Hybrid, direct-control, and robotic-assisted surgical systems
By designing a hybrid surgical system that combines manual laparoscopy and remote operation robot-assisted, the existing system is addressed with high cost, high complexity and lack of direct interaction, reducing complexity, cost and setup time while providing natural force feedback and high-precision operation.
Patent Information
- Application Number
- CN202080063232.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-09-14
- Filing Date
- 2020-09-14
- Publication Date
- 2025-06-06
- Estimated Expiration
- 2040-09-14
AI Technical Summary
The existing remote-operated robot-assisted surgical systems have problems such as high cost, high complexity, long setup time and lack of direct interaction between surgeons and patients.
Design a hybrid, direct control and robot-assisted surgical system that combines the key features of manual laparoscopy and remotely operated robot-assisted systems, employs a compact balanced remote motor center mechanism that supports interchangeable surgical tools and provides electric actuation when needed.
Reduces system complexity and cost, simplifies setup time, while providing natural force feedback, improving surgeons' operational convenience and precision.
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Figure CN114423366B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 900,471, filed on September 14, 2019, the entire contents of which are hereby incorporated by reference. Technical Field
[0003] In one aspect of the present invention, the present invention is directed to a hybrid, directly controlled and robotically assisted surgical system stabilization device, which can be used to support at least a portion of the weight of a surgical device used by a user / surgeon, so that at least some movements of the surgical device are manually driven by the user, while at least some functions of the surgical device can be driven by an electric actuation unit. Background Art
[0004] U.S. Patent No. 10,639,066 (Vidal et al.) discloses a system for controlling the displacement of an intervention device having an end for insertion into a patient's body, comprising a base in a fixed position relative to the patient. The first part has an arc-shaped part and is pivotally mounted on the base around a first axis (A1). The second part comprises a support member and a bearing member. The support member partially rotates around a second axis (A2). The third part comprises a retaining member, and a sliding member mounted on the support member along a translation axis (AT). The retaining member is arranged so that the translation of the sliding member causes the intervention device to translate along a third axis (A3). The third axis (A3) is parallel to the translation axis (AT) and offset from the translation axis. When the bearing member is located in the middle of the arc-shaped part, the first axis (A1), the second axis (A2) and the third axis (A3) are orthogonal.
[0005] U.S. Patent No. 9,999,473 (Madhani et al.) discloses an articulated surgical instrument for enhancing the performance of minimally invasive surgery. The instrument has a high degree of dexterity, low friction, low inertia, and good force reflection. A unique cable and pulley drive system operates to reduce friction and enhance force reflection. A unique wrist mechanism operates to enhance surgical dexterity compared to standard laparoscopic instruments. The system is optimized to reduce the number of actuators required and thus produce a fully functional articulated surgical instrument of minimal size.
[0006] U.S. Patent Publication No. 2008 / 0091066 discloses an improved interface between a surgeon and an endoscopic system for laparoscopic surgery, the interface holding a laparoscopic camera and / or controlling an automated endoscopic assistant, the interface comprising: at least one wireless transmitter having at least one operating key (12a); at least one wireless receiver (11); at least one conventional laparoscopic computerized system (15) loaded with conventional surgical instrument spatial positioning software and conventional automated assisted manipulation software, the software loaded onto the conventional laparoscopic system being capable of visually responding to depressions of at least one key on the wireless transmitter and interfacing with the conventional automated assisted manipulation software to effect movement of the endoscope; and at least one video screen (30). Summary of the invention
[0007] Abdominal surgery (e.g., general surgery, gynecological surgery, urological surgery, etc.) typically uses an open approach (where a large incision is made to access the surgical site) or a minimally invasive surgery (MIS) approach (where multiple smaller incisions are made), and uses elongated instruments to manipulate the tissue of the surgical site. MIS, also known as keyhole or laparoscopic surgery, provides many advantages to patients, such as reducing blood loss, reducing scars, and shortening hospital stays. However, in many cases, the MIS approach is very difficult to perform and an open approach is implemented instead. Multiple reasons cause the challenges of MIS, but the main difficulty stems from the limitations of surgical instruments and the lack of adequate visualization. Surgical instruments generally lack dexterity, so it is difficult to perform delicate tasks such as suturing in highly confined spaces.
[0008] Robotic-assisted surgery makes difficult MIS surgeries easier to perform by providing many advantages, including improved surgical instrument dexterity, improved visualization, motion scaling, and improved ergonomics. Since the FDA approval of the da Vinci Surgical System (dVSS) by Intuitive Surgical in 2000, the use of robots in surgery has continued to increase. In 2018, dVSS was used in more than 1 million surgeries worldwide. Robotic-assisted surgical systems are typically remotely operated, with the surgeon sitting at a main console and the surgeon's hand movements replicated by one or more robotic arms that operate on the patient. Examples of other remotely operated robotic-assisted systems include products under development or on the market from companies such as CMR Surgical, TransEnterix, Titan Medical, and Medtronic.
[0009] Currently available teleoperated robotic-assisted systems have several disadvantages. Most importantly, many in the medical community claim that there is not enough clinical evidence to justify the cost of robotic-assisted surgery compared to traditional minimally invasive surgery; the capital cost of these robotic systems can exceed $2 million (USD) and can range from $2,000 to $6,000 more per procedure compared to traditional laparoscopic surgery. Another major disadvantage is the lack of direct surgeon-patient interaction, as the surgeon sits at the main console during the procedure, resulting in a loss of any natural tactile feedback and an increased risk of injury due to erroneous instrument movement. Additionally, current surgical robotic systems are bulky, require expensive maintenance due to their complexity, and increase setup time compared to traditional surgery, resulting in longer surgeries.
[0010] The teachings herein describe a surgical system that is intended to combine at least some of the key features of manual laparoscopic surgery and remotely operated robotically assisted surgical systems. More specifically, the teachings herein relate to a compact, balanced remote center of motion mechanism to which interchangeable surgical tools (e.g., wristed surgical instruments and / or endoscopes, etc.) are attached if desired and to which electric actuation is provided when necessary. The system preferably allows the surgeon to manually position the distal end / tip of the attached surgical device while providing robotic assistance to control the end effector of the device when necessary, for example by driving the orientation of the wristed end effector by replicating the surgeon's hand orientation on the handle portion of the system.
[0011] Thus, the teachings described herein can provide one or more advantages of robotic-assisted surgery, such as relatively increased dexterity and reduced technical complexity. This reduced complexity can be facilitated by reducing and / or eliminating remote operation methods. Instead, robotic assistance is directly integrated into a laparoscope-like instrument supported by a mechanism that can be directly attached to an operating table, or ceiling-mounted or vehicle-mounted. By effectively integrating robotic assistance directly into surgical instruments, complexity, cost, and setup time are reduced while still providing natural force feedback.
[0012] According to one broad aspect of the teachings described herein, a hybrid, direct-control, and robotic-assisted surgical system for a surgical device may include a stabilizing device configured to at least partially support the weight of a surgical device and define a remote center of motion, the surgical device having an elongated shaft extending from a distal tip including an end effector. The stabilizing device may have a base member configured to be fixed relative to a patient, and the stabilizing device may include a device attachment unit that is movable relative to the base member and configured to removably receive a surgical device having an elongated shaft and a distal tip. The stabilizing device may be configured to constrain movement of the device attachment unit such that the device attachment unit and the distal tip are on opposite sides of the remote center of motion and the elongated shaft intersects the remote center of motion when the stabilizing device is in use. A handle may be mechanically attached to the device attachment unit and may be configured to be grasped by a user, whereby the handle causes a corresponding Cartesian movement of the distal tip of the surgical device received in the device attachment unit by manual Cartesian movement of the user relative to the base member. The robotic-assisted system can be configured to drive an end effector of a surgical device and can include: a sensor assembly configured to monitor at least a first property of a handle and generate a corresponding sensor signal; a controller communicatively connected to the sensor assembly to receive the sensor signal and generate a corresponding main control signal; and an electric actuation unit communicatively connected to the controller to receive the main control signal and configured to actuate the end effector of the surgical device received in a device attachment unit based on the main control signal.
[0013] The stabilization device may further include: a hub rotatably connected to the base and rotatable around a rotation axis; an arcuate track connected to the hub and extending around a center of curvature; and a linear translation device connected to the arcuate track and movable relative to the hub so as to be pivotable around a pivot axis passing through the center of curvature. The device attachment unit may translate relative to the arcuate track along the translation axis.
[0014] The intersection of the rotation axis, the pivot axis, and a device axis parallel to the translation axis may define a remote center of motion of the stabilization device. The device attachment unit may be configured such that when the surgical device is attached to the device attachment unit, the elongated shaft extends along the device axis and intersects the remote center of motion.
[0015] The linear translation apparatus may include a linear rail extending from a fixed end connected to the arcuate rail to a free end axially spaced from the fixed end, and wherein the device attachment unit is slidably connected to the linear rail and translatable between the fixed end and the free end.
[0016] The translational balancing system may be configured to apply a biasing force on the device attachment unit to at least partially balance the mass of the device attachment unit when the device attachment unit translates along the translation axis.
[0017] The arcuate track may be movably connected to the hub so as to be pivotable about the pivot axis.The linear translation device may be non-movably connected to the arcuate track.
[0018] The arc balancing system may include a biasing device configured to apply a biasing force on the arcuate track to at least partially balance the torque acting about the pivot axis.
[0019] The surgical device may be removed from the device attachment unit independently of the handle.The device attachment unit may be configured to removably receive a second surgical device.
[0020] The device attachment unit may be moved relative to the base member in response to manual input from a user and without engaging the motor when the system is in use.
[0021] The handle may include a grip portion movable relative to the device attachment unit about at least a first degree of freedom. The first property may include an orientation of the handle about the first degree of freedom.
[0022] The handle may also be movable relative to the device attachment unit about at least second and third degrees of freedom.The sensor assembly may be configured to monitor: a second property including orientation of the handle about the second degree of freedom; and a third property including orientation of the handle about the third degree of freedom.
[0023] The handle may include a wrist grip portion that is movable relative to the device attachment unit around a pitch axis, a roll axis, and a yaw axis. The sensor assembly may be configured to detect movement around each of the pitch axis, the roll axis, and the yaw axis. The sensor signal may include a multi-channel signal. The primary control signal may include a corresponding multi-channel control signal. The electric actuation unit may be configured to cause corresponding movement of the end effector around the actuator pitch axis, the actuator roll axis, and the actuator yaw axis, whereby movement of the grip portion may be converted into corresponding movement of the end effector via the robotic assistance system.
[0024] The electric actuation unit may include a plurality of rotatable actuation discs configured to engage with corresponding drive discs on the surgical device, thereby driving the end effector about an effector pitch axis, an effector roll axis, and an effector yaw axis.
[0025] The sensor assembly may include at least one potentiometer or encoder to detect the orientation / position of the handle about at least one of the pitch axis, the roll axis and the yaw axis.
[0026] The pitch axis, the roll axis, and the yaw axis may intersect each other at a common point.
[0027] The handle may further include an auxiliary user input device communicatively connected to the controller. The controller may be configured such that triggering the auxiliary user input device triggers a corresponding auxiliary action on the end effector.
[0028] The auxiliary user input device may include at least one of a switch, a button, and a knob, and the auxiliary action on the end effector may include at least one of cauterization, grasping, irrigation, and suction.
[0029] The translational balancing system may include a counterweight translatable along the linear track and operably connected to the device attachment unit, whereby translation of the device attachment unit causes relative translation of the counterweight to at least partially balance translation of the device attachment unit along the linear track.
[0030] The device attachment unit may be attached to a first side of the linear track, and wherein a counterweight is attached to an opposing second side of the linear track, and when the device attachment unit translates in one direction, the counterweight translates in an opposite direction, thereby balancing the device attachment unit.
[0031] When the surgical device is attached to the device attachment unit, the combined linear centroid of the linear track, the device attachment unit, the handle, the surgical device, and the counterweight can be located at a reference position relative to the remote center of motion. When the device attachment unit and the counterweight translate along the linear track, the combined linear centroid substantially remains in the reference position.
[0032] The mass of the counterweight may be substantially equal to the combined mass of the device attachment unit, the handle, and the surgical device.
[0033] As the angular position of the first end of the bow track relative to the hub changes from about 0 degrees to about 90 degrees, the magnitude of the torque acting about the remote center of motion can increase, and the biasing device can be configured so that the magnitude of the biasing force increases as the angular position of the first end of the bow track relative to the hub changes from about 0 degrees to about 90 degrees.
[0034] The magnitude of the biasing force may remain substantially equal to the magnitude of the torque when the angular position of the first end of the arcuate track relative to the hub is between about 0 degrees and about 90 degrees.
[0035] The device attachment unit may include an electric actuation unit, whereby the electric actuation unit is movable in unison with the device attachment unit relative to the base member.
[0036] The controller may be communicatively connected to the sensor assembly using at least one of a cable and a wireless communication protocol.
[0037] The device attachment unit may be configured such that when the surgical device is attached to the device attachment unit, the axis of the elongated shaft is parallel to the translation axis.
[0038] The device attachment unit can translate along the linear track independently of moving the arcuate track relative to the hub.
[0039] The hub, arcuate track, and device attachment unit may move in response to manual input from a user without engaging a motor.
[0040] When the base member is fixed, the axis of rotation may be substantially vertical.
[0041] The braking device may be selectively engageable to prevent movement of the device attachment unit about at least one of the rotational axis, the pivotal axis and the translational axis.
[0042] The handle may be mechanically attached to the device attachment unit such that a force exerted on the distal tip of a surgical device received in the device attachment unit is transmitted to the handle, thereby providing passive force feedback to a user grasping the handle.
[0043] The stabilization device may include: a hub, which is rotatably connected to the base and can rotate around a rotation axis; a parallelogram structure, which is connected to the hub; and a linear translation device, which is connected to a movable end of the parallelogram structure and can move relative to the hub together with the movable end of the parallelogram structure so as to be pivotable around a pivot axis, wherein the device attachment unit can translate along the translation axis relative to the parallelogram structure.
[0044] The companion stabilization device may be configured to at least partially support the weight of the companion surgical device. The companion stabilization device may have a companion base component configured to be fixed relative to the patient, and the companion stabilization device may include a companion device attachment unit that is movable relative to the companion base component and configured to removably receive a companion surgical device having an elongated shaft and a distal tip. The robotic-assisted system may also include a companion electric actuation unit that is communicatively connected to the controller. The system may optionally operate in a companion mode, wherein: the controller receives the sensor signal and generates a corresponding companion control signal; and the companion electric actuation unit may actuate the companion surgical device based on the companion control signal.
[0045] When the system is in the companion mode, the controller may not generate primary control signals, whereby movement of the handle does not actuate the end effector of the surgical device received in the device attachment unit.
[0046] The companion stabilization device can be configured to define a second remote motion center and constrain the movement of the companion device attachment unit so that the distal tips of the companion device attachment unit and the companion surgical device are on opposite sides of the second remote motion center, and when the companion stabilization device is in use, the slender shaft of the companion device can intersect the second remote motion center.
[0047] The companion base member may be spaced apart from the base member.
[0048] The accompanying surgical device may include an endoscope. BRIEF DESCRIPTION OF THE DRAWINGS
[0049] Embodiments of the present disclosure will be described with reference to the accompanying drawings, wherein like reference numerals represent like parts, and wherein:
[0050] Figure 1 is a schematic illustration of an overview of one example of a surgical system deployed in an operating room;
[0051] Figure 2 is a perspective view of an example of a surgical system attached to an operating table;
[0052] Figure 3 is a schematic illustration of an example of a Remote Center of Motion (RCM) mechanism;
[0053] Figure 4 It is equipped with surgical instruments Figure 3 Schematic description of the RCM organization;
[0054] Figure 5 yes Figure 2 A front perspective view of a portion of a surgical system;
[0055] Figure 6 It is attached with surgical instruments Figure 5 A front perspective view of a portion of a surgical system;
[0056] Figure 7 is a side view of a portion of a surgical system with a surgical instrument attached;
[0057] Figure 8 It is a top view of the surgical system;
[0058] Figures 9 to 10 is a top view showing one example of a series of movements around the hub of the surgical system;
[0059] Figures 11 to 12 is a side view showing one example of a series of motions of one example of an arcuate track of a surgical system;
[0060] Figures 13 to 14 is a side view showing one example of a sequence of motions of a translation device of a surgical system;
[0061] Fig.15 It is an enlarged view of a portion of the surgical system;
[0062] Fig.16 It is taken along line 16-16 Fig.15 a cross-sectional perspective view of a portion of a surgical system shown in;
[0063] Fig.17 is a flow chart illustrating a schematic diagram of a local remote operation control;
[0064] Fig.18a is a side view of another example of a surgical system;
[0065] Fig.18b yes Fig.18a Another side view of the surgical system;
[0066] Fig.18c yes Fig.18a Another side view of the surgical system;
[0067] Fig.19 yes Fig.18a A cross-sectional view of a surgical system;
[0068] Fig. 20 is a partial cross-sectional view of one example of an electric actuation unit taken along line 20 - 20 ;
[0069] Fig.21 It is an enlarged view of the surgeon’s handle;
[0070] Fig. 22 is an enlarged view of an alternative surgeon's handle;
[0071] Fig.23 is a side view of the surgical system, highlighting the center of mass of the moving components;
[0072] Figures 24a to 24b is a schematic illustration showing an overview of moments that may be generated in a surgical system;
[0073] Fig.25 is a side view showing an overview of the balancing system;
[0074] Figures 26a to 26b is a schematic diagram illustrating an example of translational balancing for a surgical system;
[0075] Fig. 27 is a side view of an example of translational balancing for a surgical system;
[0076] Fig.28 is used for Fig. 27 A side view of an example of translational balancing of a surgical system;
[0077] Fig.29 is a schematic diagram showing an example of a balancing system for a surgical system;
[0078] Figures 30 to 31 is a cross-sectional view showing an example of a spring-cam balancing system for a surgical system;
[0079] Figures 32 to 33 is a cross-sectional view showing an example of a spring-cam balancing system for a surgical system;
[0080] Figures 34a to 34c is an example of a sinusoidal torque generated when using a surgical system;
[0081] Fig.35 is an example of a surgical system in which an electric actuator is used to balance the system; and
[0082] Fig.36 Describes an example of a surgical system in which a parallelogram structure is used to stabilize the device to form a remote center of motion;
[0083] Fig.37 is an example of a surgical system in which the attached surgical device is an endoscope; and
[0084] Fig.38 is a flow chart illustrating one example of a control scheme for operating a surgical system in companion mode. DETAILED DESCRIPTION
[0085] Various devices or processes will be described below to provide examples of embodiments of each claimed invention. The embodiments described below do not limit any claimed invention, and any claimed invention may cover processes or devices different from those described below. The claimed invention is not limited to devices or processes having all the features of any device or process described below, nor is it limited to features common to multiple or all devices described below. The device or process described below may not be an embodiment of any claimed invention. Any invention disclosed in the device or process described below that is not claimed in this document may be the subject of another protective device, such as the subject of a continuation patent application, and the applicant, inventor, or owner does not intend to abandon, give up, or dedicate any such invention to the public by disclosing in this document.
[0086] The teachings described herein relate at least in part to a surgical system comprising a stabilizing device having a device attachment unit that can receive one or more preferably interchangeable surgical devices such that when the surgical device is in use, at least a portion of the weight of the surgical device is supported by the stabilizing device. The surgical devices used with the system can be any suitable type of device and can include surgical instruments with some type of actively actuatable end effectors (including those with wrist-type end effectors), surgical instruments with relatively simple or static end effectors (suction devices or retractors), endoscopes, or other cameras or vision systems, etc. Preferably, a common stabilizing device can be used to support different types of surgical devices at different times. This can facilitate the use and preferably reuse of 1, 2 or more relatively standardized stabilizing devices by a variety of different surgical devices at different times, such as using one stabilizing device to support an endoscope and using a second stabilizing device to support a surgical instrument with a wrist-type end effector close to a single patient.
[0087] The stabilizing device can be configured to allow the supported surgical device to move around 1, 2, 3 or more degrees of freedom. This can allow the user to move the surgical device in the same manner as usual, so that the device can be moved without using the stabilizing device. Preferably, the stabilizing device can also constrain the movement of the surgical device (when attached) to a predetermined range of motion in one or more related degrees of freedom, so that it can allow the surgical device to move around the remote center of motion as described herein. In addition to supporting at least some of its weight, this can help guide and / or constrain the movement of the distal tip of the attached surgical device within a predefined field of motion. That is, the configuration of the joints in the stabilizing device is preferably specifically configured to facilitate surgery by limiting the movement of the attached surgical device to a series of movements around a pivot point for minimally invasive access (also referred to as a remote center of motion configuration). The surgeon can directly control the position and orientation of the end effector of the attached surgical device via any suitable user input device, such as a multi-degree-of-freedom (DOF) handle as part of the unit in the example described herein. The stabilization device is preferably configured so that the surgeon can control the position of the distal tip of the surgical instrument via the surgeon's handle in substantially the same manner as a manual instrument, with the entire motion assembly being preferentially constrained and supported by the remote center of motion.
[0088] Preferably, the stabilization device will include one or more device attachment units that can be configured to removably receive a surgical device so that two or more different surgical devices can be used with the stabilization device. This can include using a different type of surgical device in a subsequent surgery and / or using a new sterile version of the same type of surgical device. The surgical device used can be removed and, optionally, a different type of surgical device can be attached to the same device attachment unit without actually having to reconfigure the stabilization device or the device attachment unit itself.
[0089] Optionally, the surgical system may also include a robotic assistance system that may be configured to drive, manipulate, and otherwise actuate the end effector or other such actuatable features on the surgical device. Preferably, the robotic assistance unit may include a sensor assembly that is configured to monitor at least a first attribute or input from a user (e.g., the position of a handle, the triggering of a switch or button, the pressure applied to a pressure-sensitive sensor, etc.) using a suitable sensor and generate a corresponding sensor signal. The sensor signal may be provided to a suitable controller (which may be a computer, PLC, microprocessor, etc.), which may receive the sensor signal and generate a corresponding control or output signal suitable for the specific surgical device in use. The output signal is provided to a suitable electric actuation unit that is communicatively connected to the controller and configured to drive the surgical device in use. That is, the electric actuation unit is configured to engage and drive the end effector of the surgical device based on the user input, and preferably simulates the input from the user into a corresponding action / output of the end effector.
[0090] In some instances, the surgical device used may be a surgical instrument that has a wrist-type end effector to allow for increased dexterity and can be attached to or removed from the unit as needed during surgery, depending on the type of instrument required. The robotic-assisted unit is positioned above the patient during surgery by a positioning arm.
[0091] An example of a stabilization device unit may include a compact multi-degree-of-freedom joint mechanism that holds, stabilizes, and provides electric actuation for a wrist-type end effector to which a surgical instrument is attached. The configuration of the joint is preferably specialized for surgery by constraining motion to a pivot point for minimally invasive access (also known as a remote center of motion configuration). The surgeon directly controls the position and orientation of the end effector of the attached surgical instrument via a multi-degree-of-freedom (DOF) handle that is part of the unit. The surgeon controls the position of the distal tip of the instrument via the surgeon's handle only when the surgeon controls the manual instrument, where the motion is constrained and supported by the remote center of motion. The robotic-assisted actuation system integrated into the unit allows the surgeon to control the wrist of the end effector of the surgical instrument through natural hand motion captured by the multi-DOF surgeon's handle.
[0092] Using this configuration, the surgeon's hand movements are replicated by the wrist end effector without the need for a master-slave teleoperation system; therefore, the complexity and, therefore, the cost of the surgical system of the present invention may be lower than that of a master-slave teleoperation system.
[0093] Optionally, the surgical system may also include a balancing system that can help balance the weight / mass of the surgical device about 1, 2, 3 or more degrees of freedom of movement of the surgical device. As used herein, balance can be understood to mean offsetting at least a portion of the weight of the movable components of the surgical system to help reduce the load experienced by the user or actuator when moving and / or manipulating the components of the surgical system. That is, if the movable component of the system applies a torque around a given rotational axis, or a linear force along a given translational axis, the surgical system may include a balancing system configured to apply a torque or linear force (for example) with a predetermined magnitude in the opposite direction to help reduce the net force acting on the movable component. The user or actuator (if applicable) only needs to support the net force to keep the movable component fixed in the desired position. If the net force acting on the component is zero or substantially close to zero, the movable component can be considered to be completely or approximately 100% balanced, so that the net force applied to the user is approximately zero and the movable component can remain virtually fixed without user intervention.
[0094] The amount of balance that a given instance of the system described herein can provide about a given axis of motion can be between about 0% of the force applied by the movable system component (e.g., the user feels the full weight of the component) and about 100% of the force applied by the movable system component (e.g., the user does not generally feel the weight of the movable component), and can be set to a value between 0% and 100%. For example, the amount of balance provided can be at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, and / or at least about 90% or more of the weight of the associated movable system component. Preferably, the balance system can be configured to support at least 50% of the weight of the movable component (about a given joint / axis), and more preferably configured to support at least 75%, at least 85%, or at least 90% of the weight of the movable component. Similarly, the amount of weight of the movable system components carried by the user can be less than approximately 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% and / or approximately 10% of the total weight of the movable system components.
[0095] For example, the balancing system may preferably be configured so that the surgical device is substantially balanced when attached, so that the surgical device will generally remain in position in the absence of forces applied by the user. This may allow the device to be positioned and then held in position without the user continuing to hold the device, and it may then operate as a generally hands-free device until the user again grasps the device (e.g., repositions it). The balancing system may alternatively be configured to balance only a portion of the weight of the surgical device. For example, in addition to surgical instruments, the system may also be configured to hold and stabilize an endoscope to enable advanced visualization.
[0096] The balancing system can optionally be configured as a completely or at least substantially passive system that can use suitable springs, biasing components, cables, cams, gears, etc. to balance the movement of the medical device without the need for motors, pneumatic or hydraulic systems, or powered actuators or other active drive units. This can help simplify the operation and maintenance of the stabilizing device and can provide the user with a desired hand feel experience. It can also help reduce the need for fast-acting sensors and drive calculations for any such motors, etc. Preferably, the force applied by the balancing system can generally match the force applied by the surgical device, so that if the user releases the handle and / or stops applying force to the system, the stabilizing device and any device supported thereon will remain in place. This can allow the user to release their handle, for example to rest their arm or reposition, while the surgical device remains substantially in the same position.
[0097] Alternatively, the balancing system may include one or more electrically actuated devices that can provide some or all of the desired balancing forces. For example, the system may include one or more motors that can provide different torque levels when used, for example, a system having a system that can vary the torque output of a given motor based on the position of a movable component. The system may include servomotors, suitable back-drivable motors, etc.
[0098] Optionally, a stabilization device that is considered passive for purposes herein (e.g., without a drive mechanism to cause motion about one of its degrees of freedom) can include one or more braking devices that can help prevent and optionally stop / lock movement about one or more of its degrees of freedom. Engaging such a locking mechanism can help ensure that the stabilization device and surgical device remain in a desired position / orientation even if the balancing forces are not adequately balanced and / or the device is bumped or otherwise contacted when it is desired to maintain the device in a given position. The braking device can include any suitable type of device, such as a latch, clutch, clip, pin, clamp, magnet, etc., and can be manually triggered or can be remotely triggered using any suitable system (e.g., mechanical, electrical, hydraulic, and pneumatic activation systems).
[0099] Optionally, one or more joints in the system may be sensorized to track their absolute or relative position, or both. Tracking the position of each joint in the system can help facilitate relatively accurate tracking of the position / orientation of the distal tip of the surgical device to enable advanced functionality.
[0100] The systems described herein can also optionally provide the type of tactile feedback associated with traditional laparoscopic surgery because the surgeon directly manipulates the surgical instruments that interact with the surgical site and any resistance or force affecting the position of the distal tip of the surgical device is mechanically and typically directly transferred to the handle via the stabilization device experienced by the user.
[0101] A larger surgical system may include one or more stabilizing devices having device attachment units as described herein, each device attachment unit holding a surgical device such as a surgical instrument. The surgical instrument preferably has a wrist-type end effector to allow for increased dexterity and can be attached to or removed from the stabilizing device as needed during surgery, depending on the type of instrument required. The device attachment unit can be held above the patient by the stabilizing device during surgery. The surgeon can directly control each device attachment unit and attached instrument as if he were controlling a manual instrument. Some advantages of the described system may include the ability to manipulate a dexterous wrist, relatively improved ergonomics and reduced fatigue compared to purely manual manipulation of instruments (e.g., not supported by a stabilizing device), while also providing a similar level of fine motor control compared to a fully robotic system.
[0102] In addition to surgical instruments, the system can also be adapted to hold and stabilize other devices such as endoscopes to achieve advanced visualization. Each joint of the system can be sensorized so that the instrument tip can be accurately tracked to achieve advanced functions. The advantages of the described system include a dexterous wrist compared to manual instruments, improved ergonomics and reduced fatigue, and similar levels of fine motor control compared to robotic systems. The present invention also provides tactile feedback associated with traditional laparoscopic surgery because the surgeon directly manipulates the surgical instruments that interact with the surgical site.
[0103] Optionally, the system described herein can be configured to operate in both a primary mode and a companion mode, and can be selectively changed between modes. In the primary mode, the user can engage the system handle and use the system handle to physically manipulate the movable components of the stabilization system and electronically / robotically drive or otherwise control the surgical device attached to the stabilization system. In the companion mode, the system can also include a second companion stabilization system, which can support and actuate a second companion surgical device based on the input provided by the user using the same primary system handle. In such instances, the control system for the surgical system (including a controller and a handle monitoring sensor) can be configured (e.g., via a switch, voice command, etc.) so that the controller will receive an input signal related to the primary handle attribute from the sensor, but preferably, instead of generating a primary control signal to actuate the first / primary surgical device, the controller will generate a secondary / companion control signal, which is transmitted to the second / companion electric actuation unit, which can then actuate the second / companion surgical device. This can allow the user to selectively control two different surgical devices, optionally on two separate stabilization systems, using a common physical handle.
[0104] Optionally, the companion stabilization device can be spaced apart from the primary stabilization device and can be moved independently of the primary stabilization device. The primary surgical device can include a wristed surgical instrument (with an articulated end effector), and the companion surgical device can be an endoscope spaced apart from the surgical instrument and supported by a separate companion stabilization system. The surgeon can then use the primary handle to move and control the surgical instrument and its end effector, and then convert the system to its companion mode, in which the same handle can be used to reposition or otherwise adjust the operating parameters of the endoscope. With the endoscope reconfigured, the system can then return to its primary operating mode so that the handle can once again control the local surgical instrument.
[0105] refer to Figure 1, an example of a robotic-assisted surgery system 100 is schematically illustrated as being within an operating room. In this example, a surgeon ("S") performs surgery on a patient ("P") lying on an operating table ("O"). This example of a robotic-assisted surgery system 100 has an example of a robotic surgery unit 104 having an example of a stabilizing device including a support arm 102 attached to the side of the operating table O and mechanically holding and supporting an attachment device attachment unit. The surgeon S, standing or sitting, manipulates each robotic-assisted unit via integrated surgeon handles 108 and 110 to control the attached surgical devices, which in this example include surgical instruments 112 and 114.
[0106] In this example, the surgeon views the surgical site via live video on monitor 116; imaging is delivered via endoscopic camera 118, which in this example is also attached to a device attachment unit 120 supported by second passive support arm 103 and can be manipulated by a surgical assistant ("A") via surgeon handle 122. In alternative arrangements, the endoscope can be controlled by the surgeon without the need for a surgical assistant. In other examples, a robotic assistance unit to which the endoscope is attached can be programmed to automatically track the tips of surgical instruments 108 and 110 to help maintain a desired view of the surgical site, optionally without human assistance.
[0107] The endoscope can be controlled using any suitable mechanism, including, for example, by the surgeon via one of the handles of a separate unit 108 or 110, or a foot pedal, a handheld device, a glove-type device that translates the surgeon's hand movements into movements of the endoscope, voice commands, or commands generated by a computer program, etc. The surgeon can optionally view the endoscopic images via a head-mounted unit rather than a monitor, or via a fixed stereoscopic viewing system. The images provided to the surgeon can be 2D or 3D, the latter requiring a 3D image viewing method, such as stereo goggles or a 3D viewing monitor and associated glasses.
[0108] In these examples, the support arms 102, 103 each include multiple joints for positioning the attached device attachment unit in a desired position and orientation for accessing the patient's abdominal wall (or elsewhere) to reach the surgical site. The device attachment units are each attached to a respective linear translation device, which in this example includes support members 126, 128, 130 extending from the passive support arms 102, 103. Once the device attachment unit is in the correct position for accessing the surgical site, the support arm joints are optionally locked in place by mechanical or electronic brakes to secure the entry point for the surgical instruments until released by the surgeon or surgical assistant.
[0109] Cartesian positioning of the distal tip of the attached surgical instrument may be performed manually by a surgeon controlling surgeon handles (e.g., handles 108 and 110) and achieved by joints of a stabilization device rigidly coupled to surgeon handles 108 or 110. In an example, the joints and / or associated axes in the stabilization device are configured to constrain the entry point of the device attachment unit in a configuration referred to as a remote center of motion (RCM).
[0110] The attached surgical instrument used in this example (e.g., instrument 112 or 114) preferably has a wrist-type end effector at its tip with at least three degrees of freedom (e.g., pitch, yaw, and roll capabilities), and may preferably include gripping or some additional end effector actuation to increase the surgeon S's manipulation of the surgical site compared to non-wristed instruments. Because it may be difficult to mechanically control multiple degrees of freedom of an end effector, the device attachment unit preferably includes an electric actuation unit configured to control the orientation of the wrist-type end effector of the surgical instrument.
[0111] For example, to control a wristed instrument, the surgeon's handle 108 or 110 may also have multiple degrees of freedom in the form of a joystick, glove, wristed handle, etc., preferably such that the surgeon's hand movements are replicated or translated using matrix transformations and / or mathematical operations to convert the movements from the handle to the instrument tip effector. The surgeon's handle may also include, but is not limited to, other auxiliary or alternative control mechanisms, such as various buttons or knobs for higher-level functions of the attached surgical instrument, such as activating suction, irrigation, or cauterization, etc. or controlling the position of the endoscope 118. The described configuration may allow the surgeon to control the wristed end effector of the instrument by replicating his hand movements captured by the surgeon's handle; such a control scheme is referred to herein as "local teleoperation."
[0112] As used herein, remote center of motion (RCM) is understood to refer to a configuration in which a series of joints or degrees of freedom pivot around a single point to which a mechanism (e.g., a stabilizing device in this example) is not physically connected.RCM can be used for minimally invasive surgery because it allows surgical instruments to enter a fixed body through a single point (referred to herein as "pivot point") while allowing surgical instruments to move within this constraint. This configuration may help prevent surgical instruments from moving at the site of entering the patient's body (usually the abdominal wall), thereby helping to limit soft tissue damage at or around this position.RCM can be implemented by constraints imposed by mechanical joints or software. In order to achieve the RCM imposed by software, actuation or drive joints are usually performed. Although described with reference to a possible surgery, the system described herein can be used for minimally invasive surgery to enter feasible surgery, and need not be limited to the surgery currently performed using minimally invasive methods. In addition, the system can be located outside the patient's body at a remote center of motion, such as for use in the case of transoral robotic surgery (TORS).
[0113] Figure 1 The arrangement shown in includes three robotic surgery units 104, 106 and 120, two of which are used to hold surgical instruments and one for holding an endoscopic camera. The number of device attachment units with attached surgical instruments used for surgery can vary based on many factors, including space limitations and the surgery being performed, among other factors. Space constraints may arise from the footprint of the stabilizing device relative to the operating table, and / or to avoid any collision between the device attachment units or instruments when the device attachment units or instruments are used during surgery. In an alternative arrangement, the robotic surgery units 104, 106 and 120 can be mechanically supported in a desired position using any suitable base member (e.g., a rod or bracket) that can be connected to the operating table, or the base member can include a patient side cart on the operating room floor, a ceiling mount or other such mounting hardware. Depending on the surgical task, at any time during the surgical procedure, surgical instruments 112 and / or 114 can be removed from the corresponding robotic surgery units 104 and / or 106 by the surgeon or the surgeon's assistant and replaced with different surgical instruments 124 from the bedside tray ("T").
[0114] Figure 2A more detailed view of a preferred embodiment of the surgical system 100 is shown. In this example, the stabilization device base includes a support arm 102, which is attached to the operating table at an attachment point 160. The robotic surgical unit 104 is attached to the support arm 102 and the surgical instrument 112 is removably attached to the robotic surgical unit 104. In this example, the robotic surgical unit 104 and its stabilization device define a mechanical remote center of motion 162. The end effector 164 of the surgical instrument 112 is manipulated by the surgeon via the surgeon's handle 108. The attachment of the stabilization device to the operating table can be achieved in a variety of ways, such as a clamping mechanism, a bolt connection system, etc. The operating table can be manufactured with connection points or connection methods specifically for attaching the support arm 102, or the support arm can be designed so that it can be attached to any existing operating table.
[0115] Figure 3 A preferred configuration of the joints 190 of a robotic surgical unit 104 for position control of an end effector to which a surgical instrument is attached is shown, the configuration comprising a series of three joints that help achieve and define a remote center of motion. The mechanism is referred to herein as an "RCM mechanism". The first joint of the RCM mechanism is a hub, which in this example comprises a revolute joint 192 (referred to herein as a "revolute joint") having an axis of rotation or rotation axis 194. The second joint comprises an arcuate track that extends around a center of curvature and can be described as a remote revolute joint (referred to herein as an "arc joint"), which in this example comprises an arcuate track 196 that can move relative to a motion bracket 198 fixed in the hub 192, which produces a remote axis of rotation or pivot axis 200 that passes through the center of curvature of the arcuate track 196. The remote rotation axis 200 intersects perpendicularly with the axis 194 of the first revolute joint 192. The third and final joint of this example of the RCM mechanism comprises a linear translation device having a prismatic joint 202 (referred to herein as a "prismatic joint") secured to the arcuate track 196. The prismatic joint 202 is arranged such that its translation axis 204 passes through the intersection of the axis 194 and the axis 200. The combined intersection of each joint axis defines the remote center of motion 162. The configuration of the joint described above can facilitate insertion of an attached surgical instrument into a patient's body for minimally invasive access.
[0116] In a preferred embodiment, the revolute joint in the hub is the first joint in a series of joints that form the RCM mechanism, followed by the arc and prismatic joints. In a preferred embodiment, the revolute joint is configured as illustrated in this figure so that the axis of rotation is at least substantially vertical when the system 100 is in use, i.e., the axis of rotation is perpendicular to the floor. In other embodiments, the arrangement of the revolute, arc and prismatic joints can be changed to achieve the same or similar RCM motion. For example, the revolute joint can be moved to a lateral position with its axis of rotation parallel to the floor. In another case, the arcuate track 196 is fixed to the hub 192, and the bracket 198 containing rolling elements can move along the arcuate track 196. In this example, the prismatic joint 202 is fixed to the movable bracket 198 to maintain the remote motion center. Figure 4 The same RCM mechanism 190 is shown with the surgical instrument 112 attached. The surgical instrument 112 is attached to the prismatic joint, the last of the three joints comprising the RCM mechanism. The surgeon manipulates the end effector 164 of the surgical instrument 112 via the surgeon handle 108.
[0117] Figure 5 A preferred embodiment of the robotic surgery unit 104 is shown, including all robotic-assisted components and RCM mechanisms, wherein the surgical instruments are removed from the image for clarity. Figure 2 , this embodiment includes: a remote center of motion 162; a surgeon's handle 108; a handle connector 218; a device attachment unit including an instrument interface 220 and an actuation unit 222; a linear translation device including a prismatic track 224, an arcuate track 226; a hub including a revolute joint 228; and a base member including a connection plate 232 and a base 234 for fixing to a support arm 102. This system also includes a translational balancing system in the form of a prismatic balancing system 600, and an arcuate balancing system in the form of a spring-cam balancing system 602.
[0118] In this example, the surgeon can control the robotic surgical unit via the surgeon's handle 108. In this preferred embodiment, the surgeon's handle 108 consists of a joystick-like device with multiple degrees of freedom for robotically manipulating the wrist-type end effector of the surgical instrument. The surgeon's handle contains multiple sensors to read the current orientation of the surgeon's handle 108. The surgeon's handle 108 is rigidly attached to the actuation unit 222 via a handle connector 218, which is hollow and carries multiple wires extending between the sensors in the surgeon's handle and the actuation unit. The actuation unit 222 houses a motor, a motor driver, a motor encoder, and a microcontroller for controlling and actuating the end effector of the attached surgical instrument. The instrument interface 220 is a mechanism to which the surgical instrument is attached and has a rotational motion for actuating the end effector of the surgical instrument, and is part of the same component as the actuation unit 222. The surgical instrument is designed to be easily attached to the instrument interface, engaged with the instrument interface, and subsequently released from the instrument interface.
[0119] In this example, the actuation unit 222 and the prismatic track 224 are each part of a prismatic joint of the RCM mechanism. The prismatic track 224 is a linear track or guide rail component extending between a first end thereof and an opposite free second linear track end, the first end preferably being rigidly attached to the arcuate track 226. The track 224 is preferably at least substantially linear, so that an axis parallel to the translation axis defined by the linear track will intersect other axes as needed to help define the RCM point. For the purposes of the present teachings, slight deviations from a completely linear track will not misalign the axis or interfere with the RCM point function, which can still be considered to be substantially linear.
[0120] The arcuate track 226 passes through a revolute joint 228 in the hub to form an arcuate joint for this example of a stabilizing device. A mounting plate 232 is located at the rear of the base 234 for attachment to the support arm 102. The spring-mass balance system 602 is housed within the base 234, and the prismatic balance system 600 is positioned along the prismatic track 224.
[0121] Figure 6A surgical system is shown with a surgical instrument 112 connected to its device attachment unit. In this example, the surgical instrument 112 includes: a surgical instrument base 250; an elongated shaft 252 extending along the shaft axis between the base 250 and the distal tip; and an end effector 164 disposed at the distal tip. In this example, the surgical instrument has at least 3 degrees of freedom at the end effector of the wrist configuration, plus a fourth degree of freedom for actuating a gripper, scissors, etc. The end effector 164 can be driven by any number of methods, such as cables, push rods, fluid actuation, etc., to translate motion at the instrument base 250 down the elongated shaft 252 to the end effector 164. A mechanical wrist end effector can be implemented by a variety of methods, such as gears, pulleys, bending joints, etc. The stabilization device can include other device attachment and stabilization features that can help support, orient, and align the surgical device. In this example, the arcuate track 226 includes a device aperture 570 sized to accommodate the elongated shaft 252 of the surgical instrument. The cannula can be fitted into the device aperture 570 and secured via a press fit and can help guide the surgical instrument when it is connected to the stabilizing device. The cannula can also provide an access point for minimally invasive surgery. The cannula can be disposable and can use different sizes of cannula depending on the instrument used during surgery, for example, to fit a standard surgical instrument shaft with a diameter of 5 mm or 8 mm.
[0122] Also refer to Figure 7 , the revolute joint 228 in the hub is the first joint in a series of three joints that comprise the RCM mechanism and consists of a U-clip type inner revolute pair 280 and an outer revolute pair 282. The outer revolute pair 282 supports the inner revolute pair 280 at both the top and bottom of the joint. The inner revolute pair 280 rotates freely around an axis 284, while the outer revolute pair 282 is fixed. The second joint is a remote revolute joint formed by an arcuate track, also called an arc joint, which rotates around the remote center of motion 162. This arc joint includes an arcuate track 226 and rolling elements contained within the inner revolute pair 280. The arcuate track 226 and the subsequent attachment components including the prismatic track 224 and the actuation unit 222 rotate around the remote center of motion 162 with an arc diameter indicated by the arc / circle 286. The prismatic joint includes a device attachment unit having an electric actuation unit 222 configured to include a linear translation element that can engage a linear track 224 so that the device attachment unit can move / translate along a fixed prismatic track 224 fixed to an arcuate track 226. When the instrument is attached, the shaft axis 254 defined by the elongated shaft 252 is parallel to the translation axis 288 of the linear track 224 and intersects the remote center of motion 162 to complete a 3-DOF remote center of motion mechanism.
[0123] In other embodiments, there may be alternative mechanical methods to achieve the motion produced by each joint while maintaining the same overall joint configuration. For example, a revolute joint may be achieved without a clevis joint design, where the outer revolute pair 280 is attached to the inner revolute pair 282 only at the top or bottom of the joint. In another embodiment, an arcuate joint may be achieved by a fixed arcuate track 226 and a rolling element included at the distal end of the prismatic track 224 to allow the arcuate joint to travel along the arcuate track 226. In another embodiment, an arcuate joint may be achieved by a telescopic joint design, thereby eliminating the need for roller elements included in the inner revolute joint 280. For example, a telescopic arcuate joint may be composed of several links that contract and extend relative to each other to produce the desired remote revolute motion. Similarly, a prismatic joint may be achieved by including rolling elements on the arcuate track 226 and allowing the entire prismatic track 224 to translate along the axis 288. In this example, the rolling elements in the actuating unit 222 will be removed, and instead, the actuating unit will be rigidly fixed to the prismatic track 224. In another example, the prismatic track can be implemented by the telescopic method described above for the arcuate joint. The advantage of the telescopic joint design is the elimination of components such as the arcuate track 226 and the prismatic track 224 that remain fixed in size.
[0124] In this embodiment, the stabilization device is completely passive and serves as a positioning system for the end effector 164 to which the surgical instrument 112 is attached. In another embodiment, each joint of the RCM mechanism may contain a sensor such as a potentiometer or an encoder to continuously record joint data. Since the RCM mechanism is a three-degree-of-freedom system, there is an analytical motion model for such a system, and the position of the end effector 164 can be calculated by a suitable controller using the joint data captured by such sensors. The position of the end effector 164 of the instrument can be used in a variety of ways, such as for intraoperative instrument navigation and tracking, recording all instrument data during surgery, or for surgical education purposes. For example, the economy of surgical tip motion (i.e., path length) or jerk (derivative of acceleration) can be analyzed in real time or postoperatively to determine the surgeon's skills and / or surgical results.
[0125] In an optional alternative embodiment, any or all of the three RCM joints may include suitable braking devices for additional functions, such as electronically or mechanically controlled brakes, such as the ability to actively inhibit any or all joints for more refined motion control, a virtual clamp for preventing damage to tissue away from the surgical site, or the ability to lock one or more joints during a given surgical task. For example, the ability to selectively lock and unlock one or more joints can allow the surgeon to keep tissue in a specific position or enable the RCM mechanism to maintain its accurate position during instrument replacement. The advanced functions discussed above, such as joint inhibition, joint locking or virtual clamps, can be controlled by the surgeon in a variety of ways, such as via buttons, switches, knobs, etc. included on a surgical handle, a touch screen within the surgeon's reach, or via a foot pedal. In an alternative embodiment, the advanced functions can be activated by a surgical assistant. In an alternative embodiment, any or all of the RCM joints can be motorized by an actuator including, for example, a motor, which is integrated into each joint for direct drive, or is positioned away from the joint and driven via a transmission system, such as using a cable or belt or gear system. Sensorization of the motorized joints of the RCM mechanism (i.e., adding sensors to each joint) will allow more advanced functionalities such as active tactile feedback, full teleoperation (the surgeon controls the robotic unit via a console), or semi-autonomous or fully autonomous surgical tasks.
[0126] When a stabilization device is used, the hub can allow the arcuate track, linear translation device, and device attachment unit mounted thereto to rotate within a predetermined range of motion about the rotation axis 284. This range of motion can be limited to any suitable range of motion, including about 45 degrees or less, about 90 degrees or less, about 180 degrees or less, about 270 degrees or less, and / or about 360 degrees, using any suitable stops or other such hardware or software limits. This can help limit the range of motion of the surgical device to the desired range of use and can help prevent collisions between the surgical device and other objects in the operating room. Alternatively, the hub can allow free rotation of a full 360 degrees about the rotation axis 284, which can also help provide a generally unrestricted range of rotational motion during use. For example, Figure 8 A top view of a robotic surgical unit is shown with an attached surgical instrument in a first rotational position, and Fig. 9 and Fig.10 An example illustrating how portions of a stabilization device may rotate about the hub / revolute joint 228 and axis of rotation 284 of the RCM mechanism.
[0127] Similarly, in this illustrative example, the revolute joint 228 and the arcuate track 226 are configured to permit the arcuate track 226 to move through a desired range of motion along its path of curvature / arc 286 (and about the pivot axis 200 / remote pivot axis 162). In this example, the range of motion of the arcuate track 226 (and other components mounted thereon) is generally limited by the physical extent / configuration of the track 226, as it can generally move along its length between respective arcuate track ends. In the illustrated example, the arcuate track 226 has an arc length (e.g., subtended and angled) of approximately 45 degrees, but in other examples may have a shorter or longer arc length, which may then provide a smaller or greater range of motion / travel about the pivot axis 200. For example, Fig.11 and Fig.12 It is shown how arcuate joint motion is achieved along arc 286 and how rotation is achieved about remote center of motion 162 for this example. Fig.11 In the embodiment, the arcuate track 226 is located near the first limit position, wherein the end of the arcuate track 226 connected to the linear translation device is adjacent to the hub, and Fig.12 The relative arcuate position is shown with the opposite second end of the arcuate track adjacent the hub and the end of the arcuate track 226 connected to the linear translation device spaced from the hub. In the illustrated example, movement of the arcuate track 226 is independent of rotation of the hub about the rotation axis 284.
[0128] The stabilization apparatus is also preferably configured so that translation along a linear translation axis (e.g., axis 288 in this example) can occur independently of rotation above axis 284 or pivoting about pivot axis 200. Similar to the movement of arcuate track 226, in the illustrated example, the translation range of the device attachment unit is generally limited to the physical length / range of linear track 224 because the device attachment unit can slide along track 224 between its opposite fixed and free ends. For example, Fig.13 and Fig.14 The movement of the device attachment unit relative to the rest of the stabilization apparatus along the translation axis 288 is shown, wherein Fig.13 The actuation unit 222 is shown in an outboard or retracted position (where the actuation unit 222 is at the free end of the track 224), and Fig.14 The actuation unit 222 is shown in an inboard or extended position (where the actuation unit 222 is at a fixed end of the track 224 , adjacent the arcuate track 226 ).
[0129] The hub for stabilizing the device may include any suitable hardware that can support the bow rail and other system components while still permitting the desired rotation about the hub's axis of rotation. Figures 15 to 16 The revolute joint 228 is described in more detail in FIG. Fig.15 and 16 In this example, the revolute joint 228 is a U-shaped clamp arrangement, including an inner revolute joint 280 that can rotate and a fixed outer revolute joint 282. The flanged bearings 340 and 342 are press-fitted into the bearing housings 344 and 346 that are part of the outer revolute joint 282. D-shaped shafts 348 and 350 pass through the flanged bearings 340 and 342 and are press-fitted into the corresponding housings of the inner revolute joint 280. All shafts and bearings are fixed with set screws. The inner revolute joint 280 contains four v-grooved rollers 356, which cooperate with the 90-degree track profile 358 of the arcuate track 226, thereby allowing the arcuate track 226 to move. The cutout 360 in the wall of the inner revolute joint 280 allows the arcuate track 226 to pass through the exact center, thereby aligning the axis of the revolute joint and the arc joint. The U-shaped clamp arrangement shown limits the range of motion of the revolute joint to approximately 270 degrees. Alternative embodiments may eliminate this reduced range of motion by, for example, eliminating the bottom of the clevis joint.
[0130] Fig.17 is a schematic representation of an example of a robotic assistance system that can be used with a stabilization device, as the robotic assistance system can be used to provide robotic assistance by replicating or translating the surgeon's hand movements to a wrist-type end effector of a surgical instrument via a mathematical transformation, which is referred to herein as local teleoperation. According to this example, the robotic assistance system can include a handle sensor 410, such as a potentiometer or encoder, that records the handle orientation of a handle (e.g., handle 108), and continuously feeds information from these sensors to a suitable controller, such as a microcontroller unit 412, in the form of a suitable sensor signal. The microcontroller unit 412 can then calculate the desired end effector wrist orientation based on the orientation of the surgeon's handle and generate a corresponding controller output signal, and can then send commands / signals to a motor controller 414, which in turn can provide appropriate commands and signals to the motor 454. The motors 454 preferably each have a motor encoder 418, and information from the motor encoder can be optionally fed back to the microcontroller 412 via the motor controller 414 in a closed-loop system. The motor 454 can actuate the end effector 420 of the surgical instrument based on the output of the handle sensor 410 to produce the desired end effector orientation. This type of local teleoperation can be referred to as a "man in the loop" system in which the surgeon closes the control loop. For example, Fig.18a , 18b18c show an example of a local teleoperation method implemented on a preferred embodiment of a stabilization device, wherein the orientation of the surgeon's handle 108 is replicated by the end effector 164 of the surgical instrument. The example illustrates that synchronization of the handle 108 in a single degree of freedom and movement in other degrees of freedom can be implemented in the end effector 164 in a similar manner.
[0131] Also refer to Fig.19 , in this example, the surgeon's handle 108 is located at the proximal end of the surgical system and is controlled by the surgeon's hand. The surgeon's handle 108 has at least 3 degrees of freedom; in a preferred embodiment, this is a yaw-pitch-roll configuration. The angle of each joint in the surgeon's handle is tracked via a sensor 410, such as a potentiometer or encoder. The surgeon's handle 108 is rigidly connected to the actuation unit 222 via a handle connector 218. The handle connector 218 can have any suitable configuration, and in this example, the handle connector contains a hollow internal channel that can contain wires originating from the sensor 410 located in the surgeon's handle 108. These wires are connected to a microcontroller 412, which is housed on or off the actuation unit 222. The microcontroller 412 reads the outputs from the sensor 410 located in the surgeon's handle 108 and converts these outputs into motor commands, which are transmitted to a motor controller 414, which can also be located on or off the actuation unit 222. The motor controller 414 instructs a plurality of motors 454 (at least four in a preferred embodiment) housed in the actuation unit 222. Rotational motion from the motor 454 is transmitted to the surgical instrument 112 via the attachment interface 220 and is transmitted downwardly along the shaft of the instrument 252 to the wrist end effector 164 via a cable, push rod, etc.
[0132] A power cable extending to the actuator unit 222 may provide power to some or all of the electronics and motors, and / or some aspects of the control system may run on one or more batteries or other suitable power sources. The components in the control system may be communicatively connected to each other and to other external devices, optionally using any suitable connection means including wires. In alternative embodiments, the control system may be connected via, for example, Bluetooth. TM The control electronics (microcontroller and / or motor controller) may be included in the base 234 of the system including the support arm 102 to help reduce the mass on the prismatic joint, with either a cable connecting the electronics in the base to the motor of the actuation unit, or via Bluetooth. TM or another wireless communication protocol to perform communications.
[0133] The device attachment unit and its subassemblies can be configured to work with one or more different types of surgical devices by having appropriate attachment / connection mechanisms and optionally having complementary drive mechanisms that can engage and drive components on the surgical device. Fig.19 , showing the instrument interface 220 and the actuation unit 222 in cross-section. In this example, the attachment interface 220 is disposed on the front face of the actuation unit 222 and includes four identical actuation discs 480 powered by a motor 454. These actuation discs 480 engage with corresponding discs on the surgical instrument and provide rotational motion, which is then converted into motion of the end effector. The attachment interface 220 may contain an engagement component in the form of a guide that can mechanically hold the surgical instrument in a friction fit and ensure that the actuation discs 480 are aligned with the corresponding discs on the surgical instrument. Optionally, the actuation discs may be spring loaded to engage and disengage with the surgical instrument, or coupled to the surgical instrument discs via magnetic coupling, gear coupling, friction coupling, etc.
[0134] Also refer to Fig. 20 , in this example, the actuating disc 480 is connected to the motor 454 and the motor 454 is connected to the actuating unit 222 via the motor bracket 540, which in this example includes through holes for connecting two screws to the panel of the motor. The motor 454 is preferably rigidly fixed to the motor bracket 540, and the motor encoder 542 can be attached to the motor 454 subsequently. The motor 454 has a D-shaped shaft, wherein a corresponding D-shaped hole is provided on the actuating disc 480. The actuating disc 480 is preferably loosely fitted on the motor shaft 544 to allow it to slide prismatically. The loose fitting can help the actuating disc 480 to slide and engage with the corresponding instrument disc. A spring or other suitable biasing member can be located between the back side of the actuating disc 480 and the motor face, thereby providing a force to push the actuating disc 480 into engagement with the corresponding instrument disc. The actuating disc 480 can be optionally retracted to disengage from the instrument disc via the retractor plate. The retractor plate can preferably disengage all four discs 480 from the attachment instrument simultaneously when pulled.When the retractor plate is released, the discs 480 can be pushed back into their engaged position by the biasing member.
[0135] Also refer to Fig. 20 , the device attachment unit and the actuation unit 222 contained therein may be movably mounted to the track 224 using any suitable mechanism, including suitable brackets, shuttles, sliders, rollers, etc. In some embodiments, linear actuation mechanisms may be preferred because they may help resist thrust loads, thereby keeping the actuation unit 222 securely fixed to the prismatic track 224 even during surgical tasks that may exert relatively high lateral forces on the medical device and / or the device attachment unit.
[0136] The handle on the stabilization device is preferably configured to be easily grasped by a user, and optionally resembles some aspects of the handle design on conventional handheld instruments so that it may feel familiar to surgeons who have experience using handheld instruments. Fig.21 , an example of a surgeon's handle 108 is provided in a yaw-pitch-roll configuration. A first yaw joint 510 having an axis 518 is connected to a pitch joint 512 having an axis 520, followed by a roll joint 514 having an axis 522. All axes intersect at a remote point 524 to form a spherical wrist configuration. The surgeon grasps the handle by a finger ring on a gripper 516. The gripper 516 allows additional degrees of freedom to actuate / activate instrument functions, depending on the attached surgical instrument. For example, the gripper 516 can be used to control the opening and closing gripping motion of the end effector of the attached surgical instrument. The gripper may contain additional buttons to activate additional instrument functions, such as cauterization on an energy instrument. Each joint contains a sensor such as a potentiometer or encoder, which has a hollow link to pass the wires through the handle to avoid interfering with the surgeon's hand. The wires then pass through the handle connector 218, which is also hollow, to the actuation unit 222. The handle shown in the preferred embodiment is a "universal joint" style.
[0137] refer to Fig. 22 , which is another example of a handle 1108. That is, in this example, handle 108 has: a yaw joint 1510 that can rotate about a yaw axis 1518, the yaw joint is connected to a pitch joint 1512 that can move about a pitch axis 1520; and a roll joint 1514 that can move about a roll axis 1522. Handle 1108 is generally similar to handle 108 and similar features are identified using similar reference numbers indexed by 1000. In this example, handle axes 1518, 1520, and 1522 are configured to intersect at a common point 1524, which can help provide a spherical wrist configuration for handle 1108. In this example, a button 1516 is embedded in the last roll link for additional degrees of freedom or for actuating / activating additional instrument functions, depending on the attached surgical instrument. For example, button 1516 can be used to control the opening and closing gripping motion of the end effector of the attached surgical instrument, or to activate the delivery of bipolar cautery. The button 1516 may be a mechanical switch, a capacitive element, etc. Each joint may optionally contain a sensor such as a potentiometer or encoder, and may preferably be configured with a hollow link to pass the wires through the handle 1108 to avoid interfering with the surgeon's hand. The wires then pass through the handle connector 218, which is also preferably hollow, to the actuation unit 222.
[0138] The handle 1108 is a "pen-style" handle, in which the grip of the surgeon's hand imitates how to hold a pen. Several alternative embodiments of the surgeon's handle are not limited to the "pen-style". Other alternatives may include a pistol-grip handle with a 3-DOF joint located at the distal or proximal end of the handle, and / or a handle with a virtual pivot point in the same position as the center of mass of the user's wrist. Optionally, the handle may have more than three degrees of freedom for controlling a higher degree of freedom instrument. In yet another embodiment, the handle may contain additional sensors for advanced functions, such as locking a joint on the RCM mechanism or adjusting the inhibition of the electronic control of the RCM mechanism. In another embodiment, the handle may have a "disable switch" type sensor, such as a trigger or a capacitive touch sensor, which will be used to lock the RCM mechanism to prevent the end effector of the surgical instrument from moving unintentionally unless the surgeon holds the handle. In another embodiment, as understood in the context of the present invention, the handle may be a glove that is at least partially assembled on the user's hand.
[0139] The handle connector 1218 may also have a number of alternative embodiments, such as the ability to make it reconfigurable and adjustable, such as the ability to increase the lateral offset between the surgeon's handle 108 and the actuation unit 222. Since the control method is completely fly-by-wire and no mechanical actuation occurs through the handle connector (e.g., a cable), there are fewer design restrictions on the handles 108 and 1108. A reconfigurable or adjustable handle may be beneficial in certain procedures where the surgeon must often operate the instrument in awkward and fatiguing positions, such as in a prostatectomy.
[0140] Optionally, as described herein, one or more degrees of freedom and / or joints in the stabilization device can be balanced using a suitable balancing device. The balancing device is preferably passive, i.e., non-motorized, so that it can move freely in response to manual input from a user (e.g., pushing or pulling handle 108) without engaging a motor or other drive mechanism. This type of balancing may be desirable in some embodiments of the surgical system because robotic / auxiliary components such as motors, electronics, and sensors may significantly increase the weight of the surgical system, and therefore a balancing system is implemented in a preferred embodiment. Balancing can help to reduce and possibly eliminate or minimize any input forces required by the surgeon to hold the surgical instruments in a stable position. The force required to balance the system is a function of the mass and position of the surgical instruments. More specifically, the mass block includes a Fig.23Any components shown in the figure that are capable of moving in the XZ plane include but are not limited to the surgeon's handle 108, the prismatic rail 224, the arcuate rail 226, the actuation unit 222, and the attached surgical instruments 112. Preferably, as shown in this example, the stabilization device is arranged so that when the system is in use, the rotation axis 284 of the revolute joint 228 is substantially vertical (i.e., parallel to the gravity vector). In this arrangement, the stabilization device does not require any material balance around the revolute joint 228, and only the gravity generated by the arcuate rail 226 and the prismatic rail 224 need to be balanced. The term center of mass (COM) as used herein refers to the center of mass of all components that need to be balanced due to movement along an arcuate joint or a prismatic joint. For simplicity, as shown in the figure, Fig.23 As depicted in , the COM is schematically illustrated as being located between the base of the surgical instrument and the surgeon's handle, but may be located differently in different instances of the surgical system.
[0141] In this arrangement, the COM generates a torque about the remote center of motion 162, and this torque changes as the surgical instrument and associated components move along the prismatic track 224 or arcuate track 226. Fig.23 As shown in FIG. 1 , the angle of COM along the arcuate track 226 is labeled θ, and the position of COM along the prismatic track 224 measured from the remote center of motion 162 is labeled x. As shown in FIG. 1 , the simplified system representation Fig.24a As shown in , the torque generated depends on the lateral distance ("T") from COM to the vertical axis of the remote center of motion 162 and the force ("mg") based on the mass of the associated components. The torque is the product of T and mg. As x or θ increases, the length of T also increases, thereby increasing the torque about the remote center of motion 162. When the surgical system is in a fully lateral position and when x is maximized, the torque reaches a maximum when θ approaches 90 degrees. Figure 24bThe special case where θ is set to 0 degrees is illustrated; the COM of the instrument is directly vertical above the remote center of motion 162, thereby reducing T or the normal distance between COM and the vertical remote center of motion 30 axis to zero. In other words, at 0 degrees θ, the joint created by the arcuate track 226 does not contribute to the balance requirement. In this arrangement, the torque acting about the remote center of motion 162 increases as the angular position of the first end of the arcuate track relative to the hub (i.e., θ) changes from about 0 degrees to about 90 degrees. Optionally, as described herein, the balance system can include a biasing device configured such that the magnitude of the biasing force (to help balance the gravity load) can increase as the angular position of the first end of the arcuate track relative to the hub changes from about 0 degrees to about 90 degrees, such that the biasing force remains substantially equal to (e.g., within about 10% of each other, between about 10% and 20%, and optionally greater than 20%) the magnitude of the torque T when the angular position of the first end of the arcuate track relative to the hub is between about 0 degrees and about 90 degrees. Although no torque is generated about the remote center of motion 162, components moving along the prismatic track 224 are in line with the gravity vector and require balancing.
[0142] Fig.25 An overview of one example of a suitable balancing system that may be implemented in the surgical system 100 is shown. To balance the illustrated example of the surgical system, two separate balancings are implemented in a preferred embodiment. First, a prismatic pulley-mass balancing system 600 is implemented along the prismatic track 224. The mass of the balancing weights required for the prismatic balancing system 600 is selected so that the mass is at least substantially equal to the sum of the masses of all components capable of moving along the prismatic track 224, which in this example include the actuation unit 222, the surgical instruments 112, and the surgeon's handle 108. The function of the prismatic balancing system is preferably twofold: (1) to help balance the prismatic motion (i.e., surgical instrument insertion and retraction) of the attached surgical instruments, and (2) to help maintain a substantially constant center of mass for all components moving along the prismatic track (including the attached surgical instruments), regardless of their linear position. Using the system 600 to help provide this substantially constant center of mass helps facilitate the use of a second balancing system 602 acting on the arcuate track. In the illustrated example, the arcuate balance system 602 is a cable driven spring-cam balance system located primarily in the base 234 of the stabilizer. The second balance system 602 is designed to help counteract the torque generated about the remote center of motion 162. This two-part balance approach implemented in the preferred embodiment substantially separates the balance requirements of the prismatic track 224 and the arcuate track 226 and can simplify the design and operation of each system.
[0143] refer to Fig.26a and Figure 26b, which shows a schematic diagram of a prismatic translational balancing system 600 and a spring cam arc balancing system 602. In this illustration, a prismatic pulley-mass balance helps provide a relatively constant COM as a prismatic assembly, such as a handle and an actuation unit (represented together in this figure by unit M), moves along a prismatic track 224. Substantially equal balancing masses, preferably made of a denser material (thus requiring less volume), are represented by "C." The prismatic track 224 contains guide components in the form of pulleys at either end ("P"), and mass M and mass C are connected by a cable. As mass M travels in either direction along the prismatic track 224, mass C moves in the opposite direction. Because the masses are nearly equal, the spatial position of COM relative to the prismatic track 224 is maintained substantially constant. This Figure 26b Depicted in Fig.26a Compared to the position of the masses in the arcuate track 226, mass M has moved toward the RCM and mass C has moved in the opposite direction, but COM remains in the same position. Due to this relatively fixed position of COM, the torque generated by the translation assembly about the RCM is maintained at a substantially constant level. This generated torque is then balanced by the spring-cam balance system 602, which can generate a generally constant and identical, but relative torque represented by "Fc" via cables extending along the arcuate track 226.
[0144] Figures 27 to 28 A preferred example of a prismatic balancing system 600 is shown. In this example, a carriage 650 extends along a dedicated balancing track on the rear side of the prismatic track 224. The linear carriage 650 holds a balancing weight 680 that is sized to equal the weight of all moving components on the prismatic track 224. Guide members / pulleys 656 and 658 are at either end of the prismatic track 224. A cable 660 is connected to the carriage 650, wraps around pulley 656 and terminates at the actuation unit 222. A second cable 666 is connected to the opposite end of the carriage 650, wraps around pulley 658 and terminates at the opposite end on the actuation unit 222. Various systems such as turnbuckles, capstans, etc. may be used to tighten and attach the cable system at the connection points on the carriage 650 and the actuation unit 222 to achieve the proper cable tension.
[0145] Also refer to Fig.29 , it will be appreciated that COM remains at the same position along the prism track 224 and thus produces Fig.29. The spring-cam balancing system 602 is then preferably configured / calibrated to substantially counteract this torque for any angle θ. In the illustrated example, a flexible tension member, such as a wire or cable 700, extends along the arcuate track 226 and is attached to one end of the arcuate track 226 at location 702, i.e., at the same end of the track as the linear translation device. The opposite end of the cable 700 is wrapped around and connected to a cam 720. The cam 720 is rigidly attached to a cam shaft 712 supported by bearings so that both the cam 720 and the cam shaft 712 rotate as a single unit. A second tension member, such as a cable 722, is wrapped around and connected to the cam shaft 712 and is connected at the other end to a suitable biasing member, such as an extension spring 724, an elastic band, etc.
[0146] In this arrangement, the cable 700 is effectively shortened by the same ratio as the ratio between the diameters of the cam and the camshaft, resulting in a significantly shorter output cable 722. If the original cable length is maintained, a spring with a stroke length similar to the arc length of the arcuate track 226 may be required. By effectively reducing the cable length of the cable 722, a significantly smaller spring can be implemented. This can help reduce the overall size of the surgical system. In an alternative embodiment, a constant force spring is wrapped around the cam to apply the torque required for balancing. In an alternative embodiment, a gearbox system can be used to achieve the reduced cable length.
[0147] In this example, the spring generates a force ("Fspring") acting on the cable system and generates a force ("Fc") in a tangential direction at the end of the arcuate track 226. The cam, camshaft, and spring are designed so that the torque generated by Fc is equal and opposite to the torque generated by mg. If this balance is maintained, the system can be considered to be completely balanced.
[0148] Figures 30 to 31 A cross section of the system base and hub is shown to illustrate the inner workings of one example of a spring-cam balancing system 602. The system uses a tension member in the form of a cable 700 that is attached to the end of the arcuate track 226 at a connection point 702. The cable system is indirectly connected to a spring 726 that provides a force to balance the torque generated by the associated component mass about the remote center of motion.
[0149] In this arrangement, the cable 700 is attached to a cable attachment point 702 located on the arc track 226. When the cable 700 enters the revolute joint, the cable is vertically redirected by a guide member / pulley 706 located in the housing of the inner revolute joint 280. The pulley 706 is preferably positioned so that this section of the cable 700 is parallel to the rotation axis 284, and more preferably so that the section of the cable 700 is coaxial with the rotation axis 284 and passes through the center of the revolute joint / hub. This arrangement can help reduce and / or prevent the arc balance system 602 from generating torque around the revolute joint axis 284. The cable 700 then passes through the D-shaped shaft 348, which is preferably hollow and is again redirected by a second guide member / pulley 708 located in the housing of the outer revolute joint 282. The cable 700 is wrapped around the cable guide on the cam 720 and terminates at the cam 720. The cam 720 is rigidly connected to the camshaft 712. A second cable 722 is wrapped around and terminates at the camshaft 712, which includes a cable groove to help guide the cable 712. The other end of the cable 722 is connected to a tension spring 724. The spring 724 is attached to an adjustable spring stud 726, which is attached to the frame 282. The adjustable spring stud 726 is used to make minor adjustments to the position of the spring to ensure proper cable tension in the system. In a preferred embodiment, two springs 724 are used to create sufficient balancing force.
[0150] Fig.30 The system is shown when the arcuate track is fully retracted (small θ). As the surgeon moves the handle downward, the torque created by the mass of the system increases. Movement of the arcuate track causes the cable 700 to extend and deploy from the cam 720. Rotation of the cam 720 and camshaft 712 causes the cable 722 to wind and effectively shorten to pull on the spring 724. Simultaneous deployment of the cable 700 and winding of the cable 722 caused by the same rotation is achieved by feeding the respective cables to opposite sides of the cam / camshaft. Fig.31 The resulting extension spring is shown when the arcuate track 226 is fully extended (large θ). Figures 32 to 33 A top view showing the cable system and tension spring.
[0151] The balancing system can work as follows, for example: when the surgeon moves the handle 108 downward in the vertical direction, θ increases, thereby increasing the torque generated around the remote center of motion 162 due to gravity. When this happens, the cable 700 routed upward along the arc track through the rotating joint generates a torque on the cam 720, causing the cam to rotate and feed additional cables to accommodate the increase in arc length. At the same time, when the cam 720 rotates, the cam rotates the cam shaft 712 that fixes it. Rotating the cam shaft 712 causes the attached cable 722 to shorten the cam shaft 712 and wrap around the cam shaft 712. When the cable 722 shortens, the cable pulls on the spring 724. In summary, as θ increases, the cable system extends the spring. The spring force increases the tension in the cable 700, which generates a torque in the opposite direction to the torque generated by the mass of the associated components due to gravity. Conversely, if the surgeon moves the handle 108 in the opposite direction, reducing θ, the spring restoring force rotates the cam shaft 712 in the opposite direction and allows excess cable 700 to wrap around the cam 720. At any angle θ, the torque produced by the balancing system and the torque produced by the mass of the components should be equal so that the surgical system is properly balanced; in other words, the torque produced by the spring and by the mass of the associated system are preferably equal (or preferably at least within about 5%, 10%, 15%, 20% or about 25% of each other).
[0152] Figures 34a to 34c The distribution of the torque generated about the remote center of motion as a function of angle θ is illustrated. As the center of mass of the instrument rotates about the remote center of motion 162, the torque generated increases in a sinusoidal manner. At 0 degrees θ, the torque generated is zero and reaches a maximum value at 90 degrees θ. In theory, the torque continues to decrease from the peak at 90 degrees θ until it reaches zero again at 180 degrees θ, as it is a function of the lateral distance from the center of mass to the vertical axis passing through the remote center of motion 162. In order to match this sinusoidal torque generated about the remote center of motion 162, the spring 724 must generate a matching sinusoidal balancing force using a specific winding cam 720 with a predetermined balancing cam profile.
[0153] For example, a circular cam with an attached cable that rotates to pull a linear compression spring will produce a linear torque because the cable length increases linearly with each degree of rotation while the torque arm based on the cam diameter remains constant. The torque generated about the cam shaft is the product of the cumulative cable length pulling the spring and the instantaneous moment arm from the cable to the center of the shaft. Therefore, these two factors can be taken into account when generating non-linear torque about the cam. In a preferred embodiment, the profile of the cam 720 is shaped so that the product of the cumulative cable length and the moment arm produces a sinusoidal torque to match or at least substantially match the sinusoidal torque generated when the surgical instrument moves about the arcuate track 224, as shown in FIG. Figures 34a to 34c as shown in .
[0154] An alternative embodiment of the described balancing system may use a mass for the balancing system contained in the base instead of a spring system.
[0155] In the examples described herein, the arcuate tracks and linear tracks shown as forming part of the translation device are shown as substantially rigid, fixed-length components that are self-supporting and whose configuration generally remains constant while the system and stabilization device are in use. In this example, movement of the tracks and / or translation of system components is achieved by sliding or translating an entirety along the length of the respective tracks using the described movable carriage or shuttle components. In this arrangement, the device attachment unit can, for example, be adjacent to the distal / free end of the linear track when the surgical device is retracted away from the patient, and can then be moved away from the free end of the track and toward the fixed end of the linear track connected to the arcuate track when the surgical device is moved toward the patient.
[0156] Alternatively and optionally, at least one of these tracks may have a variable length and may change length when the device is in use. This may facilitate movement of the device attachment unit by changing the length or configuration of these tracks rather than translating along the tracks. For example, a linear translation device may include a linear support member that can shorten and extend its length in the direction of the translation axis. The device attachment unit may be connected to the distal end of the variable length support, and then the device attachment unit may move toward and away from the arched support member (along the translation axis) as the distal end of the variable length support itself moves toward and away from the arched support member (rather than translating along the linear track). The variable length support may have any suitable configuration, including having two or more retractable sections, compressible and / or extendable sections, sliding or nested components, etc. The arched support may similarly be configured to have a variable length (e.g., a variable arc length), such that the arched support may retract to move the linear translation device toward the hub and extend to move the linear translation device away from the hub.
[0157] Fig.35 An example of a balancing method using electric actuators (in this example, motors 460 and 464) is shown. To apply a biasing force to the linear translation device, motor 464 would be connected to a cable similar to 660. To enable manual manipulation of the movable assembly, the motor would be back-drivable and apply a specified torque based on the position of the joint so as to compensate for the weight of the assembly but not affect the position during manual manipulation. Motor 460 would have similar functionality for compensating for an arcuate track joint. This embodiment implements a hold position mode that would limit joint movement by maintaining the motor position. This could potentially be used during instrument changes and other situations during surgical procedures where the device should not move.
[0158] In addition, non-electric balancing mechanisms can be used in conjunction with electric actuators to reduce the load on the actuators while enhancing safety. In one such example, the non-electric balancing mechanism will at least partially balance the weight of the moving assembly. In the case where the electric actuators are motors, this will reduce their torque requirements. The electric actuators can drive various joints to achieve automatic positioning or to maintain a specific position. Having the non-electric balancing mechanism substantially offset the weight of the moving assembly will increase the level of safety during power failures.
[0159] Fig.36 An alternative example of a surgical system is described in which the arcuate track is replaced with an alternative structure comprising a parallelogram structure 260 having a plurality of movably connected linkage members. One end of the parallelogram structure 260 is connected to a rotatable hub and the other end is connected to and supports a translation device (e.g., linear track 224). The parallelogram structure 260 can enable a remote rotation axis of a surgical device port in the same manner as the arcuate track described in the other examples. The parallelogram structure 260 can be used to rotate the surgical device port remotely. Fig.31 A similar cable and spring based approach as shown in or using Fig.35 The electric actuator shown in balances the resulting axis of the parallelogram.
[0160] As described herein, the surgical system can optionally be configured to operate in a companion mode in addition to its primary mode. Figure 1 , the surgical system may include three robotic surgical units 104, 106, and 120 with corresponding stabilization devices, wherein two units 104 and 106 are used to hold surgical instruments and one unit 120 is configured to hold an endoscopic camera. In this arrangement, the surgeon may place their hands on the handles 108 and 110 of the two wrist instruments, and it may be desirable to allow the surgeon to also control the accompanying endoscope unit, preferably wherein the stabilization device of the endoscope unit may be driven by an electric actuator, and the surgeon may then control the position of the endoscope from the handles they are already holding, and may not require an assistant (or other user) to position it. This type of companion mode may be activated by pressing a button on either handle or other such auxiliary input device to switch between controlling the local wrist end effector to which the handle is physically attached and positioning a separate endoscope.
[0161] This type of companion mode may be advantageous over conventional stand-alone motorized endoscope positioners, which may require a separate input mechanism, such as voice commands, foot pedals, or head tilt for control (because the surgeon places their hands on the instrument). In contrast, the system described herein may help surgeons control the position of a companion device, such as an endoscope, through their hand movements on the handle of the primary device.
[0162] refer to Fig.37 , one example of a second / companion remote center of motion mechanism 2104 includes an attachment endoscope 2112, which is composed of a base 2250, a shaft 2162, and a distal end 2164. The endoscope base 2250 is removably attached to a mating connection interface 2220 on a second device attachment unit. This example of a stabilization device is not a passive device because it has an accompanying electric drive system, which can include a motor 2456 and / or other suitable electric actuators that can be communicatively connected to a controller of a separate primary stabilization device (e.g., controller 412). In this arrangement, the electric drive system can be used to move portions of the stabilization device to help move the device attachment unit 2220, and the endoscope 2112 can be positioned in response to input from a primary control handle (e.g., handles 108 and 1108). Fig.38 One schematic example of a control system for a surgical system incorporating a companion mode is shown. In this arrangement, when the system is switched to companion mode (e.g., for endoscope control), the handle sensor 410 and controller 412 may be connected (via wires, wireless protocols, etc.) to a separate motor controller 2414 to control the motor 2456 (with optional feedback provided via encoder 2418) and thereby control the position of the tip of the endoscope (with optional feedback provided via tip position encoder 2164). When the endoscope 2112 is in its desired position, the system may be returned to its primary operating mode and used as described above. Fig.17 The control scheme shown (or other suitable system).
[0163] Although this specification contains references to illustrative embodiments and examples, this specification is not intended to be understood in a limiting sense. Therefore, various modifications to the illustrative embodiments, as well as other embodiments of the invention described herein, will be apparent to those skilled in the art upon reference to this specification. Therefore, the appended claims are intended to cover any such modifications or embodiments.
[0164] All publications, patents, and patent applications mentioned herein are incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety.
Claims
1. A hybrid, direct-controlled and robotic-assisted surgical system for a surgical device having an elongated shaft extending from a distal tip including an end effector, the surgical system include: A stabilization device configured to at least partially support the weight of the surgical device and define a point, the stabilization device comprising: a base member configured to be fixed relative to the patient during manipulation of the surgical device, and a device attachment unit movable relative to the base member and configured to removably receive the surgical device having the elongated shaft and the distal tip, the stabilization device being configured to guide movement of the device attachment unit such that the device attachment unit and the distal tip are on opposite sides of the point and the elongated shaft intersects the point when the stabilization device is in use; a handle mechanically coupled to the device attachment unit and configured to be grasped by a user, whereby movement of the handle relative to the base member causes corresponding movement of the distal tip of the surgical device received in the device attachment unit; and A robot-assisted system configured to drive the end effector of the surgical device and comprising: a sensor assembly configured to monitor at least a first property of the handle and generate a corresponding sensor signal, a controller communicatively connected to the sensor assembly to receive the sensor signal and generate a corresponding primary control signal, and an electric actuation unit communicatively connected to the controller to receive the primary control signal and configured to actuate the end effector of the surgical device received in the device attachment unit based on the primary control signal; and a balancing system configured to apply a biasing force on at least one of the device attachment unit, the handle, and the surgical device and to at least partially balance the mass of at least one of the device attachment unit, the handle, and the surgical device, wherein the balancing system is configured to at least one of: be configured to apply a biasing force on the device attachment unit to at least partially balance the mass of the device attachment unit when the device attachment unit translates along a translation axis; or be configured to apply a biasing force to at least partially balance a torque about the point generated by the mass of at least one of the device attachment unit, the handle, and the surgical device, Wherein the point is the remote center of motion or pivot point for minimally invasive entry.
2. The system of claim 1, wherein the stabilization device further include: a) a hub rotatably connected to the base member and rotatable about an axis of rotation; b) an arcuate track connected to the hub and extending about a center of curvature; as well as c) a linear translation device connected to the arcuate track and movable relative to the hub so as to be pivotable about a pivot axis passing through the center of curvature, wherein the device attachment unit is translatable relative to the arcuate track along the translation axis, wherein the stabilization device defines the point.
3. A system according to claim 2, wherein the intersection of the rotation axis, the pivot axis, and the device axis parallel to the translation axis defines the point of the stabilization device, and the device attachment unit is configured so that when the surgical device is attached to the device attachment unit, the slender shaft extends along the device axis and intersects the point.
4. A system according to claim 2, wherein the linear translation device includes a linear rail extending from a fixed end connected to the arcuate rail to a free end axially spaced apart from the fixed end, and wherein the device attachment unit is slidably connected to the linear rail and is capable of translating between the fixed end and the free end.
5. The system of claim 4, wherein the balancing system is configured to apply a biasing force on the device attachment unit to at least partially balance the mass of the device attachment unit when the device attachment unit translates along the translation axis.
6. The system of claim 2, wherein the arcuate track is movably connected to the hub so as to be pivotable about the pivot axis, and wherein the linear translation device is non-movably connected to the arcuate track.
7. The system of claim 2, wherein the balancing system includes a biasing device configured to apply a biasing force on the arcuate track to at least partially balance a torque acting about the pivot axis.
8. The system of claim 1, wherein the surgical device is removable from the device attachment unit independently of the handle, and wherein the device attachment unit is configured to removably receive a second surgical device.
9. The system of claim 1, wherein when the system is in use, the device attachment unit is movable relative to the base member in response to manual input from a user without engaging a drive mechanism.
10. The system of claim 1, wherein the handle comprises a grip portion movable relative to the device attachment unit about at least a first degree of freedom, and wherein the first property comprises an orientation of the grip portion about the first degree of freedom.
11. The system of claim 10, wherein the handle portion is further movable relative to the device attachment unit about a second degree of freedom, and wherein the sensor assembly is configured to monitor a second property including an orientation of the handle portion about the second degree of freedom.
12. The system of claim 1, wherein the handle comprises a grip portion movable relative to the device attachment unit about a pitch axis, a roll axis, and a yaw axis, and wherein a) the sensor assembly is configured to detect movement about each of the pitch axis, the roll axis, and the yaw axis; b) the sensor signal comprises a multi-channel signal; c) the main control signal includes a corresponding multi-channel control signal; and d) The electric actuation unit is configured to cause corresponding movements of the end effector around an end effector pitch axis, an end effector roll axis, and an end effector yaw axis, thereby translating movements of the handle portion into corresponding movements of the end effector via the robotic assistance system.
13. The system according to claim 12, wherein the electric actuation unit comprises a plurality of rotatable actuation discs, which are configured to be connected to corresponding drive discs on the surgical device, thereby being able to drive the end effector around the end effector pitch axis, the end effector roll axis and the end effector yaw axis.
14. The system of claim 13, wherein the sensor assembly includes at least one potentiometer or encoder to detect the orientation or position of the handle portion about at least one of the pitch axis, the roll axis, and the yaw axis.
15. The system of claim 12, wherein the pitch axis, the roll axis, and the yaw axis intersect each other at a common point.
16. The system of claim 1, wherein the handle further comprises an auxiliary user input device communicatively coupled to the controller, and wherein the controller is configured such that triggering the auxiliary user input device triggers a corresponding auxiliary action of the surgical device.
17. The system of claim 16, wherein the auxiliary user input device comprises at least one of a switch, a button, and a knob, and wherein the auxiliary action comprises causing at least one of cauterization, grasping, irrigation, and suction using the end effector.
18. A system according to claim 5, wherein the balancing system includes a counterweight, which is capable of translating along the linear track and is operably connected to the device attachment unit, whereby translation of the device attachment unit causes relative translation of the counterweight to at least partially balance translation of the device attachment unit along the linear track.
19. The system of claim 18, wherein the device attachment unit is attached to a first side of the linear track, and wherein the counterweight is attached to an opposite second side of the linear track, and when the device attachment unit translates in one direction, the counterweight translates in an opposite direction, thereby balancing the device attachment unit.
20. A system according to claim 19, wherein when the surgical device is attached to the device attachment unit, the combined linear centroid of the linear track, the device attachment unit, the handle, the surgical device and the counterweight is located at a reference position relative to the remote motion center, and wherein when the device attachment unit and the counterweight translate along the linear track, the combined linear centroid remains in the reference position.
21. The system of claim 19, wherein the mass of the counterweight is equal to the combined mass of the device attachment unit, the handle, and the surgical device.
22. A system according to claim 7, wherein the magnitude of the torque acting about the remote center of motion increases as the angular position of the first end of the arcuate track relative to the hub changes from 0 degrees to 90 degrees, and wherein the biasing device is configured such that the magnitude of the biasing force increases as the angular position of the first end of the arcuate track relative to the hub changes from 0 degrees to 90 degrees.
23. The system of claim 22, wherein the magnitude of the biasing force remains equal to the magnitude of the torque when the angular position of the first end of the arcuate track relative to the hub is between 0 degrees and 90 degrees.
24. The system of claim 1, wherein the device attachment unit comprises the electric actuation unit, whereby the electric actuation unit is movable in unison with the device attachment unit relative to the base member.
25. The system of claim 24, wherein the controller is communicatively connected to the sensor assembly using at least one of a cable and a wireless communication protocol.
26. The system of claim 2, wherein the device attachment unit is configured such that when the surgical device is attached to the device attachment unit, an axis of the elongated shaft is parallel to the translation axis.
27. The system of claim 4, wherein the device attachment unit is capable of translating along the linear track independent of movement of the arcuate track relative to the hub.
28. The system of claim 2, wherein the hub, the arcuate track, and the device attachment unit are movable in response to manual input from a user without engaging a drive mechanism.
29. The system of claim 2, wherein the axis of rotation is vertical when the base member is fixed.
30. The system of claim 2, further comprising a braking device selectively engageable to prevent movement of the device attachment unit about at least one of the rotation axis, the pivot axis, and the translation axis.
31. A system according to claim 1, wherein the handle is mechanically attached to the device attachment unit so that the force applied on the distal tip of the surgical device received in the device attachment unit is transmitted to the handle and is configured to provide passive force feedback.
32. The system of claim 1, wherein the stabilization device further include: a) a hub rotatably connected to the base and rotatable about an axis of rotation; b) a parallelogram structure connected to the hub; as well as c) a linear translation device connected to the movable end of the parallelogram structure and movable together with the movable end of the parallelogram structure relative to the hub so as to be pivotable about a pivot axis, wherein The device attachment unit is translatable relative to the parallelogram structure along a translation axis, wherein the stabilization apparatus defines the point.
33. The system according to claim 1, The system is configured to operate in a primary mode and a companion mode, wherein in the companion mode the system includes a second stabilization device configured to support and actuate a companion surgical device based on input received from the handle.
34. The system of claim 33, wherein the robotic assistance system further comprises a companion electric drive system communicatively connected to the controller, and wherein the system is selectively operable in the companion mode, in: The controller receives the sensor signal and generates a corresponding companion control signal; and the companion electric drive system moves the companion surgical device based on the companion control signal, and Wherein when the system is in the companion mode, the controller does not generate the primary control signal, whereby movement of the handle does not actuate the end effector of the surgical device received in the device attachment unit.
35. A system according to claim 33, wherein the second stabilizing device is configured to define a second remote motion center and constrain the movement of the companion device attachment unit, so that the distal tips of the companion device attachment unit and the companion surgical device are on opposite sides of the second remote motion center, and when the second stabilizing device is in use, the slender shaft of the companion surgical device intersects with the second remote motion center.
36. The system of claim 33, wherein the base member of the second stabilizing device is spaced apart from the base member of the stabilizing device.
37. The system of claim 33, wherein the concomitant surgical device comprises an endoscope.
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