Robotic Medical Systems

Abstract

Described herein is a specimen collector configured for use with a robotic medical system. The robotic medical system can include a medical instrument that can be inserted into a patient to capture a specimen. A robotic manipulator can be configured to engage and 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. The specimen collector can include a receptacle portion within the sterile field configured to receive the specimen when the distal end of the medical instrument is withdrawn from the patient, and a connector coupled to the receptacle portion and configured to attach to the robotic medical system. The robotic system can deposit the specimen in the receptacle portion.

Description

[Technical field]

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 62 / 955,050, filed December 30, 2019, which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The systems and methods disclosed herein are directed to robotic medical systems, and more specifically, to specimen collectors for robotic medical systems. [Background technology]

[0003] Robotic medical systems can be configured to perform a wide variety of medical procedures, including endoscopic, laparoscopic, and open procedures, among others. During some procedures, medical instruments can be used to remove objects, specimens, or samples from a patient. As an example, a medical instrument can be used to remove a kidney stone or kidney stone fragments during a kidney stone removal procedure. [Brief description of the drawings]

[0004] The disclosed aspects are hereinafter described in conjunction with the accompanying drawings, which illustrate, by way of example only, and not by way of limitation, the disclosed aspects, and in which like designations refer to like elements. [Figure 1] 1 illustrates an embodiment of a cart-based robotic system deployed for diagnostic and / or therapeutic bronchoscopy. [Diagram 2] 2 is a further embodiment of the robotic system of FIG. 1. [Diagram 3] 2 illustrates an embodiment of the robotic system of FIG. 1 positioned for ureteroscopy. [Figure 4] 2 illustrates an embodiment of the robotic system of FIG. 1 positioned for a vascular procedure. [Diagram 5] 1 illustrates an embodiment of a table-based robotic system positioned for a bronchoscopy procedure. [Figure 6]FIG. 6 is an alternative view of the robotic system of FIG. [Figure 7] 1 is an exemplary system configured to accommodate a robotic arm(s). [Figure 8] 1 is an embodiment of a table-based robotic system configured for a ureteroscopy procedure. [Figure 9] 1 is an embodiment of a table-based robotic system configured for laparoscopic procedures. [Figure 10] FIG. 10 is an embodiment of the table-based robotic system of FIGS. 5-9 with pitch or tilt adjustment. [Figure 11] FIG. 11 is a detailed explanatory diagram of the interface between the table and column of the table-based robotic system of FIGS. 5-10. [Figure 12] 1 is an alternative embodiment of a table-based robotic system. [Figure 13] FIG. 13 is an end view of the table-based robotic system of FIG. [Figure 14] FIG. 1 is an end view of a table-based robotic system with a robotic arm attached. [Figure 15] FIG. 1 illustrates an exemplary instrument driver. [Figure 16] 1 illustrates an exemplary medical instrument with a pair of instrument drivers. [Figure 17] 13A-13C show alternative designs of the instrument driver and instrument, where the axis of the drive unit is parallel to the axis of the elongated shaft of the instrument. [Figure 18] FIG. 1 illustrates an instrument having an instrument-based insertion architecture. [Figure 19] FIG. 2 illustrates an example controller. [Figure 20] FIG. 19 is a block diagram illustrating a localization system that estimates the location of one or more elements of the robotic system of FIGS. 1-10, such as the location of the instrument of FIGS. 16-18, in accordance with an exemplary embodiment. [Figure 21] FIG. 1 illustrates a top view of an embodiment of a robotic medical system including a specimen collector. [Figure 22] FIG. 22 is a side view of the robotic medical system and specimen collector of FIG. [Diagram 23] FIG. 1 is a perspective view of the distal end of an embodiment of a robotic arm covered with a sterile drape and including a specimen collector. [Figure 24] FIG. 22 is a block diagram illustrating exemplary control components for the robotic medical system of FIG. 21. [Diagram 25] 25 is a flowchart illustrating an example control method that may be performed using the control components of FIG. 24 to operate the robotic medical system of FIG. 21. [Figure 26] FIG. 1 is a front view of an embodiment of a specimen collector. [Figure 27] FIG. 27 is an exploded view of the specimen collector of FIG. 26. [Figure 28] 1 is a flow chart illustrating an exemplary method for using a robotic medical system to deposit a specimen into a specimen collector. [Figure 29] FIG. 1 illustrates an isometric view of an embodiment of a sterile drape including a specimen collector. [Diagram 30] FIG. 30 is a perspective view of the sterile drape embodiment of FIG. 29 mounted on a cart including three robotic arms. [Diagram 31] 1 is another embodiment of a sterile drape including a specimen collector. [Diagram 32] 1 is an embodiment of a sterile barrier assembly including a specimen collector. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0005] 1. Overview. Aspects of the present disclosure may be integrated into a robotic-enabled medical system capable of performing a variety of medical procedures, including both minimally invasive procedures such as laparoscopy, and non-invasive procedures such as endoscopic procedures. Among endoscopic procedures, the system may perform bronchoscopy, ureteroscopy, gastroscopy, etc.

[0006] In addition to performing a wide range of procedures, the system can provide additional benefits such as enhanced imaging and guidance to assist the physician. Additionally, the system can provide the physician with the ability to perform procedures from an ergonomic position without requiring awkward arm movements and postures. Still further, the system can provide the physician with the ability to perform procedures with improved ease of use, such that one or more of the instruments of the system can be controlled by a single user.

[0007] Various embodiments are described below in conjunction with the drawings for purposes of explanation. It should be understood that many other implementations of the disclosed concepts are possible, and that various advantages may be achieved in the disclosed implementations. Headings are included herein for reference and to aid in locating the various sections. These headings are not intended to limit the scope of the concepts described therein. Such concepts may have applicability throughout this specification.

[0008] A. Robotic System - Cart. Robot-enabled medical systems can be configured in a variety of ways depending on the particular procedure. FIG. 1 illustrates an embodiment of a cart-based robot-enabled system 10 arranged for a diagnostic and / or therapeutic bronchoscopy procedure. During a bronchoscopy procedure, the system 10 can include a cart 11 having one or more robotic arms 12 for delivering a medical instrument, such as a steerable endoscope 13, which can be a procedure-specific bronchoscope for bronchoscopy, to a natural orifice access point (i.e., the patient's mouth, which in this example is positioned on a table) for delivering the diagnostic and / or therapeutic tools. As shown, the cart 11 can be positioned adjacent to the patient's upper torso to provide access to the access point. Similarly, the robotic arms 12 can be actuated to position the bronchoscope relative to the access point. The arrangement of FIG. 1 can also be utilized when performing a gastrointestinal (GI) procedure with a gastroscope, which is a specialized endoscope for GI procedures. FIG. 2 illustrates an exemplary embodiment of the cart in more detail.

[0009] With continued reference to FIG. 1, once the cart 11 is properly positioned, the robotic arm 12 can insert the steerable endoscope 13 into the patient robotically, manually, or a combination thereof. As shown, the steerable endoscope 13 may include at least two nested parts, such as an inner leader portion and an outer sheath portion, each portion coupled to a separate instrument driver from a set of instrument drivers 28, each instrument driver coupled to the distal end of an individual robotic arm. This linear arrangement of the instrument drivers 28, which facilitates coaxial alignment of the leader portion with the sheath portion, forms a "virtual rail" 29 that can be repositioned in space by manipulating one or more robotic arms 12 to different angles and / or positions. The virtual rails described herein are shown in the figures using dashed lines, and thus the dashed lines do not indicate the physical structure of the system. Translation of the instrument driver 28 along the virtual rail 29 nests the inner leader portion relative to the outer sheath portion or advances or retracts the endoscope 13 from the patient. The angle of the virtual rail 29 may be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and position of the virtual rail 29 as shown represents a compromise that provides the physician access to the endoscope 13 while minimizing friction from bending the endoscope 13 into the patient's mouth.

[0010] The endoscope 13 may be directed downstream of the patient's trachea and lungs after insertion using precise commands from the robotic system until the target destination or surgical site is reached. To facilitate navigation through the patient's pulmonary network and / or to reach the desired target, the endoscope 13 may be steered to telescope the inner leader portion out from the outer sheath portion for enhanced articulation and a larger bend radius. The use of a separate instrument driver 28 also allows the leader portion and sheath portion to be driven independently of one another.

[0011] For example, the endoscope 13 may be directed to deliver a biopsy needle to a target, such as a lesion or nodule in the patient's lung. The needle may be deployed down a working channel that spans the length of the endoscope to obtain a tissue sample that is analyzed by a pathologist. Depending on the results of the pathology, additional tools may be deployed downstream of the working channel of the endoscope for additional biopsies. After identifying the nodule as malignant, the endoscope 13 may endoscopically deliver a tool to ablate the potential cancerous tissue. In some cases, diagnostic and therapeutic procedures may be provided in separate procedures. In these situations, the endoscope 13 may also be used to deliver fiducials to "mark" the location of the target nodule. In other examples, diagnostic and therapeutic procedures may be delivered during the same procedure.

[0012] The system 10 may also include a movable tower 30 that may be connected to the cart 11 via a support cable to provide support for control, electronics, fluidics, optics, sensors, and / or power to the cart 11. Locating such functionality within the tower 30 allows for a smaller form factor cart 11 that can be more easily adjusted and / or repositioned by the operating physician and his / her staff. Additionally, the division of functionality between the cart / table and the support tower 30 reduces clutter in the operating room and facilitates improved clinical workflow. The cart 11 may be positioned in close proximity to the patient, while the tower 30 may be housed in a remote location so as not to get in the way during the procedure.

[0013] To support the robotic system described above, the tower 30 may include computer-based control system components that store computer program instructions in a non-transitory computer-readable storage medium, such as, for example, a persistent magnetic storage drive, a solid-state drive, or the like. Execution of these instructions, whether execution occurs in the tower 30 or in the cart 11, may control the entire system or subsystems thereof. For example, when executed by a processor in the computer system, the instructions may cause the components of the robotic system to actuate associated carriages and arm mounts, operate a robotic arm, and control a medical instrument. For example, in response to receiving control signals, motors in the joints of the robotic arm may position the arm in a particular pose.

[0014] The tower 30 may also include pumps, flow meters, valve controls, and / or fluid access to provide controlled irrigation and aspiration functions to a system that may be deployed through the endoscope 13. These components may also be controlled using the computer system of the tower 30. In some embodiments, irrigation and aspiration capabilities may be delivered directly to the endoscope 13 via separate cables.

[0015] The tower 30 may include voltage and surge protection designed to provide filtered and protected power to the cart 11, thereby avoiding the need to place power transformers and other auxiliary power components within the cart 11 and making the cart 11 smaller and more mobile.

[0016] The tower 30 may also include support equipment for sensors deployed throughout the robotic system 10. For example, the tower 30 may include optoelectronic equipment for detecting, receiving, and processing data received from optical sensors or cameras throughout the robotic system 10. In combination with a control system, such optoelectronic equipment may be used to generate real-time images for display within any number of consoles deployed throughout the system, including within the tower 30. Similarly, the tower 30 may also include electronic subsystems for receiving and processing signals from deployed electromagnetic (EM) sensors. The tower 30 may also be used to house and position EM field generators for detection by EM sensors in or on the medical instrument.

[0017] The tower 30 may also include a console 31 in addition to other consoles available to the rest of the system, for example a console mounted on top of a cart. The console 31 may include a user interface for the operator physician and a display screen, such as a touch screen. The consoles in the system 10 are generally designed to provide both pre-operative and real-time information of the procedure, such as robotic control and navigation and localization information for the endoscope 13. If the console 31 is not the only console available to the physician, the console 31 may be used by a second operator, such as a nurse, to provide procedure-specific data, such as navigation and localization information, as well as monitor the patient's health or vitals and the operation of the system 10. In other embodiments, the console 30 is housed in a body separate from the tower 30.

[0018] The tower 30 may be coupled to the cart 11 and the endoscope 13 via one or more cables or connections (not shown). In some embodiments, support functions from the tower 30 may be provided to the cart 11 through a single cable, simplifying and decluttering the operating room. In other embodiments, certain functions may be coupled with separate wiring and connections. For example, power may be provided to the cart 11 through a single power cable, while support for control, optics, fluidics, and / or navigation may be provided through separate cables.

[0019] FIG. 2 provides a detailed view of an embodiment of a cart 11 from the cart-based robot-enabled system shown in FIG. 1. The cart 11 generally includes an elongated support structure 14 (often referred to as a "column"), a cart base 15, and a console 16 at the top of the column 14. The column 14 may include one or more carriages, such as a carriage 17 (alternatively an "arm support") for supporting the deployment of one or more robotic arms 12 (three are shown in FIG. 2). The carriage 17 may include an individually configurable arm mount that rotates along a vertical axis to adjust the base of the robotic arm 12 for better positioning relative to the patient. The carriage 17 also includes a carriage interface 19 that allows the carriage 17 to translate vertically along the column 14.

[0020] The carriage interface 19 is connected to the column 14 through slots, such as slots 20 located on either side of the column 14 to guide the vertical translation of the carriage 17. The slots 20 include vertical translation interfaces for positioning and holding the carriage 17 at various vertical heights relative to the cart base 15. The vertical translation of the carriage 17 allows the cart 11 to adjust the reach of the robotic arm 12 to meet various table heights, patient sizes, and physician preferences. Similarly, an individually configurable arm mount on the carriage 17 allows the robotic arm base 21 of the robotic arm 12 to be angled in various configurations.

[0021] In some embodiments, a slot cover may be added to the slot 20 that is flush and parallel with the slot surface to prevent dirt and fluids from entering the interior chamber of the column 14 and the vertical translation interface as the carriage 17 translates vertically. The slot cover may be deployed through a pair of spring spools located near the vertical top and bottom of the slot 20. The cover is coiled within the spools until it is deployed to extend and retract from the coil as the carriage 17 translates vertically up and down. The spring loading of the spools provides the force to retract the cover into the spools as the carriage 17 translates towards the spools, while also maintaining a seal as the carriage 17 translates away from the spools. The cover may be connected to the carriage 17 using, for example, a bracket within the carriage interface 19 to ensure that the cover extends and retracts properly as the carriage 17 translates.

[0022] Column 14 may include mechanisms therein, such as gears and motors, designed to use a vertically aligned leadscrew to mechanically translate carriage 17 in response to control signals generated in response to user input, such as input from console 16.

[0023] The robotic arm 12 may generally include a robotic arm base 21 and an end effector 22 separated by a series of links 23 connected by a series of joints 24, each joint including an independent actuator, each actuator including an independently controllable motor. Each independently controllable joint represents an independent degree of freedom available to the robotic arm 12. Each of the robotic arms 12 may have seven joints, thus providing seven degrees of freedom. A large number of joints results in a large number of degrees of freedom, allowing for "redundant" degrees of freedom. Having redundant degrees of freedom allows the robotic arms 12 to position their respective end effectors 22 at specific positions, orientations, and trajectories in space using different link positions and joint angles. This allows the system to position and orient the medical instrument from a desired point in space, while allowing the physician to move the arm joints away from the patient to a clinically advantageous position to create better access while avoiding arm collisions.

[0024] The cart base 15 balances the weight of the column 14, carriage 17, and robotic arm 12 on the floor. Thus, the cart base 15 houses the heavier parts such as electronics, motors, power supplies, and components that allow either movement and / or immobilization of the cart 11. For example, the cart base 15 includes casters 25 in the form of rollable wheels that allow the cart 11 to be easily moved around the room before a procedure. After reaching the proper position, the casters 25 may be immobilized using wheel locks to hold the cart 11 in place during a procedure.

[0025] The console 16 positioned at the vertical end of the column 14 allows for both a user interface and a display screen (or dual-purpose device, e.g., touch screen 26) for receiving user input to provide both pre-operative and intra-operative data to the physician user. Potential pre-operative data on the touch screen 26 may include pre-operative planning, navigation and mapping data derived from a pre-operative computerized tomography (CT) scan, and / or notes from a pre-operative patient interview. Intra-operative data on the display may include optical information provided by tools, sensor and coordinate information from sensors, and vital patient statistics such as respiration, heart rate, and / or pulse. The console 16 may be positioned and angled to allow the physician to access the console 16 from the opposite side of the column 14 from the carriage 17. From this position, the physician can view the console 16, the robotic arm 12, and the patient while operating the console 16 from behind the cart 11. As shown, the console 16 also includes a handle 27 to aid in maneuvering and stabilizing the cart 11.

[0026] FIG. 3 illustrates an embodiment of the robot-enabled system 10 positioned for ureteroscopy. In a ureteroscopy procedure, the cart 11 may be positioned to deliver a ureteroscope 32, a procedure-specific endoscope designed to traverse the patient's urethra and ureters, to the patient's lower abdominal region. In a ureteroscopy, it may be desirable for the ureteroscope 32 to be directly aligned with the patient's urethra to reduce friction and forces on sensitive anatomical structures in the region. As shown, the cart 11 may be aligned to the table leg to allow the robotic arm 12 to position the ureteroscope 32 to directly access the patient's urethra in a straight line. From the table leg, the robotic arm 12 may insert the ureteroscope 32 along a virtual rail 33 directly through the urethra and into the patient's lower abdomen.

[0027] After insertion into the urethra using control techniques similar to those in bronchoscopy, the ureteroscope 32 may be navigated to the bladder, ureters, and / or kidneys for diagnostic and / or therapeutic applications. For example, the ureteroscope 32 may be aimed at the ureters and kidneys to break up formed kidney stones using a laser or ultrasonic lithotripsy device deployed down the working channel of the ureteroscope 32. After the lithotripsy is completed, the resulting stone fragments may be removed using a basket deployed down the ureteroscope 32.

[0028] FIG. 4 shows an embodiment of a robot-enabled system 10 similarly positioned for a vascular procedure. In a vascular procedure, the system 10 may be configured such that the cart 11 can deliver a medical instrument 34, such as a steerable catheter, to an access point in the femoral artery in the patient's leg. The femoral artery presents both a larger diameter for navigation and a less circuitous and tortuous path to the patient's heart, simplifying navigation. As in a ureteroscopy procedure, the cart 11 may be positioned toward the patient's leg and lower abdomen, allowing the robotic arm 12 to provide a virtual rail 35 with direct linear access to the femoral artery access point in the patient's thigh / hip region. After insertion into the artery, the medical instrument 34 may be oriented and inserted by translating the instrument driver 28. Alternatively, the cart may be positioned around the patient's upper abdomen to reach alternative vascular access points, such as the carotid and brachial arteries near the shoulder and wrist.

[0029] B. Robot system-table. An embodiment of a robot-enabled medical system may also incorporate a patient table. The incorporation of a table reduces the amount of capital equipment in the operating room by eliminating carts and allows greater access to the patient. FIG. 5 shows an embodiment of such a robot-enabled system deployed for a bronchoscopy procedure. The system 36 includes a support structure or column 37 for supporting a platform 38 (shown as a "table" or "bed") above the floor. As with cart-based systems, the end effector of the robotic arm 39 of the system 36 includes an instrument driver 42 designed to manipulate an elongated medical instrument, such as the bronchoscope 40 of FIG. 5, through or along a virtual rail 41 formed from the linear alignment of the instrument driver 42. In practice, a C-arm for providing fluoroscopic imaging may be positioned above the upper abdominal region of the patient by placing emitters and detectors around the table 38.

[0030] FIG. 6 provides an alternative view of the system 36 without the patient and medical instruments for illustrative purposes. As shown, the column 37 may include one or more carriages 43, illustrated as a ring shape in the system 36, which may be the base for one or more robotic arms 39. The carriages 43 may translate along a vertical column interface 44 that spans the length of the column 37 to provide different vantage points where the robotic arms 39 may be positioned to reach the patient. The carriages 43 may rotate around the column 37 using a mechanical motor positioned within the column 37 to allow the robotic arms 39 to have access to multiple sides of the table 38, such as both sides of the patient. In embodiments with multiple carriages, the carriages may be individually positioned on the column and may translate and / or rotate independently of the other carriages. The carriages 43 do not have to surround the column 37 or even be circular, but the ring shape as illustrated facilitates the rotation of the carriages 43 around the column 37 while maintaining structural balance. Rotation and translation of carriage 43 allows system 36 to align medical instruments such as endoscopes and laparoscopes to different access points on the patient. In other embodiments (not shown), system 36 can include a patient table or bed with adjustable arm supports in the form of parallel extending bars or rails. One or more robotic arms 39 can be mounted on adjustable arm supports that can be adjusted vertically (e.g., via a shoulder with an elbow joint). By providing vertical adjustment, robotic arm 39 can advantageously be stored compactly under a patient table or bed and then raised during a procedure.

[0031] The robotic arm 39 may be mounted to the carriage 43 via a set of arm mounts 45 that include a series of joints that may rotate and / or nest independently to provide additional configurability to the robotic arm 39. Additionally, the arm mounts 45 may be positioned on the carriage 43 such that, when the carriage 43 is appropriately rotated, the arm mounts 45 may be positioned either on the same side of the table 38 (as shown in FIG. 6), on opposite sides of the table 38 (as shown in FIG. 9), or on adjacent sides of the table 38 (not shown).

[0032] The column 37 structurally provides support for the table 38 and a path for the vertical translation of the carriage 43. Internally, the column 37 may include a lead screw for guiding the vertical translation of the carriage, and a motor for mechanizing the translation of the carriage 43 based on the lead screw. The column 37 may also transmit power and control signals to the carriage 43 and to a robotic arm 39 mounted thereon.

[0033] The table base 46 serves a similar function as the cart base 15 of the cart 11 shown in FIG. 2, housing the heavier components to counterbalance the table / bed 38, column 37, carriage 43, and robotic arm 39. The table base 46 may also incorporate rigid casters to provide stability during a procedure. The casters that deploy from the bottom of the table base 46 extend in opposite directions on either side of the base 46 and may be retracted when the system 36 needs to be moved.

[0034] Continuing to refer to FIG. 6, the system 36 may also include a tower (not shown) that divides the functionality of the system 36 between the table and the tower to reduce the form factor and bulk of the table. As with the previously disclosed embodiments, the tower may provide various support functions to the table, such as processing, computing, and control capabilities, power, fluidics, and / or optical and sensor processing. The tower may also be movable so that it can be positioned away from the patient to improve physician access and keep the operating room neat and tidy. Additionally, locating components in the tower allows for more storage space in the table base 46 for potential accommodation of the robotic arm 39. The tower may also include a master controller or console that provides both a user interface for user input, such as a keyboard and / or pendant, and a display screen (or touch screen) for pre-operative and intra-operative information, such as real-time imaging, navigation, and tracking information. In some embodiments, the tower may also include a holder for a gas tank used for insufflation.

[0035] In some embodiments, the table base may house and store the robot arm when not in use. FIG. 7 shows a system 47 for housing the robot arm in an embodiment of a table-based system. In the system 47, the carriage 48 may be translated vertically into the base 49 to house the robot arm 50, arm mount 51, and carriage 48 therein. The base cover 52 may be translated and retracted to open to deploy the carriage 48, arm mount 51, and robot arm 50 about the column 53, and closed to house and protect them when not in use. The base cover 52 may be sealed with a membrane 54 along the edge of its opening to prevent dirt and fluid ingress when closed.

[0036] 8 shows an embodiment of a robot-enabled table-based system configured for a ureteroscopy procedure. For ureteroscopy, the table 38 may include a swivel portion 55 for positioning the patient off-angle from the column 37 and table base 46. The swivel portion 55 may rotate or pivot about a pivot point (e.g., located below the patient's head) to position the bottom of the swivel portion 55 away from the column 37. For example, pivoting the swivel 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 the table 38. By rotating the carriage 35 (not shown) about the column 37, the robotic arm 39 may insert the ureteroscope 56 directly into the patient's groin area along the virtual rail 57 to reach the urethra. In ureteroscopy, stirrups 58 may also be secured to the swivel portion 55 of the table 38 to support the position of the patient's legs during the procedure and to allow clear access to the patient's groin area.

[0037] In a laparoscopic procedure, minimally invasive instruments may be inserted into a patient's anatomy through small incisions in the patient's abdominal wall. In some embodiments, the minimally invasive instruments include an elongated rigid member, such as a shaft, that is used to access anatomy within the patient. After distension of the patient's abdominal cavity, the instruments may be directed to perform a surgical or medical task, such as grasping, cutting, ablation, suturing, etc. In some embodiments, the instruments may include a scope, such as a laparoscope. FIG. 9 illustrates an embodiment of a robot-enabled table-based system configured for a laparoscopic procedure. As shown in FIG. 9, the carriage 43 of the system 36 may be rotated and adjusted vertically to position a pair of robotic arms 39 on either side of the table 38 such that instruments 59 may be positioned using arm mounts 45 to pass through minimal incisions on either side of the patient to reach the patient's abdominal cavity.

[0038] To accommodate laparoscopic procedures, the robotic table system may also tilt the platform to a desired angle. FIG. 10 shows an embodiment of a robotic medical system with pitch or tilt adjustment. As shown in FIG. 10, the system 36 can accommodate the tilt of the table 38 to position one portion of the table further away from the floor than the other portion. Additionally, the arm mount 45 may rotate to match the tilt so that the robotic arm 39 maintains the same planar relationship with the table 38. To accommodate steeper angles, the column 37 may also include a nesting portion 60 that allows the column 37 to extend vertically to prevent the table 38 from contacting the floor or colliding with the table base 46.

[0039] FIG. 11 provides a detailed view of the interface between the table 38 and the column 37. The pitch rotation mechanism 61 may be configured to change the pitch angle of the table 38 relative to the column 37 in multiple degrees of freedom. The pitch rotation mechanism 61 may be enabled by the positioning of orthogonal axes 1, 2 at the column-table interface, each actuated by a separate motor 3, 4 in response to an electrical pitch angle command. Rotation along one screw 5 allows tilt adjustment in one axis 1, and rotation along the other screw 6 allows tilt adjustment along the other axis 2. In some embodiments, a ball joint may be used to change the pitch angle of the table 38 relative to the column 37 in multiple degrees of freedom.

[0040] For example, pitch adjustment is particularly useful when attempting to position the table in the Trendelenburg position, i.e., positioning the patient's lower abdomen higher off the floor than the patient's upper abdomen for lower abdominal surgery. The Trendelenburg position allows gravity to slide the patient's internal organs toward the patient's upper abdomen, emptying the abdominal cavity for entry of minimally invasive tools to perform lower abdominal surgical or medical procedures, such as laparoscopic prostatectomy.

[0041] 12 and 13 show isometric and end views of another embodiment of a table-based surgical robotic system 100. The surgical robotic system 100 includes one or more adjustable arm supports 105 (see, e.g., FIG. 14) that can be configured to support one or more robotic arms relative to a table 101. In the illustrated embodiment, a single adjustable arm support 105 is shown, but additional arm supports can be provided on the opposite side of the table 101. The adjustable arm support 105 can be configured to move relative to the table 101 to adjust and / or change the position of the adjustable arm support 105 and / or any robotic arm attached thereto relative to the table 101. For example, the adjustable arm support 105 can be adjusted with one or more degrees of freedom relative to the table 101. The adjustable arm support 105 provides the system 100 with great versatility, including the ability to easily accommodate one or more adjustable arm supports 105 and any robotic arms attached thereto under the table 101. The adjustable arm support 105 can be raised from a stowed position to a position below the top surface of the table 101. In other embodiments, the adjustable arm support 105 can be raised from a stowed position to a position above the top surface of the table 101.

[0042] The adjustable arm support 105 can provide several degrees of freedom, including lift, lateral translation, tilt, etc. In the illustrated embodiment of Figs. 12 and 13, the arm support 105 is configured with four degrees of freedom, which are indicated by arrows in Fig. 12. The first degree of freedom allows for adjustment of the adjustable arm support 105 in the z-direction ("Z-lift"). For example, the adjustable arm support 105 can include a carriage 109 configured to move up and down along or relative to the column 102 that supports the table 101. The second degree of freedom allows the adjustable arm support 105 to tilt. For example, the adjustable arm support 105 can include a rotational joint, which can allow the adjustable arm support 105 to align with the bed in a Trendelenburg position. The third degree of freedom can allow the adjustable arm support 105 to "pivot up", which can be used to adjust the distance between the side of the table 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 table.

[0043] The surgical robotic system 100 of Figures 12 and 13 can include a table supported by a column 102 mounted to a base 103. The base 103 and the column 102 support the table 101 against a support surface. A bed axis 131 and a support axis 133 are shown in Figure 13.

[0044] The adjustable arm support 105 can be mounted to the column 102. In other embodiments, the arm support 105 can be mounted to the table 101 or the base 103. The adjustable arm support 105 can include a carriage 109, a bar or rail connector 111, and a bar or rail 107. In some embodiments, one or more robotic arms mounted to the rail 107 can translate and move relative to each other.

[0045] The carriage 109 may be attached to the column 102 by a first joint 113, which allows the carriage 109 to move relative to the column 102 (e.g., up and down on a first or vertical axis 123). The first joint 113 may provide a first degree of freedom ("Z lift") for the adjustable arm support 105. The adjustable arm support 105 may include a second joint 115 that provides a second degree of freedom (tilt) for the adjustable arm support 105. The adjustable arm support 105 may include a third joint 117 that may provide a third degree of freedom ("upward pivot") for the adjustable arm support 105. An additional joint 119 (shown in FIG. 13) may be provided that mechanically constrains the third joint 117 to maintain the orientation of the rail 107 when the rail connector 111 is rotated about a third axis 127. The adjustable arm support 105 can include a fourth joint 121 that can provide a fourth degree of freedom (translation) to the adjustable arm support 105 along a fourth axis 129 .

[0046] 14 shows an end view of a surgical robotic system 140A having two adjustable arm supports 105A, 105B mounted on either side of a table 101. A first robotic arm 142A is attached to a bar or rail 107A of the first adjustable arm support 105B. The first robotic arm 142A includes a base 144A attached to the rail 107A. The distal end of the first robotic arm 142A includes an instrument drive mechanism 146A that can be attached to one or more robotic medical instruments or tools. Similarly, the second robotic arm 142B includes a base 144B attached to the rail 107B. The distal end of the second robotic arm 142B includes an instrument drive mechanism 146B. The instrument drive mechanism 146B can be configured to attach to one or more robotic medical instruments or tools.

[0047] In some embodiments, one or more of the robotic arms 142A, 142B include arms with seven or more degrees of freedom. In some embodiments, one or more of the robotic arms 142A, 142B can include eight degrees of freedom, including an insertion axis (one degree of freedom including insertion), wrist (three degrees of freedom including wrist pitch, yaw, and roll), elbow (one degree of freedom including elbow pitch), shoulder (two degrees of freedom including shoulder pitch and yaw), and base 144A, 144B (one degree of freedom including translation). In some embodiments, the insertion degree of freedom can be provided by the robotic arms 142A, 142B, while in other embodiments, the instrument itself provides the insertion via an instrument-based insertion architecture.

[0048] C. Instrument drivers and interfaces. The end effector of the robotic arm of the system may include (i) an instrument driver (alternatively called an "instrument drive mechanism" or "instrument device manipulator") that incorporates electromechanical means for actuating the medical instrument, and (ii) a removable or detachable medical instrument, which may lack any electromechanical components such as a motor. This dichotomy may be caused by the need to sterilize the medical instruments used in medical procedures and the inability to adequately sterilize expensive capital equipment due to the complex mechanical assembly of medical instruments and the sensitivity of electronics. Thus, medical instruments may be designed to be detached, removed, and replaced from the instrument driver (and thus the system) for individual sterilization or disposal by the physician or physician's staff. In contrast, instrument drivers do not need to be replaced or sterilized and can be draped for protection.

[0049] FIG. 15 illustrates an exemplary instrument driver. The instrument driver 62, located at the distal end of the robotic arm, includes one or more drive units 63 arranged with parallel axes to provide a controlled torque to the medical instrument via a drive shaft 64. Each drive unit 63 includes an individual drive shaft 64 for interacting with the instrument, a gear head 65 for converting the rotation of the motor shaft to a desired torque, a motor 66 for generating the drive torque, an encoder 67 for measuring the speed of the motor shaft and providing feedback to the control circuit, and a control circuit 68 for receiving control signals to operate the drive unit. Each drive unit 63 is independently controlled and motorized, and the instrument driver 62 can provide multiple (e.g., four as shown in FIG. 15) independent drive outputs to the medical instrument. In operation, the control circuit 68 receives the control signals, sends motor signals to the motors 66, compares the resulting motor speed measured by the encoders 67 to a desired speed, and modulates the motor signals to generate the desired torque.

[0050] For procedures requiring a sterile environment, the robotic system may incorporate a drive interface, such as a sterile adapter connected to a sterile drape, located between the instrument driver and the medical instrument. The primary purpose of the sterile adapter is to transmit angular motion from the drive shaft of the instrument driver to the drive input of the instrument while maintaining physical separation, and therefore sterility, between the drive shaft and the drive input. Thus, an exemplary sterile adapter may include a set of rotational inputs and outputs intended to mate with the drive shaft of the instrument driver and a drive input to the instrument. The sterile drape connected to the sterile adapter is composed of a thin flexible material, such as a transparent or translucent plastic, and is designed to cover the instrument driver, the robotic arm, and capital equipment, such as a cart (in a cart-based system) or a table (in a table-based system). The use of the drape allows the capital equipment to be positioned in close proximity to the patient while still being located in an area that does not require sterility (i.e., the non-sterile field). On the other side of the sterile drape, the medical instrument may interface with the patient in an area that requires sterility (i.e., the sterile field).

[0051] D. Medical equipment. FIG. 16 illustrates an exemplary medical instrument with a paired instrument driver. Similar to other instruments designed for use with a robotic system, the medical instrument 70 includes an elongated shaft 71 (or elongated body) and an instrument base 72. The instrument base 72, also referred to as an "instrument handle" due to its design intended for manual interaction by a physician, may generally include a rotatable drive input 73, e.g., a receptacle, pulley, or spool, designed to mate with a drive output 74 that extends through a drive interface on an instrument driver 75 at the distal end of a robotic arm 76. When physically connected, latched, and / or coupled, the mated drive input 73 of the instrument base 72 may share an axis of rotation with the drive output 74 on the instrument driver 75 to enable the transfer of torque 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 receptacle on the drive input 73.

[0052] The elongated shaft 71 is designed to be delivered through either an anatomical opening or lumen, such as in an endoscope, or a minimally invasive incision, such as in a laparoscopy. The elongated shaft 71 may be either flexible (e.g., with properties similar to an endoscope) or rigid (e.g., with properties similar to a laparoscope), or may include a customized combination of both flexible and rigid portions. When designed for laparoscopy, the distal end of the rigid elongated shaft may be connected to an end effector extending from a jointed wrist formed from a clevis having at least one degree of freedom, and a surgical tool or medical instrument, such as a grasper or scissors, that may be actuated based on forces from a tendon as the drive input rotates in response to torque received from the drive output 74 of the instrument driver 75. When designed for endoscopy, the distal end of the flexible elongated shaft may include a steerable or controllable bend that may articulate and bend based on torque received from the drive output 74 of the instrument driver 75.

[0053] Torque from the instrument driver 75 is transferred downstream of the elongated shaft 71 using tendons along the elongated shaft 71. These individual tendons, such as pull wires, may be individually secured to individual drive inputs 73 in the instrument handle 72. From the handle 72, the tendons are routed down one or more pull lumens along the elongated shaft 71 and secured to a distal portion of the elongated shaft 71, or to a wrist at the distal portion of the elongated shaft. During a surgical procedure, such as a laparoscopic, endoscopic, or hybrid procedure, these tendons may be coupled to a distally attached end effector, such as a wrist, grasper, or scissors. Under such a configuration, torque exerted on the drive input 73 transfers tension to the tendons, thereby actuating the end effector in some way. In some embodiments, during a surgical procedure, the tendons can rotate the joint about an axis, thereby moving the end effector in one direction or another. Alternatively, the tendon may be connected to one or more jaws of a grasper at the distal end of the elongate shaft 71, with tension from the tendon causing the grasper to close.

[0054] In endoscopy, the tendons may be coupled to a flex or articulating section located along (e.g., at the distal end) of the elongate shaft 71 via adhesive, control rings, or other mechanical fixation. If fixedly attached to the distal end of the flex, torque exerted on the drive input 73 is transferred downstream of the tendons, causing the softer flex (sometimes called the articulatable section or articulatable region) to flex or articulate. Along the non-flexing portions, it may be advantageous to spiral or convolute the individual pull lumens that direct the individual tendons along (or inwardly) the wall of the endoscope shaft to counterbalance radial forces resulting from tension in the pull wires. The angle of the helix and / or spacing between them can be altered or designed for a particular purpose, with tighter helices exhibiting less shaft compression under load forces, while lesser amounts of helices result in greater shaft compression under load forces but limited bending. At the other end of the spectrum, the pull lumen may be oriented parallel to the longitudinal axis of the elongate shaft 71 to allow for controlled articulation at a desired bend or articulatable section.

[0055] In endoscopy, the elongated shaft 71 houses several components that aid in robotic procedures. The shaft 71 may include a working channel for deploying surgical tools (or medical instruments), irrigating, and / or aspirating the surgical field at the distal end of the shaft 71. The shaft 71 may also house wires and / or optical fibers for transmitting signals to and from an optical assembly at the distal tip, which may include an optical camera. The shaft 71 may also house optical fibers for carrying light from a proximally located light source, such as a light emitting diode, to the distal end of the shaft 71.

[0056] At the distal end of the instrument 70, the distal tip may include a working channel opening for delivering tools to the surgical site for diagnosis and / or treatment, irrigation, and aspiration. The distal tip may also include a port for a camera, such as a fiberscope or digital camera, to capture images of the internal anatomical space. Relatedly, the distal tip may also include a port for a light source to illuminate the anatomical space when a camera is used.

[0057] 16, the drive shaft axis, i.e., the drive input axis, is orthogonal to the axis of the elongated shaft 71. However, this arrangement complicates the ability of the elongated shaft 71 to roll. Rolling the elongated shaft 71 along its axis while holding the drive input 73 stationary can result in undesirable entanglement of tendons as they extend out of the drive input 73 and into the pull lumen within the elongated shaft 71. Such resulting entanglement of tendons can interfere with control algorithms intended to predict the movement of the flexible elongated shaft 71 during an endoscopic procedure.

[0058] FIG. 17 shows an alternative design of the instrument driver and instrument, where the axis of the drive unit is parallel to the axis of the elongated shaft of the instrument. As shown, a circular instrument driver 80 includes four drive units with parallel aligned drive outputs 81 at the end of a robotic arm 82. The drive units and their respective drive outputs 81 are housed in a rotating assembly 83 of the instrument driver 80, which is driven by one of the drive units in the assembly 83. In response to torque provided by the rotating drive units, the rotating assembly 83 rotates along a circular bearing connecting the rotating assembly 83 to a non-rotating portion 84 of the instrument driver 80. Power and control signals may be transferred from the non-rotating portion 84 of the instrument driver 80 to the rotating assembly 83 via electrical contacts that may be maintained throughout the rotation by a brushed slip ring connection (not shown). In other embodiments, the rotating assembly 83 may be responsive to a separate drive unit that is integrated into the non-rotatable portion 84 and thus not parallel to the other drive units. The rotation mechanism 83 enables the instrument driver 80 to rotate the drive units and their respective drive outputs 81 as a single unit about the instrument driver axis 85 .

[0059] Similar to the previously disclosed embodiments, the instrument 86 may include an elongated shaft portion 88 and an instrument base 87 (shown with a clear exterior skin for purposes of illustration) that includes a number of drive inputs 89 (such as receptacles, pulleys, and spools) configured to receive the drive outputs 81 in the instrument driver 80. Unlike the previously disclosed embodiments, the instrument shaft 88 extends from the center of the instrument base 87 with an axis that is substantially parallel to the axis of the drive inputs 89, rather than orthogonal as in the design of FIG.

[0060] When coupled to the rotation assembly 83 of the instrument driver 80, the medical instrument 86, including the instrument base 87 and the instrument shaft 88, rotates with the rotation assembly 83 about the instrument driver axis 85. Because the instrument shaft 88 is positioned at the center of the instrument base 87, the instrument shaft 88 is coaxial with the instrument driver axis 85 when attached. Rotation of the rotation assembly 83 therefore causes the instrument shaft 88 to rotate about its own longitudinal axis. Furthermore, as the instrument base 87 rotates with the instrument shaft 88, any tendons connected to the drive input 89 within the instrument base 87 do not become entangled during rotation. Thus, the parallelism of the axes of the drive output 81, drive input 89, and instrument shaft 88 allows for shaft rotation without entangling any of the control tendons.

[0061] FIG. 18 illustrates an instrument having an instrument-based insertion architecture, according to some embodiments. The instrument 150 can be coupled to any of the instrument drivers described above. The instrument 150 includes an elongated shaft 152, an end effector 162 connected to the shaft 152, and a handle 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 therethrough. Thus, the one or more cables 180 extend along the outer surface of the elongated shaft 152. In other embodiments, the cables 180 can extend through the elongated shaft 152. Manipulation of one or more of the cables 180 (e.g., via an instrument driver) results in actuation of the end effector 162.

[0062] The instrument handle 170, which may also be referred to as an instrument base, generally includes a mounting interface 172 having one or more mechanical inputs 174, e.g., receptacles, pulleys, or spools, designed to reciprocate with one or more torque couplers on a mounting surface of an instrument driver. In some embodiments, the instrument 150 includes a series of pulleys or cables that allow 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 accommodates the insertion of the instrument, thereby minimizing reliance on a robotic arm to provide insertion of the instrument 150. In other embodiments, the robotic arm may be significantly involved in the insertion of the instrument.

[0063] E. Controller. Any of the robotic systems described herein can include an input device or controller for manipulating an instrument attached to the robotic arm. In some embodiments, the controller can be coupled (e.g., communicatively, electronically, electrically, wirelessly, and / or mechanically) to the instrument such that manipulation of the controller causes a corresponding manipulation of the instrument, e.g., via master-slave control.

[0064] 19 is a perspective view of an embodiment of controller 182. In this embodiment, controller 182 includes a hybrid controller that can have both impedance control and admittance control. In other embodiments, controller 182 can utilize only impedance or passive control. In other embodiments, controller 182 can utilize only admittance control. By being a hybrid controller, controller 182 can advantageously have a lower perceived inertia during use.

[0065] In the illustrated embodiment, the controller 182 is configured to enable operation of two medical instruments and includes two handles 184. Each of the handles 184 is connected to a gimbal 186. Each gimbal 186 is connected to a positioning platform 188.

[0066] 19, each positioning platform 188 includes a selective compliance assembly robot arm (SCARA arm) 198 coupled to a column 194 by a prismatic joint 196. The prismatic joint 196 is configured to translate along the column 194 (e.g., along a rail 197) to allow each of the handles 184 to be translated in the z-direction, providing a first degree of freedom. The SCARA arm 198 is configured to enable movement of the handles 184 in the xy-plane, providing two additional degrees of freedom.

[0067] In some embodiments, one or more load cells are positioned within the controller. For example, in some embodiments, a load cell (not shown) is positioned within the body of each of the gimbals 186. By providing load cells, a portion of the controller 182 can operate under admittance control, thereby advantageously reducing the perceived inertia of the controller during use. In some embodiments, the positioning platform 188 is configured for admittance control while the gimbal 186 is configured for impedance control. In other embodiments, the gimbal 186 is configured for admittance control and the positioning platform 188 is configured for impedance control. Thus, in some embodiments, the translational or positional degree of freedom of the positioning platform 188 can rely on admittance control while the rotational degree of freedom of the gimbal 186 relies on impedance control.

[0068] F. Navigation and Control. Traditional endoscopy may involve the use of fluoroscopy (e.g., as may be delivered through a C-arm) and other forms of radiation-based imaging modalities to provide intraluminal guidance to the operator-physician. In contrast, the robotic system contemplated by the present disclosure may provide non-radiation-based navigation and localization means to reduce the physician's exposure to radiation and reduce the amount of equipment in the operating room. As used herein, the term "localization" may refer to determining and / or monitoring the position of an object in a reference coordinate system. Techniques such as pre-operative mapping, computer vision, real-time EM tracking, and robot command data may be used individually or in combination to achieve a radiation-free operating environment. In other cases where radiation-based imaging modalities are still used, pre-operative mapping, computer vision, real-time EM tracking, and robot command data may be used individually or in combination to improve the information obtained solely by radiation-based imaging modalities.

[0069] FIG. 20 is a block diagram illustrating a localization system 90 for estimating the position of one or more elements of a robotic system, such as the location of an instrument, according to an exemplary embodiment. The localization system 90 may be a set of one or more computing devices configured to execute one or more instructions. The computing devices may be embodied by a processor (or processors) and computer readable memory in one or more of the components discussed above. By way of example, and not by way of limitation, the computing devices may be in the tower 30 shown in FIG. 1, in the cart 11 shown in FIGS. 1-4, or in the bed shown in FIGS. 5-14.

[0070] 20, the localization system 90 may include a localization module 95 that processes the input data 91-94 to generate position data 96 of the distal tip of the medical instrument. The position data 96 may be data or logic that represents the position and / or orientation of the distal tip of the instrument relative to a frame of reference. The frame of reference may be relative to a known object such as the patient's anatomy or an EM field generator (see below for a description of the EM field generator).

[0071] The various input data 91-94 will now be described in more detail. Pre-operative mapping can be accomplished using the acquisition of low-dose CT scans. The pre-operative CT scans are reconstructed into three-dimensional images that are visualized, for example, as cutaway "slices" of the patient's internal anatomy. When analyzed as a whole, an image-based model can be generated for the anatomical cavities, spaces, and structures of the patient's anatomy, such as the patient's pulmonary network. Techniques such as center-line geometry can be determined and approximated from the CT images to create a three-dimensional volume of the patient's anatomy, referred to as model data 91 (also referred to as "pre-operative model data" when generated using only pre-operative CT scans). The use of center-line geometry is discussed in U.S. Patent Application Serial No. 14 / 523,760, the contents of which are incorporated herein in their entirety. Network topological models may also be derived from CT images and are particularly suited for bronchoscopy.

[0072] In some embodiments, the instrument may be equipped with a camera to provide visual data (or image data) 92. The localization module 95 may process the visual data 92 to enable one or more vision-based (or image-based) position tracking modules or functions. For example, the pre-operative 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 advancing through a working channel of the endoscope). For example, using the pre-operative model data 91, the robotic system may generate a library of predicted endoscopic images from the model based on the expected path of travel of the endoscope, with each image linked to a location in the model. During surgery, this library may be referenced by the robotic system to compare real-time images captured by a camera (e.g., a camera at the distal end of the endoscope) to those in the image library to assist with localization.

[0073] Other computer vision based tracking techniques use feature tracking to determine the motion of the camera, and therefore the endoscope. Some features of the localization module 95 may identify circular geometric shapes in the pre-operative model data 91 that correspond to anatomical lumens and track changes in those geometries to determine which anatomical lumens have been selected, as well as the relative rotational and / or translational motion of the camera. The use of a phase map may further enhance vision-based algorithms or techniques.

[0074] Optical flow, another computer vision based technique, may analyze the displacement and translation of image pixels in a video sequence in the visual data 92 to infer camera movement. Examples of optical flow techniques may include motion detection, object segmentation calculations, luminance, motion compensated coding, stereo disparity measurements, etc. By comparing multiple frames over multiple iterations, the movement and position of the camera (and therefore the endoscope) can be determined.

[0075] The localization module 95 can use real-time EM tracking to generate a real-time position of the endoscope in a global coordinate system that can be registered to the patient's anatomy represented by the pre-operative model. In EM tracking, an EM sensor (or tracker) including one or more sensor coils embedded in one or more locations and orientations in a medical instrument (e.g., an endoscopic instrument) measures variations in an EM field generated by one or more static EM field generators placed in known locations. The position information detected by the EM sensor is stored as EM data 93. The EM field generator (or transmitter) can be placed in close proximity to the patient to generate a low-intensity magnetic field that can be detected by the embedded sensor. The magnetic field induces small currents in the sensor coils 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" intraoperatively to the patient's anatomy (e.g., the pre-operative model) to determine a geometric transformation that aligns a single location in the coordinate system with a location in the pre-operative model of the patient's anatomy. Once registered, an EM tracker embedded at one or more locations on the medical instrument (e.g., the distal tip of an endoscope) can provide a real-time indication of the medical instrument's progression through the patient's anatomy.

[0076] The robotic commands and kinematic data 94 may also be used by a localization module 95 to provide localization data 96 for the robotic system. The device pitch and yaw resulting from the articulation commands may be determined during pre-operative calibration. Intraoperatively, these calibration measurements may be used in combination with known insertion depth information to estimate the position of the instrument. Alternatively, these calculations may be analyzed in combination with EM, vision, and / or phase modeling to estimate the position of the medical instrument within the network.

[0077] As Fig. 20 illustrates, several other input data can be used by the localization module 95. For example, although not shown in Fig. 20, an instrument that utilizes shape sensing fibers can provide shape data that the localization module 95 can use to determine the position and shape of the instrument.

[0078] The localization module 95 may use a combination of the input data 91-94. In some cases, such a combination may use a probabilistic approach in which the localization module 95 assigns a confidence weight to the location determined from each of the input data 91-94. Thus, if the EM data may be unreliable (such as when EM interference is present), the reliability of the location determined by the EM data 93 may be reduced, and the localization module 95 may rely more heavily on the vision data 92 and / or the robot command and kinematic data 94.

[0079] As discussed above, the robotic systems discussed herein can be designed to incorporate one or a combination of two or more of the above-mentioned techniques. The computer-based control system of the tower, bed, and / or cart-based robotic system may store, for example in a non-transitory computer-readable storage medium, such as a persistent magnetic storage drive, solid-state drive, etc., computer program instructions that, when executed, cause the system to receive and analyze sensor data and user commands, generate system-wide control signals, and display navigation and localization data, such as instrument position within a global coordinate system, anatomical maps, etc.

[0080] 2. Specimen collector for robotic medical systems Robotic medical systems, such as those described above with reference to Figures 1-20, etc., can be used in robotic medical procedures involving the removal of objects, specimens, or samples from a patient. For example, the robotic medical systems can be used to perform kidney stone removal procedures. During a robotic kidney stone removal procedure, a physician can use a controller to manipulate various robotic medical instruments (such as the endoscopes and laparoscopes described above). The robotic medical instruments can be engaged with robotic manipulators (such as robotic arms, robotic drive devices, and robotic instrument drive mechanisms) that position and manipulate the instruments.

[0081] As an example, a robotic medical system can include three robotic arms configured for use during a ureteroscopic kidney stone removal procedure. A first robotic arm can manipulate and control (e.g., control articulation of) the robotic ureteroscope and basket device. A distal drive device positioned on the second robotic arm can insert the ureteroscope into the patient and retract it out of the patient. In some embodiments, a third robotic arm can optionally be used to control a percutaneously inserted robotic laparoscope (e.g., during percutaneously assisted ureteroscopy (PAU)). A physician can control the system to capture the kidney stone with the basket device. Then, when the robotic ureteroscope is holding the stone, the robotic ureteroscope can be retracted to remove the stone from the patient. Once positioned outside the patient's body, the basket device can be opened to release the stone. The robotic ureteroscope can then be reinserted into the body to remove additional stones as needed. Typically, the stone is retained for analysis after the procedure.

[0082] The present disclosure relates to a specimen collector configured for use with a robotic medical system to facilitate a robotic medical procedure involving removal of an object, specimen, or sample from a patient. The specimen collector may be configured to allow the robotic medical system to robotically deposit a specimen therein, thereby minimizing manual or physical interaction. In a manual object removal procedure (e.g., manual kidney stone removal), the object removed from the patient is manually placed in a specimen cup, typically physically held by a physician or other sterile user in an operating room. The use of such manual specimen cups may be disadvantageous for use with a robotic medical system because of the increased cost and / or decreased roboticity due to the need for a clinician to hold or have a specially designed holder.

[0083] As described in more detail below, the specimen collectors described herein can be specifically configured for use with a robotic medical system to facilitate and / or optimize a robotic procedure. For example, the specimen collectors described herein can be configured to be integrated into and / or supported by components of a robotic medical system in a location where a robotically controlled medical instrument can quickly and efficiently deposit specimens therein. As a first example, a specimen collector configured for use with a robotic medical system can be integrated into a sterile drape configured to cover various robotic components of the system. The specimen collector can be positioned on the drape such that it is advantageously positioned when the drape is installed. For example, the specimen collector can be positioned in a position directly beneath a robotically controlled basket device when the basket device is retracted from the patient. In this position, the basket device can simply open and allow collected objects to drop into the specimen collector. The specimen collector can be configured with at least one porous portion that allows fluid to drain therethrough while retaining objects deposited therein. The specimen collector can be configured with an aperture retention device (e.g., a flexible wire or metal strip) configured to hold the aperture of the specimen collector such that a large area is present for depositing the object therein. Additionally, the specimen collector can be configured to allow the drape to be removed (e.g., torn away) so that the object can be easily delivered for analysis. In some embodiments, the inclusion of the specimen collector on the drape provides a cost-effective solution that provides significant benefits.

[0084] These and other features are described in more detail below with reference to the embodiments illustrated in the figures, which are intended to illustrate certain exemplary features and aspects of the specimen collector described herein. The illustrated embodiments are not intended to be limiting, and those skilled in the art will understand, upon consideration of the present disclosure, that various modifications can be made that are within the scope of the present disclosure.

[0085] 21 and 22 show top and side views, respectively, of an embodiment of a robotic medical system 200 that includes a specimen collector 300. The specimen collector 300 is configured such that a specimen retrieved from within a patient 202 can be deposited therein using the robotic system 200. In the illustrated embodiment, the system 200 includes a medical instrument 204, a robotic manipulator (e.g., a drive device 206), a sterile barrier 208 (as shown in FIG. 22), and the specimen collector 300, among other components.

[0086] In the illustrated embodiment, the medical instrument 204 comprises a robotic-enabled ureteroscope, which may be similar to the ureteroscope 32 described above with reference to FIG. 3. In other embodiments, the medical instrument 204 may comprise any of the medical instruments described above with reference to FIGS. 1-20, as well as other types of medical instruments, including endoscopes, laparoscopes, and catheters. As shown in the embodiment of FIGS. 21 and 22, the medical instrument 204 may include an instrument base 210 and an elongated shaft 212. In the illustrated embodiment, the proximal end of the elongated shaft 212 extends from the instrument base 210. In some embodiments, the elongated shaft 212 includes a flexible shaft and / or an articulating shaft.

[0087] The distal end 214 of the elongate shaft 212 is configured to be inserted into the patient 202. For example, a robotic manipulator (e.g., the drive device 206, described in more detail below) may be configured to drive the insertion and / or retraction of the elongate shaft 212 such that the distal end 214 of the elongate shaft 212 can be inserted into and retracted from the patient 202. In the illustrated embodiment, the medical instrument 204 is shown in a position where the distal end 214 of the elongate shaft 212 has been retracted from the patient 202.

[0088] In the illustrated embodiment, the system 200 includes an access sheath 216. The access sheath 216 may be inserted into the patient 202 to provide a channel or conduit through which the elongate shaft 212 of the medical instrument 204 may 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 may be used that may be inserted into other natural patient openings or other surgical ports (e.g., laparoscopic ports). In some embodiments, the access sheath 216 comprises a tube.

[0089] The medical instrument 204 can be configured to capture (e.g., grasp, grab, hold, etc.) a specimen from within the patient. For example, in the case of a kidney stone removal procedure, the medical instrument 204 can include a basket device configured to capture the kidney stone so that it can be removed from the patient 202. As mentioned above, in some embodiments, the basket device can be configured as a tool (robotically and / or manually controllable) that can be inserted through a working channel of the elongated shaft 212 of the medical instrument 204. In some embodiments, the basket device is integrated directly within the medical instrument 204. Although the examples described herein relate to the removal of kidney stones, the medical instrument 204 can be configured to collect and retrieve other types of objects, specimens, or samples within the patient 202. For example, in some embodiments, the medical instrument 204 is configured to take a biopsy sample from the patient 202.

[0090] In the robotic medical system 200 shown in Figures 21 and 22, various robotic manipulators are shown for operating the robotic instruments 204. In the illustrated embodiment, the system 200 includes a robotic manipulator configured as a drive device 206, an instrument drive mechanism 228, and a robotic arm 226. The instrument drive mechanism 228 and the robotic arm 226 can be seen in a side view in Figure 22. These robotic manipulators can be engaged with the medical instruments 204 in a variety of ways, as described above and in more detail below.

[0091] In the illustrated embodiment, the drive device 206 is configured to engage the elongated shaft 212 of the medical instrument 204 and drive axial movement (e.g., insertion and / or retraction) of the distal tip 214 of the elongated shaft 212 into and out of the patient 202. For example, as shown in FIG. 21 , the drive device 206 includes rollers 222 that can engage or contact the elongated shaft 212. In some embodiments, the rollers 222 can include a deformable material that provides grip between the rollers 222 and the elongated shaft 212. In some embodiments, the material includes silicone rubber. In the illustrated embodiment, as the rollers 222 rotate, the elongated shaft 212 can be pulled, pushed, or otherwise driven axially through or relative to the drive device 206. Rotating the rollers 222 in a first direction can cause insertion of the elongated shaft 212, and rotating the rollers 222 in a second, opposite direction can cause retraction of the elongated shaft 212. In some embodiments, other drive mechanisms can be used instead of or in addition to the rollers 222. In the illustrated embodiment, the elongate shaft 212 passes through a channel 224 of the drive device 206. The channel 224 can include a closed channel and / or an open channel. The use of the open channel 224 can facilitate loading the elongate shaft 212 of the medical instrument 204 into the drive device 206, which can simplify use of the device and reduce operation time. For example, the open channel can facilitate loading and / or unloading of the medical instrument 204 during a surgical procedure or medical procedure, such that a user, such as a medical professional, can manually make adjustments to the medical instrument 204 without having to fully retract the medical instrument 204 from within the patient.

[0092] As shown in FIG. 22 , the drive device 206 can be attached, mounted, or otherwise connected to a robotic arm 226. The robotic arm 226 can include an instrument drive mechanism 228 to which the drive device 206 can be attached. The instrument drive mechanism 228 can include a drive output configured to engage and actuate a corresponding drive input on the drive device 206 to actuate the drive device 206. In the illustrated embodiment, a sterile adapter 230 is positioned between the instrument drive mechanism 228 and the drive device 206 such that the drive device 206 engages the instrument drive mechanism 228 through the sterile adapter 230. The sterile adapter 230 can be configured to couple or otherwise transfer motion between the drive output of the instrument drive mechanism 228 and a corresponding drive input on the drive device 206. Additionally, the sterile adapter 230 can be configured to define or provide a portion of a sterile barrier 208 (as best seen in FIG. 22 ), as described in more detail below.

[0093] 22, the robotic arm 226 to which the drive device 206 is mounted can be configured to move to manipulate the position of the drive device 206 in space. In some embodiments, for example, as shown, the drive device 206 can be positioned proximate to the access sheath 216. Positioning the drive device 206 proximate to the point at which the elongate shaft 212 is inserted (e.g., near the access sheath 216) can reduce buckling of the elongate shaft 212.

[0094] While the illustrated embodiment of the system 200 includes a drive device 206 for driving axial movement of the elongated shaft 212 of the medical instrument 204, other types of robotic manipulators can be used to drive the axial movement in other embodiments. For example, in some embodiments, the axial movement is driven by moving a robotic arm 226 to which the base 210 of the medical instrument 204 is attached. In other embodiments, the base 210 of the medical instrument 204 is configured to drive the axial movement of the elongated shaft, for example, as described above with reference to FIG.

[0095] As shown in FIG. 22, the base 210 of the medical instrument 204 may also be engaged with a robotic manipulator. In the illustrated embodiment, the base 210 is engaged with a second instrument drive mechanism 228 positioned on a second robotic arm 226. As shown, another sterile adapter 230 may be positioned between the instrument base 210 and the instrument drive mechanism 228. The instrument drive mechanism 228 engaged with the base 210 may be configured such that a drive output of the instrument drive mechanism 228 drives a corresponding drive input on the base 210 of the medical instrument 204 to control, for example, the articulation of the elongate shaft 212 and / or the articulation, opening, and / or closing of the basket device. The engagement between the instrument base 210 and the instrument drive mechanism 228 has been described above with reference to, for example, FIGS. 15-17.

[0096] The robotic arm 226 can be, for example, a robotic arm mounted to or extending from a cart as shown in Figures 1-4 and / or a robotic arm extending from a patient platform or table as shown in Figures 5-14. An exemplary instrument drive mechanism 228 that can be positioned on the distal end of the robotic arm 226 is shown in Figures 16-18.

[0097] FIG. 22 illustrates that the robotic medical system 200 can include a sterile barrier 208. The sterile barrier 208 can be configured to separate a sterile field from a non-sterile field. In the illustrated embodiment, the sterile barrier 208 is provided by one or more sterile drapes 232 and a sterile adapter 230 as described above. The sterile drape 232 can comprise a flexible sheet (e.g., a plastic sheet) configured to a size and shape to cover the components of the robotic medical system 200 positioned within the non-sterile field. As shown, the sterile drape 232 covers the robotic arm 226 and the instrument drive mechanism 228. More detailed examples of sterile drapes are shown in FIGS. 29-31, which are described in more detail below.

[0098] 22, some components of the robotic medical system 200 are positioned within the sterile field and other components are positioned within the non-sterile field. For example, in the illustrated embodiment, the medical instrument 204, drive device 206, access sheath 216, and patient 202 are positioned within the sterile field, while the robotic arm 226 and instrument drive mechanism 228 are positioned in the non-sterile field. Other configurations are possible.

[0099] As mentioned above, the system 200 also includes a specimen collector 300 into which a specimen removed from the patient 202 using the medical instrument 204 can be deposited. As best seen in the side view of FIG. 22, the specimen collector 300 can include a receptacle portion 302 and a connector 304. The receptacle portion 302 is configured to provide a receptacle, container, tube, or repository into which a specimen can be deposited, and the connector 304 is configured to attach the receptacle portion 302 to a component of the robotic medical system 200 to support and position the specimen collector 300. The connector 304 can be coupled to the receptacle portion 302. In some embodiments, the receptacle portion 302 is made from a flexible material, such as a plastic sheet formed to create a receptacle or container. In some embodiments, the receptacle portion 302 comprises a flexible bag. The receptacle portion 302 includes an opening into which a specimen can be deposited. In some embodiments, the specimen collector 300 further comprises an opening retention device configured to position the opening of the receptacle portion 302 and hold the opening in an open configuration to facilitate deposition of a specimen therein. Various features and embodiments of the receptacle portion 302 and the connector 304 are described in more detail below. A more detailed view of the specimen collector 300 is shown in Figures 26-27.

[0100] 22, the specimen collector 300 may be positioned within the sterile field. For example, in the illustrated embodiment, the connector 304 of the specimen collector 300 is attached to a sterile drape 232 that covers the robotic arm 226 to which the drive device 206 is connected. Other locations for the specimen collector 300 are possible. For example, in some embodiments, the connector 304 attaches the specimen collector 300 to a sterile adapter 230, to the access sheath 216, or to the drive device 206 or instrument drive mechanism 228 itself.

[0101] 21 and 22 also illustrate that in some embodiments, the specimen collector 300 may be advantageously positioned on the robotic system 200 to facilitate deposition of the specimen therein. In the illustrated embodiment, the specimen collector 300 is positioned in a position below (e.g., directly below) the distal tip 214 of the elongate shaft 212 of the medical instrument 204 as the distal tip 214 is withdrawn from the patient 202 and / or the access sheath 216. In this arrangement, depositing the specimen into the receptacle portion 302 may be accomplished by releasing the specimen (e.g., opening a basket device) and allowing the specimen to fall by gravity into the receptacle portion 302. This arrangement of the specimen collector 300 may also maintain alignment between the elongate shaft 212 and the access sheath 216 such that after the specimen is deposited into the receptacle portion 302, the distal tip 214 of the elongate shaft 212 may be quickly reinserted into the patient 202 to continue the procedure. This can reduce the overall length of the procedure and improve patient outcomes.

[0102] 21 and 22, in some embodiments, the specimen collector 300 may be advantageously positioned on the robotic system 200 in a location proximate to access into the patient (e.g., the access sheath 216). In the illustrated embodiment, for example, the specimen collector 300 is positioned distal (i.e., facing the patient) side of the drive device 206. This arrangement may beneficially minimize the amount of movement required to position the distal tip 214 of the medical instrument 204 onto the specimen collector 300. Again, this may shorten the overall length of the procedure. Additionally, the robotic arm 226 may position the drive device 206 proximate to access into the patient 202 to further minimize the amount of movement required to position the distal tip 214 of the medical instrument 204 onto the specimen collector 300. For example, as shown in FIG. 22, the distal side of the drive device 206 is positioned adjacent to the proximal side of the access sheath 216 such that the specimen collector is positioned just proximal to the access sheath 216 .

[0103] 22 (and described in more detail below with reference to FIGS. 26 and 27), the connector 304 can include a mounting tab. The receptacle portion 302 can extend from the mounting tab. That is, the receptacle portion 302 can be attached to the mounting tab. The mounting tab can be configured to attach to a component of the robotic medical system 200 that supports the specimen collector 300. For example, the mounting tab can be configured to attach to a sterile drape 232, a sterile adapter 230, a drive device 206, an access sheath 216, or other component of the robotic medical system 200.

[0104] As noted above, in the illustrated embodiment, the connector 304 is attached to the sterile drape 232. In some embodiments, the connector 304 is fixedly or permanently attached to the sterile drape 232. That is, in some embodiments, the specimen collector 300 is a component of the sterile drape 232. In these embodiments, the specimen collector 300 can be positioned on the drape 232 such that when the drape 232 is placed on the robotic medical system 200, the specimen collector 300 is positioned in a favorable or desired location as described above. In other embodiments, the connector 304 can be configured to selectively attach to the sterile drape 232 (or other components of the robotic medical system 200). For example, the connector 304 can include an adhesive strip on an attachment tab. A user can then use the adhesive strip to attach the specimen collector 300 to a component of the robotic medical system 200 as desired.

[0105] The receptacle portion 302 can be attached to the mounting tab or connector 304 in a removably manner such that the receptacle portion 302 can be removed from the connector 304. In some embodiments, once a specimen is deposited in the receptacle portion 302, the receptacle portion 302 can be removed from the connector 304 while retaining the specimen therein. The receptacle portion 302 can then be sent for analysis of the specimen. As described below, in some embodiments, the specimen collector 300 includes perforations between the mounting tab or connector 304 and the receptacle portion 302 that are configured such that the receptacle portion 302 can be torn from the mounting tab or connector 304. As described below, other methods for removing the receptacle portion 302 from the connector 304 are also possible.

[0106] In some embodiments, at least a portion of the receptacle portion 302 is porous and configured to allow fluid to drain from the receptacle portion 302 while retaining the specimen. During some medical procedures, fluids, such as irrigants or patient fluids used during the procedure, can get into the receptacle portion 302. The porous portion of the receptacle portion 302 can allow this fluid to drain. In some embodiments, the specimen collector 300 can include a drain port that can be connected to a fluid system that can actively or passively collect such fluids from the receptacle portion 302. The porosity of the porous portion can be configured to allow fluid to drain through the porous portion while the collected specimen is retained within the receptacle portion.

[0107] 23 is a perspective view of the distal end of the robotic arm 226 with the instrument drive mechanism 228 positioned thereon. In the illustrated embodiment, the robotic arm 226 is covered with a sterile drape 232. As shown, the sterile drape 232 can be part of a sterile barrier that includes a sterile adapter 230 configured to fit over the instrument drive mechanism 228. The sterile adapter 230 can have a collar 234 that can be configured to engage the sterile drape 232, and can provide a sterile interface between the instrument drive mechanism 228 and a component attached thereto (such as the instrument base 210 or drive device 206).

[0108] Figure 23 also illustrates an embodiment of the specimen collector 300 attached to the sterile drape 232. In some embodiments, the specimen collector 300 can be attached to the sterile drape 232 at the collar 234. In the embodiment illustrated in Figure 23, the specimen collector 300 is configured as a flexible bag.

[0109] FIG. 24 is a block diagram of example control components of the robotic medical system 200. In the illustrated embodiment, the control components include a processor 240, a memory 242, and a controller 244. The memory 242 can include instructions that, when executed, configure the processor 240 to perform various functions to control aspects of the robotic medical system 200. For example, the memory 242 can include instructions that, when executed, configure the processor 240 to perform functions described below with reference to FIG. 25. A physician or other operator can use the controller 244 to provide inputs for controlling the robotic medical system 200. In some embodiments, the controller 244 is a handheld controller that includes one or more joysticks, buttons, or other user inputs. In some embodiments, the controller 244 can be the controller described above with reference to FIG. 19.

[0110] FIG. 25 is a flow chart illustrating an exemplary control method 248 that may be executed using the control components of FIG. 24 to operate the robotic medical system 200. The control method may be stored, for example, as instructions in the memory 242. The method 248 may begin at block 250, where the instructions configure the processor 240 to control the insertion of the distal end 214 of the medical instrument 204 into the patient 202. In some embodiments, the insertion is commanded and / or otherwise controlled by a physician using the controller 244. As noted above, the insertion may be provided in a variety of ways. For example, with reference to the embodiment shown in FIG. 21 and FIG. 22, the drive device 206 may drive the insertion using rollers 222. In other embodiments, the insertion may be accomplished by using a robotic arm 226 to move the medical instrument 204 and / or by driving the insertion of the elongate shaft 212 relative to the instrument base 210 using an instrument-based insertion architecture, as described with reference to FIG. 18, for example. In some embodiments, the insertion is provided through an access sheath 216.

[0111] At block 252, the method 248 may include collecting a specimen from within the patient 202 using the medical instrument 204. In some embodiments, a physician may navigate and control the distal tip 214 of the medical instrument 204 within the patient 202 using the controller 244, thereby allowing the physician to locate and collect the sample. As noted above, in the case of a kidney stone removal procedure, collecting the sample may include capturing the kidney stone in a basket device inserted through a working channel of the elongated shaft 212 of the medical instrument 204.

[0112] With the sample collected, the method 248 moves to block 254 where the distal tip 214 and collected sample are retracted from the patient 202. Retraction may be commanded by a physician using, for example, the controller 244. Retraction may be effected using the same mechanisms as described above with respect to insertion. For example, retraction may be driven by the drive device 206 by moving the robotic arm 226 and / or using an instrument-based insertion architecture that drives the retraction of the elongated shaft 212 relative to the instrument base 210. In block 254, the distal tip 214 of the medical instrument 204 may be retracted to a position where the specimen may be deposited in the specimen collector 300. For example, the distal tip 214 may be retracted to a position above the specimen collector 300 as shown in FIGS. 21 and 22. In some embodiments, retraction to this deposition position may be triggered by a single user command. For example, once a sample has been captured, a user can provide a single input to the controller 244, which can cause the system 200 to automatically retract the distal tip 214 to a deposition position.

[0113] At block 256, the method 248 may include depositing the specimen into the receptacle portion 302 of the sample collector 300. In the illustrated embodiment of the system 200, depositing the specimen into the receptacle portion 302 of the specimen collector 300 may include releasing the specimen from the distal tip 214 of the medical instrument 204 such that the specimen falls under gravity into the receptacle portion 302 of the specimen collector 300. In other embodiments, deposition may be accomplished by articulating the elongated shaft 212 of the medical instrument 204 to insert the specimen into the specimen collector 300. In some embodiments, depositing the specimen into the specimen collector 300 may occur automatically after receiving a deposition command provided using the controller 244. For example, upon receiving the command, the system 200 may automatically move the distal end 214 of the medical instrument 204 to a deposition position and robotically deposit the specimen into the receptacle portion 302 of the specimen collector 300. In some embodiments, the system 200 is aware of the location of the specimen collector 300 such that movement to and deposition into the specimen collector 300 may be performed automatically by the system 200 (e.g., automatically upon receipt of a user command). That is, in some embodiments, the physician does not need to navigate the distal end 214 to the specimen collector 300. Instead, such navigation may occur automatically.

[0114] 26 and 27 are front and perspective exploded views, respectively, of an embodiment of a specimen collector 300. In the illustrated embodiment, the specimen collector 300 includes a receptacle portion 302 configured to receive a specimen removed from a patient and a connector 304 coupled to the receptacle portion 302 and configured to be attached to a medical system (e.g., to a component thereof, such as a drape) to position the receptacle portion 302 relative to the medical system. A porous portion may be included in at least a portion of the receptacle portion 302. The porous portion may be configured to allow liquid to drain from the receptacle portion 302 while retaining specimen deposited within the receptacle portion 302.

[0115] As best shown in the exploded view of FIG. 27, the specimen collector 300 can comprise a first layer 312 and a second layer 314. In some embodiments, the first layer 312 and the second layer 314 can each comprise a flexible layer, such as a plastic sheet, such that the specimen collector 300 comprises a flexible bag-like structure. The receptacle portion 302 can be formed between the first layer 312 and the second layer 314. For example, the first layer 312 can comprise a first top edge 312A, a first right edge 312B, a first left edge 312C, and a first bottom edge 312D, and the second layer 314 can include a second top edge 314A, a second right edge 314B, a second left edge 314C, and a second bottom edge 314D. The second right edge 314B, the second left edge 314C, and the second bottom edge 314D can be connected to the first right edge 312B, the first left edge 312C, and the first bottom edge 312D, respectively, such that the first flexible layer 312 and the second flexible layer 314 form a pocket having an opening defined by (e.g., between) the first top edge 312A and the second top edge 314A.

[0116] The connector 304 can include an attachment tab formed by a portion of the first layer 312 extending from the first top edge 312A. As shown in FIGS. 26 and 27, the connector 304 can include a notch 316. The notch 316 can be configured in a size and shape to correspond to a component to which the connector 304 can be attached. For example, in the illustrated embodiment, the notch 316 is semicircular to correspond to the generally circular shape of the collar 234 (FIG. 23) and / or the instrument drive mechanism 228 or the sterile adapter 230 (FIGS. 21 and 22). Other shapes and configurations of the notch 316 on the connector 304 are also possible. In some embodiments, the notch 316 can be omitted.

[0117] In some embodiments, the connector 304 or mounting tabs may be permanently connected to another structure, such as the sterile drape 232 or the sterile adapter 230, such that the specimen collector 300 is a component of that structure. The connector 304 may be connected to the structure such that when the structure is installed on a robotic system, the specimen collector 300 is advantageously positioned in a desired location. In other embodiments, the connector 304 or mounting tabs are configured to selectively attach to the robotic system. For example, the connector 304 or mounting tabs may include an adhesive backing on at least a first side thereof such that the specimen collector 300 may be adhesively attached to the robotic medical system 200 at a desired location.

[0118] 26 and 27, on the first layer 312, the connector 304 can be attached to the receptacle portion 302 at a perforation portion 318. That is, the perforation 318 can be positioned between the receptacle portion 302 and the connector 306. The perforation can be configured to allow the receptacle portion 302 to be torn from the connector 306, as described above. In some embodiments, other methods for configuring the receptacle 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.

[0119] The specimen collector 300 may also include an open retaining device 320. The open retaining device 320 may be configured to hold the opening of the receptacle portion 302 in an open configuration to facilitate deposition of the specimen into the receptacle portion 302. In some embodiments, the open retaining device 320 may be positioned at the opening of the receptacle portion 302, for example as shown. In the illustrated embodiment, the open retaining device 320 comprises a formable metal strip 322. In the illustrated embodiment, the formable metal strip 322 is attached on a first side to the first layer 312 with a mounting pad 324 and on a second side to the second layer 314 with a mounting pad 324. The formable metal strip 322 may be bent into a configuration that holds the opening of the receptacle portion 302. Other mechanisms for the open retaining device 320 are also possible, such as a formable shape-retaining wire that may be embedded in the opening. In some embodiments, the open retaining device 320 may be omitted.

[0120] As described above, the specimen collector 300 can include a porous portion to allow fluid to drain from the receptacle portion 302. In some embodiments, one or both of the first layer 312 and the second layer 314 can be porous. In some embodiments, a portion of one or both of the first layer 312 and the second layer 314 can be porous.

[0121] 28 is a flow chart illustrating an exemplary method 400 for using a robotic medical system, such as robotic medical system 200, to deposit a specimen in a specimen collector 300. The method 400 may begin at block 402, which includes robotically inserting the distal end 214 of the elongated body 212 of the medical instrument 204 into the patient 202. In some embodiments, the robotic manipulator comprises the drive device 206 described above configured to engage and drive the insertion and retraction of the elongated body of the medical instrument. The insertion may be driven by the drive device 206. In some embodiments, the robotic manipulator comprises a robotic arm 226 and an instrument drive mechanism 228 positioned at a distal end of the robotic arm 226. The instrument drive mechanism 228 may be attached to the base 210 of the medical instrument 204 and configured to operate the medical instrument 204. In some embodiments, robotically inserting the elongated body 212 of the medical instrument includes moving the robotic arm 226. In some embodiments, robotically inserting the elongate body 212 of the medical instrument 204 includes driving an insertion mechanism of the base 210 using the instrument drive mechanism 228 to insert the elongate body 212 relative to the base 210.

[0122] At block 404, the method 400 includes manipulating the medical instrument 204 with a robotic manipulator to capture a specimen within the patient. In some embodiments, the base 210 of the medical instrument 204 is engaged with the instrument drive mechanism 228 such that a drive output of the instrument drive mechanism 228 actuates a drive input in the base 210 to cause articulation of the elongate shaft 212. A physician or other operator can control the articulation and / or insertion and retraction of the elongate shaft 212 to capture a specimen with the distal end 214 of the medical instrument 204. Navigation within the patient can be facilitated by a navigation and localization system as described above with reference to FIG. 20 .

[0123] At block 406, the method 400 includes robotically retracting the elongate shaft 212 of the medical instrument 204 to withdraw the distal end 214 and the specimen from the patient. In some embodiments, the robotic manipulator comprises a drive device 206 configured to engage and drive the insertion and retraction of the elongate body 212 of the medical instrument 204. The retraction may be driven by the drive device 206. In some embodiments, the robotic manipulator comprises a robotic arm 226 and an instrument drive mechanism 228 positioned at a distal end of the robotic arm 226. The instrument drive mechanism 228 may be attached to the base 210 of the medical instrument 204 and configured to operate the medical instrument 204. In some embodiments, robotically retracting the elongate shaft 212 of the medical instrument 204 includes moving the robotic arm 226. In some embodiments, robotically retracting the elongated body 212 of the medical instrument 204 includes driving a retraction mechanism of the base 210 using the instrument drive mechanism 228 to retract the elongated shaft 212 relative to the base 210.

[0124] At block 408, the method 400 includes robotically depositing the specimen into the specimen collector 300. As described with reference to Figures 21 and 22, depositing the specimen into the specimen collector 300 may include positioning the specimen on the specimen collector 300 and releasing the specimen so that it falls into the specimen collector 300. In some embodiments, robotically depositing the specimen into the specimen collector includes automatically moving the distal end 214 of the elongate shaft 212 to a deposition position relative to the specimen collector 300 upon receipt of a user command.

[0125] The method 400 may also include draping a sterile barrier 232 over the robotic medical system to separate a sterile field including at least the medical instrument 204 and the specimen collector 300 from a non-sterile field including at least the robotic manipulator. In some embodiments, the specimen collector 300 is attached to the sterile barrier 232 at a location where the medical instrument can robotically deposit a specimen.

[0126] In some embodiments, the method 400 also includes adhesively attaching the specimen collector 300 to the sterility barrier 232. In some embodiments, the receptacle portion 302 of the specimen collector 300 is detachable from the connector 304, and the method 400 further includes separating the receptacle portion 302 from the connector 304. The method 400 may further include draining fluid through a porous portion of the receptacle portion 302 while retaining the specimen within the receptacle portion 302. In some embodiments, the method 400 also includes positioning an opening of the specimen collector in an open position using an opening retention device 320 of the specimen collector 300.

[0127] FIG. 29 shows an isometric view of an embodiment of a sterile drape 232 including a specimen collector 300. The sterile drape 232 can form part of a sterile barrier 208 that can also include a sterile adapter 230, as shown in FIG. 21 and FIG. 22. The sterile drape 232 can be made of a sterile, flexible material, such as a plastic sheet. In the illustrated embodiment, the sterile drape 232 is configured to drape over a cart of a robotic medical system that includes, for example, three robotic arms, as shown in FIG. 2 and FIG. 30. As shown, the sterile drape 232 includes three flexible tubes 253. The three flexible tubes 253 are configured to be sized and shaped to snugly cover the three robotic arms. The flexible tubes 253 extend from a cart cover portion 254 that is configured to be sized and shaped to snugly cover the cart.

[0128] In the illustrated embodiment, a specimen collector 300 is positioned at the distal end of each of the flexible tubes 253 such that the specimen collector 300 is positioned in a strategic location (as described above) when the drape 232 is installed. Figure 30 is a perspective view of an embodiment of a sterile drape 232 installed on a cart including three robotic arms 226. In the illustrated embodiment, the robotic arms 226 have been moved into an exemplary drape position that may facilitate installation of the drape 232. Once the drape 232 is installed, the robotic arms 226 can be moved into position for the medical procedure.

[0129] FIG 31 illustrates another embodiment of a sterile drape 232 including a specimen collector 300. The drape 232 of FIG 31 is configured for use with a robotic medical system including a robotic arm 226 movably mounted on a bar or rail 260. Such a system is described and illustrated above with reference to FIGS. 12-14. In this embodiment, the drape 232 includes three flexible tubes 253 configured to hang on the robotic arm 226 and a rail drape portion 256 configured to hang on the rail 260. As shown, the specimen collector 300 can be positioned at the distal end of the flexible tubes 253.

[0130] 32 illustrates an embodiment of the sterile barrier 208 configured as an assembly including a sterile drape 232, a sterile adapter 230, and a specimen 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 can rotate about their respective drive axes relative to the upper and lower plates 540, 550. The sterile adapter 230 includes an attachment mechanism 570 (e.g., clips, latches, magnets, etc.) that can secure the sterile adapter 230 to the instrument drive mechanism 228. The attachment mechanism 570 and / or torque coupler 520 within the sterile adapter 230 can align with corresponding features on the instrument drive mechanism 228, and the specimen collector 300 can be attached to the sterile barrier 208 in a known or fixed position relative to the sterile adapter 230 such that the robotic arm can hold the specimen collector 300 in a position advantageous for specimen collection when securing the sterile barrier to the robotic system, without the user having to manually position the specimen collector 300. 32, the sterile adapter can define a distal side 515 and a proximal side 525 based on the set of torque couplers 520 and the position of the attachment mechanism 570. The specimen collector 300 can be attached to the sterile adapter 230 on the distal side 515. Such a position allows medical instruments (e.g., ureteroscopes and basket tools) extending from the distal side to easily extract and deposit the specimen in the specimen collector on the distal side 515 as it is retracted from the patient's body.

[0131] 3. Mounting system and terminology Implementations disclosed herein provide systems, methods, and devices for a specimen collector configured for use with a robotic medical system.

[0132] It should be noted that, as used herein, the terms "couple," "coupled," "coupled," or other variations of the word coupled, may indicate either an indirect connection or a direct connection. For example, when a first component is "coupled" to a second component, the first component may be either indirectly connected to the second component through another component, or directly connected to the second component.

[0133] Phrases referring to certain computer-implemented processes and functions described herein may be stored as a processor-readable medium or one or more instructions on a computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such media 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 disk storage, magnetic disk storage, or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. It should be noted that computer-readable media may be tangible and non-transitory. As used herein, the term "code" may refer to software, instructions, code, or data that is executable by a computing device or processor.

[0134] The methods disclosed herein include one or more steps or acts for achieving the described method. Method steps and / or acts may be interchanged without departing from the scope of the claims. In other words, unless a specific order of steps or acts is required for the proper operation of the described method, the order and / or use of specific steps and / or acts may be modified without departing from the scope of the claims.

[0135] As used herein, the term "plurality" refers to two or more. For example, a plurality of components refers to two or more components. The term "determining" encompasses a wide variety of acts, and thus "determining" can include calculating, computing, processing, calculating, investigating, looking up (e.g., looking in a table, database, or another data structure), ascertaining, and the like. "Determining" can also include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. "Determining" can also include resolving, selecting, electing, establishing, and the like.

[0136] The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes both "based only on" and "based at least on."

[0137] The foregoing description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the scope of the present invention. For example, those skilled in the art will recognize that many corresponding alternative and equivalent structural details may be employed, such as equivalent methods of fastening, mounting, coupling, or engaging tool components, equivalent mechanisms for producing specific actuation motions, and equivalent mechanisms for delivering electrical energy. Thus, the present invention is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0138] [Embodiment] (1) A robotic medical system, comprising: a medical instrument including a distal end configured to be inserted into a patient and capture a analyte within the patient; a robotic manipulator engaged with the medical instrument and configured to operate the medical instrument; a sterile barrier configured to separate a sterile field containing the medical instrument from a non-sterile field containing the robotic manipulator; A specimen collector comprising: a receptacle portion within the sterile field, the receptacle portion configured to receive the specimen when the distal end of the medical instrument is withdrawn from the patient; and a specimen collector comprising a connector coupled to the receptacle portion and configured for attachment to the robotic medical system; (2) through the operation of the robot manipulator, inserting the distal end of the medical instrument into the patient; collecting the specimen from within the patient using the medical device; retracting the distal end of the medical instrument and the specimen from the patient; 2. The system of claim 1, further comprising at least one processor configured to robotically deposit the specimen into the receptacle portion of the specimen collector. (3) the at least one processor, upon receipt of a user command, operates the robotic manipulator; moving the distal end of the medical instrument into a deposition position; 3. The system of claim 2, further configured to robotically deposit the specimen into the receptacle portion of the specimen collector. (4) the connector includes a mounting tab; 2. The system of embodiment 1, wherein the receptacle portion is removable from the mounting tab. (5) The system of embodiment 4, wherein the specimen collector comprises a perforation between the mounting tab and the receptacle portion configured such that the receptacle portion can be torn from the mounting tab.

[0139] (6) The system of embodiment 1, wherein at least a portion of the receptacle portion is porous and configured to allow fluid to be expelled from the receptacle portion while retaining the specimen. (7) The system of embodiment 1, wherein the receptacle portion is flexible. (8) The system of embodiment 1, wherein the specimen collector further comprises an opening holding device positioned in the opening of the receptacle portion and configured to hold the opening in an open configuration. (9) The system of embodiment 1, wherein the sterile barrier comprises a sterile drape configured to cover at least a portion of the robotic manipulator. (10) The system of embodiment 9, wherein the connector is configured to be attached to the sterile drape such that when the sterile drape is positioned on the robotic manipulator, the receptacle portion is positioned within the sterile field at a location where the medical instrument can robotically deposit the specimen.

[0140] (11) The sterile barrier comprises a sterile adapter configured to be positioned between a base of the medical instrument and the robotic manipulator such that the robotic manipulator engages the medical instrument through the sterile adapter; the sterile adapter defining a distal side and a proximal side whereby the medical instrument extends from the distal side; The system of embodiment 1, wherein the connector is attached to the distal sterile barrier such that when the sterile adapter is positioned on the robotic manipulator, the receptacle portion is positioned within the sterile field between the robotic manipulator and an access site of the patient. (12) further comprising an access sheath positioned within the sterile field and configured for insertion into the patient, the distal end of the medical instrument being configured for insertion into the patient through the access sheath; 2. The system of embodiment 1, wherein the connector of the specimen collector is attached to the access sheath. (13) The connector includes a mounting tab; 2. The system of claim 1, wherein the mounting tab comprises an adhesive surface configured to adhere to the robotic medical system, whereby the receptacle portion is positioned within the sterile field at a location where the medical instrument can robotically deposit the specimen. (14) The system of embodiment 1, wherein the robotic manipulator comprises a drive device configured to engage with the elongated body of the medical instrument and drive its insertion and retraction. (15) The robot manipulator A robot arm; 2. The system of embodiment 1, comprising: an instrument drive mechanism positioned at the distal end of the robotic arm and configured to be attached to a base of the medical instrument to operate the medical instrument.

[0141] (16) The system of embodiment 15, wherein the robotic arm is articulatable to position the specimen collector adjacent to an access site of the patient. (17) The system of embodiment 15, wherein the base of the medical instrument is configured to be driven by the instrument drive mechanism to insert or retract the elongated body of the medical instrument relative to the base. (18) The sterility barrier comprises: a sterile drape positioned on the robotic arm; 16. The system of claim 15, further comprising a sterile adapter positioned between the instrument drive mechanism and the base of the medical instrument. (19) The system of embodiment 1, wherein the specimen comprises a kidney stone. (20) A robotic medical method, comprising: robotically inserting a distal end of an elongate body of a medical instrument into a patient; manipulating the medical instrument with a robotic manipulator to capture a specimen within the patient; robotically retracting the elongate body of the medical instrument to withdraw the distal tip and the specimen from the patient; and robotically depositing the specimen into a specimen collector.

[0142] (21) applying a sterile barrier to the robotic medical system to separate a sterile field including at least the medical instrument and the specimen collector from a non-sterile field including at least the robotic manipulator; 21. The method of embodiment 20, wherein the specimen collector is attached to the sterile barrier at a location where the medical instrument can robotically deposit the specimen. 22. The method of claim 21, further comprising adhesively attaching the specimen collector to the sterile barrier. (23) robotically depositing the specimen into the specimen collector upon receiving a user command; automatically moving the elongate distal end to a deposition position relative to the specimen collector; 21. The method of embodiment 20, comprising robotically automatically depositing the specimen into the specimen collector. (24) The specimen collector, a receptacle portion configured to receive the sample removed from the patient using the medical instrument; The method of embodiment 20, comprising: a connector extending from the receptacle portion and attached to and supported by a component of a robotic medical system, whereby the receptacle portion is positioned at a location where the medical instrument can robotically deposit the specimen. 25. The method of claim 24, wherein the receptacle portion of the sample collector is removable from the connector, the method further comprising separating the sample collector from the connector.

[0143] (26) The method of embodiment 24, further comprising discharging fluid through a porous portion of the receptacle portion while retaining the specimen within the receptacle portion. (27) The method of embodiment 20, wherein the robotic manipulator comprises a drive device, the method further comprising engaging the elongate body of the medical instrument and driving its insertion and retraction with the drive device. (28) The method of claim 20, wherein the robotic manipulator comprises a robotic arm and an instrument drive mechanism positioned at a distal end of the robotic arm and configured to be attached to a base of the medical instrument to operate the medical instrument. (29) The method of claim 28, wherein robotically inserting and retracting the elongate body of the medical instrument comprises moving the robotic arm. (30) The method of embodiment 28, wherein robotically inserting and retracting the elongate body of the medical instrument includes using the instrument drive mechanism to drive an insertion mechanism of the base to insert or retract the elongate body relative to the base.

[0144] 31. The method of claim 20, wherein the specimen comprises a kidney stone. (32) The method of embodiment 20, further comprising positioning the opening of the specimen collector in an open position using a specimen collector opening retention device. (33) A specimen collector for a medical system, comprising: a receptacle portion configured to receive a specimen removed from a patient; a connector coupled to the receptacle portion and configured to be attached to a medical system to position the receptacle portion relative to the medical system; a porous portion formed on at least a portion of the receptacle portion, the porous portion configured to allow liquid to be drained from the receptacle portion while retaining a specimen deposited within the receptacle portion. (34) The receptacle portion is a first flexible layer having a first top edge, a first right edge, a first left edge, and a first bottom edge, the connector extending from the first top edge; and a second flexible layer having 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 connected to the first right edge, the first left edge, and the first lower edge, respectively, whereby the first flexible layer and the second flexible layer form a pocket having an opening defined by the first upper edge and the second upper edge. (35) The specimen collector of embodiment 34, further comprising a perforation positioned between the receptacle portion and the connector and configured to allow the receptacle portion to be torn from the connector.

[0145] (36) The specimen collector of embodiment 33, further comprising an opening retention device positioned at the opening of the receptacle portion and configured to retain the opening in an open configuration. (37) The specimen collector of embodiment 36, wherein the open retention device comprises a formable metal strip. (38) The specimen collector of embodiment 33, wherein the connector comprises a mounting tab including an adhesive backing on at least a first side of the mounting tab. 39. The specimen collector of claim 33, wherein the specimen comprises a kidney stone. (40) A sterility barrier for a robotic medical system, comprising: a sterile drape comprising a first flexible tube configured to cover at least a portion of the first robotic arm; A specimen collector as described in embodiment 33, wherein an attachment tab of the sample collector device is attached to the sterile drape at a distal end of the first flexible tube.

[0146] (41) The sterile drape, a second flexible tube configured to cover the second robotic arm; and a third flexible tube configured to cover the third robotic arm; and The barrier of embodiment 40, further comprising a flexible cart cover configured to be hung on a cart to which the first robotic arm, the second robotic arm, and the third robotic arm extend. (42) A sterile adapter connected to a distal end of the first flexible tube, 41. The barrier of embodiment 40, wherein the specimen collector is attached to the sterile barrier adjacent the distal end of the first flexible tube.

Claims

1. 1. A robotic medical system, comprising: a medical instrument including a distal end configured to be inserted into a patient and capture a analyte within the patient; a robotic manipulator engaged with the medical instrument and configured to operate the medical instrument; a sterile barrier configured to separate a sterile field containing the medical instrument from a non-sterile field containing the robotic manipulator; A specimen collector comprising: a receptacle portion within the sterile field, the receptacle portion configured to receive the specimen when the distal end of the medical instrument is withdrawn from the patient; and a specimen collector comprising a connector coupled to the receptacle portion and configured to attach to the sterile barrier or the robotic manipulator of the robotic medical system.

2. Through the operation of the robot manipulator, inserting the distal end of the medical instrument into the patient; collecting the specimen from within the patient using the medical device; retracting the distal end of the medical instrument and the specimen from the patient; 2. The robotic medical system of claim 1, further comprising at least one processor configured to: robotically deposit the specimen into the receptacle portion of the specimen collector.

3. the at least one processor, upon receipt of a user command, operating the robotic manipulator; moving the distal end of the medical instrument into a deposition position; 3. The robotic medical system of claim 2, further configured to robotically deposit the specimen into the receptacle portion of the specimen collector.

4. the connector includes a mounting tab; The robotic medical system of claim 1 , wherein the receptacle portion is detachable from the mounting tab.

5. 5. The robotic medical system of claim 4, wherein the specimen collector comprises a perforation between the mounting tab and the receptacle portion configured such that the receptacle portion can be torn from the mounting tab.

6. The robotic medical system of claim 1 , wherein at least a portion of the receptacle portion is porous and configured to retain the specimen while allowing fluid to exit the receptacle portion.

7. 10. The robotic medical system of claim 1, wherein the specimen collector further comprises an opening retention device positioned in the opening of the receptacle portion and configured to retain the opening in an open configuration.

8. 10. The robotic medical system of claim 1, wherein the sterile barrier comprises a sterile drape configured to cover at least a portion of the robotic manipulator.

9. the sterile barrier comprises a sterile adaptor configured to be positioned between a base of the medical instrument and the robotic manipulator such that the robotic manipulator engages the medical instrument through the sterile adaptor; the sterile adapter defining a distal side and a proximal side whereby the medical instrument extends from the distal side; 2. The robotic medical system of claim 1, wherein the connector is attached to the distal sterile barrier such that when the sterile adapter is positioned on the robotic manipulator, the receptacle portion is positioned within the sterile field between the robotic manipulator and an access site on the patient.

10. the connector includes a mounting tab; 10. The robotic medical system of claim 1, wherein the mounting tab comprises an adhesive surface configured to adhere to the robotic medical system such that the receptacle portion is positioned within the sterile field at a location where the medical instrument can robotically deposit the specimen.

11. 11. The robotic medical system of claim 1, wherein the specimen collector comprises a porous portion formed on at least a portion of the receptacle portion configured to retain the specimen deposited within the receptacle portion while allowing liquid to drain from the receptacle portion.

12. The receptacle portion is a first flexible layer having a first top edge, a first right edge, a first left edge, and a first bottom edge, the connector extending from the first top edge; and a second flexible layer comprising a second top edge, a second right edge, a second left edge, and a second bottom edge, wherein the second right edge, the second left edge, and the second bottom edge are connected to the first right edge, the first left edge, and the first bottom edge, respectively, whereby the first flexible layer and the second flexible layer form a pocket having an opening defined by the first top edge and the second top edge.

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