阅读说明：本技术 用于医疗缝合的系统和方法 (Systems and methods for medical suturing ) 是由 T·M·舒赫 D·T·华莱士 于 2020-01-29 设计创作，主要内容包括：本公开的某些方面涉及用于使医疗器械进行关节运动的系统和技术。在一个方面,该器械包括具有至少两个运动自由度的腕部以及耦接到腕部的端部执行器。端部执行器可包括上钳口、下钳口和击发机构,该击发机构被构造成能够在组织中形成钉。击发机构的致动可与腕部在至少两个自由度上的运动脱离。(Certain aspects of the present disclosure relate to systems and techniques for articulating a medical instrument. In one aspect, the instrument includes a wrist having at least two degrees of freedom of motion and an end effector coupled to the wrist. The end effector can include an upper jaw, a lower jaw, and a firing mechanism configured to form staples in tissue. Actuation of the firing mechanism may be decoupled from movement of the wrist in at least two degrees of freedom.)

1. An apparatus, comprising:

a wrist having at least two degrees of freedom of motion; and

an end effector coupled to the wrist, the end effector comprising an upper jaw, a lower jaw, and a firing mechanism configured to form staples in tissue,

wherein actuation of the firing mechanism is decoupled from movement of the wrist in at least two degrees of freedom.

2. The instrument of claim 1, wherein the wrist comprises a proximal clevis and a distal clevis.

3. The instrument of claim 2, wherein the proximal clevis and the distal clevis are cable driven.

4. The instrument of claim 1, wherein the firing mechanism comprises a tab movable along an axis of the end effector, the tab configured to interact with a cartridge containing the staples to drive the staples into the tissue.

5. The instrument of claim 4, wherein the tab comprises an I-beam.

6. The apparatus of claim 4, further comprising:

one or more cable segments configured to pull the tab forward; and

one or more cable segments configured to pull the tab rearward.

7. The instrument of claim 6, wherein the one or more cable segments configured to pull the tab forward are coupled to a pair of distal pulleys.

8. The instrument of claim 6, wherein the one or more cable segments configured to pull the tab forward are coupled to one or more idlers within the tab.

9. The apparatus of claim 6, further comprising:

a shaft coupled to a proximal end of the wrist and including one or more idlers,

wherein the one or more cable segments configured to pull the tab forward are coupled to the one or more idler wheels within the shaft.

10. The instrument of claim 9, wherein the one or more cable segments configured to pull the tab forward terminate at the tab.

11. The instrument of claim 6, wherein the one or more cable segments configured to pull the tab rearward are coupled to one or more idlers within the tab.

12. The apparatus of claim 6, further comprising:

a shaft coupled to a proximal end of the wrist and including one or more idlers,

wherein the one or more cable segments configured to pull the tab rearward are coupled to the one or more idler wheels within the shaft.

13. The instrument of claim 12, wherein the one or more cable segments configured to pull the tab rearwardly terminate at the tab.

14. The instrument of claim 6, wherein the one or more cable segments configured to pull the tab rearward are coupled to one or more springs.

15. The instrument of claim 6, further comprising one or more cable segments configured to articulate the wrist.

16. The instrument of claim 4, further comprising one or more pushing shafts configured to push the tabs toward a distal end of the instrument.

17. The instrument of claim 16, further comprising a pair of pusher shafts.

18. The instrument of claim 17, wherein the pair of pusher shafts are configured to engage a pair of engagement surfaces coupled to the tab.

19. The instrument of claim 18, wherein the firing mechanism further comprises a pair of cup members coupled to the tabs, and the pair of engagement surfaces are part of the cup members.

20. The instrument of claim 16, wherein the tab is configured to be coupled to a retractable blade.

21. The instrument of claim 20, wherein the one or more pushing shafts are configured to push the retractable blade through the tab to expose the retractable blade.

22. An apparatus, comprising:

a wrist portion;

an end effector coupled to the wrist, the end effector comprising an upper jaw, a lower jaw, and a firing mechanism configured to form staples in tissue; and

a pair of pusher shafts configured to drive actuation of the firing mechanism.

23. The instrument of claim 22, wherein the firing mechanism is configured to be coupled to a retractable blade.

24. The instrument of claim 23, wherein the firing mechanism further comprises a spring coupled to the retractable blade, and the push shaft is configured to engage the spring to push the retractable blade forward to expose the retractable blade.

25. The instrument of claim 23, wherein the pair of pusher shafts are configured to expose the retractable blade from the firing mechanism and translate the firing mechanism.

26. The instrument of claim 23, wherein the firing mechanism is configured to be coupled to a tab that is movable along an axis of the end effector, the tab configured to interact with a cartridge containing the staples to drive the staples into the tissue.

27. The instrument of claim 26, wherein the tab comprises an I-beam.

28. The instrument of claim 26, wherein the tab comprises a pair of engagement members, the firing mechanism further configured to be operably coupled to the tab via the pair of engagement members.

29. The instrument of claim 28, wherein each of the engagement members comprises a ball-and-socket joint, and the pair of pusher shafts are configured to engage the ball-and-socket joints.

30. The instrument of claim 28, wherein each engagement member of the pair of engagement members comprises a cup member.

31. The instrument of claim 22, wherein the wrist comprises at least two constraints configured to prevent buckling of the push shaft.

32. The instrument of claim 31, wherein each of the constraints has a tubular shape.

33. An apparatus, comprising:

a wrist having at least two degrees of freedom of motion; and

an end effector coupled to the wrist, the end effector comprising an upper jaw and a lower jaw, the end effector configured to removably couple with a cartridge.

34. The instrument of claim 33, wherein the cartridge comprises a slot configured to receive a firing mechanism.

35. The instrument of claim 34, wherein the firing mechanism is configured to be coupled to a retractable blade.

36. The instrument of claim 34, wherein the slot of the cartridge is configured to align with a slot of the upper jaw and the firing mechanism is configured to engage with the slot of the upper jaw.

37. The instrument of claim 36, wherein the upper jaw comprises a clearance slot wider than the slot of the upper jaw, the clearance slot configured to allow passage of the firing mechanism.

38. The instrument of claim 36, wherein the slot of the cartridge is configured to align with a slot of the lower jaw and the firing mechanism is configured to engage with the slot of the lower jaw.

39. The instrument of claim 38, wherein the lower jaw comprises a clearance slot wider than the slot of the lower jaw, the clearance slot configured to allow passage of the firing mechanism.

40. The apparatus of claim 34, further comprising:

a drive mechanism configured to advance the firing mechanism along the end effector.

41. The instrument of claim 40, wherein the cartridge is configured to be removable without retracting the firing mechanism.

Technical Field

The systems and methods disclosed herein relate to medical instruments, and more particularly to medical staplers including a wrist that is capable of articulating.

Background

The medical stapler can be used in a variety of different medical procedures including, for example, laparoscopic procedures, where the medical stapler can be used to transect and/or seal tissue. A medical stapler can include two jaws configured to clamp tissue therebetween and then transect and seal the tissue clamped therebetween. When used as part of a robotic system, it may be desirable to provide one or more degrees of freedom of motion (DOF) at the wrist where it is capable of articulating.

Disclosure of Invention

The systems, methods, and devices of the present disclosure each have several innovative aspects, none of which are solely responsible for the desirable attributes disclosed herein.

In one aspect, there is provided an apparatus comprising: a wrist having at least two degrees of freedom of motion; and an end effector coupled to the wrist, the end effector comprising an upper jaw, a lower jaw, and a firing mechanism configured to form staples in tissue, wherein actuation of the firing mechanism is decoupled from movement of the wrist in at least two degrees of freedom.

In another aspect, an apparatus is provided, the apparatus comprising: a wrist portion; an end effector coupled to the wrist, the end effector comprising an upper jaw, a lower jaw firing mechanism, the firing mechanism configured to form staples in tissue; and a pair of pusher shafts configured to drive actuation of the firing mechanism.

In yet another aspect, an instrument is provided, the instrument comprising: a wrist having at least two degrees of freedom of motion; and an end effector coupled to the wrist, the end effector comprising an upper jaw and a lower jaw, the end effector configured to removably couple with the cartridge.

Drawings

The disclosed aspects will hereinafter be described in conjunction with the appended drawings, provided to illustrate and not to limit the disclosed aspects, wherein like numerals denote like components.

Fig. 1 shows an embodiment of a cart-based robotic system arranged for diagnosing and/or treating bronchoscopy procedures.

Fig. 2 depicts additional aspects of the robotic system of fig. 1.

Fig. 3 shows an embodiment of the robotic system of fig. 1 arranged for ureteroscopy.

Fig. 4 shows an embodiment of the robotic system of fig. 1 arranged for a vascular procedure.

Fig. 5 shows an embodiment of a table-based robotic system arranged for bronchoscopy procedures.

Fig. 6 provides an alternative view of the robotic system of fig. 5.

FIG. 7 illustrates an exemplary system configured to stow a robotic arm.

Fig. 8 illustrates an embodiment of a table-based robotic system configured for a ureteroscopy procedure.

Fig. 9 illustrates an embodiment of a table-based robotic system configured for laparoscopic procedures.

Fig. 10 illustrates an embodiment of the table-based robotic system with pitch and tilt adjustments of fig. 5-9.

Fig. 11 provides a detailed illustration of the interface between the stage of fig. 5-10 and the column of the stage-based robotic system.

Fig. 12 shows an alternative embodiment of a table-based robotic system.

Fig. 13 shows an end view of the table-based robotic system of fig. 12.

FIG. 14 shows an end view of a table-based robotic system with a robotic arm attached thereto.

Fig. 15 illustrates an exemplary mechanical driver.

FIG. 16 illustrates an exemplary medical instrument having a pair of instrument drivers.

Fig. 17 shows an alternative design of the instrument driver and instrument, in which the axis of the drive unit is parallel to the axis of the elongate shaft of the instrument.

Fig. 18 illustrates an instrument having an instrument-based insertion architecture.

Fig. 19 shows an exemplary controller.

Fig. 20 depicts a block diagram showing a positioning system that estimates a position of one or more components of the robotic system of fig. 1-10 (such as the position of the instrument of fig. 16-18), according to an exemplary embodiment.

Fig. 21 illustrates an exemplary embodiment of a medical device according to aspects of the present disclosure.

Fig. 22A and 22B illustrate an exemplary embodiment in which an end effector is configured to be used as a medical stapler, according to aspects of the present disclosure.

Fig. 23A and 23B illustrate an exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure.

Fig. 24 illustrates a close-up view of the lower jaw of fig. 23A and 23B including a portion of the inner member of the tab, in accordance with aspects of the present disclosure.

Fig. 25 illustrates another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure.

Fig. 26 illustrates yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure.

Fig. 27 illustrates yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure.

Fig. 28 and 29 show top-down and end-point views of yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist, according to aspects of the present disclosure.

Fig. 30 illustrates an exemplary embodiment of a push shaft driven medical instrument including a wrist capable of articulation according to aspects of the present disclosure.

Fig. 31 provides a view of the cartridge of fig. 30 separated from the instrument, in accordance with aspects of the present disclosure.

FIG. 32 illustrates another view of the pusher shaft driven medical instrument of FIG. 30, according to aspects of the present disclosure.

Fig. 33 illustrates yet another view of the pusher shaft driven medical instrument of fig. 30 from a bottom view in accordance with aspects of the present disclosure.

Fig. 34 illustrates yet another view of the pusher shaft driven medical instrument of fig. 30 without a cartridge mounted thereto, in accordance with aspects of the present disclosure.

Fig. 35A-35D provide various views of a tab that may be included in a firing mechanism of a pusher shaft driven medical instrument according to aspects of the present disclosure.

Detailed Description

1. Overview

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

In addition to performing a wide range of procedures, the system may provide additional benefits, such as enhanced imaging and guidance to assist the physician. In addition, the system may provide the physician with the ability to perform procedures from an ergonomic orientation without requiring awkward arm movements and orientations. Additionally, the system may provide the physician with the ability to perform a procedure with improved ease of use such that one or more of the instruments of the system may be controlled by a single user.

For purposes of illustration, various embodiments are described below in connection with the following figures. It should be understood that many other embodiments of the disclosed concept are possible and that various advantages can be achieved with the disclosed embodiments. Headings are included herein for reference and to aid in locating the 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 present specification.

A. Robotic system-cart

The robot-enabled medical system may be configured in a variety of ways, depending on the particular protocol. Fig. 1 shows an embodiment of a cart-based robot-enabled system 10 arranged for diagnosing and/or treating bronchoscopy procedures. During bronchoscopy, the system 10 may include a cart 11 having one or more robotic arms 12 to deliver medical instruments, such as a steerable endoscope 13 (which may be a protocol-specific bronchoscope for bronchoscopy), to a natural orifice entry point (i.e., the mouth of a patient positioned on a table in this example) to deliver diagnostic and/or therapeutic tools. As shown, the cart 11 may be positioned near the upper torso of the patient in order to provide access to the access point. Similarly, the robotic arm 12 may be actuated to position the bronchoscope relative to the entry point. The arrangement of fig. 1 may also be utilized when performing a Gastrointestinal (GI) procedure with a gastroscope, a dedicated endoscope for GI procedures. Fig. 2 depicts an exemplary embodiment of a cart in more detail.

With continued reference to fig. 1, once the cart 11 is properly positioned, the robotic arm 12 may robotically, manually, or a combination thereof insert the steerable endoscope 13 into the patient. As shown, the steerable endoscope 13 may include at least two telescoping portions, such as an inner guide portion and an outer sheath portion, each coupled to a separate instrument driver from a set of instrument drivers 28, each coupled to the distal end of a separate robotic arm. This linear arrangement of the instrument driver 28, which facilitates coaxial alignment of the guide portion with the sheath portion, creates a "virtual track" 29 that can be repositioned in space by manipulating one or more robotic arms 12 to different angles and/or orientations. The virtual tracks described herein are depicted in the figures using dashed lines, and thus the dashed lines do not depict any physical structure of the system. Translation of the instrument driver 28 along the virtual track 29 causes the inner guide member portion to telescope relative to the outer sheath portion, or the endoscope 13 to be advanced or retracted from the patient. The angle of the virtual track 29 may be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and orientation of virtual track 29 as shown represents a compromise between providing the physician with access to endoscope 13 while minimizing friction caused by bending endoscope 13 into the patient's mouth.

After insertion, the endoscope 13 may be directed down the patient's trachea and lungs using precise commands from the robotic system until the target destination or surgical site is reached. To enhance navigation through the patient's pulmonary network and/or to a desired target, the endoscope 13 can be manipulated to telescopically extend the inner guide member portion from the outer sheath portion to achieve enhanced articulation and a larger bend radius. The use of a separate instrument driver 28 also allows the guide portion and sheath portion to be driven independently of each other.

For example, endoscope 13 may be guided to deliver a biopsy needle to a target, such as a lesion or nodule within a patient's lung. The needle may be deployed down a working channel that extends the length of the endoscope to obtain a tissue sample to be analyzed by a pathologist. Depending on the pathological outcome, additional tools may be deployed down the working channel of the endoscope for additional biopsies. After identifying that the nodule is malignant, the endoscope 13 may pass an endoscopic delivery tool to resect the potentially cancerous tissue. In some cases, the diagnostic and therapeutic treatments may be delivered in separate protocols. In these cases, the endoscope 13 may also be used to deliver fiducials to "mark" the location of the target nodule. In other cases, the diagnostic and therapeutic treatments may be delivered during the same protocol.

The system 10 may also include a movable tower 30 that may be connected to the cart 11 via support cables to provide control, electronic, fluidic, optical, sensor, and/or electrical support to the cart 11. Placing such functionality in the tower 30 allows for a smaller form factor cart 11 that can be more easily adjusted and/or repositioned by the operating physician and his/her staff. Additionally, dividing functionality between the carts/tables and the support towers 30 reduces operating room clutter and facilitates improved clinical workflow. While the cart 11 may be positioned close to the patient, the tower 30 may be stowed in a remote location to not block the way during the procedure.

To support the above-described robotic system, the tower 30 may include components of a computer-based control system that stores computer program instructions, for example, within a non-transitory computer-readable storage medium such as a permanent magnet storage drive, a solid state drive, or the like. Whether execution occurs in the tower 30 or in the cart 11, execution of these instructions may control the entire system or its subsystems. For example, when executed by a processor of a computer system, the instructions may cause components of the robotic system to actuate an associated carriage and arm mount, actuate a robotic arm, and control a medical instrument. For example, in response to receiving a control signal, a motor in a joint of the robotic arm may position the arm in a particular pose.

The turret 30 may also include pumps, flow meters, valve controllers, and/or fluid passageways to provide controlled irrigation and aspiration capabilities to the system that may be deployed through the endoscope 13. These components may also be controlled using the computer system of the tower 30. In some embodiments, irrigation and aspiration capabilities may be delivered directly to endoscope 13 through separate cables.

The tower 30 may include a voltage and surge protector designed to provide filtered and protected power to the cart 11, thereby avoiding the placement of power transformers and other auxiliary power components in the cart 11, resulting in a smaller, more mobile cart 11.

The tower 30 may also include support equipment for sensors deployed throughout the robotic system 10. For example, the tower 30 may include optoelectronic devices for detecting, receiving, and processing data received from optical sensors or cameras throughout the robotic system 10. In conjunction with the control system, such optoelectronic devices may be used to generate real-time images for display in any number of consoles deployed throughout the system (including in the tower 30). Similarly, the tower 30 may also include an electronics subsystem for receiving and processing signals received from deployed Electromagnetic (EM) sensors. The turret 30 may also be used to house and position an EM field generator for detection by an EM sensor in or on the medical instrument.

The tower 30 may include a console 31 in addition to other consoles available in the rest of the system (e.g., a console mounted on top of the cart). The console 31 may include a user interface and display screen, such as a touch screen, for the physician operator. The console in system 10 is typically designed to provide both robotic control and preoperative and real-time information for the procedure, such as navigation and positioning information for endoscope 13. When the console 31 is not the only console available to the physician, it may be used by a second operator (such as a nurse) to monitor the patient's health or vital signs and operation of the system, as well as to provide protocol-specific data, such as navigation and positioning information. In other embodiments, the console 30 is housed in a body separate from the tower 30.

The tower 30 may be coupled to the cart 11 and endoscope 13 by one or more cables or connectors (not shown). In some embodiments, the support function from tower 30 may be provided to cart 11 by a single cable, thereby simplifying the operating room and eliminating operating room clutter. In other embodiments, certain functions may be coupled in separate wires and connections. For example, although power may be provided to the cart via a single cable, support for control, optics, fluids, and/or navigation may also be provided via separate cables.

Fig. 2 provides a detailed illustration of an embodiment of a cart from the cart-based robot-enabled system shown in fig. 1. The cart 11 generally includes an elongated support structure 14 (commonly referred to as a "column"), a cart base 15, and a console 16 at the top of the column 14. The column 14 may include one or more carriages, such as carriages 17 (alternatively "arm supports") for supporting the deployment of one or more robotic arms 12 (three shown in fig. 2). The carriage 17 may include a separately configurable arm mount that rotates along a vertical axis to adjust the base of the robotic arm 12 for better positioning relative to the patient. The carriage 17 also includes a carriage interface 19 that allows the carriage 17 to translate vertically along the column 14.

The carriage interface 19 is connected to the column 14 by slots, such as slots 20, positioned on opposite sides of the column 14 to guide vertical translation of the carriage 17. The slot 20 includes a vertical translation interface to position and hold the carriage at various vertical heights relative to the cart base 15. Vertical translation of the carriage 17 allows the cart 11 to adjust the reach of the robotic arm 12 to meet various table heights, patient sizes, and physician preferences. Similarly, the separately configurable arm mount on the carriage 17 allows the robotic arm base 21 of the robotic arm 12 to be angled in a variety of configurations.

In some embodiments, the slot 20 may be supplemented with a slot cover that is flush and parallel with the slot surface to prevent dust and fluid from entering the internal cavity of the column 14 and the vertical translation interface as the carriage 17 translates vertically. The slot cover may be deployed by a pair of spring spools positioned near the vertical top and bottom of the slot 20. The lid is coiled within the reel until deployed to extend and retract from the coiled state of the lid as the carriage 17 translates vertically up and down. The spring loading of the spool provides a force to retract the cover into the spool as the carriage 17 translates toward the spool, while also maintaining a tight seal as the carriage 17 translates away from the spool. The cover may be connected to the carriage 17 using, for example, a bracket in the carriage interface 19 to ensure proper extension and retraction of the cover as the carriage 17 translates.

The column 14 may internally include a mechanism, such as a gear and motor, designed to use a vertically aligned lead screw to mechanically translate the carriage 17 in response to control signals generated in response to user inputs (e.g., inputs from the console 16).

The robotic arm 12 may generally include a robotic arm base 21 and an end effector 22 separated by a series of links 23 connected by a series of joints 24, each joint including an independent actuator, each actuator including an independently controllable motor. Each independently controllable joint represents an independent degree of freedom available to the robotic arm. Each of the arms 12 has seven joints and thus provides seven degrees of freedom. Multiple joints result in multiple degrees of freedom, allowing for "redundant" degrees of freedom. The redundant degrees of freedom allow the robotic arm 12 to position its respective end effector 22 at a particular position, orientation, and trajectory in space using different link positions and joint angles. This allows the system to position and guide the medical instrument from a desired point in space while allowing the physician to move the arm joint to a clinically advantageous orientation away from the patient to create greater proximity while avoiding arm collisions.

The cart base 15 balances the weight of the column 14, carriage 17 and arm 12 on the floor. Thus, the cart base 15 houses heavy components such as electronics, motors, power supplies, and components that enable the cart to be moved and/or secured. For example, the cart base 15 includes rollable wheel casters 25 that allow the cart to be easily moved around a room prior to a procedure. After reaching the proper orientation, the caster 25 may be secured using a wheel lock to hold the cart 11 in the proper orientation during the procedure.

The console 16, positioned at the vertical end of the column 14, allows both a user interface for receiving user input and a display screen (or dual-purpose device such as, for example, a touch screen 26) to provide both pre-operative and intra-operative data to the physician user. Potential preoperative data on touchscreen 26 may include preoperative planning, navigation and mapping data derived from preoperative Computed Tomography (CT) scans, and/or records from preoperative patient interviews. The intraoperative data on the display may include optical information provided from the tool, sensors and coordinate information from the sensors as well as important patient statistics such as respiration, heart rate and/or pulse. The console 16 may be positioned and tilted to allow the physician to access the console from the side of the column 14 opposite the carriage 17. From this orientation, the physician can view the console 16, the robotic arm 12, and the patient while manipulating the console 16 from behind the cart 11. As shown, the console 16 also includes a handle 27 to assist in maneuvering and stabilizing the cart 11.

Fig. 3 shows an embodiment of a robot-enabled system 10 arranged for ureteroscopy. In a ureteroscopy procedure, the cart 11 may be positioned to deliver a ureteroscope 32 (a procedure-specific endoscope designed to traverse the patient's urethra and ureter) to the lower abdominal region of the patient. In ureteroscopy, it may be desirable for the ureteroscope 32 to be directly aligned with the patient's urethra to reduce friction and forces on sensitive anatomical structures in this region. As shown, the cart 11 may be aligned at the foot of the table to allow the robotic arm 12 to position the ureteroscope 32 for direct linear access to the patient's urethra. The robotic arm 12 may insert the ureteroscope 32 from the foot of the table along a virtual track 33 directly into the lower abdomen of the patient through the urethra.

After insertion into the urethra, ureteroscope 32 may be navigated into the bladder, ureter, and/or kidney for diagnostic and/or therapeutic applications using similar control techniques as in bronchoscopy. For example, the ureteroscope 32 may be guided into the ureter and kidney to break up accumulated kidney stones using a laser or ultrasonic lithotripsy device deployed down the working channel of the ureteroscope 32. After lithotripsy is complete, the resulting stone fragments may be removed using a basket deployed down ureteroscope 32.

Fig. 4 shows an embodiment of a similarly arranged robot-enabled system for vascular procedures. In a vascular procedure, the system 10 may be configured such that the cart 11 may deliver a medical device 34 (such as a steerable catheter) to an entry point in the femoral artery of the patient's leg. The femoral artery presents both a larger diameter for navigation and a relatively less tortuous and tortuous path to the patient's heart, which simplifies navigation. As in the ureteroscopy procedure, the cart 11 may be positioned towards the patient's legs and lower abdomen to allow the robotic arm 12 to provide a virtual track 35 of direct linear access to the femoral access point in the thigh/hip region of the patient. After insertion into the artery, the medical device 34 may be guided and inserted by translating the device driver 28. Alternatively, the cart may be positioned around the patient's upper abdomen to access alternative vascular access points, such as the carotid and brachial arteries near the shoulder and wrist.

B. Robot system-table

Embodiments of the robot-enabled medical system may also incorporate a patient table. The bond table reduces the amount of capital equipment in the operating room by removing the cart, which allows for greater access to the patient. Fig. 5 shows an embodiment of such a robot-enabled system arranged for bronchoscopy procedures. The system 36 includes a support structure or column 37 for supporting a platform 38 (shown as a "table" or "bed") on the floor. Much like the cart-based system, the end effector of robotic arm 39 of system 36 includes an instrument driver 42 designed to manipulate an elongate medical instrument, such as bronchoscope 40 in fig. 5, through or along a virtual track 41 formed by the linear alignment of instrument driver 42. In practice, a C-arm for providing fluoroscopic imaging may be positioned over the upper abdominal region of the patient by placing the emitter and detector around table 38.

Fig. 6 provides an alternative view of the system 36 without the patient and medical instruments for discussion purposes. As shown, the column 37 may include one or more carriages 43, shown as rings in the system 36, upon which one or more robotic arms 39 may be based. The carriage 43 may translate along a vertical column interface 44 extending along the length of the column 37 to provide different vantage points from which the robotic arm 39 may be positioned to reach the patient. Carriage 43 may be rotated about column 37 using a mechanical motor positioned within column 37 to allow robotic arm 39 access to multiple sides of table 38, such as both sides of a patient. In embodiments having multiple carriages, the carriages may be positioned individually on the column and may be translated and/or rotated independently of the other carriages. While the bracket 43 need not be circular or even circular about the post 37, the circular shape as shown facilitates rotation of the bracket 43 about the post 37 while maintaining structural balance. The rotation and translation of the carriage 43 allows the system to align medical instruments, such as endoscopes and laparoscopes, into different entry points on a patient. In other embodiments (not shown), system 36 may include a patient table or bed with an adjustable arm support in the form of a rod or rail extending alongside the patient table or bed. One or more robotic arms 39 may be attached (e.g., via a shoulder having an elbow joint) to an adjustable arm support that may be vertically adjusted. By providing vertical adjustment, the robotic arm 39 advantageously can be compactly stored under a patient table or bed, and subsequently raised during a procedure.

The arm 39 may be mounted on the carriage by a set of arm mounts 45 that include a series of joints that may individually rotate and/or extend telescopically to provide additional constructability to the robotic arm 39. Additionally, the arm mount 45 may be positioned on the carriage 43 such that when the carriage 43 is properly rotated, the arm mount 45 may be positioned on the same side of the table 38 (as shown in FIG. 6), on the opposite side of the table 38 (as shown in FIG. 9), or on an adjacent side of the table 38 (not shown).

The post 37 structurally provides support for the table 38 and provides a path for vertical translation of the carriage. Internally, the column 37 may be equipped with a lead screw for guiding the vertical translation of the carriage, and a motor to mechanize the translation of said carriage based on the lead screw. The post 37 may also transmit power and control signals to the carriage 43 and the robotic arm 39 mounted thereon.

The table base 46 has a similar function to the cart base 15 in the cart 11 shown in fig. 2, accommodating the heavier components to balance the table/bed 38, column 37, carriage 43, and robotic arm 39. The table base 46 may also incorporate rigid casters to provide stability during the procedure. Casters deployed from the bottom of table base 46 may extend in opposite directions on both sides of base 46 and retract when system 36 needs to be moved.

Continuing with FIG. 6, system 36 may also include a tower (not shown) that divides the functionality of system 36 between the stage and the tower to reduce the form factor and volume of the stage. As in the previously disclosed embodiments, the tower may provide various support functions to the station, such as processing, computing and control capabilities, electrical, fluidic and/or optical, and sensor processing. The tower may also be movable to be positioned away from the patient, thereby improving physician access and eliminating operating room clutter. In addition, placing the components in the tower allows more storage space in the table base for potential stowing of the robotic arm. The tower may also include a master controller or console that provides a user interface for user input, such as a keyboard and/or a tower crane, and a display screen (or touch screen) for pre-operative and intra-operative information, such as real-time imaging, navigation, and tracking information. In some embodiments, the column may also comprise a holder for a gas tank to be used for gas injection.

In some embodiments, the table base may stow and store the robotic arm when not in use. Fig. 7 shows a system 47 for stowing a robotic arm in an embodiment of the table-based system. In the system 47, the carriage 48 may be vertically translated into the base 49 to stow the robotic arm 50, arm mount 51, and carriage 48 within the base 49. The base cover 52 may translate and retract open to deploy the carriage 48, arm mount 51, and arm 50 about the post 53 and close to stow the carriage 48, arm mount 51, and arm 50 to protect them when not in use. The base cover 52 may be sealed with a membrane 54 along the edges of its opening to prevent ingress of dust and fluids when closed.

Fig. 8 illustrates an embodiment of a robot-enabled table-based system configured for a ureteroscopy procedure. In ureteroscopy, table 38 may include a rotating portion 55 for positioning the patient at an angle off of column 37 and table base 46. The rotating portion 55 can rotate or pivot about a pivot point (e.g., located under the patient's head) to position a bottom portion of the rotating portion 55 away from the post 37. For example, pivoting of rotating portion 55 allows a C-arm (not shown) to be positioned over the patient's lower abdomen without competing for space with a post (not shown) below table 38. By rotating the bracket 35 (not shown) about the post 37, the robotic arm 39 can insert the ureteroscope 56 directly into the patient's groin area along the virtual track 57 to reach the urethra. In ureteroscopy, the stirrup 58 may also be fixed to the rotating portion 55 of the table 38 to support the orientation of the patient's leg during the procedure and to allow full access to the patient's groin area.

In laparoscopic procedures, minimally invasive instruments are inserted into a patient's anatomy through a small incision in the abdominal wall of the patient. In some embodiments, a minimally invasive instrument includes an elongated rigid member, such as a shaft, for accessing anatomical structures within a patient. After inflation of the patient's abdominal cavity, the instrument may be guided to perform surgical or medical tasks, such as grasping, cutting, ablating, suturing, and the like. In some embodiments, the instrument may comprise a scope, such as a laparoscope. Fig. 9 illustrates an embodiment of a robot-enabled table-based system configured for laparoscopic procedures. As shown in fig. 9, the carriage 43 of the system 36 may be rotated and vertically adjusted to position the pair of robotic arms 39 on opposite sides of the table 38 so that the instrument 59 may be positioned through the smallest incision on both sides of the patient using the arm mounts 45 to reach his/her abdominal cavity.

To accommodate laparoscopic procedures, the robot-enabled table system may also tilt the platform to a desired angle. Fig. 10 illustrates an embodiment of a robot-enabled medical system with pitch or tilt adjustment. As shown in FIG. 10, system 36 may accommodate the tilt of table 38 to position one portion of the table at a greater distance from the base plate than another portion. In addition, arm mount 45 may be rotated to match the tilt so that arm 39 maintains the same planar relationship with table 38. To accommodate the steeper angle, column 37 may also include a telescoping portion 60 that allows vertical extension of column 37 to prevent table 38 from contacting the floor or colliding with base 46.

Fig. 11 provides a detailed illustration of the interface between table 38 and column 37. Pitch rotation mechanism 61 may be configured to change the pitch angle of table 38 relative to column 37 in multiple degrees of freedom. The pitch rotation mechanism 61 may be implemented by positioning orthogonal axes 1, 2 at the pylon interface, each axis being actuated by a separate motor 3, 4 in response to an electrical pitch angle command. Rotation along one screw 5 will enable tilt adjustment in one axis 1, while rotation along the other screw 6 will enable tilt adjustment along the other axis 2. In some embodiments, a spherical joint may be used to change the pitch angle of table 38 relative to column 37 in multiple degrees of freedom.

For example, pitch adjustment is particularly useful when attempting to position the table in a trendelenburg position (i.e., to position the patient's lower abdomen at a higher elevation than the patient's lower abdomen from the floor) for lower abdomen surgery. The low head position causes the patient's internal organs to slide by gravity toward his/her upper abdomen, clearing the abdominal cavity for minimally invasive tools to enter and perform lower abdominal surgery or medical procedures, such as laparoscopic prostatectomy.

Figures 12 and 13 show isometric and end views of an alternative embodiment of a table-based surgical robotic system 100. The surgical robotic system 100 includes one or more adjustable arm supports 105 that may be configured to support one or more robotic arms (see, e.g., fig. 14) relative to the table 101. In the illustrated embodiment, a single adjustable arm support 105 is shown, but additional arm supports may be provided on opposite sides of the table 101. The adjustable arm support 105 may be configured such that it may be moved relative to the table 101 to adjust and/or change the orientation of the adjustable arm support 105 and/or any robotic arm mounted thereto relative to the table 101. For example, the adjustable arm support 105 may be adjusted in one or more degrees of freedom relative to the table 101. The adjustable arm supports 105 provide the system 100 with high flexibility, including the ability to easily stow the one or more adjustable arm supports 105 and any robotic arms attached thereto below the table 101. The adjustable arm support 105 may be raised from a stowed orientation to an orientation below the upper surface of the table 101. In other embodiments, the adjustable arm support 105 may be raised from a stowed orientation to an orientation above the upper surface of the table 101.

The adjustable arm support 105 may provide several degrees of freedom including lift, lateral translation, tilt, and the like. In the illustrated embodiment of fig. 12 and 13, the arm support 105 is configured to have four degrees of freedom, which are shown by the arrows in fig. 12. The first degree of freedom allows adjustment of the adjustable arm support 105 in the Z direction ("Z lift"). For example, the adjustable arm support 105 may include a carriage 109 configured to move up or down along or relative to the column 102 of the support table 101. The second degree of freedom may allow the adjustable arm support 105 to tilt. For example, the adjustable arm support 105 may include a swivel that may allow the adjustable arm support 105 to be aligned with the bed in a trendelenberg position. The third degree of freedom may allow adjustable arm support 105 to "pivot upward," which may be used to adjust the distance between one side of table 101 and adjustable arm support 105. The fourth degree of freedom may allow the adjustable arm support 105 to translate along the longitudinal length of the table.

The surgical robotic system 100 in fig. 12 and 13 may include a table supported by a post 102 mounted to a base 103. The base 103 and the column 102 support the table 101 relative to a support surface. The floor axis 131 and the support axis 133 are shown in fig. 13.

The adjustable arm support 105 may be mounted to the post 102. In other embodiments, the arm support 105 may be mounted to the table 101 or the base 103. The adjustable arm support 105 may include a bracket 109, a rod or rail connector 111, and a rod or rail 107. In some embodiments, one or more robotic arms mounted to the track 107 may translate and move relative to each other.

The bracket 109 may be attached to the post 102 by a first joint 113 that allows the bracket 109 to move relative to the post 102 (e.g., such as up and down along a first or vertical axis 123). The first joint 113 may provide a first degree of freedom ("Z lift") to the adjustable arm support 105. Adjustable arm support 105 may include a second joint 115 that provides a second degree of freedom (tilt) for adjustable arm support 105. Adjustable arm support 105 may include a third joint 117 that may provide a third degree of freedom ("pivot upward") to adjustable arm support 105. An additional joint 119 (shown in fig. 13) may be provided that mechanically constrains the third joint 117 to maintain the orientation of the rail 107 as the rail connector 111 rotates about the third axis 127. Adjustable arm support 105 may include a fourth joint 121 that may provide a fourth degree of freedom (translation) for adjustable arm support 105 along a fourth axis 129.

Fig. 14 shows an end view of a surgical robotic system 140A having two adjustable arm supports 105A, 105B mounted on opposite sides of the table 101, according to one embodiment. The first robotic arm 142A is attached to the rod or rail 107A of the first adjustable arm support 105B. The first robot arm 142A includes a base 144A attached to the guide rail 107A. The distal end of the first robotic arm 142A includes an instrument drive mechanism 146A that is attachable to one or more robotic medical instruments or tools. Similarly, the second robotic arm 142B includes a base 144B attached to the rail 107B. The distal end of the second robotic arm 142B includes an instrument drive mechanism 146B. The instrument drive mechanism 146B may be configured to attach to one or more robotic medical instruments or tools.

In some embodiments, one or more of the robotic arms 142A, 142B includes an arm having seven or more degrees of freedom. In some embodiments, one or more of the robotic arms 142A, 142B may include eight degrees of freedom, including an insertion axis (including 1 degree of freedom for insertion), a wrist (including 3 degrees of freedom for wrist pitch, yaw, and roll), an elbow (including 1 degree of freedom for elbow pitch), a shoulder (including 2 degrees of freedom for shoulder pitch and yaw), and a base 144A, 144B (including 1 degree of freedom for translation). In some embodiments, the insertion freedom may be provided by the robotic arms 142A, 142B, while in other embodiments the instrument itself provides insertion via an instrument-based insertion architecture.

C. Instrument driver and interface

The end effector of the robotic arm of the system includes (i) an instrument driver (alternatively referred to as an "instrument drive mechanism" or "instrument device manipulator") that incorporates an electromechanical device for actuating a medical instrument, and (ii) a removable or detachable medical instrument that may be free of any electromechanical components, such as a motor. The bisection 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 its complex mechanical components and sensitive electronics. Thus, the medical instrument may be designed to be detached, removed, and interchanged from the instrument driver (and thus from the system) for individual sterilization or disposal by the physician or a physician's staff. In contrast, the instrument driver need not be changed or sterilized and may be covered for protection.

Fig. 15 illustrates an exemplary mechanical driver. A device driver 62 positioned at the distal end of the robotic arm includes one or more drive units 63 arranged in parallel axes to provide a controlled torque to the medical device via a drive shaft 64. Each drive unit 63 comprises a separate drive shaft 64 for interacting with the instrument, a gear head 65 for converting motor shaft rotation into a desired torque, a motor 66 for generating the drive torque, an encoder 67 to measure the speed of the motor shaft and provide feedback to the control circuit, and a control circuit 68 for receiving control signals and actuating the drive unit. Each drive unit 63 is independently controlled and motorized, and the instrument driver 62 can provide a plurality (e.g., four as shown in fig. 15) of independent drive outputs to the medical instrument. In operation, the control circuit 68 will receive the control signal, transmit the motor signal to the motor 66, compare the resulting motor speed measured by the encoder 67 to a desired speed, and modulate the motor signal to generate a desired torque.

For procedures requiring a sterile environment, the robotic system may incorporate a drive interface, such as a sterile adapter connected to a sterile cover, located between the instrument driver and the medical instrument. The primary purpose of the sterile adapter is to transmit angular motion from the drive shaft of the instrument driver to the drive input of the instrument while maintaining a physical separation between the drive shaft and the drive input and thus maintaining sterility. Thus, an exemplary sterile adapter may include a series of rotational inputs and rotational outputs intended to mate with a drive shaft of a device driver and a drive input on a device. A sterile cover composed of a thin flexible material (such as transparent or translucent plastic) connected to a sterile adaptor is designed to cover capital equipment such as instrument drivers, robotic arms and carts (in cart-based systems) or tables (in table-based systems). The use of a cover would allow capital equipment to be located near the patient while still being located in areas where sterilization is not required (i.e., non-sterile areas). On the other side of the sterile cover, the medical instrument may be docked with the patient in the area that requires sterilization (i.e., the sterile field).

D. Medical instrument

FIG. 16 illustrates an exemplary medical instrument having a pair of instrument drivers. Similar to other instruments designed for use with robotic systems, the medical instrument 70 includes an elongate shaft 71 (or elongate body) and an instrument base 72. The instrument base 72, also referred to as the "instrument handle" due to its intended design for manual interaction by a physician, may generally include a rotatable drive input 73 (e.g., a socket, pulley, or reel) designed to mate with a drive output 74 extending through a drive interface on an instrument driver 75 at the distal end of the robotic arm 76. When physically connected, latched, and/or coupled, the mating drive input 73 of the instrument base 72 may share an axis of rotation with the drive output 74 in the instrument driver 75 to allow torque to be transferred from the drive output 74 to the drive input 73. In some embodiments, the drive output 74 may include splines designed to mate with a socket on the drive input 73.

Elongate shaft 71 is designed to be delivered through an anatomical opening or lumen (e.g., as in endoscopy) or through a minimally invasive incision (e.g., as in laparoscopy). Elongate shaft 71 may be flexible (e.g., having endoscopic-like characteristics) or rigid (e.g., having laparoscopic-like characteristics), or comprise a customized combination of both flexible and rigid portions. When designed for laparoscopy, the distal end of the rigid elongate shaft may be connected to an end effector that extends from an articulated wrist formed by a clevis having at least one degree of freedom and a surgical tool or medical instrument (e.g., a grasper or scissors) that may be actuated based on forces from the tendons as the drive input rotates in response to torque received from the drive output 74 of the instrument driver 75. When designed for endoscopy, the distal end of the flexible elongate shaft may include a steerable or controllable bending section that articulates and bends based on torque received from the drive output 74 of the instrument driver 75.

Torque from instrument driver 75 is transmitted down shaft 71 to elongate shaft 71 using tendons. These separate tendons (e.g., pull wires) may be separately anchored to separate drive inputs 73 within the instrument handle 72. From handle 72, the tendons are guided down one or more pull lumens of elongate shaft 71 and anchored at a distal portion of elongate shaft 71, or in a wrist at a distal portion of the elongate shaft. During surgical procedures such as laparoscopic, endoscopic, or hybrid procedures, these tendons may be coupled to a distally mounted end effector such as a wrist, grasper, or scissors. With such an arrangement, torque applied to the drive input 73 transfers tension to the tendons, causing the end effector to actuate in some manner. In some embodiments, during a surgical procedure, a tendon can cause a joint to rotate about an axis, thereby causing an 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 elongate shaft 71, wherein tension from the tendon causes the grasper to close.

In endoscopy, the tendons can be coupled to a bending or articulation section located along (e.g., at the distal end of) elongate shaft 71 via an adhesive, control loop, or other mechanical fastener. When fixedly attached to the distal end of the bending section, the torque applied to the drive input 73 will be transmitted down the tendons, causing the softer bending section (sometimes referred to as the articulatable section or region) to bend or articulate. Along the unbent section, it may be advantageous to spiral or spiral a separate pull lumen that guides a separate tendon along the wall of the endoscope shaft (or internally) to balance the radial forces caused by the tension in the pull wire. For particular purposes, the angle of the spirals and/or the spacing therebetween may be varied or designed wherein a tighter spiral exhibits less shaft compression under load forces and a lower amount of the spiral causes more shaft compression under load forces but also exhibits limited bending. In another instance, the distraction cavity can be directed parallel to the longitudinal axis of the elongate shaft 71 to allow for controlled articulation in a desired bending or articulatable segment.

In endoscopy, elongate shaft 71 houses a number of components to assist in robotic procedures. The shaft may include a working channel for deploying a surgical tool (or medical instrument), irrigation and/or suction to an operating area at the distal end of the shaft 71. The shaft 71 may also house wires and/or optical fibers to transmit signals to/from an optical assembly at the distal tip, which may include an optical camera. The shaft 71 may also house an optical fiber to carry light from a proximally located light source (e.g., a light emitting diode) to the distal end of the shaft.

At the distal end of the instrument 70, the distal tip may also include an opening for a working channel for delivering tools for diagnosis and/or treatment, irrigation and aspiration of the surgical site. The distal tip may also include a port for a camera, such as a fiberscope or digital camera, to capture images of the internal anatomical space. Relatedly, the distal tip may also include a port for a light source for illuminating the anatomical space when the camera is in use.

In the example of fig. 16, the axis of the drive shaft, and thus the drive input axis, is orthogonal to the axis of the elongate shaft. However, this arrangement complicates the rolling ability of elongate shaft 71. Rolling elongate shaft 71 along its axis while holding drive input 73 stationary can cause undesirable tangling of tendons as they extend out of drive input 73 and into a pull lumen within elongate shaft 71. The resulting entanglement of such tendons can disrupt any control algorithm intended to predict the motion of the flexible elongate shaft during an endoscopic procedure.

Fig. 17 shows an alternative design of the instrument driver and instrument, in which the axis of the drive unit is parallel to the axis of the elongate shaft of the instrument. As shown, the circular instrument driver 80 includes four drive units whose drive outputs 81 are aligned in parallel at the end of a robotic arm 82. The drive units and their respective drive outputs 81 are housed in a rotation assembly 83 of the instrument driver 80 driven by one of the drive units within the assembly 83. In response to the torque provided by the rotational drive unit, the rotation assembly 83 rotates along a circular bearing that connects the rotation assembly 83 to the non-rotating portion 84 of the instrument driver. Power and control signals may be transmitted from the non-rotating portion 84 of the instrument driver 80 to the rotating assembly 83 through electrical contacts that may be maintained through rotation of a brush-slip ring connection (not shown). In other embodiments, the rotation assembly 83 may be responsive to a separate drive unit integrated into the non-rotatable portion 84, and thus not parallel to the other drive units. Rotation mechanism 83 allows instrument driver 80 to allow the drive unit and its corresponding drive output 81 to rotate as a single unit about instrument driver axis 85.

Similar to the previously disclosed embodiments, instrument 86 may include an elongated shaft portion 88 and an instrument base 87 (shown with a transparent outer skin for discussion purposes) that includes a plurality of drive inputs 89 (such as sockets, pulleys, and spools) configured to receive drive outputs 81 in instrument driver 80. Unlike the previously disclosed embodiment, the instrument shaft 88 extends from the center of the instrument base 87, which has an axis that is substantially parallel to the axis of the drive input 89, rather than orthogonal as in the design of fig. 16.

When coupled to the rotation assembly 83 of the instrument driver 80, the medical instrument 86, including the instrument base 87 and the instrument shaft 88, rotates about the instrument driver axis 85 in combination with the rotation assembly 83. Since the instrument shaft 88 is positioned at the center of the instrument base 87, the instrument shaft 88 is coaxial with the instrument driver axis 85 when attached. Thus, rotation of the rotation assembly 83 causes the instrument shaft 88 to rotate about its own longitudinal axis. Furthermore, when instrument base 87 rotates with instrument shaft 88, any tendons connected to drive inputs 89 in instrument base 87 do not tangle during rotation. Thus, the parallelism of the axes of drive output 81, drive input 89 and instrument shaft 88 allows the shaft to rotate without tangling any control tendons.

Fig. 18 illustrates an instrument having an instrument-based insertion architecture, according to some embodiments. The instrument 150 may be coupled to any of the instrument drivers described above. The instrument 150 includes an elongate shaft 152, an end effector 162 connected to the shaft 152, and a handle 170 coupled to the shaft 152. The elongate shaft 152 includes a tubular member having a proximal portion 154 and a distal portion 156. The elongate shaft 152 includes one or more channels or grooves 158 along its outer surface. The groove 158 is configured to receive one or more wires or cables 180 therethrough. Accordingly, one or more cables 180 extend along an outer surface of the elongate shaft 152. In other embodiments, the cable 180 may also pass through the elongate shaft 152. Manipulation of the one or more cables 180 (e.g., via an instrument driver) causes actuation of the end effector 162.

The instrument handle 170 (which may also be referred to as an instrument base) may generally include an attachment interface 172 having one or more mechanical inputs 174, such as a socket, pulley, or reel, designed to reciprocally mate with one or more torque couplers on an attachment surface of the instrument driver.

In some embodiments, the instrument 150 includes a series of pulleys or cables that enable the elongate shaft 152 to translate relative to the handle 170. In other words, the instrument 150 itself includes an instrument-based insertion architecture that accommodates insertion of the instrument, thereby minimizing reliance on robotic arms to provide for insertion of the instrument 150. In other embodiments, the robotic arm may be largely responsible for instrument insertion.

E. Controller

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

Fig. 19 is a perspective view of an embodiment of the controller 182. In this embodiment, the controller 182 comprises a hybrid controller that may have both impedance and admittance control. In other embodiments, the controller 182 may utilize only impedance or passive control. In other embodiments, the controller 182 may utilize admittance control only. By acting as a hybrid controller, the controller 182 advantageously may have a lower perceived inertia when in use.

In the exemplified embodiment, the controller 182 is configured to allow manipulation of two medical instruments and includes two handles 184. Each of the shanks 184 is connected to a gimbal 186. Each gimbal 186 is connected to a positioning platform 188.

As shown in fig. 19, each positioning stage 188 includes a SCARA arm (selective compliant assembly robot arm) 198 coupled to the post 194 by a prismatic joint 196. The prismatic joint 196 is configured to translate along the post 194 (e.g., along the guide track 197) to allow each of the shanks 184 to translate in the z-direction, thereby providing a first degree of freedom. The SCARA arm 198 is configured to allow the handle 184 to move in the x-y plane, providing two additional degrees of freedom.

In some embodiments, one or more load sensors are positioned in the controller. For example, in some embodiments, a load sensor (not shown) is positioned in the body of each of the gimbals 186. By providing a load sensor, portions of the controller 182 can operate under admittance control, advantageously reducing the perceived inertia of the controller when in use. In some embodiments, positioning stage 188 is configured for admittance control, while gimbal 186 is configured for impedance control. In other embodiments, gimbal 186 is configured for admittance control, while positioning stage 188 is configured for impedance control. Thus, for some embodiments, the translational or azimuthal degree of freedom of positioning stage 188 may depend on admittance control, while the rotational degree of freedom of gimbal 186 depends on impedance control.

F. Navigation and control

Conventional 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 intraluminal guidance to the operating physician. In contrast, robotic systems contemplated by the present disclosure may provide non-radiation based navigation and positioning means to reduce physician exposure to radiation and reduce the amount of equipment in the operating room. As used herein, the term "positioning" may refer to determining and/or monitoring the orientation of an object in a reference coordinate system. Techniques such as preoperative mapping, computer vision, real-time EM tracking, and robotic command data may be used alone or in combination to achieve a radiation-free operating environment. In still other cases where a radiation-based imaging modality is used, preoperative mapping, computer vision, real-time EM tracking, and robot command data may be used, alone or in combination, to improve the information obtained only by the radiation-based imaging modality.

Fig. 20 is a block diagram illustrating a positioning system 90 that estimates a position of one or more components of a robotic system, such as a position of an instrument, according to an exemplary embodiment. Positioning system 90 may be a set of one or more computer devices configured to execute one or more instructions. The computer apparatus may be embodied by a processor (or multiple processors) and computer readable memory in one or more of the components discussed above. By way of example and not limitation, the computer device may be located in the tower 30 shown in fig. 1, the cart shown in fig. 1-4, the bed shown in fig. 5-14, or the like.

As shown in fig. 20, the localization system 90 may include a localization module 95 that processes the input data 91-94 to generate position data 96 for the distal tip of the medical instrument. The position data 96 may be data or logic representing the position and/or orientation of the distal end of the instrument relative to a reference frame. The reference frame may be a reference frame relative to a patient anatomy or a known object, such as an EM field generator (see discussion below for EM field generators).

The various input data 91-94 will now be described in more detail. Preoperative mapping can be accomplished by using a set of low dose CT scans. The pre-operative CT scan is reconstructed into a three-dimensional image that is visualized, for example, as a "slice" of a cross-sectional view of the patient's internal anatomy. When analyzed in general, an image-based model of the anatomical cavities, spaces, and structures for a patient's anatomy (such as a patient's lung network) may be generated. Techniques such as centerline geometry may be determined and approximated from the CT images to form a three-dimensional volume of the patient anatomy, referred to as model data 91 (also referred to as "pre-operative model data" when generated using only pre-operative CT scans). The use of centerline geometry is discussed in U.S. patent application No. 14/523760, the contents of which are incorporated herein in their entirety. The network topology model can also be derived from CT images and is particularly suitable for bronchoscopy.

In some embodiments, the instrument may be equipped with a camera to provide visual data 92. The positioning module 95 may process visual data to enable one or more vision-based location tracking. For example, the pre-operative model data may be used in conjunction with the vision data 92 to enable computer vision-based tracking of a medical instrument (e.g., an endoscope or an instrument advanced through a working channel of an endoscope). For example, using the pre-operative model data 91, the robotic system may generate a library of expected endoscope images from the model based on the expected path of travel of the endoscope, each image connected to a location within the model. In operation, the robotic system may reference the library in order to compare real-time images captured at a camera (e.g., a camera at the distal end of the endoscope) with those in the image library to assist in positioning.

Other computer vision based tracking techniques use feature tracking to determine the motion of the camera, and thus the endoscope. Some features of the localization module 95 may identify circular geometries in the pre-operative model data 91 that correspond to anatomical cavities and track changes in those geometries to determine which anatomical cavity was selected, as well as track relative rotational and/or translational motion of the cameras. The use of a topological map may further enhance the 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 visual data 92 to infer camera motion. Examples of optical flow techniques may include motion detection, object segmentation computation, luminance, motion compensated coding, stereo disparity measurement, and so forth. Through multiple frame comparisons for multiple iterations, the motion and position of the camera (and thus the endoscope) can be determined.

The localization module 95 may use real-time EM tracking to generate a real-time location of the endoscope in a global coordinate system that may be registered to the patient's anatomy represented by the pre-operative model. In EM tracking, an EM sensor (or tracker) comprising one or more sensor coils embedded in one or more positions and orientations in a medical instrument (e.g., an endoscopic tool) measures changes in the EM field generated by one or more static EM field generators positioned at known locations. The position information detected by the EM sensor is stored as EM data 93. An EM field generator (or transmitter) may be placed close to the patient to generate a low-intensity magnetic field that the embedded sensor can 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 "registered" intra-operatively to the patient anatomy (e.g., a pre-operative model) to determine a geometric transformation that aligns a single location in a coordinate system with a position in the pre-operative model of the patient's anatomy. Once registered, embedded EM trackers in one or more positions of the medical instrument (e.g., the distal tip of an endoscope) may provide real-time indications of the progress of the medical instrument through the patient's anatomy.

The robot commands and kinematic data 94 may also be used by the positioning module 95 to provide position data 96 for the robotic system. Device pitch and yaw derived from the articulation commands may be determined during pre-operative calibration. During surgery, these calibration measurements may be used in conjunction with known insertion depth information to estimate the orientation of the instrument. Alternatively, these calculations may be analyzed in conjunction with EM, visual, and/or topological modeling to estimate the position of the medical instrument within the network.

As shown in fig. 20, the location module 95 may use a number of other input data. For example, although not shown in fig. 20, an instrument utilizing shape sensing fibers may provide shape data that the localization module 95 may use to determine the position and shape of the instrument.

The positioning module 95 may use the input data 91-94 in combination. In some cases, such a combination may use a probabilistic approach in which the localization module 95 assigns confidence weights to locations determined from each of the input data 91-94. Thus, in situations where the EM data may be unreliable (as may be the case with EM interference), the confidence in the location determined by EM data 93 may be reduced, and positioning module 95 may rely more heavily on vision data 92 and/or robot commands and kinematic data 94.

As discussed above, the robotic systems discussed herein may be designed to incorporate a combination of one or more of the above techniques. The computer-based control system of the robotic system located in the tower, bed and/or cart may store computer program instructions within, for example, a non-transitory computer-readable storage medium (such as a permanent magnetic storage drive, solid state drive, etc.) that, when executed, cause the system to receive and analyze sensor data and user commands, generate control signals for the entire system, and display navigation and positioning data, such as the position of the instrument within a global coordinate system, anatomical maps, etc.

2. Introduction to articulatable medical devices

Embodiments of the present disclosure relate to systems and techniques for articulating a medical instrument. Fig. 21 illustrates an exemplary embodiment of a medical instrument 200 according to aspects of the present disclosure. In the embodiment shown in fig. 21, the medical instrument 200 includes a shaft 205, a handle 210, and an end effector 215. The instrument 200 may be coupled to any of the instrument drivers described above. One or more cables (not shown) may extend along an outer surface of the shaft 205, and/or one or more cables may also extend through the elongate shaft 205. Manipulation of the one or more cables (e.g., via an instrument driver) results in actuation of the end effector 215.

The handle 210 (also referred to as an instrument base) may generally include an attachment interface having one or more mechanical inputs, such as a socket, pulley, or reel, designed to reciprocally mate with one or more torque couplers on an attachment surface of an instrument driver.

Depending on the particular implementation of the particular instrument 200, the end effector 215 may be implemented to perform one or more different medical and/or surgical tasks that may be accomplished via tensioning one or more cables. In some embodiments, instrument 200 includes a series of pulleys to which one or more cables are operably coupled to enable shaft 205 to translate relative to handle 210.

In some embodiments, the instrument 200 can include an end effector 215 adapted to transect and/or seal tissue. Fig. 22A and 22B illustrate an exemplary embodiment in which an end effector 215 is configured to be used as a medical stapler, according to aspects of the present disclosure. Specifically, fig. 22A shows the end effector 215 in an open position, while fig. 22B shows the end effector 215 in a closed position. As shown in fig. 22A and 22B, the end effector 215 in the illustrated embodiment includes a lower jaw 310, an upper jaw 315, and a firing mechanism 320. One or more grooves (not shown) may be formed in upper jaw 315. Additionally, the lower jaw 310 (also referred to as a cartridge jaw) can include a lower jaw slot 330, and the upper jaw 315 can include an upper jaw slot 335. In certain implementations, the firing mechanism 320 can include tabs and/or an I-beam, as will be described in more detail below. In certain embodiments, the firing mechanism 320 is configured to interact with a cartridge (not shown) containing a plurality of staples (not shown) to drive the staples into tissue. In some embodiments, the firing mechanism may include a cantilevered member or a pusher block.

Referring to fig. 22A, the firing mechanism 320 can be located at the proximal end of the end effector 215 when the end effector 215 is in the open position. The firing mechanism 320 can be configured to engage each of the lower jaw slot 330 and the upper jaw slot 335. In embodiments where the firing mechanism 320 includes an I-beam, the lower jaw slot 330 and the upper jaw slot 335 can be shaped to form a track along which the lower flange and the upper flange of the I-beam are configured to travel. Further, the tracks of lower jaw slot 330 and upper jaw slot 335 may be shaped such that as the I-beam of the firing mechanism advances a defined distance from the proximal end of end effector 215, the I-beam closes upper jaw 315 toward lower jaw 310, which may be used to clamp tissue between upper jaw 315 and lower jaw 310.

As described above, the end effector 215 may be embodied as a medical stapler that may be used to seal and/or transect tissue. As shown in fig. 22B, once the firing mechanism 320 has advanced laterally along the end effector 215 beyond a defined distance from the proximal end of the end effector 215, the end effector 215 will be clamped into the closed position shown. The medical instrument 300 may be operated by: tissue is clamped between two jaws (e.g., a lower jaw 310 and an upper jaw 315) of the medical instrument 300, and a firing mechanism 320 is then pushed laterally along the lower jaw 310 and the upper jaw 315 to form staples and transect the tissue. A medical stapler such as medical instrument 300 may be used, for example, for gastric stapling and/or gastrojejunostomy (roux-en-y) gastric bypass.

In the illustrated embodiment, the medical instrument 300 can move the upper jaw 315 toward the lower jaw 310 (or vice versa in other embodiments) by advancing the firing mechanism 321 from the proximal ends of the two jaws 310 and 315 toward the distal end of the medical instrument 300. In more detail, the firing mechanism 321 can be coupled to and engaged with the lower jaw slot 330 and the upper jaw slot 335 such that the upper jaw 315 is actuated toward the lower jaw 310 as the firing mechanism 321 advances a defined distance from the proximal ends of the two jaws 310 and 315. 22A and 22B, the upper jaw slot 335 can be shaped such that as the firing mechanism 321 advances along the upper jaw slot 335, the upper jaw 315 is forced to actuate toward the lower jaw 310. In other embodiments, lower jaw slot 330 can be shaped such that lower jaw 310 is forced to actuate toward upper jaw 315 as firing mechanism 321 advances along lower jaw slot 330.

Once the firing mechanism 321 has advanced a defined distance, thereby trapping tissue between the upper jaw 315 and the lower jaw 310, the firing mechanism 321 can be further advanced to perform the resection of the tissue. For example, the firing mechanism 321 can include a tab that receives a blade or other cutting surface configured to excise tissue when the firing mechanism 321 is pushed toward the distal ends of the upper jaw 315 and the lower jaw 310. In addition, the firing mechanism 321 may also be configured to interact with the cassette 323 to drive staples contained in the cassette 323 into tissue. The staples can pierce through tissue and be forced into one or more channels 325 of upper jaw 315, which can allow the staples to bend and be redirected back into the tissue.

In some embodiments, the medical instrument 300 may have a wrist configured to enable articulation in 1 degree of freedom (DOF). For certain medical procedures, for example, robotically controlled laparoscopic procedures, it is desirable to have a 2-DOF wrist. However, there may be design challenges associated with 2-DOF wrists for medical staplers that may not exist when designing 1DOF wrists. For example, it can be difficult to direct the amount of force required to provide sufficient clamping force to the jaws through the 2-DOF wrist. Furthermore, it can be difficult to provide control of the 2-DOF wrist (e.g., provide pitch and yaw DOF), while also controlling the stapler and firing mechanism independently of the 2-DOF motion of the wrist, alone. In addition, staplers (whether manual or robotic) are typically designed for single use (e.g., disposable), which may increase the costs associated with the stapler. Finally, designing a medical stapler to be thin can improve the maneuverability of the stapler in constricted spaces, but this can be difficult.

A. Medical instrument-cable driven firing mechanism

Fig. 23A and 23B show views of an exemplary embodiment of a cable driven medical instrument 400 including an articulatable wrist 405, according to aspects of the present disclosure. In particular, the medical instrument 400 includes a wrist 405 and a lower jaw 420 (e.g., lower jaw as shown). Wrist 405 includes proximal clevis 410 and distal clevis 415. The medical instrument 400 also includes a firing mechanism 430 that is received in the lower jaw 420. As described below, the firing mechanism 430 is configured to advance through the lower jaw 420 to facilitate driving certain components in the cartridge. In some embodiments, the firing mechanism 430 can be in the form of a beam, such as an I-beam as shown in fig. 23A and 23B, configured to be driven along the lower jaw 420. The I-beam may include an upper flange 431 (described below) that may interact with the anvil of the upper jaw and a lower flange 433 that may interact with the lower jaw 420.

Although not shown, the medical instrument 400 can further include an upper jaw that can form an anvil (e.g., as shown by upper jaw 315 shown in fig. 22A and 22B) that is configured to be actuated via movement of a firing mechanism 430 to clamp tissue between the upper and lower jaws 420. As such, the instrument 400 can include an end effector that includes a lower jaw 420 and an upper jaw (e.g., including an anvil), as well as a firing mechanism 430. The firing mechanism 430 can be configured to clamp the anvil to the lower jaw 420 and transect and seal tissue by forming staples in the tissue in a manner similar to that described above in connection with fig. 22A and 22B. Accordingly, the firing mechanism 430 can further include a cutting mechanism (e.g., a blade or other cutting surface) configured to transect tissue as the firing mechanism 430 is advanced toward the distal end of the lower jaw 420. In other embodiments, the firing mechanism 430 is coupled to a separate cutting mechanism configured to be advanced by the firing mechanism 430. The firing mechanism 430 can be configured to move along an axis of an end effector (e.g., lower jaw 420) during actuation of the firing mechanism 430. In certain embodiments, the firing mechanism 430 can be configured to interact with a cartridge containing staples to drive the staples into tissue. A cassette (not shown) may be received in the lower jaw 420.

The instrument 400 shown in fig. 23A and 23B is configured to drive a firing mechanism 430 via one or more cables. In particular, to provide 2DOF motion of the wrist 405 and control actuation of the firing mechanism 430, the instrument 400 further includes: one or more cables 435 configured to pull the firing mechanism 430 forward toward the distal end of the lower jaw 420; one or more cables 440 configured to pull the firing mechanism rearward toward the proximal end of lower jaw 420; and a plurality of pulleys 425, 450, 451, 453, and 455 configured to guide the cables 435 and 440 through the instrument 400. In some embodiments, the instrument 400 may further include one or more cable return surfaces configured to facilitate routing of the cables 435 and 440 through the instrument 400. Instrument 400 also includes one or more cables 445 configured to control actuation of wrist 405 in 2DOF (e.g., in yaw and pitch directions). Thus, wrist 405 may have at least two degrees of freedom of motion. In particular, the one or more cables 445 may be configured to drive the movement of the proximal clevis 410 and the distal clevis 415. In certain embodiments, the wrist 405 may be configured to be actuated according to an N +1 drive system, where N +1 cables are used to provide N DOF actuation for the wrist 405.

The paths traced by the cables 435 and 440 through the instrument 400 may be configured to decouple actuation (e.g., motion) of the firing mechanism 430 from movement of the wrist 405 in at least two degrees of freedom (e.g., rotation of the wrist 405 in a pitch direction and a yaw direction). Thus, actuation of the firing mechanism (e.g., via movement of the firing mechanism 430 along the end effector) may be advantageously controlled independently of rotation of the wrist 405 without adjusting the length of the cables 435 and 440.

The medical instrument 400 is configured to articulate the wrist 405 in a pitch direction and/or a yaw direction using one or more cables 445, and the cables 435 and 440 are directed through the wrist 405 for driving the firing mechanism 430 through a cartridge (not shown) that houses staples and is integrated into the lower jaw 420; however, in other embodiments, the cartridge can be a separate component that is removable from the lower jaw 420.

Cable 435 can include two cable segments that engage firing mechanism 430 via pulley 425 located near the distal end of lower jaw 420 to pull firing mechanism 430 forward toward the distal end of lower jaw 420. Similarly, cable 440 can include two cable segments that engage firing mechanism 430, which is configured to pull firing mechanism 430 back toward wrist 405 away from the distal end of lower jaw 420. Cable 445 may include a set of two cable segments configured, along with at least one additional cable segment, to enable wrist 405 to articulate in a pitch direction (e.g., about an axis concentric with proximal pulley 451 of distal clevis 415) and in a yaw direction (e.g., about an axis concentric with distal pulley 453 of distal clevis 415).

In some embodiments, the one or more cables or cable segments 435 configured to pull the firing mechanism 430 forward are larger than the one or more other cables or cable segments 440 and 445. This may advantageously provide the ability to advance the firing mechanism 430 with a greater force during actuation of the firing mechanism 430, which may be required to clamp tissue between the upper and lower jaws 420 and transect tissue as the firing mechanism 430 advances. In some embodiments, the cable 435 configured to pull the firing mechanism 430 forward has a strength diameter of about 0.63mm, while the other cables 440 and 445 have a diameter of about 0.50 mm. In other embodiments, the cables may have different diameters and/or each of the cables 435, 440, and 445 may have substantially the same diameter.

As described above, the lower jaw 420 houses a pair of distal return pulleys 425 (also referred to simply as distal pulleys) that are enclosed in the front of the lower jaw 420. Each cable segment configured to pull the cable 435 of the firing mechanism 430 forward is guided around two distal return pulleys 425. The cable segments of the cable 435 may share a pull load requirement and may decouple motion of the firing mechanism 430 from motion of the wrist 405 in the pitch and yaw directions. In some embodiments, the load of each cable segment of the cable 435 associated with pulling the firing mechanism 430 forward may be about 250N, which may be split across two cable segments of the cable 435.

Fig. 24 illustrates a close-up view of the lower jaw 420 of fig. 23A and 23B including a portion of the internal components of the firing mechanism 430 according to aspects of the present disclosure. Referring to fig. 23A, 23B, and 24, cable segments of the cable 435 can be connected around a return idler 460 housed in the firing mechanism 430. Herein, the term "idler" may refer to a pulley that is not connected to the output drive (e.g., movement of a cable or cable segment about the idler is decoupled from actuation of the end effector).

The overall length of the cable 435, including the cable segments, is conserved as the length of one of the cable segments increases during articulation of the wrist 405, while the length of the other cable segment decreases by substantially the same amount. Conservation of the overall length of the cable segments of the cable 435 may provide decoupling between actuation of the firing mechanism (e.g., movement of the firing mechanism 430 along the end effector) and articulation of the wrist 405.

Similarly, the cable segments of the cable 440 may be connected around a return idler 465 housed in the firing mechanism 430. The total length of the cable segments of cable 435 is also conserved during articulation of wrist 405. By balancing the cable length variation of each of cables 435 and 440, the total cable path length is conserved even during wrist 405 articulation.

Fig. 25 illustrates another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure. In the embodiment shown in fig. 25, the firing mechanism 431 does not include the pair of idler pulleys 460 and 465 shown in fig. 24. Instead, each cable segment of cables 435 and 440 may terminate at firing mechanism 430, and each cable segment of cables 435 and 440 connect around one or more idler pulleys 470 and 475 positioned in a shaft 480 of instrument 400 that is coupled to the proximal end of wrist 405. Each of the idler pulleys 470 and 475 may be coupled to a proximal cable or cable segment 485 and 490, respectively, which may be used to advance and retract the firing mechanism 430. Thus, in some embodiments, each cable segment of the cable 435 configured to pull the firing mechanism 430 forward is coupled to an idler wheel 470 within the shaft 480, which in turn is connected to the proximal cable 480. Similarly, in some embodiments, each cable segment of the cable 440 configured to pull the firing mechanism rearward is coupled to an idler 475 within the shaft 480, which in turn is connected to a proximal cable 490.

Fig. 26 illustrates yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure. In the embodiment shown in fig. 26, distal return pulley 427 may have a smaller size and smaller profile than the distal return pulley in the embodiment shown in fig. 23 and 23B. In some embodiments, distal return pulley 427 of fig. 26 can have a diameter between 3.0mm-5.0mm, while distal return pulley 425 of fig. 23A and 23B can have a diameter between 5.0mm-7.0 mm. The use of a smaller distal return pulley 427 may allow the entire travel of the cable 435 to be lower along the lower jaw 420 and shorten the space occupied by the distal return pulley 427, thereby advantageously reducing the profile of the instrument. For some circumstances, the larger distal return pulley 425 of fig. 23A and 23B may be advantageous because the larger distal return pulley 425 may introduce relatively less wear on the larger cables coupled thereto than the smaller distal return pulley 427 of fig. 26.

Fig. 27 illustrates yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist according to aspects of the present disclosure. In the embodiment shown in fig. 27, the instrument may include a single retraction cable segment 441 coupled to a return spring (not shown), which may be located proximal to wrist 405. By incorporating a spring, the number of cable segments and pulleys required for the wrist and firing mechanism may be reduced, thereby simplifying the design of the instrument.

Fig. 28 and 29 show top-down and end-point views of yet another exemplary embodiment of a cable driven medical instrument including an articulatable wrist, according to aspects of the present disclosure. In this embodiment, the profile of the instrument can be reduced by reducing the separation distance between: cable 440 is used to pull the various cable segments of the firing mechanism rearwardly, and cable 435 is used to pull the various cable segments of the firing mechanism forwardly. In some embodiments, the height of the firing mechanism can vary in vertical height, thereby affecting the overall height of the end effector. In some embodiments, each cable segment of cable 440 and/or associated pulley can move up approximately 0.5mm to 1.5mm (e.g., 1.0mm) and/or down approximately 1.5mm to 2.5mm (e.g., 2 mm). In some embodiments, each cable segment of cable 435 and/or its associated pulley can move up to about 0.25mm to 0.75mm (e.g., 0.5mm) and/or down to about 1.5mm to 2.5mm (e.g., 2 mm). To move the cable segments of cable 440 downward, the associated pulleys may also be moved downward. In some embodiments, each cable segment of cable 435 can also move upward, but this can also be accommodated by increasing the diameter of distal return pulley 425.

Advantageously, the above-described embodiments in which the firing mechanism is cable driven may include a greater range of motion than other devices that may utilize a single pusher shaft or lead screw to drive the I-beam. This is because the cables and pulleys provide a more flexible drive mechanism and, therefore, efficiency losses are not the same as the increased range of motion of the wrist when transferring forces.

B. Medical instrument-push shaft driving firing mechanism

In this embodiment, the surgical stapler is provided with a pusher shaft driven firing mechanism. Advantageously, the stapler is designed to provide a unique pusher shaft mechanism to drive a firing mechanism (e.g., an I-beam) through a replaceable cartridge, thereby allowing multiple reuses (e.g., 5, 10, or more) of the base or core instrument.

Fig. 30 illustrates an exemplary embodiment of a push shaft driven medical instrument 500 including an articulatable wrist 505 according to aspects of the present disclosure. As shown in fig. 30, instrument 500 includes a wrist 505 and an end effector comprising a lower jaw 525, an upper jaw 530, and a firing mechanism 540 configured to form staples in tissue. Wrist 505 includes a proximal clevis 510, a distal clevis 515, and a lower jaw connector 520 configured to couple to lower jaw 525. In the embodiment of fig. 30, the lower jaw 525 may comprise an anvil and the upper jaw 530 may comprise a cartridge.

The medical instrument 500 also includes an interchangeable cartridge 545 housed in the upper jaw 530, and the firing mechanism includes a firing mechanism 540 housed in the interchangeable cartridge 545. In some embodiments, the firing mechanism 540 can include a beam (such as an I-beam as shown in fig. 22) configured to be driven along the cartridge 545. The reusable upper jaw 530 is configured to receive a cartridge 545 having a firing mechanism 540 and a blade (not shown) that can be discarded when the procedure is completed. Thus, the end effector (e.g., including the upper jaw 530) is configured to be removably coupled with the cartridge 545.

Fig. 31 provides a view of the cartridge 545 of fig. 30 separated from the instrument 500, in accordance with aspects of the present disclosure. As shown in fig. 31, the cartridge 545 includes an upper slot 550 along which the firing mechanism 540 is configured to advance during actuation of the firing mechanism. Thus, the upper slot may be configured to receive a firing mechanism. Referring to fig. 30 and 31, the firing mechanism 540 includes one or more engagement surfaces 535 configured to be coupled to one or more pusher shafts 503, respectively. The pusher shaft 503 is configured to push the firing mechanism 540 toward the distal end of the instrument 500. In some embodiments, the pushing shaft 503 may comprise a three-wire wound cable or laser cut metal. In some embodiments, the push shaft 503 is formed to have a compressive strength and lateral flexibility so as to bend without buckling with the articulation of the wrist 505.

In some embodiments, the instrument includes a pair of engagement surfaces 535 and a pair of pushing shafts 503. In some embodiments, the firing mechanism may include a pair of cup members 535 coupled to the firing mechanism 540, and the engagement surface may be formed as part of the cup members 535.

In certain embodiments, the firing mechanism can be formed by a lower jaw 525, a firing mechanism 540, a cup member 535, an upper jaw 530, and a cartridge 545. The firing mechanism can be configured to transect and seal tissue by forming staples in the tissue in a manner similar to that described above in connection with fig. 22. Accordingly, the firing mechanism 430 can further include a tab that houses a cutting mechanism (e.g., a blade or other cutting surface) configured to transect tissue as the firing mechanism 540 is advanced toward the distal end of the instrument 500.

Because the cartridge 545 is replaceable, the remaining components of the instrument 500 can be reused. In some embodiments, the reusable portion of the instrument 500 can be reused 3 or more times, 5 or more times, 8 or more times, or 10 or more times.

As previously described, the instrument 500 includes a pair of pusher shafts 503 that are engageable with a pair of cup members 535 that are coupled to the firing mechanism 540 and the blade of the disposable cartridge 545. The disposable cartridge 545 includes an upper slot 550 and a lower slot (not shown) through which the firing mechanism 540 and the blade may be pushed. In some embodiments, the disposable cartridge 545 can be snap-fit into the instrument 500 (e.g., into the upper jaw 530).

When the cartridge 545 is snapped into the instrument 500, the pusher shaft 503 may move forward and engage the firing mechanism 540. The pusher shaft 503 may be configured to snap into the firing mechanism 540. In certain embodiments, the connection between the push shaft 503 and the cup member 535 comprises a ball joint connection. In other embodiments, the pusher shaft 503 may fit into an engagement surface formed in the firing mechanism 540 without a snap fit therebetween. In some embodiments, the engagement surface formed in the firing mechanism 540 is tapered.

In some embodiments, rather than using a pair of pushing shafts 503, a single pushing shaft may be used. However, the use of two pusher shafts 503 as shown in FIG. 30 advantageously distributes the pushing force evenly throughout the firing mechanism 540 and provides a gap area between the two pusher shafts 503. The firing mechanism 540 and blade may be translated through a slot formed in the upper jaw 530 using two pusher shafts 503.

Fig. 32 illustrates another view of the pusher shaft driven medical instrument 500 of fig. 30, in accordance with aspects of the present disclosure. Advantageously, the upper jaw 530 includes a wider clearance slot 560 at the end of the slot 555 to allow removal of the firing mechanism 540 through the upper jaw 530. Fig. 33 illustrates yet another view of the push shaft driven medical instrument 500 of fig. 30 from the bottom, in accordance with aspects of the present disclosure. As shown in fig. 33, the lower jaw 525 includes a slot 565 having a wider clearance slot 570 similar to the clearance slot 560 in the upper jaw 530. The firing mechanism 540 is configured to engage the slot 555 of the upper jaw 530 and the slot 565 of the lower jaw 525 during actuation of the firing mechanism 540. A pair of clearance slots 560 and 570 are sized to allow the firing mechanism 540 to pass through (one in the upper jaw 530 and the other in the lower jaw 525), and due to the presence of the pair of clearance slots, the firing mechanism 540 and disposable cartridge 545 can be easily removed without having to return the firing mechanism 540 to its proximal position after actuation of the firing mechanism. That is, because the firing mechanism 540 can pass through both the upper jaw 530 and the lower jaw 525, the firing mechanism 540 can be removed from the distal end of the instrument without returning to the proximal end of the cartridge 545.

As shown in fig. 33, the wrist 505 may include one or more anti-flexion constraints 575 by which the push shaft 503 may move through the wrist 505. The anti-buckling constraint 575 may be shaped to constrain each of the pusher shafts 503 from buckling by providing lateral support to the pusher shafts 503 as the pusher shafts 503 are guided through the wrist 505. In some embodiments, the anti-flexion constraint 575 may include one or more channels (e.g., the anti-flexion constraint 575 may have a tubular shape) configured to guide and support the push shaft 503 through the wrist 505. Thus, in some embodiments, the anti-buckling constraint 575 may prevent buckling of the push shaft 503.

Fig. 34 illustrates yet another view of the pusher shaft driven medical instrument 500 of fig. 30 without a cartridge mounted thereto, in accordance with aspects of the present disclosure. Specifically, fig. 34 shows clearance slot 560 of upper jaw 530 and clearance slot 570 of lower jaw 525. As previously described, the clearance slots 560 and 570 formed in the upper jaw 530 and the lower jaw 525 enable the cartridge 545 and the firing mechanism 540 (see, e.g., fig. 30) to be removed from the instrument 500 without returning the firing mechanism 540 to the proximal end of the upper jaw 530 (e.g., the initial proximal position of the firing mechanism 540).

In one embodiment, after the firing mechanism 540 translates to the distal end of the cartridge 545, removing the cartridge 545 can comprise: firing mechanism 540 is pushed through gap slot 560 of upper jaw 530 and drops through gap slot 570 of lower jaw 525. The upper jaw 530 can then be lifted upward away from the lower jaw 525 to remove the cartridge 545 from the upper jaw 530.

In some embodiments, the instrument 500 may include a unique firing mechanism that includes a housing that houses a cutting mechanism or blade that may be automatically retracted to a safe covering position when the firing mechanism is not pushed through tissue. Fig. 35A-35D provide various views of a firing mechanism 600 that may be included in a pusher shaft driven medical instrument 500 according to aspects of the present disclosure. In particular, fig. 35A shows a hidden line view of the firing mechanism 600 with the retractable blade 630, fig. 35B shows a hidden line view of the firing mechanism 600 with the retractable blade 630 exposed, fig. 35C shows a perspective view of the firing mechanism 600 with the retractable blade 630 retracted, and fig. 35D shows a perspective view of the firing mechanism 600 with the retractable blade 630 exposed.

The firing mechanism 600 includes a tab 610, a pair of engagement surfaces 605, a retractable blade 630, and a spring 615. Similar to the previous embodiments, the firing mechanism 600 can be configured to interact with a cartridge containing staples to drive the staples into tissue. In some embodiments, the electrical conductor 600 may comprise an I-beam. The retractable blade 630 is connected to an engagement surface 605 (which may be formed as part of a cup member as described above) such that a driving force applied to the engagement surface 605 via the push shaft is transmitted to the retractable blade 630. In some embodiments, each of the engagement members 605 comprises a ball joint, and the push shaft is configured to engage the ball joint. Retractable blade 630 is also connected to spring 615 and includes a slot 625 coupled to a pin 620 that is attached to tab 610.

Retractable blades 630 are configured to retract into tabs 610, as shown in fig. 35A and 35C. In particular, when no force is exerted on the engagement surface 605, the spring 615 is configured to pull the retractable blade 630 into a retracted position in which no portion of the retractable blade 630 is exposed from the tab 610. The pin 620 of the tab 610 in conjunction with the slot 625 in the retractable blade 630 can limit the distance the spring 615 can pull the retractable blade 630 into the tab 610, thereby maintaining an amount of tension in the spring 615 when the retractable blade 630 is in the retracted position.

When a force is applied to the engagement surface 605 by the pushing shaft, the force due to the pushing shaft may overcome the retention force of the spring 615, moving the retractable blade 630 out of the tab 610, thereby exposing the retractable blade 630. Thus, as the firing mechanism 600 is pushed through the cartridge via the pusher shaft, the retractable blades 630 can be exposed from the tabs 610 to transect the tissue. In other words, the pusher shaft can be configured to engage the spring 615 to push the retractable blade 630 forward, thereby exposing the retractable blade 630 while translating the firing mechanism 600 along the axis of the end effector.

Although the firing mechanism 600 has been described in connection with a pusher-shaft driven instrument (e.g., the instrument 500 of fig. 30), the firing mechanism 600 including the retractable blade 630 may also be modified for use with a cable driven instrument (e.g., the instrument 400 of fig. 23A and 23B). Accordingly, the firing mechanism 600 may be configured to be advanceable along the end effector via different types of drive mechanisms (e.g., pusher shafts or cables).

Advantageously, certain embodiments of the pusher-shaft driven instrument provide a convenient way to safely integrate a retractable blade into a firing mechanism. In addition, the pusher shaft drive embodiment of the instrument provides a good and unique separation point for the cartridge, allowing for the reuse of a larger portion of the instrument.

3. Implementation System and terminology

Implementations disclosed herein provide systems, methods, and apparatus for articulating a medical instrument, such as a medical stapler, including an articulatable wrist.

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

The functionality for controlling the articulation of the medical instrument 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 media can include 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 computer-readable media may be tangible and non-transitory. As used herein, the term "code" may refer to software, instructions, code or data that is executable by a computing device or processor.

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

The term "plurality", as used herein, means two or more. For example, a plurality of components indicates two or more components. The term "determining" encompasses a variety of actions, and thus "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Additionally, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Additionally, "determining" may include resolving, selecting, choosing, establishing, and the like.

The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes that "is based only on" and "is based at least on" both.

The previous embodiments of the disclosed embodiments are 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 should be understood that one of ordinary skill in the art will be able to employ a number of corresponding alternative and equivalent structural details, such as equivalent ways of fastening, mounting, coupling or engaging tool components, equivalent mechanisms for generating specific 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.