Sample collector for robotic medical system

Abstract

Described herein are sample collectors configured for use with robotic medical systems. A robotic medical system can include a medical instrument that can be inserted into a patient to capture a sample. A robotic manipulator can be engaged with the medical instrument and configured to operate the medical instrument; a sterile barrier can be used to separate a sterile field containing the medical instrument from a non-sterile field containing the robotic manipulator; a sample collector can include a receiver portion positioned in the sterile field and configured to receive the sample when a distal end of the medical instrument is retracted from the patient; and a connector coupled to the receiver portion and configured to attach to the robotic medical system. The robotic system can place the sample in the receiver portion.

Description

[0001] Priority application

[0002] This application claims priority to U.S. Provisional Application 62 / 955,050, filed December 30, 2019, which is incorporated herein by reference. Technical Field

[0003] The systems and methods disclosed herein relate to robotic medical systems, and more specifically to sample collectors for robotic medical systems. Background Technology

[0004] Robotic medical systems can be configured to perform a variety of medical procedures, including endoscopic, laparoscopic, and open surgeries. During some procedures, medical instruments can be used to remove objects, samples, or specimens from the patient's body. As an example, in kidney stone removal surgery, medical instruments can be used to remove kidney stones or fragments of kidney stones. Attached Figure Description

[0005] The disclosed aspects will be described below in conjunction with the accompanying drawings, which are provided to illustrate and not limit the disclosed aspects, wherein similar reference numerals denote similar elements.

[0006] Figure 1 An implementation scheme of a cart-based robotic system deployed for diagnostic and / or therapeutic bronchoscopy is shown.

[0007] Figure 2 Depicting Figure 1 Another aspect of robotic systems.

[0008] Figure 3 The setup for ureteroscopy is shown. Figure 1 The implementation plan for the robot system.

[0009] Figure 4 The diagram shows the arrangement used for vascular procedures. Figure 1 The implementation plan for the robot system.

[0010] Figure 5 An implementation scheme of a table-based robotic system deployed for bronchoscopy procedures is shown.

[0011] Figure 6 Provided Figure 5 An alternative view of the robot system.

[0012] Figure 7 An exemplary system configured to retract a robotic arm is shown.

[0013] Figure 8An implementation scheme of a table-based robotic system configured for ureteroscopy procedures is shown.

[0014] Figure 9 An implementation scheme of a table-based robotic system constructed for laparoscopic procedures is shown.

[0015] Figure 10 It shows Figures 5 to 9 An implementation scheme for a platform-based robot system with pitch and tilt adjustment.

[0016] Figure 11 Provided Figures 5 to 10 A detailed diagram of the interface between the platform and the column of the platform-based robotic system.

[0017] Figure 12 An alternative implementation of a stage-based robotic system is shown.

[0018] Figure 13 It shows Figure 12 An end view of a platform-based robotic system.

[0019] Figure 14 An end view of a platform-based robotic system with a robotic arm attached is shown.

[0020] Figure 15 An exemplary device driver is shown.

[0021] Figure 16 An exemplary medical device with paired instrument drivers is shown.

[0022] Figure 17 An alternative design of the instrument actuator and the instrument is shown, wherein the axis of the actuator is parallel to the axis of the slender axis of the instrument.

[0023] Figure 18 An instrument with an instrument-based insertion architecture is shown.

[0024] Figure 19 An example controller is shown.

[0025] Figure 20 A block diagram according to an exemplary embodiment is depicted, illustrating the estimation Figures 1 to 10 The location of one or more components of a robotic system (such as...) Figures 16 to 18 A positioning system for the location of instruments.

[0026] Figure 21 A top view of an implementation of a robotic medical system including a sample collector is shown.

[0027] Figure 22 yes Figure 21Side view of the robotic medical system and sample collector.

[0028] Figure 23 This is a perspective view of the distal end of an embodiment of a robotic arm covered with a sterile covering and including a sample collector.

[0029] Figure 24 It is shown that it is used for Figure 21 A block diagram of an exemplary control component of the robotic medical system shown.

[0030] Figure 25 It shows that it can be used Figure 24 The control unit shown performs the operation. Figure 21 A flowchart illustrating an exemplary control method for the robotic medical system.

[0031] Figure 26 This is a front view of one implementation of a sample collector.

[0032] Figure 27 yes Figure 26 The diagram shows an exploded view of the sample collector.

[0033] Figure 28 This is a flowchart illustrating an exemplary method of placing a sample in a sample collector using a robotic medical system.

[0034] Figure 29 An isometric view of an embodiment including a sterile cover for a sample collector is shown.

[0035] Figure 30 It is mounted on a cart that includes three robotic arms. Figure 29 A perspective view of the implementation scheme for the sterile covering.

[0036] Figure 31 Another embodiment of a sterile cover including a sample collector is shown.

[0037] Figure 32 An implementation scheme of a sterile barrier assembly including a sample collector is shown. Detailed Implementation

[0038] 1. Overview .

[0039] The aspects of this disclosure can be integrated into robot-enabled medical systems capable of performing a variety of medical procedures, including minimally invasive procedures such as laparoscopy and non-invasive procedures such as endoscopy. In endoscopic procedures, the system may be able to perform bronchoscopy, ureteroscopy, gastroscopy, etc.

[0040] In addition to executing a wide range of procedures, the system can provide additional benefits such as enhanced imaging and guidance to assist physicians. Furthermore, the system allows physicians to execute procedures from an ergonomic orientation, eliminating the need for cumbersome arm movements and positioning. Additionally, the system provides physicians with improved ease of use, enabling one or more instruments within the system to be controlled by a single user.

[0041] For illustrative purposes, various embodiments will be described below in conjunction with the accompanying drawings. It should be understood that many other specific embodiments of the disclosed concepts are possible, and various advantages can be achieved using the disclosed specific embodiments. Titles are included herein for reference and to aid in locating the various sections. These titled sections are not intended to limit the scope of the concepts described therein. Such concepts may be applicable throughout the specification.

[0042] A. Robotic System – Trolley .

[0043] Robot-enabled medical systems can be configured in a variety of ways, depending on specific procedures. Figure 1 An embodiment of a trolley-based, robot-enabled system 10 arranged for diagnostic and / or therapeutic bronchoscopy is illustrated. During bronchoscopy, system 10 may include a trolley 11 having one or more robotic arms 12 to deliver medical instruments, such as a manipulable endoscope 13 (which may be a procedure-specific bronchoscope for bronchoscopy), to a natural orifice entry point (i.e., the patient's mouth positioned on the table in this example), to deliver diagnostic and / or therapeutic instruments. As shown, trolley 11 may be positioned near the patient's upper torso to provide access to the entry point. Similarly, robotic arms 12 may be actuated to position the bronchoscope relative to the entry point. This can also be used when performing GI procedures using a gastroscopy (a dedicated endoscope for gastrointestinal (GI) procedures). Figure 1 The layout within. Figure 2 An exemplary implementation of the cart is described in more detail.

[0044] Continue to refer to Figure 1Once the trolley 11 is correctly positioned, the robotic arm 12 can robotically, manually, or in combination thereof insert the maneuverable endoscope 13 into the patient. As shown, the maneuverable endoscope 13 may include at least two telescopic portions, such as an inner guide portion and an outer sheath portion, each portion coupled to a separate instrument actuator from a set of instrument actuators 28, each instrument actuator coupled to the distal end of a separate robotic arm. This linear arrangement of the instrument actuators 28, which facilitates coaxial alignment of the guide portion and the sheath portion, creates a “virtual track” 29, which can be repositioned in space by maneuvering one or more robotic arms 12 to different angles and / or positions. The virtual track described herein is depicted using dashed lines in the accompanying drawings, and therefore the dashed lines do not depict any physical structure of the system. Translation of the instrument actuators 28 along the virtual track 29 causes the inner guide portion to extend or retract relative to the outer sheath portion, or to advance or retract the endoscope 13 from the patient. The angle of the virtual track 29 can be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and orientation of the virtual track 29 shown in the figure represent a trade-off between providing the physician with access to the endoscope 13 and minimizing friction caused by the endoscope 13 bending into the patient's mouth.

[0045] After insertion, endoscope 13 can be guided downwards through 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 lung network and / or reach the desired target, endoscope 13 can be manipulated to telescopically extend the inner guide portion from the outer sheath portion to achieve enhanced joint movement and a larger radius of flexion. The use of separate instrument actuators 28 also allows the guide portion and sheath portion to be driven independently of each other.

[0046] For example, endoscope 13 can be guided to deliver a biopsy needle to a target, such as a lesion or nodule in a patient's lung. The needle can be deployed downwards along the working channel, which extends the length of the endoscope to obtain a tissue sample to be analyzed by a pathologist. Depending on the pathological findings, additional tools can be deployed downwards along the working channel of the endoscope for additional biopsies. After the nodule is identified as malignant, endoscope 13 can be used to deliver endoscopic tools to remove the potential cancerous tissue. In some cases, diagnostic and therapeutic procedures can be delivered in a separate procedure. In these cases, endoscope 13 can also be used to deliver a reference point to "mark" the location of the target nodule. In other cases, diagnostic and therapeutic procedures can be delivered during the same procedure.

[0047] System 10 may also include a movable tower 30, which can be connected to the trolley 11 via support cables to provide control, electronic, fluid, optical, sensor, and / or electrical support to the trolley 11. Placing such functionality in the tower 30 allows for a smaller form factor trolley 11 that can be more easily adjusted and / or repositioned by the operating physician and his / her staff. Additionally, the division of functionality between the trolley / table and the support tower 30 reduces operating room clutter and facilitates improved clinical workflow. While the trolley 11 can be positioned close to the patient, the tower 30 can be retracted in a remote location to avoid obstructing the path during procedures.

[0048] To support the aforementioned robotic system, tower 30 may include components of a computer-based control system that stores computer program instructions in a non-transitory computer-readable storage medium such as a permanent magnet memory drive, a solid-state drive, etc. Whether execution occurs within tower 30 or cart 11, the execution of these instructions can control the entire system or its subsystems. For example, when executed by the processor of the computer system, the instructions can cause components of the robotic system to actuate relevant brackets and arm mounts, actuate the robotic arm, and control medical devices. For instance, in response to receiving a control signal, motors in the joints of the robotic arm can position the arm into a specific posture.

[0049] Tower 30 may also include pumps, flow meters, valve controllers, and / or fluid passages to provide controlled flushing and suction capabilities to a system that can be deployed via endoscope 13. These components may also be controlled using a computer system of tower 30. In some embodiments, flushing and suction capabilities may be delivered directly to endoscope 13 via a separate cable.

[0050] Tower 30 may include voltage and surge protectors designed to provide filtered and protected power to trolley 11, thereby avoiding the need to place power transformers and other auxiliary power components in trolley 11, resulting in a smaller and more mobile trolley 11.

[0051] Tower 30 may also include support devices for sensors deployed throughout the robotic system 10. For example, 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 a control system, such optoelectronic devices can be used to generate real-time images for display in any number of consoles deployed throughout the system (including displays within tower 30). Similarly, tower 30 may also include electronic subsystems for receiving and processing signals received from deployed electromagnetic (EM) sensors. Tower 30 may also be used to house and position EM field generators for detection by EM sensors in or on a medical device.

[0052] In addition to other consoles available in the rest of the system (e.g., a console mounted on top of a cart), tower 30 may also include console 31. Console 31 may include a user interface and display, such as a touchscreen, for physician operators. Consoles in system 10 are generally designed to provide both robot control and preoperative and real-time information for procedures, such as navigation and positioning information for endoscope 13. When 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 system 10, as well as to provide procedure-specific data, such as navigation and positioning information. In other embodiments, console 30 is housed in a separate body from tower 30.

[0053] Tower 30 can be coupled to cart 11 and endoscope 13 via one or more cables or connectors (not shown). In some embodiments, support functionality from tower 30 can be provided to cart 11 via a single cable, thereby simplifying the operating room and eliminating clutter. In other embodiments, specific functions can be coupled in separate wiring and connections. For example, while power can be provided to cart 11 via a single cable, support for controls, optics, fluid, and / or navigation can also be provided via separate cables.

[0054] Figure 2 Provided from Figure 1 The illustration shows a detailed depiction of an embodiment of a cart 11 in a cart-based robot-enabled system. The cart 11 typically includes an elongated support structure 14 (often referred to as a "post"), a cart base 15, and a console 16 at the top of the post 14. The post 14 may include one or more brackets, such as those for supporting one or more robotic arms 12. Figure 2 The bracket 17 (or alternatively, "arm support") is deployed in three configurations. The bracket 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 bracket 17 also includes a bracket interface 19 that allows the bracket 17 to translate vertically along the post 14.

[0055] The bracket interface 19 is connected to the column 14 via a slot, such as slot 20, positioned on the opposite side of the column 14 to guide the vertical translation of the bracket 17. Slot 20 includes a vertical translation interface to position and hold the bracket 17 relative to the trolley base 15 at various vertical heights. The vertical translation of the bracket 17 allows the trolley 11 to adjust the reach of the robotic arm 12 to accommodate various table heights, patient sizes, and physician preferences. Similarly, individually configurable arm mounts on the bracket 17 allow the robotic arm base 21 of the robotic arm 12 to be configured at various angles.

[0056] In some embodiments, slot 20 may be supplemented with a slot cover flush and parallel to the slot surface to prevent dust and fluid from entering the internal cavity of column 14 and the vertical translation interface during the vertical translation of bracket 17. The slot cover can be deployed via a pair of spring reels positioned near the vertical top and bottom of slot 20. The cover is coiled within the reels until it is deployed to extend and retract from its coiled state during the vertical up-and-down translation of bracket 17. The spring loading of the reels provides a force to retract the cover into the reels as bracket 17 translates toward the reels, while maintaining a tight seal as bracket 17 translates away from the reels. The cover can be attached to bracket 17 using, for example, a bracket in bracket interface 19, to ensure proper extension and retraction of the cover during the translation of bracket 17.

[0057] The column 14 may internally include mechanisms such as gears and motors, which are designed to mechanically translate the bracket 17 using vertically aligned lead screws in response to control signals generated in response to user input (e.g., input from the console 16).

[0058] A robotic arm 12 typically includes 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, and each actuator including an independently controllable motor. Each independently controllable joint represents an independent degree of freedom available to the robotic arm 12. Each robotic arm in the robotic arm 12 may have seven joints, and thus provide seven degrees of freedom. Multiple joints result in multiple degrees of freedom, thus allowing for “redundant” degrees of freedom. Having redundant degrees of freedom allows the robotic arm 12 to position its corresponding end effector 22 in a specific orientation, orientation, and trajectory in space using different joint positions and joint angles. This allows the system to locate and guide medical devices from desired points in space, while allowing physicians to move the arm joints to a clinically advantageous orientation away from the patient to achieve greater proximity while avoiding arm collisions.

[0059] The cart base 15 balances the weight of the counterweight 14, bracket 17, and robotic arm 12 on the floor. Therefore, the cart base 15 houses heavier components such as electronics, motors, power supplies, and components that enable the cart 11 to move and / or be secured. For example, the cart base 15 includes rollable wheel-shaped casters 25 that allow the cart 11 to easily move around the room before the procedure. Once in the correct orientation, the casters 25 can be secured using wheel locks to hold the cart 11 in the correct orientation during the procedure.

[0060] The console 16, positioned at the vertical end of column 14, allows both a user interface for receiving user input and a display screen (or dual-purpose device, such as, for example, touchscreen 26) to provide both preoperative and intraoperative 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. Intraoperative data on the display screen may include optical information from tools and sensors, coordinate information from sensors, and important patient statistics such as respiration, heart rate, and / or pulse. The console 16 can be positioned and tilted to allow the physician to access it from the side of column 14 opposite to bracket 17. From this orientation, the physician can operate the console 16 from behind cart 11 while observing the console 16, robotic arm 12, and patient. As shown, the console 16 also includes a handle 27 to aid in manipulating and stabilizing cart 11.

[0061] Figure 3 An embodiment of a robot-enabled system 10 arranged for ureteroscopy is shown. In a ureteroscopy procedure, a trolley 11 is positioned to deliver a ureteroscope 32 (a procedure-specific endoscope designed to traverse the patient's urethra and ureter) to the patient's lower abdominal region. During ureteroscopy, it is desirable to align the ureteroscope 32 directly with the patient's urethra to reduce friction and force on sensitive anatomical structures in that region. As shown, the trolley 11 can be aligned at the foot of the table to allow the robotic arm 12 to position the ureteroscope 32 for direct linear access into the patient's urethra. The robotic arm 12 can insert the ureteroscope 32 directly into the patient's lower abdomen through the urethra from the foot of the table along a virtual track 33.

[0062] After insertion into the urethra, using control techniques similar to those used in bronchoscopy, the ureteroscope 32 can be navigated to the bladder, ureter, and / or kidney for diagnostic and / or therapeutic applications. For example, the ureteroscope 32 can be guided into the ureter and kidney to break up accumulated kidney stones using a laser or ultrasonic lithotripsy device deployed downwards along the working channel of the ureteroscope 32. After lithotripsy is complete, the resulting stone fragments can be removed using a basket deployed downwards along the ureteroscope 32.

[0063] Figure 4An embodiment of a robot-enabled system 10 for vascular procedures is illustrated similarly. In vascular procedures, system 10 can be configured such that a trolley 11 delivers a medical device 34 (such as a manipulable catheter) to an entry point in the femoral artery in the patient's leg. The femoral artery presents both a relatively large diameter for navigation and a relatively less circuitous and tortuous path to the patient's heart, which simplifies navigation. As in ureteroscopy procedures, the trolley 11 can be positioned toward the patient's leg and lower abdomen to allow the robotic arm 12 to provide a virtual track 35 for direct linear access to the femoral artery entry point in the patient's thigh / hip region. After insertion into the artery, the medical device 34 can be guided and inserted via a translational device actuator 28. Alternatively, the trolley can be positioned around the patient's upper abdomen to reach alternative vascular entry points, such as the carotid and brachial arteries near the shoulder and wrist.

[0064] B. Robot System – Unit .

[0065] Implementation plans for robot-enabled medical systems can also incorporate patient-integrated tables. Integrating tables reduces the amount of capital equipment in the operating room by removing trolleys, allowing for greater accessibility to the patient. Figure 5 An embodiment of such a robot-enabled system arranged for a bronchoscopy procedure is shown. System 36 includes a support structure or column 37 for supporting a platform 38 (shown as a "table" or "bed") on a floor. Much like a trolley-based system, the end effector of the robotic arm 39 of system 36 includes an instrument actuator 42, which is designed to manipulate elongated medical instruments, such as… Figure 5 The bronchoscope 40 is used in the bronchoscopy. In practice, the C-arm used to provide fluorescence imaging can be positioned above the patient's upper abdominal region by placing the transmitter and detector around the stage 38.

[0066] Figure 6An alternative view of system 36 without a patient and medical devices is provided for discussion purposes. As shown, column 37 may include one or more brackets 43, shown as annular in system 36, upon which one or more robotic arms 39 may be based. The brackets 43 may translate along a vertical column interface 44 extending along the length of column 37 to provide different vantage points from which the robotic arms 39 may be positioned to reach the patient. The brackets 43 may be rotated about column 37 using mechanical motors positioned within column 37 to allow the robotic arms 39 to access multiple sides of table 38, such as both sides of the patient. In embodiments with multiple brackets, the brackets may be individually positioned on the column and may translate and / or rotate independently of other brackets. While the brackets 43 need not be circular or even encircling column 37, the annular shape shown facilitates rotation of the brackets 43 about column 37 while maintaining structural balance. Rotation and translation of the brackets 43 allow system 36 to align medical devices such as endoscopes and laparoscopes to different access points on the patient. In other embodiments (not shown), system 36 may include a patient examination table or bed with an adjustable arm support, which takes the form of a rod or rail extending beside the patient examination table or bed. One or more robotic arms 39 (e.g., via a shoulder with an elbow joint) may be attached to the adjustable arm support, which can be vertically adjusted. By providing vertical adjustment, the robotic arms 39 can advantageously be compactly stored under the patient examination table or bed and subsequently raised during procedures.

[0067] The robotic arm 39 can be mounted on the bracket 43 via a set of arm mounts 45 comprising a series of joints that can be individually rotated and / or telescopically extended to provide additional configurability to the robotic arm 39. Additionally, the arm mounts 45 can be positioned on the bracket 43 such that, when the bracket 43 is properly rotated, the arm mounts 45 are positioned on the same side of the stage 38 (e.g., ...). Figure 6 As shown), on the opposite side of platform 38 (as shown) Figure 9 (as shown) or on the adjacent side of platform 38 (not shown).

[0068] Column 37 structurally supports platform 38 and provides a path for the vertical translation of bracket 43. Internally, column 37 may be equipped with a lead screw for guiding the vertical translation of the bracket, and a motor for mechanizing the lead screw-based translation of bracket 43. Column 37 may also transmit power and control signals to bracket 43 and the robotic arm 39 mounted thereon.

[0069] Platform base 46 has with Figure 2The trolley base 15 in the illustrated trolley 11 serves a similar function, accommodating heavier components to balance the table / bed 38, column 37, bracket 43, and robotic arm 39. The table base 46 may also incorporate rigid casters to provide stability during operation. Casters deployed from the bottom of the table base 46 can extend in opposite directions on either side of the base 46 and retract when the system 36 requires movement.

[0070] continue Figure 6 System 36 may also include a tower (not shown) that divides the functionality of system 36 between the table and the tower to reduce the form factor and volume of the table. As in previously disclosed embodiments, the tower may provide the table with a variety of support functions, such as processing, computing and control capabilities, electrical, fluid 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 clutter in the operating room. Additionally, placing components in the tower allows for more storage space in the table base 46 for potential retraction of the robotic arm 39. The tower may also include a main controller or console that provides both a user interface (such as a keyboard and / or widgets) for user input and a display screen (or touchscreen) for preoperative and intraoperative information (such as real-time imaging, navigation, and tracking information). In some embodiments, the tower may also include a gripper for a gas canister to be used for inflatation.

[0071] In some implementations, the base can be retracted and stored when not in use. Figure 7 A system 47 for retracting a robotic arm is illustrated in an embodiment of a platform-based system. In system 47, a bracket 48 can be vertically translated into a base 49 to retract the robotic arm 50, arm mount 51, and bracket 48 within the base 49. A base cover 52 can be translated and retracted to open to deploy the bracket 48, arm mount 51, and robotic arm 50 around a post 53, and to close to retract the bracket, arm mount, and robotic arm for protection when not in use. The base cover 52 can be sealed along the edges of its opening using a membrane 54 to prevent dust and fluid from entering when closed.

[0072] Figure 8An embodiment of a robot-enabled table-based system configured for a ureteroscopy procedure is illustrated. During ureteroscopy, table 38 may include a rotating portion 55 for positioning the patient at an angle to the column 37 and table base 46. The rotating portion 55 may rotate or pivot about a pivot point (e.g., below the patient's head) to position the lower portion of the rotating portion 55 away from the column 37. For example, pivoting the rotating portion 55 allows a C-arm (not shown) to be positioned above the patient's lower abdomen without competing for space with the column (not shown) below table 38. By rotating a bracket 35 (not shown) about the column 37, a robotic arm 39 can insert a ureteroscope 56 directly into the patient's groin region along a virtual track 57 to reach the urethra. During ureteroscopy, stirrups 58 may also be fixed to the rotating portion 55 of table 38 to support the orientation of the patient's legs during the procedure and allow full access to the patient's groin region.

[0073] In laparoscopic procedures, minimally invasive instruments are inserted into the patient's anatomical structures through one or more small incisions in the abdominal wall. In some embodiments, the minimally invasive instruments include elongated rigid components, such as axes, for accessing the anatomical structures within the patient. After the patient's abdominal cavity is inflated, the instruments can be guided to perform surgical or medical tasks, such as grasping, cutting, ablation, suturing, etc. In some embodiments, the instruments may include endoscopes, such as laparoscopes. Figure 9 An implementation of a table-based, robot-enabled system configured for laparoscopic procedures is shown. Figure 9 As shown, the bracket 43 of system 36 can be rotated and vertically adjusted to position the pair of robotic arms 39 on opposite sides of table 38, so that the instrument 59 can be positioned through the smallest incision on both sides of the patient to reach his / her abdominal cavity using arm mount 45.

[0074] To accommodate laparoscopic procedures, the robot-enabled platform system can also tilt the platform to the desired angle. Figure 10 An implementation scheme for a robot-enabled medical system with pitch or tilt adjustment is shown. For example... Figure 10 As shown, system 36 can adapt to the tilt of platform 38 to position one part of the platform at a greater distance from the base plate than another part. Additionally, arm mount 45 can rotate to match the tilt, ensuring that robot arm 39 maintains the same planar relationship with platform 38. To accommodate steeper angles, column 37 may also include a telescopic portion 60 that allows vertical extension of column 37 to prevent platform 38 from contacting the floor or colliding with platform base 46.

[0075] Figure 11Detailed illustrations are provided of the interface between platform 38 and column 37. The pitch-rotation mechanism 61 can be configured to change the pitch angle of platform 38 relative to column 37 in multiple degrees of freedom. The pitch-rotation mechanism 61 is achieved by positioning orthogonal axes 1 and 2 at the column interface, each axis being actuated by separate motors 3 and 4 in response to electrical pitch angle commands. Rotation along one screw 5 enables tilt adjustment along axis 1, while rotation along another screw 6 enables tilt adjustment along another axis 2. In some embodiments, ball joints may be used to change the pitch angle of platform 38 relative to column 37 in multiple degrees of freedom.

[0076] For example, pitch adjustment is particularly useful when attempting to position the table in a head-down, feet-up position (i.e., positioning the patient's lower abdomen higher than their upper abdomen above the floor) for lower abdominal surgery. The head-down, feet-up position causes the patient's internal organs to slide down to their upper abdomen by gravity, clearing the abdominal cavity to allow minimally invasive instruments to enter and perform lower abdominal surgical or medical procedures, such as laparoscopic prostatectomy.

[0077] Figure 12 and Figure 13 Isometric and end views of an alternative embodiment of a stage-based surgical robot system 100 are shown. The surgical robot system 100 includes one or more robotic arms (see, for example) that can be configured to support a stage 101 relative to it. Figure 14 One or more adjustable arm supports 105 are provided. In the illustrated embodiment, a single adjustable arm support 105 is shown, but additional arm supports may be positioned on opposite sides of the platform 101. The adjustable arm support 105 may be configured such that it is movable relative to the platform 101 to adjust and / or change the orientation of the adjustable arm support 105 and / or any robotic arm attached to it relative to the platform 101. For example, the adjustable arm support 105 may be adjusted with one or more degrees of freedom relative to the platform 101. The adjustable arm support 105 provides high flexibility to the system 100, including the ability to easily retract one or more adjustable arm supports 105 and any robotic arms attached thereto under the platform 101. The adjustable arm support 105 may be raised from a retracted orientation to an orientation below the upper surface of the platform 101. In other embodiments, the adjustable arm support 105 can be raised from a retracted position to a position above the upper surface of the platform 101.

[0078] The adjustable arm support 105 provides several degrees of freedom, including lifting, lateral translation, and tilting. Figure 12 and Figure 13 In the exemplary embodiment, the arm support 105 is configured to have four degrees of freedom, which are in Figure 12The arrows indicate the first degree of freedom, which allows adjustment of the adjustable arm support 105 in the z-direction (“Z-lift”). For example, the adjustable arm support 105 may include a bracket 109 configured to move up or down along or relative to the column 102 of the support platform 101. The second degree of freedom allows the adjustable arm support 105 to tilt. For example, the adjustable arm support 105 may include a rotary joint that allows the adjustable arm support 105 to be aligned with the bed in a head-down, feet-up position. The third degree of freedom allows the adjustable arm support 105 to “pivot upwards”, which can be used to adjust the distance between one side of the platform 101 and the adjustable arm support 105. The fourth degree of freedom allows the adjustable arm support 105 to translate along the longitudinal length of the platform.

[0079] Figure 12 and Figure 13 The surgical robot system 100 may include a platform supported by a column 102 mounted to a base 103. The base 103 and the column 102 support the platform 101 relative to a support surface. A floor axis 131 and a support axis 133 are... Figure 13 As shown in the image.

[0080] The adjustable arm support 105 can be mounted to the column 102. In other embodiments, the arm support 105 can be mounted to the platform 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 rail 107 can translate and move relative to each other.

[0081] The bracket 109 can be attached to the post 102 via a first connector 113, which allows the bracket 109 to move relative to the post 102 (e.g., such as up and down movement along a first axis or vertical axis 123). The first connector 113 can provide a first degree of freedom (“Z-lift”) to the adjustable arm support 105. The adjustable arm support 105 may include a second connector 115, which provides a second degree of freedom (tilt) to the adjustable arm support 105. The adjustable arm support 105 may include a third connector 117, which provides a third degree of freedom (“upward pivot”) to the adjustable arm support 105. An additional connector 119 may be provided (in... Figure 13 (As shown in the diagram), the additional joint mechanically constrains the third joint 117 to maintain the orientation of the guide rail 107 as the guide rail connector 111 rotates about the third axis 127. The adjustable arm support 105 may include a fourth joint 121 that can provide a fourth degree of freedom (translation) for the adjustable arm support 105 along the fourth axis 129.

[0082] Figure 14An end view of a surgical robot system 140A according to one embodiment, having two adjustable arm supports 105A, 105B mounted on opposite sides of a stage 101, is shown. A first robotic arm 142A is attached to a rod or rail 107A of the first adjustable arm support 105B. The first robotic arm 142A includes a base 144A attached to the rail 107A. The distal end of the first robotic arm 142A includes an instrument drive mechanism 146A that can be attached to one or more robotic medical instruments or tools. Similarly, a second robotic arm 142B includes a base 144B attached to the rail 107B. The distal end of the second robotic arm 142B includes an instrument drive mechanism 146B. The instrument drive mechanism 146B can be configured to be attached to one or more robotic medical instruments or tools.

[0083] In some embodiments, one or more of the robotic arms 142A and 142B include an arm with seven or more degrees of freedom. In some embodiments, one or more of the robotic arms 142A and 142B may include eight degrees of freedom, including an insertion axis (including one degree of freedom for insertion), a wrist (including three degrees of freedom for wrist pitch, yaw, and roll), an elbow (including one degree of freedom for elbow pitch), a shoulder (including two degrees of freedom for shoulder pitch and yaw), and a base 144A and 144B (including one degree of freedom for translation). In some embodiments, the insertion degree of freedom may be provided by the robotic arms 142A and 142B, while in other embodiments, the instrument itself provides insertion via an instrument-based insertion architecture.

[0084] C. Instrument drivers and interfaces .

[0085] The end effector of the system's robotic arm may include: (i) an instrument actuator (alternatively referred to as an "instrument drive mechanism" or "instrument device manipulator") incorporating electromechanical devices for actuating medical devices; and (ii) a removable or detachable medical device, which may lack any electromechanical components, such as motors. This dichotomy may be driven by the need to sterilize medical devices used in medical procedures, and the inability to adequately sterilize expensive capital equipment due to its complex mechanical components and sensitive electronics. Therefore, medical devices may be designed to be detached, removed, and interchanged from the instrument actuator (and thus from the system) for individual sterilization or disposal by a physician or physician staff. In contrast, the instrument actuator does not need to be altered or sterilized and can be covered for protection.

[0086] Figure 15An example instrument actuator is shown. The instrument actuator 62, positioned at the distal end of a robotic arm, includes one or more drive units 63 arranged parallel to an axis to provide controlled torque to a medical device via a drive shaft 64. Each drive unit 63 includes a separate drive shaft 64 for interacting with the device, a gear head 65 for converting motor shaft rotation into desired torque, a motor 66 for generating drive torque, an encoder 67 for measuring the speed of the motor shaft and providing feedback to control circuitry, and control circuitry 68 for receiving control signals and actuating the drive unit. Each drive unit 63 is independently controlled and motorized, and the instrument actuator 62 can provide multiple (e.g., as...) to the medical device. Figure 15 Four independent drive outputs are shown. In operation, the control circuit 68 receives control signals, transmits motor signals to the motor 66, compares the motor speed measured by the encoder 67 with the desired speed, and modulates the motor signals to generate the desired torque.

[0087] For procedures requiring a sterile environment, the robotic system can incorporate a drive interface, such as a sterile adapter connected to a sterile cover, positioned between the instrument actuator and the medical device. The primary purpose of the sterile adapter is to transmit angular motion from the drive shaft of the instrument actuator to the drive input of the device, while maintaining physical separation between the drive shaft and the drive input, thus preserving sterility. Therefore, an exemplary sterile adapter may include a series of rotary inputs and rotary outputs designed to mate with the drive shaft of the instrument actuator and the drive input on the device. The sterile cover, composed of a thin, flexible material (such as transparent or translucent plastic), is connected to the sterile adapter and designed to cover capital devices, such as instrument actuators, robotic arms, and trolleys (in trolley-based systems) or tables (in table-based systems). The use of the cover allows the capital device to be positioned near the patient while still within an area that does not require sterilization (i.e., a non-sterile area). On the other side of the sterile cover, the medical device can dock with the patient in an area that requires sterilization (i.e., a sterile area).

[0088] D. Medical devices Machinery.

[0089] Figure 16An example medical device with paired instrument actuators is shown. Similar to other devices designed for use with robotic systems, the medical device 70 includes an elongated shaft 71 (or elongated 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, typically includes a rotatable drive input 73 (e.g., a receiver, pulley, or reel) designed to mate with a drive output 74 on a drive interface extending through 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 can share a rotational axis with the drive output 74 in the instrument driver 75 to allow torque to be transmitted from the drive output 74 to the drive input 73. In some embodiments, the drive output 74 may include a spline designed to mate with a receiver on the drive input 73.

[0090] The elongated shaft 71 is designed to be delivered through an anatomical opening or cavity (e.g., as in endoscopy) or through a minimally invasive incision (e.g., as in laparoscopy). The elongated shaft 71 can be flexible (e.g., having endoscope-like properties) or rigid (e.g., having laparoscopy-like properties), or a customized combination of both flexible and rigid portions. When designed for laparoscopy, the distal end of the rigid elongated shaft can be connected to an end effector extending from a connector wrist formed by a connecting fork having at least one degree of freedom and a surgical tool or medical instrument (such as, for example, a gripper or scissors), which can be actuated based on forces from a tendon when the drive input rotates in response to torque received from the drive output 74 of the instrument actuator 75. When designed for endoscopy, the distal end of the flexible elongated shaft can include a manipulable or controllable bending segment that articulates and bends based on torque received from the drive output 74 of the instrument actuator 75.

[0091] Torque from the instrument actuator 75 is transmitted along the elongated shaft 71 using tendons. These individual tendons (e.g., traction cables) may be individually anchored to a separate drive input 73 within the instrument handle 72. From the handle 72, the tendons are guided downward along one or more traction chambers of the elongated shaft 71 and anchored at the distal portion of the elongated shaft 71, or at the wrist at the distal portion of the elongated shaft. During surgical procedures such as laparoscopy, endoscopy, or mixed procedures, these tendons may be coupled to a distally mounted end effector, such as a wrist, gripper, or scissors. In such an arrangement, torque applied to the drive input 73 transmits tension to the tendons, thereby actuating the end effector in a certain way. In some embodiments, during surgery, the tendons may cause the connector to rotate about the axis, thereby causing the end effector to move in one direction or the other. Alternatively, the tendons may be connected to one or more jaws of a gripper at the distal end of the elongated shaft 71, wherein tension from the tendons causes the gripper to close.

[0092] During endoscopy, tendons can be coupled via adhesives, control rings, or other mechanical fasteners to flexural or articulated segments positioned along an elongated axis 71 (e.g., at the distal end). When fixedly attached to the distal end of a flexural segment, torque applied to the drive input 73 is transmitted down the tendon, causing the softer flexural segment (sometimes referred to as an articulated segment or region) to flex or articulate. Along non-flexural segments, it can be advantageous to helve or coil individual traction cavities that guide individual tendons along the wall (or inside) of the endoscope axis to balance radial forces caused by tension in the traction lines. For a particular purpose, the angle of the helices and / or the spacing between them can be varied or designed, with tighter helices exhibiting less axial compression under load, while a lower amount of helix causes greater axial compression under load but restricts flexion. Alternatively, traction cavities can be guided parallel to the longitudinal axis of the elongated axis 71 to allow controlled articulation in the desired flexural or articulated segment.

[0093] In endoscopic procedures, the elongated shaft 71 accommodates multiple components to assist in robotic procedures. The shaft 71 may include, at its distal end, a working channel for deploying surgical instruments (or medical devices), rinsing and / or aspirating the surgical area. The shaft 71 may also be adapted with wires and / or optical fibers to transmit signals to / from optical components at its distal end, which may include an optical camera. The shaft 71 may also be adapted with optical fibers to carry light from a proximal light source (such as a light-emitting diode) to the distal end of the shaft 71.

[0094] At the distal end of the instrument 70, the distal end may further include an opening for delivering tools for diagnosis and / or treatment, and for a working channel for rinsing and aspirating the surgical site. The distal end may also include a port for a camera (such as a fiberoptic endoscope or digital camera) to capture images of the internal anatomical space. Relatedly, the distal end may also include a port for a light source used to illuminate the anatomical space when the camera is used.

[0095] exist Figure 16 In the example, the axis of the drive shaft, and therefore the axis of the drive input, is orthogonal to the axis of the elongated shaft 71. However, this arrangement complicates the rolling capability of the elongated shaft 71. Rolling the elongated shaft 71 along its axis while keeping the drive input 73 stationary can cause undesirable tangling of the tendon as it extends from the drive input 73 and enters the traction cavity within the elongated shaft 71. Such tendon tangling can disrupt any control algorithms designed to predict the movement of the flexible elongated shaft 71 during endoscopic procedures.

[0096] Figure 17 An alternative design of the instrument actuator and instrument is shown, wherein the axis of the drive unit is parallel to the axis of the slender axis of the instrument. As shown, the circular instrument actuator 80 includes four drive units whose drive outputs 81 are aligned parallel to each other at the end of the robot arm 82. The drive units and their respective drive outputs 81 are housed in a rotating assembly 83 of the instrument actuator 80, driven by one of the drive units within assembly 83. In response to torque provided by the rotating drive unit, the rotating assembly 83 rotates along a circular bearing that connects the rotating assembly 83 to the non-rotating portion 84 of the instrument actuator 80. Electrical and control signals can be transmitted from the non-rotating portion 84 of the instrument actuator 80 to the rotating assembly 83 via electrical contacts, which can be maintained by rotation of a brush slip ring connection (not shown). In other embodiments, the rotating assembly 83 may be responsive to a separate drive unit integrated into the non-rotating portion 84 and therefore not parallel to the other drive units. The rotation mechanism 83 allows the instrument actuator 80 to allow the drive units and their respective drive outputs 81 to rotate as a single unit about the instrument actuator axis 85.

[0097] Similar to previously disclosed embodiments, the instrument 86 may include an elongated shaft portion 88 and an instrument base 87 (shown as having a transparent outer surface for discussion purposes), the instrument base including a plurality of drive inputs 89 (such as receivers, pulleys, and reels) configured to receive drive outputs 81 in the instrument driver 80. Unlike previously disclosed embodiments, the instrument shaft 88 extends from the center of the instrument base 87, and the axis of the instrument base is substantially parallel to the axes of the drive inputs 89, rather than... Figure 16 It is orthogonal as in the design.

[0098] When coupled to the rotating assembly 83 of the instrument driver 80, the medical instrument 86, including the instrument base 87 and the instrument shaft 88, rotates in combination with the rotating assembly 83 about the instrument driver axis 85. Since the instrument shaft 88 is positioned at the center of the instrument base 87, it is coaxial with the instrument driver axis 85 when attached. Therefore, rotation of the rotating assembly 83 causes the instrument shaft 88 to rotate about its own longitudinal axis. Furthermore, when the instrument base 87 rotates together with the instrument shaft 88, any tendons connected to the drive input 89 in the instrument base 87 do not become entangled during rotation. Therefore, the parallelism of the axes of the drive output 81, the drive input 89, and the instrument shaft 88 allows the shaft to rotate without causing any control tendons to become entangled.

[0099] Figure 18 An instrument with an instrument-based insertion architecture according to some embodiments is illustrated. Instrument 150 is coupled to any of the instrument drivers described above. Instrument 150 includes an elongated shaft 152, an end effector 162 connected to the shaft 152, and a shank 170 coupled to the shaft 152. The elongated shaft 152 includes a tubular member having a proximal portion 154 and a distal portion 156. The elongated shaft 152 includes one or more channels or grooves 158 along its outer surface. The grooves 158 are configured to receive one or more wires or cables 180 passing through the grooves. Thus, one or more cables 180 extend along the outer surface of the elongated shaft 152. In other embodiments, the cables 180 may also pass through the elongated shaft 152. Manipulation of the one or more cables 180 (e.g., via an instrument driver) actuates the end effector 162.

[0100] The instrument handle 170 (also referred to as the instrument base) typically includes an attachment interface 172 having one or more mechanical inputs 174, such as sockets, pulleys, or reels, which are designed to reciprocately engage with one or more torque couplers on the attachment surface of the instrument actuator. In some embodiments, the instrument 150 includes a series of pulleys or cables that enable the elongated shaft 152 to translate relative to the handle 170. In other words, the instrument 150 itself includes an instrument-based insertion architecture that adapts to the insertion of the instrument, thereby minimizing reliance on a robotic arm to provide the insertion of the instrument 150. In other embodiments, the robotic arm may be largely responsible for the instrument insertion.

[0101] E. Controller .

[0102] Any of the robotic systems described herein may include an input device or controller for manipulating a device attached to a robotic arm. In some embodiments, the controller may be coupled to the device (e.g., communicative, electronic, electrical, wireless, and / or mechanical), such that manipulation of the controller, for example via master-slave control, causes corresponding manipulation of the device.

[0103] Figure 19 This is a perspective view of an embodiment of controller 182. In this embodiment, controller 182 includes a hybrid controller that may have both impedance and admittance control. In other embodiments, controller 182 may utilize only impedance or passive control. In other embodiments, controller 182 may utilize only admittance control. By being a hybrid controller, controller 182 advantageously has lower perceived inertia during use.

[0104] In the illustrated embodiment, controller 182 is configured to allow manipulation of two medical devices and includes two handles 184. Each handle 184 is connected to a universal joint 186. Each universal joint 186 is connected to a positioning platform 188.

[0105] like Figure 19 As shown, each positioning platform 188 includes a SCARA arm (selective compliant assembly robot arm) 198 connected to a post 194 via a prism joint 196. The prism joint 196 is configured to translate along the post 194 (e.g., along guide rail 197) to allow each handle 184 to translate in the z-direction, thus providing a first degree of freedom. The SCARA arm 198 is configured to allow the handle 184 to move in the xy-plane, thus providing two additional degrees of freedom.

[0106] In some embodiments, one or more load sensors are located within the controller. For example, in some embodiments, load sensors (not shown) are located within the body of each gimbal in gimbal 186. By providing load sensors, portions of controller 182 are able to operate under admittance control, thereby advantageously reducing the sense inertia of the controller during use. In some embodiments, positioning platform 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 platform 188 is configured for impedance control. Thus, for some embodiments, the translational or orientational degrees of freedom of positioning platform 188 may depend on admittance control, while the rotational degrees of freedom of gimbal 186 may depend on impedance control.

[0107] F. Navigation and Control .

[0108] Traditional endoscopy can involve the use of fluoroscopy (e.g., delivered via a C-arm) and other forms of radiation-based imaging modalities to provide intracavitary guidance to the operating physician. In contrast, the robotic system envisioned in this disclosure can provide radiation-free navigation and positioning, reducing physician exposure to radiation and the amount of equipment required in the operating room. As used herein, the term "positioning" can 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 robot command data can be used individually or in combination to achieve a radiation-free operating environment. In other cases where radiation-based imaging modalities are still used, preoperative mapping, computer vision, real-time EM tracking, and robot command data can be used individually or in combination to improve upon information obtained solely through radiation-based imaging modalities.

[0109] Figure 20 This is a block diagram illustrating a positioning system 90 for estimating the position of one or more components of a robotic system (such as the position of a machine) according to an example embodiment. The positioning system 90 may be one or more computer devices configured to execute one or more instructions. The computer devices may be embodied by a processor (or multiple processors) and computer-readable storage among the components discussed above. By way of example and not limitation, the computer devices may be located in... Figure 1 Tower 30 shown Figures 1 to 4 The trolley 11 shown Figures 5 to 14 The bed, etc. shown.

[0110] like Figure 20 As shown, the positioning system 90 may include a positioning module 95 that processes input data 91-94 to generate position data 96 for the distal end of a medical device. The position data 96 may be data or logic representing the position and / or orientation of the distal end of the device relative to a reference frame. The reference frame may be relative to a patient's anatomy or a known object (such as an EM field generator) (see the discussion of EM field generators below).

[0111] The various input data are now described in more detail 91-94. Preoperative mapping can be accomplished using a collection of low-dose CT scans. The preoperative CT scans are reconstructed into three-dimensional images, which are visualized, for example, as “slices” of cross-sectional views of the patient’s internal anatomy. When analyzed in whole, image-based models of the anatomical cavities, spaces, and structures of the patient’s anatomical structures, such as the patient’s lung network, can be generated. Techniques such as centerline geometry can be determined and approximated from CT images to form a three-dimensional volume of the patient’s anatomy, which is referred to as model data 91 (also referred to as “preoperative model data” when generated using only preoperative CT scans). The use of centerline geometry is discussed in U.S. Patent Application 14 / 523,760, the contents of which are incorporated herein by reference in their entirety. Network topology models can also be derived from CT images and are particularly well-suited for bronchoscopy.

[0112] In some implementations, the instrument may be equipped with a camera to provide visual data (or image data) 92. A positioning module 95 may process the visual data 92 to enable one or more vision-based (or image-based) position tracking modules or features. For example, preoperative model data 91 may be used in conjunction with the visual data 92 to enable computer vision-based tracking of a medical instrument (e.g., an endoscope or an instrument propelled through the working channel of an endoscope). For example, using the preoperative model data 91, a robotic system may generate a library of expected endoscopic images based on the model, with each image linked to a location within the model, based on the expected path of the endoscope's movement. During surgical procedures, the robotic system may refer to this library to compare real-time images captured at a camera (e.g., a camera at the distal end of the endoscope) with those images in the image library to aid in positioning.

[0113] Other computer vision-based tracking techniques use feature tracking to determine camera motion, and thus, endoscope motion. Some features of the localization module 95 can identify circular geometries corresponding to anatomical cavities in the preoperative model data 91 and track changes in those geometries to determine which anatomical cavity has been selected, as well as track the relative rotation and / or translational motion of the camera. The use of a topology map can further enhance vision-based algorithms or techniques.

[0114] Optical flow (another computer vision-based technique) can analyze the displacement and translation of image pixels in a video sequence within visual data 92 to infer camera motion. Examples of optical flow techniques can include motion detection, object segmentation computation, brightness, motion compensation coding, stereo parallax measurement, and more. Through multiple iterations and comparisons of multiple frames, the motion and position of the camera (and therefore the endoscope) can be determined.

[0115] The positioning module 95 can use real-time EM tracking to generate the real-time position of the endoscope in a global coordinate system that can be registered to the patient's anatomy represented by a preoperative model. In EM tracking, an EM sensor (or tracker), including one or more sensor coils embedded in one or more locations and orientations within the 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 positional information detected by the EM sensor is stored as EM data 93. The EM field generator (or transmitter) can be placed close to the patient to generate a low-intensity magnetic field detectable by the embedded sensor. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. These distances and orientations can be "registered" to the patient's anatomy (e.g., a preoperative model) during surgery to determine the geometric transformations that align a single location in the coordinate system with its orientation in the preoperative model of the patient's anatomy. Once registered, an embedded EM tracker in one or more orientations of the medical device (e.g., the distal end of an endoscope) can provide real-time indication of the medical device’s progress through the patient’s anatomy.

[0116] Robot commands and kinematic data 94 can also be used by the positioning module 95 to provide orientation data 96 for the robotic system. Device pitch and yaw from joint movement commands can be determined during preoperative calibration. During surgical procedures, these calibration measurements can be combined with known insertion depth information to estimate the instrument's orientation. Alternatively, these calculations can be analyzed in conjunction with EM, vision, and / or topology modeling to estimate the medical device's orientation within the network.

[0117] like Figure 20 As shown, the positioning module 95 can use multiple other input data. For example, although in Figure 20 Although not shown, the device using shape sensing fibers can provide shape data, which the positioning module 95 can use to determine the position and shape of the device.

[0118] The localization module 95 can use the input data 91-94 in combination. In some cases, such combination can use a probabilistic method, where the localization module 95 assigns confidence weights to the location determined based on each of the input data 91-94. Therefore, in cases where the EM data may be unreliable (e.g., in the presence of EM interference), the confidence of the location determined by the EM data 93 may be reduced, and the localization module 95 may rely more heavily on the visual data 92 and / or robot commands and kinematic data 94.

[0119] As discussed above, the robotic systems discussed in this paper can be designed as a combination of one or more of the technologies mentioned above. The computer-based control system of a robotic system located in a tower, bed, and / or trolley can store computer program instructions in, for example, a non-transitory computer-readable storage medium (such as a permanent magnetic storage drive, a solid-state drive, etc.). When executed, these computer program instructions 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 instrument's orientation in a global coordinate system and anatomical diagrams.

[0120] 2. Sample collector for robotic medical systems

[0121] Robotic medical systems (as referenced above) Figures 1-20 These (and others depicted in the figures) can be used in robotic medical procedures involving the removal of objects, samples, or specimens from a patient's body. For example, robotic medical systems can be used to perform kidney stone removal surgery. In robotic kidney stone removal surgery, the physician can use controllers to operate various robotic medical instruments (e.g., the endoscopes and laparoscopes mentioned above). Robotic medical instruments can be coupled with robotic manipulators (such as robotic arms, robotic drives, and robotic instrument drive mechanisms) for positioning and manipulating the instruments.

[0122] As an example, a robotic medical system may include three robotic arms configured for use during ureteroscopic kidney stone removal surgery. A first robotic arm can operate and control the robotic ureteroscope and basket assembly (e.g., control the joint connections between the robotic ureteroscope and basket assembly). A distal drive mechanism located on a second robotic arm can insert and remove the ureteroscope from the patient. In some embodiments, a third robotic arm may optionally be used to control a percutaneously inserted robotic laparoscopy (e.g., during percutaneous assisted ureteroscopy (PAU)). The physician can control the system to capture the kidney stone with the basket assembly. The robotic ureteroscope can then be retracted to remove the stone from the patient while it has gripped it. Once positioned outside the patient, the basket assembly can be opened to release the stone. If necessary, the robotic ureteroscope can be reinserted to remove more stones. Typically, the stones are retained for postoperative analysis.

[0123] This disclosure relates to a sample collector configured for use with a robotic medical system to facilitate robotic medical procedures involving the removal of objects, samples, or specimens from a patient. The sample collector can be configured such that the robotic medical system can automatically place the sample therein, minimizing human or physical interaction. In manual object removal procedures (e.g., manual kidney stone removal), the object removed from the patient is manually placed into a sample cup, typically held by a physician or other sterile person in the operating room. The use of such a manual sample cup can be disadvantageous for robotic medical systems because it requires the cup to be held by a clinician or has a specially designed support, increasing cost and / or reducing automation.

[0124] As will be described in more detail below, the sample collector described herein can be specifically configured for use with robotic medical systems to facilitate and / or optimize robotic surgery. For example, the sample collector described herein can be integrated into components of a robotic medical system and / or configured to be supported by components of the robotic medical system at a location where an automatically controlled medical device can quickly and efficiently place a sample. As an initial example, a sample collector configured for use with a robotic medical system can be integrated into a sterile cover configured to cover various robotic components of the system. The sample collector can be positioned on the sterile cover to facilitate its placement when the sterile cover is installed. For example, when the basket device retracts from the patient, the sample collector can be positioned directly below the automatically controlled basket device. In this position, the basket device can be easily opened to place the retrieved object into the sample collector. The sample collector can be configured with at least one porous portion that allows fluid to drain through it while retaining the object placed therein. The sample collector may be configured with an opening retaining device (e.g., a flexible wire or strip) to keep the opening of the sample collector open, providing a large area for placing the object. Furthermore, the sample collector may be configured to be removable from a sterile cover (e.g., torn off), allowing the object to be easily sent for analysis. In some embodiments, a sample collector contained within a sterile cover provides a cost-effective solution offering significant benefits.

[0125] These and other features will be described in more detail below with reference to embodiments illustrated in the accompanying drawings, which are intended to illustrate certain exemplary features and aspects of the sample collector described herein. The illustrated embodiments are not limiting, and those skilled in the art will understand, upon consideration of this disclosure, that various modifications may be made within the scope of this disclosure.

[0126] Figure 21 and Figure 22 Top and side views of an embodiment of a robotic medical system 200 including a sample collector 300 are shown, respectively. The sample collector 300 is configured such that samples retrieved from a patient 202 can be stored therein using the robotic system 200. In the illustrated embodiment, the system 200 includes a medical device 204, a robotic manipulator (e.g., a drive unit 206), and a sterile barrier 208 (e.g., a medical device 204, a robotic manipulator 206, and a sterile barrier 208). Figure 22 (as shown) and components such as the sample collector 300.

[0127] In the illustrated embodiment, medical device 204 includes an automatically controllable ureteroscope, which can be similar to the one described above. Figure 3 The ureteroscope 32 is described. In other embodiments, medical device 204 may include other types of medical devices (as described above). Figures 1-20 The description includes any medical devices and other instruments, including endoscopes, laparoscopes, and catheters. Figure 21 and Figure 22 As shown in the illustrated embodiments, the medical device 204 may include a device base 210 and an elongated shaft 212. In the illustrated embodiments, the proximal end of the elongated shaft 212 extends from the device base 210. In some embodiments, the elongated shaft 212 includes a flexible shaft and / or a hinged shaft.

[0128] The distal end 214 of the elongated shaft 212 is configured to be inserted into the patient 202. For example, a robotic manipulator (e.g., the drive mechanism 206 described in more detail below) may be configured to drive the insertion and / or retraction of the elongated shaft 212, such that the distal end 214 of the elongated shaft 212 can be inserted into and retracted from the patient 202. In the illustrated embodiment, the medical device 204 is illustrated in a position where the distal end 214 of the elongated shaft 212 has been retracted from the patient 202.

[0129] In the illustrated embodiment, system 200 includes an access sheath 216. The access sheath 216 can be inserted into the patient 202 to provide a channel or catheter through which the elongated shaft 212 of the medical device 204 can be inserted. In the illustrated embodiment, the access sheath 216 is a ureteral access sheath inserted into the urethra of the patient 202, although other types of access sheaths can also be used (which can be inserted into other natural patient orifices or other surgical ports (e.g., laparoscopic ports)). In some embodiments, the access sheath 216 includes a tube.

[0130] Medical device 204 can be configured to capture (e.g., grasp, hold, retain, etc.) samples from within a patient. For example, in the case of kidney stone removal surgery, medical device 204 may include a basket device configured to capture kidney stones, allowing the stones to be removed from the patient 202. As described above, in some embodiments, the basket device may be configured as a tool (automatically and / or manually controlled) that can be inserted through a working channel of the elongated shaft 212 of medical device 204. In some embodiments, the basket device is directly integrated into medical device 204. Although the examples described herein relate to kidney stone removal, medical device 204 can be configured to collect and retrieve other types of objects, samples, or specimens from the patient 202. For example, in some embodiments, medical device 204 is configured to remove biopsy samples from the patient 202.

[0131] exist Figure 21 and Figure 22 The illustrated robotic medical system 200 shows various robotic manipulators for operating robotic instruments 204. In the illustrated embodiment, system 200 includes robotic manipulators configured as drive units 206, instrument drive mechanisms 228, and robotic arms 226. Figure 22 The side view shows the instrument drive mechanism 228 and the robotic arm 226. These robotic manipulators can engage with the medical device 204 in various ways as previously described, which will be described in more detail below.

[0132] In the illustrated embodiment, the drive device 206 engages with the elongated shaft 212 of the medical device 204 and is configured to drive the distal end 214 of the elongated shaft 212 to move axially (e.g., insert and / or retract) into or out of the patient 202. For example, as Figure 21As shown, the drive unit 206 includes a roller 222 that can engage or contact the elongated shaft 212. In some embodiments, the roller 222 may include a deformable material that provides grip between the roller 222 and the elongated shaft 212. In some embodiments, the material includes silicone rubber. In the illustrated embodiment, the elongated shaft 212 can be pulled, pushed, or otherwise axially driven by or relative to the drive unit 206 as the roller 222 rotates. Rotating the roller 222 in a first direction can cause insertion of the elongated shaft 212, and rotating the roller 222 in the opposite second direction can cause retraction of the elongated shaft 212. In some embodiments, other drive mechanisms may be used instead of the roller 222, or other drive mechanisms may be used in addition to the roller. In the illustrated embodiment, the elongated shaft 212 passes through a channel 224 of the drive unit 206. The channel 224 may include a closed channel and / or an open channel. Using the open channel 224 can facilitate the loading of the elongated shaft 212 of the medical device 204 into the drive unit 206, which simplifies the use of the device and reduces operation time. For example, the open channel can facilitate the loading and / or unloading of the medical device 204 during surgery or medical procedures, allowing users (such as medical personnel) to manually adjust the medical device 204 without having to fully retract the medical device 204 from the patient's body.

[0133] like Figure 22 As shown, the drive unit 206 can be attached, mounted, or otherwise connected to the robotic arm 226. The robotic arm 226 may include an instrument drive mechanism 228, and the drive unit 206 may be attached to the instrument drive mechanism 228. The instrument drive mechanism 228 may include a drive output configured to engage and actuate a corresponding drive input on the drive unit 206 to actuate the drive unit 206. In the illustrated embodiment, a sterile adapter 230 is located between the instrument drive mechanism 228 and the drive unit 206, such that the drive unit 206 engages with the instrument drive mechanism 228 via the sterile adapter 230. The sterile adapter 230 may be configured to connect or transmit motion between the drive output of the instrument drive mechanism 228 and the corresponding drive input on the drive unit 206. Further, the sterile adapter 230 may be configured to define or provide a portion of a sterile barrier 208 (as shown in the illustration). Figure 22 (as shown below), as described in more detail below.

[0134] Continue to refer to Figure 22 The robotic arm 226, equipped with the drive unit 206, can be configured to move to manipulate the position of the drive unit 206 in space. In some embodiments, for example, as shown, the drive unit 206 may be located near the entry sleeve 216. Positioning the drive unit 206 near the point where the elongated shaft 212 will be inserted (e.g., close to the entry sleeve 216) can reduce the bending of the elongated shaft 212.

[0135] While the illustrated embodiment of system 200 includes a drive mechanism 206 for driving axial movement of the elongated shaft 212 of the medical device 204, in other embodiments, other types of robotic manipulators may be used to drive the axial movement. For example, in some embodiments, axial movement is driven by moving a robotic arm 226 attached to the base 210 of the medical device 204. In other embodiments, the base 210 of the medical device 204 is configured to drive axial movement of the elongated shaft, for example, as referenced above. Figure 18 As stated above.

[0136] like Figure 22 As shown, the base 210 of the medical device 204 can also engage with a robotic manipulator. In the illustrated embodiment, the base 210 engages with a second instrument drive mechanism 228 located on a second robotic arm 226. As shown, another sterile adapter 230 may be located between the instrument base 210 and the instrument drive mechanism 228. The instrument drive mechanism 228, engaged with the base 210, can be configured such that its drive output drives a corresponding drive input on the base 210 of the medical device 204 to control, for example, the joint movement of the elongated shaft 212 and / or the joint movement, opening and / or closing of the basket device. The engagement between the instrument base 210 and the instrument drive mechanism 228 is illustrated above by reference, for example, to... Figures 15-17 It has been described.

[0137] The robotic arm 226 can be, for example, Figures 1-4 The robotic arm shown is mounted on or extends from the trolley, and / or as shown in the image. Figures 5-14 The robotic arm shown extends from the patient platform or patient table. Figures 16-18 An exemplary instrument drive mechanism 228 is shown, which can be positioned at the distal end of the robotic arm 226.

[0138] Figure 22 The illustrated robotic medical system 200 may include a sterile barrier 208. The sterile barrier 208 can be configured to separate sterile areas from non-sterile areas. In the illustrated embodiment, the sterile barrier 208 is provided by one or more sterile covers 232 and the aforementioned sterile adapter 230. The sterile covers 232 may include a flexible sheet (e.g., a plastic sheet) whose size and shape are configured to cover components of the robotic medical system 200 located within non-sterile areas. As shown, the sterile covers 232 cover the robotic arm 226 and the instrument drive mechanism 228. Figures 29-31 More detailed examples of sterile coverings are shown, which will be described in more detail below.

[0139] like Figure 22As shown, some components of the robotic medical system 200 are located in a sterile area, while others are located in a non-sterile area. For example, in the illustrated embodiment, the medical device 204, drive unit 206, access sleeve 216, and patient 202 are located in a sterile area, while the robotic arm 226 and device drive mechanism 228 are located in a non-sterile area. Other configurations are also possible.

[0140] As described above, system 200 also includes a sample collector 300 in which samples taken from patient 202 using medical device 204 can be placed. As... Figure 22 As shown in the side view, the sample collector 300 may include a receiver portion 302 and a connector 304. The receiver portion 302 is configured to provide a receiver, container, vessel, or reservoir in which a sample can be stored, and the connector 304 is configured to attach the receiver portion 302 to a component of the robotic medical system 200 to support and position the sample collector 300. The connector 304 may be coupled to the receiver portion 302. In some embodiments, the receiver portion 302 is made of a flexible material (such as a plastic sheet used to manufacture a receiver or container). In some embodiments, the receiver portion 302 includes a flexible bag. The receiver portion 302 includes an opening through which a sample can be placed. In some embodiments, the sample collector 300 further includes an opening retaining device positioned at the opening of the receiver portion 302 and configured to retain the opening in an open configuration to facilitate sample placement therein. Various features and embodiments of the receiver portion 302 and the connector 304 will be described in more detail below. Figures 26-27 A more detailed implementation of the sample collector 300 is shown.

[0141] like Figure 22 As shown, the sample collector 300 can be located within a sterile area. For example, in the illustrated embodiment, the connector 304 of the sample collector 300 is attached to a sterile cover 232 that covers the robotic arm 226 to which the drive unit 206 is attached. Other locations for the sample collector 300 are also possible. For example, in some embodiments, the connector 304 attaches the sample collector 300 to a sterile adapter 230, an access sleeve 216, or the drive unit 206 or the instrument drive mechanism 228 itself.

[0142] Figure 21 and Figure 22It is also shown that, in some embodiments, the sample collector 300 can be advantageously positioned on the robotic system 200 to facilitate sample placement therein. In the illustrated embodiment, the sample collector 300 is positioned below (e.g., directly below) the distal end 214 of the elongated shaft 212 of the medical device 204 when the distal end 214 is retracted from the patient 202 and / or the access sleeve 216. In this position, sample placement in the receiver portion 302 can be achieved by releasing the sample (e.g., opening the basket device) and allowing the sample to fall into the receiver portion 302 due to gravity. This position of the sample collector 300 also maintains alignment between the elongated shaft 212 and the access sleeve 216, allowing the distal end 214 of the elongated shaft 212 to be quickly reinserted into the patient 202 to continue the procedure after the sample has been placed in the receiver portion 302. This can reduce the overall length of the procedure and improve patient outcomes.

[0143] Furthermore, such as Figure 21 and Figure 22 As shown, in some embodiments, the sample collector 300 can be advantageously positioned on the robotic system 200 near the patient entrance (e.g., into sheath 216). For example, in the illustrated embodiment, the sample collector 300 is located on the distal (i.e., patient-facing) side of the drive unit 206. This position can advantageously minimize the amount of movement required to position the distal end 214 of the medical device 204 onto the sample collector 300. Similarly, this can reduce the overall length of the procedure. Alternatively, the robotic arm 226 can position the drive unit 206 near the entrance of the patient 202 to further minimize the amount of movement required to position the distal end 214 of the medical device 204 onto the sample collector 300. For example, as... Figure 22 As shown, the distal side of the drive unit 206 is located near the proximal side of the entry sleeve 216, so that the sample collector is located exactly on the proximal side of the entry sleeve 216.

[0144] like Figure 22 As shown (and as will be referred to below) Figure 26 and Figure 27 (In more detail), connector 304 may include an attachment tab. Receiver portion 302 may extend from the attachment tab. That is, receiver portion 302 may be attached to the attachment tab. The attachment tab may be configured to attach to a component of the support sample collector 300 of the robotic medical system 200. For example, the attachment tab may be configured to attach to sterile cover 232, sterile adapter 230, drive unit 206, access sleeve 216, or other components of the robotic medical system 200.

[0145] As described above, in the illustrated embodiment, connector 304 is attached to sterile cover 232. In some embodiments, connector 304 is fixedly or permanently attached to sterile cover 232. That is, in some embodiments, sample collector 300 is a component of sterile cover 232. In these embodiments, sample collector 300 can be positioned on cover 232 such that when cover 232 is mounted on robotic medical system 200, sample collector 300 is positioned in the advantageous or desired location as described above. In other embodiments, connector 304 can be configured to selectively attach to sterile cover 232 (or other components of robotic medical system 200). For example, connector 304 may include adhesive tape on attachment tabs. The user can then use the adhesive tape to attach sample collector 300 to components of robotic medical system 200 as needed.

[0146] The receiver portion 302 can be removably attached to the attachment tab or connector 304, allowing the receiver portion 302 to be removed from the connector 304. In some embodiments, once a sample is placed in the receiver portion 302, the receiver portion 302 can be removed from the connector 304, leaving the sample therein. The receiver portion 302 can then be sent for sample analysis. As described below, in some embodiments, the sample collector 300 includes a perforation located between the attachment tab or connector 304 and the receiver portion 302, the perforation being configured to allow the receiver portion 302 to be torn off from the attachment tab or connector 304. Other methods for removing the receiver portion 302 from the connector 304 are also possible, as described below.

[0147] In some embodiments, at least a portion of the receiver portion 302 is porous and configured to allow fluid to drain from the receiver portion 302 while retaining the sample. In some medical procedures, fluids (such as irrigation fluids or patient fluids used in surgery) may enter the receiver portion 302. The porous portion of the receiver portion 302 allows this fluid to drain. In some embodiments, the sample collector 300 may include a drain port that can be connected to a fluid dynamics system that can actively or passively collect such fluid from the receiver portion 302. The porosity of the porous portion can be configured to allow fluid to drain through it while the collected sample is retained within the receiver portion.

[0148] Figure 23This is a perspective view of the distal end of a robotic arm 226 on which an instrument drive mechanism 228 is positioned. In the illustrated embodiment, the robotic arm 226 is covered with a sterile cover 232. As shown, the sterile cover 232 may be part of a sterile barrier including a sterile adapter 230 configured to mount on the instrument drive mechanism 228. The sterile adapter 230 may have a collar 234 configured to engage with the sterile cover 232, and the sterile adapter 230 may provide a sterile interface between the instrument drive mechanism 228 and components attached thereto, such as the instrument base 210 or the drive unit 206.

[0149] Figure 23 An embodiment of a sample collector 300 attached to a sterile cover 232 is also shown. In some embodiments, the sample collector 300 may be attached to the sterile cover 232 at a collar 234. Figure 23 In the illustrated implementation, the sample collector 300 is configured as a flexible bag.

[0150] Figure 24 This is a block diagram of an exemplary control component of a robotic medical system 200. In the illustrated embodiment, the control component includes a processor 240, a memory 242, and a controller 244. The memory 242 may include instructions configuring the processor 240 to perform various functions to control aspects of the robotic medical system 200. For example, the memory 242 may include instructions that, when executed, configure the processor 240 to perform the functions described below. Figure 25 The functions described. A doctor or other operator can use controller 244 to provide input for controlling the robotic medical system 200. In some embodiments, controller 244 is a handheld controller including one or more joysticks, buttons, or other user inputs. In some embodiments, controller 244 may be as described above. Figure 19 The controller described.

[0151] Figure 25 It shows that it can be used Figure 24 The flowchart shown illustrates an exemplary control method 248 performed by the control components to operate the robotic medical system 200. The control method may be stored, for example, as instructions in memory 242. Method 248 may begin at block 250, where instructions configure processor 240 to control the insertion of the distal end 214 of medical device 204 into the patient 202. In some embodiments, insertion is commanded and / or otherwise controlled by a physician using controller 244. As described above, insertion can be provided in various ways. For example, refer to... Figure 21 and Figure 22In the illustrated embodiment, the drive unit 206 can use roller 222 to drive insertion. In other embodiments, insertion can be achieved by using a robotic arm 226 to move the medical device 204 and / or by using a device-based insertion structure relative to the device base 210 to drive the elongated shaft 212, for example, as shown in the reference. Figure 18 As described above. In some embodiments, insertion is provided through the sheath 216.

[0152] At box 252, method 248 may include collecting a sample from the patient 202 using medical device 204. In some embodiments, a physician may use controller 244 to navigate and control the distal end 214 of medical device 204 within the patient 202, thereby allowing the physician to locate and collect the sample. As described above, in the case of kidney stone removal surgery, sample collection may include capturing the kidney stone within a basket device inserted through a working channel of the elongated shaft 212 of medical device 204.

[0153] As the sample is collected, method 248 moves to box 254, where the distal end 214 and the collected sample are retracted from the patient 202. Retraction can be commanded by a physician using controller 244, for example. The same mechanism described above for insertion can be used to provide retraction. For example, retraction can be driven by drive device 206, by moving robotic arm 226, and / or by a device-based insertion structure utilizing a drive slender shaft 212 to retract relative to the device base 210. At box 254, the distal end 214 of the medical device 204 can retract to a position where the sample can be placed into the sample collector 300. For example, the distal end 214 can retract to a position above the sample collector 300, such as... Figure 21 and Figure 22 As shown. In some implementations, retraction to the storage location can be triggered by a single user command. For example, once a sample is captured, the user can provide a single input on controller 244, which can cause system 200 to automatically retract the distal end 214 to the placement position.

[0154] At block 256, method 248 may include placing a sample into the receiver portion 302 of the sample collector 300. In the illustrated embodiment of system 200, placing a sample into the receiver portion 302 of the sample collector 300 may include releasing the sample from the distal end 214 of the medical device 204, allowing the sample to fall into the receiver portion 302 of the sample collector 300 under gravity. In other embodiments, placement may be accomplished by hinged to the elongated shaft 212 of the medical device 204 to insert the sample into the sample collector 300. In some embodiments, the sample may be placed into the sample collector 300 automatically upon receiving a placement command from controller 244. For example, upon receiving a command, system 200 may automatically move the distal end 214 of the medical device 204 to a placement position and automatically place the sample into the receiver portion 302 of the sample collector 300. In some implementations, system 200 knows the location of sample collector 300, such that moving and placing a sample into sample collector 300 can be performed automatically by system 200 (e.g., automatically upon receiving a user command). That is, in some implementations, the physician does not need to guide the distal end 214 into sample collector 300; instead, this guidance can occur automatically.

[0155] Figure 26 and Figure 27 These are a front view and an exploded perspective view of one embodiment of the sample collector 300. In the illustrated embodiment, the sample collector 300 includes a receiver portion 302 and a connector 304, wherein the receiver portion 302 is configured to receive a sample removed from a patient, and the connector 304 is coupled to the receiver portion 302 and configured to attach to a medical system (e.g., a component attached to a medical system, such as a cover) for positioning the receiver portion 302 relative to the medical system. A porous portion may be included in at least a portion of the receiver portion 302. The porous portion may be configured to allow fluid to drain from the receiver portion 302 while retaining the sample placed within the receiver portion 302.

[0156] As Figure 27As shown, the sample collector 300 may include a first layer 312 and a second layer 314. In some embodiments, each of the first layer 312 and the second layer 314 may include a flexible layer (such as a plastic sheet), such that the sample collector 300 includes a flexible bag-like structure. A receiver portion 302 may be formed between the first layer 312 and the second layer 314. For example, the first layer 312 may include a first upper edge 312A, a first right edge 312B, a first left edge 312C, and a first lower edge 312D, and the second layer 314 may include a second upper edge 314A, a second right edge 314B, a second left edge 314C, and a second lower edge 314D. The second right edge 314B, the second left edge 314C, and the second lower edge 314D can be connected to the first right edge 312B, the first left edge 312C, and the first lower edge 312D, respectively, such that the first flexible layer 312 and the second flexible layer 314 form a recess having an opening defined (e.g., between) by the first upper edge 312A and the second upper edge 314A.

[0157] Connector 304 may include an attachment tab formed by a portion of a first layer 312 extending from a first upper edge 312A. For example... Figures 26 to 27 As shown, connector 304 may include a cutout 316. The cutout 316 may be configured in size and shape to correspond to a component to which connector 304 may be attached. For example, in the illustrated embodiment, the cutout 316 is semi-circular to correspond to collar 234 ( Figure 23 ) and / or instrument drive mechanism 228 or sterile adapter 230 ( Figure 21 and 22 The cutout 316 on connector 304 is generally circular. Other shapes and configurations of the cutout 316 are also possible. In some embodiments, the linear cutout 316 may be omitted.

[0158] In some embodiments, connector 304 or attachment tab may be permanently attached to another structure (such as sterile cover 232 or sterile adapter 230) such that sample collector 300 is a component of that structure. Connector 304 may be attached to this structure such that, when the structure is mounted on the robotic system, sample collector 300 is advantageously positioned in a desired location. In other embodiments, connector 304 or attachment tab is configured to selectively attach to the robotic system. For example, connector 304 or attachment tab may include an adhesive backing on at least a first side thereof, such that sample collector 300 can be adhesively attached to robotic medical system 200 in a desired location.

[0159] like Figure 26 and Figure 27As shown, on the first layer 312, the connector 304 can be attached to the receiver portion 302 via a perforated portion 318. That is, the perforation 318 can be located between the receiver portion 302 and the connector 306. As described above, the perforation can be configured to allow the receiver portion 302 to be torn off the connector 306. In some embodiments, other methods for configuring the receiver portion 302 to be removable from the connector 304 are possible. For example, the perforation 318 can be replaced with a tear strip or other suitable structure.

[0160] The sample collector 300 may also include an opening retaining device 320. The opening retaining device 320 may be configured to retain the opening of the receiver portion 302 in an open configuration to facilitate sample placement into the receiver portion 302. In some embodiments, for example, as shown, the opening retaining device 320 may be positioned at the opening of the receiver portion 302. In the illustrated embodiment, the opening retaining device 320 includes a formable metal strip 322. In the illustrated embodiment, the formable metal strip 322 is attached to a first layer 312 on a first side via an attachment pad 324, and to a second layer 314 on a second side via an attachment pad 324. The formable metal strip 322 may be bent into a configuration that accommodates the open opening of the receiver portion 302. Other mechanisms for the opening retaining device 320 are also possible, such as formable shape-retaining lines that can be embedded in the opening. In some embodiments, the opening retaining device 320 may be omitted.

[0161] As described above, the sample collector 300 may include a porous portion that allows fluid to drain from the receiver portion 302. In some embodiments, one or both of the first layer 312 and the second layer 314 may be porous. In some embodiments, a portion of one or both of the first layer 312 and the second layer 314 may be porous.

[0162] Figure 28This is a flowchart illustrating an exemplary method 400 for placing a sample in a sample collector 300 using a robotic medical system (such as robotic medical system 200). Method 400 may begin at block 402 and includes automatically inserting the distal end 214 of an elongated body 212 of a medical device 204 into the body of a patient 202. In some embodiments, the robotic manipulator includes the aforementioned drive 206, which is configured to engage with and drive the insertion and retraction of the elongated body of the medical device. The drive 206 can drive the insertion. In some embodiments, the robotic manipulator includes a robotic arm 226 and a device drive mechanism 228 positioned at the distal end of the robotic arm 226. The device drive mechanism 228 may be configured to attach to the base 210 of the medical device 204 to operate the medical device 204. In some embodiments, automatically inserting the elongated body 212 of the medical device includes moving the robotic arm 226. In some embodiments, the elongated body 212 of the automated insertion medical device 204 includes an insertion mechanism that drives the base 210 using a device drive mechanism 228 to insert the elongated body 212 relative to the base 210.

[0163] At block 404, method 400 includes manipulating a medical device 204 with a robotic manipulator to capture a sample from a patient. In some embodiments, the base 210 of the medical device 204 engages with a device drive mechanism 228 such that a drive output of the device drive mechanism 228 actuates a drive input in the base 210 to form an articulation of an elongated shaft 212. A physician or other operator can control the articulation and / or insertion and retraction of the elongated shaft 212 to capture a sample using the distal end 214 of the medical device 204. This can be referenced above. Figure 20 The navigation and positioning system described herein enables navigation within the patient's body.

[0164] At block 406, method 400 includes an elongated shaft 212 of an automatically retracting medical device 204 to remove a distal end 214 and a sample from a patient. In some embodiments, the robotic manipulator includes a drive 206 configured to engage with and drive the elongated shaft 212 of the medical device 204 for insertion and retraction. The drive 206 can drive retraction. In some embodiments, the robotic manipulator includes a robotic arm 226 and a device drive mechanism 228 positioned at the distal end of the robotic arm 226. The device drive mechanism 228 may be configured to attach to a base 210 of the medical device 204 to manipulate the medical device 204. In some embodiments, the elongated body 212 of the automatically retracting medical device 204 includes a mobile robotic arm 226. In some embodiments, the elongated shaft 212 of the automatically retracting medical device 204 includes a retraction mechanism that drives the base 210 using the device drive mechanism 228 to retract the elongated shaft 212 relative to the base 210.

[0165] At box 408, method 400 includes automatically placing the sample into sample collector 300. See reference... Figure 21 and Figure 22 The process of placing a sample into the sample collector 300 may include positioning the sample on the sample collector 300 and releasing the sample so that it falls into the sample collector 300. In some embodiments, automatically placing a sample into the sample collector includes automatically moving the distal end 214 of the elongated shaft 212 to a placement position relative to the sample collector 300 upon receiving a user command.

[0166] Method 400 may further include covering the robotic medical system with a sterile barrier 232 to separate a sterile area containing at least the medical device 204 and the sample collector 300 from a non-sterile area containing at least the robotic manipulator. In some embodiments, the sample collector 300 is attached to the sterile barrier 232 at a location where the medical device can automatically place a sample.

[0167] In some embodiments, method 400 further includes adhesively attaching sample collector 300 to sterile barrier 232. In some embodiments, the receiver portion 302 of sample collector 300 is removable from connector 304, and method 400 further includes detaching receiver portion 302 from connector 304. Method 400 may further include draining fluid through porous portion of receiver portion 302 while retaining the sample within receiver portion 302. In some embodiments, method 400 further includes positioning the opening of sample collector 300 in an open position using opening retaining device 320 of sample collector 300.

[0168] Figure 29 An isometric view of an embodiment including a sterile cover 232 of a sample collector 300 is shown. The sterile cover 232 may form part of a sterile barrier 208, which may further include, for example... Figure 21 and Figure 22 The sterile adapter 230 is shown. The sterile cover 232 can be made of a sterile flexible material (such as a plastic sheet). In the illustrated embodiment, the sterile cover 232 is configured to cover a trolley comprising a robotic medical system including three robotic arms, for example, as... Figure 2 and Figure 30 As shown, the sterile cover 232 includes three flexible tubes 253. The three flexible tubes 253 are configured in size and shape to be mounted on three robotic arms. The flexible tubes 253 extend from a cart cover portion 254, which is configured in size and shape to be mounted on a cart.

[0169] In the illustrated embodiment, the sample collector 300 is positioned at the distal end of each flexible tube 253 so that it is positioned in an advantageous position when the cover 232 is installed (as described above). Figure 30 This is a perspective view 226 of an embodiment of a sterile covering 232 mounted on a cart comprising three robotic arms. In the illustrated embodiment, the robotic arms 226 have been moved to an exemplary covering position that facilitates the installation of the covering 232. Once the covering 232 is installed, the robotic arms 226 can be moved to a position for performing medical procedures.

[0170] Figure 31 Another embodiment of a sterile cover 232 including a sample collector 300 is shown. Figure 31 The cover 232 is configured for use with a robotic medical system including a robotic arm 226, which is movably mounted on a rod or track 260. (See above reference) Figures 12-14 Such a system is shown and described. In this embodiment, the cover 232 includes three flexible tubes 253 configured to cover the robotic arm 226 and a track cover portion 256 configured to cover the track 260. As shown, the sample collector 300 can be positioned at the distal end of the flexible tubes 253.

[0171] Figure 32 An embodiment of a sterile barrier 208 is shown, configured to include an assembly of a sterile cover 232, a sterile adapter 230, and a sample collector 300. The sterile adapter 230 includes an upper plate 540, a lower plate 550, and a torque coupler 520 rotatably supported within the sterile adapter 230, such that they are rotatable relative to the upper plate 540 and the lower plate 550 about their respective drive axes. The sterile adapter 230 includes an attachment mechanism 570 (e.g., a clip, latch, magnet, etc.) that can secure the sterile adapter 230 to an instrument drive mechanism 228. The attachment mechanism 570 and / or torque coupler 520 in the sterile adapter 230 can be aligned with corresponding features on the instrument drive mechanism 228, and the sample collector 300 can be attached to the sterile barrier 208 at a known or fixed position relative to the sterile adapter 230, such that when the sterile barrier is secured to the robotic system, the robotic arm can hold the sample collector 300 in a favorable position for sample collection without requiring manual positioning of the sample collector 300 by the user. For example, as Figure 32As shown, the sterile adapter can define a distal side 515 and a proximal side 525 based on the location of the set of torque couplers 520 and attachment mechanisms 570. The sample collector 300 can be attached to the sterile adapter 230 on the distal side 515. Utilizing this location, medical devices extending from the distal side (e.g., ureteroscopes and basket-loading tools) can easily place samples into the sample collector on the distal side 515 during sample retrieval and retraction from the patient.

[0172] 3. Implementation System and Terminology .

[0173] The embodiments disclosed herein provide systems, methods, and apparatus for sample collectors configured for use with robotic medical systems.

[0174] It should be noted that, as used herein, the terms “coupled,” “linked,” “connected,” or other variations of the word “coupled” can indicate an indirect or direct connection. For example, if a first component is “coupled” to a second component, the first component may be indirectly connected to the second component or directly connected to the second component via another component.

[0175] Phrases referring to specific computer-implemented processes / functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" means any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such media may 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 disc storage devices, magnetic disk storage devices 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 can be tangible and non-transitory. As used herein, the term "code" may mean software, instructions, code, or data that can be executed by a computing device or processor.

[0176] The methods disclosed herein include one or more steps or actions for implementing the methods. The method steps and / or actions may be interchanged without departing from the scope of the claims. In other words, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims unless proper operation of the described method requires a specific order of steps or actions.

[0177] As used herein, the term "multiple" means two or more. For example, multiple components indicates two or more components. The term "determine" encompasses a variety of actions, and therefore, "determine" can include calculation, operation, processing, derivation, investigation, lookup (e.g., searching in a table, database, or another data structure), ascertainment, etc. Additionally, "determine" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. Furthermore, "determine" can include parsing, selecting, picking, building, etc.

[0178] Unless otherwise explicitly stated, the phrase “based on” does not mean “based on only”. In other words, the phrase “based on” describes both “based on only” and “based on at least”.

[0179] The foregoing description of the disclosed specific embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these specific embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other specific embodiments without departing from the scope of the invention. For example, it should be understood that those skilled in the art will be able to employ numerous corresponding alternatives and equivalent structural details, such as equivalent methods of fastening, mounting, coupling, or engaging tool components, equivalent mechanisms for generating specific actuating movements, and equivalent mechanisms for delivering electrical energy. Therefore, the invention is not intended to be limited to the specific embodiments shown herein, but is endowed with the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A robotic medical system, comprising: A medical device, the medical device including a distal end configured to be inserted into a patient and capture a sample within the patient; A robotic manipulator, which engages with and is configured to operate the medical device; A sterile barrier configured to separate a sterile area containing the medical device from a non-sterile area containing the robotic manipulator; A sterile adapter configured to be positioned between the base of the medical device and the robotic manipulator, such that the robotic manipulator engages the medical device via the sterile adapter, the sterile adapter defining a distal side and a proximal side, such that the medical device extends from the distal side; as well as A sample collector, comprising: A receiver portion, located in the sterile area and configured to receive the sample when the distal end of the medical device is removed from the patient, and A connector coupled to the receiver portion and configured to attach to the robotic medical system, wherein the connector is attached to the sterile barrier on the distal side such that when the sterile adapter is positioned on the robotic manipulator, the receiver portion is positioned within the sterile zone between the robotic manipulator and the patient's access site.

2. The robotic medical system of claim 1, further comprising at least one processor configured to operate via the robotic manipulator: The distal end of the medical device is inserted into the patient; The sample is collected from the patient using the medical device; Retract the distal end of the medical device and the sample from the patient; and The sample is automatically placed into the receiver section of the sample collector.

3. The robotic medical system of claim 2, wherein the at least one processor is further configured to operate the robotic manipulator upon receiving a user command to: Move the distal end of the medical device into the placement position; and The sample is automatically placed into the receiver section of the sample collector.

4. The robotic medical system according to claim 1, wherein: The connector includes an attachment tab; and The receiver portion can be removed from the attachment tab.

5. The robotic medical system of claim 4, wherein the sample collector includes a perforation between the attachment tab and the receiver portion, the perforation being configured to allow the receiver portion to be detached from the attachment tab.

6. The robotic medical system of claim 1, wherein at least a portion of the receiver portion is porous and configured to allow fluid to drain from the receiver portion while retaining the sample.

7. The robotic medical system of claim 1, wherein the sample collector further comprises an opening retaining device positioned at an opening in the receiver portion and configured to retain the opening in an open configuration, and wherein the sterile barrier comprises a sterile cover configured to cover at least a portion of the robotic manipulator.

8. The robotic medical system according to claim 1, wherein: The connector includes attachment tabs, and The attachment tab includes an adhesive surface configured to adhere to the robotic medical system such that the receiver portion is positioned within the sterile area at a location where the medical device can automatically place the sample.

9. A sample collector for a robotic medical system, the robotic medical system including a medical device, a robotic manipulator, and a sterile barrier, the medical device including a distal end configured to be inserted into a patient and capture a sample within the patient, the robotic manipulator engaging with the medical device and configured to operate the medical device, and the sterile barrier configured to separate a sterile area containing the medical device from a non-sterile area containing the robotic manipulator. A sterile adapter is configured to be positioned between the base of the medical device and the robotic manipulator, such that the robotic manipulator engages the medical device via the sterile adapter, the sterile adapter defining a distal and a proximal side, such that the medical device extends from the distal side. The sample collector includes: A receiver portion, located in the sterile area and configured to receive a sample removed from the patient when the distal end of the medical device is removed from the patient; A connector coupled to the receiver portion and configured to be attached to the robotic medical system to position the receiver portion relative to the robotic medical system, wherein the connector is attached to the sterile barrier on the distal side such that when the sterile adapter is positioned on the robotic manipulator, the receiver portion is positioned within the sterile zone between the robotic manipulator and the patient's access site. as well as A porous portion is formed on at least a portion of the receiver portion, the porous portion being configured to allow liquid to drain from the receiver portion while retaining a sample placed within the receiver portion.

10. The sample collector of claim 9, further comprising an opening retaining device positioned at the opening of the receiver portion and configured to retain the opening in an open configuration, wherein the receiver portion includes: A first flexible layer, the first flexible layer including a first upper edge, a first right edge, a first left edge and a first lower edge, wherein the connector extends from the first upper edge; as well as The second flexible layer includes a second upper edge, a second right edge, a second left edge, and a second lower edge, wherein the second right edge, the second left edge, and the second lower edge are respectively connected to the first right edge, the first left edge, and the first lower edge, such that the first flexible layer and the second flexible layer form a recess, the recess having an opening defined by the first upper edge and the second upper edge.

11. The sample collector of claim 10, further comprising a perforation located between the receiver portion and the connector, and configured such that the receiver portion can be detached from the connector.

12. The sample collector of claim 9, wherein the connector includes an attachment tab, the attachment tab including an adhesive backing on at least a first side of the attachment tab.

13. A sterile barrier for use in a robotic medical system, the sterile barrier comprising: A sterile cover, the sterile cover including a first flexible tube configured to cover at least a portion of a first robotic arm; as well as The sample collector of claim 9, wherein the attachment tab of the sample collector is attached to the sterile cover at the distal end of the first flexible tube.

14. The sterile barrier of claim 13, wherein the sterile adapter is connected to the distal end of the first flexible tube, and wherein the sample collector is attached to the sterile barrier near the distal end of the first flexible tube. The sterile covering also includes: A second flexible tube, configured to cover a second robotic arm; A third flexible tube, the third flexible tube being configured to cover a third robotic arm; as well as A flexible trolley cover, configured to cover a trolley from which a first robotic arm, a second robotic arm, and a third robotic arm extend.

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