Systems and methods for a medical clip applier

Certain aspects relate to systems and techniques for articulating medical instruments. In one aspect, the instrument includes a wrist having at least one degree of freedom of movement, and an end effector coupled to the wrist. The end effector can include a cartridge for delivering a plurality of clips to tissue. The wrist may include one or more cables capable of moving an actuator with one degree of freedom of movement within the end effector to advance one or more clips through the end effector.

TECHNICAL FIELD

The systems and methods disclosed herein are directed to medical instruments, and more particularly to clip appliers.

BACKGROUND

Medical clips can be used in a variety of different medical procedures, including, for example, laparoscopic procedures in which the medical clips may be used to ligate and/or seal tissue to stop bleeding. The use of clips can reliably engage tissue and be retained and secured in place. The use of clips to ligate tissue can advantageous as they can be faster than the use of sutures to ligate tissue.

SUMMARY

In a first aspect, a robotically-controlled surgical instrument includes a wrist extending from the distal end of the elongate shaft, the wrist providing at least one degree of freedom of movement, and an end effector extending from the wrist and moveable with the wrist, the end effector comprising a cartridge for delivering a plurality of clips in succession without reloading.

The robotically-controlled surgical instrument may further include one or more of the following features in any combination: (a) wherein the plurality of clips includes at least four clips; (b) wherein the plurality of clips are nested with each other within the cartridge; (c) wherein a length of the plurality of clips is at least 50% less than if the plurality of clips were each laid end to end; (d) wherein first open ends of the plurality of clips are positioned within the first track; (e) wherein the shaft is coupled to a robotic arm; (f) wherein each of the plurality of clips includes a first arm with a distal end and a second arm with a distal end, the first and second arms connected together at their respective proximal ends; (g) wherein the cartridge includes a first track and a second track, and wherein the distal end of each of the first arms is positioned within the first track and the distal end of each of the second arms is positioned within the second track to hold each of the plurality of clips in an open position; (h) wherein when each of the clips are expelled from the cartridge, the first and second arm of each of the clips move towards each other to a closed position; (i) wherein in the closed position the distal end of the first arm is intermeshed with the distal end of the second arm; (j) wherein each of the plurality of clips are configured to be stored in the cartridge in the open position and be closed onto tissue in the closed position, wherein the distal end of the first arm and the distal end of the second arm are separated from each other in the open position, wherein the distal end of the first arm and the distal end of the second arm are intermeshed with each other; (k) wherein the distal end of the first arm includes a tab; (l) wherein the distal end of the second arm includes a loop that is larger than the tab of the first arm; (m) wherein the tab of the first arm includes a loop that is smaller than the loop of the second arm; (n) wherein the first and second arms connect together at their respective proximal ends by a loop; (o) wherein the first and second arms connect together at their respective proximal ends by a plurality of loops; and/or (p) wherein the elongate shaft is capable of movement in one degree of freedom.

In another aspect, a surgical instrument includes an elongate shaft extending between a proximal end and a distal end, a wrist extending from the distal end of the elongate shaft, and an end effector extending from the wrist. The wrist can include one or more cables capable of moving an actuator with one degree of freedom of movement within the end effector to advance one or more clips through the end effector. The one or more clips can be capable of being both delivered and automatically clipped by the one degree of freedom movement of the actuator.

The surgical instrument may further include one or more of the following features in any combination: (a) wherein the one or more clips are received in a cartridge; (b) wherein the one or more clips move along a track within the cartridge; (c) wherein the track is configured to engage with a distal end of each of the one or more clips to hold the each of the one or more clips in an open position prior to delivery; (d) wherein the actuator advances the one or more clips along the track with the cartridge; and/or (e) wherein the elongate shaft is capable of movement in one degree of freedom.

In another aspect, a surgical instrument for securing tissue includes a cartridge including one or more clips, the one or more clips each includes a first arm including a first distal portion and a second arm including a second distal portion. The one or more clips can include a first configuration in an open position and a second configuration in a closed position. The first distal portion can be capable of intermeshing with the second distal portion when the clip is in the closed position. The first arm may include a single strut and the second arm may include a pair of struts, the single strut of the first arm capable of moving between pair of struts of the second arm.

In yet another aspect, a surgical clip configured to close on tissue includes a first arm including a first strut, and a second arm including a second strut and a third strut. A distal end of the first arm can intermesh with a distal end of the second arm. A proximal end of the first arm and a proximal end of the second arm are joined to form a vertex, the vertex forming a torsion spring.

The surgical clip configured to close on tissue may further include one or more of the following features in any combination: (a) wherein the distal end of the first strut forms a loop; (b) wherein the distal ends of the second strut and third strut form a loop that is larger than the loop of the first strut; (c) wherein the larger loop of the second strut and the third strut receives the smaller loop of the first strut when the clip is in a closed position; (d) wherein the first strut is received between the second strut and the third strut when the clip is in a closed position; and/or (e) wherein the torsion spring comprises one or more loops.

DETAILED DESCRIPTION

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. 1illustrates an embodiment of a cart-based robotically-enabled system10arranged for a diagnostic and/or therapeutic bronchoscopy. During a bronchoscopy, the system10may comprise a cart11having one or more robotic arms12to deliver a medical instrument, such as a steerable endoscope13, 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 cart11may be positioned proximate to the patient's upper torso in order to provide access to the access point. Similarly, the robotic arms12may be actuated to position the bronchoscope relative to the access point. The arrangement inFIG. 1may also be utilized when performing a gastro-intestinal (GI) procedure with a gastroscope, a specialized endoscope for GI procedures.FIG. 2depicts an example embodiment of the cart in greater detail.

With continued reference toFIG. 1, once the cart11is properly positioned, the robotic arms12may insert the steerable endoscope13into the patient robotically, manually, or a combination thereof. As shown, the steerable endoscope13may 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 drivers28, each instrument driver coupled to the distal end of an individual robotic arm. This linear arrangement of the instrument drivers28, which facilitates coaxially aligning the leader portion with the sheath portion, creates a “virtual rail”29that may be repositioned in space by manipulating the one or more robotic arms12into 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 drivers28along the virtual rail29telescopes the inner leader portion relative to the outer sheath portion or advances or retracts the endoscope13from the patient. The angle of the virtual rail29may be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and position of the virtual rail29as shown represents a compromise between providing physician access to the endoscope13while minimizing friction that results from bending the endoscope13into the patient's mouth.

The endoscope13may 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 endoscope13may 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 drivers28also allows the leader portion and sheath portion to be driven independently of each other.

For example, the endoscope13may 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 endoscope13may 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 endoscope13may 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 system10may also include a movable tower30, which may be connected via support cables to the cart11to provide support for controls, electronics, fluidics, optics, sensors, and/or power to the cart11. Placing such functionality in the tower30allows for a smaller form factor cart11that 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 tower30reduces operating room clutter and facilitates improving clinical workflow. While the cart11may be positioned close to the patient, the tower30may be stowed in a remote location to stay out of the way during a procedure.

In support of the robotic systems described above, the tower30may 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 tower30or the cart11, 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 tower30may 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 endoscope13. These components may also be controlled using the computer system of the tower30. In some embodiments, irrigation and aspiration capabilities may be delivered directly to the endoscope13through separate cable(s).

The tower30may include a voltage and surge protector designed to provide filtered and protected electrical power to the cart11, thereby avoiding placement of a power transformer and other auxiliary power components in the cart11, resulting in a smaller, more moveable cart11.

The tower30may also include support equipment for the sensors deployed throughout the robotic system10. For example, the tower30may include optoelectronics equipment for detecting, receiving, and processing data received from the optical sensors or cameras throughout the robotic system10. 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 tower30. Similarly, the tower30may also include an electronic subsystem for receiving and processing signals received from deployed electromagnetic (EM) sensors. The tower30may also be used to house and position an EM field generator for detection by EM sensors in or on the medical instrument.

The tower30may also include a console31in addition to other consoles available in the rest of the system, e.g., console mounted on top of the cart. The console31may include a user interface and a display screen, such as a touchscreen, for the physician operator. Consoles in the system10are 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 endoscope13. When the console31is 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 system10, as well as to provide procedure-specific data, such as navigational and localization information. In other embodiments, the console30is housed in a body that is separate from the tower30.

The tower30may be coupled to the cart11and endoscope13through one or more cables or connections (not shown). In some embodiments, the support functionality from the tower30may be provided through a single cable to the cart11, 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 cart11, the support for controls, optics, fluidics, and/or navigation may be provided through a separate cable.

FIG. 2provides a detailed illustration of an embodiment of the cart11from the cart-based robotically-enabled system shown inFIG. 1. The cart11generally includes an elongated support structure14(often referred to as a “column”), a cart base15, and a console16at the top of the column14. The column14may include one or more carriages, such as a carriage17(alternatively “arm support”) for supporting the deployment of one or more robotic arms12(three shown inFIG. 2). The carriage17may include individually configurable arm mounts that rotate along a perpendicular axis to adjust the base of the robotic arms12for better positioning relative to the patient. The carriage17also includes a carriage interface19that allows the carriage17to vertically translate along the column14.

The carriage interface19is connected to the column14through slots, such as slot20, that are positioned on opposite sides of the column14to guide the vertical translation of the carriage17. The slot20contains a vertical translation interface to position and hold the carriage17at various vertical heights relative to the cart base15. Vertical translation of the carriage17allows the cart11to adjust the reach of the robotic arms12to meet a variety of table heights, patient sizes, and physician preferences. Similarly, the individually configurable arm mounts on the carriage17allow the robotic arm base21of the robotic arms12to be angled in a variety of configurations.

In some embodiments, the slot20may 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 column14and the vertical translation interface as the carriage17vertically translates. The slot covers may be deployed through pairs of spring spools positioned near the vertical top and bottom of the slot20. The covers are coiled within the spools until deployed to extend and retract from their coiled state as the carriage17vertically translates up and down. The spring-loading of the spools provides force to retract the cover into a spool when the carriage17translates towards the spool, while also maintaining a tight seal when the carriage17translates away from the spool. The covers may be connected to the carriage17using, for example, brackets in the carriage interface19to ensure proper extension and retraction of the cover as the carriage17translates.

The column14may internally comprise mechanisms, such as gears and motors, that are designed to use a vertically aligned lead screw to translate the carriage17in a mechanized fashion in response to control signals generated in response to user inputs, e.g., inputs from the console16.

The robotic arms12may generally comprise robotic arm bases21and end effectors22, separated by a series of linkages23that are connected by a series of joints24, 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 arm12. Each of the robotic arms12may 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 arms12to position their respective end effectors22at 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 base15balances the weight of the column14, carriage17, and robotic arms12over the floor. Accordingly, the cart base15houses heavier components, such as electronics, motors, power supply, as well as components that either enable movement and/or immobilize the cart11. For example, the cart base15includes rollable wheel-shaped casters25that allow for the cart11to easily move around the room prior to a procedure. After reaching the appropriate position, the casters25may be immobilized using wheel locks to hold the cart11in place during the procedure.

Positioned at the vertical end of the column14, the console16allows for both a user interface for receiving user input and a display screen (or a dual-purpose device such as, for example, a touchscreen26) to provide the physician user with both preoperative and intraoperative data. Potential preoperative data on the touchscreen26may 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 console16may be positioned and tilted to allow a physician to access the console16from the side of the column14opposite the carriage17. From this position, the physician may view the console16, robotic arms12, and patient while operating the console16from behind the cart11. As shown, the console16also includes a handle27to assist with maneuvering and stabilizing the cart11.

FIG. 3illustrates an embodiment of a robotically-enabled system10arranged for ureteroscopy. In a ureteroscopic procedure, the cart11may be positioned to deliver a ureteroscope32, 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 ureteroscope32to be directly aligned with the patient's urethra to reduce friction and forces on the sensitive anatomy in the area. As shown, the cart11may be aligned at the foot of the table to allow the robotic arms12to position the ureteroscope32for direct linear access to the patient's urethra. From the foot of the table, the robotic arms12may insert the ureteroscope32along the virtual rail33directly into the patient's lower abdomen through the urethra.

After insertion into the urethra, using similar control techniques as in bronchoscopy, the ureteroscope32may be navigated into the bladder, ureters, and/or kidneys for diagnostic and/or therapeutic applications. For example, the ureteroscope32may 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 ureteroscope32. After lithotripsy is complete, the resulting stone fragments may be removed using baskets deployed down the ureteroscope32.

FIG. 4illustrates an embodiment of a robotically-enabled system10similarly arranged for a vascular procedure. In a vascular procedure, the system10may be configured such that the cart11may deliver a medical instrument34, 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 cart11may be positioned towards the patient's legs and lower abdomen to allow the robotic arms12to provide a virtual rail35with direct linear access to the femoral artery access point in the patient's thigh/hip region. After insertion into the artery, the medical instrument34may be directed and inserted by translating the instrument drivers28. 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. 5illustrates an embodiment of such a robotically-enabled system arranged for a bronchoscopic procedure. System36includes a support structure or column37for supporting platform38(shown as a “table” or “bed”) over the floor. Much like in the cart-based systems, the end effectors of the robotic arms39of the system36comprise instrument drivers42that are designed to manipulate an elongated medical instrument, such as a bronchoscope40inFIG. 5, through or along a virtual rail41formed from the linear alignment of the instrument drivers42. 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 table38.

FIG. 6provides an alternative view of the system36without the patient and medical instrument for discussion purposes. As shown, the column37may include one or more carriages43shown as ring-shaped in the system36, from which the one or more robotic arms39may be based. The carriages43may translate along a vertical column interface44that runs the length of the column37to provide different vantage points from which the robotic arms39may be positioned to reach the patient. The carriage(s)43may rotate around the column37using a mechanical motor positioned within the column37to allow the robotic arms39to have access to multiples sides of the table38, 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 carriages43need not surround the column37or even be circular, the ring-shape as shown facilitates rotation of the carriages43around the column37while maintaining structural balance. Rotation and translation of the carriages43allows the system36to align the medical instruments, such as endoscopes and laparoscopes, into different access points on the patient. In other embodiments (not shown), the system36can include a patient table or bed with adjustable arm supports in the form of bars or rails extending alongside it. One or more robotic arms39(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 arms39are advantageously capable of being stowed compactly beneath the patient table or bed, and subsequently raised during a procedure.

The robotic arms39may be mounted on the carriages43through a set of arm mounts45comprising a series of joints that may individually rotate and/or telescopically extend to provide additional configurability to the robotic arms39. Additionally, the arm mounts45may be positioned on the carriages43such that, when the carriages43are appropriately rotated, the arm mounts45may be positioned on either the same side of the table38(as shown inFIG. 6), on opposite sides of the table38(as shown inFIG. 9), or on adjacent sides of the table38(not shown).

The column37structurally provides support for the table38, and a path for vertical translation of the carriages43. Internally, the column37may be equipped with lead screws for guiding vertical translation of the carriages, and motors to mechanize the translation of the carriages43based the lead screws. The column37may also convey power and control signals to the carriages43and the robotic arms39mounted thereon.

The table base46serves a similar function as the cart base15in the cart11shown inFIG. 2, housing heavier components to balance the table/bed38, the column37, the carriages43, and the robotic arms39. The table base46may also incorporate rigid casters to provide stability during procedures. Deployed from the bottom of the table base46, the casters may extend in opposite directions on both sides of the base46and retract when the system36needs to be moved.

With continued reference toFIG. 6, the system36may also include a tower (not shown) that divides the functionality of the system36between 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 base46for potential stowage of the robotic arms39. 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. 7illustrates a system47that stows robotic arms in an embodiment of the table-based system. In the system47, carriages48may be vertically translated into base49to stow robotic arms50, arm mounts51, and the carriages48within the base49. Base covers52may be translated and retracted open to deploy the carriages48, arm mounts51, and robotic arms50around column53, and closed to stow to protect them when not in use. The base covers52may be sealed with a membrane54along the edges of its opening to prevent dirt and fluid ingress when closed.

FIG. 8illustrates an embodiment of a robotically-enabled table-based system configured for a ureteroscopic procedure. In a ureteroscopy, the table38may include a swivel portion55for positioning a patient off-angle from the column37and table base46. The swivel portion55may 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 portion55away from the column37. For example, the pivoting of the swivel portion55allows a C-arm (not shown) to be positioned over the patient's lower abdomen without competing for space with the column (not shown) below table38. By rotating the carriage35(not shown) around the column37, the robotic arms39may directly insert a ureteroscope56along a virtual rail57into the patient's groin area to reach the urethra. In a ureteroscopy, stirrups58may also be fixed to the swivel portion55of the table38to 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. 9illustrates an embodiment of a robotically-enabled table-based system configured for a laparoscopic procedure. As shown inFIG. 9, the carriages43of the system36may be rotated and vertically adjusted to position pairs of the robotic arms39on opposite sides of the table38, such that instrument59may be positioned using the arm mounts45to 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. 10illustrates an embodiment of the robotically-enabled medical system with pitch or tilt adjustment. As shown inFIG. 10, the system36may accommodate tilt of the table38to position one portion of the table at a greater distance from the floor than the other. Additionally, the arm mounts45may rotate to match the tilt such that the robotic arms39maintain the same planar relationship with the table38. To accommodate steeper angles, the column37may also include telescoping portions60that allow vertical extension of the column37to keep the table38from touching the floor or colliding with the table base46.

FIG. 11provides a detailed illustration of the interface between the table38and the column37. Pitch rotation mechanism61may be configured to alter the pitch angle of the table38relative to the column37in multiple degrees of freedom. The pitch rotation mechanism61may be enabled by the positioning of orthogonal axes1,2at the column-table interface, each axis actuated by a separate motor3,4responsive to an electrical pitch angle command. Rotation along one screw5would enable tilt adjustments in one axis1, while rotation along the other screw6would enable tilt adjustments along the other axis2. In some embodiments, a ball joint can be used to alter the pitch angle of the table38relative to the column37in 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.

FIGS. 12 and 13illustrate isometric and end views of an alternative embodiment of a table-based surgical robotics system100. The surgical robotics system100includes one or more adjustable arm supports105that can be configured to support one or more robotic arms (see, for example,FIG. 14) relative to a table101. In the illustrated embodiment, a single adjustable arm support105is shown, though an additional arm support can be provided on an opposite side of the table101. The adjustable arm support105can be configured so that it can move relative to the table101to adjust and/or vary the position of the adjustable arm support105and/or any robotic arms mounted thereto relative to the table101. For example, the adjustable arm support105may be adjusted one or more degrees of freedom relative to the table101. The adjustable arm support105provides high versatility to the system100, including the ability to easily stow the one or more adjustable arm supports105and any robotics arms attached thereto beneath the table101. The adjustable arm support105can be elevated from the stowed position to a position below an upper surface of the table101. In other embodiments, the adjustable arm support105can be elevated from the stowed position to a position above an upper surface of the table101.

The adjustable arm support105can provide several degrees of freedom, including lift, lateral translation, tilt, etc. In the illustrated embodiment ofFIGS. 12 and 13, the arm support105is configured with four degrees of freedom, which are illustrated with arrows inFIG. 12. A first degree of freedom allows for adjustment of the adjustable arm support105in the z-direction (“Z-lift”). For example, the adjustable arm support105can include a carriage109configured to move up or down along or relative to a column102supporting the table101. A second degree of freedom can allow the adjustable arm support105to tilt. For example, the adjustable arm support105can include a rotary joint, which can allow the adjustable arm support105to be aligned with the bed in a Trendelenburg position. A third degree of freedom can allow the adjustable arm support105to “pivot up,” which can be used to adjust a distance between a side of the table101and the adjustable arm support105. A fourth degree of freedom can permit translation of the adjustable arm support105along a longitudinal length of the table.

The surgical robotics system100inFIGS. 12 and 13can comprise a table supported by a column102that is mounted to a base103. The base103and the column102support the table101relative to a support surface. A floor axis131and a support axis133are shown inFIG. 13.

The adjustable arm support105can be mounted to the column102. In other embodiments, the arm support105can be mounted to the table101or base103. The adjustable arm support105can include a carriage109, a bar or rail connector111and a bar or rail107. In some embodiments, one or more robotic arms mounted to the rail107can translate and move relative to one another.

The carriage109can be attached to the column102by a first joint113, which allows the carriage109to move relative to the column102(e.g., such as up and down a first or vertical axis123). The first joint113can provide the first degree of freedom (“Z-lift”) to the adjustable arm support105. The adjustable arm support105can include a second joint115, which provides the second degree of freedom (tilt) for the adjustable arm support105. The adjustable arm support105can include a third joint117, which can provide the third degree of freedom (“pivot up”) for the adjustable arm support105. An additional joint119(shown inFIG. 13) can be provided that mechanically constrains the third joint117to maintain an orientation of the rail107as the rail connector111is rotated about a third axis127. The adjustable arm support105can include a fourth joint121, which can provide a fourth degree of freedom (translation) for the adjustable arm support105along a fourth axis129.

FIG. 14illustrates an end view of the surgical robotics system140A with two adjustable arm supports105A,105B mounted on opposite sides of a table101. A first robotic arm142A is attached to the bar or rail107A of the first adjustable arm support105B. The first robotic arm142A includes a base144A attached to the rail107A. The distal end of the first robotic arm142A includes an instrument drive mechanism146A that can attach to one or more robotic medical instruments or tools. Similarly, the second robotic arm142B includes a base144B attached to the rail107B. The distal end of the second robotic arm142B includes an instrument drive mechanism146B. The instrument drive mechanism146B can be configured to attach to one or more robotic medical instruments or tools.

In some embodiments, one or more of the robotic arms142A,142B comprises an arm with seven or more degrees of freedom. In some embodiments, one or more of the robotic arms142A,142B can include eight degrees of freedom, including an insertion axis (1-degree of freedom including insertion), a wrist (3-degrees of freedom including wrist pitch, yaw and roll), an elbow (1-degree of freedom including elbow pitch), a shoulder (2-degrees of freedom including shoulder pitch and yaw), and base144A,144B (1-degree of freedom including translation). In some embodiments, the insertion degree of freedom can be provided by the robotic arm142A,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. 15illustrates an example instrument driver. Positioned at the distal end of a robotic arm, instrument driver62comprises one or more drive units63arranged with parallel axes to provide controlled torque to a medical instrument via drive shafts64. Each drive unit63comprises an individual drive shaft64for interacting with the instrument, a gear head65for converting the motor shaft rotation to a desired torque, a motor66for generating the drive torque, an encoder67to measure the speed of the motor shaft and provide feedback to the control circuitry, and control circuitry68for receiving control signals and actuating the drive unit. Each drive unit63being independently controlled and motorized, the instrument driver62may provide multiple (e.g., four as shown inFIG. 15) independent drive outputs to the medical instrument. In operation, the control circuitry68would receive a control signal, transmit a motor signal to the motor66, compare the resulting motor speed as measured by the encoder67with 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 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. 16illustrates an example medical instrument with a paired instrument driver. Like other instruments designed for use with a robotic system, medical instrument70comprises an elongated shaft71(or elongate body) and an instrument base72. The instrument base72, also referred to as an “instrument handle” due to its intended design for manual interaction by the physician, may generally comprise rotatable drive inputs73, e.g., receptacles, pulleys or spools, that are designed to be mated with drive outputs74that extend through a drive interface on instrument driver75at the distal end of robotic arm76. When physically connected, latched, and/or coupled, the mated drive inputs73of the instrument base72may share axes of rotation with the drive outputs74in the instrument driver75to allow the transfer of torque from the drive outputs74to the drive inputs73. In some embodiments, the drive outputs74may comprise splines that are designed to mate with receptacles on the drive inputs73.

The elongated shaft71is 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 shaft71may 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 outputs74of the instrument driver75. 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 outputs74of the instrument driver75.

Torque from the instrument driver75is transmitted down the elongated shaft71using tendons along the elongated shaft71. These individual tendons, such as pull wires, may be individually anchored to individual drive inputs73within the instrument handle72. From the handle72, the tendons are directed down one or more pull lumens along the elongated shaft71and anchored at the distal portion of the elongated shaft71, 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 inputs73would 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 shaft71, 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 shaft71(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 inputs73would 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 shaft71to allow for controlled articulation in the desired bending or articulable sections.

In endoscopy, the elongated shaft71houses a number of components to assist with the robotic procedure. The shaft71may 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 shaft71. The shaft71may 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 shaft71may also accommodate optical fibers to carry light from proximally-located light sources, such as light emitting diodes, to the distal end of the shaft71.

At the distal end of the instrument70, 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 ofFIG. 16, the drive shaft axes, and thus the drive input axes, are orthogonal to the axis of the elongated shaft71. This arrangement, however, complicates roll capabilities for the elongated shaft71. Rolling the elongated shaft71along its axis while keeping the drive inputs73static results in undesirable tangling of the tendons as they extend off the drive inputs73and enter pull lumens within the elongated shaft71. The resulting entanglement of such tendons may disrupt any control algorithms intended to predict movement of the flexible elongated shaft71during an endoscopic procedure.

FIG. 17illustrates 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 driver80comprises four drive units with their drive outputs81aligned in parallel at the end of a robotic arm82. The drive units, and their respective drive outputs81, are housed in a rotational assembly83of the instrument driver80that is driven by one of the drive units within the assembly83. In response to torque provided by the rotational drive unit, the rotational assembly83rotates along a circular bearing that connects the rotational assembly83to the non-rotational portion84of the instrument driver80. Power and controls signals may be communicated from the non-rotational portion84of the instrument driver80to the rotational assembly83through electrical contacts that may be maintained through rotation by a brushed slip ring connection (not shown). In other embodiments, the rotational assembly83may be responsive to a separate drive unit that is integrated into the non-rotatable portion84, and thus not in parallel to the other drive units. The rotational mechanism83allows the instrument driver80to rotate the drive units, and their respective drive outputs81, as a single unit around an instrument driver axis85.

Like earlier disclosed embodiments, an instrument86may comprise an elongated shaft portion88and an instrument base87(shown with a transparent external skin for discussion purposes) comprising a plurality of drive inputs89(such as receptacles, pulleys, and spools) that are configured to receive the drive outputs81in the instrument driver80. Unlike prior disclosed embodiments, the instrument shaft88extends from the center of the instrument base87with an axis substantially parallel to the axes of the drive inputs89, rather than orthogonal as in the design ofFIG. 16.

When coupled to the rotational assembly83of the instrument driver80, the medical instrument86, comprising instrument base87and instrument shaft88, rotates in combination with the rotational assembly83about the instrument driver axis85. Since the instrument shaft88is positioned at the center of instrument base87, the instrument shaft88is coaxial with instrument driver axis85when attached. Thus, rotation of the rotational assembly83causes the instrument shaft88to rotate about its own longitudinal axis. Moreover, as the instrument base87rotates with the instrument shaft88, any tendons connected to the drive inputs89in the instrument base87are not tangled during rotation. Accordingly, the parallelism of the axes of the drive outputs81, drive inputs89, and instrument shaft88allows for the shaft rotation without tangling any control tendons.

FIG. 18illustrates an instrument having an instrument based insertion architecture in accordance with some embodiments. The instrument150can be coupled to any of the instrument drivers discussed above. The instrument150comprises an elongated shaft152, an end effector162connected to the shaft152, and a handle170coupled to the shaft152. The elongated shaft152comprises a tubular member having a proximal portion154and a distal portion156. The elongated shaft152comprises one or more channels or grooves158along its outer surface. The grooves158are configured to receive one or more wires or cables180therethrough. One or more cables180thus run along an outer surface of the elongated shaft152. In other embodiments, cables180can also run through the elongated shaft152. Manipulation of the one or more cables180(e.g., via an instrument driver) results in actuation of the end effector162.

The instrument handle170, which may also be referred to as an instrument base, may generally comprise an attachment interface172having one or more mechanical inputs174, 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 instrument150comprises a series of pulleys or cables that enable the elongated shaft152to translate relative to the handle170. In other words, the instrument150itself 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 instrument150. 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. 19is a perspective view of an embodiment of a controller182. In the present embodiment, the controller182comprises a hybrid controller that can have both impedance and admittance control. In other embodiments, the controller182can utilize just impedance or passive control. In other embodiments, the controller182can utilize just admittance control. By being a hybrid controller, the controller182advantageously can have a lower perceived inertia while in use.

In the illustrated embodiment, the controller182is configured to allow manipulation of two medical instruments, and includes two handles184. Each of the handles184is connected to a gimbal186. Each gimbal186is connected to a positioning platform188.

As shown inFIG. 19, each positioning platform188includes a SCARA arm (selective compliance assembly robot arm)198coupled to a column194by a prismatic joint196. The prismatic joints196are configured to translate along the column194(e.g., along rails197) to allow each of the handles184to be translated in the z-direction, providing a first degree of freedom. The SCARA arm198is configured to allow motion of the handle184in 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 gimbals186. By providing a load cell, portions of the controller182are capable of operating under admittance control, thereby advantageously reducing the perceived inertia of the controller while in use. In some embodiments, the positioning platform188is configured for admittance control, while the gimbal186is configured for impedance control. In other embodiments, the gimbal186is configured for admittance control, while the positioning platform188is configured for impedance control. Accordingly, for some embodiments, the translational or positional degrees of freedom of the positioning platform188can rely on admittance control, while the rotational degrees of freedom of the gimbal186rely on impedance control.

F. Navigation and 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. 20is a block diagram illustrating a localization system90that 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 system90may 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 tower30shown inFIG. 1, the cart11shown inFIGS. 1-4, the beds shown inFIGS. 5-14, etc.

As shown inFIG. 20, the localization system90may include a localization module95that processes input data91-94to generate location data96for the distal tip of a medical instrument. The location data96may 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 data91-94are 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 data91(also referred to as “preoperative model data” when generated using only preoperative CT scans). The use of center-line geometry is discussed in U.S. patent application Ser. No. 14/523,760, the contents of which are herein incorporated in its entirety. 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)92. The localization module95may process the vision data92to enable one or more vision-based (or image-based) location tracking modules or features. For example, the preoperative model data91may be used in conjunction with the vision data92to 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 data91, 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 module95may identify circular geometries in the preoperative model data91that 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 data92to 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 module95may 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 data93. 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 data94may also be used by the localization module95to provide localization data96for 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.

AsFIG. 20shows, a number of other input data can be used by the localization module95. For example, although not shown inFIG. 20, an instrument utilizing shape-sensing fiber can provide shape data that the localization module95can use to determine the location and shape of the instrument.

The localization module95may use the input data91-94in combination(s). In some cases, such a combination may use a probabilistic approach where the localization module95assigns a confidence weight to the location determined from each of the input data91-94. 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 data93can be decrease and the localization module95may rely more heavily on the vision data92and/or the robotic command and kinematics data94.

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 systems and techniques for applying clips to ligate tissue. Medical clips can be used in a variety of different medical procedures, including, for example, laparoscopic procedures in which the medical clips may be used to ligate and/or seal tissue to stop bleeding. The use of clips to ligate tissue can be advantageous as they can be faster than the use of sutures to ligate tissue. When used as part of a robotic system, it can be desirable to provide a one or more of degrees of freedom (DOF) of movement at an articulating wrist of the medical clip applier. It can also be desirable for the clip applier to multi-fire wherein multiple clips are preloaded into the instrument. Multiple clips applied from a single instrument allows multiple clips to quickly be applied in succession while keeping the applier at the target tissue, without reloading the applier. Embodiments of the disclosure herein relate to the use of medical clips as part of a robotic system and in certain embodiments, the robotic system can provide one or more of degrees of freedom (DOF) of movement at an articulating wrist of an end effector that is configured to apply one or more medical clips. Certain embodiments can be configured with an end effector that includes multiple clips that are preloaded into a cartridge such that the a plurality of clips can be delivered. Multiple clips applied from a single end effector can allow multiple clips to quickly be applied in succession while keeping the effector at the target tissue, without having to reload. Such an instrument that can deliver multiple clips in succession can be referred to as a multi-fire clip applier. Advantageously, in some embodiments, the multi-fire clip can deliver a multitude of clips in succession without having to reload the clips.

There are a number of challenges in providing a robotically controlled multi-fire clip applier. As it is desired to reduce the size of incisions formed in a patient, instruments are becoming increasingly smaller in size. Robotic instruments incorporate a number of pulleys and cables, thereby reducing the overall available space within the instruments. As these instruments increase their number of DOFs (e.g., from a single DOF wrist to a multi-DOF wrist), thereby increasing the complexity of the pulleys and cables within the instruments, these size constraints are exacerbated.

One example of a surgery that can apply a multi-fire clip applier is a colon resection, wherein a portion of a colon is removed. In such a procedure, a multi-fire clip end effector can apply first and second clips on one side of a colon portion to be resection, and a third clip on another side of the colon portion to be resected. The first and second clips can be applied to the high-pressure side. Tissue may be cut in the space between the second and third clips.

Another example of a surgery that can apply a multi-fire clip applier is a laparoscopic cholecystectomy, wherein a gall bladder of a patient is removed. In such a procedure, a multi-fire clip applier can apply first and second clips on one side of a cystic duct away from the gall bladder near the common bile duct, and a third clip on another side of the cystic duct nearer the gall bladder. The cystic duct may be cut in the space between the second and third clips. The gall bladder may be removed with the first and second clips providing redundant ligation security on the cystic duct near the common bile duct, while the third clip near the gall bladder keeps bile and stones from disgorging during the removal of the gall bladder.

FIG. 21illustrates an example embodiment of a medical instrument200in accordance with aspects of this disclosure. In the embodiment illustrated inFIG. 21, the medical instrument200can be a robotically-controlled surgical instrument that can include a shaft205, a handle210, and an end effector215. The instrument200can be coupled to any of the instrument drivers discussed above. One or more cables (not illustrated) can run along an outer surface of the shaft205and/or one or more cables can also run through the elongated shaft205. Manipulation of the one or more cables (e.g., via an instrument driver) results in actuation of the end effector215.

The handle210, which may also be referred to as an instrument base, may generally include an attachment interface having one or more mechanical inputs, 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.

Depending on the implementation of the particular instrument200, the end effector215may be embodied to perform one or more different medical and/or surgical tasks, which can be effectuated via tensioning the one or more cables. In some embodiments, the instrument200comprises a series of pulleys to which the one or more cables can be operatively coupled that enable the shaft205to translate relative to the handle210.

In some embodiments, the instrument200may include an end effector215that is adapted to apply one or more clips adapted to grip and to close onto tissue, and in certain embodiments the end effector216is coupled to a wrist providing at least one degree of freedom of movement.

FIGS. 22A-22Dillustrate an example embodiment of a novel clip300to be fired from a clip applier, as discussed above.FIGS. 22A and 22Billustrate front perspective views of the clip300.FIGS. 22C and 23Dillustrate side perspective views of the clip300.FIGS. 22A and 22Cillustrate the clip300in an open position.FIGS. 22B and 22Dillustrate the clip300in a closed position.

The clip300can include a first arm320and a second arm330. A proximal end of the first arm320and a proximal end of the second arm330can be joined to form a vertex310. The vertex310may include one or more loops312. The loops312of the vertex310may form a spring, such as a torsion spring formed by the one or more loops or coils. The spring may be biased to bias the first arm320and second arm330towards each other in the closed position. The clip300may use the spring to assist with the automatic closing. The use of at least one complete loop312at the vertex310also advantageously prevents any gap or unclamped area between the first arm320and second arm330when the clip300is in the closed position. Therefore, when the clip300is closed on tissue, the tissue received in the clip300is fully ligated. Advantageously, the illustrated embodiment of the clip300can create an overlap between first arm320and second arm330that result in no gap near the vertex310.

As shown inFIGS. 22A and 22B, the first arm320can be formed of a single strut322while the second arm330can be formed by a pair of struts including a second strut332and a third strut334. The distal end of the first strut322of the first arm320may form a first loop340. The distal ends of the second strut332and the third strut334of the second arm330may meet to form a second loop350. The first loop340may be smaller in diameter than the second loop350such that the first loop340can fit within the second loop350as shown inFIG. 22B. In other embodiments, the distal end of the first arm320may form a first tab (not shown) and the distal end of the second arm330may form a second tab (not shown) that can abut against each other in a closed position. In some embodiments, the first strut322can overlap and cross beyond the second and third struts332,334in the closed configuration. In other words, in a closed configuration, first strut322can advantageously pass slightly beyond a plane formed by second and third struts332,334. This overlap advantageously helps to ensure that a vessel/lumen/duct/tissue that is clipped by a clip will not leak.

The first loop340may be aligned with the length of the first strut322. The length of the first loop340may also be aligned with an axis not parallel to the length of the first strut322. Similarly, the length of the second loop350may aligned with an axis not parallel to the length of the second and third struts332,334. For example, the length of the first loop340and length of the second loop may be configured to be parallel with each other when the clip300is in a fully open position, as shown inFIG. 22A. Similarly, the length of the first loop340and the length of the second loop350can be configured to form an acute angle when the clip300is in the closed position, as shown inFIG. 22D.

In the open position, the distal end of the first arm320and the distal end of the second arm330are separated from each other. In the open position, such as shown inFIGS. 22A and 22C, the first loop340of the first arm320and the second loop350of the second arm330are separated from each other. In the closed position, such as shown inFIGS. 22B and 22D, the distal end of the first arm320and the distal end of the second arm330are intermeshed with each other. In the closed position, the first loop340of the first arm320and the second loop350of the second arm330are intermeshed with each other. In some embodiments, the first loop340may be received within the second loop350when the clip300is in the closed position. In particular, this is seen inFIG. 22D, where the first loop340extends past the second loop350. In some embodiments, the single strut322of the first arm320may be received between the pair of struts332,334of the second arm330when the clip300is in the closed position. As shown inFIG. 22E, the first arm320may extend past or beyond the second arm330in the closed position. The clip300may have a center plane from the center of the vertex310, such that each of the first arm320and second arm330are equally spaced at each point along their respective lengths from the center plane when the clip300is in the open position. The center plane may bisect the clip300such that each of the first arm320and the second arm330are equally angled from the center plane in the open position. In the closed position, each of the first arm320and the second arm330pass the center plane. As described previously, the first arm320may be formed by a single strut322and the second arm330can be formed by a pair of struts, the second strut332and third strut334. In the closed position, the first strut322may pass between and beyond the second and third struts332,334. The first arm320and the second arm330may pass beyond each other to form an angle relative to each other.

FIG. 23illustrates the clip300positioned closed on a vessel302. The clip300is configured to lock or over-close at the distal end of the clip300as described herein, so that the clip300will not slip off of the vessel302. In the closed configuration, the clip300is designed such that the distal loop340of the first arm320interlocks, intermeshes, or interdigitates with the distal loop350of the second arm330. This is enabled by having the distal loop340of the first arm320be of a relatively smaller size than the distal loop350of the second arm330, thereby allowing the distal loop340of the first arm320to pass through the distal loop350of the second arm330. By including distal portions of the arms that interlock with one another, the clip300provides a secure grip of a vessel302, as shown inFIG. 23.

In addition to the distal loops340,350interlocking, the first arm320is formed of one strut322, while the second arm330is formed of two struts332,334. Accordingly, the clip300uses three clamping struts for ligation. In this embodiment, the single strut322passes between and through two struts332,334. When vessel is caught between the first and second arms320,330of the clip300, the vessel302is forced into a zig-zag shape which advantageously increases ligation security.

FIGS. 24A and 24Billustrate another embodiment of a clip400that can be used to ligate tissue. As shown inFIGS. 24A and 24B, the clip400in the illustrated embodiment includes a first arm420and a second arm430. The first arm420and second arm430may each include one strut or member432, as shown inFIGS. 25A-25B. The first arm420and second arm430may be connected or joined at one end to form a vertex410. A proximal end of the first arm420and a proximal end of the second arm430can be joined to form the vertex410. The vertex410may include one or more loops412. The one more loops of the vertex410form include a spring, such as a torsion spring. The torsion spring may be biased to bias the first arm420and second arm430towards each other in the closed position. The clip400may use a multi-coil spring to assist with the automatic closing. The clip400may be configured as described above with at least one loop412to advantageously prevent any gap or unclamped area between the first arm420and the second arm430.

The distal end of the first arm420may include a first clamp440. The distal end of the second arm430may include a second clamp450. The first clamp440and second clamp450may be configured to interlink or interlock with each other when the clip400is in the closed position. The first clamp440and the second clamp450may be cup shaped or “U” shaped such that there is an open face and a closed face of each clamp as well as a first side and a second side of each clamp. The first clamp440and second clamp450may be oriented in opposite directions such that when the clip400is in a closed position, the open faces of the first clamp440and the second clamp450may interlock with each other.

The first clamp440may be offset from the first arm420in a first direction. For example, the first side of the first clamp440may be connected to the strut422of the first arm420. Similarly, the second clamp450may be offset from the second arm430in an opposite direction from the first direction. For example, the second side of the second clamp450may be connected to the strut432of the second arm430. With this configuration, the first arm420and the second arm430are in secured closely together with each other when the first clamp40and the second clamp450are interlocked in the closed position.

FIGS. 25A-25Cillustrate an embodiment of a cartridge500that holds and dispenses one or more clips, such as the clips300,400as described herein. The cartridge500may be disposable, such that the cartridge500is intended to be thrown away after each use. The cartridge500may also be rechargeable, such that the cartridge500may be sterilized and reloaded with one or more clips to be reused. Additionally, some components of the cartridge500may be disposable while others are rechargeable.

The cartridge500can be removably coupled to the robotic arm. The robotic arm may include an elongate shaft (as described above) extending between a proximal end and a distal end, and a wrist600extending from the distal end of the elongate shaft. The wrist600may be used in combination with the robotic system as described above. The wrist600may provide at least one degree of freedom to actuate and/or dispense the one or more clips out of the cartridge500along an actuation axis550and certain embodiments the wrist600can provide at least one degree of freedom of movement. In some embodiments, the wrist600may provide at least two degrees of freedom (e.g., a proximal pitch and a distal yaw) to actuate and/or dispense one or more clips out of a cartridge along an actuation axis. For example, in the illustrated embodiment the wrist600can be configured to rotate the cartridge500about at least a first axis and in certain embodiments also about second axis. An advantage of the illustrated embodiment, is that a clip and/or multiple clips can be dispensed with only one degree of movement or actuation. By utilizing one degree of freedom of movement for dispensing the clips, remaining cables and/or pulleys can be used to provide for one or degrees of freedom of movement.

As noted above, the wrist600may provide more than one degree of freedom, such as two degrees of freedom. In certain arrangements, the elongate shaft may provide one degree of freedom, such that the shaft may be translated along the one degree of freedom, such as along an insertion or retraction axis, such as the actuation axis550. The wrist600may also include one or more pulleys650, which may receive one or more cables capable of moving an actuator to advance one or more clips through the cartridge500. In this manner, the wrist600may actuate deployment of the one or more clips from the cartridge500, wherein the one or more clips are capable of being both delivered and automatically clipped by the one degree of freedom movement of the actuator.

As shown inFIG. 25A, the cartridge500may include a first plate530and a second plate540on opposing sides of the cartridge500, such as on the top side and bottom side. The cartridge500may include a first channel or track510and a second channel or track520on opposing sides of the cartridge500as shown inFIG. 25C. The first track510can receive or engage with the first loops340of the one or more clips300. The second track520may receive or engage with the second loops350of the one or more clips300. Advantageously, by having the tracks engage with the loops, this helps to keep the clips open as they translate along the cartridge. The first track510and second track520may be separated on either side of the cartridge500. The tracks510,520may be configured to hold each of the plurality of clips300in an open position, such that the distal ends or loops of each of the clips300are separated from each other. When each clip300is actuated to be pushed out of the distal end of the cartridge500, the clip300dispensed will snap shut in a closed position, such that the distal ends of each clip300are positioned close to each other, such as where the distal ends are interlocked with each other as described above.

The one or more clips300may be configured to automatically shut when dispensed from the cartridge500. As discussed herein, the clip300may include a torsion spring where the arms of the clip300are biased towards each other in the closed position an can assist with automatic closing. This is advantageous as other instruments may not have clips that are automatically shut, thereby utilizing at least two types of actuation to both translate and shut a clip that is deployed from a clip applier.

FIG. 26illustrates the cartridge500with the second plate540removed. As shown inFIG. 26, the cartridge500may hold four clips300in a nested configuration within the cartridge500. The cartridge500may also include between one, two, three, four or more than four clips300. As described previously, the first loops340of the clips300may be held in a first channel510while the second loops350of the clips300may be held in a second channel520. The clips300may be nested such that the clips300are placed close to each other within the cartridge500. The thickness of the clips300can be minimized so that clips300may be placed close together in a skeletonized area of the cartridge500. Additionally, the minimized thickness of the clips300can also advantageously provide greater visibility for the surgeon to see around the one or more clips300. The clips300having a three arm configuration where a first arm320having one strut322and a second arm330having two struts332,334also allows the plurality of clips300to next closely together.

The nesting configuration allows the one or more clips to be loaded or packed into the cartridge500. The nesting configuration advantageously allow the cartridge500length to be reduced than if the one or more clips were laid end to end. For example, the cartridge500may be reduced by 55%, 65%, 75% or more.

FIGS. 27A and 27Billustrate side views of the cartridge500wherein portions of the outer housing is transparent. As shown inFIG. 27A, the first track510may include a series of one or more ratchet elements such as tangs or prongs514configured to hold each clip300in place along the length of the cartridge500. The ratchet elements are also configured to only allow the clips300to move in one direction, and thus prevent clips from moving in a backwards direction.

The first track510may include ratchet elements such as a series of tangs or prongs514. The prongs514may be positioned on only one side of the first track510, as shown on the bottom side of the first track510inFIG. 27A. In other embodiments, the first track510may also include a second series of ratchet elements such as prongs524, on the other side of the first track510, such as the top side. The second prongs524may be configured to actuate movement of the clips300out of the distal end of the cartridge500. The second prongs524may be similarly structured to the first prongs514, to only allow a one way ratchet motion. The second prongs524may act as an actuator to actuate the one or more clips along the tracks of the cartridge500. For example, the second prongs524may be advanced by actuating a pulley, as described more below. The prongs514,524of the first track510may be configured to engage with the first distal loops340of the clips300. Similarly, as shown inFIG. 27B, the second track520may include a first series of one or more prongs or tangs514configured to hold each clip300in place along the length of the cartridge500. Similarly, the second track520may include a set of second prongs524configured to actuate movement of the clips300out of the distal end of the cartridge500. The prongs514,524of the second track520may be configured to engage with the second distal loops350of the clips300.

As described previously, the prongs514,524may be configured to prevent the clips300from moving in a reverse direction or backing up. The prongs514,524are oriented in a first angle and direction such that when each clip300is advanced forward (toward the distal end of the cartridge500), the distal loops340,350push the prongs514,524of the tracks510,520fold down, such that the distal loops340,350may slide over the prongs514,524of the tracks510,520. When the distal loops340,350of the clips300have advanced past the prongs514,524, the prongs514,524pop back up. The prongs514,524oriented at an angle prevent the distal loops340,350from sliding back in a reverse direction.

The channels or tracks510,520may hold the clips300open and in place until the clip300is positioned at the end of each channel or track510,520. When the first and second loops340,350of the clip300reaches the end of the tracks510,520, an incremental push of moves the first and second loops340,350out of the tracks510,520and the clip300snaps closed. This incremental push may come from an actuator pushing the first clip at one end of the cartridge500, which in turn pushes the remainder of the plurality of clips, to push the last clip positioned at the end of the tracks510,520out of the cartridge500. The clips300may also be advanced through movement of the first plate530or second plate540. The first plate530or second plate540may be advanced forward and backwards to advance each clip300. For example, the second plate540may be actuated to move the one or more clips forward while the first plate530remains static.

FIGS. 28A and 28Billustrate side views of the cartridge500wherein portions of the outer housing is removed. As shown inFIGS. 28A and 28B, where the first plate530is removed, the and second prongs524may be connected or integral with the second plate540. As shown inFIG. 28B, the pulley650may include a pin655that is received within a slot545of the second plate540. As the pulley650is actuated to rotate, the second plate540may be advanced through the connection of the pin655received in the slot545. The advancement of the second plate540advances the first clip300out of the distal end of the cartridge through engagement of the second prongs524with the distal loops of the clip300. While the second prongs524actuates the movement of the clips300, the distal loops of the clips300fold down and allow the distal ends to move past the first prongs514, as described previously.

The wrist600may include a two pulleys650. The second pulley650may control yaw rotation of the cartridge500. The pulleys650may move synchronously with the one pulley650when the cartridge500is being rotated in the yaw direction. The differential movement between the pulleys650drives the second plate540forward and backward to advance the clips300.

3. Implementing Systems and Terminology.

Implementations disclosed herein provide systems, methods and apparatus for clip appliers and associated clips to ligate tissue including an articulating wrist.

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 functions for controlling the articulating medical instruments 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 previous description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the scope of the invention. For example, it will be appreciated that one of ordinary skill in the art will be able to employ a number corresponding alternative and equivalent structural details, such as equivalent ways of fastening, mounting, coupling, or engaging tool components, equivalent mechanisms for producing particular actuation motions, and equivalent mechanisms for delivering electrical energy. Thus, the present invention is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.