Extensible outer sleeve for flexible elongate devices

Abstract

The invention relates to an extendable outer cannula for a flexible elongate device. An apparatus for movably coupling a robotic system to an airway management device includes an outer cannula and a connection mechanism. The outer sleeve includes a flexible tubular portion. The connection mechanism includes a first portion configured to receive the outer cannula, a second portion configured to connect with a proximal end of the airway management device, a lumen defined within the first and second portions, and a locking mechanism configured to connect to the flexible tubular portion of the outer cannula. When the outer cannula is coupled to the coupling mechanism, the flexible tubular portion of the outer cannula is within the lumen of the coupling mechanism and extends distally of the distal end of the airway management device. The flexible tubular portion of the outer cannula structurally supports a flexible elongate device when the flexible elongate device is received within the flexible tubular portion.

Description

[0001] This application claims the priority of U.S. Provisional Application No. 63 / 603,355, filed on November 28, 2023, the entire content of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to an airway management device that provides structural support for a flexible elongate device. Background Art

[0003] Minimally invasive medical techniques are designed to reduce the amount of tissue damage during a medical procedure, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques can be performed through natural orifices in a patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, an operator can insert minimally invasive medical devices, including surgical instruments, diagnostic instruments, therapeutic instruments, or biopsy instruments, to reach a target tissue location. One such minimally invasive technique is to utilize a flexible elongate device, such as a flexible catheter, bronchoscope, or endoscope, that can be inserted into an anatomical passageway and navigated towards an area of interest within a patient's anatomy. Inserting a flexible elongate device into the anatomy often involves using a device that structurally supports and guides the flexible elongate device into the anatomy. Summary of the Invention

[0004] In accordance with some examples, an apparatus for movably coupling a robotic system to an airway management device includes an outer sheath and a connection mechanism. The outer sheath includes a flexible tubular portion. The connection mechanism includes a first portion, a second portion, a lumen, and a locking mechanism. The first portion is configured to receive the outer sheath. The second portion is configured to connect to the proximal end of the airway management device. The lumen is defined within the first portion and the second portion. The locking mechanism is configured to connect to the flexible tubular portion of the outer sheath. When the outer sheath is connected to the connection mechanism, the flexible tubular portion of the outer sheath is located within the lumen of the connection mechanism and extends distally beyond the distal end of the airway management device.

[0005] In some examples, the apparatus may further include a first seal, and the first seal may be configured to seal the lumen of the flexible tubular portion of the outer sheath.

[0006] In some examples, the first seal may include a cross-slit valve and a diaphragm.

[0007] In some examples, the apparatus may further include a cap for the outer sheath, and the cap may include the first seal.

[0008] In some examples, the apparatus may further include a second seal, and the second seal may be configured to seal the lumen of the connection mechanism.

[0009] In some examples, the second seal may include a diaphragm seal and a cross-slit valve.

[0010] In some examples, the locking mechanism can be configured to secure the second seal around the flexible tubular portion to prevent movement of the outer cannula.

[0011] In some examples, the locking mechanism can include a first locking member and a second locking member. The first locking member can include a threaded base. The second locking member can include a threaded wall configured to engage the threaded base of the first locking member. The second locking member can further include a leg extending inwardly from the threaded wall. The second locking member can be positioned adjacent to the second seal. Relative movement between the threaded base of the first locking member and the threaded wall of the second locking member can cause the leg of the second locking member to compress the second seal, causing the second seal to expand radially inwardly to engage the flexible tubular portion of the outer cannula.

[0012] In some examples, the locking mechanism can further include a housing, and the second locking member can include splines on the outer side of the threaded wall. The splines can be configured to engage the housing such that the second locking member cannot rotate relative to the housing.

[0013] In some examples, the connection mechanism can be configured to at least partially disconnect from the robotic system when the movement between the robotic system and the airway management device includes a displacement above a threshold of the airway management device relative to the robotic system.

[0014] In some examples, the displacement above the threshold can generate a force that overcomes the magnetic force securing the connection mechanism to the robotic system.

[0015] In some examples, the flexible tubular portion of the outer cannula includes an atraumatic tip.

[0016] In some examples, the flexible tubular portion has an inner surface including a low friction interface.

[0017] Consistent with some examples, a medical system includes a robotic system, an airway management device, and an outer cannula. The robotic system is configured to drive a flexible elongate device. The airway management device includes a cylindrical channel and an engagement portion. The cylindrical channel is configured to be coupled to the robotic system. The engagement portion is attached to the cylindrical channel. The engagement portion is configured to engage a patient's anatomy adjacent to the trachea. The outer cannula includes a flexible tubular portion configured to be inserted into the cylindrical channel of the airway management device. The flexible tubular portion is configured to extend distally of the engagement portion of the airway management device when inserted into the cylindrical channel of the airway management device. The flexible tubular portion structurally supports the flexible elongate device when the flexible elongate device is received within the flexible tubular portion.

[0018] In some examples, the robotic system can include an instrument carriage and a flexible elongate device guide configured to provide lateral support for the flexible elongate device during movement of the instrument carriage.

[0019] In some examples, the flexible elongate device guide may be configured to receive an outer sheath.

[0020] In some examples, the medical system may further include a connection mechanism. The connection mechanism may include a first portion, a second portion, a lumen, and a locking mechanism. The first portion may be configured to receive the outer sheath. The second portion may be configured to connect to the proximal end of the airway management device. The lumen may be defined within the first portion and the second portion. The locking mechanism may be configured to connect to the flexible tubular portion of the outer sheath.

[0021] Consistent with some examples, a method of positioning a flexible elongate device includes providing a connection mechanism having a first portion and a second portion. The method further includes connecting the second portion of the connection mechanism to the airway management device. The method further includes using a robotic system to insert a distal portion of the flexible elongate device into the anatomical structure a first distance such that the flexible elongate device extends through the connection mechanism and distally to the airway management device. The method further includes extending an outer sheath over the flexible elongate device such that the flexible tubular portion of the outer sheath extends through the connection mechanism and distally to the airway management device. The method further includes using the robotic system to further insert the flexible elongate device into the anatomical structure beyond the first distance, wherein the flexible tubular portion of the outer sheath provides structural support for the flexible elongate device distal to the airway management device.

[0022] In some examples, the method may include locking the flexible tubular portion of the outer sheath to the connection mechanism.

[0023] In some examples, locking the flexible tubular portion of the outer sheath to the connection mechanism may include sealing the lumen of the connection mechanism with a second seal.

[0024] In some examples, the connection mechanism may include a locking mechanism that includes: a first lock member including a threaded base, a second lock member including a threaded wall, and a leg extending inwardly from the threaded wall, the threaded wall being configured to engage the threaded base of the first lock member. The method may further include causing relative movement between the threaded base of the first lock member and the threaded wall of the second lock member to cause the leg of the second lock member to compress a seal, thereby causing the seal to expand radially inwardly to engage the flexible tubular portion of the outer sheath.

[0025] In some examples, the robotic system may include an instrument carriage and a flexible elongate device guide configured to provide lateral support for the flexible elongate device during movement of the instrument carriage. The method may include extending the flexible elongate device guide when the flexible elongate device is inserted into the anatomical structure a first distance.

[0026] In some examples, a robotic system can include an instrument carriage and a flexible elongate device guide configured to provide lateral support for a flexible elongate device during movement of the instrument carriage. A method can include retracting the flexible elongate device guide to enable insertion of an outer sheath over the flexible elongate device and extending the flexible elongate device again after insertion of the outer sheath.

[0027] In some examples, extending the outer sheath over the flexible elongate device can not result in extending the flexible tubular portion of the outer sheath distally of the flexible elongate device.

[0028] In some examples, a displacement above the threshold generates a force that overcomes a magnetic force securing the connection mechanism to the robotic system.

[0029] In some examples, the flexible tubular portion of the outer sheath includes an atraumatic tip.

[0030] In some examples, the flexible tubular portion has an inner surface including a low friction interface.

[0031] In accordance with some examples, a medical system includes: A robotic system configured to drive a flexible elongate device; An airway management device including: A cylindrical channel configured to couple with the robotic system; and An engagement portion attached to the cylindrical channel; Wherein the engagement portion is configured to engage patient anatomy proximal to the trachea; and An outer sheath including: A flexible tubular portion configured to be inserted into the cylindrical channel of the airway management device, the flexible tubular portion being configured to extend distally of the engagement portion of the airway management device when inserted into the cylindrical channel of the airway management device and structurally support the flexible elongate device when the flexible elongate device is received within the flexible tubular portion.

[0032] In some examples, the robotic system includes an instrument carriage and a flexible elongate device guide configured to provide lateral support for the flexible elongate device during movement of the instrument carriage.

[0033] In some examples, the flexible elongate device guide is configured to receive the outer sheath.

[0034] In some examples, the medical system further includes: A connection mechanism including: A first portion configured to receive the outer cannula; A second portion configured to be connected to the proximal end of the airway management device; A cavity defined within the first portion and the second portion; and A locking mechanism configured to be connected to the flexible tubular portion of the outer cannula.

[0035] In some examples, the medical system further includes a first seal configured to seal the cavity of the flexible tubular portion of the outer cannula.

[0036] In some examples, the first seal includes a cross-slit valve and a diaphragm.

[0037] In some examples, the medical system further includes a cap for the outer cannula, the cap including the first seal.

[0038] In some examples, the medical system further includes a second seal configured to seal the cavity of the connection mechanism.

[0039] In some examples, the second seal includes a diaphragm seal and a cross-slit valve.

[0040] In some examples, the locking mechanism is configured to fix the second seal around the flexible tubular portion to prevent movement of the outer cannula.

[0041] In some examples, the locking mechanism includes: A first locking member including a threaded base; and A second locking member including a threaded wall configured to engage the threaded base of the first locking member, the second locking member further including a leg extending inwardly from the threaded wall, the second locking member being positioned adjacent to the second seal; wherein relative movement between the threaded base of the first locking member and the threaded wall of the second locking member causes the leg of the second locking member to compress the second seal, thereby causing the second seal to expand radially inwardly to engage the flexible tubular portion of the outer cannula.

[0042] In some examples, the locking mechanism further includes a housing, and the second locking member includes splines on an outer side of the threaded wall, the splines being configured to engage the housing such that the second locking member cannot rotate relative to the housing.

[0043] In some examples, the connection mechanism is configured to disconnect at least partially from the robotic system when the movement between the robotic system and the airway management device includes a displacement above a threshold of the airway management device relative to the robotic system.

[0044] In some examples, the displacement above the threshold generates a force that overcomes the magnetic force fixing the connection mechanism to the robotic system.

[0045] In some examples, the flexible tubular portion of the outer cannula includes a non-invasive tip.

[0046] In some examples, the flexible tubular portion has an inner surface including a low-friction interface.

[0047] Consistent with some examples, a method of positioning a flexible elongate device includes: providing a connection mechanism having a first portion and a second portion; connecting the second portion of the connection mechanism to an airway management device; using a robotic system to insert a distal portion of the flexible elongate device into an anatomical structure a first distance such that the flexible elongate device extends through the connection mechanism and distally to the airway management device; extending an outer cannula over the flexible elongate device such that a flexible tubular portion of the outer cannula extends through the connection mechanism and distally to the airway management device; and using the robotic system to further insert the flexible elongate device into the anatomical structure beyond the first distance, wherein the flexible tubular portion of the outer cannula provides structural support for the flexible elongate device distal to the airway management device.

[0048] In some examples, the method further includes locking the flexible tubular portion of the outer cannula to the connection mechanism.

[0049] In some examples, locking the flexible tubular portion of the outer cannula to the connection mechanism includes sealing a cavity of the connection mechanism using a second seal.

[0050] In some examples, where the connection mechanism includes a locking mechanism, the locking mechanism includes: a first lock member including a threaded base; a second lock member including a threaded wall configured to engage the threaded base of the first lock member; and feet extending inwardly from the threaded wall; and the method further includes causing relative movement between the threaded base of the first lock member and the threaded wall of the second lock member to cause the feet of the second lock member to compress the second seal, thereby causing the second seal to expand radially inwardly to engage the flexible tubular portion of the outer cannula.

[0051] In some examples, where the robotic system includes an instrument carriage and a flexible elongate device guide configured to provide lateral support to the flexible elongate device during movement of the instrument carriage; and the method further includes extending the flexible elongate device guide when the flexible elongate device is inserted a first distance into the anatomical structure.

[0052] In some examples, where the robotic system includes an instrument carriage and a flexible elongate device guide configured to provide lateral support to the flexible elongate device during movement of the instrument carriage; and the method further includes retracting the flexible elongate device guide such that the outer cannula can be inserted over the flexible elongate device and extending the flexible elongate device again after the outer cannula is inserted.

[0053] In some examples, extending the outer cannula over the flexible elongate device does not cause the flexible tubular portion of the outer cannula to extend distally of the flexible elongate device. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Aspects of the present disclosure are best understood from the following detailed description when read with the accompanying drawings. It is to be emphasized that, in accordance with standard practice in the industry, the various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or decreased for clarity of discussion. Additionally, the present disclosure may repeat reference numerals and / or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and / or configurations discussed.

[0055] Figure 1 is a simplified diagram of a robotic and / or remotely operated medical system according to some embodiments.

[0056] Figure 2A is a simplified diagram of a medical device system according to some embodiments.

[0057] Figure 2BSimplified diagram of a medical device with an extended medical tool according to some embodiments.

[0058] Figure 3A and Figure 3B Simplified side view of a patient coordinate space of a medical device including a medical device mounted on an insertion assembly according to some embodiments.

[0059] Figure 4 Example of an instrument manipulator including a flexible elongate device according to some embodiments is shown.

[0060] Figure 5 An airway management device according to some embodiments is shown.

[0061] Figure 6A Exploded view of a connection mechanism according to some embodiments is shown.

[0062] Figure 6B Shows Figure 6A Perspective view of the connection mechanism.

[0063] Figure 7 Perspective view of a device for movably coupling a robotic system to an airway management device according to some embodiments.

[0064] Figure 8 Is according to some embodiments Figure 7 Perspective view of an outer sleeve of a device, including a cross-sectional view showing the interior of the outer sleeve.

[0065] Figure 9 Is according to some embodiments Figure 7 Cross-sectional perspective view of a first seal of a device.

[0066] Figure 10 Is Figure 7 Cross-sectional view of a device.

[0067] Figure 11 Is according to some embodiments Figure 7 and Figure 10 Perspective view of a first locking member of a connection mechanism of a device.

[0068] Figure 12 Is according to some embodiments Figure 7 and Figure 10 Perspective view of a second locking member of a connection mechanism of a device.

[0069] Figure 13 Is according to some embodiments Figure 7 and Figure 10 Perspective view of a first portion of a housing of a connection mechanism of a device.

[0070] Figure 14 Is according to some embodimentsFigure 7 and Figure 10 Perspective view of a second part of a housing of a connection mechanism of a device.

[0071] Figure 15 is according to some embodiments Figure 7 and Figure 10 Perspective view of a second seal of a device.

[0072] Figure 16 Schematically shows a method of using Figure 7 and Figure 10 a device to position a flexible elongate device according to some embodiments.

[0073] The examples of the present disclosure and their advantages are best understood by reference to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more of these figures, where the illustrations in the figures are for the purpose of illustrating examples of the present disclosure and not for limiting the present disclosure. Detailed Description

[0074] In the following detailed description of various aspects of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the disclosed embodiments. However, it will be apparent to those skilled in the art that the embodiments of the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments of the present invention. Also, to avoid unnecessary descriptive repetition, one or more components or actions described in accordance with an illustrative embodiment can be used or omitted where applicable to other illustrative embodiments. For the sake of brevity, multiple recitations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the figures to refer to the same or similar components.

[0075] In one example, an endotracheal tube (ET tube) can be inserted through a patient's nose or mouth and placed within the trachea. Then a medical device or apparatus can be inserted through the endotracheal tube and used to observe the trachea and other bronchial passages and / or for performing biopsies and / or diagnosing lung diseases and infections. The ET tube is used for airway management (e.g., during mechanical ventilation) and to prevent damage to patient anatomy such as the vocal cords during medical procedures. Since the ET tube extends distally into the trachea beyond the vocal cords, the ET tube provides structural support for the insertion of, for example, a flexible elongate device, thereby providing the necessary stability for navigating the flexible elongate device to its target destination.

[0076] A laryngeal mask airway (LMA) can be used to replace an ET tube. The LMA includes a cuff that forms an airtight seal near the vocal cords. Since the LMA does not extend into the trachea, the LMA cannot provide as much structural support for inserting a flexible elongate device into the lung. Without such support, the flexible elongate device can prolapse and fail to reach the target destination. In addition, when used with certain systems, without support distal to the vocal cords, movement (e.g., lateral) of the flexible elongate device can trigger false positive detection of patient movement by the system, resulting in error messages or other undesirable delays. The devices and methods described below address these problems to facilitate the use of the LMA.

[0077] As Figure 1 shown, the medical system 100 generally includes a manipulator assembly 102 for operating a medical device 104 during various procedures performed on a patient P. The manipulator assembly 102 can be remotely operated, non-remotely operated, or a hybrid of remotely operated and non-remotely operated, having selectable degrees of freedom of movement that can be motorized and / or remotely operated and selectable degrees of freedom of movement that can be non-electric and / or non-remotely operated. The manipulator assembly 102 is mounted to or near the operating table T. The master assembly 106 allows an operator O (e.g., a surgeon, clinician, and / or physician as Figure 1 shown) to view the intervention site and control the manipulator assembly 102.

[0078] The master assembly 106 can be located at an operator console, which is typically in the same room as the operating table T, such as on one side of the operating table where the patient P is located. However, it should be understood that the operator O can be located in a different room from the patient P or in a completely different building. The master assembly 106 generally includes one or more control devices for controlling the manipulator assembly 102. The control devices can include any number of various input devices, such as joysticks, trackballs, data gloves, trigger guns, manually operated controllers, voice recognition devices, body movement or presence sensors, and / or similar devices. To give the operator O a strong sense of directly controlling the medical device 104, the control devices can be provided with the same degrees of freedom as the associated medical device 104. In this way, the control devices give the operator O a sense of telepresence or that the control device is integrated with the medical device 104.

[0079] In some embodiments, the control devices can have more or fewer degrees of freedom than the associated medical device 104 and still provide telepresence to the operator O. In some embodiments, the control devices can optionally be manually operated input devices that move in six degrees of freedom and can also include an actuatable handle for actuating the instrument (e.g., for closing grasping jaws, applying an electrical potential to an electrode, delivering a drug treatment, and / or similar operations).

[0080] The manipulator assembly 102 supports the medical device 104 and may include a kinematic structure of one or more non-servo-controlled linkages (e.g., one or more linkages that can be manually positioned and locked in place, often referred to as a set-up structure), and / or one or more servo-controlled linkages (e.g., one or more linkages that can be controlled in response to commands from a control system), as well as a manipulator. The manipulator assembly 102 may optionally include a plurality of actuators or motors that drive inputs on the medical device 104 in response to commands from a control system (e.g., control system 112). The actuators may optionally include a drive system that, when coupled to the medical device 104, can advance the medical device 104 into a naturally occurring or surgically created anatomical aperture. Other drive systems can move the distal end of the medical device 104 in multiple degrees of freedom, which may include degrees of freedom of three linear motions (e.g., linear motions along the X, Y, and Z Cartesian axes) and three rotational motions (e.g., rotations about the X, Y, and Z Cartesian axes). Additionally, the actuators can also be used to actuate an articulating end effector of the medical device 104 to grasp tissue in the jaws of a biopsy device and / or similar device. Actuator orientation sensors such as resolvers, encoders, potentiometers, and other mechanisms can provide sensor data to the medical system 100 that describes the rotation and orientation of the motor shaft. This orientation sensor data can be used to determine the motion of the object manipulated by the actuator.

[0081] The medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the instruments of the manipulator assembly 102. Such subsystems may include an orientation / orientation sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the orientation, orientation, velocity, rate, pose, and / or shape of the distal end and / or along one or more segments of a flexible body that may form the medical device 104; and / or a visualization system for capturing images from the distal end of the medical device 104.

[0082] The medical system 100 further includes a display system 110 for displaying an image or representation of the clinical site and the medical device 104 generated by the subsystems of the sensor system 108. The display system 110 and the main assembly 106 may be oriented such that the operator O can control the medical device 104 and the main assembly 106 with a sense of telepresence.

[0083] In some embodiments, the medical device 104 may include components of an imaging system that records concurrent or real-time images of a clinical site and provides the images to an operator or operator O via one or more displays of the medical system 100, such as one or more displays of the display system 110. The imaging system may be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors, which may include the processor of the control system 112.

[0084] The display system 110 may also display images of the clinical site and the medical device captured by the visualization system. In some examples, the medical system 100 may configure the controllers of the medical device 104 and the main component 106 such that the relative orientation of the medical device approximates the relative orientation of the operator O's eyes and hands. In this way, the operator O can manipulate the medical device 104 and the hand controller as if viewing the workspace in a substantially true presence.

[0085] The medical system 100 may also include a control system 112. The control system 112 includes at least one memory and at least one computer processor (not shown) for implementing control between the medical device 104, the main component 106, the sensor system 108, and the display system 110. The control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the methods described in accordance with the various aspects disclosed herein, including instructions for providing information to the display system 110. Although the control system 112 is shown as a single block in the Figure 1 simplified schematic diagram, the system may include two or more data processing circuits, with a portion of the processing optionally being performed on or near the manipulator assembly 102 and another portion being performed on the main component 106, and / or similar circuits. The processor of the control system 112 may execute instructions, including instructions corresponding to the processes disclosed herein and described in more detail below. Any of a variety of centralized or distributed data processing architectures may be employed. Similarly, the programmed instructions may be implemented as multiple separate programs or subroutines, or they may be integrated into many other aspects of the robotic system described herein. In one embodiment, the control system 112 supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE 802.11, DECT, and wireless telemetry.

[0086] In some embodiments, the control system 112 may receive force and / or torque feedback from the medical device 104. In response to the feedback, the control system 112 may transmit a signal to the main assembly 106. In some examples, the control system 112 may transmit a signal instructing one or more actuators of the manipulator assembly 102 to move the medical device 104. The medical device 104 may extend through an opening in the patient P into an internal clinical site within the patient P. Any suitable conventional and / or dedicated actuator may be used. In some examples, one or more actuators may be separate from or integrated with the manipulator assembly 102. In some embodiments, one or more actuators and the manipulator assembly 102 are provided as part of a remote operation cart positioned near the patient P and the operating table T.

[0087] The control system 112 may optionally further include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based on a reference to a pre-operative or intra-operative data set of the acquired anatomical passageway. The virtual visualization system processes images of the clinical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermography, impedance imaging, laser imaging, nanotube x-ray imaging, and / or similar techniques. Software, which may be used in conjunction with manual input, is used to convert the recorded images into a segmented two-dimensional or three-dimensional composite representation of a local or entire anatomical organ or anatomical region. The image data set is associated with the composite representation. The composite representation and the image data set describe the various positions and shapes of the passageway and its connectivity. The images used to generate the composite representation may be recorded before surgery or intra-operatively during the clinical procedure. In some embodiments, the virtual visualization system may use a standard representation (i.e., non-patient specific) or a hybrid of a standard representation and patient-specific data. The composite representation and any virtual images generated from the composite representation may represent the static pose of a deformable anatomical region during one or more motion phases (e.g., during the inhalation / exhalation cycle of the lungs).

[0088] During a virtual navigation procedure, the sensor system 108 can be used to calculate the approximate position of the medical device 104 relative to the anatomy of the patient P. This position can be used to generate a macroscopic-level (external) tracking image of the anatomy of the patient P and a virtual internal image of the anatomy of the patient P. The system can implement one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display the medical device and pre-operative recorded surgical images, such as those from a virtual visualization system. For example, PCT Publication WO 2016 / 191298 (published December 1, 2016) (disclosing "Systems and Methods of Registration for Image-Guided Surgery") and U.S. Patent Application Serial No. 13 / 107,562 (filed May 13, 2011) (disclosing "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery"), each of which is incorporated herein by reference in its entirety, disclose such systems. The medical system 100 can further include optional operating and support systems (not shown), such as a lighting system, a steering control system, a flushing system, and / or a suction system. In some embodiments, the medical system 100 can include more than one manipulator assembly and / or more than one master assembly. The exact number of remotely operated manipulator assemblies will depend on factors such as the medical procedure and the space constraints within the operating room. The master assemblies 106 can be collocated, or they can be located in separate positions. Multiple master assemblies allow more than one operator to control one or more remotely operated manipulator assemblies in various combinations. The robotic system of the medical system 100 can include a manipulator assembly 102, a control system 112, and a sensor system 108. In some arrangements, the robotic system can further include a display system 110 and the master assemblies 106.

[0089] Figure 2A is a simplified schematic diagram of a medical device system 200 according to some embodiments. In some embodiments, the medical device system 200 can be used as the medical device 104 in an image-guided medical procedure performed with the medical system 100. In some examples, the medical device system 200 can be used for non-remotely operated exploration procedures or for procedures involving traditional manually operated medical devices, such as endoscopy. Optionally, the medical device system 200 can be used to collect (i.e., measure) a set of data points corresponding to positions within the anatomical passageway of a patient, such as patient P.

[0090] The medical device system 200 includes an elongate device 202, such as a flexible catheter, coupled to a drive unit 204. The elongate device 202 includes a flexible body 216 having a proximal end 217 and a distal or tip portion 218. In some embodiments, the flexible body 216 has an outer diameter of approximately 3 mm. The outer diameters of other flexible bodies may be larger or smaller.

[0091] The medical device system 200 further includes a tracking system 230 for determining the orientation, orientation, velocity, rate, posture, and / or shape of the distal end 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices, as described in further detail below. The entire length of the flexible body 216 between the distal end 218 and the proximal end 217 can be effectively divided into segments 224. If the medical device system 200 is consistent with the medical device 104 of the medical system 100, the tracking system 230 can optionally be implemented as: hardware, firmware, software, or a combination thereof, which interact with or are otherwise executed by one or more computer processors - which may include Figure 1 the processor of the control system 112 in

[0092] The tracking system 230 may optionally use the shape sensor 222 to track one or more of the distal end 218 and / or the segment 224. The shape sensor 222 may optionally include optical fibers aligned with the flexible body 216 (e.g., provided within an internal channel (not shown) or mounted externally). In one embodiment, the optical fibers have a diameter of approximately 200 μm. In other embodiments, the size may be larger or smaller. The optical fibers of the shape sensor 222 form an optical fiber bend sensor for determining the shape of the flexible body 216. In an alternative, optical fibers, including Fiber Bragg Gratings (FBG), are used to provide strain measurements in a structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of optical fibers in three dimensions are described in the following patent applications: U.S. Patent Application Serial No. 11 / 180,389 (filed July 13, 2005) (discloses "Fiber optic position and shape sensing device and method relating thereto"); U.S. Patent Application Serial No. 12 / 047,056 (filed July 16, 2004) (discloses "Fiber-optic shape and relative position sensing"); and U.S. Patent No. 6,389,187 (filed June 17, 1998) (discloses "Optical Fibre Bend Sensor"), all of which are hereby incorporated by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering. In some embodiments, other techniques may be used to determine the shape of the elongate device. For example, the history of the distal pose of the flexible body 216 can be used to reconstruct the shape of the flexible body 216 over a period of time. In some embodiments, the tracking system 230 may optionally and / or additionally use the orientation sensor system 220 to track the distal end 218. The orientation sensor system 220 may be a component of an EM sensor system having the orientation sensor system 220 - which includes one or more conductive coils that may be subjected to an externally generated electromagnetic field. Then, each coil of the EM sensor system generates an induced electrical signal, and the characteristics of the induced electrical signal depend on the orientation and orientation of the coil relative to the externally generated electromagnetic field. In some embodiments, the orientation sensor system 220 may be configured and positioned to measure six degrees of freedom (e.g., three orientation coordinates X, Y, and Z and three orientation angles indicating pitch, yaw, and roll of a reference point) or five degrees of freedom (e.g., three orientation coordinates X, Y, and Z and two orientation angles indicating pitch and yaw of a reference point).A further description of the orientation sensor system is provided in U.S. Patent No. 6,380,732, filed Aug. 11, 1999 (which discloses "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety.

[0093] In some embodiments, the tracking system 230 may alternatively and / or additionally rely on known points for the instrument system, historical pose, orientation, or alignment data stored along a cycle of an alternating motion, such as respiration. This stored data may be used to develop shape information about the flexible body 216. In some examples, a series of orientation sensors (not shown), such as electromagnetic (EM) sensors similar to the sensors in the orientation sensor 220, may be positioned along the flexible body 216 and then used for shape sensing. In some examples, the history of data obtained from one or more of these sensors during a procedure may be used to represent the shape of the elongate device 202, particularly where the anatomical passageway is generally static.

[0094] The flexible body 216 includes a channel 221 sized and shaped to receive the medical device 226. Figure 2BIs a simplified schematic of the flexible body 216 when the medical device 226 is extended, according to some embodiments. In some embodiments, the medical device 226 can be used in procedures such as surgery, biopsy, ablation, illumination, irrigation, or aspiration. The medical device 226 can be deployed through the channel 221 of the flexible body 216 and used at a target location within the anatomical structure. The medical device 226 can include, for example, an image acquisition probe, a biopsy instrument, a laser ablation fiber, and / or other surgical tools, diagnostic tools, or treatment tools. The medical tool can include an end effector having a single working member (such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like). Other end effectors can include, for example, forceps, graspers, scissors, clip applicators, and / or the like. Other end effectors can further include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, and / or the like. In various embodiments, the medical device 226 is a biopsy instrument that can be used to obtain a sample tissue or cell sample from a target anatomical location. The medical device 226 can be used in conjunction with an imaging device (e.g., an image acquisition probe) that is also within the flexible body 216. In various embodiments, the medical device 226 itself can be an imaging device (e.g., an image acquisition probe) that includes a distal portion having a stereoscopic camera or a single field-of-view camera at or near the distal end 218 of the flexible body 216 for acquiring images (including video images), and the images are processed by an imaging system 231 for display and / or provided to a tracking system 230 to support tracking of one or more of the distal end 218 and / or the segment 224. The imaging device can include a cable coupled to the camera for transmitting the acquired image data. In some examples, the imaging device can be an optical fiber bundle coupled to the imaging system 231, such as a fibroscope. The imaging device can be single-spectral or multi-spectral, for example, acquiring image data in the form of one or more of the visible spectrum, the infrared spectrum, and / or the ultraviolet spectrum. Alternatively, the medical device 226 itself can be an image acquisition probe. The medical device 226 can be advanced from the opening of the channel 221 to perform a procedure and then retracted into the channel when the procedure is completed. The medical device 226 can be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along the flexible body 216.

[0095] The medical device 226 may additionally accommodate a cable, linkage, or other actuation control (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical device 226. Steerable instruments are described in detail in the following patents: U.S. Patent No. 7,316,681 (filed Oct. 4, 2005) (disclosing "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent Application Serial No. 12 / 286,644 (filed Sep. 30, 2008) (disclosing "Passive Preload and Capstan Drive for Surgical Instruments"), the entire contents of which are incorporated herein by reference.

[0096] The flexible body 216 may also accommodate a cable, linkage, or other steering control (not shown) extending between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 (e.g., as depicted by the dashed lines 219 of the distal end 218). In some examples, at least four cables are used to provide independent "up and down" steering to control the pitch of the distal end 218 and "left and right" steering to control the yaw of the distal end 218. Steerable elongate devices are described in detail in U.S. Patent Application Serial No. 13 / 274,208 (filed Oct. 14, 2011) (disclosing "Catheter with Removable Vision Probe"), which is incorporated herein by reference in its entirety. In embodiments where the medical device system 200 is actuated by a remote operation assembly, the drive unit 204 may include a drive input that is removably coupled to and receives power from a drive element (such as an actuator) of the remote operation assembly. In some embodiments, the medical device system 200 may include a grasping feature, a manual actuator, or other components for manually controlling the movement of the medical device system 200. The elongate device 202 may be steerable, or alternatively, the system may be non-steerable, with no integrated mechanism for an operator to control the bending of the distal end 218. In some examples, one or more lumens are defined in the wall of the flexible body 216 through which the medical device can be deployed and used at a target surgical location.

[0097] In some embodiments, the medical device system 200 can include a flexible bronchial instrument, such as a bronchoscope or a bronchial catheter, for the examination, diagnosis, biopsy, or treatment of the lungs. The medical device system 200 is also adapted to navigate and treat other tissues in any of a variety of anatomical systems via a connection pathway created naturally or surgically, including the colon, intestine, kidney and renal calyces, brain, heart, circulatory system (including vasculature), and / or similar tissues.

[0098] Information from the tracking system 230 can be sent to the navigation system 232, where it is combined with information from the imaging system 231 and / or a preoperatively obtained model to provide real-time orientation information to the operator. In some examples, the real-time orientation information can be displayed on Figure 1 the display system 110 of to control the medical device system 200. In some examples, Figure 1 the control system 112 of can utilize the orientation information as feedback for positioning the medical device system 200. PCT Publication WO 2016 / 191298 (published Dec. 1, 2016) (disclosing “Systems and Methods of Registration for Image Guided Surgery”) and U.S. Patent Application Serial No. 13 / 107,562 (filed May 13, 2011) (disclosing “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), each incorporated herein by reference in its entirety, provide various systems for registering and displaying a surgical instrument with a surgical image using fiber optic sensors.

[0099] In some examples, the medical device system 200 can be remotely operated within Figure 1 the medical system 100 of. In some embodiments, Figure 1 the manipulator assembly 102 of can be directly controlled by the operator instead. In some examples, the direct operator control can include various handles and operator interfaces for the handheld operation of the instrument.

[0100] Figure 3A and Figure 3B are simplified schematic side views of a patient coordinate space including a medical device mounted on an insertion assembly, according to some embodiments. As Figure 3A and Figure 3B shown, the surgical environment 300 includes being positioned within Figure 1Patient P on stage T. Patient P can be stationary within the surgical environment as the overall movement of the patient is restricted by sedation, restraint, and / or other means. Periodic anatomical movements, including the patient's respiratory and cardiac movements, can continue unless the patient is asked to hold his or her breath or mechanical ventilation is paused to temporarily arrest respiratory movement. Thus, in some embodiments, data can be collected at a specific phase of respiration and labeled and identified with that phase. In some embodiments, the phase during which data is collected can be inferred from physiological information collected from patient P. Within surgical environment 300, point collection instrument 304 is coupled to instrument carriage 306. In some embodiments, point collection instrument 304 can use EM sensors, shape sensors, and / or other sensor modalities. Instrument carriage 306 is mounted to insertion gantry 308 fixed within surgical environment 300. Alternatively, insertion gantry 308 can be movable but have a known position within surgical environment 300 (e.g., via a tracking sensor or other tracking device). Instrument carriage 306 can be a component of a manipulator assembly (e.g., manipulator assembly 102) that is coupled to point collection instrument 304 to control the insertion movement (i.e., movement along axis A) and optionally control the movement of the distal end 318 of elongate device 310 in multiple directions (including yaw, pitch, and roll). Instrument carriage 306 or insertion gantry 308 can include an actuator (such as a servo motor) (not shown) that controls the movement of instrument carriage 306 along insertion gantry 308.

[0101] Elongate device 310 (which can be substantially similar to elongate device 202 described above with reference to FIG. 2) is coupled to instrument body 312. As shown in FIG. 3, instrument body 312 is coupled and fixed relative to instrument carriage 306. In some embodiments, fiber optic shape sensor 314 is fixed at proximal point 316 on instrument body 312. In some embodiments, proximal point 316 of fiber optic shape sensor 314 can be capable of moving with instrument body 312, but the position of proximal point 316 can be known (e.g., via a tracking sensor or other tracking device). Shape sensor 314 measures the shape from proximal point 316 to another point, such as distal end 318 of elongate device 310. Point collection instrument 304 can be substantially similar to medical device system 200 described above with reference to FIG. 2.

[0102] Returning to Figure 3, as the instrument body 312 moves along the insertion axis A on the insertion gantry 308, the orientation measurement device 320 provides information about the orientation of the instrument body 312. The orientation measurement device 320 can include a resolver, an encoder, a potentiometer, and / or other sensors that determine the rotation and / or orientation of the actuator that controls the movement of the instrument carriage 306 and thus the movement of the instrument body 312. In some embodiments, the insertion gantry 308 is linear. In some embodiments, the insertion gantry 308 can be curved or have a combination of curved and linear sections.

[0103] Figure 3A Shown is the instrument body 312 and the instrument carriage 306 in a retracted orientation along the insertion gantry 308. In this retracted orientation, the proximal point 316 is at the orientation L0 on the axis A. In this orientation along the insertion gantry 308, the component of the position of the proximal point 316 can be set to zero and / or another reference value to provide a base reference for describing the orientation of the instrument carriage 306 and thus the proximal point 316 on the insertion gantry 308. In the case of this retracted orientation of the instrument body 312 and the instrument carriage 306, the distal end 318 of the elongate device 310 can be positioned just within the access aperture of the patient P. An airway management device (such as the airway management device 500 discussed below) can be inserted through the patient's mouth into the patient's trachea to provide access to the patient's anatomy for the distal end 318 of the instrument body 312. Optionally, the airway management device 500 can be releasably coupled to the insertion gantry 308. Also in this orientation, the orientation measurement device 320 can be set to zero and / or another reference value (e.g., I = 0). In Figure 3B In, the instrument body 312 and the instrument carriage 306 have been advanced along the linear track of the insertion gantry 308, and the distal end 318 of the elongate device 310 has been advanced into the patient P's body. In this advanced orientation, the proximal point 316 is at the orientation L1 on the axis A. In some examples, an encoder and / or other orientation data from one or more actuators that control the movement of the instrument carriage 306 along the insertion gantry 308 and / or one or more orientation sensors associated with the instrument carriage 306 and / or the insertion gantry 308 are used to determine the orientation Lx of the proximal point 316 relative to the orientation L0. In some examples, the orientation Lx can further be used as an indicator of the distance or insertion depth at which the distal end 318 of the elongate device 310 is inserted into the patient P's anatomical passageway.

[0104] Figure 4 Shown is a detailed example of an instrument manipulator 406, which can be used as the manipulator assembly 102 of the Figure 1 robot system in. The instrument manipulator 406 can include a base 404, an insertion gantry 402 (which can be substantially similar to Figure 3A and Figure 3BThe insertion gantry 308) and the instrument carrier 408 (which can be substantially similar to Figure 3A and Figure 3B the instrument carrier 306), a flexible elongate device 410 (which can be substantially similar to the elongate device 202 of FIG. 2 or the elongate device 310 of FIG. 3) is coupled to the instrument carrier 408. In one or more embodiments, Figure 4 The instrument manipulator 406 shown provides insertion and retraction of the flexible elongate device 410 relative to the patient's anatomy by moving the instrument carrier 408 and the insertion gantry 402 relative to the base 404 and telescopically along the linear axis A. Thus, the instrument manipulator 406 provides an insertion degree of freedom for the insertion and retraction of the flexible body portion 410a along the linear axis A. In a medical scenario, insertion can advance the flexible body portion 410a into the patient's anatomy, while retraction can withdraw the flexible body portion 410a from the patient's anatomy.

[0105] The base 404 includes a shaft portion 404a and a main portion 404b. As described in detail below, the shaft portion 404a is removably coupled to a connection mechanism 418 that receives the flexible body portion 410a. The insertion gantry 402 is coupled to the main portion 404b of the base 404 and translates along the main portion 404b. The instrument carrier 408 is coupled to the insertion gantry 402 and translates along the insertion gantry 402. The flexible elongate device 410 can include a flexible body portion 410a and a control assembly 410b. The instrument carrier 408 is coupled to the control assembly 410b at an instrument interface 414 of the instrument carrier 408. The instrument manipulator 406 is also coupled to a probe assembly 416 that includes a probe 416b and a probe connector 416a. The probe assembly 416 can be inserted into the working lumen of the flexible body portion 410a through a connector 412 on the control assembly 410b and can pass through the flexible body portion 410a. The probe 416b can include, for example, an endoscope assembly that provides an image of the clinical site. The instrument carrier 408 can include electronic and optical components that provide endoscopic capabilities for the probe 416b. In some embodiments, the probe assembly 416 can be separated from the instrument manipulator 406 and the control assembly 410b and disassembled from the flexible elongate device 410. Alternative instruments such as biopsy needles, ablation tools, and other flexible instruments can be coupled to the instrument manipulator 406 and / or the flexible elongate device 410 through the working lumen of the flexible body portion 410a.

[0106] Continue Figure 4, the connection mechanism 418 may include a manipulator interface removably coupled to the base 404, a distal end removably coupled to the patient medical device 420 (e.g., an airway management device), and a proximal end that can receive the flexible body portion 410a. The patient medical device 420 (e.g., an endotracheal tube, a laryngeal mask airway, a cannula, etc.) can be fixed to the patient anatomy to facilitate the insertion of various medical devices into the patient anatomy. For example, the patient medical device 420 can be a laryngeal mask airway 500, as further discussed below. Various systems and methods related to the connection mechanism are described in PCT / US2018 / 017085 (filed on February 6, 2018) (disclosing "Systems and Methods for Coupling Components of a Medical System"), which is incorporated herein by reference in its entirety. In some embodiments, the flexible body portion 410a passes through the flexible elongate device guide 422, which is a device capable of selective folding and extension and supports the length of the flexible body portion 410a during the movement of the instrument carriage 408. The unguided flexible body portion 410a may buckle in areas without lateral support, such as the space between the instrument interface 414 and the connection mechanism 418. To avoid buckling, the flexible elongate device guide 422 can operate as a flexible elongate device guide by providing lateral support to the flexible body portion 410a closer to the patient. Various systems and methods related to the flexible elongate device guide are described in PCT / US2017 / 041160 (filed on July 7, 2017) (disclosing "Guide Apparatus for Delivery of an Elongate Device and Methods of Use"), which is incorporated herein by reference in its entirety.

[0107] Figure 5 An example of the airway management device 500 is shown, and the airway management device 500 can be used as the patient medical device 420 in combination with the above-described instrument manipulator 406. Specifically, Figure 5Shows an LMA which, when the patient is supine and the neck is slightly extended, is inserted into the patient through the patient's mouth using, for example, the instrument manipulator 406 discussed above. The airway management device 500 includes an elongated flexible hollow tube 510 that is curved between its distal end 516 and proximal end 514 for insertion through the upper airway passage. The proximal end 514 of the hollow tube 510 is also the proximal end 514 of the airway management device 500. The airway management device 500 may further include an inflatable balloon-like structure or cuff 520 disposed at the distal end 516 of the airway management device 500, which is inflated using a cuff inflation tube 530. This balloon-like structure or cuff 520 forms an airtight seal proximal to the larynx and trachea, thereby preventing air pumped by a ventilator / respirator connected to the proximal end of the tube 510 from escaping back through the trachea 540 and into the oral and nasal passages. As shown, the airway management device 500 is not placed within the patient's trachea.

[0108] To avoid trauma to the patient due to expected or unexpected patient movement during a medical procedure and / or to avoid displacement of the airway management device 500 from the patient's body, the connection mechanism between the instrument manipulator 406 of a robotic system (e.g., Figure 1 medical system 100) and the airway management device 500 is configured to move with various degrees of freedom to accommodate expected and unexpected patient movement. In the case where patient movement results in a significant amount of displacement and thus applies a force to the connection mechanism between the robotic system and the airway management device 500, the connection mechanism can be configured to decouple / separate from the robotic system or the airway management device. The decoupling mechanism can be purely mechanical or can include sensors that sense the force on the connection and, when necessary, decouple the connection when the force exceeds a predetermined threshold to ensure patient safety. Alternatively, sensors coupled to the patient can be used to sense patient movement.

[0109] Referring to the following figures, namely Figure 6A and Figure 6B, which describes an example of a suitable connection mechanism for coupling an airway management device 500 to an instrument manipulator 406 or other components of a robotic system. An exemplary form of the connection mechanism 600 is shown in the figure. The connection mechanism 600 may be rotatably (e.g., relative to an axis) coupled to a mating socket 602, which may be integrated into a docking beam of the flexible manipulator assembly 460 or other components of the robotic system. More specifically, the connection mechanism 600 includes cylindrical coupling members 604 and 606 that extend from opposite ends of a connector body 608 located at an intermediate portion of the connection mechanism 600. A channel 610 extends through the body 608. One end 612 of the connection mechanism 600 may be coupled to an elongate device (e.g., elongate device 410), while a second end 614 of the connection mechanism 600 may be coupled to an airway management device (e.g., airway management devices 311 and / or 478).

[0110] The first end portion may include the coupling members 604 and 606. The members 604 and 606 have curved (e.g., cylindrical, annular, partially spherical, etc.) outer surfaces that mate with the curved surfaces 616 and 618 of the socket 602, respectively, and are thus ultimately coupled to the robotic system. The coupling members 604 and 606 may be held magnetically, and correspondingly, the members 604 and 606 as well as the socket 602 may each include magnets and / or materials responsive to magnetic fields. In some such examples, the socket 602 includes magnets (e.g., permanent magnets, electromagnets, hybrid magnets, etc.) near the curved surfaces 616 and 618, while the coupling members 604 and 606 include magnets or materials responsive to magnetic fields (e.g., iron, nickel, cobalt, ferrite compounds, etc.), and vice versa.

[0111] When attached magnetically, as Figure 6B shown, the coupling members 604 and 606 may rotate relative to the socket 602 about a longitudinal axis L while the body 608 remains laterally coupled to the socket. The amount of rotation may be limited by contact with the socket 602, which may also allow the connection mechanism 600 to rotate a full 360 degrees. Thus, in various embodiments, the connection mechanism 600 may rotate between about 180° and about 360°. In other embodiments, the connection mechanism 600 can be configured to rotate less than 180°. This rotation may occur in response to slight movement of the patient or the manipulator assembly 460. A tube 620 couples the connection mechanism 600 to an air source and / or anesthetic source. The magnetic connection allows the connector to rotate freely in response to forces from the air and anesthetic tubing. When the connection mechanism 600 is attached to the airway management device 500 ( Figure 5In the case (as shown), patient movement greater than a threshold can generate a force that causes the magnetic members 604 and 606 to be released from the cradle 602. Accordingly, the connection mechanism 600, which is coupled to the airway management device 500 (all attached to the patient), separates from the cradle 602. The magnets of the members 604 and 606 can be selected to release in response to a predetermined force or movement.

[0112] Optionally, the connection mechanism 600 and / or the cradle 602 can include Hall sensors to detect when the connection mechanism is fully seated, partially seated, or not seated to the cradle 602. Various control modes of the robotic system can be activated based on the detected seating of the connection mechanism 600. Optionally, the connection mechanism 600 can include a set of fins 622 that form a tapered body profile that aids in orienting the installation (i.e., prevents reverse installation). As Figure 6A shown, the curved surface 616 is tapered to mate with the corresponding tapered body profile of the connection mechanism 600.

[0113] In some embodiments, the portion of the connection mechanism 600 that is coupled to the air source, the elongate device, and / or the tracheal tube rotates or is allowed to rotate relative to the connection mechanism 600 to make the connection more compliant and to make it easier to complete the connection. In one such example, the tube 620 that provides a direct coupling to the air source and / or the anesthesia source rotates and / or allows the coupled source to rotate. In one such example, the first end 612 of the connection mechanism 600 that is coupled to the elongate device and the second end 614 of the connection mechanism 600 that is coupled to the airway management device rotate and / or are allowed to rotate. This can also prevent the coupled device from inadvertently causing the connection mechanism 600 to be released from the cradle 602, or prevent the connection mechanism 600 from being inadvertently released.

[0114] When the airway management device 500 terminates proximal to the patient's trachea, for example, in the case of using an LMA, a device can facilitate providing structural support for moving a flexible elongate device (e.g., the elongate device 202 or 310 or the flexible body portion 410a) to a target location. As described in the Background section above, without such structural support, the flexible elongate device may prolapse (e.g., have instability such as folding, buckling, weakening, etc.) and be unable to reach the target destination. The devices disclosed herein are capable of both acting as a connection mechanism substantially similar to the connection mechanism 600 described above and further obtaining a cannula that provides the necessary structural support. Figures 7 - 15 Such a device 700 is shown.

[0115] The device 700 movably couples a robotic system (e.g., the medical system 100) to an airway management device (e.g., 420 or 500). As Figure 7As shown, device 700 includes an outer sheath 702 and a connection mechanism 704. The connection mechanism 704 is substantially similar to the connection mechanism 600, but is modified to connect to the outer sheath 702. The outer sheath 702 includes a flexible tubular portion 706. The connection mechanism includes a mating socket or docking spar 602. The connection mechanism 704 includes a first portion 708 configured to receive the outer sheath 702). The connection mechanism 704 further includes a second portion 710 configured to connect to the proximal end (e.g., Figure 5 the proximal end 514 of the airway management device 500). A cavity 712 is defined within the proximal portion 708 and the second portion 710. A locking mechanism 714 is configured to connect to the flexible tubular portion 706 of the outer sheath 702. When the outer sheath 702 is connected to the connection mechanism 704, the flexible tubular portion 706 of the outer sheath 702 is located within the cavity 712 of the connection mechanism 704 and can extend distally beyond the distal end (e.g., Figure 5 the distal end 516 of the airway management device 500). The proximal portion 703 of the outer sheath 702 is wider than the width of the cavity 712, thereby restricting the distal movement of the outer sheath 702 through the connection mechanism 704.

[0116] The robotic system to which the device 700 is connected (e.g., Figure 1 the system components of the medical system 100) is configured to drive a flexible elongate device (e.g., the elongate device 202 of FIG. 2). The airway management device to which the device 700 is connected (e.g., Figure 5 the airway management device 500) includes a cylindrical passage (e.g., a hollow tube 510) configured to be coupled to the robotic system via the connection mechanism. The airway management device further includes an engagement portion (e.g., a cuff 520) attached to the cylindrical passage, the engagement portion being configured to engage the patient's anatomy proximal to the trachea. Figure 7 The flexible tubular portion 706 of the outer sheath 702 is configured to be inserted into the cylindrical passage (e.g., the hollow tube 510) of the airway management device 500 and to extend distally beyond the engagement portion (e.g., the cuff 520) when inserted into the cylindrical passage of the airway management device. With this configuration, as Figure 8 shown, when the flexible elongate device driven by the robotic system is received within the flexible tubular portion 706 of the outer sheath 702, the flexible tubular portion 706 structurally supports the flexible elongate device and provides additional support beyond the airway management device 500.

[0117] As described above with respect to Figure 4 the robotic system includes an instrument carriage (e.g., the instrument carriage 408) and a flexible elongate device guide (e.g., the flexible elongate device guide 422) configured to provide lateral support to the flexible elongate device during movement of the instrument carriage. In Figure 7In the arrangement shown, the flexible elongate device guide 422 includes an aperture 705 that is aligned with the outer sheath 702 and the arm 707. When used with the device 700, the flexible elongate device guide (e.g., flexible elongate device guide 422) is configured to receive the outer sheath 702. Since the outer sheath 702 must have a larger outer diameter than the flexible elongate device (e.g., flexible body portion 410a) in order for the flexible elongate device to move within the flexible tubular portion 706, at least some dimensions of the flexible elongate device guide may be increased to allow the outer sheath 702 to pass through. In some arrangements, portions of the flexible elongate device guide may be modified (such as the aperture 705 and the distal connection 701) for use with the device 700.

[0118] Steering Figure 8 , the flexible tubular portion 706 of the outer sheath 702 may include an atraumatic tip 716. The atraumatic tip 716 ensures that the outer sheath 702 does not harm the patient during insertion by, for example, having a blunt or curved surface or being made of a material that is relatively softer than the main portion of the outer sheath 702. As shown in the cross-sectional portion, the flexible tubular portion 706 has an inner surface 718 that includes a low-friction interface that defines a lumen 722. The low-friction interface enables the flexible elongate device (e.g., elongate device 202 or flexible body portion 410a) to move more easily through the outer sheath 702. The diameter of the flexible tubular portion is Dt. The end 703 of the outer sheath has a diameter greater than Dt, thereby constraining the distal movement of the outer sheath 702 through the connection mechanism 704 as discussed above.

[0119] Go to Figure 9 , the device 700 further includes a first seal 720. The first seal 720 is configured to seal the lumen 722 of the flexible tubular portion 706 of the outer sheath 702. In the arrangement shown, the first seal 720 includes a cross-slit valve 721 and a diaphragm 723. The diaphragm 723 is positioned proximal to the cross-slit valve 721 such that when the flexible elongate device is inserted, the diaphragm 723 seals around the flexible elongate device before the cross-slit valve 721 is opened by the flexible elongate device. The first seal 720, and specifically the cross-slit valve 721, may be configured to seal the lumen 722 of the outer sheath 702 in the absence of a flexible elongate device within the outer sheath 702. The first seal 720, and specifically the diaphragm 723, may be configured to seal around the flexible elongate device to continue sealing the lumen 722 when the flexible elongate device is inserted through the outer sheath 702. As shown, the seal 720 is provided on a cap 724 that is fixed to the proximal end 726 of the outer sheath 702 and extends partially into the lumen 722 of the flexible tubular portion 706 of the outer sheath 702.

[0120] As Figure 10As shown, device 700 further includes a second seal 728. The second seal 728 is configured to seal the cavity 712 of the connection mechanism 704. The second seal 728 may include a diaphragm seal 729 and a cross-slit valve 731, similar to the first seal 720 depicted above Figure 9 but larger to accommodate the outer sleeve 702 when the outer sleeve 702 is inserted into the connection mechanism 704. The second seal 728, and specifically the cross-slit valve 731, may be configured to seal the cavity 712 of the connection mechanism 704 in the absence of the outer sleeve 702 within the connection mechanism 704. The second seal 728, and specifically the diaphragm 729, may be configured to seal around the outer sleeve 702 to continue sealing the cavity 712 when the outer sleeve 702 is inserted through the connection mechanism 704. Although the first seal 720 and the second seal 728 are described as each including a cross-slit valve and a diaphragm, other types of sealing structures may also be used for each of these seals to provide sealing and prevent fluid transmission in both the presence and absence of the inserted object.

[0121] The locking mechanism 714 is configured to mechanically fix the outer sleeve 702 to the connection mechanism 704. For example, the locking mechanism 714 is configured to fix the second seal 728 (and specifically the diaphragm seal 729) around the flexible tubular portion 706 to prevent movement of the outer sleeve 702. The locking mechanism 714 includes a first lock member 730 having a threaded base 732. The locking mechanism 714 further includes a second lock member 734 having a threaded wall 736 configured to engage the threaded base 732. The second lock member 734 also has legs 738 extending inwardly from the threaded wall 736. The second lock member 734 is positioned adjacent to the second seal 728, and relative movement between the threaded base 732 of the first lock member 730 and the threaded wall 736 of the second lock member 734 causes the legs 738 of the second lock member 734 to compress the second seal 728, thereby causing the second seal 728 to expand radially inwardly to engage the flexible tubular portion 706 of the outer sleeve 702. The locking mechanism 714 further includes a housing 740. As Figure 12As shown, the second locking member 734 includes splines 742 on the outer side 744 of the threaded wall 736. The splines 742 are configured to engage the housing 740 such that the second locking member 734 cannot rotate relative to the housing 740. The first locking member 730 is vertically constrained, such that when the second locking member 734 rotates relative to the first locking member 730, the first locking member 730 does not move vertically. Since the second locking member 734 cannot rotate due to the presence of the splines 742, the threads on the first locking member 730 and the second locking member 734 cause the first locking member 730 and the second locking member 734 to separate. Since the first locking member 730 is vertically constrained, the second locking member 734 moves downward and compresses the second seal 728. Specifically, the first locking member 730 includes a groove 775 (discussed below) that engages a lip 774 of the coupling member 770, and the engagement between the groove and the lip 774 vertically constrains the first locking member 730. In an alternative example where the first locking member 730 is not vertically constrained, the first locking member 730 can be directly threaded into the housing 740 to compress the second seal 728.

[0122] Figure 10 Features of the device 700 that are substantially similar or provide similar functionality to features of the connection mechanism 600 are also shown. For example, the connection mechanism 704 includes a tube 746 that is similar to the tube 620. The tube 746 connects the device 700 and the airway management device to a ventilator, a fluid source, and / or a vacuum source. As is generally understood, the connection can include one or more sealing members, such as O-rings. Similar to the tube 620, the tube 746 can be rotatably coupled to allow free rotation in response to forces from the air and anesthesia tubing. The device further includes coupling members 770 and 771, which are similar to the coupling members 604 and 606, respectively, allowing the connection mechanism 704 to be coupled to a manipulator assembly (such as the instrument manipulator 406) in a manner that allows rotation about an axis L. The device 700 includes a cavity 712 that is similar to the channel 610 and extends through the housing 740. Although Figure 6A and Figure 6BIn the connecting mechanism 600, the mating socket 602 can be magnetically coupled to the coupling members 604 and 606. However, for the device 700, the coupling members 770 and 771 can be magnetically coupled to the mating socket 602. The coupling members 770 and 771 can include magnets (e.g., permanent magnets, electromagnets, hybrid magnets, etc.) or materials that allow magnetic attachment in response to a magnetic field. Due to the coupling members 770 and 771, the connecting mechanism 704 is configured to at least partially disconnect from the robotic system when the movement between the robotic system and the airway management device includes a displacement above a threshold relative to the robotic system by the airway management device. The displacement above the threshold generates a force that overcomes the magnetic force fixing the connecting mechanism 704 to the robotic system. As described above with respect to the connecting mechanism 600, this decoupling avoids trauma to the patient due to patient movement during a medical procedure and avoids displacement of the airway management device from the patient's body.

[0123] The device 700 further includes a coupler 750 connected to the proximal end 514 of the airway management device 500. The coupler 750 is capable of rotating relative to the housing 740 and the coupling member 771.

[0124] Figure 11 The first lock member 730 is shown. As discussed above, the first lock member 730 includes a threaded base 732 connected to the second lock member 734. The first lock member 730 further includes a hole 756 for receiving the outer sleeve 702 and a grippable surface 758 to facilitate relative movement between the first lock member 730 and the second lock member 734 by, for example, rotating the first lock member 730. The grippable surface 758 can include divots, textures, or other features to increase the ease with which the grippable surface can be manipulated.

[0125] Figure 12 The second lock member 734 is shown. As discussed above, the second lock member 734 includes a threaded wall 736 to engage the threaded base 732 of the first lock member 730. The second lock member 734 also includes a hole 760 for receiving the outer sleeve 702. The legs 738 of the second lock member 734 are adjacent to and extend inwardly toward the hole 760. The splines 742 of the second lock member 734 that prevent the second lock member 734 from rotating relative to the housing 740 are located on the outer side 744 of the second lock member 734.

[0126] Figure 13 The housing 740 is shown. A channel 762 extends through the housing 740. The inner surface 764 of the housing 740 includes splines 766 to engage the splines 742 of the second lock member 734, thereby preventing the second lock member 734 from rotating relative to the housing 740. In the illustrated arrangement, the housing 740 includes a threaded outer surface 768.

[0127] Figure 14Shown is a coupling member 770 having a threaded inner surface 772 for coupling to a threaded outer surface 768. As Figure 10 shown, the coupling member 771 can include a threaded inner surface similar to that Figure 14 shown for the coupling member 770 for coupling to the threaded outer surface 768. The coupling member 770 also has an upper lip 774 that is positioned proximal to the housing 740 and extends inwardly toward the channel 762 of the housing 740.

[0128] Figure 15 Shown is a second seal 728, depicted herein as a diaphragm. The second seal 728 has a height Ha and an outer diameter Do and includes a diaphragm aperture 776 having an inner diameter Da. As the first locking member 730 and the second locking member 734 move along the threads of the thread base 732 and the thread wall 736, the feet 738 of the second locking member 734 compress the second seal 728. As the second seal 728 is compressed, the height Ha is reduced. In the absence of restraint, as the height Ha is reduced, the diameter Da would decrease and the outer diameter Do would expand. However, the locking mechanism 714 restrains the second seal 728 such that the outer diameter Do expands only slightly before being restricted by the locking mechanism 714, resulting in a greater reduction in the diameter Da than would occur without the locking mechanism 714. Optimally, the diameter Da is sized relative to the diameter Dt of the flexible tubular portion 706 of the outer cannula 702 to allow insertion of the outer cannula 702 through the device 700 before or during limited engagement of the feet 738, while allowing sufficient engagement between the second seal 728 and the flexible tubular portion 706 of the outer cannula 702 for the second seal 728 to form a seal around the flexible tubular portion 706. The diameter Da then decreases as the feet 738 compress the second seal 728, resulting in engagement between the second seal 728 and the outer cannula 702. At the same time, the slight increase in the outer diameter Do causes the second seal 728 to press against the housing 740, thereby increasing the integrity of the seal.

[0129] Figure 16A method 800 for positioning a flexible elongate device (e.g., elongate device 202) is shown. At block 802, method 800 includes providing a connection mechanism 704 having a first portion 708 and a second portion 710. At block 804, method 800 includes connecting the second portion 710 of the connection mechanism 704 to an airway management device 500 and then to a robotic system. At block 806, method 800 includes using the robotic system to insert the flexible elongate device into the anatomical structure a first distance such that the distal portion of the flexible elongate device extends through the connection mechanism 704 and extends distally of the airway management device 500. For example, the distal portion of the flexible elongate device may extend into the trachea distally of the engagement portion of the airway management device. At block 808, method 800 includes extending an outer sheath 702 over the flexible elongate device such that the flexible tubular portion 706 of the outer sheath 702 extends through the connection mechanism 704 and extends distally of the airway management device 500. In some examples, the outer sheath 702 is initially configured not to extend beyond the airway management device 500. In some examples, the flexible tubular portion 706 of the outer sheath does not extend distally of the distal portion of the flexible elongate device. This allows the flexible elongate device to act as a guide for the entire insertion of the outer sheath 702, thereby ensuring the correct outer sheath insertion position and minimizing the likelihood of damaging the anatomical structure. At block 810, method 800 includes using the robotic system to further insert the flexible elongate device into the anatomical structure beyond the first distance, wherein during the further insertion, the flexible tubular portion 706 of the outer sheath 702 provides structural support for the flexible elongate device distal of the airway management device. Method 800 may include repeating the steps described in blocks 808 to 810 to achieve subsequent distances (second distance, third distance, etc.). For example, the insertion distance of the outer sheath within the anatomical structure may be adjusted as needed to provide sufficient support for the flexible elongate device beyond the distal end of the airway management device.

[0130] Method 800 may further include locking the flexible tubular portion 706 of the outer cannula 702 to the connection mechanism 704. Locking the flexible tubular portion 706 of the outer cannula 702 to the connection mechanism may include sealing the cavity 712 of the connection mechanism 704 using a second seal 728. Method 800 may further include causing relative movement between the threaded base 732 of the first lock member 730 and the threaded wall 736 of the second lock member 734 to cause the legs 738 of the second lock member 734 to compress the seal 728, thereby causing the seal 728 to expand radially inwardly to engage the flexible tubular portion 706 of the outer cannula 702. Method 800 may further include extending a flexible elongate device guide (e.g., flexible elongate device guide 422) when the flexible elongate device is inserted a first distance into the anatomical structure. Method 800 may further include retracting the flexible elongate device guide (e.g., flexible elongate device guide 422) after the outer cannula 702 has been extended over the flexible elongate device such that the flexible tubular portion 706 of the outer cannula 702 extends through the connection mechanism 704 and distally to the airway management device 500.

[0131] In the description, specific details have been set forth in order to describe some examples. A number of specific details have been set forth in order to provide a thorough understanding of these examples. However, it will be apparent to one of ordinary skill in the art that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are intended to be illustrative and not limiting. One of ordinary skill in the art may recognize other elements that, although not specifically described herein, fall within the scope and spirit of the present disclosure.

[0132] Elements described in reference to one example, embodiment, implementation, or application may, where practicable, be included, optionally, in other examples, implementations, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one example and not described with reference to a second example, it may still be argued that the element is included in the second example. Thus, to avoid unnecessary repetition in the foregoing description, one or more elements shown and described in connection with one example, implementation, or application may be incorporated into other examples, implementations, or applications, unless the one or more elements would render the example or implementation inoperative, or unless two or more of these elements provide conflicting functions. Similarly, it should be understood that any particular element, including system components or method processes, is optional and not considered an essential feature of the present disclosure unless expressly stated otherwise.

[0133] Any changes and further modifications to the described devices, apparatuses, methods, and any further applications of the principles of this disclosure are fully contemplated, as would typically be thought of by one of ordinary skill in the art to which this disclosure pertains. Specifically, it is fully contemplated that features, components, and / or steps described with respect to one example may be combined with features, components, and / or steps described with respect to other examples of this disclosure. Additionally, the dimensions provided herein are for specific examples, and it is contemplated that different sizes, dimensions, and / or ratios may be utilized to implement the concepts of this disclosure.

[0134] Although some examples are provided herein in the context of medical procedures, any reference to a medical device or surgical instrument and a medical or surgical method is non - limiting. For example, the apparatuses, systems, and methods described herein may be used for non - medical purposes, including industrial uses, general robotic uses, and sensing or manipulating non - tissue workpieces. Other example applications involve cosmetic improvements, imaging of the human or animal anatomical structure, collecting data from the human or animal anatomical structure, and training medical or non - medical personnel. Additional example applications include uses for procedures on tissue removed from the human or animal anatomical structure (without returning to the human or animal anatomical structure) and performing procedures on a human or animal cadaver. Further, these techniques may also be used in surgical and non - surgical medical treatment or diagnostic procedures.

[0135] The methods described herein are shown as a set of operations or processes. Not all of the processes shown may be performed in all examples of the method. Additionally, one or more processes not explicitly shown or described may be included before, after, between, or as part of the example processes. In some examples, one or more of the processes may be performed by a control system (e.g., control system 112), and may also be at least partially implemented in the form of executable code stored on a non - transitory, tangible machine - readable medium, which when run by one or more processors (e.g., the processors of control system 112) may cause the one or more processors to perform one or more of the processes.

[0136] One or more elements in the examples of the present disclosure may be implemented in software to be executed on a processor of a computer system such as a control processing system. When implemented in software, the elements of the examples of the present disclosure are essentially coded segments that perform the necessary tasks. The program or coded segments can be stored in a processor-readable storage medium or device, which can be downloaded in the form of a computer data signal embodied in a carrier wave via a transmission medium or a communication link. The processor-readable storage device can include any medium capable of storing information including optical media, semiconductor media, and magnetic media. Examples of the processor-readable storage device include electronic circuits, semiconductor devices, semiconductor storage devices, read-only memory (ROM), flash memory, erasable programmable read-only memory (EPROM), floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. The coded segments can be downloaded via a computer network such as the Internet, Ethernet, etc. Any of a variety of centralized or distributed data processing architectures can be employed. The programmed instructions can be implemented as multiple separate programs or subroutines, which can also be integrated into many other aspects of the systems described herein. In one example, the control system supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE 802.11, DECT, and wireless telemetry.

[0137] Note that the processes and displays presented may not be inherently related to any particular computer or other device. According to the teachings herein, various general-purpose systems can be used with the program, and it has also proven convenient to construct more specialized devices to perform the described operations. The structures required for various such systems will appear as elements in the claims. Additionally, the examples of the present disclosure are not described with reference to any particular programming language. It should be understood that a variety of programming languages can be used to implement the teachings of the present disclosure.

[0138] The present disclosure describes various instruments, parts of instruments, and anatomical structures in terms of their states in three-dimensional space. As used herein, the term "orientation" refers to the position of an object or a part of an object in three-dimensional space (e.g., three translational degrees of freedom along the Cartesian x, y, and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a part of an object (three rotational degrees of freedom - e.g., roll, pitch, and yaw). The "pitch" direction and the "yaw" direction need not be limited to vertical and horizontal movement, respectively, but can be any directions orthogonal to each other. As used herein, the term "pose" refers to the orientation of an object or a part of an object in at least one translational degree of freedom and refers to the orientation of the object or the part of the object in at least one rotational degree of freedom (up to a total of six degrees of freedom). As used herein, the term "shape" refers to a set of poses, orientations, or orientations measured along the length of an object. As used herein, the term "about", when used in conjunction with a recited numerical indication, means the recited numerical indication plus or minus up to 10% of the recited numerical indication. For example, the phrase "about 50" encompasses the range from 45 to 55. Similarly, the phrase "about 5" encompasses the range from 4.5 to 5.5.

[0139] As used in this specification and the appended claims, the word "distal" refers to the direction toward the working part, and the word "proximal" refers to the direction away from the working part. Thus, for example, the end of a medical device that is closest to the target tissue will be the distal end of the medical device, and the end opposite the distal end will be the proximal end of the medical device.

[0140] In addition, the particular words chosen to describe one or more embodiments and optional elements or features are not intended to limit the invention. For example, spatially relative terms - such as "below", "beneath", "under", "above", "on", "proximal", "distal", etc. - may be used to describe the relationship of one element or feature to another element or feature shown in the figures. These spatially relative terms are intended to cover different orientations (i.e., translational placement) and orientations (i.e., rotational placement) of the device during use or operation, in addition to the orientations and orientations shown in the figures. For example, if the device in the figure is flipped over, an element described as "below" or "beneath" another element or feature will be "above" or "on" that other element or feature. Thus, the term "below" can include both the above and below orientations and orientations. The device can be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein are to be interpreted accordingly. Similarly, the descriptions of movement along (translational) and around (rotational) various axes include various spatial orientations and orientations. The combination of the orientation and orientation of the body defines the pose of the body.

[0141] Similarly, geometric terms such as "parallel", "perpendicular", "circular", or "square" are not intended to require absolute mathematical precision unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functionality. For example, if an element is described as "circular" or "substantially circular", components that are not precisely circular (e.g., slightly oval or polygonal components) are still covered by this description.

[0142] In addition, the singular forms "a", "an", and "the" are also intended to include the plural forms unless the context indicates otherwise. The terms "comprising", "including", "having", etc. specify the presence of the stated features, steps, operations, elements, components, etc., but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, or groups.

[0143] Unless otherwise indicated, the terms device, medical device, medical instrument, and their variants can be used interchangeably.

[0144] Although certain exemplary examples of the present disclosure have been described and illustrated in the drawings, it should be understood that such examples are merely illustrative and not limiting of the broad disclosure herein, and the examples of the present disclosure should not be limited to the specific constructions and arrangements shown and described, as various other modifications can be envisioned by those of ordinary skill in the art.

Claims

1. An apparatus for removably coupling a robotic system to an airway management device, the apparatus comprising: an outer sleeve including a flexible tubular portion; and A connecting mechanism comprising: a first portion configured to receive the outer sleeve; a second portion configured to couple to a proximal end of the airway management device; a cavity defined within the first portion and the second portion; and a locking mechanism configured to be coupled to the flexible tubular portion of the outer sleeve; When the outer sleeve is connected to the connecting mechanism, the flexible tubular portion of the outer sleeve is within the cavity of the connecting mechanism and extends to the distal side of the distal end of the airway management device.

2. The apparatus of claim 1, further comprising a first seal configured to seal the lumen of the flexible tubular portion of the outer sleeve.

3. The apparatus of claim 2, wherein the first seal comprises a cross-slit valve and a diaphragm.

4. The apparatus of claim 2 or claim 3, further comprising a cap for the outer sleeve, the cap comprising the first seal.

5. The apparatus of any one of claims 1 to 3, further comprising a second seal configured to seal the cavity of the connection mechanism.

6. The apparatus of claim 5, wherein the second seal comprises a diaphragm seal and a cross-slit valve.

7. The apparatus of claim 5, wherein the locking mechanism is configured to secure the second seal around the flexible tubular portion to prevent movement of the outer sleeve.

8. The device according to any one of claims 1 to 3, wherein the locking mechanism comprises: a first lock component including a threaded base; a second lock component including a threaded wall configured to engage the threaded base of the first lock component, the second lock component further including a foot extending inwardly from the threaded wall, the second lock component being positioned adjacent to a second seal; and wherein relative movement between the threaded base of the first locking component and the threaded wall of the second locking component causes the legs of the second locking component to compress the second seal, thereby causing the second seal to expand radially inwardly to engage the flexible tubular portion of the outer sleeve.

9. The device of claim 8, wherein the locking mechanism further comprises a housing, and the second lock component comprises splines on an outer side of the threaded wall, the splines being configured to engage the housing such that the second lock component cannot rotate relative to the housing.

10. The apparatus of any one of claims 1 to 3, wherein the connection mechanism is configured to at least partially disconnect from the robotic system when movement between the robotic system and the airway management device includes a displacement of the airway management device relative to the robotic system above a threshold.

Images