Patent Description:
Certain wristed instruments use sheathing, which at least partially covers the wrist, for electrical insulation or sealing purposes. For example, certain monopolar instruments, such as monopolar scissors, may use sheathing to prevent tissue from being inadvertently burned due to stray electrical current being applied to tissue from locations other than an end effector of the scissors. The sheath can serve as a cover or sleeve that can be placed over the instrument before use in a surgery, or may be permanently fixed over the instrument wrist. The sheathing can extend from the instrument shaft to the end effector and can be designed to cover the wrist throughout a medical procedure.

<CIT> discusses an endoscopic stitching device that includes a handle assembly; an elongate shaft supported by and extending from the handle assembly; and an end effector supported on a distal end of the elongate shaft. The end effector includes a neck assembly configured and adapted for articulation in one direction between a substantially linear configuration and an off-axis configuration, and a pair of juxtaposed jaws pivotally associated with one another.

<CIT> discusses an electrically energized medical instrument that uses one or more drive cables to both actuate mechanical components of a wrist mechanism or an effector and to electrically energize the effector. Electrical isolation can be achieved using an insulating main tube through which drive cables extend from a backend mechanism to the effector, an insulating end cover that leaves only the desired portions of the effector exposed, and one or more seals to prevent electrically conductive liquid from entering the main tube.

<CIT> discusses electromechanical surgical systems configured for use with removable disposable loading units and/or single use loading units for clamping, cutting and/or stapling tissue. A force transmitting assembly of surgical instrument transmits a rotation of a rotatable drive member of the surgical instrument to the rotation receiving member of the end effector. A distal neck assembly of the surgical instrument includes at least one gear system configured to convert a rotational input of the rotatable drive member into at least two output forces to the end effector; and an articulating neck assembly interconnecting the tubular body and the distal neck housing. The articulating neck assembly is configured to enable off-axis articulation of the distal neck assembly. The rotatable drive member extends through the articulating neck assembly.

<CIT> discusses a surgical apparatus that includes a shaft having a proximal end and a distal end, an end effector coupled to the distal end of the shaft, and a sheath disposed on an external surface of the instrument shaft.

<CIT> discloses a wrist joint, such as for a surgical instrument, including a first disc, a second disc adjacent the first disc, and a drive tendon that extends through the first disc and the second disc. The first disc and the second disc may include respective opposing joint features that intermesh with one another. The first disc and the second disc may further include opposing load bearing surfaces separate from the joint features. The drive tendon may exert a force on at least one of the first and second discs to cause relative rotation between the first and second discs. The first and second discs may have a maximum rotational range of motion greater than about +/-<NUM> degrees relative to each other.

The invention is defined by appended claim <NUM>. The systems, methods and devices of this disclosure each have several innovative aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

In one aspect, there is provided an instrument, comprising: a shaft; an end effector; and a wrist connecting the shaft to the end effector, the wrist comprising a proximal clevis, a distal clevis, and an intermediary frame positioned between the proximal clevis and the distal clevis.

In another aspect, there is provided an instrument, comprising: a shaft; a wrist comprising a proximal clevis and distal clevis that form a rolling joint; and a mechanical stop configured to limit a pitch angle between the proximal clevis and the distal clevis.

In yet another aspect, there is provided a method of actuating an instrument, the instrument comprising an end effector and a wrist, the method comprising: advancing or retracting at least one cable segment that engages a distal clevis of the instrument, the wrist comprising a proximal clevis, the distal clevis, and an intermediary frame positioned between the proximal clevis and the distal clevis, wherein the advancing or retracting at least one cable segment articulates the distal clevis with respect to the proximal clevis.

In still yet another aspect, there is provided an instrument, comprising: a shaft; an end effector; a mechanical hardstop; and a wrist connecting the shaft to the end effector, the wrist comprising a proximal clevis and a distal clevis, wherein the hardstop is configured to serve as a mechanical stop to limit a pitch angle between the proximal clevis and the distal clevis.

The invention is shown in <FIG>.

Aspects of the present disclosure may be integrated into a robotically-enabled medical system capable of performing a variety of medical procedures, including both minimally invasive, such as laparoscopy, and non-invasive, such as endoscopy, procedures. Among endoscopic procedures, the system may be capable of performing bronchoscopy, ureteroscopy, gastroscopy, etc..

In addition to performing the breadth of procedures, the system may provide additional benefits, such as enhanced imaging and guidance to assist the physician. Additionally, the system may provide the physician with the ability to perform the procedure from an ergonomic position without the need for awkward arm motions and positions. Still further, the system may provide the physician with the ability to perform the procedure with improved ease of use such that one or more of the instruments of the system can be controlled by a single user.

Various embodiments will be described below in conjunction with the drawings for purposes of illustration. It should be appreciated that many other implementations of the disclosed concepts are possible, and various advantages can be achieved with the disclosed implementations. Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.

The robotically-enabled medical system may be configured in a variety of ways depending on the particular procedure. <FIG> illustrates an embodiment of a cart-based robotically-enabled system <NUM> arranged for a diagnostic and/or therapeutic bronchoscopy. During a bronchoscopy, the system <NUM> may comprise a cart <NUM> having one or more robotic arms <NUM> to deliver a medical instrument, such as a steerable endoscope <NUM>, which may be a procedure-specific bronchoscope for bronchoscopy, to a natural orifice access point (i.e., the mouth of the patient positioned on a table in the present example) to deliver diagnostic and/or therapeutic tools. As shown, the cart <NUM> may be positioned proximate to the patient's upper torso in order to provide access to the access point. Similarly, the robotic arms <NUM> may be actuated to position the bronchoscope relative to the access point. The arrangement in <FIG> may also be utilized when performing a gastro-intestinal (GI) procedure with a gastroscope, a specialized endoscope for GI procedures. <FIG> depicts an example embodiment of the cart in greater detail.

With continued reference to <FIG>, once the cart <NUM> is properly positioned, the robotic arms <NUM> may insert the steerable endoscope <NUM> into the patient robotically, manually, or a combination thereof. As shown, the steerable endoscope <NUM> may comprise at least two telescoping parts, such as an inner leader portion and an outer sheath portion, each portion coupled to a separate instrument driver from the set of instrument drivers <NUM>, each instrument driver coupled to the distal end of an individual robotic arm. This linear arrangement of the instrument drivers <NUM>, which facilitates coaxially aligning the leader portion with the sheath portion, creates a "virtual rail" <NUM> that may be repositioned in space by manipulating the one or more robotic arms <NUM> into different angles and/or positions. The virtual rails described herein are depicted in the Figures using dashed lines, and accordingly the dashed lines do not depict any physical structure of the system. Translation of the instrument drivers <NUM> along the virtual rail <NUM> telescopes the inner leader portion relative to the outer sheath portion or advances or retracts the endoscope <NUM> from the patient. The angle of the virtual rail <NUM> may be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and position of the virtual rail <NUM> as shown represents a compromise between providing physician access to the endoscope <NUM> while minimizing friction that results from bending the endoscope <NUM> into the patient's mouth.

The endoscope <NUM> may be directed down the patient's trachea and lungs after insertion using precise commands from the robotic system until reaching the target destination or operative site. In order to enhance navigation through the patient's lung network and/or reach the desired target, the endoscope <NUM> may be manipulated to telescopically extend the inner leader portion from the outer sheath portion to obtain enhanced articulation and greater bend radius. The use of separate instrument drivers <NUM> also allows the leader portion and sheath portion to be driven independently of each other.

For example, the endoscope <NUM> may be directed to deliver a biopsy needle to a target, such as, for example, a lesion or nodule within the lungs of a patient. The needle may be deployed down a working channel that runs the length of the endoscope to obtain a tissue sample to be analyzed by a pathologist. Depending on the pathology results, additional tools may be deployed down the working channel of the endoscope for additional biopsies. After identifying a nodule to be malignant, the endoscope <NUM> may endoscopically deliver tools to resect the potentially cancerous tissue. In some instances, diagnostic and therapeutic treatments can be delivered in separate procedures. In those circumstances, the endoscope <NUM> may also be used to deliver a fiducial to "mark" the location of the target nodule as well. In other instances, diagnostic and therapeutic treatments may be delivered during the same procedure.

The system <NUM> may also include a movable tower <NUM>, which may be connected via support cables to the cart <NUM> to provide support for controls, electronics, fluidics, optics, sensors, and/or power to the cart <NUM>. Placing such functionality in the tower <NUM> allows for a smaller form factor cart <NUM> that may be more easily adjusted and/or re-positioned by an operating physician and his/her staff. Additionally, the division of functionality between the cart / table and the support tower <NUM> reduces operating room clutter and facilitates improving clinical workflow. While the cart <NUM> may be positioned close to the patient, the tower <NUM> may be stowed in a remote location to stay out of the way during a procedure.

In support of the robotic systems described above, the tower <NUM> may include component(s) of a computer-based control system that stores computer program instructions, for example, within a non-transitory computer-readable storage medium such as a persistent magnetic storage drive, solid state drive, etc. The execution of those instructions, whether the execution occurs in the tower <NUM> or the cart <NUM>, may control the entire system or sub-system(s) thereof. For example, when executed by a processor of the computer system, the instructions may cause the components of the robotics system to actuate the relevant carriages and arm mounts, actuate the robotics arms, and control the medical instruments. For example, in response to receiving the control signal, the motors in the joints of the robotics arms may position the arms into a certain posture.

The tower <NUM> may also include a pump, flow meter, valve control, and/or fluid access in order to provide controlled irrigation and aspiration capabilities to the system that may be deployed through the endoscope <NUM>. These components may also be controlled using the computer system of the tower <NUM>. In some embodiments, irrigation and aspiration capabilities may be delivered directly to the endoscope <NUM> through separate cable(s).

The tower <NUM> may include a voltage and surge protector designed to provide filtered and protected electrical power to the cart <NUM>, thereby avoiding placement of a power transformer and other auxiliary power components in the cart <NUM>, resulting in a smaller, more moveable cart <NUM>.

The tower <NUM> may also include support equipment for the sensors deployed throughout the robotic system <NUM>. For example, the tower <NUM> may include optoelectronics equipment for detecting, receiving, and processing data received from the optical sensors or cameras throughout the robotic system <NUM>. In combination with the control system, such optoelectronics equipment may be used to generate real-time images for display in any number of consoles deployed throughout the system, including in the tower <NUM>. Similarly, the tower <NUM> may also include an electronic subsystem for receiving and processing signals received from deployed electromagnetic (EM) sensors. The tower <NUM> may also be used to house and position an EM field generator for detection by EM sensors in or on the medical instrument.

The tower <NUM> may also include a console <NUM> in addition to other consoles available in the rest of the system, e.g., console mounted on top of the cart. The console <NUM> may include a user interface and a display screen, such as a touchscreen, for the physician operator. Consoles in the system <NUM> are generally designed to provide both robotic controls as well as preoperative and real-time information of the procedure, such as navigational and localization information of the endoscope <NUM>. When the console <NUM> is not the only console available to the physician, it may be used by a second operator, such as a nurse, to monitor the health or vitals of the patient and the operation of the system <NUM>, as well as to provide procedure-specific data, such as navigational and localization information. In other embodiments, the console <NUM> is housed in a body that is separate from the tower <NUM>.

The tower <NUM> may be coupled to the cart <NUM> and endoscope <NUM> through one or more cables or connections (not shown). In some embodiments, the support functionality from the tower <NUM> may be provided through a single cable to the cart <NUM>, simplifying and de-cluttering the operating room. In other embodiments, specific functionality may be coupled in separate cabling and connections. For example, while power may be provided through a single power cable to the cart <NUM>, the support for controls, optics, fluidics, and/or navigation may be provided through a separate cable.

<FIG> provides a detailed illustration of an embodiment of the cart <NUM> from the cart-based robotically-enabled system shown in <FIG>. The cart <NUM> generally includes an elongated support structure <NUM> (often referred to as a "column"), a cart base <NUM>, and a console <NUM> at the top of the column <NUM>. The column <NUM> may include one or more carriages, such as a carriage <NUM> (alternatively "arm support") for supporting the deployment of one or more robotic arms <NUM> (three shown in <FIG>). The carriage <NUM> may include individually configurable arm mounts that rotate along a perpendicular axis to adjust the base of the robotic arms <NUM> for better positioning relative to the patient. The carriage <NUM> also includes a carriage interface <NUM> that allows the carriage <NUM> to vertically translate along the column <NUM>.

The carriage interface <NUM> is connected to the column <NUM> through slots, such as slot <NUM>, that are positioned on opposite sides of the column <NUM> to guide the vertical translation of the carriage <NUM>. The slot <NUM> contains a vertical translation interface to position and hold the carriage <NUM> at various vertical heights relative to the cart base <NUM>. Vertical translation of the carriage <NUM> allows the cart <NUM> to adjust the reach of the robotic arms <NUM> to meet a variety of table heights, patient sizes, and physician preferences. Similarly, the individually configurable arm mounts on the carriage <NUM> allow the robotic arm base <NUM> of the robotic arms <NUM> to be angled in a variety of configurations.

In some embodiments, the slot <NUM> may be supplemented with slot covers that are flush and parallel to the slot surface to prevent dirt and fluid ingress into the internal chambers of the column <NUM> and the vertical translation interface as the carriage <NUM> vertically translates. The slot covers may be deployed through pairs of spring spools positioned near the vertical top and bottom of the slot <NUM>. The covers are coiled within the spools until deployed to extend and retract from their coiled state as the carriage <NUM> vertically translates up and down. The spring-loading of the spools provides force to retract the cover into a spool when the carriage <NUM> translates towards the spool, while also maintaining a tight seal when the carriage <NUM> translates away from the spool. The covers may be connected to the carriage <NUM> using, for example, brackets in the carriage interface <NUM> to ensure proper extension and retraction of the cover as the carriage <NUM> translates.

The column <NUM> may internally comprise mechanisms, such as gears and motors, that are designed to use a vertically aligned lead screw to translate the carriage <NUM> in a mechanized fashion in response to control signals generated in response to user inputs, e.g., inputs from the console <NUM>.

The robotic arms <NUM> may generally comprise robotic arm bases <NUM> and end effectors <NUM>, separated by a series of linkages <NUM> that are connected by a series of joints <NUM>, each joint comprising an independent actuator, each actuator comprising an independently controllable motor. Each independently controllable joint represents an independent degree of freedom available to the robotic arm <NUM>. Each of the robotic arms <NUM> may have seven joints, and thus provide seven degrees of freedom. A multitude of joints result in a multitude of degrees of freedom, allowing for "redundant" degrees of freedom. Having redundant degrees of freedom allows the robotic arms <NUM> to position their respective end effectors <NUM> at a specific position, orientation, and trajectory in space using different linkage positions and joint angles. This allows for the system to position and direct a medical instrument from a desired point in space while allowing the physician to move the arm joints into a clinically advantageous position away from the patient to create greater access, while avoiding arm collisions.

The cart base <NUM> balances the weight of the column <NUM>, carriage <NUM>, and robotic arms <NUM> over the floor. Accordingly, the cart base <NUM> houses heavier components, such as electronics, motors, power supply, as well as components that either enable movement and/or immobilize the cart <NUM>. For example, the cart base <NUM> includes rollable wheel-shaped casters <NUM> that allow for the cart <NUM> to easily move around the room prior to a procedure. After reaching the appropriate position, the casters <NUM> may be immobilized using wheel locks to hold the cart <NUM> in place during the procedure.

Positioned at the vertical end of the column <NUM>, the console <NUM> allows for both a user interface for receiving user input and a display screen (or a dual-purpose device such as, for example, a touchscreen <NUM>) to provide the physician user with both preoperative and intraoperative data. Potential preoperative data on the touchscreen <NUM> may include preoperative plans, navigation and mapping data derived from preoperative computerized tomography (CT) scans, and/or notes from preoperative patient interviews. Intraoperative data on display may include optical information provided from the tool, sensor and coordinate information from sensors, as well as vital patient statistics, such as respiration, heart rate, and/or pulse. The console <NUM> may be positioned and tilted to allow a physician to access the console <NUM> from the side of the column <NUM> opposite the carriage <NUM>. From this position, the physician may view the console <NUM>, robotic arms <NUM>, and patient while operating the console <NUM> from behind the cart <NUM>. As shown, the console <NUM> also includes a handle <NUM> to assist with maneuvering and stabilizing the cart <NUM>.

<FIG> illustrates an embodiment of a robotically-enabled system <NUM> arranged for ureteroscopy. In a ureteroscopic procedure, the cart <NUM> may be positioned to deliver a ureteroscope <NUM>, a procedure-specific endoscope designed to traverse a patient's urethra and ureter, to the lower abdominal area of the patient. In a ureteroscopy, it may be desirable for the ureteroscope <NUM> to be directly aligned with the patient's urethra to reduce friction and forces on the sensitive anatomy in the area. As shown, the cart <NUM> may be aligned at the foot of the table to allow the robotic arms <NUM> to position the ureteroscope <NUM> for direct linear access to the patient's urethra. From the foot of the table, the robotic arms <NUM> may insert the ureteroscope <NUM> along the virtual rail <NUM> directly into the patient's lower abdomen through the urethra.

After insertion into the urethra, using similar control techniques as in bronchoscopy, the ureteroscope <NUM> may be navigated into the bladder, ureters, and/or kidneys for diagnostic and/or therapeutic applications. For example, the ureteroscope <NUM> may be directed into the ureter and kidneys to break up kidney stone build up using a laser or ultrasonic lithotripsy device deployed down the working channel of the ureteroscope <NUM>. After lithotripsy is complete, the resulting stone fragments may be removed using baskets deployed down the ureteroscope <NUM>.

<FIG> illustrates an embodiment of a robotically-enabled <NUM> system similarly arranged for a vascular procedure. In a vascular procedure, the system <NUM> may be configured such that the cart <NUM> may deliver a medical instrument <NUM>, such as a steerable catheter, to an access point in the femoral artery in the patient's leg. The femoral artery presents both a larger diameter for navigation as well as a relatively less circuitous and tortuous path to the patient's heart, which simplifies navigation. As in a ureteroscopic procedure, the cart <NUM> may be positioned towards the patient's legs and lower abdomen to allow the robotic arms <NUM> to provide a virtual rail <NUM> with direct linear access to the femoral artery access point in the patient's thigh / hip region. After insertion into the artery, the medical instrument <NUM> may be directed and inserted by translating the instrument drivers <NUM>. Alternatively, the cart may be positioned around the patient's upper abdomen in order to reach alternative vascular access points, such as, for example, the carotid and brachial arteries near the shoulder and wrist.

Embodiments of the robotically-enabled medical system may also incorporate the patient's table. Incorporation of the table reduces the amount of capital equipment within the operating room by removing the cart, which allows greater access to the patient. <FIG> illustrates an embodiment of such a robotically-enabled system arranged for a bronchoscopic procedure. System <NUM> includes a support structure or column <NUM> for supporting platform <NUM> (shown as a "table" or "bed") over the floor. Much like in the cart-based systems, the end effectors of the robotic arms <NUM> of the system <NUM> comprise instrument drivers <NUM> that are designed to manipulate an elongated medical instrument, such as a bronchoscope <NUM> in <FIG>, through or along a virtual rail <NUM> formed from the linear alignment of the instrument drivers <NUM>. In practice, a C-arm for providing fluoroscopic imaging may be positioned over the patient's upper abdominal area by placing the emitter and detector around the table <NUM>.

<FIG> provides an alternative view of the system <NUM> without the patient and medical instrument for discussion purposes. As shown, the column <NUM> may include one or more carriages <NUM> shown as ring-shaped in the system <NUM>, from which the one or more robotic arms <NUM> may be based. The carriages <NUM> may translate along a vertical column interface <NUM> that runs the length of the column <NUM> to provide different vantage points from which the robotic arms <NUM> may be positioned to reach the patient. The carriage(s) <NUM> may rotate around the column <NUM> using a mechanical motor positioned within the column <NUM> to allow the robotic arms <NUM> to have access to multiples sides of the table <NUM>, such as, for example, both sides of the patient. In embodiments with multiple carriages, the carriages may be individually positioned on the column and may translate and/or rotate independently of the other carriages. While the carriages <NUM> need not surround the column <NUM> or even be circular, the ring-shape as shown facilitates rotation of the carriages <NUM> around the column <NUM> while maintaining structural balance. Rotation and translation of the carriages <NUM> allows the system <NUM> to align the medical instruments, such as endoscopes and laparoscopes, into different access points on the patient. In other embodiments (not shown), the system <NUM> can include a patient table or bed with adjustable arm supports in the form of bars or rails extending alongside it. One or more robotic arms <NUM> (e.g., via a shoulder with an elbow joint) can be attached to the adjustable arm supports, which can be vertically adjusted. By providing vertical adjustment, the robotic arms <NUM> are advantageously capable of being stowed compactly beneath the patient table or bed, and subsequently raised during a procedure.

The robotic arms <NUM> may be mounted on the carriages <NUM> through a set of arm mounts <NUM> comprising a series of joints that may individually rotate and/or telescopically extend to provide additional configurability to the robotic arms <NUM>. Additionally, the arm mounts <NUM> may be positioned on the carriages <NUM> such that, when the carriages <NUM> are appropriately rotated, the arm mounts <NUM> may be positioned on either the same side of the table <NUM> (as shown in <FIG>), on opposite sides of the table <NUM> (as shown in <FIG>), or on adjacent sides of the table <NUM> (not shown).

The column <NUM> structurally provides support for the table <NUM>, and a path for vertical translation of the carriages <NUM>. Internally, the column <NUM> may be equipped with lead screws for guiding vertical translation of the carriages, and motors to mechanize the translation of the carriages <NUM> based the lead screws. The column <NUM> may also convey power and control signals to the carriages <NUM> and the robotic arms <NUM> mounted thereon.

The table base <NUM> serves a similar function as the cart base <NUM> in the cart <NUM> shown in <FIG>, housing heavier components to balance the table/bed <NUM>, the column <NUM>, the carriages <NUM>, and the robotic arms <NUM>. The table base <NUM> may also incorporate rigid casters to provide stability during procedures. Deployed from the bottom of the table base <NUM>, the casters may extend in opposite directions on both sides of the base <NUM> and retract when the system <NUM> needs to be moved.

With continued reference to <FIG>, the system <NUM> may also include a tower (not shown) that divides the functionality of the system <NUM> between the table and the tower to reduce the form factor and bulk of the table. As in earlier disclosed embodiments, the tower may provide a variety of support functionalities to the table, such as processing, computing, and control capabilities, power, fluidics, and/or optical and sensor processing. The tower may also be movable to be positioned away from the patient to improve physician access and de-clutter the operating room. Additionally, placing components in the tower allows for more storage space in the table base <NUM> for potential stowage of the robotic arms <NUM>. The tower may also include a master controller or console that provides both a user interface for user input, such as keyboard and/or pendant, as well as a display screen (or touchscreen) for preoperative and intraoperative information, such as real-time imaging, navigation, and tracking information. In some embodiments, the tower may also contain holders for gas tanks to be used for insufflation.

In some embodiments, a table base may stow and store the robotic arms when not in use. <FIG> illustrates a system <NUM> that stows robotic arms in an embodiment of the table-based system. In the system <NUM>, carriages <NUM> may be vertically translated into base <NUM> to stow robotic arms <NUM>, arm mounts <NUM>, and the carriages <NUM> within the base <NUM>. Base covers <NUM> may be translated and retracted open to deploy the carriages <NUM>, arm mounts <NUM>, and robotic arms <NUM> around column <NUM>, and closed to stow to protect them when not in use. The base covers <NUM> may be sealed with a membrane <NUM> along the edges of its opening to prevent dirt and fluid ingress when closed.

<FIG> illustrates an embodiment of a robotically-enabled table-based system configured for a ureteroscopic procedure. In a ureteroscopy, the table <NUM> may include a swivel portion <NUM> for positioning a patient off-angle from the column <NUM> and table base <NUM>. The swivel portion <NUM> may rotate or pivot around a pivot point (e.g., located below the patient's head) in order to position the bottom portion of the swivel portion <NUM> away from the column <NUM>. For example, the pivoting of the swivel portion <NUM> allows a C-arm (not shown) to be positioned over the patient's lower abdomen without competing for space with the column (not shown) below table <NUM>. By rotating the carriage <NUM> (not shown) around the column <NUM>, the robotic arms <NUM> may directly insert a ureteroscope <NUM> along a virtual rail <NUM> into the patient's groin area to reach the urethra. In a ureteroscopy, stirrups <NUM> may also be fixed to the swivel portion <NUM> of the table <NUM> to support the position of the patient's legs during the procedure and allow clear access to the patient's groin area.

In a laparoscopic procedure, through small incision(s) in the patient's abdominal wall, minimally invasive instruments may be inserted into the patient's anatomy. In some embodiments, the minimally invasive instruments comprise an elongated rigid member, such as a shaft, which is used to access anatomy within the patient. After inflation of the patient's abdominal cavity, the instruments may be directed to perform surgical or medical tasks, such as grasping, cutting, ablating, suturing, etc. In some embodiments, the instruments can comprise a scope, such as a laparoscope. <FIG> illustrates an embodiment of a robotically-enabled table-based system configured for a laparoscopic procedure. As shown in <FIG>, the carriages <NUM> of the system <NUM> may be rotated and vertically adjusted to position pairs of the robotic arms <NUM> on opposite sides of the table <NUM>, such that instrument <NUM> may be positioned using the arm mounts <NUM> to be passed through minimal incisions on both sides of the patient to reach his/her abdominal cavity.

To accommodate laparoscopic procedures, the robotically-enabled table system may also tilt the platform to a desired angle. <FIG> illustrates an embodiment of the robotically-enabled medical system with pitch or tilt adjustment. As shown in <FIG>, the system <NUM> may accommodate tilt of the table <NUM> to position one portion of the table at a greater distance from the floor than the other. Additionally, the arm mounts <NUM> may rotate to match the tilt such that the robotic arms <NUM> maintain the same planar relationship with the table <NUM>. To accommodate steeper angles, the column <NUM> may also include telescoping portions <NUM> that allow vertical extension of the column <NUM> to keep the table <NUM> from touching the floor or colliding with the table base <NUM>.

<FIG> provides a detailed illustration of the interface between the table <NUM> and the column <NUM>. Pitch rotation mechanism <NUM> may be configured to alter the pitch angle of the table <NUM> relative to the column <NUM> in multiple degrees of freedom. The pitch rotation mechanism <NUM> may be enabled by the positioning of orthogonal axes <NUM>, <NUM> at the column-table interface, each axis actuated by a separate motor <NUM>, <NUM> responsive to an electrical pitch angle command. Rotation along one screw <NUM> would enable tilt adjustments in one axis <NUM>, while rotation along the other screw <NUM> would enable tilt adjustments along the other axis <NUM>. In some embodiments, a ball joint can be used to alter the pitch angle of the table <NUM> relative to the column <NUM> in multiple degrees of freedom.

For example, pitch adjustments are particularly useful when trying to position the table in a Trendelenburg position, i.e., position the patient's lower abdomen at a higher position from the floor than the patient's upper abdomen, for lower abdominal surgery. The Trendelenburg position causes the patient's internal organs to slide towards his/her upper abdomen through the force of gravity, clearing out the abdominal cavity for minimally invasive tools to enter and perform lower abdominal surgical or medical procedures, such as laparoscopic prostatectomy.

<FIG> illustrate isometric and end views of an alternative embodiment of a table-based surgical robotics system <NUM>. The surgical robotics system <NUM> includes one or more adjustable arm supports <NUM> that can be configured to support one or more robotic arms (see, for example, <FIG>) relative to a table <NUM>. In the illustrated embodiment, a single adjustable arm support <NUM> is shown, though an additional arm support can be provided on an opposite side of the table <NUM>. The adjustable arm support <NUM> can be configured so that it can move relative to the table <NUM> to adjust and/or vary the position of the adjustable arm support <NUM> and/or any robotic arms mounted thereto relative to the table <NUM>. For example, the adjustable arm support <NUM> may be adjusted one or more degrees of freedom relative to the table <NUM>. The adjustable arm support <NUM> provides high versatility to the system <NUM>, including the ability to easily stow the one or more adjustable arm supports <NUM> and any robotics arms attached thereto beneath the table <NUM>. The adjustable arm support <NUM> can be elevated from the stowed position to a position below an upper surface of the table <NUM>. In other embodiments, the adjustable arm support <NUM> can be elevated from the stowed position to a position above an upper surface of the table <NUM>.

The adjustable arm support <NUM> can provide several degrees of freedom, including lift, lateral translation, tilt, etc. In the illustrated embodiment of <FIG>, the arm support <NUM> is configured with four degrees of freedom, which are illustrated with arrows in <FIG>. A first degree of freedom allows for adjustment of the adjustable arm support <NUM> in the z-direction ("Z-lift"). For example, the adjustable arm support <NUM> can include a carriage <NUM> configured to move up or down along or relative to a column <NUM> supporting the table <NUM>. A second degree of freedom can allow the adjustable arm support <NUM> to tilt. For example, the adjustable arm support <NUM> can include a rotary joint, which can allow the adjustable arm support <NUM> to be aligned with the bed in a Trendelenburg position. A third degree of freedom can allow the adjustable arm support <NUM> to "pivot up," which can be used to adjust a distance between a side of the table <NUM> and the adjustable arm support <NUM>. A fourth degree of freedom can permit translation of the adjustable arm support <NUM> along a longitudinal length of the table.

The surgical robotics system <NUM> in <FIG> can comprise a table supported by a column <NUM> that is mounted to a base <NUM>. The base <NUM> and the column <NUM> support the table <NUM> relative to a support surface. A floor axis <NUM> and a support axis <NUM> are shown in <FIG>.

The adjustable arm support <NUM> can be mounted to the column <NUM>. In other embodiments, the arm support <NUM> can be mounted to the table <NUM> or base <NUM>. The adjustable arm support <NUM> can include a carriage <NUM>, a bar or rail connector <NUM> and a bar or rail <NUM>. In some embodiments, one or more robotic arms mounted to the rail <NUM> can translate and move relative to one another.

The carriage <NUM> can be attached to the column <NUM> by a first joint <NUM>, which allows the carriage <NUM> to move relative to the column <NUM> (e.g., such as up and down a first or vertical axis <NUM>). The first joint <NUM> can provide the first degree of freedom ("Z-lift") to the adjustable arm support <NUM>. The adjustable arm support <NUM> can include a second joint <NUM>, which provides the second degree of freedom (tilt) for the adjustable arm support <NUM>. The adjustable arm support <NUM> can include a third joint <NUM>, which can provide the third degree of freedom ("pivot up") for the adjustable arm support <NUM>. An additional joint <NUM> (shown in <FIG>) can be provided that mechanically constrains the third joint <NUM> to maintain an orientation of the rail <NUM> as the rail connector <NUM> is rotated about a third axis <NUM>. The adjustable arm support <NUM> can include a fourth joint <NUM>, which can provide a fourth degree of freedom (translation) for the adjustable arm support <NUM> along a fourth axis <NUM>.

<FIG> illustrates an end view of the surgical robotics system 140A with two adjustable arm supports 105A, 105B mounted on opposite sides of a table <NUM>. A first robotic arm 142A is attached to the bar or rail 107A of the first adjustable arm support 105B. The first robotic arm 142A includes a base 144A attached to the rail 107A. The distal end of the first robotic arm 142A includes an instrument drive mechanism 146A that can attach to one or more robotic medical instruments or tools. Similarly, the second robotic arm 142B includes a base 144B attached to the rail 107B. The distal end of the second robotic arm 142B includes an instrument drive mechanism 146B. The instrument drive mechanism 146B can be configured to attach to one or more robotic medical instruments or tools.

In some embodiments, one or more of the robotic arms 142A, 142B comprises an arm with seven or more degrees of freedom. In some embodiments, one or more of the robotic arms 142A, 142B can include eight degrees of freedom, including an insertion axis (<NUM>-degree of freedom including insertion), a wrist (<NUM>-degrees of freedom including wrist pitch, yaw and roll), an elbow (<NUM>-degree of freedom including elbow pitch), a shoulder (<NUM>-degrees of freedom including shoulder pitch and yaw), and base 144A, 144B (<NUM>-degree of freedom including translation). In some embodiments, the insertion degree of freedom can be provided by the robotic arm 142A, 142B, while in other embodiments, the instrument itself provides insertion via an instrument-based insertion architecture.

The end effectors of the system's robotic arms may comprise (i) an instrument driver (alternatively referred to as "instrument drive mechanism" or "instrument device manipulator") that incorporates electro-mechanical means for actuating the medical instrument and (ii) a removable or detachable medical instrument, which may be devoid of any electro-mechanical components, such as motors. This dichotomy may be driven by the need to sterilize medical instruments used in medical procedures, and the inability to adequately sterilize expensive capital equipment due to their intricate mechanical assemblies and sensitive electronics. Accordingly, the medical instruments may be designed to be detached, removed, and interchanged from the instrument driver (and thus the system) for individual sterilization or disposal by the physician or the physician's staff. In contrast, the instrument drivers need not be changed or sterilized, and may be draped for protection.

<FIG> illustrates an example instrument driver. Positioned at the distal end of a robotic arm, instrument driver <NUM> comprises one or more drive units <NUM> arranged with parallel axes to provide controlled torque to a medical instrument via drive shafts <NUM>. Each drive unit <NUM> comprises an individual drive shaft <NUM> for interacting with the instrument, a gear head <NUM> for converting the motor shaft rotation to a desired torque, a motor <NUM> for generating the drive torque, an encoder <NUM> to measure the speed of the motor shaft and provide feedback to the control circuitry, and control circuity <NUM> for receiving control signals and actuating the drive unit. Each drive unit <NUM> being independently controlled and motorized, the instrument driver <NUM> may provide multiple (e.g., four as shown in <FIG>) independent drive outputs to the medical instrument. In operation, the control circuitry <NUM> would receive a control signal, transmit a motor signal to the motor <NUM>, compare the resulting motor speed as measured by the encoder <NUM> with the desired speed, and modulate the motor signal to generate the desired torque.

For procedures that require a sterile environment, the robotic system may incorporate a drive interface, such as a sterile adapter connected to a sterile drape, that sits between the instrument driver and the medical instrument. The chief purpose of the sterile adapter is to transfer angular motion from the drive shafts of the instrument driver to the drive inputs of the instrument while maintaining physical separation, and thus sterility, between the drive shafts and drive inputs. Accordingly, an example sterile adapter may comprise of a series of rotational inputs and outputs intended to be mated with the drive shafts of the instrument driver and drive inputs on the instrument. Connected to the sterile adapter, the sterile drape, comprised of a thin, flexible material such as transparent or translucent plastic, is designed to cover the capital equipment, such as the instrument driver, robotic arm, and cart (in a cart-based system) or table (in a table-based system). Use of the drape would allow the capital equipment to be positioned proximate to the patient while still being located in an area not requiring sterilization (i.e., non-sterile field). On the other side of the sterile drape, the medical instrument may interface with the patient in an area requiring sterilization (i.e., sterile field).

<FIG> illustrates an example medical instrument with a paired instrument driver. Like other instruments designed for use with a robotic system, medical instrument <NUM> comprises an elongated shaft <NUM> (or elongate body) and an instrument base <NUM>. The instrument base <NUM>, also referred to as an "instrument handle" due to its intended design for manual interaction by the physician, may generally comprise rotatable drive inputs <NUM>, e.g., receptacles, pulleys or spools, that are designed to be mated with drive outputs <NUM> that extend through a drive interface on instrument driver <NUM> at the distal end of robotic arm <NUM>. When physically connected, latched, and/or coupled, the mated drive inputs <NUM> of the instrument base <NUM> may share axes of rotation with the drive outputs <NUM> in the instrument driver <NUM> to allow the transfer of torque from the drive outputs <NUM> to the drive inputs <NUM>. In some embodiments, the drive outputs <NUM> may comprise splines that are designed to mate with receptacles on the drive inputs <NUM>.

The elongated shaft <NUM> is designed to be delivered through either an anatomical opening or lumen, e.g., as in endoscopy, or a minimally invasive incision, e.g., as in laparoscopy. The elongated shaft <NUM> may be either flexible (e.g., having properties similar to an endoscope) or rigid (e.g., having properties similar to a laparoscope) or contain a customized combination of both flexible and rigid portions. When designed for laparoscopy, the distal end of a rigid elongated shaft may be connected to an end effector extending from a jointed wrist formed from a clevis with at least one degree of freedom and a surgical tool or medical instrument, such as, for example, a grasper or scissors, that may be actuated based on force from the tendons as the drive inputs rotate in response to torque received from the drive outputs <NUM> of the instrument driver <NUM>. When designed for endoscopy, the distal end of a flexible elongated shaft may include a steerable or controllable bending section that may be articulated and bent based on torque received from the drive outputs <NUM> of the instrument driver <NUM>.

Torque from the instrument driver <NUM> is transmitted down the elongated shaft <NUM> using tendons along the elongated shaft <NUM>. These individual tendons, such as pull wires, may be individually anchored to individual drive inputs <NUM> within the instrument handle <NUM>. From the handle <NUM>, the tendons are directed down one or more pull lumens along the elongated shaft <NUM> and anchored at the distal portion of the elongated shaft <NUM>, or in the wrist at the distal portion of the elongated shaft. During a surgical procedure, such as a laparoscopic, endoscopic or hybrid procedure, these tendons may be coupled to a distally mounted end effector, such as a wrist, grasper, or scissor. Under such an arrangement, torque exerted on drive inputs <NUM> would transfer tension to the tendon, thereby causing the end effector to actuate in some way. In some embodiments, during a surgical procedure, the tendon may cause a joint to rotate about an axis, thereby causing the end effector to move in one direction or another. Alternatively, the tendon may be connected to one or more jaws of a grasper at the distal end of the elongated shaft <NUM>, where tension from the tendon causes the grasper to close.

In endoscopy, the tendons may be coupled to a bending or articulating section positioned along the elongated shaft <NUM> (e.g., at the distal end) via adhesive, control ring, or other mechanical fixation. When fixedly attached to the distal end of a bending section, torque exerted on the drive inputs <NUM> would be transmitted down the tendons, causing the softer, bending section (sometimes referred to as the articulable section or region) to bend or articulate. Along the non-bending sections, it may be advantageous to spiral or helix the individual pull lumens that direct the individual tendons along (or inside) the walls of the endoscope shaft to balance the radial forces that result from tension in the pull wires. The angle of the spiraling and/or spacing therebetween may be altered or engineered for specific purposes, wherein tighter spiraling exhibits lesser shaft compression under load forces, while lower amounts of spiraling results in greater shaft compression under load forces, but limits bending. On the other end of the spectrum, the pull lumens may be directed parallel to the longitudinal axis of the elongated shaft <NUM> to allow for controlled articulation in the desired bending or articulable sections.

In endoscopy, the elongated shaft <NUM> houses a number of components to assist with the robotic procedure. The shaft <NUM> may comprise a working channel for deploying surgical tools (or medical instruments), irrigation, and/or aspiration to the operative region at the distal end of the shaft <NUM>. The shaft <NUM> may also accommodate wires and/or optical fibers to transfer signals to/from an optical assembly at the distal tip, which may include an optical camera. The shaft <NUM> may also accommodate optical fibers to carry light from proximally-located light sources, such as light emitting diodes, to the distal end of the shaft <NUM>.

At the distal end of the instrument <NUM>, the distal tip may also comprise the opening of a working channel for delivering tools for diagnostic and/or therapy, irrigation, and aspiration to an operative site. The distal tip may also include a port for a camera, such as a fiberscope or a digital camera, to capture images of an internal anatomical space. Relatedly, the distal tip may also include ports for light sources for illuminating the anatomical space when using the camera.

In the example of <FIG>, the drive shaft axes, and thus the drive input axes, are orthogonal to the axis of the elongated shaft <NUM>. This arrangement, however, complicates roll capabilities for the elongated shaft <NUM>. Rolling the elongated shaft <NUM> along its axis while keeping the drive inputs <NUM> static results in undesirable tangling of the tendons as they extend off the drive inputs <NUM> and enter pull lumens within the elongated shaft <NUM>. The resulting entanglement of such tendons may disrupt any control algorithms intended to predict movement of the flexible elongated shaft <NUM> during an endoscopic procedure.

<FIG> illustrates an alternative design for an instrument driver and instrument where the axes of the drive units are parallel to the axis of the elongated shaft of the instrument. As shown, a circular instrument driver <NUM> comprises four drive units with their drive outputs <NUM> aligned in parallel at the end of a robotic arm <NUM>. The drive units, and their respective drive outputs <NUM>, are housed in a rotational assembly <NUM> of the instrument driver <NUM> that is driven by one of the drive units within the assembly <NUM>. In response to torque provided by the rotational drive unit, the rotational assembly <NUM> rotates along a circular bearing that connects the rotational assembly <NUM> to the non-rotational portion <NUM> of the instrument driver <NUM>. Power and controls signals may be communicated from the non-rotational portion <NUM> of the instrument driver <NUM> to the rotational assembly <NUM> through electrical contacts that may be maintained through rotation by a brushed slip ring connection (not shown). In other embodiments, the rotational assembly <NUM> may be responsive to a separate drive unit that is integrated into the non-rotatable portion <NUM>, and thus not in parallel to the other drive units. The rotational mechanism <NUM> allows the instrument driver <NUM> to rotate the drive units, and their respective drive outputs <NUM>, as a single unit around an instrument driver axis <NUM>.

Like earlier disclosed embodiments, an instrument <NUM> may comprise an elongated shaft portion <NUM> and an instrument base <NUM> (shown with a transparent external skin for discussion purposes) comprising a plurality of drive inputs <NUM> (such as receptacles, pulleys, and spools) that are configured to receive the drive outputs <NUM> in the instrument driver <NUM>. Unlike prior disclosed embodiments, the instrument shaft <NUM> extends from the center of the instrument base <NUM> with an axis substantially parallel to the axes of the drive inputs <NUM>, rather than orthogonal as in the design of <FIG>.

When coupled to the rotational assembly <NUM> of the instrument driver <NUM>, the medical instrument <NUM>, comprising instrument base <NUM> and instrument shaft <NUM>, rotates in combination with the rotational assembly <NUM> about the instrument driver axis <NUM>. Since the instrument shaft <NUM> is positioned at the center of instrument base <NUM>, the instrument shaft <NUM> is coaxial with instrument driver axis <NUM> when attached. Thus, rotation of the rotational assembly <NUM> causes the instrument shaft <NUM> to rotate about its own longitudinal axis. Moreover, as the instrument base <NUM> rotates with the instrument shaft <NUM>, any tendons connected to the drive inputs <NUM> in the instrument base <NUM> are not tangled during rotation. Accordingly, the parallelism of the axes of the drive outputs <NUM>, drive inputs <NUM>, and instrument shaft <NUM> allows for the shaft rotation without tangling any control tendons.

<FIG> illustrates an instrument having an instrument based insertion architecture in accordance with some embodiments. The instrument <NUM> can be coupled to any of the instrument drivers discussed above. The instrument <NUM> comprises an elongated shaft <NUM>, an end effector <NUM> connected to the shaft <NUM>, and a handle <NUM> coupled to the shaft <NUM>. The elongated shaft <NUM> comprises a tubular member having a proximal portion <NUM> and a distal portion <NUM>. The elongated shaft <NUM> comprises one or more channels or grooves <NUM> along its outer surface. The grooves <NUM> are configured to receive one or more wires or cables <NUM> therethrough. One or more cables <NUM> thus run along an outer surface of the elongated shaft <NUM>. In other embodiments, cables <NUM> can also run through the elongated shaft <NUM>. Manipulation of the one or more cables <NUM> (e.g., via an instrument driver) results in actuation of the end effector <NUM>.

The instrument handle <NUM>, which may also be referred to as an instrument base, may generally comprise an attachment interface <NUM> having one or more mechanical inputs <NUM>, e.g., receptacles, pulleys or spools, that are designed to be reciprocally mated with one or more torque couplers on an attachment surface of an instrument driver.

In some embodiments, the instrument <NUM> comprises a series of pulleys or cables that enable the elongated shaft <NUM> to translate relative to the handle <NUM>. In other words, the instrument <NUM> itself comprises an instrument-based insertion architecture that accommodates insertion of the instrument, thereby minimizing the reliance on a robot arm to provide insertion of the instrument <NUM>. In other embodiments, a robotic arm can be largely responsible for instrument insertion.

Any of the robotic systems described herein can include an input device or controller for manipulating an instrument attached to a robotic arm. In some embodiments, the controller can be coupled (e.g., communicatively, electronically, electrically, wirelessly and/or mechanically) with an instrument such that manipulation of the controller causes a corresponding manipulation of the instrument e.g., via master slave control.

<FIG> is a perspective view of an embodiment of a controller <NUM>. In the present embodiment, the controller <NUM> comprises a hybrid controller that can have both impedance and admittance control. In other embodiments, the controller <NUM> can utilize just impedance or passive control. In other embodiments, the controller <NUM> can utilize just admittance control. By being a hybrid controller, the controller <NUM> advantageously can have a lower perceived inertia while in use.

In the illustrated embodiment, the controller <NUM> is configured to allow manipulation of two medical instruments, and includes two handles <NUM>. Each of the handles <NUM> is connected to a gimbal <NUM>. Each gimbal <NUM> is connected to a positioning platform <NUM>.

As shown in <FIG>, each positioning platform <NUM> includes a SCARA arm (selective compliance assembly robot arm) <NUM> coupled to a column <NUM> by a prismatic joint <NUM>. The prismatic joints <NUM> are configured to translate along the column <NUM> (e.g., along rails <NUM>) to allow each of the handles <NUM> to be translated in the z-direction, providing a first degree of freedom. The SCARA arm <NUM> is configured to allow motion of the handle <NUM> in an x-y plane, providing two additional degrees of freedom.

In some embodiments, one or more load cells are positioned in the controller. For example, in some embodiments, a load cell (not shown) is positioned in the body of each of the gimbals <NUM>. By providing a load cell, portions of the controller <NUM> are capable of operating under admittance control, thereby advantageously reducing the perceived inertia of the controller while in use. In some embodiments, the positioning platform <NUM> is configured for admittance control, while the gimbal <NUM> is configured for impedance control. In other embodiments, the gimbal <NUM> is configured for admittance control, while the positioning platform <NUM> is configured for impedance control. Accordingly, for some embodiments, the translational or positional degrees of freedom of the positioning platform <NUM> can rely on admittance control, while the rotational degrees of freedom of the gimbal <NUM> rely on impedance control.

Traditional endoscopy may involve the use of fluoroscopy (e.g., as may be delivered through a C-arm) and other forms of radiation-based imaging modalities to provide endoluminal guidance to an operator physician. In contrast, the robotic systems contemplated by this disclosure can provide for non-radiation-based navigational and localization means to reduce physician exposure to radiation and reduce the amount of equipment within the operating room. As used herein, the term "localization" may refer to determining and/or monitoring the position of objects in a reference coordinate system. Technologies such as preoperative mapping, computer vision, real-time EM tracking, and robot command data may be used individually or in combination to achieve a radiation-free operating environment. In other cases, where radiation-based imaging modalities are still used, the preoperative mapping, computer vision, real-time EM tracking, and robot command data may be used individually or in combination to improve upon the information obtained solely through radiation-based imaging modalities.

<FIG> is a block diagram illustrating a localization system <NUM> that estimates a location of one or more elements of the robotic system, such as the location of the instrument, in accordance to an example embodiment. The localization system <NUM> may be a set of one or more computer devices configured to execute one or more instructions. The computer devices may be embodied by a processor (or processors) and computer-readable memory in one or more components discussed above. By way of example and not limitation, the computer devices may be in the tower <NUM> shown in <FIG>, the cart <NUM> shown in <FIG>, the beds shown in <FIG>, etc..

As shown in <FIG>, the localization system <NUM> may include a localization module <NUM> that processes input data <NUM>-<NUM> to generate location data <NUM> for the distal tip of a medical instrument. The location data <NUM> may be data or logic that represents a location and/or orientation of the distal end of the instrument relative to a frame of reference. The frame of reference can be a frame of reference relative to the anatomy of the patient or to a known object, such as an EM field generator (see discussion below for the EM field generator).

The various input data <NUM>-<NUM> are now described in greater detail. Preoperative mapping may be accomplished through the use of the collection of low dose CT scans. Preoperative CT scans are reconstructed into three-dimensional images, which are visualized, e.g. as "slices" of a cutaway view of the patient's internal anatomy. When analyzed in the aggregate, image-based models for anatomical cavities, spaces and structures of the patient's anatomy, such as a patient lung network, may be generated. Techniques such as center-line geometry may be determined and approximated from the CT images to develop a three-dimensional volume of the patient's anatomy, referred to as model data <NUM> (also referred to as "preoperative model data" when generated using only preoperative CT scans). The use of center-line geometry is discussed in <CIT>. Network topological models may also be derived from the CT-images, and are particularly appropriate for bronchoscopy.

In some embodiments, the instrument may be equipped with a camera to provide vision data (or image data) <NUM>. The localization module <NUM> may process the vision data to enable one or more vision-based (or image-based) location tracking modules or features. For example, the preoperative model data <NUM> may be used in conjunction with the vision data <NUM> to enable computer vision-based tracking of the medical instrument (e.g., an endoscope or an instrument advance through a working channel of the endoscope). For example, using the preoperative model data <NUM>, the robotic system may generate a library of expected endoscopic images from the model based on the expected path of travel of the endoscope, each image linked to a location within the model. Intraoperatively, this library may be referenced by the robotic system in order to compare real-time images captured at the camera (e.g., a camera at a distal end of the endoscope) to those in the image library to assist localization.

Other computer vision-based tracking techniques use feature tracking to determine motion of the camera, and thus the endoscope. Some features of the localization module <NUM> may identify circular geometries in the preoperative model data <NUM> that correspond to anatomical lumens and track the change of those geometries to determine which anatomical lumen was selected, as well as the relative rotational and/or translational motion of the camera. Use of a topological map may further enhance vision-based algorithms or techniques.

Optical flow, another computer vision-based technique, may analyze the displacement and translation of image pixels in a video sequence in the vision data <NUM> to infer camera movement. Examples of optical flow techniques may include motion detection, object segmentation calculations, luminance, motion compensated encoding, stereo disparity measurement, etc. Through the comparison of multiple frames over multiple iterations, movement and location of the camera (and thus the endoscope) may be determined.

The localization module <NUM> may use real-time EM tracking to generate a real-time location of the endoscope in a global coordinate system that may be registered to the patient's anatomy, represented by the preoperative model. In EM tracking, an EM sensor (or tracker) comprising one or more sensor coils embedded in one or more locations and orientations in a medical instrument (e.g., an endoscopic tool) measures the variation in the EM field created by one or more static EM field generators positioned at a known location. The location information detected by the EM sensors is stored as EM data <NUM>. The EM field generator (or transmitter), may be placed close to the patient to create a low intensity magnetic field that the embedded sensor may detect. The magnetic field induces small currents in the sensor coils of the EM sensor, which may be analyzed to determine the distance and angle between the EM sensor and the EM field generator. These distances and orientations may be intraoperatively "registered" to the patient anatomy (e.g., the preoperative model) in order to determine the geometric transformation that aligns a single location in the coordinate system with a position in the preoperative model of the patient's anatomy. Once registered, an embedded EM tracker in one or more positions of the medical instrument (e.g., the distal tip of an endoscope) may provide real-time indications of the progression of the medical instrument through the patient's anatomy.

Robotic command and kinematics data <NUM> may also be used by the localization module <NUM> to provide localization data <NUM> for the robotic system. Device pitch and yaw resulting from articulation commands may be determined during preoperative calibration. Intraoperatively, these calibration measurements may be used in combination with known insertion depth information to estimate the position of the instrument. Alternatively, these calculations may be analyzed in combination with EM, vision, and/or topological modeling to estimate the position of the medical instrument within the network.

As <FIG> shows, a number of other input data can be used by the localization module <NUM>. For example, although not shown in <FIG>, an instrument utilizing shape-sensing fiber can provide shape data that the localization module <NUM> can use to determine the location and shape of the instrument.

The localization module <NUM> may use the input data <NUM>-<NUM> in combination(s). In some cases, such a combination may use a probabilistic approach where the localization module <NUM> assigns a confidence weight to the location determined from each of the input data <NUM>-<NUM>. Thus, where the EM data may not be reliable (as may be the case where there is EM interference) the confidence of the location determined by the EM data <NUM> can be decrease and the localization module <NUM> may rely more heavily on the vision data <NUM> and/or the robotic command and kinematics data <NUM>.

As discussed above, the robotic systems discussed herein may be designed to incorporate a combination of one or more of the technologies above. The robotic system's computer-based control system, based in the tower, bed and/or cart, may store computer program instructions, for example, within a non-transitory computer-readable storage medium such as a persistent magnetic storage drive, solid state drive, or the like, that, upon execution, cause the system to receive and analyze sensor data and user commands, generate control signals throughout the system, and display the navigational and localization data, such as the position of the instrument within the global coordinate system, anatomical map, etc..

Embodiments of the disclosure relate to improved shielding for wristed instruments. <FIG> illustrates one embodiment of an instrument wrist in accordance with aspects of this disclosure. As shown in <FIG>, the instrument <NUM> includes: a proximal clevis <NUM>; a distal clevis <NUM>; and a pin joint <NUM> forming a pitch axis <NUM>. The distal clevis <NUM> is configured to be articulated with respect to the proximal clevis <NUM> around the pitch axis <NUM>. As used herein, the point of articulation between the proximal and distal clevises <NUM> and <NUM> may be referred to as a "wrist. " Depending on the embodiment, the wrist may include additional degrees of freedom of movement (e.g., additional axes around which at least a portion of the instrument <NUM> can be articulated).

The instrument <NUM> may benefit from the inclusion of a sheath (not illustrated in <FIG>) formed over at least a portion of the wrist. The sheath may shield at least a portion of the wrist of the instrument <NUM> from the environment. The sheath may be formed of a flexible material, an elastomeric material, an electrically insulating material, etc. In some embodiments, the instrument <NUM> can also include an end effector, such as a monopolar scissors, which may apply a current through tissue to a grounding pad. In this embodiment, the sheath may electrically insulate the wrist from the patient, thereby preventing current from flowing to/from the patient via the wrist. The sheath may also substantially seal the wrist such that fluids or other foreign materials can be prevented from penetrating into the moving parts of the wrist.

The sheath may be formed of a flexible material in order to enable freedom of movement of the wrist. As the distal clevis <NUM> is articulated, the sheath can be inadvertently pinched and torn by the wrist. In particular, as shown in <FIG>, in the regions <NUM> and <NUM> illustrated by circles, the sheath can be potentially pinched between the distal clevis <NUM> and the proximal clevis <NUM>, particularly as the amount of articulation increases. In some instances, the pinching can result in detrimental wear and tear of the sheath.

<FIG> illustrate an embodiment in which the sheath may be pinched in accordance with aspects of this disclosure. Specifically, <FIG> illustrates that the distal clevis <NUM> may be articulated at a varying angle θ with respect to the proximal clevis <NUM>. In <FIG>, a portion of the sheath <NUM> is illustrated as being located at a pinch point <NUM> between the proximal and distal clevises <NUM> and <NUM>. With repeated articulation, the sheath <NUM> may be worn down and/or torn at the pinch point <NUM>, leading to premature wear on the sheath <NUM> and decreasing the life of the sheath <NUM>. Instrument embodiments described below reduce the risk of wear and/or tear of the sheath.

Aspects of this disclosure relate to embodiments of wristed instruments which reduce and/or prevent premature wear due to pinching of the sheath between portions of an articulating wrist. <FIG> provide views of an example instrument including a shielded wrist in accordance with the invention. Referring to <FIG>, the instrument <NUM> includes a proximal clevis <NUM>, a distal clevis <NUM>, an end effector <NUM>, a sheath <NUM>, a frame <NUM> (also referred to as a "cage"), and a shaft <NUM>. The sheath <NUM> can be formed to extend from the shaft to cover a portion of the end effector <NUM>, thereby covering the wrist including the proximal clevis <NUM>, the distal clevis <NUM>, and the frame <NUM>.

<FIG> illustrates an example joint formed between a proximal clevis and a distal clevis in accordance with the invention. Specifically, in <FIG>, an interface between the proximal clevis <NUM> and the distal clevis <NUM> is shown without the other components of the instrument in order to focus on certain aspects of the joint <NUM>. The interface comprises a rolling joint <NUM> formed via one or more "teeth" on each of the proximal and distal clevises <NUM> and <NUM>. As shown in <FIG>, a tooth or protrusion on the distal clevis <NUM> engages with an opening or groove formed between teeth on the proximal clevis <NUM> to form the rolling joint <NUM>. In some embodiments, the rolling joint <NUM> is embodied in the form of a cycloidal joint.

In contrast to the use of a pin joint, the rolling joint <NUM> does not have a fixed pivot axis. For example, the rolling joint <NUM> may define a proximal pitch axis <NUM> and a distal pitch axis <NUM>. Together, the proximal pitch axis <NUM> and the distal pitch axis <NUM> provide two functional pivots for the pitch degree of freedom of the wrist. When embodied as a cycloidal joint, the rolling joint <NUM> may define pitch circles <NUM> and <NUM>, respectively centered around the proximal pitch axis <NUM> and a distal pitch axis <NUM>. The pitch circles <NUM> and <NUM> may define certain aspects of the articulation of the wrist including, for example, how the distal pitch axis <NUM> rotates with respect to the proximal pitch axis <NUM> during articulation of the wrist.

<FIG> illustrate side views of an example wrist in accordance with the invention. Specifically, <FIG> illustrates a side view of the wrist without the frame <NUM>, whereas <FIG> illustrates a side view of the wrist including the frame <NUM>, and whereas <FIG> illustrates a cross-sectional side view of the wrist including the frame <NUM>. As shown in <FIG>, the frame <NUM> is positioned between the proximal clevis <NUM> and the distal clevis <NUM>. The frame <NUM> includes a plurality of joint posts <NUM> including ball ends configured to mate with a corresponding socket in each of the proximal clevis <NUM> and the distal clevis <NUM>. In certain embodiments, the frame <NUM> may be held in place with respect to the proximal clevis <NUM> and the distal clevis <NUM> due to tension in one or more pull wires that extend through the proximal clevis <NUM> and the frame <NUM> to the distal clevis <NUM>.

In some embodiments, the frame <NUM> advantageously functions as a mechanical stop to limit the pitch angle between the proximal clevis <NUM> and the distal clevis <NUM> during articulation. In some embodiments, the frame <NUM> includes a plurality of distally extending posts <NUM> and a plurality of proximally extending posts <NUM>. In order to provide the limit in the pitch angle, at least some of the distally extending posts <NUM> may engage corresponding surfaces on the distal clevis <NUM> at the same time that at least some of the proximally extending posts <NUM> engage corresponding surfaces on the proximal clevis <NUM>. Thus, the frame <NUM> can serve as a mechanical stop that limits the pitch angle between the proximal and distal clevis <NUM> and <NUM>. The frame can advantageously help to (i) constrain the rotation of the rolling joint <NUM> and (ii) physically block the sheath from being pinched between the two clevises when the wrist is articulated to full pitch.

<FIG> illustrate side views of an example wrist and sheath in accordance with the invention. In particular, <FIG> illustrates a side view of the wrist without the sheath <NUM>, whereas <FIG> illustrates a side view of the wrist including the sheath <NUM>. With reference to <FIG>, the wrist is articulated to the full pitch angle θ at which the frame <NUM> contacts surfaces of each of the proximal and distal clevises <NUM> and <NUM>. As can be seen from <FIG>, at full pitch, the angle θ/<NUM> formed between the frame <NUM> and the proximal clevis <NUM> is half of the full pitch angle θ. Additionally, the frame <NUM> may block the sheath <NUM> from being pinched between surfaces of the proximal clevis <NUM> and the distal clevis <NUM>. For example, the presence of the frame <NUM> physically moves the sheath <NUM> away from a region in which the sheath <NUM> can be potentially pinched (e.g., regions <NUM> and <NUM> of <FIG>).

The use of the rolling joint <NUM> can reduce the maximum strain on the sheath <NUM>. For example, without the use of the rolling joint <NUM>, if the sheath <NUM> is approximated as a tubular surface with a radius R, then the maximum travel that the sheath <NUM> will be stretched at any point along its length is the arc length of Rθ, where θ is the pitch angle of the wrist (e.g., see <FIG>). In contrast, using the rolling joint <NUM>, if the sheath <NUM> has the same radius R, due to the symmetrical nature of the frame <NUM> in certain embodiments, the arc length is dropped by half to θ/<NUM> for the maximum travel that the sheath <NUM> will be stretched at any point along its length (e.g., see <FIG>).

<FIG> illustrate isometric and side views of an example frame in accordance with the invention. As shown in <FIG>, the frame <NUM> includes the joint posts <NUM>, the distally extending posts <NUM>, and the proximally extending posts <NUM>. Advantageously, the frame <NUM> further includes a plurality of openings or channels <NUM> and <NUM> formed to allow wires to pass through the frame <NUM>. The channels <NUM> may be configured to guide electrical wire(s) through the frame <NUM> to deliver electrical current to the end effector. In certain embodiments, the electrical wires may be configured to apply current to the end effector. The channels <NUM> may be configured to guide one or more pull wires through the frame <NUM> to articulate one or more of the end effector and the wrist (e.g., the distal clevis <NUM>).

<FIG> illustrate a plurality of views of an example wrist including a frame in accordance with the invention. The frame <NUM> of <FIG> includes a plurality of channels <NUM> and <NUM>. In this embodiment, the channels <NUM> have the shape of a slot rather than the circular shape of the channels <NUM>. Also illustrated is a pathway <NUM> formed by the channels <NUM> along which the electrical wire(s) can be guided through the frame <NUM>. The pathways <NUM> may be configured to shield the electrical wire(s) from the teeth forming the rolling joint between the proximal and distal clevises <NUM> and <NUM>.

The joint(s) and frame(s) illustrated in the embodiments of <FIG> may be configured to reduce the risk of pinch and wear on the sheath. The intermediary frame can serve as a physical stop that works in conjunction with the rolling joint to physically block the sheath from being pinched between proximal and distal clevises <NUM> and <NUM> at full pitch. Additionally, in certain embodiments, the wrist architecture advantageously provides a pathway for structures such as electrical wires or tubing such that the wires/tubing can easily be incorporated into the instrument and protected from wear (e.g., from the teeth forming the rolling joint). Thus, the rolling joint provides space that allows electrical wire or tubing to be delivered therethrough.

In order to actuate one of the instruments illustrated in <FIG>, an instrument driver may advance and/or retract at least one cable segment that engages a distal clevis of the instrument. The wrist, as shown in the figures, includes a proximal clevis, a distal clevis, and an intermediary frame positioned between the proximal clevis and the distal clevis. The advancing or retracting of the at least one cable segment articulates the distal clevis with respect to the proximal clevis. The instrument driver may further rotate the distal clevis with respect to a pitch axis that lies perpendicular to the longitudinal axis of the tool shaft by advancing or retracting at least one cable segment. In certain embodiments, the instrument driver may rotate the distal clevis with respect to the proximal clevis along the rolling joint.

Aspects of this disclosure relate to embodiments which may reduce and/or prevent premature wear due to pinching of the sheath without the use of a frame. This disclosure may also relate to embodiments of an instrument in which a wire configured to provide a signal from an electrosurgical generator to end effector(s) terminates in a fashion that does not compromise the integrity of the signal during articulation of the instrument wrist. This disclosure may further relate to embodiments of an instrument in which the range of motion for the instrument wrist can be determined mechanically and through software. It is desirable to provide both (i) a software constraint, which can limit mechanical wear and (ii) a mechanical constraint, which can prevent unexpected motions in case of software failure. The mechanical constraint can be enforced through clevis to clevis surface collisions. These collisions can be especially damaging in cases where a sheath is used to cover at least a portion of the wrist, such as the insulating sheath which can be used on, e.g., monopolar shears.

<FIG> illustrates an example instrument in accordance with aspects of this disclosure. The instrument <NUM> includes a proximal clevis <NUM>, a distal clevis <NUM>, an end effector <NUM>, a yaw axis <NUM>, a pitch axis <NUM>, an electrode <NUM>, an auxiliary axis <NUM>, and a sheath <NUM>. The sheath <NUM> can be placed over the instrument <NUM> to cover the proximal and distal clevises <NUM> and <NUM>. Advantageously, in some embodiments, the electrode <NUM> can serve as a hardstop that limits a pitch angle between the proximal clevis <NUM> and the distal clevis <NUM>, thereby reducing the risk of pinching and tearing of the sheath <NUM>.

<FIG> provide close up views of the pitch axis illustrated in <FIG>. The pitch axis <NUM> may include a pitch pin <NUM> formed in the proximal clevis <NUM>. Each of the distal clevis <NUM>, the electrode <NUM>, and a plurality of pitch pulleys <NUM> can be coupled to the pitch pin <NUM>. The pitch pin <NUM> may form a pin joint connecting the proximal clevis and the distal clevis. Similarly, the auxiliary axis <NUM> may include an auxiliary pin <NUM> formed in the proximal clevis <NUM>. A plurality of auxiliary pulleys <NUM> can be coupled to the auxiliary pin <NUM>. One or more electrical wires (not illustrated) and one or more pull wires (not illustrated) may be engaged with pitch pulleys <NUM> and/or the auxiliary pulleys <NUM>.

In order to ensure that integrity of the signal provided by the electrode <NUM> is not affected due to articulation of the wrist, the electrode <NUM> can function similar to a ring terminal, in which the electrode <NUM> hangs off the boss on distal clevis <NUM>. A disc spring <NUM> can also be coupled to the pitch pin <NUM> in order to maintain contact between the electrode <NUM> and the distal clevis <NUM>. A larger contact area between the electrode <NUM> and the wrist can be formed by holding the electrode <NUM> on the distal clevis <NUM> using the disc spring <NUM>, thereby reducing the chance that the signal provided to the distal clevis <NUM> via the electrode <NUM> is affected by articulation of the wrist. By positioning the electrode <NUM> on the pitch pin <NUM> in direct contact with the distal clevis <NUM>, the rotation of the distal clevis <NUM> against the electrode <NUM> during articulation helps to abrade/remove potential oxide buildup on the electrode <NUM> and/or the distal clevis <NUM>. The shape of the electrode <NUM> can also aid with alignment of the pitch pulleys <NUM>.

The design of the electrode <NUM> may simplify the structure of the wrist, reducing the costs associated with machining the instrument <NUM>. Additionally, as noted above, the electrode <NUM> can be used as a hardstop to prevent surface of the proximal clevis <NUM> and the distal clevis <NUM> from pinching and/or perforating the sheath <NUM>. Accordingly, the hardstop can serve as a mechanical stop to limit a pitch angle between the proximal clevis <NUM> and the distal clevis <NUM>. <FIG> and <FIG> illustrate the hardstop <NUM> provided as the distal clevis <NUM> contacts the electrode <NUM>, rather than the proximal clevis <NUM>, in accordance with aspects of this disclosure.

In limiting the range of motion of the articulation of the distal clevis <NUM> to provide the hardstop <NUM>, the width of the electrode <NUM> may determine the possible pitch angle achievable by the distal clevis <NUM> around the pitch axis before reaching the mechanical hardstop <NUM>. The hardstop <NUM> prevents the proximal and distal clevises <NUM> and <NUM> from pressing down on any portion of the sheath <NUM>. In certain embodiments, due to the shapes of the proximal and distal clevises <NUM> and <NUM>, the proximal and distal clevises <NUM> and <NUM> may have line contact if no hardstop <NUM> is provided. Thus, the pressure between the proximal and distal clevises <NUM> and <NUM> can act as a blade, shearing the sheath <NUM>. By preventing contact between the proximal and distal clevises <NUM> and <NUM>, breaks or cuts in the sheath <NUM> can be prevented.

In certain embodiments, the disc spring <NUM> and electrode <NUM> can be combined into a single piece. For example, a hooked piece, or spring piece that ends up enclosing the boss on the electrode <NUM> can be used instead of a ring. <FIG> illustrates another embodiment of the distal clevis in accordance with aspects of this disclosure. As shown in <FIG>, the electrode <NUM> can be routed through a hole on the distal clevis <NUM> ear instead of via a boss. In some embodiments, the electrode <NUM> can be formed of wire <NUM> instead of sheet metal. In other embodiments, contact pins/plunger electrodes can also be installed within the distal clevis to carry a signal from an electrode sitting in a plastic proximal clevis.

<FIG> illustrates another embodiment of the proximal clevis in accordance with aspects of this disclosure. With reference to <FIG>, instead of a ring terminal, hardstops <NUM> can be built into the internal spacing of the proximal clevis <NUM>. <FIG> illustrates yet another embodiment of the proximal and distal clevises in accordance with aspects of this disclosure. With reference to <FIG>, a pin (not illustrated) and slot <NUM> feature can be incorporated into the proximal clevis <NUM> and distal clevis <NUM>, respectively, to provide the hardstop feature.

Implementations disclosed herein provide systems and apparatuses for shielded wrists, and methods for actuating instruments with wrists.

It should be noted that the terms "couple," "coupling," "coupled" or other variations of the word couple as used herein may indicate either an indirect connection or a direct connection. For example, if a first component is "coupled" to a second component, the first component may be either indirectly connected to the second component via another component or directly connected to the second component.

The shielded wrist functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such a medium may comprise random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, compact disc read-only memory (CD-ROM) or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. It should be noted that a computer-readable medium may be tangible and non-transitory. As used herein, the term "code" may refer to software, instructions, code or data that is/are executable by a computing device or processor.

The method steps and/or actions may be interchanged with one another without departing from the scope of the disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the method that is being described, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the disclosure.

As used herein, the term "plurality" denotes two or more. For example, a plurality of components indicates two or more components.

Claim 1:
An instrument, comprising:
a shaft (<NUM>);
an end effector; and
a wrist connecting the shaft to the end effector,
the wrist comprising a proximal clevis (<NUM>) and a distal clevis (<NUM>);
wherein the proximal clevis (<NUM>) and the distal clevis (<NUM>) form a rolling joint (<NUM>), the rolling joint comprising one or more teeth formed on one of the proximal clevis (<NUM>) and the distal clevis (<NUM>) that mate with one or more grooves formed on the other one of the proximal clevis (<NUM>) and the distal clevis (<NUM>);
characterised in that the wrist further comprises an intermediary frame (<NUM>) positioned between the proximal clevis (<NUM>) and the distal clevis (<NUM>).