Method and apparatus for navigating using pair of rigidified devices

Abstract

Systems and methods for navigating a system including a nested pair of rigidified devices through a body lumen are disclosed herein. The rigidifying device is configured to alternately rigidify and transition between a rigidified state and a flexible state, and replicate the shape of the device when advanced or retracted. Examples of an apparatus for automatically or semi-automatically photographing a body cavity using a nested pair of rigidifying devices are also described herein.

Description

[0001] Priority claim

[0002] This patent application claims priority to patent 63 / 324,011, filed on March 25, 2022, entitled "METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES," which is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0005] background

[0006] During a medical procedure, a nested or telescopic device can be advanced by coordinated movement of both an internal device (an internal member, a daughter body, a catheter, an endoscope, etc.) and an external device (e.g., an external member, a mother body, an outer sleeve, etc.). However, when navigating through curved or tortuous anatomical structures (including body regions where the device may bend, bend, and even loop or fold on itself), coordinating the movement of the internal and external members may be particularly challenging. This may make both advancement and / or retraction of the medical device difficult.

[0007] These problems may be particularly severe in anatomical areas (e.g., gastrointestinal areas) that may be tortuous and may form loops. Gastrointestinal looping, which is caused when a conventional endoscope cannot be advanced due to excessive bending or looping of the gastrointestinal tract, is a particularly well-known clinical challenge for endoscopy. Gastrointestinal looping prolongs the operation and can cause pain to the patient because it stretches the vessel walls and mesentery. In addition, gastrointestinal looping leads to an increased incidence of perforation. Similar problems typically occur in a wide range of endoscopic procedures, including colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy, endoscopic retrograde pancreaticocholangiopancreatography (ERCP), interventional endoscopic procedures (including ESD (endoscopic submucosal dissection) and EMR (endoscopic mucosal resection)), robotic flexible endoscopy, transoral robotic surgery (TORS), changing anatomical cases (including Roux-en-Y), and during NOTES (natural orifice endoscopic surgery). Therefore, there is a need for a device that can prevent gastrointestinal looping and / or can otherwise provide a more successful approach to the gastrointestinal tract. In particular, there is a need for a method and device that can safely and effectively coordinate the movement of all telescoping members of a nested device having both inner and outer rigidizing members during advancement and retraction of the device.

[0008] Overview of the Disclosure

[0009] Described herein are methods and apparatus (e.g., devices, systems, etc.) for controlling a pair of nested and optionally rigidified members during advancement and retraction within a body cavity. One or both of the optionally rigidified members may be steerable at the distal region of the member by applying tension to one or more tendons to cause bending of the distal region in a desired direction. In some examples, the device may include a pair of nested rigidified devices that may be alternately rigidified and advanced (or retracted) distally or proximally through the body cavity. In the absence of constraints, the transition between the rigidified state and the flexible state may involve significant shape changes, which in some cases may be harmful to the surrounding anatomical structures. There is a need for methods and systems that can provide a safe and smooth transition between a rigidified state and a flexible state for such a device.

[0010] In general, these methods and devices may include estimating the current shape of a nested group by remembering a sequence of commanded turns (articulation) and replications, and / or using the estimated shape to improve control of guidance (e.g., steering) of a device within a space (such as within a body cavity). The memory of the current shape may be called up ("remembered") by using a first flexible device to replicate the shape of a second rigidified (e.g., locked) device nested with the first device.

[0011] In some examples, these methods and devices can be used to withdraw (proximally) a device comprising a pair of nested devices while maintaining the orientation of the distal tip of the device, for example, so that a camera on a distal surface of a first rigidized device or a second rigidized device can maintain its orientation (e.g., maintain a net articulation angle). This can advantageously allow these devices to smoothly transition between a rigid state and a non-rigid state without substantial deflection. For example, a method of controlling a nested pair of rigidized devices, the method comprising: retracting a first rigidized device in the nested pair of rigidized devices relative to a second rigidized device in the nested pair of rigidized devices while the first rigidized device is in a flexible state and the second rigidized device is in a rigidified state; rigidifying the first rigidized device; and before and / or while transitioning the second rigidized device from the rigid state to the flexible state, actuating a steering member within the second rigidized device to maintain the orientation of the distal surface of the second rigidized device constant relative to an external region.

[0012] Any of these methods or devices may include: after actuating the steering member, retracting the second rigidizing device relative to the first rigidizing device when the second rigidizing device is in a flexible state. These methods and devices may also be configured to rigidify the second rigidizing device and retract the first rigidizing device over the second rigidizing device when the first rigidizing device is in a flexible state. Retracting the second rigidizing device may include retracting the second rigidizing device at least partially into the first rigidizing device. In any of these methods and devices (e.g., systems), actuating the steering member within the second rigidizing device to maintain the orientation of the distal face of the second rigidizing device may include maintaining a net turning angle between the distal end of the second rigidizing device relative to a proximal portion of the second rigidizing device. In any of these methods and devices, actuating the steering member within the second rigidizing device to maintain the orientation of the distal face of the second rigidizing device constant relative to the external region may include maintaining the orientation of the distal face of the second rigidizing device relative to the cavity wall. For example, actuating a steering member within the second rigidizing device to maintain a constant orientation of a distal face of the second rigidizing device relative to an external region includes maintaining the orientation of the distal face of the second rigidizing device such that an angular orientation of the distal face of the second rigidizing device varies by less than + / - 15 degrees. Actuating the steering member may include applying a tensile force to at least one of the steering members. In some examples, actuating the steering member includes displacing at least one of the steering members. Any of these methods and apparatus may include actuating the steering member by automatically actuating the steering member.

[0013] The methods and apparatus described herein may include retracting the first rigidizing device, wherein retracting the first rigidizing device includes proximally retracting the first rigidizing device relative to the second rigidizing device.

[0014] The first rigidizing device may be nested within the second rigidizing device. Alternatively, the second rigidizing device may be nested within the first rigidizing device.

[0015] The methods and apparatus described herein may include imaging the external region by a sensor at a distal face of the second rigidification device.

[0016] Also described herein are devices (e.g., systems) configured to perform any of the methods described herein. The devices may include a nested pair of rigidized devices, the nested pair of rigidized devices including a first rigidized device and a second rigidized device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidized devices.

[0017] Also described herein are methods for automatically (or semi-automatically) performing shape replication. Specifically, described herein are methods for automatically performing shape replication when triggered by a user actuating a control, and for continuing the automatic shape replication while the user continues to actuate the control, but for stopping the automatic shape replication if the user stops actuating the control. For example, the control may be actuated by pressing a button or a switch; the shape replication process may be automatically performed when the user presses the button, but may stop when the user stops pressing the button.

[0018] For example, a method of controlling a nested pair of rigidifiers may include: receiving a copy command from a user input; automatically executing a shape copy sequence, wherein the shape copy sequence includes: advancing a first rigidifier in the nested pair of rigidifiers relative to a second rigidifier in the nested pair of rigidifiers while the first rigidifier is in a flexible state and the second rigidifier is in a rigidified state, wherein the first rigidifier is initially located proximal to the second rigidifier such that the first rigidifier copies the shape of the second rigidifier; and preventing the first rigidifier from being advanced distal to the second rigidifier.

[0019] Any of these methods can include continuing to advance the first rigidizing device until a distal end of the first rigidizing device reaches a distal end of the second rigidizing device.

[0020] As described above, advancing the first rigidizing device may include advancing the first rigidizing device only when replication commands are continuously received. Any of these methods (or apparatus) may further or alternatively be configured to prevent the first device (e.g., the first rigidizing device) from exceeding the distal region of the second device (e.g., the second rigidizing device). These features allow for rapid and efficient operation of these nested systems while maintaining a high degree of user control that would not be possible without preventing overshoot and / or without partial stopping by the automated shape replication process.

[0021] The shape replication sequence may include rigidifying the second rigidizing device into a rigid state prior to advancing the first rigidizing device. In some examples, the shape replication sequence also includes de-rigidizing the first rigidizing device into a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device. The shape replication sequence may also include rigidifying the first rigidizing device into a rigid state after the first rigidizing device has been advanced relative to the second rigidizing device. In any of these methods and apparatuses, prior to receiving a replication command, the method may include advancing the second rigidizing device in a flexible state while steering a distal region of the second rigidizing device, wherein the first rigidizing device is in a rigid state.

[0022] For example, a method of controlling a nested pair of rigidifiers may include: receiving a copy command from a user input; and automatically executing a shape copy sequence upon receiving the user input, wherein the shape copy sequence includes: advancing a first rigidifier of the nested pair of rigidifiers relative to a second rigidifier of the nested pair of rigidifiers while the first rigidifier is in a flexible state and the second rigidifier is in a rigidified state, wherein the first rigidifier is initially located proximal to the second rigidifier such that the first rigidifier copies a shape of the second rigidifier.

[0023] Also described herein are methods and apparatus (e.g., systems) for automatically replicating a shape upon detecting an automatic replication trigger. The automatic replication trigger may be, for example, extending one of the first or second nested rigidization devices distally relative to the other rigidization device, a time delay longer than a set threshold when moving one of the nested rigidization devices relative to the other, a hysteresis in the movement of one or the other rigidization device, etc.

[0024] For example, a method of controlling a nested pair of rigidifying devices including a first rigidifying device and a second rigidifying device, the method comprising automatically executing a shape replication sequence when an automatic replication trigger event is detected by a control circuit, the method comprising: receiving one or more of sensor data and / or user movement inputs in a controller; comparing one or more of the sensor data and / or user movement inputs to an automatic replication trigger threshold; and triggering the shape replication sequence when the automatic replication trigger threshold is detected, wherein the shape replication sequence comprises: advancing the first rigidifying device relative to the second rigidifying device while the first rigidifying device is in a flexible state and the second rigidifying device is in a rigidified state.

[0025] As described above, in some examples, the automatic replication triggering threshold can be a relative axial travel distance between the first rigidizing member and the second rigidizing member. The automatic replication triggering threshold can include exceeding a time delay after the second rigidizing member moves relative to the first rigidizing member. Automatically executing the shape replication sequence can include advancing the first rigidizing device relative to the second rigidizing device until a distal region of the first rigidizing device is adjacent to a distal region of the second rigidizing device.

[0026] The first rigidizing device may be nested on the second rigidizing device.

[0027] The shape replication sequence may further include rigidifying the second rigidizing device into a rigid state before advancing the first rigidizing device. In some examples, the shape replication sequence may further include de-rigidizing the first rigidizing device into a flexible state before advancing the first rigidizing device relative to the second rigidizing device. The shape replication sequence may further include rigidifying the first rigidizing device into a rigid state after the first rigidizing device has been advanced relative to the second rigidizing device.

[0028] A method of controlling a nested pair of rigidified devices may include: distally advancing a second rigidified device of the nested pair of rigidified devices relative to a first rigidified device of the nested pair of rigidified devices while the second rigidified device is in a flexible state and the first rigidified device is in a rigidified state; and automatically performing a shape replication sequence when the second rigidified member is extended to a predetermined travel distance relative to the first rigidified member, wherein the shape replication sequence includes: advancing the first rigidized device relative to the second rigidized device while the first rigidized device is in a flexible state and the second rigidized device is in a rigidified state.

[0029] The predetermined travel distance may be a maximum distance. Propelling the second rigidising device may include propelling and steering.

[0030] As described above, automatically performing the shape replication sequence may include advancing the first rigidizing device relative to the second rigidizing device until the distal region of the first rigidizing device is adjacent to the distal region of the second rigidizing device. The shape replication sequence may also include rigidifying the second rigidizing device to a rigid state before advancing the first rigidizing device. The shape replication sequence may also include de-rigidizing the first rigidizing device to a flexible state before advancing the first rigidizing device relative to the second rigidizing device. The shape replication sequence may also include rigidifying the first rigidizing device to a rigid state after the first rigidizing device has been advanced relative to the second rigidizing device.

[0031] Any of the methods and apparatus described herein may also include controlling the timing of tension release of an actuated steering member of a steerable distal end of a nested rigidized device when transitioning from a rigid state to a flexible state, for example, by actuating the steering member to maintain curvature when the device transitions to a flexible state.

[0032] For example, a method of controlling a nested pair of rigidified devices may include: advancing a first rigidified device of the nested pair of rigidified devices distally relative to a second rigidified device of the nested pair of rigidified devices, wherein the first rigidified device is in a flexible state and the second rigidified device is in a rigid state; transitioning the first rigidified device from the flexible state to the rigid state; and transitioning the second rigidified device from the rigid state to the flexible state while actuating a steering member of the second rigidified device to maintain a curvature of a distal end of the second rigidified device as the second rigidified device transitions to the flexible state.

[0033] Any of these methods may include advancing a flexible second rigidizing device distally, and further actuating a steering member to steer a distal end of the second rigidizing device while the first rigidizing device remains in a rigid state. Actuating the steering member within the second rigidizing device may include pulling one or more tendons. Actuating the steering member may include applying tension to at least one of the steering members. Actuating the steering member may include automatically actuating the steering member.

[0034] In some examples, the first rigidized device is nested within the second rigidized device. Any of these methods may include imaging the external area with a sensor at a distal end face of the second rigidized device, and / or advancing the second rigidized device in a flexible state and steering the second rigidized device while advancing, and then repeating the steps of distally advancing the first rigidized device, transitioning the first rigidized device to a rigid state, and transitioning the second rigidized device to a flexible state.

[0035] Also described herein are methods of advancing or retracting a system including a nested pair of rigidized devices along a body cavity. Any of these methods may include: advancing or retracting a first rigidized device in a flexible state relative to a second rigidized device in a rigid state, and steering the first rigidized device using a steering member coupled to the first rigidized device; rigidifying the first rigidized device; advancing or retracting the second rigidized device in a flexible state at least partially over the rigidized first rigidized device; rigidifying the second rigidized device; actuating the steering member to correspond to the curvature of the rigidized second rigidized device; and transitioning the first rigidized device to a flexible state.

[0036] Actuating the steering member in the first rigidizing device may include maintaining a previously commanded curvature of the first rigidizing device throughout advancement or retraction and rigidizing of the second rigidizing device. In some examples, prior to transitioning the first rigidizing device to the flexible state, actuating the steering member in the first rigidizing device includes adjusting the steering member to correspond to a new curvature of the rigidized second rigidizing device that is different from the curvature prior to rigidifying the first rigidizing device. In some examples, actuating the steering member is performed prior to transitioning the first rigidizing device to the flexible state. Actuating the steering member may be performed while transitioning the first rigidizing device to the flexible state.

[0037] In either of these methods, the system may be configured to automatically maintain an existing curvature command control for the steering member during advancement or retraction and rigidification of the second rigidifying device.

[0038] Advancing or retracting the second rigidizing device may include advancing the second rigidizing device so that a distal end of the second rigidizing device is substantially aligned with a distal end of the first rigidizing device. In some examples, the system may be configured to automatically maintain an existing curvature command control for the steering member during advancement or retraction and rigidification of the second rigidizing device.

[0039] The system may be configured to automatically actuate the steering members when the first rigidizing device transitions to the flexible state. Actuating the steering members may include applying tension to at least one of the steering members. Actuating the steering members may include displacing at least one of the steering members. The system may be configured to automatically actuate the steering members to impart a curvature to the first rigidizing device that is less than a previously commanded curvature applied by the steering members by a predetermined percentage.

[0040] Advancing or retracting the first and second rigidizing devices may include distally advancing. Advancing or retracting the first and second rigidizing devices may include proximally retracting.

[0041] In some examples, actuating the steering member can include actuating the steering member to correspond to the shape of a portion of the first rigidizing device to be exposed when the second rigidizing device is proximally retracted on the first rigidizing device. Actuating the steering member can include maintaining an angle between a distal face of the first rigidizing device and a cross-section of the first rigidizing device at a proximal end of the portion of the first rigidizing device approximately constant. For example, actuating the steering member can include maintaining an orientation of a distal end of the first rigidizing device relative to a proximal end of the portion of the first rigidizing device.

[0042] For example, a method of advancing a system including a nested pair of rigidified devices along a body cavity may include: advancing a first rigidified device in a flexible state through the body cavity and steering a distal region of the first rigidified device using a steering member coupled to the first rigidified device; rigidifying the first rigidized device; advancing a second rigidified device in a flexible state at least partially over the rigidified first rigidized device; rigidifying the second rigidized device; before transitioning the first rigidized device to a flexible state, actuating the steering member to correspond to a new curvature of the rigidified second rigidized device that is different from the curvature prior to rigidifying the first rigidized device; and transitioning the first rigidized device to a flexible state.

[0043] A method for retracting a system including a nested pair of rigidifying devices along a body cavity may include: retracting a first rigidifying device in a flexible state through the body cavity relative to a second rigidifying device in a rigidified state, and steering a distal region of the first rigidifying device using a steering member coupled to the first rigidifying device; rigidifying the first rigidifying device; retracting the second rigidifying device in a flexible state at least partially over the rigidified first rigidifying device; rigidifying the second rigidifying device; actuating the steering member to maintain an orientation of a distal end of the first rigidifying device relative to a proximal portion of the second rigidifying device; and retracting the first rigidizing device into the second rigidizing device while the first rigidizing device is in a flexible state.

[0044] For example, a method of retracting a system including a nested pair of rigidified devices along a body cavity may include: retracting a first rigidified device in a flexible state through the body cavity relative to a second rigidified device in a rigidified state, and steering a distal region of the first rigidified device using a steering member coupled to the first rigidified device; rigidifying the first rigidized device; retracting the second rigidified device in a flexible state at least partially over the rigidified first rigidized device; rigidifying the second rigidized device; actuating the steering member to maintain a constant curvature; and retracting the first rigidized device into the second rigidized device while the first rigidized device is in a flexible state.

[0045] The present invention also describes a system comprising: a first rigidizing device positioned within a second rigidizing device; a controller comprising one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for advancing an internal rigidizing device and an external rigidizing device within a body cavity, the method comprising: advancing or retracting the first rigidizing device in a flexible state relative to a second rigidizing device in a rigid state, and steering the first rigidizing device using a steering member coupled to the first rigidizing device; rigidifying the first rigidizing device; advancing or retracting the second rigidizing device in a flexible state at least partially over the rigidized first rigidizing device; rigidifying the second rigidizing device; actuating the steering member to correspond to the curvature of the rigidized second rigidizing device; and transitioning the first rigidizing device to a flexible state.

[0046] In any of these devices and methods, the internal rigidizing device may be referred to as an inner member, a daughter, a catheter, an endoscope, etc., and the external rigidizing device may be referred to as an outer member, a mother body, an outer sleeve, etc. The external rigidizing device may be referred to as a first rigidizing device, and the internal rigidizing device may be referred to as a second rigidizing device; alternatively, the external rigidizing device may be referred to as a second rigidizing device and the internal rigidizing device may be referred to as a first rigidizing device. Typically, the internal rigidizing device is nested within the external rigidizing device, and the external rigidizing device is nested on the internal rigidizing device, so that the two rigidizing devices can move longitudinally (distal and proximally) relative to each other.

[0047] In any of these examples, the first (inner) rigidifier can be retracted into a non-straight (e.g., bent, curved, etc.) distal region of the second (outer) rigidifier, and the non-straight region can be compensated for by turning the curved region to match such a curve, for example, when the first rigidifier is pulled back into the second rigidifier.

[0048] In any of these apparatuses, actuating the steering member in the first rigidizing device may include maintaining a previously commanded curvature of the first rigidizing device throughout advancement and rigidification of the second rigidizing device. In some examples, actuating the steering member in the first rigidizing device may include adjusting the steering member to correspond the shape of the first rigidizing device to the rigidified shape of the second rigidizing device. Actuating the steering member may be performed prior to transitioning the first rigidizing device to the flexible state. Actuating the steering member may be performed while transitioning the first rigidizing device to the flexible state.

[0049] Any of these systems may be configured to automatically maintain an existing curvature command control on the steering member during advancement and rigidification of the second rigidifying device.

[0050] In some examples, advancing the second rigidizing device may include advancing the second rigidizing device such that a distal end of the second rigidizing device is substantially aligned with a distal end of the first rigidizing device. The system may be configured to automatically maintain an existing curvature command control on the steering member during advancement and rigidification of the second rigidizing device. In some examples, the system is configured to automatically actuate the steering member when the first rigidizing device transitions to a flexible state.

[0051] In any of these examples, actuating the steering members includes applying tension to at least one of the steering members. For example, actuating the steering members can include displacing at least one of the steering members. The system can be configured to automatically actuate the steering members to impart a curvature to the first rigidizing device that is less than a previously commanded curvature applied by the steering members by a predetermined percentage. In some examples, advancing the first rigidizing device and the second rigidizing device includes advancing distally. Advancing the first rigidizing device and the second rigidizing device can include advancing proximally.

[0052] Actuating the steering member may include actuating the steering member to correspond to a shape of a portion of the first rigidizing device to be exposed when the second rigidizing device is proximally retracted over the first rigidizing device. Actuating the steering member may include maintaining an approximately constant angle between a distal face of the first rigidizing device and a cross-section of the first rigidizing device at a proximal end of the portion of the first rigidizing device. In some examples, actuating the steering member includes maintaining a position of a distal end of the first rigidizing device relative to a proximal end of the portion of the first rigidizing device.

[0053] Also described herein is a method of screening a body cavity of a patient, the method comprising: navigating a system including a first rigidized device positioned within a second rigidized device through the body cavity, the first rigidized device including a camera at a distal end; exposing a distal portion of the first rigidized device; turning the distal portion of the first rigidized device to perform a circular pass (e.g., using a distal end to perform a circular motion) to visualize a circumference of a first portion of the body cavity through the camera; retracting the system to a selected length so that the distal portion of the first rigidized device is exposed; and turning the distal portion of the first rigidized device to perform a circular motion (e.g., using a distal end to perform a circular motion) to visualize a circumference of a second portion of the body cavity through the camera, wherein at least a portion of the second portion is positioned proximal to the first portion. As used herein, a circular scanning movement can be a circular movement and is not limited to a circular path, but can be elliptical or irregular, although the path can radially circumscribe a surrounding cavity. The circular scanning movement can start and stop at approximately the same position; in some examples, the circular scanning movement extends beyond the radial starting position.

[0054] In any of these examples, the system can be retracted (or configured to be retracted) as described above, including retracting a selected length such that a distal portion of the first rigidification device is exposed.

[0055] Typically, the devices described herein may include a controller. The controller may include a control circuit (e.g., one or more processors (microprocessors), memory, timer, registers, etc.) and control logic, which may be software, hardware, and / or firmware. These controllers may be equivalently referred to as "control circuits" herein. The controller may be implemented in software, firmware, hardware, or some suitable combination of at least two of the three.

[0056] In some examples, the system can be configured to automatically perform the method. For example, the system can include a controller and the controller includes one or more processors; and the system can include a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method to advance an internal rigidification device and an external rigidification device within a body cavity, and wherein the method is implemented by the system. The selected length can be calculated based on a desired distance from a portion of the cavity that has been visualized by the camera. In some examples, the first portion and the second portion can overlap.

[0057] Any of these methods may include compiling data received by a camera to generate a model of at least a portion of the cavity.The method may include machine sensing to provide positioning information related to the center of the cavity.

[0058] For example, the system described herein includes: a first rigidizer positioned within a second rigidizer; a controller comprising one or more processors; and a memory connected to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for photographing a body cavity, the method comprising: exposing a distal portion of the first rigidizer; turning the first rigidizer distal portion to perform a circular scanning movement to visualize the circumference of the first portion of the body cavity through a camera; retracting the system to a selected length so that the distal portion of the first rigidizer is exposed; and turning the distal portion of the first rigidizer to perform a circular scanning movement (e.g., using the end to perform a rotational motion) to visualize the circumference of a second portion of the body cavity through a camera, at least a portion of the second portion being positioned proximal to the first portion.

[0059] The selected length may be calculated based on a desired distance from a portion of the cavity that has been visualized by the camera.The first portion and the second portion may overlap.

[0060] The system may also include compiling data received by the camera to generate a model of at least a portion of the cavity.Any of these systems may include machine sensing to provide positioning information about the center of the cavity.

[0061] Any combination of all methods and apparatus described herein are contemplated herein and may be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The novel features of the invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments in which the principles of the invention are utilized, wherein:

[0064] Figure 1 A rigidification device is shown.

[0065] FIG. 2A to FIG. 2B Exemplary rigidifying shapes of the rigidifying device are shown.

[0066] FIG. 3A to FIG. 3B An example of a portion of a vacuum rigidification apparatus as described herein is shown. Figure 3A A cross section through an exemplary vacuum rigidifying member of the apparatus is shown. Figure 3B An enlarged view of a portion of a cross section is shown, illustrating the arrangement of the layers in an unrigidified configuration.

[0067] FIG. 3C to FIG. 3F An example of a portion of a vacuum rigidification apparatus having multiple rigidification layers as described herein is shown. Figure 3CA perspective view of a vacuum rigidified member is shown with the outer layers removed (showing the outermost braid layer). Figure 3D yes Figure 3C An enlarged view of a portion of. Figure 3E Shown through Figure 3C Longitudinal section of a vacuum rigidified member. Figure 3F It passes through Figure 3C The cross section of the rigidified member.

[0068] FIG. 4A to FIG. 4B An exemplary pressure rigidification device is shown.

[0069] Figure 5 A rigidified device having a distal region is shown.

[0070] Figure 6 A rigidified device having a distal section with a plurality of actively controlled linkages is shown.

[0071] Figure 7 A nested rigidified system is shown.

[0072] Figure 8 A nested rigidification system is shown having a cover between an inner rigidification device and an outer rigidification device.

[0073] FIG. 9A to FIG. 9B A nested rigidification system is shown, where the outer rigidification device includes the steering device and the imaging device.

[0074] FIG. 10A to FIG. 10H An exemplary use of a nested rigidification system is shown.

[0075] FIG. 11A to FIG. 11E An example of using an actuated steering member of a rigidifying device to facilitate transition of the rigidifying device from a rigidified state to a flexible state is schematically illustrated.

[0076] FIG. 12A to FIG. 12E An example of using an actuated steering member of a rigidifying device to facilitate transition of the rigidifying device from a rigidified state to a flexible state is schematically illustrated.

[0077] FIG. 13A to FIG. 13E An example of using an actuated steering member of a rigidifying device to facilitate transition of the rigidifying device from a rigidified state to a flexible state is schematically illustrated.

[0078] FIG. 14A to FIG. 14F An exemplary method for performing a imaging procedure in a body cavity using a nested rigidization system is shown.

[0079] FIG. 15A to FIG. 15CAn example of a method for replicating shape between a nested pair of rigidified devices is shown.

[0080] FIG. 16A to FIG. 16D A method of controlling a nested pair of rigidifying devices to distally advance the nest by executing multiple shape replication sequences is shown.

[0081] 17A to 17D A method of controlling a nested pair of rigidifying devices to proximally retract the nested pair is presented, the method comprising controlling an inner rigidifying device to assume a memory shape to facilitate withdrawal of the inner rigidifying device.

[0082] 18A to 18F A method of controlling a nested pair of rigidifying devices is presented, the method comprising controlling tension on one or more steering actuators when transitioning between a rigid state and a non-rigid state.

[0083] FIG. 19A to FIG. 19B A method of automatically replicating shapes between a nested pair of rigidifiers when one of the rigidifiers of the nested pair is advanced is shown.

[0084] FIG. 20A to FIG. 20C A method of coordinating the roll of one rigidizer of a nested pair of rigidizers is shown.

[0085] FIG. 21A to FIG. 21B An example of a method of controlling operation of a nested pair of rigidification devices is shown, the method including automatically controlling movement of the nested pair.

[0086] FIG. 22A to FIG. 22B An example of a method of controlling the operation of a nested pair of rigidifying devices that may result in contradictory movement is shown.

[0087] FIG. 23A to FIG. 23B An example of a method of controlling the operation of a nested pair of rigidification devices including automatic detection and correction of contradictory movements is shown.

[0088] Detailed Description

[0089] In general, nested rigidized devices (e.g., apparatus, systems, etc.) and methods of using the same are described herein, which can be configured to navigate and / or facilitate delivery of a scope (e.g., an endoscope) or other medical instrument through a tortuous or looped portion of the body (e.g., a portion of the gastrointestinal tract, including but not limited to the colon). Specifically, methods and devices are described herein for navigating through a tortuosity (including both advancement and retraction) of a body region (such as the colon) using a nested pair of rigidized devices.

[0090] The rigidizing devices described herein can be long, thin, and hollow (or solid), and can quickly transition from a flexible configuration (i.e., a relaxed, soft, or floppy configuration) to a rigid configuration (i.e., a configuration that is hard and / or maintains its shape when rigidified). The rigidizing device can include multiple layers (e.g., a coiled or reinforcing layer, a sliding layer, a rigidizing layer, a bladder layer, and / or a sealing sheath), which together can form the wall of the rigidizing device, which can be referred to as a "layered rigidizing device". Unless the context clearly indicates otherwise, the methods and devices described herein can refer to any suitable rigidizing device, including layered rigidizing devices. For example, the rigidizing devices (components, devices, etc.) described herein can be rigidified by plugging particles, by phase change, by interlocking components (e.g., cables with discs or cones, etc.), or any other rigidizing mechanism. For example, the rigidizing device can be transformed from a flexible configuration to a rigid configuration by applying a vacuum or pressure to or within the walls of the rigidizing device. With the vacuum or pressure removed, the layers can easily shear or move relative to each other. With the vacuum or pressure applied, the layers can transform to a state in which they exhibit significantly enhanced resistance to shear, movement, bending, torque, and buckling, thereby providing system rigidification. Any of the devices described herein can be configured for use in one or more of the following: the neurovascular system (e.g., aortic arch, subclavian artery, carotid artery, spine, basilar artery, hindbrain, circle of Willis, Willis), midbrain, forebrain, etc.), upper GI tract (oroesophagus, stomach, pylorus, bile duct and pancreatic duct, etc.), small intestine (e.g., small intestine, duodenum, jejunum, ilium, etc.), lower GI tract (rectum, colon region, such as sigmoid colon, descending colon, transverse colon, ascending colon, cecocolon, ileocecal valve colon, etc.), urinary tract (urethra, bladder, kidney, ureter, etc.), peripheral vasculature (e.g., femur, ilium, mesentery, lumbar spine, kidney, celiac trunk, liver, thoracic cavity, etc.), cardiac region (e.g., aorta, right coronary artery, left coronary artery, etc.), left heart (e.g., aorta, aortic valve, left ventricle, etc.), right heart (e.g., vena cava, right atrium, left atrium, mitral valve, coronary sinus, tricuspid valve, right ventricle, pulmonary valve, pulmonary vasculature, etc.), and / or right lung region (e.g., oral cavity, larynx, trachea, bronchial tree and lung lobe, etc.).

[0091] Any of the rigidizable devices described herein may include a rigidizing layer or region engaged with a compression layer (which may be or may include a capsule) that applies a force to the rigidizing layer to rigidify the rigidizing layer or, in some cases, to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizable devices may include a rigidizing layer that may include a braid, knit, woven, cut, randomly distributed or randomly oriented wires or strands, adapters, links, scales, plates, segments, particles, granules, crossed wires, or other materials that form a rigidizing layer. For example, the rigidizing layer may include multiple strand lengths or strand segments that cross each other (e.g., as part of a braid, knit, braid, etc.); the compression layer may apply a force to drive the crossed strand lengths or strand segments against each other. Although many of the examples shown herein are braids, any of these devices may alternatively or additionally include a general rigidizing layer that includes crossed strand lengths or strand segments.

[0092] Examples of rigidification devices described herein can use pressure (positive pressure) and / or negative pressure to selectively and controllably rigidify. In some examples, the methods described herein can be used with any suitable rigidification device.

[0093] The rigidification (e.g., selective rigidification) devices described herein can provide rigidification for various medical applications, including catheters, sheaths, viewing instruments (e.g., endoscopes), wires, outer cannulas, trocars, or laparoscopic instruments. The rigidification device can be used as a separate add-on device, or can be integrated into the body of a catheter, sheath, viewing instrument, wire, or laparoscopic instrument. The devices described herein can also provide rigidification for non-medical structures.

[0094] Figure 1An exemplary rigidizing device is shown in FIG. The system shown includes a rigidizing device 300 having a wall with multiple layers, including a rigidizing layer, an outer layer (in this example, a portion of the outer layer is cut away to show the rigidizing layer below the outer layer, which is configured as a braided layer in this example) and an inner layer. The system also includes a handle 342 having a vacuum or pressure inlet 344 to supply vacuum or pressure to the rigidizing device 300. An actuating element 346 can be used to turn the vacuum or pressure on and off, thereby transitioning the rigidizing device 300 between a flexible configuration and a rigid configuration. The distal end 339 of the rigidizing device 300 can be smooth, flexible and atraumatic to facilitate distal movement of the rigidizing device 300 through the body. In addition, the end 339 can be tapered from the distal end to the proximal end to further facilitate distal movement of the rigidizing device 300 through the body. In this example, the rigidizing device is configured as an outer sleeve, but other configurations can be used.

[0095] exist Figure 2A and Figure 2B An exemplary rigidizing device in a rigidized configuration is shown in FIG. When the rigidizing device is rigidified, the rigidizing device locks into the shape it was in before vacuum or pressure was applied, i.e., the rigidizing device does not straighten, bend, or otherwise substantially change its shape (e.g., the rigidizing device may be rigidified in a manner such as Figure 2A The ring configuration shown or Figure 2B The serpentine shape shown stiffens). The air reinforcement effect on the inner or outer layer (e.g., made of coil-wound tube) can account for a small percentage (e.g., 5%) of the maximum load capacity of the rigidizing device when bent, thereby allowing the rigidizing device to resist straightening. When the vacuum or pressure is released, the strands within the rigidizing layer of the device can unlock relative to each other and move again to allow the rigidizing device to bend. Similarly, when the rigidizing device becomes more flexible by releasing the vacuum or pressure, the rigidizing device becomes more flexible in the shape it had before the vacuum or pressure was released, that is, the rigidizing device does not straighten, bend, or otherwise substantially change its shape. Thus, the rigidizing device described herein can be transformed from a flexible, less stiff configuration to a more rigid rigid configuration by restricting movement between overlapping strands of a rigidizing layer (e.g., a braided layer) (by applying a vacuum or pressure).

[0096] The rigidized devices described herein can be quickly converted between rigid and flexible configurations, and in some examples have an unlimited number of transition cycles. In some examples, the degree of rigidization (e.g., stiffness) of the device can also be adjusted, for example, by adjusting positive pressure (in examples rigidified due to positive pressure) or vacuum (in examples rigidified due to vacuum). As interventional medical devices become longer and inserted deeper into the human body, and as interventional medical devices are expected to perform more rigorous treatment surgeries, the demand for precision and control increases. As described herein, the selective rigidization device (including the selective rigidization outer sleeve) can advantageously provide both the benefits of flexibility (when needed) and the benefits of rigidity (when needed). In addition, the rigidified devices described herein can be used, for example, in classical endoscopes, colonoscopes, robotic systems and / or navigation systems, such as those described in U.S. patent application Ser. No. 17 / 644,758, filed on December 16, 2021, entitled “DEVICE FOR ENDOSCOPICADVANCEMENT THROUGH THE SMALL INTESTINE,” the entire contents of which are incorporated herein by reference.

[0097] The rigidizing devices described herein may additionally or alternatively include any of the features described with reference to the following patent applications: U.S. patent application Ser. No. 17 / 644,758, filed Dec. 16, 2021, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” U.S. patent application Ser. No. 16 / 631,473, filed Jul. 19, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE,” U.S. patent application Ser. No. 17 / 604,203, filed Jan. 16, 2020, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. patent application Ser. No. 17 / 619,994, filed Sept. 2, 2022, entitled “NESTED RIGIDIZING OVERTUBE,” No. 17 / 902,770, entitled “Nested Rigidized Devices,” U.S. patent application No. 17 / 995,294, filed on March 29, 2021, entitled “LAYERED WALLS FOR RIGIDIZING DEVICES,” and U.S. patent application No. 18 / 044,027, filed on September 3, 2021, entitled “DYNAMICALLY RIGIDIZING GUIDERAIL AND METHODS OF USE,” the entire contents of which are incorporated herein by reference.

[0098] The rigidized devices described herein can be provided in a variety of configurations, including different lengths and diameters. In some examples, the rigidized devices can include a working channel (e.g., for allowing typical endoscopic tools to pass within the body of the rigidized device), a balloon, a nesting element, and / or a side loading feature.

[0099] For example, a rigidizing device 100 (also referred to as a device, such as a system and / or apparatus, including a rigidizable member) can be configured to be rigidified due to the application of a vacuum (e.g., negative pressure). These devices can generally be formed of multiple layers that are configured to form a laminate structure when negative pressure is applied, such that one or more rigidizing layers can be reversibly fused to a flexible outer layer that is driven against a more rigid inner layer. FIG. 3A to FIG. 3B An example of a cross section through a rigidizing member of an apparatus (eg, device, system) that is rigidified due to the application of a vacuum is shown. Figure 3B Shows Figure 3A1 is an enlarged view of the arrangement of the layers of the rigid member in a non-rigidified configuration. In this example, the rigidizable member includes an innermost layer 115, which is configured to provide an inner surface against which the remaining layers can be consolidated (e.g., when a vacuum is applied). The innermost layer 115 may include a reinforcing element or coil. The rigidized member may also include a sliding layer 113 above the innermost layer (e.g., radially outward). The sliding layer can be, for example, a lubricant, a coating, and / or a powder (e.g., talcum powder) on the outer surface of the inner layer 115 and / or within the gap layer 111. A radial gap layer 111 can separate a sliding layer 113 from a rigidizing layer (shown as a braided or woven layer in this example) 109 (referred to herein as a "rigidizing layer" for convenience), thereby providing a space between the rigidizing layer and the sliding layer for the rigidizing layer to move within the space (e.g., when no vacuum is applied); when a vacuum is applied, the space or gap can be removed, thereby allowing the rigidizing layer (e.g., a braided or woven layer in some examples) to move radially inward when a vacuum is applied. A second gap layer 107 can exist between the rigidizing layers 109 and can be similar to layer 111. As will be described with reference to FIG. 3C to FIG. 3F As described, multiple rigidizing layers (e.g., 2, 3, 4 or more rigidizing layers) may be included, and these rigidizing layers may be separated by additional gap layers and / or sliding layers. The outermost layer 101 may be separated from the rigidizing layer by the gap layer, and may be configured to move radially inward when a vacuum is applied to pull down against the rigidizing layer and adhere to the surface of the rigidizing layer. The outermost layer 101 may be soft and trauma-resistant, and may be sealed at both ends to generate a vacuum-tight chamber with the innermost layer 115. The outermost layer 101 may be elastomeric, for example, made of urethane. The hardness of the outermost layer 101 may be, for example, 30A to 80A. In addition, the outermost layer 101 may have a thickness of 0.0001 inch to 0.01 inch, for example, a thickness of approximately 0.001 inch, 0.002 inch, 0.003 inch, or 0.004 inch. Alternatively, the outermost layer may be a plastic including, for example, LDPE, nylon or PEEK.

[0100] FIG. 3C to FIG. 3F An example of a tubular rigidizing member of the device 100 comprising a plurality of rigidizing layers is shown. FIG. 3A to FIG. 3B In the present invention, the device includes a tube having a wall formed by multiple layers positioned around a lumen 120 (e.g., for placing an instrument or endoscope through lumen 120). A vacuum can be supplied between the layers to rigidify the rigidizing device 100. Any tubular device described herein may alternatively include a solid core forming an inner layer 115.

[0101] The innermost layer 115 can be configured to provide an inner surface against which the remaining layers can consolidate, for example, when a vacuum is applied within the wall of the rigidization device 100. The structure can be configured to minimize bending forces and / or maximize flexibility under non-vacuum conditions. In some examples, the innermost layer 115 can include reinforcing elements 150z or coils within a matrix, as described above. Figure 3E In the example shown, layer 113 above innermost layer 115 (i.e., radially outward from innermost layer 115) may be a sliding layer. Layer 111 may be a radial gap (i.e., space). Gap layer 111 may provide a space within which a rigidized layer above gap layer 111 may move (when no vacuum is applied), and a space within which a rigidized layer may move radially inward (when a vacuum is applied).

[0102] Layer 109 can be a first rigidizing layer, which in this example includes braided strands 133 similar to those described elsewhere herein. The rigidizing layer can be, for example, 0.001 inches to 0.040 inches thick. For example, the rigidizing layer can be 0.001 inches, 0.003 inches, 0.005 inches, 0.010 inches, 0.015 inches, 0.020 inches, 0.025 inches, or 0.030 inches thick. In some examples, such as Figure 3D As shown, the rigidizing layer can include a braid having tensile fibers or hoop fibers 137. The hoop fibers 137 can be spiral and / or woven into the rigidizing layer. In addition, the hoop fibers 137 can be positioned at 2-50 hoops per inch (e.g., 20-40 hoops). The hoop fibers 137 can advantageously provide high compressive stiffness in the radial direction (to resist buckling or bending), but can remain compliant in the direction of the longitudinal axis 135 of the rigidizing device 100. That is, if compression is applied to the rigidizing device 100, the rigidizing layer 109 will attempt to expand in diameter as it is compressed. The hoop fibers 137 can resist this diametrical expansion, thereby resisting compression. Therefore, the hoop fibers 137 can provide a system that is flexible in bending but still resists both tension and compression.

[0103] Layer 107 may be another radial gap layer similar to layer 111 .

[0104] In some examples, the rigidization devices described herein may have more than one rigidization layer. For example, the rigidization device may include two, three, or four rigidization layers. Figure 3E, layer 105 can be a second rigidized layer 105. The second rigidized layer 105 can have any of the properties described with respect to the first rigidized layer 109. In some examples, the second rigidized layer 105 can be the same as the first rigidized layer 109. In other examples, the second rigidized layer 105 can be different from the first rigidized layer 109. For example, in some examples, the rigidized layer is a braided layer; Figure 3E , the braid of the second braided layer 105 may include fewer strands and have a larger braid angle α than the braid of the first braided layer 109. Having fewer strands can help increase the flexibility of the rigidizing device 100 (relative to a second braid having the same number of strands or a greater number of strands), and the larger braid angle α can help narrow the diameter of the first braided layer 109 (e.g., in the event that the first braided layer is compressed) and increase / maintain the flexibility of the rigidizing device 100. As another example, the braid of the second braided layer 105 can include more strands and have a larger braid angle α than the braid of the first braided layer 109. Having more strands can result in a relatively tough and smooth layer, while having a larger braid angle α can help narrow the diameter of the first braided layer 109.

[0105] Layer 103 may be another radial gap layer similar to layer 111. Gap layer 103 may have a thickness of 0.0002 inches to 0.04 inches, for example, a thickness of about 0.03 inches. A thickness within this range may ensure that the strands 133 of the rigidization layer may easily slide and / or bulge relative to each other to ensure flexibility during bending of the rigidization device 100.

[0106] The outermost layer 101 can be configured to move radially inward when a vacuum is applied to pull downward against the rigidizing layers 105, 109 and conform to the surfaces of the rigidizing layers 105, 109. The outermost layer 101 can be soft and atraumatic and can be sealed at both ends to create a vacuum-tight chamber with the layer 115. The outermost layer 101 can be elastomeric, such as made of urethane. The hardness of the outermost layer 101 can be, for example, 30A to 80A. In addition, the outermost layer 101 can have a thickness of 0.0001 inches to 0.01 inches, such as a thickness of approximately 0.001 inches, 0.002 inches, 0.003 inches, or 0.004 inches. Alternatively, the outermost layer can be a plastic, including, for example, LDPE, nylon, or PEEK.

[0107] In some examples, the outermost layer 101 can, for example, have tensile fibers or hoop fibers 137 extending therethrough. The hoop fibers 137 can be made of, for example, aramid (e.g., Technora, nylon, Kevlar), Vectran, Dyneema, carbon fiber, fiberglass, or plastic. In addition, the hoop fibers 137 can be positioned at 2-50 hoops per inch (e.g., 20-40 hoops). In some examples, the hoop fibers 137 can be laminated in an elastomeric sheath. Compared to one direction, the hoop fibers can advantageously provide higher stiffness in another direction (e.g., can be very hard in the hoop direction, but very compliant in the direction of the longitudinal axis of the rigidizing device). In addition, the hoop fibers can advantageously provide low hoop stiffness until the fibers are placed under a tensile load, at which time the hoop fibers can suddenly exhibit high hoop stiffness.

[0108] In some examples, the outermost layer 101 may include a lubricant, coating, and / or powder (e.g., talcum powder) on its outer surface to improve the sliding of the rigidized device through the anatomical structure. The coating may be hydrophilic (e.g., Coating or The coating may be applied, for example, by dipping, painting, or spraying the coating thereon.

[0109] The innermost layer 115 may similarly include a lubricant, coating (e.g., a hydrophilic or hydrophobic coating), and / or powder (e.g., talc) on its inner surface that is configured to allow adjacent layers to shear more easily relative to each other, particularly when no vacuum is applied to the rigidized device 100, to maximize flexibility.

[0110] In some examples, the outermost layer 101 can be loosely positioned above the radially inward layer. For example, the inner diameter of layer 101 (assuming it constitutes a tube) can have a diameter gap of 0 inches to 0.200 inches with the next layer radially inward (e.g., with the rigidization layer). This can make the vacuum rigidization system more flexible when not under vacuum while still maintaining a high rigidization factor. In other examples, the outermost layer 101 can be stretched somewhat over the next layer radially inward (e.g., the rigidization layer). For example, the zero strain diameter of the tube constituting layer 101 can be 0 inches to 0.200 inches smaller than the diameter of the next layer radially inward, and then stretched over the next layer. When not under vacuum, the system has less flexibility than a system with a looser outer layer 101. However, the system may also have a smoother appearance and be less likely to tear during use.

[0111] In some examples, the outermost layer 101 can be loosely positioned above the radially inward layers. A small positive pressure can be applied below the layer 101 to gently expand the layer 101 and allow the rigidized device to bend more freely in the flexible configuration. In this example, the outermost layer 101 can be elastomeric and a compressive force can be maintained on the rigidizing layer to impart stiffness. Once positive pressure is supplied (which is sufficient to nominally cause the sheath to unfold from the rigidizing layer, such as 2psi), the outermost layer 101 is no longer a contributor to stiffness, which can enhance baseline flexibility. Once rigidification is required, the positive pressure can be replaced by negative pressure (vacuum) to impart stiffness.

[0112] The vacuum that can be achieved within the rigidizing device 100 can range from a minimum to a full atmospheric vacuum (e.g., approximately 14.7 psi). In some examples, there can be a bleed valve, regulator, or pump controller that allows the vacuum to bleed downward to any intermediate level to provide variable stiffness capabilities. The vacuum pressure can be advantageously used to rigidify the rigidizing device structure by pressing layers of a rigidizing layer (e.g., a braided sleeve) against adjacent layers. The rigidizing layer (e.g., a braided, knitted, or woven material) can be naturally flexible when bent (i.e., when bent orthogonal to its longitudinal axis), and the grid structure formed by the interlaced strands deforms as the sleeve bends so that the rigidizing layer conforms to the bent shape when the rigidizing layer is placed on the inner layer. In some examples, this results in a grid geometry in which the corner angle of each grid element changes as the braided sleeve bends. When compressed between conformal materials (e.g., the layers described herein), the mesh elements are locked in their current angles and have an increased ability to resist deformation when a vacuum is applied, thereby rigidifying the entire structure in bending when a vacuum is applied. Additionally, in some examples, hoop fibers passing through or over the braid can carry tensile loads, which helps prevent local buckling of the braid under applied high bending loads.

[0113] When transitioning from a flexible configuration to a rigid configuration, the stiffness of the rigidizing device 100 can increase from 2 times to more than 30 times, such as 10 times, 15 times, or 20 times. In one specific example, the stiffness of a rigidizing device similar to the rigidizing device 100 was tested. The test rigidizing device had a wall thickness of 1.0 mm and an outer diameter of 17 mm, and a force was applied at the end of a 9.5 cm long cantilevered portion of the rigidizing device until the rigidizing device deflected 10 degrees. The pressure required to do this when in the flexible mode was only 30 grams, while the pressure required to do this when in the rigid (vacuum) mode was 350 grams.

[0114] In some examples of vacuum rigidizer 100, there may be only one rigidizer layer. In other examples of vacuum rigidizer 100, there may be two, three, or more rigidizer layers. In some examples, one or more of the radial gap layer or the sliding layer of rigidizer 100 may be removed. In some examples, some or all of the sliding layers of rigidizer 100 may be removed.

[0115] The rigidization layer described herein can serve as a variable stiffness layer. The variable stiffness layer can include one or more variable stiffness elements or structures, and when activated (for example, when applying a vacuum), bending stiffness and / or shear resistance increase, resulting in higher rigidity. In addition to or in place of the rigidization layer, other variable stiffness elements can also be used. In some examples, the joint can be used as a variable stiffness element, as described in International Patent Application No. PCT / US2018 / 042946 entitled "DYNAMICALLYRIGIDIZING OVERTUBE (dynamic rigidification outer tube)" filed on July 19, 2018, the entire contents of which are incorporated herein by reference. Alternatively or additionally, the variable stiffness element can include particles or fine particles, a plugging layer, a scale, a rigidized axial member, a rigidized member, a longitudinal member, or a substantially longitudinal member.

[0116] The rigidizable devices described herein can also be rigidified by applying positive pressure instead of vacuum. FIG. 4A to FIG. 4B , the rigidization device (e.g., apparatus or system) 2100 can be similar to the rigidization device 100 described above, except that the rigidization device (e.g., apparatus or system) 2100 can be configured to maintain a pressure (e.g., greater than 1 atmosphere) therein for rigidification rather than a vacuum. The pressure-activated rigidification device 2100 can also include a plurality of layers positioned around a cavity 2120 (e.g., for placing an instrument or endoscope through the cavity 2120).

[0117] For example, FIG. 4A to FIG. 4B Longitudinal and radial cross-sections through an example of a pressure-activated rigidifiable member of a rigidifying device are shown. Figure 4A and Figure 4B The rigidification device 2100 shown in the figure may include an innermost layer 2115 (similar to innermost layer 115), a sliding layer 2113 (similar to sliding layer 113), a pressure gap 2112, a sac layer 2121, a gap layer 2111 (similar to gap layer 111), a rigidification layer 2109 (similar to rigidification layer 109, for example, a braided layer) or other variable stiffness layers as described herein, a gap layer 2107 (similar to layer 107) and an outermost containing layer 2101.

[0118] The pressure gap 2112 can be a sealed chamber that provides a gap for applying pressure to the layers of the rigidized device 2100. Pressure can be supplied to the pressure gap 2112 using a fluid or gas expansion / pressure medium. The expansion / pressure medium can be water or saline, or, for example, a lubricating fluid such as oil or glycerin. In the flexible configuration, the lubricating fluid can, for example, help the layers of the rigidized device 2100 flow over each other. The expansion / pressure medium can be supplied to the gap 2112 during rigidization of the rigidized device 2100, and can be partially or completely discharged from the gap 2112 to transform the rigidized device 2100 back to a flexible configuration. In some examples, the pressure gap 2112 of the rigidized device 2100 can be connected to a pre-filled pressure source, such as a pre-filled syringe or a pre-filled insufflator, thereby reducing the setup time required by the physician.

[0119] The bladder layer 2121 can be made of, for example, a low-hardness elastomer (e.g., Shore 20A to 70A) or a thin plastic sheet. The bladder layer 2121 can be formed by a thin plastic or rubber sheet that has been sealed lengthwise to form a tube. The lengthwise seal can be, for example, a butt or lap joint. For example, the lap joint can be formed lengthwise with a rubber sheet by melting rubber at the lap joint or by using an adhesive. In some examples, the bladder layer 2121 can be 0.0002 inches to 0.020 inches thick, for example, about 0.005 inches thick. The bladder layer 2121 can be soft, high-friction, resilient and / or can be easily wrinkled. In some examples, the bladder layer 2121 is a polyolefin or PET. The bladder 2121 can be formed, for example, by using a method for forming a heat shrink tube, such as extrusion of a base material, and then forming it by thinning the wall with heat, pressure and / or radiation. When pressure is supplied across the pressure gap 2112, the bladder layer 2121 can expand through the gap layer 2111 to push the rigidization layer 2109 against the outermost containment layer 2101, thereby reducing relative movement of the rigidization layer strands.

[0120] The outermost containment layer 2101 can be a tube, such as an extruded tube. Alternatively, the outermost containment layer 2101 can be a tube in which a reinforcing member (e.g., a metal wire, including a circular or rectangular cross-section) is encapsulated in an elastomeric matrix, similar to the innermost layer described with respect to other examples described herein. In some examples, the outermost containment layer 2101 can include a helical spring (e.g., made of a circular or flat wire), and / or a tubular rigidification layer (e.g., made of a circular or flat metal wire) and a thin elastomeric sheet that is not bonded to other elements in the layer. The outermost containment layer 2101 can be a tubular structure with a continuous and smooth surface. This can facilitate the external member to slide very closely against the tubular structure and have a local high contact load (e.g., a nested configuration as further described herein). In addition, the outer layer 2101 can be configured to support a compressive load, such as pinching. Furthermore, outer layer 2101 (eg, having reinforcing elements therein) can be configured to prevent rigidification device 2100 from changing diameter even when pressure is applied.

[0121] Because both the outer layer 2101 and the inner layer 2115 include reinforcing elements therein, the rigidification layer 2109 can reasonably inhibit diameter contraction (under tensile loads) and diameter growth (under compressive loads).

[0122] By using pressure rather than vacuum to transition from a flexible state to a rigid state, the rigidity of the rigidized device 2100 can be increased. For example, in some examples, the pressure supplied to the pressure gap 2112 can be between 1 atmosphere and 40 atmospheres, such as between 2 atmospheres and 40 atmospheres, such as between 4 atmospheres and 20 atmospheres, such as between 5 atmospheres and 10 atmospheres. In some examples, the supplied pressure is about 2 atmospheres, about 4 atmospheres, about 5 atmospheres, about 10 atmospheres, about 20 atmospheres. In some examples, the relative bending stiffness of the rigidized device 2100 from the flexible configuration to the rigid configuration (as measured in a simple cantilever configuration) can exhibit a change of 2-100 times, such as 10-80 times, such as 20-50 times. For example, the relative bending stiffness of the rigidified device 2100 from a flexible configuration to a rigid configuration may have a change of approximately 10, 15, 20, 25, 30, 40, 50, or more than 100 times.

[0123] Any of the rigidifying devices described herein may have a distal region or multiple distal regions that have a different design than the elongated body of the rigidifying device. Figure 5As shown, for example, the rigidization device 5500 can have an elongated body 5503z and a distal section 5502z. Only the distal section 5502z, only the elongated body 5503z, or both the distal section 5502z and the elongated body 5503z can be rigidified as described herein (e.g., by vacuum and / or pressure). In some examples, one section 5502z, 5503z is activated by pressure, while the other section 5502z, 5503z is activated by vacuum. In other examples, both sections 5502z, 5503z are activated by pressure or vacuum, respectively.

[0124] Any of the rigidifying devices (e.g., the internal rigidifying device and / or the external rigidifying device) can be configured to steer (e.g., controllably bend or bend), particularly at the distal region of these rigidifying devices. Any of these devices can include one or more actuating steering members configured to actually steer the device, for example, from the proximal end of the device. The actuating steering member can be any suitable steering member, including mechanical steering (e.g., one or more tendons, cables, wires, etc., actuators, etc.), pneumatic steering, magnetic steering, thermal steering (e.g., using shape memory alloys or shape memory polymers, etc.). Although the examples described herein primarily include actuating steering members comprising one or more cables, any suitable actuating steering member can be used in any of these devices and methods.

[0125] refer to Figure 6, in other examples, the distal section 7602z can include a plurality of links 7604z that are actively controlled, for example, via an actuated steering member (e.g., cable 7624) for steering the rigidized device 7600. The device 7600 is similar to the device 5800, except that the device 7600 includes a cable 7624 that is configured to control movement of the device. Although the cables 7624 are not shown in FIG. 26 as extending through the rigidized elongated body 7603z (i.e., having the outer wall 7601, the rigidized layer 7609, and the inner layer 7615), the cables 7624 can extend through the rigidized elongated body 7603z in any manner as described elsewhere herein. In some examples, one or more layers of the rigidized elongated body 7603z can continue into the distal section 7602z. For example, and as shown in FIG. 26 , the inner layer 7615 can extend into the distal section 7602z, for example, can be located radially inward of the link 7604z. Similarly, any additional layer from the rigidified proximal section (e.g., the rigidified layer 7609 or the outer layer 7601 can extend into the distal section 7602z and / or be located radially inward of the link 7604z). In other examples, none of the layers of the rigidified elongated body 7603z extend into the distal section 7602z. The link 7604z (and any link described herein) can include a covering 7627z located thereon. The covering 7627z can advantageously make the distal section 7602z trauma-proof and / or smooth. The covering 7627z can be a membrane, such as an expanded PTFE. The expanded PTFE can advantageously provide a smooth, low-friction surface with low bending resistance but high buckling resistance.

[0126] In some examples, the rigidifying devices described herein can be used in combination with one or more other rigidifying devices described herein. For example, an endoscope can include a rigidifying mechanism described herein, and a rigidifying device can include a rigidifying mechanism described herein. When used together, they can create a nested system that can be advanced one after the other, allowing one of the elements to always remain rigid, thereby reducing or eliminating looping (i.e., they can create a nested system that is advanced sequentially).

[0127] Figure 7An exemplary nested system 2300z is shown in FIG. The system 2300z can include an external rigidizing device 2300 and an internal rigidizing device 2310 (here, configured as a rigidized scope), which can be axially moved concentrically or non-concentrically relative to each other. The external rigidizing device 2300 and the internal rigidizing device 2310 can include any rigidifying features described herein. For example, the external rigidizing device 2300 can include an outermost layer 2301a, a rigidizing layer 2309a, and an inner layer 2315a, wherein the inner layer 2315a includes a coil wound through the inner layer 2315a. The external rigidizing device 2300 can, for example, be configured to receive a vacuum between the outermost layer 2301a and the inner layer 2315a to provide rigidification. Similarly, the internal viewing instrument 2310 can include an outer layer 2301b (e.g., having a coil wound therethrough), a rigidizing layer 2309b, a bladder layer 2321b, and an inner layer 2315b (e.g., having a coil wound therethrough). The internal viewing instrument 2310 can be configured, for example, to receive pressure between the bladder 2321b and the inner layer 2315b to provide rigidification. In addition, an air / water channel 2336z and a working channel 2355 can extend through the internal rigidizing device 2310. Additionally, the internal rigidizing viewing instrument 2310 can include a distal section 2302z having a camera 2334z, an illuminator 2335z, and a steerable link 2304z. A covering 2327z can extend over the distal section 2302z. In another example, the camera and / or illumination device can be delivered in separate components (e.g., the camera and illumination device can be bundled together in a catheter and delivered down the working channel 2355 and / or additional working channels to the distal-most end 2333z).

[0128] The interface 2337z can be located between the inner rigidizer 2310 and the outer rigidizer 2300. The interface 2337z can be a gap, for example, a gap having a dimension d of 0.001 inches to 0.050 inches, for example 0.0020 inches, 0.005 inches, or 0.020 inches thick (see Figure 5 ). In some examples, the interface 2337z can be low friction and include, for example, a powder, coating, or lamination to reduce friction. In some examples, there can be a seal between the inner rigidizer 2310 and the outer rigidizer 2300, and the intermediate space can be pressurized, for example, with a fluid or water, to create a hydrostatic bearing. In other examples, there can be a seal between the inner rigidizer 2310 and the outer rigidizer 2300, and the intermediate space can be filled with small spheres to reduce friction.

[0129] The internal rigidizing device 2310 and the external rigidizing device 2300 can be moved relative to each other and alternately rigidified to impart a bend or shape down the length of the nested system 2300z. For example, the internal device 2310 can be inserted into a cavity and bent or turned into a desired shape. Pressure can be applied to the internal rigidizing device 2310 to engage and lock the rigidifying layer elements in this configuration. The rigidizing device (e.g., in a flexible state) 2300 can then be advanced on the rigid internal device 2310. When the external rigidizing device 2300 reaches the end of the internal device 2310, a vacuum can be applied to the rigidizing device 2300 to engage and lock the layers to fix the shape of the rigidizing device. The internal device 2310 can be transformed to a flexible state, advanced, and the process repeated. Although the system 2300z is described as including a rigidizing device and an internal device configured as a viewing instrument, it should be understood that other configurations are possible. For example, the system can include two overtubes, two catheters, or a combination of overtubes, catheters, and scopes.

[0130] Figure 8 Another exemplary nesting system 2700z is shown. System 2700z is similar to system 2300z, except that system 2700z includes a cover 2738z attached to the inner rigidization device 2710 and the outer rigidization device 2700. For example, the cover 2738z can be low durometer and thin-walled to allow elasticity and stretch. The cover 2738z can be a rubber, such as urethane, latex, or silicone. The cover 2738z can protect the interface / radial gap between the inner device 2710 and the outer device 2700. The cover 2738z can prevent contaminants from entering the space between the inner tube and the outer tube. The cover 2738z can further prevent tissue and other substances from being trapped in the space between the inner tube and the outer tube. The cover 2738z can stretch to allow the inner device 2710 and the outer device 2700 to travel independently of each other within the elastic limit of the material. The cover 2738z can be bonded or attached to the rigidizing device 2710, 2700 in a manner such that the cover 2738z is always at least slightly stretched. This example can be wiped from the outside for cleaning. In some examples, the cover 2738z can be configured as a "rolling" seal, such as disclosed in US6447491, the entire disclosure of which is incorporated herein by reference.

[0131] FIG. 9A to FIG. 9BAnother exemplary nesting system 9400z is shown. In this system 9400z, the external rigidized device 9400 includes a steering device and an imaging device (e.g., similar to a scope), while the internal device includes only a rigidized device (however, the internal device may include additional steering elements as described elsewhere herein). Thus, the external device 9400 includes a link or other steering device 9404z, a camera 9434z, and an illumination device 9435z disclosed herein. The external device 9400 may also include a central passage 9439z (e.g., a cavity, such as a working channel in the central passage 9439z) for accessing the internal device 9410. In some examples, a bellows or loop of tubing may connect the passage 9439z to the cavity of the internal device 9410. Similar to other nesting systems, at least one of the devices 9410, 9400 may be rigidized at one time, while the other of the devices 9410, 9400 may conform to the rigidization and / or move through the anatomical structure. Here, the external device 9400 may guide the internal device 9410 (the internal device 9410 is Fig.9A is shown retracted relative to the external device 9400 and in Figure 7 B as extending substantially flush with the external device 9400). Advantageously, the system 9400z can provide a smooth external surface to avoid pinching of anatomical structures and / or fluid access between the internal device 9410 and the external device 9400. Steering the external device 9400 can also provide additional leverage for steering the tip. In addition, due to the larger diameter of the external device 9400 and its ability to accommodate a larger camera, the external device can facilitate better imaging capabilities.

[0132] FIG. 10A to FIG. 10H An exemplary use of the nesting system 2400z described herein is shown. Fig. 10A In the embodiment, the steerable inner rigidizing device 2410 is positioned within the outer rigidizing device 2400 such that the distal end of the inner rigidizing device 2410 extends outside the outer rigidizing device 2400. Fig. 10B In the embodiment of the present invention, the distal end of the internal rigidization device 2410 is bent in a desired direction / orientation (e.g., via an actuation steering member, such as cable 7624), and then rigidified (e.g., using vacuum or pressure as described herein). Fig. 10C , the outer rigidizing device 2400 (in a flexible configuration) is advanced over the rigidized inner rigidizing device 2410 (including over the curved distal region). Once the distal end of the outer rigidizing device 2400 is sufficiently advanced over the distal end of the inner rigidizing device 2410, the outer rigidizing device 2400 can be rigidified (e.g., using a vacuum or pressure as described herein). Fig. 10D, the internal rigidization device 2410 can then be transitioned to a flexible state (e.g., by removing the vacuum or pressure as described herein, and by allowing the steering cables to slack so that the distal end can move easily) and can be propelled and guided / oriented / steered as desired. Fig. 10D In the embodiment of the present invention, when the internal rigidizing device 2410 is revealed, the internal rigidizing device 2410 can be actively steered (manually or via computational control) so that the internal rigidizing device 2410 minimizes the load on the rigidized outer tube. Minimizing the load on the outer rigidizing device 2400 makes it easier for the tube to maintain the rigidized shape. Once the internal rigidizing device 2410 is rigidified, the outer rigidizing device 2400 can be transformed into a flexible state and advanced over the internal rigidizing device 2410 (e.g., Fig. 10E The process can then be repeated, as shown in FIG. 10F to FIG. 10H The repeated process can result in "shape replication" whereby the inner rigidized device 2410 and the outer rigidized device 2400 in the flexible configuration continuously conform to (or replicate) the shape of any device 2410, 2400 in the rigid configuration. In some examples, upon completion of FIG. 10A to FIG. 10H When following the sequence shown in , the third rigidizing device can be slid over the first two rigidizing devices (2400, 2410) and rigidified. The rigidizing devices 2400 and 2410 can then be withdrawn. Finally, the fourth rigidizing device can be inserted through the lumen of the third tube. The fourth rigidizing device can have a larger diameter and more features than the rigidizing device 2410. For example, it can have a larger working channel, more working channels, a better camera, or a combination thereof. This technology can allow two smaller tubes (smaller tubes tend to be more flexible and maneuverable) to be inserted deeper into the body while ultimately still delivering a larger tube for therapeutic purposes. Alternatively, in the above example, the fourth rigidizing device can be a conventional endoscope known in the art.

[0133] In some examples, after completing FIG. 10A to FIG. 10HIn the sequence shown, the external rigidizing device 2400 can be rigidized and then the internal rigidizing device 2410 can be removed. For example, the rigidizing device 2410 can be a "navigation" device that includes a camera, an illumination device, and a distal steering region. The "navigation" device 2410 can be well sealed, making it easy to clean between surgeries. Then, a second internal device can be placed within the rigidified external device 2400 and advanced through the distal end of the external device 2400. The second internal device can be a "treatment" tube that includes elements such as a camera, light, water, suction devices, and various tools. The "treatment" device may not have a steering region or rigidification capability, thereby providing additional space in the body of the treatment tube to include other features, such as tools for performing treatment. Once in place, the tools on the "treatment" tube can be used to perform treatment in vivo, for example, such as performing a mucosal resection or stripping in the human gastrointestinal tract (GI tract).

[0134] In another example, after completing FIG. 10A to FIG. 10H After or during the sequence shown, a third device can be inserted into the inner tube 2410. The third device can be a rigidification device and / or an endoscope.

[0135] In some examples, after completing FIG. 10A to FIG. 10H The entire system 2400z can be removed from the anatomical structure after completing the sequence shown and any treatment performed with the system 2400z in place. In an exemplary withdrawal method, the system 2400z can be transformed into a flexible configuration (i.e., both the inner device 2410 and the outer device 2400 can be transformed into a flexible configuration), and the flexible system 2400z can be pulled proximally. In this method, tension between the patient's body (e.g., anus) and the robotic arm (e.g., arm 1023y described below) can prevent the system 2400z from falling out of the body when it is removed (e.g., due to more of the flexible system 2400z being located outside the body than inside the body).

[0136] As another exemplary retraction method, shape replication can be similar to FIG. 10A to FIG. 10HThe present invention also provides a method for controlling the steerable distal end of the external rigidizer 2400 by adjusting the internal rigidizer 2410 to move the steerable distal end of the external rigidizer 2400 proximally (e.g., until the distal end of the internal rigidizer 2410 is flush with the distal end of the external rigidizer 2400). In this example, the internal rigidizer 2410 can be rigidized and the external rigidizer 2400 can be withdrawn proximally over the internal rigidizer 2410 (when in a flexible configuration). The external rigidizer 2400 can then be rigidized and the internal rigidizer 2410 can be relaxed and moved proximally within the external rigidizer 2400 (e.g., until the distal end of the internal rigidizer 2410 is flush with the distal end of the external rigidizer 2400). In this example, the tension on the steering cables can be kept constant (e.g., kept at a low value, such as one-quarter lb or less) while the internal rigidizer 2410 is withdrawn into the external rigidizer 2400 to ensure that the steerable distal end portion will move into the shape of the external rigidizer 2400 without disturbing the fixed shape of the external rigidizer 2400. Alternatively or additionally, if the outer rigidizer 2400 is rigidified into a straight shape, the inner rigidizer 2410 can be pulled into the outer rigidizer 2400 and the tension on each steering cable can be equal (i.e., the same value so that the daughter shape conforms to the inner shape of the parent).

[0137] As another exemplary withdrawal method, the steerable distal tip of the internal rigidizer 2410 may be actively steered proximally into a known, assumed, or measured shape of the external rigidizer 2400 while or after the distal tip is retracted into the external rigidizer 2410. That is, the distal tip of the internal rigidizer 2410 may be steered to match the shape of a portion of the external rigidizer 2400 that is proximate to the distal tip of the internal rigidizer 2410. In one specific example, the internal rigidizer 2410 may protrude 4 inches from the external rigidizer 2400, and the last 4 inches of the external rigidizer 2400 may form a 90 degree curve around a 2.5 inch bend radius. In this example, the internal rigidizer 2410 may be steered into a 90 degree curve around a 2.5 inch bend radius and then withdrawn (in this shape) into the external rigidizer 2400. This can advantageously ensure that the inner rigidizing device 2410 is easily pulled into the outer rigidizing device 2400 (ie, because the shapes of the inner rigidizing device 2410 and the outer rigidizing device 2400 match).

[0138] In some examples, certain methods, controls, and / or algorithms may be used to enhance the advancement or withdrawal of nested rigidized devices (such as those described herein). As described above, during advancement or withdrawal of the nested system, the device alternately becomes flexible and rigidized to travel along the body cavity. Once the flexible device is advanced on or within the rigidized device and the flexible device replicates the shape of the rigidized device, the rigidized device may then become flexible to be advanced or withdrawn. In some examples, an actuated steering member (e.g., such as steering cable 7624) may be used to control the shape of the rigidized device and / or maintain control of the device when / when the rigidized device moves to its flexible state.

[0139] For example, when advancing the nested system, after the outer rigidizer (e.g., outer rigidizer 2400) has been advanced over the inner rigidizer and has copied its shape, the inner rigidizer (e.g., inner rigidizer 2410) transitions to a flexible state before the inner rigidizer is advanced. Fig. 10D At the time point shown, the internal rigidizing device may be steered to maintain a previously commanded curvature of the internal rigidizing device. The previously commanded curvature may refer to the curvature imposed by the actuating steering member prior to rigidification of the internal device.

[0140] Maintaining the previously commanded curvature may have advantages over allowing the inner rigidizer to transition to a flexible state in the event of slack in the steering cables. For example, during a partial replication of the inner rigidizer, where the outer rigidizer is not fully advanced over the inner rigidizer, it may be undesirable to allow the exposed length of the inner device to straighten when the partial replication is complete. In some examples, in the absence of rigidification or tension from the cables, the inner rigidizer may tend to relax to an unbent (or less bent) state. For another example, during a full replication of the inner rigidizer, where the outer rigidizer is fully advanced over the inner rigidizer, in order to propel the inner rigidizer away from the outer device, the inner device must first be driven directly out of the outer device before it can turn.

[0141] In some examples, an actuating steering member (e.g., cable 7624) can provide a bending moment that maintains approximately the same bending moment during shape replication. Maintaining the bending moment can advantageously help the internal rigidizer maintain its current shape during the replication process, thereby improving shape replication accuracy. Maintaining the bending moment during shape replication can also reduce artificial "tightening" of the bend as the exposed length of the internal rigidizer decreases. In addition, maintaining the bending moment can allow the desired curvature of the internal rigidizer to be maintained / set / reset when the internal rigidizer is positioned within the external device. When the internal rigidizer is subsequently advanced, it can be advanced along a constant curvature arc. For example, such control can allow a user to drive the internal rigidizer outward along the tightest possible bend.

[0142] In some examples, the system is configured to automatically use an actuated steering member as described above to assist in transitioning the internal device from the rigidified state to the flexible state.

[0143] In some examples, the system may still allow the commanded curvature to be reset to zero when the shape copy is complete.

[0144] For example, the system may be configured to maintain an existing curvature command for a partial shape copy and reset the curvature command to zero for a full shape copy.

[0145] In some examples, the operator can select whether to reset the curvature to zero upon completion of a full shape copy (eg, a partial shape copy, a full shape copy, both a partial shape copy and a full shape copy).

[0146] In some examples, for continuously commanded shape replication, where shape replication progresses gradually as the operator activates a control (e.g., presses and holds a button) and stops when the operator releases the control (e.g., releases the button), the previously commanded curvature can be maintained during advancement of the external rigidization device 2400, and then the previously commanded curvature gradually decreases to zero if the operator continues to activate the control after the external device has been advanced to the full extent allowed.

[0147] There are two main aspects that can be used to control the distal end bending section of the internal device by actuating the steering member. For example, when using steering cables (or tendons, etc.), the first aspect is by applying a bending moment. The bending moment can be generated by stretching the steering cables. The second aspect is by imparting geometric changes. The geometric changes can be imposed by displacing the steering cables, resulting in different path lengths along different steering cables, thereby forming the bending section. The effect of the steering cable displacement depends on the shape of the entire bending section, including the portion of the bending section located within the external device (if any).

[0148] Thus, in some examples, the shape of the outer rigidizing device can be used to control the shape of the inner rigidizing device when the inner rigidizing device transitions to a flexible state. The shape can be learned using shape sensing techniques. In some examples, tracking the movement of the inner rigidizing device can allow for estimation of the replicated shape of the outer device.

[0149] The shape of the internal device can generally be preserved during shape replication. This can allow for a smooth exit from the shape replication sequence because the actuation steering member control is not changed. It may still be important to know the distal shape of the external device as the internal device is advanced because less and less of the internal device distal tip will be constrained by the shape of the external device as the internal device is advanced.

[0150] While ideal shape replication would accurately preserve the shape of the replicated device, in practice, the process may result in a slightly modified shape due to factors such as measurement errors, physical effects (such as different radial tolerances between devices), less curved or non-curved regions of the replicated device, etc. To account for the modification of the shape when estimating the shape of the replicated device, the system may assume that the shape loses a certain amount or percentage of the current curvature (e.g., about 10%, 5%-10%, 5%-20%, etc.). In such an example, the system may slightly modify the actuation steering member control to maintain the curvature of the outer rigidized device before transitioning the replicated inner device to the flexible state.

[0151] Retracting the nested system may be the reverse of the forward sequence described above.During retraction of the external rigidified replication device, the commanded curvature may be maintained or adjusted / controlled.

[0152] The difference during retraction is that the actuation steering member may not provide enough freedom for the inner device to maintain the previous shape it had within the outer device (e.g., when the shape includes multiple curves in different directions). It has been found that maintaining or simulating the shape of the inner device along the portion of the inner device that will be exposed after the outer device is retracted can provide the smoothest transition for the inner device as it transitions from the rigidized state.

[0153] Various examples of controlling a replicated device as it transitions to a flexible state after an outer rigidizing device ("mother" or outer rigidizing member) is retracted relative to an inner rigidizing device ("daughter" or inner rigidizing member) are described in FIG. 11A to FIG. 13E Shown in.

[0154] refer to FIG. 11A to FIG. 11E , showing various examples of retracting the outer rigidizer 1100 while actuating an actuating steering member (eg, a steering cable) of the inner device to various degrees to adjust and / or maintain the shape of the exposed inner rigidizer 1110. Fig.11AThe initial positions of the inner rigidizing device 1110 and the outer rigidizing device 1100 are shown. In this example, the inner rigidizing device 1110 extends from the outer rigidizing device and is bent in one direction and in one plane. The exposed portion 1102 of the inner device is at an angle phi and a radius of curvature r c Bending. A portion of the bending region of the internal rigidification device is Fig.11A Within the external rigidification device. Fig.11A Also shown is the net turning angle theta. This is the angle between the inner rigidizing device 1110 at the distal tip of the inner rigidizing device 1110 and the proximal point on the inner rigidizing device to which the outer device will be retracted. Fig. 11B A pair of devices 1100, 1110 are shown nested when the outer rigidizing device 1100 is retracted and the inner rigidizing device remains rigid.

[0155] Fig. 11C An example of an undesirable condition indicated by an "X" is shown, where the steering cable is tensioned to maintain the original radius of curvature (r c ), causing the internal rigidizing device 1110 to move and take a hook shape at its distal end in the position shown. Unless prevented by structures within the body cavity, the end of the internal rigidizing device 1110 can bend as shown because the now flexible distal region is driven by tension from the cables to maintain the radius of curvature in the exposed distal region. This can also cause the distal side of the internal rigidizing member 1110 to rotate in different directions, which can reposition the direction in which the distal end of the internal rigidizing device is pointing, including any cameras or working channels. As described above, this may not be desirable within a body cavity. This change in shape may be due to the sub-body (internal rigidizing device 1110) being moved from Fig. 11B The rigid configuration in the Fig. 11C The flexible configuration in Fig. 11C In the flexible configuration in , the bending movement is imparted by the steering cables in the distal region; as shown, the newly exposed bending section can be further actuated.

[0156] In some examples, such as Fig.11D As shown, the steering cables may alternatively be controlled to maintain the angle phi during retraction of the external rigidification device 1100. Fig.11DIn some examples, the device can apply sufficient (and adjustable) bending moment, such as tension, on one or more steering cables to maintain the exposed turning angle (phi) when the internal rigidizer 1110 is de-rigidified. In this example, the distal surface of the internal rigidizer 1110 remains oriented in the same direction. In some examples, the controller can coordinate the bending moment applied by the steering cables on the rigidizer to maintain the turning angle (phi). Therefore, in some examples, when the internal rigidizer is de-rigidized, the controller can dynamically adjust the steering cables, such as by releasing the positive or negative pressure that rigidifies the internal rigidizer.

[0157] In some examples, the device can be configured to maintain the theta angle (e.g., the net turning angle between the distal face of the inner rigidizer 1110 relative to the point on the inner rigidizer that the outer rigidizer will retract to). FIG. 11A to FIG. 11D In the example shown, the theta angle is equivalent to the phi angle. Therefore, Fig.11E 1 shows the positions of the outer rigidizer 1100 and the inner rigidizer 1110 when the steering cables are controlled to maintain the theta angle during retraction of the outer device 1100. Fig.11D and Fig.11E As shown, in this case, maintaining the previously exposed turn angle phi is equivalent to controlling the net turn angle of the final exposed length. As is generally the case herein, when the more proximal region of the device is relatively fixed (e.g., relative to the patient's anatomy), maintaining the net turn angle (theta) will maintain the orientation of the distal face of the internal rigidizing member relative to the patient's anatomy (e.g., cavity).

[0158] FIG. 12A to FIG. 12E Another example is shown where the phi angle and theta angle are not the same. FIG. 12A to FIG. 12E In, similar to FIG. 11A to FIG. 11E The device includes an internal rigidization device 1210 (sub-body) and an external rigidization device 1200 (parent body). Fig. 12A In the embodiment, the internal rigidification device 1210 has a radius of curvature (r c ) but with a larger phi angle. The external rigid member will be withdrawn to the same FIG. 11A to FIG. 11E The substantially same relative positions are shown, however, the net turning angle theta is different (in this example, greater than, for example, 180 degrees) than the bending angle (phi) of the inner rigidizer 1210 at the initial exposure area 1202 . Fig. 12A The initial positions of the inner rigidization device 1210 and the outer rigidization device 1200 are shown. Fig. 12A , the inner rigidizing device 1210 extends distally from the outer rigidizing device and bends such that the inner rigidizing device 1210 is hook-shaped to face proximally.

[0159] Fig. 12B The apparatus including the internal rigidizing device 1210 and the external rigidizing device 1200 is shown when the external rigidizing device 1200 is retracted while the internal rigidizing device remains rigid. The rigidity of the internal rigidizing device can then be released (e.g., by releasing positive or negative pressure or otherwise), and an actuated steering member (e.g., a steering cable) can be used to maintain one or more of the following: bend angle (phi), radius of curvature (r c ) and / or the net turning angle (theta). Fig. 12C As shown, the steering cable can be controlled by a controller (eg, software, firmware, etc.) and used to maintain the original curvature r c , resulting in Fig. 12C , in which the inner rigidization device 1210 remains in a hook shape at its distal end as the outer rigidization device is withdrawn proximally.

[0160] Alternatively, in some examples, the controller may maintain a connection with Fig.12D 1200. In this example, the controller can control (e.g., dynamically control) the actuation steering member to maintain the angle phi during retraction of the outer device 1200. As shown by the "X" in this example, this may be a less desirable configuration because the distal tip region may translate as shown and may also change the orientation and position of the distal face of the device 1210.

[0161] In some examples, the controller may instead maintain the net turning angle (theta), and may maintain the approximate orientation (and in some examples, position) of the distal face of the internal rigidification device. Fig.12E In the embodiment of the present invention, the position of the inner rigidizer 1210 can be maintained by the actuated steering member during the retraction of the outer rigidizer 1200 (to maintain the angle theta). Fig. 12C and Fig.12E As shown, in this example, the radius of curvature r of the internal rigidifying member is maintained by controlling the bending moment of, for example, the steering cable when the pressure (positive or negative) is released. c and / or a net turning angle (theta) can result in the exposed length of the internal rigidization device having substantially the same shape and generally maintaining the position and orientation of the distal surface of the device 1210, particularly when controlled in a simple configuration of an external rigidization device and an internal rigidization device.

[0162] FIG. 13A to FIG. 13EAn example is shown in which the inner rigidizing member 1310 of the device has a compound curvature (bending in more than one direction or plane) at a distal region (e.g., a region that may be exposed by proximally withdrawing the outer rigidizing member), and the curvature radius (r) is controlled during withdrawal of the rigidizing device. c ), bend angle (phi), or net turn angle (theta) to control the effect of the shape. Again, it may be most desirable to maintain the net turn angle (theta) in order to maintain the position / orientation of the distal side of the internal rigidization device 1310. Fig.13A The distal radius of curvature (r c ) and a bend angle (phi). In this example, the bend angle is different from the net turn angle (theta). In this example, the inner device 1310 extends distally from the outer device and bends in a first direction, similar to Fig.11A 1302. However, in this example, a more proximal portion of the inner rigidization device 1310 (proximal to the exposed outer distal portion 1302) and the outer rigidization device 1300 initially positioned on the inner rigidization device 1310 are bent in a second direction different from the first direction. The bend angle and radius of curvature of the second region can be the same or different than the bend angle and radius of curvature of the distal region. Similarly, the bend plane and bend angle can be different or the same. In this example, the net turning angle is theta. Fig. 13B The inner rigidizing device 1310 is shown still in a rigid configuration while the outer rigidizing device 1300 is withdrawn proximally. The device (e.g., a controller) can then coordinate the bending moment applied by the actuated steering member to maintain the same radius of curvature (r) when the pressure (positive or negative) is released. c ), bend angle (phi) or net turning angle (theta).

[0163] For example, in Fig. 13C In the embodiment, the controller can control the actuation of the steering member to maintain the original curvature radius r c , resulting in Fig. 13C , in which the distal end of the internal rigidization device 1310 is in a different orientation and significantly displaced relative to its original position when rigidified. As indicated by the "X" in this example, this may therefore be an undesirable result.

[0164] Fig.13D An example is shown in which the controller of the device can alternatively maintain a constant bend angle (phi). In this example, the position of the distal tip of the internal rigidification device 1310 and the orientation of the distal face of the distal tip are both constant with respect to the initial position (eg, FIG. 13A to FIG. 13B Therefore, this example is also marked with an "X" as shown.

[0165] In contrast, in Fig.13E In , the controller can coordinate the bending moment applied to the actuated steering member to maintain a net turning angle (theta) after retraction of the outer device 1300 and release of the rigidifying pressure (positive or negative) of the inner rigidifying device 1310. Fig.13E In the embodiment, the curvature of the inner device 1310 is different from Fig.13A and Fig. 13B The curvature of the original shape shown in is changed, but the orientation of the distal face is maintained.

[0166] Thus, in any of these devices, a controller can coordinate actuation of a steering member to maintain a net turn angle (theta) and / or orientation of a distal surface of an internal rigidizing device during retraction of an external rigidizing device. Maintaining the net turn angle theta can result in the orientation and position of the distal surface of the internal rigidizing device being most closely matched after releasing the rigidization of the internal rigidizing device. This can allow for a reasonably smooth transition between a rigidified state and a flexible state when retracting (and in some cases advancing) the device. As shown by these examples, maintaining the net turn angle theta results in maintaining the orientation of the distal surface of the internal rigidizing device as the internal rigidizing device transitions from a rigidified state to a less rigid (e.g., flexible) state. Maintaining the net turn angle (theta) or distal orientation can result in the shape of the device after retraction being approximately the shape before retraction.

[0167] like FIG. 11A to FIG. 13E As shown, the turn angle theta can be measured between a plane including the distal surface of an internal rigidized device (e.g., device 1110, 1210, 1310, etc.) and a cross-section of the internal rigidized device taken at the point where the internal rigidized device will be exposed (or at any point more proximal where it is relatively fixed in place relative to the patient's anatomy). Measuring the turn angle in this manner can help maintain the orientation of the distal surface of the internal rigidized device (e.g., the direction it faces), which can be used to maintain the orientation of the camera (e.g., the pointing direction) rather than its position in applications where the internal device includes a camera. Maintaining the orientation of the camera can help provide continuity and accuracy during the imaging process.

[0168] It should be understood that the clear turn angle may be measured differently in a manner that still best maintains the shape of the internal device to be exposed, but does not necessarily maintain the angle of the distal end of the internal device.

[0169] As described above, shape sensing techniques may be used to learn the shapes of the inner and outer devices. In some examples, tracking the movement of the inner rigidized device may allow for estimation of a replicated shape of the outer device.

[0170] In any of these examples, when transitioning the internal device from a rigidized state to a flexible state, the actuation steering member can be adjusted before the device is de-rigidified. Such a sequence can allow for a smoother and / or more predictable transition between the initial shape of the rigidized internal device and the subsequent shape of the sub-body device in the flexible state.

[0171] In some examples, the actuation steering member is adjusted as the outer rigidization device is advanced or retracted. Such a sequence can improve user responsiveness because the inner device is immediately ready to be de-rigidified once the replication process is complete.

[0172] Methods for photographing body cavities

[0173] In some examples, the device can be configured to operate in a "shooting mode" in which the device performs automatic movement of the internal rigidized device to sweep the camera view across the surface of the interior of a cavity (e.g., the intestine) to search for abnormalities (e.g., polyps). The automatic movement can include circumferential movement of the internal device. The internal rigidized device can include one or more cameras at its distal end. In some examples, the automatic movement can be performed while the system retracts the device through the cavity. In some examples, a controller of the device can include control logic to coordinate the movement of the internal rigidized device to scan in the shooting mode as described herein.

[0174] FIG. 14A to FIG. 14F An example of a device including an internal rigidizing device 1410 and an external rigidizing device 1400 is schematically shown. In one example of a capture mode, the device 1400z may allow selection of an initial orientation of a camera 1434z positioned at the distal end of the internal rigidizing device. Here, a user may select an orientation of the internal device, such as orienting the camera view at the center of the cavity and indicating a center point within the cavity (centered in the ring 1402), as shown in FIG. Fig.14A The curved section of the inner device is then rotated about this center point in a circular scanning movement 1402 to capture a view of the wall around and distal to the center point. Fig. 14BThe internal rigidizing device 1410 is shown at different points during rotation. The internal rigidizing device 1410 is shown in a flexible configuration (e.g., not rigidized), while the external rigidizing device 1400 is rigidized (e.g., by applying positive or negative pressure). In some examples, as the internal rigidizing device 1410 navigates in a circular scanning movement, the internal rigidizing device 1410 can be advanced distally and / or slightly retracted (e.g., distally / proximally) to keep the tip in a plane transverse to the area of ​​the cavity in which it is located. In any of these examples, the controller can automatically control the actuation steering member and / or the rigidity of the internal rigidizing device and / or the rigidity of the external rigidizing device to coordinate rotation and imaging. The controller can coordinate the rotation rate and the movement rate of the tip of the internal rigidizing member; in some examples, the rotation rate and the movement rate can be based on the ability of the image collection and analysis module of the device to collect and process the collected images. The rate can be constant or can be variable. For example, the controller can adjust the rotation rate and / or movement rate of the tip under automatic or semi-automatic control based on feedback from the image collection and / or processing (e.g., image analysis) module. In some examples, this can allow the system to image the cavity faster than manual inspection, but can allow a user (e.g., a physician, technician, etc.) to simultaneously or later inspect the imaged cavity or a model (e.g., a data file) of the cavity generated by the image collection and / or processing module.

[0175] Reference now Fig. 14C Once the circular scanning movement 1402 is completed, the device 1400z can be operated to retract the selected length (or in some examples, advance the selected length). Fig. 14C In the example shown, the inner rigidizer 1410 in a flexible / non-rigid configuration can be retracted into the outer rigidizer 1400. In this example, the actuating steering member (e.g., steering cable) can be allowed to be adjusted to be slack or tensioned so that the inner rigidizer can be easily pulled into the outer rigidizer 1400. FIG. 14A to FIG. 14D The examples shown show devices and lumens extending in straight lines, but the processes described herein may also be performed in curved or tortuous lumens.

[0176] like Fig.14DAs shown, the external rigidizing device 1400 can then be retracted relative to the internal rigidizing device 1410 to expose a region of the internal device 1410. In some examples, the internal rigidizing device 1410 can be rigidified (e.g., by applying positive or negative pressure, or in other ways), and the external rigidizing device 1400 can be made flexible / de-rigidified (e.g., by releasing pressure) so that the external rigidizing device 1400 can maintain its shape as it extends proximally. When retracting the device, the methods and devices described herein can make full use of any of the above methods and processes. For example, the controller can maintain a net turning angle by controlling the actuation steering member after the withdrawal of the external rigidizing device 1400 and the transformation of the internal rigidizing device 1410 into a flexible configuration.

[0177] The length 1480 of the external rigidification device withdrawal can be the same or can vary and can be determined based on the extent to which the cavity wall has been captured by the camera (which can depend at least in part on the field of view of the camera). In some examples, the withdrawal length 1480 can depend at least in part on the degree of curvature of the cavity. The device 1400z can be configured to retract the selected withdrawal length from a first position that allows observation of the first portion of the cavity to a second position that allows observation of the second portion of the cavity. The portions can be non-overlapping or minimally overlapping; for example, the second portion can be located proximal to the first portion. For example, the first portion of the cavity and the second portion of the cavity can be positioned adjacent to each other so that there is no overlap between the portions. In some examples, adjacent portions can overlap so that the first portion of the cavity and the second portion of the cavity overlap a selected amount (e.g., 0mm-5mm, 0mm-10mm, etc.), which can help ensure a complete scan.

[0178] Once Fig.14D With the inner rigidizer 1410 shown retracted and the outer rigidizer 1400 exposed, the device 1400z is ready to perform another circular scan of imaging. This process can be repeated over a predetermined or selected (e.g., automatically or user-selected) length of the lumen. For example, referring to Fig.14E and Fig.14F Once the device 1400z has been retracted to the withdrawal length, the inner device 1410 can be rotated again in a circular scanning movement 1402 to image the walls of the cavity. Fig.14E and Fig.14F shows a previous scan (e.g., Fig. 14B The first part 1406 of the cavity is adjacent to the second part 1408 of the cavity, which is proximal to the first part of the cavity. The camera 1434z is along Fig.14E and Fig.14F The circular scanning movement 1402 in is shown at different points.

[0179] As described above, in some examples, imaging analysis can be performed on the received imaging data to generate a model of the cavity. For example, any of the devices described herein may include an image collection and / or analysis module (e.g., an image processing module). The controller can coordinate and / or receive input from the image processing module to repeat imaging (e.g., perform ring movement) or reposition the distal end based on feedback from the image processing module. In any of these examples, machine learning can be used to provide information about the center of the cavity. This information can be used together with the imaging data to generate a model of the cavity. Typically, the image processing module may include one or more machine learning agents to determine the position and / or orientation of the end of the device during a scan, or to help collect scans, identify targets (e.g., polyps), and / or guide or manipulate the device.

[0180] Example

[0181] As described above, any of these devices and methods can be configured to perform a predetermined series of coordinated operations to enhance, simplify and / or accelerate the operation of a nested pair of rigidized devices, which can be collectively referred to as a robotic system herein. These predetermined series or groups of coordinated operations can include these movements: advancing and / or retracting, rigidifying / de-rigidifying (e.g., transitioning from a rigid state to a flexible state), and / or rolling one or both rigidized devices in the nested pair of rigidized devices. These groups of operations can be specific to operations utilizing a pair of nested (e.g., telescoping) devices, and the rigidized device can be any of the rigidized devices described herein. These predetermined series or groups of coordinated operations can be automatically performed based on one or more sensed or detected parameters (e.g., relative positions of the nested rigidized devices, sensed shapes of one or more of the rigidized devices, positions relative to the patient's body, etc.), and / or can be activated by a user operating the device.

[0182] For example, the above discussed FIG. 11A to FIG. 11E , FIG. 12A to FIG. 12E and FIG. 13A to FIG. 13EAn example of a method for controlling a nested pair of rigidifying devices 1100, 1110 is shown so that the distal face of one of the rigidifying devices (e.g., the inner rigidifying device 1110) faces approximately in the same direction when the devices are retracted. This may also be referred to as maintaining approximately the same net turning angle between the distal end of the second rigidifying device relative to the proximal portion of the second rigidifying device. As described, this may provide a smooth and clear image to the user when retracting the devices (even through tortuous anatomical structures). For example, the method may be a method of controlling a nested pair of rigidifying devices, the method comprising: retracting a first rigidifying device in the nested pair of rigidifying devices relative to a second rigidifying device in the nested pair of rigidifying devices while the first rigidifying device is in a flexible state and the second rigidifying device is in a rigidified state; rigidifying the first rigidizing device; actuating a steering member within the second rigidizing device before and / or while transitioning the second rigidizing device from the rigid state to the flexible state to maintain the direction of the distal face of the second rigidizing device constant relative to an outer region; and retracting the second rigidizing device relative to the first rigidizing device while the second rigidizing device is in the flexible state.

[0183] As mentioned, any of these methods can be implemented as an apparatus (e.g., a system) comprising: a nested pair of rigidized devices, the nested pair of rigidized devices comprising a first rigidized device and a second rigidized device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a method for controlling the nested pair of rigidized devices (e.g., a computer-implemented method).

[0184] Any of these methods can include rigidifying and de-rigidifying (e.g., transitioning between a rigid state and a flexible state) by controlling pressure (e.g., positive pressure and / or negative pressure). As described above, the application of positive and / or negative pressure can apply or release a force that drives the bladder layer against the rigidification layer. In some examples, the device can include a source of positive and / or negative pressure, and the controller can control and / or coordinate the application of positive and / or negative pressure to control the transition of each rigidification device in a nested pair of rigidification devices between a rigid state and a flexible state.

[0185] For example, FIG. 15A to FIG. 15CAn example of a method of automatically replicating shape between a pair of nested rigidized devices is shown, which can allow one rigidized device to be continuously replicated in shape relative to a second rigidized device. Such continuous replication can be triggered, for example, by a user actuating a control (e.g., a button, dial, switch, pedal, etc.) to trigger the shape replication. In some examples, the method (or a system performing the method) can be configured to continue the continuous and automatic shape replication only while the user continues to actuate the control (e.g., pressing and holding a button).

[0186] For example, in Fig.15A In FIG. 1 , a nested pair of rigidifying devices includes a first (e.g., outer) rigidifying device 1500 and a second (e.g., inner) rigidifying device 1510. The second rigidifying device may extend just distally and steer the tip region by controlling one or more actuating steering members (e.g., tendons, pull wires, etc.). Fig.15A In , the user can then activate a control, e.g., press and hold a button, to trigger a copy command such that the first rigidized device will copy the shape of the second (inner) rigidized device, and in this example, the first rigidized device begins executing the copy sequence as shown. In this example, the internal rigidized device 1510 can optionally be rigidified (e.g., transitioned from a flexible state to a rigid state by applying positive or negative pressure). The tension on the actuated steering member can be maintained at least until the internal rigidized device is fully rigid. Similarly, the first (e.g., outer) rigidized device can be in or transitioned to a flexible state (e.g., by releasing positive and / or negative pressure). In Fig. 15B , the user keeps pressing the copy command input (control), and the external member continues to perform the copy sequence; as shown, the first rigidizing device 1500 is advanced distally over the second (inner) rigidizing device, the second (inner) rigidizing device remains in a rigid state, and the external rigidizing device 1500 remains in a flexible state. Each of these steps can be controlled and coordinated by a controller. At any point during the process, if the user interrupts the control (e.g., releases a button), the shape copying can stop. For example, the user can release the copy command and the external rigidizing device 1500 ends the copy sequence at its location, regardless of the extent to which the internal rigidizing device 1510 has been copied.

[0187] therefore, FIG. 15A to FIG. 15CA method of controlling a nested pair of rigidified devices is shown, the method comprising: receiving a copy command from a user input; automatically executing a shape copy sequence, wherein the shape copy sequence comprises: advancing a first rigidified device in the nested pair of rigidified devices relative to a second rigidified device in the nested pair of rigidified devices while the first rigidified device is in a flexible state and the second rigidified device is in a rigidified state, wherein the first rigidized device is initially located proximal to the second rigidized device such that the first rigidized device copies a shape of the second rigidized device; and preventing the first rigidized device from being advanced distal to the second rigidized device.

[0188] Also described herein are predetermined series of coordinated operations for shape replication when advancing the device and / or when retracting the device. Generally, these methods and devices can perform multiple repetitive steps of shape replication. Any of these examples can include tracking or memorizing the shape. For example, a method or device can include tracking the angle of a curved region (e.g., a distal end region) of an inner rigidizer nested in an outer rigidizer. FIG. 16A to FIG. 16D Multiple shape replication steps are shown as a nested pair of rigidifying devices are advanced. Fig.16A , the inner rigidizer 1610 extends distally from the outer rigidizer 1600 and may have been turned into a bent shape using one or more actuated steering members while being advanced distally away from the outer rigidizer 1600. The inner rigidizer is shown bent at an approximately 90 degree angle, bending to the left. Fig. 16B When the inner rigidizing device has been set to a rigid state and the outer rigidizing device has been set to a flexible state, the outer rigidizing device can replicate the shape by advancing distally on the inner rigidizing device. Once the shape of the inner rigidizing device has been replicated by the outer rigidizing device, the outer rigidizing device can be rigidified, e.g., transformed into a rigid state, and the inner rigidizing device can be transformed into a flexible state so that the inner rigidizing device can be advanced distally when steered (e.g., by actuation of one or more actuating steering members), as shown in FIG. Fig. 16C The device can control the tension applied to the actuated steering member, as shown below FIG. 18A to FIG. 18F More detailed description. Fig.16D middle, FIG. 16A to FIG. 16B The shape replication described in can be repeated so that the outer rigidizing device 1600 in a flexible state can be advanced over the inner rigidizing device 1610 in a rigid state. FIG. 16A to FIG. 16D These repeated shape replication steps described in can be automated or assisted by a controller of the system, for example, using automatic shape replication (e.g., similar to FIG. 15A to FIG. 15C), and / or generally coordinate transitions between rigid and flexible states of external rigidizing devices and internal rigidizing devices.

[0189] FIG. 16A to FIG. 16D The method described in shows an example of the apparatus and method described herein, which remembers the shape previously replicated proximal to the turning zone of the inner member, and this memory is retained in the shape of the nesting area, allowing the inner member to reverse operation when retracting the system backward, such as backward into the existing rigidified outer member shape, as shown below in FIG. 17A to FIG. 17D In FIG. 16A to FIG. 16D In , the method shows the process of inchworming forward and preserving the shape (history) of the curve that the system has copied. 17A to 17D As described, these methods can allow reverse operation based on those same curves retained during distal advancement, each time using an actuated steering member (e.g., a steering cable) to gradually bend the distal region of the turn into that previously remembered shape so as to better retain the proximal shape of the system, because if the steerable region does not at least somewhat mimic the shape of that section, the previous curve may be formed into another shape upon rearward retraction; when the curved section is retracted rearward into the external member, the curved section may default to a less curved (or uncurved) turn.

[0190] This memory or retention of the curvature thus allows tracking of the entire rigidified length, not just the portion that is actively steered, without having to sense that shape directly. FIG. 11A to FIG. 11E , FIG. 12A to FIG. 12E and FIG. 13A to FIG. 1 32E, because these devices retain (and "know") the shape of the external components immediately adjacent to the turning area. Therefore, based on the turns in the steerable distal area, the curves that have been laid down and replicated can be retained as an image of the shape that the entire system is in, without the need to directly sense the shape of those curves.

[0191] 17A to 17C An example of shape replication when retracting the device is shown. In general, when reversing or (proximally) retracting the device, the inner rigidizing device may shape replicate the outer rigidizing device, while when advancing (distal), the outer rigidizing device may shape replicate the inner rigidizing device (e.g., FIG. 16A to FIG. 16D described). Fig.17A In the embodiment, the device includes an outer rigidizing device 1700 and an inner rigidizing device 1710 that are nested together. Fig.17AA nested pair of rigidizing devices is shown, wherein the inner rigidizing device 1710 has been retracted in a flexible state into the first rigidizing device 1700, which remains in a rigid state. Although in some cases the entire device can be withdrawn from the patient by transitioning both the inner and outer rigidizing devices to a flexible state (and relaxing the (one or more) steering members), in many cases it is more preferable to retract the device from the distal region of the device, leaving the more proximal curves and bends, which can prevent strain on the lumen wall and can allow controlled visualization of the surrounding area as the device is withdrawn. For example, as FIG. 17B to FIG. 17C As shown, by maintaining the internal rigidizing device 1710 in a rigid state, preferably with the turning steering member under tension, maintaining the curvature of the distal tip, the device can be smoothly withdrawn proximally over various curves; as shown, the external rigidizing device can be in a flexible state and can be withdrawn proximally over the most distal bend in the internal rigidizing device. The external rigidizing device 1700 can then be rigidified, and the internal rigidizing device 1710 can be transitioned to a flexible state and retracted proximally into the now rigid external rigidizing device 1700. These steps can be repeated, as shown. FIG. 17C to FIG. 17D shown.

[0192] In any of these steps, it may be helpful (and the system may be configured to) turn the distal end region of the inner rigidizing device as it is withdrawn proximally into the outer rigidizing device. This may be accomplished, as described above, for example by maintaining a generally constant orientation of the end faces and / or maintaining a net turning angle between the distal end of the second rigidizing device relative to the proximal portion of the second rigidizing device.

[0193] 18A to 18F An example of a method of controlling the timing of release of tension on the distal tip of an internal rigidizing device that can be steered at its distal tip region when transitioning from a rigid state to a flexible state by actuating a steering member to maintain curvature as the device transitions to the flexible state is shown. FIG. 18A to FIG. 18F The timing of the transition of driving the inner rigidizer 1810 and / or the outer rigidizer 1800 after replication is shown.

[0194] For example, 18A to 18FA method of controlling a nested pair of rigidified devices is shown by: advancing a first rigidified device 1800 of the nested pair of rigidified devices distally relative to a second rigidified device 1810 of the nested pair of rigidified devices, wherein the first rigidified device 1800 is in a flexible state and the second rigidified device 1810 is in a rigid state; transitioning the first rigidified device 1800 from a flexible state to a rigid state; and transitioning the second rigidified device from a rigid state to a flexible state while actuating a steering member of the second rigidified device to maintain a curvature of a distal end of the second rigidified device as the second rigidified device transitions to the flexible state.

[0195] exist Fig.18A In the embodiment, the inner (eg, second in this example) rigidifying device generates the shape (curve), and the actuating steering member can maintain the shape. For example, the actuating steering member can be a steel cable. In the embodiment, the inner (eg, second in this example) rigidifying device generates the shape (curve), and the actuating steering member can maintain the shape. Fig.18B In the embodiment of the present invention, the internal rigidizing device 1810 can then be transformed into a rigid state; the actuating steering member can maintain the curve formed by the distal region of the internal rigidizing device. Fig. 18C In the embodiment of the present invention, the external rigidizing device 1800 can then be advanced over the internal rigidizing member in a flexible state while the internal rigidizing member remains in a rigid state and the steering member is actuated to maintain the bend in the steerable end region. Fig.18D In the embodiment of the present invention, the outer rigidizing device can then be rigidified (e.g., by applying pressure) to a rigid state while the steering member is actuated to maintain the bend in the steerable end region of the inner rigidizing member. Fig.18E In the embodiment of the present invention, the inner member can then be transformed into a flexible state (e.g., by releasing the pressure on the inner rigidizing member) while the steering member is actuated to maintain the bend in the steerable end region. Fig.18F In an embodiment, the interior member may be actively steered by controlling an actuated steering member, which may be responsive to a command input.

[0196] Any of the methods and devices described herein can be configured such that when an automatic copy trigger event is detected (e.g., when an automatic copy trigger threshold is detected), one of the rigidized devices automatically (or semi-automatically, e.g., after confirmation with a user, or after a user triggers an automatic mode, etc.) copies the shape of the other rigidized device. For example, the automatic copy trigger event can occur when the distance between the distal ends of the two rigidized devices exceeds a threshold, when the user stops the movement of one (e.g., inner) rigidized device, when the driving performance of the first (e.g., outer) rigidized device and / or the second (e.g., inner) rigidized device deteriorates below a threshold, e.g., based on feedback from a camera and / or shape sensor after a move command or some other heuristic step.

[0197] For example, in some examples, the apparatus and methods may be configured such that when the distance between the distal ends of the two rigidifiers exceeds a threshold, one of the rigidifiers automatically copies the shape of the other rigidifier. Thus, the automatic replication trigger threshold may be the relative axial travel distance between the first rigidifier and the second rigidifier. For example, as shown in FIG19A , automatic shape replication may be triggered when the distance between the distal end of the internal rigidifier and the distal end of the external rigidifier is at a maximum extension distance (in the “Z” direction). In this example, the method or apparatus may automatically cause the external rigidifier 1900 to replicate the shape of the internal rigidifier 1910. For example, the system may automatically perform the shape replication step without any input from the user. Fig.19B In one embodiment, the inner rigidizing device 1910 can remain in a rigid state while the outer rigidizing device is in a flexible state and advanced distally over the inner rigidizing device.

[0198] FIG. 19A to FIG. 19B A method of controlling a nested pair of rigidified devices is shown by: advancing a second rigidified device of the nested pair of rigidified devices distally relative to a first rigidified device of the nested pair of rigidified devices while the second rigidified device is in a flexible state and the first rigidified device is in a rigidified state; and automatically performing a shape replication sequence when the second rigidified device is extended to a predetermined travel distance relative to the first rigidified device, wherein the shape replication sequence includes: advancing the first rigidized device relative to the second rigidized device while the first rigidized device is in a flexible state and the second rigidized device is in a rigid state.

[0199] Any of the automatic replication triggering events that cause one of the rigidizing devices to automatically or semi-automatically replicate the shape of the other rigidizing device can be controlled by a controller that can receive input (e.g., sensor input) and can apply control logic to drive the automatic or semi-automatic movement of the rigidizing devices.

[0200] For example, the automatic replication trigger event can be the cessation of movement of one or both of the first rigidizing device and the second rigidizing device. Thus, the automatic replication trigger threshold can be a time delay after the second rigidizing member moves relative to the first rigidizing member (e.g., the replication trigger event time delay). In one example, the device can be configured to detect the cessation of movement of the steerable internal rigidizing device; the movement of the internal rigidizing device can be detected by user input advancing and / or retracting the internal rigidizing device and / or by the user steering (bending) the internal rigidizing device. When the controller does not detect the user input (e.g., advancing / retracting and / or steering) after the time delay, the automatic replication trigger event can be triggered. In some examples, the device can be configured (or controlled by user input to enter an automatic or semi-automatic state) such that after the steerable inner rigidized device is advanced (either fully advanced or advanced by some minimum amount) such that the other rigidized device is located proximal to the steerable inner rigidized device, once the controller no longer detects control inputs (e.g., steering and advancement) that drive movement of the inner rigidized device (and optionally, the controller also does not detect movement of the outer rigidized device), then after a time delay period (e.g., an automatic replication trigger event time delay), the controller can cause the shape of the outer rigidized device to replicate the shape of the inner rigidized device, as described herein. The automatic replication trigger event time delay can be a fixed time delay, such as 2 seconds or more, 3 seconds or more, 4 seconds or more, 5 seconds or more, 6 seconds or more, 7 seconds or more, 8 seconds or more, 9 seconds or more, 10 seconds or more, etc. Alternatively, the automatic replication trigger event time delay can be determined based on user input (preferences) and / or based on previous movement commands (including steering and / or advancement / retraction). Shape replication can include rigidifying the internal rigidizing device (transitioning to a rigid state while controlling a turning steering member as described herein), derigidizing the external rigidizing device (e.g., transitioning to a flexible state), and advancing the external rigidizing device so that the external rigidizing device extends completely or partially to a distal region of the internal rigidizing device.

[0201] The controller may receive inputs from one or more sensors (e.g., sensor data) and / or inputs from one or more controllers (e.g., control of propulsion / retraction and / or steering). The control inputs and sensor data may be processed by the controller using control logic as described herein and used to identify one or more auto-replication triggering events. Another auto-replication triggering event may be coupled with an analysis of the drive movement by the controller, such as detection of movement performance; as described above, one auto-replication triggering event may be detection of degradation of the drive movement of the internal rigidizer and / or the external rigidizer. For example, when the internal rigidizer and / or the external rigidizer is slower than a threshold rate value in executing a movement command (propulsion / retraction, roll, and / or steering), degradation of movement may be determined (and an auto-replication triggering event may be triggered). Alternatively or additionally, in some examples, when driven movement of the internal rigidizer and / or the external rigidizer does not perform a full or complete movement (e.g., an “expected” movement), based on position or shape detection (e.g., shape sensing), in some examples based on camera feedback versus a commanded pose, degradation of the movement can be determined (and an automatic replication trigger event can be triggered).

[0202] In any of these methods and apparatus, the method may include moving an inner rigidized device of a nested pair of rigidized devices to pan around itself, such as to image the wall of the cavity at 360 degrees or nearly 360 degrees. For example, FIG. 20A to FIG. 20C Different types of rolls are shown that can be coordinated by the methods and systems described herein. Fig. 20A A rotation (e.g., roll) 2040 of the distal tip of the inner rigidizing device 2010 relative to the distal end of the outer rigidizing device 2000 is shown. This first type of roll of the inner rigidizing device 2040 causes the distal tip to bend and the region extending from the outer rigidizing device to swing in a loop 2030. This can be used to move the camera around a structure (e.g., a cavity). The inner rigidizing device 2010 can be in a rigid state or a flexible state. Fig. 20B The use of an actuated steering member to maintain the angle and orientation of the internal rigidizer 2010 as the internal rigidizer rolls 2040 is shown. As a result, the distal face of the internal rigidizer rotates (rolls) 2035 as shown. In this example, the internal rigidizer can be in a flexible state. This can be particularly useful when orienting the field of view of an imaging device that forms a distal region of the internal rigidizer. A similar effect can be achieved by rigidifying the external rigidizer 2000 so that it can support the roll of the internal rigidizer, which can be in a flexible state so that rolling the internal rigidizer 2010 results in rolling only the end face of the device.

[0203] Thus, for example, if the user wants to rotate their view, a commanded rotation of the inner member 2010 can cause the user's viewpoint to rotate about the centerline of the nearest side of the outer member due to the rigid support provided by the outer member. Fig. 20B ), which can cause the user's viewpoint to travel along path d 2030. To rotate around the centerline of the inner member instead, the system can command the turn steering member (e.g., cable) to coordinate with the roll movement and keep the user facing the same direction, or preferably, the outer member will replicate to become flush with the inner member and support the rotation, so the user's viewpoint is now looking in one direction, while only the view is rotated, such as Fig. 20C shown.

[0204] Thus, the method or apparatus may be configured to enable rolling of the internal rigidized device when examining a lesion or other condition by performing full shape replication so that the external rigidized device holds the internal rigidized device in place as it rolls, thereby eliminating the need to use an actuated steering member to coordinate the roll when the device is bent at an angle. This may allow the distal aspect of the internal device to roll about its centerline, rather than rotating the entire bending section, such as Fig. 20C shown.

[0205] In general, any of these devices and methods can be configured to automatically or semi-automatically operate and / or determine when the external rigidizer should perform a shape replication of the internal rigidizer (or when the internal rigidizer should perform a shape replication of the external rigidizer) and to what extent the shape replication should be performed. For example, as described above with reference to FIG. 19, the device can be configured to automatically perform replication if the user reaches the end of the allowed insertion length of the internal rigidizer.

[0206] For example, in some cases, if the system detects contradictory movement of the device, it may be beneficial to choose to automatically perform shape replication to support internal device movement in the new direction. FIG. 21A to FIG. 21B (showing a normal scene), FIG. 22A to FIG. 22B (showing contradictory moves) and FIG. 23A to FIG. 23B (showing detection and correction of contradictory movements).

[0207] exist FIG. 21A to FIG. 21B In the example, the internal rigidizer faces the +z direction, and there are no turns in the internal rigidizer. The user wants to reach point c, so enters a command to move the system forward. This causes both point b and point a (e.g., the far side of the internal rigidizer, which may correspond to the camera position) to move in the +z direction, and the user's viewpoint at point a sees movement in the correct direction toward their goal.

[0208] However, in some cases, such as FIG. 22A to FIG. 22B As shown, the internal rigidizer may be facing in the -z direction, and there is a turn of approximately 180 degrees on the internal rigidizer. The user wants to reach point c, so enters a command to move the system forward. Due to the bend in the internal rigidizer, this causes both point b and point a to move in the +z direction, but now (paradoxically) the user's viewpoint at point a sees movement away from their target point c, despite entering the same command and seeing that the distance from point a to point c appears to be the same. FIG. 21A to FIG. 21B To the user, the system appears to be moving in the opposite direction of what they commanded.

[0209] Any of the devices described herein may be configured to perform FIG. 22A to FIG. 22B The method described in is used to correct and / or prevent contradictory movements. FIG. 23A to FIG. 23C , the internal rigidizer faces in the -z direction, and there is a nearly 180 degree turn on the internal member. The user wants to reach point c, so enters a command to move the system forward. The system can be configured to discern (e.g., by analyzing the change in distance from point c from the image or based on discerning the angle of the turn and the direction of movement that will occur due to the angle of the turn, and / or recognizing the curvature of the rigidizer and knowing where element 2300 is located) that the user will not move in the desired direction, and therefore can automatically perform shape replication to advance the external rigidizer before advancing the internal rigidizer, thereby including all of the bends of the internal rigidizer; alternatively, the device can suggest that the user perform the shape replication. Fig. 23B As shown, shape replication may include advancing the outer rigidizing device 2300 into the current position of the distal region of the inner rigidizing device 2310. After performing the shape replication, if the user now inputs a command to move the system forward (e.g. Fig.23C ), the inner rigidisation device will slide from the outer rigidisation device along the rigid support and point a will move in the -z direction towards the target point c, and the user's point of view will now move towards their target arrival point c.

[0210] In general, it should be recognized that although many of the examples described herein are described in the context of using these methods and devices within the human body (or other mammal), any of these methods and devices can be used in non-biological areas, such as but not limited to use in catheters, pipes, geotechnical areas, or other areas.

[0211] Single full-length rigid device equipment

[0212] Although most of the devices and methods described herein are described in the context of a nested pair of rigidized devices, where both the inner rigidized device and the outer rigidized device have a relatively long length (longitudinal length) that is rigidified, many of these methods and devices can be performed using a single rigidized device having a relatively long rigidizable length and a non-rigidized or partially rigidized steerable device. The second non-rigidized or partially rigidized steerable device can be rigidized (or at least configured to control or lock a steerable distal region in a selected curve or shape) over a length of the device that is shorter than the length of the rigidized device having the relatively long rigidizable length. In some examples, the locked or rigidified length of the second device can be only the length of the steerable distal region.

[0213] In particular, methods and apparatus are also described herein that include a first rigidized device as described herein, which can be rigidized along a majority of its length (e.g., more than half of its length, more than 60% of its length, more than 70% of its length, more than 80% of its length, more than 85% of its length, more than 90% of its length, etc.), and a second steerable device in which a distal region is steerable by one or more actuated steering members. This distal region of the second device can be rigid or pseudo-rigid (e.g., locked), but the distal region can be much shorter than the rigidized length of the first rigidized device. For example, the second rigidized device can be pseudo-rigidized by controlling the actuated steering members so that the shape of the steerable distal region remains ("locked") in a determined or selected shape, while a region located proximal to the steerable distal region remains flexible. The first rigidizing device can be rigidified along a majority of the insertion length or at least a region that is longer (e.g., 1.5 times longer or longer, 2 times longer or longer, 3 times longer or longer, 4 times longer or longer, 5 times longer or longer, 10 times longer or longer, etc.) than the steerable end region of the second device. In some examples, the first rigidizing device is an external rigidizing device configured as described above. The second (steerable device) can be nested within the external rigidizing device and can include a steerable distal region that can be rigidified (or equivalently pseudo-rigidified by manipulating the actuating steerable member).

[0214] Thus, in some examples, the distal end region of the inner member may not have a rigidized structure, but may be configured to maintain position using an actuated steering member (e.g., a steering cable). Thus, the methods and apparatus described herein may be performed by a nested pair of devices comprising a first full-length rigidized device and a second elongated device nested with the first full-length rigidized device, wherein the second elongated device comprises a steerable distal region that can be locked in a selected shape. The selected shape may be a user-defined (steered) shape that can be replicated by the first full-length rigidized device, and / or the shape can be set by replicating the curvature of a region of the first full-length rigidized device. The selected shape may be maintained ("rigidized" or "pseudo-rigidized") by controlling the actuated steering member. In some examples, the selected shape ("rigidized") may be maintained by locking the rigidizing layer as described above. In some examples, the steerable distal region of the second elongated device may be controlled by actuating one or more actuated steering members; alternatively or additionally, the second elongated device may be rigidizable only on the distal region including all or some of the steerable distal region. In the example where a second elongate device is being rigidized, the region being rigidized may be rigidizable over a much shorter length than the rigidized region of another (eg, first) rigidized device.

[0215] For example, a method of controlling a nested pair of devices (including at least one rigidizing device configured to be rigidized along a majority of its length and a second rigidizing device configured to be rigidized along a distal steerable region of its length) may include: retracting a first rigidizing device in the nested pair of devices relative to a second device in the nested pair of devices while the first rigidizing device is in a flexible state and a distal region of the second rigidizing device is in a rigidified (e.g., locked) state; rigidifying the first rigidizing device; and actuating a steering member within the second device to maintain a constant orientation of a distal face of the second device relative to an external region before and / or while transitioning the second device from a rigid state to a flexible state.

[0216] A method of controlling a nested pair of devices, including at least one rigidized device configured to be rigidized along a majority of its length and a second rigidized device configured to be rigidized along a distal steerable region of its length, may include: receiving a copy command from a user input; automatically executing a shape copy sequence, wherein the shape copy sequence includes: advancing a first rigidized device in the nested pair of devices relative to a second device in the nested pair of rigidized devices while the first device is in a flexible state and the second device is in a rigidized state in which the steerable distal region is rigid, wherein the first rigidized device is initially located proximal to the second device such that the first rigidized device copies the shape of the second device; and optionally preventing the first rigidized device from being advanced distal to the second device. Advancing the first rigidized device may include advancing the first rigidized device only when the copy command is continuously received.

[0217] A method of controlling a nested pair of devices (including at least one rigidized device configured to be rigidified along a majority of its length and a second rigidized device configured to be rigidified along a distal steerable region of its length), the method comprising automatically executing a shape replication sequence when an automatic replication trigger event is detected by a control circuit, the method may include: receiving one or more of sensor data and / or user movement inputs in a controller; comparing one or more of the sensor data and / or user movement inputs to an automatic replication trigger threshold; and triggering the shape replication sequence when the automatic replication trigger threshold is detected, wherein the shape replication sequence includes: advancing a first rigidized device relative to a second device while the first rigidized device is in a flexible state and the second device is in a rigidified state.

[0218] For example, a method of controlling a nested pair of rigidified devices (including at least one rigidified device configured to be rigidified along a majority of its length and a second rigidified device configured to be rigidified along a distal steerable region of its length) may include: advancing a second rigidified device in the nested pair of rigidified devices distally relative to a first rigidified device in the nested pair of rigidified devices while the second rigidified device is in a flexible state and the first rigidified device is in a rigidified state; and automatically executing a shape replication sequence when the second rigidified member is extended to a predetermined travel distance relative to the first rigidified member, wherein the shape replication sequence includes: advancing the first rigidized device relative to the second rigidified device while the first rigidized device is in a flexible state and the second rigidized device is in a rigid state.

[0219] A method for controlling a nested pair of rigidified devices (including at least one rigidified device configured to be rigidified along a majority of its length and a second rigidified device configured to be rigidified along a distal steerable region of its length) may include: advancing a first rigidified device in the nested pair of devices distally relative to a second device in the nested pair of devices, wherein the first rigidified device is in a flexible state and the second device is in a rigid state in which the distal region is rigid (e.g., locked); transitioning the first rigidified device from the flexible state to the rigid state; and when the second device transitions to the flexible state, transitioning the second device from the rigid state to the flexible state (unlocking the steerable distal region so that it can bend freely) by slowly releasing a steering member of the second device to release the curvature of the distal end of the second rigidified device.

[0220] A method for advancing or retracting a system along a body cavity, the system comprising a nested pair of devices (including at least one rigidized device configured to be rigidized along a majority of its length and a second rigidized device configured to be rigidized along a distal steerable region of its length), the method may include: advancing or retracting a first device in a flexible state (wherein a steerable distal end of the first device is allowed to move freely) relative to a second rigidized device in a rigid state, and steering the first device using a steering member of the first device; rigidifying (e.g., locking) the first device so that the steerable distal region is locked in a selected configuration; advancing or retracting the second rigidized device in a flexible state at least partially over the rigidified first device; rigidifying the second rigidized device; actuating the steering member to correspond to the curvature of the rigidified second rigidized device; and transitioning the first device to a flexible state (e.g., by releasing tension on the steering member).

[0221] Similarly, a method for photographing a body cavity of a patient may include: navigating a system through the body cavity, the system including a nested pair of devices, the nested pair of devices including a first device positioned to be nested within a second rigidified device, the first device including a camera at a distal end, wherein the distal region is manipulable; exposing a distal portion of the first device; turning the distal portion of the first device to perform a circular scanning movement (e.g., circumduction) to visualize the circumference of the first portion of the body cavity through the camera; retracting the system to a selected length so that the distal portion of the first device is exposed; and turning the distal portion of the first device to perform a circular scanning movement to visualize the circumference of a second portion of the body cavity through the camera, wherein at least a portion of the second portion is positioned proximal to the first portion.

[0222] Systems incorporating any of these methods are also described.

[0223] When a feature or element is described as "on another feature or element" in this article, it can be directly on another feature or element, or there may also be intermediate features and / or elements. On the contrary, when a feature or element is described as "directly on another feature or element", there are no intermediate features or elements. It should be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is described as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to an example, the features and elements described or shown in this way can be applied to other examples. It should be understood by those skilled in the art that the structure or feature mentioned as "adjacent" another feature setting may have a portion overlapping or below an adjacent feature.

[0224] The terms used herein are only used for the purpose of describing specific examples and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should also be understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more associated listed items and may be abbreviated as " / ".

[0225] Spatially related terms, such as "under", "below", "lower", "over", "upper", etc., may be used herein for ease of description to describe the relationship of one element or feature to another one or more elements or features as shown in the accompanying drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is reversed, the elements described as "below other elements or features" or "below other elements or features" will be oriented to "above other elements or features". Therefore, the exemplary term "below" can cover both the above and below orientations. The device can be oriented otherwise (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes only.

[0226] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0227] Throughout this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0228] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all numbers may be read as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing an amplitude and / or position to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise indicates. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between these values ​​are also disclosed as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0229] Although various illustrative examples are described above, any of several changes may be made to the various examples without departing from the scope of the invention as described in the claims. For example, in alternative examples, the order in which the various described method steps are performed may generally be changed, and in other alternative examples, one or more method steps may be skipped altogether. Optional features of the various device and system examples may be included in some examples and not included in other examples. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0230] The examples and descriptions included herein show specific examples in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other examples can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such examples of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and if in fact more than one is disclosed, it is not intended that the scope of the present application is actively limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments that are not specifically described herein.

Claims

1. A method of controlling a nested pair of rigidifying devices, the method comprising: retracting a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state; rigidifying the first rigidifying device; as well as A steering member within the second rigidifying device is actuated to maintain a constant orientation of a distal face of the second rigidifying device relative to an exterior region, followed by and / or simultaneously transitioning the second rigidifying device from a rigid state to a flexible state.

2. The method according to claim 1, further comprising: After actuation of the steering member, the second rigidifying means is retracted relative to the first rigidifying means when the second rigidifying means is in the flexible state.

3. The method according to claim 1, further comprising: When the first rigidizing device is in a flexible state, the second rigidizing device is rigidified and the first rigidizing device is retracted on the second rigidizing device.

4. The method according to claim 1, wherein: Retracting the second rigidifying device comprises at least partially retracting the second rigidifying device into the first rigidifying device.

5. The method of claim 1 , wherein actuating the steering member within the second rigidizing device to maintain the orientation of the distal face of the second rigidizing device comprises maintaining a net turning angle between the distal end of the second rigidizing device relative to a proximal portion of the second rigidizing device.

6. The method of claim 1 , wherein actuating the steering member within the second rigidifying device to maintain a constant orientation of the distal face of the second rigidifying device relative to the exterior region comprises maintaining an orientation of the distal face of the second rigidifying device relative to a cavity wall.

7. The method of claim 1 , wherein actuating the steering member within the second rigidifier to maintain the orientation of the distal face of the second rigidifier constant relative to the external region comprises maintaining the orientation of the distal face of the second rigidifier such that the angular orientation of the distal face of the second rigidifier varies by less than + / - 15 degrees.

8. The method of claim 1, wherein actuating the steering members comprises applying a tensile force to at least one of the steering members.

9. The method of claim 1, wherein actuating the steering members comprises displacing at least one of the steering members.

10. The method of claim 1, wherein actuating the steering member comprises automatically actuating the steering member.

11. The method of claim 1, wherein retracting the first rigidizing device comprises retracting the first rigidizing device proximally relative to the second rigidizing device.

12. The method according to claim 1, wherein: The first rigidifying device is nested within the second rigidifying device.

13. The method according to claim 1, wherein: The second rigidifying device is nested within the first rigidifying device.

14. The method of claim 1, further comprising imaging the exterior region with a sensor at the distal face of the second rigidification device.

15. A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: retracting the first rigidizing device relative to the second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state; rigidifying the first rigidifying device; and A steering member within the second rigidifying device is actuated to maintain a constant orientation of a distal face of the second rigidifying device relative to an external region, followed by and / or simultaneously transitioning the second rigidifying device from a rigid state to a flexible state.

16. The system of claim 15, wherein: The computer-implemented method further includes, after actuating the steering member, retracting the second rigidizing device relative to the first rigidizing device when the second rigidizing device is in the flexible state.

17. The system of claim 15, wherein the computer-implemented method further comprises: When the first rigidizing device is in a flexible state, the second rigidizing device is rigidified and the first rigidizing device is retracted on the second rigidizing device.

18. The system of claim 15, wherein: Retracting the second rigidifying device comprises at least partially retracting the second rigidifying device into the first rigidifying device.

19. The system of claim 15, wherein actuating the steering member within the second rigidizer to maintain the orientation of the distal face of the second rigidizer comprises maintaining a net turning angle between the distal end of the second rigidizer relative to a proximal portion of the second rigidizer.

20. The system of claim 15, wherein actuating the steering member within the second rigidizing device to maintain a constant orientation of the distal face of the second rigidizing device relative to the exterior region comprises maintaining an orientation of the distal face of the second rigidizing device relative to a lumen wall.

21. The system of claim 15, wherein actuating the steering member within the second rigidifier to maintain the orientation of the distal face of the second rigidifier constant relative to the external region comprises maintaining the orientation of the distal face of the second rigidifier such that an angular orientation of the distal face of the second rigidifier varies by less than + / - 15 degrees.

22. The system of claim 15, wherein actuating the steering members comprises applying a tensile force to at least one of the steering members.

23. The system of claim 15, wherein actuating the steering members comprises displacing at least one of the steering members.

24. The system of claim 15, wherein actuating the steering member comprises automatically actuating the steering member.

25. The system of claim 15, wherein retracting the first rigidizing device comprises retracting the first rigidizing device proximally relative to the second rigidizing device.

26. The system of claim 15, wherein: The first rigidifying device is nested within the second rigidifying device.

27. The system of claim 14, wherein: The second rigidifying device is nested within the first rigidifying device.

28. The system of claim 15, wherein: The computer-implemented method also includes imaging the exterior region with a sensor at the distal face of the second rigidification device.

29. A method of controlling a nested pair of rigidifying devices, the method comprising: receiving a copy command from a user input; Automatically performing a shape replication sequence, wherein the shape replication sequence comprises: - advancing a first rigidizing device of the nested pair of rigidizing devices relative to a second rigidizing device of the nested pair of rigidizing devices while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigid state, wherein the first rigidizing device is initially located proximal to the second rigidizing device such that the first rigidizing device replicates the shape of the second rigidizing device; and - preventing said first rigidifying means from being advanced distally of said second rigidifying means.

30. The method of claim 29, wherein: Advancing the first rigidizing device includes advancing the first rigidizing device only when the replication command is continuously received.

31. The method of claim 29, wherein: Also includes: The first rigidizing device continues to be advanced until the distal end of the first rigidizing device reaches the distal end of the second rigidizing device.

32. The method of claim 29, wherein: The first rigidizing device is nested on the second rigidizing device.

33. The method of claim 29, wherein: The shape replication sequence further includes rigidifying the second rigidifying device into a rigid state before advancing the first rigidifying device.

34. The method of claim 29, wherein: The shape replication sequence further includes derigidizing the first rigidizing device to a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device.

35. The method of claim 29, wherein: The shape replication sequence further includes rigidifying the first rigidifying device into a rigid state after the first rigidifying device has been advanced relative to the second rigidifying device.

36. The method of claim 29, further comprising: Prior to receiving the replication command, the second rigidizing device in a flexible state is advanced while a distal region of the second rigidizing device is deflected, wherein the first rigidizing device is in a rigid state.

37. A method of controlling a nested pair of rigidifying devices, the method comprising: receiving a copy command from a user input; and automatically executing a shape replication sequence upon receiving the user input, wherein the shape replication sequence comprises: Advancing a first rigidized device of the nested pair of rigidized devices relative to a second rigidized device of the nested pair of rigidized devices while the first rigidized device is in a flexible state and the second rigidized device is in a rigidified state, wherein the first rigidized device is initially located proximal to the second rigidized device such that the first rigidized device replicates a shape of the second rigidized device.

38. A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: receiving a copy command from a user input; Automatically performing a shape replication sequence, wherein the shape replication sequence comprises: advancing a first rigidizing device relative to a second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidified state, wherein the first rigidizing device is initially located proximal to the second rigidizing device such that the first rigidizing device replicates a shape of the second rigidizing device; and The first rigidifying device is prevented from being advanced distally of the second rigidifying device.

39. The system of claim 38, wherein: Advancing the first rigidizing device includes advancing the first rigidizing device only when the replication command is continuously received.

40. The system of claim 38, wherein: The computer-implemented method also includes continuing to advance the first rigidifying device until a distal end of the first rigidifying device reaches a distal end of the second rigidifying device.

41. The system of claim 38, wherein: The first rigidizing device is nested on the second rigidizing device.

42. The system of claim 38, wherein: The shape replication sequence further includes rigidifying the second rigidifying device to a rigid state prior to advancing the first rigidifying device.

43. The system of claim 38, wherein: The shape replication sequence further includes derigidizing the first rigidizing device to a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device.

44. The system of claim 38, wherein: The shape replication sequence further includes rigidifying the first rigidifying device to a rigid state after the first rigidifying device has been advanced relative to the second rigidifying device.

45. The system of claim 38, wherein: The computer-implemented method further includes, prior to receiving the replication command, advancing the second rigidizing device in a flexible state while steering a distal region of the second rigidizing device, wherein the first rigidizing device is in a rigid state.

46. ​​A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: receiving a copy command from a user input; automatically executing a shape copy sequence upon receiving the copy command, wherein the shape copy sequence comprises: A first rigidizing device is advanced relative to a second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state, wherein the first rigidizing device is initially located proximal to the second rigidizing device such that the first rigidizing device replicates a shape of the second rigidizing device.

47. A method of controlling a nested pair of rigidifying devices, the nested pair of rigidifying devices comprising a first rigidifying device and a second rigidifying device, the method comprising automatically executing a shape replication sequence when an automatic replication trigger event is detected by a control circuit, the method comprising: receiving, in the controller, one or more of sensor data and / or user movement input; comparing one or more of the sensor data and / or the user movement input to an auto-copy trigger threshold; and When the automatic replication trigger threshold is detected, the shape replication sequence is triggered, wherein the shape replication sequence includes advancing the first rigidizing device relative to the second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state.

48. The method of claim 47, wherein: The auto-replication trigger threshold is a relative axial travel distance between the first rigidifying member and the second rigidifying member.

49. The method of claim 47, wherein: The auto-copy triggering threshold comprises exceeding a time delay after the second rigidifying member is moved relative to the first rigidifying member.

50. The method of claim 47, wherein: Automatically performing the shape replication sequence includes advancing the first rigidifying device relative to the second rigidifying device until a distal region of the first rigidifying device is adjacent to a distal region of the second rigidifying device.

51. The method of claim 47, wherein: The first rigidizing device is nested on the second rigidizing device.

52. The method of claim 47, wherein: The shape replication sequence further includes rigidifying the second rigidifying device into a rigid state before advancing the first rigidifying device.

53. The method of claim 47, wherein: The shape replication sequence further includes derigidizing the first rigidizing device to a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device.

54. The method of claim 47, wherein: The shape replication sequence further includes rigidifying the first rigidifying device into a rigid state after the first rigidifying device has been advanced relative to the second rigidifying device.

55. A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: receiving, in the controller, one or more of sensor data and / or user movement input; comparing one or more of the sensor data and / or the user movement input to an auto-copy trigger threshold; and When the automatic replication trigger threshold is detected, the shape replication sequence is triggered, wherein the shape replication sequence includes advancing the first rigidizing device relative to the second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidized state.

56. A method of controlling a nested pair of rigidifying devices, the method comprising: advancing a second rigidized device of the nested pair of rigidized devices distally relative to a first rigidized device of the nested pair of rigidized devices while the second rigidized device is in a flexible state and the first rigidized device is in a rigidified state; and When the second rigidizing member is extended to a predetermined travel distance relative to the first rigidizing member, a shape replication sequence is automatically performed, wherein the shape replication sequence includes: advancing the first rigidizing device relative to the second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidified state.

57. The method of claim 56, wherein: The predetermined travel distance is a maximum distance.

58. The method of claim 56, wherein: Propelling the second rigidifying device includes propulsion and steering.

59. The method of claim 56, wherein: Automatically performing the shape replication sequence includes advancing the first rigidifying device relative to the second rigidifying device until a distal region of the first rigidifying device is adjacent to a distal region of the second rigidifying device.

60. The method of claim 56, wherein: The first rigidizing device is nested on the second rigidizing device.

61. The method of claim 56, wherein: The shape replication sequence further includes rigidifying the second rigidifying device into a rigid state before advancing the first rigidifying device.

62. The method of claim 56, wherein: The shape replication sequence further includes derigidizing the first rigidizing device to a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device.

63. The method of claim 56, wherein: The shape replication sequence further includes rigidifying the first rigidifying device into a rigid state after the first rigidifying device has been advanced relative to the second rigidifying device.

64. A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: advancing the second rigidizing device distally relative to the first rigidizing device while the second rigidizing device is in a flexible state and the first rigidizing device is in a rigidified state; and When the second rigidizing member is extended to a predetermined travel distance relative to the first rigidizing member, a shape replication sequence is automatically performed, wherein the shape replication sequence includes: advancing the first rigidizing device relative to the second rigidizing device while the first rigidizing device is in a flexible state and the second rigidizing device is in a rigidified state.

65. The system of claim 64, wherein: The predetermined travel distance is a maximum distance.

66. The system of claim 64, wherein: Propelling the second rigidifying device includes propulsion and steering.

67. The system of claim 64, wherein: Automatically performing the shape replication sequence includes advancing the first rigidifying device relative to the second rigidifying device until a distal region of the first rigidifying device is adjacent to a distal region of the second rigidifying device.

68. The system of claim 64, wherein: The first rigidizing device is nested on the second rigidizing device.

69. The system of claim 64, wherein: The shape replication sequence further includes rigidifying the second rigidifying device into a rigid state before advancing the first rigidifying device.

70. The system of claim 64, wherein: The shape replication sequence further includes derigidizing the first rigidizing device to a flexible state prior to advancing the first rigidizing device relative to the second rigidizing device.

71. The system of claim 64, wherein: The shape replication sequence further includes rigidifying the first rigidifying device into a rigid state after the first rigidifying device has been advanced relative to the second rigidifying device.

72. A method of controlling a nested pair of rigidifying devices, the method comprising: advancing a first rigidizing device of the nested pair of rigidizing devices distally relative to a second rigidizing device of the nested pair of rigidizing devices, wherein the first rigidizing device is in a flexible state and the second rigidizing device is in a rigid state; transforming the first rigidizing device from a flexible state to a rigid state; as well as The second rigidizing device is transitioned from the rigid state to the flexible state while actuating a steering member of the second rigidizing device to maintain a curvature of a distal end of the second rigidizing device when the second rigidizing device is transitioned to the flexible state.

73. The method of claim 72, further comprising: A flexible second rigidizing device is advanced distally, and the steering member is further actuated to steer the distal end of the second rigidizing device while the first rigidizing device remains in a rigid state.

74. The method of claim 72, wherein: Actuating the steering member within the second rigidifying device comprises pulling one or more tendons.

75. The method of claim 72, wherein: Actuating the steering members includes applying a tensile force to at least one of the steering members.

76. The method of claim 72, wherein: Actuating the steering member includes automatically actuating the steering member.

77. The method of claim 72, wherein: The first rigidifying device is nested within the second rigidifying device.

78. The method of claim 72, further comprising: The exterior region is imaged by a sensor at the distal face of the second rigidifying device.

79. The method of claim 72, further comprising: The second rigidizing device in the flexible state is advanced and steered while being advanced, and then the steps of distally advancing the first rigidizing device, transitioning the first rigidizing device to the rigid state, and transitioning the second rigidizing device to the flexible state are repeated.

80. A system comprising: a nested pair of rigidifying devices, comprising a first rigidifying device and a second rigidifying device; one or more processors; and a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for controlling the nested pair of rigidification devices, the method comprising: advancing the first rigidizing device distally relative to the second rigidizing device, wherein the first rigidizing device is in a flexible state and the second rigidizing device is in a rigid state; transforming said first rigidifying means from a flexible state to a rigid state; and The second rigidizing device is transitioned from a rigid state to a flexible state while actuating a steering member of the second rigidizing device to maintain a curvature of a distal end of the second rigidizing device as the second rigidizing device transitions to the flexible state.

81. The system of claim 80, wherein: The computer-implemented method also includes advancing a flexible second rigidizing device distally, and further actuating the steering member to steer the distal end of the second rigidizing device while the first rigidizing device remains in a rigid state.

82. The system of claim 80, wherein: Actuating the steering member within the second rigidifying device comprises pulling one or more tendons.

83. The system of claim 80, wherein: Actuating the steering members includes applying a tensile force to at least one of the steering members.

84. The system of claim 80, wherein: Actuating the steering member includes automatically actuating the steering member.

85. The system of claim 80, wherein: The first rigidifying device is nested within the second rigidifying device.

86. The system of claim 80, further comprising: The second rigidizing device in the flexible state is advanced and steered while being advanced, and then the steps of distally advancing the first rigidizing device, transitioning the first rigidizing device to the rigid state, and transitioning the second rigidizing device to the flexible state are repeated.

87. A method of advancing or retracting a system including a nested pair of rigidifying devices along a body cavity, comprising: advancing or retracting a first rigidizing device in a flexible state relative to a second rigidizing device in a rigid state and steering the first rigidizing device using a steering member coupled to the first rigidizing device; rigidifying the first rigidifying device; advancing or retracting the second rigidizing device in a flexible state at least partially over the rigidized first rigidizing device; rigidifying the second rigidifying device; actuating the steering member to correspond to the curvature of the rigidified second rigidizing device; and The first rigidified device is transformed into a flexible state.

88. The method of claim 87, wherein: Actuating the steering member in the first rigidifying device includes maintaining a previously commanded curvature of the first rigidifying device throughout advancement or retraction and rigidification of the second rigidifying device.

89. The method of claim 87, wherein: Prior to transitioning the first rigidizing device to a flexible state, actuating the steering member in the first rigidizing device includes adjusting the steering member to correspond to a new curvature of the rigidized second rigidizing device that is different from the curvature prior to rigidizing the first rigidizing device.

90. The method of claim 87, wherein: Actuating the steering member is performed prior to transitioning the first rigidifying device to a flexible state.

91. The method of claim 87, wherein: Actuating the steering member is performed simultaneously with transitioning the first rigidifying device to a flexible state.

92. The method of claim 87, wherein: The system is configured to automatically maintain an existing curvature command control for the steering member during advancement or retraction and rigidification of the second rigidifying device.

93. The method of claim 87, wherein: Advancing or retracting the second rigidizing device includes advancing the second rigidizing device until a distal end of the second rigidizing device is substantially aligned with a distal end of the first rigidizing device.

94. The method of claim 93, wherein: The system is configured to automatically maintain an existing curvature command control for the steering member during advancement or retraction and rigidification of the second rigidifying device.

95. The method of claim 87, wherein: The system is configured to automatically actuate the steering member when the first rigidifying device transitions to a flexible state.

96. The method of claim 87, wherein: Actuating the steering members includes applying a tensile force to at least one of the steering members.

97. The method of claim 87, wherein: Actuating the steering members includes displacing at least one of the steering members.

98. The method of claim 87, wherein: The system is configured to automatically actuate the steering member to impart a curvature to the first rigidifying device that is less than the previously commanded curvature applied by the steering member by a predetermined percentage.

99. The method of claim 87, wherein: Advancing or retracting the first rigidizing device and the second rigidizing device includes distally advancing.

100. The method of claim 87, wherein: Advancing or retracting the first and second rigidifying devices includes proximal retraction.

101. The method according to claim 100, wherein: Actuating the steering member includes actuating the steering member to correspond to a shape of a portion of the first rigidizing device to be exposed when the second rigidizing device is proximally retracted over the first rigidizing device.

102. The method according to claim 101, wherein: Actuating the steering member includes maintaining an approximately constant angle between a distal face of the first rigidifying device and a cross-section of the first rigidifying device at a proximal end of the portion of the first rigidifying device.

103. The method of claim 102, wherein: Actuating the steering member includes maintaining an orientation of a distal end of the first rigidifying device relative to a proximal end of the portion of the first rigidifying device.

104. A method of advancing a system comprising a nested pair of rigidifying devices along a body cavity, comprising: advancing a first rigidizing device in a flexible state through the body cavity and steering a distal region of the first rigidizing device using a steering member coupled to the first rigidizing device; rigidifying the first rigidifying device; advancing the second rigidizing device in a flexible state at least partially over the rigidized first rigidizing device; rigidifying the second rigidifying device; before converting the first rigidizing device to a flexible state, actuating the steering member to correspond to a new curvature of the rigidized second rigidizing device, the new curvature being different from the curvature prior to rigidifying the first rigidizing device; and The first rigidified device is transformed into a flexible state.

105. A method of retracting a system comprising a nested pair of rigidification devices along a body cavity, comprising: retracting the first rigidizing device in the flexible state through the body cavity relative to the second rigidizing device in the rigidized state; rigidifying the first rigidifying device; prior to transitioning the second rigidizable device to a flexible state, actuating a steering member within the second rigidizable device to maintain a clear turning angle between a distal end of the second rigidizable device relative to a proximal portion of the second rigidizable device; causing the second rigidizing device in the flexible state to at least partially retract into the rigidized first rigidizing device; rigidifying the second rigidifying means; and The first rigidifying means is retracted on the second rigidifying means when the first rigidifying means is in the flexible state.

106. A method of retracting a system comprising a nested pair of rigidification devices along a body cavity, comprising: retracting a first rigidizing device in a flexible state through the body cavity relative to a second rigidizing device in a rigidized state and steering a distal region of the first rigidizing device using a steering member coupled to the first rigidizing device; rigidifying the first rigidifying device; retracting the second rigidizing means in a flexible state at least partially over the rigidized first rigidizing means; rigidifying the second rigidifying device; actuating the steering member to maintain a constant curvature; and The first rigidizing device is retracted into the second rigidizing device when the first rigidizing device is in the flexible state.

107. A system comprising: a first rigidizing device positioned within a second rigidizing device; a controller comprising one or more processors; as well as a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for advancing an internal rigidization device and an external rigidization device within a body cavity, the method comprising: advancing or retracting a first rigidizing device in a flexible state relative to a second rigidizing device in a rigid state and steering the first rigidizing device using a steering member coupled to the first rigidizing device; rigidifying the first rigidifying device; causing the second rigidizing device in a flexible state to at least partially advance or retract over the rigidized first rigidizing device; rigidifying the second rigidifying device; actuating the steering member to correspond to the curvature of the rigidified second rigidizing device; and The first rigidified device is transformed into a flexible state.

108. The system of claim 107, wherein: Actuating the steering member in the first rigidifying device includes maintaining a previously commanded curvature of the first rigidifying device throughout advancement and rigidification of the second rigidifying device.

109. The system of claim 107, wherein: Actuating the steering member in the first rigidifying device includes adjusting the steering member so that the shape of the first rigidifying device corresponds to the rigidified shape of the second rigidifying device.

110. The system of claim 107, wherein: Actuating the steering member is performed prior to transitioning the first rigidifying device to a flexible state.

111. The system of claim 107, wherein: Actuating the steering member is performed simultaneously with transitioning the first rigidifying device to a flexible state.

112. The system of claim 107, wherein: The system is configured to automatically maintain an existing curvature command control for the steering member during advancement and rigidification of the second rigidification device.

113. The system of claim 107, wherein: Advancing the second rigidizing device includes advancing the second rigidizing device until a distal end of the second rigidizing device is substantially aligned with a distal end of the first rigidizing device.

114. The system of claim 107, wherein: The system is configured to automatically maintain an existing curvature command control for the steering member during advancement and rigidification of the second rigidification device.

115. The system of claim 107, wherein: The system is configured to automatically actuate the steering member when the first rigidifying device transitions to a flexible state.

116. The system of claim 107, wherein: Actuating the steering members includes applying a tensile force to at least one of the steering members.

117. The system of claim 107, wherein: Actuating the steering members includes displacing at least one of the steering members.

118. The system of claim 107, wherein: The system is configured to automatically actuate the steering member to impart a curvature to the first rigidifying device that is less than the previously commanded curvature applied by the steering member by a predetermined percentage.

119. The system of claim 107, wherein: Advancing the first and second rigidifying devices includes distal advancement.

120. The system of claim 107, wherein: Advancing the first and second rigidifying devices includes advancing proximally.

121. The system of claim 107, wherein: Actuating the steering member includes actuating the steering member to correspond to a shape of a portion of the first rigidizing device to be exposed when the second rigidizing device is proximally retracted over the first rigidizing device.

122. The system of claim 107, wherein: Actuating the steering member includes maintaining an approximately constant angle between a distal face of the first rigidifying device and a cross-section of the first rigidifying device at a proximal end of the portion of the first rigidifying device.

123. The system of claim 107, wherein: Actuating the steering member includes maintaining a position of a distal end of the first rigidifying device relative to a proximal end of the portion of the first rigidifying device.

124. A method for photographing a patient's body cavity, the method comprising: navigating a system including a first rigidized device positioned within a second rigidized device through the body cavity, the first rigidized device including a camera at a distal end; exposing a distal portion of the first rigidifying device; turning the distal portion of the first rigidization device to perform a circular scanning movement to visualize a circumference of a first portion of the body cavity with the camera; retracting the system to a selected length such that the distal portion of the first rigidification device is exposed; and The distal portion of the first rigidification device is turned to perform a circular scanning movement to visualize a circumference of a second portion of the body cavity by the camera, wherein at least a portion of the second portion is positioned proximal to the first portion.

125. The method of claim 124, wherein: The system is configured to automatically perform the method.

126. The method of claim 124, wherein: The system includes: a controller, and the controller includes one or more processors; and a memory connected to the one or more processors, the memory storing computer program instructions, which, when executed by the one or more processors, perform a computer-implemented method to advance an internal rigidification device and an external rigidification device within a body cavity, and wherein the method according to claim 124 is implemented by the system.

127. The method of claim 124, wherein: The selected length is calculated based on a desired distance from a portion of the lumen that has been visualized by the camera.

128. The method of claim 124, wherein: The first portion and the second portion overlap.

129. The method of claim 124, further comprising compiling data received by the camera to generate a model of at least a portion of the cavity.

130. The method of claim 124 further comprising machine sensing to provide positioning information relative to the center of the cavity.

131. A system comprising: a first rigidizing device positioned within a second rigidizing device; a controller comprising one or more processors; as well as a memory coupled to the one or more processors, the memory storing computer program instructions that, when executed by the one or more processors, perform a computer-implemented method for photographing a body cavity, the method comprising: exposing a distal portion of the first rigidifying device; turning the first rigidified distal portion to perform a circular scanning movement to visualize a circumference of a first portion of the body cavity by the camera; retracting the system to a selected length such that the distal portion of the first rigidification device is exposed; and The distal portion of the first rigidification device is turned to perform a circular scanning movement to visualize a circumference of a second portion of the body cavity by the camera, at least a portion of the second portion being positioned proximal to the first portion.

132. The system of claim 131, wherein: The selected length is calculated based on a desired distance from a portion of the lumen that has been visualized by the camera.

133. The system of claim 131, wherein: The first portion and the second portion overlap.

134. The system of claim 131 further comprising compiling data received by the camera to generate a model of at least a portion of the cavity.

135. The system of claim 131 further comprising machine sensing to provide positioning information on the center of the cavity.

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