and withdraw through this internal channel to translate anvil 1130 along a longitudinal axis relative to staple assembly 520 to approximate or un-approximate anvil 1130 relative to staple assembly 520.
[00176] In this embodiment, anvil head 1132 comprises a central component 1140 and first and second lateral components 1142, 1144. In one embodiment, central component 1140 forms the central portion of a generally circular head 1132 and lateral components 1142, 1144 each comprise a semi-circular outer portion of the circular head 1132. In an exemplary embodiment, lateral components 1142, 1144 generally have the same size and shape, although it will be understood that one of the lateral components may be larger than the other.
[00177] As shown in FIG. 36B, central component 1140 is pivotally coupled to shaft 1134 such that it is movable from a collapsed configuration, wherein central component 1140 extends in a direction transverse, or substantially parallel to. shaft 1134 (FIG. 36B), to an expanded configuration, wherein central component 1140 extends in a direction traverse to, or substantially perpendicular to. shaft 1134 (FIG. 36C). In addition, first and second lateral components 1142, 1144 are pivotally coupled to central component 1140 such that they are movable between a collapsed configuration (FIG. 36B), wherein they are folded together towards central component 1140 and extend substantially perpendicular to central component 1140, to an expanded configuration, wherein lateral components 1142, 1144 extends substantially parallel to central component 140 to form an anvil suitable for cooperation with staple assembly 520 (FIG. 36C).
[00178] Anvil 1130 is configured such that it has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1134) in the collapsed configuration than in the expanded configuration. Lateral dimension is herein defined as the radial distance from the longitudinal axis of shaft to the furthest radial surface or point of the anvil 1130 from the longitudinal axis. In certain embodiments, anvil 1130 has a lateral dimension (or diameter in certain embodiments) of less than about 14 mm in the collapsed configuration such that anvil 1130 may be advanced through a cannula or other percutaneous entry point in the patient. Anvil 1130 may have a lateral dimension (or diameter) of at least about 20 mm or at least about 25 mm, or about 21 to about 33 mm in the expanded configuration, although it will be recognized that the dimensions of anvil 1130 may vary depending on the surgical procedure and the size of the percutaneous entry point into the patient.
[00179] Anvil head 1132 is configured such that when central portion 1140 and lateral portions 1142, 1144 are in the expanded configuration, they form a substantially circular disc. The disc has sufficient rigidity to withstand the forces of clamping and/or driving staples through the tissue against the staple pockets on the proximal surface of head 1132. In addition, the staples pockets are aligned with the circumferential staples that are driven against these pockets by staple assembly 120.
[00180] Anvil 1130 may further include one or more driver(s) (not shown) within shaft 1134 that have a distal end portion coupled to the pivot joints between shaft 1134 and central component 1140 and/or the pivot joints between lateral components 1142, 1144 and central component 1140 for pivoting or rotating these components relative to each other. Alternatively, the driver(s) may be disposed within the circular stapler assembly 520, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00181] Referring now to FIGS. 37 and 38A-38C, another embodiment of an anvil 1200 includes an anvil head 1202 and an anvil shaft 1204. Anvil shaft 1204 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. The capturing device (not shown) is configured to advance and withdraw through this internal channel to translate anvil 1200 along a longitudinal axis relative to staple assembly 520 to approximate or un-approximate anvil 1200 relative to staple assembly 520. Anvil head 1202 is movable between a collapsed or substantially linear configuration (see FIGS. 37 and 38C) and an expanded or circular disc-shaped configuration (see FIG. 37A). Head 1202 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1204) in the linear configuration than in the circular configuration.
[00182] Anvil head 1202 comprises one or more linkages that are movable between the linear and circular configurations. In one embodiment, head 1202 comprises first, second and third linkages 1206, 1208, 1210. Each linkage comprises an outer surface 1217 and an inner surface 1218 that form at least a partial sector of a circle (or a sector of a circle having a hollow central area). All of the linkages are designed to pivot towards each other such that the linkages form a circular disc 1240 (see FIG. 37A). Each linkage 1206, 1208, 2110 further comprises a tissue contacting surface defining staple forming pockets (not shown) for receiving staples 200 (see FIGS. 34A-34D discussed above).
[00183] In an exemplary embodiment, each linkage 1206, 1208, 1210 is substantially the same shape (i.e., sector) and thus forms one-third of the circular disc 1240 (see FIG. 38 A), although it will be recognized that each linkage may have different shapes. In addition, it will be recognized that anvil head 1202 may comprise 2 linkages or 4 or more linkages. In addition, it should be recognized that certain of the linkages may be larger than the other linkages. For example, linkage 1206 may be semicircular, i.e., forming one-half of the disc 1240, while the remaining half is formed of 2 or more linkages. The staple forming pockets are circumferentially arranged on each linkage such that they align with staple bays in staple assembly 120 when the linkages are formed into disc 1240.
[00184] First linkage 1206 includes a pin 1224 pivotally coupled to a universal joint or disc 1212 on a distal end portion 1240 of anvil shaft 1204. Second linkage 1208 is pivotally coupled to first and third linkages 1206, 1210 with connecting pins 1214, 1216, respectively. Each linkage 1206, 1208, 1210 has a distance or radius between inner and outer surfaces 1217, 1218 that may be less than the overall radius of the circular disc when the linkages have formed together. Thus, as shown in FIG. 38 A, the linkages form a central opening 1232 in the expanded configuration. This configuration reduces the overall size of the linkages, which facilitates the deployment process.
[00185] In one embodiment, disc 1212 of anvil shaft 1204 is a universal joint configured to transmit rotary power from shaft 1204 or an actuator within shaft 1204. Disc 1212 is rotatably coupled to distal end portion 1240 of shaft 1204 at pin 1222. Disc 1212 may be rotatable relative to shaft 1204 such that, for example, counterclockwise (or clockwise) rotation of disc 1212 causes linkage 1206 to rotate in a clockwise (or counterclockwise) direction. This rotation further causes linkage 1208 to rotate in a clockwise direction which, in turn causes linkage 1210 to rotate in the same direction until the side surfaces of each linkage contact each other to form the circular disc 1240 (see FIGS. 38A-38C).
[00186] Disc 1212 is also configured to pivot between a first configuration, wherein disc 1212 is substantially parallel to shaft 1204, and a second configuration, wherein disc 1212 is transverse to shaft 1204, or preferably perpendicular to shaft 1204. Disc 1212 is coupled to first linkage 1206 such that this rotation, in turn, rotates circular disc 1240 until it is substantially perpendicular to anvil shaft 1204 and presents the tissue contacting surface in the proximal direction for receiving staples from staple assembly 120.
[00187] In use, disc 1212 and that attached linkages 1206, 1208, 1210 first rotate about pin 1222 until they are substantially perpendicular to shaft 1204. Then, linkages 1206, 1208, 1210 sequentially rotate about their connecting pins 1224, 1214 and 1216 until they each contact disc 1212 to form the overall circular disc 1240.
[00188] Anvil 1200 may further include one or more driver(s) (not shown) within shaft 1204 that has a distal end portion coupled to joint 1212 for rotating and/or pivoting joint 1212. Alternatively, the driver(s) may be disposed within the circular stapler assembly 120, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00189] Referring now to FIGS. 39A and 39B, another embodiment of an anvil 1300 includes an anvil head 1304 and an anvil shaft 1302. As in previous embodiments, anvil shaft 1302 is insertable into an internal channel of staple assembly 120 and is removably and slidably securable therein. Anvil head 1304 comprises one or more linkages 1306, 1308 that are movable between linear and circular configurations. Each linkage comprises an outer surface 1316 and an inner surface 1318 that form a sector of a circle. All of the linkages are designed to pivot towards each other such that the linkages form a circular disc (similar to disc 1240 in FIG. 38A). Each linkage further comprises a tissue contacting surface defining staple forming pockets (not shown) for receiving staples 2000.
[00190] In an exemplary embodiment, anvil head 1302 comprises four linkages that are substantially the same shape (i.e., a partial sector of a circle) and thus form one-fourth of the circular disc, although it will be recognized that each linkage may have different shapes. In addition, it will be recognized that anvil head 1302 may comprise 2, linkages, 3 linkages or 5 or more linkages. For example, FIG. 39B illustrates an embodiment with 2 linkages 1306, 1308 that each comprise a semicircle. In addition, it should be recognized that certain of the linkages may be larger than the other linkages. For example, linkage 1306 may be a semicircular, forming one- half of the discs, while the remaining half is formed of 2 or more linkages.
[00191] Linkages 1306, 1308 are pivotally coupled to each other at a joint 1340, 1342 on their side surfaces. The proximal linkage 1306 is also pivotally coupled to a bar or rod 1320 at a joint 1330. Bar 1320 is, in turn, pivotally coupled to a head 1322 of a distal end portion 1326 of shaft 1302 by a joint 1332. Distal end portion 1326 is, in turn, is pivotally coupled to the remainder of shaft 1302 by a hinge or pin 1324 that extends through a channel (not shown) in shaft 1302 such that distal end portion 1326 may pivot between a substantially parallel orientation relative to shaft 1304 (see FIG. 39A) to a substantially perpendicular orientation (see FIG. 39B).
[00192] In use, distal end portion 1326 rotates about pin 1332 into a substantially perpendicular orientation relative to shaft 1302 (see FIG. 39B). Then, the various linkages 1306, 1308 rotate about head 1322 until they form the circular disc that presents the tissue contacting surface in the proximal direction for receiving staples from staple assembly 120.
[00193] Anvil 1300 may further include one or more driver(s) (not shown) within shaft 1304 that has a distal end portion coupled to head 1322 for rotating and/or pivoting head 1322. Alternatively, the driver(s) may be disposed within the circular stapler assembly 120, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00194] Referring now to FIGS. 40A and 40B, another embodiment of an anvil 1350 includes an anvil head 1352 and an anvil shaft 1354. Similar to previous embodiments, anvil shaft 1354 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. Anvil head 1352 is movable between a collapsed or stacked configuration (FIG. 40A) and an expanded or circular disc-shaped configuration (FIG. 40B). Head 1352 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1354) in the stacked configuration than in the circular configuration.
[00195] In this embodiment, anvil head 1352 comprises one or more linkages that are movable between “stacked” and “unstacked” configurations. In one embodiment, head 1352 comprises first, second, third and fourth linkages 1356, 1358, 1360, 1362. Each linkage comprises an outer surface and an inner surface that form a sector of a circle. All of the linkages are designed to move from a stacked configuration (FIG. 40A) to an unstacked configuration such that the linkages form a circular disc (see FIG. 40B). The linkages are substantially aligned with the longitudinal axis of shaft 1354 in the stacked configuration. Anvil 1350 may further include one or more driver(s) (not shown) within shaft 1354 having a distal end portion coupled to a joint or linkage at the distal end of shaft 1354 for rotating and/or pivoting linkages 1356, 1358, 1360, 1362. Alternatively, the driver(s) may be disposed within the circular stapler assembly 520, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00196] As shown in FIG. 40B, in the stacked configuration, each linkage comprises proximal and distal surfaces 1382, 1380. The proximal surfaces 1382 contain staple pockets (not shown) for receiving staples from staple assembly 120. In this configuration, the proximal surface 1382 of linkage 1356 faces anvil shaft 1354 and may be in contact with shaft 1354. The proximal surface 1382 of linkage 1358 faces the distal surface 1380 of linkage 1360 and may be in contact with this surface (and so on for each linkage in the stack).
[00197] Each linkage 1356, 1358, 1360, 1362 has a distance or radius between their inner and outer surfaces that may be less than the overall radius of the circular disc when the linkages have formed together. Thus, as shown in FIG. 40B, the linkages form a central opening 1370 in the expanded configuration. This configuration reduces the overall size of the linkages, which facilitates the deployment process.
[00198] In an exemplary embodiment, linkages 1356, 1358, 1360, 1362 are substantially the same shape (i.e., sector) and thus form one-fourth of the circular disc, although it will be recognized that each linkage may have different shapes. In addition, it will be recognized that anvil head 1352 may comprise 2 or 3 linkages or 5 or more linkages. In addition, it should be recognized that certain of the linkages may be larger than the other linkages. For example, linkage 356 may be a semicircular, forming one-half of the discs, while the remaining half is formed of 2 or more linkages.
[00199] Referring now to FIGS. 41 A, 41B and 42A-42C, another embodiment of an anvil 1400 includes an anvil head 1402 and an anvil shaft 1404. Similar to previous embodiments, anvil shaft 1404 is insertable into an internal channel of staple assembly 120 and is removably and slidably securable therein. Anvil head 1402 is movable between a collapsed or folded configuration (see FIG. 42 A) and an expanded or dome-shaped configuration (see FIG. 42C). Head 1402 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1404) in the collapsed configuration than in the expanded configuration.
[00200] As shown in FIGS. 42A-42C, anvil head 1402 comprises a plurality of leaves or petals 1406 coupled to each other such that the petals 1406 overlap with each other in the folded configuration. Upon expansion, petals 1406 are configured to form a substantially domed or umbrella shape with a convex outer surface 1440 having an apex 1442 and a concave inner surface 1436 (see FIGS. 41 A and 41B). Apex 1442 may be coupled to a distal end portion of shaft 1404. Alternatively, petals 1406 may be configured to expand further such that anvil head 1402 has a substantially flat or circular disc shape in the expanded configuration (similar to previous embodiments). Head 1402 may include at least two petals 1406, or three or more petals 1406.
[00201] One or more of the petals 1406 (or all of the pedals) comprise a tissue contacting surface 1436 that comprises staple forming pockets (not shown) for receiving staples from staple assembly 120. The petals 1406 are configured such that, in the expanded configuration, the staple pockets are configured to align with the staples in staple assembly 120. In certain embodiments, each of the petals 1406 comprises one or more staple forming pockets. In other embodiments, the staple forming pockets may alternate between pedals 1406 such that, for example, one pedal may contain a staple forming pocket while its adjacent pedals do not contain a staple forming pocket.
[00202] In this embodiment, petals 1406 are designed to overlap with each other in both the expanded and collapsed or folded configurations. Thus, in the expanded configuration, petals 406 overlap with each other to provide mutual support and rigidity to anvil head 1402 such that it can resist the forces of the stapling operation. Anvil 1400 may further include a driver (not shown) within shaft 1404 that has a distal end portion coupled to head 1402 for expanding and collapsing pedals 1406. For example, anvil head 1402 may include one or more rigid elements coupled to pedals 1406 designed to telescope or move radially outward to push pedals outward and expand head 1402. Alternatively, the driver(s) may be disposed within the circular stapler assembly 520, or within a separate anvil delivery instrument (not shown). The actuator may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00203] Referring now to FIGS. 43 A and 43B, another embodiment of an anvil 1500 includes an anvil head 1502 and an anvil shaft 1504. As with previous embodiments, anvil shaft 1504 is insertable into an internal channel of staple assembly 120 and is removably and slidably securable therein. Anvil head 1502 is movable between a collapsed or folded configuration (see FIG. 43B) and an expanded or dome-shaped configuration (see FIG. 43 A). Head 1502 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1504) in the folded configuration than in the dome-shaped configuration.
[00204] Anvil head 1502 comprises a plurality leaves or petals 1506 coupled to each other such that the petals 1506 overlap with each other in the folded configuration. Upon expansion, petals 1506 are configured to form a substantially domed or umbrella shape with a convex outer surface 1508 and a concave inner surface (not shown). Alternatively, petals 1506 may be configured to expand further such that anvil head 1502 has a substantially flat or circular disc shape in the expanded configuration. Head 1502 may include at least two petals 1506, or three or more petals 1506.
[00205] One or more of the petals 1506 (or all of the pedals) have a tissue contacting surface comprising one or more staple forming pockets (not shown) for receiving staples from the staple assembly 520. The petals 1506 are configured such that, in the expanded configuration, the staple pockets are configured to align with the staples in staple assembly 520. In certain embodiments, each of the petals 1506 comprises one or more staple forming pockets. In other embodiments, the staple forming pockets may alternate between pedals 1506 such that, for example, one pedal may contain a staple forming pocket while its adjacent pedals do not contain a staple forming pocket.
[00206] Anvil head 1502 further comprises one or more substantially rigid elements or rods 1510 extending substantially from a proximal surface edge 1512 to a central portion or apex 1514 of head 1502. Rods 1510 are configured to expand outward with petals 1506 and provide stability and rigidity to head 1502 in the expanded configuration. Rods 1510 may include one or more ridges or other surface features thereon to provide additional stability to head 1502 as it is expanded. Rods 1510 are configured to pivot at apex 1514 and proximal surface 1512 to allow transformation of anvil head 1502 between the expanded and collapsed configurations.
[00207] In some embodiments, anvil head 1502 may further include one or more cables extending around head 1502 to transition the head between the collapsed and expanded configurations. In one such embodiment, head 1502 comprise a lower cable 1530 and an upper cable 1532. Lower cable 1530 is disposed in a proximal region of pedals 1506 near proximal surface 1512 and upper cable 1532 is disposed in a distal region of head 1502 near apex 1514. Cables 1530, 1532 are coupled to one or more driver(s) (not shown) that extend through shaft 1504 of anvil 1500 and are configured to tension cables 1530, 1532 to expand anvil head 1502 into the umbrella or dome shape. The driver(s) (not shown) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00208] Referring now to FIGS. 44A-44C, another embodiment of an anvil 1600 includes an anvil head 1602 and an anvil shaft 1604. Similar to previous embodiments, anvil shaft 1604 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. Anvil head 1602 is movable between a collapsed or folded configuration (see FIG. 44 A) and an expanded or dome-shaped configuration (see FIGS. 44B and 44C). Head 1602 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1604) in the collapsed configuration than in the expanded configuration.
[00209] As shown in FIG. 44A, anvil head 1602 comprises a plurality leaves or petals 1606 coupled to each other such that the petals 1606 overlap with each other in the collapsed configuration. Upon expansion, petals 1606 are configured to form a substantially domed or umbrella shape with a convex outer surface 1608 and a concave inner surface 1612. Alternatively, petals 1606 may be configured to expand further such that anvil head 1602 has a substantially flat or circular disc shape in the expanded configuration. Head 1602 may include at least two petals 1606, or three or more petals 1606.
[00210] One or more of the petals 1606 (or all of the pedals) comprise a tissue contacting surface 1636 defining staple forming pockets (not shown) for receiving staples 200. The petals 1606 are configured such that, in the expanded configuration, the staple pockets are configured to align with the staples in staple assembly 520 (i.e., such that the staple legs or tines align with the staple bays or pockets so that the staples form properly. In certain embodiments, each of the petals 1606 comprises one or more staple forming pockets. In other embodiments, the staple forming pockets may alternate between pedals 1606 such that, for example, one pedal may contain a staple forming pocket while its adjacent pedals do not contain a staple forming pocket.
[00211] Similar to previous embodiments, anvil 1600 may further include one or more driver(s) (not shown) within shaft 1604 that each have a distal end portion coupled to head 1602 for expanding and collapsing pedals 1606. For example, anvil head 1602 may include one or more rigid elements coupled to pedals 1606 designed to telescope or move radially outward to push pedals outward and expand head 1602. Alternatively, the driver(s) may be disposed within the circular stapler assembly 120, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).
[00212] In this embodiment, anvil 1600 further comprises an expandable element 1610, such as a balloon or the like, configured to expand and apply pressure to outer surface 1608 of head 1602. This ensures that the staple pocket plane is capable of resisting the force from the clamping of tissue and then from the firing and cutting forces. Balloon 1610 may be inflated in any suitable manner, such as fluid inflation (e.g., air or other gases, or fluid), chemical inflation or (e.g., mixing certain materials together to form an expanding gas within the balloon) and the like. In one embodiment, balloon 1610 comprises a proximal end configured for coupling to a suitable fluid source, such as carbon dioxide, saline or the like. The fluid source may be any suitable source, such as a carbon dioxide tank under pressure, a syringe filled with gas to fluid, such as saline, or a source of insufflation.
[00213] Referring now to FIGS. 45 A, 45B and 46A-46C, another embodiment of an anvil 1700 includes an anvil head 1702 and an anvil shaft 1704. Anvil shaft 1704 is insertable into an internal channel of staple assembly 520 and is removably and slidably securable therein. Anvil head 1702 is movable between a collapsed configuration (see FIG. 46A) and an expanded configuration (see FIG 46C). Head 1702 has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 1704) in the collapsed configuration than in the expanded configuration.
[00214] In this embodiment, anvil head 1702 comprises an expandable element 1710, such as a balloon or the like. Balloon 1710 may be inflated in any suitable manner, such as fluid inflation (e.g., air or other gases, or fluid), chemical inflation or (e.g., mixing certain materials together to form an expanding gas within the balloon) and the like. In one embodiment, balloon 1710 comprises a proximal end configured for coupling to a suitable fluid source, such as carbon dioxide, saline or the like. The fluid source may be any suitable source, such as a carbon dioxide tank under pressure, a syringe filled with gas to fluid, such as saline, or a source of insufflation.
[00215] Anvil 1700 further comprises an annular film 1720 having an inner surface 1722 with a larger diameter than shaft 1704. Film 1720 includes a tissue contacting surface 7136 defining staple forming pockets (not shown) for receiving staples 200. Film 1720 preferably comprises any suitable material, such as metal or a hard polymer, having sufficient stiffness to configured to resist the forces applied by clamping of tissue and then from the firing and cutting forces of the stapler assembly.
[00216] In one embodiment, film 1720 is coupled to a proximal surface of balloon 1710 (see FIGS. 46A-46C). Film 1720 may be configured to expand radially outward as the balloon 1710 is inflated such that, in the expanded configuration, the staple pockets are configured to align with the staples in staple assembly 120 (i.e., such that the staple legs or tines align with the staple bays or pockets so that the staples form properly). In another embodiment, film 1720 is configured to advance along anvil shaft 1704 in the distal direction after balloon 1710 has been expanded. In this embodiment, film 1720 may be configured to expand via a separate actuator after film 1720 has been advanced in contact with balloon 1710. Balloon 1710 is configured to apply pressure to a distal surface of film 1720 to ensure that film 1720 resists the forces applied during the stapling operation.
[00217] The proximal end portion of the anvils described above are operatively connected to one or more drivers or actuation mechanisms (not shown), although as those skilled in the art reading this description will appreciate, components of the drivers may extend into, and/or pass through the anvil shafts and/or the stapler instrument 100. In various embodiments, the anvils and/or instrument 100 will include a proximal handle (not shown) for actuating the drivers that move the anvils between the collapsed and expanded configurations, and, in some embodiments, for controlling the orientation and movement of the anvils. Alternatively, the system may include an anvil delivery instrument that includes one or more drivers for expanding and collapsing the anvils.
[00218] Referring now to FIG. 47, an anvil delivery instrument 1800 includes an elongate shaft 1802 sized to advance through a suitable percutaneous penetration in the patient, such as a trocar, cannular and the like. In certain embodiments, shaft 1802 has an outer dimension of less than about 14 mm, although it will be recognized that the dimensions of shaft 1802 may vary depending on the surgical procedure and the size of the percutaneous entry point into the patient.
[00219] Instrument 1800 further includes first and second jaws 1804, 1806, that are movable between open and closed positions relative to each other. In certain embodiments, second jaw 1806 is a movable jaw configured to move from an open position to a closed position relative to first jaw 1804. In other embodiments, first jaw 1804 is a movable jaw configured to move between open and closed positions relative to second jaw 1806. In the exemplary embodiment, both jaws 1804, 1806 are movable relative to each other.
[00220] Referring now to FIG. 51, jaws 1804, 1806 preferably pivot about a hinge that may include a pivot pin 1810 extending through a slot (not shown) in each of the jaws 1804, 1806. Instrument 1800 includes a driver (not shown) within shaft 1802 that opens and closes jaws 1804, 1806 about pivot pin 1810. Jaws 1804, 1806 may be opened and closed may any suitable mechanisms including, but not limited to, those described in any of the publications incorporated herein by reference. First and second jaws 1804, 1806 may also be capable of articulating together relative to shaft 1802 about an axis substantially perpendicular to the longitudinal axis (e.g., the yaw or pitch axes). In these embodiments, instrument 1800 may further include a wrist assembly (not shown) that allows jaws 1804, 1806 to articulate relative to shaft 1802.
[00221] In an exemplary embodiment, jaws 1804, 1806 are configured to move into a substantially parallel position with each other in the closed position (as shown in FIG. 51). Jaws 1804, 1806 are preferably sized such that each jaw contacts and grips onto an outer surface of anvil shaft 1134 in the closed position. This configuration provides a stronger grip on shaft 1134 and inhibits the shaft from watermelon seeding from the jaws, as is the case with typical prior art instruments that do not close in a substantially parallel orientation.
[00222] In an exemplary embodiment, jaw 1804 includes a jaw grasping portion 1840 and a proximal support 1842. Proximal support 1842 extends downward towards a jaw grasping portion 1844 of jaw 1806 and is coupled thereto by pivot pin 1810. Proximal support 1842 is sized and shaped such that pivot pin 1810 is located closer to jaw grasping portion 1844 of jaw 1806 than jaw grasping portion 1842 of jaw 1804. Thus, pin 1810 and grasping portion 1842 are disposed on one side of a central longitudinal axis 1850 of shaft 1802 and jaw grasping portion 1840 is located on the other side of longitudinal axis 1850. This provides an asymmetrical location for the hinge or pivot point between jaws 1804, 1806 such that the jaws can be position in a closed position around shaft 1134 of anvil 1130 with substantially parallel surfaces facing shaft 1134.
[00223] Referring again to FIG. 47, delivery instrument 1800 includes a driver for moving anvil head 1132 between the collapsed and expanded configurations. In one embodiment, the driver comprises a rod 1820 that extends through shaft 1802. Rod 1820 includes a distal end portion 1822 configured to extend at least partially through jaws 1804, 1806. In one embodiment, rod 1820 is sized and configured to extend through an internal lumen (not shown) in anvil shaft 1134 and is configured for distal advancement through shaft 1134 to engage anvil head 1132 (see FIGS. 24 and 25). Rod 1820 includes an engagement mechanism (not shown) on distal end portion 1822 that cooperates with an engagement mechanism on anvil head 1134 to move anvil head 1132 between the collapsed and expanded configurations.
[00224] In one embodiment, rod 1820 includes a rotatable element (not shown) configured to rotate relative to rod 1820. In another embodiment, the entire rod 1820 is configured to rotate relative to shaft 1802. Rotation of rod 1820 or the rotation element causes central component 1140 of anvil head 1132 to pivot about a hinge on anvil shaft 1134 between the collapsed and expanded configurations. In addition, rotation of rod 1820 causes lateral components 1142, 1144 to pivot about hinges between lateral components 1142, 1414 and central component 1140. In an alternative embodiment, instrument 1800 includes a second driver on rod 1820 or on another element of instrument 1800 that causes lateral components 1142, 1144 to pivot relative to central component 1140 (i.e., movement of anvil head 1132 into the collapsed configuration may be caused by a single or multiple drivers in instrument 1800).
[00225] In another embodiment, distal end portion 1822 of rod 1820 is configured to actuate anvil head 1132 through a push-pull mechanism. For example, longitudinal movement of rod 1820 relative to instrument 1800 causes central component 1140 to pivot about anvil shaft 1134 and/or lateral components 1142, 1144 to pivot about central component 1140.
[00226] The proximal end portion of instrument 1800 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 instrument 1800. In various embodiments, instrument 1800 will include a proximal handle (not shown) for actuating jaws 1804, 1806 and rod 1820 and, in some embodiments, for controlling the orientation and movement of the distal end portion of instrument 1800. In other embodiments, instrument 1800 is adapted to be used with a robotic system. In these embodiments, instrument 1800 will generally include an actuation mechanism that controls the orientation and movement of the end effector, the opening and closing of jaws 1804, 1806 and the actuation of rod 1820. 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 either rotate rod 1820 or move rod 1820 in the longitudinal direction for expanding and collapsing anvil 1130.
[00227] Referring now to FIG. 16, a control input 600 particularly useful for controlling circular stapling instrument 500 will now be described. As shown, control input 600 comprises an adaptor 602 configured to removably couple to second end 179 of housing 176 of input device 108. As discussed earlier, second end 179 of housing 176 is on the opposite side of housing 176 from first end 177, wherein control input 180 is typically mounted. As in previous embodiments, adaptor 602 may comprise any suitable connection means that allows control input 600 to be removably attached to second end 179 of housing 176. In an exemplary embodiment, adaptor 602 comprises a tube having a central channel (not shown) having a diameter sized to allow the tube to slide over second end 179 of housing 176. The tube of adaptor 602 may, for example, attach via a compression fit or the like, such that movement of control input 600 causes movement of housing 176.
[00228] In this embodiment, control input 600 comprises a shaft 604 that couples adaptor 602 to a proximal handle 606 that resembles staple assembly 606. In this embodiment, shaft 604 and handle 606 closely resemble circular stapling instrument 500, which allows the surgeon to more intuitively perceive movement of control input 600 relative to the instrument. In addition, since control input 600 is inverted relative to device 108, movement of control input 600 will substantially match the movement of instrument 500 on the monitor (i.e., instrument has been inserted in the opposite direction as the endoscope).
[00229] Referring now to FIG. 17, another embodiment of a secondary or primary control input 700 will now be described. Control input 700 comprises an adaptor 702 configured for coupling control input 700 to either first or second ends 177, 179 of housing 176 of control device 108. Thus, control input 700 may be used as a “regular” or an “inverted” control device for a surgical instrument. Adaptor 702 includes electrical connections that may be, for example, attached to electrical connections in housing 176 to provide the control input signals to processor via the electrical connections.
[00230] Control input 700 further comprises a handle 704 coupled to adaptor 702 that generally comprises a cylindrical body 706 that extends vertically relative to the user or substantially perpendicular to housing 176 of control device 108. Body 706 is designed for gripping by a user’s hand and may be moved up/down, left/right or forwards/backwards in order to transmit suitable signals to processor 102 for similar movements by instrument 250 (see FIGS. 1 and 2).
[00231] Alternatively, the electrical connections may be provided by an external connector 712 located on handle 704 of control input 700. In this configuration, mechanical movement of handle 704 may provide control of the instrument through mechanical movement of housing 176 (as described above) or through the electrical connections.
[00232] Control input 700 may further comprise a number of user control inputs on body 706 to provide additional controls to the instrument. For example, control input 700 may include a button 708 on the upper surface of body 706 that may be pressed by the user, e.g., with the thumb while the hand is grasping body 706, to provide a control input to the instrument 250. For example, if the instrument is a circular stapling instrument such as the one shown in FIG. 15 A, button 708 may cause actuation of the drive mechanism that deploys the staples and/or the knife against the anvil. In addition, or alternatively, control input 700 may comprise a slide 710 that is moved forwards or backwards (relative to the user) by the user’s thumb to provide additional controls to the instrument.
[00233] Referring now to FIGS. 18A and 18B, a control input 820 is provided that is particularly useful for controlling a needle delivery instrument 800 having a needle 802 that extends from a shaft 804, such as a biopsy needle or the like, will now be described. In the case of needle delivery, like that of a biopsy, careful motion and delivery is required. As shown, control input 820 comprises an adaptor 822 configured for coupling a handle 824 of control input 820 to either first or second ends 177, 179 of housing 176 of control device 108. Thus, control input 820 may be used as a “regular” or an “inverted” control device for a surgical instrument. Adaptor 822 includes electrical connections that may be, for example, attached to electrical connections in housing 176 to provide the control input signals to processor via the electrical connections. In some embodiment, mechanical movement of handle 704 may provide control of the instrument through mechanical movement of housing 176 (as described above) or through the electrical connections.
[00234] Handle 824 may be pivotally coupled to adaptor 822 at a joint 826. Handle 824 comprises a finger slider 828 that is slidably disposed within a channel or track 830 in handle 824. Finger slider 828 may be configured to control the longitudinal movement of needle 802 relative to instrument shaft 804. Input 802 may further include a linear encoder or potentiometer within track 830 to provide positional sensing of the input from control input 824 with respect to the position of the needle 802 or instrument 800 within the patient’s body.
[00235] The finger slider 828 is extremely intuitive to the user as the motion of moving the slider 828 forward, for example, is the same motion as the needle 802 moving forward relative to the shaft 804 of the instrument. In some embodiments, input device 108 may additionally include one or more foot pedals for providing additional inputs to the instrument, such as drug therapy delivery or actions related to capturing the biopsy core.
[00236] Referring now to FIGS. 19A and 19B, a control input 860 that is particularly useful for controlling a needle driver or holder 850 will now be described. Needle holder 850 may comprise a shaft 852 having an end effector 854 pivotally coupled to shaft 852, and a needle holder 856 extending from end effector 854. Needle holder 856 may comprise, for example, a pair of jaws that open and close relative to each other to hold a needle 858 that may be used, for example, for suturing tissue.
[00237] As shown, control input 860 comprises an adaptor 862 configured for coupling a handle 864 of control input 860 to either end of housing 176 of control device 108. Thus, control input 820 may be used as a “regular” or an “inverted” control device for a surgical instrument. Adaptor 862 includes electrical connections that may be, for example, attached to electrical connections in housing 176 of input device 108 to provide the control input signals to processor via the electrical connections. In some embodiment, mechanical movement of handle 864 may provide control of the instrument through mechanical movement of housing 176 (as described above) or through the electrical connections.
[00238] Handle 864 is configured such that the user may place it into the palm of their hand (as opposed to just their fingers in the finger loops). Handle 864 comprises a pair of arms 866, 868 coupled to adaptor 862 by a universal joint 870. Arms 866, 868 may be squeezed together, and they may be rotated relative to adaptor 862 by j oint 870. The universal j oint and the circular track between control input 860 and device control 108 allows for roll and sweeping motion that is performed to rotate the needle 858 through tissue.
[00239] A major difference in non-robotic suturing is that the technique is performed more with the wrist and forearm (as opposed to with the fingers and wrist for conventional robotic interfaces). This requires a different set of muscles and thus does not allow the user to access the muscle memory that has been developed previous to robotic surgery. Allowing the user to rely on non-robotic muscle memory decreases the learning curve and decreases the mental load on the user. Because this interface utilizes larger muscle groups (such as the palm) as opposed to just the fingers to conduct the suturing, it would induce lower fatigue to the user over the length of the procedure.
[00240] Referring now to FIGS. 20A and 20B, a control input 920 is provided that is particularly useful for controlling an instrument with multiple functions. One example of such an instrument 900 (e.g., a bipolar clamping instrument 900) is shown in FIG. 20A. Bipolar instrument 900 comprises a shaft 902 having an end effector 908 with first and second jaws 904, 906 for clamping tissue. Jaws 904, 906 may include one or more electrodes 914 thereon for coagulation or sealing of tissue and a cutting element or knife 912 for severing tissue. Instrument 900 may further include a fluid line 910 to provide integrated suction and/or saline delivery.
[00241] Control input 920 for instrument 900 comprises an adaptor 922 configured for coupling a handle 924 of control input 920 to either end of housing 176 of control device 108. Thus, control input 820 may be used as a “regular” or an “inverted” control device for a surgical instrument. Adaptor 922 includes electrical connections that may be, for example, attached to electrical connections in housing 176 of input device 108 to provide the control input signals to processor via the electrical connections. In some embodiment, mechanical movement of handle 924 may provide control of the instrument through mechanical movement of housing 176 (as described above) or through the electrical connections.
[00242] Handle 924 comprises a shape that enables the user to easily grasp the handle with the palm of their hand, while freeing their fingers and thumbs to manipulate various control inputs on handle 924. Handle 924 may be pivotally coupled to adaptor 922 at a joint 926 to allow relative movement of handle 924 to be translated to movement of end effector 908 relative to shaft 902. In addition, handle 924 comprises a first control input 930 at the base of handle 924, a second control input or button 932 on the side of handle 924 and one or more control inputs or buttons 934, 936, on the inside surface of handle 924. All of these control inputs may be easily manipulated by the user’s fingers or thumb while grasping handle 924 with the palm of the hand. The control inputs may provide multiple functionality to instrument 900, such as opening and closing jaws 904, 906 to seal tissue, driving knife 912 to cut tissue, providing electrical energy to coagulate and seal tissue (e.g., cautery) and providing suction and/or saline delivery through tube 910.
[00243] Referring now to FIGS. 21A and 22B, another control input 960 that is particularly useful for controlling an instrument with multiple functions will now be described. A representative instrument 950 is shown in FIG. 21 A. Instrument 950 comprises a shaft 952 having an end effector 954 movably coupled to the distal end of shaft 952. Instrument 950 further comprises a driver (not shown) for delivering an anchor 956, such as a tacker, staple, clip or the like into tissue, and a fluid line 958 for providing suction and/or fluid delivery to the target site.
[00244] Control input 960 for instrument 950 comprises an adaptor 962 configured for coupling a handle 964 of control input 960 to either end of housing 176 of control device 108. Thus, control input 960 may be used as a “regular” or an “inverted” control device for a surgical instrument. Adaptor 962 includes electrical connections that may be, for example, attached to electrical connections in housing 176 of input device 108 to provide the control input signals to processor via the electrical connections. In some embodiment, mechanical movement of handle 964 may provide control of the instrument through mechanical movement of housing 176 (as described above) or through the electrical connections.
[00245] As shown in FIG. 2 IB, handle 964 comprises a pistol grip shape and is pivotally coupled to adaptor 962 at a universal joint 966 to articulate the end effector 954 relative to shaft 952 of instrument 950. The pistol grip shape enables the user to easily grasp the handle with the palm of their hand, while freeing their fingers and thumbs to manipulate various control inputs on handle 964. For example, handle 964 may include a first control input 982, such as a trigger, and second and third control inputs 980, such as buttons, for providing multiple functionalities to instrument 950, such as delivering anchor 956 and providing suction and/or saline delivery through tube 958.
[00246] 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.
[00247] 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.
[00248] 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 positions (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).
[00249] 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 disclosure. 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 disclosure 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.
[00250] For example, in a first aspect, a first embodiment is a robotic surgical system for use with a surgical instrument. The robotic surgical system comprises a robotic arm configured for coupling to the surgical instrument, an input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument and a control input comprising an adaptor and a handle. The adaptor is configured for removable coupling to the input device, wherein movement of the handle of the control input causes movement of the input device to provide the desired movement of the robotic arm. The system further comprises a controller configured to control the robotic arm based on the movement of the input device.
[00251] A second embodiment is the first embodiment, wherein the input device comprises a first electrical connection coupling the input device to the controller, the adaptor of the control input further comprising a second electrical connection configured for removable coupling to the first electrical connection.
[00252] A third embodiment is any combination of the first 2 embodiments, wherein the control input comprises a user interface coupled to the second electrical connection, wherein movement of the user interface generates an electrical signal transmitted from the second electrical connection through the first electrical connection to the controller.
[00253] A 4th embodiment is any combination of the first 3 embodiments, wherein the input device comprises a first end and a second end, the system further comprising a monitor for providing a view of a surgical site within the patient.
[00254] A 5th embodiment is any combination of the first 4 embodiments, further comprising an endoscope coupled to the monitor and having a distal viewing end facing a first direction for providing the view of the surgical site on the monitor.
[00255] A 6th embodiment is any combination of the first 5 embodiments, wherein the control input is removably coupled to the first end of the input device.
[00256] A 7th embodiment is any combination of the first 6 embodiments, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 0 degrees to about 90 degrees relative to the first direction and wherein the control input is removably coupled to the first end of the input device.
[00257] An 8th embodiment is any combination of the first 7 embodiments, wherein the control input is removably coupled to the second end of the input device.
[00258] A 9th embodiment is any combination of the first 8 embodiments, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 90 degrees to about 270 degrees relative to the first direction and wherein the control input is removably coupled to the second end of the input device.
[00259] A 10th embodiment is any combination of the first 9 embodiments, further comprising a second control input removably coupled to the first end of the input device, wherein movement of the first control input in a first direction causes movement of the instrument in the first direction and wherein movement of the second control input in a second direction causes movement of the instrument in the second direction.
[00260] An 11th embodiment is any combination of the first 10 embodiments, wherein the instrument is a first instrument having a distal end facing away from the view on the monitor, the system further comprising a second instrument having a distal end facing towards the view on the monitor.
[00261] A 12th embodiment is any combination of the first 11 embodiments, wherein the first control input is configured to control the first instrument and the second control input is configured to control the second instrument.
[00262] A 13th embodiment is any combination of the first 12 embodiments, wherein the input device comprises a shaft and the adaptor of the control input comprises a tube having an internal channel with a diameter greater than a diameter of the shaft of the input device.
[00263] A 14th embodiment is any combination of the first 13 embodiments, wherein the tube of the control input is configured to advance over the shaft of the input device.
[00264] A 15th embodiment is any combination of the first 14 embodiments, wherein the handle comprises an elongate shaft coupled to the adaptor and a proximal handle portion coupled to the shaft opposite the adaptor.
[00265] A 16th embodiment is any combination of the first 15 embodiments, wherein the proximal handle portion comprises a substantially cylindrical shape with a larger diameter than the elongate shaft of the handle.
[00266] A 17th embodiment is any combination of the first 16 embodiments, wherein the surgical instrument comprises a circular stapling instrument comprising a staple assembly and an anvil removably coupled to the staple assembly, wherein the proximal handle portion of the control input has a shape substantially the same as the staple assembly.
[00267] An 18th embodiment is any combination of the first 17 embodiments, wherein movement of the control input causes movement of the staple assembly.
[00268] In another aspect, a first embodiment is a robotic surgical system for use with a surgical instrument. The system comprises a robotic arm configured for coupling to the surgical instrument, an input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument and a control input comprising an adaptor and a handle. The adaptor is configured for removable coupling to the input device, the control input further comprising a user input such that movement of the user input causes the desired movement of the robotic arm. The system further comprises a controller configured to control the robotic arm based on the movement of the user interface.
[00269] A second embodiment is the first embodiment, wherein the input device comprises a first electrical connection coupling the input device to the controller, the adaptor of the control input further comprising a second electrical connection configured for removable coupling to the first electrical connection.
[00270] A 3rd embodiment is any combination of the first 2 embodiments, wherein the input device comprises a shaft and the adaptor of the control input comprises a tube having an internal channel with a diameter greater than a diameter of the shaft of the input device.
[00271] A 4th embodiment is any combination of the first 3 embodiments, wherein the handle comprises a gripping member extending transversely to the shaft of the input device, wherein the user input is disposed on the gripping member.
[00272] A 5th embodiment is any combination of the first 4 embodiments, wherein the gripping member extends substantially in a vertical direction relative to the user and the user input comprises a button disposed on an upper surface of the gripping member.
[00273] A 6th embodiment is any combination of the first 5 embodiments, further comprising a second user input on the gripping member, wherein the second user input comprises a switch disposed on the upper surface of the gripping member.
[00274] A 7th embodiment is any combination of the first 6 embodiments, wherein the handle comprises a shaft rotatably coupled to the adaptor.
[00275] An 8th embodiment is any combination of the first 7 embodiments, wherein the shaft comprises a channel and the user input comprises a slider slidably disposed within the channel and configured for longitudinal movement relative to the shaft.
[00276] A 9th embodiment is any combination of the first 8 embodiments, wherein the surgical instrument comprises a needle delivery instrument comprising a shaft and a needle, wherein longitudinal movement of the slider causes longitudinal movement of the needle relative to the shaft.
[00277] A 10th embodiment is any combination of the first 9 embodiments, wherein the needle delivery instrument comprises an end effector rotatably coupled to the shaft, wherein rotational movement of the handle of the control input causes rotational movement of the end effector relative to the shaft.
[00278] A 11th embodiment is any combination of the first 10 embodiments, wherein the handle comprises first and second arms rotatably coupled to the adaptor at a joint.
[00279] A 12th embodiment is any combination of the first 11 embodiments, wherein the first and second arms are movable towards and away from each other.
[00280] A 13th embodiment is any combination of the first 12 embodiments, wherein the surgical instrument comprises a needle holder comprising a shaft having an end effector comprising first and second jaws movable towards and away from each other.
[00281] A 14th embodiment is any combination of the first 13 embodiments, wherein movement of the first and second arms relative to each other causes movement of the first and second jaws relative to each other.
[00282] A 15th embodiment is any combination of the first 14 embodiments, wherein rotational movement of the first and second arms relative to the adaptor causes rotational movement of the end effector relative to the shaft of the needle holder.
[00283] A 16th embodiment is any combination of the first 15 embodiments, wherein the handle is rotatably coupled to the adaptor at a joint and comprises a base portion on a proximal portion of the handle opposite the adaptor configured for gripping with a palm.
[00284] A 17th embodiment is any combination of the first 16 embodiments, further comprising first and second user inputs disposed between the base portion and the adaptor and configured for manipulation with a finger or thumb.
[00285] An 18th embodiment is any combination of the first 17 embodiments, wherein the first and second user inputs comprise first and second buttons disposed on a distal surface of the handle.
[00286] A 19th embodiment is any combination of the first 18 embodiments, further comprising a third user input disposed on the handle between the proximal portion and the distal surface.
[00287] A 20th embodiment is any combination of the first 19 embodiments, wherein the surgical instrument comprises a clamping instrument having an elongate shaft, first and second movable jaws and one or more electrodes on at least one of the movable jaws, wherein rotational movement of the handle relative to the adaptor causes rotational movement of the jaws relative to the shaft of the clamping instrument.
[00288] A 21st embodiment is any combination of the first 20 embodiments, wherein manipulation of the first button causes the first and second jaws to move together to clamp tissue disposed therebetween.
[00289] A 22nd embodiment is any combination of the first 21 embodiments, wherein manipulation of the second button causes an electrical impulse to be applied to the one or more electrodes.
[00290] A 23rd embodiment is any combination of the first 22 embodiments, wherein the clamping instrument further comprises a cutting element movably disposed relative to the first and second jaws, wherein manipulation of the third user input causes longitudinal movement of the cutting element.
[00291 ] A 24th embodiment is any combination of the first 23 embodiments, wherein the handle comprises a pistol grip rotatably coupled to the adaptor at a joint.
[00292] A 25th embodiment is any combination of the first 24 embodiments, wherein the pistol grip comprises a proximal base portion for gripping by a palm and a trigger disposed on a distal surface of the pistol grip.
[00293] A 26th embodiment is any combination of the first 25 embodiments, wherein the handle further comprises one or more user inputs located on an upper portion of the proximal base portion.
[00294] A 27th embodiment is any combination of the first 26 embodiments, wherein the surgical instrument comprises a shaft, an end effector and a driver for applying a fastener to tissue, wherein rotational movement of the pistol grip relative to the adaptor causes rotational movement of the end effector relative to the shaft of the surgical instrument.
[00295] A 28th embodiment is any combination of the first 27 embodiments, wherein manipulation of the trigger causes the driver to apply the fastener to the tissue.
[00296] A 29th embodiment is any combination of the first 28 embodiments, wherein the input device comprises a first end and a second end, the system further comprising a monitor for providing a view of a surgical site within the patient.
[00297] A 30th embodiment is any combination of the first 29 embodiments, wherein the control input is removably coupled to the first end of the input device.
[00298] A 31st embodiment is any combination of the first 30 embodiments, further comprising an endoscope coupled to the monitor and having a distal viewing end facing a first direction for providing the view of the surgical site on the monitor.
[00299] A 32nd embodiment is any combination of the first 31 embodiments, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 0 degrees to about 90 degrees relative to the first direction and wherein the control input is removably coupled to the first end of the input device.
[00300] A 33rd embodiment is any combination of the first 32 embodiments, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 90 degrees to about 270 degrees relative to the first direction and wherein the control input is removably coupled to the second end of the input device..
[00301] A 34th embodiment is any combination of the first 33 embodiments, further comprising a second control input removably coupled to the first end of the input device, wherein movement of the first control input in a first direction causes movement of the instrument in the first direction and wherein movement of the second control input in a second direction causes movement of the instrument in the second direction.
[00302] A 35th embodiment is any combination of the first 34 embodiments, wherein the instrument is a first instrument having a distal end facing away from the view on the monitor, the system further comprising a second instrument having a distal end facing towards the view on the monitor.
[00303] A 36th embodiment is any combination of the first 35 embodiments, wherein the first control input is configured to control the first instrument and the second control input is configured to control the second instrument.
[00304] In another aspect, a first embodiment includes any of the system embodiments described above, wherein the instrument comprises a circular surgical stapling instrument comprising: a staple assembly comprising a plurality of staples and a cutting element; an anvil positioned distal to the staple assembly; and a driver configured to advance the staples and the cutting element such that the staples contact the anvil before the cutting element is advanced distal of the staple assembly.
[00305] A second embodiment is the first embodiment, wherein the driver simultaneously advances the staples and the cutting element.
[00306] A third embodiment is any combination of the above embodiments, wherein the driver advances the staples a first distance and the cutting element a second distance, wherein the second distance is greater than the first distance.
[00307] A 4th embodiment is any combination of the above embodiments, wherein the cutting element is recessed proximally from the staples before the driver advances the staples.
[00308] A 5th embodiment is any combination of the above embodiments, wherein the driver is configured to sequentially advance the staples and then the cutting element.
[00309] A 6th embodiment is any combination of the above embodiments, wherein the staples are deformed against the anvil before the cutting element advances distally of the staple assembly.
[00310] A 7th embodiment is any combination of the above embodiments, further comprising a first pusher coupled to the staples and a second pusher coupled to the cutting element, wherein the driver comprises a rotatable element coupled to the first and second pushers.
[00311] An 8th embodiment is any combination of the above embodiments, wherein the rotation of the driver causes longitudinal movement of the first and second pushers.
[00312] A 9th embodiment is any combination of the above embodiments, wherein the driver comprises a first set of threads coupled to the first pusher and a second set of threads coupled to the second pusher.
[00313] A 10th embodiment is any combination of the above embodiments, wherein the first and second sets of threads are longitudinally spaced from each other to define a gap therebetween.
[00314] An 11th embodiment is any combination of the above embodiments, wherein the first and second pushers each comprise threads configured to cooperate with the first and second sets of threads of the driver, respectively, to advance the first and second pushers upon rotation of the driver.
[00315] A 12th embodiment is any combination of the above embodiments, wherein the first set of threads on the driver disengages from the threads on the first pusher while the second set of threads are still engaged with the threads of the second pusher.
[00316] A 13th embodiment is any combination of the above embodiments, wherein the first set of threads has a different pitch than the second set of threads.
[00317] A 14th embodiment is any combination of the above embodiments, wherein the driver is disposed within the first and second pushers and the first and second sets of threads are disposed on an outer surface of the driver.
[00318] A 15th embodiment is any combination of the above embodiments, wherein the driver is disposed laterally outward from the first and second pushers.
[00319] A 16th embodiment is any combination of the above embodiments, wherein the driver is disposed laterally outward from the second pusher and laterally inward from the first pusher.
[00320] A 17th embodiment is any combination of the above embodiments, wherein the driver defines an internal channel, the instrument further comprising a capturing device configured to advance through the internal channel to engage the anvil.
[00321 ] An 18th embodiment is any combination of the above embodiments, wherein the staples are disposed circumferentially around an internal channel within the stapling assembly, the instrument further comprising an annular staple alignment guide disposed between the staples and the anvil.
[00322] A 19th embodiment is any combination of the above embodiments, wherein the cutting element is disposed laterally inward from the staples and has a substantially annular shape.
[00323] A 20th embodiment is any combination of the above embodiments, wherein the driver is positioned within the channel and spaced laterally inward from the staples and the cutting element.
[00324] A 21st embodiment is any combination of the above embodiments, further comprising an elongate shaft with a wrist, wherein the stapling assembly is rotatably coupled to the shaft at the wrist.
[00325] A 22nd embodiment is any combination of the above embodiments, wherein the driver extends through the wrist and comprises a flexible portion configured to bend as the stapling assembly rotates relative to the shaft.
[00326] A 23rd embodiment is any combination of the above embodiments, wherein the driver comprises a compressive element coupled to the first and second pushers, wherein longitudinal movement of the compressive element advances the first and second pushers.
[00327] A 24th embodiment is any combination of the above embodiments, wherein the compressive element comprises a bendable hypo tube.
[00328] A 25th embodiment is any combination of the above embodiments, further comprising an actuator coupled to a proximal end of the driver and configured to rotate the driver.
[00329] A 26th embodiment is any combination of the above embodiments, wherein the actuator is configured for coupling to a robotic surgical system.
[00330] A 27th embodiment is any combination of the above embodiments, wherein the driver comprises a first component for advancing the staples and a second component for advancing the cutting element.
[00331] A 28th embodiment is any combination of the above embodiments wherein the driver is configured to apply a first force to the staples to advance the staples and a second force to the cutting element to advance the cutting element, wherein the first force is greater than the second force.
[00332] A 29th embodiment is the 28th embodiment with any combination of the above embodiments.
[00333] A 30th embodiment is any combination of the above embodiments, wherein a ratio of the second force to the first force is about 1 : 1.25 to about 1 :2.
[00334] A 31st embodiment is any combination of the above embodiments, wherein a ratio of the second force to the first force is about 1 : 1.5.
[00335] A 32nd embodiment is any combination of the above embodiments, wherein the driver is configured to advance the staples and the cutting element such that the staples contact the anvil before the cutting element is advanced distal of the stapling assembly.
[00336] A 33rd embodiment is any combination of the above embodiments, further comprising a first pusher coupled to the staples and a second pusher coupled to the cutting element, wherein the driver comprises a rotatable element coupled to the first and second pushers.
[00337] A 34th embodiment is any combination of the above embodiments, wherein the rotation of the driver causes longitudinal movement of the first and second pushers.
[00338] A 35th embodiment is any combination of the above embodiments, wherein the driver comprises a first set of threads coupled to the first pusher and a second set of threads coupled to the second pusher.
[00339] A 36th embodiment is any combination of the above embodiments, wherein the first set of threads has a first thread pitch and the second set of threads has a second thread pitch, wherein a ratio of the second thread pitch to the first thread pitch is about 1 : 1.25 to about 1 : 2.0.
[00340] A 37th embodiment is any combination of the above embodiments, wherein the ratio is about 1 : 1.5.
[00341] A 38th embodiment is any combination of the above embodiments, wherein the first and second pushers each comprise threads configured to cooperate with the first and second sets of threads of the driver, respectively, to advance the first and second pushers upon rotation of the driver.
[00342] A 39th embodiment is any combination of the above embodiments, wherein the first set of threads on the driver disengages from the threads on the first pusher while the second set of threads are still engaged with the threads of the second pusher.

Claims

1. A robotic surgical system for use with a surgical instrument comprising: a robotic arm configured for coupling to the surgical instrument; an input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument; a control input comprising an adaptor and a handle, wherein the adaptor is configured for removable coupling to the input device, wherein movement of the handle of the control input causes movement of the input device to provide the desired movement of the robotic arm; and a controller configured to control the robotic arm based on the movement of the input device.
2. The system of claim 1, wherein the input device comprises a first electrical connection coupling the input device to the controller, the adaptor of the control input further comprising a second electrical connection configured for removable coupling to the first electrical connection.
3. The system of claim 2, wherein the control input comprises a user interface coupled to the second electrical connection, wherein movement of the user interface generates an electrical signal transmitted from the second electrical connection through the first electrical connection to the controller.
4. The system of any one of claims 1 to 3, wherein the input device comprises a first end and a second end, the system further comprising a monitor for providing a view of a surgical site within the patient.
5. The system of claim 4, further comprising an endoscope coupled to the monitor and having a distal viewing end facing a first direction for providing the view of the surgical site on the monitor.
6. The system of claim 5, wherein the control input is removably coupled to the first end of the input device.
7. The system of claim 6, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 0 degrees to about 90 degrees relative to the first direction and wherein the control input is removably coupled to the first end of the input device.
8. The system of claim 5, wherein the control input is removably coupled to the second end of the input device.
9. The system of claim 8, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 90 degrees to about 270 degrees relative to the first direction and wherein the control input is removably coupled to the second end of the input device.
10. The system of claim 9, further comprising a second control input removably coupled to the first end of the input device, wherein movement of the first control input in a first direction causes movement of the instrument in the first direction and wherein movement of the second control input in a second direction causes movement of the instrument in the second direction.
11. The system of any one of claims 9 and 10, wherein the instrument is a first instrument having a distal end facing away from the view on the monitor, the system further comprising a second instrument having a distal end facing towards the view on the monitor.
12. The system of any one of claims 10 and 11, wherein the first control input is configured to control the first instrument and the second control input is configured to control the second instrument.
13. The system of any one of claims 1 to 12, wherein the input device comprises a shaft and the adaptor of the control input comprises a tube having an internal channel with a diameter greater than a diameter of the shaft of the input device.
14. The system of claim 13, wherein the tube of the control input is configured to advance over the shaft of the input device.
15. The system of any one of claims 1 to 14, wherein the handle comprises an elongate shaft coupled to the adaptor and a proximal handle portion coupled to the shaft opposite the adaptor.
16. The system of claim 15, wherein the proximal handle portion comprises a substantially cylindrical shape with a larger diameter than the elongate shaft of the handle.
17. The system of claim 16, wherein the surgical instrument comprises a circular stapling instrument comprising a staple assembly and an anvil removably coupled to the staple assembly, wherein the proximal handle portion of the control input has a shape substantially the same as the staple assembly.
18. The system of claim 17, wherein movement of the control input causes movement of the staple assembly.
19. The system of claim 17, wherein the staple assembly comprises a plurality of staples and a cutting element and the surgical instrument further comprises a driver configured to advance the staples and the cutting element such that the staples contact the anvil before the cutting element is advanced distal of the staple assembly.
20. The system of claim 19, further comprising a first pusher coupled to the staples and a second pusher coupled to the cutting element, wherein the driver comprises a rotatable element coupled to the first and second pushers, wherein the rotation of the driver causes longitudinal movement of the first and second pushers.
21. The system of claim 20, wherein the driver comprises a first set of threads coupled to the first pusher and a second set of threads coupled to the second pusher, wherein the first and second sets of threads are longitudinally spaced from each other to define a gap therebetween, wherein the first and second pushers each comprise threads configured to cooperate with the first and second sets of threads of the driver, respectively, to advance the first and second pushers upon rotation of the driver.
22. The system of claim 21, wherein the first set of threads on the driver disengages from the threads on the first pusher while the second set of threads are still engaged with the threads of the second pusher.
23. The system of any one of claims 19-2, wherein the first set of threads has a different pitch than the second set of threads.
24. A robotic surgical system for use with a surgical instrument comprising: a robotic arm configured for coupling to the surgical instrument; an input device remotely spaced from the robotic arm and movable to provide a desired movement of the robotic arm and the surgical instrument; a control input comprising an adaptor and a handle, wherein the adaptor is configured for removable coupling to the input device, the control input further comprising a user input, wherein movement of the user input causes the desired movement of the robotic arm; and a controller configured to control the robotic arm based on the movement of the user interface.
25. The system of claim 24, wherein the input device comprises a first electrical connection coupling the input device to the controller, the adaptor of the control input further comprising a second electrical connection configured for removable coupling to the first electrical connection.
26. The system of any one of claims 24 to 25, wherein the input device comprises a shaft and the adaptor of the control input comprises a tube having an internal channel with a diameter greater than a diameter of the shaft of the input device.
27. The system of any one of claims 24 to 26, wherein the handle comprises a gripping member extending transversely to the shaft of the input device, wherein the user input is disposed on the gripping member.
28. The system of claim 27, wherein the gripping member extends substantially in a vertical direction relative to the user and the user input comprises a button disposed on an upper surface of the gripping member.
29. The system of claim 28, further comprising a second user input on the gripping member, wherein the second user input comprises a switch disposed on the upper surface of the gripping member.
30. The system of any one of claims 24 to 29, wherein the handle comprises a shaft rotatably coupled to the adaptor.
31. The system of claim 30, wherein the shaft comprises a channel and the user input comprises a slider slidably disposed within the channel and configured for longitudinal movement relative to the shaft.
32. The system of claim 31, wherein the surgical instrument comprises a needle delivery instrument comprising a shaft and a needle, wherein longitudinal movement of the slider causes longitudinal movement of the needle relative to the shaft.
33. The system of claim 32, wherein the needle delivery instrument comprises an end effector rotatably coupled to the shaft, wherein rotational movement of the handle of the control input causes rotational movement of the end effector relative to the shaft.
34. The system of any one of claims 24 to 33, wherein the handle comprises first and second arms rotatably coupled to the adaptor at a joint.
35. The system of claim 34, wherein the first and second arms are movable towards and away from each other.
36. The system of claim 35, wherein the surgical instrument comprises a needle holder comprising a shaft having an end effector comprising first and second jaws movable towards and away from each other.
37. The system of claim 36, wherein movement of the first and second arms relative to each other causes movement of the first and second jaws relative to each other.
38. The system of claim 36, wherein rotational movement of the first and second arms relative to the adaptor causes rotational movement of the end effector relative to the shaft of the needle holder.
39. The system of any one of claims 24 to 38, wherein the handle is rotatably coupled to the adaptor at a joint and comprises a base portion on a proximal portion of the handle opposite the adaptor configured for gripping with a palm.
40. The system of claim 39, further comprising first and second user inputs disposed between the base portion and the adaptor and configured for manipulation with a finger or thumb.
41. The system of claim 40, wherein the first and second user inputs comprise first and second buttons disposed on a distal surface of the handle.
42. The system of claim 41, further comprising a third user input disposed on the handle between the proximal portion and the distal surface.
43. The system of claim 42, wherein the surgical instrument comprises a clamping instrument having an elongate shaft, first and second movable jaws and one or more electrodes on at least one of the movable jaws, wherein rotational movement of the handle relative to the adaptor causes rotational movement of the jaws relative to the shaft of the clamping instrument.
44. The system of claim 43, wherein manipulation of the first button causes the first and second jaws to move together to clamp tissue disposed therebetween.
45. The system of claim 44, wherein manipulation of the second button causes an electrical impulse to be applied to the one or more electrodes.
46. The system of claim 45, wherein the clamping instrument further comprises a cutting element movably disposed relative to the first and second jaws, wherein manipulation of the third user input causes longitudinal movement of the cutting element.
47. The system of any one of claims 24 to 46, wherein the handle comprises a pistol grip rotatably coupled to the adaptor at a joint.
48. The system of claim 47, wherein the pistol grip comprises a proximal base portion for gripping by a palm and a trigger disposed on a distal surface of the pistol grip.
49. The system of claim 48, wherein the handle further comprises one or more user inputs located on an upper portion of the proximal base portion.
50. The system of claim 49, wherein the surgical instrument comprises a shaft, an end effector and a driver for applying a fastener to tissue, wherein rotational movement of the pistol grip relative to the adaptor causes rotational movement of the end effector relative to the shaft of the surgical instrument.
51. The system of claim 50, wherein manipulation of the trigger causes the driver to apply the fastener to the tissue.
52. The system of any one of claims 24 to 51, wherein the input device comprises a first end and a second end, the system further comprising a monitor for providing a view of a surgical site within the patient.
53. The system of claim 52, wherein the control input is removably coupled to the first end of the input device.
54. The system of claim 53, further comprising an endoscope coupled to the monitor and having a distal viewing end facing a first direction for providing the view of the surgical site on the monitor.
55. The system of claim 54, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 0 degrees to about 90 degrees relative to the first direction and wherein the control input is removably coupled to the first end of the input device.
56. The system of claim 54, wherein the surgical instrument has a distal end facing a second direction and the second direction is between about 90 degrees to about 270 degrees relative to the first direction and wherein the control input is removably coupled to the second end of the input device.
57. The system of any one of claims 52 to 56, further comprising a second control input removably coupled to the first end of the input device, wherein movement of the first control input in a first direction causes movement of the instrument in the first direction and wherein movement of the second control input in a second direction causes movement of the instrument in the second direction.
58. The system of claim 57, wherein the instrument is a first instrument having a distal end facing away from the view on the monitor, the system further comprising a second instrument having a distal end facing towards the view on the monitor.
59. The system of claim 58, wherein the first control input is configured to control the first instrument and the second control input is configured to control the second instrument.
PCT/US2025/0200752024-03-182025-03-14Control devices for robotic surgery systemsPendingWO2025198972A1 (en)

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