System for performing minimally invasive surgery

Abstract

The system 10 for performing minimally invasive surgery includes a holding arm 12, a holding arm interface 30, an actuation unit 20 removably disposed on the holding arm interface 30, and an endoscope sheath assembly disposed on the holding arm interface 30 opposite the actuation unit 20. The actuation unit 20 includes a component bay 210 configured to receive a camera 22, a lens, and first and second removable disposable cartridges 410. Each cartridge 410 includes a concentric tube array 414 extending therefrom, each array 414 including at least one guide tube and a surgical tool 46 disposed within the guide tube. Numerous safety and communication features are located on the various components of the system 10 to ensure fail-safe operation and prevent damage to the equipment or harm to the patient.

Description

[Technical field]

[0001] The present invention relates to surgical devices and associated methods for performing surgery, and more particularly, to tools and methods for minimally invasive surgery using concentric tube assemblies. [Background technology]

[0002] Minimally invasive surgery using electromechanical robots is a developing field in medicine. Conventional devices for performing minimally invasive surgery, such as endoscopes and resectoscopes, typically include a distal tip that is inserted through an incision or natural orifice in the patient's body. The distal tip includes an optical lens that, when placed inside the body, allows the surgeon to view a field of view proximate to the distal tip. Endoscopes usually have a camera attached to the lens to display the field of view on a monitor in the operating room. In some applications, the endoscope includes a camera located at the distal tip of the endoscope. The device also includes a constricted working channel extending through the device. One or more elongated surgical tools may be inserted through the working channel. Instruments such as dissection devices, baskets, or laser optics may be included in the surgical tools. The distal end of the surgical tool protrudes from the distal tip of the device, allowing the surgeon to visually observe the manipulation of the tool within the patient's body during surgery.

[0003] Over the past few decades, it has become increasingly clear that entering the body in the most minimally invasive way possible during surgery offers significant benefits to patients. Minimally invasive surgery is a general term that describes any surgical procedure that enters the body without large incisions.

[0004] Minimally invasive surgery includes laparoscopic surgery, which uses a tube (endoscope) to provide visualization and view the surgical field, and long rigid instruments that pass through small ports inside the body. In traditional laparoscopic surgery, the endoscope is usually only used to visualize the surgical field, and tools do not pass through it. Tools are redirected outside the body through incision ports to provide instrument manipulation at the surgical site. Tool manipulation in laparoscopic surgery is performed by pivoting long rigid shafts through ports inside the body. For surgery in the pneumoperitoneum, thoracic cavity, pelvis, or any other anatomically working volume with sufficient space, this concept often provides a good minimally invasive solution to provide instrument manipulation. However, when the surgical site is under a long narrow channel, the ability to pivot these long rigid shafts is reduced. As the access channel becomes longer and / or narrower, the ability to manipulate tools decreases rapidly.

[0005] Minimally invasive surgery further includes endoscopic surgery. Laparoscopic surgery differs in that an endoscope is used to provide visualization, whereas endoscopic surgery passes surgical instruments through a working channel in the endoscope tube itself. Examples of surgical instruments that can be used during endoscopic surgery are scissors, forceps, laser fiber, monopolar / bipolar cautery, etc. Endoscopes include both rigid and flexible endoscopes, where rigid endoscopes are used for surgery that follow a linear path from outside the body to the surgical site, and flexible endoscopes are used for surgery that require a tortuous path through curved anatomical tissue. Rigid endoscopes are currently used in almost all surgical fields, including but not limited to neurosurgery, thoracic surgery, orthopedics, urology, gynecology, etc. Rigid endoscopes are currently used in surgery throughout the body, but are not without their drawbacks. The tools that operate through the working channel of a rigid endoscope are similar to laparoscopic tools in that they are usually straight and rigid tools. Typically, these tools are also limited to two degrees of freedom of movement relative to the endoscope, which can be axially inserted / retracted and rotated. In some cases, the surgeon may have the ability to swivel / tilt the endoscope outside the body, which makes the task particularly difficult since as the endoscope moves, the field of view of the endoscope moves with it. Also, due to the size constraints of the working channel of the endoscope, the surgeon can only reach the surgical site with one instrument at a time most of the time, effectively eliminating the ability for bimanual manipulation with both hands. Thus, the limitation of only one tool at a time, the constantly changing field of view, the limited degrees of freedom, and the lack of instrument dexterity at the tip of the endoscope make endoscopic surgery a particularly challenging type of minimally invasive surgery.

[0006] Electromechanical surgical robots are a rapidly developing field of medicine with great potential to assist in surgical instrument manipulation, especially due to their ability to perform precision, spatial reasoning, and dexterity. Surgical robots have been widely adapted and used in hundreds of thousands of surgeries worldwide. Most of the surgical robotic systems designed to date assist in instrument manipulation and can be broadly categorized as pivoting and flexible tools. Pivoting laparoscopic systems, such as the widely used da Vinci Xi robot (Intuitive Surgical), obtain instrument manipulation by tilting through a port inside the body, similar to laparoscopic tools. For surgical applications where it is not possible to tilt or rotate the tool outside the body, several groups in the research community have developed flexible element-based robotic systems. These systems are often referred to as continuum robots, or robots with continuously bending, elastic structures. There is also the concentric tube manipulator, a type of miniature needle-sized continuum robot composed of concentric elastic tubes. Concentric tube robots show promise in many types of minimally invasive surgical interventions that require small diameter robots with articulations inside the body. Examples include surgery on the eye, ear, sinuses, lungs, prostate, brain, etc. In many of these applications, a higher curvature is generally desirable to allow the robot to turn "tighter corners" within the human body and operate with precision at the surgical site. In the context of endoscopic surgery, the reserve curvature of the concentric tube determines how close the manipulator can operate to the tip of the endoscope, which is critical during endoscopic surgery.

[0007] In traditional endoscopic surgery, surgeons typically hold an endoscope in one hand and an endoscopic instrument in the other, which generally makes it impossible for surgeons to manipulate two instruments simultaneously. Due to the aspect of human error, whenever a surgeon needs to exchange an endoscopic instrument for another, this can result in careful and potentially dangerous endoscopic movements. However, surgeons often require the ability to precisely manipulate two instruments simultaneously in certain situations, especially when attempting to precisely grasp, manipulate, and cut material. Even when an endoscope can accommodate two or more tools at the same time, the tools can only be oriented in a straight line and parallel to each other, preventing true collaboration between the tools. While surgeons can greatly benefit from the improved precision, dexterity, and vision that robotic surgical systems offer, such traditional systems have limited maneuverability.

[0008] Conventional surgical robots for performing laparoscopic and endoscopic procedures generally include a robotic arm coupled to an electromechanical actuator configured to manipulate a surgical tool located at its distal end. In practice, the robotic arm and actuator must be controllable through an electronic interface. Such systems are software-based and can be programmed to operate within different ranges of motion. Since the tissue workspace is rather small compared to the overall size of such robotic systems, ensuring safeguards to prevent equipment damage or patient injury is of great importance in the design and operation of robotic surgical systems. Many conventional surgical robots lack sufficient safety systems.

[0009] In addition, due to the overall complexity of surgical robots and the number of individual parts involved in such systems, it is essential to maintain a sterile interface between the robotic system and the surgical field. Conventional surgical robots often lack sufficient sterile features to ensure both ease of operation and a sterile environment.

[0010] Another complication of robotic surgery involves communication between the surgeon and the hardware that controls the robot. For example, individual components of a robotic surgery system can operate in different modes, and it is important for the surgeon to quickly identify which mode the device is in and make changes if necessary. Many conventional robotic surgery systems only provide such information on the operator panel, which requires the surgeon to take their eyes off the surgical field.

[0011] Thus, there is a need for improved devices and methods for performing robotic surgery, particularly with regard to safety systems, sterile approaches, electronic interfaces and status indicators. Summary of the Invention

[0012] This Summary is provided to introduce some concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0013] An apparatus for performing minimally invasive surgery includes a holding arm, a holding arm interface removably attached to the holding arm, an actuation unit removably attached to the holding arm interface, and a sheath assembly removably attached to the holding arm interface opposite the actuation unit.

[0014] The system provides robust operation and includes numerous safety and operational features to prevent damage to the equipment or injury to the patient.

[0015] Numerous other objects, advantages and features of the present disclosure will become readily apparent to those skilled in the art upon review of the following drawings and description of the preferred embodiments. [Brief description of the drawings]

[0016] [Figure 1]FIG. 1 is a perspective view of one embodiment of a system for performing minimally invasive surgery. [Diagram 2] FIG. 1 is a perspective view of one embodiment of a system for performing minimally invasive surgery. [Diagram 3] FIG. 1 is a partially exploded perspective view of one embodiment of a system for performing minimally invasive surgery. [Figure 4] FIG. 13 is a front perspective view of one embodiment of a holding arm interface according to the present disclosure; [Diagram 5] FIG. 5 is a rear perspective view of the embodiment of the holding arm interface of FIG. [Figure 6] FIG. 13 is a partially exploded view of one embodiment of a holding arm interface and sheath assembly according to the present disclosure. [Figure 7] FIG. 13 is a partial exploded view of one embodiment of a retaining arm interface according to the present disclosure. [Figure 8] FIG. 13 is a partial exploded view of one embodiment of a brake for a retention arm interface according to the present disclosure. [Figure 9] FIG. 13 is a detailed perspective view of one embodiment of a handle and interface mount on a holding arm instrument according to the present disclosure. [Figure 10] FIG. 13 is a front detailed perspective cross-sectional view of one embodiment of a retention arm interface according to the present disclosure. [Figure 11] FIG. 13 is a rear detailed perspective cross-sectional view of one embodiment of a retention arm interface according to the present disclosure. [Figure 12] FIG. 1 illustrates a rear perspective view of one embodiment of a system according to the present disclosure. [Figure 13] FIG. 1 is a perspective view of one embodiment of a cartridge according to the present disclosure. [Figure 14] FIG. 1 illustrates a rear perspective view of one embodiment of a system according to the present disclosure. [Figure 15] FIG. 1 is a perspective view of one embodiment of a system according to the present disclosure. [Figure 16] FIG. 1 is a perspective view of one embodiment of a physician input console according to the present disclosure. [Figure 17] 1 is a perspective view of one embodiment of a top tray of a physician input console according to the present disclosure; FIG. [Figure 18] FIG. 1 is a block diagram of one embodiment of a graphical user interface displayed on a physician input console according to the present disclosure. [Figure 19A] FIG. 2 is a plan view of one embodiment of a graphical user interface that instructs a user how to realign an input control after misalignment in accordance with the present disclosure. [Figure 19B] FIG. 1 is a plan view of one embodiment of a graphical user interface that instructs a user how to realign an input control after misalignment in accordance with the present disclosure. [Figure 20A] FIG. 1 is a side perspective view of one embodiment of a physician input console handle according to the present disclosure. [Figure 20B] FIG. 13 is another side perspective view of an embodiment of a physician input console handle according to the present disclosure. [Figure 21] FIG. 2 illustrates a top perspective view of one embodiment of an actuation unit according to the present disclosure. [Figure 22] FIG. 2 is a bottom perspective view of one embodiment of an actuation unit according to the present disclosure. [Figure 23A] FIG. 1 is a perspective view of one embodiment of an input control handle according to the present disclosure. [Figure 23B] 13 is a perspective view of another embodiment of an input control handle according to the present disclosure. [Figure 24] 1A-1C are side views depicting various embodiments of a surgeon's grip of the input controls. [Diagram 25] 1 is a cross-sectional side view of one embodiment of an input control handle according to the present disclosure. [Figure 26] FIG. 2 is a perspective cross-sectional view of one embodiment of an input control handle according to the present disclosure. [Figure 27A] FIG. 1 is a perspective view of a draped physician input console according to the present disclosure. [Figure 27B] FIG. 1 is a perspective view of one embodiment of an input control covered with a drape according to the present disclosure. [Figure 28] FIG. 1 is a perspective view of one embodiment of an articulated holding arm base according to the present disclosure. [Figure 29]FIG. 1 is a perspective view of one embodiment of an articulated holding arm base in a table-mounted configuration in accordance with the present disclosure; [Diagram 30] FIG. 1 is a schematic block diagram of one embodiment of a control system for a safety officer in accordance with the present disclosure. [Diagram 31] FIG. 2 is a schematic block diagram of one embodiment of a working element of a cartridge sensing subsystem according to the present disclosure. [Diagram 32] FIG. 2 is a perspective view of an actuation unit covered with a drape in accordance with the present disclosure. [Figure 33A] FIG. 1 is a perspective view of one embodiment of a tip of a concentric tube manipulator in accordance with the present disclosure; [Figure 33B] 13 is a perspective view of another embodiment of a tip of a concentric tube manipulator according to the present disclosure. FIG. [Diagram 34] FIG. 1 is a perspective view of one embodiment of an optical support guide according to the present disclosure.

[0017] Although the making and use of various embodiments of the invention are described in detail below, it should be understood that the invention provides many applicable inventive concepts embodied in a wide variety of specific contexts. The specific embodiments described herein are merely illustrative of specific ways to make and use the invention and do not limit the scope of the invention. Those skilled in the art will recognize many equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the invention and encompassed by the claims.

[0018] In the figures, for clarity, not all reference numbers are included in each figure. Additionally, positional terms such as "upper," "lower," "side," "top," "bottom," and the like refer to the device in the orientation shown in the figures. Those skilled in the art will recognize that the device may assume a different orientation when in use. Overall System

[0019] With reference to Figures 1 and 2, the present disclosure provides a robotic system 10 for performing minimally invasive surgery. The system 10 includes a holding arm 12 mounted on a base 14. The holding arm 12 may include an articulated holding arm. The holding arm 12 may include a robotic arm or may include a passive arm. The holding arm 12 may provide assistance in manipulating the holding arm 12. For example, the system 10 may include a passive counterbalance or may include one or more motors that may provide gravity or dynamic compensation. In some embodiments, the holding arm 12 may be mounted directly to the operating table 50 rather than on the base 14. In some embodiments, the base 14 may provide a vertical / adjustable degree of freedom such that the holding arm 12 may be compensable to the alignment of the patient positioning orientation. The holding arm 12 is configured to provide multiple degrees of freedom for controlling the position and angular orientation of a surgical instrument in the three-dimensional space of the surgical field, for example, above the operating table 50 as shown in Figure 1. The holding arm 12 is specifically configured for at least the applications described in this disclosure. In some embodiments, the holding arm 12 is mounted to an angled wedge 16 that is fixed to the base 14. In some embodiments, the wedge 16 improves positioning of the surgical instrument on the operating table 50. In other embodiments, the holding arm 12 is mounted directly to the base 14. The base 14 may be stationary or may be movable.

[0020] The actuation unit 20 is positioned on the system 10 to provide control of one or more instruments for performing minimally invasive surgical procedures. In some embodiments, the actuation unit 20 includes a concentric tube assembly 24 configured for endoscopic surgery. The actuation unit 20 may receive an insertable and replaceable instrument cartridge 410 that may control the concentric tube assembly 24 and the tools attached thereto. Also disposed on the actuation unit 20 is a camera 22 for real-time observation of the surgical field at the distal end of the concentric tube assembly 24 on a display 60 during surgery. An optical system or telescope 260 may provide a light path and light to the surgical site through the concentric tube assembly 24 and an interface for the camera 22 attachment in an eyepiece. In further embodiments, the features disclosed herein may be readily implemented into a robotic system for performing minimally invasive laparoscopic surgery.

[0021] A holding arm interface (HAI) 30 connects the actuation unit 20 to the holding arm 12. The holding arm interface 30 comprises a mechanical link between the actuation unit 20 and the holding arm 12. In some embodiments, an interface mount 36 is disposed at an upper end of the holding arm interface 30. The interface mount 36 mechanically engages with a corresponding arm mount 18 positioned at a distal end of the holding arm 12. In some embodiments, the engagement between the interface mount 36 and the arm mount 18 comprises both a mechanical and an electrical interface.

[0022] The physician input console 40 is directly or indirectly connected to the actuation unit 20. The physician input console 40 includes first and second input controls 42, 44 configured to control one or more surgical tools disposed on the actuation unit 20. In some embodiments, the holding arm interface 30 may also include one or more electronic interfaces coupling the actuation unit 20 and the physician input console 40.

[0023] The system 10 includes numerous features to provide precise control, safety, sterility, and communication for performing a surgical procedure. Many of the safety features are provided to ensure that components of the system are not damaged during use or transport, while other safety features are provided to protect the patient and medical personnel before, during, or after surgery. The safety features described herein are independent and may be employed as separate features or in combination with one another as part of a comprehensive surgical system.

[0024] 2, one embodiment of the actuation unit 20 mounted to the holding arm interface 30 is shown. The actuation unit 20 includes a base 202 having a first sidewall 204 and a second sidewall 206 spaced apart from the first sidewall 204. A platform 208 spans between the first and second sidewalls 204, 206 forming a U-shaped frame. A component bay 210 is defined above the platform 208 between the first and second sidewalls 204, 206. A platform handle 212 extends rearwardly from the platform 208 to allow a user to manually reposition the actuation unit 20 during use. The platform handle 212 may also be used to engage or disengage the actuation unit 20 with the holding arm interface 30.

[0025] 3, the holding arm interface 30 includes a body 32 and a bracket 34 extending upwardly from the body 32. An interface mount 36 is disposed on an upper end of the holding arm interface 30 for attachment of the arm mount 18 on the holding arm 12. In some embodiments, an interface handle 38 is positioned on the holding arm interface 30 between the body 32 and the interface mount 36. The interface handle 38 provides a place for a user to grasp the holding arm interface 30 to manually manipulate the concentric tube assembly 24 relative to the tissue working space.

[0026] Holding Arm Interface (HAI) Slide-out Failsafe As shown in FIGS. 2 and 3, a detachable joint 214 is provided between the actuation unit 20 and the holding arm interface 30. In this manner, the actuation unit 20 may be selectively decoupled from the holding arm interface 30. Such decoupling may occur when the holding arm interface 30 is securely fastened to the holding arm 12. This modular configuration allows the actuation unit 20 to be physically disengaged from the holding arm interface 30 during transportation or even during a surgical procedure. For example, during a procedure, it may be necessary to quickly pull one or more structures out of the tissue working space of a patient. By providing a releasable attachment between the actuation unit 20 and the holding arm interface 30, the actuation unit 20, together with its subassemblies, may be quickly pulled away from the patient. In one embodiment, the actuation unit 20 may include a user latch release 315 (see FIG. 22). The user latch release 315 may be located at the bottom of the actuation unit 20. A user may pull the user latch release 315 to release the latch and decouple the holding arm interface 30 from the actuation unit 20.

[0027] Another feature of the present disclosure provides for the actuation unit 20 to be attached or detached along a longitudinal insertion axis 26, which is collinear with the axis of movement of the endoscopic tool housed in the tube assembly 24. By inserting or removing the actuation unit 20 and its components along the same longitudinal axis as the endoscope axis, side-to-side movement within the tissue working space is minimized, greatly reducing the potential for trauma to surrounding tissue, thus improving safety. Any other decoupling design that does not limit movement to the longitudinal insertion axis 26 may be more dangerous and may lead to unacceptable risk to the patient or damage to the equipment.

[0028] Another feature of the present disclosure provides for an actuation unit 20 that can be disengaged from the system with or without power. The detachable joint 214 utilizes a mechanical disconnect that can be mechanically released in the event of a loss of power or malfunction. This additional safety feature helps prevent cases in which one or more surgical tools may be unintentionally held in place within a patient's body during a power loss.

[0029] In some embodiments, a release switch 216 is located on the platform handle 212. A user may operate the release switch 216 to release the mechanical engagement between the actuation unit 20 and the holding arm interface 30. In various embodiments, the release switch 216 may include a mechanical switch or an electrical switch.

[0030] The holding arm interface 30 and the actuation unit 20 are also configured such that the electrical interface between the two can be easily disconnected during separation of the detachable joint 214. For example, in some embodiments, the holding arm interface 30 includes an electrical connector 344 forming one or more pin sockets positioned to receive a corresponding connector on the distal end of the actuation unit 20. When the actuation unit 20 is disconnected from the holding arm interface 30, the electrical connector 344 on the holding arm interface 30 disengages from the corresponding connector on the actuation unit 20 along the same direction of movement as the disengagement motion.

[0031] Holding Arm Interface (HAI) Safety Critical Signals 4-6, the holding arm interface 30 provides an electromechanical coupling between the holding arm 12 and the actuation unit 20. The holding arm interface 30 includes an interface body 32 configured to receive the actuation unit 20. A bracket 34 extends upwardly from the interface body 32, and an interface mount 36 is disposed at an upper end of the holding arm interface 30. The interface mount 36 is attached to a corresponding arm mount 18 on the arm 12. The interface mount 36 includes a mechanical engagement with the arm mount 18 to securely lock the holding arm interface 30 in place at the distal end of the holding arm 12.

[0032] In some embodiments, the holding arm 12 includes one or more sensors positioned on or near the arm mount 18 configured to detect engagement with the interface mount 36. Such sensors may include any suitable mechanical or electrical sensors known in the art for detecting contact or engagement with the holding arm interface 30. In further embodiments, the holding arm interface 30 includes one or more sensors positioned on or near the interface mount 36. Such sensors may include any suitable sensors known in the art for detecting contact or engagement with the holding arm 12. In further embodiments, a first sensor is disposed on the holding arm 12 and a second sensor is disposed on the holding arm interface 30. The first sensor is configured to detect engagement with the holding arm interface 30 and the second sensor is configured to detect engagement with the holding arm 12. In this manner, the system 10 includes redundant safety sensors, each capable of independently detecting the presence of an opposing structure.

[0033] When the holding arm interface 30, the holding arm 12, or both detect engagement between the holding arm interface 30 and the holding arm 12, a holding arm interface safety signal is generated. The HAI safety signal is received by one or more safety relays on the robot holding arm 12. When the holding arm 12 detects the HAI safety signal, the safety relay on the holding arm 12 prevents autonomous movement of the holding arm 12. This can be accomplished in a variety of different ways on the holding arm 12, including electrical, software and / or mechanical operations to limit the movement of the holding arm 12. This safety function utilizes the HAI safety signal to detect the condition when the holding arm interface 30 is attached to the holding arm 12. If such a condition is detected, the holding arm 12 is temporarily prevented from being capable of autonomous movement as long as the holding arm interface 30 is attached. When the holding arm interface 30 is disconnected and the HAI safety signal indicates such disconnection, the holding arm 12 may resume autonomous movement.

[0034] Additionally, during periods when the holding arm interface 30 is detected as attached to the holding arm 12, the first and second control buttons 314, 316 on the holding arm interface 30 alternate between impedance modes. These buttons are also tied directly to the safety controller and safety relay of the holding arm 12. This also provides a safety function for the overall system.

[0035] Referring to FIG. 5, the holding arm interface 30 may include a first flat surface 318 that may allow movement in a direction parallel to the first flat surface 318 that may include the longitudinal axis of the endoscope. The mating joint of the holding arm 12 may similarly include a flat female receptacle. The endoscope may move along the longitudinal axis while being uncoupled from the holding arm 12, thereby allowing safe uncoupling of the holding arm interface 30 from the holding arm 12 while the endoscope is still inside the patient's body. Because the holding arm 12 may stop and brake, for example during a loss of power, it may be advantageous to be able to safely remove the endoscope from the patient's body in a manner that does not require or is passive in the movement of the holding arm 12. The holding arm interface 30 may include a second flat surface (e.g., on the mounting flange 308) that allows the user to uncouple the holding arm interface 30 from the holding arm 12 and allow the holding arm 12 to rest on this second flat surface under gravity without having to bear the weight of the actuation unit 20. This feature provides the benefits of improved safety and ease of use.

[0036] With further reference to Figures 4-6, the retention arm interface 30 includes numerous features that enhance ease of use and safety. As shown in Figure 4, the retention arm interface 30 includes an interface mount 36 that provides a mechanical and electrical connection with the retention arm 12. In some embodiments, the interface mount 36 includes a rotating collar 302 having a threaded arrangement 304. An electrical interface 310 is positioned above the threaded mount to engage corresponding electrical contacts on the retention arm 12. A mount flange 308 in some embodiments extends laterally from the mount to provide mechanical engagement with corresponding structure on the arm mount 18 in some embodiments.

[0037] In some embodiments, the interface handle 38 is located below the interface mount 36 and includes a grip area with finger grooves 317. In some embodiments, the interface handle 38 includes a grip of cushioning material, such as plastic, foam, or rubber. The interface handle 38 includes first and second control buttons 314, 316 that may be configured for different control functions, such as releasing the arm 12 to allow manual manipulation or repositioning of the holding arm interface 30. Also, in different embodiments, the first and second buttons 314, 316 may control other functions of the device. The bracket 34 connects the interface handle 38 to the body 32.

[0038] Sheath removal The body 32 is configured to releasably engage the actuation unit 20 at its proximal side and the tube assembly 24 at its distal side facing the patient. A sheath mount 320 is disposed distally of the body 32, facing the patient and away from the actuation unit 20. The sheath mount 320 provides a releasable joint between the holding arm interface 30 and the tube assembly 24, which houses the endoscope channel that guides the insertion and retraction of the endoscope tubes and instruments, the inner sheath and the outer sheath. The sheath mount 320 provides a releasable mechanical engagement that can be quickly released, allowing the tube assembly to be decoupled and removed along the longitudinal insertion axis 26.

[0039] 6, the inner sheath 80 includes an inner sheath latch 82 that mechanically engages with a sheath mount 320 on the retention arm interface 30. In some embodiments, the inner sheath latch 82 slides onto the sheath mount 320 and rotates into a locked position. In this manner, the inner sheath latch 82 forms a tight connection and seal between the sheath mount 320 and the inner sheath 80. The inner sheath 80 is inserted onto the sheath mount 320 along the longitudinal insertion axis 26, which provides an additional safety measure since movement of the components is restricted to a common axis.

[0040] The outer sheath 90 slides over the inner sheath 80 and the outer sheath latches 92 engage the inner sheath latches 82 to secure the outer sheath 90 to the inner sheath 80, which in some embodiments forms a tight connection and seal between the inner sheath 80 and the outer sheath 90. In one embodiment, the endoscopic sheath assembly includes the inner sheath 80 and the outer sheath 90.

[0041] The channel assembly 70 includes first and second tubular channels 76 that each receive a concentric tube assembly 24 that houses an endoscopic instrument. The channel assembly 70 includes a proximal end 72 and a distal end 74. The channel assembly 70 may be inserted along a longitudinal insertion axis 26 through a passage in the retaining arm interface 30 and into the inner sheath 80. This provides an additional safety measure since movement of the components is restricted to a common axis.

[0042] By providing a detachable interface between the sheath and the holding arm interface 30, a safer configuration is achieved. If the sheath were permanently fixed to the actuation unit 20 or holding arm interface 30, insertion of the tool into the patient would be more dangerous and difficult due to the additional bulk of the robot and actuation unit 20. The present disclosure provides embodiments that allow manual insertion of the outer sheath and decoupling of the inner sheath from the remainder of the actuation unit 20. Decoupling of the sheath may also allow the use of existing conventional equipment during atraumatic insertion and may eliminate the need for special tools to insert the robotic system 10 into the patient.

[0043] Rotational Degrees of Freedom Another feature of the present disclosure provides a system for performing robotic surgery that has a rotational degree of freedom about the longitudinal insertion axis 26. With reference to FIG. 7, the holding arm interface 30 includes a rotational joint 324 that allows rotation of the actuation unit 20 relative to the body 32, bracket 34, interface handle 38 and interface mount 36. In other words, the actuation unit 20 and tube assembly 24 can be rotated about the longitudinal insertion axis 26 while the remainder of the holding arm interface 30 remains rigidly fixed to the holding arm 12. This rotational degree of freedom allows the endoscope to be rotated about the longitudinal axis, allowing the surgeon to look around the anatomy with a non-zero viewing direction on the rod lens.

[0044] The rotation joint 324 includes a base plate 330 proximal to the retention arm interface 30. The base plate 330 can rotate relative to an outer shell 350 on the body 32. The outer shell 350 includes a conical shape with a flat rear surface. A rigid funnel housing 352 is positioned inside the body 32, and the base plate 330 is attached to the funnel housing 352 using one or more fasteners. A first bearing 352 is disposed between the funnel housing 352 and the outer shell 350, such that the funnel housing 352 can rotate about the longitudinal insertion axis 26 inside the outer shell 350 while the outer shell 350 remains stationary. In this manner, when the base plate 330 is secured to the funnel housing 352, the base plate 330 can also rotate in both directions 27 about the longitudinal insertion axis 26 simultaneously with the rotation of the funnel housing 352. When the actuation unit 20 and its corresponding components are secured to the base plate 330 via the mounting posts 340a, 340b and bottom latch 346, the actuation unit 20 also rotates with the base plate 330 and funnel housing 352, thereby enabling rotation of the camera lens and endoscope concentric tube array that extend through the tube assembly into the tissue working space.

[0045] When an operator rotates the actuation unit 20 to a desired angular orientation via the rotation joint 324 on the holding arm interface 30, it may be desired to maintain the new angular orientation for a period of time. To accomplish this, the present disclosure provides a brake 334 that allows the base plate 330 to be locked in a desired angular orientation relative to the body 32. The brake 334 includes a brake knob 336 attached to a brake pin 339, shown in FIG. 8. A brake housing 338 is secured to the base plate 330, and a brake pin orifice 337 allows the brake pin 339 to be selectively extended to engage a corresponding brake pin socket 358 defined on a surface 351 of the body 32 facing the base plate 330. When the brake 334 is engaged, the brake pin 339 extends into the brake pin socket 358, thereby locking the base plate 330 in the desired angular orientation. The brake 334 may be released by operating the brake knob 336 with a pushing and twisting motion, thereby withdrawing the brake pin 339 from the brake pin socket 358 .

[0046] In some applications, it is desirable to limit the free rotation of the actuation unit 20 so that the device cannot freely pivot about the longitudinal insertion axis 26 when the brake 334 is disengaged. To provide some resistance to free angular rotation of the base plate 330, an angled detent assembly is provided. The angled detent assembly includes a plurality of angled detent recesses 359 defined on the rearwardly directed surface 351 of the body 32. In some embodiments, each angled detent recess 359 is angularly aligned with a brake pin socket 358 such that the brake pin 339 is biased into alignment with the brake pin socket 358 at each angular position.

[0047] 10 and 11, the angled detent assembly 374 is circumferentially disposed about the circumference of the body 32 and defines a number of predetermined angular stops. As the base plate 330 rotates relative to the shell 350, the detent balls or posts are biased toward the shell 350 and slide into corresponding recesses 359. The force imparted by the detent structure is configured not to lock the base plate 330 relative to the shell 350, but rather to provide a temporary engagement that operates to limit unlimited rotation of the assembly while allowing easy alignment of the brake pin 339 with the brake pin socket.

[0048] In some embodiments, the angle lock plunger may be provided by a solenoid or another actuation mechanism. In embodiments where the angle lock plunger is actuated, a user input for locking or unlocking this angular degree of freedom may be remotely located on the actuation unit 20. In one embodiment, referring to FIG. 21, one or more buttons 300a, 300b for unlocking the angular rotation degree of freedom may be located on the side walls 204, 206 of the actuation unit 20. In some embodiments, the control algorithm may require multiple buttons 300a, 300b to be depressed simultaneously, e.g., buttons 300a and 300b pressed simultaneously, to unlock this degree of freedom. This provides an additional safety measure to ensure that this degree of freedom is not accidentally released during use.

[0049] 10 and 11, the rotational joint 324 is configured such that the funnel housing 352 is supported by a first bearing 354 proximal to the body 32 and also by a second bearing 370 proximal to the body 32. In this manner, the funnel housing 352 can rotate axisymmetrically about the longitudinal insertion axis 26 without wobble or lateral movement.

[0050] The funnel 360 is inserted into the funnel housing 352 along the longitudinal insertion axis 26 through an access opening 332 on the base plate 330 shown in FIG. 5. The funnel 360 may include first and second tapered channels that allow a concentric tube assembly housing a surgical tool to be inserted longitudinally into the channel assembly 70 and along the length of the tube assembly 24 toward the patient. The first and second channels 362, 364 each include a taper that narrows as the channel advances toward the patient, thereby centering each concentric tube assembly 24 in the corresponding channel. The distal end of the funnel 360 includes first and second channel sockets 366, 368, each sized to receive a corresponding tubular channel assembly 70. The inner sheath 80 is configured to slide over the distal end of the funnel 360 and engage the sheath mount 320. The sheath mount 320 is rigidly fixed to the forward end of the funnel housing 352 such that as the base plate 330 rotates relative to the shell 350, the sheath mount 320 rotates with the funnel housing 352 at a forward rotation joint 372. A funnel latch 361 is located at the rear end of the funnel 360 and axially secures the funnel 360 to the retainer arm interface 30.

[0051] When the actuation unit 20 is rotated about the rotation joint 324 relative to the holding arm interface 30, it is desirable to index the degree of angular rotation so that the surgeon always understands the direction and degree of angular rotation. To achieve this, the present disclosure, in some embodiments, provides an angle sensor on the holding arm interface 30 that detects the angular position of the base plate 330 relative to the shell 350. The angle sensor provides a rotation signal, and a graphic indicator representing the rotation signal is displayed on the display 60. In some embodiments, the indicator includes a compass that indicates the direction and degree of rotation of the actuation unit 20 relative to the holding arm interface 30.

[0052] Flat Head Cartridge Interface 12-13, the present disclosure provides a removable instrument cartridge 410 including a concentric tube array 414 extending from a distal end of the cartridge 410. Each concentric tube array 414 includes one or more tubes for directing a surgical tool and one or more surgical tools 46 that extend through the tubes from the distal end of the tube assembly 24 into the patient's body during surgery. Each cartridge 410 is configured with a unique surgical tool 46 housed within the concentric tube array 414. The surgical tool 46 and one or more concentric tubes within the concentric tube array 414 may be individually manipulated via a set of geared linkages within each cartridge 410. For example, a guide tube within the concentric tube array 414 may be translated axially relative to the cartridge 410 and rotated about its longitudinal axis relative to the cartridge 410. Similarly, the surgical tools 46 housed inside the guide tubes may be independently translated axially and rotated.

[0053] Each cartridge 410 includes multiple independent cartridge joint interfaces, including first, second, third, fourth and fifth cartridge joint interfaces 420, 422, 424, 426, 428. Each cartridge joint interface may be rotated to control an individual degree of freedom of the concentric tube array 414. For example, the first cartridge joint interface 420 may be used to control the axial translation of the guide tube. The second cartridge joint interface 422 may be used to control the rotation of the guide tube. The third cartridge joint interface 424 may be used to control the axial translation of the surgical tool 46. The fourth cartridge joint interface 426 may be used to control the rotation of the surgical tool 46. These are merely examples, and each cartridge 410 may be configured for customized applications depending on the type of surgical tool 46 employed in the concentric tube array 414.

[0054] Each cartridge fitting interface includes a fitting slot 432, and the cartridge 410 includes a cartridge slot 430. When each fitting slot 432 is aligned with a cartridge slot 430, a continuous linear slot is formed along the length of the cartridge 410. However, if an individual fitting slot 432 is misaligned with respect to the cartridge slot 430, the continuous linear slot along the length of the cartridge 410 is interrupted.

[0055] In use, each cartridge joint interface is controlled by rotation. With reference to FIG. 12, the actuation unit 20 includes a first cartridge slot 220 and a second cartridge slot 230 in the component bay 210. The first cartridge slot 220 includes a first cartridge track 222 including a dovetail track configured to engage a corresponding dovetail track 436 including one or more cartridge flanges 438 on each cartridge exterior surface, shown in FIG. 13. In use, the cartridge 410 may be aligned with its concentric tube array 414 inserted and advanced into the first funnel 362 to feed the concentric tube array 414 into the funnel 360 and into the tube assembly 24 along the longitudinal axis toward the tissue working space. As the cartridge 410 and tube array 414 advance, the dovetail track 436 on the cartridge 410 slides into the first track 222 of the first cartridge slot 220.

[0056] If the cartridge fitting slot 432 is aligned with the cartridge slot 430, the cartridge 410 can only continue forward from this position to the desired position to form an unobstructed slot along the length of the cartridge. This is because the actuation unit 20 includes a number of actuation fittings 226 that correspond to the cartridge fittings 420, 422, 424, 426, 428, respectively. For example, the first actuation fitting 226 includes a linear flange 228 that protrudes into the first cartridge slot 220. The flat-headed linear flange 228 is dimensioned to slide within the cartridge slot 430 and further within each cartridge fitting slot 432 as the cartridge 410 advances along its track. However, if the linear flange 228 reaches a cartridge fitting that is misaligned, the cartridge 410 is not allowed to advance further along the track. This safety feature prevents the insertion of a cartridge that is not properly configured for the initial state with respect to the concentric tube array 414. For example, each concentric tube array 414 has a desired initial state for its distal end to ensure that the concentric tube array 414 can be inserted through the tube assembly 24 without getting caught or damaged, and to ensure patient safety by ensuring that any surgical tools 46 are in a retracted position at their initial state. However, if the cartridge fitting is inadvertently rotated, such rotation can cause the concentric tube array 414 to become misaligned from its desired initial state. The present disclosure provides for a flat head flange alignment between the cartridge fitting and the actuation fitting, preventing insertion if either fitting side has any member misaligned from the initial state.

[0057] 12, once the cartridge 410 is fully inserted into its cartridge slot, the cartridge forward end 416 reaches a travel stop position that limits further forward travel and the cartridge is locked in place with a cartridge latch 418. The cartridge latch 418 engages a corresponding latch on the first track 222, thereby mechanically securing the cartridge in place. During operation, the cartridge 410 may be retracted from the actuation unit 20 by releasing the cartridge latch 418 and pulling the cartridge rearwardly away from the actuation unit 20.

[0058] 14, each cartridge slot 220, 230 includes a corresponding motor pack housed in the adjacent sidewall 204, 206. When the cartridge 410 is properly installed in the actuation unit 20, each actuation coupling engages a corresponding cartridge coupling, thereby causing each coupling flange 228 to be received in a corresponding cartridge coupling slot 432 on the cartridge 410. From this position, an independent drive motor in each of the first and second motor packs on the first and second sidewalls 204, 206 can be operated to initiate rotation of the engaged coupling. As an example, in FIG. 14, the cartridge 410 is installed in the second cartridge slot 430. A motor pack 446 housed within the second sidewall 206 includes a separate drive motor, each drive motor corresponding to an individual coupling. Each drive motor can be independently operated to control a particular coupling. Each coupling drives a component in the concentric tube array 414 via a gear assembly 448. Precise control of the cartridge joint is achieved by precisely controlling the rotation of the actuation joint 226, which, via gears, translates into desired, scaled-down movement of the individual components within the concentric tube array 414.

[0059] Electrosurgical Interface In one embodiment, the instrument cartridge 410 delivers electrosurgical probes through a concentric tube assembly 414 to ablate and coagulate tissue at a surgical site. These probes may be monopolar or bipolar and may operate in a fluid or air medium. A bipolar probe may operate as bipolar in saline with both sides of the circuit provided on the same instrument, or two instruments may each have one side of a bipolar circuit, such that the ablation path is between the instruments. The electrosurgical instruments may be actuated using a foot pedal attached directly to the electrosurgical generator. This generator may be external to the robotic system 10 or may be included in the system 10. The foot pedal may be attached to the base 14 or to the physician input console 40. The foot pedal may generate a control signal that travels via a cable to the electrosurgical generator. The system 10 may be configured to actuate electrosurgery through the first or second input controls 42, 44, or through a foot pedal attached to the system 10, or through a foot pedal attached directly to the electrosurgical generator.

[0060] Fail-safe use of flat head interface One issue associated with the use of the cartridge slot flat head interface is that the cartridge may not be removed if any of the cartridge fittings are misaligned with the cartridge slot 430. During use, as the fittings are rotated, a loss of power to the actuation unit 20 can lead to a scenario where the fittings are misaligned with the cartridge slot 430 and the cartridge needs to be removed. If this were to occur during a surgical procedure, it could be dangerous to the patient.

[0061] The present disclosure provides a fail-safe mechanism that allows removal of each cartridge even if the fittings are not aligned. For example, each cartridge track includes a removable dovetail base 450. Once the cartridge 410 is installed in its corresponding cartridge track 222, 232, a track release switch 452 may be operated to immediately release the removable base 450 from the actuation unit 20 if the cartridge 410 must be immediately removed without having the fittings aligned. Because each cartridge is engaged with the base 450 in a dovetail configuration, the cartridge 410 and base 450 are released together as one attached unit. This safety feature provides a fail-safe in the event that power to the actuation unit 20 is lost and the cartridge must be removed.

[0062] Cartridge Identification In some embodiments, each cartridge 410 includes one or more devices for verifying proper positioning and identification of the cartridge. For example, as shown in FIG. 13, the cartridge 410 includes an embedded cartridge chip set 441 that is programmed with information specific to the cartridge. The cartridge chip set 441 includes information that identifies the particular cartridge, including, but not limited to, a cartridge ID number, cartridge manufacturing information, cartridge sterilization information, information regarding the concentric tube array 414, such as the surgical tool 46 and guide tube configuration, etc. Each cartridge chip set 441 may also include information regarding prior use of the cartridge. In some embodiments, each cartridge chip set 441 may include read-only memory, while in other embodiments, each cartridge chip set 441 includes read and write capabilities.

[0063] In some embodiments, each cartridge chip set 441 includes a radio frequency identification (RFID), (electrically erasable programmable read only memory) EEPROM, or near field communication (NFC) tag device configured to store information about the cartridge. Information stored in each cartridge chip set 441 can be communicated to the actuation unit 20 via one or more communication interfaces 440. For example, in some embodiments, the cartridge 410 includes first and second cartridge communication interfaces 440a, 440b. Each communication interface enables communication with corresponding circuitry on the actuation unit 20. Information obtained from each cartridge chip set 441 is processed by the actuation unit 20 or a remote processor. Such information can be used to determine whether a cartridge is properly installed or whether a proper cartridge is installed. If information obtained through the cartridge communication interfaces reveals an error, a system failure may occur and the system will not be operational until the failure is corrected.

[0064] In some applications, each cartridge 410 is programmed via chipset 441 so that the cartridge can be used only once and then discarded. If a previously used cartridge is installed in actuation unit 20, a system failure will occur and the cartridge cannot be used.

[0065] Optical Support Guide 12 and 14, an optical support guide 260 is provided to ensure proper alignment of the rod lens with the holding arm interface 30 and the tube assembly 24. The optical support guide 260 defines an insertion location for a rod lens 266 that travels along the length of the tube assembly 24 to provide real-time viewing of the tissue working space and the surgical tool 46. The optical guide support 260 is located between the first and second cartridge slots 220, 230. The optical guide support 260 comprises a hollow tube mounted on a rigid standoff secured to the platform 208 on the actuation unit 20. The first and second cartridge tracks 222, 232 are angled to form a gap space between the tracks. This gap provided by the angled orientation of the first and second cartridge tracks provides space for positioning the camera and lens. If the first and second cartridge tracks 222, 232 did not have an angled orientation, there would not be enough room to position the camera and lens. However, if the first and second cartridge tracks 222, 232 are spaced apart in a parallel configuration, it would be nearly impossible to insert each concentric tube array toward its corresponding funnel channel. In some embodiments, the first and second cartridge tracks 222, 232 each have an angle between about 5° and about 30° relative to the central longitudinal axis. As shown in FIG. 14, a lens opening 264 is defined in the funnel, and a rod lens may be inserted through the optical support guide 260 and into the lens opening 264. The aperture of the optical support guide 260 is axially aligned with the lens opening 264 and the corresponding linear lens channel defined through the funnel. With reference to FIG. 34, in some embodiments, the optical support guide 260 is provided with a manual adjustment feature 200 that allows the optics to be manually adjusted and locked in place. In some embodiments, the adjustment feature 200 may include a thumbscrew that tightens onto the optical support guide 260.

[0066] Visual Control and Coordination In some embodiments, the optical system may utilize an "end-of-tip" imaging sensor, such as CMOS or CCD technology with integrated illumination, thereby eliminating the need for the camera 22 or telescope 260. In one or more embodiments, the imaging sensor may be mounted at the tip of the concentric tube assembly 24, thereby allowing the surgeon's field of view to be dynamically changed during the procedure. This may be done by a third concentric tube manipulator. In some embodiments, the robotic system 10 may provide actuation of either the optical system, i.e., the telescope 260, or the image sensor, thereby allowing the surgeon's field of view to be dynamically changed during the procedure. Changing the surgeon's field of view may be under the surgeon's direct control via input at the physician input console 40, or a control algorithm may move the image sensor in response to the surgeon's instrument movements communicated at the first or second input controls 42, 44. This may include "eye-in-hand" technology, allowing tracking of instruments, or points or areas between instruments.

[0067] Status Light In some embodiments, the actuation unit 20 and holding arm interface 30 each include status lights that provide information to a user based on light pattern, light color, and light duration. For example, as shown in FIG. 14, a first status light 272 may indicate that the first cartridge slot 220 is ready to receive a first cartridge, and a second status light 274 may indicate that the second cartridge slot 230 is ready to receive a second cartridge. Such lights may also indicate if a fault has occurred with the cartridge, motor, or coupling.

[0068] 15, an arm light 280 is located on the arm mount 18 on the holding arm 12. The arm light 280, in some embodiments, comprises a ring of light oriented around the periphery of the arm mount 18. The arm light 280 may be illuminated in different colors to indicate different operational or fault conditions of the system. Due to the location of the arm light 280, an operator may visually observe the arm light 280 to gain an immediate understanding as to the status of the system. In some embodiments, the arm light 280 is configured to indicate an impedance mode of the holding arm 12. Such modes may include a first color indicating an endoscope shaft mode, a second color indicating a stable holding mode, and a third color indicating a free motion mode. Such a visual feedback mechanism provides an additional human factor safety feature.

[0069] In some embodiments, the status lights 272, 274 may also be used to indicate when it is safe to remove the actuation unit 20 from the patient's body. It is possible that a surgeon or operating room staff may forget to fully retract the manipulator before removing the actuation unit 20 and the entire endoscope from the patient. Failure to retract the manipulator may result in injury to the patient during this process. One or more status lights 272, 274 on the actuation unit 20 may indicate when it is safe to remove the actuation unit 20. This information may be included as part of the operating room staff and surgeon training. Additionally, the status lights 272, 274 on the actuation unit 20 or the light indicators 106 on the physician input console 40 (as depicted in FIG. 17 ) may change color to match the color of the inserted instrument cartridge 410 once the inserted instrument cartridge 410 is recognized by the robotic system 10. The color of the instrument cartridge 410 may be tool specific, and this change in the status lights 272, 274 or indicator lights 106 may provide feedback to the user that the system 10 has recognized the correct instrument. Finally, during actuation of the electrosurgical instrument cartridge 410, the status lights 272, 274 or indicator lights 106 may change to yellow or blue. Yellow may be the color recognized for electrosurgical ablation, and blue may be the color recognized for electrosurgical coagulation. In one or more embodiments, other colors may be used. This may provide feedback that the system 10 is behaving as expected and allow easier detection by the user of any incorrect operation of the system. In some embodiments, these status light features provide a safer system 10 and allow the user more awareness of the status of the system.

[0070] Embedded Motor Control Referring again to FIG. 14, another feature of the present disclosure provides a system including an actuation unit 20 with integrated motor control of the actuation unit 20 and on-board safety controller hardware. Some conventional robotic systems for performing surgery include remote motor control and safety controller hardware that is connected to the actuator via a communication cable. However, in the present system, due to the multiple degrees of freedom control presented for each cartridge, such a conventional configuration is not feasible. The present disclosure provides a system including motor control and safety controller hardware housed on-board the actuator.

[0071] Grip tool release Some cartridges may employ a surgical tool 46 that can be actuated to grip or grasp tissue. Such instruments include a resection device, a gripper device, a forceps, or a basket. If the grip tool 46 engages tissue and a power loss occurs, it may be necessary to manually release the grip tool 46 from the tissue, thereby allowing the tool 46 to be retracted without causing trauma. The present disclosure provides a grip mechanism cartridge that includes a mechanical grip release such that the grip can be released in the event of a power loss. The grip release in some embodiments includes a manually retractable pin that releases the grip. Numerous other suitable mechanical grip release mechanisms for gripping the grip tool 46 cartridge may be employed.

[0072] Holding Arm Interface As mentioned above, the holding arm interface 30 includes a mechanical and electrical connection between the holding arm 12 and the actuation unit 20. The holding arm interface 30 is configured with numerous features that may be used alone or in combination with other functions in a surgical system. Additionally, the holding arm interface 30 is configured to provide sterility in the surgical field by allowing modular attachment of various components, including the endoscope sheath assembly and the actuation unit 20.

[0073] Joint Limits and Tool Tip Safety Limits The present disclosure provides a number of safety features to reduce the risk of patient injury or equipment damage. In some embodiments, the present disclosure provides a system that utilizes software-based limits on the range of motion of the surgical tools 46 and the concentric tube arrays 414. Such software-based limits prevent the drive joints from overextending any tube arrays 414 or tools 46 within the tissue working space beyond a predetermined range, even though the range of motion that can actually be mechanically achieved by the device extends beyond the programmed field. By programming the control software to impose limits on the range of motion of the tube arrays 414 and tools 46 within the working space, a safety factor can be provided to prevent inadvertent damage to surrounding tissue during surgery.

[0074] In addition to software-based limitations, the cartridge itself includes hardware-based constraints on the range of motion available to the tube arrays 414 and tools 46. For example, the gear drive 448 includes mechanical stops on the drive gears due to the limits on the range of motion that can be imposed on each tube array 414 and tool 46.

[0075] Another variable that defines the working space for the tube array 414 and tools 46 includes the field of view of the camera 22 and rod lens endoscope. The rod lenses provide a field of view at the distal end of the tube assembly 24. In some embodiments, the system is configured with software and / or hardware based constraints to constrain the movement of the tube array 414 and tools 46 to the space visible within the field of view of the lenses. If the tube array 414 or tools 46 attempt to extend beyond the field of view, an error fault is generated and the range of motion is immediately restricted to prevent the tube array 414 or tools 46 from passing outside the field of view.

[0076] Surgeon Workspace Interface 16 and 17, in one embodiment, the physician input console 40 provides an interface to the surgeon. The interface may include a screen 102, one or more buttons 104, a speaker, or a light indicator 106. The screen 102 may include a touch screen and may be operable through the drape, and may display system status, surgical procedure duration, status of the holding arm 12, or indicate which instrument is on the left side of the system or the right side of the instrument. One embodiment of a graphical user interface 108 that may be displayed on the screen 102 is shown in FIG. 18. The interface 108 may also display recoverable or non-recoverable fault information and instructions to the user to resume. The interface 108 may provide graphical instructions to re-register the input control 42. The physician input console 40 may issue an audible signal before the start of a new manipulator movement, which may serve as a safety feature to detect and alert the operating room staff of an intentional subsystem failure. One or more buttons 104 or touch screen 102 may provide input that can start surgery, pause surgery, or end surgery. The screen 102 may provide instructions for proper system set-up, failure, and operation. The screen 102 or speaker may alert the user if system steps are performed out of sequence, for example if the actuation unit 20 is unplugged before removing the instrument cartridge 410.

[0077] 17, in one embodiment, the physician input console 40 provides an input control adjuster 110 that, when rotated, provides side-to-side adjustment of the first or second input controls 42, 44 in one or more horizontal tracks 112. This ergonomic adjustment provides comfort to the surgeon across anatomical variations and preferences. The input control adjuster 110 may include a knob, dial, or other type of input control adjuster.

[0078] Surgeon Input Device Re-Registration Process The first or second input control 42, 44 may become disregistered with the concentric tube manipulator when no intent is detected, when the procedure is paused, when a fault is detected, or when it is moved before or after the procedure is started. Re-registration instructions are provided on the screen 102. The re-registration instructions may include a real-time transparent three-dimensional overlay of the current position or orientation of the first or second input control 42, 44 on top of the desired / re-registered pose of the first or second input control 42, 44 and a progress indicator that displays the progress of the re-registration. Similarly, the re-registration instructions may include a two-dimensional target marker and a current two-dimensional position marker along with the progress indicator. A possible embodiment of the re-registration instructions on the graphical interface is shown in Figures 19A and 19B.

[0079] Surgeon Workspace Ergonomics In some embodiments, the robotic system 10 may impose one or more anatomical constraints on the surgeon using the system 10. These anatomical constraints may create short-term or chronic surgeon discomfort because some surgical procedures may be long and the surgeon may perform some procedures repetitively. The system 10 includes a physician input console 40 that can adjust the position of the upper tray 114 or the first or second input controls 42, 44, thereby allowing the surgeon operator to stand or sit when using the input controls 42, 44. In one embodiment, a four-bar linkage 116 allows this movement and a gas spring 118 provides gravity compensation to keep the tray from falling due to gravity. The design of the four-bar linkage 116 moves the upper tray 114 toward the surgeon as it moves downward, thereby creating additional foot space on the ground when the surgeon is in a seated position. In some embodiments, the physician input console 40 may not impose specific foot position requirements on the surgeon to operate any of the surgeon controls of the physician input console 40. In one or more embodiments, the base 120 of the physician input console 40 is configured as an "X" or "U" shape to increase the available leg room for the surgeon while providing a large wheel base for stability of the physician input console 40 during transport. The base 120 may include one or more casters 122 or other types of wheels for transporting the physician input console 40. The surgeon or other operator may adjust the position of the upper tray 114 by depressing an input either in the side handle 124 or on the bottom of the upper tray 114. In some embodiments, this input may include a toggle input 126, as shown in FIG. 20A. In other embodiments, the input may include a push input 128, as shown in FIG. 20B.

[0080] Prior art surgical robotic systems often require a specific elbow, head, forehead, or forearm position in the physician interface. Often, the surgeon controls are only activated when a sensor measures a specific position of the elbow, head, forehead, or forearm. In certain embodiments, the physician input console 40 does not impose elbow or forearm position constraints on the surgeon. Prior art surgical robotic systems may provide a physician interface that limits the surgeon's view of the operating room. The surgeon's view may be limited by a large screen in front of them or by requiring them to look into an eyepiece integrated into the physician interface. In one embodiment, the physician input console 40 does not obstruct the view of the operating room while operating the first or second input controls 42, 44. The physician interfaces of prior art surgical robotic systems typically prevent a surgeon in the later stages of pregnancy from operating the surgeon controls due to anatomical constraints imposed by the physician interface. The physician input console 40 may not impose anatomical constraints that would prevent use by an operator in the later stages of pregnancy.

[0081] Surgeon Input Device Ergonomics In the disclosure that follows, the subject matter will be discussed with reference to the first input control 42, but such discussion is also applicable to the second input control 44. With reference to FIGS. 23A and 23B, in one embodiment, the first control 42 handle is cylindrically shaped to allow for a precision grip, a full grasp, an overhand grip, or an underhand grip. The first input control 42 may be shaped or configured to allow for depression of the tool button by the index finger or thumb, each of such grips being shown in FIG. 24. The cylindrical shape may allow for a precision or strong / full grasp. The first input control 42 may be shaped such that the grip surface is contained within a bounding cylinder of 1 inch diameter and 1.5 inches diameter. The first input control 42 handle may include other orientation features, such as one or more flats 130 or raised edges 132, allowing the surgeon to tactilely orient the handle in their hand without having to look down at the handle. This makes surgery safer by allowing the surgeon to keep their gaze fixed on the display 60 in the operating room. In some grips, a rounded top 134 of the handle may fit in the palm of the surgeon's hand (see FIG. 24). By securing this rounded top 134 in the palm, a strong and stable support structure for control of the first control 42 may be created in the surgeon's palm. This may be made possible by an internal bearing 138 depicted in FIG. 25. The handle may include a roll degree of freedom about the main axis 136. In one embodiment, these sensors 140 may include potentiometers, and redundant angular position sensors 140 may be provided in the first input control 42 for additional safety. The roll degree of freedom may be sensed by one or more angular position sensors 140. The first input control 42 may be configured to provide damped friction for each degree of freedom. In the handle of the first input control 42, this may include a friction add feature 142. The first control 42 can be released and re-gripped. The first control 42 can be lightweight or statically balanced so that it cannot move once released.

[0082] Surgeon Input Device Tool Buttons As can be seen from FIG. 23A, in some embodiments, the first control 42 may include two integrated tool buttons 144a, 144b. The system 10 may deliver an array of tools 46, including, among others, gripping tools, tools that encircle and grasp tissue, such as baskets or snares, or energy delivery tools, such as lasers or electrosurgical probes. The first input control 42 may include two tool buttons 144a and 144b for actuation of these tools 46. For tools 46 that are capable of extension / retraction, the distal (i.e., furthest from the surgeon) button 144a may include an arrow pointing away from the surgeon. When pressed and held, the button 144a may cause the tool 46 to extend out of the manipulator. The proximal button 144b may include an arrow pointing towards the surgeon. When pressed and held, the button 144b may cause the tool 46 to retract back into the manipulator tip. One of the two tool buttons 144a, 144b may be colored yellow and activate an electrosurgical cut input. The other of the two tool buttons 144a, 144b may be colored blue and activate an electrosurgical coagulation input. Depression of these buttons may open or close an electrical contact or generate another electrical information signal that may serve as an activation input to an electrosurgical generator. This electrosurgical generator may be included in the system 10 or may interface with the system 10. These tool buttons 144a, 144b may be between 40 and 80 millimeters from the end of the first input control 42 handle. This measurement is shown as length A in FIG. 23B.

[0083] Surgeon input device intent sensing Referring to FIG. 26, in one embodiment, the first input control 42 handle includes an internal flexible circuit board 184 wrapped around the longitudinal axis and is capable of sensing capacitance changes in multiple channels (146a, 146b, 146c) resulting from contact, including through drapes and gloved conditions. The purpose of this capacitance sensing is to determine intent. In one embodiment, the capacitive touch sensor includes seven independent channels around the longitudinal axis. If the first input control 42 is accidentally bumped or struck by the cable, or if the physician input console 40 is accidentally bumped, these movements are not communicated to the concentric tube manipulator. While intent sensing is an important safety consideration, this embodiment may not impose additional non-ergonomic constraints on the surgeon (e.g., elbow position, forehead position, etc.) as is common in other systems. The control system may include multiple channels 146a, 146b, 146c for activating potentially non-adjacent channels to transmit the surgeon's control actions to the manipulators at the surgical site, which may provide additional safety by preventing motion from being transmitted to the concentric tube manipulators if the first input 42 is bumped on one side and not gripped on both sides.

[0084] Physician interface in the sterile field Prior art surgical robotic systems typically require the physician interface to be used outside the sterile field. The physician input console 40 may be configured to be used within the sterile field if desired. With reference to FIGS. 16 and 27A, in some embodiments, a drape bar 150 may allow the drape 148 to be "tensioned" over the first or second inputs 42, 44 so that they do not interfere with the drape 148 during operation. After the drape 148 is tensioned over the drape support bar 150, the drape 148 may descend toward the floor and cover approximately halfway between the upper tray 114 and the floor. As can be seen from FIG. 27B, in one embodiment, the drape 148 may extend above both the first or second input controls 42, 44 and may include tear tabs 152 and coated wires at the interface between the handles on both sides and the main input control 42, 44 shaft. In one embodiment, the coated wire can be fixed and the tear tab 152 can be torn away such that the handle portion of the drape 148 is independent of the rest of the drape, allowing the drape 148 to rotate without binding and without restriction while still maintaining a sterile interface.

[0085] Articulated Arm Base 28, in some embodiments, the articulated arm base 154 may provide instructions for setup and shutdown on a screen or touch screen 156. This screen 156 may allow the user to command the extension of the articulated holding arm 12 to apply drapes. The screen 156 may further allow the user to command the calibration of the holding arm 12 and may allow the application of caster brakes 158. The screen 156 may include the display 60 or the screen 102. In some embodiments, the articulated arm base 154 may provide actuated or passive vertical adjustments that allow the articulated holding arm 12 to be positioned further or closer to the ground. The articulated arm base 154 may include storage 160 for other system equipment, such as a holding arm electronic controller, power supply, or isolation transformer. The articulated arm base 154 may include space for endoscopic equipment and an electrosurgical generator.

[0086] 29, an articulated arm base 162 may be mountable to a rail of an operating table 50. The holding arm 12 may be actuated or passive with a brake function. The mounting may include a vertical bar 164 that may allow adjustment of the vertical position of the articulated holding arm 12 to accommodate patient positioning and patient anatomy.

[0087] In one embodiment, the articulated arm base 162 may include a cart similar to that of Fig. 28, but may also include mounting features similar to operating room rails, allowing the articulated holding arm 12 to be detached and reattached in many possible configurations. This allows for further versatility for patient positioning and clinical display relative to the system 10.

[0088] emergency stop device 17, in one embodiment, the physician input console 40 includes an emergency stop device 166 that can immediately prevent movement of the holding arm 12 (if activated), movement of the manipulator, or electrosurgical output. With reference to FIGURE 29, the articulated arm base 154 can include an emergency stop device near the touch screen 156 that performs a function equivalent to the emergency stop device 166 of the physician input console 40. The emergency stop device 166 is a feature for the safety of operating room staff or surgeon in the event that the system 10 is behaving in an unexpected or unsafe manner.

[0089] Motor Control Safety Monitoring System Referring to FIG. 30 , in one embodiment, the actuation unit 20 includes a safety monitoring system 170. The purpose of this system 170 is to stop one or more motors 172 in a motor system 174 if safety limits are violated. This safety monitoring system 170 includes redundant computing elements (such as safety central processors 176(1) and 176(2)) that read and compare motor position and speed values ​​to commanded position and speed values. If these values ​​are within safety limits, the computing elements send a heart rate signal to a heart rate monitor integrated circuit chip (such as heart rate monitor 178(1) or 178(2)), which latches a safety relay (such as safety relay 180(1) or 180(2)) in communication with one or more motor drivers 182 that control motor power to the actuators. If the computing elements become stuck or unresponsive, the heart rate monitor 178(1) or 178(2) activates relay 180(1) or 180(2) to stop the motor 172. Without power, the safety relay 180(1) or 180(2) is open, so no power reaches the motor 172. This basic path is repeated in parallel with redundant sensors so that the safety monitoring system 170 has internal redundancy. During start-up and / or intermittently during operation, the relays 180(1) or 180(2) self-test to ensure that they can still be opened and closed as intended. This safety monitoring system 170 allows three independent failures to occur simultaneously and undetected compromising safety, which is highly unlikely. This safety monitoring system 170 may be integrated within the actuation unit 20 itself.

[0090] Cartridge Sensing Subsystem 31, in one embodiment, the instrument cartridge 410 may include a cartridge magnet 184 and an RFID tag 186. The RFID tag 186 may include information regarding the tool type of the instrument cartridge 410, information regarding whether the instrument cartridge 410 has been used before, and a password encrypted by the system 10 that may prevent the RFID tag 186 from being written to by a third party and may prevent use of an unauthorized instrument cartridge 410. Once the instrument cartridge 410 is inserted, the system 10 may verify that the instrument cartridge 410 has not been used before and may adjust the manipulator kinematics for the inserted tool 46. Additionally, the cartridge sensing subsystem may utilize an embedded magnet and Hall sensors 188 to detect when the instrument cartridge 410 is fully inserted. The actuator movement may be prevented until the instrument cartridge 410 is confirmed to be valid and fully inserted. The RFID module 190 can modulate the read power to distinguish which cartridge 410 is inserted on the left side of the actuation unit 20 and which cartridge 410 is inserted on the right side of the actuation unit 20. This subsystem allows for additional equipment to be built that only requires performing a software update on the rest of the system 10. In one embodiment, the cartridge chip set 441 can include the cartridge magnet 184 or the RFID tag 186.

[0091] Movement Through Drapery: Motor Pack 12, in one or more embodiments, the actuation unit 20 may include a drape plate 224 with integral couplings 228. This plate 224 may provide motor movement through a sterile interface to allow actuation of a manipulator integrated into a sterile instrument cartridge 410. The drape plate 224 snaps onto the side walls 204, 206 of the actuation unit 20, allowing nursing staff to easily assemble it during set-up. The motor output couplings may be located directly behind the drape plate couplings 228 and may include axial springs that allow the drape plate 224 to be snapped onto the wall without aligning its couplings with the motor couplings. During actuation, the actuation unit 20 rotates 360 degrees on each of its axes, allowing the motor output couplings to flex into the correct mating position with the drape plate 224. The couplings are then held flat to allow insertion of the instrument cartridge 410 utilizing a flat head interface. FIG. 32 depicts a drape plate 224 integrated into the actuation unit drape 192 .

[0092] Articulated holding arm unlocked In one embodiment, the articulated holding arm 12 includes a grip handle for a strong power grip. The handle diameter may be 1-4 inches. The handle may include an unlocking mechanism. In the case of an actuated holding arm 12, the unlocking mechanism may include a button or switch contact that may be connected to the holding arm control system. The unlocking mechanism may include multiple buttons that allow different types of motion, such as motion only along the endoscope axis, heavily damped motion, lightly damped motion, translation only (no rotation), rotation only, or rotation only about a selectable center of rotation. In the case of a passive holding arm 12, the unlocking mechanism may include a mechanism to unlock all joints of the articulated holding arm 12. The handle may be located near the center of mass of the actuation unit 20, making it easier for operating room staff to operate without feeling large torques in their hands.

[0093] Device Cartridge Delivery Tool Interface Referring to FIG. 14, in one embodiment, the instrument cartridge 410 may include user access to the lumen of the concentric tube manipulator from the back of the instrument cartridge 410. A moving rod 490 may provide user access. This moving rod 490 may move with the innermost tube of the concentric tube manipulator. The distal tip of the innermost tube of the concentric tube manipulator may include the tip of the instrument that the surgeon sees in the surgical field. When a deliverable tool 46 or instrument is delivered to the tip of the manipulator through this rod 490 and secured to the movable rod 490, the instrument may move with the tip of the manipulator. The movable rod 490 may include a collet mechanism or similar mechanism to axially hold a deliverable instrument such as a laser fiber or electrosurgical probe. This allows for the use of existing probes or devices inside the instrument cartridge 410 that do not need to be provided pre-assembled. Also, if these instruments can be re-fabricated, this allows for the possibility of reuse, saving hospitals money for procedures.

[0094] Non-circular concentric tube manipulator tip 33A and 33B, in one embodiment, the tip 194 of the innermost tube of the concentric tube assembly 24 is shown. In some tool configurations, it is useful to form the tip 194 into a non-circular cross section. The concentric tube manipulator may include Nitinol, a material that can be temperature set into different shapes. This non-circular shape may be useful for tools 46 that have a non-circular cross section. These tools 46 may still be able to translate within the tube, but are prevented from rotating relative to the manipulator tip 194. This means that the tools 46 may provide a relatively high torsional stiffness, which may be useful in many surgical situations. This may, for example, allow for electrosurgical probes to be made stiffer, more robust, or for gripping or retracting tools to be more robust, allowing for more force to be applied to tissue without deflection, allowing for more useful retracting tools.

[0095] Thus, while specific embodiments of a novel and useful system for performing minimally invasive surgery of the present invention have been described, such references are not intended to be construed as limiting the scope of the invention except as set forth in the following claims or any additional claims that may be provided in a future application claiming priority to this provisional application.

Claims

1. A holding arm; a holding arm interface removably secured to the holding arm; an actuation unit removably secured to the holding arm interface; an endoscope sheath assembly comprising an inner sheath and an outer sheath removably secured to the holding arm interface opposite the actuation unit.

2. The device of claim 1 , wherein the holding arm comprises an articulated holding arm.

3. 10. The instrument of claim 1, further comprising a removable cartridge disposed on the actuation unit, the removable cartridge comprising a concentric tube array extending through the retaining arm interface and into the endoscope sheath assembly.

4. The instrument of claim 3 , further comprising a channel disposed inside the inner sheath, the array of concentric tubes being positioned inside the channel.

5. The instrument of claim 4 , further comprising an interface mount on the holding arm interface, the interface mount providing a connection between the holding arm and the holding arm interface.

6. The instrument of claim 4 , wherein the actuation unit is detachable from the holding arm interface along a longitudinal axis.

7. The instrument of claim 6 , wherein the endoscope sheath assembly is detachable from the holding arm interface along the longitudinal axis.

8. The concentric tube array comprises: Axial movable along said longitudinal axis; or The instrument of claim 7 , at least one of which is angularly movable about said longitudinal axis.

9. The instrument of claim 8 , wherein the holding arm interface comprises a base plate and a shell, the base plate being angularly movable relative to the shell about the longitudinal axis at a rotational joint.

10. The instrument of claim 9 , wherein the actuation unit is angularly movable relative to the holding arm interface via the rotational joint.

11. 11. The instrument of claim 10, further comprising a brake disposed on the holding arm interface, the brake configured to selectively angularly lock the actuation unit at a desired angular orientation relative to the holding arm interface.

12. The instrument of claim 11 , further comprising a handle on the holding arm interface.

13. The instrument of claim 12, further comprising a first button on the handle, the first button configured to selectively activate a function of the system.

14. The device of claim 3 , wherein the cartridge further comprises a plurality of cartridge fittings.

15. The instrument of claim 14 , wherein the actuation unit further comprises a plurality of actuation joints, each actuation joint corresponding to a cartridge joint.

16. a linear cartridge slot defined on the cartridge; a joint flange protruding from each of the actuation joints; The instrument of claim 15 , wherein each fitting flange is received within the linear cartridge slot when the cartridge is inserted into the actuation unit.

17. 17. The instrument of claim 16, further comprising a linear fitting slot defined in each cartridge fitting, each cartridge fitting receiving a corresponding fitting flange when the cartridge is fully inserted into the actuation unit.

18. 20. The instrument of claim 17, further comprising a plurality of drive motors disposed on the actuation unit, each drive motor coupled to an actuation joint, each drive motor operative to control rotation of a corresponding cartridge joint.

19. 20. The apparatus of claim 18, further comprising a chipset disposed on the cartridge, the chipset comprising a memory configured to store information regarding the cartridge.

20. 20. The instrument of claim 19, further comprising a latch on the actuation unit, the latch selectively operable to secure or detach the cartridge to the actuation unit.

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